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NCT05004103 | Cosmetic Products and Facial Skin Microbiome | The skin microbiome diversity in female healthy volunteers will be studied along with cosmetic products application in 1 month period. This study is also aimed to investigate the efficacy of cosmetic products on skin rejuvenation. . | The study is conducted in COVID-19 pandemic era, thus every person involved in this study must follow health protocol for COVID-19.
The study procedure, consist of screening visit (D -7), 7-day wash out, baseline visit (D 0), first follow up ( D 14), and second follow up (D 28).
1. Screening visit: obtained Informed Consent, COVID-19 detection by swab RT-PCR, and inclusion and exclusion criteria, wash out product dispensing, and subject's diary dispensing.
2. Baseline visit: Investigator will check vital signs, facial skin value by Cutometer, Mexameter, Sebumeter, Corneometer, Colorimeter, Tewameter, dan pH meter, and kin taping by Corneofix tape. Investigational Products will dispensed in this visit for 2 weeks usage.
3. First follow up: Investigator will check vital signs and facial skin value. Investigational Products will dispensed in this visit for 2 weeks usage.
4. Second follow up: Investigator will check vital signs, facial skin value, and skin taping by Corneofix tape.
All adverse events (AEs) occurred during study will be recorded in Case Report Form. | Inclusion Criteria:
1. female 18-35 years old
2. signed the informed consent
Exclusion Criteria:
1. infected by COVID-19
2. females with skin diseases on face and neck such as atopic dermatitis, skin allergy, acne with moderate and severe degree, seborrheic dermatitis, malignancy
3. females with ongoing skin treatments. |
NCT02491125 | The Effect of Prebiotics on Gastrointestinal Functioning and Metabolism | The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism. | A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life. | Inclusion Criteria:
* Overweight to obese men and women (BMI ≥ 25 kg/m2 \<35 kg/m2)
* Aged 20-50 years
* Caucasian
* Normal fasting glucose (\<6.1 mmol/L.)
* Normal blood pressure (systolic blood pressure 100-140 mmHg, diastolic blood pressure 60-90 mmHg)
* Weight stable in last 3 months (±2 kg)
* A low defecation frequency, \<4 times/week and no constipation or underlying pathology, as determined by gastro-intestinal questionnaires).
* A slow whole gut transit (\>35h)
Exclusion Criteria:
* Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
* Regular smokers
* People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
* Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
* Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years
* Following a hypocaloric diet
* Gluten intolerance
* Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study
* More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as
1. Straining in \>1/4 defecations;
2. Lumpy or hard stools in \>1/4 defecations;
3. Sensation of incomplete evacuation in \>1/4 defecations;
4. Sensation of anorectal obstruction/blockade in \>1/4 defecations
5. Manual maneuvers to facilitate \>1/4 defecations (e.g., digital evacuation, support of the pelvic floor); and/or
6. \<3 defecations/week
* Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
* Not to be able to understand the study information
* Blood donation 2 months prior to the study and during the study
* Participation in other studies |
NCT05314530 | The ReTA-model: Rehabilitation Trail for Workers on Long-term Sick Leave in the Healthcare Sector | The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care. | The ReTA-model is a rehabilitation model for return to work after long-term sickness absence (LTSA) due to stress or burnout. The ReTA-model will be validated in this trial among nurses and physicians currently in LTSA. The ReTA-model includes a three-week treatment with exercise, individual and collegial talks with psychology and lecturing. The control group will receive conventional rehabilitation from regular care. | Inclusion Criteria:
* currently on sick leave for burnout
* employed in the Swedish healthcare services as a nurse or as a physician
Exclusion Criteria:
- |
NCT01672385 | Improving Transition Outcomes Through Accessible Health IT and Caregiver Support | Background: Older hospitalized adults frequently experience preventable short-term readmissions due to inadequate transition support. Although proactive telephone follow-up improves transition outcomes, these services often are unsystematic and of low intensity. Informal caregivers are invaluable for ensuring successful transitions, but many patients live alone, have an in-home caregiver who is struggling with competing demands, or live at a distance from adult children or other potential sources of support. New models are needed for transition support that include low-cost technologies and more structured assistance for patients' informal caregiving network, while providing patients' clinical teams with the information they need to avert health crises.
Objectives: Consistent with NIA's goals to improve transition outcomes, we will evaluate a novel intervention designed to improve the effectiveness of transition support for older adults with common chronic conditions via three mechanisms of action: (a) direct tailored communication to patients via regular automated calls post discharge, (b) support for informal caregivers living outside of the patient's household via structured feedback about the patient's status and advice about how they can help, and (c) support for proactive care management including a web-based disease management tool, automated alerts about potential problems, and the capacity for asynchronous communication with patients and their caregivers. Specifically, the trial will determine: 1) whether the CarePartner intervention improves patients' readmission risk and functional status; 2) the impact of the intervention on patients' self-care behaviors and the quality of the transition process; and 3) whether the intervention improves caregiver burden and stress levels. | Methods: 846 older adults with complex chronic conditions will be identified upon admission to two community-based acute care medical services. Patients will be asked to identify a CarePartner (CP) living outside their household, i.e., an adult child or other social network member willing to play an active role in their transition support and organizing their broader network of informal caregivers. Patients will be randomized to the intervention or usual care. Intervention patients will receive automated assessment and behavior change calls, and their CPs will receive structured feedback and advice following each assessment. Patients' clinical team will have access to patients' assessment results via the web, will receive automated reports about urgent health problems, and will be able to communicate asynchronously with patients and CPs using a secure web page and a specially designed voicemail service. Patients will complete surveys at baseline, 30- and 90- days post discharge; utilization data will be obtained from hospital records. CPs, other caregivers, and clinicians will be interviewed to evaluate intervention effects on processes of self-care support, caregiver stress and communication, and the intervention's potential for broader implementation. The primary outcomes will be 30 day readmission rates; 2ndary outcomes measured at 30 and 90 days include functional status, self-care behaviors, and mortality risk. | Inclusion Criteria:
* Being discharged from study site with any diagnoses that indicate a chronic condition with a high risk of short-term readmission, for example: stroke, heart failure, coronary artery disease, cardiac arrhythmias, chronic obstructive pulmonary disease, peripheral vascular disease, deep venous thrombosis, pulmonary embolism, pneumonia, diabetes, urinary tract infection, cellulitis, gastroenteritis, fevers, and other infections
* At least 50 years of age
Exclusion Criteria:
* Serious mental illness, e.g., psychosis
* Are in hospice care
* Do not speak English
* Are unable to use a telephone
* Have a non-health system-affiliated primary care provider
* Are unable to nominate a potentially eligible CarePartner
* Are cognitively impaired as determined by a validate screener |
NCT06519331 | Development of a New Method for Liver Stiffness Measurement Using FibroScan | This is an European, prospective, interventional, multicenter clinical investigation that will take place in 2 French sites. 114 adults patients will be included. The study objective is to develop a new method for measuring liver stiffness using FibroScan. | Inclusion Criteria:
* Adult patients (≥ 18 years of age) followed in the hepatology or endocrinology department for liver disease, suspected liver disease or consequences of liver disease, all etiologies combined.
* Adult patient able to give his written consent
* Patient affiliated to the French Social Security system
Exclusion Criteria:
* Vulnerable patients
* Patients with liver ascites
* Patients with heart failure |
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NCT03200366 | Comparing Interventions to Increase Colorectal Cancer Screening | The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department.
The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care. | Colorectal cancer (CRC) often can be prevented through regular screening and although multiple screening tests are available, colonoscopy is often the only screening test offered to patients. Unfortunately, up to half of people in some hospitals who receive a recommendation and are scheduled for colonoscopy do not complete the test. Reasons for not completing colonoscopy include lack of awareness of the need for, and benefits of, screening, fear of pain, fear of finding cancer, unpleasantness of the bowel preparation, cost, transportation issues, and the unwillingness to undergo an invasive test in the absence of symptoms. The process of bowel cleansing is one of the most challenging aspects of having a colonoscopy. Interventions that improve patients' knowledge about CRC screening, including test options other than colonoscopy, enhance access, improve skills needed to complete CRC screening, and reduce barriers will lead to greater numbers of people being screened. Patient navigation and computer tailored interventions have been shown to be effective approaches to increase CRC and other cancer screening but there is no evidence of their comparative effectiveness. The purpose of this study is to compare two health system-based interventions, with one another and with usual care, to increase completion rates among a diverse sample of patients. The investigators will enroll an ethnically diverse group of 450 men and women aged 50-75,or aged 45-75 if African American, who are at average risk for CRC and were referred and scheduled for colonoscopy at one endoscopy department but canceled or did not attend their scheduled appointment. Participants will be randomized to receive: (1) a mailed tailored digital video disc (DVD) alone; 2) the mailed tailored DVD plus a telephone-based Patient Navigator; or 3) usual care. Data will be collected at baseline, at 6 months and at 9 months post-baseline. Interviews to assess receipt, viewing, and satisfaction with the tailored DVD will be conducted 2 weeks after mailing. Satisfaction with the patient navigator will be assessed at 6 months. Multivariable logistic regression analyses will be used to test the interventions' effects on CRC screening test completion and, for those who complete colonoscopy, quality of bowel preparation. The investigators will also examine whether these interventions change knowledge about CRC and screening as well as health beliefs (perceived risk, perceived benefits, barriers, and self-efficacy) about screening. From this study, the investigators will learn how effective these two standardized, easy to disseminate health system-based interventions are compared to each other and to usual care. If the interventions are found to be equally effective, or differentially effective for different subgroups of patients, healthcare systems may consider implementing one or both of these interventions in their settings. | Inclusion Criteria:
* Referred for a screening colonoscopy that was not done (i.e, canceled or no show)
Exclusion Criteria:
* Unable to speak, read, and write English
* Personal history of CRC or polyps
* Personal history of conditions that place participants at high risk for CRC such as ulcerative colitis, Crohn's disease, or known hereditary syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer
* Family history of CRC which increases the participant's risk for CRC
* Advised by a health care provider to not have a colonoscopy due to the participant's health
* Speech impairment
* Hearing impairment
* Cognitive impairment
* Vision impairment |
NCT03163745 | Asymptomatic Spontaneous Bacterial Peritonitis in Patients With Decompensated Liver Cirrhosis | Spontaneous bacterial peritonitis is defined as the presence of an infection in a previously sterile ascites in the absence of an intra-abdominal source of infection or malignancy .
The variants of Spontaneous bacterial peritonitis includes - (i) Classic Spontaneous bacterial peritonitis: -ascitic fluid polymorphonuclear leukocyte counts more than 250/mm3 and positive culture. (ii) Culture negative neutrocytic ascitis but the ascitic fluid polymorphonuclear leukocyte counts more than 250/mm3 and (iii) Bacterascites: - a culture positive ascitic fluid but the polymorphonuclear leukocyte counts less than 250/mm3 | Spontaneous bacterial peritonitis is a serious complication in patient with decompensated liver cirrhosis . The incidence in ascetic patients varies between 7-30 % as a consequence result of impaired defense mechanism and increased susceptibility to bacterial infection in cirrhotic patients with ascites Spontaneous bacterial peritonitis may complicated by hepatorenal syndrome or systemic sepsis and has high recurrence rate - estimated as approximately 70% within 1 year of follow up .
The clinical detection of spontaneous bacterial peritonitis requires a high index of suspicion because symptoms and signs of infection are obscure in most of patients.
About 13% of patients are asymptomatic and a few studies reported the incidence of asymptomatic spontaneous bacterial peritonitis in cirrhotic patients with ascites The most common clinical manifestations defined by Jeffries et al and Castellote et al in 2007 are: temperature above 38 °C or below 36.5 °C, chills, abdominal tenderness suggestive of peritonitis, developing or worsening hepatic encephalopathy, acute renal failure (defined by an increase in the serum creatinine level to above 133 μmol/L) and arterial hypotension (systolic arterial pressure below 80 mmHg).
The American Association for the Study of Liver Diseases recommends performing exploratory paracentesis in each patient with cirrhosis and ascites .
A study was done in Poland in 2011, shows the prevalence of spontaneous bacterial peritonitis in asymptomatic inpatients with decompensated liver cirrhosis and found that two of 37 asymptomatic cirrhotics who were included in the study met criteria of asymptomatic spontaneous bacterial peritonitis (5%) .
A french study was done in 2013 in asymptomatic cirrhotic outpatients and found that the incidence of asymptomatic Spontaneous bacterial peritonitis was only 1.2% .
Another study was done in Pakistan in 2015 and found that the incidence of asymptomatic spontaneous bacterial peritonitis in outpatient patient with cirrhosis was 10%(8 out of 80).
Another Egyptian study was done in 2016 on asymptomatic spontaneous bacterial peritonitis in adult Egyptian patient with decompensated cirrhosis and found that 21 (13%) patient was asymptomatic spontaneous bacterial peritonitis out of 160 cirrhotic patient ascetic patient who fulfill the inclusion criteria . | Inclusion Criteria:
Patients diagnosed with decompensated liver cirrhosis with ascites (Child B and C) regardless of the etiology of liver cirrhosis
Exclusion Criteria:
1. Symptomatic spontaneous bacterial peritonitis (patients with fever, abdominal pain or tenderness, leucocytosis, hepatic encephalopathy, impaired renal function)
2. Patients taking antibiotics for any other infections within 2 weeks e.g. pneumonia, urinary tract infection..etc
3. Patients taking antibiotics as prophylaxis for spontaneous bacterial peritonitis |
NCT01748019 | ST1968 Intravenous (Weekly) in Solid Tumors | ST1968 is a novel camptothecin derivative which interacts with topoisomerase I-DNA complex, inducing S-Phase specific cytotoxicity. It is endowed with a potent antitumor activity and an increased Therapeutic Index with respect to the clinically used analogues (i.e.irinotecan and topotecan) in some xenograft models (ovary, colon, head \& neck, cervix). Anti-tumor activity has been also noted in platinum resistant ovarian cell xenografts and in topoisomerase I mutant prostate cell lines. The acceptable toxicity profile in animals and the activity in camptothecin-resistant cell lines make ST1968 a good candidate for clinical trials. | Multicenter, open label, uncontrolled Phase I pharmacokinetic trial to determine the Maximum Tolerated Dose (MTD) of ST1968 given intravenously (I.V.) once every week for 2 consecutive weeks every 3 weeks and the MTD of ST1968 given I.V. once every 3 weeks. A starting dose of 1.5mg/m2 given as a flat dose of 2.5mg is defined, given once on Day 1, Day 8 every 21 Days (D1, D8 Q21D schedule), over 2 h. Starting dose for the Day 1 every 21 Days (D1 Q21D schedule) has to be determined from the MTD of D1, D8 Q21D schedule.
Plasma, urine pharmacokinetics in all patients (minimum of 3 pts for each cohort) during the first cycle of treatment and in at least 6 patients at the Recommended Dose (RD).
During the study any hints of anti-tumor activity will also be evaluated by RECIST criteria. | Inclusion Criteria:
* Histological/cytological diagnosis of solid tumors for which therapy of proven efficacy does not exist.
* Preferably measurable disease
* ECOG performance status ≤ 1.
* Age ≥ 18 years.
* Ongoing toxicity associated with prior anticancer therapy ≤ grade 1 (NCI-CTCAE V3.0).
* Maximum of 2 prior chemotherapy lines for advanced disease (not including neoadjuvant or adjuvant chemotherapy)
* Adequate hematological, liver and renal function
* Hemoglobin ≥ 9 g/dl; ANC ≥ 1.5 x 109/L; platelets ≥ 100 x 109/L;
* Serum bilirubin ≤ upper normal limit (UNL). ALT, AST ≤ UNL but ≤ 2.5 x UNL in case of liver metastases; alkaline phosphatase (liver isoenzyme fraction) ≤ UNL or ≤ 1.5xULN in case of liver metastases; albumin within normal limits;
* Creatinine ≤1.5 mg/dl or calculated creatinine clearance ≥ 60 ml/min.
* Life expectancy of at least 3 months
* Capacity of understanding the nature of the trial and giving written informed consent.
Exclusion Criteria:
* Less than 4 weeks since last chemotherapy, radiotherapy or prior investigational therapy. Less than 2 weeks since last hormone or immunotherapy or signal transduction therapy.
* Active infection.
* Presence of cirrhosis or chronic hepatitis
* Presence of serious cardiac (congestive heart failure, angina pectoris, myocardial infarction within one year prior to study entry, uncontrolled hypertension or arrhythmia), neurological or psychiatric disorder.
* Presence of uncontrolled intercurrent illness or any condition which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study.
* Symptomatic brain metastases (this does not include primary brain tumors) or leptomeningeal disease.
* Pregnancy or lactation or unwillingness to use adequate method of birth control |
NCT00179985 | The Impact of Implementing NIDCAP on the Developmental Sensitivity of Nurses Caring for Preterm Infants | The purpose of this study is to determine whether implementing the Newborn Individualized Developmental Care and Assessment Program increases NICU nurses' sensitivity in meeting the developmental care needs of preterm infants. | Therapies that have brought about sharp decreases in neonatal mortality have not brought about similar decreases in neurodevelopmental morbidity for preterm infants. Developmentally supportive care is NICU (Neonatal Intensive Care Unit) care that seeks to optimize the developmental course and outcomes for preterm infants. In controlled trials, implementation of the Newborn Individualized Developmental Care and Assessment Program (NIDCAP) has been associated with with positive medical and neurobehavioral outcomes. The purpose of this study is to examine the impact of implementing the NIDCAP on the developmental sensitivity of nurses caring for preterm infants in a tertiary level NICU in a children's hospital in the midwest. The NIDCAP program consists of 1) structured behavioral observations which are conducted at regular intervals during the preterm infant's hospitalization, 2) written plans which outline specific, individualized interventions to address the infant's unique developmental needs which are updated following each observation, and 3) consultations with the infant's caregivers to articulate the infant's current needs and plan. A convenience sample of 32 NICU nurses will be observed during a routine caregiving episode with one preterm infant before and another preterm infant after the implementation of the NIDCAP program with preterm infants in the NICU. Following the observations, the nurse's developmental sensitivity will be scored using a standardized tool. The nurses' developmental sensitivity before the implementation of the NIDCAP program will be compared with their developmental sensitivity following NIDCAP implementation. Informed consent will be obtained from the nurses participating in the study. | Inclusion Criteria:
* be an RN,
* be an employee of the NICU at the study site,
* have completed the NICU nursing orientation at the study site,
* work at least 0.4 FTE in the NICU at the study site, and
* be observed while caring for a preterm infant born at less than or equal to 36 weeks gestation and at less than or equal to 1500 grams
Exclusion Criteria:
* Nurses will not be observed while caring for fullterm infants or preterm infants receiving heavy sedation or paralyzing medications. |
NCT06651905 | Nerve Block Vs Sedation Infusion for Awake Fiberoptic Intubation. | This study compares the efficacy and safety of dexmedetomidine infusion versus superior laryngeal nerve block during awake fiberoptic intubation in hemimandibulectomy patients. | Inclusion Criteria:
* Age range ≥ 18 or ≤60.
* Both sexes.
* American Society of Anesthesiologists (ASA) II-III.
* Body mass index:18.5 to 30 kg/m2.
* Hemimandibulectomy patients with an anticipated difficult airway \[El-Ganzouri Risk Index (EGRI)\>3\].
Exclusion Criteria:
* Patient's refusal.
* Known allergy to drugs used in the study.
* Neurological disorders.
* Advanced liver or kidney disease.
* Patient with psychiatric disorders.
* Patient who needs postoperative ICU.
* Airway distortion and cervical spine movement. |
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NCT02689102 | Confocal Laser Endomicroscopy and Optical Coherence Tomography for Diagnosing ILD. | Often, assessing a classifying diagnosis in patients with interstitial lung disease provides a diagnostic challenge. Currently HRCT, endoscopic or surgical video assisted thoracoscopic surgery(VATS) assessment including lung biopsies are diagnostic tools for patients with suspected ILD. However, tissue acquisition is associated with morbidity in these patients with an already compromised pulmonary function. In clinical practice this results in the fact that only a minor part of patients with an indication for tissue acquisition are actually undergoing biopsies. The aim of this study is to determine ILD-characteristics on imagign collected with minimal invasive novel optical techniques, to examine whether the addition of novel optical techniques to the diagnostic process of ILD could potentially limit the need for a tissue- (surgical) diagnosis and/or reduce the sampling error rate of biopsies by providing additional information on biopsy location. | Novel probe based optical techniques such as Confocal laser endomicroscopy (pCLE) and Optical coherence tomography (pOCT) are non-invasive optical techniques, compatible with conventional diagnostic bronchoscopes and provide non-invasive, real-time information on the airway wall and the alveolar compartment. Therefore, immediate validation of optical measurements during a biopsy is possible. Optical techniques might either obviate the need for an tissue biopsy or improve the diagnostic yield of conventional biopsy methods and make surgical lung biopsies that are associated with high morbidity and costs redundant.
Hypothesis: Novel optical techniques (pCLE and pOCT) provide real time information about the characteristics of the mucosa and/or the alveolar compartment in ILD. | Inclusion Criteria:
* 18 years of age
* Supected ILD and referred for diagnostic bronchoscopic procedure with cryobiopsy
Exclusion Criteria:
* Smoked in the last 6 months
* Inability and willingness to provide informed consent
* Inability to comply with the study protocol |
NCT00000614 | Prevention of Recurrent Venous Thromboembolism (PREVENT) | A multicenter randomized, double blind placebo controlled trial to determine the efficacy of long-term, low dose warfarin in the secondary prevention of venous thromboembolism. | BACKGROUND:
Venous thromboembolism is associated with more than 300,000 hospitalizations and results in thousands of deaths annually. Conventional therapy consists of intravenous heparin followed by oral anticoagulants usually given for three to six months. The recommended intensity of oral anticoagulants (warfarin) has been derived from clinical trials. Such therapy is usually quite effective. However, some patients develop recurrent disease after the oral anticoagulants are stopped. A recent randomized study evaluated the optimal duration of oral anticoagulant therapy. After acute treatment with heparin, subjects were treated with oral anticoagulants for either six weeks or six months with a target INR \* of 2 to 2.85. There was no difference in mortality in the two groups. Recurrence was not seen while the patients were under treatment. When anticoagulants were stopped, recurrent thrombosis was documented in 18 percent of the patients treated for six weeks and in 9.5 percent of those treated for six months. The period of greatest risk of recurrence for the six weeks patients was immediately after therapy was stopped. There was a linear increase in cumulative risk of 5 to 6 percent per year for both treatment groups during the following 18 months.
For patients who have experienced idiopathic venous thrombosis, the risk of recurrence may continue even after several months of conventional therapy. Further prophylactic therapy might be beneficial for the patients who are at risk for late recurrence. But, because of the presumed risk of bleeding and inconvenience of monitoring standard warfarin therapy, most physicians usually limit treatment to three to six months.
In 1997, Simioni showed a cumulative recurrence rate of VTE of 39.7 percent among those with factor V Leiden mutation, with all recurrences occurring within three years, a rate 2.4 times higher than among individuals without the mutation. The factor V Leiden mutation is found in 4 to 6 percent of Caucasians and is the single most important cause of thromboembolism in a variety of conditions. Heterozygous carriers with the mutation have VTE at a younger age than do noncarriers. Among those with first VTE, the prevalence of the mutation is 15 to 40 percent and among those with a family history of VTE, as high as 50 percent. However, in a large study of men participating in the Physicians Health Study, those individuals with the mutation had an increased rate of VTE over time. These age-specific incidence rate differences ranged from 1.23 to 5.97 in those aged 70 or older. These data suggest that confounders other than genetic predisposition are important in the development of VTE.
\* The INR or international normalized ratio is the ratio of patient prothrombin to control prothrombin multiplied by the international sensitivity index. The INR was introduced by the World Health Organization to standardize control of anticoagulant therapy internationally.
DESIGN NARRATIVE:
Multicenter, randomized, double-blind, placebo-controlled. A total of 253 patients were randomized to usual care plus placebo and a total of 255 patients to usual care plus a three-to-four year regimen of low-dose warfarin (target INR 1.5 to 2.0), which after initial titration required infrequent outpatient monitoring. Double-blind INR assessment and dose adjustment were performed every three months to ensure patient safety and to monitor compliance. Primary endpoints included recurrent venous thromboembolism, major bleeding episodes, and all-cause mortality. Separate analysis was performed of all-cause mortality in the total patient population and in those with factor V Leiden.
The study consisted of 52 clinical centers, a laboratory coordinating center, the clinical coordinating center, and the data coordinating center.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record. | Patients with venous thromboembolism, including patients with factor V Leiden. Patients had completed prescribed anticoagulation therapy within the last two years before the trial and were not currently on anticoagulation therapy. |
NCT01997450 | A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age | This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age. | This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigational product will be administered in this study. A nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. This study will be conducted at 4 sites in the United States of America. The duration of study participation for each subject is one day. | Inclusion Criteria:
* Community-dwelling children and adolescents 2 to 17 years of age.
* Written Informed Consent or Assent.
* Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit)
* Symptom onset less than 5 days prior to study visit.
* Subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator.
Exclusion Criteria:
* Treatment with an antiviral drug for influenza (oseltamivir or Tamiflu®, zanamivir or Relenza®) during the 14 days before enrollment
* Any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results
* Concurrent enrollment in another clinical study
Patient already enrolled during this influenza season
* Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals. |
NCT01590017 | Cisplatin and Radiation Therapy in Treating Patients With HIV-Associated Locally Advanced Cervical Cancer | RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x rays to kill tumor cells. Giving cisplatin together with radiation therapy may be an effective treatment for cervical cancer.
PURPOSE: This trial studies how well cisplatin and radiation therapy work in treating participants with HIV-associated locally advanced cervical cancer. | OBJECTIVES:
Primary
* To determine if it is feasible to administer a regimen of cisplatin/radiotherapy in HIV-infected women with locally advanced cervical cancer (LACC) on antiretroviral therapy (ART).
* To evaluate the safety and tolerability of concomitant chemoradiotherapy with cisplatin in HIV-infected women with LACC who are also receiving concomitant ART.
Secondary
* To determine the 1-year progression-free survival (PFS) of HIV-infected women with LACC Stage IB, II, III, or IVA who receive weekly cisplatin concomitant with radiotherapy and ART. (Exploratory)
* To describe the quality of life (QOL) of enrolled participants via assessments before, immediately after, and at 3 and 9 months after completion of therapy, using QOL metrics that have been validated in similar populations. (Exploratory)
* To describe the effects of treatment on participants' CD4 counts, HIV viral load, and concurrent AIDS-defining conditions. (Exploratory)
* To describe cervical cancer recurrence patterns in HIV-infected participants with LACC defined as loco-regional and/or distant recurrences. (Exploratory)
* To determine 1-year overall survival and causes of death (i.e., cancer-related, HIV-related, or other). (Exploratory)
* To collect serum, cytology, and tissue for future studies specific to cervical and anal disease. (Exploratory)
* To evaluate the effects of weekly cisplatin concomitant with radiotherapy on adherence to ART. (Exploratory)
OUTLINE: This is a multicenter study.
Participants receive cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36 (6 weeks total). Participants also undergo whole pelvic radiotherapy (WPRT) 5 days a week for 5 weeks followed by intracavitary brachytherapy.
Participants complete the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-30 and the Cervical Cancer Module (QLQ-CX24) at baseline and periodically during study treatment.
After completion of study treatment, participants are followed up every 3 months for 12 months. | DISEASE CHARACTERISTICS:
* Participants (who have been adequately clinically staged by standard clinical guidelines) with primary, untreated, histologically confirmed, documented invasive squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix, stages IB2, IIA, IIB, IIIA, IIIB, and IVA (Stage IIA tumors must be greater than 4 cm)
* HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 ribonucleic acid (RNA) viral load
* NOTE: the term "licensed" refers to a United States (U.S) Food and Drug Administration (FDA)-approved kit or for sites located in countries other than the United States, a kit that has been certified or licensed by an oversight body within that country and validated internally
* WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment; a reactive initial rapid test should be confirmed by either another type of rapid assay or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a western blot or a plasma HIV-1 RNA viral load
* No participants with carcinoma of the cervical stump
PATIENT CHARACTERISTICS:
* Hemoglobin ≥ 10 g/dL (6.2 mmol/L)
* Platelet count ≥ 100,000/mm³ (100 x 10\^9/L)
* Absolute neutrophil count (ANC) ≥ 1000/mm³ (1.0 x 10\^9/L) (participants receiving transfusion, erythropoietin, or myeloid growth factor support will be eligible for this study)
* Creatinine clearance ≥ 60 mL/min (1.00 mL/s) calculated by the Cockcroft-Gault equation for women
* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times upper limit of normal (ULN)
* Total bilirubin ≤ 2 times ULN unless related to antiretroviral use (e.g., atazanavir and indinavir), then the direct bilirubin must be ≤ 2 times ULN
* Ability to understand and the willingness to provide informed consent to participate
* Karnofsky performance status of ≥ 60%
* Participants of childbearing potential, defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months), must have a negative urine or serum pregnancy test within 3 weeks prior to enrollment and agree to use an effective form of contraception (e.g., barrier contraception, highly effective hormonal contraception)
* Life expectancy of greater than 12 months
* No acute active (such as tuberculosis or malaria), serious, uncontrolled infection; participants with a CD4 count \< 50/mm³ (0.05 x 10\^9/L) will be excluded if they have had an opportunistic infection within the past 3 months, or if there is evidence of resistance to antiretroviral therapy (i.e., HIV viral load ≥ 400 copies/mL despite combination antiretroviral therapy for at least 4 months)
* No prior invasive malignancy other than LACC diagnosed within the past 24 months, excluding anal intraepithelial neoplasia, non-melanoma skin carcinoma, or Kaposi sarcoma that has not required systemic chemotherapy within the past 24 months
* No pregnancy or breast-feeding
* No medical or psychiatric illness that precludes ability to give informed consent or is likely to interfere with the ability to comply with the protocol stipulations
* No participants with circumstances that will not permit completion of the study or required follow-up; for instance, if travel to and from treatment site is an issue
* No participants with cardiovascular disease manifested as:
* History of myocardial infarction
* Unstable angina
* Currently taking medication for treatment of angina
* History of coronary artery bypass surgery
* New York Heart Association class 3 or 4 heart failure
PRIOR CONCURRENT THERAPY:
* See Patient Characteristics
* All patients must be prescribed combination antiretroviral therapy with the goal of virological suppression using an acceptable regimen that adheres to national guidelines for treatment of HIV infection
* Non-suppressed, treatment-experienced patients, defined as patients with a viral load \> 400 copies/mL who have been on antiretroviral therapy for more than 4 months, can be enrolled if a genotype assay is performed and an acceptable regimen is prescribed based on the genotyping results
* Patients who undergo emergency radiation therapy prior to enrollment may participate at the investigator's discretion
* No participants who have undergone hysterectomy
* No concurrent intensity-modulated radiotherapy or interstitial brachytherapy |
NCT03184896 | Services Mapping Among Older Adults With Hip Fracture | Hip fracture is a osteoporosis-related fracture with higher mortality, and is a major public health issue in China. The British Orthopedic Association and the British Geriatric Society have published the UK Blue Book, which summarizes current evidence and best practice in the hip fracture care and secondary prevention, but this kind of standardized practice in hip fracture care is not yet existed in China. The Blue Book standards will be used as the most contemporary evidence-based guidelines for management of hip fracture.This study is to prospectively examine the barriers and facilitators in the current management of hospital in China by comparing the Blue Book standards. | Inclusion Criteria:
* Adults aged 65 years old or over;
* Hip fracture with X-ray-confirmed femoral neck, trochanteric or sub-trochanteric fracture;
* Within 21 days of a hip fracture;
* Willingness to sign informed consent form;
Exclusion Criteria:
* Patients with pathological fractures;
* With terminal malignancies. |
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NCT03969524 | Functional MRI in Predicting Response to Chemotherapy | • Address the accuracy of functional MRI techniques to predict response to neoadjuvant chemotherapy given to local advanced breast cancer patients with correlation with pathology thus allowing early chemotherapy regimen modification to increase number of patients achieving pathological complete response or save patients from toxic effects of ineffective chemotherapy. | patient selection:
Selection of patients diagnosed with of biopsy proven breast cancer (BIRAD VI ) :
• Inclusion criteria: patient in different age groups with local advanced breast cancer who are eligible for neoadjuvant chemotherapy and breast conservative surgery and in need for clip placement for tumor localization
Breast cancer (BC) is the second most common cancer in the world and by far the most frequent cancer among women. In Egypt the incidence rate of breast cancer is 29.9/100,000 population in the age group of 30-34 years with the highest population among young women. (1).
