cyrilzakka/clinical-trials huggingface dataset:
Tahiti-families: Polynesian Families of Gout Patients

Gout is a chronic disease caused by the deposit of monosodium urate (MSU) crystals in body tissues secondary to hyperuricemia. Patients with gout suffer severe attacks of acute joint pain. As the disease progresses, the joint pain becomes chronic and associated with disabling and deformative manifestations called tophus. This disease is strongly associated with several comorbidities such as cardiovascular disease and chronic kidney failure. Gout is a very common disease, which is affecting 0.9% of the adult population in France and nearly 4% of the North-American population. Data from New Zealand show a particularly high prevalence of gout among Polynesians (minority populations in New Zealand and other islands of the South Pacific) that would be explained by genetic susceptibility and frequently interrelated metabolic diseases. Data on the Polynesian population in New Caledonia suggest prevalence figures close to 7% and prevalence in French Polynesia is assumed to be higher. International genomic studies of gout and hyperuricaemia have identified alleles associated with the occurrence of gout.

The aim is to focus on families with several gouty members (numerous in French Polynesia, and geographically clustered) in order to enable the study of individuals with monogenic gout or with a low number of variants (= cases) determining in the occurrence of gout, as well as a non-gouty family member (= controls).

Dual-energy CT scan (DECT) allows identification and quantification of UMS crystal deposits in the tissue. The volume of crystals correlates not only with the inflammatory activity of the disease but also with the comorbidities that complicate it. Dual-energy scanning has shown the presence of UMS crystals in some hyperuricemic individuals, which could help to identify those individuals most at risk of developing the disease as they already have the stigma of sub-clinical inflammatory activity.


Eligibility Criteria:
Inclusion Criteria :

Case group :

* Gout patients
* Polynesian origin
* Aged 18 to 80 years
* Agreeing to participate in the study
* Having a 1st or 2nd degree relative who is also gouty and a 1st degree relative of the same generation and sex who is not gouty

Control group :

* Non-gouty individuals who are 1st degree relatives of a gouty patient of the same generation and sex
* Aged 18 to 80 years
* Agreeing to participate in the study

Exclusion Criteria :

* Pregnant women
* Persons under guardianship, curatorship or other legal incapacity
* Persons with a contraindication to Magnetic resonance imaging (MRI) examination
* For non-gouty controls : current hyperuricemic treatment (Allopurinol, Febuxostat, Probenecid or Benzbromarone)
* For gouty case : not participating in the TOPATA study (NCT04812886)
FARAPULSE™ Pulsed Field Ablation System

To obtain real world data on the use of, and provide continued evidence on safety and effectiveness of the FARAPULSE™ Pulsed Field Ablation (PFA) system when used per hospitals' standard of care in Chinese population.

The study is an observational, prospective, non-randomized, single-arm, multi-center post-market study.

All subjects signing the informed consent form, will be included in the study. All subjects treated with the FARAPULSE™ PFA system will be followed for three years.

Subjects will undergo the index procedure per hospitals' standard of care after enrollment, and followed at pre-discharge, 3 Month, 6 Month (Phone call only), 12 Month (in-clinic visit mandatory), 24 Month (2 Year) and 36 Month (3 Year).

Eligibility Criteria:
Inclusion Criteria:

1. Subjects intended to be treated with the FARAPULSE™ Pulsed Field Ablation system for cardiac tissue ablation, per physician's medical judgement, and as per hospitals' standard of care
2. Subjects who are willing and capable of providing informed consent
3. Subjects who are willing and capable of participating in all testing associated with this clinical study at an approved clinical investigational center
4. Subjects whose age is 18 years or above.

