cyrilzakka/clinical-trials huggingface dataset:
Efects of FIFA 11+Warm-Up Program on Agilitiy, Balance And Proprioception Parameters in The Professional Football Players

This study aimed to compare the effects of the FIFA 11+ warm-up program with a traditional warm-up on agility, balance, and proprioception in professional football players aged 18-30. Forty-four players were randomly assigned to either the FIFA 11+ group, which performed the program for 10 weeks, or the control group, which continued their usual warm-up routine.


Eligibility Criteria:
Inclusion Criteria:

* being 18-30 years, individuals who currently play professional football and actively participate in training and matches,
* participants with at least two years of professional football coaching experience,
* no history of any medical conditions that would hinder their ability to perform the required exercises.

Exclusion Criteria:

* a history of musculoskeletal surgery and fractures in the lower extremities,
* a history of acute injury to the musculoskeletal structures of other lower extremity joints in the last three months, affecting joint integrity and function and causing interruption of the desired physical activity for at least one day
* having a history of balance and vestibular disorders were excluded from the study.
Sevoflurane in Cardiac Surgery

Patients undergoing high risk cardiac surgery (combined CABG and valvular procedures) will be randomized to receive a total intravenous anesthesia or an anesthesia plan with sevoflurane.

The investigators want to document whether the cardioprotective properties of volatile agents could translate in an improved outcome after cardiac surgery in high risk patients.

Background

It is commonly believed that the choice of the primary anesthetic agent does not result in different outcomes after cardiac surgery. Recent evidence however has indicated that volatile anesthetics improve post-ischemic recovery. These results have been summarized in a meta-analysis of 22 randomized studies, involving 1922 patients: the use of volatile anesthetics was associated with significant reductions of myocardial infarctions (24/979 \[2.4%\] in the volatile anesthetics group vs 45/874 \[5.1%\] in the control arm, odds ratio \[OR\]=0.51 \[0.32-0.84\], and mortality (4/977 \[0.4%\] vs 14/872 \[1.6%\], OR=0.31 \[0.12-0.80\].

Furthermore, the use of volatile anesthetics was associated with shorter intensive-care unit stay (WMD=-7.10 hours \[-11.47; -2.73\], and time to hospital discharge (WMD=-2.26 days \[-3.83; -0.68\].

All the studies of the meta-analysis included low risk patients undergoing isolated procedures (mostly coronary artery bypass grafting).

Objectives

Investigators are planning a large multicentre randomized controlled study to confirm the beneficial cardioprotective effects of volatile anesthetics in cardiac surgery as indicated by a reduced intensive care stay and/or death in an high risk population of patients undergoing combined valvular and coronary procedures. Secondary endpoints will be: cardiac troponin release; incidence of myocardial infarction; time on mechanical ventilation; postoperative hospital stay

Methods

Various centers will randomize 200 patients to receive either a total intravenous anesthesia with propofol or an anesthesia with sevoflurane. All patients will receive a standard middle dose opiates anesthesia. All the perioperative management will be otherwise identical and standardized. Transfer out of the intensive care will be performed with SpO2 94% or greater at an FiO2 of 0.5 or less by facemask, adequate cardiac stability with no hemodynamically significant arrhythmias, chest tube drainage less than 50 ml/h, urine output greater than 0.5 ml/kg/h, no intravenous inotropic or vasopressor therapy in excess of dopamine 5 ug/kg/min, and no seizure activity.

Expected Results

The reduced cardiac damage (reduction in cardiac troponin release and in the incidence of myocardial infarction) will translate into a better tissue perfusion and faster recovery as documented by reduced intensive care unit.

Eligibility Criteria:
Inclusion Criteria:

* age \>18 years
* written informed consent
* scheduled procedures

Exclusion Criteria:

* ongoing acute myocardial infarction
* cardiac troponin \>1 ng/ml
* previous unusual response to an anesthetic
* use of sulfonylurea, theophylline or allopurinol
* thoracotomy
A Study to Assess the Efficacy and Safety of YM060 in Female Patients With Diarrhea-predominant Irritable Bowel Syndrome (IBS)

To demonstrate the superiority of YM060 to a placebo in global assessment of relief of overall IBS symptoms and stool form normalization, and to evaluate safety in female patients with diarrhea-predominant irritable bowel syndrome (D-IBS).


