cyrilzakka/clinical-trials huggingface dataset:
Blood Flow Restriction Versus Standard Exercise After Rotator Cuff Repair

The goal of this clinical trial is to determine the effectiveness of postoperative standard exercises with blood flow restriction therapy (BFRT) versus standard exercises alone on shoulder muscle strength and mass in participants with surgically treated rotator cuff tear. It is presumed that the addition of BFRT will significantly improve the shoulder strength and muscle mass at the end of the intervention period compared to the group receiving only standard exercises.

Patients who agree to participate in this research will be randomly assigned to a control group (standard exercises alone) or an experimental group (standard rehabilitation with BFRT). The duration of the postoperative intervention will be 12 weeks. The primary variables will be the shoulder muscle strength and muscle mass. Secondary variables will be the active shoulder mobility, pain intensity, upper limb disability, and health-related quality of life. Results will be measured at 0, 4 and 12 weeks postoperative.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40-65 years
* Symptomatic degenerative rotator cuff tear diagnosed by magnetic resonance imaging
* Undergoing arthroscopic rotator cuff repair
* Be able to read and understand Spanish

Exclusion Criteria:

* Massive irreparable rotator cuff tear
* Concomitant fracture
* Labral or nerve injury
* Suspicious of developing a frozen shoulder
* Revision surgery after rotator cuff repair
* Previous corticosteroid injection (\< 6 months)
* Recent surgery (\< 1 year) in the contralateral shoulder
* History of deep venous thrombosis/pulmonary embolism, peripheral vascular disease, thrombophilia or clotting disorders
* Severe or uncontrolled hypertension, or any comorbid condition that impedes participants to complete the intervention
Trial to Evaluate Efficacy and Safety of Lenabasum in Diffuse Cutaneous Systemic Sclerosis

This is a Phase 3 multicenter, double-blind, randomized, placebo-controlled study assessing the efficacy and safety of lenabasum for the treatment of diffuse cutaneous systemic sclerosis (SSc). Approximately 354 subjects will be enrolled in this study at about 60 sites in North America, Europe, Australia, and Asia. The planned duration of treatment with study drug is 52 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

1. ≥ 18 years of age at the time Informed Consent is signed.
2. Diffuse cutaneous SSc (skin thickening on upper arms, upper legs, or trunk).
3. Disease duration ≤ 6 years from the first non-Raynaud's symptom.
4. No new or increased doses of immunosuppressive medications within 8 weeks prior to Screening.

Key Exclusion Criteria:

1. Unstable SSc or SSc with end-stage organ involvement at Screening or Visit 1.
2. Any of the following values for laboratory tests at Screening:

   1. A positive pregnancy test in women of childbearing potential;
   2. Hemoglobin \< 9 g/dL for males and \< 8 g/dL for females;
   3. Neutrophils \< 1.0 ×10\^9/L;
   4. Platelets \< 75 ×10\^9/L;
   5. Creatinine clearance \< 50 mL/min according to the Modification of Diet in Renal Disease (MDRD) Study equation;
   6. Aspartate aminotransferase or alanine aminotransferase \> 2.0 × upper limit of normal.
3. Any medical condition or concurrent medical therapies at Screening or Visit 1, including a history of non-compliance with medical treatments, that may put the subject at greater safety risk, influence response to study product, or interfere with study assessments.
Carotid Revascularization for Radiation Induced Carotid Artery Stenosis

Cervical radiotherapy (RT) has greatly reduced the mortality of patients with malignant head and neck tumors, which, however, causes a higher risk of carotid artery stenosis, namely, radiation-induced carotid artery stenosis (RICS) and results in a significant increased risk of ischemic stroke. The systematic review and meta-analysis conducted by our team showed carotid endarterectomy (CEA) can yield better results for these patients than carotid artery stenting (CAS), which was contrary to most previous clinical guidelines. A large-scale prospective study is needed to verify the results. We will conduct a prospective registry of RICS patients treated with CEA to evaluate both short-term safety and long-term efficacy outcomes in a Chinese population.


