cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial on Acupuncture Therapy in Patients With Gastrointestinal Neoplasms Laparoscopic Surgery

Patients accepted laparoscopic radical operation for carcinoma of colon and upper middle section of the rectum will be as the research object. Cancer patients are diagnosed based on pathology or cell biology. The trial is randomized, parallel and open. They are randomized into 2 groups: both groups receive surgery. The experimental group receives conventional treatment combine with electroacupuncture Zusanli point .etc finish operation and the contrast receives the same conventional treatment with experimental group. Clinical evaluation includes gastrointestinal tract recovery of function, pain relief, life quality improvement. Blood biochemistry tests mainly include gastrin(GAS), stress related hormone, peroxidatic reaction and the ratio of immune cells.


Eligibility Criteria:
Inclusion Criteria:

* Weight: 40kg-90kg, male and female.
* Diagnosis: imaging, cell and pathology report.
* Brain, heart, lung, liver, kidney are at good condition in 2 weeks before surgery.
* No conscious obstacle and limbs disability.

Exclusion Criteria:

* Fainting during acupuncture.
* Electrolyte imbalance.
* Serious and life-threatening complications after surgery.
* In addition, patients taking part in other clinical trials, being treated with other biotherapy or immunotherapy and researchers consider not suitable for clinical subjects for other reasons will be excluded.
Effect of Sarpogrelate, a Serotonin Receptor Antagonist, on Coronary Artery Disease

This is a prospective interventional study to assess the effect of sarpogrelate compared with aspirin in Korean type 2 diabetic patients with atherosclerosis.

Type 2 diabetes has been increased exponentially, arousing serious economic, social and health repercussions. Also, macrovascular complications of diabetes such as myocardial infarct or stroke have been increased. Individuals with diabetes have a greater risk of cardiovascular disease (CVD), approximately two to four times than that of those without diabetes. Currently, the U.S. Food and Drug Administration requires demonstration that new anti-hyperglycemic agents do not increase cardiovascular risk. The comprehensive and multifactorial management in type 2 diabetes, which includes control of hypertension, dyslipidemia and obesity, is known to significantly reduce the risk of CVD as shown in Steno-2 study. However, most anti-diabetic agents currently used in clinical practice do not seem to provide enough cardiovascular protection.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes with HbA1c ≥ 6.5% at screening visit
* Male or female between 30 and 80 years of age
* Coronary artery stenosis: 10-75% without no evidence of acute coronary syndrome
* No history of previous myocardial infarction

Exclusion Criteria:

* Systolic blood pressure / diastolic blood pressure \> 160/110 mmHg
* Congestive heart failure
* Allergy to radiocontrast dye
* Allergy to aspirin or sarpogrelate
* Acute bleeding
* History of ulcer bleeding
* GOT/GPT \> 100/100
* Other antiplatelet medication
PD-1 Inhibitor Combined With Azacytidine and Homoharringtonine，Cytarabine, G-CSF for Refractory or Relapsed AML

This is an single center, single arm, phase 3 study to evaluate efficacy and safety of PD-1 Inhibitor combined with DNA methyltransferase inhibitor Azacytidine and HAG regimen for patients with relapsed and refractory acute myeloid leukemia.

Treatment for Acute Myeloid Leukemia（AML） that has not responded to treatment (refractory) or has returned after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy drug, combined with a less intense chemotherapy, may be able to help.

Eligibility Criteria:
Inclusion Criteria:

* Chinese guidelines for the diagnosis and treatment of relapsed and refractory acute myeloid leukemia (2017 edition)，excludes acute promyelocytic leukemia (M3、APL)

  * Hematopoietic stem cell transplantation ≥3 months, Discontinue immunosuppressant ≥3 weeks, Patients without graft-versus-host disease；
  * Be at least 18 years of age on day of signing informed consent.
  * Have a performance status of less than or equal to 2 on the Eastern Cooperative Oncology Group（ECOG） Performance Scale
  * Demonstrate adequate organ function as defined below, all screening labs should be performed before treatment initiation：

    1. ALT(SGPT) less than or equal to 2.5 × Upper Limit of Norma（ULN）；
    2. AST (SGOT) less than or equal to 2.5 × ULN；
    3. Serum total bilirubin Less than or equal to 2.0 × ULN Note: If total bilirubin \>2.0×ULN, subjects with Gilbert syndrome records are allowed to join the group
    4. Serum Creatinine ≥ 30 mL/min
    5. Total white blood cell (WBC) count ≤10,000/µL； Note: hydroxyurea therapy is allowed to reduce white blood cells to meet this inclusion criteria.white blood cells should be determined ≥24 hours after the last hydroxyurea administration. Final hydroxyurea administration should not ≤3 days prior to the first azacytidine administration.
  * Treatment without anthracycline or demethylation. Ability to comprehend the investigational nature of the study and provide informed consent

Exclusion Criteria:

* Patients with chronic myeloid leukemia，AML of other myeloproliferative disorders Malignant neoplasms with other progression Those who can not control severe infections and other underlying diseases can not tolerate chemotherapy Patients with cardiac insufficiency： ejection fraction (EF)\<30%，New York Heart Association（NYHA） standards，Cardiac insufficiency II or above Patients with liver and kidney dysfunction：Serum bilirubin (SB)≥2mg/dl，AST is 2.5 times higher than normal upper limit, serum creatinine (SCr) is more than 2.5 mg/dl Serious mental illness uncooperative Refusal to join the study
A Study of Baricitinib (LY3009104) in Participants With Systemic Lupus Erythematosus (SLE)

The main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.


Eligibility Criteria:
Inclusion Criteria:

* Have received a diagnosis of SLE at least 24 weeks prior to screening, meeting the American College of Rheumatology (ACR) 1982 revised criteria OR the 2012 Systemic Lupus Erythematosus International Collaborating Clinics (SLICC) criteria.
* Have a positive antinuclear antibody (ANA) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsDNA) as assessed by a central laboratory at screening.
* Have a SLEDAI-2K score ≥4 based on clinical symptoms (not including lab values) at randomization.
* Have active arthritis and/or active rash as defined by the SLEDAI-2K at randomization.

Exclusion Criteria:

* Have active severe lupus nephritis.
* Have active severe central nervous system (CNS) lupus.
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data.
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection.
* Are currently receiving oral corticosteroids at doses \>20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization.
* Have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (NSAIDs) (for which the NSAID use is intended for treatment of signs and symptoms of SLE) within 4 weeks of planned randomization.
* Have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization.
* Have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization.
* Have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
Integrated Telemonitoring and Nurse Support Evaluation

The purpose of the study is to test a new medical device for optimizing treatment of heart failure and compare its effect on outcome of patients with a recent hospitalization for worsening heart failure

Patients after an episode of acute heart failure have an increased risk of rehospitalisation and impaired prognosis for survival. Neither a sole mobile nurse support nor a sole telemonitoring system has been able to provide consistent data on a beneficial influence on prognosis. Furthermore, the influence of frequent measurements of NT-pro-BNP in a home setting of heart failure patients has not been investigated so far.

This study will test a new medical device (software) for optimizing treatment of heart failure patients and evaluate its impact on outcome of these patients.

Eligibility Criteria:
Inclusion Criteria:

* acute systolic heart failure with admission for at least 4 consecutive days
* treatment with an ACE-inhibitor/angiotensin receptor blocker, beta-blocker, mineralocorticoid receptor antagonist according to current ESC-guidelines
* treatment with a loop diuretic
* stable renal function (eGFR according to MDRD of at least 30ml)
* written informed consent
* minimum age of 18 years

Exclusion Criteria:

* unstable coronary artery disease with revascularisation of any type within the last two months
* planned revascularisation or operation for valvular heart disease within the next 6 months
* planned heart transplantation
* uncontrolled hypertension
* active myocarditis
* malignant disease with a life expectancy of less than 18 months
* chronic use of high-dose NSAID or COX-2-inhibitors
* psychiatric disorders that make it unlikely to understand the protocol
* participation in an other randomized trial
* inability to operate a smartphone
Laparoscopic Single Anastomosis Sleeve Ileal Bypass Versus Laparoscopic Sleeve Gastrectomy for Morbid Obesity

This study will compare two bariatric surgical interventions in terms of weight loss, gastroesophageal reflux, and effects on obesity-related comorbid conditions in morbidly obese patients.

Sleeve gastrectomy is an established therapeutic option for morbidly obese patients without preexisting gastroesophageal reflux disease. The novel single anastomosis sleeve ileal bypass (SASI) procedure is already introduced in Norway at a private high-volume bariatric hospital. The purpose of this study is to evaluate the effects of SASI in comparison to an established bariatric procedure, i.e. sleeve gastrectomy. The primary end point is 2-year changes in BMI after sleeve gastrectomy and SASI.

Eligibility Criteria:
Inclusion Criteria:

1. Morbid obesity at referral for bariatric surgery (i.e. a body-mass index \[BMI\] of ≥35 kg/m2 with obesity-related comorbid conditions or ≥40 kg/m2 with or without such comorbidities).
2. Age 20-60 years.
3. Previous failed attempts of weight loss.
4. Norwegian speaking patients.

Exclusion Criteria:

1. BMI ≥55 kg/m2.
2. A history of major abdominal or bariatric surgery (excluding appendectomy, cholecystectomy, and sectio).
3. Established disabling cardiopulmonary disease, ongoing treatment for cancer, long-term steroid use, and conditions believed to be associated with poor adherence after surgery.
4. Previous or current gastroesophageal reflux symptoms with daily use of antireflux medication. Patients are also excluded if preoperative manometry identifies a hiatal hernia (≥4cm in axial length) or if preoperative upper endoscopy identifies esophagitis grade C or D (LA classification), peptic stricture, Barrett's esophagus, or esophageal carcinoma.
5. Achalasia
6. Pregnancy.
FOCUS (Nifedipine GITS's Effect on Central Pressure Assessed by Applanation Tonometry)

To determine whether the combination of nifedipine GITS and valsartan is more effective in reducing central blood pressure than nifedipine GITS or valsartan alone, and to determine whether nifedipine GITS is comparable to valsartan


Eligibility Criteria:
Inclusion Criteria:

* Untreated grade 2 or grade 3 hypertension defined by mean diastolic blood pressure (BP) \>/= 100 and/or mean systolic BP \>/= 160mmHg without anti-hypertensive treatment or Treated grade 2 hypertension defined by mean diastolic BP \>/= 100 and/or mean systolic BP \>/=160mmHg with current diuretics and/or beta-blockers use for \>/= 4 weeks

Exclusion Criteria:

* Secondary form of hypertension
* Mean systolic BP \>/= 200mmHg and or mean diastolic BP \>/= 120mmHg
* Treated with other antihypertensive medication except diuretics or beta-blockers
* Type 1 diabetes mellitus
* Known cardiovascular disease including history of angina pectoris, heart failure, history of myocardial infarction or revascularization procedure, or cerebrovascular disease (including stroke and transient ischaemic attack) within the previous 12 months
* Renal insufficiency defined as a serum creatinine: \>/= 1.7 mg/dl
* Pregnancy or not using contraceptive in childbearing aged women
* Breast feeding women
* Any disease or condition that in the opinion of the investigator may interfere with completion of the study
OxCKD1 -Empowering Healthy Lifestyle Choices in Chronic Kidney Disease

Patients with kidney disease benefit from reducing the amount of salt in the food that they eat. The benefits include lower blood pressure and better kidney function. Therefore, lowering the amount of salt that is eaten could reduce the number of people who will develop kidney failure. The effect on blood pressure could also reduce the number of strokes and heart attacks. Similar benefits are also seen for people without kidney disease.

Guidelines for patients with kidney disease recommend that they lower the amount of salt that they eat, but most patients do not manage to do this. The reasons for this are not unclear, but are likely to reflect the difficulty that patients have in reducing the amount of salt in their food and the nature of the advice that they are given.

The investigators have developed a package of interventions to help patients to make healthier choices that will lower their salt intake. The package helps patients to learn about salt in food and how to avoid it. It provide practical advice on cutting down on salt using information booklets, text messages, emails, telephone calls, and a website.

Participants will be recruited from hospital kidney clinics and general practice. The investigators will randomly allocate participants to receive either the normal care that they would get or to receive the new package of interventions to help them lower salt. The package of interventions will involve patients receiving text messages, telephone calls, emails and written information. They will complete a questionnaire and collect urine samples which will can be used to measure the amount of salt that they are eating. No more than 6 visits will be required. The study is funded by the British Renal Society which is a charity that funds research to help patients with kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Diagnosed with CKD and an eGFR ≥ 20 ml/min/1.73m2
* Participant has clinically acceptable laboratory data available to confirm the diagnosis.
* Able (in the opinion of the Investigators) and willing to comply with all study requirements.
* Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study

Exclusion Criteria:

* Female participants who is pregnant, lactating or planning pregnancy during the course of the study.
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Inability to understand English or special communication needs because the interventions will use English and is not funded to deal with special communication needs.
* Known salt losing nephropathy
Early Parenting Intervention Comparison

The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.


Eligibility Criteria:
Inclusion Criteria:

* child 2 to 5 years old
* parent reports reason for referral is child behavior problems
* parent is a biological or adoptive parent, or legal guardian of child

Exclusion Criteria:

* parent is psychotic or actively abusing substances
* child is autistic or severely developmentally delayed
Human IgGs and Endothelial Function in Vivo in Humans

Endothelial dysfunction and insulin resistance play a key role in the onset and development of atherosclerosis, cardiovascular diseases, and diabetes. Data in mice models have recently demonstrated that circulating immunoglobulins G (IgG) could be involved in the process. Patients with common variable immunodeficiency (CVID), who are characterized by low circulating levels of IgG, might represent an ideal model to clarify the role played in vivo in humans by circulating IgG. Polyclonal IgG, obtained from multiple donors, given intravenously (IVIgG), are used to treat various immunodeficiencies and autoimmune diseases, including CVID. By using this disease and its treatment by IVIgG as a model, aim of the current study is to clarify whether IgG affect endothelial function and insulin sensitivity in humans in vivo and whether the action of IgG on the endothelium involves a direct interaction with the endothelial cells.

For this purposes, 24 patients with CVID, receiving the last therapeutic dose of IVIgG infusion 5-weeks before the baseline measurements (CVID-IVIgG group), are studied. In all subjects, endothelial function is evaluated as flow mediated dilation (FMD) of the brachial artery, measured by ultrasonographic technique at baseline and 1, 7, 14, and 21 days after IVIgG infusion. FMD is also measured in a group of IVIgG naive CVID patients (number of patients recruited depending on availability) and a group of control healthy subjects. The latter FMD measurements serve only as a mere reference of pathological or normal values in condition of deficiency or normal levels of circulating IgG and are not used for primary outcome evaluation. To dissect further the mechanisms of improved endothelial function after IVIgG infusion, we investigate the role of human IgG on the production of Nitric Oxide (NO) in vitro on Human Coronary Artery Endothelial Cells (HCAEC) isolated from normal human coronary arteries.

Eligibility Criteria:
Inclusion Criteria:

* Common Variable Immunodeficiency

Exclusion Criteria:

* Cancer, liver Cirrhosis, recent acute myocardial infarction, treatment with nitroderivates, Reynaud syndrome, heart failure
Alcohol and Neural Cardiovascular Control in Binge Drinkers

This study evaluates the impact of evening alcohol consumption on sympathetic activity and baroreflex function in binge drinkers. Our central hypothesis is that evening binge alcohol consumption will lead to sympathetic overactivity and blunted baroreflex function.

This study will recruit male and female binge drinkers who will participate in a randomized, cross-over, double-blind, placebo-based study to examine the impact of an evening of alcohol vs. placebo/fluid-control on autonomic and cardiovascular control at night and the subsequent morning. The study will utilize established techniques for assessing sleep (polysomnography) and autonomic/cardiovascular control (microneurography, beat-to-beat finger plethysmography, electrocardiogram, etc.). All subjects will undergo a familiarization night in the sleep laboratory prior to their first randomized test session with either alcohol or placebo/fluid-control. Both men and women will be tested to address a secondary aim of determining the impact of sex (male vs. female) and ovarian cycle (early follicular vs. midluteal phase) on sympathetic neural responsiveness to evening alcohol in binge drinkers. Finally, as a tertiary/exploratory aim, participants that have a respiratory disturbance index of ≥5 episodes per hour during the alcohol treatment will be asked to consider one additional overnight session where they will be randomly assigned to either continuous positive airway pressure (CPAP) or sham-CPAP for one additional night of evening alcohol consumption.

Eligibility Criteria:
Inclusion Criteria:

* Men and women age 21 - 40 years
* Binge drinkers as defined by a pattern of consuming ≥4 drinks if female (≥5 drinks if males) in ≤ 2 hours on more than one occasion within the past 6 months, and at least once in the past 30 days. The National Institute of Alcohol Abuse and Alcoholism (NIAAA) definition of a "drink" will be used.
* Women must be eumenorrheic and premenopausal with regular and consistent menstrual cycles (i.e., \~25-30 days ovarian/uterine cycles that include 2-7 days of menstruation)
* Willingness to abstain from exercise and caffeine at least 12 hours prior to any autonomic and cardiovascular testing, and abstain from alcohol 24 hours prior to any autonomic and cardiovascular testing (unless experimentally administered).

Exclusion Criteria:

* Body mass index ≥ 35 kg/m2
* Smokers
* A physician diagnosis of diabetes
* Pregnancy
* Taking any cardiovascular medications
* Severe obstructive sleep apnea as determined by an apnea-hypopnea index of ≥ 30 episodes per hour
* Moderate-to-severe Alcohol Use Disorder (AUD) as determined by the Diagnostic and Statistical Manual of Mental Disorders (DSM-V)
* Individuals suspected to have mutant alcohol dehydrogenase 2 (ALDH2) isoenzyme as determined using a validated flushing questionnaire
* Women using hormonal contraceptives (i.e., oral, intrauterine, etc.) in the prior 6 months