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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. | [
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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 | [
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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:
- | [
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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 | [
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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 | [
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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 | [
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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 | [
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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. | [
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] |
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 | [
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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. | [
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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. | [
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] |
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 | [
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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. | [
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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 | [
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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. | [
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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 | [
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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) | [
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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 | [
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End of preview. Expand
in Data Studio
Clinical Trials Embeddings Dataset
Overview
This dataset contains information extracted from clinical trial records collected from ClinicalTrials.gov (Date Accessed: 05/02/2025) along with briefSummary columns embeddings generated using minishlab/potion-base-8M. It focuses on key descriptive fields that provide insight into trial objectives, eligibility criteria, and study design. The dataset is designed for researchers, healthcare professionals, and AI/ML practitioners interested in analyzing clinical trial data, understanding treatment development, or building tools to assist in clinical trial matching.
Dataset Structure
Each record in the dataset represents a single clinical trial and contains the following key fields:
- nctId: The unique identifier for the clinical trial as registered on ClinicalTrials.gov
- briefTitle: A short title of the study
- briefSummary: A concise summary of the trial's purpose and objectives
- detailedDescription: An extended description of the trial, including methodology and other details
- eligibilityCriteria: Specifications for who can and cannot participate in the trial
- embedding: Embeddings for the
briefSummarycolumn
- Downloads last month
- 104
Size of downloaded dataset files:
1.89 GB
Size of the auto-converted Parquet files:
1.89 GB
Number of rows:
535,475