louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00966485: Dose-related Effect of Aspirin on Laboratory-defined Acetylsalicylic Acid Resistance and Clinical Outcome After Coronary Stenting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Stenting
Keywords: ASA resistance
coronary stenting
platelet function
laboratory ASA resistance
MACE
Positive SPECT
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2009-08-27
Enrollment: 106
Sex: ALL
Minimum age (years): 40
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators prospectively studied the effect of aspirin on platelet function in 106 stable outpatients 6 months after successful percutaneous coronary angioplasty. Participants were randomized in a double-blind, double-crossover study (80 or 500 mg per day for 6 months).T

Detailed description: Background:

Acetylsalicylic acid (aspirin) is widely used in the secondary prevention of coronary artery disease. There is controversy regarding the prevalence of aspirin resistance in patients with coronary artery disease and the effect of dose on resistance. Our primary aims were to determine the degree of platelet responsiveness to aspirin, and to study the influence of dose on platelet inhibition and clinical outcomes after coronary stenting.

Eligibility criteria: Inclusion Criteria:

* 6 months post stent without complication

Exclusion Criteria:

* subacute stent thrombosis
* unable to discontinue plavix
* dont accept to participate
* contraindication for ASA use

Primary outcomes:
measure: laboratory ASA resistance
timeFrame: 6 months
Secondary outcomes:
measure: major adverse cardiac events and positive cardiac scan for ischemia
timeFrame: 6 months
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Namazi hospital
state: Fars
Study officials:
affiliation: Shiraz University of Medical Sciences
name: javad kojuri, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT07016685: Prognosis of Veno-Venous Extracorporeal Membrane Oxygenation in Emergency Thoracic Surgery
Official title: Prognostic Factors for 90-day Mortality in Patients Undergoing Veno-venous Extracorporeal Membrane Oxygenation for Emergency Thoracic Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: VV-ECMO
Thoracic Surgery
Emergency Surgery
ARDS
Retrospective Cohort
Propensity Score Matching
Mortality
ECMO Outcomes
Keywords: thoracic surgery
VV-ECMO
emergency surgery
ARDS
retrospective cohort
propensity score matching
mortality
ECMO outcomes
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
First posted: 2025-06-12
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ≥ 18 years, Patients undergoing emergency thoracic procedures requiring VV-ECMO and patients treated with VV-ECMO for medical respiratory failure.

Brief summary: Veno-vneous extracorporeal membrane oxygenation (VV-ECMO) is an established support strategy for acute respiratory failure, but its role in the perioperative management of emergency thoracic surgery remains poorly defined. This retrospective, multicenter, observational study aims to assess the clinical outcomes and prognostic factors in this high-risk population. Patients undergoing emergency thoracic procedures requiring VV-ECMO will be compared to a control cohort of patients treated with VV-ECMO for medical respiratory failure. Data will be collected from two French academic centers (CHU Amiens-Picardie and CHU Dijon).


Eligibility criteria: Inclusion Criteria:

* Adults ≥ 18 years
* VV-ECMO initiated during or after emergency thoracic surgery
* No opposition to data use

Exclusion Criteria:

* Pregnant women
* Veno-Arterial ECMO patients
* Patients under legal protection

Primary outcomes:
measure: 90-day all-cause mortality
timeFrame: 90 days
Secondary outcomes:
measure: 90-day mortality in oncologic vs. non-oncologic thoracic surgery
timeFrame: 90 days
measure: Postoperative complication rates
timeFrame: 90 days
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHRU Amiens
Study officials:
References:
Clinical trial NCT00311285: Physical and Mental Load in the Surgeon Performing Laparoscopic Tasks
Official title: Physical and Mental Load During Laparoscopic Tasks. A Prospective Randomized Trial of the Ergonomics in a Black Box Model
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Keywords: Electromyography
Glucocorticoids
Heart Rate
Physical workload
Mental workload
Ergonomics
Laparoscopy
Workload
Biomechanics
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2006-04-05
Enrollment: 12
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. The purpose is to establish a model of how to measure mental and physical load in laparoscopy.

Detailed description: The surgeons load during laparoscopic surgery is still unclear. Laparoscopic surgery is more demanding because of the challenge of operating through small scars in the abdominal wall without any tactile feedback depending only on the visual feedback on a monitor. Most studies have been conducted in laboratory set-ups: Black Box.

This study will establish a model of how to measure the biomechanical loads at muscular, joint and postural level, as well as measuring stress-hormone and cardiac rhythm. The study is a precursor of ergonomic studies performed inside the operating room. Advanced operating rooms designed specially for laparoscopy have been introduced in many departments. We do not know if they are more ergonomically correct. We will simulate laparoscopic tasks in an operating room. The hypothesis is that a traditional laparoscopic set-up is more demanding than a set-up mimicking an advanced operating room.

Eligibility criteria: Inclusion Criteria:

* Healthy doctors

Exclusion Criteria:

* Pregnancy
* Left handed
* Endocrine disease
* Cardiac rhythm disturbances
* History of recent injury in shoulder/arms

Primary outcomes:
measure: EMG
measure: Goniometry
measure: Inclinometry
measure: HRV
measure: Salivary Cortisol
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: UHGentofte
city: Hellerup
country: Denmark
facility: UHGentofte
Study officials:
affiliation: University Hospital, Gentofte, Copenhagen
name: Helga R Munch-Petersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04779385: Cost and Effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy in Patients With Peritoneal Carcinoma.
Official title: Cost and Effectiveness of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Patients With Peritoneal Carcinoma.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Evaluate the Cost of a PIPAC Procedure and the Associated Hospital Stay in France
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-03-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with peritoneal carcinomatosis of any origin treated with PIPAC.

Brief summary: The presence of peritoneal carcinomatosis indicates a neoplastic disease evolved. Without intervention, the prognosis is poor with survival of only a few months. Standard treatment is based on systemic chemotherapy, however, the pharmacokinetics of drug delivery to the peritoneum is poor, with limited efficacy compared to other metastatic sites such as the liver or lung. When the carcinomas are is resectable, selected patients can benefit from targeted therapeutic approaches combining peritonectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC), offering a significant improvement in survival. A new surgical technique has been developed for patients with unresectable Chemotherapy intraperitoneal aerosol spray (PIPAC). The objective is to improve the survival time, quality of life but can also make PC resectable and therefore accessible to complete excisional surgery. The cost of this treatment is not yet fully assessed in France. The main objective of this study is to assess the real cost of PIPAC in order to allow its dissemination.


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Patients treated with PIPAC and monitored for peritoneal carcinoma
* Patients informed

Exclusion Criteria:

* Patients opposition

Primary outcomes:
measure: Evaluate the cost of a PIPAC
timeFrame: 90 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHUGA
Study officials:
References:
Clinical trial NCT05525585: Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants
Official title: Early Human Milk Fortification After Early, Exclusive, Enteral Nutrition in Very Preterm Infants: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prematurity
Light-For-Dates
Enteral Feeding Intolerance
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Mead Johnson Nutrition
First posted: 2022-09-01
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this proposed clinical trial, the investigators will randomize 80 very preterm (VPT) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher FFM-for-age z scores and more diversity in the gut microbiome.


