cyrilzakka/clinical-trials huggingface dataset:
Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids

This research study helps to demonstrate that adding vitamins and fats (nutritional supplements) to a diet will help reduce body weight and improve the lipid profile. This will be done by examining the body weight and chemicals in the blood. The chemicals are the result of the brain using the fat that subjects eat in their diet. Some medications may also change the amount of these chemicals in a person's blood.

To demonstrate that supplementation of antioxidants and omega-3 fatty acids will improve clinical outcome including cognitive performance in olanzapine treated patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 55
* VA outpatient
* Diagnosis of schizophrenia by DSM-IV criteria
* Active treatment with olanzapine
* Medically healthy

Exclusion Criteria:

* Diagnosis of MR
* MMSE score of \< 26
* Not on a stable dose of olanzapine
Tack Optimized Balloon Angioplasty (TOBA) Study

A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Eligibility Criteria:
Inclusion Criteria:

* Rutherford clinical category 2, 3 or 4
* ABI less than or equal to 0.90
* Reference vessel diameter is between 2.5mm and 5.5mm
* Target lesion has stenosis greater than or equal to 70% or is occluded
* Target lesion is less than or equal to 10cm in length

Exclusion Criteria:

* Previously implanted stent in the ipsilateral superficial femoral or popliteal artery
* Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)
Glucocorticoid in Treatment of Adult Idiopathic Nephrotic Syndrome：a Prospective Observational Study

This study is to assess the efficacy and safety of 8-weeks full-dose induction protocol (prednisone 1mg/kg, maximum 60mg/day) and protracted tapering protocol in the treatment of adult idiopathic nephrotic syndrome.

In full-dose induction period, patients scheme to visit at the 4th and 8th week, and in protracted tapering period at 10th , 22nd, 42nd and 66th week. If the patients reach complete remission within 4 weeks, prednisone may be decreased at the 6th week, otherwise keep on the course to the 8th week. All patients reach complete remission will shift to protracted tapering period and follow up until prednisone withdrawal, except the cases that relapse and drop out the study. If proteinuria reappears in someone, angiotensin-converting enzyme inhibitor（ACEI） or angiotensin receptor blocker（ARB） will be considered combination, on the premise of the blood pressure is affordable.

Eligibility Criteria:
Inclusion Criteria:

* Patients who signed written informed consent form
* Age between 18-65 years, female or male
* Patients with diagnosis of nephrotic syndrome ( proteinuria ≥3.5 g/24h, and serum albumin ≤30g/L ),
* Pathological diagnosis with minimal change disease (MCD), focal segmental glomerulosclerosis (FSGS) and podocyte disease
* Serum creatinine \< 3mg/dl ( 265.2umol/L), estimated glomerular filtration rate(eGFR) no less than 30 ml/min.1.73 m2

Exclusion Criteria:

* Patients who didn't sign written informed consent form
* Patients who have received full-dose prednisone treatment for more than 2 weeks, or pulsed methylprednisolone (\>7.5mg/kg.day) within 2 weeks
* Patients who have taken immunosuppressants within 3 months, as Cyclosporine A, Tacrolimus, Mycophenolate Mofetil, Cyclophosphamide, or Leflunomide etc.
* Patients who have impaired liver function, with Alanine aminotransferase(ALT) or Aspartate aminotransferase(AST) twice more than the normal upper limit, or who have viral hepatitis B with hepatitis B e antigen(HBeAg) positive or hepatitis B virus DNA (HBV-DNA) reduplicative
* Patients who have contraindications to glucocorticoid, for example diabetes, obesity (BMI\>28kg/m2 before disease onset), femoral head necrosis, or active infection.
* Patients who have family history of kidney disease
* Patients who have definite secondary facts of this disease.
Propolis Extract, Nanovitamin C and Nanovitamin E in Peri-implant Mucositis

The objective of this study was to perform the first clinical trial to evaluate the effectiveness of propolis extract, nanovitamin C and nanovitamin E gel as adjuvant to mechanical debridement in clinical and microbiological parameters of implants with peri-implant mucositis


Eligibility Criteria:
Inclusion Criteria:

* cooperative adult patients,
* with one or more implants with peri-implant mucositis, and
* presenting at least 18 months of functional loading.

