cyrilzakka/clinical-trials huggingface dataset:
Investigation of Cortico-Rectal Pathways in Healthy Subjects and Constipated Patients

Biofeedback therapy improves bowel symptoms and anorectal function in patients with dyssynergic defecation, however its mechanism of action is not known. The investigators hypothesize that biofeedback therapy enhances gut-brain-gut communication by altering cortical processing of information and improving cortically mediated neuromuscular function of the gut. However, in order to better understand these mechanisms in patients, the investigators need to examine and establish normative data and compare findings with healthy subjects. The investigators specific aims are to examine and evaluate the following 40 normal subjects; (1) To evaluate the afferent cortical evoked potentials in response to the electrical stimulation of the anorectum and (2) To evaluate the corticofugal tracts (efferent) by recording the anal and rectal electromyographic responses following noninvasive lumbosacral and transcranial magnetic stimulation.

1. Cortical evoked potentials:A probe with 2 ring electrodes is placed in anus and rectum. A small amount of electrical current is passed. The cortical evoked responses to the anal and rectal electrical stimulation is measured from the scalp using a neurophysiology recorder.
2. Motor evoked potentials: A magnetic coil is placed on the scalp at the anorectal cortical site and discharged using magnetic energy. The anal and rectal motor evoked potentials are then measured using a probe with 2 ring electrodes.

Eligibility Criteria:
Inclusion criteria:

* Right-handed adults between ages 18 years and 99 years, who are free of bowel disorders or other medical illnesses.

Exclusion Criteria:

* Potential subjects with comorbid illnesses; severe cardiac disease, chronic renal failure or previous gastrointestinal surgery except cholecystectomy and appendectomy.
* Neurologic diseases e.g.; head injury, epilepsy, multiple sclerosis, strokes, spinal cord injuries.
* People who have metal in their skull or under the skull, or have metal in the back or hips.
* People who have a cardiac pacemaker, implanted defibrillator or medication pump.
* Impaired cognizance (mini mental score of \< 15) and/or legally blind.
* Pregnant or likely to conceive during the course of the study. Women with potential for pregnancy must be willing to use contraceptive measures during the study.
* Previous pelvic surgery, rectocele repair, bladder repair, radical hysterectomy.
* Rectal prolapse or anal fissure or anal surgery.
Effect of Enhanced Counseling Using Complementary Feeding Recommendation Based on Linear Programming on Nutritional Status,Omega-3 Fatty Acids, Malondialdehyde, and Alpha-Tocopherol in Overweight Children in East Jakarta

The epidemic of pediatric obesity has become a public health burden in both developed and developing countries, due to its serious health consequences, including an increased risk of type 2 Diabetes Mellitus and heart disease. Currently, dietary and exercise changes are still the center of preventive and treatment measures of obesity. Recently, the omega-3 group, one of the groups of polyunsaturated fatty acids (PUFAs), has been associated with many positive effects leading to the improvement of many diseases related to obesity. Nevertheless, the consumption of this essential nutrient requires certain ration to optimize its favorable result. Although previous studies have examined the efficacy of dietary counseling approach as treatment for obesity, none of them as explicitly explore the use of linear programming to create a tailored diet containing high omega-3 fatty acid food as a part of dietary counseling in obesity management program among children. Thus, this study is intended to contribute the clinical evidence regarding this area of knowledge, specifically the effects of enhanced counseling containing complementary feeding recommendation on nutritional status, omega-3 fatty acid, malondialdehyde, and alpha Tocopherol among children with risk of overweight aged 12 -23 months in East Jakarta.

Randomized-Controlled-Trial with two arms of intervention:

1. Control group: receive standard counseling with general existing menu recommendation
2. Intervention group: receive enhanced counseling (additional information on omega-3 fatty acids) with population-based menu ganerated from linear programming (LP)

There is a protocol on stratified block randomization. 2 blocks, stratified by: area, age, BMI-for-age status.

Total sample size for analysis:

Overall: 20 control - 18 intervention Blood sample: 18 control - 14 intervention

Eligibility Criteria:
Inclusion Criteria:

* aged 12-23 months old at first counseling
* body mass index more than +1 standard deviation in WHO Z-score
* parent agree to participate in the study by signing informed consent

Exclusion Criteria:

* Children with congenital disease and serious diseases
* Children with parent/caregiver who is illiterate
* Children with parent/caregiver who had communication disability
Stromal Vascular Fraction Cell Therapy to Improve the Repair of Rotator Cuff Tears

Rotator cuff disease is one of the most prevalent musculoskeletal conditions across the world. Patients with chronic rotator cuff tears often have substantial muscle atrophy and fatty infiltration. Surgical repair of the tear does not reverse the atrophy, and many patients continue to experience weakness, pain, and a persistent reduction in the quality of life. An important limitation in our ability to successfully rehabilitate these injuries postoperatively and return patients to normal function has to do with the poor quality of the muscle and tendon after rotator cuff repair. The stromal vascular fraction (SVF) of subcutaneous adipose tissue is highly enriched with cells (SVFCs) that can both directly participate in tissue regeneration by differentiating into myogenic and tenogenic cells, and indirectly by secreting growth factors and small molecules which activate pathways associated with healthy tissue regeneration. High numbers of autologous SVFCs can be isolated using the cost-effective, intraoperative Icellator (Tissue Genesis, Honolulu, HI) point-of-care system. This clinical trial will be determine if the use of SVFCs can enhance outcomes for patients who are undergoing surgical repair of a torn supraspinatus rotator cuff.


Eligibility Criteria:
Inclusion Criteria:

* Males and females
* Age 45-65 years old at the time of enrollment
* Full-thickness supraspinatus tendon tear with endon retraction ≤ 3 cm
* Magnetic resonance imaging Goutallier score ≤ grade 2
* Completed at least 6 weeks of standard physical therapy but continue to have pain and limited function (failed physical therapy)
* Sufficient subcutaneous abdominal adipose tissue to allow the recovery of 60-120cc of lipoaspirate
* Must pass standard of care blood work screening

Exclusion Criteria:

* Any tears of any cuff tendon other than the supraspinatus
* Magnetic resonance imaging Goutallier scores ≥ 3
* Frank signs of glenohumeral osteoarthritis on magnetic resonance imaging
* A history of previous rotator cuff repair
* A history of upper extremity fracture or other moderate to severe upper extremity trauma
* A BMI \< 20 or \> 35
* Pregnant or breast feeding
* Premenopausal women who are not using contraception
* Previous abdominal liposuction or any major open abdominal surgery
* Type I or type II diabetes, or glycated hemoglobin (hemoglobin A1C) values \> 6.5 or other metabolic disorders
* Hypercholesterolemia (total cholesterol ≥240mg/dL)
* History of cancer
* Autoimmune disorder or HIV+ status
* Use of nicotine products
* Have any other history of major medical illness, disease or other relevant orthopaedic disability
* Who do not speak English
* Liodcaine allergy
A Study of IDN-6556 in Subjects With NAFLD and Raised Transaminases

The purpose of this study is to determine the safety and efficacy of IDN-6556 compared to placebo in patients with diagnosed fat deposits in their liver (not caused by alcohol) and with abnormal liver tests

This is a double-blind, randomized study to evaluate the effects of IDN-6556 on serum transaminases and pharmacodynamics of IDN-6556 in subjects with non-alcoholic fatty liver disease with elevated alanine aminotransferase.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects of minimum adult legal age (according to local laws for signing the informed consent document), able to provide written informed consent, and understand and comply with the requirements of the study
* Diagnosis of non-alcoholic fatty liver disease (NAFLD) as evidenced by imaging or other diagnostic assessments
* Alanine aminotransferase (ALT) levels ≥1.5 x ULN on at least two occasions, seven or more days apart, during the Screening period
* alpha-fetoprotein (AFP) ≤ 100 ng/mL
* Hemoglobin ≥10 g/dL, a platelet count ≥ 100 x 10\^9/L, and a white blood cell count ≥ 3.0 x 10\^9/L
* If on metformin, sulfonylureas, statins, or fibrates, subjects must be on a stable dose of these drugs for at least three months prior to Screening and during the study

Exclusion Criteria:

* Known infection with HIV, HCV, or HBV
* Decompensated or severe liver disease as evidenced by one or more of the following:

  1. Confirmed cirrhosis or suspicion of cirrhosis
  2. Esophageal varices
  3. Ascites
  4. Suspicion of portal hypertension
  5. Hospitalization for liver disease within 60 days of screening
  6. Bilirubin \>2 x ULN, or ALT or AST \> 10 x ULN
* Inflammatory bowel disease
* Diagnosed or suspected systemic lupus erythematosus (SLE) and/or rheumatoid arthritis (RA)
* Hepatocellular carcinoma (HCC) at entry into the study
* History of or active non-liver malignancies other than curatively treated skin cancer (basal cell or squamous cell carcinomas)
* Significant systemic or major illness other than liver disease, including coronary artery disease, cerebrovascular disease, pulmonary disease, renal insufficiency, and/or serious psychiatric disease, that, in the opinion of the Investigator would preclude the subject from participating in and completing the study
* History or presence of alcohol abuse, defined as consumption of more than 210 mL of alcohol per week (the equivalent of 14 4-ounce glasses of wine or 14 12-ounce cans/bottles of beer or wine coolers), or other substance abuse within the prior two years
Minimally Invasive Versus Open Scarf Osteotomy for Hallux Valgus Correction: a Randomized Controlled Trial

The purpose of this study was to compare a minimally invasive scarf technique and the well-established open scarf technique for correction of hallux valgus deformity.

Hallux valgus surgery is a common procedure being the open scarf osteotomy, one of the most studied techniques for correction of the hallux valgus. It is widely reported its capacity to reduce the angle of the first metatarso-phalangeal joint.

Minimally invasive scarf (MIS) technique has been designed to decrease the soft tissue damage and postoperative pain. This procedure does not require ischemia, being able to do under local anesthesia and sedation. This technique is more suitable for outpatient surgery.

There is a lack of studies comparing both techniques, and our purpose is to do a prospective comparative study among the two approaches of the scarf osteotomy: open vs MIS.

Eligibility Criteria:
Inclusion Criteria:

- Patients undergo hallux valgus surgery

Exclusion Criteria:

* Intermetatarsal angle \>20º
* Previous hallux valgus surgery
* Metatarsalgia of the lesser rays that requires an osteotomy during the surgical procedure
* 1st cuneometatarsal instability
* Infection
* Vascular ischemia
* Neuropathy
Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain

There is evidence, of a single randomized controlled trial, that CFT is better than combined manual therapy and motor control exercise for chronic low back pain. However, this study had significant methodological shortcomings regarding the failure to carry out the intention to treat analysis and a considerable loss of follow-up of patients. As it is, it is important to carry out more studies involving CFT compared to other interventions already used in clinical practice and to correct these methodological shortcomings. Therefore, the aim of the study is to assess the efficacy of Cognitive Functional Therapy in patients with chronic non specific low back pain.

Randomized controlled trial with concealed allocation, blinded assessor, blinded participants and intention to treat analysis. Patients will be evaluated at baseline, 8 weeks, 6 and 12 months after randomization, to assess the maintenance of any effect of treatment. The patients in the CFT group will be treated by a physical therapists that attended twice the CFT workshops with two of the tutors of the method. She completed 106 hours of training including workshops, patient examinations and a pilot study with the supervision of a physical therapist with more than three years of clinical experience in CFT. Patients in CORE-MT group will be treated by a physical therapist with clinical experience in manual therapy and core training exercises.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 18 and 65 years
* Low back pain for more than 3 months
* Disability score of 14% or more on the Oswestry Disability Index (ODI)
* Being able to walk independently with or without support
* Understand Portuguese well enough to be able to fill in the questionnaires

Exclusion Criteria:

* Main pain area is not the lumbar spine (from T12 to buttocks)
* Main pain as leg pain (eg: nerve root compression or herniated disc with radicular pain / radiculopathy, lateral and central stenosis)
* Less than 6 months after lumbar spine, lower limb or abdomen surgery
* Invasive procedures for pain relief (ex: epidural injection, rhizotomy) in the last 3 months
* Pregnancy
* Inflammatory/rheumatological diseases (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, systemic lupus erythematosus, Scheuermann's disease)
Prevention of Radial Artery Occlusion: Prophylactic Hyperperfusion Evaluation Trial

Evaluating the effect of ulnar artery compression while pressing on radial artery to stop bleeding, in maintaining radial artery potency, after cardiac catheterization through the radial artery. We prospectively plan to compare 3000 patients referred for cardiac catheterization, randomized into two groups, one group receiving radial artery compression for stopping bleeding, in a standard fashion following best practices, and the other group receiving radial artery compression using standard best practices and ulnar artery compression. Radial artery status will be evaluated in 24 hours and 30 days of the procedure to evaluate its potency, using plethysmography.


Eligibility Criteria:
Inclusion Criteria:

* patients referred for diagnostic cardiac catheterization.

Exclusion Criteria:

* previous ipsilateral radial artery puncture, warfarin therapy, absence of intact palmar collateral circulation, scleroderma, ipsilateral radial artery surgery, lone upper extremity (contralateral upper extremity amputation), ipsilateral upper extremity chronic pain.
Community-based Nutrition Program Effectiveness Evaluation in Afghanistan

The study will be a mixed methods, two-arm, cluster-randomized controlled trial. The primary aim of this evaluation is to measure the effectiveness of the Community-Based Nutrition Package intervention on child feeding practices among parents/caregivers to children 6 to 23 months of age in Afghanistan.

The study will be a mixed methods, two-arm cluster-randomized controlled trial (CRT). Health facilities eligible to implement the CBNP in their catchment areas will serve as the unit of implementation and be randomly allocated to treatment or control groups. For each health facility, up to four health posts, among the 6-10 health posts typically attached to a health facility, will be randomly selected. Households in communities served by selected health posts will be mapped and a list of households with eligible participants will generated from which a random sample will be selected. Structured questionnaires will be administered to separate samples of women with children 6-23 months of age at baseline then approximately 18 months later. Semi-structured, in-depth interviews will also be conducted with a sub-set of selected women and samples of their husbands and mothers-in-law at baseline and endline.

Eligibility Criteria:
Inclusion criteria:

* Married adult woman (all married women are considered adults in Afghanistan, regardless of age)
* Has a child between 6 and 23 months of age. For women with more than one living child between ages 6 and 23 months, questions will be asked regarding dietary experiences for the elder of the two. For twins or multiple order siblings, the eldest will be selected based on birth order.
* Resident in the household

Exclusion criteria:

No specific exclusion criteria.
Ovulation Triggering 2 Vs 3 Follicles

Poor responders in in-vitro fertilization (IVF) cycles represent a major challenge for fertility specialists. Although poor responders tend to have sub-optimal fertility treatment outcomes, many of these patients wish to attempt at least one IVF cycle. Traditionally, IVF cycles producing less than 3 to 4 mature follicles (measuring at least 14 mm) have either been cancelled or converted to intra-uterine insemination (IUI) due to the low pregnancy rates associated with these cycles. The minimal number of follicles required to proceed with egg collection is based on clinical experience, having been determined by weighing the probability of implantation and pregnancy versus the risk of not obtaining quality oocytes or reaching embryo transfer when fewer mature follicles are present. This retrospective quality control study aims to compare pregnancy rates in IVF cycles producing 3 follicles measuring 14 mm and more on trigger day, versus 2 or fewer follicles.


Eligibility Criteria:
Inclusion Criteria:

* Stimulated IVF cycle at clinique ovo
* Patients with a maximum of 3 mature follicles (≥14mm) on the day of ovulation trigger

Exclusion Criteria:

* Cycle cancelation due to no follicles
* History of recurrent implantation failure
* Contraindication of ovulation induction medication
BMS-986325 in Healthy Participants and Participants With Primary Sjögren's Syndrome

The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986325 in healthy participants and participants with primary Sjögren's syndrome. The results will guide the future clinical development with BMS-986325.


Eligibility Criteria:
Inclusion Criteria:

Healthy Participants (Part A and Part B)

* Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations
* Males and Females, ages 18, or local age of majority, to 50 years, inclusive at screening
* Body mass index (BMI):18.0 to 30.0 kg/m2, weight: ≥ 50 kg at screening
* Must be fully vaccinated against SARS-CoV-2

Participants with Sjögren's Syndrome (Part C)

* Sjögren's syndrome in the absence of another immune-mediated disease or rheumatologic condition based on the 2016 American College of Rheumatology-European League Against Rheumatism (EULAR) Classification Criteria for primary Sjögren's syndrome (pSS). Historical diagnosis as pSS documented in medical records, using the 2016 ACR/EULAR criteria, is also acceptable
* Seropositive for anti-Sjögren's syndrome antigen A antibody (anti-SSA). Previous anti-SSA are also acceptable, and results should be documented in the Case Report Form (CRF) as past medical history
* Males and females, ages 18, or local age of majority, to 75 years, inclusive at screening
* Body mass index (BMI): 18.0 to 35.0 kg/m2; weight ≥ 50 kg at screening
* Must be fully vaccinated against SARS-CoV-2 according to local regulations

Exclusion Criteria:

Healthy Participants (Part A and Part B) - Any significant acute or chronic medical illness

Healthy Participants (Part A and Part B) and Participants with Primary Sjögren's Syndrome (pSS) (Part C)

- Any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study

Other protocol-defined inclusion/exclusion criteria apply
Advancing Adolescent Bedtime by MI and Text Reminders

Chronic sleep deprivation among adolescents is a prevalent health problem across the world and is associated with a series of short and long term consequences. However, effective interventions targeting on this vulnerable adolescent population is very limited. Majority of the previous sleep education programme are conducted in a school context which personal factors and individualized problems were not addressed. In addition, failure to address "knowledge-action gap" may also explain why individual fail to enact health behaviors even holding positive motivation. In regard to this, investigators proposed an active and person-oriented protocol with the aid of advanced technology in order to improve adolescent sleep health.

This study will conduct a randomized control trial to evaluate the effectiveness of group-based sleep intervention using motivational interviewing plus text reminders in changing adolescent sleep deprivation problem with both subjective and objective measurements. The intervention will consists of 4 weekly group therapy targeting on adolescent with school day sleep duration less than 7 hours.

Eligibility Criteria:
Inclusion Criteria:

* Chinese aged 12-18 years old
* Written informed consent of participation into the study is given by adolescents and his/her parents;
* Being able to comply with the study protocol;
* Having weekday sleep duration less than 7 hours for past 1 month as reported by questionnaire and average of \<7hr weekday sleep as reported by sleep diary as an indication of chronic sleep deprivation status.
* Possess a mobile phone

Exclusion Criteria:

* A current or past history of neuropsychiatric disorder(s);
* A prominent medical condition or taking medication with potential side effects that may influence sleep quantity and quality
* Having a clinical sleep disorder that may potentially contribute to the disruption of sleep quantity and quality as ascertained by both Structured Diagnostic Interview for Sleep patterns and Disorders such as insomnia, delayed sleep phase and narcolepsy.
* have enrolled in any intervention programme that may affect their sleep patterns in the past three months or are planning to join intervention programme in the next three month
PHOX2B Mutation-Confirmed Congenital Central Hypoventilation Syndrome in A Chinese Family: Presentations From Newborn to Adulthood

Detect the PHOX2B Mutation-confirmed congenital central hypoventilation syndrome

Background: Congenital central hypoventilation syndrome (CCHS) is characterized by compromised chemo-reflexes that results in hypoventilation during sleep. Recently, a heterozygous PHOX2B gene mutation was identified in CCHS. This report was made to increase physicians' awareness of this rare disease.

Methods: A Chinese family of CCHS with presentations from newborn to adulthood and genetic analysis confirming the PHOX2B mutation was analyzed. After identifying central hypoventilation in an adult male (index case), clinical evaluation was performed on the complete family, which consisted of the parents, five siblings, and five offsprings. In addition, pulmonary function test, overnight polysomnography, arterial blood gas, and hypercapnia ventilatory response, and genetic screening for PHOX2B gene mutations were performed on living family members.

Eligibility Criteria:
Inclusion Criteria:

* Members of familiar congenital central hypoventilation syndrome

Exclusion Criteria:

* Refuse to participate study