cyrilzakka/clinical-trials huggingface dataset:
Aerobic Training on Cardio-respiratory Fitness and Health Related Quality of Life

Stroke is a major health problem among Egyptian population; an obvious raise in stroke prevalence in all Egyptian governorates. Most stroke survivors commonly develop disabilities those were correlated with restricted physical activity levels. Stroke survivors' cardio-respiratory fitness has several negative impacts such as elevated risk of being affected by other cardiovascular diseases. So, the current study will be conducted to cover the lack in literature concerning the effect of aerobic training on cardiovascular endurance in stroke survivors aiming to faster recovery and reduce the risk of cardiac dysfunction and recurrent strokes.

Stroke as a cerebrovascular accident has a significant prevalence, as well it was addressed a one of major etiologies for other comorbidities, even mortality. Where, cardiac rehabilitation is a structured exercise program that almost designed to offer an opportunity to break the inactivity cycle, reduce associated cardiovascular risks, also improve perceived confidence and quality of life in stroke survivors . Therefore, aerobic training could be defined as a core component that focuses on cardio-respiratory fitness, walking speed and endurance for stroke survivors. Up on that, this clinical trial will be conducted to investigate the effect of aerobic training on cardiorespiratory fitness and health related quality of life in stroke survivors. It will be conducted on eighty post stroke patient (hemiplegic; 55-65 years old with functional ambulatory category more than 3) from Outpatient clinic of neurological department of El-Kasr El-Aini Hospital. They will be allocated into 2 groups; Group A will involves 40 patients will receive aerobic training program, plus traditional physical therapy program. While, Group B will involves 40 patients will receive traditional physical therapy program only. 6-Menutes walk test, Stroke impact scale are the outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Both genders,
* Age range is 55-65 years old,
* Within one year post ischemic stroke,
* Right or left sided stroke,
* hemiplegic and hemiparetic patients,
* Medications include anti-spastics, Beta blockers, ACE inhibitors, and diuretics.
* Functional ambulatory category of three or more,
* Hemodynamic stable,
* Did not participate in any other research study within at least 3 months.

Exclusion Criteria:

* Sever anemia,
* Uncontrolled hypertension, or diabetes mellitus,
* Recent cardiothoracic surgeries,
* Cognitive disorders 'mini mental state exam less than 24'
* Auditory and visual problems,
* Dementia,
* Modified Rankin score 3 or more,
* Seizure,
* Musculoskeletal disorders,
* Stroke or serious head trauma within last 3 months,
* Vertrobrobasilar stroke,
Trial of Educational Outcomes of WISE-MD

The purpose of this study is to compare the educational efficacy of instructional design enhancements in on-line learning modules in the context of clinical medical education.

This study involved medical students from seven US medical schools participating in a trial of two WISE-MD computer-based learning modules. Students were randomized to 1 of 4 study arms. The 4 content-equivalent conditions were: screen shots with voiceover and no interactivity; learner control of pacing through multi-media content; social networking features; and social networking features plus user interface enhancements.

Eligibility Criteria:
Inclusion Criteria:

* All third-year medical students at all of the 7 collaborating schools (N= 2308) rotating through the surgery clerkship from July 2009 and September 2011.

Exclusion Criteria:

* Students who do not consent to participate and who decide to withdraw from participation.
Robot-Assisted Therapy and Motor Learning: An Active Learning Program for Stroke

Stroke is the leading cause of long-term disability in older adults in the United States. At six months after stroke, up to 65% of the more than 795,000 persons who experience a stroke each year continue to have motor impairments that inhibit functional use of the weaker arm during daily activities and negatively impact quality of life. Rehabilitation robots provide clinicians with new treatment options to improve movement and arm function after stroke. The purpose of this pilot study is to develop and test a therapy called the "Active Learning Program for Stroke" (ALPS). We are combining this therapy program with robot-assisted therapy and a home program for the stroke-affected arm and hand.

Little is known about how individuals learn to utilize robot-trained movements during upper extremity (UE) activities in the home and community and whether specific instruction can enhance motor learning and carry-over.. Systematic reviews of robot-assisted therapy for the paretic UE confirm gains in motor capacity as measured by clinical assessments, but provide little evidence of improved UE performance during daily tasks and occupations. These findings may be attributed to the limited availability of rehabilitation robots to train the paretic hand and a primary focus on intensity of practice with little regard for other principles of motor learning and experience-dependent neuroplasticity. These principles, including the salience of training tasks, transfer of acquired skills to similar activities, and active engagement and problem solving, are key to task-oriented training paradigms in stroke (e.g. constraint-induced movement therapy) but have not been well integrated into robot-assisted therapy protocols. The transfer of robot-trained movements to UE activities within the home and community needs further exploration before widespread use in rehabilitation practice is expected.

Eligibility Criteria:
Inclusion Criteria:

* Moderate UE hemiparesis (i.e. some ability to move shoulder, elbow \& hand and initial score on the Fugl-Meyer Assessment (FMA) between 21-50/66))
* Intact cognitive function to understand and actively engage in the ALPS robotic therapy procedures (Montreal Cognitive Assessment Score \>/=26/30)12 during initial evaluation visit

Exclusion Criteria:

* No more than moderate impairments in paretic UE sensation, passive range of motion, and pain that would limit ability to engage in therapy
* Increased muscle tone as indicated by score of \>/= 3 on the Modified Ashworth Scale;
* Hemispatial neglect or visual field loss measured by the symbol cancellation subtest on the Cognitive Linguistic Quick Test 13
* Aphasia sufficient to limit comprehension and completion of the treatment protocol
* Currently enrolled or has plans to enroll in other upper limb therapy/research during the study period
* Contraindications for robot-assisted therapy including recent fracture or skin lesion of paretic UE
Clevidipine in the Perioperative Treatment of Hypertension (ECLIPSE-NTG)

The purpose of this study is to establish the safety of clevidipine in the treatment of perioperative hypertension. Approximately 500-900 patients with perioperative hypertension undergoing coronary artery bypass grafting (CABG), off-pump coronary artery bypass (OPCAB) or minimally invasive direct coronary artery bypass (MIDCAB) surgery and/or valve replacement/repair procedures were anticipated to be randomly assigned to one of two treatment groups: clevidipine or nitroglycerin.

The primary objective was to establish the safety of clevidipine in the treatment of perioperative hypertension, as assessed by comparing the incidences of death, stroke, MI and renal dysfunction in the clevidipine and nitroglycerin treatment groups from the initiation of study drug infusion through postoperative Day 30. Secondary objectives were to evaluate the efficacy of study drug, assessed by the blood pressure (BP) lowering effect, and additional safety variables.

Eligibility Criteria:
Prerandomization Inclusion Criteria:

* Provide written informed consent before initiation of any study related procedures.
* Be at least 18 years of age
* Be scheduled for Coronary Artery Bypass Grafting (CABG), Off Pump Coronary Artery Bypass (OPCAB), Minimally Invasive Direct Coronary Artery Bypass (MIDCAB) surgery, and/or valve replacement/repair surgery

Prerandomization Exclusion Criteria:

* Women of child-bearing potential (unless they have a negative pregnancy test)
* Recent cerebrovascular accident (within 3 months before randomization)
* Known intolerance to calcium channel blockers
* Known or suspected hypersensitivity to nitroglycerin
* Allergy to soybean oil or egg lecithin (components of the lipid vehicle)
* Pre-existing permanent ventricular pacing
* Any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial
* Participation in another therapeutic drug or therapeutic device trial within 30 days of starting study

Postrandomization Inclusion Criteria:

* Determined to be hypertensive perioperatively as determined by the investigator
Single-dose Mass Balance Recovery and Metabolite Profile and Identification of 14C-XEN1101

This study will evaluate the mass balance recovery and metabolite profile, and will identify metabolite structures following a single oral dose of 14C-XEN1101 in healthy adult male subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Body mass index (BMI) of 18.0 to 32.0 kg/m2
* Must be willing and able to communicate and participate in the whole study
* Provide written informed consent
* Adhere to the specified contraception requirements

Key Exclusion Criteria:

* Subjects who have received any investigational medicinal product (IMP) in a clinical research study within 90 days
* Evidence of any current infection or an infection within 14 days before study drug administration
* History of any drug or alcohol abuse in the past 2 years
* Subjects with pregnant or lactating partners
* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 millisievert (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study
* Participation in a clinical trial involving administration of radiolabelled compound(s) within 180 days of the planned dosing date of this study
* Clinically significant abnormal clinical chemistry, haematology, coagulation or urinalysis. Subjects with Gilbert's Syndrome will be excluded.
* Confirmed positive drugs of abuse test result
* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results
* History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder
* Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood
Prospective L-arginine Study

HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and exercise tolerance will be abnormal in the population of young heart transplant patients at baseline, and that each will show a trend towards improvement following a 12 week course of oral L-arginine, with regression towards the baseline following the 12 week washout period.


Eligibility Criteria:
Inclusion Criteria:

* University of Michigan Pediatric Heart Transplant Clinic patient.
* Greater than or equal to 8 years of age.
* Heart transplant between 1 and 8 years prior to enrollment in the study

Exclusion Criteria:

* Relative hypotension for age
* Refusal to participate
* Inability to cooperate with Endo-PAT testing
* Pregnant or nursing women.
* Insulin dependent diabetes
Stabilizer in Abdominal Wall Muscles

The aim of the study will be tried to observe if the propioceptive Stabilizer training is effective in abdominal wall muscles in healthy subjects. All the participants will be examined in two times. Initially, baseline measurements with ultrasound imaging will be taken without muscle activity. After, they will do the abdominal manoeuvre and it will take the ultrasound images.

Inclusion criteria will be health participants with age between 18 to 45 years. Exclusion criteria were a BMI higher than 31 kg/m2, hypocapnia, any musculoskeletal condition in lumbopelvic region, skin and lower limb pathology (i.e., fracture, surgery).

Initially, baseline measurements will make following Whittaker et al. guidelines to measure thickness of the abdominal wall muscles (external oblique, EO; internal oblique, IO; transversus abdominis, TrA and rectus anterior, RA). All evaluations will be carry out by a single operator (B.M.P), who was a specialized physical therapist with 3 years of USI experience. A diagnostic ultrasound tool (Toshiba Aplio 500 Platinum, Toshiba American Medical Systems; CA, USA) with a 7 to 14-MHz-range linear transducer (18L7 PLT-1204BT type; 40-mm footprint) will be used for B mode ultrasound imaging. Ultrasound images of the EO, IO and TrAb muscles will be taken with the patients in supine position, with a cross reference point placed between the iliac crest and the inferior border of subcostal line, and the midaxilary line on the right side ; RA muscle was aligned with the umbilicus; and interrecti distance (IRD) will be measured just under the umbilicus. The measure for the thickness during the rest condition will be perform by the mean of 3 repeated values for each measure at the end of expiration, maintaining the transducer at the same point. Muscle thickness will be considered as the distance between the inside caliper lines of each muscle border. IRD will be described as the distance between the inside caliper lines of each RA muscles.

Once baseline measurements will be taken, the same measurements will make while the patients perform the exercise. This exercise specifically targets the abdominal wall muscles (EO, IO, TrA and RA). At the beginning, patients will be in a supine position, the lower edge of the StabilizerTM will be placed between the posterior superior iliac spines, aligned with the sacral base. Abdominal draw in maneuver (ADIM) was developed by the patients until they reach 40 mmHg and hold steadily for 10 seconds. Prior the examination, each subject will be practiced the ADIM three times with an ultrasound image feedback.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* Body mass index higher than 31 kg/m2,
* Hypocapnia,
* Any musculoskeletal condition in lumbopelvic region,
* Skin and lower limb pathology (i.e., fracture, surgery)
Improvement of Nutrition Status, Digestive Conditions, and Upper Respiratory Infections by Using Oral Nutritional Supplementation on Children in Vietnam

Evaluating the efficiency of using the nutrient production toward nutrition status (anthropometric index, the prevalence of wasting), digestive disorders, anorexia, and upper respiratory infections in children aged 24 - 71 months.

The research involves a randomized controlled clinical trial (RCT), the plan is expected to conduct from 2022 to 2023 with over 600 children aged 24-71 months. The nutritional product produces a high amount of energy that provides over 468 kcal/100g; 12,5g/100g of protein; 12,5/100 of fat; 59,5g/100g of carbohydrate 1000ng/100g of IgG (immunoglobulin G) Colostrum; 15,3mg/100g of 2'FL HMO (health maintenance organization); 160mg/100g of MCT(Medium chain triglycerides) ; 3,7mg/100g of FOS(Fructo-Oligosaccharide) /Inulin; 810mg/100g of Lysine; 525mg/100g of Calcium; 55,6mg/100g of Magnesium; 5,6mg/100g of Iron; 3mg/100g of Zinc; 35,7µg/100g of Manganese; 8,1µg/100g of Selenium; 1290IU/100g of Vitamin A; 220 IU/100g of Vitamin D3; 33,1µg/100g of Vitamin K1; 510µg/100g of Vitamin B1; 700µg/100g of Vitamin B2; 360µg/100g of Vitamin B6; 1,4µg/100g Vitamin B12; 3120µg/100g of Acid Pantothenic; 62,7µg/100g of Acid Folic. 90 grams of the product which equals 2 packs (210ml x 2 per day) will supply about 33,0% - 43,6% of the required energy for children aged 2-5 years. Other 25 micronutrients and minerals include some essential vitamins such as Calcium 78,8 - 94,5 % RDAs, Iron 91-93% RDAs(recommended daily allowances), Vitamin A 86-103,2% RDAs, Zinc 56-66% RDAs, Vitamin D3 33% RDAs, Selenium 37-43% RDAs, Vitamin K1 43-50% RDAs, Folic Acid 38-56% RDAs. With other elements such as 2'FL HMO (15,3 mg), FOS/inulin (3700 mg), Choline ( 28 mg, Taurin 15,5 mg) ,colostrum IgG 24 1000mg. The study will be conducted at schools and homes: 600 children erratically divided into 2 groups, 1 group will use the product for 3 months (with the amount of use: twice per day, 45,0 grams each time). The product will be distributed to the students through the schools. Monitoring will be performed carefully by the commune and district Health Department and the Centers for Disease Control and Prevention weekly. The study aims to evaluate the efficiency of nutritional products toward nutrition status ( anthropometric index, the prevalence of wasting), digestive disorders, anorexia, and upper respiratory infections in children aged 24-71 months.

Eligibility Criteria:
Inclusion Criteria:

* Children between the age of 24 - 71 months old that currently study in 10 preschools in the area of 10 selected communes.
* The family volunteered for the child to participate in the study
* Currently residing at 10 selected communes (over 1 year of residing)
* Z-score WHZ/BAZ \< - 0.5

Exclusion Criteria:

* Lactose intolerance
* Children with a history of allergies, congenital diseases
* Intellectual disability or are suffering from acute and chronic infectious diseases
Correlation Between SFRP1 and Colorectal Cancer and Adenoma

In summary, our study demonstrated the methylation sites of SFRP1 gene promoter in patients with colorectal cancer and adenoma and found SFRP1_16_17_18 CpG site was good performance as a diagnostic marker of colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* consecutive adult patients undergoing an outpatient endoscopy and histopathologically diagnosed as colorectal cancer or adenoma. Also, healthy individuals were invited to be enrolled.

Exclusion Criteria:

* Lynch syndrome
* Familial adenomatous polyposis
* MUTYH associated polyposis
* Peutz-Jeghers syndrome
* Juvenile polyposis syndrome
* Serrated polyposis syndrome
A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)

The purpose of these continuing post-licensure studies is to evaluate the long-term effectiveness of VARIVAX® \[Varicella Virus Vaccine Live (Oka/Merck)\] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster.

Parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during a six-month period in 1995 (June-November) at KPMCP Northern California were interviewed by telephone at 6-month intervals to ascertain whether their child had varicella or herpes zoster in the 6 months prior to interview. Follow-up continued for a minimum of 14 years after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Subject was a member of Kaiser Permanente Northern California, age 12-23 months, received a dose of varicella vaccine between June and November 1995, and parents accepted to participate in 15-year follow-up

Exclusion Criteria:

* Subjects diagnosed with varicella before study enrollment
* Subject's parents unable to complete telephone interviews in English, Spanish, or Cantonese
A Study to Assess the Effects on the Single-Dose Drug Levels of Mavacamten in Healthy Participants

The purpose of this study is to assess the effects on the single-dose drug levels of mavacamten in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 18 and 32 kilograms/meter squared (kg/m\^2) inclusive, at the screening visit.
* Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -1.
* Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
* CYP2C19 poor (\*2/\*2, \*3/\*3, or \*2/\*3) or intermediate (\*1/\*2, \*1/\*3, \*2/\*17) metabolizer, as determined by genotyping during screening.
* Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.

Note: Other protocol-defined inclusion/exclusion criteria apply.
Efficacy and Safety of Emodepside in Adults Infected With Trichuris Trichiura and Hookworm

The rationale of the study is to provide evidence on the efficacy and safety of Emodepside in adults infected with Trichuris trichiura and hookworm.


Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged between 18 and 45 years
* Written and signed informed consent
* Examined by a study physician before treatment
* Provided two stool samples at baseline
* Trichuris trichiura and hookworm EPG ≥ 48 and at least two Kato-Katz thick smears slides with more than one Trichuris trichiura and hookworm eggs

Exclusion Criteria:

* Pregnant or lactating and/or planning to become pregnant within three months after drug treatment
* Type 1 and/or 2 diabetes
* Psychiatric disorders
* History of ophthalmological conditions
* Presence or history of major systemic or chronic illnesses, as assessed by a medical doctor, during initial clinical assessment
* Suffers from severe anaemia (Hb \< 80 g/l)
* Received anthelminthic treatment within past four weeks
* Attending other clinical trials during the study
* Received strong CYP3A4 inducers or inhibitors as well as concomitant treatments that are relevant substrate for CYP3A4 such as clarithromycin, erythromycin and rifampicin
* Received strong P-gp inhibitors as well as concomitant treatments that are relevant substrates for P-gp such as clotrimazole and ritonavir