Exclusion Criteria:

* refuse to participate in the study,
* patients who had implants with peri-implantitis (BOP and/or suppuration together with progressive radiographic marginal bone loss),
* patients with uncontrolled periodontitis (presence of nine or more sites with PD ≥ 5 mm and with full-mouth bleeding score (FMBS) \> 25%),
* systemic diseases or conditions that could alter the results of the study (diabetes mellitus, immunosuppression, infectious diseases, rheumatoid disease, history of bisphosphonate treatment, radiotherapy, chemotherapy, etc.),
* patients who had taken local and/or systemic antibiotics less than 2 months ago,
* pregnant or breastfeeding women, and
* patients with history of allergies to the test and/or placebo components administered.
Unknown Glucose Metabolism Disorders In Patients With Coronary Artery Disease

This study aimed to examine the prevalence of glucose metabolism disorders (GMD)in the patients with coronary artery disease and the relationship between different GMDs and coronary artery disease (CAD).

Context: There are more than 220 million people diagnosed with diabetes mellitus (DM) in the world. DM is a serious risk factor for coronary artery disease (CAD). This study aimed to examine the prevalence of glucose metabolism disorders (GMD) in te patients with coronary artery disease and the relationship between different GMDs and CAD.

Settings: 230 patients with coronary artery disease and without any known GMDs were included the study. Coronary angiography was used to diagnose CAD. Patients were administered the 75 g Oral Glucose Tolerance Test (OGTT).

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery disease and who had no glucose metabolism disorders were included to study.

Exclusion Criteria:

* Patients who had previous GMDs, malignancies, chronic liver and kidney diseases, rheumatologic disorders, and a BMI higher than 35 kg/m2 were excluded from the study.
Effect of Resistant Starch Type 4 on Glycemia and Insulin Sensitivity in Young Adults

This study tested the effects of resistant starch type 4 on blood sugar and hunger in young adults with Type 2 diabetes.

To measure the blood glucose response, after an overnight fast, blood samples were collected before eating and at 15, 30, 45, 60, 90, and 120 minutes after each each bar. The incremental area under the curve was used to calculate the glycemic index and insulin sensitivity via minimal model.

Eligibility Criteria:
Inclusion Criteria:

* Apparently Healthy (not diagnosed with disease)
* Young Adults (18-35)

Exclusion Criteria:

* Diagnosed with diabetes or other metabolic disorders
* Allergies to Wheat
* Non-smokers
Safety and Efficacy of Fluoroscopy-free Technique During Retrograde Intrarenal Surgery for Renal Stones

Aiming to reduce radiation exposure to patients and physicians, the investigators conduct this study protocol to evaluate the possibility of performing retrograde intrarenal surgery (RIRS) under direct visualization without fluoroscopy. the investigators will prospectively evaluate the outcome of fluoroscopy-free RIRS for renal stones in comparison with the standard technique. The investigators expected that the fluoroscopy-free technique has high safety and efficacy even in complicated cases.

With improved flexible URS instrumentation and lithotripsy technology, retrograde intrarenal surgery (RIRS) became an alternative and excellent option for renal stones. Fluoroscopy imaging may be necessary during various steps of RIRS, such as insertion of a guidewire and stent, access sheath insertion, detection of stone location and size, and assessment of collecting system anatomy.

In an effort to decrease radiation exposure, several studies were conducted to evaluate the possibility of performing RIRS under direct visualization without fluoroscopy. Most studies concluded that fluoroscopy-free RIRS is a feasible, effective, and safe technique. The reported stone-free rate ranged from 83.8% to 95.7%. No major complications were observed.

Despite the reported high safety and efficacy of the fluoroscopy-free RIRS technique, most of the studies were retrospective and included only uncomplicated cases, and none of the studies address its results against control.

In the present study, the investigators will prospectively evaluate the efficacy and safety of fluoroscopy-free RIRS for renal stones in comparison with fluoroscopy-guided technique as standard control. The study will include all patients with renal stones amenable to RIRS. The investigators expected that the fluoroscopy-free technique can deal with large stones and complex situations with high safety and success rate. The study hypothesis is that "the fluoroscopy-free technique has efficacy and safety similar to the fluoroscopy-guided technique".

The investigators also aim to determine the patients and surgical characteristics impacting the need for fluoroscopy. The intra-operative fluoroscopy imaging is expected to be necessary during RIRS, especially in complicated cases. In the fluoroscopic-free group, the fluoroscopic equipment will be available in the operating room and will be used if needed.

Eligibility Criteria:
Inclusion Criteria:

* Renal stone.
* Stone size: ≥10 mm.

Exclusion Criteria:

* Partial and complete staghorn stones.
* Pregnant women.
* Morbid obesity.
* Uncorrectable coagulation disorders.
* Active urinary tract infection (UTI).
* Stone in a calyceal diverticulum.
* Urinary tract obstruction distal to the stone.
* Concomitant pathology that needs intervention in the same setting.
Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation

Furosemide is an old drug that has been used frequently in the postoperative period of kidney transplantation, aiming to achieve adequate urine output. There is no previous study that directly evaluate the urine response to standardized dose of furosemide in the postoperative period. The objective is to measure the urine output after standardized dose of furosemide is delivered, as a biomarker to predict the graft function in perioperative period.


Eligibility Criteria:
Inclusion Criteria:

* Deceased donor kidney transplantation at KCMH
* informed consent is accepted

Exclusion Criteria:

* Known allergy to furosemide
* Surgical complication of allograft
* Urgently needed for dialysis (refractory hypervolemia, uremic symptoms, and hyperkalemia)
Long-term Effects of the Addition of Diathermy by Emission of Radiofrequency to Therapeutic Exercise in Patellofemoral Pain Syndrome Patients

Introduction: the management of Patellofemoral Pain (PFP) is focused on therapeutic exercise (TE) to improve muscle strength and motor control. Recent studies suggest that the addition of radiofrequency diathermy (RFD) obtain greater short-term improvements in knee pain than TE alone. As there is no follow up data, the aim of this research is to assess the long-term effects of adding RFD to TE on pain, function and quality of life on PFP patients.

Methods: a single-blind randomized controlled trial will be conducted. Participants diagnosed of PFP will be allocated in either a TE group or a RFD+TE one. Sociodemographic data, knee pain, and lower limb function will be collected. Each group will performed 20 min of daily knee and hip supervised TE along three weeks with the addition of ten sessions of RFD for the RFD+TE group.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between 30 and 50 years old without radiological findings of osteoarthritis.
* Subjects referring during the last month almost three points of pain in the anterior surface of knee measured with Visual Analogue Scale.

Exclusion Criteria:

* Subjects with contraindications for the treatment with radiofrequency diathermy (tumors, use of pacemakers or any other implanted electronic device, thrombophlebitis or deep venous thrombosis, pregnancy, fever, active tuberculosis, infections and rheumatoid arthritis).
* Subjects who have received corticoid or hyaluronic acid or platelet-rich plasma injections treatment in the knee.
Chloroquine Phosphate Prophylactic Use in Health Personnel Exposed to COVID-19 Patients

The primary objective of this study is to evaluate the efficacy and security of chloroquine phosphate prophylactic use for reducing the risk of infection by severe acute respiratory syndrome coronavirus-2 in Health Care Workers exposed to COVID-19 patients.

Health Care Workers as first line of hospital care, are at high risk of infection by severe acute respiratory syndrome coronavirus-2 due for the exposure to COVID-19 patients. The pharmacological treatment with chloroquine phosphate has emerged as one of the main therapeutic approaches for COVID-19 patients. However, some studies have described and hypothesized that the use of prophylactic chloroquine phosphate could provide some protection against COVID-19 infection reducing the chances of contagion in Health Care personnel during the development of the pandemic. A controlled clinical trial will be conducted in a tertiary hospital in Mexico City, Mexico. Participants will be divide in two groups; 1) intervention: who will receive chloroquine phosphate (300 mg/day during the first 30 days and 150mg/day during the last 30 days) and 2) control, both with a follow up for 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Health Care Workers as first line of hospital care exposed to COVID-19 patients.
* Initial polymerase chain reaction assay negative test for severe acute respiratory syndrome coronavirus-2 infection.
* Both sexes
* Agree to participate in the study after signing an informed consent letter.

Exclusion Criteria:

* Health Care Workers as first line of hospital care exposed to COVID-19 patients with history of heart disease, arrhythmias or QT segment prolongation.
* Health Care Workers as first line of hospital care exposed to COVID-19 patients with liver or kidney disease of any etiology.
* Health Care Workers as first line of hospital care exposed to COVID-19 patients with retinopathy of any etiology.
* Health Care Workers as first line of hospital care exposed to COVID-19 patients with allergy to chloroquine.
* Health Care Workers as first line of hospital care exposed to COVID-19 patients with a history or diagnosis of psoriasis.
* Health Care Workers as first line of hospital care exposed to COVID-19 patients with important primary clinical alterations: renal (creatinine\> 3), liver (Alanine Aminotransferase and Aspartate Aminotransferase x 3), endocrine, neurological.
Evaluation of Hepatic Arterial Infusion of Cisplatin and 5-FU in Biomarker Stratified HCC

This study is to assess the efficacy and the safety of hepatic arterial infusion of cisplatin and 5-fluorouracil (HAIC) in advanced HCC patients stratified by biomarker expression predicting therapeutic response.

Hepatic arterial infusion chemotherapy (HAIC) with cisplatin and 5-fluorouracil has been used in advanced HCC. However, cisplatin or 5-fluorouracil acts on cells without tumor selectivity. Therefore, to improve the tumor selectivity and effectiveness of HAIC, molecular subtyping-based stratification strategies should be considered. In this study, patients who have progressed or intolerance to sorafenib with non-metastatic HCC in TNM stage III-IVA and ECOG PS 0 or 1, Child-Pugh class A will be enrolled. 96 patients with pre-treatment tumor biopsy will receive Cisplatin (60mg/m2 for 2h on day 2) and 5-fluorouracil (500mg/m2 for 5h on days 1-3) through implanted port system. This treatment will be repeated every 4 weeks, up to 6 times. The primary objective is to determine overall response rate, where benefit is defined as complete or partial response according to mRECIST V1.1. Secondary endpoints include time to progression, progression free survival. The biopsy tissue will be subjected to real time reverse transcriptase polymerase chain reaction for quantification of gene expression levels. Patients will be categorized into two groups according to gene expression results, and then AUC value of ROC curve analysis will be evaluated as an exploratory endpoint to assess predictive performance of biomarker for therapeutic response of HAIC.

Eligibility Criteria:
Inclusion Criteria:

* over 20 years old
* Patients with advanced hepatocellular carcinoma who have progressed or intolerance to Sorafenib
* Patients with advanced hepatocellular carcinoma who cannot be treated with surgery, transplantation, RFA, or TACE.
* TNM stage III/IV (including intrahepatic single or multiple tumors without extrahepatic metastasis regardless of lymph node metastasis)
* ECOG performance status of 0 or 1
* Liver function status of Child-Pugh Class A or B
* more than 3 months of life expectancy
* serum creatinine \<1.5 mg/dL
* aminotransferase \<5 times the upper limit of normal
* absolute neutrophil count \>1,500 cells/lL
* platelet count \>75,000/lL
* hemoglobin \>10 g/dL

Exclusion Criteria:

* patients with extrahepatic tumors
* Patients requiring combined treatment with chemotherapy, radiotherapy, TACE, RFA, or others
* Patients in any severe and/or uncontrolled medical conditions
* patients with history of allergic response to CT contrast media
* patients who participated as subjects in other interventional clinical studies (as of the date of visit) within 60 days before drug administration
* Any person deemed inappropriate by reason of the investigator for other reasons
Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient

The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient.


Eligibility Criteria:
Inclusion Criteria:

* Post cesarean section women

Exclusion Criteria:

* allergic to ginger
* time of cesarean section more than 1 hour
* perform another operation such as appendectomy, cystectomy
* former use carminative drugs
* already have abdominal distention
A Study of the Safety, Tolerability and Pharmacokinetics of ALN-TTR02 in Japanese Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of patisiran (ALN-TTR02) in Japanese subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese adult males and females aged 20 to 65 years, inclusive (The subject was born in Japan and has lived outside of Japan for \<10 years, and subject's biological parents and grandparents are fully Japanese and were born in Japan);
* Subjects who are healthy as determined by clinical assessments;
* Females subjects must be of non-childbearing potential;
* Males with partners of child-bearing potential, must agree to use appropriate contraception.

Exclusion Criteria:

* Subjects with a history of serious mental illness;
* Subjects who have a clinically relevant medical or surgical history;
* Subjects with a positive screen for alcohol or drugs of abuse;
* Subjects with safety laboratory test results deemed clinically significant;
* Subjects with known hepatitis B surface antigen (HBsAg), hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection;
* Subjects who have received an investigational agent within the 3 months prior to study entry.
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

To evaluate the efficacy and safety of RTA 402 in patients with type 2 diabetes mellitus.

To evaluate the safety and tolerability of RTA 402.

Eligibility Criteria:
Inclusion Criteria:

* CKD patients with type 2 diabetes mellitus
* Patients whose eGFR levels are eligible for this study
* Patients being treated with stable dose of ACE inhibitors and/or ARB etc.

Exclusion Criteria:

* Patients with Type 1 diabetes
* Patients with known non-diabetic renal disease
* Patients with a history of renal transplantation
* Patients with mean SBP \> 160 mmHg or mean DBP \> 90 mmHg
* Patients with HbA1C \> 10%
* Patients with cardiovascular disease specified in the study protocol etc.
Comparison of Text and Pictorial Waterpipe Tobacco Warnings Among Young Adults

The purpose of this study is to whether exposure to waterpipe tobacco warnings reduce young adults' intentions to smoke waterpipe in the future.

Young adults, defined as those 18-29 years old, have the highest rates of waterpipe tobacco smoking, which increases their risk of a variety of pulmonary, neurological, and oncological health conditions, among many others. This trial will randomly assign young adult waterpipe users or those susceptible to use to view waterpipe tobacco packages with text warning, pictorial warnings, or no warnings in a one-time online study. Participants will answer a series of questions regarding each package.

Eligibility Criteria:
Inclusion Criteria:

* United States (US) Resident
* Has used waterpipe tobacco within the past year (self-report) OR
* Has not used waterpipe tobacco within the past year but is susceptible to use (self-report)

Exclusion Criteria:

* Younger than 18 or older than 29
* Not a US Resident
* Has not used waterpipe tobacco within the past year and is not susceptible to use (self-report)
Pharmacokinetics of Thymoglobulin in Paediatric Haematopoietic Stem-cell Transplants

This study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (rATG) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing hematopoeitic stem cell transplantation (HSCT).

Allogeneic hematopoeitic stem cell transplantation (HSCT) is a therapeutic option for patients with malignancies as well as metabolic and genetic diseases. Conditioning regimens given prior to donor cell infusion aim to ablate the recipient bone-marrow, to allow engraftment of the stem-cells infused, and to prevent acute versus host disease (aGVHD). Anti-thymocyte globulin (ATG) is one of the immunosuppressive drugs given as a preparative regimen for HSCT. Subjects will be given an ATG infusion daily for 3 days prior to HSCT and serum levels will be collected, as per schedule, with the last sample taken +100 days post-HSCT.

Eligibility Criteria:
Inclusion Criteria:

* All patients who are scheduled to receive ATG 2.5mg/kg/day for 3 days as part of the preparative regimen for HSCT, as determined by the responsible HSCT physician.
* Written, informed consent

Exclusion Criteria:

* Hypersensitivity to rabbit proteins or to any product excipients
* Active acute or chronic infections, which would contraindicate any additional immunosuppression
* Known pregnancy or breastfeeding