Exclusion Criteria:

1. Subjects with a current interatrial baffle or patch
2. Subjects with a known or suspected atrial myxoma
3. Subjects with a myocardial infarction within 14 days prior to enrollment
4. Subjects with a recent (within 30 days prior to enrollment) Cerebral Vascular Accident (CVA)
5. Subjects who do not tolerate anticoagulation therapy
6. Subjects with an active systemic infection \*
7. Subjects with a presence of atrial known thrombus \*
8. Subjects with a known inability to obtain vascular access
9. Subjects who are pregnant or planning to be pregnant
10. Subjects with atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
11. Subjects with any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty
12. Subjects with a contraindication to an invasive electrophysiology procedure where insertion or manipulation of a catheter in the cardiac chambers is deemed unsafe per physician's medical judgement, such as, but not limited to, a recent previous cardiac surgery (e.g., ventriculotomy or atriotomy, CABG, PTCA/PCI/coronary stent procedure), recent previous unstable angina and/or in patients with congenital heart disease where the underlying abnormality increases the risk of the ablation (e.g., severe rotational anomalies of the heart or great vessels)
13. Subjects with a life expectancy of ≤ 1 year per investigator's opinion
14. Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments. Each instance must be brought to the attention of the sponsor to determine eligibility.
CURE Addiction Center of Excellence: Brain Mechanisms of Relapse and Recovery

The proposed project will use fMRI and specific probes of reward and inhibition as biomarkers predicting drug use during and after treatment in 72 subjects addicted to prescription opioids/medications. Subjects will be scanned before, during, and after 12 weeks of active medication. The brain fMRI measures will be correlated with the primary clinical outcome of drug use (by urine drug screen) during the treatment and follow-up phase.


Eligibility Criteria:
Inclusion Criteria:

1. Sign an informed consent form;
2. Be between the ages of 18 and 60;
3. Have a diagnosis of opioid dependence according to DSM IV-TR criteria (as assessed by the MINI);
4. Be in good general health as determined by complete physical examination and laboratory tests;
5. Have a negative result for urinary opioids and must self report being at least 3 days opioid free. Participants may have a diagnosis of alcohol dependence so long as they do not have severe alcohol dependence that requires medical supervision for alcohol withdrawal.

Exclusion Criteria:

1. Current severe alcohol dependence that requires medical supervision for alcohol withdrawal;
2. Current psychosis, dementia, mental retardation, or history of schizophrenia;
3. Significant clinical abnormalities in hematology, chemistry, or urinalysis;
4. Significant clinical cardiovascular, neurological, hepatic, renal, pulmonary, metabolic, endocrine, or gastrointestinal disorders;
5. Female subjects who are pregnant or lactating, or female subjects of childbearing potential who are not using birth control (oral contraceptives, barrier (diaphragm or condom) plus spermicide, or levonorgestrel implant); (Pregnancy testing will be done on all females of child bearing age); and
6. Current diagnosis of chronic pain disorder.
Validity and Reliability of 30SFPW Test Patients With TKA

Walking speed after total knee arthroplasty (TKA) can be used as a simple tool to monitor postoperative recovery. There are different protocols for gait assessment in patients with TKA. The 30 Second Fast Walk Test (30SFW) is a simple, low-cost and easy-to-apply assessment method that requires very little equipment in clinical settings. 30SFW is a reliable, valid test of walking ability in patients with knee osteoarthritis (OA).

Objective: To investigate the reliability and validity of the 30SFW test in the evaluation of gait in patients with TKA.


Eligibility Criteria:
Inclusion Criteria:patients who had primary TKA surgery at least six months ago, being diagnosed with preoperative knee OA, and volunteering to participate in the research -

Exclusion Criteria:had a previous orthopedic, neurological, or systemic disease that effects walking or standing, body mass index of 40 kg / m2 and over, having any other surgery on the same limb that effect walking, and revision TKA.

-
An Observational Study of Ertapenem in Outpatient Parenteral Antibiotic Therapy (OPAT) for Complicated Urinary Tract Infections.

The aim of this study is to determine the outcomes when using ertapenem for complicated urinary tract infections in the OPAt setting.

The study hypothesis: Ertapenem is an efficacious and safe therapeutic option for complicated urinary tract infections in the OPAt setting.

Enterobactericae spp. is a common cause of urinary tract infections. The prevalence of quinolone-resistance in Enterobactericae is rising and often co-exists with expression of extended-spectrum beta-lactamases (ESBL, limiting viable outpatient therapeutics options.

In Singapore, there is an increasing trend of treating patients who respond favourably to initial antimicrobial therapy in the outpatient setting (Fisher, et.al, 2006). Ertapenem is one of several agents with excellent antimicrobial activity against Enterobactericae (including ESBL producers). In view of its safety profile and its viability in elastromeric pump, it has great potential to be used in OPAT patients.

There is no study analyzing outcomes in a large cohort of patients with complicated urinary tract infections treated with ertapenem.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients between 21 years old to 70 years old.
* Diagnosed with complicated urinary tract infection due to pathogen susceptible to ertapenem based on microbiology report, and the use of ertapenem is deemed clinically appropriate by the Infectious Disease physician in charge.

Exclusion Criteria:

* Hypersensitivity reactions to Ertapenem.
* Participation in another interventional clinical investigation within 30days
* Unable to obtain informed consent.
Triiodothyronine for the Treatment of Critically Ill Patients With COVID-19 Infection

This study is a phase II, parallel, prospective, randomized, double-blind, placebo controlled trial. The present study will aim to address the efficacy and safety of acute administration of triiodothyronine on ICU patients diagnosed with pulmonary infection due to COVID-19 and require mechanical respiratory support or ECMO.

It seems that thyroid hormone is critical in the response to body injury and is now considered as potential pharmaceutical intervention to limit acute tissue injury. TH (via its regulation of stress induced p38 MAPK activation) exerts antiapoptotic action and protects tissue from injury, with additional favorable effects on immune system and on viral load in infected tissue. This may be a novel and more effective treatment for critically ill viral infected patients.

ThyRepair is the first study which is underway and investigates the safety and efficacy of high dose T3 treatment in patients with acute myocardial infarction undergoing primary angioplasty. The preliminary reports show that this treatment is safe and the efficacy on tissue repair is promising. This therapeutic modality could also be tested in the acute setting of sepsis in which thyroid hormone is involved in the pathophysiology of multi-organ dysfunction. The safety and efficacy of T3 on heamodynamics in sepsis has been previously demonstrated in a small trial.

The present study is phase II, parallel, prospective, randomized, double-blind, placebo controlled trial which aims to investigate the potential effect of T3 intravenous use in the recovery of critically ill patients admitted in ICU due to COVID19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with pulmonary infection due to COVID-19, admitted in ICU and require mechanical ventilation or ECMO
* Male and female with Age\>18 years old
* Signed informed consent from patient or relatives

Exclusion Criteria:

* Pregnant or breast-feeding women
* Severe systemic disease (cancer, auto-immune etc) before infection accompanied by reduced life expectancy \<6 months
* Participation in another trial of an investigational drug or device
* Corticosteroid Use before initiation of treatment
* Sympathomimetic Use before initiation of treatment (epinephrine, norepinephrine, dobutamine, dopamine, phenylephrine)
Compliance to ERAS After Gastric Surgery

The purpose of this study is to prospectively evaluate the overall compliance to the enhanced recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.

The feasibility and effectiveness of ERAS program for various major surgical procedures have been well studies in the literature. However, ERAS program has not been widely accepted for patients undergoing gastric cancer surgery because of the paucity of evidence about its feasibility and efficacy. In this study, we developed ERAS program for gastric cancer surgery, based on the systemic review about perioperative cares. The main elements of ERAS program includes: 1preoperative patient education, 2)no preoperative bowel preparation, 3) provision of normal diet until the night before surgery, 4)carbohydrate rich drink 2 hrs before surgery, 5)epidural anesthesia for pain control, 6) local wound anesthetic infiltration for pain control, 7)no routine abdominal drain, 8)no naso-gastric tube insertion, 9)intraoperative antibiotics, 10)thromboprophylaxis using intermittent pneumatic compression device, 11)intraoperative normothermia using warm air blanket, 12)low oxygen supply during immediate postoperative period, 13)restrictive postoperative fluid administration, 14)early postoperative oral diet, 15)early active ambulation, 16)early removal of the urinary catheter, 17)patient education before discharge, and 18)hospital discharge based on discharge criteria.

The aim of study is to evaluate the compliance to these main elements of ERAS program in patients undergoing gastric cancer surgery.

