louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04987476: Rhabdoid Tumors Cellular Architecture by Single-cell Analyses (InnovRT-2)
Official title: Hétérogénéité Des Tumeurs Rhabdoides : Approches En " Cellules Uniques " Pour Identifier Des Cibles Thérapeutiques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ATRT
Keywords: ATRT
SMARCB1
single-cell RNAseq
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut Curie
First posted: 2021-08-03
Enrollment: 15
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children having or likely having a rhabdoid tumor according to clinical and radiological features

Brief summary: The aim is to describe at the cellular level the heterogeneity of rhabdoid tumors, and identify how this diversity influences resistance to treatment.

Detailed description: Rhabdoid tumors are aggressive cancers of infancy. Although frequently chemosensitive at the very beginning, they very often show resistance, suggesting some intra-tumor diversity or plasticity. Moreover, morphological analysis of rhadoid tumors often reveal some variety in tumor cell shapes and immunohistochemical profiling. Altogether, this suggests some intra-tumor heterogeneity, that has been scarcely studied so far.

This project aims to describe the intra-tumor heterogeneity by single-cell sequencing approaches.

After surgical resection, fresh tumor samples will be dissected and analysed using the 10X Chromium technology. Briefly, cells will be grouped in clusters according to their gene expression signalling, and each cluster will be defined in comparison with all other ones. Differential analyses will allow identifying the main characteristic of each cell sub-population. Potential filiations between clusters will be analysed using classical algorithms. The study will be performed on 10 to 15 tumor samples.

Eligibility criteria: Inclusion Criteria:

* Aged 0-17 years old
* having a rhabdoid tumor according to clinical and radiological features Or likely having a rhabdoid tumor according to clinical and radiological features
* surgical resection in standard care
* sufficient material for both diagnosis and experimental procedures
* parents' agreement

Primary outcomes:
measure: Intra-tumor heterogeneity
timeFrame: Inclusion
Secondary outcomes:
measure: Cell clusters recurrent from one sample to the other
timeFrame: Inclusion
measure: Naming of potential targetable gene
timeFrame: Inclusion
measure: Identification of cytotoxic cells
timeFrame: Inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: APHP Assistance Publique des Hôpitaux de Paris
name: Kevin Beccaria, MD, PhD, Pr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03734276: Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study
Official title: Effect of High-intensity Training on the Level of Physical Activity After Thoracoscopy Surgery: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rehabilitation
Thoracic Surgery
Physical Activity
Lead sponsor: HEDSV
Sponsor class: UNKNOWN
First posted: 2018-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: feasibility Study with randomized control trial
Primary purpose: TREATMENT

Brief summary: Goal of this study is to evaluate management with high intensity re-entrainment during the postoperative hospital phase.

This type of early treatment with as little intervention time has so far never been done. The investigators therefore want to carry out this feasibility study in order to collect the data needed to calculate the number of randomized control trial. Investigators will also evaluate the feasibility of this project concerning recruitment, intervention in the hospital phase and data collection once the return home. The evaluation of the activity will be done one month after the return to home by means of a actigraphy of one week.


Eligibility criteria: Inclusion Criteria:

* Indication of thoracoscopic surgery
* Autonomous mobilization (with or without auxiliary device)

Exclusion Criteria:

* Patient dependent on oxygen before the procedure
* chronic obstructive pulmonary disease patient with forced expiratory volume at one second \<50% predicted

Primary outcomes:
measure: Evaluate the impact of the intervention on the level of physical activity when returning home by actigraphy
timeFrame: change from baseline number of steps at 7 days after back home and at 30 days after back home
Secondary outcomes:
measure: Evaluate the impact of the intervention on the level of physical activity by questionnaires.
timeFrame: change from baseline questionnaire at 7 days after back home and at 30 days after back home
measure: Evaluate the impact of the intervention on the level of physical activity by questionnaires.
timeFrame: change from baseline questionnaire at 7 days after back home and at 30 days after back home
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03771976: Risk of Cesarean Section in Primiparous Women Over 35 Years of Age.
Official title: Risk of Cesarean Section and Perinatal Complications in Primiparous Women Over 35 Years of Age. A Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Complications
Keywords: Older women (>35 years of age)
Primipara
Cesarean section
Lead sponsor: Saint Thomas Hospital, Panama
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 572
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primiparous women, between 22 and 42 weeks of gestation.

Brief summary: The investigators reviewed Saint Thomas Maternity Hospital's database during a 5 year period and compared two cohorts of patients (primiparous women over 35 years of age and primiparous woman between 20 and 34 years of age). The objective was to determine the risk of cesarean section and other perinatal complications between the groups.


Eligibility criteria: Inclusion Criteria:

* Pregnant Primiparous women.
* Birth after 22 weeks and neonatal weight \> 501g.

Exclusion Criteria:

* Multiparity.
* Birth before 22 weeks or neonatal weight \< 500g.

Primary outcomes:
measure: Risk of cesarean section
timeFrame: 5 years
Secondary outcomes:
measure: Perinatal complications
timeFrame: 5 years
Other outcomes:
Locations:
city: Panama
country: Panama
facility: Saint Thomas H
Study officials:
References:
Clinical trial NCT01725776: Inhaled Milrinone in Cardiac Surgery
Official title: Pharmacokinetic and Pharmacodynamic of Inhaled Milrinone in Cardiac Surgical Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Keywords: Pulmonary hypertension
Cardiac surgery
Cardiopulmonary Bypass (CPB)
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Fonds de la Recherche en Santé du Québec
name: St. Justine's Hospital
First posted: 2012-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the concentration-effect relationship of inhaled milrinone after prophylactic administration in cardiac surgical patients with preoperative pulmonary hypertension undergoing cardiopulmonary bypass.

Detailed description: Milrinone elimination will be verify with blood and urine samples analysis.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective cardiac surgery under CPB
* High risk patients: NYHA class II-III
* Preoperative diagnostic of pulmonary hypertension:

  * Systolic pulmonary artery pressure (sPAP) \> 35 mm Hg; or
  * Mean pulmonary artery pressure (mPAP) \> 25 mm Hg; or
  * mAP/mPAP \< 3.0 (after induction of anesthesia).

Exclusion Criteria:

* Open Heart Surgery
* Contraindication to transesophageal echocardiography (TEE)
* Hemodynamic instability before surgery
* Emergency surgery

Primary outcomes:
measure: Study the elimination rate of milrinone administered by inhalation
timeFrame: up to 24 hours
Secondary outcomes:
measure: Demonstrate the presence or absence of hemodynamic and echographic effects observed after inhalation of milrinone
timeFrame: 15 min after the of study drug administration
measure: Confirmation of the safety of inhaled milrinone
timeFrame: 24 hours after cardiac surgery
measure: Determination of the efficacy of inhaled milrinone in the treatment of pulmonary hypertension
timeFrame: 15 min after end of milrinone administration
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Andrée Denault, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06393127: A Study in Healthy People to Compare How 2 Different High Dose Formulations of BI 1015550 Are Taken up in the Body
Official title: Bioequivalence of the BI 1015550 High Dose Formulation C2 and the BI 1015550 High Dose Formulation C1 (Phase 3 Formulation) Following Oral Administration in Healthy Subjects (an Open-label, Randomised, Single-dose, Two-way Crossover Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-05-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to establish the bioequivalence of the BI 1015550 Formulation C2 (Test, T) and the BI 1015550 Formulation C1 (Reference, R), following a single oral dose administration.


Eligibility criteria: Inclusion Criteria:

1. Healthy male or female subject according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
2. Age of 18 to 50 years (inclusive)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (inclusive)
4. Signed and dated written informed consent in accordance with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply.

Exclusion Criteria:

1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
2. Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 50 to 90 beats per minute (bpm) at screening
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance, in particular, hepatic parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin) or renal parameters (creatinine) exceeding the upper limit of normal (ULN) at screening
4. Any evidence of a concomitant disease assessed as clinically relevant by the investigator Further exclusion criteria apply

Primary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
timeFrame: up to 7 days.
measure: Maximum measured concentration of the analyte in plasma (Cmax)
timeFrame: up to 7 days.
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
timeFrame: up to 7 days.
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Research Organisation GmbH
Study officials:
References:
Clinical trial NCT01665027: Effect of Vacuum on Fetal and Maternal Complications During Difficult Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complications; Cesarean Section
Keywords: caesarean section,
vacuum,
fetal head extraction,
maternal complication,
fetal complication
Lead sponsor: Shahid Sadoughi University of Medical Sciences and Health Services
Sponsor class: OTHER
First posted: 2012-08-15
Enrollment: 108
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Cesarean Section (C/S) rate from 1970 to 2007 in U.S is 31.8% and in Iran From 2000 to 2009 rose to 50-65%. This Surgical Procedure is not without risk. Difficult head Extraction in C/S occur in 1-2% of all deliveries. This study was designed to compare the results of delivery by vacuum in C/S with normal caesarean section.


Eligibility criteria: Inclusion Criteria:

* term pregnant women with cephalic presentation and singleton gestation that had difficult labor and difficult head extraction during caesarean.

Exclusion Criteria:

* Elective cesarean

Primary outcomes:
measure: Mean duration time between incision and fetal head delivery
timeFrame: during surgery
Secondary outcomes:
measure: fetal complications
timeFrame: after extraction of fetus and during cleaning of fetus under warmer
Other outcomes:
measure: maternal complications
timeFrame: during surgery and first hour after childbirth (after extraction of fetus when surgeon wanted to correct the lesions)
Locations:
city: Yazd
country: Iran, Islamic Republic of
facility: Shahid sadoughi University of medical sciences
Study officials:
References:
Clinical trial NCT06781827: Research on the Use of Probiotics in the Prevention and Treatment of Inflammatory Bowel Disease
Official title: Application Research of Lactobacillus Reuteri in the Treatment of Inflammatory Bowel
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Disease
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project involves the use of oral Lactobacillus reuteri as an adjunct therapy for 8 weeks. Endoscopic observation of intestinal inflammation will be conducted at 1 month, 3 months, 6 months, and 12 months after the administration of the drug. Intestinal fluid will be collected endoscopically for 16S RNA analysis to assess changes in the gut microbiota. Inflammatory changes in the patients will be detected through peripheral blood tests, and fecal calprotectin levels will be measured to evaluate the progression of the disease.


Eligibility criteria: Inclusion Criteria:

1. Be over 18 years old
2. Agree to sign informed consent; Have been diagnosed with IBD for at least 3 months but not more than 3 years -

Exclusion Criteria:

1. Does not meet the diagnostic criteria of CD
2. Patients with other autoimmune diseases, infectious diseases and malignant tumors Patients with CD during pregnancy and lactation; Patients with serious diseases of the liver, kidney, heart and lung, etc
3. Patients with allergic diseases such as asthma and allergic rhinitis; alcoholic Patients with mental illness
4. Patients with suspected cancer in their intestines
5. Antibiotics, probiotics and prebiotics have been used in the past three months Had intestinal surgery (except appendicitis surgery)
6. There is currently an infection
7. He has had cancer in the last 5 years -

Primary outcomes:
measure: Improvement of Intestinal Inflammation Assessed by Endoscopic Scoring System
timeFrame: 12 months
Secondary outcomes:
measure: Assessment of Intestinal Flora Changes Using 16S RNA Analysis
timeFrame: 8 weeks
measure: Assessment of Inflammatory Changes Using Peripheral Blood Inflammatory Markers
timeFrame: 8 weeks
measure: Disease progression
timeFrame: 8 weeks
measure: Evaluation of Crohn's Disease Severity Using the Crohn's Disease Activity Index (CDAI)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Suqian
country: China
facility: Gastroenterology Department of Jiangsu Province （Suqian）Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT05531227: Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint
Official title: Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Septic
Keywords: Arthritis, Septic
synovitis
Corticosteroid therapy
Inflammatory response
Native joint
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021

Brief summary: Acute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon.

Corticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use.

There are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* having presented with septic arthritis and treated at the Strasbourg University Hospital between January 1, 2012 and December 31, 2021
* clinical finding of persistent synovitis, defined by the presence of pain, effusion or joint stiffness despite well-conducted treatment
* having had a diagnosis of joint infection proven by a positive culture of the joint fluid to a pathogenic germ
* having had treatment with local or systemic corticosteroids.

Exclusion criteria:

* Patient who has expressed his opposition to the reuse of his data for scientific research purposes.
* Absence of corticosteroid treatment

Primary outcomes:
measure: Complete regression of the pain in a fast way
timeFrame: 6 months after treatment with corticosteroids
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
Study officials:
affiliation: Service de Chirurgie Orthopédique Septique - CHU de Strasbourg - France
name: Jeannot GAUDIAS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00051727: Prevention of School Dropout for Mexican American Adolescents
Official title: Preventive Intervention for Mexican American Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depression
Conduct Disorder
Lead sponsor: Arizona State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-01-17
Enrollment: 480
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the efficacy of a family-based psychosocial intervention to prevent school disengagement and reduce the incidence of depression, conduct disorders, and school dropout for Mexican American adolescents.

Detailed description: Mexican American adolescents are at an increased risk for interrelated problems of poor mental health and school dropout. Unfortunately, there is a lack of interventions specifically designed to address this risk. This study will evaluate a preventive intervention for low-income Mexican American adolescents.

Participants are randomly assigned to either a multi-component intervention called the Bridges to High School Program or a Low Dose Workshop. The 11-week multi-component intervention takes place during the fall semester of seventh grade and consists of an adolescent group, a parenting group, a combined (parent-adolescent) family group, and a school liaison. This intervention focuses on adolescent coping skills, parenting practices, family cohesion, and parental support for education. The Low-Dose Workshop consists of a 3-hour workshop in which adolescents and parents are given information and resources to facilitate school engagement. Participants are assessed prior to and immediately following the intervention and again in eighth and ninth grade. Academic and mental health outcomes are measured with questionnaire-based interviews given to caregivers and adolescents. Teachers are asked to complete questionnaires; archival school data are also collected. Diagnostic interviews are conducted at the ninth grade assessment.

Eligibility criteria: Inclusion criteria:

* Mexican American adolescent with at least one primary caregiver
* Enrolled in seventh grade in one of four inner-city schools
* Adolescent and participating caregivers must be able to receive intervention in the same language (English or Spanish)

Exclusion criteria:

* High risk for suicide

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Prevention Research Center, Arizona State University
state: Arizona
Study officials:
affiliation: Arizona State University
name: Nancy A Gonzales, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: