cyrilzakka/clinical-trials huggingface dataset:
Treatment of Premature Ovarian Insufficiency Using Bone Marrow Cells

investigator is doing single armed clinical interventional study to treat premature ovarian insufficiency with autologous bone marrow derived mononuclear cells to be given systematically and locally to the ovaries under ultrasound guidance with experienced gynecologist and to look for the results including: laboratory evidence through hormonal study ultrasound proof of ovarian follicle development. premature ovarian insufficiency is characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotropin hormones and low estrogen and anti-Mullerian hormone.

Autologous use of stem cells from bone marrow are alternative safe minimal manipulative products that can provide a solution to this clinical problem without the need for oocyte donation program.

Premature ovarian insufficiency is a clinical syndrome characterized by early loss of ovarian function (less than 40 years of age) manifested by menstrual irregularity or amenorrhea with elevated levels of gonadotrophin hormones and low estrogen and anti-Mullerian hormone. The average age for menopause is 50-52 years in the developed world ,it is believed that about 1% for women less than 40 years of age and 0.1 in less than 30 years of age has premature ovarian insufficiency.

Etiology of POI may be genetic, chromosomal, or auto immune.in addition to cancer treatment and surgical causes.

Hormonal replacement therapy is recommended for POI patients to alleviate vasomotor symptoms in addition to prevent osteoporosis and ischemic heart disease.

Regenerative medicine is a new medical approach to treat variety of diseases involving many tissues or organs in human body using cells, biological products instead of drugs or physical factors.

Autologous use of stem cells from bone marrow or adipose tissue (stromal vascular fraction) or platelet rich plasma are alternative safe minimal manipulative products that can provide a solution to this clinical syndrome.

Only few cases had been mentioned in the literature offering autologous stem cells for treating POI including bone marrow or adipose derived stem cells in addition to mesenchymal stem cells expanded invitro.

the investigator use autologous bone marrow concentrate with transvaginal approach under ultrasound guidance to treat POI.

Eligibility Criteria:
Inclusion Criteria:

1. clinical diagnosis of premature Ovarian insufficiency.
2. ineffective hormonal therapy.
3. biochemical evidence of high gonadotropins.

Exclusion criteria:

1. solid or hematological malignancies.
2. bleeding disorders.
3. rejection of the procedure.
A Clinical Follow-up Study of Heart Failure Patients.

Heart failure (HF), a current worldwide pandemic with an unacceptable high level of morbidity and mortality, brings an enormous medical and societal burden. Chronic HF is characterized by progressive alteration of cardiac structure and function. But the molecular mechanism of these alterations is still not well-established and needs to be discussed further. HF is a highly heterogeneous disease that can be caused by a multiple of diseases. Dilated cardiomyopathy (DCM) and ischemic cardiomyopathy (ICM) are the main causes of this syndrome. Although HF is the common manifestation of DCM and ICM, the etiology and pathogenesis are different. Understanding the different pathophysiological mechanisms will contribute to the prevention and individualized therapy of heart failure. Therefore, this study aims to observation the different characteristics of the molecular biology and clinical courses in DCM and ICM patients.


Eligibility Criteria:
Inclusion Criteria:

* LVEF≤ 55%
* enlarged left ventricular end-diastolic dimension
* ICM group: with history of MI or revascularization; ≥ 75% stenosis of LM or proximal LAD; ≥ 75% stenosis of two or more epicardial vessels.
* symptomatic heart failure

Exclusion Criteria:

* Known malignant tumour diseases
* Pregnancy or lactation period；
* Investigators think not suitable to participate in this trial.
Effects of Online App Weight Loss Programs on Liver Health in Obese Adults

The primary objective of this trial is to assess the effects of online app weight loss programs on liver health in obese adults.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, \>18 years of age, inclusive, at Day -7.
* BMI of 30.00 to 49.99 kg/m2, inclusive, at Day -7.
* Has no plan to change smoking habits during the study period.
* Has ability to access study related online programs and apps.
* Willing to follow study instructions, as well as complete online questionnaires.
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigators, Sponsor and Collaborator.

