cyrilzakka/clinical-trials huggingface dataset:
Randomized Phase III Study of Folfiri+Avastin Versus Xeliri+Avastin as 1st Line Treatment of CRC

This phase III study will compare two combinations of irinotecan, Folfiri versus Xeliri, with the addition of Avastin as 1st line treatment of colorectal cancer.

There is no data of comparison for Folfiri and Xeliri regimens. The reported data demonstrated that the addition of Avastin in the combination of irinotecan/bolus 5-FU/LV has significant improvement of overall survival. Further analysis of these results showed that patients receiving irinotecan in combination with Avastin, as 1st line treatment and oxaliplatin with Avastin, as second line treatment, have median overall survival 25, 1 months, which is the longest survival that has been reported.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic colorectal cancer
* Measurable or evaluable disease
* ECOG performance status ≤ 2
* Age 18 - 72 years
* Adequate liver (Bilirubin ≤ 1.5 UNL, SGOT/SGPT ≤ 4 UNL, ALP ≤ 2.5 UNL), renal (Creatinine ≤ 1.5 UNL) and bone marrow (ANC ≥ 1,500/mm3, PLT ≥ 100,000/mm3) function
* Patients with history of hemoptysis or with increased risk of thromboembolic events should be observed carefully due to administration of Avastin
* Patients must be able to understand the nature of this study
* Written informed consent

Exclusion Criteria:

* Previous 1st line chemotherapy
* Adjuvant chemotherapy with Irinotecan regimen with relapse \< 6 months after the completion
* Active infection
* History of serious cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
* Previous radiotherapy within the last 4 weeks or \> 25% of bone marrow
* Patients with unstable CNS metastases
* Patients with chronic diarrhea (at least for 3 months) or partial bowel obstruction
* Second primary malignancy, except for non-melanoma skin cancer and in situ cervical cancer
* Psychiatric illness or social situation that would preclude study compliance
* Pregnant or lactating women
* Patients \> 65 years with history of arterial thromboembolic, myocardial infarction, unstable angina and pulmonary embolism
Breathing-based Leg Resistance Exercise Improves Wound Healing, Blood Sugar and Quality of Life for Diabetic Foot Ulcers

The purpose of the study was designed leg resistance training combined with breathing approach, and evaluated its effect on wound healing, blood sugar control and quality of life in type 2 diabetic patients with foot ulcers.

A randomized controlled trial was used. type 2 diabetic patients who suffered from foot ulcers were recruited from one medical center of Northern Taiwan, and randomly assigned into the exercise or control group. The control group received usual care for diabetic foot. The exercise group received usual care and breathing-based leg resistance exercise program for 12 weeks. Outcomes were measured by wound healing area, the fasting of blood glucose, hemoglobin A1c (HbA1c), and the World Health Organization quality of life-BREF (WHOQOL-BREF) before the intervention as baseline, and the 4th, 8th and 12th weeks during the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* patients 20 years or older
* who were diagnosed with type 2 diabetic foot
* ulcers of Meggitt-Wagner Grade 1-2
* who were conscious and could perform the prescribed exercise.

Exclusion Criteria:

* peripheral arterial occlusion disease
* osteomyelitis
* inability to perform exercise as assessed by physicians.
Quality of Life After Surgery for Pancreatic Carcinoma

Pancreatic cancer has a high mortality rate. Patients with an intended curative resection show a median survival of 17-23 months. Therefore, quality of life is very important in this patient group. In this study, the effect of pancreatic surgery on quality of life is measured.


Eligibility Criteria:
Inclusion Criteria:

* patients with a suspected pancreatic malignancy
* eligible for surgery with curative intent
* being able to complete questionnaires in Dutch
* age \>=18 years

Exclusion Criteria:

* none
Evaluation of a Residential In-Reach Program in Regional and Rural Australia

Residential In-Reach (RIR) programs are designed to provide responsive care for residents in residential aged care homes (RACH) with the aim of avoiding unnecessary hospital transfers. The evidence for their clinical and cost-effectiveness and implementation has been established in urban settings, but there is a small amount of low-quality evidence for rural and regional settings. The Grampians Region Health Service Partnership Resi-In-Reach Redesign Committee will be implementing a new RIR program to be offered to all RACHs in the Grampians region, this project aims to evaluate the clinical and cost-effectiveness of this program, and its implementation in the rural and regional setting. A stepped-wedge trial will be conducted so that as the RIR program is gradually rolled-out across the region, outcomes can be compared in the same facilities across time and between different facilities. The primary outcome measure will be presentation to emergency departments and urgent care centres, and data will also be collected on other clinical outcomes and barriers and enablers of implementing the program. It is anticipated that there will be a reduction in hospital presentations, and a range of barriers and enablers unique to the rural and regional setting will emerge.


