cyrilzakka/clinical-trials huggingface dataset:
Fujian Province Cardiovascular Diseases Study

This proposal delineates a research plan to collect blood from the patients with cardiovascular diseases for the purpose of establishing a molecular biological bank registry. The Fujian provincial hospital will enroll 8,000 patients.The blood collected will be processed to create a repository of molecular biological plasma. Along with a sample of blood collected from individual patients, a concise general medical history, demographic data, electrocardiographic data, echocardiographic data, and laboratory data will be collected. A short interview will take place after enrollment during the outpatient visit or hospital stay, or may be conducted via phone call after enrollment. All the clinical data gathered will be compiled in Fujian provincial hospital center database, and would be stored in a format where a culmination of clinical findings, i.e. representing a disease of interest, can be used to search the database to identify the blood samples of all patients with such characteristics for further study.

The study is to commence on May 1st 2015 and is to be completed within 3-5 years. The targeted number of patients to be enrolled is 8,000. All patients have the history of cardiovascular diseases, will be eligible to be enrolled. Patients inclusion criteria are as follows, once informed consent is obtained:

1. Males or females at least 18 years old.
2. Patient has not been previously enrolled in the molecular biological bank registry of the Fujian provincial hospital.
3. Patient able to give informed consent.
4. Any patient with history of cardiovascular diseases (If a subject reports history of cardiovascular diseases at another facility, outside records will be obtained to confirm the diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 year old males and non-child-bearing period females.
* Clinical diagnosed with acute coronary syndrome including NSTE-ACS ,MI and STEMI.
* Patients with STEMI((ST segment elevation myocardial infarction) and NSTEMI(non-ST segment elevation myocardial infarction) will be recruited within 48 hours of symptom onset.
* Patients with cerebrovascular disease was made or confirmed by a board-certified neurologist with fellowship training in cerebrovascular disease and confirmed by standard diagnostic techniques such as head CT, MRI, MR angiography, CT angiography, carotid ultrasound, etc.
* Sign the ICF(inform consent form)

Exclusion Criteria:

* child-bearing women
* hypothyroidism,
* active liver disease or dysfunction including agnogenic serum transaminase sustained elevation or higher than 3 times ULN(upper limit of normal)
* severe anemia (hemoglobin,hematocrit \< 28%)
* A history of psychiatric disorders
* A history of jejunoileal bypass or gastric bypass surgery
* Currently take steroids therapy
* Diagnosed with malignant within 5 years
* Severe renal function damage (creatinine clearance rate\<30 ml/min)
Simultaneous Integrated Boost Radiotherapy and Concurrent Chemotherapy for Locally Advanced Esophageal Carcinoma

This phase Ⅰ/Ⅱ trial is designed to explore a higher radiation dose by using IMRT simultaneous integrated boost technique with or without concurrent chemotherapy for locally advanced esophageal carcinoma.

Despite the application of IMRT and the studies of concurrent chemoradiation in esophageal carcinoma, which improves 5-year survival rate from 10% to 20%-40% and decrease recurrence rate from 80% to 50%-60%, local recurrence remains to be the most common failure pattern. Therefore, enhancing local control is the key to obtain a better survival.

A phase Ⅱ study of radical radiotherapy with IMRT simultaneous integrated boost technique and concurrent chemotherapy for esophageal carcinoma use the same radiation dose as the high dose arm in RTOG 94-05, which reveals an significantly improved median survival time of 23 months and 3-year overall survival rate of 44.4%. This study implies the simultaneous integrated boost technique may be effective to some extent. But the question is how to identify patients who may gain potential benefits, and whether this therapeutic model can be copied in the specific situation in China? Few adverse effects such as perforation, hemorrhage and stenosis was reported, mainly owing to the lack of cases. For widely application of this new technique in the clinic, more studies need to be conducted in the future to obtain sufficient evidence.

The current IMRT can simultaneously achieve prophylactic dose (DT 50Gy) and radical dose (DT 60-64Gy) in respective target volume by using inverse intensity-modulated planning system. However, it is still controversial on whether esophageal carcinoma can receive prescription dose more than 2.0Gy each time. That is to say, it is challengeable to find an optimal fraction dose and total dose between tumor and adverse effects. For this reason, the dose escalation trial is to be conducted to explore the clinical value and optimal dose to esophageal carcinoma with different radiosensitivity, and also provide data support for phase Ⅲ clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of clinical stage T2-4N0-1M1a untreated squamous esophageal carcinoma
* KPS≥70
* Adequate organ function
* No known history of drug allergy

Exclusion Criteria:

* Known drug allergy
* Insufficient hepatorenal function
* Severe cardiovascular diseases, diabetes with uncontrolled blood sugar, mental disorders, uncontrolled severe infection, active ulceration which need intervention.
A Study of Evacetrapib and Digoxin in Healthy Participants

The main purpose of this study is to determine how much digoxin gets into the blood stream and how long it takes the body to get rid of it when given with the study drug evacetrapib. This study will also look at the effect of evacetrapib on the removal of digoxin from the body by the kidneys. Information about any side effects that may occur will be collected. This study will last approximately 33 days for each participant, not including screening.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males and females (of non-childbearing potential)
* Have a body mass index of 18 to 32 kilograms per square meter (kg/m\^2)
* Normal renal function

Exclusion Criteria:

* Participants who currently smoke or use tobacco or nicotine products
Treatment of Women With Hyperandrogenic PCOS With Two Different Ratios of Myo-inositol:D-chiro-inositol: A Comparison

In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.

Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.

In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.


Eligibility Criteria:
Inclusion Criteria:

* PCOS according to the Rotterdam Criteria
* Clinical or biochemical hyperandrogenism

Exclusion Criteria:

* other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)
* other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)
* use of medications that influence ovulation
* hormonal treatments
* chronic pharmacological therapies
* use of inositol-containing supplements
* regular consumption of inositol-enriched food
Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis

Knee osteoarthritis (OA) is characterized by loss of cartilage leading to instability, reduced range of motion, and functional limitations. Current treatment has various limitations so that alternative options to restore function and alleviate joint pain, with the ultimate goal of healing damaged articular cartilage are needed. Mesenchymal stem cells (MSCs) therapy has shown promising results. However, MSCs are limited by complex regulatory issues. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue through mild mechanical force. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems.


Eligibility Criteria:
Inclusion Criteria:

* Age of eighteen or older
* Diagnosis of symptomatic knee osteoarthritis
* Radiographic evidence of knee osteoarthritis
* Failure of conservative treatment

Exclusion Criteria:

* Treatment with any intra-articular knee injection within 8 weeks before surgery
* Any disease or condition potential to interfere study outcome
* Under 18 years of age
Study to Examine the Effect of Antacid and Omeprazole on the Single-Dose Pharmacokinetics of Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) in Healthy Adult Subjects

To assess the effect of a single dose of aluminum hydroxide/magnesium hydroxide/simethicone and omeprazole on the pharmacokinetics (PK) of TBPM, following a single dose of TBPM-PI-HBr in healthy adult subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy, adult, male or female, 18-55 years of age, inclusive, at the screening visit.
* Continuous non-smoker
* Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.

Key Exclusion Criteria:

* Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected to have during the conduct of the study.
* History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
* History of any illness that, in the opinion of the PI or designee, might confound the results of the study or poses an additional risk to the subject by their participation in the study.
* History of significant allergic disease requiring treatment
* History or presence of alcoholism or drug abuse within the past 2 years prior to the first dose.
* History or presence of hypersensitivity or idiosyncratic reaction to the study drugs or related compounds (especially fluoroquinolone-, carbapenem-, penicillin-, and cephalosporin-antibiotics sensitivity).
* History of known genetic metabolism anomaly associated with carnitine deficiency (e.g., carnitine transporter defect, methylmalonic aciduria, propionic acidemia).
* History of cholecystectomy.
* Female subjects with a positive pregnancy test at the screening visit or first check-in or who are lactating.
* Positive urine drug or alcohol results at the screening visit or first check-in.
* Positive results at the screening visit for human immunodeficiency virus (HIV 1 and 2), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
PeriOperative ISchemic Evaluation-3 Trial: A Pilot Study

A placebo-controlled, factorial trial to assess the impact of rosuvastatin and tranexamic acid (TXA) in patients undergoing noncardiac surgery who are at risk of a perioperative cardiovascular event.

The POISE-3 pilot is a randomized controlled trial of 100 patients with, or at risk of, atherosclerotic disease who are undergoing noncardiac surgery. Utilizing a partial factorial design, the POISE-3 pilot will determine the effect of rosuvastatin versus placebo and TXA versus placebo in the perioperative setting.

Eligibility Criteria:
Inclusion Criteria:

1. undergoing noncardiac surgery
2. \>45 years of age
3. expected to require at least an overnight hospital admission after surgery; AND
4. have a preoperative NT-pro-BNP measurement \>100 ng/mL; OR
5. if a preoperative NT-pro-BNP measurement is not available, then the patient must fulfill 1 or more of the following 5 criteria:

   * history of coronary artery disease
   * history of peripheral vascular disease
   * history of stroke
   * undergoing major vascular surgery
   * have any 3 of the following 9 risk criteria:

     * undergoing major surgery
     * history of congestive heart failure
     * history of a transient ischemic attack
     * diabetic and currently taking an oral hypoglycemic agent or insulin
     * age \>70 years
     * hypertension
     * serum creatinine \> 175 umol/L (\>2.0 mg/dl)
     * history of smoking within 2 years of surgery
     * undergoing emergent/urgent surgery

Exclusion Criteria:

1. planned use of systemic Tranexamic Acid during surgery
2. hypersensitivity or known allergy to TXA
3. creatinine clearance \<30 mL/min (MDRD)
4. history of seizure disorder
5. history of venous thromboembolism
6. acute arterial thrombosis
7. no preoperative measurement of hemoglobin
8. subarachnoid hemorrhage within the past 30 days
9. hematuria caused by diseases of the renal parenchyma
10. previously enrolled in POISE-3 pilot trial
11. not consenting to participate in POISE-3 pilot trial prior to surgery

Patients meeting any of the following criteria will be excluded from the Rosuvastatin/Placebo arm:

1. preoperative treatment with a statin or a non statin lipid lowering drug or ciclosporin during the 48 hours before surgery
2. hypersensitivity or known allergy to Rosuvastatin
3. pre-disposed factors for myopathy or rhabdomyolysis
Rollover Study Protocol for Pediatric Patients in South Africa for Continued Access to Emtricitabine

The primary objectives of this trial are to provide FTC-203 study participants in South Africa with continued access to the study drug, emtricitabine (FTC), following completion of the FTC-203 study and to collect long-term safety information in participants receiving emtricitabine in combination with other antiretroviral agents.


Eligibility Criteria:
Key Inclusion Criteria:

* Complete or have previously completed at least through the Week 96 Visit (i.e., 96 weeks on study) for the FTC-203 study.
* Complete all End-of-Study Visit procedures for the FTC-203 study.
* Either (a) have a plasma HIV-1 RNA viral load of ≤ 400 copies/mL at the End-of-Study Visit for the FTC-203 study, or (b) if the subject's plasma HIV-1 RNA viral load at the End-of-Study Visit for FTC-203 study is \> 400 copies/mL, their viral load is \< 1.0 log10 above the nadir recorded after Week 8 of the FTC-203 study and there is reliable genotypic evidence showing a lack of resistance to emtricitabine.
* A parent or other legal guardian has provided written informed consent to the subject participating in the rollover protocol. As applicable, based on the subject's age and normal institution practice, the subject should additionally provide their written informed consent or assent to participate in the rollover protocol.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Olive Oil With Omega 3 to Treat Stasis Dermatitis

Olive oil and Omega 3 have many anti inflammatory effects that may be beneficial in the inflammation and edema of chronic stasis dermatitis. The olive oil contains many mono unsaturated fatty acids and anti oxidants that may add to the well being of a diseased skin by improving cell membrane homeostasis.

Patients with chronic stasis dermatitis due to venous insufficiency will be treated with the study cream and as control we will use "Venoroutone" . Patients will be followed weekly at the clinic of the vascular surgery at Assaf Harofeh MC.

Eligibility Criteria:
Inclusion Criteria:

* Patints with stasis dermatitis for 6 months at least

Exclusion Criteria:

* skin ulceration or infection
Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results

Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG), can be used to identify detectable oscillations that are correlated with the mean, the diastolic and the systolic pressure values of the pulmonary artery, as measured using the gold-standard Swan-Ganz method.


