louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04340466: French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management Study
Official title: French Multicentre Observational Study on SARS-Cov-2 Infections (COVID-19) ICU Management: the FRENCH CORONA Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia, Viral
Critically Ill
Corona Virus Infection
Keywords: COVID-19
SARS-Cov-2
Intensive Care Unit
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2020-04-09
Enrollment: 1003
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The target population of the study is all patients with suspected or proven SARS-Cov-2 infection (COVID-19)

Brief summary: Since December 2019, a new agent, the SARS-Cov-2 coronavirus has been rapidly spreading from China to other countries causing an international outbreak of respiratory illnesses named COVID-19. In France, the first cases have been reported at the end of January with more than 60000 cases reported since then. A significant proportion (20-30%) of hospitalized COVID-19 patients will be admitted to intensive care unit. However, few data are available for this special population in France.

We conduct a large observational cohort of ICU suspected or proven COVID-19 patients that will enable to describe the initial management of COVID 19 patients admitted to ICU and to identify factors correlated to clinical outcome.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to ICU for suspected or proven SARS-Cov-2 infection, defined by positive SARS-Cov-2 PCR or CT scan images
* Patient \> or= 18 years

Exclusion Criteria:

* Patient study refusal
* Patient already enrolled in the present study
* Patient with respiratory illness with negative COVID-19 CT scan images and negative COVID_19 PCR

Primary outcomes:
measure: Mortality at day 28
timeFrame: day 28
Secondary outcomes:
measure: severe complications
timeFrame: up to day 28
measure: Imaging
timeFrame: day 1
measure: Delay in Microbiological diagnosis
timeFrame: day 1
measure: Antiviral therapy
timeFrame: up to day 28
measure: Antibiotic therapy
timeFrame: day 28
measure: Covid-19 treatments
timeFrame: up to day 28
measure: Patients receiving renal replacement therapy
timeFrame: up to day 28
measure: Patients receiving mechanical ventilation
timeFrame: up to day 28
measure: Vital status
timeFrame: day 28
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: CLAIRE ROGER
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00212966: Shared Mental Health Care Linking Mental Health Services With Family Medicine Groups
Official title: Shared Mental Health Care Linking General Hospital Acute Care Mental Health Services With Two Comprehensive Family Medicine Groups
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosocial Factors
Keywords: psychosocial
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: NON_PROBABILITY_SAMPLE
Study population: family practice patients

Brief summary: The purpose of this study is to assess how a multidisciplinary team of mental health professionals provides services to patients from two family medicine practices.


Eligibility criteria: Inclusion Criteria:

* Patients referred by family physicians

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
Study officials:
affiliation: OHRI
name: Robert Swenson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00606866: MRI Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Official title: Dynamic-Contrast Enhanced MRI Pharmacodynamic Study of BAY 43-9006 in Metastatic Renal Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Renal Cell Carcinoma
Keywords: renal, metastatic, carcinoma
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Bayer
First posted: 2008-02-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine maximum tumor shrinkage, time to progression, survival, drug concentration, and degree of skin toxicity.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed metastatic clear cell renal cell cancer;
* At least one lesion that can be accurately measured in at least one dimension;
* Patients must not have been treated with prior anti-timor kinase inhibitors or VEGF pathway inhibitors;
* Age 18 and older;
* ECOG performance status 0-2;
* Blood pressure higher than 140/90 on 2 separate occasions not more than 6 weeks prior to enrollment and not less than 24 hours apart;
* Normal organ function: total bilirubin less than upper limit of normal, AST less than 2.5 X upper limit of normal, creatinine less than 2.8 mg/dl;
* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation;
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Chemotherapy or radiotherapy within 4 weeks prior to entering the study;
* Any other investigational agents;
* Known brain metastases;
* Uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
* Pregnancy.

