cyrilzakka/clinical-trials huggingface dataset:
Comparison of Aerobic and Resistance Training on Exercise Capacity, Depression and Quality of Life in Hypothyroidism.

the study will show the effects of aerobic and resistance training on exercise capacity, depression and quality of life in patients with hypothyroidism. The evaluation of TSH level before and after the exercise sessions will provide valuable data.

The study aims to investigate the effects of aerobic exercise and resistance training by comparing the two types of exercises, the finding of this study gain insights into the most effective approach for patients with hypothyroidism particularly in relation to exercise capacity, depression and quality of life. The study design is Randomized Controlled Trial. Sample size is calculated using G power program. the study duration is 6 months after the approval of research board. Non probability Purposive sampling is used for this study. Data will be analyzed by using SPSS version 20.

Eligibility Criteria:
Inclusion Criteria:

Both males and females Age between 40 to 60 years Diagnosed cases of hypothyroidism Duration: 2 years being diagnosed Patients who easily perform exercises

Exclusion Criteria:

Patients with serious comorbidities like cancer Uncontrolled hypertension Vitally unstable patients Red flags for physiotherapy
Automatic Versus Intentional Movement Exercises to Enhance Arm Functions After Stroke

Many patients retain upper-limb motor impairment following stroke. Most conventional rehabilitation techniques are aimed to improve motor intentional movement by repeated exercises. These techniques require attentional load and are responsible for significant fatigue that probably represents a limiting factor. Alternatively, the automatic control of action is now well documented. A rehabilitation method based on this principle could allow recovery of more natural movements.

Hypothesis: Stimulating automatic motricity improves upper-limb motor skills compared with a rehabilitation technique based on intentional movements.


Eligibility Criteria:
Inclusion Criteria:

* All subjects must be between the ages of 18-80 and must not be pregnant
* Patients volunteer to participate in the study, with a written informed consent signed
* Affiliation to a national health insurance program
* Hemiplegia after stroke
* Stroke onset \>6 weeks and \<4 years prior to study enrollment
* Patients able to perform the exercises on the automated table

Exclusion Criteria:

* Pregnancy
* Excessive pain in any joint of the paretic extremity (VAS\>5)
* Coexistent major neurological or psychiatric disease as to decrease number of confounders
* Subjects with global aphasia and deficits of comprehension
* Any substantial decrease in alertness, language reception, or attention that might interfere with understanding instructions for motor testing
Disturbances in BCAA Metabolism and the Effects of Feeding and Exercise in COPD

Studies on resting human muscle show that ingestion of the branched-chain amino acids (BCAA): leucine, valine and isoleucine have an anabolic effect on muscle protein metabolism. However, the effects of BCAA intake on protein metabolism during exercise are less clear. When BCAA were supplied as single amino acids, without other amino acids and/or carbohydrates, no effects were observed on protein kinetics. On the other hand, ingestion of BCAA during running appeared to reduce the catabolic effect of running on muscle protein metabolism. These experiments were all performed with mixtures of the BCAA with or without carbohydrates but not in the form of complete meals with food protein as a basis. Therefore, it is still unknown whether a protein meal, containing a substantial amount of BCAA is beneficial during exercise by inducing an anabolic effect.

Whey and Casein protein contain a substantial amount of BCAA in contrast to Soy protein. Therefore, it is hypothesized that milk-based proteins are a better and more physiological source of BCAA during exercise and will lead to more protein anabolism. Most of the available studies have been carried out in young and fit humans but there are hardly any data are available in the increasing population of the elderly. Therefore it is still unknown whether a BCAA rich protein meal can enhance the anabolic effect of exercise in older individuals.

Besides sarcopenia, a substantial part of the elderly is suffering from a chronic systemic disease such as chronic obstructive pulmonary disease (COPD). COPD represents an important health care problem. COPD is the fourth leading cause of death and will be the third leading cause worldwide in 2020. Besides the local impairment, COPD is a chronic wasting disease, associated with alterations in intermediary metabolism. Substantial disturbances have been found in BCAA (and related) metabolism in these patients at rest and during exercise. It might therefore be of clinical relevance to study the metabolic effects of BCAA rich protein meals in patients with COPD at rest and during exercise.