Eligibility criteria: Inclusion Criteria:

* Gestational age 29 to 33 weeks of gestation
* Birth weight \< 1800 g
* Postnatal age \< 96 hours

Exclusion Criteria:

* Small for gestational age (\<5th percentile)
* Major congenital/chromosomal anomalies
* Terminal illness needing withhold or limit support

Primary outcomes:
measure: Fat-free mass(FFM)-for-age Z-score
timeFrame: Postnatal day 14 to 21
Secondary outcomes:
measure: Fecal microbiome composition
timeFrame: Birth to 36 weeks postmenstrual age
measure: Growth - Weight
timeFrame: Birth to 36 weeks postmenstrual age or hospital discharge
measure: Growth - Length
timeFrame: Birth to 36 weeks postmenstrual age or hospital discharge
measure: Growth - Head circumference
timeFrame: Birth to 36 weeks postmenstrual age or hospital discharge
measure: Growth rate
timeFrame: Birth to 36 weeks postmenstrual age or hospital discharge
measure: Number of participants with postnatal growth faltering
timeFrame: Birth to 36 weeks postmenstrual age or hospital discharge
measure: Number of participants with diagnosis of necrotizing enterocolitis
timeFrame: Birth to 60 days or discharge
measure: Number of participants with diagnosis of intestinal perforation
timeFrame: Birth to 10 days
measure: Death
timeFrame: Birth to 60 days
measure: Duration of hospital stay in days
timeFrame: Birth to 60 days or discharge, whichever occurs first
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Ariel A. Salas, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salas AA, Gunawan E, Jeffcoat S, Nguyen K. Early full enteral nutrition with fortified milk in very preterm infants: a randomized clinical trial. Am J Clin Nutr. 2025 May;121(5):1117-1123. doi: 10.1016/j.ajcnut.2025.02.019. Epub 2025 Feb 21.
Clinical trial NCT01682785: Incidence of Metabolic Syndrome and Thyroid Dysfunction in Patients With Major Depressive Disorder
Official title: Incidence and Prevalence of and Factors Associated With Metabolic Syndrome and Thyroid Dysfunction in Patients With Major Depressive Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Disorder
Metabolic Syndrome
Thyroid Dysfunction
Keywords: Major depressive disorder
Metabolic syndrome
Thyroid dysfunction
incidence
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2012-09-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: major depressive disorder

Brief summary: Aim 1 is to study prevalence and 1 year incidence of metabolic syndrome in major depressive disorder and factors correlation.

Aim 2 is to study prevalence and 1 year incidence of thyroid dysfunction in major depressive disorder and factors correlation.


Eligibility criteria: Inclusion Criteria:

* patient with major depressive disorder
* age over 18 years

Exclusion Criteria:

* subject who cannot give information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00458185: Study Evaluating Etanercept in Patients With Ankylosing Spondylitis
Official title: Multicentre, Open-Labeled Study Of Etanercept In The Treatment Of Patients With Ankylosing Spondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ankylosing Spondylitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy of etanercept for the treatment of Ankylosing Spondylitis (AS).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis, aged between 18 and 70 years of age.
* BASDAI greater than or equal to 40 (all scores on a scale of 0 to 100).
* Negative result of serum human chorionic gonadotropin (HCG) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal.

Exclusion Criteria:

* Complete ankylosis (fusion) of spine.
* Previous receipt of etanercept, antibody to TNFα, or other TNFα inhibitors.
* Use of disease modifying antirheumatic drugs (DMARDs) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. Patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.

Primary outcomes:
measure: To determine the efficacy of etanercept (25 mg, twice weekly) based on the percentage of patients who achieve the Assessment in Ankylosing Spondylitis (ASAS) Response Criteria at 20% level at week 12.
Secondary outcomes:
measure: Efficacy at 50% and 70% levels week 12; frequency and time to partial remission; safety; patient and physician global assessment, nocturnal and total back pain, BASFI, BASDAI; spinal mobility; complete joint assessment; hip involvement; ESR, CRP.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00386685: XRP9881 in Combination With Trastuzumab in Metastatic Breast Cancer
Official title: Open Label, Uncontrolled Study of XRP9881 in Combination With Trastuzumab (Herceptin®) in Patients With HER2 Positive Metastatic Breast Cancer (MBC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: Cancer
Breast
metastatic breast cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-11
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the activity of XRP9881 in combination with trastuzumab.

The secondary objectives are safety and pharmacokinetic interaction


Eligibility criteria: Inclusion Criteria:

* Metastatic breast cancer (MBC)
* HER2 (Human Epidermal Growth Factor Receptor 2) positive: FISH (Fluorescent In Situ Hybridization) positive or IHC (Immunohistochemistry) 3+
* Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST)
* Adequate organs functions

Exclusion Criteria:

* More than one previous chemotherapy regimen for metastatic disease
* Cardiac dysfunction

Primary outcomes:
measure: Response rate (best overall response under treatment)
timeFrame: study period
Secondary outcomes:
measure: Incidence of grade 3-4 toxicities, pharmacokinetic interaction
timeFrame: study period
Other outcomes:
Locations:
city: Diegem
country: Belgium
facility: Sanofi-Aventis Administrative Office
city: Paris
country: France
facility: Sanofi-Aventis Administrative Office
city: Bromma
country: Sweden
facility: Sanofi-Aventis Administrative Office
city: Geneva
country: Switzerland
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Institut Claudius Regaud - Toulouse - France
name: Henri Roche, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00867685: Phase I 2-Way Crossover Study to Assess Relative BA of Tablet Versus Liquid Suspension and Food Effect on Tablet Formulation
Official title: A Phase I, Randomized, Open Label, 2-Way Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of AZD2624 (Tablet Versus Liquid Suspension) Followed by an Additional Period to Assess the Food Effect on the Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-03-24
Enrollment: 16
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 purpose of this study is to compare the liquid suspension form of AZD 2624 to a tablet form of the same drug. This study will also study the effect of food on the tablet form of the drug.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female volunteers

Exclusion Criteria:

* Donation of plasma or blood products within one month of of screening
* Clinically relevant abnormalities in physical examination, vital signs,ECG, clinical chemistry, hematology, or urinalysis.
* Previous participation in an AD2624 study.

Primary outcomes:
measure: Serial blood draws will be used to measure the plasma levels of AZD2624 for the liquid suspension and the tablet formulation in a fed and fasted state.
timeFrame: Seventeen blood draws will be collected during each treatment period for a total of 51 samples for the study.
Secondary outcomes:
measure: Safety will be measured by the collection of AEs, ECGs, physical exams, and vital signs.
timeFrame: Subjects inquiry on AE daily, ECGs collected at 2 timepoints each period, clinical labs collected at 3 timepoints each period, physical exams completed 3 timepoints each period, and vital signs collected each day of each period
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
Study officials:
affiliation: AstraZeneca Clinical Pharmacology Unit, US
name: Sylvan Hurewitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04265885: Gender Dysphoria and Transition
Official title: Gender Dysphoria and Transition: Testimony From Transgender People
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gender Dysphoria
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: University of Lorraine
First posted: 2020-02-12
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The participation to the study will be offered consecutively to adult subjects with gender dysphoria followed in the department of endocrinology, diabetology and nutrition of the University Hospital of Nancy.

Brief summary: Persons with gender dysphoria present the difficulties of access to health care. Little time is devoted to education of health professionals about the care of transgender persons. According to the proposal of the French Ministry of Social Affairs and Health there is a need to increase knowledge in this area and to improve the care of transgender people including prevention and screening.

Similarly, little is known about social and medical needs of the transgender population.

This project proposes to illustrate gender dysphoria through testimonies of transgender people with the aim to increase the investigator's understanding aout the needs and the desires of this population and to describe the process of medical and social transition.


Eligibility criteria: Inclusion Criteria:

* Person affiliated to a social security system
* Person having received complete information on the organisation of the research and having signed the informed consent
* Person having carried out a prior clinical examination adapted to the research
* Age\> 18 years
* Diagnosis of gender incongruence (dysphoria) according to the international classification of diseases, revision 11

Exclusion Criteria:

* Severe, uncontrolled psychiatric or somatic illness
* Substance and alcohol addiction
* Pregnancy

Primary outcomes:
measure: Illustrate the real-life experiences of transgender people
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: