louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03556436: Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448
Official title: An Open-label, Single-dose Phase 1 Clinical Trial to Evaluate the Safety and Effects of Ethnicity and Food on Pharmacokinetics of YH25448 in Healthy Korean and Caucasian Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Cancer
Keywords: YH25448
Non-Small Cell Lung Cancer
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
Collaborators: name: Seoul National University Hospital
First posted: 2018-06-14
Enrollment: 24
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Clinical trial is to evaluate the effect of ethnicity and food on the pharmacokinetics (how a drug is absorbed, metabolized, distributed and excreted; plasma drug concentration will be measured in this clinical trial) of YH25448, which Yuhan Corporation plans to develop as a therapeutic agent for Non-Small Cell Lung Cancer.

Detailed description: This clinical trial will be conducted in healthy Korean and Caucasian volunteers at Seoul National University Hospital (SNUH) Clinical Trial Center.

It is expected to take approximately 39 days from the first dosing of Investigational Product until the final follow-up visit. It will be hospitalized twice for 9 nights and 10 days with 21 days of interval, and one visit will be needed for safety evaluation between 14-17 days from the last dosing of the Investigational Product.

Eligibility criteria: Inclusion Criteria:

1. Informed of the investigational nature of this study and voluntarily agree to participate in this study.
2. Subjects with BMI range of ≥18.5 kg/m2 and \< 30.0 kg/m2 and weighing ≥ 50 kg
3. Subjects without congenital or chronic diseases within the last 3 years and without pathologic symptoms as determined by medical diagnosis
4. Healthy Korean and Caucasian males who aged ≥ 19 and ≤ 55 years at the time of consent

Exclusion Criteria:

1. Clinically significant chronic infection (e.g. AIDS) or clinically significant medical or psychiatric illness
2. Hypotension (SBP ≤ 90 mmHg or DBP ≤ 50 mmHg) or hypertension (SBP ≥ 150 mmHg or DBP ≥ 100 mmHg)
3. A marked baseline prolongation of QTc greater than 450 msec by Bazett's formula
4. Within 14 days prior to the first administration of investigational product, use of prescription drugs or herbal medication, or within 7 days use of any over-the-counter medications

Primary outcomes:
measure: AUClast of YH25448
timeFrame: 0-192 hrs
measure: Cmax of YH25448
timeFrame: 0-192 hrs
Secondary outcomes:
measure: AUCinf of YH25448
timeFrame: 0-192 hrs
measure: Tmax of YH25448
timeFrame: 0-192 hrs
measure: t1/2 of YH25448
timeFrame: 0-192 hrs
measure: CL/F of YH25448
timeFrame: 0-192 hrs
measure: Vd/F of YH25448
timeFrame: 0-192 hrs
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital Clinical Trial Center
Study officials:
References:
Clinical trial NCT06261736: The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
Official title: The Effectiveness of Prophylactic Antibiotics for Urethral Bulking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Postoperative Urinary Tract Infection
Urethral Bulking
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to evaluate if prophylactic antibiotics in urethral bulking are effective in reducing postprocedural urinary tract infections.

Detailed description: Urethral bulking is a minimally invasive surgical treatment option for stress urinary incontinence (SUI). One commonly reported post-procedural complication is urinary tract infection (UTI). UTI rates are variable where studies have reported rates from as low as 0% to as high as 40%. Along with this variability, the instructional inserts for various bulking agents have inconsistent recommendations for use of prophylactic antibiotics. The American Urologic Association recommends antimicrobial prophylaxis for cystourethroscopy procedures involving minor manipulation. Currently, there are no clear guidelines regarding the utility of prophylactic antibiotics for urethral bulking. The objective of our study is to determine the effectiveness of prophylactic antibiotics in urethral bulking for reducing post procedural UTIs.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo a urethral bulking procedure
* Age 18 ≥ over

Exclusion Criteria:

* History of recurrent urinary tract infections
* Known history of urinary retention
* Allergies or contraindications to multiple antibiotics
* Inability to tolerate oral antibiotics
* Concomitant surgical procedures at the time of urethral bulking
* Pregnant or breastfeeding

Primary outcomes:
measure: Rate of urinary tract infection (UTI)
timeFrame: Within 4 weeks after the procedure
Secondary outcomes:
measure: Rate of postoperative urinary retention
timeFrame: Within 4 weeks after the procedure
measure: Rates of other postoperative complications
timeFrame: Within 4 weeks after the procedure
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Atlantic Health
state: New Jersey
Study officials:
affiliation: Atlantic Health System
name: Erika Wasenda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06508736: Cyberbullying, Empathy, and Storytelling in Adolescents
Official title: The Effect of Storytelling on Cyberbullying and Empathy in Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cyberbullying
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized trial with experimental and control groups
Primary purpose: PREVENTION

Brief summary: The type of this study is a randomized controlled experimental study. The aim of this study is to determine the effect of storytelling method on cyberbullying and empathy level in adolescents. The population of the study consisted of 5th and 6th grade middle school students. The sample of the study will consist of students involved in cyberbullying. The sample will be selected through randomization and stratified selection will be made according to gender. The students in the intervention group will receive 4 sessions of storytelling intervention. The active control group will receive 4 sessions of cyberbullying training. Questions that the research aims to answer:

Is there a difference between the intervention group and the control group in terms of cyberbullying level? Is there a difference between the intervention groups and the control group in terms of empathy level?

Participants:

The intervention group will participate in 4 sessions of storytelling intervention.

The control group will participate in 4 sessions of cyberbullying training.


Eligibility criteria: Inclusion Criteria:

* Family approval
* Volunteering to participate in the study.
* Being a 5th and 6th grade student
* Engaging in cyberbullying behavior

Exclusion Criteria:

* Having a diagnosis of any mental illness
* Having at least one of vision, speech and hearing disabilities
* Foreign nationality
* Being a 7th and 8th grade student
* Not engaging in cyberbullying behavior

Primary outcomes:
measure: cyberbullying
timeFrame: 6 months
Secondary outcomes:
measure: empathy
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06664736: Effects of Home-Based Exercise Program in Children After Acute Lymphoblastic Leukemia
Official title: Effects of Home-Based Exercise Program in Children After Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: leukemia
acute lymphoblastic
interleukins
inflammation
exercise
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective randomized controlled study aimed to investigate the effects of a home-based exercise program on physical functions, inflammatory markers, and Brain-Derived Neurotrophic Factor (BDNF) in children followed after Acute Lymphoblastic Leukemia (ALL) treatments. Ankle dorsiflexion range of motion (ROM), dorsiflexion and knee extensor muscle strength, hand grip strength, aerobic endurance, and functional mobility were assessed using a goniometer, digital dynamometer; hand dynamometer, 6 Minute Walk Test (6 MWT), Timed Up and Go Test respectively. Interleukin-1 Beta, Tumor Necrosis Factor-Alpha, Interleukin-6 (IL-6), and BDNF values were examined using ELISA kits. 20 patients will be included in the study. The patients randomly divided into 2 groups: exercise (n:10) and control (n:10). The exercise group performed a home-based exercise program consisting of aerobics 3 days a week and strengthening and stretching exercises 2 days a week, with videos and infographics, for 8 weeks. The control group was advised to increase physical activity.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 6-18,
* Having clinical diagnose of Acute Lymphoblastic Leukemia,
* Being completed medical treatment

Exclusion Criteria:

* Having a history of neurological, developmental, or genetic disorders,
* Communicating problems
* Medical conditions such as advanced cardiac damage, decreased bone quality, acute infection, and cancer recurrence.

Children who could not accomplish the exercises and evaluations, who did not want to continue the study, who could not be contacted for more than 2 weeks, and who disrupted the exercise program for more than 2 weeks were excluded from the study.

Primary outcomes:
measure: Difference between baseline and final active ankle dorsiflexion range of motion
timeFrame: 8 weeks
measure: Difference between baseline and final muscle strength
timeFrame: 8 weeks
measure: Difference between baseline and final handgrip strength
timeFrame: 8 weeks
measure: Difference between baseline and final aerobic endurance
timeFrame: 8 weeks
measure: Difference between baseline and final functional mobility
timeFrame: 8 weeks
measure: Difference between baseline and final serum inflammatory markers and brain derived neurotrophic factor levels
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Hospital
Study officials:
References:
Clinical trial NCT06913036: Myocene Sensivity to Cycling Intensities
Official title: Muscular Response to Short vs. Prolonged Cycling: A Crossover Trial on Low-Frequency Fatigue Sensitivity
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Fatigue Intensity
Lead sponsor: University of Maia
Sponsor class: OTHER
First posted: 2025-04-06
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to address this gap by assessing LFF following different efforts in cycling, aiming to identify a pattern. Also, we expect that this study helps to clarify to which efforts (prolonged vs short) are more likely to trigger substantial changes in LFF responses.


Eligibility criteria: Inclusion Criteria:

* Road cyclists

Exclusion Criteria:

* Injured or recently injured participants

Primary outcomes:
measure: low-frequency fatigue
timeFrame: Baseline, 30 minutes post, 24 hours post
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05546736: iCanWork: A Randomized Controlled Trial
Official title: Effects of the iCanWork Intervention to Improve Cancer Survivors' Experience With Return to Work: A Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cancer-related Problem/Condition
Survivorship
Quality of Life
Keywords: return to work
cancer survivors
vocational rehabilitation
randomized controlled trial
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 270
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: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effectiveness of the iCanWork intervention in assisting cancer survivors (CS) to return to work (RTW) and its impact on their health-related quality of life (QoL), health service utilization, RTW readiness, time to RTW, and work capacity.

Detailed description: The iCanWork intervention comprises several elements related to health and work, taken from the latest reviews that recommend a remote and individual intervention, led by a vocational rehabilitation counsellor (VRC), experts in assisting RTW for CS. The intervention includes 6 sessions with a VRC and 1-4 sessions with an occupational therapist (OT). A total of 270 CS will be recruited into 2 groups (intervention or control). The duration of this study is 24 months. Study participants will complete electronic questionnaires measuring study variables at baseline before randomization and at 6-month, 12-month, 18-month, and 24-month follow-ups.

Eligibility criteria: Inclusion Criteria:

* diagnosed with cancer (all types) treated with curative intent and of working age (between 18 and 65 at the time of diagnosis)
* gainfully employed at the time of diagnosis (full or part-time, including students)
* still on sick leave, including long-term disability leave, but for less than 2 years
* has not started to return to work, since stopping due to cancer
* can read and understand English or French
* reside in Canada.

Exclusion Criteria:

- If the cancer survivor's physicians consider returning to work unwise, such as due to a metastatic cancer diagnosis

Primary outcomes:
measure: Change from baseline return to work status in the course of the 24-month study
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months
Secondary outcomes:
measure: Change from baseline health related quality of life in the course of the 24-month study
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months
measure: Change from baseline readiness to return to work in the course of the 24-month study
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months
measure: Change from baseline work capacity in the course of the 24-month study
timeFrame: baseline, 6 months, 12 months, 18 months, 24 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
References:
Clinical trial NCT02775513: Metabolism of Patients With Genetically Caused Cardiac Arrhythmia
Official title: Metabolism of Patients With Genetically Caused Cardiac Arrhythmia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Long QT Syndrome
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with functional mutations in ion channels and matched healthy controls

Brief summary: Loss-of-function mutations in voltage-gated potassium channels cause long QT syndrome (LQTS) due to a prolonged cardiac repolarisation phase. Hypoteses: patients with loss-of-function mutations also exhibit altered hormone release upon glucose ingestion.

Detailed description: Loss-of-function mutations in voltage-gated potassium channels cause long QT syndrome (LQTS) due to a prolonged cardiac repolarisation phase.

Voltage-gated potassium (Kv-) channels are known for their relation to malignant cardiac arrhythmias, but also play a role in pancreatic alpha- and beta cell hormone secretion, and possibly in incretin hormone secretion. We hypothesised that patients with loss-of-function mutations also exhibit altered hormone release upon glucose ingestion.

Eligibility criteria: Inclusion Criteria:

LQTS Gain of function Matched healthy controls

Exclusion criteria:

none

Primary outcomes:
measure: glucose homeostasis
timeFrame: 6 hours
Secondary outcomes:
measure: QT
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
References:
citation: Hylten-Cavallius L, Iepsen EW, Wewer Albrechtsen NJ, Svendstrup M, Lubberding AF, Hartmann B, Jespersen T, Linneberg A, Christiansen M, Vestergaard H, Pedersen O, Holst JJ, Kanters JK, Hansen T, Torekov SS. Patients With Long-QT Syndrome Caused by Impaired hERG-Encoded Kv11.1 Potassium Channel Have Exaggerated Endocrine Pancreatic and Incretin Function Associated With Reactive Hypoglycemia. Circulation. 2017 May 2;135(18):1705-1719. doi: 10.1161/CIRCULATIONAHA.116.024279. Epub 2017 Feb 24.
Clinical trial NCT05690113: Translation and Validation of the "Children and Adolescent Trauma Screen" in French
Official title: Translation and Validation in French of a Child Psychotrauma Identification Scale - the CATS (Child and Adolescent Trauma Screen)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Psychiatry
Adolescent Psychiatry
Keywords: psychotraumatism
children
adolescent
scale
french translation
validation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 500
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will focus on children and adolescents between 7 and 17 years who have been potentially exposed to a traumatic event and who are treated in one of the participating services.

This study will also focus on children and adolescents aged 7 to 17 years in the general population, enrolled in school in the Grenoble Academy.

Brief summary: Child psychotraumatism and complex psychotraumatism, mainly consecutive to child maltreatment, is a major unaddressed public health issue.

The investigators aim to translate and validate a screening scale to help professionals to better detect and refer children at risk of psychotraumatism.

This study aims to validate the psychometric properties of a french version of the CATS 2.0, in partnership with the original authors of the scale.


Eligibility criteria: Inclusion Criteria:

* child aged between 7 and 17
* at least an adult of reference (parent or tutor) reachable
* agreement of adult of reference
* for clinical population : have been potentially exposed to a potential traumatic event (according to DSM-V)

Exclusion Criteria:

* non-mastery of French language

Primary outcomes:
measure: Psychometric properties of the Children and Adolescent Trauma Screen (CATS) scale
timeFrame: Day 0 (D0)
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Psychopathologie de l'Enfant et l'Adolescent, Hôpital Femme Mère Enfant
city: Chambéry
country: France
facility: Laboratoire de Psychologie et de NeuroCognition, Domaine Universitaire de Jacob Bellecombette
city: Lyon
country: France
facility: Centre Régional de Psychotraumatisme, Hôpital Edouard Herriot
city: Lyon
country: France
facility: Service de Médecine Légale, Hôpital Edouard Herriot
city: Nice
country: France
facility: Centre d'Evaluation de Psychotraumatisme Pédiatrique, CHU Lenval
city: Strasbourg
country: France
facility: Centre Psychotrauma Grand Est Alsace Nord, Hôpital civil et hôpital de l'Elsau
Study officials:
affiliation: Centre Régional de Psychotraumatisme, Hôpital Edouard Herriot, Hospices Civils de Lyon
name: Pauline ESPI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00193713: Bifeprunox in the Treatment of Schizophrenia
Official title: A Randomized, Double-Blind, Olanzapine-Referenced, Parallel-Group Safety and Efficacy Study of Flexible Doses of Bifeprunox in the Long-term Treatment of Schizpohrenia (Extension of S1543003)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: double-blind study in the treatment of schizophrenia
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of the long-term efficacy and safety of bifeprunox in the treatment of schizophrenia.


Eligibility criteria: Inclusion Criteria:

* diagnosis of schizophrenia
* understand nature of study
* able to be managed in out-patient setting for long-term bifeprunox treatment

Exclusion Criteria:

* current primary diagnosis other than schizophrenia
* suicide risk
* diagnosis or history of substance abuse
* uncontrolled hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT01774513: EUS-guided Procore-biopsy in Diagnosing Autoimmune Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autoimmune Pancreatitis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2013-01-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this prospective study is to evaluate the feasibility of the Core Biopsy Needle with reverse bevel (Procore TM) in diagnosing autoimmune pancretitis


Eligibility criteria: Inclusion Criteria:

* patient age 18 years and older
* patients with suspicion of autoimmune pancreatitis (based on the findings in EUS and MRI)

Exclusion Criteria:

* unable to obtain informed consent
* ASA class 4 and 5
* known pregnancy
* contraindication for endoscopy or for biopsy sampling
* patients with high suspicion on pancreatic cancer (based on the findings in radiology and EUS)

Primary outcomes:
measure: diagnostic yield
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar
state: Bavaria
Study officials:
References: