louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06657443: The Effect of a Peer Mentoring Program on Nursing Students
Official title: The Effect of a Peer Mentoring Program on Nursing Students' Perceived Empathic Self-Efficacy, Social Self-Efficacy, and Youth Leadership Characteristics: A Pretest-Posttest Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peer Group
Mentoring
Program Evaluation
Nurse
Empathy Skills
Social Skills
Leadership
Keywords: Peer mentoring program
Nursing students,
Empathic Self-Efficacy
Social Self-Efficacy
Youth Leadership
Lead sponsor: Suleyman Demirel University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project is designed as a quasi-experimental study to evaluate the effect of the Peer Leadership Program, established in the Nursing Department, on nursing peer mentor students' empathic self-efficacy, social self-efficacy, and youth leadership characteristics.

Detailed description: The study population comprises second, third and fourth-year students enrolled at Süleyman Demirel University, Faculty of Health Sciences, Department of Nursing, during the 2024-2025 academic year. Peer mentor students, selected on the basis of volunteerism, will be randomly assigned mentors by an independent researcher to ensure randomness. The study will be conducted over a period of six weeks. During this period, the peer mentors will undergo training in communication techniques, interview methods, empathic approach, social motivation and leader-member interaction, with the subsequent sharing of postcasts. Furthermore, a presentation and evaluation meeting will be held between the peer mentors and their mentees, with the aim of fostering empathy and understanding between the two groups. The meeting will be based on the theme of 'nursing and society'. In order to assess the effectiveness of the intervention, the peer mentors' empathic self-efficacy, social self-efficacy and youth leadership characteristics will be evaluated before and after the meeting. Additionally, the socio-demographic data of the students will be recorded in a data collection form.

Eligibility criteria: Inclusion Criteria:

* The term "volunteers" is used to designate students enrolled in the 2024-2025 academic year, in their second, third or fourth year of studies, who are actively engaged in the education and training process.

Exclusion Criteria:

* Students who indicated a preference for not being a first-year student and instead volunteered to serve as peer mentors.

Primary outcomes:
measure: Perceived Empathic Self-Efficacy and Social Self-Efficacy Scale
timeFrame: Before Training and Activities (First Session) and at the Final Session After 6 Weeks
Secondary outcomes:
measure: Youth Leadership Traits scale
timeFrame: Before Training and Activities (First Session) and at the Final Session After 6 Weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00928343: First-in-Human Single Ascending Subcutaneous (s.c.) Dose and Single Oral Dose of GLPG0187
Official title: Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics (PK), and Pharmacodynamics (PD) of Single Ascending Subcutaneous and Oral Doses of GLPG0187 in Healthy Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2009-06-25
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) subcutaneous and single oral dose of GLPG0187 compared to placebo.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0187 after single subcutaneous and oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.


Eligibility criteria: Inclusion Criteria:

* healthy male, age 18-50 years
* BMI between 18-30 kg/m², inclusive

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Safety and tolerability of single subcutaneous and oral dosing
timeFrame: up to day 10 postdose
Secondary outcomes:
measure: Pharmacokinetics of single subcutaneous and oral doses
timeFrame: up to 10 days postdose
measure: Exploratory evaluation of S-CTX
timeFrame: up to 24 hrs postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Giocondo Lorenzon, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Eva Vets, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529043: MINISTOP Plus Program for Pre-school Children With Overweight and Obesity
Official title: MINISTOP Plus Program for Pre-school Children With Overweight and Obesity: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Mobile-based intervention intended to stop obesity in preschoolers (MINISTOP) program has been developed to be a comprehensive digital support program for all children irrespective of weight status. However, a one size fits all approach may not be sufficient as some families may require extra support through in-person activities to achieve the required lifestyle behaviour change in order to attain and maintain a healthy weight. Therefore, the aims of this pilot randomized controlled trial are to evaluate the efficacy and feasibility of the MINISTOP Plus Program in pre-school children with overweight and obesity on: (i) children's BMI z-scores; (ii) intake of fruit and vegetables, sweet and savoury snacks, and sweet drinks; (iii) time spent in different physical activity intensities; (iv) screen time; and (v) parental self-efficacy.


Eligibility criteria: Inclusion Criteria:

* 2 to 5 year old children with overweight and obesity residing in the municipality of Kungsbacka.

Exclusion Criteria:

* If a child has a disease or disorder that affects body size or feeding.
* Children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family.
* Children from families who will not be able to understand the app content, i.e., those who do not speak Swedish, English, Arabic, or Somali

Primary outcomes:
measure: Body mass index
timeFrame: At the end of the intervention which is 12-months after baseline
Secondary outcomes:
measure: Intake of key dietary indicators as assessed by a questionnaire.
timeFrame: At the end of the intervention which is 12-months after baseline.
measure: Physical activity assessed using an accelerometer
timeFrame: At the end of the intervention which is 12-months after baseline
measure: Screen time as assessed by a questionnaire
timeFrame: At the end of the intervention which is 12-months after baseline
measure: Self-efficacy self-efficacy for promoting healthy dietary and physical activity behaviours in their children's
timeFrame: At the end of the intervention which is 12-months after baseline
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Department of Biosciences and Nutrition
Study officials:
affiliation: Karolinska Institutet
name: Christine Delisle Nyström, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06270043: Focal Therapy for Localized Prostate Cancer
Official title: A Prospective Registry and Longitudinal Study of Patients Undergoing Focal Therapy for Localized Prostate Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Keywords: Focal Therapy
High Intensity Frequency Ultrasound
Transurethral Ultrasound Ablation
Cryoablation
Irreversible Electroporation
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have biopsy-proven adenocarcinoma of the prostate, who have met all study inclusion and exclusion criteria, and have elected to receive or have already received the focal therapy as part of their routine prostate cancer treatment, will be invited to participate in this observational registry study.

Brief summary: This prospective registry and longitudinal study that is designed to carefully measure details of prostate cancer patients' outcomes with focal therapy. The goal of which is to improve patient care.

Detailed description: This observational study will serve to collect data from medical record and review questionnaires before and after focal ablation of prostate tissue. All enrolled subjects will have already undergone or scheduled to receive the focal therapy as part of their prostate cancer treatment.

Eligibility criteria: Inclusion Criteria:

* Subject has elected or already undergone focal therapy as their standard of care treatment method and declined alternative treatment (active surveillance, radical prostatectomy, and radiation therapy)
* PSA ≤ 20
* Ability to complete informed consent form

Exclusion Criteria:

* Contraindication to follow-up multi parametric MRI or prostate biopsy
* Unable to tolerate general or regional anesthesia

Primary outcomes:
measure: Oncological Response
timeFrame: 1 year
Secondary outcomes:
measure: Erectile Dysfunction
timeFrame: 1 year
measure: Incontinence
timeFrame: 1 year
measure: Prostate cancer recurrence. Patients will be monitored with a Prostate Specific Antigen (PSA) every 6 months until 10 years from the intervention. Patients with a rising PSA will receive a prostate biopsy to determine if they have a recurrence.
timeFrame: 10 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
citation: Javier-DesLoges J, Dall'Era MA, Brisbane W, Chamie K, Washington SL 3rd, Chandrasekar T, Marks LS, Nguyen H, Daneshvar M, Gin G, Kane CJ, Bagrodia A, Cooperberg MR. The state of focal therapy in the treatment of prostate cancer: the university of California collaborative (UC-Squared) consensus statement. Prostate Cancer Prostatic Dis. 2024 Dec;27(4):579-581. doi: 10.1038/s41391-023-00702-1. Epub 2023 Aug 8. No abstract available.
Clinical trial NCT03416543: Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis
Official title: Effect of a New BI-specifiC Antibody Towards Dendritic Cells on Inflammation in Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Gout
Osteoarthritis
Keywords: Rheumatoid arthritis
Dendritics cells
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 45
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: Patients with acute arthritis of RA or Gout or with osteoarthritis. Puncture necessary for daily practice (diagnostic or therapeutic)

Brief summary: First, this study will evaluate, in vitro, the cellular composition of the synovial fluid from patient with rheumatoid arthritis, gout or osteoarthritis.

Then samples will be test with a new format of bispecific antibody targeting dendritic cells. The production of IL-10 will be the principal criteria of judgment. Production of others cytokines like IL-1B, IL-6, IL-12 and IFN will be checked as well.

Detailed description: Rheumatoid arthritis (RA) is one of the most common autoimmune disease in adult. It exists several drugs but none target dendritic cells even if it seems they play a major role in the physiopathology.

One of the unit of research of Tours recently develop a new format of bispecific antibody which target dendritic cells. The first results in PBMC (unpublished yet) show an increase of the production of IL-10 In this study, we are going to first evaluate the cellular composition of synovial fluid from patients with RA and patients with gout (for the comparison, because the inflammatory mechanisms are different) and with osteoarthritis (comparison with a non inflammatory disease) Then, we will use this new antibody and evaluate the response by dosing Il-10, IL-6, IL-12, IL1B and IFNy The aim is to verify in vitro if, with this new drug, it is possible to reverse the inflammation and induce a tolerance.

Eligibility criteria: Inclusion Criteria:

* Male or female over 18 years old
* Proven and possible RA or Gout or osteoarthritis
* Arthritis accessible to a puncture
* Necessary puncture for diagnosis or therapeutic

Exclusion Criteria:

* Microcrystalline rheumatism other than Gout
* Known SpA
* Septic arthritis
* Biomedicament treatment
* Patient having objected to the processing of his data

Primary outcomes:
measure: Production of IL-10
timeFrame: 48 hours
Secondary outcomes:
measure: Production of Il-6
timeFrame: 48 hours
measure: Production of IFN
timeFrame: 48 hours
measure: Production of IL1B
timeFrame: 48 hours
measure: Production of IL12
timeFrame: 48 hours
Other outcomes:
Locations:
city: Tours
country: France
facility: Rheumatology Department, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Denis MULLEMAN, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06271343: Kidney Graft Tolerance KTOL
Official title: Non-interventional Single-center Study of the Contribution of DP8α Regulatory T Cells Induced by a Gut Microbiota Bacterium to Kidney Transplant Tolerance.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Transplant Tolerance
Keywords: DP8 Regulatory Lymphocytes
Intestinal Microbiota
Tolerance
Transplant
Kidney
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2024-02-21
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will use PBMCs from 15 patients receiving a kidney transplant from a living, ABO-compatible donor from their family or acquaintance. These PBMC will be obtained from blood samples taken before and 3 months after transplantation, in the context of normal patient management. The study will also use PBMC from the donor, taken before the transplant.

Brief summary: Prospective experimental study using PBMC from a limited number of adult patients (15) treated at Nantes University Hospital for a kidney transplant from a related living donor.

The study will be carried out on PBMC from both donors and recipients, collected during visits scheduled as part of the clinical management of the donor/recipient pair.

The study will test the hypothesis that DP8α Tregs expressing CD73, whose frequency in blood increases stably after non-rejected kidney transplants, but not when patients have undergone or will subsequently undergo rejection, are enriched in donor-specific cells, which would be a strong argument in favor of a direct role for these Tregs in preventing transplant rejection, through their ability to inhibit immune responses directed against donor alloantigens.


Eligibility criteria: Inclusion Criteria:

* Adult donor-recipient pair.
* First or second kidney transplant from a related ABO-compatible living donor.
* BMI \< 35 for recipients.
* Adult patients.
* Patients weighing over 50 kgs.

Exclusion Criteria:

* Donor/recipient ABO incompatibility
* BMI \> 35 for recipients

Primary outcomes:
measure: To test the role of donor-specific DP8α Tregs in preventing kidney transplant rejection.
timeFrame: 3 months
Secondary outcomes:
measure: Determine whether the increased anti-donor reactivity of the patient's DP8α Tregs after transplantation results from the amplification among them of clones and establish, if possible, the anti-donor reactivity of amplified clones.
timeFrame: 3 months
measure: Determine whether clones of DP8α Tregs (reactive or not to donor antigens) are reactive to F. prausnitzii bacteria.
timeFrame: 3 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
References:
Clinical trial NCT04515043: EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754)
Official title: AN EXPLORATORY FOLLOW-UP STUDY OF LONG TERM ANTI-TELOMERASE IMMUNE RESPONSE AFTER INVAC-1 VACCINATION IN PATIENTS WITH LONG TERM SURVIVAL. Addendum to INVAC1-CT-101 PROTOCOL - EUDRACT NUMBER : 2013-004369-15
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor, Adult
Lead sponsor: Invectys
Sponsor class: INDUSTRY
First posted: 2020-08-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018).

Detailed description: The primary goal of the study is to analyze anti-telomerase specific memory responses in blood of long term survival patients and to correlate these immune responses to their subsequent treatment since the end of INVAC1-CT-101 phase I study. Six patients are expected to participate in this study.

Eligibility criteria: Inclusion Criteria:

1. Patients who participated in the phase I study and are still alive at the present time
2. Ability to provide written informed consent and to understand and comply with the requirements of the study.

Exclusion Criteria:

1. Anemia (Hgb \< 7g/dL) according to L-1121-1 annexe 2 of Code de Santé Publique
2. Systolic blood pressure below 90 mm Hg

Primary outcomes:
measure: long term anti telomerase specific memory responses
timeFrame: 1 day visit
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Saint Louis Hospital
Study officials:
affiliation: AP-HP Paris Hospital
name: Luis Teixeira
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01440543: Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy
Official title: Combination of Water Immersion and Carbon Dioxide Insufflation for Minimal Sedation Colonoscopy - a Prospective, Randomized, Single-center Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonoscopy
Keywords: colonoscopy
water immersion
CO2 insufflation
patients referred for diagnostic outpatient colonoscopy
(screening, surveillance, symptoms)
patient discomfort associated with diagnostic colonoscopy
Lead sponsor: Vitkovice Hospital
Sponsor class: OTHER
First posted: 2011-09-26
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Water immersion insertion and carbon dioxide (CO2)instead of room air insufflation as alternative colonoscopy techniques have been documented to decrease patient discomfort during and after the procedure.

This prospective, randomized, single-center trial was designed to evaluate whether the combination of water immersion during insertion and CO2 insufflation during withdrawal (Water/CO2)for minimal sedation colonoscopy (2 mg of midazolam i.v.)is superior to the other colonoscopy methods (Water/Air, CO2/CO2, Air/Air).


Eligibility criteria: Inclusion Criteria:

* men and women older than 18 years referred for diagnostic outpatient colonoscopy
* provided written consent

Exclusion Criteria:

* history of colorectal surgery
* known diagnosis of inflammatory bowel disease
* chronic benzodiazepine use
* refusal of minimal sedation

Primary outcomes:
measure: Success Rate of Minimal Sedation Colonoscopy
timeFrame: six months
measure: Success Rate of Minimal Sedation Colonoscopy
timeFrame: 6 months
Secondary outcomes:
measure: Patient Comfort During the Procedure and During First 24 Hours After Procedure
timeFrame: six months
Other outcomes:
Locations:
city: Ostrava
country: Czech Republic
facility: Digestive Diseases Center - Vitkovice Hospital
Study officials:
affiliation: Digestive Diseases Center, Vitkovice Hospital, Ostrava, Czech Republic
name: Premysl Falt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Falt P, Liberda M, Smajstrla V, Kliment M, Bartkova A, Tvrdik J, Fojtik P, Urban O. Combination of water immersion and carbon dioxide insufflation for minimal sedation colonoscopy: a prospective, randomized, single-center trial. Eur J Gastroenterol Hepatol. 2012 Aug;24(8):971-7. doi: 10.1097/MEG.0b013e3283543f16.
Clinical trial NCT00156143: Transition Study: Growth Hormone Therapy In Partial Growth Hormone Deficient Adolescents
Official title: GH Therapy in Partial GHD Adolescents : Evaluation of Efficacy Based on Body Composition and Comparison of 2 Different Doses of Genotonorm®. Open-Label, Randomised, Comparative, Controlled, Parallel-Group, Multi-Center Phase IIIB Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 90
Sex: ALL
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate in boys and girls the improvement in body composition under GH treatment in adolescents with CO-GHD who remain partially GHD after GH discontinuation.


Eligibility criteria: Inclusion Criteria:

* Males or females : Chronological age \> or = 15 years and \< or = 20 years for females
* Chronological age \> or = 17 years and \< or = 20 years for males
* GHD of childhood onset treated for at least 2 years
* Last GH injection at least 12 months before baseline visit

Exclusion Criteria:

* Turner's syndrome
* Chronic hepatic impairment as shown by GGT and / or ASAT and / or ALAT \> 2 X ULN

Primary outcomes:
measure: Change from baseline of the % of fat mass assessed by DEXA after 1 year of treatment.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: