cyrilzakka/clinical-trials huggingface dataset:
Optimal Heating Temperature in Major Burns Patients

pre and post intervention quasi-experimental epidemiological study without a control group will be carried out in large burned patients that will evaluate the influence on metabolic expenditure of the inclusion of active external rewarming in the control of body temperature.

the heavily burned patient requires specific care to prevent hypothermia and maintain body temperature. You are at high risk of developing hypothermia in the acute phase due to heat losses from convection, radiation, evaporation, and conduction. After the acute phase, the patient due to physiological mechanisms and the hypermetabolic response mainly demands a temperature close to 38.5ºC, ruling out the infectious focus. According to the authors, environmental temperatures between 28-33ºC are recommended for the care of these patients to decrease energy expenditure. The research carried out has studied the influence of passive external heating (environmental regulation), without including the influence of active external heating (heat blankets, heating plate ...) or the study of the thermal comfort of large burned patients and of professionals who provide them they attend.

A pre and post intervention quasi-experimental epidemiological study without a control group will be carried out in large burned patients that will evaluate the influence on metabolic expenditure of the inclusion of active external rewarming in the control of body temperature. Metabolic expenditure will be measured by indirect calorimetry in the usual treatment with passive external rewarming and post-intervention in the combination of passive and active external heating. The combination of passive and active external reheating will previously study the operating temperature in various cases for optimal application, as well as the definition of thermal comfort in the large burn unit. The specific training of the personnel involved in the care of these patients will be required for the application of the evidence-based recommendations and the evaluation of their implementation.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age.
* Patients with thermal burns.
* Patient with high burn criteria according to ABA:
* 2nd degree burn
* Patient 18 - 59 years: SCQ\> 20%
* Patient\> 60 years or pathology: SCQ\> 10%
* 3rd degree burn
* SCQ\> 10%
* Patients on mechanical ventilation

Exclusion Criteria:

* Sepsis criteria according to ABA.
* Enzyme debridement application (data within 24 hours).
* 6 hours after a surgical intervention.
* After 2 hours after healing burns
* Patients in hemorrhagic shock
A Relative Bioavailability and Food-Effect Study of the Fixed Dose Combination of GSK3640254 and Dolutegravir (DTG) in Healthy Participants

This is a two part study to compare the relative bioavailability (BA) of 2 fixed dose combinations (FDCs) of GSK3640254/DTG with GSK3640254 and DTG administered together as single agents (Part 1) and to assess the effect of food on the pharmacokinetic (PK) of the selected FDC of GSK3640254/DTG (Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
* Participants capable of giving signed informed consent.

Exclusion Criteria:

* Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
* A pre-existing condition interfering with normal gastro intestinal anatomy or motility (for example \[e.g.\], gastroesophageal reflux disease, gastric ulcers, gastritis) or hepatic and/or renal function that could interfere with the absorption, metabolism, and/or excretion of the study intervention or render the participant unable to take oral study intervention.
* Prior cholecystectomy surgery (prior appendectomy is acceptable).
* Clinically significant illness, including viral syndromes within 3 weeks of dosing.
* Participant with known or suspected active Coronavirus disease (COVID)-19 infection or contact with an individual with known COVID-19, within 14 days of study enrollment.
* Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention (including an investigational COVID vaccine) or any other type of medical research.
* Prior exposure to GSK3640254 or prior intolerance to DTG in this or another clinical study.
* Any positive (abnormal) response confirmed by the investigator on a screening clinician- or qualified designee-administered Columbia Suicide Severity Rating Scale (C-SSRS).
* Any significant arrhythmia or ECG finding (e.g., prior myocardial infarction in the past 3 months, symptomatic bradycardia, non-sustained or sustained atrial arrhythmias, non-sustained or sustained ventricular tachycardia, any degree of atrioventricular block, or conduction abnormality) which, in the opinion of the investigator or ViiV Healthcare (VH)/GlaxoSmithKline (GSK) medical monitor, will interfere with the safety for the individual participant.
Safety and Efficacy of YH14617 in Diabetes Mellitus

The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617 after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.


Eligibility Criteria:
Inclusion Criteria:

* Have signed a written informed consent voluntary, prior to the any procedure
* Volunteers of aged between 20 years to 75 years
* Have been diagnosed with type 2 diabetes at least 3 months prior to study
* Have a body mass index (BMI) of \> 23kg/m2 and have a history of stable body weight during 3 months prior to the first administration (not varying by \> 5% in weight)
* Have been treated with stable dose regimen of Metformin \> 1500mg/day or maximum tolerant dose for at least 3 months prior to the first administration
* Have an HbA1c between 7% and 10% inclusive

Exclusion Criteria:

* Have been treated with insulin, sulfonylurea, thiazolidinedione class hypoglycemic drugs, exenatide or other GLP-1 receptor agonist, DPP4-inhibitor, glucocorticoid and drugs that promote weight loss within 3 months prior to the first administration
* Have acute disease, other untreated disease or diabetic complications that needs additional treatment
* Have severe renal disorder(serum creatinine concentration \> 1.5 times of normal upper limit) or liver disorder(liver enzyme \> 2 times of normal upper limit)
* Have blood pressure \> 160/100mmHg
* Have been hospitalized due to cardiac disorder(angina, cardiac infarction, heart failure and etc.) within 1 year prior to the first administration
* Have history of critical disease within 1 year prior to the first administration
* Have untreated malignant tumor or have history of significant malignant tumor within 5 years prior to the first administration
* Have fasting plasma glucose(FPG) \> 250mg/dl or have random glucose level \> 350mg/dl
* Have more than 1 history of severe hypoglycemia that needed others help within 3 months prior to the first administration
* Have a known allergy or hypersensitivity to drugs
* Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
* Participated in any other clinical trials within 30 days prior to the first administration
* Subject who is judged to be ineligible by principal investigator or sub-investigator according to various reasons other than above
Fluoxetine to Reduce Hospitalization From COVID-19 Infection (FloR COVID-19)

The current research is a pilot study to determine the feasibility of recruiting and retaining 40 participants diagnosed with COVID-19. The purpose is to observe the early use of fluoxetine (commonly known as Prozac) to reduce the severity of the COVID-19 illness. Fluoxetine is a drug that has been approved by the U.S. Food and Drug Administration (FDA) since 1987 for various mental health disorders.

Morbidity and mortality resulting from COVID-19 infections are associated with multisystem organ failure due to a rapid increase in cytokine production. Fluoxetine has been shown to reduce the mechanisms that cause the cytokine storm that leads to COVID-19 fatalities.

This is a pilot study to assess feasibility of recruiting and retaining participants diagnosed with COVID-19. The purpose of this study is to observe the early use of fluoxetine treatments on illness outcome: primary outcome is hospitalization and secondary outcomes of complications including intubation and death. Additional secondary outcomes include effects on outcomes for depression and post-traumatic stress disorder, two common illnesses which may be improved by fluoxetine.

Eligibility Criteria:
Inclusion Criteria:

1. English speaking participant
2. 18 years of age or older
3. able to give informed consent
4. Tested positive for active SARS-CoV-2 infection and

   1. It's been less than 10 days since symptoms first appeared;
   2. Fever persists for longer than 24 hours without the use of fever reducing medications; and
   3. Experiencing other symptoms of COVID-19 as described by the CDC

Exclusion Criteria:

1. Prisoner or institutionalized patient
2. Unable to give informed consent
3. Less than 18 years of age
4. Hospitalization
5. Active bleeding requiring blood products in past week
6. Diagnosed with bipolar disorder and not on mood stabilizing medication
7. Known allergy or hypersensitivity to fluoxetine
8. Currently taking a monoamine oxidase inhibitor (MAOI)
9. Currently taking an selective serotonin reuptake inhibitor (SSRI) or selective norepinephrine reuptake inhibitor (SNRI)
10. Outpatient and currently taking hydroxychloroquine
11. Known pregnancy
12. Breastfeeding
13. Known prolonged QTc, such as congenital prolonged QTc syndromes
Phase 1 Study of Quizartinib

This is a dose escalation study to evaluate the safety, tolerability, and pharmacokinetics of quizartinib for Japanese acute myeloid leukemia (AML) subjects.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory AML
* AML for which no standard treatment is available
* ECOG Performance Status (PS) of 0 to 2

Exclusion Criteria:

* Acute Promyelocytic Leukemia
* chronic myelogenous leukemia in blast phase (BCR-ABL fusion gene positive)
* History of other malignancies within 3 years prior to enrollment, except curatively treated in-situ carcinoma, AML, or MDS.
Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis

Phase 1b/2a, double-blind, randomized, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability and phage recovery profile of AP-PA02 multi-bacteriophage therapeutic candidate administered by inhalation in subjects with cystic fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection.

The study consists of two parts. Subjects with Cystic Fibrosis and chronic pulmonary Pseudomonas aeruginosa (PA) infection will be enrolled in either Part 1 (single-ascending dose cohorts) or Part 2 (multiple-ascending dose cohorts).

Part 1 will evaluate single doses of AP-PA02 at two ascending dose levels, administered by inhalation. Treatment assignment will be randomized, double-blind, placebo-controlled in each of two ascending dose cohorts. Part 2 will also be double-blinded, randomized, placebo controlled, and will evaluate the safety and efficacy of multiple doses of AP-PA02 in each of two ascending dose level cohorts.

Subjects in both Parts 1 and 2 will be followed for approximately 4 weeks and evaluated for safety, tolerability, phage titer profile and immunogenicity.

Eligibility Criteria:
Key Inclusion Criteria:

* ≥ 18 years old
* Body mass index (BMI) of ≥ 18 kg/m2
* Documented diagnosis of CF
* Evidence of chronic pulmonary Pseudomonas aeruginosa infection
* Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
* For SAD: FEV1 ≥ 60% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening
* For MAD: FEV1 ≥ 40% of predicted normal \[per Global Lung Function Initiative (GLI) standards\] at Screening
* Adequate renal function

Key Exclusion Criteria:

* Recent significant weight loss
* Abnormal vital signs at Screening
* History of prolonged QT syndrome
* Use of supplemental oxygen during the day at rest
* Abnormal liver function tests greater than 3X the upper limit of normal (ULN)
* Recent oral or IV antibiotics received for acute pulmonary exacerbation. Inhaled antibiotic use for chronic suppression of P. aeruginosa is acceptable.
* Recent clinically significant infection requiring systemic antimicrobial therapy
* Currently receiving anti-pseudomonal antibiotic treatment for acute sinusitis.
* Currently receiving systemic corticosteroids
* Currently receiving treatment for active infection with nontuberculous mycobacteria (NTM), Staphylococcus aureus, or Burkholderia cepacia complex lung infection
* Currently receiving treatment for aspergillosis or ABPA (allergic bronchopulmonary aspergillosis)
* Initiation of a CFTR potentiator/corrector therapy, such as Trikafta®, less than 90 days prior to Screening
* Acquired or primary immunodeficiency syndromes
* Active pulmonary malignancy (primary or metastatic)
* History of lung transplantation
* Recent hemoptysis
* Female pregnant or breastfeeding
* Heavy smoker
Long Term Follow up of Recipients of Functional Islet Allografts

Since its inception, the Diabetes Research Institute (DRI) has made significant contributions to the field of diabetes, pioneering many of the techniques used in diabetes centers around the world. Through several clinical trials, DRI has demonstrated that diabetes can be successfully reversed as a result of islet cell transplant.

Over the years the following protocols in islet cell transplantation have been initiated: 2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210.

All of the studies listed above will be source of study subjects for this study. Approximately 30 subjects are expected to be enrolled and followed in this trial.

After islet-cell transplantation in the parent studies, each subject receives maintenance immunosuppressive medications.

The purpose of this protocol is to collect additional follow-up for safety and efficacy from subjects with graft function after their completion in their parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their parent study.

To provide long term follow up in subjects with functional islet allografts.

Eligibility Criteria:
Inclusion Criteria:

1. Participation in any of the following parent studies: 2000/0329; 2000/0196; 2004/0205; 2000/0024; 2006/0200; 2006/0508; 2006/0210
2. A functioning pancreatic islet graft (absence of graft failure as defined in parent study) requiring immunosuppression.
3. Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation.
4. Ability to provide written informed consent.

Exclusion Criteria:

1. For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.
2. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.
A Multicenter, Multinational, Cohort Long-term Post-market Clinical Follow-up (PMCF) of the Safety and Efficacy of the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Implant System When Used for Transhumeral Implantation in Amputee Patients

This non-interventional clinical investigation is initiated for the purpose of long-term Post-Market Clinical Follow-up (PMCF) and the follow-up time of patients is expected to span from 6 months to \>20 years in function. It will collect and evaluate clinical data on the safety and performance of the OPRA™ Implant System when used on transhumeral amputees and within the scope of the intended use.

All subjects that will be enrolled in this investigation should have been treated with the OPRA TM Implant System for a transhumeral unilateral or bilateral amputation completed before 01-Jan-2024.

This retrospective, non-interventional, clinical investigation is designed as a multicenter, multinational, cohort investigation for long-term follow-up of safety and efficacy endpoints. The investigation will also include prospective visit(s) for enrollment of subjects and collection of present data on device functionality and the use of the device.

No control group or comparator will be used in this investigation.

All patient reported outcome questionnaires used in the investigation will be available at the investigation site for completion by the subjects during one of the subjects' visits to the site. Depending on the subjects' preferences it will also be possible to provide those questionnaires to the subjects, through use of regular mail, email or through an electronic Patient Reported Outcome system (ePRO). It will be possible for the subjects to complete the questionnaires either on paper, electronically or over phone, depending on their preferences.

Preferably, the subjects prosthesis functional tests should be performed as part of the follow-up visit at the site. The tests may also be performed remotely, depending on subjects' preferences. If done remotely, this will require the functionality test being performed during a videoconference with the test administrator. No photos or video-recordings (if conducted according to the sites normal practice) of the performed tests will be part of the investigation documentation, only the related medical record notes will be used as source data for those parameters.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral or bilateral amputation
* OPRA™ implant system placed, and with S2 completed before 01-Jan-2024
* Having a minimum of 6 months of follow-up between S2 and enrolment

Exclusion Criteria:

* Subject not willing to consent
* Subject implanted with the e-OPRA system at the humeral level.
Development and Validation of a Regional Multi-scale System for the Prediction of the Patient Flow in the Emergencies and the Need for Hospitalization

The main objective of this retrospective study is to validate a prediction system of emergencies department (ED) attendance on a wide range of time and the need for hospitalization, at various levels of perimeter (with all emergency departments or one ED in particular), with all patients or with one sub-group of patients (age, gravity, care).

As secondary objectives, the study aims:

* to measure the influence of different factors as environmental or structural and to identify the modifiable factors, then to allow us to test by simulation, impact of various interventions (for example: opening of hospitals and reinforcement of ED teams) on arrival flows or regenerated tension inside ED teams.
* to study the relation between the flows (arrival patients, hospitalized patients) and the time of ED visit or the indicators of tension of ED team.
* Typology of ED in the region of Paris permitting afterward comparison the benchmarking type between similar structures.

This retrospective study will be performed on database: individual data in the region of Paris of summation of ED visits and data on the structures of health cares, as well as environmental data (principal given cares, weather, moves, circulations, pollution, strikes, vacations, etc.)

Eligibility Criteria:
Inclusion Criteria:

* All subjects have been recorded as patients in emergency departments between 2010 and 2015.

Exclusion Criteria:

* None
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation

ABLATE is a prospective, non-randomized multi-center clinical trial to demonstrate the safety and effectiveness of the AtriCure Bipolar System for treating permanent atrial fibrillation during concomitant on-pump cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is greater than or equal to 18 years of age
2. Subject has history of permanent atrial fibrillation as defined by the ACC/AHA/ESC Guidelines
3. Subject is scheduled to undergo elective on-pump cardiac surgical procedure(s) for one or more of the following:

   * Mitral valve repair or replacement
   * Aortic valve repair or replacement
   * Tricuspid valve repair or replacement
   * Coronary Artery Bypass procedures
   * Atrial Septal Defect Repair
   * Patent Foramen Ovale closure
4. Subject's Left Ventricular Ejection Fraction ≥ 30%
5. Subject is able and willing to provide written informed consent and comply with study requirements
6. Subject has life expectancy of at least 1 year

Exclusion Criteria:

1. Stand alone AF without indication(s) for concomitant CABG, valve surgery, ASD repair, or PFO closure
2. Previous cardiac ablation including catheter ablation, AV-nodal ablation, or surgical Maze procedure
3. Wolff-Parkinson-White syndrome
4. Prior cardiac surgery (Redo)
5. Class IV NYHA heart failure symptoms
6. Prior history of cerebrovascular accidents within 6 months or at any time if there is residual neurological deficit
7. Documented MI within 6 weeks prior to study enrollment
8. Need for emergent cardiac surgery (i.e. cardiogenic shock)
9. Known carotid artery stenosis greater than 80%
10. LA size greater than or equal to 8cm
11. Current diagnosis of active systemic infection
12. Severe peripheral arterial occlusive disease defined as claudication with minimal exertion
13. Pregnancy or desire to get pregnant within 12-months of the study enrollment
14. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
15. Renal failure requiring dialysis or hepatic failure
16. Requires anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
17. Therapy resulting in compromised tissue integrity including: thoracic radiation, chemotherapy, long term treatment with oral or injected steroids, or known connective tissue disorders