Eligibility Criteria:
Inclusion Criteria:

* Heart Failure patient scheduled for right heart catheterization (Swan-Ganz)
* Age range: 18 - 80 years
* Pulmonary artery systolic pressure values ≤50 mmHg according to Swan - Ganz measurement
* Able and willing to sign informed consent

Exclusion Criteria:

* History or current diagnosis of asthma or any other significant pulmonary disease
* Jugular access site
* Atrial fibrillation
* Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
* Requirement for any ventilator support (including CPAP or BPAP)
* Use of long-term oxygen therapy
* Known upper airway obstruction
* Known susceptibility to pneumothorax or pneumothorax in the medical history
* Chest surgery or pacemaker implantation in the prior 6 months
* Significant primary valvular disease
* Major cardiovascular event within the prior 3 months
* Current heavy smoker (more than one pack per day)
* Any diagnosed respiratory tract infection (including upper respiratory tract), airway or lung disease or COPD exacerbation in the prior 3 months
* Female patient pregnant or breast-feeding or planning to be pregnant in the next year
* Diagnosis of Obstructive Sleep Apnea
* Unexplained muscle weakness. Unable to comfortably lie down for 30 minutes
* Current hospitalization due to CHF deterioration
* Patients with a Body Mass Index (BMI) ≥ 40kg/m2
* Any condition that the PI believes could interfere with the intent of the study or would make participation not in the best interest of the patient
A Study of Carbon-14-Labeled [14C]-LY3549492 in Healthy Participants

The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it. This study will be conducted in healthy males and has two parts. In Part A, participants will receive carbon-14 (14C) radiolabeled LY3549492 (\[14C\] LY3549492) given by mouth. In Part B, participants will receive LY3549492 by mouth. Three hours later, participants will receive \[14C\] LY3549492 given into a vein.

The radioactive substance C14 will be incorporated into the study drug to investigate the study drug and breakdown products to find out how much of these passes from blood into urine, stool, and breath.

The study will last about 2 months in Part A and about 1½ months in Part B. This includes screening, treatment, and follow-up visits.


Eligibility Criteria:
Inclusion Criteria:

* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and electrocardiogram (ECG).
* Participants who have safety laboratory test results within normal reference ranges, or results with acceptable deviations that are deemed not clinically significant by the investigator.
* Body mass index (BMI) within the range of 20.0 to 40.0 kilograms per meter squared (kg/m2), inclusive.
* Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

* Have known allergies to LY3549492, glucagon-like peptide-1 (GLP-1) non-peptide agonist (NPA)-related compounds or any components of the formulation as appropriate, or history of atopy.
* Have a clinical diagnosis of a long QT syndrome.
* Have any abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, may increase the risk associated with participation in the study or may confound ECG data analysis.
* Have significant history of any current serious medical condition.
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis) or have an elevation in serum amylase or lipase (\>1.0×Upper Limit Normal (ULN)).
The Effect of Needle-free Injection System During Palatal Anesthesia

Needle-free injection systems can contribute to the prevention of needle-related pain during palatal infiltration anesthesia (PIA) in children. Research with this topic on children is required.The purpose of this clinical study was to evaluate the effectiveness of the needle-free system versus traditional anesthesia on pain perception during PIA in children.The study was designed as a randomized, controlled cross-over clinical study with 48 children aged 6 to 12 years requiring dental treatment with PIA in bilateral maxillary primary molars. It has been revealed that the application of a needle-free system during PIA ensured a decrease in pain perception in children.


Eligibility Criteria:
Inclusion Criteria:

* In need of treatment of right and left primary molar teeth of maxilla,
* Does not have any systemic disorder,
* High level of communication that can provide logical answers to the questions we ask
* With parental consent,
* Volunteers who want to participate in the research
* 6-12 years old patients who are compatible with routine dental treatments in the pediatric clinic

Exclusion Criteria:

* No need for treatment of right and left primary molar teeth of maxilla,
* Has a systemic condition
* Low level of communication that cannot provide reasonable answers to the questions we ask
* Without parental consent
* Do not want to participate voluntarily in the research
* Do not attend a check-in
* Patients not in the 6-12 age group