cyrilzakka/clinical-trials huggingface dataset:
Adapted Physical Activity Effect on Aerobic Function and in Patients in Pre Liver Transplantation

Physical exercise has been identified as a major beneficial factor in the management of patients suffering from many chronic diseases especially cancer and in the context of cardiac or pulmonary transplantation. It contributes to an improvement of the quality of life and decreases treatment side effects and mortality. Aerobic fitness is constantly altered in cirrhotic patients and correlated to the severity of the hepatic disease. Moreover, in this setting, other etiological factors may be added like chronic obstructive bronchitis and alcoholic cardiomyopathy. In this population, muscle abnormalities with fatigue and cramps have been described. Muscle weakness in this condition may be comparable to that described in patients with chronic obstructive bronchitis and contributes to the decrease of aerobic fitness. Different causes such as muscle deconditioning, hypoxemia, denutrition, anti-rejection drugs increase this phenomenon after liver transplantation. Finally, the aerobic capacity or VO2max is a prognostic factor for survival and is linked to the number and the length of hospitalizations after liver transplantation (LT).

Therefore, physical activity is a valid and relevant way to improve quality of life, increase survival, and limit costs of hospitalizations. The aim of this study is to assess the effects of a personalized physical activity retraining program on aerobic capacity, strength and fatigue, in a population awaiting liver transplantation.

Purpose: The hypothesis is that an at home adapted retraining program conducted before LT, and including physical activity (aerobic and strength training), will improve aerobic fitness, peripheral strength, quality of life and decrease the hospitalization length in intensive care unit after LT.


Eligibility Criteria:
Inclusion Criteria:

* Males and females between 18 and 70 years of age,
* Signed informed consent,
* Medical indication to LT whatever the cause of the liver disease

Exclusion Criteria:

* Inability to understand the instructions of the trial,
* Patients who are subject to a court protection, wardship or guardianship order,
* Uncontrolled cardiac disease and ventricular ejection fraction (vef) \< 50 %,
* Any other serious conditions which are not stabilized and in which physical exercise is contra-indicated,
* Pregnancy or suckling,
* Patients transplanted in extreme emergency.
Environmental Intervention on Delirious Patients

The implementation of environmental intervention program reduced the duration of delirium and length of stay at the ICU in critically-ill surgical patients.

Purpose: Delirium occurs among patients in intensive care unit at high rates and increases the risk for morbidity and mortality. The purpose of this study is to investigate the effects of environmental interventions for the prevention of delirium.

Methods: A total of 192 patients who had been admitted to the surgical intensive care unit (SICU) in Asan Medical Center during the pre-intervention period (Jun 2013 to Oct 2013) and the post-intervention period (Jun 2014 to Oct 2014) was enrolled and prospective cohort study was done. The environmental intervention included cognitive assessment, providing orientation and comfortable environment, and a proper sleeping environment. The primary outcomes were the incidence rate of delirium, time of delirium onset, and the duration of delirium.

Eligibility Criteria:
Inclusion Criteria:

* with an age of 18 years or older
* who understood the purpose of this study and agreed to participate
* stayed in the SICU for a period of 48 hours or longer

Exclusion Criteria:

* who remained unresponsive \[defined as the Richmond Agitation-Sedation Scale (RASS) less than -4\]
* who could not measure Confusion Assessment Method (CAM-ICU) due to severe visual or hearing disturbance
* who had a history of severe psychiatric or neurologic deficit
* who required an isolation room due to transplantation or immunologic compromise
* who were discharged from ICU within 48 hours
* who were re-admitted to the ICU
* who were less than 18 years old
* who were admitted to the Surgical ICU through another ICU
A Study to Evaluate the Efficacy and Safety of CP-101,606 in Subjects With an Acute Stroke

The purpose of this study is to determine whether a new research medication is effective and safe for the treatment of acute stroke when given within 6 hours of the onset of stroke.


Eligibility Criteria:
Inclusion Criteria:

Males \& females age 40-90 years

Enrolled in study within 6 hours of onset of stroke symptoms

Willing to sign informed consent form

No significant disabilities prior to stroke

Exclusion Criteria:

Treatment with t-PA (tissue plasminogen activator)

Premorbid modified rankin scale score of 2 or more
Ascending Multiple-Dose Study to Evaluate VIA-3196 in Healthy Subjects

This is a single-center, randomized, double-blind, placebo-controlled, ascending multiple-dose study of VIA-3196 to evaluate the Safety, Pharmacokinetics and Pharmacodynamics of VIA-3196 in Healthy Subjects. Study dosing is organized into cohorts corresponding to escalating doses of VIA-3196 or matching placebo. Subjects will be dosed daily for 14 days.


Eligibility Criteria:
Inclusion Criteria:

* The subject must be willing and able to provide written informed consent.
* Healthy, non-smoking, males and females between the ages of 18 and 55 years of age (inclusive).
* If female, the subject is of non-child bearing potential (i.e., surgically \[bilateral oophorectomy, hysterectomy, or tubal ligation\] or naturally sterile \[\>12 consecutive months without menses\]). Verify by FSH at screening as appropriate.
* Body weight \> 50 kg and BMI between 18 and 30 kg/m2 (inclusive).
* LDL cholesterol ≥ 110mg/dL.

Exclusion Criteria:

* History of thyroid disorder or abnormal thyroid function tests at screening. Repeat testing is allowed once at the discretion of the Investigator. - History of unexplained syncope.
* History of hepatobiliary disease; or AST, ALT or direct bilirubin greater than the upper limit of reference range at screening.
* Positive screening test for HIV antibody, Hepatitis B surface antigen or Hepatitis C antibody.
* Abnormal screening ECG: including machine-read QTc \>450 msec (confirmed by manual over read), QRS \>110 msec, intermittent bundle branch block, frequent premature atrial or premature ventricular contractions, or any rhythm other than normal sinus rhythm which is interpreted by the Investigator to be clinically significant.
* History of sensitivity to a similar study drug (e.g., Karo Bio KB2115 or Metabasis MB7811), or a history of important drug or other allergy (except for untreated, asymptomatic seasonal allergies at time of dosing) unless deemed not clinically significant by the Investigator.
* History of sensitivity to thyroid medication.
* History of asthma, or intolerance to beta-blockers.
* Use of acetaminophen within 7 days before dosing and throughout the study.
* History of regular use of tobacco or nicotine containing products within the past 6 months.
* Positive urine drug screen or alcohol test at screening or Day -1.
Tendon Mechanical Properties and Morphological Characteristics of Human Bicep and Tricep Muscles: An In Vivo Ultrasonographical Study

This current study tests whether the load-displacement and stress-strain characteristics of human bicep and tricep muscles and tendons change during graded maximal voluntary elbow extension and flexion exercises.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects
* Age range from 18-35 years

Exclusion Criteria:

* History of shoulder/elbow which needs medical treatment or surgery
Gemcitabine, Oxaliplatin in Combination With Bevacizumab in Patients With Hepatocellular Carcinoma

The purpose of this study is to test the safety of bevacizumab when given in combination with gemcitabine and oxaliplatin and to see what effects (good or bad) it has on patients with hepatocellular carcinoma.

* Treatment is given in cycles, each cycle (except for cycle 1) is 4 weeks long. Cycle 1 is only 2 weeks long.
* During cycle one only, bevacizumab will be given intravenously on day one. Two weeks after receiving bevacizumab, the patient will return to the clinic for treatment with all 3 study drugs.
* During cycle 2 and every cycle thereafter patients will receive; bevacizumab intravenously on day one and day 15; gemcitabine intravenously on day 2 and day 16; oxaliplatin intravenously on day 2 and day 16.
* The following evaluations will be conducted on day 1 and day 15 of each cycle (once every 2 weeks): physical examination, vital signs, medical history, blood tests and urine tests.
* Tumor measurements done by CT and/or MRI will be repeated at the end of cycle 3 and every 2 cycles thereafter.
* Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) of the liver and Perfusions CT scans will also be done on days 10-12 following bevacizumab treatment during cycle 1, and the Perfusion CT will be repeated at the end of cycle 3.
* Once study treatment is stopped the following evaluations will be performed: physical exam, vital signs, blood work, urine tests, CT scan of chest, abdomen and pelvis, and tumor measurements by CT or MRI scans.
* Follow-up will consist of physical examinations and blood tests every 6 months.
* Patients will continue to receive study treatment as long as there is no disease progression or unacceptable side affects.

Eligibility Criteria:
Inclusion Criteria:

* Unresectable or metastatic hepatocellular carcinoma
* Measurable tumors
* Adequate hepatic function: total bilirubin \< 3.0mg/dl; AST \< 7x ULN
* Adequate bone marrow function: ANC \> 1,000/mm3; platelets \> 75,000/mm3
* INR \< 1.5 for those who are not on anticoagulation
* Up to two prior chemotherapy regimens for hepatocellular carcinoma
* 18 years of age or older
* ECOG performance status of 0-1
* Life expectancy of \> 12 weeks

Exclusion Criteria:

* Clinically apparent central nervous system metastases or carcinomatous meningitis
* Uncontrolled serious medical or psychiatric illness
* Pregnant or lactating women
* Current or recent (within 4 weeks of first study infusion) participation in experimental study drug
* Uncontrolled hypertension
* Significant proteinuria
* Serious, non-healing wound, ulcer, or bone fracture
* Evidence of bleeding diathesis or coagulopathy
FCH vs FDG PET/CT in Detection of Lesions in Patients With Multiple Myeloma (MIM)

Hybrid positron emission tomography/computed tomography (PET/CT) has now become available to detect tumors in patients with multiple myeloma. The radioactive glucose 18F-fluorodeoxyglucose (FDG) is the most widely used tracer but findings suggest that PET/CT reveal more lesions when using FCH.

In this study, FDG is compared with a more recent metabolic tracer, 18F-fluorocholine (FCH), for the detection of multiple myeloma lesions at time of initial extension assessment.

The principal objective of this sudy is to compare the number of suspected hypermetabolic foci of myeloma detected by 18F-fluorocholine PET and by 18F-fluorodeoxyglucose PET during the initial extension assessment.


Eligibility Criteria:
Inclusion Criteria:

* Patient with initial diagnosis of multiple myeloma has just been established
* Therapeutic indication and eligible for a HSC autograft (if the HSC autograft could not be performed, the patient will still be retained in the study).
* Status ECOG 0, 1 or 2
* Age ≥ 18 and \< 75 ans years
* Effective contraception for women
* Informed consent signed
* Patient able to lie flat for 30 minutes
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Patient diagnosed with a diagnosis of MGUS (Monoclonal Gammapathy of Undetermined Significance = monoclonal gammopathy of undetermined significance), indolent myeloma ("smoldering myeloma"), non-secreting myeloma or recurrent myeloma,
* Patient already under treatment for myeloma.
* Patient not eligible for intensive treatment followed by a HSC autograft.
* Patient with concomitant neoplasia
* Patient with a history of hematological or solid neoplasia, except if it is a basal cell carcinoma of the skin or an adenocarcinoma in situ of the uterine cervix.
* Patient with a history of sarcoidosis
* Uncontrolled diabetes.
* Patient treated with long-term corticosteroids
* Patient being treated with hematopoietic growth factors
* Patient in sepsis.
* Claustrophobic patient.
* Refusal of patient consent.
* Pregnant or lactating woman.
* Women of childbearing potential without effective contraception.
* Person deprived of liberty or under guardianship
* Impossibility to submit to the medical follow-up of the trial for geographic, social or psychological reasons.
* History of allergic reaction attributed to 18F-fluorodeoxyglucose or to 18F-fluorocholine.
Early Versus Late Administration of Insulin Glargine in T1DM During Fasting Ramadan

To compare different timing of insulin Glargine administration (early-6 pm versus standard bedtime-10 pm) as part of standard of care in patients with type1 diabetes who wish to fast the month of Ramadan.

The investigators aim to compare the effectiveness and safety of two management strategies currently used in basal insulin adjustment for treatment of Type1 diabetes (T1DM) during fasting the holy month of Ramadan.

Primary Objective:

To determine if taking basal insulin Glargine at 6 pm is associated with less rates of hypoglycemia -(we will consider glucose level of 70 mg/dl ( 3.9 mmol/l) and below as the level of hypoglycemia ) - compared to bedtime timing (10-12pm) during fasting Ramadan in patients with T1DM

Secondary Objectives:

1. To estimate the difference between the two groups in glucose variability
2. To estimate the difference between the two groups in number of days they needed to brake their fast
3. To assess the difference in glycemic control between the two groups
4. To estimate the difference between the two groups in overnight and daytime hyperglycemia.
5. To estimate the difference between the two groups in rate of severe hyperglycemia and /or DKA

It is a multi-center open label randomized study that will take place in the diabetes/Endocrine clinics at National Guards Hospitals in four cities (Jeddah, Riyadh, Alhasa, and Dammam)

Variables to be Assessed:

1. Patient's demographics including (age, gender, type and duration of diabetes), and baseline measurements (weight, height,BMI, ...).
2. Rate of Hypoglycemic events (as per SMBG records and CGM) in both groups
3. Number of days fasting was broken in both groups
4. Rate of severe hyperglycemic episodes (BG\>250mg/dl) or DKA in both groups
5. Mean blood glucose for the month of Ramadan as calculated from sum of each patient's 7-point blood sugar home measurements in both groups.
6. Mean 24-hour blood glucose as measured by a continuous glucose monitoring devise in both groups.
7. Mean fasting blood glucose for the month period as calculated from patients home blood sugar measurements in both groups.
8. Mean 2-hour post-prandial blood glucose for the as calculated from patients home blood sugar measurements in both groups.
9. Fructosamine and HbA1c level before and after Ramadan in both groups

Results of this study will help fill a current gap of knowledge and may also contribute to the development of future guidelines for the management of type1DM during Ramadan.

Eligibility Criteria:
Inclusion Criteria:

1. DM type 1
2. Age \> 14 years
3. Diagnosis of type 1 DM of more than 6 months.
4. Committed to do SMBG

Exclusion Criteria:

1. Renal and hepatic impairment
2. Adrenal insufficiency
3. Pregnancy
4. Alcohol consumption
5. Any diagnosed psychiatric disease
An Open-label, Single-arm Longitudinal Study With Dupilumab for Patients With Atopic Dermatitis

24-week, open-label, single-arm longitudinal study of patients with AD, including a comparison between baseline values for adult patients with moderate-to-severe AD and untreated normal control patients.

Patients with AD: ≤24 to 29 weeks, including the screening period Normal control patients: ≤2 days to 5 weeks, including the screening period.

Patients with AD: adults with moderate-to-severe AD whose disease cannot be adequately controlled with topical medications or for whom topical treatment is medically inadvisable (eg, intolerance, other important side effects or safety risks)

Normal control patients: adults without AD or other atopic disease


Eligibility Criteria:
Inclusion Criteria:

All patients:

* Male or female, 18 years or older
* Willing and able to comply with clinic visits and study-related procedures
* Provide signed informed consent
* Have applied a stable dose of topical emollient (moisturizer) once daily for at least 7 days before the day 1 visit

AD patients only:

* Chronic AD
* Eczema Area and Severity Index (EASI) ≥16 at screening and day 1 visits
* Investigator's global assessment (IGA) ≥3 (on the 0 to 4 IGA scale, in which 3 is moderate and 4 is severe) at the screening and day 1 visits
* Body surface area of involvement of AD (BSA) ≥10% at screening and day 1 visits
* Documented recent history (within 6 months before screening visit) of inadequate response to treatment with topical medications or for whom topical treatments are otherwise medically inadvisable

Exclusion Criteria for all patients (not all inclusive):

* Prior use of dupilumab or other anti-IL-4 treatments (prescription or as part of a clinical study) within 1 year of screening
* Treatment with an investigational drug within 8 weeks or within 5 half-lives (if known) before the day 1 visit, whichever is longer
* Having used immunosuppressive drugs or phototherapy within the last 4 weeks
* Treatment with TCS or TCI within 1 week before the day 1 visit
* Regular use (\>2 visits/week) of a tanning booth/parlor within 4 weeks before the screening visit
The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) Post Marketing Surveillance (PMS) (CoreValve India PMS)

The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) has been demonstrated to be safe and effective for high through extreme risk patients with symptomatic severe native aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure. Per DCGI systematic post marketing surveillance requirement, the purpose of this PMS plan is to provide local post marketing surveillance data regarding the safety of Medtronic CoreValve System Family

The objective of this PMS will be to monitor and gather data on the safety of The Medtronic Transcatheter Aortic Valve Implant System (CoreValve System Family) in the approved intended use.

