cyrilzakka/clinical-trials huggingface dataset:
Effects of a Dietary Fibre Supplementation of a Low Calorie Diet on Appetite and Body Weight

This 18 week, randomized, double blind, placebo controlled trial will examine the effects of thick dietary fibre (PGX) supplementation of a low calorie diet (LCD) on appetite, weight loss, body composition, and compliance in overweight and moderately obese female.

The investigators believe that 15 grams/day PGX supplementation of a low calorie diet over a 14-weeks period will elicit a better appetite score (e.g. reduced hunger) compared to the rice flour supplementation of the LCD.


Eligibility Criteria:
Inclusion Criteria:

* BMI 25 - 35 Kg/m2

Exclusion Criteria:

* Medications and supplements that affect appetite
* Known diabetes
* Contraindications to LCD
* Any other medical, social or geographic condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
Adaptation of an eHealth (Web-application) Platform for Delivery of a Sedentary Behavior Intervention Among Prostate Cancer Patients

The overall objective of this study is to adapt and refine an existing eHealth (web-application/web-app/app) platform designed to promote spontaneous movement (reducing sedentary behavior) among older adults, to men with prostate cancer.

Primary treatments for prostate cancer (PCa) accelerate aging-related changes in body composition and declines in physical function and quality of life ; the median age at PCa diagnosis is 66 years and approximately 64% of PCa survivors are \> 70 years. The negative side effects of treatments are pronounced in older, sedentary, overweight or obese men with existing comorbidities. The concomitant loss of skeletal muscle mass, increased deposition of adipose tissue and loss of bone mineral density leads to fractures, cancer-related fatigue, frailty, compromised physical functioning, disability and loss of independence as well as anxiety and depression. Regular physical activity reduces morbidity, improves survival and can buffer PCa patients against the negative side-effects of treatment, yet less than 20% are meeting recommended guidelines-and most spend up to 70% of their time each day in sedentary behavior. Targeting a reduction in sedentary behavior by promoting regular spontaneous movement in conjunction with regular resistance training may be an effective approach for PCa patients who are likely to be fatigued and functionally impaired. Traditional theory-based exercise interventions have shown preliminary efficacy for promoting short-term exercise, but can be improved for longer-term efficacy. Traditional exercise interventions are generally not individually tailored, and therefore cannot incorporate behavioral theory to re-engage participants when lapses in self-regulation occur. eHealth technologies can enhance traditional theory-based exercise interventions. The study team hypothesizes that an eHealth delivered intervention can effectively facilitate the development and maintenance of self-regulatory skills that are critical to sustaining long-term behavior change.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed prostate cancer.
* Currently (in last 2-years) receiving care for prostate cancer at WFBMC.
* Currently owns a smartphone or a tablet computer (iOS and major brand Android devices not including eReaders).
* English-speaking.

Exclusion Criteria:

* Unable to provide informed consent (e.g., delirium).
* Unable to ambulate safely (fall risk).
Breathing Exercises in Asthma Targeting Dysfunctional Breathing

Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around every forth patient with asthma have DB. Breathing exercises (BrEX) can improve asthma-related quality of live (QOL) in less severe asthma. No study has investigated the effect of BrEX on QOL neither on level of physical activity in severe asthma.

A randomised controlled multicentre trial will include 190 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥0.8) from seven outpatient departments and one specialized private clinic. Patients will be allocated to either usual care (no intervention) or breathing exercises (BrEX)-treatment consisting of 12-week intervention including three physiotherapist-sessions focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up.

In Denmark around 300,000 suffer from asthma. Dyspnoe can disable patients with asthma. Dysfunctional breathing (DB), resulting in dyspnoe, can mimic or exaggerate asthma. Around 20-29% of asthmatic patients have DB. Breathing exercises (BrEX) can improve asthma-related quality of life (QOL) and control of asthma symptoms in less severe asthma. No study has investigated the effect of BrEX on QOL neither on level of physical activity in severe asthma.

A randomised controlled multicentre trial will include 190 adults with poor asthma control (Asthma Control Questionnaire (ACQ6)-score≥0.8) from seven outpatient departments and one specialized private clinic. After optimizing of inhalation technique, patients will be allocated to either usual care (no intervention) or BrEX-treatment consisting of 12-week intervention including three physiotherapist-sessions focusing on breathing pattern modification (Papworth Method; Buteyko technique) in rest and activity and 10 minutes home-exercise twice daily. Primary outcome is change in Mini Asthma Quality of Life Questionnaire (MiniAQLQ) at six-months follow-up. Secondary outcomes are changes in ACQ6, Nijmegen Hyperventilation Questionnaire (NQ), Hospital Anxiety and Depression Scale (HAD), accelerometry (physical activity level, number of steps), 6 minutes walk distance, and forced expiratory volume in first second (FEV1), besides response of Global perceived effect rate (GPE) in asthma-related QOL and asthma control.

Eligibility Criteria:
Inclusion Criteria:

* Referred from GP to a secondary, out-patient respiratory clinic for lack of asthma control
* Pulmonologist-diagnosed asthma
* ≥ 2 consultations at a pulmonologist-lead asthma clinic
* ACQ6 ≥0.8
* Able to provide written informed consent.

Exclusion Criteria:

* Trained in breathing exercises by physiotherapist last 6 months
* Aged \<18
* Pregnancy
* Not able to speak, read or understand Danish
* Any severe disease as judged by the responsible physician
* Participating in another pulmonary interventional research-project.
Study of the Efficacy and Safety of Tezosentan in Patients With Pre-operative Pulmonary Hypertension, Due to Left Heart Disease, Undergoing Open Heart Surgery

Endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. Tezosentan is an investigational intravenous drug that blocks the endothelin receptors. This clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (CPB). Treatment time is from the start of surgery up to 24 hours.

Endothelin-1 levels are increased during and after cardiac surgery with cardiopulmonary bypass (CPB), and are associated with many deleterious consequences, including increased pulmonary arterial pressure (PAP), increased pulmonary vascular resistance (PVR), reduced myocardial contractility, and ultimately right ventricular failure. Right ventricular failure during weaning from CPB increases the risk of mortality and morbidity, especially in patients with elevated PAP prior to cardiac surgery. Endothelin receptor antagonists (ERAs) have been shown to decrease PVR and pulmonary arterial pressure (PAP), and improve right ventricular function in patients with pulmonary arterial hypertension. In animal models, ERAs have been shown to decrease the incidence of post-bypass pulmonary hypertensive crises. The primary objective of this trial is to demonstrate that tezosentan, a dual ERA, reduces the incidence of clinically relevant right ventricular failure in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing CPB.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age
* Male or female patients (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception).
* Patients undergoing complex\* cardiac surgery on CPB and having systolic PAP \> 40 mmHg or mean PAP \> 30 mmHg (\*surgery on 2 valves, 1 valve and revascularization, or reoperation of a valve)
* Patients undergoing cardiac surgery on CPB and having pre-operative pulmonary hypertension due to left heart disease with systolic PAP \> 60 mmHg
* Signed written informed consent

Exclusion Criteria:

* Systolic blood pressure \< 100 mmHg
* Significant chronic lung disease
* Emergency surgery
* Pregnant/breast-feeding
* Investigational drug use within 28 days prior to randomization
* Complex adult congenital heart disease.
* Severe concomitant illness limiting life expectancy to \< 6 months
* Participation in a device study that will affect the outcome of the study
* Pre-operative use of balloon pump, inotropes/vasopressors, treatment of pulmonary arterial hypertension
* Known hypersensitivity to tezosentan or drugs of the same class, or any of their excipients
* Severe liver impairment
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients

This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.


Eligibility Criteria:
Inclusion Criteria:

* Recipient of a first-time kidney transplant
* Between the ages of 18 and 70 years, inclusive

Exclusion Criteria:

* Recipient of any non-kidney transplant
Stress Management in Patients With Coronary Artery Disease

Introduction: Stress can cause hemodynamic and metabolic changes that contribute to endothelial dysfunction and there is a significant association between high stress and cardiovascular events. Objective: To evaluate the influence of stress management on endothelial function in patients undergoing percutaneous coronary intervention (PCI). Methods: Randomized, controlled, parallel, intention-to-treat clinical trial. Will be considered eligible patients who underwent percutaneous coronary intervention and who have high stress (above average for the Brazilian population) in the Perceived Stress Scale (PSS-10). Patients will be evaluated on PCI admission and stress management with cognitive behavioral techniques will be implemented one month after hospital discharge in the intervention group. Group sessions will be held between 6-9 people. There will be 4 1-hour meetings for 8 weeks. The primary outcome will be the difference in the variation of brachial artery flow-mediated dilatation (FMD) between the groups and at 3 months of baseline evaluation and at 6-month follow-up after the intervention and the secondary outcome will be the difference in the variation of the velocity of brachial artery. Pulse wave evaluated at the same time periods as DMF. Outcomes will be evaluated by Generalized Estimation Equations (GEE). Expected Results: In patients undergoing high-stress percutaneous coronary intervention, the use of cognitive behavioral techniques for stress management will improve endothelial function and vascular stiffness.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Patients with CAD - obstruction of one or more epicardial arteries with at least 70% stenosis and / or Left Coronary Trunk (TBI) with at least 50% - measured by catheterization (CATE) and having performed elective PCI
* High stress: above average score for the Brazilian population in the Perceived Stress Scale (PSS-10)
* Signing of the Informed Consent.

Exclusion Criteria:

* Age ≥ 80 years
* Patients with inpatient events (AMI, CABG, stroke)
* Indication of catheterization for valvulopathies or congenital heart disease
* Severe aortic stenosis / Ejection fraction \<30%, cardiomyopathy, severe congestive heart disease
* Severe diseases with life expectancy \<6 months
* Cognitive or mental difficulties to understand the instrument
* Inability to follow up visits
Study Of Chemokine Coreceptor 5 (CCR5) Antagonist GW873140 In R5/X4-Tropic Treatment-Experienced HIV-Infected Subjects

The purpose of this study is to evaluate the safety and efficacy of the CCR5 antagonist GW873140 or placebo in combination with an optimized background regimen in treatment-experienced HIV-infected subjects with R5/X4-tropic virus


Eligibility Criteria:
Inclusion criteria:

* HIV-infected.
* Screening viral load at least 5000copies/mL.
* R5/X4-tropic virus at screening.
* Total prior antiretroviral experience of at least 3 months.
* Documented resistance to at least one drug in each of the following classes: nucleoside reverse transcriptase inhibitors (NRTI), non-nucleoside reverse transcriptase inhibitors (NNRTI), and protease inhibitors (PI), stable antiretroviral regimen (or no antiretroviral treatment) for at least 4 weeks before screening.
* Able to receive a ritonavir-boosted protease inhibitor during treatment studies.
* Women of childbearing potential must use specific forms of contraception.

Exclusion criteria:

* Acute laboratory abnormalities.
* History of pancreatitis or hepatitis, hepatitis B or hepatitis C coinfection, or any chronic liver disease. Screening liver function tests will be used to determine eligibility.
* R5-tropic only.
* X4-tropic only.
* non-phenotypeable virus at screening.
* Changes to antiretroviral therapy from 4 weeks prior to screening until Day 1 of treatment study.
* Pregnancy or breastfeeding women.
* Recent participation in an experimental drug trial.
* Prior use of a CCR5 or CXCR4 antagonist.
* Significant ECG abnormalities or significant history of active pancreatitis, hepatitis, opportunistic infections, malabsorption disorders, cancer, or severe illness.
* Current use of certain medications may exclude participation in this study.
* Additional qualifying criteria and laboratory test requirements to be assessed by study physician.
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB

The antibiotic linezolid when given for the treatment of multi-drug resistant tuberculosis is safe and tolerated at a low dose (600 mg daily) for a limited duration (16 weeks)


Eligibility Criteria:
Inclusion Criteria

1. Pulmonary tuberculosis with or without extrapulmonary TB with a M. tuberculosis isolate that is confirmed to be resistant to at least rifampin and isoniazid (without regard to prior treatment for TB).
2. A documented positive sputum culture result for M. tuberculosis from a sputum obtained in the four months prior to enrollment.
3. Willingness to have HIV testing performed, if HIV serostatus is not known or if the last documented negative HIV test was more than 6 months prior to enrollment.
4. Residence within the Durban Functional Region (Durban Metropolitan Area) or Tugela Ferry, Msinga District, KZN, RSA.
5. Age ≥ 18 years.
6. Karnofsky score of \> 50 (see section 18.1)
7. Willingness by the patient to attend scheduled follow-up visits and undergo study assessments.
8. Women with child-bearing potential must agree to practice an adequate method of birth control or to abstain from heterosexual intercourse during study therapy. (Standard birth control measures are provided free of charge by public health institutions)
9. Laboratory parameters done within 14 days prior to screening:

   1. Serum creatinine level \< 2 times upper limit of normal
   2. Hemoglobin level ≥ 9.0 g/dL
   3. Platelet count of ≥ 80,000/mm3
   4. Absolute neutrophil count (ANC) \> 1000/ mm3
   5. Negative pregnancy test (for women of childbearing potential)
10. Able to provide informed consent or legally authorized representative able to do so if decisionally impaired.

Exclusion Criteria

1. Currently breast-feeding or pregnant.
2. Known allergy or intolerance to linezolid.
3. Planned therapy during the intensive phase of tuberculosis treatment using drugs having unacceptable interactions with linezolid, including dopamine, selective serotonin uptake inhibitors (citalopram, fluoxetine, fluvoxamine, paroxetine, and sertraline), amitriptyline, bupropion, mirtazepine, levodopa, carbidopa, sinemet, or herbal medications.
4. Significant peripheral neuropathy as evidenced by \< 5 seconds of vibratory sense to a 128 Hz tuning fork on either big toe
5. Pain, aching or burning of the feet that interfere with walking or sleep.
6. In the judgment of the physician the patient is not expected to survive for more than 4 weeks.
7. Anticipated surgical intervention for the treatment of pulmonary tuberculosis
8. Visual acuity of 20/200 (6/60 meters) best corrected vision or less.
9. Poor color vision as evidenced by incorrect answers on \> four of 12 screening Ishihara plates
10. Participation in another drug trial.
11. The patient has received second line TB drugs for \> 7 days immediately prior to enrollment (note: use of first line drugs such as INH, Rifampin, PZA, or ethambutol for \> 7 days immediately prior to enrollment is allowed)
Outcome of Chest Trauma Patients in One Year in Sohag University Hospital

The history of chest trauma is as old as that of man himself. One of the earliest writings about chest trauma is found in the Edwin Smith Surgical Papyrus, written in 3000 bc.

Over the last century, there has been considerable reduction in the mortality of chest trauma owing to improved pre-operative care, availability of positive pressure ventilation, increasing availability of antibiotics, improvement of radiological techniques and improved lung toilets measures etc.

Chest trauma implies trauma to any or combination of different thoracic structures, which can be divided into 4 anatomical regions i.e. the chest wall, the pleural space, the lung parenchyma, and the mediastinum.

Trauma is one of the top ranking causes of accidental or unnatural deaths. Chest trauma is a significant source of morbidity and mortality worldwide. overall, it accounts for 25%-30% of all trauma related deaths and is implicated in an additional 25% of patients, who died from injuries.

In most cases, blunt chest trauma is by far the commonest and road traffic accidents account for 70%-80% of such injuries. Fire-arm injuries, falling from height, blast, stabs, and various acts of violence are the other causative mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* males and females
* adults and children
* isolated chest trauma
* polytraumatized patients
* penetrating chest trauma
* blunt chest trauma

Exclusion Criteria:

* patients presented with cardiac arrest
* patients presented dead
* patients with glasco coma scale 5 or less
* patients with sever abdominal injuries
Safe & Easy for Alzheimer's Disease and Related Pathologies

All over the world the increasing prevalence of chronic disorders and its impact on functional decline is challenging the sustainability of health care systems. Older individuals also frequently experience the reversible "frailty syndrome", which overlaps with chronic diseases, increasing incidence of disability.

Building a global system aiming to take in charge all causes leading to loss of autonomy is a rather complicated task involving numerous Information and Communication technologies (ICT) solutions which are not always easy to use in everyday life.

The SafEE (Safe Easy Environment) project aim is to improve the safety, autonomy and quality of life of older people at risk.

The SafEE2 project develop non pharmacological therapeutic through diferent ICT (stimulation aromatherapy automatic fragrance ...) .

The goal of this study is to validate the acceptability, sensitivity and efficacy of the systems.

The non pharmacological therapeutic will be install at hospital room :

* aromatherapy,
* music therapy,
* cognitive training in multimedia application offering cognitive games.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of Alzheimer's disease according to NINCDS-ADRDA (McKhann, Drachman et al. 1984) or typical or atypical Alzheimer's disease (Dubois B. et al. 2007).
* Score at Mini Mental Test (MMSE) ≥16.
* Subjects residing in nursing homes.
* Subjects beneficiaries of a social security scheme.
* Signature of free and informed consent.

Exclusion Criteria:

* Failure to pass the neuropsychological tests because of a sensory or motor deficit.
* Sensory deficit (olfactory or visual) preventing the patient made perfectly meet the therapeutic solutions.
* Prescription of a new treatment psychotropic (hypnotic, anxiolytic, antidepressant, antipsychotic) in the week before the evaluation;
* Persons deprived of liberty (administrative or judicial).
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.


Eligibility Criteria:
Inclusion criteria

* 18 years or greater
* Confirmed diagnosis of ACTH-dependent Cushing's disease
* Not considered candidate for pituitary surgery

Exclusion criteria

* History of pituitary irradiation in the last 10 years
* Cushing's syndrome not caused by pituitary tumor
* Patients with active malignant disease (cancer) in the last 5 years
* Women who are pregnant or lactating

Other protocol-defined inclusion/exclusion criteria apply.
Stem Cell Therapy for Type 2 Diabetes Mellitus

The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.

* To evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments.
* To assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

1. Free will taking part in the study and ability to provide written informed consent;
2. Type 2 diabetes mellitus (as guideline WHO, 1999);
3. Age 18-75 years old，Male/Female;
4. 19≤Body mass index (BMI)≤30㎏/㎡;
5. Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;
6. Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;
7. Not pregnant or nursing;
8. Negative pregnancy test;
9. Fertile patients will use effective contraception.

Exclusion Criteria:

1. Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
2. Active infection requiring treatment;
3. Unexplained febrile illness;
4. Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.