In this study we investigate whether milk based protein sources of BCAA (casein and whey proteins) are superior to soy protein in the stimulation of protein anabolism before, during and after cycle exercise in COPD and healthy elderly and young subjects, and whether adding BCAA to soy protein will increase protein anabolism in these subjects.

To investigate Leucine, Isoleucine and Valine metabolism during and after exercise in COPD and healthy subjects

Eligibility Criteria:
Inclusion Criteria:

* Irreversible chronic airflow limitation (FEV1 \<70% of predicted)
* Clinically stable condition

Exclusion Criteria:

* Oxygen supplementation
* Respiratory tract infection or exacerbation of his disease at least 4 weeks prior to the study
* Oral corticosteroids as maintenance medication
* Other concomitant metabolic disease (ie malignancy, cardiac failure, recent surgery, severe endocrine, hepatic or renal disorder)
The Innate Immune System and Inflammatory Bowel Disease

The study includes individuals with ulcerative colitis, Crohn's disease and healthy controls. The purpose of this study is to examine the innate immune system (IIS) by exposing peripheral blood monocytes to various ligands relevant for stimulation of the IIS and study the immune response. Colonic mucosal samples are examined to find gene expression patterns which may distinguish the two forms of disease from each other and from healthy controls.

The hypothesis is that the innate immune system has responses unique for the disease states, and that the diseases may be differentiated by examination of gene expression patterns in mucosal biopsies.


Eligibility Criteria:
Inclusion Criteria:

* Presence of ulcerative colitis
* Presence of Crohn's disease
* Healthy (no sign of inflammatory bowel disease)

Exclusion Criteria:

* Anticoagulation
* Cardiac valvular disease
* Intravascular prosthesis
* Coagulation disorders
* Gastrointestinal malignancy
Recording Methods of Muscle Activity "Onset".

Delayed anticipatory muscle activity response in deep low back and abdominal muscles has been observed in patients with low back pain, indicative of a pathological condition. Muscle activity onset is traditionally recorded by intramuscular electromyography, but there is a need for a less cumbersome recording method in large clinical studies. The purpose of this experimental study is to explore whether high-frame rate m-mode ultrasound and tissue velocity imaging could measure anticipatory muscle responses ("onset") in the abdominal muscles reliably and comparably accurate to intramuscular EMG.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 30-65 yrs

Exclusion Criteria:

* recent low back pain
* low back, neck or shoulder pain inflicting work absence or bed rest
* cardiac, rheumatic or other serious illness
* pregnancy
Prevalence of Latent Tuberculosis in High Risk Children

identify the prevalence of latent tuberculosis (according to new guideline ;NICE tuberculosis) among these high risk groups of children and notify ministry of health

TB is an infectious disease caused by the bacillus Mycobacterium tuberculosis. It typically affects the lungs (pulmonary TB) but can also affect other sites (extrapulmonary TB). The disease is spread when people who are sick with pulmonary TB expel bacteria into the air, for example by coughing. Overall, a relatively small proportion (5-15%) of the estimated 1.7 billion people infected with M. tuberculosis will develop TB disease (active disease) during their lifetime. However, the probability of developing TB disease is much higher among people infected with HIV, and also higher among people affected by risk factors such as under-nutrition, diabetes, smoking and alcohol consumption. Latent tuberculosis infection (LTBI) is defined as a state of persistent immune response to stimulation by Mycobacterium tuberculosis antigens with no evidence of clinically manifest active TB. As there is no "gold standard" test for LTBI, the global burden is not known with certainty; however, up to one third of the world's population is estimated to be infected with M. tuberculosis , and the vast majority have no signs or symptoms of TB disease and are not infectious, although they are at risk for active TB disease and for becoming infectious. Several studies have shown that, on average, 5-10% of those infected will develop active TB disease over the course of their lives, usually within the first 5 years after initial infection . The risk for active TB disease after infection depends on several factors, the most important being immunological status

Eligibility Criteria:
Inclusion Criteria:

children aged under 5 yearsold with one of the following risk factor :

1. have diabetes
2. have chronic kidney disease or receive haemodialysis

Exclusion Criteria:

1. All children aged above 12 years old
2. History of recent contact with TB positive patient
3. All children under 5 yearsold without any other risk factor
Study of Ravulizumab in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)

The objectives of this study are to evaluate the safety and efficacy of ravulizumab administered by intravenous (IV) infusion compared to placebo and demonstrate proof-of-concept of the efficacy of terminal complement inhibition in participants with LN (LN Cohort) or IgAN (IgAN Cohort).

This study consists of a 6-week Screening Period, 26-week Initial Evaluation Period, a 24-week Extension Period, and a 36-week post-treatment Follow-up Period.

Eligibility Criteria:
Inclusion Criteria:

Common to both disease cohorts:

* Proteinuria ≥1 (gram \[g\]/day or g/g)
* Vaccinated against meningococcal infection
* Vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements

For LN cohort:

* Diagnosis of active focal or diffuse proliferative LN Class III or IV
* Clinically active LN, requiring/receiving immunosuppression induction treatment

For IgAN cohort:

* Diagnosis of primary IgAN
* Compliance with stable and optimal dose of renin-angiotensin system inhibitor treatment for ≥ 3 months

Exclusion Criteria:

Common to both disease cohorts:

* eGFR \< 30 milliliters/minute/1.73 meters squared
* Previously received a complement inhibitor (for example, eculizumab)
* Concomitant significant renal disease other than LN or IgAN
* History of other solid organ or bone marrow transplant
* Uncontrolled hypertension

For IgAN cohort:

* Diagnosis of rapid progressive glomerulonephritis
* Prednisone or prednisone equivalent \> 20 milligram (mg) per day for \> 14 consecutive days or any other immunosuppression within 6 months
the Clinical Performance of a Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0) Compared to the Conventional Universal Adhesive (3m ESPE Single Bond Universal Adhesive)

this trial is to test the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)

To evaluate the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)

P: Population: Geriatric patients with non-carious cervical lesions (NCCLs) I: Intervention: Novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) C: Comparator : 3m ESPE Single Bond Universal Adhesive O: Outcome:Clinical Performance using FDI criteria

Eligibility Criteria:
Inclusion Criteria:

1. Non-carious cervical lesions in anterior and posterior teeth.
2. Geriatric patients from age 60 years and above.
3. Patients willing to commit to the whole period of the study.
4. Males \& Females included.

Exclusion Criteria:

1. Lack of written informed consent to participate
2. Cervical hypersensitivities
3. Underage patients
4. Allergies to components of the materials used
5. Infectious diseases
6. Mucosal diseases with unclear diagnosis
7. Inadequate oral hygiene
8. Bruxism
9. High caries activity
10. Non-vital pulp
11. Severe periodontal diseases
12. Severe dysgnathia/traumatic occlusion
13. Undergoing orthodontic treatments
14. Undergoing bleaching procedures
Stopping ACE-inhibitors in COVID-19

ACEI-COVID-19 is a multicenter, randomized trial testing the hypothesis that stopping/replacing chronic treatment with ACE-inhibitors (ACEI) or angiotensin receptor blockers (ARB) improves outcomes in symptomatic SARS-CoV2-infected patients

The COVID-19 pandemic currently poses unprecedented challenges to the health systems of all countries. Experimental studies show that the SARS-CoV2 virus enters human cells via the angiotensin converting enzyme II receptor 2 (ACE2). ACE inhibitors (ACEI) and angiotensin receptor blockers (ARB) can lead to an increase in the expression of ACE2. Therefore, there is concern that in patients treated with ACEI or ARB, the absorption of the virus is facilitated, thereby accelerating its spread in the body.

