cyrilzakka/clinical-trials huggingface dataset:
Extern Validation of a Predictive Score of Brain Death in Severe Stroke (DIAPASON1)

There is currently a shortage of organ in France, for patients with chronic diseases who are on the waiting list for an organ. The first source of organ donor in France is patients with brain death. 58% of patients in brain death are patients with a severe stroke ( ischemic or hemorrhagic). In order to identify which patient with a severe stroke and with unfavorable prognosis who can evolve to brain death, we have conducted a retrospective study in Lorrain, in France, and we have built a predictive score of brain death in these patients. It is important to validate this predictive score in a prospective study on a greater scale than the first study.

Main objective :

External validation of a brain death evolution predictive score GRAHAL65 (initial Glasgow score ≤6, systolic blood pressure \>150 mmHg, past history of alcohol abuse, herniation, hydrocephalus, and stroke volume\>65 ml) for patients with severe stroke and withhold therapy built.

Secondary objectives :

Identification of other clinical and paraclinical predictive factors of brain death evolution:

* Age,sex,
* Temperature and glycemia
* Rostro-caudal abolition of brainstem reflexes
* Other cardiovascular risk factors (hypertension, diabetes, atrial fibrillation, dyslipidemia,)
* Antiplatelet therapy, anticoagulant treatment,
* Intravenous thrombolytic therapy or thrombectomy
* Type of stroke
* Infarct location
* Type of brain herniation

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years and over.
* Patient with a sever stroke less than 48 hours diagnosed by brain imaging magnetic resonance imaging or computed tomography (including cerebral infarction, intra-parenchymal hemorrhage and subarachnoid haemorrhage
* Patient with Glasgow Scale score \<8 Engaged vital prognosis
* Absence of therapeutic resources
* Decision of resuscitation measures to protect the organs in the purpose organ donation after brain death

Exclusion Criteria:

* Pregnant woman
* Patient with recent traumatic brain injuries (subdural hematoma, extradural hematoma and contusions)
* Obvious contraindication of organ donation excluding the patient from organ protection measures in intensive care unit (expression of patient opposition, HIV infection, active tuberculosis, spongiform encephalopathy,
* human growth hormones treatment origin, rabies, active cancer)
* Opposition of family member of the patient
Randomised Clinical Trial Comparing Drug-coated Balloon to Plain Balloon for All Peripheral AVF Stenosis

To compare the access circuit primary patency after Ranger drug-coated balloon angioplasty of arteriovenous fistula (AVF) stenosis with that after conventional balloon angioplasty

This is a blinded randomized controlled trial recruiting 94 patients with AVF stenosis who will be randomized in a 1:1 ratio to either drug-coated balloon (Ranger) or conventional balloon. All peripheral AVF stenoses will be treated with the allocated balloon type.

The primary outcome measure is 6-month access circuit patency.

Eligibility Criteria:
Inclusion Criteria:

1. Failing AVF with at least 1 AVF stenosis presenting with any clinical, physiological or haemodynamic abnormalities. Both de novo and recurrent stenosis are accepted.
2. AVF has been used successfully for at least 1 month (non-mature AVF are not allowed).
3. Less than 30% residual stenosis after angioplasty.
4. ≥ 21 years old
5. Informed and valid consent given.

Exclusion Criteria:

1. Thrombosed AVFs
2. Haemodynamically significant central vein stenosis
3. Target lesion not treatable with the available sizes of drug eluting balloon (up to 8mm)
4. Contraindication to antiplatelet therapy
5. Coagulopathy or thrombocytopenia that cannot be managed adequately with periprocedural transfusion.
6. Allergy / contraindication to paclitaxel.
7. Acute infection over proposed puncture site.
8. Women who are breastfeeding, pregnant \* or planning on becoming pregnant during study.
9. Participant with medical conditions, which in the opinion of the investigator may cause noncompliance with protocol.
10. Currently participating in an investigational drug, biologic or device trial that may have an impact on the dialysis access or previous enrolment in this study.
Effect of Regional Versus General Anesthesia on Thirty-day Outcomes Following Carotid Endarterectomy: a Matched-pairs Cohort Study.

The goal of this observational study is to assess the effect of regional versus general anesthesia on carotid endarterectomy thirty-day outcomes. The main questions it aims to answer are:

* Is regional anesthesia associated with lower incidence of major morbidity and mortality?
* Is regional anesthesia associated with lower incidences of secondary adverse events?

Participants will be sampled from the 2015-2019 American College of Surgeons National Surgical Quality Improvement Program


Eligibility Criteria:
Inclusion Criteria:

* Elective, non-emergent cases
* Regional anesthesia
* General anesthesia

Exclusion Criteria:

* Concurrency in procedures
* Acute kidney injury (preoperative)
* End-stage renal disease (preoperative)
* Metastatic disease (preoperative)
* Wound infection (preoperative)
* Sepsis (preoperative)
* ASA 5
Assessment of Atrial Cardiomyopathy Using MRI as a Predictor of Cardiac Post-Operative Atrial Fibrillation After Cardiac Surgery.

After cardiac surgery, there is a high prevalence of postoperative atrial fibrillation (POAF). However, its diagnostic and therapeutic management is poorly codified.

This pathology is caused by atrial abnormalities which form the concept of atrial cardiomyopathy.

New tools affording to itemize the atrial cardiomyopathy are needed. Indeed, current tools, as echocardiography and electrocardiogram are relevant but only lead to a raw evaluation of the atrial cardiomyopathy. MRI, because of the assessment of the atrial fibrosis by late gadolinium assessment (LGE) and 4D flow magnetic resonance imaging (MRI) could be relevant to specify the atrial cardiomyopathy.

The aim of the study is to evaluate the atrial cardiomyopathy, assessed by magnetic resonance imaging (MRI), as a predictor of postoperative atrial fibrillation (POAF) after with coronary artery bypass graft surgery .

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Indication for surgical myocardial revascularization by coronary artery bypass
* Patient affiliated or entitled to a social security scheme
* Informed consent for participation in the study

Exclusion Criteria:

* Contraindication to cardiac MRI (Severe Kidney disease, Allergy to gadoliniumn, ...)
* History of Atriale Fibrillation (AF)
* Indication of cardiac valve surgery concomitantly with Coronary Artery Bypass Grafting (CABG).
* pregnant or breast-feeding women
Evaluation of Thermospot Accuracy in Nigerian Infants Exposed to Ambient Temperature and Validation of Maternal Readings and Responses

This project will focus on testing the accuracy of ThermoSpot -a low-cost, color-based, temperature indicator in estimating the body temperature of Nigerian babies exposed to ambient temperature conditions. The particpants will be recruited among babies receiving Filtered Sunlight Phototherapy (FSPT) at Bowen University Teaching Hospital, Ogbomoso and other babies in the nursery at Bowen University Teaching Hospital.

There will also be an educational session to teach health workers and mothers about the signs for hypothermia and hyperthermia on the indicator. Then, the investigators will collect observational cross-sectional data on random days to see how many of the trained health workers and mothers were able to accurately recognize and provide appropriate response to warning signs on the indicator.

ThermoSpot is a liquid crystal display thermometer. It comes as a sticky disc (12mm in diameter) which can be applied to the skin over the liver, in the armpit, or over the neck blood vessels of an infant. ThermoSpot was designed as a non-invasive hypothermia indicator for infants. The device changes color when the baby's core body temperature changes, allowing it to be understood even by a non-literate parent. It has been tested and proven to accurately detect hypothermia in Malawi, Nepal and India. However, no large-scale studies have been performed on babies exposed to ambient temperatures for long periods such as those under FSPT.

The main objective of the project is to determine whether ThermoSpot can be used to detect hypothermia or hyperthermia in babies receiving FSPT instead of thermometers. The ability of a parent to respond in a timely manner to the temperature indicator will help provide critical information on technical, as well as educational components required for FSPT scale-up in Nigeria and other resource-limited countries with health worker shortage.

Specific objectives

1. Compare the performance of ThermoSpot in the detection of hypothermia or hyperthermia with the standard axillary thermometer measurement.
2. Determine if parents are able to correctly interpret the color indicators on ThermoSpot
3. Determine whether parents carry out the appropriate action based on the ThermoSpot indicator.

Eligibility Criteria:
Inclusion Criteria:

1. Babies under 4 weeks of age receiving FSPT (Infants ≥35wks gestation, or ≥2.2kg if gestational age is not available, and ≤14 days old at time of study enrollment), for whom parents or guardians have given consent to participate in the study.
2. Babies under 6 weeks of age in the nursery at Bowen University Teaching Hospital.
3. Parents or guardians of babies receiving FSPT who are interested in learning how to determine temperature using ThermoSpot and have given consent for their babies to participate in the study.

Exclusion Criteria:

1. Parental refusal
2. Infants already clinically dehydrated
3. Infants that are sunburned.
Home Rehabilitation Using Interactive Device Versus Inpatient Rehabilitation in Total Knee Arthroplasty

Rehabilitation after total knee arthroplasty is very important in terms of range of motion of the knee, muscle power, normal gait, pain control and consequently the patient's satisfaction. Convectional rehabilitation methods in assist of therapist required high demand of resources. Recently, outpatient clinic or tele-communication tool based rehabilitations were investigated and reported equivalent results. However, those methods also required group or one-to-one facing that restricted availability of the exercise.

With development of the motion tracking technology, new device that gives real time feedback with augmented reality images can be used for rehabilitation in home-based setting.

This study aims to compare the clinical outcomes after the rehabilitation by interactive home-based device or conventional inpatient setting.

The objective of this work is to compare the pain, stiffness, function and satisfaction between groups at 6 months after the total knee arthroplasty.

The investigators hypothesized that the clinical outcomes of rehabilitation by interactive home-based device are not inferior than that by conventional inpatient setting.

The study design is a single-blind non-randomized controlled trial. Patients takes different rehabilitation method but the outcome assessor is blinded. The clinical outcome is compared at preoperative, postoperative 6weeks, 3months. And clinical outcome consists of Range of Motion (ROM), WOMAC (Western Ontario and McMaster University Arthritis Index ) score, Knee Society Score, Time-up-go (TUG) test.

Eligibility Criteria:
Inclusion Criteria:

* over 19 year old
* Patients for total knee arthroplasty of one knee
* Patients who can understand and utilize the device

Exclusion Criteria:

* who don't agree with participation of the study
* who can not understand and utilize the device
* Rheumatoid arthritis, Other inflammatory arthritis
* Neuropsychiatric patients
Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options

Internal fixation of femur fractures improves alignment and provides stability to the bone and the surrounding soft tissues. This generally allows for early motion of the adjacent joints; thus maximizing overall function of the limb. Open reduction and internal fixation with plates and screws is the standard method that has been used in the treatment of distal femoral fractures. One common traditional method of internal fixation is the 95-degree angled blade plate. Recent advances in technology for distal femur fractures include the LCP™ Condylar Plate. This implant differs from the blade plate, because the LCP offers multiple points of fixed angle contact between the plate and screws in the distal femur. The introduction of plates with the option of locked screws has provided means to increase the rigidity of fixation in osteoporotic bone or in periarticular fractures with a small distal segment, and the LCP may be technically easier to apply than the blade plate. To the investigators' knowledge, there have been no published clinical or biomechanical studies specific to the LCP Condylar Plate, although the early results of LCP implants for other fractures are promising. The investigators believe that locked plating represents a valuable advancement in fracture treatment. However, the limitations of this new technology and the indications for its use have not been completely elucidated. Furthermore, the cost of the new technology is approximately seven times more than the traditional treatment. This is a randomized, prospective, multi-center study to compare the blade plate and the LCP in the distal femur. All patients 16 years of age or older, regardless of race or gender, with a supracondylar fracture of distal femur will be considered. Whether patients are treated with a blade plate or/and LCP, they will be receiving standard orthopedic care for their injury. Neither of these methods currently places a patient at increased surgical or post-surgical risk for problems with infection, nonunion, malunion, or other complications. Because of the study, early and late complication rates and functional outcomes after these treatments may be better defined, allowing for optimization of care of people with these injuries in the future. This should reduce not only direct and indirect costs to the individual, but also costs to society.


Eligibility Criteria:
Inclusion Criteria:

* Closed or Gustilo 13,14 Type I, II or IIIA open fractures that can be treated with an angled blade plate or an LCP Condylar Plate (Orthopaedic Trauma Association fracture classification 33-A, 33- C1, 33- C2), (Tables 1 \& Figure 3)
* 16 or more years of age and skeletally-mature, regardless of race or gender

Exclusion Criteria:

* Pathologic fractures secondary to neoplasm
* Time elapsed since injury greater than 10 days before fixation
* Open fractures unable to undergo debridement and irrigation in the first 24 hours
* Inability or refusal to give consent
Step by Step: A Tailored Walking Intervention for Breast Cancer Survivors

This study aims to recruit post-treatment breast cancer survivors for a 12-week 2-arm randomized walking intervention. All intervention materials will be delivered electronically.

The investigators hypothesize that at the end of 12-weeks, participants randomized to the intervention group will engage in more weekly steps than those participants randomized to the comparison group.

More than two-thirds of breast cancer survivors are physically inactive. Inactivity is known to negatively impact both morbidity and mortality, and is especially pronounced among cancer survivors. Self-directed interventions targeting inactivity among breast cancer survivors often report clinically insignificant behavior change. More successful behavior change interventions have suggested that tailoring and, more recently, the fostering of intrinsic motivation, may have improved outcomes. However, no interventions to date have utilized these approaches to increase physical activity among sedentary cancer survivors.

AIM 1: Develop and test intervention (tailored) and comparison group (targeted) messages in a sample of sedentary women to determine message acceptability.

AIM 2: Determine the efficacy of a 12-week tailored intervention to increase the number of weekly steps taken among sedentary post-treatment breast cancer survivors compared to a 12-week, targeted intervention.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 40-70 years of age
* History of breast cancer stage I-II
* 2-10 years post-treatment
* Sedentary
* Technology access and skills
* Regular access to personal computer/ broadband internet and email account
* Comfortability using internet, and web-based tools
* US Resident

Exclusion Criteria:

* Concurrent enrollment in another physical activity/ lifestyle/ weight loss intervention program/study
* Current secondary cancer diagnosis/ treatment
* Inability to ambulate
* Refusal to wear personal activity monitor (FitBit Ultra) for the duration of the study
* Engaging in regular moderate to vigorous physical activity
Nutritional Transitions to More Plant Proteins and Less Animal Proteins: Understanding the Induced Metabolic Reorientations and Searching for Their Biomarkers (ProVegOmics)

The dietary shift from animal to plant protein sources is one of the key aspects of the nutritional transition towards more sustainable food system and diets. However the metabolic implication of this shift in protein sources are still poorly understood.

This project aims to characterize and understand the metabolic orientations specifically induced by animal and vegetable dietary proteins, in order to better analyze the metabolic reorientations that would result from the expected increase in the share of plant proteins in different dietary contexts, especially those of the Western type, often associated with the development of metabolic deregulations (obesity and cardiometabolic risk).

The main objectives of this project are:

* Characterize the metabolic adaptations induced by animal or plant protein diets and their repercussions in terms of physiology and health.
* Characterize the medium-term metabolomic signatures induced by this shift in dietary protein sources
* Validate, in a human population, biomarkers of dietary animal or plant proteins, previously identified in pre-clinical studies.

This clinical trial is open, monocentric, controlled, randomized, with a cross experimental design.

20 men or postmenopausal women will follow for 4 weeks a controlled diet with a protein fraction constituted mainly from animal or vegetal sources. After a 2-week washout period(+21D/-7D), they will follow another 4 week of controlled diet with predominantly animal or plant protein depending on 1st intervention period diet.

At the end of each intervention period, a post-prandial exploration will be conducted with the administration of a high-fat, high-sugar meal and subsequent blood and urine sampling.

The order in which participants will received the two diets will be randomized.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 35 kh/m² (terminals included)
* Waist circumference ≥ 94 cm for men and ≥80 cm for women
* at the choice, one of the following criteria: Triglyceridemia \> 1.49g/L, fasting blood glucose≥ 5.6 mmol/L , a HDL cholesterol \<1.03mmol/L for men or \<1.29 mmol/L for women , systolic blood pressure≥ 130 mmHg or diastolic≥ 85 mmHg .

Exclusion Criteria:

* Systolic blood pressure \> 150mmHg or diastolic blood pressure \> 90mmHg
* pathology and medical treatment
* diabetes
* Smoking \> 4 cigarettes /day
* Alcohol consumption \> 2 glasses/day
* Antibiotics taken during the last 3 months before the clinical trial
* Specific diets
Alcohol Screening and Pre-Operative Intervention Research Study

This study aims to learn more about how to improve patients' health before and after a scheduled surgery by examining acceptability and initial efficacy of pre-operative alcohol use reduction interventions.

The study is a randomized clinical pilot trial that assesses preliminary intervention efficacy of a two-session health coaching intervention relative to brief advice among pre-operative elective surgical patients and evaluates intervention acceptability. Study subjects will be outpatients at a large health system in the midwestern United States and fulfill the study's inclusion criteria. Subjects will be randomized to one of two intervention conditions: Health Coaching or Brief Advice.

Eligibility Criteria:
Inclusion Criteria:

* Referred for elective or semi-elective surgery or pre-operative assessment in the next 120 days
* Meet criteria for "risky drinking" as defined by study staff

Exclusion Criteria:

* Displays or shows evidence of psychotic symptoms
* Undergoing surgeries that commonly require local anesthesia only
Vernakalant Versus Flecainide: Atrial Contractility

Atrial fibrillation (AF) is associated with decreased atrial contractility which is associated with stroke. Decreased contractility becomes apparent after cardioversion of atrial fibrillation, a short period (weeks) during which stroke risk is increased. Improved contractility immediately after cardioversion may prevent arrhythmia progression. In addition, it may reduce the stroke risk. Vernakalant is a new antiarrhythmic drug able to convert atrial fibrillation to sinus rhythm and at the same time increase atrial contractility. The latter has not yet been shown in humans and is subject of the present investigation. Our hypothesis is that in humans the contractility of the atria is higher after administration of vernakalant compared to flecainide. If indeed vernakalant improves atrial contractility after cardioversion further studies into the effect on long-term arrhythmia progression and stroke prevention may follow.


Eligibility Criteria:
Inclusion Criteria:

* persistent AF or paroxysmal AF
* eligible for treatment with vernakalant or flecainide infusion to restore sinus rhythm
* receiving adequate anticoagulant therapy (or having an episode of AF lasting \< 24 hours)

Exclusion Criteria:

* refusal or inability to give informed consent to participate in this study
* atrial flutter
* contra-indications for receiving vernakalant or flecainide according to MUMC+ protocol (unstable hemodynamic condition, LVEF \< 40%, inadequate potassium levels, acute ischaemia, sinus node dysfunction)
* age \< 18 years
Comparative Study of Medial-to-Lateral Approach vs Dorsal and Medial Hybrid Approach in Laparoscopic Right Hemicolectomy

To standardize the surgery for advanced right hemi colon cancer with laparoscopy and investigate whether dorsal and medial hybrid approach could improve disease-free survival in patients with right colon cancer, compared with traditional medial-to-lateral approach in laparoscopic righ hemicolectomy.


Eligibility Criteria:
Inclusion Criteria:

* Aged more then 18 years old;
* Diagnosed as right hemi colonic cancer with colonoscopic biopsy;
* Without metastasis;
* No Invasion of surrounding tissues;
* Limited operation;
* Underwent laparoscopic radical right hemicolectomy (L-right hemicolectomy);
* BMI 18\~30kg/m2;
* Without multiple primary tumors;
* Sign on the Medical informed Consent.

Exclusion Criteria:

* Simultaneous or simultaneous multiple primary colorectal cancer;
* Preoperative imaging examination results show:

  1. Tumor involves the surrounding organs and combined organ resection need to be done;
  2. Distant metastasis;
  3. Unable to perform R0 resection;
* History of any other malignant tumor in recent 5 years;
* Patients need emergency operation;
* Not suitable for laparoscopic surgery;
* Women during Pregnancy or breast feeding period;
* Informed consent refusal