Management of breast cancer depends upon its stage. Early stages (stage I) with small sized breast masses undergo breast conservative surgery (BCS) while locally advanced breast masses (stage II and III) may require Preoperative administration of Neoadjuvant chemotherapy (NAC) to decrease the tumor burden allowing for BCS instead of mastectomy with no significant difference in disease-free survival for patients receiving breast conservation in comparison to mastectomy.(2, 3)
Patients who achieve a pathologic complete response (pCR; defined as no residual tumor or a minimal residual tumor on histologic analysis) post NAC demonstrate significantly longer disease-free and overall survival rates(4).
Predicting whether a patient will respond or not to the given chemotherapy would allow an early change in chemotherapy regime or early resort to surgery saving patients from potential toxic effects of chemotherapy and provide a greater chance of achieving a pCR.(5, 6)
Imaging is more accurate than clinical examination in monitoring response to therapy. Different imaging modalities including Digital mammography, ultrasound and MRI have been incorporated in predicting tumoral response to NAC however the MRI has the upper hand due to its higher sensitivity.(3)
Assessing tumoral response to chemotherapy based on observing the regression in the tumor size is widely accepted(7). However, changes in tumor microvasculature, cell density can predate tumoral size change therefore the use of Functional MRI techniques as diffusion-weighted MRI (DWI), MR spectroscopy (MRS) or Dynamic Contrast-Enhanced MRI (DCE) can be used to quantify these early histopathological changes in the tumor.(8)
DCE MRI was reported by multiple studies as the optimal imaging tool to determine disease response, with an accuracy of approximately 91% however there is no established cutoff of enhancement determining partial versus complete response.In three recent studies, the routine use of DWI allowed early differentiation between responders and non-responders by at least a 20% increase in apparent diffusion coefficient, thereby allowing for tailoring of chemotherapy. Also it was reported that the addition of DWI to DCE MRI resulted in improved diagnostic performance in predicting residual disease after chemotherapy.(3) 80% to 90% of patients receiving NAC have a significant response rate of the primary tumor to neoadjuvant chemotherapy. However, this significant response complicates the surgical excision because it is difficult to verify accurate localization of the site of the previous tumor. Therefore the use of a radiopaque marker placed in the tumor bed before administrating chemotherapy has been reported as a safe and inexpensive technique that allows later on for wire guided localization of the tumor bed before surgical resection (9).
In a report on patients who underwent clip placement and preoperative chemotherapy indicated that preoperative wire localization of the tumor bed would have been impossible in 35.7% of patients and difficult in 21.4% of patients without the aid of the clip. Dash et al. concluded that the clip placement was valuable in 57% of patients at the time of preoperative needle localization(10). Edeiken and colleagues reported a similar experience with ultrasound-guided implantation of metallic markers. The markers reportedly were the only remaining evidence of the original tumor site in (47%) of patients.
In a study conducted in M. D. Anderson Cancer Center, Houston, Texas in 2007 aiming to determine whether patients with breast cancer who received breast-conservation therapy after neoadjuvant chemotherapy had improved outcomes if radiopaque clips were placed to mark the primary tumor. The study concluded that the omission of tumor bed clips was associated with a hazard ratio of 3.69 for increased local recurrence compared with patients who did have radiopaque clip placement (P =.083;95% confidence interval , 0.84-16.16).(9) | Inclusion Criteria:
* patient in different age groups with local advanced breast cancer who are eligible for neoadjuvant chemotherapy and breast conservative surgery and in need for clip placement for tumor localization
Exclusion Criteria:
* Patient with breast cancer who are not eligible for NAC (pregnant patients, multicentric breast cancer, metastatic breast cancer).
* Patients who have received any prior chemotherapy, radiation therapy or tamoxifen therapy for their current breast cancer
* Patients with any general contraindication to MRI as presence of any paramagnetic substance as pacemakers, or those with claustrophobia. |
NCT04334616 | POST: Comparison of Macintosh Laryngoscope vs Video Laryngoscope in Patients Intubated by Anaesthesia Trainee | OBJECTIVES The objective of this study is to compare the frequency of POST in patients intubated by trainee anaesthetist using Video LaryngoscopeTM(VDL) versus Conventional Macintosh Laryngoscope (CL) at a tertiary care hospital in Karachi, Pakistan
OPERATIONAL DEFINITIONS
1. Sore Throat: A sore throat is pain, scratchiness or irritation of the throat usually from irritation or inflammation of the throat (pharynx)(11).
The visual analogue scale (0-10) will be used to evaluate the severity of sore throat
2. Trainee Anesthetist: Anesthesia residents level I and II having experience of more than six months. They will have to achieve the initial competence of doing intubation under direct supervision and need to be familiar with conventional as well as VDL technique.
HYPOTHESIS:
NULL HYPOTHESIS: There is no difference in the frequency of POST in patients intubated by trainee anaesthetists using VDLTM versus conventional Macintosh laryngoscope.
ALTERNATE HYPOTHESIS: There is a difference in the frequency of POST in patients intubated by trainee anaesthetists using VDLTM versus conventional Macintosh laryngoscope. | MATERIAL AND METHODS
SETTING: The study will be conducted at main Operating Room, Department of Anaesthesiology, Aga Khan University Hospital Karachi.
DURATION OF STUDY: This study will be conducted for a period of one year or till the completion of sample size after approval of synopsis by ERC and CPSP.
SAMPLE SIZE:
W.H.O software is used to calculate sample size (See Annexure 1) Frequency of POST in VDL group = 28% (7) Frequency of POST in CL Group =54% (7) Power of the test = 80% Type I error= 5% Sample size in each group =55 (Total sample size 110)
STUDY DESIGN:
Randomized Control Trial (Observer Blinded)
SAMPLING TECHNIQUE:
Non probability consecutive sampling
DATA COLLECTION: After approval from Ethical Review Committee potential patients will be screened in the ward. After eligibility, the consent will be administered by the study investigators. If patient agree to participate and signed the consent, he/she will be enrolled in the study. Selected patients will be randomly allocated by a computer-generated number, either into conventional laryngoscopy (CL) group or video laryngoscopy (VDL) group through sealed envelopes. All patients will be managed with general anaesthesia requiring control mode ventilation and intubation. The direct supervision of consultant anesthetist involved in the study protocol would be there for every case. After instituting routine American society of Anaesthesiologist (ASA) recommended monitoring standards, induction of anaesthesia would be done by the consultant anaesthetistwith Propofol 1.5-2 mg/Kg, Nalbuphine 0.1 milligram per Kg and Atracurium 0.5 mg/Kg. The readiness of intubating conditions will be judged by orbicular oculi response of train of four stimuli. Patient would be considered ready to intubate when there will be no response to the neuromuscular stimuli. The head of the patient will be placed in sniffing position with under head pillow to facilitate the sniffing position.Selection of VDL or ML will be done as per consecutive sampling. Patient in Macintosh laryngoscopy group (MLG) are going to be intubated by trainee anaesthetist as defined by operational definition with laryngoscope size 3 or 4 blade as per the decision. Similarly the patient in (VLG) will be intubated by trainee anaesthetist as defined earlier with laryngoscope size 3 or 4 as per decided plan. Intubation will be done by trainee anaesthetist using appropriate size of endotracheal tube (ETT).The size 7-7.5 mm ID would be used for adult females, while male patients will require size 8-8.5 mm ID of ETT. All ETT tubes will be lubricated with water-based gel (Aplicare Lubricating Jelly) before intubation. Number of attempts of Laryngoscopy will be noted along with the time taken if less than or greater than 30 seconds also if any alteration like bougie was used. The inflation of the cuff would be guided by any obvious leak as measured by the APL bag valve pressure of 20 mm Hg. Later on inflation of cuff pressure would also be confirmed by pressure manometer. The cuff pressure between 20-25 mm Hg is said to be adequate. The intubation time including the number of intubation attempts or any other maneuver used to aid the intubation will be noted down. Orogastric tube lubricated by water based gel (Aplicare Lubricating Jelly) will be passed in all patients. Number of attempt in passing Orogastric Tube or if the aid of Magill forceps used will be noted.All patients would be positioned supine initially and then head up (reverse trandelenberg), as per surgeons preference which is usual for laparoscopic general surgical procedures Anesthesia will be maintained with Isoflurane in mixture of O2/Air. Dual antiemetic prophylaxis that is dexamethasone 0.1 mg/Kg at start and Ondansteron 0.1 mg/Kg at the end would be used for every patient. Endotracheal tube cuff pressurewill be regularly checked at 30 mins interval. Patient will be excluded if the duration of surgery exceeds one hundred and fifty minutes. Patient will be reversed from anaesthesia when fully recovered from paralytic effect of Atracurium. This again will be judge by twitch monitoring. All patients will be extubated as guided by the subjective and objective criteria of extubation. Reversal of neuromuscular paralysis will again be assessed by twitch response to train of four stimuli at orbicularis oculi muscle. Patient would be given reversal once all four twitches would be there. Patient would be observed for postoperative sore throat at 1, 12 and 24 hours post operatively by the primary investigator who is blinded to the group allocation. The visual analogue scale (0-10) will be used to evaluate the severity of sore throat. The definite measurement of POST will be taken at 24 hours.
ADVERSE EVENTS MANAGEMENT In investigators opinion, there would be no adverse event related to the trial protocol. However, if any event either serious or non-serious happened then will be reported to the ERC and other relevant entities are per institutional guidelines.
DATA ANALYSIS: All statistical analysis will be performed using statistical packages for social science version 19 (SPSS Inc., Chicago, IL). Mean and standard deviation will be computed for age, weight, height, BMI. Frequency and percentage will be computed for gender, mallampatti grade, Type of Laryngoscope, Alteration of airway management at intubation, Cormack \&Lehane intubation grade, Number of attempts of Laryngoscopy and sore throat (at 1 hr., 12 and 24 hrs.). Both groups will be compared by Chi-square test for frequency of POST between both groups, P value ≤0.05 will be considered significant.
Stratification analysis will be performed to observe effect of confounding variables like age, BMI, gender, mallampatti grade, Type of Laryngoscope, Alteration of airway management at intubation, Cormack \& Lehane intubation grade, duration of intubation and number of attempts of Laryngoscopy. After stratification Chi-square test will be applied to compare POST between groups. p≤0.05 will be considered significant
DATA MANAGEMENT AND STORAGE Data will be stored in lock and key and no one will access other than study investigators. Electronic data would be password protected. Data will be stored for 15 years as per GCP and other regulatory guidelines. Data will be frequently monitored by PI for quality checks and queries will be resolved timely basis. | Inclusion Criteria:
1. All adult patient of age between 20-60 year
2. American society of Anesthesiologist grade I and II
3. Scheduled for elective laparoscopic cholecystectomy
4. Both male and female genders
Exclusion Criteria:
1. Anticipated difficult airway as assessed by limited mouth opening (\< 2 finger breadth), Limited neck extension.
2. Obesity having BMI\>30 kg/m2
3. Any anatomical air way abnormality like cancers of oropharngeal cavity, patient who got radiotherapy in head and neck region known to the primary investigator through patients history
4. Patient having history of GERD requiring rapid sequence induction with cricoid pressure
5. Duration of the surgery exceeding two and a half hours (150 minutes)
6. Patient not intubated within three laryngoscopy attempt |
NCT03496948 | Telephone Health Coaching and Remote Exercise Monitoring for Peripheral Artery Disease | Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide, with over 200 million people affected. Most prominent symptom is leg pain while walking known as intermittent claudication. Based on the currently existing gaps in the management of intermittent claudication, the objective of the this study is to explore the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long home-based exercise program, compared to usual care. TeGeCoach consists of telephone health coaching, remote walking exercise monitoring based on wearable activity monitors and intensified primary care. It is hypothesized that TeGeCoach will improve functional outcomes and will reduce total health care costs. | Peripheral artery disease (PAD) is the third most prevalent cardiovascular disease worldwide and has become a serious public health issue, with over 200 million people affected. Smoking and diabetes are the strongest risk factors for the development of peripheral artery disease, but also high cholesterol, high blood pressure and sedentary lifestyle. The most prominent symptom is leg pain while walking known as intermittent claudication, as the muscles do not get enough blood during exercise to meet the needs. To improve mobility, first line treatment for intermittent claudication are outpatient supervised exercise programs (SEPs); however, their implementation face manifold challenges: low patient adherence, no reimbursement by insurers, high costs of course implementation, and low course availability. These barriers led to the development of home-based exercise programs, which are similarly effective when combined with a structured approach by setting exercise goals, monitoring exercise activity, and regular follow up with a coach. Therefore, this trial aims to determine the clinical effectiveness and cost advantage of TeGeCoach, a 12-month long structured home-based exercise program (HEP), compared with usual care of intermittent claudication. It is hypothesized that TeGeCoach will improve walking impairment and will lower the need of health care resources that are spent on patients with PAD at 24-month follow-up.
The investigators will conduct a prospective, open-label, pragmatic randomized controlled clinical trial in a health insurance setting. 1760 patients with peripheral artery disease at Fontaine stage II will be randomly assigned either to TeGeCoach or Care-as-usual (usual care). TeGeCoach consists of telemonitored walking exercise using wearable activity trackers, telephone health coaching and medical supervision by a physician. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques for supporting better patient engagement and activation, disease self-care, treatment adherence and lifestyle management. Depending on the individual functional status and exercise capacity, participants will be asked to walk up to seven times a week. Usual care participants regularly receive information leaflets and can access supervised exercise programs, physical therapy and a variety of programs for promoting a healthy lifestyle. Primary outcomes are functional capacity measured by the Walking Impairment Questionnaire (WIQ). Secondary outcome measures include quality of life, health literacy and health behavior. Claims data is used to collect total health care costs, healthcare resource use and (severe) adverse events. Outcomes will be measured at three time points (0, 12, and 24 months).
Clearly, the current routine care of intermittent claudication in patients with PAD is partly ineffective und insufficient, with the consequence of a poorly served patient population and worsening disease condition. TeGeCoach may provide an effective and feasible alternative in the management of intermittent claudication by improving access to supervised exercise while at the same time potentially reducing health care costs. | Inclusion Criteria:
* Insured with one of the three participating health insurance companies
* Sufficient German language skills to follow the telephone-based health coaching
* Access to a telephone (landline or mobile);
* Primary or secondary diagnosis of PAD at Fontaine stage IIa or IIb within the last 36 months, but no primary or secondary diagnosis of PAD at Fontaine stage I within the last 12 months; or at Fontaine stage III or IV within the last 36 months
Inpatient and outpatient diagnoses from routine statutory health insurance data will be used to identify eligible patients.
Exclusion Criteria:
* Immobility that goes beyond claudication (inability to carry out intervention and competing risks)
* Severe and persistent mental disorders (adherence reasons)
* Suicidality (safety reasons)
* Life-threatening somatic diseases (e.g., cancer; competing risk)
* Active or recent participation in any other PAD intervention trial
* Ongoing hospitalization; alcoholism and other drug dependency (adherence reasons)
* Heart failure graded New York Heart Association (NYHA) class III and IV (inability to carry out intervention and competing risks)
Ineligible patients are identified based on diagnoses that were made in inpatient settings only, given the considerable number of diagnostic errors in outpatient settings. |
NCT00761787 | Cardiac Allograft Rejection Gene Expression Observational (CARGO) II STUDY | The Cardiac Allograft Rejection Gene Expression Observational (CARGO) II Study is designed to provide independent evidence of the clinical performance of the non-invasive AlloMap test. Sensitive detection of cardiac allograft rejection and dysfunction is the basis for successful recipient management. The CARGO II Study will assess the correlation between the presence or absence of acute cellular rejection as determined by examination of endomyocardial biopsy specimens with results from the AlloMap Test. Of 17 participating transplant centers, 4 are in North America and 13 are in Europe. | Inclusion Criteria:
* New and existing allograft recipients
* All patients (age ≥ 18years) receiving post-transplant care at the enrolling centers
Exclusion Criteria:
* Concurrent enrollment in a double-blind drug trial (immunosuppressive drugs). |
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NCT02873585 | Conventional Bite Wing Radiography Versus Stationary Intraoral Tomosynthesis, a Comparison Study | A comparison of caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. The secondary objective is to assess participants experience with the s-IOT device. | The primary purpose of this study is to compare caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-IOT) using a carbon nanotube X-ray source array. Patient experience with the s-IOT device will be assess using a short questionnaire.
Fifty adult patients who have been referred to the Section of Oral and Maxillofacial Radiology (OMR) at the University of North Carolina (UNC) School of Dentistry (SOD) for horizontal bitewing (BW) radiographs or a Full Mouth Series (FMX) with horizontal bitewing radiographs will be recruited for the study.
Participants will receive an experimental s-IOT bitewing radiograph on each side of their mouth and a visual exam to look for caries. Experienced observers will assess the presence or absence of caries using the two imaging modalities. The results of their analysis will be evaluated to determine statistical difference. Participants completed questionnaires will be tabulated and the data will be analyzed using descriptive statistics. | Inclusion Criteria:
* 18 years and older
* Scheduled for horizontal BW or Full (FMX) with horizontal BWs
* Patients who have in the right and left maxilla and mandible at least a canine and two posterior teeth that are in contact
* At least one proximal caries lesion in a surface of a posterior tooth (premolar or molar) that is in contact with another tooth. Lesion depth can be incipient (outer half enamel), moderate (inner half enamel) or advanced (outer half dentin) as determined by conventional BW radiography.
* At least one non-carious proximal surface of a posterior tooth (premolar or molar) that is in contact with another tooth.
* Patients should be able to provide informed consent
Exclusion Criteria:
* Institutionalized subject (prisoners, nursing home, etc.) (identified by medical record)
* Critically ill or mentally unstable patients (identified by medical record)
* Patients with no radiographic caries of the posterior teeth as determined by conventional BW radiographs
* Patients with only severe caries lesions as determined by conventional BW radiographs |
NCT02547740 | Macular Damage in Early Glaucoma and Progression | Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is getting worse. There is scientific evidence that the macula, the central part of the retina, can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very prevalent and is often missed using conventional clinical tests.
Relatively little is known about progression of early glaucoma damage and its effects on the macula. This project investigates the nature of progressive damage to the macula and proposes new methods to improve accuracy to detect clinically significant progression.The study will evaluate the nature of damage to the macula's structures through OCT imaging and eye function via visual field tests. | There is compelling evidence that glaucomatous damage to the macula occurs even in early stages of the disease. The macula comprises about 30% of all retinal ganglion cells and its information corresponds to over 50% of the visual cortex. However, glaucomatous damage to the macula is often missed in clinical practice. Some of the reasons are:
1. traditional glaucoma knowledge supports that glaucoma is fundamentally a peripheral disease;
2. inherent limitations of conventional clinical tests to detect damage to the macula; and
3. the paucity of large, prospective studies that describe the nature of glaucomatous damage to the macula.
The investigators have published numerous papers in the past two years showing that macular damage is prevalent among patients with early glaucoma if one employs the appropriate tools to assess it, namely 10-2 visual fields and high-resolution optical coherence tomography (OCT). This information comes from a unique prospective cross- sectional database and techniques the investigators developed to produce objective metrics of structure and function.
Now that the investigators understand the cross-sectional nature of macular damage, this proposal aims to:
1. develop a longitudinal database including patients with early glaucoma and healthy controls,
2. to test models that explain progression of macular damage, and
3. to apply new statistical methods combining structural and functional tests which could improve the accuracy to detect progression and shorten the length of clinical trials.
The main hypothesis is that incorporating 10-2 visual field testing and high-resolution OCT scans of the macula to the conventional repertoire of technologies used in clinical practice, in addition to translating recently described statistical methods into softwares that can be used in daily practice, enhances the performance and confidence to detect glaucoma progression.
In Aim 1 the investigators plan to follow healthy subjects and glaucoma patients at regular intervals with 10-2, 24-2 visual fields, and swept source (ss) OCT tests and define metrics of short- and long-term test variability that are needed to differentiate true progression from 'noise'. To date, there is no such database combining these technologies.
In Aim 2 the investigators plan to combine metrics of structure and function from this longitudinal database using two methods: a spatial approach, which will ultimately produce a joint structure-function index using 10-2 and ssOCT data; and a temporal approach, which will employ Bayesian statistics to measure rates of progression using trend analysis. By the end of the study, our contributions to the field should be:
1. to make available a unique and pristine longitudinal database that could be used for other hypotheses testing,
2. to translate techniques recently described in the literature into objective tools to be readily useful in clinical practice, and
3. to mitigate the burdens of progressive loss of central vision in glaucoma. | Glaucoma Group:
Inclusion Criteria:
* glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology Preferred Practice Pattern criteria)
Exclusion Criteria:
* late functional glaucomatous damage
* significant cataract
* previous ocular surgery (aside from uncomplicated cataract extraction with intraocular lens (IOL) implantation and/or trabeculectomy, LASIK or refractive surgeries)
* diabetic retinopathy with macular edema
* vein or artery occlusion
* exudative age-related macular degeneration or geographic atrophy
* macular hole or traction
* amblyopia
* uveitis
* non-open angle glaucoma (e.g. angle closure, traumatic, congenital glaucoma)
* severe myopia or hyperopia (refractive error greater than -6 or +6D, respectively)
* retinal detachment (current or post-surgery)
* retinitis pigmentosa
* significant epiretinal memberane
* significant kerotoconus
Healthy Group:
Inclusion Criteria:
* best corrected visual acuity equal or better than 20/40
* normal biomicroscopy examination
* gonioscopically open angles
* Intraocular Pressure (IOP) lower than 22 mmHg
* normal and reliable 24-2 and 10-2 SAP results
Exclusion Criteria:
* evidence of optic neuropathy
* evidence of clinically significant metabolic diseases (e.g. diabetes and hypotension) |
NCT00910715 | Duration of Antibiotic Treatment of Erythema Migrans | The purpose of this study is to compare the efficacy of 15-day versus 10-day doxycycline treatment in patients with erythema migrans. | Inclusion Criteria:
* solitary erythema migrans in patients \> 15 years
Exclusion Criteria:
* a history of Lyme borreliosis in the past
* pregnancy or lactation
* immunocompromised status
* serious adverse event to doxycycline
* taking antibiotic with antiborrelial activity within 10 days
* multiple erythema migrans or extracutaneous manifestations of Lyme borreliosis |
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NCT06307210 | Is Inpatient Rehabilitation Effective for Very Old Patients? | The goal of this retrospective longitudinal observational study is to compare the effects of physical and mental performance as well as quality of life in patients with neurological and musculoskeletal disorders.
The main question it aims to answer is: Do very old patients benefit in a similar way from inpatient rehabilitation like younger patients? Data from about 2000 patients will be retrospectively analyzed. Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) were recorded on admission and discharge.
Researchers will compare the age group 75 to 84 and 85 to 99 to see if physical and mental performance as well as quality of life will improve. | Inpatient rehabilitation has been shown to improve exercise capacity and quality of life in patients with neurological and musculoskeletal disorders.
Rehabilitation in Valens includes intensive strength and endurance training. Expectedly improvements in physical and mental performance measured by Functional Independence Measurement (FIM), Timed Up and Go Test (TUG), EuroQol 5 Dimensions (EQ-5D) and Patient Reported Outcomes Measurement Information System (PROMIS) is recognized after inpatient rehabilitation. But is this clinical effect in the same way represented in very old patients?
To the knowledge of the investigators only few studies evaluated changes after rehabilitation in patients with neurological and musculoskeletal disorders in very old patients.
Therefore, the primary goal of this study is to evaluate changes in physical and mental performance in patients with neurological and musculoskeletal disorders after inpatient rehabilitation. | Inclusion Criteria:
* german speaking
* age \>74
* patients with neurological and musculoskeletal disorders
Exclusion Criteria:
* age \<75
* patients with pulmonological and internal disorders |
NCT00778622 | Body Weight Effects on Glucophage's Efficacy in Chinese Diagnosed T2DM Patients | The purpose of this study is to investigate the effect of the baseline body mass index (BMI) on the response to Glucophage XR monotherapy in glycemic control in Chinese patients with newly diagnosed type 2 diabetes | Inclusion Criteria:
* Signed Written Informed Consent
* Age≥ 17 and \<80 years,
* Newly diagnosed T2DM (defined as T2DM diagnosed within 6 months prior to enrollment)
* Oral antidiabetic agents naïve (defined as without receiving any anti-diabetic medication therapy before, or having received anti-diabetic medication ≤ 14 days but not received any antidiabetic medication within the last 1 month prior to enrollment)
* HbA1c ≥ 7.0% and ≤10.0%
Exclusion Criteria:
* Women of child bearing potential
* body mass index (BMI)≥35 Kg/m2 or BMI \<18.5 Kg/m2
* Hemoglobin A1c (HbA1c)\>10.0% or \<7.0%
* Active liver disease and/or significant abnormal liver function
* Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma
* Congestive heart failure defined as New York Heart Association (NYHA) class III or IV and /or left ventricular ejection fraction ≤40%
* Significant cardiovascular history with the past 6 months
* Severe retinopathy, persistent uncontrolled hypertension (SBP≥180mmHg, or DBP≥105mmHg)
* Severe chronic gastrointestinal disease
* History of alcohol abuse or illegal drug abuse within the past 12 months
* Diagnosed anemia
* Creatine kinase ≥3 X ULN
* Serum creatinine ≥1.5 mg/dL(133μmol/L) \[males\], ≥1.4 mg/dL(124 μmol/L)\[females\]
* Alanine amino transferase (ALT) and/or aspartate amino transferase (AST)\> 1.5 X ULN and/or total bilirubin \> 2 X ULN
* Hemoglobin \<12g/dL \[males\], \<11g/dL \[females\]
* Allergies and Adverse Drug Reactions
* Prohibited Treatments and/or Therapies
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
* Subjects decline to participate |
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NCT04402788 | Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial | This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone. | PRIMARY OBJECTIVES:
I. To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase II) II. To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase III)
SECONDARY OBJECTIVES:
I. To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm.
II. To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and \> 3 visible tumors.
III. To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease ("complete consolidation") and patients who do not receive consolidation radiation to all visible disease ("incomplete consolidation").
EXPLORATORY OBJECTIVE:
I. To assess the association between pre-treatment tumor burden (determined by central radiographic assessment, using both tumor number and tumor volume), and PFS and OS benefit.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive atezolizumab intravenously (IV) over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive atezolizumab IV over 30 minutes +/- 10 minutes. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.
Patients undergo positron emission tomography and computed tomography (PET/CT) scan, computed tomography (CT), and magnetic resonance imaging (MRI) throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. | Inclusion Criteria:
* Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases
* Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans (positron emission tomography \[PET\]/computed tomography \[CT\] scan, diagnostic CT scan, magnetic resonance imaging \[MRI\] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide/platinum (if not receiving PCI) or 6 weeks from completion of prophylactic cranial irradiation (PCI)
* NOTE: Patients must have at least 3 cycles of E/P plus atezolizumab. They can have one cycle of induction E/P without concurrent atezolizumab if unable to receive concurrent E/P combined with atezolizumab for all cycles of induction therapy
* Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors \[RECIST\]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
* At time of enrollment after induction E/P chemotherapy and atezolizumab, if there is a pleural effusion, patients will be eligible if thoracentesis is cytologically negative or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging
* Appropriate stage for study entry based on the following diagnostic workup:
* History/physical examination within 14 days prior to registration;
* Imaging within 42 days prior to registration to include:
* MRI brain with contrast or CT brain with contrast
* CT chest, abdomen and pelvis or whole body PET/CT scan any time after the fourth cycle of chemotherapy and prior to registration
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,000/cells/mm\^3 (within 14 days prior to registration)
* Platelets \>= 75,000 cells/mm\^3 (within 14 days prior to registration)
* Hemoglobin \>= 8 g/dL (within 14 days prior to registration)
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x ULN (AST and/or ALT =\< 5 ULN for patients with liver involvement) (within 14 days prior to registration)
* Alkaline phosphatase =\< 2.5 x ULN (=\< 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)
* Adequate renal function = Creatinine clearance \>=40 mL/min by the Cockcroft-Gault (C-G) equation: (within 14 days prior to registration)
* Upfront radiation therapy of symptomatic metastatic site is permissible if causing symptoms such as pain or impending fracture
* Patients with brain metastases are eligible after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Whole brain radiation can be delivered with hippocampal sparing or 3-D conformal technique. Patients with irradiated brain metastases are eligible if they are clinically stable from a neurological standpoint after completing radiotherapy (e.g. not having uncontrolled seizures) and do not require use of steroids above a dose of 10 mg of prednisone daily
* For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration.
* Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
* Women \< 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
* Women \>= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses \> 1 year ago, had chemotherapy-induced menopause with last menses \> 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
* Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
* The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
Exclusion Criteria:
* Metastatic disease invading the liver (\> 3 metastases), heart or \> 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan counts as one site
* Patients with a concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen with atezolizumab or radiation
* Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet acceptable dose constraints for normal tissue
* Active autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn's, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener's granulomatosis; Sjogren's syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis.
* If the autoimmune disease is not active for over 3 years and the patient is not receiving immunosuppressive treatment such as methotrexate or steroids above a dose equivalent to 10 mg prednisone daily, the patient is eligible.
* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
* Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations are excluded only if they have active disease with acute exacerbation and on immunosuppressive medications within the 12 months prior to enrollment. They are eligible otherwise.
* Severe, active co-morbidity defined as follows:
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
* Active tuberculosis;
* Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
* Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen \[HBsAg\] test and a positive anti-HBc \[antibody to hepatitis B core antigen\] antibody test) are eligible
* Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test)
* Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL);
* Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of \> 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary;
* Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months;
* History of recent myocardial infarction within 6 months prior to registration.
* Clinically significant interstitial lung disease
* Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
* Women who are breastfeeding and unwilling to discontinue
* History of allogeneic organ transplant
* Patients who have had immunotherapy-induced pneumonitis |
NCT03702400 | Norepinephrine or Phenylephrine in Bolus for Hypotension in Cesarean Delivery | This study evaluate the ability of phenylephrine and of noradrenaline to maintain normal systemic arterial blood pressure and heart rate in healthy pregnant women submitted to cesarean section with spinal anesthesia. Half of participants will receive bolus of phenylephrine while the other half will receive bolus of noradrenaline. | This is a prospective, randomized, double-blind, comparative two-group clinical study to observe two vasopressor drugs, phenylephrine and noradrenaline, in the ability to maintain systemic arterial pressure in pregnant women after spinal anesthesia for cesarean section; based on the hypothesis that, since noradrenaline has a predominant alpha-adrenergic action and a weak 1- beta-adrenergic beta action, it could be as capable of maintaining blood pressure effectively as phenylephrine, but with a lower frequency of bradycardia; patients who meet the inclusion criteria will be randomly assigned to one of the groups to be studied: group F - phenylephrine at a dose of 100mcg bolus and N - noradrenaline at the dose of 5mcg. One of these drugs will be used whenever systolic blood pressure drops below 10% of the baseline, additional doses will be allowed whenever necessary, aiming at maintaining the systolic blood pressure at baseline values; the blood pressure will be measured non-invasively and the heart rate by pulse oximeter and electrocardiogram. | Inclusion Criteria:
* Pregnant women, with single gestation, with cesarean programming to be performed under spinal anesthesia;
* Age above 18 years;
* Physical State American Society of Anesthesiologists (ASA) II and III;
* Weight between 50kg and 120kg;
* Height between 140cm and 180cm.
Exclusion Criteria:
* Refusal to participate in the study;
* Pregnant women with fetus with known abnormalities;
* Pregnant women with cardiovascular disease;
* Pregnant women with pregnancy-specific hypertensive disease;
* Allergy to any medication to be used in the study;
* Users of monoamine oxidase inhibitors;
* Users of tricyclic antidepressants;
* Emergency caesarean section due to acute fetal distress;
* Situations in which the sensory level after single intrathecal injection of the local anesthetic does not reach at least T6 within 5 minutes after spinal anesthesia. |
NCT03961308 | A Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants | The purpose of this study is to compare the PK of single dose of Vedolizumab SC 108 milligram (mg) administered as PFS vs investigational device. | The drug being tested in this study is called vedolizumab SC. The study will compare the PK of a vedolizumab SC in a PFS to an investigational device.
This study will include 2 different device delivery presentations in 2 treatment groups. Participants in each treatment group will be randomized to one of the three administration sites: Abdomen, thigh, or arm. The study will enroll approximately 102 participants per group (a total of 204 participants), including 34 participants allocated to each administration site within each treatment group. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
* Group A: Vedolizumab SC PFS
* Group B: Vedolizumab SC Investigational Device
All participants will receive a single dose of study drug on Day 1.
This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 196 days. Participants will be contacted by telephone on Day 168 after their last dose of study drug for a follow-up assessment which will involve the progressive multifocal leukoencephalopathy (PML) questionnaire survey. | Inclusion Criteria:
1. Weighs greater than (\>) 50 kilogram (kg) and less than (\<) 90 kg or has a body mass index (BMI) from 18 to 28 kilogram per square meter (kg/m\^2), inclusive, at the time of informed consent.
Exclusion Criteria:
1. Has had previous exposure to approved or investigational anti-integrins (example, natalizumab, efalizumab, etrolizumab, AMG 181) or anti-mucosal addressin cell adhesion molecule-1 (anti-MAdCAM-1) antibodies or rituximab.
2. Has 1 or more positive responses on the PML subjective symptom checklist at screening or before dosing on Day 1.
3. Has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year before the Screening Visit or is unwilling to agree to abstain from alcohol for 7 days before Day -1 throughout confinement and for 48 hours before each clinic visit; and drugs throughout the study.
4. Has evidence of an active infection during the Screening Period.
5. Has received any live vaccinations within 30 days before Screening.
6. Has active or latent tuberculosis (TB) as evidenced by the following:
o A diagnostic TB test performed within 30 days of Screening or during the Screening Period that is positive, defined as:
1. Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR
2. A TB skin test reaction greater than or equal to (\>=) 5 millimeter (mm). NOTE: If participants have received Bacillus Calmette-Gueri (BCG) vaccine then a QuantiFERON TB Gold test should be performed instead of the TB skin test.
Note: Participants with documented previously treated TB with a negative QuantiFERON test can be included in the study.
7. Has poor peripheral venous access.
8. Is unable to attend all the study visits or comply with study procedures.
9. Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including serum pheresis), or had a transfusion of any blood product within 45 days before Day 1. |
NCT01102907 | Effect of Food Form on Satiety and Gastric Emptying | Our objective is to determine whether food form (liquid vs. solid) alters gastric emptying, satiety, and food intake, when all macronutrients and fiber are controlled. The study population will include 10 healthy women, who have a normal body mass index. We have chosen to evaluate only women because this is a small pilot study and one of our endpoints is gastric emptying. Gastric emptying is known to differ between men and women. Gastric emptying will be evaluated using the Smartpill technology, satiety will be evaluated using computerized visual analog scales/questions, and food intake will be measured by providing subjects with an ad libitum/buffet-style lunch.
Our hypothesis is that our subjects will be less hungry after they eat a solid breakfast compared to a liquid breakfast. We also hypothesize that our subjects will have a slower gastric emptying time after they eat the solid meal. Lastly, we think subjects will want to eat less food at lunch time if they have eaten a solid meal compared to a liquid meal for breakfast. | Inclusion Criteria:
* Healthy women
* Age 18 - 35
* Body mass index in the healthy range between 18.5 and 25
* Proficient English speakers
* Non-smoking
* Not taking medications
* Non-dieting (weight stable over last 3 months)
* Able to swallow a large capsule
Exclusion Criteria:
* Irregular or erratic breakfast eating patterns
* Food allergies to ingredients commonly found in test products or pizza
* Distaste for test products or pizza
* BMI less than 18.5 or greater than 25
* Weight change \> 5 kg in last 3 months (intentional or unintentional)
* Difficulty swallowing
* Cardiovascular disease
* Diabetes mellitus (fasting blood sugar \> 126 mg/dl)
* Cancer in prior 5 years (except basal cell carcinoma of skin)
* Kidney or liver disease
* Any gastrointestinal conditions that may affect digestion and absorption
* Recent bacterial infection (\< 3 months)
* Chronic medication use
* History of drug or alcohol abuse in prior 6 months
* Concurrent or recent intervention study participation
* Vegetarians or people who ate more than approximately 15 g of fiber per day
* Pregnant or lactating women
* Women with irregular menstrual cycles |
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NCT06591364 | Prevalence and Predictive Factors of Difficult Biliary Cannulation | The main purpose of the study is to evaluate the prevalence of difficult biliary cannulation using endoscopic retrograde cholangiopancreatography (ERCP) according to the criteria defined by the European Society of Gastrointestinal Endoscopy (ESGE) and the American Society for Gastrointestinal Endoscopy (ASGE), as well as the predictive factors for this event in a prospective, multicenter study. Consecutive patients undergoing ERCP will be included in the study
We will also assess:
Evaluate the failure of biliary cannulation in our setting. Evaluate predictive factors for difficult cannulation and cannulation failure using ESGE criteria.
Design an "a priori" predictive model for difficult cannulation and cannulation failure.
Cost study: record of materials used. | All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the indication for the procedure, and technical variables.
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience. All patients, except in cases of allergy, will receive 1 suppository of indomethacin or diclofenac before the procedure. In cases of allergy, pre-procedure hydration with Ringer's lactate will be administered if there is no contraindication (consider the protocol proposed by the ESGE: 3 mL/kg/hour during ERCP, 20 mL/kg as a bolus after ERCP, and 3 mL/kg/hour for 8 hours post-ERCP). The use of a pancreatic stent should be considered when indicated.
After the procedure, patients will remain hospitalized for at least 24 hours in the hospital. The patient's medical record will be reviewed 7 days after the procedure to check for any adverse effects, and a follow-up phone call will be made to detect any adverse effects.
Initially, a pilot study will be conducted with 600 patients, assessing based on the results-that is, the percentage of patients with difficult cannulation and the number of independent variables associated in the multiple logistic regression-the need to include a larger number of patients. For each variable included in the multiple logistic regression analysis, 8 to 10 cases of patients with difficult cannulation would be required. | Inclusion Criteria:
* Age \>18 years
* Signed informed consent
* Patients indicated for ERCP
Exclusion Criteria:
* INR \> 1.5
* Platelets \< 50,000/mm³
* Patients with a prior endoscopic sphincterotomy
* Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
* Known pancreas divisum
* Indication due to pancreatic duct pathology |
NCT06553625 | Radiofrequency (RF) Ablation Prospective Outcomes Study for Central Nervous System - RAPID for CNS | The objective of this study is to compile real-world outcomes of Boston Scientific commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery. | The objective of this study is to compile real-world outcomes of Boston Scientific Corporation commercially approved radiofrequency (RF) ablation systems used in the central nervous system (CNS) for use in functional neurosurgery. | Inclusion Criteria:
* Study candidate is scheduled to be treated with a commercially approved Boston Scientific RF system for pain or for CNS applications per local Directions for Use (DFU)
* Signed a valid, IRB/EC/REB-approved informed consent form
Exclusion Criteria:
* Meets any contraindications per locally applicable Directions for Use (DFU)
* Currently diagnosed with cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or to complete study assessments |
NCT06756828 | Effects of 3-Month Melatonin Treatment on Regional Cerebellar Structure and Blood Biomarkers in Alzheimer's Disease Spectrum | The goal of this clinical trial is to explore and verify the preventive effects of melatonin on the progression of Alzheimer's disease. The study aims to analyze the changes in blood biomarkers (phosphorylated tau, glial fibrillary acidic protein, neurofilament chain), various sleep-related subjective report questionnaire scores, physical performance, cognitive function scores and cerebellar volume change after three months of melatonin administration in patients with Alzheimer's-type mild cognitive impairment (MCI) accompanied by insomnia. The main questions it aims to answer are:
1. Does melatonin administration alter the levels of blood biomarkers associated with Alzheimer's disease?
2. What changes occur in sleep-related subjective report questionnaire scores and cognitive function scores following melatonin administration?
3. Does melatonin administration effect on physical performance?
4. Is there any relations between cognitive decline, phsycal performance and cerebellar volume change? We will compare the data collected before and after melatonin administration to determine its preventive effects on Alzheimer's disease progression.
Participants Will:
1. Take melatonin every day for 3 months and Complete sleep-related subjective report questionnaires, neuropsychological assessments and physical performance test
2. Visit the clinic at the initial visit and after 3 months for checkups and tests.
3. Complete sleep-related subjective report questionnaires and neuropsychological assessments and physical performance test
4. Provide blood samples for biomarker analysis. | Inclusion Criteria:
* Male and female participants aged 60 to 90 years
* Individuals presenting with cognitive impairment as their chief complaint at the Department of Psychiatry, St. Vincent's Hospital
* Those capable of undergoing imaging studies, including Brain MRI and Amyloid PET CT
* Individuals able to complete cognitive function tests, such as the Alzheimer's Disease Consortium test battery, K-MMSE, CDR, and GDS
* Participants who can perform tests at the hospital's Smart Center, including the Short Physical Performance Battery and body composition analysis using direct segmental multi-frequency bioelectrical impedance analysis for sarcopenia
* Individuals on acetylcholinesterase inhibitors (ACEi) or NMDA receptor antagonists who have maintained the same dosage and regimen for more than 3 months from the screening date.
* Patients who are taking medications for cognitive function treatment other than acetylcholinesterase inhibitors and NMDA receptor antagonists (e.g., pregabalin, gabapentin, choline alfoscerate), as well as medications for chronic diseases such as antidepressants, antihypertensives, diabetes, hyperlipidemia, thyroid disorders, etc., must have maintained the same dosage and regimen for more than 1 month from the screening date.
* Individuals with sufficient language proficiency to read and understand the informed consent document and respond to survey questionnaires
Exclusion Criteria:
* Individuals with progressive mental or neurological disorders (including those with a history of psychotic disorders such as major depressive disorder, bipolar disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, or unspecified psychosis; patients currently experiencing major depressive disorder with psychotic symptoms; organic mental disorders; epilepsy or seizure disorders; patients currently suffering from eating disorders or obsessive-compulsive disorder).
* Individuals with unstable or severe medical conditions.
* Patients with severe snoring, REM sleep behavior disorder, or narcolepsy.
* Illiterate individuals.
* Individuals who, in the opinion of the investigator, are deemed unable to comply with the requirements of the study.
* Patients currently taking sleeping pills within 2 weeks of the screening point. |
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NCT01580891 | Evaluate the Clinical Equivalence of Two Naftifine HCl 1% Creams in Patients With Interdigital Tinea Pedis | The objective of this study is to evaluate the efficacy and safety of the test formulation of Naftifine HCl Cream 1% (Taro Pharmaceuticals Inc.) as compared to the already marketed formulation Naftin® (Naftifine HCl) 1% Cream (Merz Pharmaceuticals) and placebo in patients with tinea pedis and to show the superiority of the active treatments over placebo when dosed once a day for 28 days. | Inclusion Criteria:
* Male or non-pregnant, non-lactating females 18 years of age or older.
* Signed informed consent form, which meets all criteria of current FDA regulations.
* If female and of child-bearing potential, have a negative urine pregnancy test at baseline visit, and prepare to abstain from sexual intercourse or use a reliable method of contraception during the study.
* A total score of at least 4 for the clinical signs and symptoms of tinea pedis for the target lesion. In addition, the most infected area must have a minimum score of at least 2 for erythema and a minimum score of at least 2 for scaling.
* A confirmed clinical diagnosis of tinea pedis with lesions localized to the interdigital spaces or predominantly interdigital, but may extend to other areas of the foot.
* The presence of tinea pedis infection, confirmed by the observation of segmented fungal hyphae during a microscopic 10% potassium hydroxide wet mount examination.
Exclusion Criteria:
* Females who are pregnant, lactating or likely to become pregnant during the study.
* Use of antipruritics, including antihistamines within 72 hours prior to baseline visit.
* Use of topical corticosteroids, antibiotics or antifungal therapies within 2 weeks prior to baseline visit.
* Use of systemic corticosteroids, antibiotics or antifungal therapies within 1 month prior to baseline visit.
* Use of oral terbinafine or itraconazole within 2 months prior to baseline visit.
* Use of immunosuppressive medication or radiation therapy within 3 months prior to baseline visit.
* Any known hypersensitivity to Naftifine HCl, any component of the formulation or other antifungal agents.
* Confluent, diffuse moccasin-type tinea pedis of the entire plantar surface.
* Significant history or current evidence of chronic infectious disease, system disorder, organ disorder, or other medical condition that would place the patient at undue risk by participation or could jeopardize the integrity of the study evaluations.
* Evidence of any concurrent dermatophytic infection of the toe nails or dermatological condition of the foot that may interfere with the evaluation of tinea pedis.
* Patients with a past history of tinea pedis infections with a lack of response to antifungal therapy.
* Patients who would be non-compliant with the requirements of the study protocol.
* Participation in a research study within 30 days prior to baseline visit.
* Employees or family members of employees of the research center or investigator.
* Previous participation in this study. |
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NCT05115149 | The Study of a Neural Interface and a Neurostimulation in the Rehabilitation of Upper Limb Movement Impairments. | The aim of the study is to investigate the effectiveness of a new rehabilitation technology for paralysis that occurs after stroke or spinal cord injury. The research will jointly use a prototype neurorehabilitation orthosis, in which a robotic device moves a paralyzed arm at the command of a non-invasive brain-computer interface to perform a game life-like task augmented using a virtual-reality display, as well as an electrical stimulation device that activates the spinal cord and/or muscles of the paralyzed arm.
Investigators expect that a portion of the patients participating in the study will have an improvement in arm mobility by the end of the study.
Participants who express their special written consent will have venous blood tests conducted three times for subsequent analysis of lipid biomarkers, in order to further evaluate the effectiveness of rehabilitation methods based on biochemical analysis. | The aim of the study is to investigate the effectiveness of a new rehabilitation technology for paralysis that occurs after stroke or spinal cord injury. The research will jointly use a prototype neurorehabilitation orthosis, in which a robotic device moves a paralyzed arm at the command of a non-invasive brain-computer interface to perform a game life-like task in virtual reality (for example, aiming a hand-held virtual toy gun at a target), as well as an electrical stimulation device that activates the spinal cord and/or muscles of the paralyzed arm.
The study is carried out to collect data on the role of central and spinal mechanisms in the plasticity of neuronal circuits that determine the effect of combined spinal neurostimulation and robotic rehabilitation under the control of non-invasive neural interfaces in patients in early and late rehabilitation period after acute cerebrovascular accident and in patients after trauma of the cervical and upper thoracic spinal cord.
The study will use two technologies - neural interfaces and transcutaneous electrical stimulation of the spinal cord. Neural interfaces are a rapidly developing area at the intersection of medicine, neuroscience, biology, engineering, robotics, physics, mathematics, and materials science, which aims to reproduce and supplement brain functions and correct these functions in cases of neurological lesions. The possibility of using neural interfaces for the treatment of neurological disorders, including disorders resulting from spinal cord and brain injuries, epilepsy, strokes, and neurodegenerative diseases, such as Parkinson's disease, has been demonstrated.
Transcutaneous spinal cord stimulation (tSCS) is a method for non-invasive control of the activity of human spinal neural networks used to restore locomotor functions after spinal cord injury (SCI). The published research results show that tSCS modulates the activity of not only spinal but also cortical neuronal networks.
It is expected that the use of tSCS in conjunction with the use of neural interfaces will increase the effectiveness of neural interfaces for the rehabilitation of neurological lesions, including stroke, and SCI.
Biochemical monitoring will be applied for objective monitoring of the physiological conditions of patients, such as the physiological state of muscle tissue and the level of neuropathic pain. This method is based on the identification of metabolic and lipid compounds associated with physiological parameters in blood plasma samples, and the subsequent use of these compounds as biomarkers to assess the effectiveness of rehabilitation techniques carried out using the neural interface, as well as to optimize them. This monitoring will be helpful for each individual patient, as it will provide additional information about the course of rehabilitation. Blood sampling and follow-up testing will only be performed for patients who gave their written consent for this procedure. The analysis results will be stored in anonymized form.
The study participants will receive up to 12 rehabilitation procedures, each lasting about one hour, within two-four weeks. During the procedure, the activity of the brain (electroencephalogram) and muscles (electromyogram) will be recorded using non- invasive electrodes placed on the scalp and body. Also, during the study, electrical stimulation will be performed with non-invasive electrodes placed on the body.
During the exercise, participants focus their attention on the target of movement and/or imagine that their arms perform a movement. If the task is completed correctly, the robot will move the arm towards the target. This movement can additionally be accompanied with functional electrical stimulation using disposable electrodes glued to the skin on the back and/or the arms. The strength of the stimulation will be adjusted so as not to cause discomfort. Participants will be randomly assigned to groups, and participants in some groups will receive tSCS and some will not.
On the day of inclusion in the study, as part of Visit 1 (screening), anamnesis will be collected, and there will be performed assessment on the study scales, BCI testing, an EMG study with registration of muscle activity (rhomboid, pectoralis major, biceps, deltoid) and / or visual determination of tSCS thresholds.
After Visit 1, patients in the study groups will undergo 12 procedures of BCI-driven robotic rehabilitation accompanied by tSCS.
Visit 2 is carried out the next day after the end of the study to assess the study scales and conduct the EMG study described above.
Visit 3 is carried out one month after the end of the study to assess the study scales and conduct an EMG study.
Throughout the study, adverse events (AEs) will be monitored. Sessions will be held daily in 6/1 or 5/2 mode, in a rehabilitation room or at patients' homes, with a session duration of about 60 minutes. The duration of Visits 1-3 will be approximately 2 hours.
Investigators expect that a portion of the patients participating in the study will have an improvement in voluntary arm movements by the end of the study.
Patient data will be recorded and stored in anonymized form. Only research team members will have access to this information. If it is necessary to publish individual results on study scales, diagnoses, anamnesis, and age of participants, participants will be identified with codes. The study data is supposed to be stored for 10 years on a protected file storage with limited access. | Criteria for inclusion in the study of patients:
1. Signed written informed consent.
2. Men or women aged 18 to 60 years after a first occurred acute cerebrovascular accident or in the recovery period after injury of the cervical and upper thoracic spinal cord.
3. Early or late rehabilitation period of acute cerebrovascular accident by the type of ischemic stroke or the consequences of SCI in the late recovery period
4. Diagnosis of "acute ischemic cerebrovascular accident", or a condition after spinal cord injury at the C3-C7 level, moderate or high severity ASIA A and ASIA B, according to the discharge summary, MRI or CT.
5. For groups of patients with stroke: the degree of severity of paresis of the upper limb from 3 points to 0 (according to the 6-point MRC muscle strength scale https://cpd-program.ru/methods/mrc.htm)
6. The patient's ability and willingness to comply with the requirements of this protocol.
7. Expressed patient motivation for rehabilitation.
Inclusion criteria for healthy volunteers:
1. Signed written informed consent.
2. Men or women between the ages of 18 and 40
3. Absence of somatic and psychiatric diseases (according to the reports of the subject and according to the examination of a medical specialist before the start of the study)
4. Ability and willingness to comply with the requirements of this protocol.
Exclusion Criteria:
1. Severe cognitive impairment (\<10 points on the Montreal Cognitive Assessment Scale).
2. The score on the Hamilton scale is above 18 points.
3. The rating on the Rankin scale is higher than 4 points.
4. Concomitant diseases that cause a decrease in muscle strength or an increase in muscle tone in the upper limbs (for example, cerebral palsy, brain damage as a result of trauma) or rigidity (for example, Parkinson's disease, contracture).
5. Late stages of arthritis or significant limitation of range of motion.
6. The absence of a part of the upper limb due to amputation caused by various reasons.
7. Any medical condition, including mental illness or epilepsy, that may affect the interpretation of the test results, the conduct of the test, or the safety of the patient.
8. Alcohol abuse, medical marijuana use, or light drug use in the previous 12 months.
9. Use of experimental drugs or medical devices within the previous 30 days prior to Visit 1.
10. Inability to comply with research procedures, according to the researcher.
11. The severity of the patient's condition according to the data of the neurological or somatic status, which does not allow full rehabilitation
12. Visual acuity less than 0.2 in the weakest eye according to the table of visual acuity of Sivtsev.
13. Unstable angina and / or heart attack during the previous month
14. History of stroke (for patients with spinal cord injury) or recurrent stroke (for patients with acute cerebrovascular accident).
15. Uncontrolled arterial hypertension.
16. Ataxia.
17. Pacemaker and / or other implanted electronic devices.
18. Taking muscle relaxants.
19. Peripheral neuropathy.
20. Concomitant diseases in the stage of exacerbation or decompensation, requiring active therapy.
21. The presence of allergic reactions and / or other skin lesions at the place of application of the heart rate electrodes at the time of the study.
22. Acute urinary tract infections.
23. Acute thrombophlebitis.
24. All forms of epilepsy.
25. Benign and malignant neoplasms. |
NCT06433518 | BEst Size for Ovulation Triggering in Poseidon 4 Patients (BEST 4 Study) | This observational clinical study aims to determine the optimal timing of ovulation triggering in women aged 35 and above with poor ovarian reserve.
For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups:
1. \*\*Experimental Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm.
2. \*\*Control Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm.
All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections.
The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates.
Primary and secondary outcomes will be compared between the two groups. | The timing of final oocyte maturation in assisted reproductive techniques is critically important. If serum steroid hormone levels are appropriate during the late follicular phase, ovulation triggering can be performed using various agents. There are numerous comparative studies in the literature on this topic.
However, a key issue is determining the most optimal timing for this trigger. In standard practice, the final triggering is performed when the follicle size reaches 17 mm or more.
The purpose of this is to obtain mature eggs from these follicles during the oocyte aspiration process.
However, in some special cases, to maximize the desired yield, this size threshold may be adjusted.
A prime example of this is in older patients with poor ovarian reserve, as the expected egg yield may not be achieved with standard practices.
During the oocyte collection process, fewer mature oocytes (M2) may be retrieved, or no oocytes may be retrieved at all, despite proper ovarian stimulation. Therefore, the optimal follicle size for these cases has not been definitively established in the literature. Thus, there is a need to determine other follicular thresholds specifically for older women with poor ovarian reserves to enhance egg and mature egg yields.
For this purpose, cases undergoing ovarian stimulation for assisted reproductive treatment and planned final oocyte triggering will be evaluated in two separate groups:
1. \*\*Experimental Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure between 13-16 mm.
2. \*\*Control Group\*\*: Final oocyte triggering will be performed when the follicle or follicles measure greater than 17 mm.
All triggers will be administered uniformly with 6500 units of recombinant hCG and 0,2 mg triptorelin injections.
The primary outcome of the study will be the number of mature oocytes. Secondary outcomes will include fertilization rates, embryo counts, and implantation rates.
Primary and secondary outcomes will be compared between the two groups. | Inclusion Criteria:
Women age \>35 years Women with low serum AMH (\<1,2 ng/ml), low AFC (\<5) Undergoing assisted reproduction with Short antagonist protocol Max daily gonadotropin dose of 300 IU
Exclusion Criteria:
* women with uterine and/or endometrial abnormality, women with endometrioma(s), short or long GnRH-agonist ovarian stimulation protocols, severe male infertiliy, genetic conditions, with normal ovarian reserve markers, \<35 years old, women with prior ovarian surgeries, PGT-a cycles |
NCT06023810 | The Effect of Motivational Interviewing on Treatment Adherence, Self-Efficacy, and Satisfaction in Individuals With Diabetic Foot Ulcers | The rise in diabetes incidence has led to a corresponding increase in diabetes-related complications. Diabetic foot ulcers, a severe consequence of diabetes, have substantial impacts on patients, the social environment, overall well-being, and nursing procedures. Given this context, there is a clear necessity for interventions that motivate patients to adopt beneficial health behaviors and educate them in effectively managing diabetes-related complications. This study seeks to investigate the impact of Watson's motivational interviewing method, which is grounded in the human care theory, on enhancing treatment adherence, self-efficacy, and satisfaction levels among individuals suffering from diabetic foot ulcers.
Hypotheses of The Research H0: There is no difference in self-efficacy for diabetic foot care, diabetic foot care behavior, treatment adherence, and satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education, and those who receive standard education.
H1: There is a difference in self-efficacy for diabetic foot care between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H2: There is a difference in diabetic foot care behavior between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H3: There is a difference in treatment adherence between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education.
H4: There is a difference in satisfaction between individuals with diabetic foot ulcers who receive Watson's human care theory-based motivational interviewing and diabetic foot care education and those who receive standard education. | According to the International Diabetes Federation (IDF) data, there are currently 425 million adults worldwide affected by diabetes, and it is projected to increase to 578 million by 2030 and 700 million by 2045. The increasing prevalence of diabetes has led to a rise in the frequency of complications arising from diabetes. The escalation in diabetes complications and their consequences is concerning. There is a need for interventions that encourage positive changes in health behaviors among patients and teach better management of diabetes-related complications.
Diabetic foot ulcer, a challenging complication of diabetes, has significant effects on physical, mental, social, and economic well-being, leading to reduced quality of life. It often necessitates prolonged hospitalizations, intensive treatment, and high medical costs. One of the nursing models frequently preferred today is the Human Care Theory, developed by Jean Watson between 1975 and 1979. The Human Care Theory is centered around providing quality care to patients and maintaining effective communication. Motivational Interviewing is a counseling approach developed by clinical psychologists William R. Miller and Stephen Rollnick.
The aim of the study is to investigate the impact of Watson's human care theory-based motivational interviewing method on treatment adherence, self-efficacy, and satisfaction in individuals with diabetic foot ulcers. In this study, a randomized controlled experimental-control group experimental design will be used. The population of the study consists of patients who applied to Kocaeli Derince Training and Research Hospital Internal Medicine outpatient clinics between June and October 2023, diagnosed with type 1 and type 2 diabetes mellitus, with first degree diabetic foot wound according to the Wagner classification. With the power analysis program G-Power 3.1.9.2, the sample size was calculated as 38 people (76) in each group. | Inclusion Criteria:
* Individuals with clear consciousness,
* No communication problems,
* Diagnosed with type 1 or type 2 diabetes,
* Grade 1 diabetic foot ulcer according to the Wagner classification,
* Receiving standard wound care,
* Residing in the Kocaeli province,
* No musculoskeletal or neurological disorders that could interfere with the study,
* Individuals willing to participate and who sign the informed consent form.
Exclusion Criteria:
- Patients who do not meet the inclusion criteria and those who decline to participate in the study will not be included. |
NCT00001061 | Comparison of Two Methods in the Treatment of Cytomegalovirus of the Eyes in Patients With AIDS | To evaluate the effect of MSL 109, human monoclonal anti-cytomegalovirus (CMV) antibody, on time to progression of CMV retinitis. To determine the safety and pharmacokinetic profile of MS 109. To evaluate the relationship between pharmacokinetic measurements of MSL 109 and efficacy and virologic markers.
Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients. | Therapeutic agents currently available for CMV retinitis are limited by their inherent toxicities and short half-lives which require frequent intravenous dosing. Alternatively, MSL 109 has demonstrated safety and effectiveness in neutralizing CMV isolates at concentrations easily maintained in AIDS patients.
Patients receive induction therapy with intravenous ganciclovir or foscarnet daily for 14 days, then are placed on standard maintenance therapy with the induction drug for at least 11 months or until progression. Patients are randomized to receive 1 of 2 doses of MLS 109 or placebo every 2 weeks during induction and maintenance. They are followed at weeks 2 and 4 and every 4 weeks thereafter for 40 weeks. Patients who have not progressed by week 40 continue study drug with follow-up every 2 months until CMV progression occurs. AS PER AMENDMENT 11/29/96: Enrollment onto the current study has been discontinued. To study the enhancement of humoral immunity, a high-dose cohort has been added. Patients are now randomized to MSL 109 given at a higher dose or placebo administered at the same intervals as before. Randomization is weighted 2:1 in favor of high-dose MSL 109. Interim analyses will be performed to provide for early discontinuation, as indicated. Patients randomized under earlier versions may continue on their original study assignment if a study endpoint has not been reached. | Inclusion Criteria
Concurrent Medication:
Allowed:
* G-CSF and GM-CSF.
* Antiretroviral therapy.
Patients must have:
* HIV infection.
* First episode of CMV retinitis.
* No prior end-organ CMV disease - PER AMENDMENT 4/25/96: No prior end organ CMV disease within the past 6 months. Subjects who have been prophylaxed with oral ganciclovir and develop an episode of CMV retinitis are eligible.
* No active AIDS-defining opportunistic infection or malignancy that requires nephrotoxic or myelosuppressive therapy.
* Life expectancy of at least 6 months.
* Consent of parent or guardian if less than 18 years of age.
NOTE:
* This protocol is approved for prisoner participation.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
* PER AMENDMENT 4/25/96: Retinal detachment not scheduled for surgical repair, in all eyes meeting other eligibility criteria. (Was written as - No current retinal detachment (although old retinal detachments unrelated to HIV infection which have been repaired are permitted).
* Corneal, lens, or vitreous opacification that precludes funduscopic exam.
* Clinically significant pulmonary or neurologic impairment, such as intubation or coma. (Patients with a CNS mass or history of seizure disorder may enroll.)
* Tuberculous, diabetic, or hypertensive retinopathy, or other retinal lesions that would interfere with measurements of response or progression.
* Known hypersensitivity to the study drugs.
PER AMENDMENT 4/25/96:
* Presence of CMV retinal lesions that are only in areas of the retina which cannot be photographed.
Concurrent Medication:
Excluded:
* Immunomodulators, biologic response modifiers, interferon, or investigational agents that may influence course of CMV infection.
* Systemic acyclovir or any nephrotoxic agent, specifically aminoglycosides, amphotericin B, and parenteral pentamidines.
* Any concomitant therapy that would preclude use of cidofovir, foscarnet or ganciclovir.
Prior Medication:
Excluded: PER AMENDMENT 4/25/96:
* Use of IV ganciclovir, foscarnet or cidofovir within 6 months prior to study enrollment. (Was written - Ganciclovir or foscarnet for non-CMV herpes infections within 6 months prior to study entry.) |
NCT03969615 | SuperNO2VA™ and General Anesthesia Postoperative Care | The purpose of the study is to randomly and prospectively evaluate the differences in outcomes between the control group (closed full facemask immediate post-extubation with standard oxygenating device used post-operatively in PACU) and the SuperNO2VA™ group (SuperNO2VA™ immediate post-extubation and post-operatively in PACU) | Inclusion Criteria:
1. Age 18 years of age or older
2. Patients scheduled for general anesthesia with a supraglottic device or ETT
3. American Society of Anesthesiology (ASA) Physical Status I-IV (E)
4. Has provided written informed consent
5. BMI \> 35 kg/m2 or documented Obstructive Sleep Apnea
Exclusion Criteria:
1. Inability to give informed consent
2. ASA V (E)
3. Allergy to Propofol
4. Any condition, in the Investigator's opinion, that would conflict or otherwise prevent the subject from complying with study required procedures, schedule or other study conduct
5. BMI \< 35 kg/m2 with no documented diagnosis (known) of Obstructive Sleep Apnea
6. Known diagnosis of moderate to severe COPD/lung disease
7. Patients that remained intubated post-operatively
8. Patient refusal to wear the treatment device (SuperNO2VA™, nasal cannula, or oxygen facemask) for the duration of the study period postoperatively |
|
NCT00483925 | Cardiovascular Risk Factors and LCH in Adults | Langerhans-cell histiocytosis (LCH) is a rare disease with features of chronic inflammation and hypopituitarism, conditions associated with increased risk of cardiovascular diseases.
Objective: To investigate glucose and lipid metabolism, insulin resistance, structural arterial and functional endothelial properties in patients with multisystem LCH in a prospective, observational study.
Interventions:Cardiovascular risk factors: arterial blood pressure, lipid profile, mathematical indices of insulin resistance (IR), intima media thickness, brachial artery flow mediated dilatation, dynamic indices of IR, pituitary function and C-reactive protein will be estimated in patients with LCH and in a control group matched for gender, age, BMI and smoking habits. | CARDIOVASCULAR RISK FACTORS IN ADULT PATIENTS WITH MULTISYSTEM LANGERHANS-CELL HISTIOCYTOSIS: EVIDENCE OF ABNORMALITIES OF CARBOHYDRATE METABOLISM
Langerhans cell histiocytosis (LCH) is a rare disease, usually affecting children although it has recently increasingly been recognized in adults with a prevalence of approximately 1/560.000 cases ( , ). LCH is characterized by the aberrant proliferation of dendritic cells of the monocyte-macrophage system that resemble normal epidermal Langerhans' cells. These cells can infiltrate many sites of the body leading to either localized lesions or widespread systemic disease. Although LCH has been shown to be a clonal disorder ( ) it also exhibits features of an inflammatory disease, as altered expression of cytokines and cellular adhesion molecules important for the migration and homing of Langerhans cell has been documented ( , ). In addition, LCH shows a particular predilection for hypothalamo-pituitary axis (HPA) involvement leading to diabetes insipidus and/ or anterior pituitary dysfunction in 15-50% and 5-20%, of patients respectively (3, , , ). These percentages may be higher in adult patients with multisystem involvement, being 94% and 59% respectively ( ).
The ongoing inflammatory process and the presence of hypopituitarism are considered to be two independent risk factors for cardiovascular diseases probably through the induction of insulin resistance (IR) ( , , ). The various therapies used for the treatment of multisystem LCH, chemotherapy, radiotherapy and particularly glucocorticoids, may also adversely affect the cardiovascular system mostly through IR ( , ). It is therefore possible that patients with LCH represent a group at higher risk for cardiovascular diseases through the additive effect of a number of different contributing mechanisms known to induce IR. Insulin resistance besides producing an adverse metabolic profile can also lead to endothelial dysfunction and early vascular disease ( ). Early vascular disease can be detected by non-invasive surrogate markers, such as intima-media thickness (IMT) for vascular structure properties and flow-mediated vasodilatation (FMD) for vascular functional properties ( , , ). Carotid IMT is considered an established marker for early atherosclerotic disease and predictor of future cardiovascular events (16) whereas brachial artery FMD has been correlated with coronary endothelial function, a well-known predictor of future cardiovascular events (18).
Main outcome measures: Cardiovascular risk factors assessment were estimated in patients with LCH and compared to controls; the effect of hypopituitarism, disease activity and/ or treatment were determined.
SUBJECTS AND METHODS All patients have to fulfil the diagnostic criteria for "definitive diagnosis" of LCH ( ). Matched to sex, age, and BMI healthy individuals, in good health and not receiving any medication known to affect carbohydrate, sex hormone metabolism, and/or endothelial function for at least 3 months prior have also to be recruited for the study.
Clinical data of the patients as well as hormonal and imaging assessment will be registered.
All subjects do not have participate in strenuous physical activities and have to be on a balanced isocaloric diet for at least 4 weeks prior to the study. Current smokers will be asked not to smoke one day before the hemodynamic study.
Cardiovascular risk factors assessment:
Clinical cardiovascular risk:
* BMI
* waist circumference
* systolic (SBP) and diastolic (DBP) blood pressure Metabolic Profile
The metabolic study of all patients will be performed after a 10h overnight fasting:
* Oral glucose tolerance test
* Glucose, insulin
* Total cholesterol, HDL-cholesterol, triglycerides
* Indices of Insulin resistance \[GIR ( ), HOMA ( ), QUICKI ( ), MATSUDA ( ), glucose and insulin response to glucose by calculating the area under the curve (AUC) during the OGTT performance for glucose (AUCGLU) and insulin (AUCINS), using the trapezoidal rule, predicted index of first phase of insulin secretion, predicted index of second phase of insulin secretion ( )\].
Hemodynamic studies
* The hemodynamic study will be performed, the day after the metabolic study. Both functional and structural arterial properties will be assessed by non-invasive, easily reproducible hemodynamic ultrasonographic methods, namely: IMT measurement in carotid arteries and both endothelium-dependent FMD and endothelium-independent nitrate-induced dilatation (NID) measurement in brachial artery. IMT, FMD and NID were measured by B-Mode high-resolution ultrasound imaging (VIVID PRO; GENERAL ELECTRIC) ( ).
* Arterial stiffness will be assessed by Applanation Tonometry (SphygmocorTM PWV MEDICAL) on radial artery.
Inflammatory index C-reactive protein (CRP) measurement. References Baumgartner I, von Hochstetter A, Baumert B, Luetolf U, Follath F 1997 Med Pediatr Oncol 28:9-14
* Dunger DB, Broadbent V, Yeoman E, Seckl JR, Lightman SL, Grant DB, Pritchard J 1989 The frequency and natural history of diabetes insipidus in children with Langerhans-cell histiocytosis N Engl J Med 321:1157-1162
* Willman CL, Busque L, Griffith BB, Favara BE, McClain KL, Duncan MH, Gilliland DG 1994 Langerhans'-cell histiocytosis (histiocytosis X)--a clonal proliferative disease N Engl J Med 331:154-160
* de Graaf JH, Tamminga RY, Dam-Meiring A, Kamps WA, Timens W 1996 The presence of cytokines in Langerhans' cell histiocytosis J Pathol 180:400-40
* Egeler RM, Favara BE, van Meurs M, Laman JD, Claassen E 1999 Differential In situ cytokine profiles of Langerhans-like cells and T cells in Langerhans cell histiocytosis: abundant expression of cytokines relevant to disease and treatment Blood 94:4195-4201
* Malpas JS 1998 Langerhans cell histiocytosis in adults Hematol Oncol Clin North Am 12:259-26
* Willis B, Ablin A, Weinberg V, Zoger S, Wara WM, Matthay KK 1996 Disease course and late sequelae of Langerhans' cell histiocytosis: 25-year experience at the University of California, San Francisco J Clin Oncol 14:2073-2082
* Grois NG, Favara BE, Mostbeck GH, Prayer D 1998 Central nervous system disease in Langerhans cell histiocytosis Hematol Oncol Clin North Am 12:287-305
* Makras P, Samara C, Antoniou M, Zetos A, Papadogias D, Nikolakopoulou Z, Andreakos E, Toloumis G, Kontogeorgos G, Piaditis G, Kaltsas GA 2006 Evolving radiological features of hypothalamo-pituitary lesions in adult patients with Langerhans cell histiocytosis (LCH) Neuroradiology 48:37-44
* Alexander RW 1994 Inflammation and coronary artery disease N Engl J Med. 1994 Aug 18;331(7):468-9
* Rosen T, Bengtsson BA 1990 Premature mortality due to cardiovascular disease in hypopituitarism Lancet 336:285-288
* Wilson PW, Kannel WB, Silbershatz H, D'Agostino RB 1999 Clustering of metabolic factors and coronary heart disease Arch Intern Med 159:1104-1109
* Wei L, MacDonald TM, Walker BR 2004 Taking glucocorticoids by prescription is associated with subsequent cardiovascular disease Ann Intern Med 141:764-770
* Andrews RC, Walker BR 1999 Glucocorticoids and insulin resistance: old hormones, new targets. Clin Sci (Lond) 96:513-523
W Wheatcroft SB, Williams IL, Shah AM, Kearney MT 2003 Pathophysiological implications of insulin resistance on vascular endothelial function Diabet Med 20:255-268
Hodis HN, Mack WJ, LaBree L, Selzer RH, Liu CR, Liu CH, Azen SP 1998 The role of carotid arterial intima-media thickness in predicting clinical coronary events.
Ann Intern Med 128:262-269
Schachinger V, Britten MB, Zeiher AM 2000 Prognostic impact of coronary vasodilator dysfunction on adverse long-term outcome of coronary heart disease.
Circulation 101:1899-1906
Anderson TJ, Uehata A, Gerhard MD, Meredith IT, Knab S, Delagrange D, Lieberman EH, Ganz P, Creager MA, Yeung AC, et al 1995 Close relation of endothelial function in the human coronary and peripheral circulations J Am Coll Cardiol 26:1235-1241
Arico M, Girschikofsky M, Genereau T, Klersy C, McClain K, Grois N, Emile JF, Lukina E, De Juli E, Danesino C 2003 Langerhans cell histiocytosis in adults. Report from the International Registry of the Histiocyte Society Eur J Cancer 39:2341-2348
Legro RS, Finegood D, Dunaif A 1998 A fasting glucose to insulin ratio is a useful measure of insulin sensitivity in women with polycystic ovary syndrome J Clin Endocrinol Metab 83:2694-2698
Bergman RN, Prager R, Volund A, Olefsky JM 1987 Equivalence of the insulin sensitivity index in man derived by the minimal model method and the euglycemic glucose clamp J Clin Invest 79:790-800
Katz A, Nambi SS, Mather K, Baron AD, Follmann DA, Sullivan G, Quon MJ 2000 Quantitative insulin sensitivity check index: a simple, accurate method for assessing insulin sensitivity in humans J Clin Endocrinol Metab 85:2402-2410
Matsuda M, DeFronzo RA 1999 Insulin sensitivity indices obtained from oral glucose tolerance testing. Comparison with the euglycemic insulin clamp Diabetes Care 22:1462-1470
Stumvoll M, Mitrakou A, Pimenta W, Jenssen T, Yki-Jarvinen H, Van Haeften T, Renn W, Gerich J Use of the oral glucose tolerance test to assess insulin release and insulin sensitivity Diabetes Care 295-301
Alexandraki K, Protogerou A, Papaioannou TG, Piperi C, Mastorakos G, Lekakis J, Panidis D, Diamanti-Kandarakis E 2006 Early Microvascular and Macrovascular Dysfunction is not Accompanied by Structural Injury in Polycystic Ovary Syndrome. HORMONES (Athens Greece) 5:126-136 | Inclusion Criteria:
* diagnostic criteria for "definitive diagnosis" of LCH
Exclusion Criteria:
* not participate in strenuous physical activities, on a balanced isocaloric diet for at least 4 weeks prior to the study |
NCT02531516 | An Efficacy and Safety Study of JNJ-56021927 (Apalutamide) in High-risk Prostate Cancer Subjects Receiving Primary Radiation Therapy: ATLAS | The purpose of this study is to determine if apalutamide plus gonadotropin releasing hormone (GnRH) agonist in participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT) results in an improvement of metastasis-free survival based on conventional or prostate specific membrane antigen-positron emission tomography (PSMA-PET) imaging evaluated by blinded independent central review (BICR). | This is a randomized, double-blind, placebo-controlled, multicenter study of apalutamide plus GnRH agonist compared with GnRH agonist among participants with high-risk, localized or locally advanced prostate cancer receiving primary radiation therapy (RT). The study will include a Screening Phase, Treatment Phase, a Posttreatment Phase, and a Long-term Follow-up Phase. Participants will either receive either apalutamide (experimental) or bicalutamide 50 milligram (mg) capsule plus placebo as control group. Safety will be monitored throughout the study. | Inclusion Criteria:
* Age \>= 18 years
* Indicated and planned to receive primary radiation therapy for prostate cancer
* Histologically confirmed adenocarcinoma of an intact prostate, and 1 of the following at diagnosis: 1) Gleason score \>=8 and \>=cT2c, 2) Gleason score \>=7, PSA \>=20 nanogram per milliliters (ng/mL), and \>=cT2c
* Charlson index (CCI) \<=3
* An Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) grade of 0 or 1
* Adequate organ function: (1) aspartate aminotransferase (AST), alanine aminotransferase (ALT), within normal limits (WNL), (2) serum creatinine less than (\<) 1.5 milligram/deciliter (mg/dL) (\<133 micromoles/Liter \[mcmol/L\]), (3) platelets greater than or equal to (\>=)140,000/microLiter (mcL), independent of transfusion and/or growth factors within 3 months prior to randomization, (4) Hemoglobin \>= 12.0 gram/deciliter (g/dL) (7.4 millimloes \[mmol\], independent of transfusion and/or growth factors within 3 months prior to randomization
* Participants who are sexually active (even men with vasectomies) and willing to use a condom and agree not to donate sperm during the trial
* Signed, written, informed consent
* Be able to swallow whole study drug tablets
Exclusion Criteria: -
* Presence of distant metastasis, (clinical stage M1). Isolated pelvic nodal disease below the iliac bifurcation (clinical stage N1) is not an exclusion. Diagnosis of distant metastasis (clinical M stage; M0 versus M1a, M1b, M1c) and pelvic nodal disease (clinical N stage; N1 versus N0) will be assessed by central radiological review. Patients are considered eligible only if the central radiological review confirms clinical stage M0.
* Prior treatment with gonadotropin releasing hormone (GnRH) analogue or anti-androgen or both for \>3 months prior to randomization
* Bilateral orchiectomy
* History of pelvic radiation
* Prior systemic (example \[e.g.\], chemotherapy) or local (e.g. radical prostatectomy, cryotherapy) treatment for prostate cancer
* History of seizure or any condition that may predispose to seizure (including, but not limited to prior stroke, transient ischemic attack or loss of consciousness \<= 1 year prior to randomization; brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing edema or mass effect)
* Prior treatment with enzalutamide, abiraterone acetate, orteronel, galeterone, ketoconazole, aminoglutethimide, estrogens, megestrol acetate, and progestational agents (including cyproterone acetate) for prostate cancer
* Prior treatment with radiopharmaceutical agents (e.g., strontium-89) or immunotherapy (e.g., sipuleucel-T) for prostate cancer
* Prior treatment with systemic glucocorticoids ≤4 weeks prior to randomization or is expected to require long-term use of corticosteroids during the study
* Use of 5-alpha reductase inhibitors (e.g., dutasteride, finasteride) \<=4 weeks prior to randomization
* Use of any investigational agent \<=4 weeks prior to randomization
* Current chronic use of opioid analgesics for \>=3 weeks for oral or \>7 days for non-oral formulations
* Major surgery \<=4 weeks prior to randomization
* Current or prior treatment with anti-epileptic medications for the treatment of seizures
* Gastrointestinal conditions affecting absorption
* Known or suspected contraindications or hypersensitivity to apalutamide, bicalutamide or GnRH agonists or any of the components of the formulations
* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject |
NCT00803374 | Combination of Anti-CD137 & Ipilimumab in Patients With Melanoma | The purpose of this study is to determine if BMS-663513 administered in combination with ipilimumab to patients with advanced malignant melanoma is safe and tolerable | Inclusion Criteria:
* Histologically or cytologically confirmed malignant melanoma
* Stage III (unresectable) or Stage IV disease which may have been treated with up to one prior cytotoxic chemotherapy and/or up to 3 other therapeutic regimens
* Willing to undergo up to 3 biopsies of an accessible lesion
Exclusion Criteria:
* Active/symptomatic brain metastases
* Primary ocular melanoma or primary tumor of unknown origin
* Concurrent autoimmune disease
* Previous treatment with a CD137 agonist or CTLA-4 inhibitor |
|
NCT06690073 | The Effect of Motor Relearning Program on Functional Mobility in Stroke Rehabilitation. | 1. To find out the effectiveness of conventional physiotherapy on improving functional mobility of lower extremity among chronic hemiplegic subjects.
2. To find out the effcctiveness of motor relearning program along with conventional physical therapy treatment on improving functional mobility of lower extremity among chronic hemiplegic subjects.
3. To find out the effectiveness of motor relearning program along with conventional physical therapy treatment over conventional physical therapy on improving functional mobility of lower extremity among chronic hemiplegic subjects. | After a careful monitor of inclusion and exclusion criteria and obtaining the institutional review board approval, the study was conducted by convenience sampling to select the suitable subjects, explaining the procedure to them, and got the written \& oral informed consent. The study included two groups, each with 16 participants, which were allocated randomly to the control and experimental groups by lottery method. CPT was administered to the control group three times per week for six weeks (45 minutes per session). CPT treatments such as mat activities, assisted movements, weight-bearing strategies, and gymnasium training were given to the control group. At the same time, the experimental group received the previously mentioned CPT treatment as well as MRP for sitting to standing for six weeks, for a total duration of 45 minutes per session (30 minutes of CPT treatment followed by 15 minutes MRP), three sessions per week.
MRP of sitting and standing activities: The physical therapist was standing in front of the participant, who was sitting in an armrest-equipped chair. Participants were initially taught to keep their feet back, followed by forward trunk positioning. The physical therapist then aided the activity by holding the involved side of the hand and shoulder, where the subject had informed to execute anterior trunk bending more quickly, if the participant did not do it well or performed it in an abnormal manner. Finally, participants were instructed to press down through the affected foot, stand up as quickly as possible, and bring their hips anterior. The physical therapist suggested pressing down through the participant's knee along the shaft of the leg while moving it anteriorly through the affected foot.
MRP of standing to sitting: The participant was on his feet. The physiotherapist assisted the participant with anterior shoulder movement and knee bending at the start of the stand-to-sit movement. The physiotherapist then assisted the participant in keeping his weight on the affected leg while sitting. The subject progressed by standing and sitting with different seat heights, stopping in different parts of the range of motion, and varying speed. These variations in time and space were directed by the physical therapist. The number of reps and intensity of the exercise were classified according to the subject's capacity level and gradually increased as they improved. Subjects were given verbal feedback on weight distribution, performance speed, and encouragement. | Inclusion criteria: The following subjects were included:
* Right or left-sided chronic hemiplegic subjects.
* More than six months after the onset of stroke.
* Age group between 45-65 years of both genders.
* Scored minimally 24/30 on the Mini-Mental State Exam (MMSE).
* Motor assessment scale of sitting to standing section.
* Having normal visual perception.
* Able to follow verbal commands.
Exclusion criteria: The following subjects were excluded:
* Less than six months after the onset of stroke.
* Unable to follow visual and oral commands.
* The age group is below 45 years and more than 65 years.
* Unilateral neglect.
* Cognitive impairments (MMSE scores less than 24/30), or language deficits.
* Any other neurological disorders and recent surgeries.
* Previous exposure to MRP. |
NCT04535505 | Pathogenic Bordetella Rapid Detection | A CPA platform based on the CRISPR technology is going to established to achieve the goal of detecting pathogenic bordetella and drug resistance genes in one step. The accuracy of this platform will be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be set as a gold standard method. | Pertussis is an acute respiratory infectious disease caused by bordetella pertussis. Although it is a vaccine-preventable disease, outbreaks and epidemic cases of whooping cough worldwide have been reported from time to time. Bordella parapertussis, Bodella bronchiseptica, and bordetella hosei can cause pertussis-like diseases with symptoms similar to those of whooping cough. The clinical manifestations are difficult to distinguish, and they are easily reported as cases of whooping cough through the infectious disease network.
The diagnosis of the infectious diseases caused by the four pathogenic bodella mainly relies on laboratory pathogenic testing. At present, the laboratory tests of bordetella that can be carried out in the clinical microbiology laboratory include culture, bordetella pertussis specific antibody (PT-IgG) serological detection, and bordetella pertussis nucleic acid PCR detection. However, none of them meet the requirements of early diagnosis.
Cross primer constant temperature amplification (CPA) is nucleic acid constant temperature amplification technology with independent property rights. The fully automated nucleic acid detection platform equipped with CPA technology would make the detection of four pathogenic bordetella easy, quick and safe and accurate.
As pathogenic bodella is difficult to cultivate and there is no standard for drug susceptibility test. Studies have shown that 57.4% of the isolated clinical isolates of bordetella pertussis have MIC value for erthomycin ≥256 μg/mL , and 23s rRNA 2047 site adenine (A) were mutated to guanine (G).CRISPR/Cas is an immune system in bacteria that can specifically recognize invading nucleic acids and shear them. The CRISPR technology developed based on the CRISPR/Cas principle can detect single point mutations in genes.
The hypothesis that 4 pathogenic bordetella and their erythromycin resistance would be detected in one testing platform simultaneously. The accuracy, reliability, predictive value of this platform would be checked through prospective diagnostic test evaluation methods. Bordetella pertussis isolation culture and identification would be as the gold standard method. | Inclusion Criteria:
* Patients with continuous cough (paroxysmal cough) for more than 1 week, peripheral white blood cell 18×109/L (infants and young children), or\> 15×109/L (children), ineffective use of cephalosporin antibacterial drugs，and these patients whose nasopharyngeal swabs are collected for routine bordetella culture identification and drug susceptibility testing would be included as research object.
Exclusion Criteria:
* Patients with pertussis are suspected clinically but no nasopharyngeal swab specimens are collected or patients with pertussis are clinically excluded. |
NCT05203679 | Evaluation of the Safety and Efficacy of Hemophilia B Gene Therapy Drug | This is a multi-center, single-arm, open-label, single-dose treatment clinical study to evaluate the safety, tolerability and efficacy of BBM-H901 injection in Hemophilia B subjects with ≤2 International unit per deciliter (IU/dl) residual factor IX (FIX) levels.
BBM-H901 is an adeno-associated virus (AAV) vector derived from recombinant DNA techniques to contain an expression cassette of the human factor IX (hFIX) transgene and raises circulating levels of endogenous FIX. | Inclusion Criteria:
1. Males ≥ 18 years of age;
2. Have hemophilia B with ≤2 IU/dL (≤2 %) endogenous FIX activity levels;
3. Have had ≥100 prior exposure days (EDs) to any recombinant and/or plasma-derived FIX protein products based on historical data from the subjects' records/histories;
4. Have had bleeding events and/or injected with FIX protein products (including recombination and plasma source) during the last 12 weeks documented in the subjects' medical records;
5. Have no prior history of hypersensitivity or anaphylaxis associated with any FIX or IV immunoglobulin administration;
6. Agree to use a reliable barrier contraception method from the beginning of signing the informed consent to 52 weeks after administration.
Exclusion Criteria:
1. Being positive for hepatitis B surface antigen (HBsAg) or hepatitis B virus-DNA (HBV-DNA). Being positive for hepatitis C virus antibody (HCV-Ab) or hepatitis C virus RNA (HCV-RNA). Subjects with medical history of hepatitis B or C can be regarded as negative only when 2 required samplings are conducted at least 3 months apart and both test results of indicators aforementioned are negative, i.e. subjects with natural clearance and anti-viral therapy clearance for hepatitis B or C are eligible;
2. Have potential liver diseases, such as previous diagnosis of portal hypertension, splenomegaly, hepatic encephalopathy or liver fibrosis (fibrosis stage ≥ 3); nodules or cysts were found by B ultrasound, or elevated alpha-fetoprotein was detected by laboratory tests. Subjects who are not eligible for the study if the abnormalities are clinically significant regarding to the medical judgement of the investigator;
3. HIV positive patients;
4. Have participated in a previous gene therapy research trial before screening, or in a clinical study with an investigational drug within 5 half-life of the investigational product, whichever is longer;
5. Have alcohol or drug dependence, or cannot stop drinking throughout the study;
6. Any concurrent clinically significant major disease or condition that the investigator deems unsuitable for participation in the study. |
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NCT03093597 | Skin Barrier Biophysical Properties and Clinical Appearance After Moisturizer in Dry Skin | The purpose of the study is to compare the changes in the appearance of dry skin after the use various moisturizers: white petrolatum ointment, coconut oil, jojoba oil, and almond oil in patients with dry skin. | The goal of this study is to compare how the appearance of dry skin changes before and after the use of following moisturizers: white petrolatum, coconut oil, jojoba oil and almond oil). Up to 40 subjects from Banner-University Medical Center/University of Arizona dermatology clinics and University of California, Davis dermatology clinics (up to 20 subjects per site) who have dry skin will be enrolled in this study and randomized to receive the four moisturizers on four locations on their forearms.There will be a total of 3 study sessions: baseline, and approximately 1 and 2 weeks for follow up assessment. At each visit, dry skin severity will be evaluated by a trained observer using a validated Dry Skin Score, skin barrier biophysical properties (transepidermal water loss and hydration) will be measured, and digital photos of the test sites will be taken for image analysis. | Inclusion Criteria:
1. Male and female, at least 18 years of age
2. Subject must receive a diagnosis of dry skin by a dermatologist.
3. Subject must be able to comprehend and read the English language.
Exclusion Criteria:
1. Subjects who do not fit the inclusion criteria.
2. Subjects unable to or unwilling to comply with the study procedures
3. Prior known allergy to white petrolatum, coconut oil, almond oil, or jojoba oil.
4. People who have used products containing white petrolatum, jojoba oil, coconut oil, or almond oil within the past week.
5. People with a known diagnosis of ichthyosis.
6. A subject who, in the opinion of the investigator, will be un-cooperative or unable to comply with study procedures.
7. Subject unable to speak or read the English language, since all consents and instructions will be provided in English.
8. Those that are prisoners or cognitively impaired |
NCT03139292 | Comparative Evaluation of Ambu AuraGain Laryngeal Mask and Proseal Laryngeal Mask Airway | Comparison of two different supraglottic airway devices i.e., the ProSeal Laryngeal Mask Airway (PLMA) and Ambu AuraGain, a third generation laryngeal mask Airway. | The study aims to compare the two devices with respect to:
Time taken for insertion. Insertion attempts or failed attempt. Oropharyngeal leak pressure Air leak Time taken to pass an orogastric tube Attempts to pass an orogastric tube or failed attempt. Haemodynamic variation Incidence of adverse events like failed insertion, aspiration-regurgitation, hypoxia (SpO2\< 90%), bronchospasm, airway obstruction, gastric insufflation, coughing, gagging, retching, hiccup, coughing during removal, blood staining of the airway device and trauma to tongue, lip, teeth, or gums. | Inclusion Criteria:
1. American Society of Anesthesiologists (ASA) Physical Status I \& II
2. Patients undergoing limb or breast surgery
3. Patients undergoing elective surgery under general anesthesia and spontaneous ventilation.
4. Patients with expected duration of surgery of less than 2 hours.
Exclusion Criteria:
1. Patients with known or predicted difficult airway or Mallampati Grade (MPG) III or IV
2. Patients with mouth opening of less than 2.5 cm or cervical spine disease
3. Patients with H/o upper respiratory tract infection in the previous 10 days.
4. Patients with increased risk of regurgitation and aspiration (non-fasting patients, gastroesophageal reflux disease etc.)
5. Patients with a body mass index (BMI) \> 30 kg/m2
6. Patients with past history of radiotherapy involving the hypopharynx/neck area 7Patients with expected duration of surgery of more than 2 hours.
8.Surgery to be performed to the head, neck or thorax, abdomen or in the lateral or prone positions |
NCT06791070 | A Study of RC48-ADC Combined With JS001 for Advanced Extramammary Paget Disease of the Scrotum | The goal of this clinical trial is to learn if Disitamab Vedotin combined with Toripalimab works to treat advanced HER2-positive extramammary Paget disease of the scrotum. It will also learn about the safety of this combination. The main questions it aims to answer are: Does this combination reduce tumor volume and delay disease progression? What medical problems do participants have when receving this combination? Participants will: Intravenous using this combination every 3 weeks until disease progression or intolerable adverse reactions occur. Visit the clinic once every 3 weeks for checkups and tests. | This study is a multiple-center, phase II clinical trial. Participants with HER2-positive advanced scrotal extramammary Paget's disease who met the eligibility criteria were enrolled after signing an informed consent form. All patients received treatment with 2mg/kg of Disitamab Vedotin and 3mg/kg of Toripalimab intravenous infusion every 3 weeks until disease progression. Follow-up was conducted until disease progression, intolerable adverse reactions, withdrawal of informed consent by the participant, loss to follow-up, or death. The area of the largest lesion on the scrotal skin was measured and clinical tumor imaging assessments were performed using RECIST during the treatment process. | Inclusion Criteria:
Voluntarily sign the informed consent form and comply with the requirements of the protocol.
Age ≥ 18 years old. Confirmed diagnosis by histological examination, combined with imaging assessment for scrotal extramammary Paget's disease; pathologically confirmed as HER2 positive, i.e., immunohistochemical test HER2 ≥ 1+.
ECOG score: 0 to 1. At least one measurable lesion (according to the RECIST criteria, non-nodal lesions with a longest diameter on CT scan ≥10 mm, and nodal lesions with a shortest diameter on CT scan ≥15 mm); or skin lesions that can be evaluated according to the WHO criteria.
Adequate organ function: Blood routine: Absolute Neutrophil Count (ANC) ≥1.5×10\^9/L, Platelet (PLT) ≥70×10\^9/L, Hemoglobin (HGB) ≥80g/L; Liver function: Total Bilirubin (TBIL) ≤1.5×Upper Limit of Normal Value (ULN); Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤3×ULN; Serum Albumin ≥28 g/L; Alkaline Phosphatase (ALP) ≤5×ULN; If the subject has received routine liver protection treatment and meets the above standards, and is stable for at least one week after assessment by the researcher, they may be enrolled; Renal function: Serum Creatinine (Cr) ≤1.5×ULN, or Creatinine Clearance ≥50 mL/min (using the standard Cockcroft-Gault formula): Coagulation function: International Normalized Ratio (INR) ≤1.5 / Prothrombin Time (PT) ≤1.5×ULN, Activated Partial Thromboplastin Time (aPTT) ≤1.5×ULN; If the subject is receiving anticoagulant therapy, as long as PT and INR are within the range specified for the anticoagulant medication, it is acceptable.
Estimated life expectancy ≥3 months.
Exclusion Criteria:
Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; Have had active autoimmune diseases within 2 years prior to the start of the study treatment that required systemic treatment (such as the use of disease-modifying drugs, corticosteroids, or immunosuppressants), except for replacement therapies (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency); currently receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy. The dose is \>10mg/day of prednisone or other equivalent hormones, and it is within 2 weeks of the first administration and still in use; Have a history of active tuberculosis; Have uncontrollable, recurrent drainage of ascites, pericardial effusion, or pleural effusion; Have undergone major organ transplantation; Received major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the study treatment; or have chronic non-healing wounds or fractures; Have a history of live attenuated vaccine administration within 14 days prior to the start of the study treatment or plan to receive live attenuated vaccine vaccination during the study period; Have had a severe hypersensitivity reaction after the use of monoclonal antibodies; known allergy to the active ingredients or excipients of this study drug; Within 4 weeks prior to the start of the study, are participating in or have participated in other clinical studies; Have a history of severe allergies; Have a risk of bleeding, or coagulation dysfunction, or are currently receiving -thrombolytic therapy; Have a history of substance abuse and are unable to quit or have mental disorders; According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the study, or there are other reasons deemed unsuitable for enrollment by the investigator. |
NCT02741232 | Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery | In this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. The patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive the pectoral block. Our hypothesis is that the pectoral nerve block reduces the opioid consumption during the surgery. | After induction of general anesthesia with propofol, remifentanil and succinylcholine, the patients will be divided either in the pectoral block group or the control group (sham block). Both groups will receive the same perioperative and postoperative anesthetic protocol. The investigator in charge of the patient will leave the operative room right before the completion of the pectoral block (or the sham block) to preserve randomisation and the block will be performed by another investigator. The pectoral block is performed under ultrasound guidance with 10 cc of lidocaine 1% with epinephrine 1/400000 between the pectoralis major muscle and the pectoralis minor muscle and 20 cc of the same solution between the pectoralis minor muscle and the serratus anterior muscle at the third rib. Anesthesia will be maintained with sevoflurane for a bispectral (BIS) index between 45 and 60. Analgesia will be provided with a perfusion of remifentanil adjusted to maintain a mean arterial blood pressure (MAP) in the range of ± 10% of the basal MAP (mean of the last three MAPs obtained before surgical incision, under sevoflurane-only anesthesia). The total remifentanil consumption will be assessed and compared between the groups. The investigators believe that the pectoral nerve block will significantly reduce the intraoperative remifentanil consumption. | Inclusion Criteria:
* ASA 1 to 3 inclusively
* breast cancer surgery with or without axillary dissection
Exclusion Criteria:
* any contraindication to the pectoral nerve block (coagulopathy, infection, pre- existing neuropathy, local anesthetic allergy and refusal of local anesthesia)
* refusal to participate in the study
* patient with dementia
* preoperative breast pain
* preoperative opioid consumption
* breast reconstructive surgery
* bilateral surgery
* pregnant patient |
NCT01789788 | A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus | This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the last dose of study drug. | Inclusion Criteria:
* Adult patients, 18 to 65 years of age, inclusive
* Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening
* On stable dose of metformin for at least 2 months prior to screening
* Fasting plasma glucose during the screening period \</= 240 mg/dL
* Hemoglobin A1c (HbA1c) levels at screening \>/= 6.5% and \</= 10.5%
* Evidence of insulin secretory capacity at screening
* Body mass index (BMI) 27 to 42 kg/m2, inclusive
* Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol
Exclusion Criteria:
* Type 1 diabetes
* Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
* History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
* Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator
* History of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening
* History or presence of clinically significant concomitant disease or disorder
* Hemoglobin level below the lower limit of reference range at screening
* Pregnant or lactating women
* History of anaphylaxis or severe systemic hypersensitivity or allergic reactions |
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NCT04228484 | The Insulin Response to the Gut Hormone GIP After Near-normalisation of Plasma Glucose in Patients With Type 2 Diabetes | The investigators hypothesise that the insulinotropic effect of endogenous GIP is improvable in patients with type 2 diabetes after three weeks of near-normalisation of plasma glucose. To test this hypothesis, a randomised, placebo-controlled, double-blinded, crossover study employing a GIP receptor antagonist, will be carried out.
Fifteen overweight (body mass index (BMI) \> 25 kg/m2) dysregulated (HbA1c \>/= 59 mmol/mol and treatment with metformin or \>53 mmol/mol and treatment with metformin + add/on) patients with type 2 diabetes will attend two experimental days followed by a three-week-four-week period of plasma glucose near-normalisation (achieved by standard treatment of type 2-diabetes), followed by another two experimental days. On experimental days, patients will receive an infusion of GIP receptor antagonist or placebo during a 75 g oral glucose tolerance test. The primary endpoint is changes in levels of C-peptide divided by changes in levels of plasma glucose and secondary endpoints include changes in circulating levels of C-peptide, insulin, glucose, GIP, glucagon-like peptide 1 (GLP-1), glucagon and markers of bone turnover as well as indices of beta cell function. Furthermore, gastric emptying rate will be assessed. | Glucose-dependent insulinotropic polypeptide (GIP) exerts a strong insulinotropic effect in healthy individuals following meal ingestion. Studies in patients with type 2 diabetes have shown that the insulinotropic effect of exogenous GIP is severely reduced and recent data from the investigators' group suggest that the insulinotropic effect of endogenous GIP is compromised too. Interestingly, after near-normalisation of plasma glucose in patients with type 2 diabetes (continuing metformin and by using empagliflozin + intensive insulin treatment), the insulinotropic effect of exogenous GIP can be restored. The investigators have previously observed a similar restoration of the beta cell secretory response to exogenous GIP after therapy with DPP-4 inhibitors, the effects of which rely on preservation of incretins.
The investigators hypothesise that the insulinotropic effect of endogenous GIP is improvable in patients with type 2 diabetes after three weeks-four weeks of near-normalisation of plasma glucose. To test this hypothesis, a randomised, placebo-controlled, double-blinded, crossover study employing a GIP receptor antagonist, will be carried out.
Fifteen overweight (body mass index (BMI) \> 25 kg/m2) dysregulated (HbA1c \>/= 59 mmol/mol and treatment with metformin or \>53 mmol/mol and treatment with metformin + add/on) patients with type 2 diabetes will attend two experimental days followed by a three-week/four-week period of plasma glucose near-normalisation (achieved by standard treatment of type 2-diabetes), followed by another two experimental days. On experimental days, patients will receive an infusion of GIP receptor antagonist or placebo during a 75 g oral glucose tolerance test. The primary endpoint is changes in levels of C-peptide divided by changes in levels of plasma glucose and secondary endpoints include changes in circulating levels of C-peptide, insulin, glucose, GIP, glucagon-like peptide 1 (GLP-1), glucagon and markers of bone turnover as well as indices of beta cell function. Furthermore, gastric emptying rate will be assessed.
Glucose-lowering drugs based on the effects of another incretin hormone, GLP-1, are successfully being used in the treatment of type 2 diabetes. However, due to the reduced insulinotropic effect of GIP in patients with inadequately controlled type 2 diabetes, treatments based on GIP receptor activation are not on the market. Recently however, a dual GLP-1/GIP receptor agonist has shown promising phase II results. The importance of GIP receptor engagement for the efficacy of these compounds remains to be shown. The present project will answer to what extent the insulinotropic effect of endogenous GIP in patients with type 2 diabetes can be restored following near-normalisation of plasma glucose and thus, provide important perspectives on how to further advance the development of GIP-based therapeutics. | Inclusion Criteria:
1. Type 2 diabetes
2. Metformin treatment
3. Haemoglobin A1c (HbA1c) I. \>/= 59 mmol/mol in case the diabetes treatment is only metformin II. 53-75 mmol/mol in case the diabetes treatment is metformin and add-on therapy
4. Body Mass Index (BMI) \> 25 kg/m2
5. Age \> 18 years
6. Caucasian
7. Normal haemoglobin levels
Exclusion Criteria:
1. Treatment with GLP-1-receptor agonist
2. Any treatment that cannot be paused for 12 hours
3. Diabetes duration more than 20 years
4. Weekly alcohol intake of more than 14 units for men or 7 units for women of alcohol (of 12 g) or narcotics abuse
5. Liver disease
6. Kidney disease (estimated glomerular filtration rate, eGFR \< 60 ml/min/1,73 m2)
7. Unusual dietary preferences or planned weight loss within the duration of the study
8. Any other condition that in the opinion of the responsible investigators is disqualifying.
9. For women I. Current or planned pregnancy for the duration of the study II. Positive pregnancy test at the screening or any of the experimental days III. Women who are currently breastfeeding |
NCT06193798 | Diagnostic Laparoscopy for Unexplained Abdominal Pain | To evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories in general surgery depatment Assuit university hospital | Abdominal pain may be a simple thing or it may be a dangerous and life threatening one.It is very difficult to come to a correct diagnosis(1).Diagnostic laparoscopy gives many advantages in the management of many intra-abdominal conditions where the correct diagnosis could not establish clinically or even with the help of imaging studies(2).Diagnostic laparoscopy can be done under direct vision using simple instruments of laparoscopy. With advances in optics, laparoscopy allows visualization of entire peritoneal cavity and further makes possible histological diagnosis of target biopsy under vision(3).In case of diagnostic uncertainty, laparoscopy may help to avoid unnecessary laparotomy, provides accurate diagnosis, helps to plan surgical treatment, improves the outcome in the majority of patients with abdominal pain and allows surgeons to diagnose and treat many abdominal conditions that cannot be properly managed otherwise(4).Many factors like high diagnostic yield, its applicability and therapeutic management in both elective and emergency setups, reduced hospital stay, low morbidity, and expenditure have made this treatment modality most popular(5). On the otherhand there are Complications related to laparoscopic surgery up to one-half of complications occur at the time of abdominal access for camera or port placement , Others arise from abdominal insufflation, tissue dissection, and hemostasis .Conversion to an open procedure may be needed to manage complications (6).Recent treatises deficient in evalution of the role of lap in cases with vague abdominal pain for this the interest of our study is to evalute the efficiency and safety of diagnostic laparoscopy for patients who have unexplained abdominal pain after completing all needed imaging and laboratories. | Inclusion Criteria:
* Patients with obscure abdominal pain
* Age from 18 years old up to 70 years old
Exclusion Criteria:
1. Current use of narcotics
2. patients have uncontrolled coagulopathy
3. Patients are Haemodynamically unstable
4. patients have Cardiopulmonary problems
5. Patients refusing the diagnostic laparoscopy after routine investigations |
NCT06800690 | Impact of Menstrual Phase on Oral Glucose Sensitivity | In this study we are determining whether the hormones associated with the phases of the menstrual cycle (menstruation \& ovulation) influence taste sensitivity to glucose. We hypothesized that women would be more sensitive to oral glucose as assessed by absolute detection threshold during ovulation than when assessed during menstruation. These phases of the cycle are associated with peak plasma estradiol levels and nadir estradiol levels. There is evidence that estrogen can increase the sensitivity of the metabolic signaling pathway of the pancreatic beta-islet cells to stimulate insulin release more readily when glucose is present by increasing sensitivity of the K-ATP channel to ATP. Since the same metabolic signaling pathway is reported to be present in taste tissue, we tested whether peak estrogen levels would enhance taste detection of glucose but not sweeteners that cannot generate ATP, such as sucralose or methyl-D-glucopyranoside (MDG). | Participants: The participants consisted of 15 healthy, non-obese, cycling females between the ages of 18-46 years. All participants completed informed consent and the study protocol was approved by the Rutgers University Institutional Review Board. 30 participants were screened for eligibility requirements. Inclusion criteria consisted of a regular menstrual cycle of 21-35 days. Exclusion criteria included hormonal contraceptives or other hormonal treatments, a history of polycystic ovarian syndrome (PCOS), menstrual irregularities, pregnancy, diabetes mellitus, thyroid conditions, recent COVID-19 infection, alterations in taste or smell, and medications affecting blood pressure. 23 participants were recruited and 7 participants became ineligible due to a variety of factors including: starting hormonal contraception, an irregular or missed cycle, \<100 ng/mL E3G throughout periovulation, a lack of increased E3G at ovulation as compared to menstruation or lost to follow up. The participants in the control group consisted of 7 healthy, non-obese males between the ages of 18-26 years old.
Ovulation Tracking: Participants were asked to test their urine at the first urination of the day with Mira fertility MAX wands (San Francisco, CA) according to product instructions for 5 days prior to expected ovulation. Mira fertility MAX wands detect urine luteinizing hormone (LH), oestrone-3-glucuronide (E3G), and pregnanediol (PdG). E3G is a metabolite of estrone and is a marker of plasma 17-beta-estradiol. When participants' E3Gs rose above their menstruation baseline and reached \> 100 ng/mL, they were asked to undergo the taste testing.
Biological males were also tested under the same conditions at comparable time differences (approximately 2 weeks apart) as a control for variation in taste testing.
Detection Threshold Testing: Participants underwent detection threshold testing with 1/8 log step serial dilutions of D-(+)-glucose (\> 99.5%, Sigma-Aldrich, USA), sucralose and methyl-D-glucopyranoside (Sigma-Aldrich, USA). The participants were randomly presented with glucose or sucralose detection testing, followed by MDG detection testing. Detection threshold testing followed a 2-alternative-forced choice (2AFC) paradigm. Two medicine cups of Millipore water and dilute stimulus were presented to the participant in random order and the participant was asked which stimulus was "not water." A 4-down-1-up modified staircase method was used to obtain the oral detection threshold of the sweet stimulus. In this method, the participant is required to make the correct choice four times until the next more dilute stimulus is presented, and if the participant is wrong once, a more concentrated stimulus is presented in the next trial. Once the participant has made 5 reversals, the last 4 concentrations are averaged and defined as the detection threshold concentration for that stimulus. Participants wore nose clips throughout their testing.
Hedonic Rating Testing: Participants were trained to use the hedonic labeled magnitude scale. Participants were presented with three rows of randomized 450 mM and 900 mM glucose solutions and asked to taste and expectorate each solution and then rate their liking of the solution on a hedonic labeled magnitude scale. The solutions were presented in random order with a 30 second rinse of Millipore water in between each stimulus. Between each row there was a 2 minute break. Subjects did not wear nose clips for this part of the study. | Inclusion Criteria:
* regular menstrual cycle of 21-35 days
Exclusion Criteria:
* hormonal contraceptives or other hormonal treatments
* a history of polycystic ovarian syndrome (PCOS)
* menstrual irregularities
* pregnancy
* diabetes mellitus
* thyroid conditions
* recent COVID-19 infection
* alterations in taste or smell
* medications affecting blood pressure |
NCT01278550 | Prevention of Recurrent Ulcer Bleeding in High-risk Users of Low-dose Aspirin | Low-dose aspirin is the mainstay of treatment for patients with coronary heart disease and stroke. However, low-dose aspirin increases the risk of ulcer bleeding. Current evidence indicates that 80 - 100 mg of aspirin daily provides good protection against vascular events and the risk of ulcer bleeding is low (about 1% per year). Since the overall risk of bleeding is low, aspirin users who do not have previous ulcer disease do not require prophylaxis with anti-ulcer drugs. In contrast, aspirin users with a history of ulcer disease have a 2- to 4-fold increased risk of ulcer bleeding. The best strategy for reducing the risk of bleeding in high-risk aspirin users remains unclear. Current strategies for high-risk patients include the use of anti-ulcer drugs, elimination of risk factors (e.g. Helicobacter pylori). Recently the investigators have shown that among aspirin users who are infected with H. pylori, the eradication of H. pylori is comparable to omeprazole, a proton pump inhibitor (PPI), in preventing recurrent ulcer bleeding in 6 months.
The investigators postulated that among patients with H. pylori infection and a history of ulcer bleeding who continue to use low-dose aspirin, the long-term risk of ulcer complications after eradication of H. pylori is comparable to that of average-risk aspirin users. | Low-dose aspirin is increasingly used for the prophylaxis against coronary heart disease and stroke. However, it is also an important cause of peptic ulcer bleeding worldwide. In England and Wales, low-dose aspirin is estimated to account for about 10% of ulcer bleeding in people aged 60 and over \[Weil 1995\]. The problem of aspirin-related ulcer disease is expanding with the increasing use of aspirin for cardiovascular prophylaxis.
No dose of aspirin is entirely free of risk. Using a daily dose of aspirin as low as 75 mg, the risk of ulcer bleeding doubles that of non-users \[Weil 1995\]. Previous ulcer disease and concurrent major medical illnesses are important risk factors for ulcer bleeding with low-dose aspirin. Among aspirin users, those with previous ulcer disease have a 5-fold increased risk of ulcer bleeding \[Lanas 2000\]. Recently the investigators have shown that among aspirin users who are infected with H. pylori, the eradication of H. pylori is comparable to omeprazole in preventing recurrent ulcer bleeding in 6 months \[Chan 2001\]. However, whether curing H. pylori infection would confer long-term protection against ulcer bleeding for patients requiring life-long aspirin is uncertain.
To compare the long-term risk of ulcer complications in high-risk aspirin users after eradication of H. pylori with that of average-risk aspirin users. The latter is defined as patients who have no prior history of ulcer bleeding.
The investigators postulated that among patients with H. pylori infection and a history of ulcer bleeding who continue to use low-dose aspirin, the long-term risk of ulcer complications after eradication of H. pylori is comparable to that of average-risk aspirin users.
References Weil J, Colin-Jones D, Langman M, et al. Prophylactic aspirin and risk of peptic ulcer bleeding. Br Med J 1005;310:827-30.
Lanas A, Bajador E, Serrano P, et al. Nitrovasodilators, low-dose aspirin, other nonsteroidal antiinflammatory drugs, and the risk of upper gastrointestinal bleeding. N Engl J Med 2000;343:834-9.
Chan FKL, Chung SCS, Suen BY, et al. Preventing recurrent upper gastrointestinal bleeding in patients with Helicobacter pylori infection who are taking low-dose aspirin or naproxen. N Engl J Med 2001;344:967-73. | High-risk cohort
Inclusion criteria:
Patients must fulfill ALL of the following:
1. History of endoscopically confirmed ulcer bleeding
2. Need long-term aspirin for cardiovascular or cerebrovascular prophylaxis
3. Successful eradication of H. pylori based on histology
Exclusion criteria:
1. Concomitant use of anti-ulcer drug, anticoagulant, non-aspirin NSAIDs or steroids
2. Previous acid-reduction gastric surgery
3. Gastric outlet obstruction, erosive esophagitis, gastroesophageal varices
4. Moribund or incurable cancers
Average-risk cohort
Inclusion criteria:
Patients must fulfill ALL of the following:
1. No history of ulcer bleeding
2. Need long-term aspirin for cardiovascular or cerebrovascular prophylaxis
3. H. pylori positive OR negative
Exclusion criteria:
1. Concomitant use of anti-ulcer drug, anticoagulant, non-aspirin NSAIDs or steroid
2. Previous acid-reduction gastric surgery
3. Moribund or incurable cancers
4. Previous attempts of H. pylori eradication |
NCT01449487 | Investigation of Efficacy and Safety of PPC-5650 to Experimental Induced Sensation and Pain in the Rectosigmoid | Irritable Bowel Syndrome (IBS) is a gastrointestinal disorder characterized by chronic abdominal pain and altered bowel habits in the absence of any organic cause. Patients with IBS visit the doctor more frequently, use more diagnostic tests, consume more medications, miss more workdays, and consume more overall direct costs than patients without IBS. More specific treatment of the localized symptoms of IBS is therefore needed, why the present study will investigate the effect and mechanisms of PPC-5650. PPC-5650 is a new chemical entity that can negatively modulate the activity of Acid sensing ion channels (ASICs). It is a potent low molecular weight inhibitor for this class of ion channels described to date.
It is hypothesized that safety, efficacy and mechanisms of local administration in the rectum of PPC-5650 can be evaluated by use of experimental induced sensation and pain in the rectum. | Clinical pain and especially visceral pain is diffuse and widespread, and normally associated with many autonomic symptoms that may blur the characterization of disease in clinical practice. When treating clinical pain analgesic effects are difficult to evaluate due to a number of factors other than the pain intensity. These modifiers of the effect may include complaints relating to psychological, cognitive and social aspects of the illness, as well as systemic reactions. Hence, any change in these factors will invariably also interfere with pain intensity and pain quality and bias the assessment of analgesics in clinical trials.
Because of the confounders mentioned above, experimental pain models are often advantageous for characterizing analgesics. Basic mechanisms in pain perception, transduction and central processing can also be explored by means of human experimental pain models. These models, when applied to healthy volunteers or to patients, provide an important translational link between preclinical animal testing and human clinical trials. In clear contrast to clinical pain, experimental pain models allow the possibility of controlling the duration, the intensity and the nature of the pain stimulus. As pain is a multidimensional perception it is obvious that the reaction to a single stimulus of a certain modality only represents a limited part of the pain experience and therefore a variety of stimulus modalities are required to mimic the clinical situation. By use of a multi-modal pain model it is possible to induce sensation and pain in the rectum, investigating safety, effect and mechanisms of drugs.
This is an exploratory study investigating effect, mechanisms and safety of PPC-5650 to experimental induced pain in patients with IBS. The study aims to provide data to support further evaluation of PPC-5650 in the gastrointestinal area. | Inclusion Criteria:
* Signed informed consent
* Postmenopausal women or women who have undergone hysterectomy, and males between 18 and 70 years of age
* Pain intensity during pain attack should be \>5 on the GSRS questionnaire
* Hypersensitivity within the last 2 years measured with the barostat
* Patients able to co-operate and tolerate the experimental procedures (as assessed in the training visit)
* Patients on stable medication
* Only patients that do not take over the counter medication 24h before the two study sessions
Exclusion Criteria:
* Any history of, or current condition or medication that, as judged by the investigator, may affect gastrointestinal function and the interpretation of the clinical data
* Any clinically relevant abnormal values from the laboratory tests on hematology, clinical chemistry, urine analyses and/or faeces testing, as judged by the investigator.
* Chronic extraintestinal pain dominating the clinical history
* Any known biochemical or structural abnormality of the digestive tract such as gluten enteropathy, bile acid diarrhea, lymphocytic colitis and/or collagenous colitis, Chronic inflammatory bowel diseases, chronic pancreatitis
* Major intra-abdominal surgery; appendectomy and minor laparoscopic gynecological surgery acceptable.
* Any planned surgical intervention within the duration of the trial.
* Any abdominal surgery
* Participation in any other clinical trial within three months prior to the pre-screening visit.
* Alcohol or drug abuse. |
NCT06183307 | Effects of Nattokinase on Inflammation and Cardiovascular Risk Markers in Patients With Dyslipidemia | The study aims to evaluate the effect of the nattokinase enzyme on inflammation and markers of cardiovascular risk in participants with dyslipidemia. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants with dyslipidemia for two months. | Nattokinase has potent fibrinolytic/antithrombotic, antihypertensive, antiatherosclerotic, lipid-lowering, antiplatelet/anticoagulant and neuroprotective activities. Nattokinase is capable of inhibiting platelet aggregation by blocking the formation of thromboxane and inactivating the type 1 plasminogen activator inhibitory factor. Recently, it was proposed that nattokinase can attenuate oxidative stress and the inflammatory process in in vitro and animal models. However, there are no studies in dyslipidemic patients evaluating these data. | Inclusion Criteria:
* Both sexes;
* Over 18 years of age;
* Isolated increase in LDL-c (LDL-c ≥ 160 mg/dL);
* Isolated increase in triglycerides (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
* increased LDL-c (LDL-c ≥ 160 mg/dL)
* TG (TG ≥ 150 mg/dL or ≥ 175 mg/dL, without fasting);
* Reduction in HDL-c (men \< 40 mg/dL and women \< 50 mg/dL) alone or in association with an increase in LDL-c or TG. If TG ≥ 400 mg/dL.
* Individuals who are already using lipid-lowering therapy (statins or non-statins) will also be included.
Exclusion Criteria:
* Participants with autoimmune and infectious diseases, diabetes, cancer and AIDS;
* Pregnant women;
* Participants using catabolic drugs or antibiotics
* Participants on anticoagulant medication
* Participants using antioxidant vitamin supplements, prebiotic, probiotic or synbiotic and who are allergic to corn or soy starch. |
NCT00966030 | Bioequivalence of the Tablet and Liquid-Filled Capsule Forms of MK0974 (0974-042) | This study will demonstrate the definitive bioequivalence of a solid dose formulation of MK0974 to the liquid filled capsule formulation of MK0974. | Inclusion Criteria:
* Subject is in good health
* Subject is a nonsmoker
* Subject is willing to comply with the study restrictions
Exclusion Criteria:
* Subject has history of stroke, chronic seizures, or any major neurological disorder
* Subject has a history of cancer
* Subject is a nursing mother
* Subject has uncontrolled high blood pressure
* Subject has or has a history of any disease or condition that might made participation in the study unsafe or confound the study results |
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NCT02085369 | Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle | Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (\~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics. | Inclusion Criteria:
* First bariatric surgery
Exclusion Criteria:
* More than one surgery |
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NCT05049889 | Screening for Individual Susceptibility Factors to Immersion Pulmonary Edema | Immersion Pulmonary Edema (IPE) is a relatively new form of hemodynamic pulmonary edema. The number of cases has been increasing over the last ten years and it has become the second most common cause of hospitalization for military divers, after decompression sickness. The pathophysiological mechanisms of IPE are not completely known. Its occurrence is linked to a combination of factors related to the environmental constraints of diving, as well as to the diver's equipment. The main external factors are increased hydrostatic pressure, cold, intense effort and emotional stress. The impact of internal factors is not known. At this time, no severe forms of IPE have been identified in the military. However, it is important to identify this pathology at an early stage, even if the signs appear minor, because the continuation of underwater activity can significantly worsen the clinical picture. The risk of recurrence (greater than 15%) could result in a severe or even lethal accident. | Inclusion Criteria:
* Military or civilian diver with at least 100 dives
* Between the ages of 18 and 60
* Good physical condition (able to run/swim for 30 minutes at a constant pace).
Exclusion Criteria:
* Divers with a current temporary medical incapacity to dive
* Persons with contraindications to physical exercise and/or scuba diving
* Pregnant or breastfeeding women |
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NCT00277017 | Combination Therapy With 5-Fluorouracil, Interferon-an Interleukin-2, & Thalidomide for Metastatic, Advanced or Recurrent Renal Cell Carcinoma | The purpose of this study is to evaluate a therapy combining the established FUNIL regimen with Thalidomide. We want to see how well the therapy works, if it can be easily done, and how well the body handles the treatment. We also wish to see if the addition of Thalidomide will increase the effectiveness of the already established treatment regimen. | Eligible patients who agree to take part in the study will receive oral dosages of Thalidomide at 200mg/day to start, with dosage gradually increasing up to a maximum of 1200mg/day. This will be taken in combination with:
5-fluorouracil, given by continuous IV infusion over 24 hours (Day 1) every week for 4 weeks.
Interferon-α, given subcutaneously on Day 1, 3 and 5 of every week for 4 weeks.
Interleukin-2, given by continuous IV infusion Days 2-5, every week for 4 weeks.
Treatment will be followed by 2 weeks of rest then repeated. | Inclusion Criteria:
* All patients must have histologically proven renal cell carcinoma which is metastatic, non-resectable and/or recurrent.
* Patients must have bidimensionally measurable disease as defined in Section 10.1a documented within 28 days prior to registration. X-rays, scans, or physical exam of all non-measurable disease must be completed within 42 days prior to registration.
* Prestudy chest x-ray must be done within 42 days prior to registration.
* Prior treatment with drugs included in this protocol is permitted if such prior treatment occurred more than 6 months previous or if patient is currently exhibiting minor, mixed or partial response to any of these drugs. Prior treatment with other drugs is allowed as long as therapy was discontinued at least one month previously.
* Prior radiation therapy (to less than 25% of the bone marrow only, see section 19.2), or surgery are allowed. At least 4 weeks must have elapsed since the completion of radiation therapy, and there must be measurable disease outside the radiation fields. At least 3 weeks must have elapsed since completion of surgery.
* Patients must have had an EKG performed within 28 days prior to registration.
* Patients must have a Southwest Oncology Group performance status of 0-2 as defined in Section 10.4.
Exclusion Criteria:
* Patients must not be receiving or planning to receive concomitant biologic therapy, radiation therapy, hormonal therapy, or other chemotherapy while on this protocol (including G/GM-CSF).
* Patients with currently untreated brain metastases or brain metastases on current therapy are not eligible. Patients with prior brain metastases S/P radiation and/or surgery, and with stable response, confirmed by MRI, off corticosteroids may be eligible. Brain MRI within 28 days of treatment and consultation with the Study Coordinator is required for such patients.
* Pregnant or nursing women may not participate. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
* Patients with other serious illnesses, serious active infections requiring treatment with antibiotics, those requiring ongoing therapy with other investigational drugs or those receiving or expected to require corticosteroids are not permitted.
* Patients with known AIDS or HIV-1 associated complex or known to be HIV antibody seropositive are not eligible.
* In calculating days of tests and measurements, the day a test or measurement is done is considered Day 0. Therefore, if a test is done on a Monday, the Monday four weeks later would be considered Day 28. This allows for efficient patient scheduling without exceeding the guidelines. If Day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day.
