louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03868644: The Impact of VCT and Condom Distribution as HIV Prevention Strategies Among Youth in Kenya
Official title: HIV Prevention Among Youth: A Randomized Controlled Trial of Voluntary Counseling and Testing for HIV and Male Condom Distribution in Rural Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS
HSV-2 Infection
Keywords: Youth
Kenya
Voluntary Counseling and Testing for HIV
Condoms
HIV prevention
HSV-2
Lead sponsor: Abdul Latif Jameel Poverty Action Lab
Sponsor class: OTHER
Collaborators: name: Innovations for Poverty Action
First posted: 2019-03-11
Enrollment: 10646
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The vast majority of new HIV infections occur in sub-Saharan Africa, where nearly 2 million people become infected with HIV/AIDS every year. Forty-five percent of these new HIV infections occur among people under 25 years old, and nearly all of them are due to unprotected sex. Ensuring the adoption of safer sexual behavior among youth is critical to keeping the new generations free of HIV.

This research study aims to examine, through a large randomized controlled trial, the impact of two HIV prevention strategies among a youth population in Kenya: Voluntary Counseling and Testing for HIV (VCT), and condom distribution.


Eligibility criteria: Inclusion Criteria:

Youth previously participated in an earlier study by Duflo, Dupas and Kremer in 328 primary schools in the same study site in Western Province, Kenya who consent to participate.

Exclusion Criteria:

Youth sampled for the study who do not consent to participate.

Primary outcomes:
measure: HSV-2 prevalence
timeFrame: 2 years post-intervention
Secondary outcomes:
measure: % of youth who have high HIV knowledge
timeFrame: 2 years post-intervention
measure: % of youth who did not use a condom at last intercourse
timeFrame: 2 years post-intervention
measure: % of youth who reported having an STI or symptoms of an STI
timeFrame: 2 years post-intervention
measure: % of youth who report ever being pregnant
timeFrame: 2 years post-intervention
measure: Number of sexual partners
timeFrame: 2 years post-intervention
measure: HIV prevalence
timeFrame: 2 years post-intervention
measure: % of youth who have accepting attitudes towards people living with HIV (PLHIV)
timeFrame: 2 years post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts Institute of Technology
name: Esther Duflo
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Pascaline Dupas
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard School of Public Health (HSPH)
name: Vandana Sharma
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duflo E, Dupas P, Ginn T, Barasa GM, Baraza M, Pouliquen V, Sharma V. HIV prevention among youth: A randomized controlled trial of voluntary counseling and testing for HIV and male condom distribution in rural Kenya. PLoS One. 2019 Jul 30;14(7):e0219535. doi: 10.1371/journal.pone.0219535. eCollection 2019.
Clinical trial NCT03756844: Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality
Official title: Effectiveness of the Just Right Challenge Food Club for Decreasing Food Selectivity and Increasing Mealtime Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Selectivity
Keywords: Avoidant Restrictive Food Intake Disorder
Lead sponsor: Western Michigan University
Sponsor class: OTHER
Collaborators: name: Blue Cross Blue Shield of Michigan Foundation
First posted: 2018-11-28
Enrollment: 7
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This was a single-subject (time series design).
Primary purpose: TREATMENT

Brief summary: This single subject study tested the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime qualify for children with developmental disabilities.

Detailed description: This study used a single subject design to test the effectiveness of the Just Right Challenge Food Club for decreasing food selectivity and increasing mealtime quality for children with developmental disabilities. Baseline data was collected during the time that participants spent on the wait list for treatment. Treatment data was collected each week during treatment session. This protocol produced a significant change in both the number of foods the children in the study ate as well as the parents perception of mealtime quality.

Eligibility criteria: Inclusion Criteria:

* Children who accepted less than 15 foods as part of their regular diet
* Children who refused whole food groups

Exclusion Criteria:

* Children with life threatening food selectivity per parent report and physician referral information

Primary outcomes:
measure: Change in Food Inventory questionnaire
timeFrame: Every week for up to 45 weeks
Secondary outcomes:
measure: Change in About Your Child's Eating questionnaire
timeFrame: Up to 45 weeks between pre and post test measures.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05507944: FeNO Hairdressers Pilot
Official title: Fraction of Exhaled Nitric Oxide (FeNO) in an Occupational Cohort of Hairdressers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Exposure
Environmental Exposure
Keywords: Airway irritants
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Employed as hairdressers or at Oslo University Hospital as healthcare workers.

Brief summary: A 5-day cohort diurnal FeNO study of exposed and unexposed to airway irritants during hair treatments and commuting.

