cyrilzakka/clinical-trials huggingface dataset:
Preoperative Radiochemotherapy With Hyperthermia for Locally Advanced Rectal Cancer

The current trial is evaluating the impact of deep regional hyperthermia on the pathological complete response rate in locally advanced rectal cancer in the context of preoperative 5FU based radiochemotherapy.


Eligibility Criteria:
Inclusion criteria:

* Histologically confirmed Adenocarcinoma of the rectum (up to 10 cm from the anal verge)
* International Union Against Cancer stages II or III
* ECOG PS 0/2
* Informed consent

Exclusion Criteria:

* Congestive heart failure (NYHA III/IV)
* History of myocardial infarction within the last 6 months.
* AV Block III
* Total hip replacement or major metal pelvic implants
* Cardiac pacemaker
* Contraindications for radiochemotherapy
* Contraindications for surgical tumor resection
* Previous pelvic radiotherapy or chemotherapy
* Active chronic inflammatory bowel disease
* Collagenosis
* Congenital diseases with increased radiosensitivity
* Pregnancy or breastfeeding
* Secondary malignancies other than locally controlled basalioma or in-situ carcinomas Infiltration of the anal canal
Observational Study of Anti-Reflux Surgery

The Anti-Reflux Surgical Study has been established to:

* Collect data about anti-reflux surgical treatment options (magnetic sphincter augmentation and Fundoplication) in everyday clinical practice
* Track the clinical course of patients from pre-operative assessment to three years post-surgery

This study will track and monitor patients treated with either the magnetic sphincter augmentation or Fundoplication, making it the first Registry to collect data on both anti-reflux surgical options in the setting of everyday clinical experience.

Eligibility Criteria:
Inclusion Criteria:

* Individuals treated with LINX Reflux Management System or Fundoplication
* Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the Anti-Reflux Surgical Registry.
* Individuals willing to complete questionnaires and comply with the three years of follow-up.

Exclusion Criteria:

* Known circumstances that would make it unlikely for an individual to complete the three year follow-up (e.g. life expectancy \<3 years)
Microvascular Effects of Intravenous Esmolol During Postoperative Atrial Fibrillation

Background: Postoperative atrial fibrillation (POAF) is commonplace after cardiothoracic surgery. A rate control strategy by using short-acting beta blockers is recommended as a first-line therapy in patients without hemodynamic instability. Microcirculatory effects of POAF and esmolol have not been yet investigated. The investigators made the hypothesis that POAF without hemodynamic instability would induce microvascular dysfunction which could be reversed by intravenous esmolol.


Eligibility Criteria:
Inclusion Criteria:

* conventional cardiac surgery
* thoracic surgery

Exclusion Criteria:

* Postoperative atrial fibrillation leading to hemodynamic instability
The Point of View of Adolescents Who Have Undergone a Suicidal Act: What Do They Expect from Their Relationship with Their Doctor?

Evaluate the expectations of adolescents who have performed a suicidal act with regard to their relationship with their doctor


Eligibility Criteria:
Inclusion Criteria:

* Adolescents who have undergone a suicidal act and who were initially treated by the paediatric emergency department of the University Hospital of Nîmes.
* Teenagers with an attending physician.
* Adolescents who do not object to participating in the study
* Parents (holder of parental authority) who do not object to their child participating in the study
* Preliminary agreement to participate in the research project of the child psychiatrist treating the child.

Exclusion Criteria:

* - Patient who has objected to the use of his data.
* Refusal by the child psychiatrist to participate in the study.
Developing mHealth to Promote PrEP Use Among Thai Young Men Who Have Sex With Men

The goal of this study is to develop and pilot test technology-based interventions to promote Pre-exposure Prophylaxis (PrEP) uptake and adherence among Thai young men who have sex with men (YMSM).

Motivational Enhancement System for Adherence (MESA) is a computer-based motivation invention, based on the Information-Motivation-Behavioral Skills (IMB) model and Motivational Interviewing (MI) principles, used to promote adherence among HIV-positive youth initiating antiretroviral treatment. In this study, the team will adapt and develop MESA to focus on PrEP uptake and adherence, which will be called Motivational Enhancement System for PrEP Uptake and Adherence (MES-PrEP). Motivational Interactive Text Messaging (MTM) will be integrated with MES-PrEP to provide ongoing support to maintain the individual's motivation for behavior change. Both interventions will be developed and refined based upon the inputs from YMSM through focus group discussion and youth advisory board.

The Investigators propose to pilot randomized controlled trial (RCT) to evaluate the feasibility, acceptability, and preliminary efficacy of an intervention combining MES-PrEP and MTM to increase PrEP uptake and adherence among Thai YMSM. Eligible YMSM will be randomized to receive either the intervention plus the standard PrEP counseling or standard PrEP counseling, and followed for 6 months with assessments at baseline, month 1, 3 and 6.

Eligibility Criteria:
Inclusion Criteria:

* Age 16-25 years old
* Men who report sex with men in the past 12 months
* Confirmed HIV-negative status
* Self-reported evidence of being at-risk for HIV acquisition, including one of the following in the past 6 months:

  1. having a sex with an HIV-positive partner
  2. having anal sex
  3. without using a condom
  4. being diagnosed with an STI or
  5. having any illicit drug use (e.g., Amphetamine type stimulants)
* Able to understand, read and speak Thai
* Either having not started PrEP (Group 1: PrEP naive) or currently on PrEP but not adherent to PrEP (taking ≤3 pills/week) in the past month (Group 2: PrEP users).

Exclusion Criteria:

* In a mutually monogamous relationship of more than 6 months with a partner who recently tested HIV-negative
* Have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent
* currently enrolled in another HIV intervention study
The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study

The PLasma for Alzheimer SymptoM Amelioration (PLASMA) Study: Intravenously-Administered Plasma From Young Donors for Treatment of Mild-To-Moderate Alzheimer's Disease


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer's disease (NIA-AA criteria)
* Mini-Mental State Examination (MMSE) score 12-24
* Availability of a study partner who knows the patient well and is willing to accompany the subject to all trial visits, to participate in questionnaires and to complete daily journal assessments

Exclusion Criteria:

* Pregnancy or unwilling to use adequate birth control method for duration of and 6 months beyond study participation
* Positive for Hepatitis B, Hepatitis C or HIV at screening
* Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study
* Related to medical history:

  * Stroke
  * Anaphylaxis
  * Prior adverse reaction to any human blood product
  * Any history of a blood coagulation disorder or hypercoagulability
  * Congestive heart failure
  * Uncontrolled hypertension
  * Renal failure
  * Prior intolerance to intravenous fluids
  * Recent history of uncontrolled atrial fibrillation
  * IgA deficiency (by history)
* Related to medications or other treatments:

  * Any concurrent use of an anticoagulant therapy. Antiplatelet drugs (e.g., aspirin or clopidogrel) are acceptable
  * Initiation or change in the dosage of a cholinesterase inhibitor or memantine during the trial. A participant already on a cholinesterase inhibitor or memantine must be on a stable dose for at least one month prior to Screening
  * Concurrent participation in another treatment trial for Alzheimer's disease. If there was prior participation, the last dose of the investigational agent must have been at least 6 months prior to Screening
  * Treatment with any human blood product, including intravenous immunoglobulin, during the 6 months prior to Screening or during the trial
  * Concurrent daily treatment with benzodiazepines, typical or atypical antipsychotics, long-acting opioids, or other medications that, in the investigator's opinion, interfere with cognition. Intermittent treatment with short-acting benzodiazepines or atypical antipsychotics may be permitted, provided that no dose is administered within the 72 hours preceding any cognitive assessment
* Related to magnetic resonance imaging:

  * Claustrophobia
  * Any metallic surgical implant, like a pacemaker or clip that is incompatible with 3T MRI.

Certain metallic implants like joint replacements may be permitted, provided that specific manufacturer specifications are available and that the device is known to be safe for 3T MRI.
Usefulness of Alpha-GST in Liver Transplantation

The primary objective of this study was to evaluate the ability of plasma alpha-GST measurements in liver donor (at the time of organ removal) to predict primary dysfunction in liver recipient. The secondary objective was to study the relationship between alpha-GST levels in the plasma of the liver transplant recipient and early graft function recovery.

Graft primary dysfunction (PDF) after liver transplantation is enhanced by the increasing use of extended-criteria allografts. This complication is burdened with high mortality and morbidity rates among liver transplant recipients. Alpha-GST is a short-life hepatocyte enzyme that may be an interesting biomarker for liver injury. A recently developped ELISA technique may allow fast and easy measurement of alpha-GST plasma concentration (Fastpack IP α-GST Immunoassay, Qualigen Inc., Carlsbad, CA). This study aims to evaluate the ability of plasma alpha-GST measurements in liver donor to predict PDF in liver recipient. Methods: Observational study conducted in one center (Beaujon hospital, APHP, Clichy, France). Measurements of plasma levels of alpha-GST using Fastpack IP α-GST Immunoassay (Qualigen Inc., Carlsbad, CA) at the time of organ removal in liver donor and daily from day 0 to day 7 after liver transplantation in recipients.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* undergoing liver transplantation at Beaujon hospital (APHP, Clichy, France )

Exclusion Criteria:

* age \>70 years and \<18 years
Clinical Non-Inferiority of Pancreatic Enzymes (Norzyme ® - Bergamo) Compared To Creon ® (Solvay Pharmaceutical) in Patients With Exocrine Pancreatic Insufficiency

The primary objective of this clinical trial is to demonstrate non-inferiority clinical development of pancreatic enzymes from Laboratory Bergamo (Norzyme ®) in relation to pancreatic enzymes from Solvay Pharmaceuticals (Creon ®), by comparing the average amount of lipids in the feces of 72 hours after 14 days of treatment with each drug.

As a secondary objective will be assessed the following parameters:

* Incidence of abdominal pain;
* Frequency of flatus;
* Frequency of bowel movements during the treatment;
* Consistency of stools during treatment;
* Amount of medication used among the treatments. All these parameters will be measured based on reports of patients in a specific diary.

Eligibility Criteria:
Inclusion Criteria:

* Patients must agree with the purposes of the study and sign the Informed Consent in two ways;
* Be aged over 18 years;
* Display chronic exocrine pancreatic insufficiency due to chronic pancreatic, post surgical or other situation that leads to severe glandular disease;
* Doing controlled clinical treatment of enzyme replacement with Creon ® 25,000 (or similar with the same concentration of lipase) during meals;
* Agree to record daily food intake in phase 2 and repeat the diet in phase 3;
* Present ability to meet the patient's diary;
* Be clinically compensated with replacement therapy;
* Must be admitted patients in both the sexes;
* Must be accepted patients of any ethnicity.

Exclusion Criteria:

* Cystic fibrosis;
* Acute pancreatitis;
* Participation in any experimental study or ingestion of any experimental drug in the 12 months preceding the study;
* Diabetes decompensated;
* Regular use of medications that interfere with the action of the drug test: the 4 weeks preceding the study or any medication that interferes with the drug test a week before the start of the study;
* Any type of treatment for morbid obesity;
* Abusive use of alcohol in the three months preceding the study;
* Pregnancy and lactation.
Cold Induced Activation of Brown Adipose Tissue in Winter Swimmers

This study investigates cold-induced brown fat activation in winter swimmers and not-winter swimmers by skin temperature measures assessed with infra red thermography imaging and skin temperatures. Winter swimmers and not-winter swimmers will participate in an acute cooling intervention and thermoneutral intervention for comparison of energy expenditure and skin temperatures at the supraclavicular area.

The field of human brown adipose tissue (BAT) research is focused on activation of BAT as a means of manipulating energy expenditure and potentially anti-obesity and anti-diabetic properties of the tissue. This is well established in rodent studies and explained as due to the specific brown fat uncoupling protein 1 (UCP1). Despite increasing evidence that indicates a metabolic regulatory role of BAT in humans, BAT activation/recruitment is not fully understood.

Cold induced brown fat activity will be measured by skin temperature measures by means of infra-red thermography imaging and skin temperature.

15 healthy male winter swimmers and 8 healthy male non-winter swimmers (controls) will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

Age 18-35 years. Men Caucasian white Body Mass Index 19-25 kg/m2. Moderate physical activity level (not more than 8-10 hours of training pr. Week) Ability to give informed consent. Ability to follow verbal and written instructions in Danish. Body fat percent under 21% measured at the pre-examination day. Winter swimmers: Min. 2 swim/ week. Swimming in winter-season in open water outdoor in Denmark from September/October until study start in March.

Not-winter swimmers: Not winter-swimmers or taken cold showers on a regular basis.

Exclusion Criteria:

* Chronic diseases: Hormonal: Metabolic Diseases mb. Graves, hypothyroidism, myxedema and goiter. Diabetes Melitus, Coronary heart disease (history of myocardial infarction, unstable angina pectoris, or congestive heart failure), cancer treated within last 3 years.

Tobacco, marijuana or intravenous drug use within 1 year of screening. Dieting, recent weight loss (\>3 kg within 3 month) or a history of an eating disorder.

Dietary supplements. History of depression, psychosis, or other psychiatric illness requiring hospitalization.

Alcohol consumption \>14 units/week. History of alcohol abuse within the past 3 years. Known liver disease or elevated liver biomarkers more than 2 times upper normal levels in the preliminary investigation.

Known kidney disease or elevated kidney biomarkers, in the preliminary investigation.

Use of daily medications, except for seasonal use of antihistamines. Diagnosed sleep disturbances.
Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution

The purpose of this study is to compare subjective drug liking using the Drug Rating Questionnaire, subject version (DRQ-S), question 2 and pharmacokinetics of Vyvanse™ and ADDERALL XR® when administered as an oral solution.

Hypothesis: DRQ-S, question 2 will show no difference between the two drugs

Not required

Eligibility Criteria:
Inclusion Criteria

* Healthy young adults, male or female (non-pregnant and non-lactating), age 18-25 years at time of consent
* Have a body mass index (BMI) between 20.0 and 29.0kg/m2
* Satisfactory medical assessment with no clinically significant or relevant
* Subject must demonstrate a positive response to amphetamine at Screening

Exclusion Criteria

* A history of current or recurrent disease that could have an effect on the study
* Subject has a history of seizures, any tic disorder, or a current diagnosis and/or a known family history of Tourette's Disorder
* Subject has a concurrent chronic or acute illness or other condition that might confound the results of safety assessments or that might increase risk to the subject
* Subject has any clinically significant ECG and/or laboratory abnormalities
* Subject has a documented allergy, hypersensitivity or intolerance to amphetamines
* Subject has been prescribed or has taken amphetamine products in the past, including childhood; recreational use may not be exclusionary per the Investigator's discretion
* Subject has a known family history of sudden cardiac death or ventricular arrhythmia
* Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine)
* Subject has participated in any investigational clinical or vaccine trial within 30 days prior to the first dose of study drug
* Subjects is currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation
Evaluation of the Efficacy and Safety of Administering Lidocaine Spray in Oesophago-gastro-duodenoscopy

This study evaluates the efficacy and safety of the administration of lidocaine spray in oesophago-gastro-duodenoscopies. Half of the patients will receive lidocaine spray, while the other half will receive a placebo.


Eligibility Criteria:
Inclusion criteria:

* Patients aged over 18
* ASA I, II and III
* Non allergic to lidocaine or any of the drugs used in the study
* Consent form signed by the patient

Exclusion Criteria:

* Stomach or esophagus diagnosed cancer
* Giant hiatal hernia diagnosed
* Zenker's diverticulum diagnosed
* Achalasia diagnosed
* Patients aged over 70
* Medical history of moderate to severe liver disease
* Medical history of moderate to severe renal insufficiency
* Medical history of moderate to severe Obstructive Sleep Apnea Syndrome (OSA) (AHI≥15).
* Severe respiratory insufficiency(asmtha or COPD) diagnosed
* Patients with encephalopaty active
* Patients with medical history of methemoglobinemia
* Patients with history of drug abuse
* Patients with mental impairment
* Patients with BMI≥ 35
* Use of pediatric tube
AcoArt Ⅰ / SFA China

The purpose of this study is to determine whether DEB is more effective than common PTA balloon in long-term vessel patency and inhibiting restenosis.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years
* Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
* an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
* Total length of treat lesion(s)is less or equal to 40cm
* signed Patient informed consent form

Exclusion Criteria:

* plasma Cr level greater than 150 umol/L in patients
* patients with acute thrombosis requiring lysis or thrombectomy
* patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
* patient requiring intervention in both lower limbs at the same time
* target lesion can't be cross by the guide wire
* distal outflow through less than one lower leg vessel
* known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
* patients participating in another clinical trials with interfere with this trial in the past 3 months
* pregnancy and lactating woman
* untreatable bleeding diatheses
* other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 2 years)
* patients unable or unwilling to participate this trial
The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation

The investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft function and postoperative renal function in subjects undergoing living-donor liver transplantation.

Ischemic reperfusion injury of liver graft and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing liver transplantation. The incidence of postoperative renal dysfunction was reported as high as 12 \~ 64% and is thought to be caused by ischemia/reperfusion injury. Ischemic pre- or postconditioning was reported to be effective for preventing ischemia/reperfusion injury during liver transplantation. Remote ischemic pre- or postconditioning was also reported to be protective for ischemia/reperfusion injury in major organs in previous animal studies. Therefore, we are trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft function and postoperative renal function in subjects undergoing living-donor liver transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing living donor liver transplantation during the study period
* Subjects older than 20 yrs who can give written informed consent

Exclusion Criteria:

* Re-transplanted recipients
* Those with peripheral vascular diseases affecting the extremities
* Those with hepatic encephalopathy
* Those with cirrhotic cardiomyopathy