cyrilzakka/clinical-trials huggingface dataset:
Study of Intraperitoneal Carboplatin with IV Paclitaxel and Bevacizumab in Untreated Ovarian Cancer

Phase I study to evaluate intraperitoneal carboplatin along with weekly intravenous paclitaxel and bevacizumab in order to establish a tolerable dose and define the toxicity of this regimen in previously untreated patients with advanced ovarian carcinoma.

Phase I study with the primary objective to determine the maximum tolerated dose of intraperitoneal carboplatin and intravenous weekly paclitaxel given in combination with intravenous bevacizumab during the second two cycles of treatment in patients with chemo-naive epithelial ovarian, primary peritoneal or fallopian tube cancer. The maximum tolerated dose is defined as the highest dose at which no more than 1 of 6 evaluable patients experiences a dose limiting toxicity during the second two cycles of treatment. Secondary objectives are to determine response rates and to estimate progression free survival and overall survival of this class of patients.

Eligibility Criteria:
Inclusion Criteria:

* Histology diagnoses epithelial ovarian, primary peritoneal, or fallopian tube(Stage II, III or IV)either optimal or suboptimal after initial surgery.

  * All patients must have had appropriate surgery for ovarian, peritoneal, or fallopian tube carcinoma with tissue available for histologic evaluation
  * Histologic epithelial cell types are eligible: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant brenner tumor, adenocarcinoma NOS.
* GOG(Gynecologic Oncology Group)performance status of 0,1,2
* Entered within 12 weeks of most recent surgery performed for diagnosis.
* Patients must have adequate bone marrow function, renal function,hepatic function, neurologic function, blood coagulation parameters within normal limits
* Sign approved consent form.

Exclusion Criteria:

* Patients who have received prior treatment other than initial surgery
* Patients who have received prior radiotherapy to any portion of their abdominal cavity or pelvis
* Patients with acute hepatitis or active infection
* Patients with active bleeding
* Patients with unstable angina
* Patients with history of invasive malignancies with the exception of nonmelanoma skin cancer and localized breast cancer.
* Patients who have received any target therapy or hormonal therapy for management of their ovarian cancer.
* Patients with synchronous primary endometrial cancer.
* Patients with epithelial tumors of low malignant potential
* Serious non healing wound, ulcer or bone fracture.
* Patients with history or evidence of CNS(central nervous system disease)
* Patients under 18 years old.
* Patients who have received prior therapy with anti-VEGF(vascular endothelial growth factor)

drug, bevacizumab

* Patients who have a history of allergic reaction to polysorbate 80.
Inflammatory Response in Myocardial Infarction Evaluated by MRI and Biomarkers

An intense inflammatory reaction is triggered by the ischemic injury during myocardial infarction. The inflammatory processes involved are complex and haven't been explored in detail in human patients. This inflammatory response can increase myocardial damage following reperfusion, leading to adverse remodeling and adverse events (heart failure, sudden cardiac death).

Cardiac MRI can assess the size of myocardial infarction and many other parameters associated with myocardial injury: edema, hemorrhage, micro-vascular obstruction.

(However the association between biomarkers of inflammation and these imaging parameters is not known).

There is very little data correlating imaging markers of myocardial injury to the biokinetics of inflammation biomarkers.

In this study, the aim is to assess the relationship between the kinetics of specific inflammatory biomarkers (interleukin-1beta, interleukin 6, interleukin 17, Tumor Necrosis Factor (TNF)-alpha, C reactive protein (CRP), soluble toll-like receptor-2 (ST2), neutrophils) and imaging markers of injury measured by cardiac MRI at the acute phase in 20 acute mycardial infarction (AMI) patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients, aged over 18, without any legal protection measure,
* Having a health coverage,
* Presenting within 12 hours of the onset of chest pain,
* Who have ST segment elevation ≥0.2 millivolt (mV) in two contiguous leads,
* For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
* he culprit coronary artery has to be the left anterior descending (LAD) or the right coronary (RC)
* The LAD or RC artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
* Preliminary oral informed consent followed by signed informed consent as soon as possible
* Final TIMI ≥ 2

Exclusion Criteria:

* Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
* Patients with cardiogenic shock
* Patient in Cardiac arrest
* History of Myocardial Infarction
* Contre-indication to MRI : claustrophobia, pacemaker or cardiac defibrillator , eye metal body allergy to gadolinium
* Patient with Atrial Fibrillation.
* Patients with loss of consciousness or (Glasgow \<14)
* known renal insufficiency (either known creatinin clearance \< 30 ml/min/1.73m² or current medical care for severe renal insufficiency)
* Patients with any disorder associated with immunological dysfunction
* Adult with legal protection measure
Renal Assist Device (RAD) for Patients With Renal Insufficiency Undergoing Cardiac Surgery

The study is a prospective, non-randomized early feasibility study intended to evaluate the safety and performance of the JuxtaFlow System (also known as the JuxtaFlow Renal Assist Device (RAD)) in participants with pre-existing renal insufficiency who are undergoing cardiac surgery.

The BIPASS-AKI study is intended to evaluate participants who are at an increased risk of developing cardiac surgery-associated acute kidney injury (CSA-AKI), and, subsequently, overall poor outcomes. Patients to be considered for participation include those undergoing elective or urgent in-house on-pump cardiac surgery (to include coronary artery bypass graft, valvular surgery, or combination) and have pre-existing renal insufficiency as defined by a pre-operative eGFR between 15-60 mL/min. Participants meeting inclusion and exclusion criteria will be enrolled into a treatment arm (single-arm study) following the completion of informed consent. Participants will receive implantation of the JuxtaFlow Catheters following completion of the their cardiac surgery while remaining under anesthesia. Treatment with the JuxtaFlow System will be initiated upon the participant's arrival into the intensive care unit and continue for up to 24 hours post-operatively. Preoperative, intra-operative, and post-operative data will be collected on participants to include 15- and 30-day follow-up periods.

Eligibility Criteria:
Inclusion Criteria:

1. Candidate cardiac surgical patients
2. Elective or Urgent on-pump coronary artery bypass grafting (CABG) and/or valvular surgery
3. Age 22 to 85 years
4. eGFR \< 60 mL/min/1.73m2
5. Signed informed consent

Exclusion Criteria:

1. End-stage renal disease (receiving hemodialysis or glomerular filtration rate \<15 ml/min/1.73m2)
2. Planned off-pump surgery
3. Any patients with high-grade proteinuria (i.e., urine protein concentration \> 300 mg/dL)
4. Pregnancy
5. Any secondary condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures, including injuries to the urinary organs and/or external genitals
6. Current or planned treatment with an investigational drug (IND), device (IDE), or other investigational intervention within 3 months prior to or during participation in this clinical trial
Influence of Different Sugary Beverages on Thirst Sensation

The purpose of this study is to determine if water and three different sugary beverages (milk, Orange juice and iced tea) have the same effect on thirst.

Participants should be in the laboratory at 8.00 in order to collect the values of weight, height, total body water, intracellular water and extracellular water in a Segmental Multi Frequency Body Composition Monitor (TANITA MC 180 MA®). Then, a blood sample will be collected for analysis of blood glucose, osmolality and plasmatic sodium. They will sit at individual tables for the duration of the session and were allowed to read, listen to music with earphones, or use their portable computers with the exception of internet access to minimize visual cues (e.g., unwanted publicity for beverages or visiting Web sites showing pictures of food and drinks), which may have effect on thirst. Breakfast will be served at 9.30 on every occasion and preload stimuli will be offered exactly 60 minutes after breakfast (at 10.30). Lunch will be provided at 13.00. Motivational ratings will be first obtained at the end of collection of blood sample (baseline or time 0) and every 30 minutes thereafter until the lunch time (times 1 through 7). After lunch (time 8), participants will complete the last set of ratings and will bring a food diary to record all food and fluid intake until 00.00 that day.

Eligibility Criteria:
Inclusion Criteria:

* body mass index(BMI) between (18,5 - 27,5 kg/m2)
* regular consumers of breakfast
* stable in weight for the past 6 months
* not dieting to gain or lose weight
* like all drinks and food available in study

Exclusion Criteria:

* pregnant and nursing women
* smokers
* athletes
* subjects under medication(except oral contraceptives in women)
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Have Type 2 Diabetes
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
* Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
* Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
* Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

* Have Type 1 Diabetes
* Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
* Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
* Have New York Heart Association functional classification IV congestive heart failure.
* Have acute or chronic pancreatitis
Assessment of Routine Oral Screening Programs for New Prisoners

In 2018, 10 detention centers in France will start organisational programs to improve the quality of screening of oral diseases, relatively to French recommendations, among new prisoners in France. Our study aims 1) to assess the prevalence and nosology of oral diseases ; 2) to describe the care pathway of participants during their stay in the detention center where they were included ; 3) to assess the cost of care per patient, from a societal perspective, using a top-down method.


Eligibility Criteria:
Inclusion criteria:

* new prisoners
* fluent French language

Exclusion criteria:

* adult guardianship
dbGaP Protocol: Genetic Variants Associated With Pentalogy of Cantrell

Background:

Pentalogy of Cantrell (POC) is a syndrome that involves many heart abnormalities as well as large defects in the chest and abdominal wall. This often results in the heart and other organs being present outside the body at birth. Surgeons have learned to replace them and repair the heart. Researchers want to find possible gene changes that cause POC. To do this, they want to study data from the Pediatric Cardiovascular Genetics Consortium (PCGC) Cohort. The PCGC collects data and DNA samples from people with heart diseases and their families

Objectives:

- To find gene mutations in people with Pentalogy of Cantrell (POC) or other related syndromes.

Eligibility:

- PCGC data and DNA samples that are open to study by the public.

Design:

* Researchers will study the data from the PCGC.
* The gene testing being done in this study was consented to in the original studies. No new consent or waiver request is required.
* The study will last 1 year.

The purpose of this protocol is to identify genetic mutations in patients with the diagnosis of Pentalogy of Cantrell (POC) or other related syndromes. We will be looking for any exomic/genomic mutations that could be associated with this syndrome. We have produced a mouse model with a mutation in the gene encoding nonmuscle myosin IIB which exhibit problems with ventral wall closure, including extrathoracic location of the heart (ectopia cordis) and defects in the abdominal wall with protrusion of the guts and liver. These mice have severe defects in both the heart and brain, and resemble humans born with POC, who manifest these same abnormalities, and so we take a special interest in mutations in nonmuscle myosin proteins.

Eligibility Criteria:
* We will analyze data from subjects from congenital cardiovascular disease databases.
Cardiac Output Autonomic Stimulation Therapy for Heart Failure (COAST-HF) - Human NeuroCatheter Study

A single-center feasibility study in patients undergoing cardiac catheterization, to investigate the acute hemodynamic effects of transvenous cardiac autonomic nerve stimulation.

A single-center feasibility study performed in patients undergoing a planned cardiac catheterization. This study investigated the feasibility of the NeuroTronik CANS Therapy™ System to improve acute hemodynamics. Purpose-built stimulation catheters were percutaneously inserted into an upper venous structure near the heart via right femoral vein and or left subclavian vein access using standard introducers and techniques. Subjects were instrumented with left ventricular and femoral artery catheters for pressure measurement and stimulated for approximately 60 minutes. Baseline hemodynamic measures were collected before stimulation and compared to measured values during stimulation. Following completion of the protocol, all in-dwelling equipment and catheters were removed.

Eligibility Criteria:
Inclusion Criteria:

* Stable symptomatic heart failure - New York Heart Association Class II or III
* Normal Sinus Rhythm

Exclusion Criteria:

* Unable to gain arterial or venous access using standard percutaneous techniques
* New York Heart Association Class IV
* Patient taking amiodarone or other anti-arrhythmic therapy
* Patients with implanted pacemaker, ICD, or CRT device
* Patients who had CABG, PCI or enzyme-positive MI within prior month
* Patients with pre-existing carotid artery or cerebral disease
* Patients with hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g. amyloidosis, sarcoidosis)
* Patients who have been hospitalized for heart failure and who required the use of heart failure IV therapy within 30 days before enrollment (measured from release)
* Patients with current or prior vagal nerve simulator
* Patients with renal failure
* Patients with hepatic failure
* Patients with narrow angle glaucoma
* Patients who are pregnant
* Patients with a life expectancy \< 12 months per physician judgment
* Patients with allergy to fentanyl, midazolam, propofol, eggs, egg products, soybeans, or soy products
Effect of a Programme Based on Professional Ethics in Physiotherapy Students

The aim of this study was to assess the effect of a higher education programme based on professional ethics in physiotherapy students.

A simple-blind clinical trial was performed. A three-months program based in professional ethics was carried out.

The investigators compared a control group (traditonal lectures) with an intervention group (syllabus, activities, face to face techniques). Students´ attitudes, knowledge, professional values, and opinions towards professional ethics were evaluated before and after the programme, in both groups. All participants were informed about the study and procedures, and provided written informed consent.

Participants. Second-year degree students of Physiotherapy Degree at the University, aged between 20 and 30 years, were recruited voluntarily from January 2019 to April 2019 . All enrolled participants were informed of the purpose of the study and procedures, and provided written informed consent. The study was carried out at the institution where the authors belong.

Research design. A prospective simple-blind trial was performed. After baseline assessment, participants were allocated to one of the two groups (control group and experimental group). An external assistant not involved in the study performed assignment.

Intervention. A Physiotherapy professor with over-10-year experience in Ethics and Physiotherapy performed the teaching methodology and opened the allocation envelopes and applied the teaching methodology to the EG according to the group assignment. The intervention consisted of a three-month program based in professional ethics, including two phases: A) syllabus and activities; and B) face to face group sessions including techniques such as concept maps, glossaries, brainstorming, four corners activity, aquarium, philip 6-6, kahoot, Realm Individual-Process Situation, reduced groups, guided debates, and discussion groups.

Eligibility Criteria:
Inclusion Criteria:

* To study the physical therapy degree at the University of Valencia

Exclusion Criteria:

* Exclusion criterion was having prior training on Ethics subject
High-dose Dexamethasone Versus Conventional Dose Prednisone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

The project was undertaking by Qilu Hospital of Shandong University and other 11 well-known hospitals in China. In order to report the efficacy and safety of high-dose dexamethasone compared to conventional dose prednisone for the first-line treatment of adults with primary immune thrombocytopenia(ITP).

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 300 adults with ITP from 11 medical centers in China. Part of the participants are randomly selected to receive high-dose dexamethasone treatment and the other part are selected to receive conventional dose of prednisone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of high-dose dexamethasone compared to conventional dose prednisone for the first-line treatment of adults with ITP.

Eligibility Criteria:
Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.
2. Untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years.
3. To show a platelet count \<30 \* 10\^9/L, and with bleeding manifestations.
4. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
5. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
7. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
8. Patients who are deemed unsuitable for the study by the investigator.
Epidemiological Study of a Prospective Cohort of Patients Aged 60 and Over Managed for Acute Myeloid Leukemia (AML) and Receiving Intensive Induction Therapy

This observational epidemiological study targets patients aged 60 and over with de novo or secondary acute myeloblastic leukemia suitable for intensive receive intensive induction therapy as defined by the group. The main aim of the study is to determine the epidemiological characteristics of AML patients, both clinically and biologically, and to correlate these to their outcome. The incidence of AML increases with age, exponentially after the age of 50, giving a median age at diagnosis of close to 70 years, with over half of patients half of patients are over 60 at diagnosis. The principle of treatment as in younger patients, is based on trying to achieve complete remission (CR). remission (CR). Observed complete remission rates range from 38 to 70%. Long-term survival of elderly subjects remains limited, at around 10 to 15%, despite the various types of consolidation tried out in recent years.

years. However, intensive chemotherapy remains the preferred option for initial treatment of these hematological diseases when general condition and comorbidities allow. As shown by Swedish registry studies, it is associated with improved life expectancy.

The proportion of patients who can receive intensive initial treatment is not well known in France, probably varies widely from one region to another, and certainly decreases with increasing age. Only the registry studies currently underway will enable us to assess this precisely.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 and over
* Patients with previously untreated de novo or secondary AML
* Patients suitable for standard intensive treatment
* Patients who have read the information document and agreed to the collection of data concerning them (signature of informed consent).

Exclusion Criteria:

* Patients with AML 3
* Patients with severe, uncontrolled infection at the time of inclusion
* Patients with psychiatric or social disorders that will prevent compliance with the protocol
* Patients without health insurance (affiliation to a social security scheme)