Exclusion Criteria:

* Self-reported presence of uncontrolled cardiac, renal, endocrine, pulmonary, biliary, pancreatic, gastrointestinal, or neurological disorders or cancer (except for non-melanoma skin cancer) that may affect the subject's ability to adhere to the study protocol and/or affect study outcomes as assessed by the PI.
* Self-reported type 1 diabetes.
* History of gastrointestinal surgery for weight reducing purposes.
* Participation in a weight loss trial or a program/service intended to alter body weight (e.g., Noom, Weight Watchers); medications, dietary supplements or products that affect weight loss, nutrient absorption, appetite and satiety; or weight loss or gain ≥10 lb (4.5 kg) within 6 mo of Day -7.
* Extreme dietary habits (e.g., Atkins diet, very high protein, intermittent fasting) or eating disorder.
* Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded.
* Female with prior medical diagnosis of premenstrual syndrome or premenstrual dysphoric disorder.
* Unstable use of hormonal contraceptives, anti-hypertensive medication, medications for mental or emotional disorders, or thyroid hormones within 90 d of Day -7.
* Exposure to any non-registered drug product within 30 d of Day -7.
* Recent history of (within 12 mo of Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or

  1½ oz distilled spirits).
* ALT or AST \> 5 x ULN at baseline.
UBE Stability / Dynamic Radio

Degenerative pathologies of the spine affect a large proportion of the increasingly ageing population, and are a major public health issue. When conservative treatments (physiotherapy, analgesics, infiltrations) fail, surgical treatment is preferred.

Traditionally, a simple lumbar recalibration operation is preferred (bilateral laminectomy decompression), but this may affect spinal stability. In cases of spondylolisthesis or preoperative instability, lumbar fusion (arthrodesis) is sometimes necessary to avoid the risk of major instability, but such an operation is not without risk and may require repeat surgery.

The development of new surgical techniques such as uni or bilateral laminotomies, which are less radical, has made it possible to avoid some arthrodeses. Nowadays, the emergence of new surgical techniques such as endoscopy has further reduced the risk of destabilization (shorter post-operative convalescence, less atrophy of the paraspinal muscles) and improved surgeon comfort (better vision and easier instrument handling).

Unilateral biportal endoscopy (UBE) is one of two endoscopic techniques and has proven its effectiveness for lumbar decompression in terms of clinical benefits. However, there is no scientific evidence on spinal stability after recalibration under UBE.

We believe that minimizing invasiveness with UBE during simple lumbar recalibration surgery can preserve spinal stability, thereby reducing the need for lumbar fixation and lowering the cost of care.

We therefore propose to study the maintenance of spinal stability using dynamic radiography at 3 months post-operatively in patients undergoing lumbar recalibration surgery with UBE.

Spinal stability is defined by the absence of abnormal mobility (sagittal translation of at least 3 mm) between flexion and extension movements and will be assessed on the 3-months postoperative dynamic radiography.

Patients will undergone an additional dynamic radiography 3 months after surgery to assess their spinal stability.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 50 ans,
* Patient requiring single-level or 2-levels lumbar decompression surgery under UBE,
* Patients who underwent dynamic radiography within 3 months prior to surgery,
* Patient who received information on the study and who signed the consent form.

Exclusion Criteria:

* Presence of a mobile spondylolisthesis with a ≥ 3 mm difference between flexion and extension movements on preoperative dynamic radiography,
* Patient with history of lumbar arthrodesis,
* Patient not available for study follow-up.
Clinical Outcome After Episealer Talus Implant in Treatment of Osteochondral Lesion of the Talus

Autologous Chondrocyte Implantation (ACI) is an appealing technique whereby cartilage is harvested from the joint in a first operation. This biopsy is processed, individual cells are freed and cultivated and, in a second procedure, injected into the defect that has been covered by a periosteal graft). A second generation includes a matrix (MACI) into which the cells are injected/cultivated. Recently, collagen membranes are used to cover the cells or cover a micro-fractured defect. Good results have been reported although return to previous sports remains a challenge . Long term results are lacking. More important is the fact that these treatments are directed towards restoring the articular cartilage whereas the patient's symptoms are generated by the bone and not the cartilage.

Treatment of an OCD with a small metallic implant has been tested in recent years. Results have been promising by some reports, while a high revision rates was reported by others. A recent 2-8 years follow-up study revealed a survival rate of 95 %


Eligibility Criteria:
Inclusion Criteria:

* Osteochondral lesion (both primary and secondary lesions) ⌀ 10-15 mm on the medial or lateral talar dome
* age between 18 and 65 years
* BMI \< 35
* patients who have given their willingness to reach the Institute for checkups.
* patients previously treated with conservative therapies, which proved unsuccessful

Exclusion Criteria:

* non-focal defect
* on-going infection in the ankle joint
* inflammatory arthritis or radiographic osteoarthritis in the ankle joint (=no joint space narrowing) Osteophytes without joint space narrowing (=Gr1 (van Dijk classification)) is not a contra indication.
* sensitivity to cobalt-chrome alloys and titanium materials
* inadequate bone stock where the Episealer is to be inserted
* existing prosthesis in the area of treatment or opposing surface
* osteochondral lesion on opposing tibial surface
* pain of unknown etiology
* demineralised bone
* instability. Instability is defined as recurrent giving way with or without laxity
* severe malalignment in the ankle joint \>5 degrees malalignment as compared to the contralateral ankle joint, as measured on the standing X-Ray
* Ipsilateral symptomatic foot, knee or hip disease which affects the mobility of the patient
* other diseases or medication that may affect the bone anchoring of the Episealer
* uncooperative patient that is not willing to follow instructions
* muscular insufficiency
* vascular insufficiency
* medical, hormonal, hematological, immunological or metabolic illnesses
* Smoking
* Pregnancy
* Diabetes
Intra-stent Tissue Evaluation Within BMS and DES > 3 Years Since Implantation

This study aims to test the hypothesis that plaque composition differs within a stent between bare metal stents and drug eluting stents (DES). It is possible that a difference in plaque composition seen within a stent may be contributory to the late thrombotic events seen more frequently with DES.


Eligibility Criteria:
Inclusion Criteria:

* Subject \> 18 years of age;
* Subject, male or female, who underwent DES or BMS implantation in a native coronary vessel more than 3 year ago;
* Subject is scheduled for a diagnostic coronary or interventional procedure;
* Subject is willing to sign the informed consent.

Exclusion Criteria:

* Subject requires emergency catheterization;
* Subject has an acute myocardial infarction defined as anginal symptoms with ST-elevation on the EKG or creatine kinase-MB elevation \>3times the upper limit of normal;
* Angiographic evidence of ≥ 70% stenosis within the target stent (visual estimate);
* Subject presented with cardiogenic shock;
* Subject has angiographically confirmed thrombus in the target coronary artery;
* Subject has a complex lesion not amenable to the IVUS/VH catheters and/or OCT catheters passing the stented segment;
* Subject has a contraindication to angiography/IVUS/OCT;
* Female subject is pregnant or lactating;
* Subject has life threatening comorbid conditions for which the investigator feels the subject should not be enrolled
Prediction of Vulnerable Plaque Using Coronary CT Angiography and Computational Fluid Dynamic in Acute Coronary Syndrome

The aim of the PVCFD trial is to predict vulnerable plaque confirmed by OCT using coronary CT angiography and computational fluid dynamics in patients with acute coronary syndrome.

Acute coronary syndrome（ACS）mainly includes unstable angina, non-ST-segment elevation myocardial infarction, and ST-segment elevation myocardial infarction, which is the leading cause of death around the world. The main pathophysiological feature of ACS is the rupture of vulnerable plaque, which can be recognized by coronary artery angiography (CAG), intravascular ultrasound (IVUS) and optical coherence tomography (OCT). Compared with CAG and IVUS, OCT is the best intravascular imaging technique so far. But all these examinations are invasive and expensive. Recently, coronary CT angiography derived adverse plaque characteristics (APC) and hemodynamic forces defined by computational fluid dynamics (CFD) can reflect plaque vulnerability and hemodynamic forces acting on the plaque, which are important factors in the progress of the rupture of vulnerable plaque. So, we want to explore predictive value of coronary CT angiography (CTA)and computational fluid dynamics for vulnerable plaque in ACS.

The PVCFD trial is a prospective and single center study, patients with ACS will be arranged to complete coronary CTA before CAG. OCT will be used to detect the characteristics of coronary atherosclerotic plaques confirmed by CAG. Lipid plaques with fibrous cap thickness less than 65um, erosion and coronary artery dissection are defined as vulnerable plaque. Patients will be divided into vulnerable plaque group and stable plaque group according to this. The coronary CTA images will be screened for APC and CFD analyses at core laboratories of Shanghai tenth's hospital. Lesions with diameter stenosis (DS) \>30% based on coronary CTA evaluation were included for subsequent APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) analysis and hemodynamic forces (FFRCT,ΔFFRCT, WSS and PWS) defined by CFD. Three prediction models (Model 1: percent diameter stenosis + lesion length, Model 2: Model 1 + APC, Model 3: Model 2 + hemodynamic force) will be constructed to identify vulnerable plaque confirmed by OCT.

Eligibility Criteria:
Inclusion Criteria:

1)acute coronary syndrome was diagnosed according to universal definition of ACS; and 2) coronary CTA was completed before CAG; and 3) definitely culprit lesion can be recognized by CAG; 4) OCT was done to detect coronary atherosclerotic plaques confirmed by CAG.

Exclusion Criteria:

1) Previous history stent implantation; 2) previous history of coronary artery bypass graft surgery; 3) ACS without clear culprit lesion; 4) poor image quality of coronary CTA for APC and CFD analysis; 5) myocardial infarction secondary to other reasons
Short Course Low Dose Oral Colchicine After ST Elevation Myocardial Infarction(STEMI)

To Study Efficacy and safety oral colchicine 0.6 mg post ST Elevation myocardial infraction (STEMI)

Colchicine is a cheap and potent anti-inflammatory. We believe anti-inflammatory is able to reduce inflammation in coronary arteries and heart muscle post ST elevation myocardial infarction which may benefit in short and long term outcome in patients. The short term outcome is measured using serum troponin and long term outcome is assessed with transthoracic echocardiogram and major adverse cardiac events.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 years to 80 years old
2. STEMI within 24 hours of admission to Pusat Perubatan UKM \& undergoing revascularization therapy (percutaneous coronary intervention) during admission

STEMI is diagnosed when there is:

* ST elevation of ≥1 mm in 2 contiguous leads or
* a new onset LBBB in the resting ECG
* in a patient with ischaemic type chest pains of \> 30 minutes and
* accompanied by a rise and fall in cardiac biomarkers (CPG MALAYSIA STEMI 2019, 4th Edition)

Exclusion Criteria:

1. Pre-existing severe heart failure with left ventricular ejection fraction less than 35%
2. Clinically unstable (Intubated or double inotropic support)
3. Refuse or not suitable for cardiac revascularization therapy
4. Anaemia induced Angina (Hb \< 9 g/dL)
5. Ongoing sepsis requiring antibiotic
6. Ongoing diarrhea (Loose stool 3 times or more per day - stool consistency Bristol chart type 6 \& 7)
7. Active Covid-19 Infection (\< 7 days for Category 1-3, \< 10 days for category 4-5)
8. Stroke within previous 3 months
9. Coronary bypass surgery either within the previous 3 years or planned
10. Active malignancy or treated malignancy within 7 years
11. Active Inflammatory bowel disease on treatment
12. Active Neuromuscular disease on treatment
13. Chronic kidney disease (CKD stage 4 - eGFR \< 30 mL/min/1.73 m2)
14. Severe hepatic disease (ALT \> 3X upper limit normal, Bilirubin \> 2X upper limit normal)
15. Active drug or alcohol abuse on therapy
16. On long term or recent systemic glucocorticoid therapy within 3 months
17. Pregnancy or breastfeeding
18. Known sensitivity to colchicine or multivitamin tablet
19. Pre-existing indication for colchicine therapy (Gout, Familial Mediterranean fever, etc)
20. Patients on oral medications that may interact with colchicine (Clarithromycin, Ketoconazole, Voriconazole, Fluconazole, Itraconazole, Cyclosporine, Ritonavir)
Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Chronic kidney disease (CKD) is an established risk factor for cardiovascular morbidity and mortality, as shown by common manifestations of left ventricular hypertrophy (LVH) and arterial calcifications in CKD patients. Fibroblast growth factor-23(FGF-23) is a recently identified phosphaturic hormone that has been reported to be associated with the development of secondary hyperparathyroidism, cardiovascular morbidity, mortality, CKD progression.

While vitamin D is the mainstay therapy in CKD mineral bone disease (CKD-MBD), increased FGF-23 levels have been reported with vitamin D administration. The purpose of this study was to investigate the effect of calcium carbonate when used in conjunction with calcitriol on FGF-23.


Eligibility Criteria:
Inclusion Criteria:

* Adults of 18\~70 years of age
* CKD stage 3 patients (GFR: 30-60ml/min/1.73m2)
* Patients who've given consent to the trial

Exclusion Criteria:

* Known allergy to Vitamin D or calcium carbonate
* Administration of vitamin D analogue or phosphate binders 3 months prior to study entry
* History of hypercalcemia (corrected serum calcium \> 10.5 mg/dL) or hypophosphatemia (serum phosphate \< 2.5 mg/dL) 3 months prior to study entry
* Patients with bone pathologies or diseases requiring vitamin D therapy that is unrelated to CKD-MBD
* Administration of concurrent medication , diseases, or history of surgeries that may affect bone-mineral metabolism or alter bone status
* Patients diagnosed with rapidly progressive glomerulonephritis(RPGN) or those in need of renal replacement therapy
* Patients with obstructive bowel diseases, or severe gastrointestinal diseases
* Patients with less than 2 years of life expectancy(ex. Malignancy diseases)
Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids1

To determine the effects of a moderate amount of amino acids on the rate of water absorption and availability as a precursor fluid for sweat. Young and healthy (male or female) volunteers will take part in three experimental trials. In each trial, volunteers will be given one of two commercially available sports drinks or a commercially available sport drink with added amino acids in a double-blinded, randomised, crossover design. Each drink will be a single 600 mL bolus. All beverages will be labelled with deuterium (D2O). Trials will be compared for temporal accumulation of deuterium in plasma over the course of 60 minutes. Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume changes calculated. It is hypothesised that the amino acid trial will increase the rate of fluid absorption.


Eligibility Criteria:
Inclusion Criteria:

* Generally fit and healthy (determined by health screen questionnaire)
* Recreationally active (minimum 3 hours of physical activity per week including walking)

Exclusion Criteria:

* Any cardiovascular, gastrointestinal, renal or acute/chronic health conditions that may influence the outcomes
* Smoking (including vaping)
* BMI of greater than 30 (combined with a body fat percentage greater than 20%) or BMI lower than 17.5
Effect of Consumption of Supplements and Enriched Olive Paste on Bone Metabolism Indices

It was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups and received supplements of Ca, Vitamin D and Mg with or without enriched olive paste and with or without Vitamin C. Changes in calciregulatory hormone were evaluated at the beginning of the study, at 5 and 12 months . Blood levels of vitamin D, vitamin C, Ca, Mg, the lipid profile, anthropometric indices and bone density were assessed at the beginning and at the end of the study.

: It was a prospective randomized controlled trial. A sample of 115 apparently healthy post-menopausal women(45 -75 years of age) randomized into four groups: (I) nutritional intervention group(n=40) received daily 1000mg vitamin C, 500mg vitamin D3, 500mg calcium(Ca) and 300mg magnesium (Mg); (II) control group(n=42) received daily 500mg vitamin D3, 500mg Ca and 300mg Mg; (III) nutritional intervention group (n=18) received daily 150mg bisphosphonates, 500mg vitamin D3, 500mg Ca and 300mg Mg; and (IV) nutritional intervention group (n=15) received daily about 364 mg polyphenols via an innovative functional food (50g olive paste enriched with mountain tea extract) along with 500mg vitamin D3, 500mg Ca and 300mg Mg. Groups I -III received supplementation for a year whereas group IV for 5 months. Changes in calciregulatory hormone parathormone (PTH) were evaluated at the beginning of the study as well as at 5 and 12 months intervals. Blood levels of vitamin D, vitamin C, Ca, Mg and the lipid profile were assessed at the beginning and at the end of the study. Anthropometric indices (weight, body fat(Kg), Body Mass Index(BMI) and bone mineral density(BMD) were evaluated at the beginning and at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* Age 45 to 75 years old
* Screening for osteoporosis (t-score ≤ - 1 normal bone density, t-score ≤ 2.5 osteoporosis ) and osteopenia of the femur strength or spine (t-score between -1 and -2.5 )

Exclusion Criteria:

* Age \> 75 y.o. and \<45 y.o
* Diagnosed with chronic diseases including cancer, diabetes, coronary heart disease and stroke