louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02665091: Peer Education Program for HIV/AIDS Related Sexual Behaviors of Secondary School Students
Official title: Impact of Peer Education Program on HIV/AIDS Related Sexual Behaviors of Secondary School Students in Rural Communities, India: a Quasi-experimental Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Lead sponsor: NMP Medical Research Institute
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 560
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Worldwide, about 50% of all new cases of HIV occur in youth between age 15 and 24 years. Studies in various countries show that both out of school and in school adolescents and youth are engaged in risky sexual behaviors. Peer-based interventions have become a common method to effect important health-related behavior changes and address the HIV/AIDS pandemic. This study therefore aimed to evaluate the effectiveness of peer education in improving HIV knowledge, attitude, and preventive practices among in-school adolescents


Eligibility criteria: Inclusion Criteria:

* at least 14 years of age;
* non-injecting use of heroin, cocaine or crack cocaine in the last six months;
* test HIV antibody negative;
* agree to provide specimens for testing (HIV, HBV and pregnancy) and be willing to learn the results of these tests;
* willing to return for visits at 1, 6, and 9 months post-enrollment;
* willing and able to provide informed consent.

Exclusion Criteria:

* history of injection drug use in the previous 3 years;
* pregnant;

Primary outcomes:
measure: Knowledge score of HIV
timeFrame: From baseline to 6 Months
Secondary outcomes:
measure: willingness to HIV testing
timeFrame: From Baseline to 6 Months
measure: willingness to participate in HIV counseling services
timeFrame: From Baseline to 6 Months
measure: frequency of use of Condoms
timeFrame: From baseline to 6 month
Other outcomes:
Locations:
Study officials:
affiliation: NMP Medical Research Institute
name: Hitesh Nayak
role: PRINCIPAL_INVESTIGATOR
affiliation: Warwick Research Services
name: Neha Sharma, PhD
role: STUDY_DIRECTOR
affiliation: Goldington Family Centre, UK
name: Valerie Murray, MA
role: STUDY_CHAIR
References:
Clinical trial NCT05632991: External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy
Official title: Ultrasound Guided External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2022-12-01
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: The laparoscopic approach has become the gold standard for many abdominal surgical procedures, including cholecystectomy. Compared to laparotomy, laparoscopy allows smaller incisions, reduces perioperative stress response, reduces postoperative pain, and results in shorter recovery time.

However, anaesthesia concerns in patients undergoing laparoscopic surgery are different from patients undergoing open abdominal surgery.

The aim of this study is to investigate the effect of the external oblique intercostal block, which is a new block, on postoperative pain score and opioid consumption.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients
* Laparoscopic cholecystectomy

Exclusion Criteria:

* Chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: first 24 hours
Secondary outcomes:
measure: Visual analog pain score
timeFrame: postextubation 0-24 hours
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Atatürk University
Study officials:
References:
citation: Woldu SL, Weinberg AC, Bergman A, Shapiro EY, Korets R, Motamedinia P, Badani KK. Pain and analgesic use after robot-assisted radical prostatectomy. J Endourol. 2014 May;28(5):544-8. doi: 10.1089/end.2013.0783. Epub 2014 Jan 30.
citation: Leitao MM Jr, Malhotra V, Briscoe G, Suidan R, Dholakiya P, Santos K, Jewell EL, Brown CL, Sonoda Y, Abu-Rustum NR, Barakat RR, Gardner GJ. Postoperative pain medication requirements in patients undergoing computer-assisted ("Robotic") and standard laparoscopic procedures for newly diagnosed endometrial cancer. Ann Surg Oncol. 2013 Oct;20(11):3561-7. doi: 10.1245/s10434-013-3064-9.
Clinical trial NCT00258791: Effects of Pretreatment With Ibuprofen in Post-Electroconvulsive Therapy (ECT) Headache
Official title: Effects of Pretreatment With Ibuprofen in Post- ECT Headache
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Mental Disorders
Keywords: Psychiatric disorders
ECT
Headache
Ibuprofen
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
First posted: 2005-11-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether ibuprofen reduces post-ECT headache or reduces its severity.

Detailed description: The aim of the study is to compare the severity of headache between patients who are receiving ibuprofen prior to ECT treatment with patients receiving placebo prior to ECT treatment.

Patients will be randomly assigned to receive either 600 mg ibuprofen 90 min prior to treatment or placebo orally, blinded to patient, physician and treatment team.

Patients will be asked about their headache with a visual analogue scale (VAS) 2 hours prior to and within 2 hours after treatment, 2-month, 6- month and 1 year follow-up \[5\].

Eligibility criteria: Inclusion Criteria:

* Patients receiving ECT

Exclusion Criteria:

* Pregnancy, contraindications to ibuprofen

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Norwegian University of Science and Technology
name: Olav Morten Linaker, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00027391: Study of Albuterol and Oxandrolone in Patients With Facioscapulohumeral Dystrophy (FSHD)
Official title: Clinical Trials of Albuterol and Oxandrolone in FSH Dystrophy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophies
Keywords: Muscle Weakness, Muscular Dystrophy
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2001-12-07
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: This is a study to determine whether albuterol or oxandrolone, alone or in combination, are able to increase strength and muscle mass in patients with FSHD. It also will determine if albuterol given in "pulsed" fashion will have more effect than when given continuously.

Detailed description: Patients will be randomized to 1 of 4 groups: placebo, pulsed albuterol, oxandrolone, or both pulsed albuterol and oxandrolone. Treatment will continue for 52 weeks unless unacceptable side effects occur. Patients will undergo testing of muscle function. All patients will return for follow-up assessments at Weeks 4, 12, 26, and 52.

Eligibility criteria: Inclusion criteria:

* Presence of 4q35 "small fragment" of less than 40 kb by standard DNA testing
* Weakness of the facial muscles, including frontalis, orbicularis oculi, or orbicularis oris
* Weakness of scapular stabilizers or foot dorsiflexors
* Ambulatory
* Weakness grade 2 or worse in the arm using upper extremity grading scale

Exclusion criteria:

* Prior use of oral beta-2 agonists for a period of at least 1 year or within the past 3 months
* Concurrent use of other sympathomimetic agents, antidepressants, or beta-2 receptor blockers
* Pregnancy
* Known hypersensitivity to anabolic steroids
* Any medical or psychological condition that would interfere with the study
* Requirement for a wheelchair

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Medical Center
state: Ohio
Study officials:
affiliation: Ohio State University
name: John T. Kissel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02198391: Study of Echinaforce Junior Tablets in Children With Acute Colds
Official title: Multicenter Open-label, Randomized Clinical Trial to Assess the Safety and Efficacy of Echinaforce® Junior Tablets in Two Dosages for the Therapy of Common Cold Symptoms in Children (4-12 Years)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Tract Diseases
Lead sponsor: A. Vogel AG
Sponsor class: INDUSTRY
First posted: 2014-07-23
Enrollment: 79
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children aged 4 - 12 years recruited in pediatrics practice

Brief summary: This study aims to investigate safety and efficacy of Echinaforce Junior tablets in two dosages of 3 x 1 and 5 x 1 tablets per day in children 4 - 12 years old with acute colds.


Eligibility criteria: Inclusion Criteria:

* age between 4 and 12 years
* signed informed consent by parents and optionally be the child
* daily access to computer / internet
* competence of german language

Exclusion Criteria:

* 13 years or older, younger than 4 years.
* presence of sinusitis, otitis media, pneumonia, bronchitis (complicated cold) at inclusion
* participation in a clinical study in the past 30 days
* intake of antimicrobial, antiviral, immunesuppressive substances, salicyl-containing medicines or bronchovaxom at first treatment period
* surgical intervention in the 3 months before inclusion or planned intervention during the observation period
* Known diabetes mellitus
* Known and treated allergic rhinitis, atopy or asthma
* cystic fibrosis, bronchopulmonic dysplasia, COPD
* immune system disorders, degenerative diseases (e.g. autoimmune disease like AIDS or leukosis)
* metabolic or resorptive disorders
* liver or kidney diseases
* serious health problems
* predisposition for complicated cold episodes in the judgement of the physician (sinusitis, otitis media, bronchitis, pneumonia)
* known allergy to plants of the compositae family (camomile or dandelion) or any of the substances of the investigational product

Primary outcomes:
measure: tolerability assessment by physicians
timeFrame: 4 months
Secondary outcomes:
measure: tolerability assessment by parents/child
timeFrame: 4 months
measure: tolerability assessment by parents/child
timeFrame: 10 days
measure: Assessment of efficacy by parents/child
timeFrame: 4 months
measure: Assessment of Cold Symptoms during Acute Treatment
timeFrame: 10 days
Other outcomes:
Locations:
city: St. Gallen
country: Switzerland
facility: Dr. med. Arnold Bächler Facharzt FMH für Kinder- und Jugendmedizin
state: Saint Gallen
Study officials:
affiliation: Facharzt FMH für Kinder- u. Jugendmedizin, Notkerstrasse 14 9006 St. Gallen, Switzerland
name: Arnold Baechler, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01723891: Study To Compare Safety and Pharmacokinetic Properties of Surfolase Capsule and HT-002-01 in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Hyundai Pharmaceutical Co., LTD.
Sponsor class: INDUSTRY
First posted: 2012-11-08
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to compare safety and pharmacokinetic properties of surfolase capsule and HT-002-01 after oral administration for one day in healthy male volunteer.


Eligibility criteria: Inclusion Criteria:

1. healthy male subjects between the age of 20 and 55 years with body mass index between 18.5 and 25
2. Volunteers without apriority of chronic disease
3. Volunteers must be in good health as determined by the investigator based on a detailed medical history, full physical examination, electrocardiogram, laboratory tests and urinalysis
4. Volunteers who comply with the protocol, understand and sign an informed consent

Exclusion Criteria:

1. Sensitive response to acebrophylline and xanthine
2. Galactose intolerance, Lapp lactase deficiency and Glucose-Galactose Malabsorption
3. Known history of renal, hepatic, respiratory, neurologic, endocrine, cardiac vascular and hematopoietic disease, especially gallstone
4. Known history of gastrointestinal disease which affects the absorption of medicine.
5. Excluded by screening tests
6. Upper limit of AST, ALT\>1.25 times Upper limit of total bilirubin\>1.5 times
7. Estimated GFR\<80mL/min/1.73m2)
8. systolic blood pressure \< 90 or \> 150, diastolic blood pressure \<50 or \>100
9. Known history of drug abuse
10. caffeine\>5cups/day, alcohol\>210g/week, 10 more cigarettes/day
11. Use of any prescription drug within 14days or over-the-counter (OTC) medication within 7 days prior to dosing
12. Participation in any clinical investigation within 60 days prior to study start
13. Donation of blood within 60 days, donation of component blood within 30days
14. Judged by the investigators to be undesirable as subjects

Primary outcomes:
measure: AUCt, Cmax
Secondary outcomes:
measure: AUCinf, Tmax, t1/2
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
References:
Clinical trial NCT06524791: Prevalence of Faecal Bacteriophage in Patients With Digestive Symptoms
Official title: Evaluation of the Prevalence of Faecal Bacteriophage Carriage in Patients With Digestive Symptoms.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastroenteritis
Keywords: bacteriophages
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-07-29
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients hospitalized at the CHRU de Nancy with digestive symptoms requiring microbiological stool analysis

Brief summary: Define the prevalence of fecal phage carriage in individuals with digestive symptoms (i) Determine the concentrations of infectious fecal phages in the stools of individuals with digestive symptoms (detection by culture)

(ii) Determine fecal phage genome concentrations in the stools of individuals with digestive symptoms (PCR detection)

(iii) Explore factors that could impact fecal phage carriage (patients with digestive symptoms vs. healthy individuals, immunocompromised patients vs. immunocompetent patients)


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 60.
* Persons having developed gastrointestinal symptoms justifying microbiological stool testing at the time of hospitalization.
* Person having received full information on the organization of the research and not having objected to the use of this data

Exclusion Criteria:

* Persons covered by articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.
* Pregnant or breast-feeding women,
* Minors (not emancipated),
* Adult subject to a legal protection measure (guardianship, curatorship, safeguard of justice),
* Persons of full age who are unable to give their consent.
* Persons deprived of their liberty by a judicial or administrative decision, persons under psychiatric care by virtue of articles L. 3212-1 and L. 3213-1.

Primary outcomes:
measure: prevalence of faecal phage carriage
timeFrame: baseline
Secondary outcomes:
measure: concentrations of infectious fecal phages
timeFrame: baseline
measure: fecal phage genome concentrations
timeFrame: baseline
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
affiliation: CHRU Nancy
name: Cédric Hartard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06896591: Deep Posterior Post Gluteal Compartment Block in Total Hip Arthroplasty: Feasability and Safety
Official title: Effets D'un Bloc Glutéal Postérieur Profond Associé À Un PENG Bloc Dans La Prothèse Totale De Hanche
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Total Hip Arthroplasty
Keywords: total hip arthroplasty
peng block
Hip
Anatomy
Sciatic nerve block
Lead sponsor: Quincy Anesthésie
Sponsor class: NETWORK
First posted: 2025-03-26
Enrollment: 35
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: This study aims to evaluate the effectiveness of a posterior hip capsule block performed in addition to a PENG (Pericapsular Nerve Group) block for patients undergoing hip arthroplasty. The primary objective is to assess whether this combined approach provides enhanced perioperative analgesia compared to the standard analgesic protocol or the PENG block alone. Secondary outcomes will focus on opioid consumption, functional recovery, and any potential complications. By targeting both the anterior and posterior innervation pathways around the hip joint, this combined technique could improve patient comfort, decrease opioid requirements, and potentially expedite rehabilitation after hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

All adults with total hip arthroplasty

-

Exclusion Criteria:

* Contraindication to regional anesthesia
* allergy
* refusal of the injection

Primary outcomes:
measure: Sciatic nerve block
timeFrame: From enrollment to the end of treatment at 1 month
Secondary outcomes:
measure: Pain postoperative
timeFrame: From enrollment to the end of treatment at 1 MONTH
measure: pain 2
timeFrame: From enrollment to the end of treatment at 1 MONTH
measure: oPIOID Consumption
timeFrame: From enrollment to the end of treatment at 7 months
measure: RAAC
timeFrame: From enrollment to the end of treatment at 1 MONTH
measure: Surgical complication
timeFrame: From enrollment to the end of treatment at 1 MONTH
Other outcomes:
Locations:
Study officials:
affiliation: Hopital Privé Claude Galien
name: yoann ELMALEH, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pun M, Ng T, Vermeylen K, Tran J. Innervation of the hip joint: implications for regional anaesthesia and image-guided interventional pain procedures. BJA Educ. 2024 Jun;24(6):191-202. doi: 10.1016/j.bjae.2024.02.005. Epub 2024 Apr 8. No abstract available.
Clinical trial NCT05648591: Safety and Tolerability of Open-Labeled Iloperidone in Adolescents
Official title: Open-label Safety Study of a 1-year 8 to 24 mg/Day Dose Regimen of Iloperidone (FANAPT®) in Adolescent Patients With Schizophrenia or Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Schizophrenia
Bipolar I Disorder
Keywords: fanapt
Lead sponsor: Vanda Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2022-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and tolerability of iloperidone in adolescent patients with schizophrenia or bipolar I disorder for up to 52 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Patient is willing and able to provide assent and willing to complete all aspects of the study
* Patient's parent or legal guardian willing and able to provide consent
* Male or female patients 12 through 17 years of age (inclusive)
* Clinical diagnosis of either schizophrenia or bipolar I disorder

Exclusion Criteria:

* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer
* A positive test for drugs of abuse

Primary outcomes:
measure: Number of participants with treatment-emergent adverse events (TEAEs) in the treatment period.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Vanda Investigational Site
state: Arkansas
city: Denver
country: United States
facility: Vanda Investigational Site
state: Colorado
city: Atlanta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Vanda Investigational Site
state: Georgia
city: Cincinnati
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Garfield Heights
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Westlake
country: United States
facility: Vanda Investigational Site
state: Ohio
city: Everett
country: United States
facility: Vanda Investigational Site
state: Washington
Study officials:
References:
Clinical trial NCT03714191: Optimizing the Tobacco Cessation Clinical Decision Support Tool.
Official title: Using Rapid Cycle Randomized Controlled Trials to Study a Tobacco Cessation Best Practice Advisory.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tobacco Use Cessation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 54417
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All providers of patients at NYU Langone Health (including NYU Winthrop) who are identified as currents smokers, as documented in the social history of their patient chart, and are eligible to receive the best practice advisory for tobacco cessation.

Brief summary: The existing tobacco cessation best practice advisory (BPA) fires for providers (physicians, residents, fellows, midwives, nurse practitioners, physician assistants) during outpatient encounters when a patient is identified as a current tobacco user in the Social History section of their chart. The BPA was designed to help facilitate tobacco cessation interventions; it is part of the The Centers for Medicare \& Medicaid Services (CMS) Quality Payment Program (QPP). The purpose of the project is to optimize this BPA utilization and improve patient outcomes by comparing multiple versions of the tobacco cessation BPA.


Eligibility criteria: Inclusion Criteria:

* All providers of patients at NYU Langone Health (including NYU Winthrop) who are identified as currents smokers, as documented in the social history of their patient chart, and are eligible to receive the best practice advisory for tobacco cessation.

Exclusion Criteria:

* non smokers

Primary outcomes:
measure: Alert acceptance rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
References:
citation: Austrian J, Mendoza F, Szerencsy A, Fenelon L, Horwitz LI, Jones S, Kuznetsova M, Mann DM. Applying A/B Testing to Clinical Decision Support: Rapid Randomized Controlled Trials. J Med Internet Res. 2021 Apr 9;23(4):e16651. doi: 10.2196/16651.