cyrilzakka/clinical-trials huggingface dataset:
Minimizing Immunosuppression in Old for Old Kidney Transplantation

Kidney transplantation in the elderly is a challenge since patient's co-morbidity and the decreased injury threshold of older grafts may limit the benefits of transplantation in these patients. To compare favourable effects between low dose tacrolimus (LD-Tac) and mycophenolate-mofetil (MMF) in this patient population the investigators conducted a one year prospective multicenter randomized controlled trial. 90 kidney transplant recipients \> 65 years with cadaveric grafts (\> 65 years) from 5 centers were enrolled and received baseline immunosuppression with daclizumab induction (1 mg/kg) at day one and day 14, LD-Tac (trough level 5-8 µg/ml), MMF (1-2 g/d) and steroids. After three months, patients were centrally randomized either to MMF (1-2 g/d) and steroids (23 patients) or to LD-Tac and steroids. Follow-up visits were performed every 4 weeks up to one year. Protocol biopsies were performed after one year. The investigators' primary hypothesis is that the biopsy proven rejection rate in the MMF group is not significantly different compared to the LD-Tac group after one year. The investigators' secondary hypothesis is that graft function in the MMF group (reflected by the glomerular filtration rate and protocol biopsy result) is superior to the graft function in the LD-Tac group.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a cadaveric kidney transplant (first or re-transplant)
* Patients must met the criteria of the EUROTRANSPLANT program
* Organ allocation with the framework of EUROPEAN SENIOR PROGRAM (ESP) by EUROTRANSPLANT
* Written consent

Exclusion Criteria:

* Not fulfilled inclusion criteria
* Cadaveric kidney from "non heart beating donors"
* One or more than one steroid resistant acute rejections within the first 3 weeks after transplantation
* Two or more than two steroid sensitive rejections (more than 2 administered steroid boli) within the first 3 weeks after transplantation
* Tacrolimus trough level \> 10ng/ml in three consecutive measurements
* Allergy against macrolide antibiotics or tacrolimus
* Systemic steroid therapy at study entry not related to transplantation
* History of Malignancy
* Clinical relevant uncontrolled infections, heavy diarrhea, vomiting or active ulcer disease
* Patients who are enrolled in other clinical studies or were enrolled in other clinical studies 28 days before transplantation
* Patients under medication not approved by the German Ministry of Health
Noninvasive Positive Pressure Ventilation for Difficult Weaning in Tracheotomy Patients

The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively. The investigators randomly allocate the subjects into two groups. One group is weaned by traditional strategy. The other one is weaned by Noninvasive Positive Pressure Ventilation by plugging the tracheotomy tube and deflating the cuff.

The investigators adopt Noninvasive Positive Pressure Ventilation for weaning in tracheotomy patients innovatively .If patients'conditions met our defined criterions, the investigators randomly allocate two groups. One group adopts traditional weaning strategy, the other adopts Noninvasive Positive Pressure Ventilation. If patients' condition deteriorated in group two, the investigators turned them to invasive positive pressure ventilation, until patients adapted in a satisfactory condition, the investigators shift them into Noninvasive Positive Pressure Ventilation. The investigators will extubate the tracheotomy tube, if patients are received Noninvasive Positive Pressure Ventilation more than 24 to 48 hours. After extubation, the investigators try to wean Noninvasive Positive Pressure Ventilation. Successful wean is defined weaning mechanical ventilation more than 48 hours.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* tracheotomy mechanical ventilation patients

Exclusion Criteria:

* pregnancy
* respiratory and hemodynamic instability
* Recent oral，nasal，facial or cranial trauma or surgery
* contra-indications for nasal or facial mask (facial skin lesions,...)
* recent history of upper gastro-intestinal surgery
* recent history of myocardial infarction
* unconscious patients
* non cooperative patient
A Study of RGT001-075 in Adult Patients With Obesity

This study is being conducted to evaluate RGT001-075 to help people who are above a healthy weight range to lose weight. In this study participants will either get RGT001-075 or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants need to take RGT001-075 or placebo once every day for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and ≤ 75 years
* Have a BMI ≥27 kg/m² and ≤ 45 kg/m²
* Have had a stable body weight for the 3 months prior to randomization

Exclusion Criteria:

* Have obesity induced by other endocrinologic disorders or diagnosed monogenetic or syndromic forms of obesity
* Have a prior or planned surgical treatment for obesity
* Have or plan to have endoscopic and/or device-based therapy for obesity
* Have any prior diagnosis of diabetes
* Have an electrocardiogram (ECG) with abnormalities
* Have a history of Major Depressive Disorder (MDD) or other severe psychiatric disorders within the last 2 years
* Have a history of suicide attempt.
PET Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP

The purpose of this protocol is to measure brain CB1 receptors in the hope to better understand how they work, so that one day we can understand how the CB1 receptors are involved in psychiatric, neurological, and behavioral disorders.

MePPEP is a ligand that is highly selective for the cannabinoid type 1 (CB1) receptor. This receptor is considered the most common G-coupled protein receptor in the brain (Pacher et al., 2006). The CB1 receptor is the site of action of Delta-9-tetrahydrocannbinol (THC), the active compound in marijuana, and is found primarily on the presynaptic terminals of dopaminergic, glutamatergic, GABAergic neurons (Howlett et al., 2002). The function of the CB1 receptor is not entirely clear; however, it has been implicated in several neurological and psychiatric disorders, and a selective inverse agonist, rimonabant, is currently in use in Europe for the treatment of obesity (Van Gaal et al., 2005). \[11C\]MePPEP was developed to enhance our understanding of the in vivo characteristics of the CB1 receptor (e.g., receptor density and receptor occupancy with pharmaceuticals).

The purpose of this protocol is to establish an accurate method to measure CB1 receptor levels in brain by performing test/retest brain imaging studies. The results of this overall study are required to apply this PET ligand in various neurological and psychiatric disorders in the future.

Eligibility Criteria:
* INCLUSION CRITERIA:

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All subjects must be healthy and aged 18 65 years, with history/physical exam, ECG, and laboratory tests within one year of the PET scan. The volunteer must sign an informed consent form.

EXCLUSION CRITERIA:

* Current psychiatric illness, substance abuse including marijuana use, or severe systemic disease based on history and physical exam.
* Laboratory tests with clinically significant abnormalities or positive urine toxicology screen.
* Prior participation in other research protocols in the last year such that radiation exposure would exceed the annual limits.
* Pregnancy and breast feeding.
* Claustrophobia.
* Presence of ferromagnetic metal in the body or heart pacemaker.
* Positive HIV test.
* Employee of the investigative site or an immediate family member of an employee of the investigative site. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
* Employee of Eli Lilly and Company.
Data Collection on ReCap/Magnum in Total Hip Replacement and Resurfacing

Observational study on ReCap/Magnum in Total Hip Replacement and Resurfacing.

This observational study intends to collect efficacy and safety data on ReCap/Magnum in Total Hip Replacement and Resurfacing.

Eligibility Criteria:
Inclusion Criteria:

Consecutive series of patients received Total Hip Replacement or Resurfacing with ReCap/Magnum for Its Respective Indications for Use/Intended Uses
Strawberry Consumption in Overweight and Obese Individuals

Our proposal represents an integrated approach to determining the cardiovascular and metabolic effects of strawberry consumption in adults who have high risk for cardiometabolic disease.

The current proposal aims to fill some of these important research gaps with regard the dose and time-course of strawberry consumption in a population where dietary intervention may of particular benefit for both primary and secondary prevention of cardiovascular and metabolic disease. Participants will participate in a double blind, placebo-controlled, randomized crossover trial. Following a 10-day run-in where no berries are consumed, participants will be randomized via Latin-square design, to three different daily strawberry powder conditions for 4-weeks at a time, with a 7 day washout between conditions.

Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese by BMI (25.0-34.9kg/m2),
* Borderline-high LDL-cholesterol (130-159mg/dL),
* Normal or elevated blood pressure ((≤129mmHg/≤80mmHg)

Exclusion Criteria:

* known allergy or intolerance to strawberries
* taking any medications for chronic diseases including anti-inflammatory, anti-hypertensive, lipid-lowering, glucose-controlling, or steroidal medications
* taking any supplements that might affect outcomes of the study including anti-oxidant or fish-oil supplements
* having anemia or any liver, thyroid, renal conditions
* current smoker or user of tobacco products, or use within the past three months
* consuming alcohol (\>1-2 drinks/day) on a regular basis
* currently pregnant or lactating
* having elevated blood pressure ≥130mmHg/≥80mmHg
* presence of diagnosed diabetes mellitus, inflammatory disease, atherosclerotic disease, or other relevant chronic conditions
* total cholesterol ≥240mg/dL
* hemoglobin normal range values for males (between 13.0-17.5g/dL) and females (between 12.5-15.5g/dL)
Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT

To prospect studying the efficacy and safety of treating NVG with the intracameral versus the intravitreal injection of Bevacizumab.

The present study comparing the safety and efficacy of 1.25mg/0.05mL Bevacizumab injection via the intracameral route versus the intravitreal route in treating the neovascular glaucoma

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of neovascular glaucoma
2. The patients having IOP \> 21 mmHg, having the indication for trabeculectomy
3. The patients' age of at least 18-year-old
4. The patients having visual potential at least hand motion.
5. Present of NVI or NVA.
6. Willing and able to provide informed consent to participate in the study
7. Able to understand the purpose of the study, his/her role, and is available to return to the clinic/hospital for all required follow-up visits

Exclusion Criteria:

1. One eye patient
2. Patients having severe corneal edema or total hyphema obscure NVI or NVA view.
3. Cannot obtain endothelial cell count.
4. History of bevacizumab or fluorescence dye allergy.
5. Active infectious ocular disease including endophthalmitis and corneal ulcer
6. History of systemic disease including ischemic heart disease, cerebrovascular disease, end-stage renal disease, liver failure, uncontrolled hypertension
7. Has or planning to be pregnant or breastfeeding
Obesity Assessment and Education Through the Internet

The purpose of this study is to develop a web-based obesity risk assessment and counseling tool and examine its feasibility and effectiveness in improving the rate and quality of physician counseling about obesity, dietary change, and physical activity.

Despite the high prevalence of obesity and its associated health risks, physicians do not address weight and behaviors that contribute to obesity because of lack of knowledge, training, and access to resources. To address these physician barriers to counseling, the investigator has developed a web-based tool that collects and integrates relevant patient clinical and behavioral information online and generates patient-specific recommendations and links to resources in the form of electronic patient and physician reports. In doing so, the tool provides physicians with a time saving device that identifies at risk patients who are motivated to make behavioral changes; at the same time, the tool provides tailored resources and recommendations that help physicians deliver more effective counseling.

The pilot study described in this application randomizes overweight primary care patients to a control group and the web-based intervention. The aims of the study are to examine the feasibility of incorporating the web-based tool into primary care practice and to collect preliminary data on its potential effectiveness on improving the rate and quality of physician-patient discussions about weight and on improving several clinical and behavioral outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Received invitation from participating primary care practices
* Scheduled non-urgent appointment with their usual primary care provider
* BMI \> 25 kg/m2
* Willing and able to participate in a web-based computerized self-administered questionnaire
* English-speaking

Exclusion Criteria:

* Pregnancy
* Terminal illness
* Not competent to give consent
Safety, Tolerability, Pharmacokinetics and Efficacy of YHD1044

safety and tolerability, pharmacokinetics/efficacy of an escalating, repeat doses of YHD1044 in premature ejaculation


Eligibility Criteria:
Inclusion Criteria:

* Patient is in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study
* History of premature ejaculation in the 6 months before study initiation
* History of intravaginal ejaculatory latency time (IELT) of \< = 2 minutes in at least half of events
* Premature Ejaculation Diagnostic Tool (PEDT) \> =11
* 6 domains of International Index of Erectile Function(IIEF) \>= 21
* Patient and partner must agree to attempt sexual intercourse at minimum intervals specified in the protocol
* Patient's partner must have a negative urine pregnancy test at time of screening

Exclusion Criteria:

* Medical history which affects ADME in the past 3 years
* Clinically significant and active disorder in ophthalmic system, gastro-intestine, cardiovascular, respiratory system, endocrine system, autoimmune system or malignant tumor,
* Subjects with clinically significant observations considered as unsuitable based on medical judgment in the physical examination and clinical laboratory tests or a medical history
* History of psychological disease
* Clinically significant allergic disease
* Hypersensitivity to TCA, SSRIs(Clomipramine, sertraline, fluoxetine, dapoxetine)
* Taken dapoxetine within 3 months
* Using other forms of therapy for treatment of PE (behavioral therapy or medications applied to the skin)
* Taken another investigational drug within 1 month
* History of drug abuse
Detecting Heart Rate, Respiration, and Sleep with the Sleeptracker-AI Under-mattress Monitor

The objective of this study is to simultaneously acquire sleep and breathing data using the under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing investigation for possible obstructive sleep apnoea (OSA).

The objective of this study is to simultaneously acquire sleep and breathing data using the under-mattress Sleeptracker (The Sleeptracker-AI Monitor (Fullpower Technologies, California, USA) during routine PSGs in patients who attend the Woolcock Institute for undergoing investigation for possible obstructive sleep apnoea (OSA). The de-identified Sleeptracker and PSG data will then be used by Fullpower Technologies to improve the accuracy of their current algorithm for detecting sleep and breathing disorders using the Sleeptracker device.

De-identified data recorded from the Sleeptracker device and PSG data from the Compumedics Grael system will be manually uploaded to a secure commercial server maintained by Fullpower Technologies.

Fullpower Technologies will use the de-identified data to refine their algorithms for detecting sleep and breathing disturbances.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 20-90 years old at time of assessment.
* Attending the Woolcock Institute for an overnight sleep study for investigation of sleep apnoea.
* Able to give informed consent.
* Fluent in English.

Exclusion Criteria:

* Unable to understand study procedure.
* Unable to sign informed consent form.
Interventional Research in Schools - Second Part

The main objective this project is the development of a measurement tool. This consists of construct and validate a questionnaire to conduct a quantitative assessment of knowledge and individual conceptions of cancer enrolled in CM1 and CM2 (9-11 years).

* exper judges by DELPHI method for content validity
* pre-testing for appearence validity
* testing for construct validity

Eligibility Criteria:
Inclusion Criteria:

* children enrolled in classes CM1 and CM2 of the departments of Loire, Essonne, Rhone and Ain

Exclusion Criteria:
OPEN LABEL, 2-PERIOD STUDY, TO COMPARE BIO-AVAILABILITY OF 2 DIFFERENT FORMULATIONS OF PF-05221304 IN HEALTHY ADULTS

The purpose of this study is to characterize the plasma pharmacokinetics of two formulations of PF 05221304 in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* Ages of 18 and 55 years old inclusive
* Body Mass Index (BMI) of \>= 17.5 and \<= 30.4 kg/m2
* Total body weight \> 50 kg (110lb)

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, allergic disease or clinical findings
Pharmacokinetic Study of Pediatric Subjects With Tinea Cruris and Tinea Pedis

This study is being done to see how the body is affected when a study drug is applied to both feet if the subject has athlete's foot or to both feet and the groin area if the subject has both athlete's foot and jock itch. Safety of the drug and how well the drug works will also be measured.

Study population, diagnosis, and main criteria for inclusion:

Tinea pedis and Tinea cruris (NAFT-500):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis and Tinea cruris infections confirmed by a positive potassium hydroxide (KOH) analysis from both the feet and bikini area. Both cases (feet and bikini area) must be characterized by clinical evidence of a Tinea pedis and Tinea cruris infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Tinea pedis (NAFT-600):

Male or non-pregnant female subjects aged 12 to 17 years, 11 months old of any race with Tinea pedis infection confirmed by a positive potassium hydroxide (KOH) analysis from both feet. Both feet must be characterized by clinical evidence of a Tinea pedis infection. Additional, approximately 4 pharmacokinetic (PK) evaluable adult subjects with the same condition will serve as a control.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have Tinea pedis on both feet and Tinea cruris infections for NAFT-500; both conditions must be characterized by clinical evidence of a Tinea infection.
* Subjects must have Tinea pedis on both feet for NAFT-600; the condition must be characterized by clinical evidence of a Tinea infection.

Exclusion Criteria:

* A known hypersensitivity to study medications or their components
* Any severe condition of Tinea pedis (incapacitating)
* Any dermatological disease and or condition in the treatment or surrounding area that may prevent application of the study product such as foot psoriasis, corns and /or callus involving any web spaces, or atopic or contact dermatitis
* Positive pregnancy test
* Any history or current evidence (physical or laboratory) of anemia
A Comprehensive ONline Program for Cognitive Enhancement, Reassurance and Training

The CONCERT Study (A Comprehensive Online program for Cognitive Enhancement, Reassurance and Training) was designed to introduce a user-friendly platform to assess and train cognition among old adults.

Our main research questions are: i) Is it possible to provide a user-friendly platform to perform multi-domain cognitive training for old adults? ii) Are there any safety issues with these platforms? Inclusion criteria include: i) Aged ≥ 65 years; ii) Owning a computer with access to the Internet and basic knowledge to use it; iii) Having sufficient English language skill; iv) Normal baseline AD8 screening test; v) agree to join the study with their partners/ close family members.

Exclusion criteria include: i) History of dementia; ii) Severe physical disability precluding to participate in meetings; those using wheelchairs can still join the study with some modification in the exercise program.

Study duration includes 24 weeks of intervention with lifestyle changes (Online: Nutrition consultation and teaching, Exercise, dance, music therapy and cognitive enhancement). Participants have options to continue the study for another 24 weeks.

Outcome will be assessed based on participants' adherence, satisfaction.

The CONCERT study is designed to provide an online platform for the public to provide healthy lifestyle recommendations and assess cognition. 60 participants (30 cases and 30 study partners) will be invited to this project. At baseline, all cases will be assessed with regard to cognition (AD8 Dementia Screening Interview), depression (Geriatric Depression Scale) and gait (Timed Up and Go). Participants will be asked to check their blood pressure at baseline and then every 3 months according to the Hypertension Canada's 2020 Guideline. All cases will be asked to participate in different educational classes, including nutrition consultation and teaching, exercise, dance (waltz), and music for 24 weeks. They will be also advised to accept the responsibility of a plant (Pothos, Spider Plant, Crocodile Fern and Aglaonema) at home. All meetings/ assessments are online. The investigators will assess adherence and satisfaction in all cases after 24 weeks. All cases will be invited to participate in another 24 weeks of intervention as an optional part of this study.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 65 years;
* Owning a computer with access to the Internet and basic knowledge to use it;
* Having sufficient English language skill;
* Normal baseline AD8 screening test;
* Agree to join the study with their partners/ close family members. Age of family member or friend is not an exclusion criteria.

Exclusion Criteria:

* History of dementia;
* Severe physical disability precluding to participate in meetings; those using wheelchairs can still join the study with some modification in the exercise program;
* Active coronary heart disease or limitation for exercise based on their previous consults with their family physician/ cardiologists.