The main focus of this PMS will be to generate additional information and report on all major adverse events up to 30 days from the day of implant procedure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic heart disease due to severe native calcific aortic stenosis or a stenosed, insufficient, or combined surgical bioprosthetic valve failure and with anatomy appropriate for the 23, 26, 29 or 31 mm valve system who are judged by a heart team, including a cardiac surgeon, to be at high or greater risk for open surgical therapy.
* Indications and contraindications are provided in the product Instructions for Use.
* Subject is scheduled to receive transcatheter aortic valve
* Subject is 18 years of age or older
* The patient or his/her Legally Authorized Representative (LAR) has been informed about the nature of the PMS and the Informed consent for both Audio Visual (AV) recording and for study participation has been obtained prior to performing any study-related procedures from the subject or Legally Authorized Representative, as per applicable local requirements in India

Exclusion Criteria:

* None
Impact of Morning Symptoms in Clinical Control of Chronic Obstructive Pulmonary Disease (COPD)

Observational study to know the Impact of morning symptoms in clinical control of COPD patients. 1200 patients will be included by General practitioners (GPs) and pneumologists. Objective: establish if there are differences in the impact of COPD on daily activities and morning symptoms measured through questionnaires of daily life activity (Capacity of Daily Living during the Morning (CDLM), Global Chest Symptoms Questionnaire (GCSQ))


Eligibility Criteria:
Inclusion Criteria:

* Patient has signed informed consent form
* Patients of both sexes,\> 40 years.
* Patients diagnosed with COPD according to global consensus on the definition, classification and management of the disease (GOLD) criteria:

  * post-bronchodilator forced expiratory volume in 1 s (FEV1) / forced vital capacity (FVC) \<70%
  * post-bronchodilator FEV1 \<80% (stage II, III and IV)

Exclusion Criteria:

* Participating in an epidemiological study or clinical trial
* Patient with other respiratory disease than COPD (eg bronchial asthma, cystic fibrosis, severe bronchiectasis, restrictive lung disease, cancer, etc.).
* Patients with mild COPD: FEV1\> 80%
Identification of Necessary Information for Treatment Induction in Newly Diagnosed Acute Lymphoblastic Leukemia/Lymphoma

The goal of this study is to provide sufficient therapy during the time a patients' B-cell Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LLy) risk category is being determined. The term "risk" refers to the chance of the ALL or LLy coming back after treatment.

Primary Objectives

* To provide sufficient therapy to enable testing of newly diagnosed acute lymphoblastic leukemia/lymphoma and mixed phenotype acute leukemia/lymphoma tumor samples to determine eligibility and appropriate risk stratification for SJALL therapeutic studies.
* To develop a central database of genomic and clinical findings.

Secondary Objectives

* To assess event free and overall survival data of patients enrolled on this study.

Patients with newly diagnosed acute lymphoblastic leukemia/lymphoma (ALL/LLy) and mixed phenotype acute leukemia/lymphoma (MPAL) will undergo diagnostic procedures either during screening or on Day 1. They will receive 7 days of chemotherapy including 13 doses of dexamethasone, 1 dose of vincristine, and 1 dose of daunorubicin (for patients with T-ALL/LLy or MPAL only). Patients will also undergo their initial lumbar puncture with intrathecal chemotherapy on Days 4 or 5 or 6 of therapy. After the completion of 7 days of chemotherapy, patients will begin therapy on either a SJALL therapeutic trial or will receive non-protocol therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 1-18.99 years
* Diagnosis of acute leukemia / lymphoma as below:

  * Acute lymphoblastic leukemia (ALL) with at least 25% bone marrow blasts or definitive evidence of ALL in peripheral blood (in those without an available bone marrow sample).
  * Lymphoblastic lymphoma (LLy) with immunophenotypic evidence of a lymphoblastic population and \<25% bone marrow blasts and less than 1,000 circulating blasts/ microL.
  * Mixed phenotype acute leukemia (MPAL) with or without 25% bone marrow involvement (i.e. patients with either leukemia or lymphoma are eligible).

Exclusion Criteria:

* Pregnant or breastfeeding
* Receipt of prior cancer directed therapy with the exclusion of up to 1 dose of intrathecal chemotherapy, 1 dose of vincristine, or emergency radiotherapy due to organ compromising malignant mass. There is no exclusion for prior steroid therapy.
* Known to be currently ineligible for available SJALL therapeutic studies (e.g. receipt of prohibited therapy, no appropriate SJALL therapeutic study available, enrolled on competing trial, etc.).

Note: The intention of this exclusion criterion is to enroll all newly diagnosed ALL/ LLy/ MPAL patients. If participant is screened as a potential participant for subsequent SJALL and later found to be ineligible due to information obtained during INITIALL, this will not make the participant ineligible for INITIALL.

* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
* Major pre-existing abnormalities such as ataxia telangiectasia, Fanconi anemia, Charcot Marie Tooth, etc.