Eligibility Criteria:
Inclusion Criteria:

* Health services that have emergency departments and/or emergency care centres that admit residents from residential aged care homes (RACH)
* RACHs that do not currently have access to RIR programs
* health service staff who have been involved with the set-up and delivery of the RIR program,
* RACH staff who have experience of or accessing the RIR service for residents at least once,
* residents living at a RACH who has experienced receiving medical care from the RIR program and can provide informed consent, or a family member of the resident,
* general practitioners whose case load includes residents from RACHs.

Exclusion Criteria:

• RACHs that already have access to a RIR program will be excluded
Knowledge, Attitude, and Perceptions Towards Artificial Intelligence Among Dental Students

The aim of this study will be to assess knowledge, attitudes, and perceptions towards Artificial intelligence among dental students of Faculty of Dentistry, Tanta University

A cross-sectional study will be adopted using an online-based questionnaire that will be sent to dental students in the Faculty of Dentistry, Tanta University. A questionnaire will be adopted from an existing similar pre validated study. The link of the survey will be created using Microsoft form and will be disseminated through various open social media groups of dental students.

Eligibility Criteria:
Inclusion Criteria:

* all dental students of Faculty of Dentistry, Tanta University

Exclusion Criteria:

* The postgraduate students
Lactobacillus Reuteri in Adult With Functional Chronic Constipation

A double-blind, placebo Randomized Controlled Trial, To evaluate the effects of L. reuteri in adult patients with functional constipation.

Patients affected by functional constipation according to Rome III criteria. The increase of Bowel Movements/week frequency was the primary outcome, while the improvement of stool consistency was the secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* functional constipation rome III

Exclusion Criteria:

* hypothyroidism or other metabolic or renal abnormalities, or
* antibiotic's treatment,
* probiotic or prebiotic supplementation in the last month
Intracranial Stenting in Non-acute Symptomatic Ischemic Stroke

In non-acute symptomatic ischemic stroke, the decision-making of medical treatment plus intracranial stenting has been more and more popular, especially in patients with intracranial large severe stenosis or occlusive artery. Nonetheless, there is no evidence from randomized controlled trials evaluating the efficacy of this treatment after the Wingspan Stent System Post Market Surveillance (WEAVE) and Wingspan One Year Vascular Imaging Events and Neurologic Outcomes (WOVEN) trial compared with medical treatment alone. This trial was to investigate whether medical treatment plus intracranial stenting would prevent the recurrent ischemic stroke in the territory of the symptomatic intracranial artery during 1-year follow-up.

In symptomatic ischemic stroke due to intracranial large severe stenosis or occlusive artery, the choice for treatment has remained controversial after results of the Stenting versus Aggressive Medical Therapy for Intracranial Arterial Stenosis (SAMMPRIS) trial because it demonstrated that the efficacy of medical treatment was superior to intracranial stenting in the low risk of periprocedural stroke or death. However, this conclusion has influenced the role of intracranial stenting in the ischemic stroke treatment and recovery time for a long time because of the unproper patient selection of this trial such as no evidence of medical failure, intracranial stenting earlier than 7 days after the stroke and intracranial stenting in patients with transient ischemic attacks only. Recently, the Food and Drug Administration (FDA) mandated study about intracranial stenting, WEAVE trial, reported not only 97.4% patients with no complication at 72 hours, but also a relatively low 8.5% recurrent stroke and death rate during 1 year in the WOVEN study. In case of the symptomatic stenosis greater than 70%, the probability of recurrent stroke and transient ischemic attack in the territory of the symptomatic stenotic artery in 1 year was 23% and 14%, respectively, despite treatment with antithrombotic therapy and standard management of vascular risk. Given a lot of patients with symptomatic ischemic stroke who have some adjustable indications for intracranial stenting deployment in the world and a paucity of evidence from randomized trials, the purpose of this trial was to compare this treatment versus medical one in the intracranial large severe stenosis or occlusive artery.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of intracranial large severe stenosis or occlusive artery in angiography.
* Absence of intracranial hemorrhage.
* Premorbid mRS score is ≤ 3.
* Recurrent stroke in the target territory during the medical treatment for ischemic stroke prevention.

Exclusion Criteria:

* Tandem lesion.
* Loss to follow-up after discharge.
* A severe or fatal combined illness before acute ischemic stroke.
* Progressive neurologic deficit within 7 days after acute ischemic stroke.
* Large middle cerebral artery infarct within 30 days after acute ischemic stroke.
Contribution of ESAOTE™ Low Field MRI for Diagnosis of Scaphoid Fractures

The Alpes Maritimes county administration (France) equipped Nice University Hospital of a 0,2T low field MRI dedicated to distal articulations, devoted to research, installed in the medical imaging unit.

The aim of our project is to study its interest in diagnosis of scaphoid fractures.