Primary outcomes:
measure: To determine whether a new experimental MRI technique called "Dynamic Contrast Enhanced MRI" (DCE-MRI) can determine the best dose of sorafenib
timeFrame: 8 weeks
Secondary outcomes:
measure: To predict which patients are most likely to experience tumor shrinkage.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
Study officials:
References:
Clinical trial NCT06571266: A Study to Assess the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes in Healthy Adult Participants
Official title: A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Formulations of Risankizumab Following Subcutaneous Administration With Prefilled Syringes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Risankizumab
ABBV-066
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 231
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the pharmacokinetics, relative bioavailability and tolerability of two formulations of risankizumab following subcutaneous (SC) administration in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Body weight 40 kg to 100 kg, inclusive, at screening and upon initial confinement
* Body Mass Index (BMI) is \> = 18.0 to \< = 32.0 kg/m2 after rounded to the tenths decimal, at Screening and upon confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* Participant with exposure to any anti-interleukin-12/23 or anti-interleukin-23 treatment for at least one year prior to Screening.
* Participant with intention to perform strenuous exercise within at least one week prior to administration of study drug or during the study.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to day 140
measure: Maximum Observed Serum Concentration (Cmax) of Risankizumab
timeFrame: Up to Day 140
measure: Time to Cmax (Tmax) of Risankizumab
timeFrame: Up to Day 140
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
timeFrame: Up to Day 140
measure: Terminal Phase Elimination Half-life (t1/2) of Risankizumab
timeFrame: Up to Day 140
measure: Area Under the Concentration-time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUC0-t)
timeFrame: Up to Day 140
measure: AUC from Time 0 to Infinity (AUC0-inf) of Risankizumab
timeFrame: Up to Day 140
measure: Number of Anti-drug antibody (ADA) Titers
timeFrame: Up to Day 140
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Cenexel Act /ID# 270310
state: California
city: Los Alamitos
country: United States
facility: Collaborative Neuroscience Research CNS /ID# 270286
state: California
city: Grayslake
country: United States
facility: Acpru /Id# 270152
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02464566: 12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Jeddah 2015
Official title: 12 Weeks Intensive Lifestyle Intervention Program in Primary Care Obesity Clinic for Obese Adults: Randomized Control Trial, Jeddah 2015
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Lead sponsor: Saudi Commission for Health Specialties, Saudi Arabia
Sponsor class: OTHER_GOV
First posted: 2015-06-08
Enrollment: 140
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With low carbohydrate dietary approach for both arms, the investigators will examine the effectiveness of 12-weeks intensive lifestyle intervention program provided in individual sessions in primary health care obesity clinic in Jeddah with aim to achieve 5% reduction of baseline weight for experimental participants in comparison with active comparator group (only one health education session).

Detailed description: The study has two arms:

Active Comparator Arm:

Only health education. One session regarding diet restriction and physical activity with printed health education papers.

Experimental Arm:

Intensive lifestyle intervention Weekly individual session in obesity clinic (15 to 20 min.) for the first 4 weeks then one individual session in obesity clinic (10 to 20 min.) every two weeks (week 5 to week 12).

Total sessions in 12 weeks: 8 (including the final data collection visit).The components of the program: 1) Low carbohydrate (aim to achieve spontaneous reduction in calorie intake) 2) increased physical activity; 3) behavioral strategies to facilitate adherence to diet and activity prescriptions.

Eligibility criteria: Inclusion Criteria:

* 20 years old or older
* Arabic Male or female
* Body mass index in kg/m2 (BMI) ≥30

Exclusion Criteria:

* Had recent weight loss equal or more than 5% of baseline weight
* Currently take weight loss medication or enrolled in another weight loss program
* Undergone or scheduled (within study duration) weight loss surgery
* History of diabetes, thyroid dysfunction or any other endocrine abnormality, gout, coronary heart disease, stroke, malignancy or psychological condition
* Medical condition that limits ability to comply with the program's physical activity recommendations
* Pregnant or lactating women
* If one participant had recruited in the study, his family members who live with him in the same home will be ineligible (to avoid contamination from the ripple effect on weight loss)

Primary outcomes:
measure: Weight Reduction
timeFrame: 1-12 weeks
Secondary outcomes:
measure: Waist circumference changes
timeFrame: 1-12 weeks
measure: Hip circumference changes
timeFrame: 1-12 weeks
measure: Systolic and Diastolic Blood pressure changes
timeFrame: 1-12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05051566: A Multiple Dose Study of LY3502970 in Healthy Participants
Official title: A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Quotient Sciences
First posted: 2021-09-21
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to assess how fast LY3502970 gets into the blood stream and how long it takes the body to remove it when administered in multiple oral doses as new formulation compared to that of reference LY3502970 formulation. Information about safety and tolerability will be collected. The study is open to healthy participants. The study is conducted in two parts and it will last up to about 6 months, inclusive of screening period.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation.
* Body mass index (BMI) of 18.5 to 35 kilograms per meter squared (kg/m²).

Exclusion Criteria:

* Have an abnormal blood pressure and/or pulse rate as determined by the investigator -minor deviations acceptable to investigator are allowed
* Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 2X ULN (Upper Limit of Normal)
* Have an abnormality in the 12-lead ECG at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
* Are women of child-bearing potential
* Are women who are lactating

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970
timeFrame: Predose up to 24 hours postdose
measure: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970
timeFrame: Predose up to 24 hours postdose
measure: PK: Time of Maximum Observed Concentration (Tmax) of LY3502970
timeFrame: Predose up to 24 hours postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical Ltd
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01050166: MRI Imaging of Labeled Human Islets Transplanted Into the Liver
Official title: Phase 1 Study to Test Safety and Efficacy of Magnetic Resonance Imaging of Human Labeled Islets Transplanted Into the Liver in Type 1 Diabetic Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 1 Diabetes Mellitus
Keywords: islet transplantation
magnetic resonance
Type 1 DM
Lead sponsor: Institute for Clinical and Experimental Medicine
Sponsor class: OTHER_GOV
First posted: 2010-01-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort will be selected from residents of Czech republic

Brief summary: The purpose of the study is to determine whether human islets labeled by iron contrast agents could be imaged using magnetic resonance after transplantation into the liver of Type 1 diabetic recipients.

Detailed description: Islet transplantation represents approved therapeutic approach in selected Type 1 diabetic recipients with syndrome of hypoglycaemia unawareness. Existing imaging methods are not sufficient to provide adequate information about amount and fate of islets transplanted into the liver. Labeling of islets with superparamagnetic contrast agent ferucarbotran significantly shortens T2 relaxing time and therefore increase the contrast between islets and liver tissue in magnetic resonance imaging. In consequence, islets transplanted into liver could be easily detectable like hypotensive areas dispersed throughout the liver. MRI examination will be done on 1, 2, 4 weeks and 3, 6 and 12 months.

Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus
* normal renal parameters
* hypoglycaemia unawareness or rapid progression of diabetic retinopathy or neuropathy

Exclusion Criteria:

* acute and chronic liver disease
* malignancy
* acute infection
* serious cardiovascular disease
* coagulopathy
* portal hypertension
* presence of metal protesis, cardio-stimulators, or other metal material in the body

Primary outcomes:
measure: Evidence of safety and efficacy of MRI imaging of transplanted human labeled islets
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Diabetes Center, Institute for Clinical and Experimental Medicine
Study officials:
affiliation: Institute for Clinical and Experimental Medicine
name: Frantisek Saudek, MD, DrSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Saudek F, Jirak D, Girman P, Herynek V, Dezortova M, Kriz J, Peregrin J, Berkova Z, Zacharovova K, Hajek M. Magnetic resonance imaging of pancreatic islets transplanted into the liver in humans. Transplantation. 2010 Dec 27;90(12):1602-6. doi: 10.1097/tp.0b013e3181ffba5e.
Clinical trial NCT03123666: Recombinant Human Granulocyte Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis
Official title: Randomized Controlled Trial of Recombinant Human Granulocye Monocyte - Colony Stimulating Factor (GM CSF) for Prevention of Pneumonia in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Informed consent obtained from the patient or the patient's legal surrogate. The window for randomization and initiation of study drug infusion is 2 days from day of Admission. All further time points are relative to the day of randomization. Patients will be randomized (1:1) to receive either recombinant human GM-CSF or placebo. Using randomized block design of 10 each generated by computer and provided in sequential, sealed, opaque envelopes. Subjects will be stratified based on Child status. Patients who fulfil the inclusion criteria will receive either slow IV infusion of GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer for 7 days OR Placebo(saline infusion and saline nebulization). Standard medical care will be given in both limbs.


Eligibility criteria: Inclusion Criteria:

* Patient with cirrhosis admitted to ICU-HDU without pneumonia at admission
* 18-70 years of Age
* Child B/ C

Exclusion Criteria:

* Patient having pneumonia
* If there is evidence of preexisting chronic respiratory failure
* If the patients is neutropenic (absolute neutrophil count \<1000 cells/mm3
* If there was a history of hematological malignancy or bone marrow transplantation
* Person having HCC
* Acute liver Failure
* Pregnancy
* HIV

Primary outcomes:
measure: Survival in both groups
timeFrame: 1 year
Secondary outcomes:
measure: Development of extra pulmonary organ failure during the course of study.
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT02887066: Observatory on Emergency Care for Acute Coronary Syndrome in Grand Est of France
Official title: Observatory on Emergency Care for Acute Coronary Syndrome in Grand Est of France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in emergency room or under medical care in mobile intensive care units for thoracic pain and suspicion of ACS.

Brief summary: The purpose is to build up a data observatory of individuals with thoracic pain evoking acute coronary syndrome (ACS). The aim is the characterization of this population of patients consulting at emergency department, the evaluation of therapeutic strategies with regard to guidelines and the becoming of patients including severe complications and mortality.


Eligibility criteria: Inclusion Criteria:

* Resident in Grand Est of France (Lorraine, Champagne Ardenne) under medical care at the emergency room or outside of hospital or in cardiology:
* Outside of hospital: for thoracic or epigastric pain with suspicion of ACS Emergency: for thoracic pain for which the doctor will prescribe troponin or troponin kinetics
* Affiliation to social security

Exclusion Criteria:

* Patient affected by ACS with ST segment elevation
* Patient with traumatic thoracic pain
* Patient with thoracic pain of parietal origin
* Patient with consciousness troubles

Primary outcomes:
measure: Mortality
timeFrame: 30 days
measure: Mortality
timeFrame: 1 year
measure: Severe complications
timeFrame: 30 days
measure: Severe complications
timeFrame: 1 year
measure: Benefit/risk ratio of treatments
timeFrame: day 0
measure: Benefit/risk ratio of treatments
timeFrame: 30 days
measure: Benefit/risk ratio of treatments
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Service SAMU - SMUR - SAU, Hôpital Central, CHRU de Nancy
name: Tahar Chouihed
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00173966: A Case Control Study to Investigate the Possible Association Between Atrial Fibrillation and Endothelium Dysfunction by Using Flow-Mediated Vasodilation Method
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Endothelial Function
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 40
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Endothelial function is closely related to the hemostasis , vascular tone, and organ perfusion in cardiovascular system, and its dysfunction would cause overactivation of the coagulative system to induce thrombus formation. So we study the relationship between the endothelial function and atrial fibrillation.


Eligibility criteria: Inclusion Criteria:

* Lone AF patients and normal controls

Exclusion Criteria:

* DM, hypertension, hyperlipidemia, smoking, pregnancy,

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Juey Jen Hwang
role: PRINCIPAL_INVESTIGATOR
References: