cyrilzakka/clinical-trials huggingface dataset:
Study of Inactivity on Metabolism of Elderly Muscles

Skeletal muscle mass declines with inactivity (casting is a good example) and increases with activity (such as weightlifting). Whether muscle mass increases or decreases, is determined by whether more new proteins within muscle are made than are broken down. The investigators know that feeding protein increases the synthesis of new proteins but that the response of older muscles to protein feeding is blunted compared with the young. This resistance of the elderly to muscle building stimuli may be the primary reason that muscle mass is lost in aging. The investigators also know that periods of muscle disuse such as casting result in a person's muscle shrinking due, the investigators believe, to a lower rate of synthesis of new muscle proteins. Age-related muscle loss begins around 50 years old and proceeds at approximately 1% for every year after. Elderly persons would likely fare well with advancing age if their muscle loss were simply linear; however, a rate of muscle loss of 1% annually is a 'population view' and does not represent what occurs during short periods of muscle disuse (i.e. during hospitalization or illness), which occur with increasing frequency in elderly persons. During periods of disuse, the resistance of elderly muscles to protein nutrition may be worsened. The investigators will measure how quickly new proteins are made at rest and after protein feeding in elderly men, before and after a 14 day period of reduced activity brought on by having people reduce their daily step count.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* Aged 60 to 80 years old
* Non-smoker Generally healthy and can tolerate the resistance exercise and protein drink

Exclusion Criteria:

* Allergies to whey protein
* Health problems such as: heart disease, rheumatoid arthritis of the knee joint, diabetes, poor lung function, uncontrolled hypertension, or any health conditions that might put participants at risks for this study
* Failed an exercise stress test
* Taking metformin and/or other medications for the control of blood glucose even though one might not be classified as diabetic
* Taking prescribed blood thinners such as warfarin and heparin but excluding aspirin
* Taking medications for lung and kidney conditions but excluding medication for asthma that is under control
An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration

This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of \[14C\]-EP262 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* Males aged 18 to 55 years
* Body mass index of 18 to 32 kg/m2 and body weight of 55 to 100 kg
* Negative result for HIV, HBV, and HCV at Screening
* Male subjects with female partners of reproductive potential must be surgically sterile or use adequate birth control
* No use of tobacco or nicotine containing products within the past 6 months

Exclusion Criteria:

* History or presence of any condition or prior surgery that could pose a significant risk in the opinion of the investigator
* History of malignancy within the past 5 years
* History of any serious allergic reactions or hypersensitivity
* Recent history of incomplete bladder emptying with voiding or awakening more than once at a night to void
* Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day
Lung Transplantation in Respiratory Failure Patients

Survival after cadaveric lung transplantation in recipients depended on ventilation support prior to transplantation has been reported to have relative high surgical mortality and morbidity rate. The objectives of this study were to describe the short-term outcomes of bilateral sequential lung transplantation under extracorporeal membrane oxygenation (ECMO) support in a consecutive series of patients who depended on noninvasive and invasive ventilation support preoperatively .

The one-year survival rate and postoperative pulmonary functional results will be reported in this study.

Eligibility Criteria:
Inclusion Criteria:

* respiratory patients depended on ventilator supports prior to lung transplant

Exclusion Criteria:

* non-cardaveric lung transplant
Biomarker-driven Phenotypic Dissection of Amyotrophic Lateral Sclerosis

The goal of this observational study is to understand the clinical variability in a population of ALS patients using multidimensional biomarkers. The main questions it aims to answer are:

* Which set of biomarkers explain genotypic-phenotypic correlations in ALS?
* Which set of biomarkers can be used to subdivide the ALS population in homogeneous subgroups?

Participants will undergo:

* neurological evaluation
* neurophysiological evaluation
* neuropsychological evaluation
* whole exome sequencing
* biomarker measurement in CSF and plasma


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of ALS or other motor neuron disease
* residence near the study centers

Exclusion Criteria:

* refusal to participate to the study
* unable/unwilling to perform follow-up visits
cTBS/fMRI Study of Hierarchical Control in the PFC

The objective of this study is to examine the effect of transcranial magnetic stimulation (TMS) on the prefrontal cortex and posterior parietal cortex.

The Comprehensive Control Task (CCT) was designed to examine hierarchical control in a single, well-controlled factorial task. On each trial, participants view a letter surrounded by a colored shape at a particular screen location. Color cues the relevant feature, letter or location, for a block of trials. The first trial of a block requires a decision of whether the stimulus is the first position of a circular sequence (sequence start). Subsequent trials require a decision of whether the viewed stimulus follows the previous stimulus in a circular sequence (sequence 1-back). The letter sequence (C-O-M-I-C) and spatial sequence (Top Left-Top Right-Bottom Left-Bottom Right-Top Left) are difficulty-matched.

Shape cues the task to perform. Squares indicate the standard baseline task, and each block begins and ends with baseline trials. Different shapes indicate sub-tasks. In Switching blocks, shape-switches (e.g. from square to circle or circle to square) cue the sequence start task. Shape-repeats cue the sequence 1-back task. In Planning blocks, triangle shapes indicate that the stimulus can be ignored (automatic "no" response). All the while, the last square-shaped stimulus must be retained as a reference for the next square-shaped stimulus. Finally, in Dual blocks, diamond shapes indicate switching (sequence start) and also planning. The reversion back to square shapes requires sequence matching to the distal, previous square.

The design is factorial with stimulus-domain x contextual control x temporal control orthogonally manipulated. Full details of the CCT have been previous described in Nee \& D'Esposito, 2016; 2017.

The focus in this study will be comparison of FPl-TMS, MFG-TMS, and S1-TMS in an interleaved fMRI-TMS-fMRI design. The logic is to test the apical status of the FPl/MFG through the extent to which TMS impacts other PFC areas and behavior.

Each experiment will begin with 1 session of the CCT with fMRI to localize PFC targets. Each participant will then perform 3 counter-balanced sessions wherein a different site will be targeted by TMS followed immediately by fMRI on the CCT.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 30
* Right-handed
* Native English speaker or fluent by the age of 6

Exclusion Criteria:

* History of psychiatric disorders
* History of neurological disorders
* Receiving medications for psychiatric or neurological disorders
* Familial history of epilepsy
* Taking any drugs or medications that are pro-epileptic
* Metal anywhere in the head excluding the mouth
* Tinnitus
* Women who are pregnant
Comprehensive Functional Assessments for NOCAD

To validate and investigate the efficacy of comprehensive functional assessments for the diagnostic and prognostic value in NOCAD.


Eligibility Criteria:
Inclusion Criteria:

1. visual evaluation of epicardial coronary artery diameter stenosis (DS%) ≤ 50%;
2. CZT-SPECT was successfully conducted within three days of CAG

Exclusion Criteria:

1. had flow-limiting epicardial stenosis (DS% \>50%) or angiography-derived FFR (Angio-FFR) ≤ 0.8;
2. severe valvular heart disease;
3. chronic heart failure and/or left ventricular ejection fraction (LVEF) of \< 50%;
4. cardiomyopathy and myocarditis;
5. severe renal or hepatic insufficiency;
6. failure in detecting SPECT;
7. failure in computing Angio-IMR, and -FFR.
Phase III Study of Gemcitabine Compared With UFT in Patients With Completely Resected Pathological Stage IB-IIIa Non Small Cell Lung Cancer

To estimate the efficacy of Gemcitabine monotherapy compared to UFT as the post operative adjuvant chemotherapy for completely resected non-small cell lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. completely resected non small cell lung cancer
2. no prior anti cancer treatment for thoracic malignancy exept for this operation
3. pathological stage IB, II, and stage IIIA with only one station of n2 disease
4. PS 0-1
5. age 20-75
6. adequate organ function for chemotherapy
7. written informed consent

Exclusion Criteria:

1. small cell lung cancer or low grade malignancy of lung cancer
2. incomplete resection
3. apparent interstitial pneumonitis at chest rentogenogram
4. inadequate condition for chemotherapy
Fibromyalgia and Naltrexone: The FINAL Study

This study evaluates the effect of low dose naltrexone (LDN) on pain in women with fibromyalgia (FM). The study is designed as a parallel randomized (1:1) double blind, placebo-controlled superiority trial. Half of the participants will receive treatment with LDN while the other half will receive treatment with placebo.

Low dose naltrexone (LDN) is used widely as off label treatment in patients with fibromyalgia, despite the lack of larger randomized controlled trials (RCT) supporting an effect.

LDN has antagonistic effect on both opioid receptors and on toll-like receptors in glia cells. Mediated via those receptors, LDN can potentially reduce neuroinflammation and induce homeostasis in the endorphin system in patients with fibromyalgia.

The aim of the trial is to investigate whether treatment with LDN has a superior effect compared to placebo on pain among female patients with fibromyalgia, evaluated after 12 weeks of treatment. The study is also exploring secondary aims regarding a possible improvement of other fibromyalgia core symptoms and a possible improvement of global assessment, daily functioning and health-related quality of life. Among the exploratory secondary objectives are changes in muscle exhaustion, physical fitness, pain sensitivity, inhibition of pain, augmentation of pain, and pro-inflammatory cytokines.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-64 years
* Understands and writes Danish
* Fulfills the American College of Rheumatology 1990 criteria for fibromyalgia
* A minimum score of 4 in self-reported average pain during the last 7 days on a 0-10 numeric rating scale at baseline
* All fertile women have to use safe anti conception (Spiral, birth control pills, contraceptive patch, contraceptive vaginal ring or gestagen injections) for 3 weeks before and 1 week after the trial. If the patients' normal lifestyle includes sexual abstinence, they do not have to use anti conception. Instead they can give an oral informed consent, that they will be sexually abstinent during the trial. A woman is considered non-fertile if she is sterilized, hysterectomized, bilateral oophorectomized or is postmenopausal. A woman is considered postmenopausal when vaginal bleeding has been absent for 1 year and is confirmed by measurement of follicle-stimulating hormone.

Exclusion Criteria:

* Known allergy against naltrexonehydroclorid
* Pregnancy or breastfeeding. A negative pregnancy test has to be available for all fertile subjects at baseline
* Use of opioids or NSAIDs during the 4 weeks before inclusion in the trial
* Abuse of alcohol or other substances
* Inflammatory rheumatic diseases
* Demyelinating diseases
* Active cancer
* Liver dysfunction
* Kidney dysfunction
* Psychotic diseases
* History of suicide attempts
* Suicide ideation - evaluated using Patient Health Questionnaire-9 (Item 9 has to be answered "never")
Visual-spatial and Visual-perceptual Disorders Following Cerebellar Strokes

This study aims at assessing the proportion of patients suffering from neuro-visual troubles (visual-spatial and/or visual-perceptual ), after cerebellar strokes.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form
* Being able to pass initial neuropsychological tests within 10 days after stroke

Exclusion Criteria:

* Previous central neural system/psychiatric/eye disease (including severe cranial trauma)
* Chronic alcoholism
* MRI contraindication.
A Comparison of Dapsone and Trimethoprim-Sulfamethoxazole in the Treatment of Pneumocystis Carinii Pneumonia (PCP) in Patients With AIDS

Evaluate the effectiveness rate of dapsone plus trimethoprim as a therapy for the first episode of Pneumocystis carinii pneumonia (PCP) in AIDS patients. Compare the rates and severity of adverse effects using dapsone versus trimethoprim - sulfamethoxazole (TMP / PurposeX). Establish relative toxicities with regard to suitability for outpatient treatment.


Eligibility Criteria:
Exclusion Criteria

Concurrent Medication:

Excluded:

* Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).

Patients with the following are excluded:

* History of allergic reaction to dapsone.
* Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).
* Patients subsequently found to be glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.

Prior Medication:

Excluded:

* Requirement for other medications found to be effective in the treatment of Pneumocystis carinii pneumonia (PCP) (i.e., DFMO, pyrimethamine, and sulfadiazine).

Patients who are glucose-6-phosphate dehydrogenase (G6PD) positive will be withdrawn from the study and treated with another regimen.

Hospitalized patients with first episode of Pneumocystis carinii pneumonia (PCP) documented by GIEMSA or methenamine stain.

* Patients must:
* Be willing and able to give informed consent.
* Be expected to survive 1 week without therapy.
* Have less than 48 hours of treatment for Pneumocystis carinii pneumonia (PCP) for this episode.
Comparative Effects Of Buteyko Breathing Techniques And Papworth Method In Asthmatic Patients

Asthma is an inflammatory condition which is characterized by coughing, sneezing, and shortness of breath. The ratio of asthma is increasing day by day around the globe. According to an estimate, more than 300 million people are affected from this chronic respiratory disorder throughout the world. The asthma is diagnosis on basis of sign and symptoms as there is no gold standard of evaluating the asthma. There are basically two treatment strategies for asthma involving medical management and physiotherapy treatment. In medical treatment, steroid drugs and bronchodilators are given to asthmatic patients. Now a day, the physiotherapy treatment has gained much importance. There are numerous physiotherapy approaches available for rehabilitating asthma patients such as breathing techniques, yoga, and relaxation exercises. Buteyko technique includes three steps (control pause, shallow breathing and combination of step 1 \& 2). While, papworth method includes five steps (breathing, education, relaxation, combination of breathing and relaxation exercise and home exercises). The randomized clinical trials will be conducted for this study and data will be calculated using simple random sampling technique. The study will be carried out in Clinical Private (Farooq Clinic) setting Khushab and THQ Khushab for a period of 10 months after approval from research and ethical committee. Firstly, consent will be taken from the study participants. Screening will be done using WHO Quality of Life Scale questionnaire and asthma control test adult scores. Lung spirometry values (FVC, FEV1, \& FEV1/FVC) and oxygen saturation will be evaluated at baseline, 2 weeks, and 4 weeks. Patients will be divided into two groups. Group A \& Group B. Buteyko breathing technique will be performed to Group A patients and papworth method will be performed to Group B. Chest physiotherapy will be performed to both groups as a conservative treatment at baseline, 2 weeks, and 4weeks


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed asthmatic patients
* Age group 20-60 years
* Both genders
* Lung function (FEV predicted \< 80% \& FEV1/FVC \< 75%)
* Nighttime awakening 3-4 times/month
* Symptoms \> 2 days/week

Exclusion Criteria:

* Unstable asthmatic patients
* Acute upper respiratory infection
* History of radiation
* Taking any oral steroid, mental disorder
A Safety and Efficacy Study for Infliximab (Remicade) With Methotrexate in Patients With Early Rheumatoid Arthritis

The purpose of this study is to evaluate the efficacy and safety of infliximab (Remicade) in patients with early rheumatoid arthritis.

This is a randomized, multicenter, double-blind, active-treatment-controlled, three-arm, parallel study of chronic treatment with infliximab. This study will determine whether infliximab, at two different doses (3 mg/kg or 6 mg/kg) in combination with methotrexate (MTX), reduces the signs and symptoms (such as joint pain, swelling and stiffness) of rheumatoid arthritis. The study will also compare their effect on slowing down the joint damage associated with rheumatoid arthritis. Additional information on the safety of infliximab treatment will be obtained. The study will last for about 1 year. Patients will receive methotrexate and total of eight intravenous infusions of the study medication (Infliximab or placebo) spaced out over the first year. After the final infusion of study medication, several follow-up visits are to be made. Patients will receive methotrexate (start at 7.5mg/wk, increased to 20mg/wk by week8) and intravenous infusions of the study medication (Infliximab 3 or 6mg/kg, or placebo) at week 0, 2, and 6, and every 8 weeks thereafter through week 46.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of rheumatoid arthritis for at least 3 months and less than or equal to 3 years before screening
* Active disease at the time of screening and pre-infusion of the drug

Exclusion Criteria:

* Pregnant, nursing, or planning a pregnancy within 18 months of enrollment
* Incapacitated, largely or wholly bedridden, or confined to a wheelchair, or had little or no ability for self care
* Rheumatic disease other than rheumatoid arthritis or any current systemic inflammatory condition
Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis

In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. Necrotizing pancreatitis is characterized by the development of an acute necrotic collection and as this collection persists beyond 4 weeks, walled off necrosis (WON) encapsulates the collection. To date, this is treated by the step-up approach, which contains percutaneous drainage and minimally invasive video assisted retroperitoneal debridement (VARD) or endoscopic ultrasound (EUS) guided drainage followed by direct endoscopic necrosectomy (DEN). Different DEN techniques are available for the treatment of WON, however, there is a lack of effective endoscopic instruments to perform DEN. Recently, the first dedicated alternative to conventional DEN has been cleared for use, namely the EndoRotor® Resection System. This device is a powered mechanical debridement device intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. Previous (pilot and feasibility) studies showed promising results in terms of the amount of procedures, adverse events and length of hospital stay.

Therefore, aim of this study is to assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off necrosis (WON) in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage.

  a. Stent must be in place for a minimum of 2 days prior to the DEN procedure.
* Patients who can tolerate repeat endoscopic procedures.
* Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments.
* ASA classification \< 5.

Exclusion Criteria:

* Documented pseudoaneurysm \> 1 cm within the WON.
* Subject unable or unwilling to provide informed consent.
* Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using endoscopy or endoscopic ultrasound).
* Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
* Any condition that in the opinion of the Investigator would create an unsafe clinical situation or stent placement that would not allow the patient to safely undergo an endoscopic procedure.
* Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
* Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.
* Prior necrosectomy on existing collection.
* Greater than 2 pancreatic / extra-pancreatic fluid collections.
The Effects of Tactile Speech Feedback on Stuttering Frequency

The purpose of this research project is to test the effects of exposure of different forms of tactile speech feedback on overt stuttering frequency.

A new medical grade device (FDA - category exempt) has been newly designed and built at the University of Mississippi within the departments of Communication Sciences \& Disorders, Exercise Science, and Computer and Electrical Engineering. The device records either sound waves (via a small standard microphone) or three dimensional accelerometer data from the throat of a stuttering subject. This data is digitally signal processed, and "fed back" to the user in the form of a small vibrating disk/film that can be held between the fingers or mounted on the skin. This feedback data does not require the subject to attend to the incoming signal.

Eligibility Criteria:
Inclusion Criteria:

* Adults diagnosed with persistent developmental stuttering

Exclusion Criteria:

* Subjects below 18 years of age
Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain

The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain


Eligibility Criteria:
Inclusion Criteria:

* RA or PsA in whom DMARDs/antiTNF antibodies/anti IL1 has been insufficient or inappropriate
* Children from 4 to 17 years old with JIA polyarticular

Exclusion Criteria:

* Clinically significant abnormal screening lab values
* Patients who are planning to undergo elective surgery during the study period.
* Other current autoimmune connective tissue diseases