louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00706888: Study on Effects of a Dairy Product Based on Polyphenols and Enriched With Vitamins B6, B9 and B12 on Some Cardiovascular Factor of Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Factors
Keywords: Reduction of cardiovascular factor of risk
Lead sponsor: Elvir SAS
Sponsor class: INDUSTRY
Collaborators: name: BioFortis
First posted: 2008-06-30
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We put forward that polyphenols and vitamins have a cardiovascular prevention effect for subject with cardiovascular risk.


Eligibility criteria: Inclusion Criteria:

* BMI less than 33 kg/m²
* Waist measurement higher than 90 cm for woman and 100 cm for man
* Normal or controled blood pressure (less than 16/9)
* non-smoker
* Female with contraception

Exclusion Criteria:

* Food allergy
* Cardiovascular pathology
* Medical treatment for cholesterol
* Higher consumption for dairy product and red fruit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nantes
country: France
facility: Biofortis
Study officials:
References:
Clinical trial NCT06981988: A Study of Linperlisib (YY-20394) in Combination With Rituximab in Patients With Relapsed/Refractory Indolent NHL
Official title: A Study to Explore the Dosage and Efficacy of Linperlisib in Combination With Rituximab and to Validate the Efficacy of Linperlisib in Patients With Relapsed/Refractory Indolent NHL
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Relapsed/Refractory Indolent NHL
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the reasonable dosage, efficacy and safety of Linperlisib in combination with rituximab in subjects with relapsed/refractory (R/R) indolent non-hodgkin lymphoma(NHL) in adults.


Eligibility criteria: Inclusion Criteria:

1. Patients received at least 1 lines of systemic therapy
2. Previously received anti- CD20 treatment
3. Subjects must have at least one bi-dimensionally measurable lesion (nodal site Ldi \> 1.5 cm or extranodal site Ldi \> 1.0cm)
4. Patients must have an acceptable organ function

Exclusion Criteria:

1. Previously treated with PI3K inhibitors
2. Unresolved toxicity of CTCAE grade \> 1 from prior anti-lymphoma therapy
3. Chemotherapy or other antitumor therapy within 14 days before starting cycle one
4. Significant concurrent medical disease or condition which according to the investigators' judgement
5. Active hepatitis B, C or HIV infection
6. Infection requiring treatment 2 weeks prior to the first dosing

Primary outcomes:
measure: MTD （Maximum tolerated dose）of Linperlisib（Stage 1）
timeFrame: Subjects are evaluated for DLTs during the first 28-day cycle
measure: RP2/3D（Recommended Phase II/III Dose) of Linperlisib （Stage 1）
timeFrame: The RP2/3D for Phase 2/3 will be selected at the end of Phase 1b, approximately 2 years
measure: Complete response rate (CRR) assessed by Investigator（Stage 2）
timeFrame: up to 5 years
measure: Progression-free Survival assessed by Investigator （Stage 2）
timeFrame: up to 5 years
Secondary outcomes:
measure: Objective Response Rate (ORR) assessed by Investigator
timeFrame: up to 5 years
measure: Duration of response (DOR) assessed by Investigator
timeFrame: up to 5 years
measure: Incidence of Adverse Events (Linperlisib when combined with Rituximab)
timeFrame: up to 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02711488: Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
Official title: Managing Adolescent Obesity at Local Level by Combining Primary and Secondary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: school-based intervention
sedentary behavior
physical activity
sugar sweetened beverages
Lead sponsor: Rio de Janeiro State University
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Rio de Janeiro
First posted: 2016-03-17
Enrollment: 3000
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The objective of the project is to develop, implement and evaluate a prevention program for obesity among adolescents in Brazil combining the primary care health system implemented in the country in recent decades with primary prevention at schools.

Detailed description: The study will combine primary prevention activities at the school level with secondary prevention at the household level, both focusing on behavior strategies such as mindfulness, reduction of eating rate; eating with others at a dinning table; healthy eating, increasing physical activity and reducing sedentary lifestyle habits.

Eligibility criteria: Inclusion Criteria:

* Both prevention programs
* 5th and 6th grades students
* consent form signed by parents/tutors
* Secondary prevention program
* Overweight and obese children

Exclusion Criteria:

* pregnant girls

Primary outcomes:
measure: Body Mass Index
timeFrame: one year
Secondary outcomes:
measure: Body composition
timeFrame: one year
Other outcomes:
measure: adherence to the protocol at household level
timeFrame: one year
measure: physical activity
timeFrame: one year
measure: physical activity
timeFrame: one year
measure: food intake
timeFrame: one year
measure: food intake
timeFrame: one year
Locations:
Study officials:
References:
citation: Sgambato MR, Cunha DB, Henriques VT, Estima CC, Souza BS, Pereira RA, Yokoo EM, Paravidino VB, Sichieri R. PAAPPAS community trial protocol: a randomized study of obesity prevention for adolescents combining school with household intervention. BMC Public Health. 2016 Aug 17;16(1):809. doi: 10.1186/s12889-016-3473-3.
Clinical trial NCT04875988: Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport
Official title: Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intravenous Access
Keywords: pediatrics
interfacility transport
intravenous access
ultrasound
POCUS
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 66
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the efficacy of POCUS (Point of Care UltraSound) for intravenous (IV) access during pediatric interfacility transport. The Butterfly iQ+ (Lightning) device will be used. Children requiring IV access for transport will be randomized to POCUS-Assisted IV placement or traditional IV placement. We will examine and compare first attempt success rates with each method.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients requiring IV access prior to transport by the Angel One Transport Team back to Arkansas Children's Hospital
* Age group: 2 weeks - 18 years

Exclusion Criteria:

* Adequate IV Access
* NICU transports
* Patients not needing IV access

Primary outcomes:
measure: First Attempt IV success rates
timeFrame: 1 day of transfer
Secondary outcomes:
measure: Beside Times during transport
timeFrame: up to 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Arkansas
name: Michael H Stroud, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01245088: Chondroitin Sulfate for Crohn's Disease
Official title: A Pilot Study of Chondroitin Sulfate (CS) for the Treatment of Mild to Moderate Crohn's Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Crohn's Disease
Keywords: Crohn's disease
chondroitin sulfate
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2010-11-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pilot trial of open-label chondroitin sulfate 400 mg TID for adult patients with mild to moderate Crohn's disease. Primary endpoint with be evidence of bilogic effect assessed through serum and tissue cytokine analysis. Secondary endpoints are evidence of clinical effect, endoscopic healing, and histologic improvment. Trial duration is 8 weeks.


Eligibility criteria: Inclusion Criteria:

* 1. Colonic or ileocolonic CD diagnosed for at least 3 months. 2. Active CD, defined as a Crohn's Disease Activity Index (CDAI; Appendix A) \[Best 1976\] of greater than 200 but less than 320 at the time entry into the study.

  3. Age \> 18 years. 4. Patients receiving oral or topical 5-aminosalicylates must be on a stable dose for four weeks prior to enrollment.

  5. Patients on azathioprine, 6-mercaptopurine, or methotrexate must be on stable doses for 14 weeks prior to enrollment.

  6. Patients on corticosteroids must be on stable doses for 2 weeks prior to enrollment.

  7. Patients receiving corticosteroid enemas must be on a stable dose for 3 weeks prior to enrollment.

  8. Patient on biologic therapy with infliximab, adalimumab, or certolizumab must be on stable therapy for 12 weeks prior to enrollment 9. Patient must sign informed consent.

Exclusion Criteria:

* 1. Patients with only small bowel CD, fistulizing CD, or gastroduodenal CD without colonic involvement.

  2. Patients with known ulcerative colitis. 3. Patients expected to require surgery within 30 days for complications of CD. 4. Patients with CD and an intraabdominal abscess. 5. Patients requiring continuous antibiotics; antibiotics may be taken up to the point of enrollment into the study.

  6. Patients with severe cardiac, pulmonary, or renal disease. 7. Patients with a h/o malignancy other than resected basal cell carcinoma of the skin 8. Patients who have participated in another clinical research study in the past 8 weeks.

  9. Patients who are pregnant.

Primary outcomes:
measure: Biologic effect on inflammation
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Case medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT02814188: Effects of Pre-Exercise Nutrition Strategies on Body Temperature and Thermoregulatory Responses
Official title: Effects of Pre-Exercise Nutrition Strategies on Body Temperature and Thermoregulatory Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Thermoregulation
Keywords: Exercise
Lead sponsor: Old Dominion University
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Carbohydrate ingestion, in particular fructose, has been shown in a handful of previous studies to elicit a thermic effect and increase core body temperature after ingestion. Carbohydrate foods and supplements are commonly consumed prior to endurance running competition, including situations where an athlete's ability to dissipate body heat is compromised. Thus, there is some potential for pre-exercise carbohydrate ingestion to have a deleterious effect on body heat regulation in hot and humid environments. Thus, this projects aims to study the effects of pre-exercise carbohydrate ingestion on core body temperature, perceived thermal stress, and perceived exertion during high-intensity running.


Eligibility criteria: Inclusion Criteria:

* Be currently running ≥20 miles per week
* Have a projected 5-km maximal effort running time between 16:00-23:00 minutes

Exclusion Criteria:

* Any gastrointestinal disorders that cause swallowing problems or frequent nausea/vomiting

Primary outcomes:
measure: Core Body Temperature
timeFrame: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
Secondary outcomes:
measure: Thermal Sensation Scale
timeFrame: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
measure: Feeling Scale
timeFrame: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
measure: Rating of Perceived Exertion
timeFrame: 80 minutes (60, 50, 40, 30, 20, and 10 min pre-run and at 1-km intervals during a 20 min 5-km run)
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Human Performance Laboratory
state: Virginia
Study officials:
References:
Clinical trial NCT01570088: Bioavailability of Folic Acid Fortified Bread
Official title: Bioavailability of Folic Acid and L-5-methyltetrahydrofolic Acid in Fortified Bread: a Randomized Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Red Blood Cell Folate
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Folic acid is the synthetic form of vitamin folate. Because of its high stability and bioavailability, it is the form of folate added to bread in Canada to reduce birth defects. There are health concerns about long-term folic acid consumption. Another form of folate, L-5-methyltetrahydrofolic acid (L-5-MTHF) has become available which does not have these health concerns. Unfortunately L-5-MTHF is not as stable as folic acid, but the investigators have developed a method to stabilize L-5-MTHF in food. The investigators plan to conduct a randomized trial to compare the bioavailability of bread fortified with L-5-MTHF versus folic acid.

The investigators hypothesize that bread fortified with L-5-MTHF will increase red cell folate over 16 weeks to the same extent as bread fortified with equimolar folic acid.

Detailed description: See above.

Eligibility criteria: Inclusion Criteria:

* 18-45 years
* Not taking a folic acid containing supplement

Exclusion Criteria:

* Adults who have medical conditions such as diabetes, asthma, cancer, cardiovascular disease, high blood pressure, celiac disease, or psychiatric illness
* Adults who are taking medications known to interfere with folate metabolism (i.e. phenytoin, sulphasalazine, methotrexate)
* Adults with wheat, milk allergy or lactose intolerance
* Adults with known B12 deficiency
* Adults who consume more than 1 alcoholic drink/day on average (1 drink=12 oz beer, 5 oz wine or 1.5 oz spirits)
* Women have been pregnant during the year previous
* Women planning a pregnancy in the next year
* Women who believe they may become pregnant during the study
* Women who have had a known previous neural tube defect affected pregnancy
* Adults who are unable to provide informed consent

Primary outcomes:
measure: red blood cell folate concentration at three time points
timeFrame: baseline, 8th week, 16th week
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Tim Green, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Green TJ, Liu Y, Dadgar S, Li W, Bohni R, Kitts DD. Wheat rolls fortified with microencapsulated L-5-methyltetrahydrofolic acid or equimolar folic acid increase blood folate concentrations to a similar extent in healthy men and women. J Nutr. 2013 Jun;143(6):867-71. doi: 10.3945/jn.113.174268. Epub 2013 Apr 24.
Clinical trial NCT02842788: Prevalence of Prone Positioning Use in ARDS Patients
Official title: Prospective Study on the Prevalence on the Use of Prone Positioning in ARDS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Keywords: prone position
acute respiratory distress syndrome (ARDS)
mechanical ventilation
ICU
prevalence
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 736
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: ARDS under mechanical ventilation

Brief summary: Prone positioning has been shown to improve survival in patients with acute respiratory distress syndrome (ARDS). However, a recent large observational study found that prone positioning was used in only 7% of all ARDS patients, and 16% in the severe category. However, this study did not focus on the prone position per se. In present study, the investigators would like to explore the rate of use of prone positioning in ARDS patients and the reasons why this treatment was not applied. The present study is one-day prevalence study repeated four times over one year.

The hypothesis is that the rate of use of prone position is greater than 50% in the severe ARDS category.


Eligibility criteria: Inclusion Criteria:

* 1.ARDS criteria (Berlin definition) fulfilled the day of the study, whatever the ARDS stage. The onset of ARDS could have been established at any time between ICU admission and study day but ARDS criteria must be still present the day of the study. The ARDS criteria are listed below

  * Within 1 week of a known clinical insult or new or worsening respiratory symptoms
  * Bilateral opacities-not fully explained by effusions, lobar/lung collapse, or nodules
  * Respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (eg, echocardiography) to exclude hydrostatic edema if no risk factor present
* 2.PaO2/FIO2 ≤ 300 with PEEP ≥ 5 cmH2O
* 3.Age ≥ 18 years
* 4.Intubated or tracheotomized and mechanically ventilated

Exclusion Criteria:

* Patient non intubated the day of the study
* No criteria for ARDS the day of the study even if these criteria were present between ICU admission and day of the study

Primary outcomes:
measure: Prevalence of the use of the prone position in ARDS
timeFrame: Day 1
Secondary outcomes:
measure: Prevalence of the use of the prone position in each ARDS category
timeFrame: Day 1
measure: Occurence of reasons for not using prone position in ARDS patients
timeFrame: Day 1
measure: PaO2
timeFrame: Day 1
measure: PaO2/FIO2
timeFrame: Day 1
measure: Duration of prone position session
timeFrame: Day 1
Other outcomes:
Locations:
city: Lyon
country: France
facility: Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France
Study officials:
affiliation: Réanimation médicale, Hôpital de la Croix Rousse, CHU de Lyon, France
name: Claude Guérin, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04211688: Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder
Official title: Real-world Effectiveness of a Combined Group-individual Schema Therapy for Borderline Personality Disorder: A Pragmatic Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Randomized Controlled Trial
Lead sponsor: Consorci Sanitari del Maresme
Sponsor class: OTHER
Collaborators: name: Department of Health, Generalitat de Catalunya
First posted: 2019-12-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background and Objectives: Schema therapy has been shown to be of benefit in treating borderline personality disorder. However, it is still unclear what the most suitable treatment implementation format is and to what extent therapeutic gains may be generalizable to regular healthcare settings with limited resources.

Methods: A pragmatic randomized controlled trial was conducted ona representative Spanish sample of outpatients with a DSM-5 main diagnosis of borderline personality disorder. Patients were allocated either to a combined (group plus individual) schema therapy format (n=40) or to a group-only schema therapy format (n=40). Borderline personality disorder severity was the primary outcome, with other clinical variables considered as secondary outcomes (e.g., early maladaptive schemas, functioning). The assessment protocol included baseline, post-treatment (after 12months of treatment), and six-month follow-up evaluations. Data was analyzed through a two-way repeated measures ANOVA. Limitations were a limited follow-up assessment and the absence of multi-center data that detracted from the long-term stability and generalizability of the findings.


Eligibility criteria: Inclusion Criteria:

* DSM-5 criteria for borderline personality disorder
* Aged 18 to 65 years

Exclusion Criteria:

* Psychotic disorders (except short, reactive psychotic episodes)
* Bipolar disorder (current hypo-manic or mixed episode)
* Antisocial personality disorder
* Substance intoxication
* Mental retardation

Primary outcomes:
measure: BPD (borderline personality disorder) symptomatology
timeFrame: 18 months
Secondary outcomes:
measure: global functioning
timeFrame: 18 months
measure: early maladaptive schemas
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
citation: Zanarini MC. Psychotherapy of borderline personality disorder. Acta Psychiatr Scand. 2009 Nov;120(5):373-7. doi: 10.1111/j.1600-0447.2009.01448.x.
citation: Farrell, J. M., & Shaw, I. A. (2012). Group schema therapy for borderline personality disorder. A step-by-step treatment manual with patient workbook. West Sussex, UK: Wiley-Blackwell.