cyrilzakka/clinical-trials huggingface dataset:
Preventing Recurrent Bleeding After Eradication of Esophageal Varices

Esophageal variceal bleeding is a severe complication of portal hypertension. Banding ligation plus non-selective beta-blockers is the current recommendation for prevention of recurrent bleeding. However, the optimal duration of use of non-selective beta-blockers is not well defined. This study aims at comparing the rebleeding rate and adverse effects in patients using or without using propranolol after eradication of esophageal varices.

Cirrhotic patients with acute or recent esophageal variceal bleeding undergo banding ligation at 1-month interval until eradication of esophageal varices. Patients start propranolol (start with 30 mg daily) at 6th day after control of acute bleeding till eradication of esophageal varices, aiming at decreasing pulse rate to 25% or to 55 bpm while systolic pressure is above 85 mmHg. Patients randomized to propranolol group continue propranolol after eradication of esophageal varices. Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices. Patients are followed to evaluate the incidence of rebleeding, adverse effects and survival.

Eligibility Criteria:
Inclusion Criteria:

* Age of 20 to 80 years
* Cirrhotic patients with acute or recent esophageal variceal bleeding proven by an endoscopy
* Stable hemodynamic condition for at least 3 days after banding ligation

Exclusion Criteria:

* Hepatocellular carcinoma or other malignancy
* Stroke or active sepsis
* Chronic kidney disease under renal replacement therapy
* Contraindications to non-selective beta-blockers
* A history of non-selective beta-blockers use, sclerotherapy, banding ligation, transjugular intrahepatic porto-systemic shunt, or shunt surgery
* Serum total bilirubin \>10 mg/dL
* Grade III/IV hepatic encephalopathy
* Refractory ascites
* Hepato-renal syndrome
* Pregnancy
* Severe heart failure (NYHA Fc III/IV)
* Bronchial asthma or chronic obstructive pulmonary disease
* Second or third degree atrioventricular block
* Sick sinus syndrome
* Pacemaker use
* Severe hypotension
* Refusal to participate
Continuous Quantified EEG in NeuroIntensive Care

To evaluate the ability of NICU (NeuroIntensive Care Unit) staff to interpret, before and after a training period, symmetry, sedation level, seizures activities and artefact on continuous cEEG/qEEG (continuous electroencephalography/quantitative electroencephalography) tracings.

Using a web based tool, the clinicians of the two study centers will review 24 hours of recording (raw EEG data + derived qEEG variables).

The intensivists will evaluate:

* simmetry,
* sedation level,
* seizures activities and
* artefact on continuous cEEG/qEEG tracings. The same tracings will be blindly reviewed by a certified neurophysiologist (using the app). The neurophysiologist evaluation will be considered as "reference".

The results of the evaluation will be compared (intensivists vs. neurophysiologist) in order to understand if the intensivists are able to adequately identify the pathological findings.

The study period will be:

* before a formal training
* after a formal training by neurophysiologist in order to understand if the training is able to improve the intensivists performance.

Eligibility Criteria:
Inclusion Criteria:

Intensivists wil evaluate daily qEEG recordings of:

* Patients in coma after a traumatic/vascular event
* Admitted to neurointensive care and
* Recorded with continuous EEG for clinical reasons

Exclusion Criteria:

* No EEG recording \> 24 hours
The Glucagonotropic Effect of Amino Acids in Humans

The objective of the study is to delineate the glucagonotropic signal exerted by selected amino acids in human subjects as well as the metabolic clearance rate of these amino acids after intravenous infusion

After being informed about the study and the potential risks, each participant giving written informed consent will participate in six experimental days. The glucagonotropic effect and metabolic clearance of selected amino acids and saline (placebo), respectively, will be evaluated in 12 healthy individuals. After screening, each participant will undergo 6 double-blinded experimental days performed in randomized order. The experimental days will each last 75 minutes. The amino acids selected for the experiment are glutamine, arginine, alanine, leucine and proline.

Eligibility Criteria:
Inclusion Criteria:

* normal fasting plasma glucose and glycated hemoglobin (HbA1c) \< 42 mmol/mol
* body mass index (BMI) between 18.5 and 25 kg/m2
* Hemoglobin \> 8.3 mmol/L
* Age between 20 and 65 years
* oral and written informed consent

Exclusion Criteria:

* Diabetes
* first-degree relatives with diabetes
* fasting plasma triglycerides indicating dyslipidemia (\> 2 mmol/L)
* nephropathy (eGFR \< 60 ml/min) and/or microalbuminuria (albumine/creatinine ratio \> 30 microgram/mg)
* liver disease and/or ALT and/or AST levels \> 2 x upper normal reference limits.
* signs of liver fibrosis and/or steatosis evaluated by transient elastography (CAP \> 238 dB/min) and/or kPa \> 6.0) and/or FIB-4 index \> 1.45
* regular use of prescription medication
* use of dietary protein supplementation
* any condition the investigator feels would interfere with trial completion
The Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain

This study aims to evaluate the effect of the paravertebral block using a multi-lumen catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to the thoracic epidural block.


Eligibility Criteria:
Inclusion Criteria:

* patients receiving surgery through a thoracotomy incision

Exclusion Criteria:

* patients with cardiovascular disease
* patients with neurologic disease
* patients with contraindications to paravertebral block or epidural block
* patients with history of previous thoracotomy incision
* patients with pain at the expected incision site
The Effect of NIV on QoL and Exercise Capacity in a COPD Exercise Rehabilitation Program

This trial hopes to demonstrate the effect of 4 weeks of outpatient exercise rehabilitation on COPD patients. In particular the effect on:

* the amount of daily physical activity
* Quality of life
* The 6-minute walk distance
* Time to exacerbation

and compare it to the effect of 4 weeks of outpatients rehabilitation with Noninvasive Ventilation as an adjunct therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of COPD III+IV
* Age \>18 years
* Former NIV treatment for at least 6 weeks with a positive end-expiratory pressure of at least 4 cmH2O and a pressure support of 8 cmH2O or higher

Exclusion Criteria:

* Pulmonary Exacerbation requiring antibiotic treatment or hospitalization during the last 6 weeks
* non-pulmonary Exercise impairment (amputation, severe heart disease, etc)
* any disease that precludes exercise training
* inability to understand the patient information
* substance abuse
* oxygen requirement of more than 6l O2/min during exercise
The Effect of Nutrient Intake on the Microbiome, Weight, and Glucoregulation (NI-MWG)

The purpose of this study is to investigate a persons dietary intake and its effect on the gut microbiome and the association of those two variables on weight and glucoregulation. Specifically, the investigators will compare the gut microbiota, fasting glucose and insulin, c-peptide and hemoglobin A1-c in three groups of subjects: obese patients (BMI ≥ 30 kg/m2) with type 2 diabetes mellitus (T2DM), obese patients without T2DM, and normal weight lean controls without T2DM. Each patient will also complete a detailed dietary recall (ASA-24) to investigate the association with diet, microbiome and weight/glucoregulation.


Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Age 18-65 (inclusive, at time of informed consent)
3. BMI ≥ 30 kg/m2 with T2DM
4. BMI ≥ 30 kg/m2 without T2DM
5. Normal weight lean controls without T2DM

Exclusion Criteria:

1. Tobacco use in past three months - will add unnecessary confound to the data.
2. Taking a medication on a routine/recent basis which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD)
3. Has taken an oral or injectable antibiotic in the past 3 months
4. Has taken a commercially prepared probiotic and/or prebiotic agent in the 3 months
5. History of significant intestinal disease or disorder (e.g., crohn's disease, ulcerative colitis)
6. History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator
7. Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
8. Unable to speak/read English
9. Breastfeeding, pregnant, or planning to become pregnant within the duration of the study as assessed through self-report on medical history
10. Unwilling to use a medically acceptable form of contraception during study involvement. Medically acceptable forms of contraception include oral contraception, physical barrier methods and/or abstinence.
11. Any known infectious disease such as Viral Hepatitis or HIV (as determined by study pharmacist/MD)
Kt and Myofascial Release in Exc Asthma

Purpose of this study was to compare between the effects of kinesio tap and myofascial release of respiratory muscles on exercise induced asthma

seventy male athletic subjects with exercise induced asthma, their age ranged from 18-30 years old in this study , with group (A) mean age (21.03+3.6 years), and mean BMI values (27.6+.9 kg/m2) ,and group (B) mean age (21.9+3.8 years),and mean BMI values (27.8+1.3 kg/m2), and group (C) mean age(22+3.1 years), and mean BMI values (27.8+1.3 kg/m2).