Conventional medical care for patients being suspected to have a scaphoid fracture consists in performing a clinical examination and a radiographic check-up with at least 4 incidences, which 2 specific incidences for the scaphoid bone.

Yet, this check up is sometimes defective, causing false positives unnecessary immobilisation and false negatives delays in patient medical care, increasing the risk of complication. Those diagnosis mistakes can bring serious consequences, from permanent partial inability, to professional reclassification.

Alternative imaging exists, but is often irradiating, and never reaches the optimal specificity and sensitivity.

MRI is totally safe, and allows to affirm or invalidate the diagnosis in almost 100% of cases. The problem is the lack of accessibility for emergency cases; therefore there is a great interest in validating the use of a MRI dedicated to distal articulations.

The few studies that study costs of diagnosis strategies including MRI in scaphoid bone fractures diagnosis show a reduction of medical costs if this technique is used early. Our project represents an essential initial step in evaluating the impact of a low field MRI dedicated to peripheral articulations in diagnosis of scaphoid fractures. The next step will be a medico-economical study, since scaphoid fractures occur frequently.

Finally, a new consensus for medical care of scaphoid fracture suspicions could be proposed.


Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of scaphoid bone fracture, whatever the radiologic check-up result is.
* Major patient who signed the informed consent form.
* Patient affiliated to French national health and pensions organization. NON INCLUSION
* MRI contraindication.
* No pain.
* No traumatic antecedent.
* Pregnant or suckler women.
* Patient under a guardianship or a trusteeship
* Patient deprived of liberty consequently to a judiciary procedure
* Patient holding a pace-maker
* Patient holding a foreign body or ferromagnetic prosthetic material.
The Role of Endogenous GIP in Glycosis Metabolism During Fasting

This research project aims to investigate the role of endogenous GIP during fasting. With the infusion of a GIP receptor antagonist (GIP\[3-30\]NH2), is it possible to selectively remove the effect of endogenous GIP, and thus describe its effects by comparing it with what happens during a saline infusion.

This research project investigates the effects endogenous GIP has in the body of healthy, overweight people. Two trial days will be held. The participant will receive intravenous infusion of either GIP\[3-30\]NH2 (800 pmol/kg/min) or placebo (saline) in a randomized order. After 20 minutes, GIP\[3-30\]NH2 is expected to have maximum effect. On time of 180 minutes, an ad libitum meal is served, which is consumed during continued infusion. When the participant is comfortably full, the infusion is turned off and the trial day ends. During the day, the participant assesses and notes on standardized VAS schedules current appetite, satiety, nausea, fatigue, malaise and thirst. Blood pressure and heart rate are measured every 30 minutes throughout the trial day and blood samples are taken. In total, there will be drawn ten blood samples between intervals of 15 to 30 min. Three times along the way, the activity in the brown adipose tissue is measured with a thermal camera (temperature measurements over the skin on the chest) and the resting metabolic rate is determined with indirect calorimetry (inhaled and exhaled air is captured by breathing under a large plastic bell).

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years
* BMI \> 30 kg/m2
* Body fat percentage \> 25 % for men og \> 35 % for women

Exclusion Criteria:

* Type 1 diabetes and/or type 2 diabetes diagnosis
* Other chronic condition
* Treatment with medications or supplements that cannot be paused for 12 hours
* \> 14 units of alcohol weekly or drug abuse
* Circulating liver enzymes (alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT)) ≥ 2 × normal value
* Renal impairment (eGFR \< 90 or creatinine level above the reference range)
* Uncontrolled high resting blood pressure (above 140/90 mmHg)
* Low blood percentage (hemoglobin \< reference range (different for women and men))
* Special diet or planned weight change within the trial period
* Any disease/condition that investigators believe will interfere with study participation
PartnerED Care: Coordinated Emergency Department Transitions for Assisted Living Patients With Alzheimer's Disease and Related Dementias

The goal of this observational study is to learn the feasibility, acceptability, appropriateness, and adherence to a case management intervention. PartnerED is a case management intervention that aims to reduce unnecessary hospital admissions by providing real-time, structured information and discharge support to emergency department providers via phone and fax. The intervention is led by chronic care managers employed by Bluestone Accountable Care Organization, a physician group primarily serving patients in assisted living centers.


Eligibility Criteria:
Inclusion Criteria:

* Bluestone Accountable Care Organization patient
* Registration in emergency department between November 1, 2023 and June 30, 2024, as recorded in electronic admission, discharge, and transfer notifications

Exclusion Criteria:

* None
OLE Study of Carbetocin Nasal Spray for the Treatment of Hyperphagia in Prader-Willi Syndrome

To evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS

This is a long-term, OLE study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg TID) in subjects with PWS. Subjects who complete the antecedent double-blind study (ACP-101-302) will be invited to participate in the present study.

Eligibility Criteria:
Inclusion Criteria:

* Has completed the Week12/EOT visit of the antecedent, Study ACP-101-302
* Met all entry criteria for the antecedent study
* May benefit from long-term treatment with open-label carbetocin in the judgment of the Investigator.
* Lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits.

Exclusion Criteria:

* History of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. A history of febrile seizures is not exclusionary.
* Active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder
* History of suicide attempt or inpatient psychiatric hospitalization
* Has a clinically significant abnormality in vital signs at Baseline
* Has an average QTcF interval of \>450 ms on the Baseline ECG performed before the first dose of carbetocin is given in the present study (i.e., the ECG performed at the EOT visit of the antecedent study)
* Has developed a clinically significant ECG finding during the antecedent study
* Subject is judged by the Investigator or the Medical Monitor to be inappropriate for the study due to AEs, medical condition, or noncompliance with investigational product or study procedures in the antecedent study

Additional inclusion/exclusion criteria apply. Subjects will be evaluated at screening to ensure that all criteria for study participation are met.
Breath, Stress and Health: a Biocultural Study of Hatha Yoga Practice

This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress, biochemical immunity and longevity markers, and validated psychological measures that relate to mental health.

This study aims to contribute uniquely to stress, longevity, and mental health research in two ways: by identifying clear protocols of breath-based yoga-meditative practice based on original materials; that are subsequently assessed with established scientific stress markers across the sympathetic-adreno-medullar (SAM) axis, biochemical immunity and longevity markers, and validated psychological measures as related to mental health. The study couples emic perspectives from the traditional yoga knowledge base, both textual and practice, with empirical measures from science as an opportunity to bridge these worlds as a first known study of hatha yoga to be tackled by the means and methods of biocultural anthropology. It therefore highlights the importance of context and detail in terms of assessing human behavioral practices, where accuracy in terms of definitions, technique detail, and original purported intentions and outcomes are addressed as relevant when measuring and explaining empirical outcomes under modern research mixed methods.

Eligibility Criteria:
Inclusion Criteria:

* Novice to breath-based yoga practice
* Multicultural international participant base
* Fluent in English comprehension and reading
* In general good health
* Have a smartphone or similar device in order to receive surveys on a dedicated app

Exclusion Criteria:

* none
Healthy Heart Score Intervention In the Primary Care Setting

In this pilot study, the investigators will assess the clinical utility and feasibility of the Healthy Heart Score in the primary clinical care setting for the primordial prevention of cardiovascular disease. The investigators will conduct a randomized clinical trial to test the lifestyle intervention based on the Healthy Heart Score compared to usual care. The aim is to include 100 participants (50 in each group). Each participant will complete 2 visits (initial and a follow up visit after 12 weeks).

Created by the Harvard T.H Chan School of Public Health, the Healthy Heart Score is a previously validated online risk calculator that determines the 20-year Cardiovascular Disease ) risk based on 9 modifiable lifestyle factors including; smoking habits, body mass index, physical activity, alcohol consumption, fruit and vegetables intake, cereal fiber, nuts, sugar-sweetened beverages, and red meat, and processed meats consumption.

In this pilot study, the investigators will assess the clinical utility and feasibility of the Healthy Heart Score in the primary clinical care setting for the primordial prevention of cardiovascular disease. The investigators will conduct a clinical trial to test our intervention compared to usual care. The investigators will conduct a randomized clinical trial to test the lifestyle intervention based on the Healthy Heart Score compared to usual care. The aim is to include 100 participants (50 in each group). Each participant will complete 2 visits (initial and a follow up visit after 12 weeks).

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older, No cardiovascular diagnosis, Body Mass Index \> 25 and/or having at least one of the following clinical risk factors: elevated blood pressure, pre-high cholesterol, pre-diabetes but not currently taking medications for the previous conditions.

Exclusion Criteria:

* Those not meeting the inclusion criteria and women who are pregnant or planning to get pregnant.
Effect of Multi-species Probiotic HOWARU® Restore, on Gut Microbiota of Elderly

The study is randomized, double-blinded and placebo-controlled with a duration of 24 weeks. Following randomization, healthy elderly are randomized into two groups receiving probiotics or placebo. Fecal samples are collected before and after the study. The samples are investigated for Clostridium difficile levels, changes in diversity of the gut microbiota as well changes in the fecal metabolome. The effects of the produced metabolites on mitochondrial activity will moreover be investigated using selected intestinal cell lines.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* aged 75 years or more

Exclusion Criteria:

* Individuals with chronic bowel diseases
* Individuals with severe immunosuppression
* Individuals with dementia
* Individuals who are terminally ill
* If severe/prolonged illness occurs after the start of the test, the subject must drop out of the study
* Individuals who have consumed probiotic products after two weeks prior to the start of the study or during it.
* Subjects with a history of substance abuse
* Subjects that, in the investigators opinion, are not expected to complete the study succesfully