Previously reported data about ERAS program for colon surgery reported overall compliance as about 65%. Considering that this is a single center study, we expected overall compliance rate of 70%. Therefore, the sample size of 173 patients was calculated based on this expected compliance rate, with permitted error of 95% confidence interval of 14%.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are to undergo gastric cancer surgery
* ASA score \< 3
* ECOG performance status 0-1
* Adequate hepatic, renal, and hematologic function
* Written informed consent

Exclusion Criteria:

* Previous abdominal operation history
* Concommitant other organ malignant disease
* Preoperative chemotherapy or radiation therapy
* Concommitant other organ resection during surgery
* Emergency operation due to bleeding or perforation
* Active underlying medical illness
* Pregnancy
Role of the Ketogenic Diet in Women With PCOS

For the fact of PCOS symptoms could be improved with weight loss and improving insulin resistance, the investigators will do this study to evaluate the role of the ketogenic diet in overweight and obese women with PCOS.

Polycystic ovary syndrome (PCOS) is one of the most common endocrinal abnormalities that affect females within the reproductive age, and are found in about 4% of women. PCOS is commonly associated with symptoms of increased testosterone such as irregular or absent menstrual cycle, increased body hair, and infertility. PCOS is also associated with other disorders such as obesity, insulin resistance, hyperinsulinemia, diabetes mellitus type 2, and dyslipidemia.

Until now, there is no known curative treatment for PCOS. However, anti-diabetic medications can improve many metabolic disorders such as insulin resistance, and increased levels of serum testosterone and total cholesterol. In addition, regulation of diet with exercise could improve the insulin sensitivity. Therefore, managements that aim to decrease the insulin level, improve the insulin resistance and decrease the body weight may be useful for improving symptoms of PCOS.

Ketogenic diets are characterized by a reduction in carbohydrates (usually to less than 50 g/day) and a relative increase in the proportions of protein and fat. People following the keto diet gain 75% of their calories from fat, 20% from protein, and 5% from carbohydrates. Previous studies have revealed that the ketogenic diet of low carbohydrate could decrease the body weight and improve the insulin resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Age range between 16-35 years.
2. BMI ≥ 27.
3. Normal Renal Function.
4. Rotterdam criteria for the diagnosis of polycystic ovary syndrome:

   * Oligo/anovulation
   * Hyperandrogenism
   * Polycystic ovaries on ultrasound.

Exclusion Criteria:

1. Age \<16 or \>35 years.
2. BMI \< 27.
3. Pregnancy.
4. Major medical disorders or other concurrent medical illnesses e.g. DM, other causes of androgen excess and hypercholesteremia
5. Current or previous use of hormonal, anti-diabetic or anti-obesity drugs, or other drugs that affect hormone levels, carbohydrate metabolism or appetite.
Treatment Strategy of Pancreatic Radiolucent Stone

Treatment strategy of chronic pancreatitis (CP) patients with large pancreatic radiolucent stone (≥ 5mm) has not been established. We aimed to figure out clinical features and efficacy of endotherapy for large pancreatic radiolucent stone.

1. Treatment strategy of CP patients with large pancreatic stone：

1. . For patients with large radiolucent stone，ERCP with balloon sphincteroplasty was performed directly to remove radiolucent stone. If ERCP intubation failed, endoscopic ultrasound-guided drainage of pancreatic duct, surgery or medication would be applied. ESWL was performed in the following situations. Frist, MPD strictures was so severe that dilation catheter can not be inserted during ERCP. Second, there was cystic dilatation in MPD and pancreatic radiolucent stone located in cystic dilatation could not be extracted by extraction balloon or basket. In the above cases, the naso-pancreatic catheterwas inserted during ERCP, and then ESWL would be performed with repeated injection of contrast medium. After ESWL, repeated washing and negative pressure drainage were performed, and at last contrast medium was injected again to make sure the stones were cleared. For patients without MPD strictures, the nasopancreatic catheter can be directly removed, otherwise the nasopancreatic duct would be cut off into a stent.
2. . For patients with large radiopaque stone, repeated P-ESWL sessions were performed, and ERCP was routinely performed 48 hours after the last P-ESWL. If ERCP intubation failed, medication or surgery would be recommended.

2. A prospective cohort study was conducted in CP patients with large radiolucent stone. Patients with large radiopaque stone were matched as the control group, with a ratio of 1:2 according to admission time.

3. The primary outcome was pain relief. The secondary outcomes were stone clearance, quality of life score, and changes in pancreatic exocrine and endocrine function.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of chronic pancreatitis; With pancreatic radiolucent stones large than 5mm

Exclusion Criteria:

Autoimmune pancreatitis; Groove pancreatitis; Pancreatic cancer diagnosed within 2 years after diagnosis of chronic pancreatitis
Adult Primary Insomnia Polysomnographic Study (0928-004)(COMPLETED)

The purpose of the study is to test the safety and effectiveness of the Investigational Drug on insomnia.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with a diagnosis of primary insomnia and in good physical and mental health

Exclusion Criteria:

* Adult patients with other medical , neurological and sleep disorders
Efficacy of Rituximab Combined With Cyclosporine in the Treatment of Idiopathic Membranous Nephropathy

Idiopathic membranous nephropathy (IMN) is one of the common types of primary glomerular diseases and the most common cause of nephrotic syndrome in adults.

Poticelli regimen is the classic treatment, but cyclophosphamide has many toxic side effects. The period of glucocorticoid therapy is relatively long, and the adverse reactions caused by glucocorticoid therapy cannot be ignored. For patients who are unwilling to receive glucocorticoids and cyclophosphanide or who have treatment contraindications, cyclosporine can be used, mainly cyclosporine and tacrolimus, with the rapid overall effect but a high short-term relapse rate. In recent years, rituximab therapy has become a first-line treatment, with a high remission rate, and few side effects, but expensive. In terms of efficacy alone, the above regimen did not exceed Poticelli regimen. However, the toxic side effects of rituximab, cyclosporine may be lower than that of Poticelli regimen. Based on the preliminary experiment, this study explored a new treatment plan: low-dose rituximab combined with cyclosporine in the treatment of IMN, the efficacy is not inferior to Poticelli regimen, but the side effects are significantly reduced. The result will provide a good choice for IMN patients.


Eligibility Criteria:
Inclusion Criteria:

1. age 18-70 years; serum albumin level \<30 g/L;
2. estimated glomerular filtration rate (eGFR according to the CKD-EPI formula) ≥60 mL/min per 1.73 m2;
3. patients with a moderate risk of IMN and decline \<50% in proteinuria despite blockade of the renin-angiotensin system 3 months before randomization;
4. patients at high risk or very high risk of IMN.

Exclusion Criteria:

1. secondary causes of MN;
2. being pregnant or breastfeeding;
3. uncontrollable active infectious disease;
4. immunosuppressive treatment in the preceding 3 months.
The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver

L-carnitine is an amino acid that is naturally produced in the liver and kidneys, it is involved in transporting fatty acids across the mitochondrial membrane, it could be an important component in treating a fatty liver disease.

The investigators conduct a study to evaluate the efficacy of the combination of L-Carnitine and Magnesium as a treatment for fatty liver.

A phase 3, randomized, double blind placebo controlled study that evaluate the efficacy of L-Carnitine and Magnesium as a treatment for fatty liver, 60 eligible patients with a diagnosis of NAFDL will be randomly assigned in a 1:1 ratio to receive either the trial product " SLIM WATER" that contains L-CARNITINE and MAGNESIUM for a duration of 16 weeks, or placebo for the initial 8 weeks and continue another 8 weeks with the trial product "SLIM WATER". 'Follow up time is estimated to be 24 week based on monthly clinic visits and accordingly assessment of lipid profile, weight and insulin resistance.

Fibrotest will be used at the beginning of the trial and at the end (week 16) comparing the fat content before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female between the age 18 and 75.
* Patients with diagnosis of NAFLD when other etiologies for fatty liver were ruled out.
* Patients who sign a confirmed consent.

Exclusion Criteria:

* Patients with liver failure.
* Patients with acute or chronic renal failure ( CCT\< 50 ml/min or creatinine \> 1.5 mg/dl)
* Patients with congestive heart failure (NYHA 3-4)
* Patients with active cancer
* Patients on Estrogen therapy, MTX, chloroquine.
* Patients with a history of Hypothyroidism or Cushing disease.
* Patients who received TPN in the past 6 months.
* Patients with chronic liver disease, A1AT, Hemochromatosis, Wilson, Autoimmune, Toxic injury.
* Patients on anticoagulation therapy - Coumadin.
* Patients who use valproic acid therapy.
* Children, Pregnancy.