cyrilzakka/clinical-trials huggingface dataset:
Effects of Laugh Therapy Associated to Cardiopulmonary Rehab

Laugh is more than visual and vocal behave, is always followed by a series of physiological changes, including contractions of musculoskeletal system, increase of cardiac frequency by catecholamine release and hyperventilation that promoves the increase of maximum breathing and oxygen saturation. Laugh therapy may be an alternative therapy, simple, and improve the quality of life of individuals can influence physiological and biochemical parameters of the human body.

Methods: Randomized clinical trial with patients from outpatient ischemic heart disease of the Hospital de Clínicas de Porto Alegre , patients of both sexes in all regular monitoring. All patients will perform 30 minutes of stretching before film sessions. The exercises will be mild to moderate (modified Borg scale between 3 and 6).

Eligibility Criteria:
Inclusion Criteria:

* ischemic heart disease diagnosis established by cardiac catheterization, with 50% lesion in at least one epicardial vessel (if the patient has had an acute coronary syndrome or have been revascularized, the event time is expected to exceed 6 months).
* Both sexes
* With availability to come to HCPA twice a week
* In conditions of entering into a cardiac rehabilitation program with exercise.

Exclusion Criteria:

* Involvement in another clinical trial.
* Presence of autoimmune disease
* Use of oral anticoagulant
* Valvulopathy with mechanical or biological cardiac prosthesis
* Presence pacemaker or implantable cardioverter
* Left bundle branch block in 12-lead ECG
* severe lung disease
* Major Depression or Bipolar Disorder
* Chronic Atrial Fibrillation
* Left ventricular dysfunction (ejection fraction \<45%)
* Active infection or cancer (other than basal cell carcinoma)
* Chronic Renal Failure
* Illiteracy
* Inability to understand the consent form
A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435

The purpose of this study is to determine the absorption, metabolism, excretion; and to evaluate the safety and tolerability of BMS-986435 in healthy male participants

Participants will be admitted to the study site for 3 weeks.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index between 18 and 32 kg/m\^2, inclusive, at screening. - Healthy male participants as determined by the investigator and sponsor.
* Adequate acoustic windows to enable accurate transthoracic echocardiogram (TTE) assessment of parameters of left ventricular (LV) systolic function by TTE.
* Documented left ventricular ejection fraction (LVEF) ≥ 60% at screening.

Key Exclusion Criteria:

* Any acute or chronic medical illness.
* History of dizziness and/or recurrent headaches (ie, daily headaches lasting for a 1-week duration in the last month prior to study intervention administration).

Head injury in the last 2 years, intracranial tumor, or aneurysm. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Prevalence Rate of Pulmonary Embolism Among Not Anticoagulated Patients

The purpose of this study is to evaluate the prevalence rate of pulmonary embolism among not anticoagulated patient older than 75 years old admitted with syncope and hospitalised in the Toulon Hospital

This study will be proposed to every patient that correspond to eligibility criteria. Will be included only those who are not opposed to the collection of their data.

The data collected will come from the routine care such as medical history, clinical datas, imaging data... The number of pulmonary imaging will be assessed before the diagnostic strategy proposed by Dr Prandoni and after the application of this strategy thanks to a questionnaire to physicians.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female over 75 years-old
* Emergency consult resulting on an hospitalization in the geriatric service or in the internal medicine service
* Hospitalised in the Centre Hospitalier Intercommunal de Toulon for syncope, presenting these symptoms:
* Loss of consciousness with quick return to normal (less than one minute)
* Spontaneous resolution

Exclusion Criteria:

* history of syncope
* other loss of consciousness (epilepsy, stroke, head trauma)
* anticoagulated treatment
* patient's objection
Effects of Transcranial Direct Current Stimulation (tDCS) and Motor Learning in Children With Cerebral Palsy (CP)

In this study, the investigators aim to assess the clinical and neurophysiological effects of a non-invasive brain stimulation technique - transcranial direct current stimulation (tDCS)- on cortical plasticity and motor learning in children with cerebral palsy. Investigators will use different assessment techniques, such as transcranial magnetic stimulation (TMS) and kinematics (sensors) to measure changes through the trial.


Eligibility Criteria:
Inclusion Criteria:

* Age of participants must be between 8 and 18 years old.
* Diagnosis of spastic or mixed CP with distribution of diplegia and/or hemiplegia form.
* Gross Motor Function Classification System for Cerebral Palsy (GMFCS) level II and III.
* Manual Ability Classification System for Children with CP (MACS) level II up to IV.
* Ability to cooperate and follow directions.

Exclusion Criteria:

* Muscle tone reduction therapy in the past 3 months prior to study onset.
* Upper limb orthopedic surgery in the past 3 months prior to study onset.
* Any other form of therapy or procedure involving motor neuron junction inhibition; either by biochemical and/or mechanical denervation, in the past 3 months prior to study onset.
* History of convulsive disorder in the past 2 years prior to study onset.
* Current use of carbamazepine as anticonvulsive therapy.
* Presence ventriculoperitoneal shunt.
Interprofessional Approach to Ultrasound Diagnosis and Intervention in Critical Care Patients With Pneumothorax and/or Hemothorax

Investigate the efficacy of interprofessional team approach to ultrasound guided diagnosis and intervention (pigtail or chest tube insertion) in critical care patients with Pneumothorax and/or hemothorax.

Evaluate the safety of the procedure {Insertion- related complications. Assess the Duration of chest tube insertion

Pneumothorax is defined as the presence of air in the pleural cavity; it can be secondary to underlying pulmonary pathology or trauma. In trauma, about 40-50% of thoracic injuries develop pneumothorax. Traditionally, following the suggestion of the American College of Chest Physicians and the Advanced Trauma Life Support (ATLS), all traumatic pneumothoraxes must be treated with a pleural drainage that could be chest tube (CT) or pigtail catheter (PC).

Insertion of pleural drains is a common surgical procedure. Percutaneous pleural drainage is the third most performed procedure in the intensive care unit (ICU) after vascular catheterization and tracheal intubation.

Bedside-ultrasound is introducing the advantage of at-time diagnosis and evaluation of different parameters without the need for risky transport of critical patients outside ICU and also guiding safe and successful intervention without complications and good learning.

.

Eligibility Criteria:
Inclusion Criteria:

* Age from 21 to 65 years
* Both sexes.
* Patients with pneumothorax or hemothorax indicated for chest tube or pig tail insertion according to British Thoracic Society (BTS) June 2022 guidelines for pleural procedures.

Exclusion Criteria:

* Absolute contraindication: patients in which the lung is completely adherent to the chest wall throughout the hemithorax.
* Relative contraindications: patients with risk of bleeding in patients:
* Taking anticoagulant medication.
* Patients with abnormal clotting profiles, coagulopathies, and platelet defects.
Study on Brain Structure and Function of Pain-related Emotion Disorder

By the method of multi-mode Magnetic Resonance Imaging, 5 patients with knee osteoarthritis are selected in this trial to observe the possible differences in the brain structure and function from the 5 healthy volunteers.

In this study, 5 patients with knee osteoarthritis and 5 healthy volunteers were selected. The degree of pain is evaluated via visual analogue pain scale (VAS). The emotional state is evaluated by Hamilton anxiety scale (HAMA) or Hamilton depression scale (HAMD). The patients and healthy volunteers who meet the include criteria are include in the research. Then the spontaneous brain electrical activity is collected by multimodal brain magnetic resonance imaging technology. The spontaneous brain electrical activity is analyzed to find the differences between knee osteoarthritis patients and healthy volunteers. Further analysis of resting brain functional connectivity and information exchange changes in multifunctional areas, in order to elaborate the central mechanism of pain and emotion modulation.

Eligibility Criteria:
Inclusion Criteria:

The experimental group was selected as:

* Meet the above diagnostic criteria.
* VAS scale score \> 4 points.
* HAMA score \> 14 or HAMD score \> 17 points.
* Agree to participate in the survey and submit an informed consent form.

The control group was selected as:

* Healthy volunteers who exclude knee osteoarthritis.
* VAS scale score ≤ 4 points.
* HAMA score ≤14 or HAMD score ≤ 17 points.
* Agree to participate in the survey and submit an informed consent form

Exclusion Criteria:

* Rheumatoid arthritis, psoriatic arthritis, gouty arthritis, bone erosion, bone tuberculosis, bone tumor patients.
* Clear diagnosis of traumatic meniscus, cruciate ligament, collateral ligament injury history and patients with history of knee trauma in the past six months.
* Have a heavier heart, brain and other medical conditions and poor overall health.
* In pregnancy, pregnancy or lactation.
* Taking antidepressant and anxiety drugs.
* Participated in other clinical studies within 2 months prior to the start of the study.
* The patient or his licensor is unwilling to sign a written informed consent or is unwilling to follow the research protocol.
Evaluation of Hysterectomy After Chemoradiation Therapy for Stage IB2/II Cervical Cancer

GYNECO 02 hypothesis is that hysterectomy reduces the possibility of local or loco-regional relapse, especially in patient with a reduced metastatic risk and who received a local chemoradiation therapy with an increase of radiotherapy doses (45 grays).


Eligibility Criteria:
Inclusion Criteria:

* operable Stage IB2/II Cervical Cancer
* adenocarcinoma, squamous cell or adenosquamous carcinoma
* Patient between 18 and 70 years old
* No lombo-aortic lymph node invasion at baseline
* Previous 45 grays external pelvic radiation with concomitant chemotherapy (cisplatin 40 mg/m2/week corresponding to 5 cycles)
* Followed by a 15 grays utero-vaginal brachytherapy, eventually combined with a 6th cycle of chemotherapy (cisplatin 40 mg/m2)
* with a pelvic boost if lymph node or parametrial invasion
* No macroscopic residual tumor after 6 to 8 weeks after brachytherapy.

Exclusion Criteria:

* Other tumor histology (neuro-endocrine)
* Stage \> II (FIGO 1995) at baseline
* Patient with remaining cervical cancer (after sub-total hysterectomy)
A Randomized Control Trial of Hinex Jelly on the Changes in Muscle Quality and Quantity

Taiwan is about to enter a super-aged society in 2025. The health problems of the elderly are getting more and more attention. Among these geriatric issues, sarcopenia is an important issue. Sarcopenia is the culprit of disability in old age. It is characterized by persistent and general loss of skeletal muscle mass and function throughout the body, which may lead to disability, decreased quality of life, and even inability to take care of yourself and an increased risk of death. Human skeletal muscle decreases with age. After the age of 40, muscle mass will be lost at a rate of 8% per decade; after the age of 70, it will be lost at a faster rate of 15% per decade in average. Although all elderly will lose muscle mass due to aging, the degree and speed of loss vary from person to person. In addition to aging, it may also be caused by chronic diseases.

Exercise intervention and nutritional intervention are the first choices for sarcopenia intervention. Regarding nutritional requirements, the elderly need at least 15 grams of essential amino acids per day for muscle building. Among them, leucine is the most important, which can increase protein production and reduce decomposition. Foods rich in leucine include soybeans, fish or beef. However, elderly people may not be able to get enough protein from their daily diet smoothly, often because of dysphagia, such as dental problems or chewing and swallowing problems. Therefore, oral nutritional supplements are relatively important for the improvement of muscle mass. Nutritional Supplement Hinex Jelly has 303 calories per serving, contains up to 15g of high-quality protein and a high amount of branched-chain amino acids, which is beneficial for muscle synthesis and tissue repair, plus a variety of minerals, vitamins, water-soluble dietary fiber, hydrolyzed collagen and other ingredients can strengthen nutritional supplements, maintain good health.

In summary, this study intends to explore the effect of Hinex Jelly nutritional supplemental intervention on muscle mass quality and quantity changes by means of randomized intervention and controlled trials.


Eligibility Criteria:
Inclusion Criteria:

* Adults over the age of 50 (include 50 years old).
* Can cooperate with the study.
* No surgical intervention within 3 months.

Exclusion Criteria:

* Those who have obvious difficulty in movement (such as amputation) and cannot cooperate with the study.
* Those who are equipped with pacemakers or internal electronic medical devices.
* Pregnant women.
* Use of drugs or interventional therapy that may affect changes in body weight or muscle mass (such as other oral nutritional supplements, medicine, weight reduction medicine, bariatric gastric endoscopy therapy, bariatric surgery, acupuncture, acupuncture, electrical stimulation, etc.).
* Allergic to dairy or soy products.
A Study of Pegylated Interferon Alfa-2b (MK-4031) as an Adjuvant Treatment in Japanese Patients With Malignant Melanoma (MK-4031-370)

This is a study to evaluate the safety and tolerability of peginterferon alfa-2b (PegIFN alfa-2b) as adjuvant treatment in Japanese participants with malignant melanoma after definitive surgical resection including complete lymphadenectomy. Participants on this study will initially receive PegIFN alfa-2b for 8 weeks (Induction Phase) and then may continue to receive PegIFN alfa-2b (Maintenance Phase) as long as they are experiencing clinical benefit (Up to 252 weeks). The primary hypothesis is that peginterferon alfa-2b administered on a weekly basis is safe and tolerated.

The study was terminated after 118 weeks from the study start, during the maintenance phase, due to regulatory approval in Japan.

Eligibility Criteria:
Inclusion Criteria:

* Stage II or III melanoma
* Primary melanoma completely excised
* Full lymphadenectomy within 84 days prior to initiation of study treatment
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Ocular melanoma or melanoma of the mucous membranes
* Evidence of distant or non-regional lymph node metastases
* In-transit melanoma
* Previously treated with interferon alpha/beta, chemotherapy, hormonal therapy, radiotherapy or immunotherapy/vaccine for melanoma
iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery

The purpose of the study is to compare the measurement of pressure inside the eye using three different FDA-approved devices (Icare, Tonopen, and Goldmann applanation).

The three above devices will be used to measure intraocular pressure in patients one day following vitreoretinal surgery. The underlying reason for surgery is not being considered in this study. The measured pressures will be compared across devices in eyes filled with fluid, gas, and silicone oil.

Eligibility Criteria:
Inclusion Criteria:

* Duke Eye Center patients 18 years or older
* capacity to give legally effective consent
* scheduled to undergo vitreoretinal surgery

Exclusion Criteria:

* individuals unable to give consent
* minors
Pharmacokinetics, Dialysability and Safety of P03277 in Healthy Volunteers and in Patients With Impaired Renal Function

This is an open-label, non-randomized, successive cohorts design, multicenter, single dose phase I study.

The primary objectives are:

* to evaluate the pharmacokinetics (plasma and urine) profile of P03277 following single intravenous injection (0.1 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference.
* to assess dialysability of P03277 following a single intravenous injection (0.1 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.

A full range design including the different degrees of renal impairment and healthy volunteers used as reference has been chosen.

Enrolment will be successive starting with both healthy volunteers (cohort 1) and patients with mild renal impairment (cohort 2), then patients with moderate renal impairment (cohort 3), then patients with severe renal impairment (cohort 4) to end with patients with end stage renal disease (cohort 5). Pharmacokinetics and safety profiles following the confinement period will be reviewed per each successive cohort by a Data Monitoring Committee before starting recruitment of patients in the next cohort. Cohorts 1 and 2 will be recruited in parallel and Data Monitoring Committee review will start after the completion of these first two cohorts.

Eligibility Criteria:
Inclusion Criteria:

For all subjects:

* Subject being 18 years or older, able and willing to participate in the trial
* Subject in good enough health status as determined by investigator according to medical history, physical examination, vital signs, 12 lead ECG and laboratory tests at screening and inclusion

For healthy volunteers / cohort 1:

Healthy volunteer with stable normal renal function defined with an absolute value of eGFR ≥ 90 mL/min based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements

For patients with renal impairment / cohorts 2 to 5:

* Cohort 2: patient with stable mild renal impairment defined with an absolute value of eGFR between 60 and 89 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements
* Cohort 3: patient with stable moderate renal impairment defined with an absolute value of eGFR between 30 and 59 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements
* Cohort 4: patient with stable severe renal impairment defined with an absolute value of eGFR between 15 and 29 mL/min included based on two eGFR assessments done at screening and inclusion, with a maximum tolerance of 15% between the 2 measurements
* Cohort 5: patient with end-stage renal failure who requires 3 hemodialysis sessions per week
Differential Effect of Ticagrelor Versus Prasugrel Maintenance Dose on Endothelial Function of Peripheral Vessels in Patients With Coronary Artery Disease

Ticagrelor administration, whose molecule resembles to adenosine, led to reduction in overall mortality and thrombotic cardiovascular (CV) events when directly compared to clopidogrel in the PLATO trial, implicating possible pleiotropic actions for the drug. It has been shown that ticagrelor increases adenosine concentration, by interfering with its red blood cells' uptake and by inducing the release of ATP which is then converted to adenosine. Recent studies in healthy volunteers and patients with coronary artery disease (CAD) have shown that ticagrelor increases the coronary blood flow in response to intravenous adenosine administration. Ticagrelor administration, in comparison with other P2Y12 inhibitors, may influence the endothelial function, as assessed by the Peripheral Arterial Tonometry method (EndoPAT 2000 system (Itamar Medical, Caesarea, Israel), which is a method for evaluating endothelial dysfunction and has been found to positively correlate with flow mediated dilatation (FMD).

This is prospective, randomized study with a crossover design, which will be conducted in patients with CAD under prasugrel maintenance dose (MD) 10mg once a day for at least a 3-month period. At Day 0 (day of randomization) eligible patients will be assigned to either:

* Ticagrelor 90mg twice a day for the next 15 days or
* Prasugrel 10mg once a day for the next 15 days At Day 0 (before treatment onset)patients wiil be subjected to a baseline peripheral arterial tonometry measurement. Measurement will be repeated at Day 15 and then treatment crossover will be performed for the next 15 days (without an intervening washout period). At Day 30 patients will be subjected again to peripheral arterial tonometry assessment. Peripheral blood sample will be taken from the patients in Day 0 for genotyping control.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-74 years old
2. Patients with stable CAD who have been submitted(?) to percutaneous intervention for Acute Coronary Syndrome and receiving prasugrel MD 10mg once a day for at least the previous 3 months.
3. Patients giving written Informed Consent.

Exclusion Criteria:

1. Acute Coronary Syndrome
2. Contraindication for administration of prasugrel or ticagrelor

   1. Known hypersensitivity to clopidogrel or ticagrelor
   2. Active bleeding (peptic ulcer, intracranial bleeding)
   3. Severe liver impairment
   4. Any previous history of intracranial bleeding or transient ischemic attack or ischemic cerebrovascular event
   5. Treatment with potent CYP3A4 inhibitors (ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir)
3. Requirement for oral anticoagulant agents prior to the day 30 visit
4. History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 3 months
5. Increased risk for bradyarrhythmias, according to the investigator's evaluation
6. Severe non-controlled chronic obstructive pulmonary disease
7. Creatinine clearance \<30ml/min/1.73mm2
8. HbA1c \> 10mg/dl