ACEI-COVID tests the hypothesis that stopping chronic ACEI / ARB therapy in SARS-CoV2-infected patients improves outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients competent to make a decision
* Proven and symptomatic SARS-CoV2 infection ≤ 5 days
* Patient age ≥ 18 years
* Provided written informed consent
* Chronic (≥ 1 month) ACEI/ARB therapy for treatment of arterial hypertension, diabetes mellitus, heart failure or coronary artery disease
* Stable hemodynamic conditions allowing to stop or continue treatment with ACEI/ARB (systolic blood pressure ≤180mmHg)

Exclusion Criteria:

* Women capable of bearing children as well as pregnant and breastfeeding women
* Participant in another interventional trail
* At screening visit, no oral medication intake possible
* Advanced heart failure NYHA Stage III-IV
* Left ventricular ejection fraction \<30% or NTproBNP ≥600pg/mL in case of clinical signs of heart failure
* Acute coronary syndrome ≤ 3 months
* Severe arterial hypertension (concomitant use of more than 4 different antihypertensive drug classes)
* Acute respiratory distress syndrome with need for mechanical ventilation
* Patients who at not capable of home blood pressure monitoring
* Patients who cannot be switched to an alternative medication
Comparison of Drug Eluting and Bare Metal Stents With or Without Abciximab in ST Elevation Myocardial Infarction

The DEBATER study is designed to determine the superiority of abciximab over no abciximab and to determine the superiority of drug eluting stents over bare metal stents in patients with acute myocardial infarction who undergo percutaneous coronary intervention.

In patients with acute myocardial infarction primary PCI without prior thrombolytic therapy, is the treatment of choice.

The recommendation for routine stenting in PCI is based on 4 studies that have demonstrated the usefulness of bare metal stents in patients with STEMI. However this recommendation cannot be extrapolated (yet) to the use of drug eluting stents. Although DES have been used widely in unstable angina and in acute myocardial infarction, to date there are no evidence-based recommendations to support the routine use of DES in STEMI.

GPI have been studied extensively in patients with non-STsegment elevation myocardial infarctions (NSTEMI) with planned or performed PCI. In STEMI tirofiban and and eptifibatide are less well investigated, and only abciximab is recommended in primary PCI, but the long term benefits require more investigation. In PCI randomized controlled clinical trials (RCT's) abciximab consistently showed a significant reduction in the rate of myocardial infarction and the need for urgent revascularization. Abciximab has been evaluated in 5 RCT's in association with primary PCI. The pooled analysis for the clinical outcome at 30 days, demonstrate a significant reduction of death, re- infarction and target vessel revascularization (TVR), mainly due to a reduction of repeat intervention. The long-term benefits require more investigation.

The DEBATER trial is designed to answer the questions about the need for abciximab and about the use of DES in primary PCI.

Eligibility Criteria:
Inclusion Criteria:

* STEMI ≤ 12 hours (or STEMI equivalent).
* No contra - indications for primary PCI.
* No contra - indications for abciximab.
* Informed consent from the patient.

Exclusion Criteria:

* Contra - indication for primary PCI: History of peripheral/coronary artery disease that is inaccessible for angiography or PCI.
* Contra - indications for GPI: Ongoing bleeding, bleeding diathesis, cerebrovascular accident \< 6 months, major surgery/trauma \< 6 months, platelet count \< 100.000 mm3 , intracranial arteriovenous malformation or neoplasm, malignant hypertension, INR \>1.5, severe hepatic dysfunction
* Contra - indications for clopidogrel:

  * Severe liver dysfunction, pathological bleeding disorders such as peptic ulcer or intracranial bleeding.
  * Thrombolytic therapy \< 24 hours.
  * Therapy with GPI \< 24 hours.
  * Anticoagulation therapy.
* Co - morbid conditions with a predictable fatal outcome in the short run.
* No informed consent: refusal, coma, artificial respiration, impaired mentation.
: External Shunt Versus Internal Shunt for Off Pump Glenn

A prospective, randomized comparative study where investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.

The bidirectional Glenn shunt (BDG) is performed for cyanotic congenital heart defects, with single-ventricle pathology . The BDG is usually performed with cardiopulmonary bypass (CPB) with its associated complications. The conduct of this operation without CPB can be associated with elevation of superior vena caval (SVC) pressure that may lead to neurological damage.

However, the safety of performing BDG without CPB reported by many authors but with some decompression techniques of the SVC at the time of clamping

Objective: investigators present results of off pump bidirectional Glenn operation done using either a venoatrial shunt or external shunt to decompress superior vena cava during clamping.

Design A prospective, randomized comparative study Setting: Single tertiary care cardiac center Participants 30 patients with functional single ventricle who will go off pump bidirectional Glenn.

Interventions: The patients will be randomly assigned into two groups: Group I (n = 15), where it will be done with a veno-atrial shunt(internal), and Group II (n = 15), where it will be done with an external shunt. All patients will go a complete neurological examination both preoperatively as well as postoperatively Intraoperative data will be collected and analyzed at the following time points: pre-clamping (post induction), during clamping and after de-clamping of SVC. variables such as arterial oxygen saturation (SaO2), systolic blood pressure (SBP), mean arterial blood pressure (MAP), diastolic blood pressure (DBP), and hematocrit, CVP, SVC pressure, cerebral perfusion pressure (CPP= MAP-CVP), PaO2, PaCO2 and ScvO2 will be analyzed.

Postoperatively, the patients will be stabilized in the intensive care unit (ICU) and after monitoring the SVC pressure for 12 h, the internal jugular vein cannula will be removed to prevent any jugular vein thrombosis. The patients will start aspirin (5 mg/kg/day), which will be continued indefinitely.

Eligibility Criteria:
Inclusion Criteria:

* single-ventricle lesions,
* good sized branch pulmonary arteries (Magoon's index \> 1.5),
* PA pressures \< 20 mmHg,
* So2 \< 80%,
* age range from (6 months-5years)
* weight range from (6-21) kg, -All these patients had adequate atrial septal defects and none of these patients required any intra cardiac repair.-

Exclusion Criteria:

* previous cardiac operation,
* known intracranial pathology,
* neurologic disease
* craniofacial anomalies.
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation

The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.

This is a multicenter, single-arm, prospective, and intervention trial. About 30% of core binding factor acute myeloid leukemia (CBF-AML) patients still relapse under current treatment. Some studies have found that KIT mutations, especially the D816V mutation, may predict relapse and decrease overall survival (OS) in CBF-AML. Avapritinib has been approved for the treatment of gastrointestinal stromal tumors with KIT or PDGFRA mutations. Avapritinib was also effective for the treatment of minimal residual disease in acute myeloid leukemia with t (8;21) and KIT mutation failing to immunotherapy after allogeneic hematopoietic stem cell transplantation in a single-center, retrospective report. 11 centers from China carry out the AVACBFKIT regimen including Avapritinib, hypomethylating agents and low dose chemotherapy for the treatment of relapsed or refractory pediatric CBF-AML with KIT mutation. The main focus of this study is to evaluate the efficacy and safety of avapritinib in the regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Gender unlimited;
2. Under 18 years;
3. Diagnosis of acute myeloid leukemia (according to the 2022 WHO classification).
4. Presence of t(8;21)/RUNX1::RUNX1T1 or inv(16)/t(16;16)/CBFβ::MYH11;
5. KIT mutation;
6. Refractory AML: AML patients who do not achieve CR or CRi after induction therapy;
7. Relapsed AML: patients who achieved remission after consolidation therapy or transplantation, FISH confirmed that the fusion gene turned positive, or extramedullary leukemia infiltration;
8. No active infections;
9. Liver function: Tbil ≤2×ULN, ALT/AST ≤3×ULN, creatinine clearance ≥50ml/min;
10. ECOG score \<2;
11. Expected survival time \>12 weeks;
12. Participants must have the ability to understand and be willing to participate in this study and must sign an informed consent form.

Exclusion Criteria:

1. Have received prior treatment with avapritinib;
2. Receiving other targeted therapies for AML at the same time, such as dasatinib, sorafenib, gilteritinib, venetoclax, etc;
3. Presence of active uncontrolled infection (including bacterial, fungal, or viral infection);
4. Present of significant underlying organ diseases: such as myocardial infarction, chronic heart failure, decompensated liver or kidney dysfunction；
5. With other malignancies requiring treatment；
6. Already enrolled in another interventional clinical study；
7. The researchers determined that the individual is not suitable to participate in this trial.