Eligibility Criteria:
Inclusion Criteria:

* Patients with carotid stenosis who had a history of radiotherapy for head and neck cancer. (The median interval between the completion of radiation therapy and development of carotid artery stenosis detected on imaging (or vascular intervention) was no less than 1 years to avoid non-related situations. The target area of the radiotherapy included at least the ipsilateral neck, including part of the carotid system. The internal carotid stenosis was confirmed by angiography, Duplex, 3D angio-CTA or angio-MRI, and stenosis was defined as \> 50% based on North American Symptomatic Carotid Endarterectomy Trial criteria), with or without symptom. Patients with a transient ischaemic attack (TIA) or stroke within 6 months were defined as symptomatic. TIA was defined as a transient episode of neurological dysfunction (focal weakness/ language disturbance/transient monocular blindness/ requiring assistance to walk) caused by focal brain or retinal ischemia that lasts for at least 10 min but resolves within 24 h.)

Exclusion Criteria:

* The patients treated for restenosis.
* Intracranial arteriovenous malformation or aneurysm
* Severe stenosis or occlusion of the ipsilateral intracranial artery
* Unstable angina, myocardial infarction (MI), or congestive heart failure in the last 6 months
* Uncorrectable coagulation abnormalities
* Uncontrolled diabetes mellitus defined as glucose \> 300 mg/dL (16.67 mmol/L)
* Pregnant or in the perinatal period
* Severe concomitant disease with poor prognosis (life expectancy \< 2 years)
* Intolerance or allergies to any of the study medications, such as aspirin or clopidogrel
Exercises Using Virtual Reality on Cancer Patients

in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment

in this study, a randomized controlled trial will be conducted to evaluate the effect of adding exercises using virtual reality on achievements in patients having breast cancer and conducted surgical treatment.

A virtual reality (VR) environment is created by combining computer systems and sensor technology with the use of three-dimensional graphics and enabling users to experience a more real, immersive experience by utilizing their various senses (vision, hearing, touch, etc.) through the use of the computer and sensor technologies and it is characterized by immersion, imagination, and interaction 2 groups will be selected randomly to receive experimental and control intervention for 1 month and outcomes will be collected before and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer female patients
* Age ≥40 years
* All patients with Eastern Cooperative Oncology Group performance status score ≤ 2
* Having to undergo primary treatment with surgery, chemotherapy, and/or radiotherapy based on the patient's need

Exclusion Criteria:

* Severe anemia (Hb ≤ 8 g/dL)
* Uncontrolled hypertension, diabetes
* severe infection, neurologic or muscular diseases prohibiting physical activity
* severe heart disease or myocardial infarction during the last six months, and a severe chronic obstructive pulmonary disease
* uncontrolled and/or extensive brain metastases, or bone metastases that were assessed to pose a risk of pathological fractures from exercising
* Contraindications given by the physician
Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm

To evaluate the efficacy of different botulinum toxin A injection patterns in treating benign essential blepharospasm and to compare their influence on condition of eye surface .

The authors performed a prospective double-blinded randomised clinical trial of 60 patients with an established diagnosis of benign essential blepharospasm from February 2013 to December 2015. Patients received a full injection pattern of 5 sites on one eye and a medial lower eyelid waived injection pattern of 4 sites on the other eye randomly. They were surveyed on ocular surface disease index (OSDI), Jankovic rating scale (JRS), blepharospasm disability index (BSDI) prior to injection and 1week, 1month and 3 months after injection. At these time points, closure of the eyelid, tear break up time (BUT), Schirmer test Ｉ, and lower lid tear meniscus height (TMH) were also measured.

Eligibility Criteria:
Inclusion Criteria:

* had a confirmed diagnosis of bilateral BEB
* a minimum of 24-week period since the last injection was required for all patients who had previously received multiple injections of BoNT-A.

Exclusion Criteria:

* blepharospasm of known etiology (caused by medication, injury, etc.)
* history of surgical intervention for BEB (myectomy or neurectomy)
* current ophthalmologic infection
* apraxia of eyelid opening associated with levator palpebrae dysfunction
Outcome of Different Pathogenic Mutations in Hypertrophic Cardiomyopathy

This is a prospective, single-center study to assess clinical phenotype and prognosis of different pathogenic mutations in Chinese patients with hypertrophic cardiomyopathy. Patients with hypertrophic cardiomyopathy were consecutively recruited, and then DNA samples were extracted from peripheral blood. Targeted sequencing of 142 genes was performed to obtain variants associated with hypertrophic cardiomyopathy. Patients will undergo face-to-face interviews, phone calls, or/and chart reviews at 6 months, 12 months, 24 months, 36 months, 48 months and 60 months for data collection of clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 1. Adults: a wall thickness ≥15 mm in one or more LV myocardial segments-as measured by any imaging technique (echocardiography, cardiac magnetic resonance imaging (CMR) or computed tomography (CT))-that is not explained solely by loading conditions;
* 2. Children: an LV wall thickness more than two standard deviations greater than the predicted mean (z-scored\>2, where a z-score is defined as the number of standard deviations from the population mean);
* 3. Relatives: the first-degree relatives of patients with unequivocal disease (LVH ≥15 mm) is based on the presence of otherwise unexplained increased LV wall thickness ≥13 mm in one or more LV myocardial segments, as measured using any cardiac imaging technique \[echocardiography, cardiac magnetic resonance (CMR) or CT\].

Exclusion Criteria:

* 1. Patients with severe valvular disease, aortic stenosis, congenital heart disease, hypertensive heart disease, diabetic cardiomyopathy, or other cardiovascular or systemic diseases that may cause ventricular hypertrophy;
* 2. Patients who had participated in any clinical trial during the first 3 months;
* 3. Previous history of cancer or tumor, or pathological examination confirmed precancerous lesions (such as breast ductal carcinoma in situ, or atypical hyperplasia of the cervix);
* 4. Patients refused to comply with the requirements of this study to complete the research work.
Controlling Rapid Atrial Fibrillation With Dexmedetomidine

The purpose of this study is to assess the effects of Dexmedetomidine (DEX), on heart rate control in patients with rapid atrial fibrillation (AF) through a pragmatic, randomized, double blinded study comparing the addition of Dex or placebo to standard of care (SOC) treatment.

Dexmedetomidine is a commonly used sedative/anxiolytic agent in the ICU with sympatholytic properties that can cause a decrease in heart rate. Eligible patients will be randomized into one of two groups: SOC plus Dex arm or SOC plus placebo (normal saline) arm. Study drug infusion will be administered at an infusion rate of 1μg/kg/hr via IV, and will not include a loading dose. Four 6-second telemetry rhythm strips will be collected per hour, starting one hour prior to study drug infusion, during the eight hour infusion period, and two hours post infusion cessation). Degree of heart rate control and time to heart rate control for both groups will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients in a SBU Hospital ICU with rapid-AF (with ventricular rates \>100 bpm).
* Patient screening will be conducted prior to patient or LAR consent.

Exclusion Criteria:

* Patients age \<18yrs;
* Anticipated ICU stay \<11hrs;
* Permanently paced heart rhythm;
* Known 2nd or 3rd degree heart block;
* Junctional rhythms;
* Known pregnancy;
* Known allergy to Dexmedetomidine;
* Receiving Dexmedetomidine prior to study onset;
* Non-intubated patients w/ Glasgow Coma Scale \<8;
* Weight \>400lbs (protocol dosing restriction);
* Untreated, symptomatic hypotension (SBP\<90mmHg);
* Received amiodarone, lidocaine, or mexiletine w/in 4hrs prior to consent.
Hyperproteic Nutrition:Correlation of BUN to Nitrogen Balance

This study is designed to determine if the following are true. When protein requirements exceed metabolic requirements, blood urea nitrogen(BUN) levels will rise. Elevated BUN levels in the absence of renal failure, hepatic failure, or GI bleeding, will be correlated with improved nitrogen balance and inversely correlated with infection rates, days of mechanical ventilation, ICU days, and total hospital days.

The purpose of this study is threefold. First, to determine if a correlation exists between BUN and nitrogen balance in the context of hyperproteic nutrition administration. Creatinine clearance will also be followed to determine if there is any harmful effect to the kidney secondary to an elevated BUN. Secondly, to determine if there is a difference in hospital acquired infection rate, ventilator days, ICU days, and hospital stay between the current nutrition standard at Penn State Hershey Medical Center and a hyperproteic nutrition protocol. Thirdly, to determine the accuracy of at least three calculated creatinine clearance formulae when compared to a measured creatinine clearance.

Eligibility Criteria:
Inclusion Criteria:

* Greater then or equal to 18 years of age and patient in Intensive Care Unit
* Receiving enteral nutrition, with expected duration of at least 5 days
* Blood urea nitrogen and creatinine clearance are part of routine blood work
* Indwelling urinary catheter in place

Exclusion Criteria:

* Renal or hepatic failure
* Current or history(past 6 mos) of GI bleeding
* Serum creatinine on day of screening of equal to or greater then 1.5 mg/dl
* Creatinine Clearance on day of screening of equal to or less then 30ml/min
* Hypovolemia resulting in increased BUN
* Septic shock
* Blood urea nitrogen on day of screening equal to or greater then 30mg/dl
Autophagy/Apoptosis Balance During Pregnancy

The object of this study is to assess the intra- and inter-individual variability of apoptosis and autophagy activities in women during pregnancy: 1 / in women with a normal pregnancy and 2 / in pregnant women particularly at risk of complications.

The study investigators hypothesize that there would be an intra-trophoblastic dialogue between the mechanisms of autophagy and apoptosis, the promotion of one partially inhibiting the other. The increase in trophoblastic autophagy during pregnancy could thus constitute an anti-apoptosis defense phenomenon, the exhaustion of which would lead to cellular apoptosis and to pathogenic consequences when it devastates the syncytiotrophoblast.


Eligibility Criteria:
Inclusion Criteria:

* Patients followed at the CHU Nîmes prior to 33 weeks gestation who give birth at the hospital
* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan

Exclusion Criteria:

* The subject is participating in a category 1 interventional study associated with a medication, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* Multiple pregnancy
Biochemical Factors for a Dry Eyed Population

The purpose of this study is to compare various symptoms and signs of dry-eye as well as stratify characteristics of the tear film in a group of dry-eyed individuals in comparison to a group of non-dry-eyed people. Dry-eye is a condition that significantly impacts the quality of life of the sufferer. These are people who are predominantly female and in the older age groups. Determining what characterises a person with dry-eyes is of importance to understanding the disease process.

Dry eye is a multifactorial disease that results in a wide variety of signs and symptoms, which are often poorly correlated. Recent work has shown that not only are there changes in the composition of the tear film (including cytokines and the presence of various mucin species and tear film proteins) but also quantifiable changes in both the structure and function of the ocular surface, including corneal sensitivity and the appearance of the epithelial cells and the sub-basal neural network. To-date, no published study has attempted to correlate various clinical and morphological changes found in dry eye with tear film and ocular surface biomarkers.

Eligibility Criteria:
Inclusion Criteria:

A person is eligible for inclusion in the study, for the dry eye group or control, if she:

1. Is Caucasian, and has full legal capacity to volunteer.
2. Is post-menopausal, with menses ceasing more than 12 months ago.
3. Has moderate or severe dry eye symptoms based on dry eye questionnaire and half of the time wants to use eye drops for dry eye symptoms (dry eye group)
4. Has read, understood and signed an information consent letter.
5. Is willing and able to follow instructions and maintain the appointment schedule.
6. Has clear corneas and no active ocular disease.
7. Has had an ocular examination in the last two years.

Exclusion Criteria:

1. Is on hormone replacement therapy (HRT).
2. Ceased menses due to autoimmune disorders, mumps, chemotherapy, pelvic irradiation or smoking.
3. Has rheumatoid arthritis, diabetes, Sjogren's syndrome or any other systemic disease affecting ocular health.
4. Is using any systemic or topical medications (other than eye drops for dry eye symptoms) that may affect ocular health and neuroendocrine system function.
5. Has undergone corneal refractive surgery.
6. Is aphakic.
7. Has any active ocular disease.
8. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
9. Is participating in any other type of clinical or research study.
10. Is a contact lens wearer.
11. Has blepharitis.
Efficacy of a Collagen Hemostatic Dressing After Tooth Extraction

This study is a multicentric randomised (2 groups, ratio 1:1) Post Market Clinical Follow-up trial. 38 subjects (teeth) requiring a simple tooth extraction or multiple tooth extraction on the same quadrant and taking curative or preventive antithrombotic treatment will be included (19 in each group).

The aim of the study is to assess the efficacy of ETIK COLLAGENE (Topical hemostatic collagen-product) on the hemostasis (time to stop bleeding) after tooth extraction.

The hemostasis is measured by assessing the presence of bleeding within the first 8 minutes post-extraction.

Group 1: intra-alveolar placement of ETIK COLLAGENE immediately after tooth extraction.

Group 2: the alveolus is left empty after tooth extraction (the use of ETIK COLLAGENE is delayed 8 minutes after tooth extraction, before suture).

Subjects will be followed-up to 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, age \> 18 years old,
* Patient undergoing a simple tooth extraction or multiple tooth extraction on the same quadrant,
* Patient taking curative or preventive antithrombotic treatment or patient with a moderate thrombocytopenia,
* Patient reachable after surgery,
* Signed informed consent form,
* Subject affiliated to a health insurance system, or is a beneficiary.

Exclusion Criteria:

* Known allergy to bovine collagen,
* Preoperative INR\<1.5 or \>3 or instable,
* Patient with high risk of bleeding, history of postoperative hemorrhagic complication,
* Treatment with bone resorption inhibitor, or patient irradiated at the cervico-facial level,
* Contraindication to anesthesia using articaine with 1:200,000 epinephrine,
* Clinical follow-up expected to be difficult,
* Presence of uncontrolled hypertension, uncompensated diabetes or other clinically relevant systemic alterations,
* Current participation in another clinical trial or subject still within the exclusion period of a previous clinical trial,
* Vulnerable subjects.
Chronic Disease Health Management Information Platform

Based on the combination of domestic and foreign experience and the needs of patients as the orientation, this research gives full play to the hospital's advantages in chronic disease management, and uses network information technology to develop a systematic and intelligent system that integrates prevention, diagnosis and treatment, follow-up, and education.

Patients with hypertension are showing a trend of getting younger and younger, and high-normal blood pressure is increasing rapidly among the young and middle-aged people aged less than 65 years.

Young and middle-aged patients with hypertension have a lower absolute short-term cardiovascular risk, but their lifetime risk is higher.

Studies have shown that the awareness rate, treatment rate and control rate ("three rates") of young and middle-aged hypertensive patients in my country need to be improved urgently.

Improving the knowledge and behavior of young and middle-aged hypertensive patients with disease, treatment compliance and self-health management has become the focus of research.

"Internet + medical" through information network technology, innovative service models have become a trend.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 to 59 years old according to the World Health Organization (WHO) age classification criteria, meet the diagnostic criteria for hypertension published in the "Guidelines for the Prevention and Control of Hypertension in China", and are diagnosed with essential hypertension;
* Patients are conscious and possess Normal reading, comprehension and expression skills;
* use a smart phone to surf the Internet and send and receive information, accept and use the outpatient chronic disease health management platform services;
* Informed consent, voluntarily participate in this research.

Exclusion Criteria:

* Patients with severe organic heart disease and other cardiovascular and cerebrovascular diseases;
* Chronic liver and kidney failure;
* Patients with malignant tumors;
* Persons who have participated in other forms of Internet + health management.
Manual Lymphatic Drainage for Pain, Muscle Strength, and Sensation

To evaluate the acute effect of MLD on pressure pain threshold (PPT), pain tolerance, tactile sensation, and muscle strength in healthy young adults.

healthy young adults were included in the study. Before and after MLD and plasebo touchs, the same physiotherapist performed PPT and pain tolerance measurements, muscle strength measurements with a hand dynamometer (Jamar®) and pinchmeter (Baseline®), and two-point discrimination (2PD) evaluation with an esthesiometer.


Eligibility Criteria:
Inclusion Criteria:

* Being aged 18-30 years
* Volunteering to participate in the study

Exclusion Criteria:

* Having any skin disease
* Having a history of neurological and/or orthopedic disease
* Having a significant scar or burn tissue in the upper extremity
* Having any condition that would prevent communication