Detailed description: The project aims to increase the knowledge of daily variations in FeNO with emphasis on exposure of airway irritants during hairdressing treatments in an occupational setting and commuting. Daily measurements of FeNO before and after workplace exposure in an exposed and an unexposed cohort during a workweek (Monday to Saturday) will indicate patterns of proinflammatory responses in a dose-dependent manner. These may or may not be indicative of an increased risk for airway related disease. Results may be used for further studies of occupational hygiene, airway related disease and identification of endogenous volatile organic compounds during proinflammatory responses.

Eligibility criteria: Inclusion Criteria:

* have given informed consent.
* employed as hairdressers or at Oslo University Hospital as healthcare workers.
* scheduled work for at least 3 hours daily for 5 days in the study week.

Exclusion Criteria:

* lung disease.
* active smoker.

Primary outcomes:
measure: Daily FeNO (ppb measured by Niox Vero) increase after occupational exposure.
timeFrame: 1 day.
measure: Daily FeNO (ppb measured by Niox Vero) increase after enviromental exposure during commuting.
timeFrame: 1 day.
measure: Diurnal FeNO (ppb measured by Niox Vero) variations during a work week after occupational exposure.
timeFrame: 6 days
measure: Diurnal FeNO (ppb measured by Niox Vero) variations during a work week after environmental exposure during commuting.
timeFrame: 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Bato Hammarstrøm, MD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oslo University Hospital
name: Hilde Heiro, MD
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Tonje Trulssen Hildre, MSc.
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Ingill Sandven, MD
role: STUDY_CHAIR
affiliation: Oslo University Hospital
name: Britt G Randem, MD/PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00874744: Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema
Official title: Phase 2 Study of Comparison of Single Intravitreal Injection of Triamcinolone or Bevacizumab for the Treatment of Diabetic Macular Edema.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Keywords: Diabetic macular edema
intravitreal injection
Pharmacological treatment
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2009-04-02
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.

Detailed description: Comparison a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab regarding the ability of central macular thickness reduction. Secondary objectives are analysis of Visual Outcomes and variations on Intraocular Pressure. The patients data were statistically analyzed if there was a 24 week follow up completed.

Eligibility criteria: Inclusion Criteria:

* Diabetic macular edema with central foveal measurement over 300 micrometers

Exclusion Criteria:

* Glaucoma
* Vitreoretinal surgery
* Cataract Surgery less than 3 months prior inclusion
* Unilateral cataract surgery
* Uncontrolled Glycosylated Hemoglobin
* Previous Intraocular Injection
* Systemic Corticosteroids less than 1 month prior inclusion
* Macular ischemia at Fluorescein Angiography
* Cataract precluding fundus examination
* Active Proliferative Diabetic Retinopathy

Primary outcomes:
measure: Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema
timeFrame: 6 months
Secondary outcomes:
measure: To compare Visual Acuity between the same drug in Initial visit, 4, 12 ans 24 weeks and Visual Acuity between two group of eyes treated with different drugs.
timeFrame: 6 months
measure: To compare Intraocular Pressure between the same drug in Initial visit, 4, 12 ans 24 weeks and Intraocular Pressure between two group of eyes treated with different drugs.
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal de Goias
name: David LC Isaac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03633344: Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form in Patients With Acute Diarrhea
Official title: Efficacy of the Administration of Colloidal Silicon Dioxide in Tablet Dosage Form (Carbowhite) in Patients With Acute Diarrhea.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diarrhoea;Acute
Keywords: Diarrhoea
Carbowhite
Colloidal silicon dioxide
Lead sponsor: Omnifarma Kiev LLC
Sponsor class: INDUSTRY
First posted: 2018-08-16
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.

Detailed description: Background: Diarrhea is a medical condition characterized by frequent stool, more than 3 times (and more than 5-7 times in newborns) within the last 24 hours, and/or loose stool. The fecal matter is liquid, its daily mass exceeds 200 g per day, and water content reaches 95%.

Objectives: To demonstrate the antidiarrheal efficacy of colloidal silicon dioxide in tablet dosage form (Carbowhite) in patients with acute diarrhea.

Methods: A randomized clinical trial, double-blind, placebo-controlled, multi-center.

Eligibility criteria: Inclusion Criteria:

* signed Informed Consent Form for patient's study participation
* male and female patients at the ages from 18 to 55 years
* acute diarrhea (more than three episodes of liquid stool a day) within 48 hours or less in patients with usually normal stool
* body temperature of ≤ 38 °C
* patient's ability to adequately cooperate in the process of study

Exclusion Criteria:

* aged of \<18 or \>55 years;
* blood or pus in stool;
* body temperature of \>38 °C;
* episodes of acute diarrhea for the last 30 days;
* administration of antidiarrheal products for the last 24 hours;
* salmonellosis (Salmonella of any serotype different from S. typhi and S. paratyphi; ICD-10: A02.0), dysentery (Shigella dysenteriae, Shigella flexneri, Shigella boydii; ICD-10: A03.0-A03.3), colibacillosis (Escherichia coli; ICD-10: A04.0-A04.4) which require administration of antimicrobial products;
* pregnancy, lactation;
* concomitant decompensated diseases or acute conditions which, according to an investigator, may affect study results
* alcoholism and drug abuse;
* participation in any other clinical study.

Primary outcomes:
measure: Reduction in Frequency of Defecation to 3 Times Per Day
timeFrame: From randomisation up to 5 days
Secondary outcomes:
measure: Compliance Rate
timeFrame: From randomisation up to 5 days
measure: Duration of Treatment
timeFrame: From randomisation up to 5 days
measure: Quantity of Used Medication
timeFrame: From randomisation up to 5 days
Other outcomes:
Locations:
Study officials:
affiliation: Omnifarma Kyiv LLC
name: Oleg Kurchenko
role: STUDY_DIRECTOR
References:
Clinical trial NCT01806844: Prehospital Cerebral Oxygenation During Cardiopulmonary Resuscitation (CPR)
Official title: Cerebral Oxygenation During Resuscitation and Post-resuscitation Phase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Keywords: Cardiac arrest
Cerebral oxygenation
Pre-hospital
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2013-03-07
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pre-hospital cardiac arrest

Brief summary: Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Beer-Lamber law, a numeric result can be calculated. During a cardiac arrest, there is no stroke volume, no cardiac output and no cerebral perfusion. By using cerebral NIRS during out-of hospital cardiac arrest, low flow time and return of spontaneous circulation, this study wants to show the prognostic value of NIRS as extra monitoring.


Eligibility criteria: Inclusion Criteria:

* \>16 year

Exclusion Criteria:

* DNR code

Primary outcomes:
measure: prognostic value
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
city: Leuven
country: Belgium
facility: Universitair ziekenhuis Leuven
state: Vlaams Brabant
city: Antwerpen
country: Belgium
facility: Ziekenhuis netwerk Antwerpen
city: Antwerp
country: Belgium
facility: GZA St Vincentius
city: Turnhout
country: Belgium
facility: AZ Turnhout
Study officials:
affiliation: Hasselt University
name: Cornelia Genbrugge, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meex I, De Deyne C, Dens J, Scheyltjens S, Lathouwers K, Boer W, Vundelinckx G, Heylen R, Jans F. Feasibility of absolute cerebral tissue oxygen saturation during cardiopulmonary resuscitation. Crit Care. 2013 Mar 1;17(2):R36. doi: 10.1186/cc12546.
Clinical trial NCT05744544: Sensory Assessment and Regression Rate of Bilateral External Oblique Intercostal Block and m-TAPA Block
Official title: Sensory Assessment and Regression Rate of Bilateral External Oblique Intercostal Block and m-TAPA Block in Patients Undergoing Laparoscopic Cholecystectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Pain, Acute
Pain
Keywords: cutaneous block
Sensory Assessment
Regression Rate
Lead sponsor: Samsun University
Sponsor class: OTHER
First posted: 2023-02-27
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing L/S cholecystectomy

Brief summary: External oblique and m-tapa blocks are routinely performed on patients undergoing laparoscopic cholecystectomy in our clinic. In this study, sensory block and regression rates will be investigated in patients who underwent block.

Detailed description: External oblique block and m-Tapa blocks may be the key to provide adequate analgesia in patients undergoing abdominal surgery by blocking the abdominal nerves. In this study, the sensory dermatome block area calculation and the regression rate of the blocks will be evaluated in patients who underwent EOIB and m-Tapa.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing L/S cholecystectomy

Exclusion Criteria:

* patients who do not want to participate

Primary outcomes:
measure: Sensory Assessment on the anterolateral abdominal wall
timeFrame: 24 hours
measure: Regression Rate of the cutaneous block on anterolateral abdominal wall
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Samsun
country: Turkey
facility: Samsun University
Study officials:
affiliation: Samsun University
name: Serkan Tulgar, M.D.
role: STUDY_CHAIR
References:
citation: Chen Y, Shi K, Xia Y, Zhang X, Papadimos TJ, Xu X, Wang Q. Sensory Assessment and Regression Rate of Bilateral Oblique Subcostal Transversus Abdominis Plane Block in Volunteers. Reg Anesth Pain Med. 2018 Feb;43(2):174-179. doi: 10.1097/AAP.0000000000000715.
citation: Stoving K, Rothe C, Rosenstock CV, Aasvang EK, Lundstrom LH, Lange KH. Cutaneous Sensory Block Area, Muscle-Relaxing Effect, and Block Duration of the Transversus Abdominis Plane Block: A Randomized, Blinded, and Placebo-Controlled Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):355-62. doi: 10.1097/AAP.0000000000000252.
Clinical trial NCT03295344: Study of Diaphragm Mobility on Tissue Doppler
Official title: Study of Diaphragm Mobility on Tissue Doppler (Thoracotomy vs Sternotomy in Diaphragm Dysfunction Following Heart Surgery)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Surgery
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-09-27
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the post-operative period following heart surgery

Brief summary: Diaphragm dysfunction is found in 10 to 90% of patients following heart surgery.

In current practice diaphragm dysfunction is evaluated by 2D ultrasonography. Tissue Doppler is a validated technique to study heart contractility. Its use in the analysis of diaphragm function must be evaluated to determine its interest as a diagnostic tool.

Better understanding of diaphragm dysfunction following heart surgery will lead to earlier management of post-operative respiratory complications and the implementation of preventive pre-operative measures.

We intend to look for correlations between the TM (Time-Movement) mode and tissue Doppler in the assessment of diaphragm mobility.


Eligibility criteria: Inclusion Criteria:

* Post-operative period following heart surgery

Exclusion Criteria:

* Patients younger than 18 years old
* Existence of a neuro-muscular disease
* Widened surgical approach
* Refusal of the patient
* Impossibility to see diaphragm movement

Primary outcomes:
measure: Measure diaphragm movement in TM (Time-Movement), in tissue Doppler
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT05588544: YSGG Application in Periodontal Treatment
Official title: Effect of Adjunctive YSGG Application in Healing Following Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Adjunctive use of Er,Cr:YSGG (erbium-chromium-yttrium-scandium-gallium-garnet) laser in combination with conventional, mechanical periodontal treatment may benefit in complete decontamination of the periodontal pocket leading to improved early healing and better long term clinical result. Radial firing periodontal tip (RFPT) offered by the Er,Cr:YSGG system is devised to let irradiation primarily in radial pattern (85%) with lesser portion in straight manner (15%), meaning laser beams are effectively emitted to affected root surface and inner epithelium of periodontal pocket with simple tip management. Therefore, using Er,Cr:YSGG laser with RFPT could be the best option for periodontal laser therapy. The aim of this study is to investigate adjunctive treatment effect using Er,Cr:YSGG laser and RFPT in moderate to severe periodontitis patients. Study subjects are randomly allocated to either 'scaling and root planing (SRP) only' or 'SRP + laser therapy' group. Periodontal parameters including probing pocket depth (PPD), clinical attachment level (CAL), modified gingival index (MGI), and plaque index (PI) are recorded at baseline and 8 weeks after treatment. Gingival crevicular fluid (GCF) samples are obtained using paper strips at baseline, 1w, 2w, 4w, and 8w post op. to determine laser-induced effect in early wound healing. Cytokine levels are evaluated from the GCF samples taken.


Eligibility criteria: Inclusion Criteria:

1. diagnosis of stage III or IV periodontitis based on the 2017 periodontitis classification (Tonetti, Greenwell, \& Kornman, 2018);
2. minimum of two teeth with probing depth (PD) ≥ 6 mm and radiographic bone loss in at least two quadrants of the whole dentition;
3. each quadrant with a minimum of four teeth; and
4. systemically healthy patients.

Exclusion Criteria:

1. history of periodontal treatment in the previous six months;
2. antibiotic medication in recent three months;
3. under steroid therapy or taking any anti-inflammatory drugs in recent three months;
4. history of any systemic disease that may influence the periodontal condition and treatment outcome, including diabetes mellitus, cancer, metabolic diseases, cardiovascular disease, and rheumatoid arthritis;
5. pregnancy or breastfeeding; and
6. smoking habits.

Primary outcomes:
measure: Change of Modified gingival index
timeFrame: 1, 2, 4, and 8 week post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital
name: Jung Soo Park
role: PRINCIPAL_INVESTIGATOR
References: