cyrilzakka/clinical-trials huggingface dataset:
Muscle Activity of the Upper Limb Between Task-Specific and Robot Assisted Training Among Individuals Post Stroke

The investigators compared the activity and fatigue of upper extremity muscles, pain levels, subject satisfaction levels, perceived exertion, and number of repetitions in Task-Specific Training (TST) compared with Robot-Assisted Training (RAT) in individuals post-stroke.

Twenty sub-acute post stroke subjects received one TST and one RAT. They marked the pain level in their paretic extremity before and after each session. Muscle activity levels and fatigue and number of repetitions were monitored during each session. The subjective assessment questionnaire of treatment and the Borg scale were administered post-session.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 85 year old individuals up to three months following stroke
* National Institutes of Health Stroke Scale (NIHSS) score 3-15
* Intact cognitive function
* mild to moderate weakness of the affected hand
* normal or corrected eyesight

Exclusion Criteria:

* neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function
* a pace-maker
Trial of a Health Promoting School Approach to Positive Youth Development and Wellness Promotion

Assess the effects of a school-based multi-component intervention on school connectedness, school engagement, and developmental assets through a group randomized, participatory trial.

Health Promoting Schools intervention including pilot-tested teacher professional development, student-defined enhanced environment, and parent-defined enhanced community/family connection. The Coalition will finalize the intervention using a phased intervention map that integrates community perspectives with theoretical approaches to evidence based practices. The study aims will be accomplished through a group randomized trial in 10 urban schools with diverse populations representing approximately 1,900 students.

Aim 1: Assess the effects of a school-based multi-component intervention on school connectedness, school engagement, and developmental assets through a group randomized, participatory trial.

Hypothesis 1a: Students in the intervention schools will experience improved school connectedness, engagement and developmental assets compared to the control group.

Aim 2: Assess the effects of a school-based multi-component intervention on emotional well-being, tobacco and other substance use, and academic outcomes through a group randomized, participatory trial.

Hypothesis 2a: Students in the intervention schools will experience improved emotional well-being, course completion, attendance, and decreased disciplinary action and substance use compared to the control group.

Aim 3: Evaluate the relationships between participatory factors , school intervention implementation, and study outcomes.

Exploratory hypothesis 3a: Perceptions of quality of collaborative processes will be associated with degree of school intervention implementation and study outcomes.

Exploratory hypothesis 3b: School capacities and context will be associated with school intervention implementation and study outcomes.

Exploratory hypothesis 3c: School capacities and context will mediate the relationship between quality of collaborative processes and school intervention implementation.

Eligibility Criteria:
Inclusion Criteria:

* 9th grade students
* enrolled in the school at the time of randomization

Exclusion Criteria:

* Being unable to participate in the survey
Perfusion CT as a Predictor of Treatment Response in Patients With Hepatic Malignancies

A research study of liver perfusion (how blood flows to the liver over time). We hope to learn whether perfusion characteristics of liver masses may be predictive of response to treatment and whether liver perfusion characteristics can be used to follow response to treatment.


Eligibility Criteria:
Inclusion Criteria:3.1.1 Patients with suspected or biopsy-proven liver masses including unresectable hepatocellular carcinoma (HCC), unresectable colon cancer metastases to the liver, and metastatic neuroendocrine tumors to the liver will be eligible for enrollment.

3.1.2 Patients who have undergone prior chemotherapy more than one year prior to the study are eligible for enrollment.

3.1.4 Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.

3.1.5 No life expectancy restrictions.

3.1.6 ECOG and Karnofsky Performance Status will not be employed.

3.1.7 Patients with renal failure are ineligible for this study (Glomerular filtration rate (GFR) must be \> 60)

3.1.8 Ability to understand and willingness to sign a written informed consent document. Exclusion Criteria:3.2.1 Patients who have undergone prior chemoembolization of hepatocellular carcinoma (HCC) are ineligible for enrollment. Patients who have undergone chemotherapy within one year prior to the study are also ineligible for enrollment.

3.2.2 No restrictions regarding use of other investigational agents.

3.2.3 Patients with severe contrast allergy are ineligible.

3.2.4 Patients who are pregnant or are trying to become pregnant are excluded from this study.

3.2.5 Patients who are cancer survivors or Human Immunodeficiency Virus (HIV)-positive will not be excluded.
Pediatric Multicenter Study of REPEL-CV

This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular (cv) surgery.

- Efficacy at second sternotomy

Eligibility Criteria:
Inclusion Criteria:

* Stage sternotomies

Exclusion Criteria:

* Delayed closure beyond 5 days
Diagnostic and Prognostic Value of New Biomarkers in Patients With Heart Disease

The objective of this work is to investigate and then to sequence new biomarkers in the plasma of patients presenting with dyspnea secondary or not to heart failure, and study their diagnostic and prognostic value.

Plasma samples for patients with dyspnea, edema, with or without heart failure; ambulatory or admitted for cardiac decompensation (even with cardiac shock and LVAD) ; or entering a cardiac rehabilitation program, will be prospectively collected.

The objective of this work is to investigate and then to sequence new proteins in the plasma of these patients for diagnostic and prognostic purpose.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with shortness of breath secondary or not to heart failure, even with cardiac shock and LVAD.
* Patients with valvular disease
* chronic stable heart failure.
* post- partum Cardiomyopathy

Exclusion Criteria:

* terminal cancer
* progressive neurological disease
* pregnancy
* opposition of the patient
Characterisation of Biofilm of the Chronic Wounds

In this prospective observational study, the investigators tried assess the presence of biofilm on chronic wound samples coming from a large cohort study of patients, whilst cross-referencing the clinical, bacteriological and wound care observations.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic wounds (period \> 6 weeks) \> 10 cm2
* Patient age \>18 for the 3 French centres
* Patient participation in a follow-up program for treatment of their wound \> 1 month
* Availability of patient information and written informed consent from them or their legal representative

Exclusion Criteria:

* Patients unable to submit to medical follow-up in the trial due to geographical constraints etc
* Patients deprived of freedom or under guardianship
Effect of Oral Administration of a Herbarium Mixture (Guazuma Ulmifolia and Tecoma Stans) on Metabolic Profile in Type 2 Diabetic Patients

To evaluate the effect of oral administration of herbarium mixture Guazuma ulmifolia (GU) and Tecoma stans (TS) on metabolic profile in type 2 diabetic patients.

A randomized, double blind, placebo controlled, clinical trial was carried out 40 type 2 diabetic patients independently of their basal hypoglycemic treatment. At beginning and at end of the study, BMI, waist circumference, a metabolic profile (fasting glucose, HbA1c, lipids and biosecurity profile), were measured. The patients were randomly assigned to receive the herbarium mixture (GU/TS) 1 g before each meal, or placebo for a period of 90 days. All patients received therapy medical nutrition.

Eligibility Criteria:
Inclusion Criteria:

* Signing of letter of consent under written information.
* Men and women with serum glucose of ≥126 and \<400 mg / dl and / or HbA1c ≥6.5% and \<10%.
* Age between 30 and 60 years.
* BMI between 25 - 39.9 kg / m2.
* With or without pharmacological treatment with oral hypoglycemic agents or insulin
* Stable body weight during the last 3 months (± 5%).
* Women in the follicular phase of the menstrual cycle (days 3 to 8 of the cycle) at the time of the laboratory tests
* Women who do not expect to be pregnant within the next 3 months.

Exclusion Criteria:

* Physical or mental incapacity that makes it impossible to carry out the intervention.
* Uncontrolled thyroid disease
* Women with suspicion or confirmation of pregnancy.
* Women who are breastfeeding.
* Hepatic disease or elevation to double the upper normal value of TGO and TGP.
* Diagnosis of renal insufficiency or creatinine\> 1.5 mg / dL or glomerular filtration rate \<60 mL / min).
* Known hypersensitivity to calcined magnesia or Guazuma ulmifolia and / or Tecoma stans.
The Effect of Indacaterol on Exercise Endurance in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

This study compared the effect of indacaterol (300 μg once daily \[od\]) on exercise endurance with that of placebo in patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults aged ≥ 40 years, who have signed an informed consent form prior to initiation of any study-related procedure.
* Co-operative outpatients with a diagnosis of moderate to severe chronic obstructive pulmonary disease (COPD), as classified by the GOLD Guidelines (2006), and:

  * Smoking history of at least 20 pack years.
  * Post-bronchodilator forced expiratory volume in 1 second (FEV1) \< 80% and ≥ 30% of the predicted normal value.
  * Post-bronchodilator FEV1/forced vital capacity (FVC) \< 70%.

Exclusion Criteria:

* Pregnant or nursing (lactating) women.
* Women of child-bearing potential.
* Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period.
* Patients requiring oxygen therapy or who experience oxygen desaturation to \< 80% during cycle exercise on room air.
* Patients with a Wmax value \< 20 W (as determined by the incremental cycle endurance test) at screening.
* Patients who have had a respiratory tract infection within 6 weeks prior to screening.
* Patients with contra-indications of cardiopulmonary exercise testing.
* Patients with concomitant pulmonary disease.
* Patients with a history (up to and including the screening visit) of asthma.
* Patients with diabetes Type I or uncontrolled diabetes Type II.
* Any patient with lung cancer or a history of lung cancer.
* Any patient with active cancer or a history of cancer with less than 5 years disease free survival time.
* Patients with a history of long QT syndrome or whose QTc interval (Bazett's) measured at the collection of informed consent visit (Visit 1) or randomization is prolonged.
* Patients who have been vaccinated with live attenuated vaccines within 30 days prior to screening or during the run-in period.
* Patients unable to successfully use a dry powder inhaler device, metered dose inhaler (MDI), or perform spirometry measurements.

Other protocol-defined inclusion/exclusion criteria applied to the study.
Safety and Effectiveness of Ozurdex Steroid Implants for DME After Vitrectomy Surgery

Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.

A total of 15 patients will be enrolled into the study. This is a 3 year randomized controlled study with the primary endpoint at 1 year. Secondary safety and efficacy endpoints will be evaluated in year 2 and year 3.

Patients will be randomly enrolled into 1 of 3 groups:

Group 1: Dexamethasone administered up to every 3 months Group 2: Dexamethasone administered up to every 6 months Group 3: Sham

Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT.

Ozurdex (dexamethasone) or Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. One month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.

Re-implantation of Ozurdex may occur at any time \> 3 months following last injection in group 1 and \> 6 months following last injection in group 2 if any of the following conditions are met:

1. Increase of \> 50 microns from the best previous CRT measurement
2. Recurrence of intraretinal cystic edema
3. Persistent intraretinal cystic edema

At 13 months, patients in the sham group will be eligible for Ozurdex implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2 (up to every 6 months).

Eligibility Criteria:
Inclusion Criteria:

1. Adults\> 18 years of age with type 1 or 2 diabetes mellitus
2. Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is \> 300 microns with intraretinal cystic edema
3. BCVA between 20/40 to 20/400
4. Patient had vitrectomy surgery.
5. Provide a signed informed consent prior to any study procedure

Exclusion Criteria:

1. Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition
2. Patient with history of steroid response with IOP \>35 mm Hg or requirement to be on \> 2 glaucoma medications following previous steroid injection.
3. Previous injection of anti-VEGF or steroid in the study eye within 90 days
4. Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days.
5. Current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula.
6. Pregnant, lactating females, or females of child-bearing potential that are not using reliable contraception.
Adjuvant Low Dose Total Body Irradiation in Elderly Patients With Diffuse Large B-Cell Lymphoma

The purpose of this study is to determine whether the application of low dose total body irradiation following chemo-immuntherapy in elderly patients with aggressive with non-Hodgkin's lymphoma would be safe and potentially benecicial adjuvant therapy


Eligibility Criteria:
Inclusion Criteria:

* previously untreated, pathology verified aggressive non-Hodgkin lymphoma of the diffuse large B-cell type according to the WHO classification. Age between 60 years and 80 years.Positive for an anti-CD20 antibody. Good performance status and normal initial normal blood count.

Exclusion Criteria:

* Patients with previous lymphoma associated with immune suppression of any sort. Diagnosis or history of indolent lymphoma or other malignancies. Marked impairment of any vital organ such as the heart, lung, liver or kidneys.
Transcranial Alternating Current Stimulation (tACS) for Auditory Hallucinations

Transcranial alternating current stimulation (tACS) can modulate and restore neural oscillations that are reduced in patients with psychiatric illnesses such as schizophrenia. Here, we performed a open-lable study of clinical trial in 30 schizophrenia patients with auditory hallucinations to show that tACS is effective for auditory hallucinations.

Each week, the patient rested quietly with her eyes open while receiving alpha-frequency tACS for 40 minutes. Stimulation was delivered at 10 Hz with 1 mA zero-to-peak amplitude in-phase to the location 1 and the location 2 acquired by the MEG technique with 5\*5 cm electrodes. A 5\* 7 cm return electrode was centered on Cz. In total, 20 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Schizophrenia with auditory hallucinations was diagnosed by DSM-IV, AHRS \>12, Take sufficient antipsychotics for at least 1 month.

Exclusion Criteria:

* current pregnancy, major medical illness affecting the central nervous system, significant neurologic disorders, intake of drugs including supplements like essential fatty acids that influence prostaglandins or niacin skin flush flash pathway metabolism, a history of suicide risk, or alcohol or drug abuse.
Acute Metabolic Effects of Estradiol

Estradiol promotes and maintains the typical female phenotype characterized by subcutaneous fat accumulation. There is evidence to suggest that this effect relies on the ability of estradiol to increase the amount of anti-lipolytic α2A-adrenergic receptors, but whether this requires long-term exposure to estradiol or is the result of an immediate effect is not clear. Objective: To study acute effects of a single dose (4 mg) of 17β-estradiol on regional and systemic lipolysis.

Estradiol affects muscle and fat distribution, and thereby lipid metabolism. A reduction in muscle power is seen after menopause, readily counteracted by female hormone therapy (HT). Treatment with HT through months to previously untreated postmenopausal women, or hormone replacement therapy (HRT) to women with Turner syndrome, increases muscle mass and reduces fat mass. HT in postmenopausal women furthermore prevents fat accumulation and increases lipoprotein lipase activity and lipolysis to an extent comparable to premenopausal women. In contrast, it has also been shown that estradiol may actually attenuate lipolysis during basal as well as catecholamine stimulated conditions. In addition, one study found whole body fat metabolism to be lower during treatment with estradiol than without, and reduced lipolysis is present in postmenopausal women during treatment with estradiol, along with an increased number of α-adrenergic receptors and a decreased number of β-adrenergic receptors.

It is not clear whether the lipolytic effect of estradiol happens acutely or is dependent on chronic exposure. Moreover, regional differences in the pharmacodynamics of estradiol have not been assessed. Finally, effects on skeletal muscle have never been examined.

The purpose of the present study was 1) by microdialysis to quantify the regional production of glycerol in two tissues (muscle and fat), and in two regions (abdominal and femoral). 2) To quantify the whole-body lipolytic effect of estradiol, and 3) in biopsies to study intracellular mechanisms behind the action of estradiol.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women assessed by FSH and estradiol levels
* Not taking any drugs
* Non-smokers

Exclusion Criteria:

* Obesity (BMI\>30)
Reducing Individual Work Stress in Healthcare Professionals Through Exchange of Job Resources

The present study focuses on prosocial job crafting as a novel strategy to reduce burnout and foster well-being among nurse professionals. Specifically, we will examine whether prosocial job crafting enhances individual and team-level well-being by increasing own and others' resources.

Below, we provide more information on the study design, study procedure, data collection, data management, and data analysis.

Study Design:

Type: Prospective, longitudinal, observational diary study. Duration: 10 workdays of daily surveys with a baseline survey at the start (Day 0).

Setting: Online survey tool (Castor), accessible via smartphones.

Study Procedure:

Day 0 - Baseline Survey: Collects demographic data and job-related information.

Days 1-10 - Daily Surveys:

Workday Verification: Confirmation of work on that day.

In addition to the outcomes listed under primary and secondary outcome measures, daily surveys will include measures of:

Prosocial Job Crafting: 12 items adapted to measure crafting behaviors to benefit other team members, using the Prosocial Job Crafting Measure (PSJCM).

Psychological Capital: 12 items measuring hope, self-efficacy, optimism, and resilience, using a shortened version of the Psychological Capital Questionnaire (PCQ).

Day 11 - Post-Study Survey: Summary of results and feedback opportunity.

Data Collection:

Survey Platform: Mobile-friendly (Castor). Questionnaire Format: Self-report measures adapted for daily context.

Data Management:

Anonymity: Participants are assigned anonymous codes for data matching. Confidentiality: Data is securely stored with access only for researchers on the project.

Statistical Analysis:

Multilevel modeling will be used to analyze the nested nature of daily data and relationships between job crafting, resource exchange, and work outcomes.

Eligibility Criteria:
Eligibility Criteria:

* Employees (nurse professionals) working in a team-based work environment (hospital setting).
* Participants must be able to complete daily surveys in the designated timeframe (end of each workday).

Exclusion Criteria:

* Part-time workers with small contracts (less than 3 days a week) or individuals not engaged in team-based work.
* Participants who do not complete the baseline survey or a minimum of 5 daily surveys.
A Study of Brepocitinib in Adults With Active, Non-Infectious, Non-Anterior Uveitis

The purpose of this study is to determine the safety and efficacy of brepocitinib in participants with active, non-anterior (intermediate, posterior, or pan) non-infectious uveitis (NIU).


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects (18-75 years old)
* Diagnosis of non-infectious uveitis (intermediate uveitis, posterior uveitis, or panuveitis)
* Active uveitic disease in at least 1 eye
* Weight \> 40 kg with a body mass index ≤ 40 kg/m2

Exclusion Criteria:

Has confirmed or suspected current diagnosis of infectious uveitis History of or have:

1. Lymphoproliferative disorder
2. active malignancy
3. cancer within 5 years prior to screening (exceptions for basal cell carcinoma, squamous cell carcinoma, ductal carcinoma in situ of the breast, carcinoma in situ of the uterine cervix, or thyroid carcinoma.)
4. thrombosis orand cerebrovascularardiovascular ischemic event disease within the last 12 months
5. a high risk for herpes zoster reactivation
6. active or recent infections