cyrilzakka/clinical-trials huggingface dataset:
Physical Training and Diet for Childhood Obesity

It is observed that children affected with COVID-19 who are physically inactive or in a sedentary lifestyle may induce and develop childhood obesity (CO). the management of this clinical condition has received very little attention, there is no well-defined exercise protocols or dietary prescription for this special population; therefore, it needs an elaborative trial in this field, so the aim of his study was to find the clinical and biochemical effects of high-intensity aerobic training with a high protein diet in childhood obesity following COVID-19 infection


Eligibility Criteria:
Inclusion Criteria:

* A positive diagnosis of COVID-19
* Male children
* 5 - 12 years of age Body mass index (BMI).
* Between 85t h to 99th percentiles were considered for childhood obesity.

Exclusion Criteria:

* Subjects with a history of physical training
* Taking medications, recent surgeries.
* Fractures and joint problems in the lower extremity.
* Cardiac and respiratory problems.
* Neurological issues, major psychiatric problems.
* Any other systemic diseases, contraindications for physical training.
Reference Intervals of the sEMG of the Pelvic Floor in Healthy Female

This study is a multi-center survey of surface electromyography (sEMG) of pelvic floor muscles in healthy female. The aim of the study is to get the reference interval of normal pelvic floor sEMG from Chinese women.

Pelvic floor dysfunction is a group of diseases caused by the damage of pelvic floor supporting structure. Pelvic floor muscles play an important role in the maintenance of pelvic floor function. Surface electromyography (sEMG) has been widely used to evaluate the function of pelvic floor muscles. The sEMG tests, which include pretest and posttest resting amplitude (µV), as well as phasic, tonic and endurance contractile amplitude (µV), are performed using Vishee neuro-muscle stimulator (MyoTrac Infiniti, model SA9800, Thought Technology Ltd., Montreal, Canada), following the Glazer protocols. A pear-shaped vaginal probe (serial number DYS180610, type VET-A, produced by Nanjing Vishee Medical Technology, Ltd.) is placed into the vagina when sEMG tests are performed. This is a cross-sectional survey. The reference intervals of pelvic floor sEMG in healthy female are evaluated.

Eligibility Criteria:
Inclusion Criteria:

* a. Having sex life and tolerable to vaginal examination b. There were no symptoms related to pelvic floor dysfunction; c. The modified Oxford grading system was 4 or 5; d. No birth or 2 years after the last delivery;

Exclusion Criteria:

* a. Duration of pregnancy and lactation; b. Within 2 years after delivery; c. Acute inflammation of vagina or discomfort of vagina; d. History of pelvic floor dysfunction: leakage of urine in the past 1 month when coughing / sneezing / lifting; leakage of urine in the past 1 month when urgency fecal incontinence in the past 1 month; usually have a bulge or something falling out that can be seen or felt in vaginal area; Pain in the abdomen or lumbosacral and buttocks below the navel for more than 6 months; e. History of radical pelvic surgery (cervical cancer, rectal cancer, bladder cancer, etc.); f. History of hysterectomy and subtotal hysterectomy; g. History of pelvic floor surgery (anti-incontinence and prolapse surgery); h. History of pelvic radiotherapy; i. Nervous system diseases that significantly affect muscle function; j. Those who can't cooperate with pelvic floor contraction
US and Neurodevelopmental Outcomes in the Neonatal Intensive Care Unit (NICU)

The objective of the project is to identify clinical factors (nutritional and non-nutritional) which are associated with ultrasound measurements of muscle and adipose tissue and to determine whether these ultrasound measurements are predictive of later metabolic and neurodevelopmental outcomes in premature infants, a population at risk for developmental delay, obesity, and metabolic disease. The investigators expect that a better understanding of these relationships will lead to the incorporation of ultrasound into routine nutritional management of preterm infants and allow for future optimization of their overall health and development.

The specific aims are as follows:

1. To identify clinical factors that are associated with muscle and adipose tissue measurements. The investigators will examine the relationship between clinical factors such as calorie and protein intake during hospitalization, days on parenteral nutrition, C-Reactive Protein and other clinical surrogates for inflammation and both muscle and adipose tissue measured bi-weekly using bedside ultrasound. The investigators will collect anthropometric and ultrasound measurements bi-weekly and whole body composition (utilizing ADP) data at 35 weeks postmenstrual age (PMA)/discharge from the Neonatal Intensive Care Unit. All other clinical data will be collected throughout the hospital stay.
2. To determine whether muscle thickness and cross-sectional area are predictive of improved neurodevelopmental outcomes. The investigators will assess the relationship between ultrasound measurements of muscle with neurodevelopmental outcomes at 35 weeks PMA/discharge and 4 months corrected age. The investigators will utilize Event Related Potentials (ERP) to measure speed of processing and recognition memory as early markers of brain development.
3. To determine whether measurements of adipose tissue are predictive of later adverse metabolic outcomes. The investigators will assess the relationship between adipose tissue thickness and blood pressure and total body adiposity (using air-displacement plethysmography) at 35 weeks PMA/discharge and 4 months corrected age.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants born between 25 and 34+6 weeks gestation admitted to University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
* medically stable at time of air displacement measurements

Exclusion Criteria:

* infants that require medical support preventing ADP measurements from being taken
Microalbuminuria as a Cardiovascular Risk Factor (PRECISED Substudy)

Microalbuminuria (MA) is an independent cardiovascular risk factor in diabetic and non-diabetic subjects.

However, in the setting of type 2 diabetes, microalbuminuria could be a marker of either early diabetic nephropathy or diffuse endothelial dysfunction. At present, there are no biomarkers that permit us to discriminate between these two conditions.

A hypothesis free approach by using proteomic/metabolomic analyses in the urine samples of selected populations seems an appropriate approach by which to explore this issue. In addition, a driven hypothesis in the same groups of patients based on a sensitive marker of kidney injury also seems appropriate.

Urinary levels of KIM-1(Kidney Injury Molecule-1 ) have been found elevated in experimental diabetic nephropathy even before that MA . In addition, urinary levels of KIM-1 were found significantly elevated in type 1 diabetic patients with MA, in comparison with diabetics with normoalbuminuria and non-diabetic healthy controls. Moreover, low urinary KIM-1 levels at baseline were associated with the regression of MA during a follow-up of 2 years . Therefore, it could be hypothesized that the presence of MA + KIM-1 in urine samples would indicate renal injury rather than endothelial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with diabetes mellitus type 2 with microalbuminuria with and without retinopathy.

Control groups: diabetes mellitus type 1 with microalbuminuria and retinopathy hypertensive patients with microalbuminuria and diabetic patients with a renal biopsy

Exclusion Criteria:

* Patients without microalbuminuria or patients with macroalbuminuria
Range of Motion of Standard and High-Flexion Posterior Cruciate Retaining Total Knee Prostheses

The purpose of this prospective, randomized study was to compare pain, functional outcome and ranges of motion of the knees in patients receiving either a standard posterior cruciate-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

The main goals of total knee arthroplasty are pain relief and improvement of function and range of motion. The purpose of this study was to compare ranges of motion of the knees in patients receiving either a standard posterior crucaite-retaining or a high-flexion posterior cruciate-retaining total knee prosthesis.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis that was severe enough to warrant total knee arthroplasty after an adequate trial of nonoperative therapy, and the need for bilateral total knee arthroplasties

Exclusion Criteria:

* inflammatory arthritis
* osteoarthritis of the hip causing pain or restricted mobility
* a foot or ankle disorder which limited walking
* dementia or a neurological disorder including a past history of stroke which affected mobility
The Systemic Concentration of Short-Chain Fatty Acids After Delivery in the Small and Large Intestine of Healthy Volunteers

The goal of this crossover study is to evaluate the systemic availability of short-chain fatty acids (SCFA) that are either administered in the small intestine or the colon in healthy volunteers. The main question it aims to answer is whether the site of administration affects the amount of SCFA that reaches the systemic circulation. On two test days participants will ingest capsules filled with SCFA that are specifically delivered in the small intestine or the colon. After ingestion, blood samples will be collected at regular time points.


Eligibility Criteria:
Inclusion Criteria:

* female and male
* healthy participants
* age within 18 - 50 years
* normal BMI (18.5-25 kg/m\^2)

Exclusion Criteria:

* Chronic gastrointestinal disorders such as inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, chronic constipation (less than 3 stools a week) and chronic frequent diarrhoea (more than 3 stools a day)
* Previous abdominal surgery, except from appendectomy
* Being on a weight loss, gluten-free, lactose-free, or vegan diet
* The donation of blood during the last 3 months or suffering from low blood haemoglobin levels
* The use of antibiotics or other medication that affects the gastrointestinal tract 3 months preceding the study and/or during the study
* The use of prebiotics or probiotics 2 weeks preceding the study and/or during the study
* Pregnancy, lactation or wish to become pregnant during the study period
* Previous or current substance/alcohol dependence or abuse (\> 2 units per day/14 units per week)
A Pilot Study on Efficacy and Safety of Ayurveda Combination in Patients With Mild-to-Moderate COVID-19

The COVID-19 pandemic is considered as the most crucial global health concern of the century. Given the complex interaction of physical and social factors on fast spreading infection, there have been increasing calls for comprehensive efforts using a community-based participatory research (CBPR) approach.

CBPR partnership composed of representatives from community-based organisations, health and academia actively developed the present study. Specific aims were (1) to assess the efficacy and safety of Ayurvedic combination, Giloy (Tinospora Cordifolia) and Pippali (Piper longum) in the management of mild-to-moderate cases of COVID-19 and (2) to determine the effect in relieving COVID-19 symptoms and preventing the onset of severe infection.


Eligibility Criteria:
Inclusion Criteria:

* With SARS-CoV-2 infection confirmed through reverse transcription followed by polymerase chain reaction (RT- PCR),
* With mild or moderate manifestations of COVID-19
* Willing to participate, and consent by signing the informed consent and not involved in another clinical trial during the study period

Exclusion Criteria:

* Patients suffering from severe COVID-19 Disease as judged by WHO criteria (REF)
* Any of the known COVID-19 complications and emergency procedures which may require shift/admission in hospital for oxygen support or intensive care unit
* Patients with ongoing immunosuppressive therapy for any reasons for example solid organ transplantation, autoimmune diseases or cancer.
* Patients with known long term infection like HIV
* Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy.
* Pregnancy and lactation
* Ayurveda practitioner decision that involvement in the study is not in the patient's best interest
Changing the Pulse of Athletics: Applying a Standardized Cardiac Athletic Screening for NCAA Athletes

This is a study supported by Duke Sports Cardiology and Duke Sports Medicine with the intent to enhance the cardiovascular screening of collegiate athletes from a regional to nationally recognized program to understand and eventually reduce cardiovascular events in athletes. The data from this ongoing registry will be used to better understand, refine, and improve the current cardiovascular Duke Athlete Screening process and use this experience as a role model to expand across the ACC.

The purpose of this study is to screen for and determine the prevalence of structural, functional, or electrophysiologic cardiac abnormalities in a population of young athletes using bedside cardiac ultrasound, electrocardiogram (ECG) and a physical exam.

The investigators will attempt to answer the question regarding the feasibility of screening all collegiate athletes with bedside cardiac ultrasound, ECG, and history/physical exams results in a higher sensitivity for abnormalities than screening using ECG and physical exams alone. The investigators will also analyze the cost and cost effectiveness of screening the young athlete population with bedside cardiac ultrasound. Costs will be calculated to include the amount of dollars spent on equipment, gels, and other supplies, but will not include the cost of performing the bedside cardiac ultrasound, which will be assumed as part of the physical exam. Additionally, the investigators will be gathering a number of data markers from the bedside cardiac ultrasound, including but not limited to right ventricular and left ventricular cavitary size, septal wall thickness, free ventricle wall on RV, and free ventricle wall on LV, in evaluation of the athlete's heart. The importance of these measurements is for the continued knowledge and data set analysis collection as there is limited known athletic cardiac measurements. There is minimal risk involved in this study. The investigators believe that by adding bedside cardiac ultrasound to the history, physical, and ECG, it will increase the sensitivity and specificity of screening for these life-threatening abnormalities in young athletes, and reduce the morbidity and mortality associated with these conditions.

Eligibility Criteria:
Inclusion Criteria:

* Athletes with previous known cardiac abnormality will be included in the study. Participants in the cardiovascular screening are young student athletes of Duke University between the ages of 18-22, of both sexes participating in their respective athletic pre-participation physical examination. Anyone who participates in NCAA Division 1 collegiate athletics is eligible to participate in the study.

Exclusion Criteria:

* Exclusions to this study include any walk-on athletes, or those not deemed a part of Duke Athletics prior to the commencement of the academic year. Also excluded will be anyone less than 18 years of age. Student athletes who do not agree to the study consent will be excluded.
Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic
* Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed
* Body Mass Index (BMI) between 27.0-42.0 kg/m\^2 (inclusive)
* HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria:

* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Proliferative retinopathy or known autonomic neuropathy
* Recurrent severe hypoglycemia as judged by the investigator
* Known or suspected allergy to trial product or related products
* Use of any drug (except for OHAs), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
* Known or suspected abuse of alcohol or narcotics
* Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
* TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL
* Type 1 or other specific causes of diabetes
The Effect of Virtual Reality Application in Cervical Dilatation and Effacement Teaching

The aim of this project is to determine the effect of virtual reality application in cervical dilatation and effacement teaching on students' satisfaction, confidence and anxiety levels.

Midwifery education is extremely important in terms of training midwives specialized in mother-child health. Cervical dilation and effacement is one of the subjects that should be learned well in order to manage the birth process well. Dilatation and effacement of the cervix is the enlargement (dilatation) and thinning (effacement) of the cervical opening and cervical canal when labor begins. Cervical dilation and effacement training is a tactile skill practice that requires constant repetition and practice. Therefore, it cannot be learned by observing, effective learning can be achieved by experiencing it repeatedly in pregnant women. Midwifery students gain experience in the teaching process by practicing with simulation training, laboratory studies and clinical applications. When the literature is examined, no study has been found about the virtual reality application related to cervical dilatation and effacement teaching. The study will be an original study as it focuses on the effect of virtual reality application in cervical dilatation and effacement education on students' satisfaction, self-confidence and anxiety levels. The findings of the study will shed light on the literature in terms of determining the effects of virtual reality application on students in cervical dilatation and effacement teaching. In addition, our project will be a pioneering study in terms of the use of virtual reality application in cervical dilatation and effacement teaching. Within the scope of the study, students will be examined in the focus of their satisfaction, self-confidence and anxiety levels. In this respect, the study will increase awareness in terms of revealing the effects of virtual reality application, which is one of the different simulation teaching methods in cervical dilatation and effacement teaching. Students will be examined as part of the study. In this way, students who have not received cervical dilatation and effacement training with virtual reality application before will have the opportunity to evaluate their exposure to this method.

Eligibility Criteria:
Inclusion Criteria:

* Being a third year student of the Midwifery Department,
* Not having received training in cervical dilation and effacement application
* Volunteering to participate in the study

Exclusion Criteria:

* Not voluntarily participating in the study,
* Having received training in cervical dilatation and effacement
The Safety and Efficacy Study of ISU302 in Patient With Type I Gaucher Disease

The purpose of this study is to compare and evaluate the efficacy and safety of ISU302, an investigational product, and Cerezyme®, comparator, for Type 1 Gaucher Disease patients


Eligibility Criteria:
Inclusion Criteria:

* The subjects have a diagnosis of Type I Gaucher Disease
* Subjects between 2 years old and 75 years old
* Subjects documented with glucocerebrosidase deficiency
* Subjects with splenomegaly (as indicated by CT volumetric analysis as 5 times over than the standard size (0.2% of total body weight in kilograms))
* A hemoglobin concentration level:Male \> 12 years of age \<12.0 g/dL Female\>12 years of age\<11.0 g/dL Child \> 2 years of age and \<12 years of age \<10.5 g/dL
* Platelet count of \< 120,000 / ㎣
* Treatment-naive to enzyme replacement therapy (ERT) or treatment- experienced subjects who have not received ERT in the 12 months before screening and antibody test result is negative
* Treatment naive to substrate reduction therapy (SRT) or treatment- experienced subjects who have not received SRT in the 12 months before screening
* Subjects or their spouses who provide consent to use one of following contraception methods, or women in menopause. (In this case, menopause is defined as a period after 12 months from the last menstruation)
* Condoms, sponge, foams, jellies, diaphragm, or intrauterine device (Spouse or patient who had vasectomy or tubal ligation/ hysterectomy)
* Total abstinence from sexual intercourse: Female patient using oral contraceptives must use other contraception method (barrier method) also during the trial period and after the completion of trial as well as up to 90 days from the conclusion of trial.
* The subject or their legal representative has signed the informed consent.

Exclusion Criteria:

* Treatment with any investigational product in 90 days before study entry
* Partial or total splenectomy
* Subjects who have a serious concurrent disease like infection or who abuse addictive drug and substances.
* Pregnant and/or breast-feeding women
* Presence of Hepatitis B surface antigen or Hepatitis C or the patients show positive reaction to human immunodeficiency virus (HIV) type1
* Subjects with a history of allergic reaction to Imiglucerase
* Subjects with a history of severe pulmonary hypertension caused by Gaucher Disease
* Any subject whom the investigator or the sub investigator considers as inad equate for this trial
Laparoscopic Extraperitoneal Total Mesorectal Excision (LE-TME): A New Feasible Technical Approach.

The study involves the use of Retroperitoneal plane for TME for rectal anterior resection. Through a pilot prospective study, LR-TME will be assessed as one arm study.

This study is based on our new suggested theory for a retro-peritoneal approach. After successful 2 cases of Laparoscopic extraperitoneal-TME. A pilot study for assessment of the feasibilty of the new approach.

Data will be registered prospectively and the perioperative outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* (Rectum, Anal or sigmoid) Malignancy requiring mesorectal excision and Fit for laparoscopic surgery

Exclusion Criteria:

* contraindication to laparoscopic surgery-unwilling to participate in the clinical trial.