Subjects were assigned randomly into tow study groups and one control group:Group(A) 30 subjects were treated by kinesio tap therapy 2sessions per week,Ground(B) 30 subjects were treated by myofascial release therapy 3 sessions per week ,Group (C) 10 subjects were not recieved treatment.

Eligibility Criteria:
Inclusion Criteria:

* Seventy male athlete with ages ranging from 18 to 28 years old. Their Body Mass Index ranged from "18.5" to "24.9". They have the same level of good aerobic fitness, muscular strength and endurance, and flexibility according to tests results; running or jogging test, push up or sit up test, and sit-and-reach test respectively.

Exclusion Criteria:

1. Pulmonary disorders.
2. Metabolic disorders (e.g. Diabetes Mellitus).
3. Coronary artery disorders .
4. Neurological disorders.
5. Recent musculoskeletal injuries.
6. Renal disorders.
7. Hepatic disorders.
8. Skin hypersensitive.
9. Smokers
Textbook Outcomes After Oesophagectomy in Regional Australia

The goal of this observational cohort study is to assess textbook outcomes after oesophagectomy in a regional Australian hospital. This is a composite quality measure that include 9 parameters related to cancer care. Researchers will compares the textbook outcome rate in this regional hospital and compare it to textbook outcomes rates from other Australian hospitals, as well as hospitals overseas. Participants will not be actively involved in this study, as all data will be collected from medical records only.

Rationale Textbook outcomes is a composite tool to assess the quality of cancer care within an institution by evaluating several perioperative and postoperative factors. Most studies assessing textbook outcomes after oesophagectomy have been conducted in high-volume centres, achieving rates of up to 50%. To the best of our knowledge this is the first study to assess textbook outcomes after oesophagectomy in a regional Australian hospital, providing a unique insight into the performance of this procedure in a country that has not widely adopted centralisation of cases.

Aims/objectives To calculate textbook outcomes rates in a regional hospital in Australia and compare to higher volume Australian and international institutions.

Methods Retrospective identification of patients from MBS codes related to oesphagectomy, and collection of data retrospectively from the medical record only. All patients undergoing oesophagectomy from January 2014 to December 2023 will be included. There are no exclusion criteria.

Data collection Baseline patient characteristics, tumour-specific factors, textbook outcome parameters, treatment details including postoperative complications, and follow up data on survival will be collected

Statistical analysis Statistical analysis will be performed in consultation with a biostatistician. The number and proportion of patients who meet each parameter of the textbook outcome will be calculated for each year and compared. Patient characteristics (age, gender, BMI and ASA grade), tumour factors (histology, AJCC clinical T and N stage), and treatment aspects (neoadjuvant therapy and surgical approach) will be assessed for association with textbook outcomes using the Chi squared test with significance considered less than 0.05. A Kaplan-Meier survival curve will be used to investigate overall survival of patients with and without a textbook outcome.

Eligibility Criteria:
Inclusion Criteria:

* all patients who underwent oesophagectomy between January 2014 and December 2023

Exclusion Criteria:

* none
Contribution of Connected Devices in the Follow-up of the Observance of a Prehabilitation Program

Poor physical performance and poor nutritional status increase the risk of complications after major surgery. Prehabilitation is the process of enhancing the functional capacity before surgery.

A major problem is the adherence of the patients to the physical program. A controlled randomized study is therefore proposed to determine the impact of coaching on functional exercise capacity. All patients will wear connected devices to measure their physical activity. They will be randomized to either a group in which coaching will be adapted to the physical activity, or a control group in which coaching is performed without any information about physical activity


Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18
* Patients scheduled for a surgical procedure 4 weeks later (more or less 1 week) after initial assessment
* Patients having consented to participate
* Patients benefiting from a social security system.

Exclusion Criteria:

* Pregnant or lactating women
* Inability to perform physical assessment
* Dependant patients
* Inability to complete questionnaires
Peanuts Second Meal Glycemic Response

Nut consumption is associated with reduced risk of Type 2 diabetes. The aim of this study was to assess the effects of peanut (whole or peanut butter) to breakfast meals on glycemic, insulinemic and selected gut hormone responses, appetite, and food intake over two consecutive meals in obese women with high Type 2 diabetes risk. Fifteen women participated in a randomized crossover trial where 42.5g of whole peanuts (P), peanut butter (PB), or no peanuts (control-C) were added to a 75g available carbohydrate-matched breakfast meal. Postprandial concentrations of blood glucose, insulin, non-esterified free fatty acids (NEFA), glucagon-like peptide-1 (GLP-1), peptide YY (PYY), cholecystokinin (CCK), appetitive sensations and food intake were assessed after breakfast treatments and a standard lunch (75g available carbohydrate).


Eligibility Criteria:
Inclusion Criteria:

* Body mass index between 30 - 35 kg/M2
* Not taking medications known to affect glycemia, fat metabolism, or appetite
* Regular breakfast consumer (≥100 kilocalories ingested within 2 hours of waking on ≥4d/wk)
* No body weight fluctuation (\<5kg in the past 3 months)
* Willingness to eat all test foods
* No self-reported allergy to the foods provided in the study
* No self-reported sleep disorders
* At least one of the following conditions: waist circumference ≥ 88 cm; reported family history of Type 2 diabetes in first degree relatives; capillary glycemia between 5.5 - 7.0 mmol/L; and/or a 2-hour blood glucose of 7.8 - 11.1 mmol/L (impaired glucose tolerance)

Exclusion Criteria:

* Type 2 diabetes mellitus
* Dyslipidemia
* High blood pressure
Prevalence of Small Bowel Polyps in Patients With Sporadic Duodenal Adenomas

Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps. The investigators aim to investigate the prevalence of small bowel polyps in patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas by performing small bowel capsule endoscopy and comparing the results to those acquired from a control cohort undergoing VCE for accepted indication at our centre.

Investigation for suspected SB tumors is an acceptable indication for VCE. SB polyps occur frequently in patients with FAP/PJS and in patients with FAP, they are significantly more common in patients with Duodenal/Ampullary polyps. Little is known about the prevalence of small bowel polyps in patients with sporadic Duodenal/Ampullary polyps.

The primary hypothesis is that patients with sporadic (ie not related to FAP or PJS) duodenal/ampullary adenomas have a higher prevalence of small bowel polyps compared with patients undergoing VCE for various indications who have not had a duodenal polyp diagnosed or removed.

Patients who have had a previous diagnosis and/or treatment of a duodenal/ampullary polyp at Westmead hospital will receive VCE examination. Control population will consist of age matched controls having VCE for OGIB/IDA at Westmead hospital. Patients will be required to have had a documented colonoscopy within the previous three years. If colonoscopy was not performed within this time frame, the patient will have a colonoscopy as part of the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Cases - Patients who were diagnosed with or underwent resection of a duodenal adenoma/ampulloma at Westmead hospital between the years 2005-2014.
* Controls - Patients undergoing VCE procedure for the evaluation of obscure gastrointestinal bleeding (OGIB) or Iron deficiency anemia (IDA).

Exclusion Criteria:

* None
Feasibility and Safety Study Using Preoperative High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy at High-Risk for Extraprostatic Cancer

This study is being done to test the safety of a single high-dose of radiation therapy before radical prostatectomy (removal of the prostate). The investigators want to find out what effects, good and/or bad, the radiation will have on men undergoing prostatectomy. The investigators are especially interested in men who are at risk for having cancer cells that have spread outside the prostate.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven prostate cancer verified at MSKCC. The biopsy will include a minimum of 10 cores
* Radical Prostatectomy (RP) chosen as the therapeutic method
* The size of the prostate will be \< 70 cc by transrectal ultrasound or endorectal MRI imaging
* No radiographic evidence of lymph node metastases, bone metastases or soft tissue disease
* Risk of extraprostatic cancer of \> 40% based on the MSKCC surgical nomogram
* Age \> or = to 18 years
* KPS \> or = to 80
* Able to tolerate immobilization cradle positioning

Exclusion Criteria:

* Allergic reaction to intravenous CT contrast (if premedicated, pt will not be excluded)
* Prior radiation to the planned target region
* Patients receiving concurrent chemotherapy
* Neoadjuvant hormonal therapy Luteinizing-hormone-releasing hormone(LHRH)agonist and/or antiandrogen)
* Prior transurethral resection of the prostate
* Normal tissue directly overlying target precluding ability to limit the bowel, bladder, rectum or other tissue to less than or equal to 15-16 Gy dose constraints
* Dominant prostatic lesion within 3 mm from the anterior rectal wall by imaging studies
* Creatinine clearance \<60 ml/min/1.73m2
Use of Acupressing in Reproductive Medicine

The objective of this preliminary study is therefore to assess the feasibility, safety and reduction of perioperative anxiety thanks to acupressing. In addition, patients undergoing oocyte retrieval often present postoperatively with nausea, abdominal pain and discomfort. Acupuncture could also help these patients.

Infertility can lead to the realization of follicular puncture or oocytes in order to obtain an embryo for medically assisted procreation. It is a long treatment for the couples concerned and this intervention, relatively simple in young patients, is associated with a very high level of anxiety. According to studies, the incidence of preoperative anxiety ranges from 11% to 80% in adult patients. In patients undergoing outpatient surgery, anxiolytics are not administered before anesthesia in outpatient surgery, as this would risk altering their "fitness for the street" and preventing their return home. Studies have shown a benefit of acupressing in the treatment of preoperative anxiety. This technique could therefore be an alternative to drug anxiety before surgery. Acupressing could also help these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Scheduled to undergo an oocyte retrieval in outpatient surgery
* Anxiety score ≥ 3 when they arrived in the outpatient unit
* Subject is willing and able to provide informed consent
* Covered by a national healthcare insurance

Non-Inclusion Criteria:

* Ear's pavilion infection
* Wrist infection
* Previous treatment with auriculotherapy or acupuncture
* With a planned intervention that does not allow the delay of 45 min delay (+/- 15 min) between the acupuncture treatment and the STAI assessment
* Being deprived of liberty or under guardianship

Exclusion criteria

* Patient having recourse to any treatment or method of anxiolysis the morning of the procedure, after having given her consent
* Patient wishing to withdraw from the study
Reach Out and Read Arabic to Promote Arabic Literacy in Toddlers

The goal of this study is to encourage parents to read Arabic books to their children from an early age and by extension children will be more likely to read Arabic books and ultimately improve their Arabic literacy.

The investigators' hypothesis is that an adapted "Reach Out and Read" program will result in an increase in the proportion of parents reading Arabic books to their children after the intervention.

Early reading for toddlers has been linked to a better grasp of the fundamentals of language as they approach school age, as reading exposes the child to rich language and diverse content. Reach Out and Read program (ROR) is an American non-profit organization that advocates for childhood literacy.

In this study the investigators aim to implement an adapted version of the "Reach Out and Read" program and to encourage parents to read Arabic books to their children in order for this to become a daily habit. The goal of this study is to see an increase in the proportion of parents who read Arabic books to their children and by extension children will grow up loving to read Arabic books and ultimately may have improved Arabic literacy.

Eligibility Criteria:
Inclusion Criteria:

* Parents must identify the study's settings as the usual site for their child regular checkups
* Families are eligible if at least one parent understands, speaks and reads Arabic.
* The child's age between 4 and 6 months at the time of the enrollment

Exclusion Criteria:

* Children diagnosed or displaying severe behavioral, cognitive, or physical impairment, that prevents them in meaningfully engaging in a reading activity example: severe autism, profound developmental or intellectual delay.