Eligibility Criteria:
Inclusion Criteria:

1. Patients satisfying the Rome III Diagnostic Criteria
2. Patients whose ≥25% of stools were loose or watery and \<25% of them were hard or lumpy stools
3. Patients who have abdominal pain or discomfort
4. Patients in whom after occurrence of IBS symptoms the following tests were conducted and in whom no organic changes were observed Pancolonoscopy or contrast enema

Exclusion Criteria:

1. Patients with a history of surgical resection of the stomach, gallbladder, small intestine or large intestine
2. Patients with a history or current evidence of inflammatory bowel disease
3. Patients with a history or current evidence of colitis ischemic
4. Patients with concurrent infectious enteritis
5. Patients with concurrent hyperthyroidism or hypothyroidism
6. Patients with concurrent active peptic ulcer
7. Patients with other concurrent disease that may affect the digestive tract passage or large intestinal function or that is likely to interfere with proper assessment of IBS abdominal pain/discomfort
Obesity Prevention in Schoolchildren

The purpose of this study is to design, implement and evaluate an intervention oriented to change alimentary practices and patterns of physical activity of children through educative activities with parents, teachers and children in school of Mexico city.

In Mexico, obesity is becoming the most public health problem. The increase in body mass is associated with the changes in the alimentary environment, resources for physical activity in a context of poor health literacy of the population and low efficacy of the health system. Schools, as social settings, are a opportunity for obesity prevention.

The study includes three phases: 1) evaluation of training, in which the psychological context in which obesity is generated is evaluated. The evaluation will be performed by collection of qualitative and quantitative information, 2) design a strategy from the information obtained. The intervention will include working sessions with teachers, parents and children, establishment of schools in window counseling in nutrition and physical activity and the secretion of a website to not communicate with the public and Provide information, 3) evaluation of the strategy in a community trial with two groups of schools, one intervention and one control.

Eligibility Criteria:
Inclusion Criteria:

* Children students in selected schools
* Anthropometric diagnostic of normality or overweight
* Informed consent of parents

Exclusion Criteria:

* Children with special diet or children with limited motor functioning
Muscle Activity of the Gastrocnemius and Soleus Muscles by Surface Electromyography.

This cross-sectional, comparative study aims to evaluate and compare the surface electromyographic (sEMG) activity of the gastrocnemius (medial and lateral) and soleus muscles during static and dynamic contraction tasks. Participants will perform three tests-resting state, isometric, concentric, and eccentric contraction, and dynamic gait-with bilateral measurements. A subgroup analysis will examine muscle activity variations based on foot posture, using the Foot Posture Index (FPI). The study uses the validated mDurance® sEMG system to obtain objective data under controlled lab conditions. The findings will enhance understanding of the functional role of each muscle and could inform rehabilitation and injury prevention strategies.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 30 years.
* No history of severe musculoskeletal disorders in the lower limbs.
* No recent surgery or injury in the last 6 months.
* No dermatological conditions affecting electrode placement.
* Not allergic to adhesives.
* Ability to perform the task without limitation.

  •. No high-intensity exercise in the 12 hours before testing
* Ability to provide informed consent and complete the assessment

Exclusion Criteria:

* Reduced lower limb mobility.
* Neuromuscular or skeletal conditions affecting the calf region.
* Intense physical activity 12 hours before testing.
* Lack of informed consent.
Levosimendan in Acute Heart Failure Following Acute Myocardial Infarction.

The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment.

Double blind placebo-controlled study with parallel groups in patients with acute PCI treated myocardial infarction complicated with decompensated heart failure. The study include a prospectively defined subgroup of patients in cardiogenic shock. Treating acute myocardial infarction with PCI restores blood flow, but decreased contractility remains for hours and days due to stunned myocardium. Levosimendan has both inotropic and vasodilatory effects which could support the failing heart after treating the acute myocardial infarction with PCI and may improve myocardial stunning and decrease pro-inflammatory cytokines. Levosimendan could improve myocardial contractility, symptoms and outcome without adverse effects. The aims of the study are to investigate whether a 24 hour infusion with levosimendan could improve regional contractility measured by echocardiography, improve BNP levels, reduce the levels of pro-inflammatory cytokines and improve symptoms in patients with acute decompensated heart failure during the first 24 hours after acute PCI.

Eligibility Criteria:
Inclusion Criteria:

* Acute ST-elevation myocardial infarction subject to acute PCI or non-ST elevation myocardial infarction subject to PCI within 72 hours after start of chest pain and:
* Revascularization by PCI,
* Signs of decreased wall-motion in at least 3 of 16 segments of the left ventricle
* Dyspnoea at rest and one of the following:

pulmonary edema, pulmonary congestion,need for CPAP or ventilator, need for IC diuretics or oliguria.

Subgroup of patients in cardiogenic shock: Systolic BP below 90 after 1 hour of volume therapy.

Exclusion Criteria:

* Age below 20 years
* Heart rate above 120 bpm
* Septic shock
* ARDS
* Creatinine \>450 micromol/l
* Hepatic impairment
* Significant mechanical outlet obstruction
* Allergy against study drug medication
* Anaemia (Hb \<8 g/dl)
* Pregnancy
Short-term Effect of Using Non-immersive Gamified Exercises on Chronic Pain in People With Stroke.

Rehabilitation after stroke is essential to minimize permanent disability. Gamification of exercises has emerged as a promising strategy for increasing motivation and rehabilitation efficacy in people with stroke. However, there is a gap in understanding how exercise gamification can aid in pain management among people with stroke who are experiencing shoulder pain difficulties.

This study aims to evaluate the short-term effect of using gamified non-immersive exercises on shoulder pain level, upper limb range of motion, and shoulder and elbow muscle activities while doing different activities in people with chronic stroke. The study will be conducted using an observational study design. Various lab assessments include measuring the ROM of the shoulder (MOCAP), EMG, FNIRS, pain intensity using VAS scale, and muscles activities patterns across upper limb joints.


Eligibility Criteria:
Inclusion Criteria:

* Experiencing motor difficulties in using the paretic arm, with some use of hand/arm as determined by therapist
* Not participating any other intervention studies
* Male/female ≥18 years old
* Had a stroke requiring with any degree of arm mobility.
* Capacity to consent to participate
* Able to communicate adequately in English with the research team
* Mild or moderate pain in shoulder or upper limb (below 6 and more than 2on the VAS scale).
* Able to walk without any assistant at least for ten meters

Exclusion Criteria:

* Any medical condition compromising the safety or the ability to take part to the study as determined by the therapist (such as insufficient vision or hearing, upper limb condition not linked to stroke, uncontrolled blood pressure, uncontrolled diabetes, co-morbidity)
* History of more than one epileptic seizures since stroke onset or uncontrolled epileptic seizure
* Unable to follow two stage command
* Moderate to severe hemi-spatial neglect compromising the ability to take part to the study, as determined by rehab team
* Severe spasticity (more than 2 on the modified Ashworth scale)
* Any device preventing use of EMG, FNIRS i.e. DBS or pacemaker
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
* Subject has experienced active vertigo during the lead-in period.
* Subject has documented asymmetric sensorineural hearing loss.
* Subject agrees to maintain their current treatments for Meniere's disease while on-study.

Exclusion Criteria:

* Subject is pregnant or lactating.
* Subject has a history of immunodeficiency disease.
* Subject has a history of significant middle ear or inner ear surgery, or endolymphatic sac surgery in the affected ear.
* Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
* Subject has a history of vestibular migraine.
* Subject has used an investigational drug or device in the 3 months prior to screening.
* Subject has previously been randomized to a clinical study of OTO-104.
Wire Instrumentation Using Radiofrequency Energy to Impact Transseptal Efficiency

This is a randomized controlled trial examining whether Baylis's Versacross RF wire versus the conventional Baylis RF needle is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by time to successful transseptal puncture, during cardiac ablation procedures.

The transseptal puncture is one of the most commonly performed procedures in the cardiac electrophysiology and interventional cardiology laboratories. Indeed, every atrial fibrillation ablation, now the predominant electrophysiology procedure performed throughout the world, routinely involves two different transseptal puncture procedures. The investigators previously performed a randomized, comparative effectiveness trial demonstrating the superiority (in both efficacy and safety) of a radiofrequency (RF) transseptal needle versus the conventional sharp-tipped mechanical needle. More recently, an alternative approach to transseptal puncture has been FDA approved and is already utilized as part of standard of care in these procedures. With this new approach, a J-shaped wire that can transmit RF energy is advanced inside the transeptal sheath rather than the more stiff RF or conventional needle. As advancing a wire is usually a step employed in any transseptal procedure (then usually requiring removal of that wire and then placement of the needle), this new approach saves a step. In addition once the wire has been advanced across the intra-atrial septum into the left atrium, the wire can be used to avoid potentially severe complications; specifically, after a transseptal needle is advanced across the left atrium, advancing the sheath over the needle can result in a sudden jump of all the equipment, risking perforation of the far left atrial wall. With the wire approach, the wire can be safely advanced into a pulmonary vein so that even if the sheath and dilator jump suddenly across the septum, they will be guided along the wire and thereby avoid perforation. The investigators will be studying patients undergoing a catheter ablation procedure at University of California, San Francisco.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patients undergoing endocardial left atrial catheter ablation procedures using radiofrequency ablation catheters for atrial fibrillation or atrial flutter ablation procedures at UCSF
* Willing and able to provide written informed consent in English
* Willing and able to comply with scheduled remote follow-up visits through 1 Year post-operative

Exclusion Criteria:

* Presence of a patent foramen ovale closure device or atrial septal defect closure device
* Cryoballoon ablation
* IVC filter
* Deemed not suitable by study personnel
Wrist Cooling for Hot Flashes Clinical Trial

This pilot randomized double blind controlled crossover study aims to determine the impact of two wrist cooling devices on symptom control of hot flashes in adult men and adult women experiencing hot flashes. The participants will record during the first two weeks of the study all of their hot flashes and severity of their hot flashes in a diary. The participants will be randomly assigned to wear one of the two wrist cooling devices that have an identical appearance at different times in the study. They will wear the first assigned device for weeks 3 and 4. They will record in their diary the severity of their hot flashes while using the device. For weeks 5 and 6 they will be ask to use a second device and record in their diary the severity of their hot flashes with the use of the device.

The devices will be attached to the wrist like a watch. When activated, one device will turn on a cooling fan with the cooling plate being active for up to 5 minutes, and the other device will turn on a cooling fan only for up to 5 minutes without the cooling plate being active.

The randomized group will determine the order that a participant uses each device. Group 1 participants will use the wrist cooling device first for two weeks and then the fan activating device for two weeks. Group 2 participants will use the fan activating device first for two weeks followed by the wrist cooling device for two weeks.

This will be a 6 week study requiring the participants to see a study team member at the beginning of the study. The participants will receive three phone calls during the study to remind them of when to use each device. They will be instructed after the 6 weeks for them to have an in person return visit and give the diaries and the devices to the study personnel.

The investigators will recruit participants and conduct the study at the Boston University School of Medicine (BUSM), locally, and virtually.

Eligibility Criteria:
Inclusion Criteria:

1. Experiencing at least 2 hot flashes per day that are either moderate and/or severe in severity.

   1. Moderate: sensation of heat with sweating/dampness but able to continue activity with only brief fanning needed
   2. Severe: sensation of intense heat with sweating and causing disruption of current activity
2. English speaking

Exclusion Criteria:

1. Temperature sensitivity due to cooling associated with an autoimmune or vascular disorder, such as Raynaud's phenomena, peripheral arterial disease or any other reasons.
2. Any wrist skin sensitivity that is known to cause discomfort when any type of device such as a wristwatch is placed on the wrist.
3. Any lack of sensitivity to coolness on the wrists or hands
4. Any use of pharmaceuticals or devices to treat hot flashes.
5. Unable to understand and speak English
Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

Nonalcoholic fatty liver disease (NAFLD), defined by fatty infiltration of the liver in the absence of excess alcohol consumption, affects an estimated 30% of adults in the United States. A proportion of people with NAFLD will develop progressive, inflammatory nonalcoholic steatohepatitis (NASH), which can progress to liver cirrhosis and liver failure. NAFLD is expected to be the most common indication for liver transplantation by the year 2020. We hypothesize that among adults with NAFLD, aspirin will reduce intrahepatic lipid content, as quantified by 1H magnetic resonance spectroscopy (1H-MRS).


Eligibility Criteria:
Inclusion Criteria:

* Ages 18 to 70 years
* NAFLD, defined by confirmed hepatic steatosis by imaging or by liver biopsy, in the absence of other causes of hepatic steatosis or significant alcohol consumption. If liver imaging or biopsy has not been performed clinically, liver ultrasound assessment will be performed as part of the screening visit.
* Early-stage liver fibrosis, defined as fibrosis less than or equal to Fibrosis Stage 3 (F3), confirmed by either (1) a recent liver biopsy or (2) a recent elastography / Fibroscan study. If no recent biopsy or elastography/Fibroscan have been performed, a Fibroscan will be performed as part of the screening visit.

Exclusion Criteria:

* Liver fibrosis stage \> 3
* Current aspirin use
* Contraindications to aspirin use
* Contraindications to magnetic resonance imaging (MRI)
* Pregnancy or desire to become pregnant
* Breastfeeding
Spartan COVID-19 System: Evaluation of Clinical Sample Collection

This study will evaluate the efficacy of various sample collection methods for use with the Spartan COVID-19 System. It will compare the results from the Spartan COVID-19 System with results that are obtained using a predicate lab-based COVID-19 test that uses a nasopharyngeal swab sample. The goal is to determine which sample collection methods are most effective in capturing SARS-CoV-2 virus.

Once the subject is recruited,two nasopharyngeal swabs using the standard method will be taken from the patient. Additionally, two nasal swab samples will be taken using the Spartan COVID-19 swabs with an adjusted tip. All samples will be analyzed using the Spartan COVID-19 System.

The lab-based predicate test will be taken at the same time, with results reported back to Spartan to be compared with results obtained from the Spartan COVID-19 System.

Eligibility Criteria:
Inclusion Criteria:

* must have tested positive for COVID-19 via the existing nucleic acid testing method.

Exclusion Criteria:

-