* Patients must be informed of the investigational nature of this study and give written in-formed consent in accordance with institutional and federal guidelines.
* Patients must be registered with the UNM Cancer Center Protocol Office. All records and flow sheets must be sent to this office.
* Active substance abuse can lead to unexpected and dangerous drug interactions and toxicities and impair compliance; therefore, this condition is an exclusion to registration or continuation on this study. Patients with a history of substance abuse must have blood or urine testing prior to registration on protocol. Psychosocial screening by the clinic psychologist or social worker is also suggested but not required. Patients found to be actively engaged in substance abuse while on protocol may be discontinued from protocol treatment at the direction of their physician and/or the study coordinator. |
NCT05364515 | Plasma Rich in Growth Factors (PRGF) for the Treatment of Lichen Sclerosus Atrophicus of the Vulva | Lichen sclerosus is a chronic dermatosis of the skin and semimucous membranes, characterized by the presence of well-defined atrophic white papules or plaques, which appear mainly on the skin of the anogenital region of both sexes, and less frequently on the skin of the trunk. , mainly affecting postmenopausal women. There is no absolutely effective treatment. Only potent topical corticosteroids control symptoms and improve outcomes, although prolonged use can increase skin atrophy. In severe vulvar lesions, 0.05% clobetasol propionate is indicated, followed by a less potent topical corticosteroid. Relapses often occur if treatment is discontinued altogether, but respond well to reintroduction of treatment.
Plasma Rich in Growth Factors (PRGF®) is a mixture of autologous proteins, prepared from a certain volume of platelet-rich plasma obtained from a small volume of blood, which does not contain leukocytes. To date, there have been no studies evaluating PRGF® treatment in vulvar lichen sclerosus. However, there are several publications that assess the efficacy of PRPs as a treatment for vulvar lichen sclerosus. This clinical study has been designed with the aim of evaluating the efficacy of PRGF® in reducing the main symptoms of vaginal lichen sclerosus atrophicus. | Inclusion Criteria:
* Age \>18 years
* Woman with symptoms associated with LEA confirmed by histological study
* Being 1 month without prior treatment in the affected area as a washing period
* Availability of observation during the treatment period
* Signature of the informed consent
Exclusion Criteria:
* Acute somatic disease
* Infection in the intervention area or active systemic infection
* History of cancerous or precancerous lesions in the intervention area
* In active treatment with other local treatments in the intervention area
* Under active treatment with immunosuppressants and/or anticoagulants
* History of allergies to blood derivatives
* Previous diagnosis of coagulopathies
* Regular and continuous treatment with NSAIDs
* Positive markers for HCV, AfHBs, HIV-I/II or PT
* Pregnancy or women of childbearing age not taking contraceptive measures
* Lactating women
* Treatment with monoclonal antibodies
* Liver failure
* Any inability to participate in the study |
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NCT05286684 | Feasibility of Exosome Analysis in Cerebrospinal Fluid During the Diagnostic Workup of Metastatic Meningitis (Exo-LCR) | The investigators are interested in one of the most frequent tumor types causing leptomeningeal metastasis in order to investigate whether a profile can be established by a high-throughput clinical proteomic approach. All the data acquired will allow a tailored and promising approach to improve the knowledge of metastatic tumor meningitis. | The primary objective is to describe on an exploratory basis the association between the type of proteomic profile from cerebrospinal fluid (CSF) microvesicles (from unsupervised bioinformatics analysis) and CSF cytology analysis (positive, negative, equivocal) in breast cancer patients with suspected leptomeningeal metastases, on initial CSF samples (hereafter referred to as initial proteomic profile and initial cytology). | Inclusion Criteria:
* Patient with histologically proven breast cancer;
* Patient with suspected metastatic leptomeningeal involvement;
* Age ≥ 18 ans ;
* WHO performance status ≤ 2 ;
* Affiliation to the National Social Security System ;
* With informed and signed consent
Exclusion Criteria:
* History of another cancer than the one for which the patient is referred;
* Contraindication to lumbar puncture or cerebrospinal MRI
* Pregnant or breastfeeding woman |
NCT02106754 | Alcohol Screening & Brief Lntervention in Juvenile Justice: Filling the Gap | This proposal is in response to RFA-AA-12-008, Evaluation of NIAAA's Alcohol Screening Guide for Children and Adolescents. Of particular interest to the agency are evaluation of the Screener in clinical and/or other settings to predict alcohol-related consequences including use disorder; its use as an initial screen for drug use, cigarette smoking, conduct disorder, and unprotected sex; and its performance in making predictions concurrently and prospectively. This proposal targets these areas of interest. In addition, the investigators will study implementation of the Brief Intervention (BI) associated with the Screener. There is a great need for both screening and BI in juvenile probation settings as many of these youths have great need but are underserved.Many probation departments are turning to BI to work with probationers and parolees. Screening and BI has demonstrated efficacy in these settings, and yet no randomized control trials have been conducted to evaluate effectiveness in juvenile probation settings. Probation Officers (POs; n=40) are randomized to Screener (S), Screener+BI (SBI), or coaching (CSBI). Youths (N=1000) are randomized to 1 of these 3 conditions, and all receive usual services (US). US consist of regular check-in with PO and access to referral services as needed (counseling, academic tutoring, etc.). Research staffers conduct in-depth assessment at baseline, 6- and 12- months. Sensitivity, specificity, and positive and negative predictive powers (SN, SP, PP, NP) are calculated to predict alcohol risk and consequences, as well as other risky behaviors concurrently and prospectively across age-groups. A 1-way design (S vs SBI vs CSBI) will be used to determine whether SBI and CSBI enhance youth services-use and reduce risks (e.g., alcohol use, risky sex). We examine moderators of outcomes (youth age, PO characteristics) and whether coaching (an important consideration in implementation science) in use of BI improves outcomes. This study will be the first randomized controlled trial evaluating the effectiveness of SBI in a juvenile probation setting. | 1. A) To evaluate SN, SP, PP and NP of the 2-question Alcohol Screener to detect: a) alcohol problems (academic, social, injuries, intoxicated driving, unprotected sex), b) abuse/dependence, c) past 4 week binge drinking. 1B) This will be repeated to predict risk prospectively over 12 months. Classification rates will be compared for race, ethnicity, gender, and age groups.
2. A) To evaluate SN, SP, PP and NP of the 2-question Screener to detect a) 30-day drug use, b) 30-day cigarette use, c) conduct disorder, d) unprotected sex. 2B) This will be repeated to predict risk prospectively over 12 months. Classification rates will be compared for race, ethnicity, gender, and age groups. 3) To evaluate BI as compared to usual procedures. The investigators hypothesize those youths in BI will a) receive more services, b) be more satisfied with services, c) rate the relationship with the PO more highly, and d) have improved outcomes (alcohol, alcohol-related problems, problem recognition). | Inclusion Criteria:
* Youths 9-18 years old
Exclusion Criteria:
* Age (\< 9, \>18 years)
* Prior enrollment in a behavioral intervention study
* PO previously engaging them with Screener |
NCT03910439 | Avelumab in Combination With Hypofractionated Radiotherapy in Patients With Relapsed Refractory Multiple Myeloma | Background:
Multiple myeloma is a cancer that forms from plasma cells which normally produce important immune response antibodies. It cannot be cured. Researchers hope the combination of radiation combined with the drug avelumab causes the immune system to kill myeloma cells more effectively.
Objective:
To see if avelumab given with radiation treatment helps treat multiple myeloma. Also to see if giving the treatments together is safe.
Eligibility:
People ages 18 and older with multiple myeloma that has come back after treatment and has spread to other parts of the body
Design:
Participants will be screened with:
Medical history
Physical exam
Blood, urine, and heart tests
Possible tumor biopsy
Bone marrow testing: A needle will be stuck into the participants hipbone to take out a small amount of marrow.
Positron emission tomography (PET)/Computed tomography (CT) scan and magnetic resonance imaging (MRI): Participants will lie in a machine that takes pictures of the body.
Participants will get avelumab through an intravenous (IV). An IV is a small plastic tube put into an arm vein. They will get avelumab every 2 weeks for 2 doses. Then they will get radiation each day for 5 days. They will continue to get avelumab every 2 weeks as long as they do not have bad side effects and the treatment is helping their disease.
Participants will have blood and urine tests, bone marrow biopsies, scans, and X-rays repeated during the study.
Participants will have a follow-up visit 30 days after their last treatment dose. Then they will have visits every 3-6 months for up to 5 years.... | Background:
* Multiple Myeloma (MM) is a hematologic neoplasm of the plasma cells defined by an M- protein greater than or equal to 3.0 g/dL or bone marrow plasma cells greater than or equal to 10% and presence of end-organ disease.
* Although significant advances in treatment have been made in the past decade, MM remains incurable with median survivals of 5-8 years.
* While therapeutic strides have been made with approvals of immunomodulatory drugs (IMiDs), proteasome inhibitors, and monoclonal antibodies, treatment of relapsed refractory MM (RRMM) remains an unmet need for patients who have exhausted available therapies.
* Extramedullary plasmacytomas arising either from focal bone involvement or from hematogenous spread occur in 7-18% of newly diagnosed MM (NDMM) with an additional 6-20% in RRMM.
* Immune checkpoint inhibitors are being evaluated in combination regimens and evidence exists that radiation therapy (XRT) may synergize with immune checkpoint inhibitors.
Objectives:
- To assess the response rate of avelumab in combination with XRT (BavXRT) in RRMM patients with plasmacytomas or lytic lesions
Eligibility:
* Patients must have previously treated RRMM refractory to, ineligible for, or intolerant of available therapeutic regimens known to provide clinical benefit (e.g, immunomodulatory \[IMiD\], proteasome inhibitor, and anti-cluster of differentiation (CD)38 monoclonal antibody-based treatments).
* Presence of greater than or equal to 1 extramedullary plasmacytoma and/or lytic lesion amenable to XRT
* Age greater than or equal to 18 years
* Adequate organ function, and without serious comorbidity or disease (e.g., autoimmune disease), that would preclude concurrent systemic treatment or radiotherapy.
Design:
* Treatment will consist of a 4-week lead-in with avelumab, followed by concurrent XRT 5 gray (Gy) x 5 days). Monotherapy avelumab will continue indefinitely until progressive disease (PD) or unacceptable toxicity; 28-day cycles.
* Routine safety and MM-specific clinical labs will be assessed. Additional research bloods will be collected for evaluating immune-subsets, endosomes, and peripheral blood T cell repertoire prior to and following treatment (lead-in and prior to XRT, at disease re- evaluations at at time of response \[i.e., complete remission (CR)/progressive disease (PD)\]).
* Bone marrow biopsies will be evaluated for Programmed death-ligand 1 (PD-1)/ligand 1 (L1) expression, and B and T cell subsets using immunohistochemistry (IHC). Flow cytometry will also be used to evaluate stimulatory and inhibitory immune subsets along with endosomes. Standard clinical histopathology and flow cytometry will also be evaluated.
* Single arm, Simon minimax two-stage phase II trial design. The first stage will enroll 13 patients; if futility is not met, second stage will enroll another 14 patients to define the response rate to BavXRT in this population. Early stopping rules for safety will also be applied. | * INCLUSION CRITERIA:
* Patients must have a documented diagnosis of multiple myeloma defined by the International Myeloma Working Group Criteria (IMWG)(3). Patients at initial diagnosis must have had a serum M-protein greater than or equal to 3 g/dL and/or bone marrow plasma cells greater than or equal to 10%, and at least one of the following:
* Anemia: Hemoglobin less than or equal to10 g/dL, or
* Renal failure: serum creatinine greater than or equal to 2.0 mg/dL, or
* Hypercalcemia: Calcium (Ca) greater than or equal to10.5 mg/dL, or
* Lytic bone lesions on X-ray, computed tomography (CT), or positron emission tomography (PET)/CT, or
* greater than or equal to 2 focal lesions on spinal magnetic resonance imaging (MRI), or
* greater than or equal to 60% bone marrow plasma cells, or
* Involved/un-involved serum free light chain ratio greater than or equal to 100
* Have at least one extramedullary plasmacytoma or lytic lesion which at the discretion of the investigators is amenable to and clinically indicated for localized radiation therapy
* Must have Relapsed or Relapsed and Refractory Multiple Myeloma. Patients must have documented evidence of progressive disease (PD) as defined by the IMWG criteria on or after their last regimen and must have achieved a minimal response (MR) or better to at least one prior regimen. Definitions by the IMWG:
* Relapsed and refractory: disease that is nonresponsive while on salvage therapy or progresses within 60 days of last therapy in patients who have achieved minor response (MR) or better
* Relapsed: disease that progresses and requires the initiation of salvage therapy but does not meet criteria for either primary refractory or relapsed and refractory MM categories
* Patients must have been previously treated for MM and be refractory to, not a candidate for (ineligible), or intolerant of available therapeutic regimens known to provide clinical benefit including immunomodulatory (IMiD), proteasome inhibitor, and anti-cluster of differentiation (CD)38 monoclonal antibody-based treatments.
* Documented measurable disease within the 4 weeks prior to registration defined by any one of the following:
* Monoclonal Bone marrow plasma cells greater than or equal to 5%
* Serum monoclonal protein greater than or equal to 0.2 g/dl
* Urine monoclonal protein \>200 mg/24 hour
* Serum immunoglobulin free light chain \>10 mg/dL AND abnormal kappa/lambda ratio
* A measurable lesion on PET/CT or MRI
* Be greater than or equal to 18 years of age on day of signing informed consent
Note: The estimated 2017 US incidence of MM of patients under the age of 20 is 0.0%; therefore, children are excluded from enrollment in this study.
* Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
* Adequate organ function as evidenced by the following laboratory parameters:
* Absolute neutrophil count (ANC) greater than or equal to 1000 /mcL
* Platelets greater than or equal to 75,000 / mcL
* Hemoglobin greater than or equal to 8 g/dL (transfusions permitted)
* Serum creatinine less than or equal to 1.5 X upper limit of normal (ULN) (except if due to myeloma)
OR
* Measured creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR) by Chronic Kidney Disease Epidemiology Collaboration (CKD- EPI) formula may be used to estimate CrCl/eGFR greater than or equal to 30 mL/min/1.73 m(2) for subject with creatinine levels \> 1.5 X ULN
* Serum total bilirubin less than or equal to 1.5 X ULN OR Direct bilirubin less than or equal to ULN for patients with total bilirubin levels \> 1.5 ULN (except if due to myeloma)
* Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic pyruvic transaminase (SGPT) less than or equal to 2.5 X ULN (except if due to myeloma)
* The effects of avelumab on the developing human fetus are unknown, however, given the known role of Programmed Cell Death Ligand 1 (PD-1)/Programmed death-ligand 1 (PD-L1) in maintaining the maternal/fetal tolerance, avelumab can be expected to have an adverse effect on pregnancy, including embryo-lethality. Women of child-bearing potential (WOCBP) and men must agree to use highly effective contraception (such as implants, injectables, combined oral contraceptives, intrauterine device (IUDs), sexual abstinence or vasectomised partner) prior to study entry and for the duration of study treatment, and for at least 30 days after the last dose of avelumab. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
NOTE: WOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.
* Negative serum or urine pregnancy test at screening for WOCBP.
* Ability of patient to understand and the willingness to sign a written informed consent document
EXCLUSION CRITERIA:
* Patients with clinically unstable lesions (e.g., impending cord compression) where a delay in receiving radiation therapy (XRT) would be detrimental are not eligible
* Current or prior anti-cancer treatment prior to the first dose of avelumab as defined below:
* Chemotherapy, targeted small molecule therapy, or other anti-cancer treatment not otherwise specified below within 2 weeks
* Radiation therapy within 2 weeks
* Anti-cancer monoclonal antibody (mAb) treatment within 4 weeks
* Use of an investigational agent (e.g., biologic, drug, or other) within 4 weeks
* Allogeneic stem cell transplant
* No autoimmune disease, as follows:
* Active (acute or chronic) autoimmune disease that might deteriorate when receiving an immuno-stimulatory agent. Patients with type I diabetes, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment may be eligible.
* History of serious autoimmune-related disorders including immune colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis whether drug- mediated or not.
* Current use of immunosuppressive medication, EXCEPT for the following:
* Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection)
* Systemic corticosteroids at physiologic doses
* Steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication)
* Uncontrolled intercurrent illness including, but not limited to the following that may limit interpretation of results or that could increase risk to the patient in the judgment of the investigator:
* Patients with a positive hepatitis B core antibody \[HBcAb\] and negative surface antigen (HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable
* Patients who are positive for hepatitis C virus (HCV) antibody must be negative for HCV by polymerase chain reaction (PCR) to be eligible for study participation
* Known acquired immunodeficiency syndrome (AIDS). Controlled and stable human immunodeficiency virus (HIV) positivity is allowed
* Prior organ transplantation including allogenic stem-cell transplantation
* Clinically significant cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (greater than or equal to New York Heart Association Classification Class III), or serious cardiac arrhythmia requiring medication. Mild arrhythmias, e.g. stable atrial fibrillation, may be allowed at the discretion of the investigator
* Active infection requiring systemic therapy (minor infections may be allowed at the discretion of the investigator)
* Known mental or physical illness that would interfere with cooperation with the requirements of the trial or confound the results or interpretation of the results of the trial and, in the opinion of the treating investigator, would make the patient inappropriate for entry into the study.
* Persisting toxicity related to prior therapy (Grade \> 1); however, alopecia, sensory neuropathy Grade less than or equal to 2, or other Grade less than or equal to 2 not constituting a safety risk based on investigator s judgment are acceptable.
* Vaccination with live vaccines within 4 weeks of the first dose of avelumab and while on study is prohibited (inactivated vaccines may be administered).
* Pregnant or lactating females. Because there is an unknown but potential risk for adverse events in nursing infants, on-study breastfeeding is not allowed.
* History of allergic reactions or hypersensitivity to avelumab or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (Grade greater than or equal to 3) unless felt to be in the best interests of the patient at the discretion of the investigator.
* Known additional malignancy that is symptomatic or requires active systemic treatment (at the discretion of the principal investigator (PI), exceptions may be made if in the best interest of the patient).
* Other severe acute or chronic medical conditions including immune colitis, inflammatory bowel disease, immune pneumonitis, pulmonary fibrosis or psychiatric conditions including recent (within the past year) or active suicidal ideation or behavior; or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. |
NCT04810624 | Relapse Prevention and Changing Habits in Anorexia Nervosa | This study aims to optimize a treatment package for the relapse prevention treatment of AN. In the Preparation Phase, we examined accessibility and feasibility of the treatment package.
In the current Optimization Phase, we will identify which components of treatment contribute to positive outcomes after acute hospitalization. We will carefully evaluate maintenance of remission, measured by rate of weight loss and end-of-trial status. | While many approaches to reducing relapse after hospital care have been tried, there is little information about which treatment elements confer benefit. This trial, Relapse Prevention and Changing Habits (REACH+), targets the habitual control of maladaptive behavior to support patients with AN in the 6 months after acute treatment, a time of high vulnerability to relapse. Each component of REACH+ addresses a question that is critical to answer in order to identify and optimize a relapse prevention treatment package that balances efficacy and burden. We will test the acceptability and feasibility of 5 components that together target habits: 1) Behavioral, 2) Cognitive, 3)Motivation, 4) Food Monitoring, and 5) Skill Consolidation. In the Preparation Phase, 10 participants were enrolled, and accessibility and feasibility of the treatment package was examined. The current Optimization Phase includes a finalized treatment manual (including an online platform) and will test each component's contribution to weight maintenance after acute treatment. | Inclusion Criteria:
* Diagnosis of Anorexia Nervosa at hospital admission
* Medically Stable
* Internet capability with videoconferencing
* Weight restored (BMI \> 19 kg/m2) at New York State Psychiatric Institute
Exclusion Criteria:
* Current substance use or other comorbid disorder requiring specialized treatment
* Pregnancy
* Imminent risk of suicide
* Serious medical illness
* Daily psychotropic medication other than antidepressants (medications that are known effect weight are exclusionary, i.e. stimulants, olanzapine, mirtazapine)
* Participation in outside psychotherapy or structured treatment program (support groups will be allowed). Individuals who are discharged on medications would need to have a non-study psychiatrist. |
NCT04202913 | Building Resilience for Healthy Kids | School based, mental-health intervention focused on improving self-efficacy and coping skills in children aged 9-13 years. The overall premise of our intervention is that by teaching children these skills they will in-turn become more resilient when faced with life-stressors and/or adverse events. | Healthy Kids is a 1:1 health coaching intervention delivered in school-settings. Students meet weekly with their assigned health coach and together they identify both strengths and areas for improvement with respect to resilience, developing resilience skills, and setting resilience goals. Topics discussed include coping skills, self-efficacy, and interpersonal relationships. The program was developed using the social determination theory (SDT), goal theory, and elements from the social-ecological model. SDT was used within the intervention to promote and facilitate behavior change. Goal theory was also utilized to develop strategies to support youth short- and long-term goal setting. Finally, weekly discussions about resilience and goal setting activities accounted for elements of the social-ecological model which acknowledges that behaviors are not independent factors, but are influenced by multiple levels of one's personal and social environment. | Inclusion Criteria:
* All children in participating school
Exclusion Criteria:
* None. |
NCT06384417 | Using an End-of-life Conversation Game to Engage Patients with Cancer in Advance Care Planning: Phase 2 | The goal of this clinical trial is to explore feasibility, acceptability, and effectiveness of end-of-life conversation game "Hello" as a tool to help individuals with various solid cancer types (including: breast, gastro-intestinal, lung, melanoma, head and neck, and/or genito-urinary cancers) treated at Penn State Health clinics and their loved ones perform advance care planning (ACP). The main questions it aims to answer are:
What modifications and/or adaptations are necessary to Hello for use in cancer populations?
What impact does participation in Hello event have on health care usage (e.g., number of hospitalizations, ICU admissions, emergency department visits, etc.)? How feasible is it to randomize participants to play either Hello for Cancer or Table Topics?
Participants will:
* Complete pre-game questionnaires
* Play either Hello or Table Topics game
* Complete post-game questionnaires
* Participate in a focus group
* Complete a telephone follow up interview 1-4 months after their event
This study is a continuation of NCT06028152. | Previous studies conducted by the investigators have shown that the Hello game demonstrates successful advance care planning (ACP) engagement in general populations, but has yet to be tailored to meet the unique needs of patients with advanced cancer and their caregivers. Outlining their care preferences by engaging in ACP is an important aspect of care according to patients with advanced cancer. However, only 55% of patients with advanced cancer patients have participated in ACP. These patients have substantial bio-psycho-social stressors that distinguish their ACP needs from others. Tailoring established interventions that foster high quality conversations about medical treatment preferences and end-of-life issues (such as the Hello game) is critically important for this population given its unique needs. As evidenced by qualitative interviews with \>200 participants, the Hello game creates a safe environment for sensitive conversations about end-of-life issues and inspired sharing of rich perspectives, with no reported adverse events, excessive burden, or negative emotional effects. That said, the intervention must be adapted for patients with cancer, particularly those with advanced cancer and their caregivers.
Additionally, while several effective ACP interventions exist (including Hello), how best to disseminate these interventions has not been rigorously or systematically studied. In other ongoing and previous studies, the investigators have demonstrated success in both engaging individuals living in underrepresented communities in ACP and successfully enrolling them in interventional research about ACP. The investigators credit these successes to their unique intervention delivery approach called the Community Based Delivery Model (CBDM). The CBDM overcomes key barriers to ACP (such as healthcare distrust, resistance, and hesitancy to discuss end-of-life issues) by leveraging established community connections to recruit participants to participate in ACP interventions as well as research. In the CBDM, trusted community "hosts" (who are leaders from local hospice organizations, senior centers, health agencies) invite participants to attend an ACP event. They introduce the research team to the attendees who may choose to participate in the ACP activity, the research, or both. Hosts are provided with marketing materials and utilize their community network channels to advertise the event. This model allows for research to be conducted more easily within hard to reach and underserved communities such as Black, Hispanic and rural communities- much like the most remote communities across the Penn State Cancer Institute's 28-county catchment area.
Patients with cancer, however, are unique, and may require an alternative approach that involves partnering with their oncology care team to introduce the concept of ACP and encourage participation in ACP and research. Notably, there is evidence that patients are more likely to engage in ACP when recommended by their physician, so how best to approach ACP for cancer patients is unknown. A common approach to ACP intervention research is to use a Healthcare Based Delivery Model (HBDM). In contrast to the CBDM, the HBDM is positioned within the healthcare system (i.e., clinic-based recruitment) as the ACP intervention is recommended by the patient's clinician (rather than through community-based outreach groups). For this intervention delivery approach, research assistants support interactions between clinicians (providers or nurses) to find appropriate patients and garner interest in performing ACP. This model is commonly used to recruit patients for clinical trials, including ACP interventions. For patients with cancer, the HBDM may have some advantages over the CBDM, given the close bonds that form between a patient and clinical care team as they interact frequently during active treatments such as infusions and radiation that often span several hours and weeks. Leveraging these therapeutic relationships may support greater acceptance of opportunities to broach ACP than a community-based model, but this remains unknown. | Inclusion Criteria Patient with Cancer:
* Adults (\> 18 years old)
* Able to speak and read English and/or Spanish
* Be an individual diagnosed with a solid tumor cancer (e.g., breast, colon, lung, melanoma, head and neck, or genitourinary/prostate cancer) as verified by primary oncologist or is the chosen caregiver for a participant with those cancers
* Receives care at Penn State Health or is the chosen caregiver for a participant treated at Penn State Health
Exclusion Criteria Patient with Cancer:
* Has completed an advance directive since cancer diagnosis as verified by presence in the patient's medical chart
* Has not received treatment for their cancer at a Penn State Health facility in the past year
* Unable to consent to participate in study
Inclusion Criteria Caregiver/Loved one:
* Adults (\> 18 years old)
* Able to speak and read English and/or Spanish
* Be the chosen caregiver for a participant with cancer
Exclusion Criteria Caregiver/Loved one:
\* Unable to consent to participate in study |
NCT03611374 | Regional Anesthesia for Cardiothoracic Enhanced Recovery (RACER) Study | The erector spinae plane block is a novel regional anesthetic technique that allows for analgesia of the thorax and abdomen with a peripheral nerve block. The goals of this study are to determine if bilateral erector spinae plane blocks (ESPB) after sternotomy for congenital heart repair in high risk children and adults can decrease outcomes such as duration of postoperative mechanical ventilation (MV), perioperative opioid consumption, days in the intensive care unit (ICU) and length of stay (LOS). | Inclusion Criteria:
i) Ages 0-99 ii) Give consent/parental consent to participate in study iii) Patients undergoing sternotomy for congenital heart repair surgeries
Exclusion Criteria:
i) Participants who do not consent or have parental consent ii) Patients who are clinically unstable or require urgent/emergent intervention iii) Patients under 5kg |
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NCT01270503 | Post-Marketing Safety Study of Menactra® in Healthy Children, Adolescents, and Adults in the Philippines | This aim of the study is to assess post-marketing safety of a single dose of Menactra® vaccine with the intent to support conversion from monitored release to initial registration of Menactra® vaccine in the Philippines.
Primary Objective:
To describe the serious adverse events occurring within 30 days among participants who have received one dose of Menactra® vaccine. | Each study participant will receive one dose of Menactra® vaccine and will be monitored for safety for 30 days post-vaccination. | Inclusion Criteria:
* Aged 2 to 11 years of age on the day of inclusion (Group 1)
* Aged 12 to 17 years of age on the day of inclusion (Group 2)
* Aged 18 to 55 years of age on the day of inclusion (Group 3)
* Provision of informed consent form signed by the parent(s) or legal representative (Group 1)
* Provision of assent form signed by the subject and informed consent form signed by the parent (s) or legal representative (Group 2)
* Provision of informed consent form signed by the subject (Group 3)
* If the subject (Group 3) or the subject's parents or legally accepted representative (Group 1 and 2) are illiterate, an independent witness is required to sign the consent form
* Subject and parent/legally acceptable representative (if applicable) able to attend all scheduled visits and comply with all trial procedures
* For a woman of child-bearing potential, sexually active, use of a medically acceptable and effective method of contraception for at least 4 weeks prior to vaccination, until at least 4 weeks after vaccination (not applicable for females not of child-bearing potential or not sexually active).
Exclusion Criteria:
* For a woman of child-bearing potential sexually active, known or suspected pregnancy or positive serum/urine pregnancy test (not applicable for females not of child-bearing potential or not sexually active)
* Breast-feeding woman
* Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the trial vaccination
* Planned participation in another clinical trial during the present trial period
* Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months or long-term systemic corticosteroid therapy
* Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or to a vaccine containing any of the same substances
* Chronic illness at a stage that could interfere with trial conduct or completion, in the opinion of the Investigator
* Receipt of any vaccine in the 4 weeks preceding the trial vaccination
* Planned receipt of any vaccine during the present trial period
* Known personal or maternal Human Immunodeficiency virus (HIV), Hepatitis B antigen or Hepatitis C seropositivity as reported by the subject/parent/guardian and/or based on medical history
* History of seizures
* Thrombocytopenia, bleeding disorder or anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection
* Personal of family history of Guillain-Barré Syndrome. |
NCT04729855 | Association of Autophagy-related Genes ,LncRNA and SNPs With Colorectal Cancer in Egyptian Population | 1. Determination of expression level of HOTTIP and EIF4EBP1(Eukaryotic translation initiation factor 4E-binding protein 1) .
2. Investigation of the SNP HOTTIP rs1859168 and it's association with CRC susceptibility.
3. Correlation of the expression of these genes with various stages of CRC to determine the prognostic value of each of them. | Colorectal cancer (CRC) is a common digestive tract tumor 1.It is the third leading cause of death in the world. Overall 5-year survival rate is less than 40%, and the occurrence is rising 2. However, the prognosis and therapy have not been significantly improved. Therefore, a proper selection of patients for aggressive treatment is necessary, new therapeutic and prognostic strategies are urgently needed 3.
Autophagy is a pathway for self-digestion, in which unwanted cytoplasmic components are recycled 4.In normal conditions, autophagy is essential for cellular homeostasis 5. Autophagy has dual roles in cancer cells, stimulation or suppression , with effects on progression and oncogenesis 6.Recent research established that autophagy is important target for controlling cancer depending on stage and type of tumor 7.Diverse molecular mechanisms contribute to cancer cells resistance to treatment 8.Among these mechanisms , autophagy appears to be critical 9.
EIF4EBP1 (Eukaryotic translation initiation factor 4E-binding protein 1) is encoded by EIF4EBP1 gene.It acts as an effector in mTOR (mammilian target of rapamycin) pathway which on activation ,EIF4EBP1 is phosphorylated promoting cell proliferation 10. Studies have suggested that EIF4EBP1 promotes carcinogenesis as in hepatocellular carcinoma .However, its role in CRC have not been elucidated 10.
Long non-coding RNAs (lncRNAs) are group of RNA , 200 nucleotides in length 11,. Expression of lncRNAs has been discovered in multiple tumors, acting as oncogenes. 'HOXA(hydrogenase transcriptional regulatory protein) transcript at the distal tip' (HOTTIP) has received attention lately.It is up-regulated in CRC tissue, regulating genes via epigenetic modification. Therefore, it might be a candidate for cancerization and therapy of CRC 12.
Expression of lncRNAs could be affected by single nucleotide polymorphisms (SNPs), the most common genetic variation in human genomes13. rs1859168 was reported as a potential functional polymorphism on HOTTIP that alters its expression level 14.. Also, it was recently reported that HOTTIP enhances interleukin 6 expression, which potentiates immune escape of cancer cells 15. | Inclusion Criteria:
* No sex predilection.
* Age (25-65 yr).
* Colorectal carcinoma confirmed by histopathological examination
Exclusion Criteria:
* -patients who received any treatment.
* Cases with other organ cancers.
* History of chemotherapy and radiotherapy.
* Systemic diseases such as renal failure, diabetes mellitus, and hypertension. |
NCT03078543 | Ten Year Implant Survivorship of the ANTHEM™ PS Total Knee System | The ANTHEM™PS Total Knee System is being conducted to demonstrate non-inferiority of 10 year implant survivorship in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature | The ANTHEM PS Study is a prospective, multicentre, cohort study to collect relevant patient reported, clinical, surgical and radiological data from 143 subjects implanted with the ANTHEM™PS Knee System for degenerative joint disease in up to 6 clinical sites globally. Total study duration for study participants will be 10 years with post-operative follow-up visits planned for 6 weeks, 1 year, 2 years, 5 years, 7.5 years and 10 years. The study will evaluate the 10 year implant survivorship and the safety and outcome of the ANTHEM™PS Knee System over 10 years. This is a post-market study of the ANTHEM™PS Total Knee System.
The primary objective of the study is to demonstrate non-inferiority (8% margin) of 10 year implant survivorship of the ANTHEM™PS Total Knee System in patients undergoing total knee arthroplasty for osteoarthritis compared to reported literature.
The secondary objectives of the study are to evaluate shorter and long term safety and outcomes of the ANTHEM™ PS Total Knee System.
* Knee injury and Osteoarthritis Outcomes Score (KOOS)
* 2011 Knee Society Score (2011 KSS)
* EQ-5D - 3L
* Femoral Fit ('Perfect Fit' rate)
* Radiographic Assessment
* Revision for any reason
* Adverse Events (AEs) | Inclusion Criteria:
1. Subject is a candidate for primary total knee arthroplasty due to degenerative joint disease
2. Subject is willing to sign and date an EC-approved consent form
3. Subject is male or female between the ages of 18 and 75 years of age
4. Subject plans to be available through ten (10) years post-operative follow-up
5. Subject agrees to follow the study protocol
Exclusion Criteria:
1. Subject would receive the ANTHEM™ Total Knee System on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty
2. Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
3. Subject has a history of patellar fracture, patellectomy, patello-femoral instability
4. Subject has inflammatory arthritis
5. Subject possesses a contralateral or ipsilateral revision hip arthroplasty
6. Subject has ipsilateral hip arthritis resulting in flexion contracture
7. Subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the Investigator:
* Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty
* Contralateral primary total knee or unicondylar knee arthroplasty
8. Subject has an active infection or sepsis (treated or untreated)
9. Subject has presence of malignant tumor, either primary or metastatic, or benign tumor on leg with the knee to be treated
10. Subject has conditions that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes mellitus i.e. not under treatment with oral/injectable medications to control blood glucose levels, fibromyalgia, moderate to severe renal insufficiency or neuromuscular disease)
11. Subject has a chronic, contralateral lower extremity condition causing abnormal ambulation, which is not related to the knee (e.g. ankle fusion, ankle arthroplasty, previous hip fracture).
12. Subject is pregnant or plans to become pregnant during the study
13. Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study, including mental illness, mental retardation, drug or alcohol abuse
14. Subject has a BMI\>40
15. Subject is enrolled in another investigational drug, biologic, or device study
16. Subject is facing current or impending incarceration
17. Subject has an inadequate bone stock to support the device which would make the procedure unjustifiable, including but not limited to: severe osteopenia/osteoporosis or family history of severe osteoporosis/osteopenia |
NCT01972802 | International Cancer of the Head and Neck, Genetics and Environment (InterCHANGE) Study | Our overall objective is to understand the role of lifestyle factors, genetics and HPV infection in the development and prognosis of head and neck cancer particularly in Asia. | Inclusion Criteria:
Age 18\~80 Incident head and neck cancer patients
* Oral, oropharynx and hypopharynx (C00-C14)
* Laryngreal cancer (C32)
* \*Esophageal cancer if possible (C15)
Exclusion Criteria:
* Salivary gland (C07-C08)
* Nasopharynx (C11)
* Thyroid (C79.3) |
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NCT02507271 | Speed of Processing Training in Traumatic Brain Injury | The purpose of this project is to test the hypothesis that Speed of Information Processing (SIP) deficits in acquired brain injury (ABI) can be remediated. The majority of individuals with acquired brain injuries have speed of information processing deficits as part of the cognitive sequelae of the brain injury. Empirical research is expected to demonstrate the efficacy of computerized cognitive Speed of Information Processing (SIP) training in individuals with ABI.
Study participants will be asked to attend two study visits over the course of approximately 13 weeks. Participants will be randomly assigned to either the experimental or control group. | The specific aims of the current research protocol are as follows: Aim 1: To test the hypothesis that SIP training of individuals with ABI will improve processing speed. This study is expected to demonstrate that individuals with ABI that receive SIP training will improve on neurocognitive measures of processing speed. Aim 2: To test the generalizability of SIP training of individuals with TBI to other cognitive domains beyond information processing speed. This study is expected to demonstrate increases in working memory, attention and executive functioning in the group that receives the cognitive training. Aim 3: To test the hypothesis that SIP training of individuals with TBI will improve mood. This study is expected to demonstrate that self-reported levels of depression will improve in the group that receives cognitive training. Aim 4: To examine if changes in the neural integrity of white matter pathways of the brain occur in individuals that undergo the SIP training.
All participants will undergo a set of baseline cognitive exams/tests, which will take approximately two hours. Participants will be randomly placed in either the experimental group or the control group. The experimental group will undergo approximately 40 hours of training on the Brain Fitness Program over an eight week period. The control group will be contacted once a week for eight weeks about their cognitively stimulating activities (i.e. reading, working on the computer, and puzzles). At approximately the thirteenth week participants from both groups will undergo post-baseline cognitive exams/tests. This evaluation will take approximately two hours. In addition there is an optional neuroimaging study which participants may elect to participate in. Participants who agree to take part in the neuroimaging portion of the study will undergo a baseline MRI scan. At approximately 13 weeks later participants will undergo a post-baseline MRI scan. Both scans will take approximately one hour. | Inclusion Criteria:
* Mild, moderate and severe traumatic brain injury or a cerebral vascular accident (Stroke)
* All subjects will be between the ages of 18 and 70 years
* Free from significant psychiatric history (such as schizophrenia or bipolar disorder), due to the potential influence of such disorders on cognitive functioning
* Free of current alcohol or drug as these factors have been shown to negatively affect cognitive abilities.
Exclusion Criteria:
* Potential participants will be excluded if they are currently taking benzodiazepines or neuroleptics due to their potential effects on cognition.
* Participant will be excluded if they are unable to comprehend the English language, either verbally or written.
* Participants will be excluded from the magnetic resonance imaging (MRI) scan portion of the study if they contain metal in their body that is not compatible with the MRI scan. |
NCT06955117 | McKenzie vs Manual Therapy for Low Back Pain | A comparative study evaluating the effectiveness of the McKenzie technique versus manual therapy in patients with nonspecific low back pain. The study aims to assess which intervention is more effective in reducing pain and improving functional mobility. | The study compares McKenzie Method, a directional preference-based approach involving repeated movements and posture correction, against Manual Therapy, which includes hands-on techniques such as mobilizations and manipulations. Patients with nonspecific low back pain will be randomly assigned to one of the two groups and treated over a defined period. Outcomes will be measured using pain and disability scores. | Inclusion Criteria: Diagnosis of nonspecific low back pain lasting \>4 weeks Age 35-45 years Willing to participate and follow protocol
Exclusion Criteria:
History of lumbar spine surgery Spinal fracture, tumor, or infection Pregnant women Severe osteoporosis or deformity |
NCT00412724 | Development and Validation of the Food Acceptability Questionnaire | The Food Acceptability Questionnaire (FAQ) is a self-report measure of palatability, ease of preparation, satisfaction, and perceived benefits and adverse effects related to a prescribed or self-selected diet. This study intends to develop a reliable and valid food acceptability questionnaire for use in clinical studies in which dietary interventions are administered. | Two hundred adult participants who follow a therapeutic diet will be recruited from the Washington DC area. Participants will be asked to rate their impression on the foods that they were eating in the past two weeks. Fifty participants will be chosen at random and asked to complete the questionnaire a second time, three weeks later, to assess reliability. Ratings will be used to assess the validity and reliability of the Food Acceptability Questionnaire (FAQ). | Inclusion Criteria:
* Participants must be older than 18 years and follow any kind of therapeutic diet.
Exclusion Criteria:
* Those who have difficulty eating by themselves will be excluded. No vulnerable subjects will be included. |
NCT03310333 | Cook Balloon Versus Propess After 12 Hours of Rupture of Membranes | The objective is to demonstrate the superiority of the strategy of labor induction by Cook® cervical ripening balloon between recommended strategy by dinoprostone (propess®) on the reduction of the time between cervical ripening and delivery in case of unfavorable cervix after 12 hours of PROM in term pregnant women. | The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning.
If the cervix is unfavourable (cervical Bishop's score \<6), the information of the study is given to the patient and the consent collected.
An antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis.
After randomization, the patient is included in one of the two groups: Cook ® balloon or Propess ®.
* In the Cook cervical ripening balloon group: the device is introduced by a resident or a doctor. No traction on the probe was done. It is left in place for maximum 12 hours. Oxytocin is added at the end of the first 6 hours even if device is fallen. An epidural analgesia can be started before or after the installation of oxytocin
* In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable.
After 24 hours, it is removed. If they are any contraction, oxytocin is started with or without epidural analgesic.
* The fetal heart rate is monitoring 30 minutes before and after the insertion of the device. After, the patient has a monitoring each 6 hours.
* Since the oxytocin is started, the monitoring is registered in continue until the delivery. | Inclusion Criteria:
* Pregnant women
* 18 years old With a singleton live cephalic pregnancy ≥ 37+0 weeks Gestational age estimated from the first trimester ultrasound (realized between 11 and 13+6 weeks of gestation) PROM without spontaneous labour in the 12 hours after the rupture. The diagnostic of PROM is clinic or biologic (ActimProm® test).
Unfavourable cervix (Bishop's score \< 6) Agreement of the patient after clear, loyal and appropriate information Subject covered by or having the rights to the French Social Security system
Exclusion Criteria:
* Vaginal infection by B streptococcus or in urinary sample during actual or anterior pregnancy Meconium fluid amniotic Contraindication of vaginal delivery (placenta praevia, ...) Temperature \> 38,2°C Suspicion of chorio-amnionitis among Newton requirements Intra-uterine growth restriction \< 3rd percentile with Doppler abnormalities History of cesarean and uterine scare Suspected genital herpes infection Known VIH seropositivity (confirmed by blood serology) Fetus with suspected severe congenital abnormalities Pathological fetal heart rate (see appendix 1) Contra-indications to Propess®, Cook® Cervical Ripening Balloon, Oxytocin Women under guardianship or trusteeship |
NCT02820961 | Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer | The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer. Additionally, this study will evaluate the safety and tolerability of entinostat in combination with exemestane, and assess the effectiveness of entinostat in combination with exemestane in terms of best overall response and overall survival. | SNDX-275-0130 is a Phase 1, two-cohort, open-label, drug-drug interaction study of entinostat and exemestane. All patients will be enrolled into one of two cohorts to receive either entinostat monotherapy followed by entinostat plus exemestane (Cohort 1), or exemestane monotherapy followed by exemestane plus entinostat (Cohort 2).
The cohorts will enroll sequentially, meaning that Cohort 1 will enroll prior to Cohort 2. Cohort 1 will evaluate exemestane's effect on the PK of entinostat. Cohort 2 will evaluate entinostat's effect on the PK of exemestane. In both Cohorts, each treatment cycle will be 28 days. Patients will participate in only one cohort.
All patients will be assessed at Screening and at specified times during the conduct of the study using standard clinical and laboratory assessment. Patients will also be assessed for tumor response per standard of care after the Screening Period. Response to treatment will be assessed by computerized tomography (CT), magnetic resonance imaging (MRI) and bone scans as appropriate. Patients will continue receiving their appropriate cycles of study treatment until tumor progression or adverse events (AEs) occur which necessitate discontinuing therapy as determined by the Investigator. | Inclusion Criteria:
* Postmenopausal female patients
* Histologically or cytologically confirmed ER+ breast cancer at initial diagnosis and have locally recurrent or metastatic disease that has progressed to where the patient is a candidate to receive exemestane as determined by the Investigator
* Patients receiving palliative radiation at the non-target lesions must be clinically stable prior to receiving the first dose of study treatment
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patient must have acceptable, applicable laboratory requirements
* Patients may have a history of brain metastasis provided certain protocol criteria are met
* Able to understand and give written informed consent and comply with study procedures
Exclusion Criteria:
* Rapidly progressive or life-threatening metastases
* Inability to swallow oral medications or gastrointestinal (GI) malabsorption syndromes
* History of significant GI surgery as determined by Investigator
* A medical condition that precludes adequate study treatment or increases patient risk
* Currently enrolled in (or completed within 30 days prior to study drug administration) another investigational drug study |
NCT03584126 | Imaging-based, Non-invasive Diagnosis of Persistent Atrial Fibrillation | The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent atrial fibrillation (AF). The result of the study is a diagnostic method which aids the medical work-up of patients suffering from this disease. | Atrial fibrillation (AF) is the most common arrhythmia associated with substantial morbidity and mortality in humans. Histopathological studies of persistent AF have reported extracellular matrix remodeling with fibrotic infiltration which may cause atrial dilation. The degree of the fibrosis might have a significant impact on wave propagation during AF. The main objective of the present project is to develop an imaging-based tool to determine the origin and cause of persistent AF. The obtained clinical parameters of patients and controls (electrocardiography, ecocardiography and MR imaging data) will be correlated with known markers in order to identify novel markers for AF diagnosis. | Inclusion Criteria:
* age: 20-80 years
* weight: 50-120 kg
* persistent, permanent or paroxysmal atrial fibrillation
* clinically stable patients: outside of an acute cardiac event with constant chronic medication
* optimum echographic window
Exclusion Criteria:
* patients with: rheumatic mitral disease; acute myocardial-pericarditis; chronic rheumatism, under chronic or immunomodulatory treatment; infectious-inflammatory process of any cause
* patients undergoing oncology treatment
* patients under medication in another study
* patients undergoing immunosuppressive therapy
* contraindication for magnetic resonance imaging (MRI)
* patients with valvular prosthesis, pacemaker of any type, metallic elements in the body (including metal particles accidentally in the body or as a result of exercising certain professions); pregnant patients; patients with known poly-allergy; patients with altered renal function (creatinine clearance \<40 mL/min determined by the Cockcroft-Gault formula). |
NCT01487915 | Gemcitabine-Carboplatin Versus Gemcitabine-Oxaliplatin in Cisplatin-unfit Urothelial Carcinoma | Cisplatin-based chemotherapy is the standard regimen for advanced urothelial carcinoma.
But cisplatin-unfit patients account for up to 30-40% of patients in clinical practice.
Recently reported phase II/III trial of EORTC 30986 comparing gemcitabine/carboplatin (GCb) with MCAVI (Methotrexate, Carboplatin, Vinblastine) suggested that GCb be the preferred regimen over MCAVI based on the response rates, adverse events, and severe acute toxicities.
But the grade 3 or worse toxicities associated with GCb are not infrequent and need more effective and more tolerable regimens.
GemOx has been reported to be effective and have very favorable toxicity profiles. | Inclusion Criteria:
* Cytologically of histologically confirmed urothelial carcinoma
* Locally advanced or metastatic disease
* Measurable disease according to RECIST v.1.1
* ECOG PS 0-2
* Cisplatin-unfit condition (any of the followings: NYHA functional class 3, creatinine clearance 30-60 ml/min, and ECOG PS=2)
* Adequate organ function
* Chemotherapy-naive
Exclusion Criteria:
* Histology other than urothelial carcinoma, but squamous cell carcinoma or adenocarcinoma mixed with urothelial carcinoma are allowed
* CNS metastases
* Peripheral neuropathy grade 2 or worse
* Serious medical or surgical conditions |
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NCT06709066 | Muscle Relaxant Effect and Safety of Mivacurium Chloride and Succinylcholine for Bronchoscopy | The goal of this clinical trial is to evaluate whether mivacurium chloride and succinylcholine can provide effective and safe muscle relaxation in adult patients aged 18-60 years undergoing bronchoscopy who require muscle relaxants during anesthesia. The main questions it aims to answer are:
* Is the recovery of spontaneous breathing within 15 minutes after drug discontinuation with mivacurium chloride non-inferior to succinylcholine?
* How do mivacurium chloride and succinylcholine compare in terms of intraoperative hemodynamics and post-operative recovery and comfort? Researchers will compare the mivacurium chloride group and the succinylcholine group to observe if mivacurium chloride can provide similar or better recovery effects compared to succinylcholine.
Participants will:
* Receive either mivacurium chloride (0.14 mg/kg induction bolus + 0.5 mg/kg/h maintenance infusion) or succinylcholine (1 mg/kg induction bolus + 5 mg/kg/h maintenance infusion) as a muscle relaxant during bronchoscopy.
* Have their vital signs, including blood pressure, oxygen saturation, and heart rate, monitored at multiple time points during the procedure.
* Be assessed post-procedure for spontaneous breathing recovery, consciousness recovery, and time to laryngeal mask airway (LMA) removal, as well as overall comfort and satisfaction. | Inclusion Criteria:
1. Patients scheduled for painless bronchoscopy who require muscle relaxants during anesthesia.
2. Aged between 18 and 60 years.
3. Classified as Grade I-III according to the American Society of Anesthesiologists (ASA) Physical Status Classification.
4. Patients voluntarily participate and sign an informed consent form.
Exclusion Criteria:
1. Patients with known allergies to any of the drugs involved in the study.
2. Patients with severe organic diseases of the brain, heart, lungs, liver, kidneys, or other major organs.
3. Patients with intracranial hypertension, asthma, cataracts, glaucoma, or other eye diseases.
4. Patients with myasthenia gravis, myasthenic syndrome, severe reduction or deficiency of cholinesterase, upper motor neuron injury, or upper motor neuron diseases that may cause abnormal responses to muscle relaxants.
5. Patients who have used medications affecting neuromuscular transmission function before the procedure.
6. Pregnant or breastfeeding patients.
7. Patients who have experienced extensive burns, acid-base imbalance, or electrolyte disturbances within the past six months.
8. Patients known or suspected to be homozygous for the atypical gene for plasma cholinesterase. |
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NCT00394550 | Treatment of Children With Obstructive Sleep Apnea and Laryngomalacia: the Role of Laser Supraglottoplasty | This is a research study of the effect of treating laryngomalacia (floppiness of tissue on top of the voice box that can possibly block breathing) found in association with obstructive sleep apnea (blockage of breathing while sleeping).
The purpose of this study is to determine which is the best treatment for children with obstructive sleep apnea and laryngomalacia: adenotonsillectomy alone or adenotonsillectomy with laser supraglottoplasty (removal of tissue on top of the voice box to open the airway). | If you agree to have your child be in the study, you will do the following things:
you are consenting to your child having the adenoid (tissue similar to lymph nodes, found in the back of the throat) and tonsils removed (if not previously performed), direct laryngoscopy (looking in the throat) and bronchoscopy (inspection of the lungs with a long tube-like device down the throat), and randomization (½ will be treated further, ½ will be observed) into treatment and no-treatment arms if your child is diagnosed with laryngomalacia. After starting general anesthesia (putting patient to sleep for procedure), the surgeon will perform direct laryngoscopy (look at the throat and voice box) and bronchoscopy (look at the entrance to the lungs \[trachea or windpipe\]). If your child is diagnosed with laryngomalacia (flopping of the tissue around the voice box, potentially causing obstruction or blockage), 50% will undergo a further treatment (laser supraglottoplasty, or removal of tissue at the entrance of the voice box) and 50% will be observed. The decision to treat or not treat will be random, as is customary for prospective research trials. All children (both treatment arms will receive a 3 week treatment of a medicine (a proton pump inhibitor) to reduce the level of stomach acid and prevent potential exposure of the larynx (voice-box) to stomach acid. If your child does not have laryngomalacia, no further treatment on the larynx (voice-box) will be performed. Next, adenotonsillectomy will be performed as is common for the Otolaryngologist performing the procedure. Postoperatively, a sleep study will be performed (identical to the preoperative study) ideally 3-6 months after surgery, (but up to one year after) to monitor your child's progress. Additional laboratory tests or drawing of blood is not routine in this procedure, but may be performed as dictated by your child's medical conditions. | Inclusion Criteria:
* 1 year old to 18 years of age, clinical signs or symptoms of obstructive sleep apnea (snoring, witnessed apneas, daytime somnolence, restless sleeping, or cyanosis), abnormal polysomnogram (mild, moderate, or severe OSA) including CO2 measures, failed or refused trial of CPAP, or not recommended by their pulmonologist or primary care doctor.
Exclusion Criteria:
* prior laser supraglottoplasty, prior adenoidectomy prior tonsillectomy, stridor with cyanosis or apnea, severe respiratory distress, recurrent pneumonia (x3), Laryngeal cyst, vocal cord (VC) Paralysis, airway vascular malformation, neoplasm, subglottic hemangioma, paradoxical vocal cord (VC) motion, posterior glottic stenosis, glottic webs, discoordinate pharyngolaryngomalacia, or refusal to participate. |
NCT02693106 | Evaluation of the Ketogenic Potential of Different Diet Supplements | Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. | The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production. | Inclusion Criteria:
* Healthy adults aged of 18 years old or older.
* Non-smoking.
Exclusion Criteria:
* Diabetes or prediabetes
* Uncontrolled hypertension
* Uncontrolled thyroid function
* Taking medication that will affect lipid/glucose metabolism
* Severe infection or inflammation
* Pregnancy |
NCT04591756 | Effectiveness of Respiratory Protection During Simulated Resuscitation: a Prospective Cohort Study | The study hypothesizes that EHMRs with P100 filters will provide superior respiratory protection during simulated CPR compared to disposable N95 FFRs as measured by qualitative fit testing.
To this end, the study is a prospective observational cohort to evaluate the effectiveness of disposable FFRs and EHMR during simulated CPR. The primary endpoint will be subject report of detection of the testing agent during a 2 minute session of simulated chest compressions on a mannequin while wearing the respiratory protection that subjects routinely wear during the course of employment. | Inclusion Criteria:
* Current use of respirator within last 7 days
* Completed fit test with respirator within last 2 years
Exclusion Criteria:
* Previous adverse reaction to fit testing or testing agent
* Development of any health problem that precludes use of a respirator since last occupational health evaluation |
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NCT00204256 | Intravenous Iron in Patients With Anemia of Chronic Kidney Disease | The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy. | This is a randomized, open label, phase IV study in anemic predialysis patients (Hb between 8 and 11.5 g/dl) who require iron supplementation. The duration of the study for each patient will be approximately 6 months. Patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (days 1-43). Treatment will be intravenous iron sucrose alone versus iron sucrose plus rhEPO. The main treatment evaluation will at the end of the correction phase: The primary end-point will be the change of hemoglobin during correction phase. Secondary end-points will be the change of ferritin and transferrin saturation from baseline to day 43. Safety assessments will include recording of adverse events, vital signs, physical examinations and clinical laboratory tests. Incidence and severity of adverse events will be compared between the two different treatment arms. | Inclusion Criteria:
Chronic kidney disease Anemia (Hb 8 - 11.5 g/dl) Age above 18 years Signed informed consent
Exclusion Criteria:
Rapid progression of kidney disease Need for dialysis Uncontrolled hypertension |
NCT00673062 | Study of the Effect of SCH 900538 on Congestion in Subjects With Seasonal Allergic Rhinitis (Study P05031)(COMPLETED) | This study is to evaluate the effectiveness of a new drug on congestion in subjects with seasonal allergic rhinitis. This effect will be compared to placebo and to the decongestant, pseudoephedrine. | Inclusion Criteria:
* Subjects must be 18 to 65 years of age, of either sex, and of any race.
* Subjects must have a history of SAR due to ragweed for the last two consecutive ragweed seasons.
* Subjects must be skin-test positive for the ragweed pollen allergen used in the Environmental Exposure Unit (pollen chamber at the Screening Visit or within 12 months prior to the Screening Visit.
* Subjects must develop a pre-defined severity of allergy symptoms within 90-minute after entering the pollen chamber during the pollen challenge at the Priming visit (Visit 2), and prior to dosing (Visit 3), in order to qualify for the study.
* Female subjects of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test prior to randomization at the Treatment Visit. Female subjects and female partners of male subjects must be using an acceptable form of birth control during the study.
* Blood pressure and pulse rate must be within normal ranges.
Exclusion Criteria:
* Subjects who have had an upper or lower respiratory tract infection within approximately 28 days (4 weeks) before Priming (Visit 2) and thereafter.
* Subjects who have a dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.
* Subjects with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
* Subjects who have used any investigational drugs, including placebo, within 30 days of Screening or for the duration of this stud, or who are participating in any other clinical study.
* Subjects with a history of rhinitis medicamentosa.
* Subjects with a history of anaphylaxis or severe or serious reaction to skin testing.
* Subjects who are being medically treated for any of the following conditions: narrow-angle glaucoma, increased intraocular pressure, urinary retention, hypertension, severe coronary artery disease, ischemic heart disease, diabetes mellitus, hyperthyroidism, renal impairment, or prostatic hypertrophy; current treatment with monoamine oxidase (MAO) inhibitors.
* Subjects with a history of a positive test, or are symptomatic, for HIV, TB (not due to vaccination), and hepatitis B (not due to vaccination) or hepatitis C.
* Subjects with asthma that requires medication other than occasional (\<=3 uses per week) use of an inhaled short-acting b-2 agonist. |
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NCT06097546 | Serum Retinoic Acid Induced Protein 14 (RAI14) and Metastasis Associated Cancer Colon -1 (MACC-1) in Breast Cancer | 1. Measurement of serum levels of Retinoic acid induced 14 (RAI14) and Metastasis associated cancer colon -1 (MACC-1) as biomarkers for diagnosis of breast cancer.
2. Study their relationship to disease stages and clinicopathological features of BC.
3. Compare the diagnostic performance of serum RAI14 and serum MACC-1 with serum Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) for diagnosis of BC. | Breast cancer (BC) is one of the most prevalent Neoplasms and the second leading reason of death from cancer in women. Every year approximately 2.3 million new cases of BC are diagnosed worldwide. Due to the high impact of this type of cancer, the early detection, early diagnosis and effective treatment, will improve the diagnosis of patients and lower the associated mortality rates. Carcinoembryonic antigen (CEA) and Cancer antigen 15-3 (CA15-3) are the most commonly used serum markers in the diagnosis and follow up of BC, However their clinical applications still remain controversial.
Retinoic acid induced protein 14 (RAI14) is an actin-binding protein which participates in physiological processes such as the regulation of cell polarity and transport of spermatozoa. Recent studies showed that RAI14 is overexpressed in several malignant tumors with a significant role in the development of tumors . The serum RAI14 is a reliable novel marker in the early diagnosis and chemotherapy monitoring of triple-negative BC.
Metastasis-associated colon cancer-1 (MACC-1) is a newly identified tumor marker, first identified in colon cancer tissue as a prognostic indicator and inducer of metastasis .It is located on human chromosome 7 (7p21.1) and shown to be a key regulator of the hepatocyte growth factor-mesenchymal epithelial transition factor( HGF-MET) pathway in colon cancer. It is shown that serum MACC-1 can be a potential biomarker for diagnosis and progression in patients with BC. There was a strong correlation between MACC-1 expression and the clinical and the primary tumor, regional nodes, metastasis (TNM) stages of BC. | Inclusion Criteria:
1. Patients with benign breast lesions.
2. Patients with breast cancer who were confirmed by histopathological studies and did not receive any treatment.
Exclusion Criteria: 1- Patients who received chemotherapy or radiotherapy. 2- Patients with known other organ malignancy. |
NCT06578416 | The Development of Stuttering in Young Children | The goal of this longitudinal research is to learn why some children "grow out" of stuttering, while others persist. Children who do and do not stutter aged 3-6 years are eligible to participate in our study. During the study, children's speech and language abilities will be assessed with standardized assessments, and they complete several child-friendly experiments. During these experiments, brain activity will be recorded using specialized caps while children describe pictures, children will speak in two virtual-reality scenarios, and produce speech while keeping to a beat. | The length of participation in our study depends on the subset of activities completed. Families in the longitudinal study will take part in three visits each lasting approximately 2 hrs for up to 5 years.
Parents and caregivers will complete parent questionnaires (1 x each year for up to 5 years) and a 5-minute, online survey in between visits to the lab (1x each year for up to 5 years). Children will take part in standardized and observational assessments (1x each year for up to 5 years). These may cover aspects of social/emotional development, cognition, and speech, language, and hearing abilities. These tests are used to assess whether a child falls within or outside of the normative range for his/her age.
Children will participate in one or more of the following tasks (1x each year for up to 5 years)
* Listen to sounds or words and view or name pictures presented on a monitor. Brain activity electroencephalography (EEG) will be recorded while children listen to speech sounds and name pictures. This will be done with an elastic cap that holds special sensors (electrodes). Sensors will also be placed behind each ear, beside each eye, and under the left eye.
* Virtual reality (VR). Children wear a VR headset and experience virtual, age-appropriate talking situations (e.g., answering questions in a classroom). While they talk in these scenarios, the headset measures where they are looking (eye tracking), and sensors on their forehead, hand, and finger measure their heart rate and sweat response.
* Children will watch cartoons of animals jumping to a consistent beat (rhythm) and produce a word in time with the animal jumping/beat.
* Children will repeat nonwords, name pictures, or count while wearing a cap with sensors. Half of the sensors emit light through while the other half measures the reflected light. These sensors give us information about brain activity and are not harmful. | Inclusion Criteria for controls:
* English as first/primary language
* No history of neurological disease
* Normal or corrected visual acuity
* No medications expected to affect performance
* No intellectual impairment, autism spectrum disorder, ADHD
* Age-appropriate scores on speech and language assessment battery
* Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally
Inclusion Criteria for children who stutter:
* English as first/primary language
* No history of neurological disease
* Normal or corrected visual acuity
* No medications expected to affect performance
* No intellectual impairment or ASD Scores on speech and language assessments indicating stuttering, phonological (speech sound), or language disorders
* Pass hearing screening at 20 dB at 500, 1000, 2000, and 4000, bilaterally |
NCT03278171 | Early Detection of Patients at Risk of Developing a Post-traumatic Stress Disorder After a Stay in Intensive Care Unit | Post-traumatic stress disorder (PTSD) is a psychiatric pathology noticed in the DSM-5, in troubles due to a traumatism or a stress factor and appearing at least 1 month after confrontation with trauma. This trouble can become chronic, and be the source of psychiatric and somatic comorbidities, which themselves have personal, professional and economic consequences at the level of the individual and society.
Some studies looked at the psychological effects induced by a stay in intensive care unit (ICU) since few years. The emergence of PTSD in these patients has been described, with an incidence varying from 4% to 60%.
The literature is contradictory about identified risk factors for PTSD. It's not possible to design a screening of these patients actually, only focused on the risk factors. It has been shown that the presence of acute stress trouble (presence of symptoms during the first month after the traumatism) was a risk factor for PTSD. Early detection of acute stress disorder could be a way to screen risk of emergence of a post-intensive care PTSD. Post-intensive care consultations have been done at 6 months, but not systematically. Only few symptoms are looked for and a sizable part of this population were not being followed probably due to a non-diagnosed-PTSD. In case of the emergence of a post-intensive care PTSD, those patients will never be diagnosed and treated, favoring all complications linked to this trouble.
Associated with other factors, IES-R (Impact Event Scale Revisited) at the ICU exit would permit an exhaustive screening of patients at risk for PTSD and could permit to propose them an adapted care and then limit the emergence of PTSD and its consequences..
In this study, the investigators will screen acute stress symptoms within 8 days following the ICU's exit, using the IES-R, in order to evaluate his ability to predict the emergence of a PTSD at three months. IES-R is an auto-questionnaire, easy and fast with good psychometrics capacities for PTSD. | Inclusion Criteria:
* Patient over 18 years old leaving an intensive care unit after a stay of more than 72 hours, in one of the medical and surgical intensive care units of the E Herriot Hospital
* Patient having given his agreement to participate in this study
Exclusion Criteria:
* Patient not understanding French language
* Confused patient (clinical assessment)
* Patient under protection measure or deprived from his rights |
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NCT05940532 | A Trial of Sugemalimab and Chemotherapy in Unresectable Stage III NSCLC | The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer. | Inclusion Criteria:
1.18 to 75 years old, both male and female;
2.ECOG score: 0-1;
3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;
4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;
5.Measurable lesions available;
6.Major organ function is basically normal;
7.Estimated survival time is at least 6 months;
8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.
Exclusion Criteria:
1. Histologically or cytologically confirmed mixed SCLC and NSCLC;
2. Subjects with driver gene mutations(EGFR mutation, ALK fusion, etc.);
3. Previous systemic anti-tumor therapy including immune checkpoint inhibitors for NSCLC;
4. Previous thoracic radiotherapy;
5. Subjects who participated in other clinical trials within 4 weeks or 5 drug half-lives(whichever is shorter) before the first dose;
6. Systemic immunostimulant therapy before the first dose;
7. Systemic immunosuppressive therapy before the first dose or were expected to require systemic immunosuppressive drugs during the study treatment;
8. Subjects with autoimmune diseases;
9. Other malignant tumors other than non-small cell lung cancer within 5 years before screening;
10. Known or suspected interstitial pneumonia;
11. Other moderate to severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity and seriously affect respiratory function;
12. Severe cardiovascular and cerebrovascular diseases;
13. Clinically significant bleeding symptoms or significant bleeding tendency within 1 month before the first dose;
14. Arteriovenous thrombotic events within 3 months before the first dose;
15. Positive HIV test;
16. Active hepatitis B or C;
17. Evidence of active tuberculosis infection within 1 year before the first dose;
18. Serious infection within 4 weeks before the first dose;
19. History of attenuated live vaccination 28 days before the first dose or expected to receive attenuated live vaccination during the study;
20. Major surgeries other than diagnosis or biopsy within 28 days prior to the first dose;
21. Previous or planned allogeneic bone marrow transplantation or solid organ transplantation;
22. History of severe allergic reactions to other monoclonal antibodies/fusion proteins;
23. Allergic to any component of the randomized treatment regimen;
24. Female subjects who are pregnant, lactating, or planning to get pregnant during the study period;
25. Subjects who have a known history of psychotropic drug abuse, alcoholism, or drug abuse;
26. Presence of other conditions that, in the opinion of the investigator, would make participation in this clinical trial inappropriate. |
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NCT04768205 | The Efficacy of Kinesio Taping With Therapy in the Treatment of Globus Pharyngeus | Globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. Kinesio tex tape is a medical tap developed by Dr. Kase for therapeutic purposes and has been widely used in physical therapy applications in recent years. Although it is not a treatment with full consensus, the patient's complaints can be corrected with a small number of different therapy techniques or regulations on life. | We conducted a therapy program with kinesio taping on patients who diagnosed with globus pharyngeus for 8 session with sham kinesio taping controlled group. This study aimed to assess of efficacy of the kinesio taping with therapy on patients patients who diagnosed with globus pharyngeus. | Inclusion Criteria:
* diagnosed with globus pharyngeus
* 18 -65 years
* give a consent form
Exclusion Criteria:
* patients with dysphagia or odynophagia
* laryngeal organic pathologies
* pharyngeal organic pathologies
* epiglottic retroversion
* malignancy
* pregnancy
* mental disorders
* neurological disorders
* major psychiatric disorders
* give not a consent form |
NCT03936348 | Effects of an Exercise Rehabilitation Programme With a Nasal Inspiratory Restriction Device in COPD Patients | This study evaluates the effects of a nasal restriction device for inspiratory muscle training (FeelBreathe) after 8 weeks of exercise intervention on exercise capacity, quality of life, dyspnea and inspitarotory muscle strength in patients with stable COPD. Participants were divided in three groups: 1) exercise intervention using the Feelbreathe® device (FB group), 2) exercise intervention with oronasal breathing without FB (ONB group) and 3) no participation in the exercise intervention as control group (CG). | The Feelbreathe® device, tested in the investigator's study can be used in static and dynamic situations and is a nasal ventilatory flow restriction device made by a strip of hypoallergenic material (3M Spain, S.A. Medical Specialties / O.E.M.) that is placed and adhered under the nostrils impairing the free pass of air through the nose by producing resistance to flow. Depend on the size or/and porosity of the device, the inspiratory process is more or less difficult. It can be used while performing dynamic exercise or doing daily living activities. The Feelbreathe® device (FB) has been authorized by the Spanish Agency for Medicines and Health Products for application on COPD patients (Expedient 521/15/EC. AEMPS-Madrid-Spain-Patent Nº: P200902402). | Inclusion Criteria:
* men with diagnosis of COPD according to guidelines criteria
* with moderate or severe airflow obstruction (GOLD 2 or 3)
* dyspnea grade 2 or greater by mMRC scale
* stable clinical condition for at least 2 months.
Exclusion Criteria:
* poor compliance
* treatment with oxygen therapy or non-invasive mechanical ventilation
* CO2 retention
* medical conditions that can produce or increase dyspnea on exercise in addition to COPD (cardiovascular, metabolic or other respiratory diseases)
* osteoarticular or neuromuscular diseases that may limit the correct performance of the 6MWT |
NCT00685516 | Green Tea, Black Tea, or Water in Treating Patients With Prostate Cancer Undergoing Surgery | RATIONALE: Green tea contains ingredients that may prevent or slow the growth of certain cancers. It is not yet known whether green tea is more effective than black tea or water in treating prostate cancer.
PURPOSE: This randomized phase II trial is studying green tea to see how well it works compared with black tea and water in treating patients with prostate cancer undergoing surgery. | OBJECTIVES:
* to determine the effect of GT and BT consumption on apoptosis (TUNEL, ratio Bax:Bcl-2), proliferation, oxidation, and inflammation in malignant radical prostatectomy tissue compared to water control using immunohistochemistry.
* to examine levels of tea polyphenols and methylated tea polyphenol metabolites in fresh frozen radical prostatectomy tissue and urine, urinary oxidative DNA damage (8OHdG) and serum prostate-specific antigen (PSA) levels.
OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive 6 cups of green tea daily for 2-8 weeks in the absence of unacceptable toxicity.
* Arm II: Patients receive 6 cups of water daily for 2-8 weeks in the absence of unacceptable toxicity.
* Arm III: Patients receive 6 cups of decaffeinated black tea daily for 2-8 weeks in the absence of unacceptable toxicity.
Patients undergo radical prostatectomy.
Blood and urine samples, as well as tissue from diagnostic biopsy and radical prostatectomy specimens, are obtained for laboratory correlative studies. Samples are assessed by IHC, high-performance liquid chromatography, or mass spectrometry for changes in prostate tumor grade, stage, and margin status; concentrations of total and free tea polyphenols (i.e., EGCG, EC, EGC, ECG), theaflavins, and conjugated/colonic tea metabolites; biomarkers of prostate cancer development and progression (i.e., serum PSA, proliferation \[i.e., Ki-67\], apoptosis \[i.e., TUNEL, Bax/Bcl-2 ratio\], inflammation \[i.e., NFkB\]), and oxidative status (i.e., 8OhdG/dG ratio); and genotype and gene expression of metabolizing enzymes (i.e., COMT, UGT, and SULT). Serum samples are also assessed by ex vivo LNCaP cell culture assay for antiproliferative activity and by competitive chemiluminescent immunoassay for concentrations of PSA, IGF-1, IGFBP-3, testosterone, SHBG, and DHEA-sulfate. | Inclusion Criteria:
* subject consents to participate in the trial.
* subject is 40-75 years of age and has a diagnosis of adenocarcinoma of the prostate.
* Scheduled to undergo radical prostatectomy.
* The subject agrees to stop consumption of tea or tea-containing products throughout the entire intervention period except for the tea provided during study intervention.
* The subject agrees to stop consumption of dietary or vitamin supplements (e.g., lycopene, Vitamin E, selenium, genistein) or herbal supplements (e.g., saw palmetto, PC-SPES)
Exclusion Criteria:
* history of hepatitis or liver dysfunction
* ongoing alcohol abuse
* significant medical or psychiatric conditions that would make the patient a poor protocol candidate
* prior sensitivity or allergic reaction to tea, tea products, or tea supplements
* allergy or sensitivity to multiple food items or nutritional supplements
* concurrent luteinizing hormone-releasing hormone agonists, androgen receptor blocking agents, or finasteride
* prior bilateral orchiectomy |
NCT03100994 | Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block. | Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block | The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics between the quadratus lumborum muscle and latissimus dorsi muscle, which is called quadratus lumborum type II block. 〝 Transmuscular quadratus lumborum block demonstrates that injectate spreads over the posterior abdominal wall to the psoas major muscle and includes the upper branches of the lumbar plexus.〞described by Adhikary in 2016. However there are no published reports comparing the 2 techniques. In our study, compared of ultrasound-guided QL2-blocks with transmuscular quadratus lumborum block to investigate analgesic consumption, pain level, opioid related side effects and mobilization. | Inclusion Criteria:
* American Society of Anesthesiologists classification (ASA) 1\~3
* adequate communication skills
* Body mass index \< 32
Exclusion Criteria:
chronic pain neurological illness/ neuropathy contraindication against local anesthetics |
NCT03536897 | IORT Following Breast Conserving Surgery for Early Stage Breast Cancer Registry | This is a prospective, registry trial which will enroll women aged 65 and above with early stage, low risk breast cancer who will be treated with partial mastectomy and intraoperative radiation therapy (IORT). The primary aim is to determine the 5-year risk of in-breast tumor recurrence. Secondary aims include identification of acute- and late-toxicity, cosmetic result, disease-free survival and overall survival. | Inclusion Criteria:
* Female
* ECOG performance status 0-1
* Age 65 years or older
* cT1 or cT2 (≤3.0 cm)
* Invasive ductal carcinoma histology
* Estrogen receptor positive (ER+)
* Grade 1 or Grade 2
* Clinically negative lymph nodes (cN0) by examination, imaging and/or nodal sampling
* Suitable for breast conserving surgery and radiation therapy
* Patient must be able to provide study-specific informed consent
Exclusion Criteria:
* Multi-centric cancer not amenable to single lumpectomy
* Prior ipsilateral whole breast radiation
* Known BRCA 1 or BRCA 2 mutation
* Status post neoadjuvant hormonal or chemotherapy
* Invasive lobular histology
* Pure ductal carcinoma in situ (DCIS)
* Grade 3
* Diffuse suspicious microcalcifications |
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NCT03879720 | Comparison of Standard and Endoscope Assisted Endotracheal Intubation | Comparison of standard endotracheal intubation and endoscopist-facilitated endotracheal intubation | Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures are typically performed using general anesthesia. During anesthesia, the anesthesiologist inserts a breathing tube (endotracheal tube) into the patient's wind pipe (trachea) and a machine helps the patient breathe (mechanical ventilation) while they are unconscious. The breathing tube is inserted with a patient laying on his/her back using a rigid metallic device (laryngoscope) to guide tube placement. The unconscious patient is then moved from the portable bed onto the X-ray table by nursing staff. The patient also has to be turned to lie on their stomach on the X-ray table for the procedure. This standard approach carries a small risk of patient injury during breathing tube placement as well as while moving and turning the unconscious patient onto the X-ray table.
At our endoscopy unit, endoscopists have, on several occasions, used a slim gastroscope to place the breathing tube under direct visualization in patients who are already positioned on their stomach for ERCP. This approach is rapid and has been uniformly successful and safe.
We hypothesize that this endoscopist-facilitated intubation approach may expedite the procedure and minimize ergonomic strain for staff during patient repositioning while minimizing patient injury during breathing tube placement and repositioning. This study seeks to formally compares the two approaches for placement of a breathing tube. | Inclusion Criteria:
* Patients undergoing ERCP at Stanford University Medical Center
Exclusion Criteria:
* Unable to consent
* Contra-indication to general anesthesia |
NCT05037838 | Strain Analysis for Assessment of Myocardic Dysfunction During Orthotopic Liver Transplantation | Mycocardial systolic function (contractility) is an essential element of cardio-circulatory physiology during major visceral surgery, in particular during liver transplantation during which several factors are likely to be at the origin of a ventricular dysfunction: acute hemorrhage, major volume changes, acute pulmonary arterial hypertension and ischemia-reperfusion syndrome.
Ventricular dysfunction is an underestimated intraoperative liver transplantation phenomenon while it constitutes a risk factor for peroperative and postoperative morbidity and mortality established that graft function can be compromised through the phenomena of low cardiac output and hepatic congestion.
Also, better analyzing myocardial systolic function during liver transplantation could guide practitioners in the treatments to be undertaken, evaluate their effects and diagnose various complications.
In addition, the usual cardiac output measurement systems (transpulmonary thermodilution techniques and pulse wave contour analysis) are poorly suited to liver transplantation. Frequent variations in blood volume, vasomotor tone and temperature require regular recalibrations and prevent a continuous and reliable estimate of cardiac output.
Thus, the choice of hemodynamic monitoring during liver transplantation performed in our center is transesophageal ultrasound, a semi-invasive method with a favorable benefit-risk ratio in this category of the population. However, analysis of right ventricular systolic function by classical indices is difficult in transesophageal ultrasound for reasons of alignment of the ultrasound shot on the right ventricular. The analysis of left ventricular systolic function is complex due to the sudden variations in volume and the difficulty in carrying out planimetry measurements in real time.
Myocardial strain imaging has been developed in recent years and is widely validated for the assessment of left ventricular contractile function. It was subsequently applied to the exploration of the right ventricular. Its measurement can be performed from recordings on dedicated software.
Thus, the strain could make it possible to better assess myocardial systolic dysfunction in liver per-transplantation from the transesophageal echographic loops recorded in current practice at the different operating times. Strain measurements will be carried out a posteriori from the images which are acquired in a standard way during the operation. | Inclusion Criteria:
* Age of 18 years old and more
* Patients undergoing a liver transplantation
Exclusion Criteria:
* Contraindication to transesophageal ultrasound
* Refusal to participate
* Age \<18 years old |
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NCT02460263 | The EvAluation of TaBlo In-CLinic and In-HOme | The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects. | Inclusion Criteria:
* Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
* Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.
Exclusion Criteria:
* Life expectancy less than 12 months from first study procedure.
* Subject has had a recent major cardiovascular adverse event within the last 3 months.
* Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
* Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
* Subject has uncontrolled blood pressure.
* Subject is intolerant to heparin.
* Subject is seroreactive for Hepatitis B Surface Antigen.
* Subject has an active, life-threatening, rheumatologic disease.
* Subject has a history of adverse reactions to dialyzer membrane material.
* Subject is expected to receive an organ transplant during the course of the study.
* Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol. |
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NCT04727333 | [Trial of device that is not approved or cleared by the U.S. FDA] | null | null | null |
NCT01481948 | Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation | The purpose of this project is to reduce health disparities in obesity risk among 8-10 year old African American girls using a culturally sensitive and developmentally appropriate internet-based program with no face-to-face interaction. This study will conduct an outcome evaluation to test short and longer term effects on obesity risk. | This research will conduct an outcome evaluation on a promising web based obesity prevention program for 8-10 year old African American girls. A pilot study with 80 girls established its feasibility: recruitment goals were met; attrition rates were \< 10%; logon rates to the online program were 74.5%; and statistically significant increases in fruit and vegetable consumption and time spent being physically active were observed. The outcome evaluation will recruit 400 child-parent pairs to examine short and longer term effects of the program on obesity risk. It will also conduct mediation analyses to examine pathways of effect. At the end of the study, the web based program will be hosted on the CNRC web site. Although the use of the internet as a method for changing health behavior is not new, the use of an internet program alone, with no face to face interaction, is novel. This is one of the first programs to attempt this, particularly in an at-risk population. | Inclusion Criteria:
* 8-10 years old
* healthy
* African American
* parent willing to participate in data collection
* internet access
* personal email address
Exclusion Criteria:
* mental, physical, or medical conditions that limit fruit-vegetable consumption, physical activity, or ability to fully participate in the program and/or complete baseline and post assessment data collection
* taking medications that influence dietary behaviors, appetite, and/or physical activity |
NCT01591824 | Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain | Through this research is to conduct a pilot clinical trial in the treatment of chronic nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that will apply a technique of physiotherapy by passive movement of the column with oscillations in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called "Pold Concept"), another group that applies the standard protocol of treatment for this condition, as used in the hospital where performed the study.
It will compare the levels of efficiency and effectiveness of each treatment and the comparison between them. This will measure the perception of pain intensity and disability. | Type of study:
This is an analytical study, the experimental group clinical trial type, controlled, randomized with complete randomization and single blind.
Two groups, the study to which the POLD treatment shall apply, and the control group with conventional treatment will be formed by complete randomization system as they arrive for consultation, with a total of 50 patients or more if they were needed for each group have a minimum of 25 having offset dropouts. The number of 25 patients per group is determined considering accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, are required at least 21 subjects in each group to detect a minimum difference of 15 percentage points between the two groups, therefore two groups of 25 assuming a standard deviation of 15 points and a loss rate of 0% tracking form.
We will study both the effectiveness and efficiency individually and comparatively between groups.
* Study population:
1. The sample was selected from patients attending the clinic with back pain and after medical diagnosis are referred to the physiotherapist report of diagnosis, prescribing physical therapy and who meet the criteria for inclusion and not exclusion .
2. A total of 25 patients in the experimental group and 25 for the standard treatment group are selected.
3. If losses to the sample will be replaced by others to maintain proportions.
* The selection of groups:
RANDOM will be used , he formed the experimental group and control directing patients overall are being incorporated randomly according to the study :
1. Group A ( study ) will apply the technique with an identical protocol POLD them all.
2. Group B (conventional control) was applied average conventional treatment of different physiotherapy centers of reference.
* Study variables to collect:
1. Subjective assessment of pain intensity using VAS, visual analog pain. ,
2. Evolution of disability by Oswestry test.
3. SF-12 on health.
* Statistical analysis:
Computer analysis using "SPSS" 13.0 ® processed program. The study will be processed as follows:
First, an initial analysis was performed to verify that there were no significant differences between groups in baseline values of the dependent variables by Student's t test for independent samples.
Second : For each dependent variable variance analysis is applied using a general linear model with 2x10 between subjects factor we call variable " Treatment " with two categories 1, 2 (experimental group = 1, conventional group = 2 ) and a temporal within-subjects factor we call "SHOOT" ( 10 sessions) .
Third: We analyze to what treatment session the differences between the two groups appear by Student's t test for independent data after the first session
Fourth, the interactions are studied by comparing the two groups after the first, fifth and 10th session using a Student t test for independent data and comparing the results of each group between 1st and 5th session and between 1st and 10th session with a Student t for paired data.
• Ethical Issues: During the study of national and international guidelines (code of ethics, Declaration of Helsinki) will continue, likewise the legal regulations on data privacy (Law 15 /1999 of 13 December on the Protection of Personal Data) | Inclusion Criteria:
* Having a diagnosis instrumental prior to treatment to rule out pathologies pollutants, neurological or structural malformations.
* No previous trauma.
* Age between 25 and 65.
* With similar clinical characteristics to have a homogenous group:
* Low back pain (\> 3 months) and that at the time the study began have a minimum of 3/10 on VAS scale, following the criteria established in similar studies
* without component of neurological lower limbs irradiation
Exclusion Criteria:
* Existence of other recent traumatic structural pathologies in the lumbar region or of another type that could disturb the study.
* Existence of irradiation metameric to lower limbs
* Current tumors in the lumbar region
* Ongoing infectious disease in the lumbar area.
* Inflammatory rheumatism in the lumbar region.
* Lumbar surgery complications.
* Ongoing pregnancy.
* They have been treated with infiltrations in the last month.
* Who are following any other treatment, whether manual or physical agents or alternative or complementary therapies. |
NCT01948752 | Clinical Trial of Menu Labeling | The current study sought to examine the effect of menu labeling on food ordering and food consumption, including the effect of displaying calories along with other nutrients, such as sodium, fat, and sugar, as well as in different formats, such as traffic lights.
The investigators hypothesize significant differences in the calorie amount of menu selections and food consumption across experimental conditions. The investigators anticipate that calorie amounts will be significantly higher in the no calorie information) compared to each of the other 3 conditions, and significantly lower in the Traffic Light conditions compared to calories only condition.
2) Individuals in Condition 1 (no calorie information) will be significantly more likely to underestimate the calorie content of their meals compared to individuals in the intervention conditions. | Inclusion Criteria:
* 18 years of age or older,
* able to speak and read English
Exclusion Criteria:
- no food allergies to gluten or other grain products |
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NCT03571828 | Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 562 in Subjects With r/r Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma | Evaluate the safety and tolerability of AMG 562 in adult subjects with DLBCL, MCL, or FL. Estimate the maximum tolerated dose (MTD) and/or a biologically active dose (e.g., recommended phase 2 dose \[RP2D\]) | Inclusion Criteria:
* Subject has provided informed consent prior to initiation of any study-specific activities/procedures
* Age ≥ 18 at the time of informed consent.
* Biopsy proven B-NHL including:
* DLBCL, which also includes DLBCL that represents transformation of indolent NHL (including follicular, marginal zone, and lymphoplasmacytic lymphoma excluding chronic lymphocytic leukemia or Hodgkin Lymphoma) and DLBCL with alterations of MYC and BCL2 and/or BCL6 also described as double-hit and triple-hit lymphomas.
* FL
* MCL Presentations of these histologies with substantial occurrence of malignant cells into the bloodstream (lymphocyte count ≥ 7 x 10\^9/L) including all leukemic presentations are excluded.
The following histologies are not eligible:
Lymphoblastic lymphoma Burkitt lymphoma Any histologies not specifically mentioned must be discussed with the Medical Monitor
* Subjects with transformation of indolent lymphoma must have received therapy after a diagnosis of transformation that is appropriate for aggressive histology.
- Subjects who received prior CD19-targeting treatment are allowed (CAR-T cell therapy is excluded). A biopsy following CD19-targeting treatment is required unless no lesions are accessible or the risk of the biopsy is deemed too high by the investigator For Part 2 (Expansion in patients with DLBCL): only biopsy proven DLBCL (biopsy proven at least at primary diagnosis), including DLBCL that represents transformation of indolent NHL (including follicular, marginal zone, and lymphoplasmacytic lymphoma excluding chronic lymphocytic leukemia or Hodgkin Lymphoma) are eligible. Other histologies are not eligible.
* Presentations of these histologies with substantial occurrence of malignant cells into the bloodstream (lymphocyte count ≥ 7 x 10\^9/L) including all leukemic presentations are excluded.
* Subjects with transformation of indolent lymphoma must have received therapy after a diagnosis of transformation that is appropriate for aggressive histology as described in inclusion criterial.
* Subjects who received prior CD19-targeting treatment are allowed (CAR-T cell therapy is excluded) A biopsy following CD19-targeting treatment is required unless no lesions are accessible or the risk of the biopsy is deemed too high by the investigator - For DLBCL: Refractory (no prior CR/CMR) to first or later line of treatment or relapsed (prior CR/CMR) after two or more prior treatments, with at least one treatment consisting of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. Examples of appropriate therapy include but are not limited to R-CHOP (14 or 21), R-CHOEP, and DA-R-EOCH.
For FL: Refractory (no prior CR/CMR) to first or later line of treatment or relapsed (prior CR/CMR) after three or more prior treatments, with at least one treatment consisting of a standard chemotherapy containing an approved anti-CD20 agent.
Examples of appropriate therapy include but are not limited to R-CHOP, R-CVP, and BR.
For MCL: Refractory (no prior CR/CMR) to first or later line of treatment or relapsed (prior CR/CMR) after three or more prior treatments, with at least one treatment consisting of a standard chemotherapy containing an approved anti-CD20 agent. Examples of appropriate therapy include but are not limited to R-CHOP, BR and hyper-CVAD alternating with R-MTX/Ara-C.
For subjects with refractory B-NHL and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
* Minimum life expectancy of 12 weeks
* Radiographically measurable disease with a clearly demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension. In the dose exploration phase in case disease is not radiographically measurable PET positivity (ie, Deauville ≥4) instead is acceptable.
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* Laboratory parameters (completed within 14 days prior to enrollment):
Hematology:
* Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L
* Platelets ≥ 75 x 10\^9/L
Chemistry:
* Creatinine clearance ≥ 60 mL/min (calculated using Cockcroft Gault equation)
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \< 3X upper limit of normal (ULN)
* Total bilirubin (TBL) \< 2x ULN (unless Gilbert's disease or if liver involvementwith lymphoma)
Exclusion Criteria:
* Treatment within 30 days prior to enrollment with another investigational device or drug (interventional clinical study / studies). Other investigational procedures while participating in this study are excluded (observational studies are permitted).
* Prior anti-cancer therapy as specified below:
* At least 6 weeks must have elapsed since any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists, etc) before the first dose of AMG 562.
* Other targeted anti-cancer therapy (chemotherapy, molecular targeted therapy, steroids) within 14 days or 5 half lives (which ever is longer) prior to first dose of AMG 562. Patients requiring continued treatment due to aggressive disease may only be included if there is agreement by both the investigator and the Amgen Medical Monitor.
* Radiation therapy completed within 28 days prior to first dose of AMG 562.
* Autologous HSCT within six weeks prior to start of AMG 562 treatment.
* At least 4 weeks must have elapsed since any prior treatment with antibody therapy (exception immune checkpoint inhibitors) before the first dose of AMG 562.
* Prior CD19-directed CAR-T cell therapies
* Prior allogeneic HSCT.
* For Part 2 (Expansion in patients with DLBCL): fluorodeoxyglucose non-avid patients.
* Baseline electrocardiogram (ECG) QTc \> 470 msec.
* Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy. Patient may be included if the treatment is discontinued more than 3 months prior to the first dose of AMG 562 at a low likelihood of relapse AND if there is agreement by both the investigator and the Amgen Medical Monitor.
* Unresolved toxicity from prior anti-tumor therapy, defined as not having resolved to CTCAE version 4.0 grade 1, or to levels dictated in the eligibility criteria with the exception of alopecia or toxicities from prior anti-tumor therapy that are considered irreversible (defined as having been present and stable for \> 28 days) which may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and the Amgen Medical Monitor.
* Presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
* Evidence of CNS involvement by NHL.
* Known infection with human immunodeficiency virus (HIV).
* Exclusion of hepatitis infection based on the following results and/or criteria:
* Positive for hepatitis B surface antigen (HBsAg) (indicative of chronic hepatitis B or recent acute hepatitis B).
* Negative HBsAg and positive for hepatitis B core antibody: Assay for hepatitis B virus DNA by polymerase chain reaction (PCR) is necessary. Detectable hepatitis B virus DNA suggests occult hepatitis B.
* Positive Hepatitis C virus antibody (HCVAb): Assay for hepatitis C virus RNA by PCR is necessary. Detectable hepatitis C virus RNA suggests chronic hepatitis C.
* History of malignancy other than B-NHL within the past 3 years with the exception of:
* Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment and felt to be at low risk for recurrence by the treating physician.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated cervical carcinoma in situ without evidence of disease.
* Adequately treated breast ductal carcinoma in situ without evidence of disease.
* Prostatic intraepithelial neoplasia without evidence of prostate cancer.
* Adequately treated urothelial papillary noninvasive carcinoma or carcinoma in situ.
* Major surgery within 28 days of first dose AMG 562.
* History of arterial thrombosis (eg, stroke or transient ischemic attack) within 12 months of first dose of AMG 562.
* Presence of fungal, bacterial, viral, or other infection requiring IV antimicrobials for management within 7 days of first dose AMG 562. NOTE: Simple UTI and uncomplicated bacterial pharyngitis are permitted after consultation with sponsor and if responding to active treatment.
* Subject has known sensitivity to immunoglobulins or any of the products or components to be administered during dosing.
* Males and females of reproductive potential who are unwilling to practice highly effective method(s) of birth control while on study through 110 days (females) and 170 days (males) after receiving the last dose of study drug. Highly effective methods of birth control include sexual abstinence (males, females); vasectomy; bilateral tubal ligation/occlusion; or a condom with spermicide (males) in combination with hormonal birth control or intrauterine device (IUD) (females).
* Females who are lactating/breastfeeding or who plan to breastfeed while on study through 110 days after receiving the last dose of study drug.
* Females with a positive pregnancy test.
* Females planning to become pregnant while on study through 110 days after receiving the last dose of study drug.
* Males who are unwilling to abstain from sperm donation while on study through 170 days after receiving the last dose of study drug.
* Subjects likely to not be available to complete all protocol- required study visits or procedures including BM aspirates/biopsies, and/or to comply with all required study procedures to the best of the subject and investigator's knowledge.
* History or evidence of any other clinically-relevant concurrent disorder, condition or disease (eg, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia requiring therapy at time of screening) with the exception of those outlined above that, in the opinion of the investigator or Amgen medical monitor, if consulted, would not pose a risk to subject safety or interfere with the study evaluation, procedures or completion. |
Subsets and Splits