cyrilzakka/clinical-trials huggingface dataset:
Vitamin D3 Supplementation Pilot Study

The purpose of this research study is to determine whether taking vitamin D, every day, over a 12 week period will improve the vitamin D status, risks for poor heart health, risks for developing type 2 diabetes, and/or muscle strength in overweight, African American teenagers with low vitamin D levels.

Vitamin D deficiency/insufficiency is common throughout the lifespan, and across all race and ethnic groups. The American Academy of Pediatrics (AAP) recently recommended supplementation dose to 400 international units (IU) daily in all children. These recommendations target rickets prevention, but address neither the vitamin D supplementation necessary to optimize bone health nor the nontraditional vitamin D roles in immune disease, insulin resistance, muscle function, and cardiovascular disease (CVD). Moreover, the AAP recommendation noted that it had little pediatric data upon which to base guidelines. The Institute of Medicine also recently published Dietary Reference Intakes for Calcium and Vitamin D: the estimated average requirement in children and adults was set at 400(IU) daily and the recommend dietary allowance was set at 600 IU daily. Data on outcomes and supplementation levels in African Americans (a population at particular risk for vitamin D deficiency) and across pediatric age ranges and body habitus types, are lacking. The Vitamin D supplementation requirement in obese, African American adolescents is particularly problematic since obesity is associated with 1) lower circulating vitamin D levels (25OHD) and 2) insulin resistance. This pilot study will examine the effect of vitamin D supplementation upon 25OHD, the serum marker of vitamin D status, in obese, African American adolescents with vitamin D deficiency. Subjects will be randomized to receive cholecalciferol 1000 IU or 5000 IU daily for 3 months. Serum 25OHD, parathyroid hormone, glucose, insulin, CVD risk markers, and measures of muscle function and pain will be obtained at baseline and post-treatment. This pilot study will provide data on serum 25OHD responses to vitamin D at doses more likely to meaningfully impact 25OHD than the current American Academy of Pediatrics (AAP) supplementation guideline. Responses to supplementation can then inform future clinical trials aimed at addressing outcomes of vitamin D replacement on insulin sensitivity and CVD risk in obese adolescents.

Eligibility Criteria:
Inclusion Criteria:

* African American
* Obese \[body mass index (BMI) greater than or equal to 95th percentile for age and sex\]
* Pubertal (Tanner Stage greater than 1)
* 25OHD less than 20 ng/mL (for treatment phase); if 25OHD is greater than or equal to 20 ng/mL, only baseline data will be obtained.
* Committed to adherence to supplementation and study completion

Exclusion Criteria:

* Pregnancy
* Chronic medical conditions or medications use that can affect growth, nutrition, bone health, vitamin D metabolism, glucose, or insulin sensitivity
* Known history of hypercalcemia or hypercalciuria
* Non-English speaking, as assessments are available only in English
MDR - PMCF Study for RingLoc Bipolar Acetabular Cup

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup when used for hip hemiarthroplasty (implants and instrumentation).

The objective of this retrospective enrollment/prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance, and clinical benefits of the RingLoc Bipolar Acetabular Cup when used for hip hemiarthroplasty (implants and instrumentation).

The primary objective of this study is the assessment of safety by analyzing implant survivorship at the longest follow-up timepoint available, greater than or equal to eight years post-implantation. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relationship of the events to implant, instrumentation and/or procedure should be specified.

The secondary objective is the assessment of performance and clinical benefits by recording patient-reported clinical outcomes measures (PROMs).

Eligibility Criteria:
Inclusion Criteria:

* Patient must be 18 years of age or older and skeletally mature
* Patient must be willing and able to sign IRB approved informed consent
* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
* Rheumatoid arthritis
* Correction of functional deformity
* Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques
* Revision procedures where other treatment or devices have failed

Exclusion Criteria:

* Off-label use
* Uncooperative patient or patient with neurological disorders who are incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, or neuromuscular disease
* Infection
* Sepsis
* Osteomyelitis
* Patient is known to be pregnant or nursing
* Patient is a prisoner
* Patient is a known alcohol or drug abuser
* Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent
* Patient is unwilling to sign an informed consent
A Study of LY3841136 in Overweight and Obese Participants

The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatide in overweight and obese patients. The study will last up to approximately 42 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation
* Have a stable body weight and Body Mass Index in range of 27 to 45 kilogram per meter square (kg/m²).
* Have clinical laboratory test results within normal reference range
* Have venous access sufficient to allow for blood sampling
* Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria:

* Have type 1 or type 2 diabetes mellitus
* Have an abnormal 12-lead electrocardiogram (ECG)
* Have a history or presence of psychiatric disorders
* Have abnormal blood pressure and pulse rate
* Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product.
Natural History and Biological Study of Netherton Syndrome

This study aims at studying the natural history of Netherton syndrome (NS), to identify the consequences of LEKTI deficiency on the immune system and to characterize new molecular mechanisms involved in the disease.


Eligibility Criteria:
Inclusion Criteria:

* Adult or child (no age limit)
* Confirmed diagnosis of Netherton syndrome
* Signed informed consent form for the patient or his legal representative

Exclusion Criteria:

* Bleeding disorder precluding skin biopsy
Digital Versus Analog Pleural Drainage Following Pulmonary Resection

This study will evaluate the impact of continuous, digital pulmonary air leak monitoring on the duration of pleural drainage after lung resection in patients with and without a pulmonary air leak on postoperative day 1.

Patients undergoing pulmonary resection who fit the inclusion criteria will be identified pre-operatively. Patients within two groups (air leak and no air leak) will be randomized to receive either the analogue system or the digital system. Both systems are approved for use in hospitals by Health Canada. There will be 88 patients in each air leak group.

Hypothesis: Continuous, quantitative monitoring of PAL following lung resection leads to an improvement in primary outcomes.


Eligibility Criteria:
Inclusion Criteria:

Elective pulmonary resection (i.e. wedge, segmentectomy, lobectomy, bilobectomy) for benign or neoplastic disease

Exclusion Criteria:

1. Development of tension pneumothorax
2. Pneumonectomy
3. Patient no longer within planned randomization window
4. Plan to remove or removal of all chest drains within 36 hours of surgery
5. Inability to provide informed consent
6. Age \< 18 years
7. Patient was previously randomized following pulmonary resection
Effect of a Warming Mattress on Perioperative Hypothermia Following Cesarean Delivery

The primary aim of the current study will be to determine if the use of an underbody heating mattress during cesarean sections will decrease the incidence of postoperative hypothermia, defined as core temperature less than 36C, and if hypothermia occurs, time to normothermia. As part of the primary outcome the difference in the incidence of shivering, its severity, and need for treatment will be investigated. As a secondary goal other maternal perioperative outcomes will be studied i.e. estimated blood loss, change in hemoglobin level on the morning after surgery ie postop day 1, need for blood transfusion, rate of wound infections, length of hospital stay, maternal satisfaction, time to first breastfeeding, time to first 'skin to skin' contact. The relationship between maternal hypothermia and newborn outcomes of temperature and APGAR scores will also be evaluated.

Active preoperative and intraoperative warming may prevents inadvertent perioperative hypothermia and may be beneficial for pregnant patients undergoing cesarean delivery. The underbody warming mattress may be a step towards finding a suitable form of warming that is comfortable for awake patients, does not interfere with skin to skin contact and maternal-fetal bonding.


Eligibility Criteria:
Inclusion Criteria:

* will be age \>18 years,
* singleton pregnancy \>37 weeks,
* neuraxial anesthesia,
* healthy afebrile patients.

Exclusion Criteria:

* • will be age \>18 years,

  * singleton pregnancy \>37 weeks,
  * neuraxial anesthesia,
  * healthy afebrile patients.
A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children With Multiple Sclerosis

A randomized multiple baseline feasibility trial where participants will start taking metformin at one of 3 randomly determined points (3-months, 6-months or 9 months) during the 12-month trial. All subjects will be on a daily dose of metformin for a minimum of 3 months and a maximum of 9 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of MS with anterior visual pathway involvement and longer than 6 months after presentation with ON or an acute demyelinating event/relapse
* Age 10 year to 25 years and 11 months
* Latency delay \> 115 milliseconds on baseline full-field transient pattern reversal VEP in at least one eye (electrophysiological evidence of demyelination) or \> 10 milliseconds difference between eyes
* Retinal Nerve Fiber Layer (RNFL) Thickness on baseline OCT ≥60 µm
* Stable immunomodulatory therapy - no switch or planned switch in \> 6 months and no change in doses in 30 days prior to screening
* No significant renal or liver abnormalities
* Expanded Disability Status Scale (EDSS) 0-6.0 (inclusive)
* Has either English as his or her native language or English comprehension needed to complete the neuropsychological testing
* Meet criteria for adequate organ function requirements as described below:

Adequate renal function defined as:

Creatinine clearance or radioisotope glomerular filtration rate (GFR) \> 70 mL/min/1.73 m2 or serum creatinine based on age/gender as follows:

Range Serum Creatinine Level (µmol/L): Age 5 to \<12 years (male)=25-50, Age 5 to \<12 years (female)=25-50; Age 12 to \<15 years (male)=37-67, Age 12 to \<15 years (female)=37-67; Age 15 to \<19 years (male)=51-89, Age 15 to \<19 years (female)=40-69; Age ≥19 years (male)=58-110; Age ≥19 years (male)=46-92

Adequate liver function defined as:

Total bilirubin \< 1.5 x upper limit of normal (ULN) for age SGOT (AST) or SGPT (ALT) \< 1.5 x upper limit of normal (ULN) for age

Exclusion Criteria:

* A history of retinal pathology (major ophthalmologic disease / concomitant ophthalmologic disorders)
* Severe refractive error (± 6 diopters)
* Unstable and/or insulin-dependent (Type 1) diabetes, metabolic acidosis and/or lactic acidosis
* History of unexplained hypoglycemia (\<2.8 mmol/L)
* Already on metformin
* Concomitant use of any other putative remyelinating therapy as determined by the Principal/Qualified Investigator
* Treatment for an acute attack with corticosteroids within 30 days prior to screening / relapse within 30 days prior to screening
* Concomitant use of insulin
* Concomitant use of any drugs that are listed to have drug-drug interactions with metformin (i.e. calcium channel blockers, diuretics, etc.) as determined by Principal/Qualified Investigator
* Lactate levels \> 1.5x upper limit of normal
* Pregnancy
Endocrinological Profile in Patients With Medication-overuse Headache Before and After Withdrawal Therapy

The project will be conducted to investigate the hormonal homeostasis in men and women, with a special emphasis on sex hormones in men and AMH level in women, before and after withdrawal of the overused analgesics among MOH patients. Additionally, a more broad endocrine profile will be explored before and after withdrawal.

It is hypothesized that patients with MOH have disturbed hormone levels, which is normalized after withdrawal of the medication-overuse.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed MOH diagnosis according to the ICHD-III (1).
* Capable of completing headache diary and headache calendar
* Age 18-60 years old for men and 18-50 years old for women
* Signed informed consent
* BMI 19-30

Exclusion Criteria:

* Severe physical illness
* Severe psychiatric disorders requiring pharmacological treatment
* Addiction to alcohol or other drugs
* Pregnancy or breastfeeding
* Menopause, either natural or surgical (only women)
* Inability to provide reliable information about medical history
PROCLAIM: Study Examining Effects of Clopidogrel Compared to Placebo on Inflammation in Subjects With Metabolic Syndrome

The purpose of this study is to examine the effects of clopidogrel compared to placebo on markers of inflammation in subjects with metabolic syndrome who are receiving background therapy including low dose aspirin.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women at least 18 years old
2. Women must be post-menopausal for one year, surgically sterilized, or using a medically accepted method of contraception and must agree to use an effective method of contraception throughout the study.
3. Subject must meet 3 of the 5 National Cholesterol Education Program/Adult Treatment Panel III (NCEP/ATP III) criteria for the classification of metabolic syndrome: triglycerides \>/= 150 mg/dL; blood pressure (BP): systolic blood pressure (SBP) \>/= 130 mmHg/diastolic blood pressure (DBP) \> 85 mmHg; fasting glucose \>/= 110 mg/dL; waist circumference: men - \> 101.6 cm (40 in)/women - \> 88.9 cm (35 in); high-density lipoprotein (HDL) cholesterol: men - \< 40 mg/dL/women - \< 50 mg/dL.
4. Subject has high-sensitivity C-reactive protein (hs-CRP) levels of \>/= 2.0 but \<10.0 mg/L at the Screening Visit (Week -2).
5. Current medication regimen must be stable for six (6) weeks, i.e. no initiation of new prescription medication nor change in dosage of any previously initiated medication within three months of entering this study.
6. Subject is normally active and judged to be in good health, based on medical history, routine safety laboratory tests (Screening Visit, Week -2), and a brief physical examination (Week -2).

Exclusion Criteria:

1. Intolerance or contraindication to the use of clopidogrel or aspirin.
2. Thrombocytopenia as defined by platelet count \< 100,000/mm3.
3. Current use or use within the past 3 months of oral anticoagulants, or dipyridamole or thienopyridine (ticlopidine or open-label clopidogrel) or oral glucocorticoids.
4. Daily aspirin in excess of 81 mg, or chronic use of non-steroidal anti-inflammatory agents.
5. Use of oral hormone replacement therapy or oral contraceptives including transdermal patch.
6. History of pathologic bleeding (i.e., peptic ulcer or intracranial hemorrhage).
7. History of chronic inflammatory disease or any recent medical event(s) resulting in tissue injury, infection, or inflammation.
8. Myocardial infarction, coronary artery bypass graft, or angioplasty within the 6 months prior to Screening.
9. Uncontrolled hypertension (systolic blood pressure \>/= 180 mmHg or diastolic blood pressure \>/= 100 mmHg) at Screening.
10. History or presence of cancer in the past 2 years, except for successfully resected basal cell carcinoma of the skin.
11. Recent history (within the past 12 months) for alcohol or substance abuse.
12. Currently taking another investigational study medication or has taken investigational study medication within 30 days prior to Screening Visit.
13. Any condition the Investigator believes would interfere with evaluation of the subject, or which could put the subject at undue risk.
Effect of Nicorandil for the Patients of Acute ST Segment Elevation Myocardial Infarction

To evaluate whether nicorandil as an adjunctive therapy for acute myocardial infarction (AMI) reduces reperfusion injury.

Reperfusion injury might occur in patients with acute ST segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(P-PCI),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and myocardial cellular apoptosis, etc.

Nicorandil is an antianginal agent with a dual mechanism of action: nitrate and K+ATP channel opener. The nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (ATP)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. Nicorandil not only decreases preload and afterload but also increases coronary blood flow.

The study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury and left ventricle remodeling in patients with acute ST segment elevation myocardial infarction undergoing the P-PCI.It is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation.So,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and worsening of chest pain.

Eligibility Criteria:
Inclusion Criteria:

* Acute ST Segment Elevation Myocardial Infarction (ASTEMI) defined as typical chest pain lasting \>30min within the previous 12 h, with a clear ST-segment elevation of \>0.1millivolt(mV) in ≥2 contiguous electrocardiographic leads, and the value of troponin I(TNI) above the maximum peak in the normal range.
* Age20-80,All genders
* The first myocardial infarction, and there is no history of PCI therapy and coronary artery bypass grafting
* The infarct-related artery(IRA) is totally occlusive
* Blood pressure is higher than 90/60 millimeters of mercury（mmHg）
* The time from myocardial infarction onset to reach the hospital is less than 12 hs
* Successful interventional treatment, the residual stenosis of IRA is less than 30% ,
* TIMI flow grade 3

Exclusion Criteria:

* kidney dysfunction (creatinine \>2 mg/dl),
* History of previous liver disease,
* Cardiogenic shock,
* History of myocardial infarction (MI)
* History of coronary artery bypass grafting
* History of allergic response to drugs
* Right ventricular infarction
* Severe hypovolemia
Swiss Autoimmune Hepatitis Cohort Study

Research project in which biological material is sampled and health-related personal data is further used and collected.

Coded data are used.

To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, a biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on AIH. In addition, the cohort will allow collaborations with reference networks on AIH abroad.

Measurements and procedures: Enrolment visit and one follow-up visit at least once a year are planned. An additional follow-up visit at 6 months postdiagnosis is planned for newly diagnosed patients.

Whole blood is collected for biobanking once a year Optionally, if available and collected during normal clinical procedures, liver fragments are obtained.

Number of subjects projected for the entire study (all sites combined): 500 (corresponding to 1/3 of the estimated global AIH population residing in Switzerland, assuming a disease prevalence of 20:100,000)

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of AIH, either type I or type II
* Only patients living in Switzerland

Exclusion Criteria:

* N/A
Carbetocin Versus Syntometrine for the Third Stage of Labour

Intramuscular carbetocin is as effective as intramuscular syntometrine for the prevention of postpartum haemorrhage

Postpartum haemorrhage(PPH)or excessive bleeding at or after childbirth is a potentially life threatening complication and is one of the major contributors to maternal mortality and morbidity worldwide (Lewis 2001).Among the various agents that have been studied in addition to the routine oxytocin and syntometrine (which has adverse effects),oxytocin agonist (carbetocin) appears to be the most promising for this indication(Chong 2004).

Carbetocin is a licensed medication for the use of prevention of postpartum haemorrhage in Singapore and many other countries. It is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties.The clinical and pharmacological properties of carbetocin are similar to those of naturally occurring oxytocin. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. In pharmacokinetic studies, intravenous injections of carbetocin produced tetanic uterine contractions within two minutes, lasting six minutes, followed by rhythmic contractions for a further hour.Intramuscular injection produced tetanic contractions in less than two minutes, lasting about 11 minutes, and followed by rhythmic contractions for an additional two hours. The prolonged duration of activity after intramuscular compared with the intravenous carbetocin was significant(Hunter 1992). In comparison to oxytocin, carbetocin induces a prolonged uterine response when administered postpartum, in terms of both amplitude and frequency of contractions.

The potential advantage of intramuscular carbetocin over intramuscular oxytocin is its longer duration of action. Its relative lack of gastrointestinal and cardiovascular side-effects should also prove advantageous compared to syntometrine and other ergot alkaloids.

Eligibility Criteria:
Inclusion Criteria:

1. Any pregnant woman expected to deliver vaginally
2. Age more than 21 if not married
3. Ability to provide informed consent

Exclusion Criteria:

1. Multiple pregnancy
2. Patients with other risk factors for postpartum haemorrhage
3. Patients planning to have an elective caesarean section
4. History of vascular disease such as coronary artery disease
5. History of hypertension requiring treatment within the last 2 years
6. History of hepatic or renal disease
7. Known or suspected coagulopathy
8. History of hypersensitivity to oxytocin or carbetocin
9. Any condition where the use of syntometrine/carbetocin is contraindicated