cyrilzakka/clinical-trials huggingface dataset:
Surgical Treatment for Morbid Obesity by Sleeve Gastrectomy Versus Gastric Bypass

The aim of this study is to assess that the sleeve gastrectomy can improve the risk benefit than the gastric bypass

In the obese patient population, the frequency of patients presenting a severe morbid obesity (40 \>= BMI \<= 50), a super obesity (BMI \>50), a super super obesity (BMI\>60), and obese patients (BMI\>35) with a failure of gastric banding is constantly increasing. In these patients, the surgery risk is proportionate to the weight and / or gastric surgery records.

This risk is high, in bariatric surgery, for gastric bypass procedure. This justifies the evaluation of new procedure to reduce the morbidity allowing the reduction of morbid /mortality associated with the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged from 18 to 60 years old
* Patient having given his consent to the use of data from the project
* Patient fulfilling the inclusion criteria for surgery of obesity according to the ANAES (french national health service)
* Patient presenting one of the following criteria:

  * A morbid obesity strict with BMI\> 40
  * A super obesity BMI\> 50
  * A super super obesity BMI\> 60
  * Obese patient in failure following the installation of a gastric banding with BMI\> 35
  * obese patient 35\>BMI\>40 with a comorbidity
* Preliminary agreement during the consultation of a psychiatrist / psychologist

Exclusion Criteria:

* Patient with complications or co morbidities associated involving life to less 6 months
* Patient presenting no anaesthetic indication
* Patient presenting no psychiatric indication for obesity surgery
* Patient not affiliated with a social security scheme
* Pregnant Patient likely to breastfeed in the first year
Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Oral Doses of BI 1021958 Tablets in Healthy Male Volunteers

Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Lidocaine and Closed-Loop Anesthesia System

The objective is to evaluate the sparing effect of Lidocaine on doses of propofol and remifentanil.


Eligibility Criteria:
Inclusion Criteria:

* patients ASA 1, 2 or 3 scheduled for a general anesthesia surgical procedure (abdominal surgery, urology, ENT major procedure) lasting between 1 and 3 hours

Exclusion Criteria:

* age under 18 years
* simultaneous general and loco-regional anesthesia
* allergy to NSAID
* treatment with verapamil, ketamine or gabapentin
* patients receiving an opioid preoperatively
* severe hepatic insufficiency
* contra-indication to lidocaine
* contra-indication to propofol or to remifentanil
* history of central nervous system disease
* patients receiving a psychotropic treatment
* patients with a pace-maker
Split Face Study of the Duration of Local Anesthetics - Fourth Arm

This is a research study to compare how long injectable pain medications (anesthetics) commonly used in dermatologic surgery are effective for. The investigators will investigate the role of anesthetic volume on the duration of action at highly vascular sites.

The investigators seek to further investigate how the vascularity of an anatomical region influences the duration of local anesthetics during dermatologic surgery. The investigators hypothesize that regional vascularity, by increasing the rate of uptake and removal of the anesthetic from the infiltrated site, will significantly reduce the duration of action of increased doses of infiltrative anesthesia. Specifically, the investigators will compare the duration of a commonly used local anesthetic (lidocaine ± epinephrine) injected at two different volumes at the nasal ala. The investigators will use a modification of a previously published approach of non-invasive pinprick testing to assess the duration of local anesthesia. The investigators aim to demonstrate that there will be no clinically significant difference in the duration of action of varying volumes of the same local anesthetic injected at bilateral areas of the face.

This study record uses the same protocol document of a previous study under Clinical Trials record NCT05767749, but documents a fourth arm for which data will be analyzed separately from data in NCT05767749

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Normal skin sensation at both nasal ala assessed by pinprick
* Ability to provide informed consent

Exclusion Criteria:

* Previous adverse reaction to local anesthetic or any components of the local anesthetics being evaluated
* Pregnant or breastfeeding volunteers (assessed by self-report)
* Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
The Benefits of Naps on Cognitive, Emotional, and Motor Learning in Preschoolers

The specific objective of the proposed research is to examine whether naps contribute to immediate and delayed benefits on multiple forms of learning in young children (3-5 yrs). By probing recall prior to and following mid-day nap or wake intervals, the overarching hypothesis is that recent memories are actively processed (as opposed to passively protected) by a nap, conferring immediate or delayed (24-hrs) benefits on declarative (Aim 1), procedural (Aim 2), and emotional (Aim 3) memories. In two conditions, children will either be nap-promoted or wake-promoted midday. Subsequently, performance will be reassessed that day as well as the following day.

The proposed research examines whether naps contribute to immediate and delayed benefits on multiple forms of learning in preschool-aged children (3-5 yrs). By probing recall prior to and following mid-day nap or wake intervals, we will examine immediate memory performance and how it is changed by an interval with a nap compared to if that interval was spent awake. There are three arm, separately assessing declarative (using a storybook learning task), procedural (using a mirror tracing task), and emotional (using an emotional storybook task). All children will participate in a nap and wake condition. On the experimental day, children will learn the task, then be nap or wake promoted (within subject, conditions counterbalanced and separated by 1 week). Subsequently, performance will be reassessed that day as well as the following day. Children will wear an actigraph watch for a 16-day interval surrounding the experimental days in order to access habitual sleep patterns (e.g., nap frequency). A subset of children will complete the experimental days in the sleep laboratory. For these children, sleep will be measured using polysomnography, a montage of electroencepholography, electromyography, and electrooculography electrodes.

Eligibility Criteria:
Inclusion Criteria:

* be enrolled in a preschool testing site or available to come into the lab

Exclusion Criteria:

* Diagnosis of any sleep disorder(other than mild parasomnia) past or present
* Current use of psychotropic or sleep-altering medications
* traveling beyond 1 time zone within 1 month of testing
* fever or symptoms of respiratory illness at the time of testing
* physical handicap which interferes with assessments (vision, hearing impairment)
* diagnosed developmental disability
Transcranial Ultrasound in Clinical SONothrombolysis

This is a randomized, placebo controlled, parallel group dose escalation trial to evaluate the safety, tolerability, and activity of four sequential dose tiers of MRX-801 and ultrasound as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.


Eligibility Criteria:
Inclusion Criteria:

* Acute ischemic stroke
* Occlusion demonstrated by transcranial Doppler ultrasound
* Eligible for tPA

Exclusion Criteria:

* Right to left cardiac shunt
* Moderate to severe COPD
* Uncontrolled hypertension
Bioefficacy of Phenolic Acids

The objective is to demonstrate the effect of phenolic acids on endothelial function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, Men and women
* Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening

Exclusion Criteria:

* Any food allergy
* Abnormal blood pressure defined as follow: systolic \<100 or \>160 mmHg and diastolic \<50 or \>100mmHg
* Pregnancy or lactating women
* Regular consumption of cholesterol-lowering or antihypertensive medication
* Smokers
* Inability to restrain from caffeine/tea and alcohol for 12hrs prior to study visits (intake1 day before screening measurements (and 1 day before each visit)
* Not restrain the intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.
* Excessive alcohol intake defined as \> 280 g per week for men and \>210g per week for women
Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults

Colonoscopy is the gold standard in bowel assessment when there is suspicion of colon and rectum pathology. Bowel cleansing is necessary to ensure an optimal visualization of colonic mucosa, allowing this form of detection and removal of polyps. Nowadays international recommendations have multiple bowel preparations. There are differences among them regarding adherence, tolerance and adverse effects. Lactulose (LAC) is widely used in treating constipation. However, there are some randomized clinical assays using LAC as bowel preparation with excellent results according to bowel preparation and tolerance scales. Adherence to bowel preparation significantly affects the result in the endoscopic study.

Safety of polyethylene glycol (PEG) formulations has been validated in several studies, it presents little severe side effects and the advantage of its applicability to patients with several comorbidities (heart, liver and kidney without water deprivation). However, its main disadvantage lies in the need to ingest large amounts of liquid (3-4L), generating intolerance thereto in 15%-45% of patients.

Bowel cleansing preparation with PEG is widely used in clinical practice. Considering that according to international studies reporting better tolerance and adherence with LAC; it is suggested to compare the level of bowel preparation, tolerance and adherence between two groups with LAC and PEG.


Eligibility Criteria:
Inclusion Criteria:

- Patients over 18 years with no bowel surgical procedures

Exclusion Criteria:

* Patients willingly deciding not to enter into the study
* Pregnant women
* Patient with colonic resections and/or ileostomies
* Inflammatory bowel disease
* Colonic optimization by prior colonoscopy with poor preparation
* Suspected intestinal occlusion or perforation, intussusception
* Patient with melenas
* Oral iron intake in the past 10 days
* Emergency colonoscopy
* Hypersensitivity to any of the components comprised in preparations.
* Diabetics
* Chronic kidney disease in dialysis
* Uncorrected severe dystonias
* Severe psychiatric illness (schizophrenia)
* Low IQ to understand bowel preparation
* Severe constipation (\< 1 weekly stool)
* Chronic diarrhea with high rate (≥ 4 daily evenly loose consistency stools for more than 4 weeks)
* Unbalanced heart diseases (ischemic cardiopathology, congestive heart failure, unstable angina, arrhythmias and untreatable high blood pressure)
* Ascites
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects

The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.


Eligibility Criteria:
Key Inclusion Criteria:

* Healthy female subjects, 18-45 years, BMI 18-32 kg/m².
* Must be using an adequate method of contraception to avoid pregnancy throughout the study.

Key Exclusion Criteria:

* Abnormal Pap smear within 1 yr of dosing, and abnormal menstrual cycle during the 3 months prior to enrollment.
* Any significant or chronic uncontrolled medical illness.
Effect of Health Belief Model Education on Water Intake in the Elderly (HBM-Water Study)

The purpose of this study is to evaluate the effectiveness of a Health Belief Model (HBM)-based education program to increase daily water consumption among elderly individuals aged 65 and above. Participants will be divided into two groups; one group will receive HBM-based education, and the other group will not receive any education. The effects of the education program on daily water consumption and dehydration symptoms will be assessed.

The study has a randomized controlled design and will last 1 month. The study group will be given a Health Belief Model (HBM)-based training program for 1 month, and the same training will be given again after 2 weeks to reinforce the training, while the control group will not receive any training. Participants; Daily water consumption will be collected and dehydration symptoms will be evaluated at baseline and at the end of 1 month, and differences between groups will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

Aged 65 years and older. Consuming less than 1000 ml of water daily.

Exclusion Criteria:

Scoring below 17 on the Mini-Mental State Examination. Being bedridden. Having a medical condition that requires fluid restriction. Taking diuretic medications.

Withdrawal Criteria:

Elderly participants who wish to withdraw from the study at any stage of the research process.

Participants who meet the exclusion criteria during the study period.
Effects of Stretch-shortening Cycle Exercises Postural Control in Down Syndrome

To investigate the effect of a 3-month, trampoline-based stretch-shortening cycle (SSC) exercises on muscle strength and postural control in children with Down syndrome.

a variety of physical therapy techniques are being used to improve lower limb muscle strength and postural control in children with Down syndrome including, but not limited to, progressive resistance training, hippotherapy, aquatic therapy, and isokinetic strength training. Stretch-shortening (SSC) exercises-also referred to as plyometric exercises, is a traditional form of resistance training that involves three-phase muscle contraction during dynamic movements (like jumping and hopping), where the muscle moves rapidly through the eccentric, isometric, and concentric phases.

Eligibility Criteria:
Inclusion Criteria:

* age between 7 and 9 years.
* able to follow one step motor commands.
* independent ambulators.
* not suffering from atlantoaxial joint instability as reported from their medical files.

Exclusion Criteria:

* Children with un-corrected cardiac anomalies.
* Children with un-corrected vision or hearing loss.
* Children with un-corrected pulmonary disorders.
* Children with un-corrected neurological signs as epilepsy.
* Children who had a history of musculoskeletal surgery in the lower extremities through the past year.
Factors Influencing Adherence to Adjuvant Endocrine Therapy

Breast cancer is the most common type of cancer and the leading cause of cancer death in women. Adjuvant endocrine therapy (AET) reduces the risk of disease recurrence and mortality in women with hormone-dependent breast cancer. This cross-sectional study aims to investigate adherence to AET and identify factors associated with adherence in the Republic of Croatia. The level of adherence, beliefs about medicines, and quality of life with AET will be investigated with validated instruments in the form of an anonymous survey. Given the available data on suboptimal adherence to AET in Europe and globally, it is clear that there is a need for investigating adherence in Croatia which hasn't been done so far. Each country, population, and health system has its own characteristics, and understanding the experience of using AET and identifying associated psychosocial factors could help in developing specific interventions supporting women and improving AET adherence.


Eligibility Criteria:
Inclusion Criteria:

* women older than 18 years of age
* clinical diagnosis of hormone receptor positive early breast cancer stages 0-III according to the American Joint Committee on Cancer (AJCC) classification
* prescribed with adjuvant endocrine therapy for more than 3 months

Exclusion Criteria:

* advanced metastatic breast cancer, stage IV according to the American Joint Committee on Cancer (AJCC) classification
* other life-threatening illnesses
* mental disorders
* behavioral disorders caused by the use of psychoactive substances
* behavioral syndromes related to physiological disorders and physical factors
* cognitive impairment
* organic and symptomatic mental disorder
* schizophrenia
* disorders similar to schizophrenia
* delusional disorders
* personality disorders
* behavior disorders
* mental retardation
* psychological development disorders
* unspecified mental disorders
* Incapable of autonomously reaching decisions
Risk Factors and Prediction Score of ARDS After Cardiac Surgery

Acute respiratory distress syndrome following cardiac surgery severely affects the prognosis of patients; the mortality is up to 40%. Although experience many years of research and exploration, the effective methods for the treatment of acute respiratory distress syndrome is still relatively limited at present, including lung protective mechanical ventilation respiratory support, fluid management, glucocorticoid and other integrated organ function maintenance measures. It is currently the research of acute respiratory distress syndrome aims at the early discovery and takes effective measures to prevent its occurrence, hoping to improve the prognosis of patients. According to risk factors is established through the analysis of lung injury score early warning system, the early identification of acute respiratory distress syndrome patients at high risk, before the occurrence of acute respiratory distress syndrome take corresponding preventive measures can effectively reduce the incidence rate and mortality. So far, domestic and foreign research on the establishment of acute respiratory distress syndrome scoring early warning system is less. Cardiac surgery has significant characteristics, type of operation, location, operation, intraoperative blood transfusion and oxygenation, postoperative factors, are likely to be the factors of acute respiratory distress syndrome. As far as investigators know, so far there are few specialized for acute respiratory distress syndrome predicting lung injury after cardiac surgery. This study will be completed after the implementation of individualized dynamic lung injury score evaluation of cardiac surgery patients, identification of high-risk acute respiratory distress syndrome patients, to assist clinicians in early decision, take preventive measures. This study will improve the prognosis of acute respiratory distress syndrome patients after cardiac surgery; it is of great significance to improve the level of intensive care after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Retrospective group: cardiac surgery patients accepted from Jan 2013 to Dec 2015
* Prospective group: cardiac surgery patients accepted from 2017 January to December

Exclusion Criteria:

* refused to participate in the study
* age less than 18 years old
* before operation performed mechanical ventilation
* before operation underwent IABP treatment
* before operation continuous renal replacement therapy
* before operation undergoing in vitro membrane oxygenator treatment
* before operation has the pulmonary imaging showed bilateral pulmonary diffuse exudation of interstitial pneumonia, pulmonary infection or respiratory failure
* the major trauma, sepsis, aspiration, shock, acute heart failure
* before operation diagnosed as malignant tumor
* Incomplete data.
The Use of Compression Bandages in Total Knee Replacement Surgery

The use of compression bandages in elective orthopaedic knee surgery is well regarded, however, there is a lack of robust, well-designed evidence to support this.

The aim is to determine the feasibility of conducting a randomised control trial comparing the use of a compression bandage worn post-operatively for 24 hours after elective total knee replacement, compared to standard practice (wool and crepe, non-compressive dressing).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Able to give written, informed consent
* Primary total knee replacement

Exclusion Criteria:

* Extensive peripheral vascular disease
* Lower limb neurological disorder
Adjuvant Endocrine Therapy for Estrogen Receptor-beta Positive Triple Negative Breast Cancer

The study is a prospective multi-center randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of adjuvant endocrine therapy for operable ER-beta positive, ER-alpha/PR negative, Her-2 negative breast cancer(triple negative breast cancer, TNBC) patients. The ER-beta positive TNBC patients who had undergone modified radical mastectomy or breast-conserving surgery were randomly (1:1) enrolled to receive toremifene (60 mg per day for premenopausal and perimenopausal patients) /anastrozole(1mg per day for postmenopausal patients) or observation within 4 weeks after adjuvant chemotherapy and/or radiation therapy if necessary.The follow-up time will be at least five years. The disease free survival(DFS) and overall survival(OS) between endocrine group and observation group will be compared to evaluate the effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* The patients signed the written informed consent.
* The patients present with histologically proven operable invasive breast cancers without distant metastasis.
* The breast tumor's positive ER/PR rate is \<1%, and positive ER-beta rate is ≥1% by immuno-histochemistry(IHC).
* The patients have no history of neoadjuvant hormone therapy.
* The patients' Karnofsky performance score ≥70%.
* Female patient who is ≥ 18yrs, and ≤ 80yrs.
* The patients are non-pregnant, and disposed to practice contraception during the whole trial.
* The patients underwent neoadjuvant chemotherapy plus surgery or directly modified radical mastectomy or breast-conserving surgery (plus sentinel lymph node biopsy or axillary lymph node dissection) after diagnosis of breast cancer.
* The patients underwent chemotherapy, radiation therapy after surgery according to the 2013 NCCN guideline.
* The results of patients' blood tests are as follows:

Hb≥90g/L; WBC≥4.0×109/L; Neutrophils≥1.5×109/L; Plt≥100×109/L; alanine aminotransferase(ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); total bilirubin(TBIL) ≤ 1.5×ULN; Creatinine ≤ 1.25×ULN.

Exclusion Criteria:

* The patients have a previous history of invasive malignant disease (breast cancer at any time, other malignant disorders within the past 10 years excluding squamous or basal-cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied).
* The patients have any severe concomitant disease which will place the patient at unusual risk or confound the results of the trial.
* The patients have history of neoadjuvant hormone therapy.
* The patients are undergoing current administration of anti-cancer therapies, or are attending other clinical trials.
* The patients are pregnant or lactational, or they refuse to practice contraception during the whole trial.
* The patients are unwilling to stop any hormonal drug including hormone replacement therapy(HRT).
* The patients can't understand the written informed consent; such as they have dementia.
* The patients have allergic history or contraindication of toremifene/anastrozole.