louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02396979: Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
Official title: Intervention of HIV, Drug Use and the Criminal Justice System in Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Human Immunodeficiency Virus
Acquired Immunodeficiency Syndrome
Opiate Addiction
Drug Dependence
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: University of Malaya
name: National Institute on Drug Abuse (NIDA)
First posted: 2015-03-24
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the relative impact a medical drug (methadone) or behavioral counseling program (Holistic Health Recovery Program) or both (methadone and Holistic Health Recovery Program) has on reducing HIV-related risk behaviors and illicit drug use among opioid-dependent, HIV-infected individuals in prison when given 90 to 180 days prior to leaving prison.


Eligibility criteria: Inclusion Criteria:

* HIV-infected
* Clinical Diagnosis of Opioid Dependence
* Fluent in Bahasa Malaysia or English
* Within 90 to 180 days of release from prison
* Planning to live in Klang Valley region after release from prison
* Able to provide informed consent

Exclusion Criteria:

* Pregnancy or planning to become pregnant (female only)

Primary outcomes:
measure: HIV Risk Events
timeFrame: Change from Baseline in HIV Risk Events at Months 3, 6, 9 and 12
Secondary outcomes:
measure: HIV Quality of Life
timeFrame: Change from Baseline in HIV Quality of Life at Months 3, 6, 9 and 12
measure: Relapse to Drug Use
timeFrame: Change from Baseline in Relapse to Drug Use at Months 3, 6, 9 and 12
measure: Addiction Severity
timeFrame: Change from Baseline in Addiction Severity at Months 3, 6, 9 and 12
measure: Reincarceration
timeFrame: Any reincarceration to prison during the 12 month post-release follow-up period
Other outcomes:
Locations:
Study officials:
affiliation: Yale University
name: Frederick L Altice, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Malaya
name: Adeeba Kamarulzaman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bazazi AR, Culbert GJ, Wegman MP, Heimer R, Kamarulzaman A, Altice FL. Impact of prerelease methadone on mortality among people with HIV and opioid use disorder after prison release: results from a randomized and participant choice open-label trial in Malaysia. BMC Infect Dis. 2022 Nov 11;22(1):837. doi: 10.1186/s12879-022-07804-6.
citation: Chandra DK, Bazazi AR, Nahaboo Solim MA, Kamarulzaman A, Altice FL, Culbert GJ. Retention in clinical trials after prison release: results from a clinical trial with incarcerated men with HIV and opioid dependence in Malaysia. HIV Res Clin Pract. 2019 Feb;20(1):12-23. doi: 10.1080/15284336.2019.1603433. Epub 2019 May 1.
Clinical trial NCT02692079: The Effectiveness of Titanium-Prepared Platelet-Rich Fibrin on Angiogenic Biomarkers in Gingival Crevicular Fluid
Official title: The Effect of Titanium-Prepared Platelet-Rich Fibrin (T-PRF) Treatment on the Angiogenic Biomarkers in Gingival Crevicular Fluid (GCF) in Infrabony Defects of Patients With Chronic Periodontitis: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Periodontitis
Intrabony Periodontal Defect
Keywords: Angiogenesis
Bilateral infrabony defect
Flap surgery
Titanium-prepared, platelet-rich ﬁbrin
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2016-02-25
Enrollment: 25
Sex: ALL
Minimum age (years): 26
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study investigates the effect of titanium-prepared platelet-rich fibrin (T-PRF) treatment on the angiogenic biomarkers in gingival crevicular fluid (GCF) in infrabony defects of patients with chronic periodontitis. In each patient, the infrabony defect of one side of arch was designated as control group (allograft), while the infrabony defect on the contralateral side of same arch was designated as test group (allograft+T-PRF).

Detailed description: Platelets are the cells initiating the wound healing and also supporting it by secreting various growth factors actively. These growth factors released by platelets act the increase of connective tissue healing, bone regeneration and repair, fibroblast mitogenesis, wound angiogenesis and the activation of macrophages by stimulating cell proliferation signals.

Titanium-prepared, platelet-rich fibrin (T-PRF), is a new platelet concentrate, is formed in titanium tubes may be more efficient to activate platelets in comparison with glass tubes.The titanium tubes is utilized to refrain any inverse effects of glass tubes and also silica.

Eligibility criteria: Inclusion Criteria:

* Clinical Diagnosis of Chronic Periodontitis
* The presence of two or three-wall intrabony defects≥3 mm deep along with an interproximal probing depth ≥5 mm after non-surgical periodontal therapy

Exclusion Criteria:

* Systemic illnesses
* Any medications known to affect the outcomes of periodontal surgery
* Pregnancy and lactation

Primary outcomes:
measure: Platelet-derived growth factor-BB (ng/µl) , vascular endothelial growth factor-A (ng/µl), fibroblast growth factor-2 (ng/µl), anjiogenin (ng/µl), angiostatin (ng/µl)
timeFrame: Within the first 30 days after surgery
Secondary outcomes:
measure: The Volume of Gingival Crevicular Fluid (microliter)
timeFrame: Within the first 30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05711979: African American Resilient Caregivers
Official title: African American Resilient Caregivers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2023-02-03
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to test the feasibility of a virtual intervention to prevent child obesity and cardiovascular disease in African American families.

Detailed description: African American children experience a high prevalence of child obesity, increasing their subsequent risk of cardiovascular disease and diabetes. There is a lack of effective obesity prevention interventions for this population. Investigators also know that African American parents and caregivers experience high levels of stress and the manifestations of stress for African American women in particular may be unique and specific. Parent stress can lead to unhealthy family behaviors including less physical activity and a less healthy diet for parents and children. Given this background the investigators are creating a new intervention that combines an adapted evidence-based obesity prevention program (Competency Based Approach to Community Health - COACH) with mindfulness-based stress reduction tailored to African American women. As an initial step the investigators will pilot the intervention in a small number of African American women to determine whether the program is feasible.

Eligibility criteria: Inclusion Criteria:

* Identify as African American and female
* Have a child between the ages of 2-5 who lives with them at least 4 days per week that they care for as a parent or guardian.
* Feel comfortable discussing personal experiences and goals related to diet, PA, stress, parenting, etc. in front of a group of peers
* Access to zoom, preferably with video

Exclusion Criteria:

• Non English Speaking

Primary outcomes:
measure: Acceptability as assessed by semi-structured interviews
timeFrame: 10 weeks (post intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health System
state: North Carolina
Study officials:
affiliation: Duke Health
name: Michelle White, MD/MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06555679: Evaluation of a Predictive Score for the Onset of Moderate to Severe Alcohol Withdrawal Syndrome, the PAWSS, in a Population of Intensive Care Patients at Brest University Hospital
Official title: Evaluation of a Predictive Score for the Onset of Moderate to Severe Alcohol Withdrawal Syndrome, the PAWSS, in a Population of Intensive Care Patients at Brest University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcohol Withdrawal Syndrome
Keywords: prediction
intensive care unit
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 403
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients

Brief summary: alcohol use disorder (AUD) is a very common condition in patients admitting in ICU's. Brutal stop of alcohol consumption may lead to a withdrawal syndrome, wich is associated with a worse outcome for ICU patients (longuer ICU and hospital stays, use of mechanical ventilation, traumas). The aim of this study is to valid a score (PAWSS : prediction of alcohol withdrawal syndrome (AWS) scale) to predict at admission mild to severe AWS in ICU patients population.


Eligibility criteria: Inclusion Criteria:

* more than 18 years old
* able to answer to PAWSS in the first 48hours of ICU stay

Exclusion Criteria:

* No alcohol consumption in the last 30 days
* hospital stay of more than 5 days at ICU admission
* hospital stay less than 5 days in total
* expected sedation time of more than 48h
* patient not able to understand the PAWSS
* no consent

Primary outcomes:
measure: Evaluation of PAWSS statistic performances to predict AWS in ICU patients
timeFrame: the first 5 days of hospital stay
Secondary outcomes:
measure: Creation of a new score, the PAWSS-ICU, able to predict AWS in ICU patients
timeFrame: during ICU stay
Other outcomes:
measure: Evaluation of alcohol use disorders (AUD) ans AWS in our population
timeFrame: during ICU stay
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References:
citation: Wood E, Albarqouni L, Tkachuk S, Green CJ, Ahamad K, Nolan S, McLean M, Klimas J. Will This Hospitalized Patient Develop Severe Alcohol Withdrawal Syndrome?: The Rational Clinical Examination Systematic Review. JAMA. 2018 Aug 28;320(8):825-833. doi: 10.1001/jama.2018.10574.
Clinical trial NCT05240079: Evaluation of a New System for Heart Rate and SpO2 Measurement.
Official title: Evaluation of Concordance Between the Measurements Obtained by an Acquisition System of Physiological Parameters (Heart Rate/SpO2) Via a Teleconsultation Camera System With Reference to Standard Acquisition Measurements
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Telemedicine
Keywords: Telemedicine
Heart rate
photoplethysmography
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Caducy is a new medical device that is able to estimate physiological number such as heart rate and SpO2 via laptop or computer camera. The goal of this study is to evaluate the concordance of Caducy system in reference to gold standard which is a heart rate monitor and an oximeter pod linked to a station of acquisition regardless the human variability. The Caducy system measurement via camera is made by filming the visage of the patient during 1 minute.


Eligibility criteria: Inclusion Criteria:

* Be 18 years of age or over.
* Patient affiliated to a social security scheme.
* Having received complete information on the organization of the research.
* Able to understand the requirements of the trial and having signed a free and informed consent prior to entering the study
* Patient taken care of by the CUMSAPA (Centre Universitaire de Médecine du Sport et Activité Physique Adaptées) service for an PFT (pulmonary function test), stress test, consultation of adapted physical activity or other functional explorations carried out by the service.
* Patient having carried out a preliminary clinical examination.

Exclusion Criteria:

* Acute phenomenon contra-indicating the performance of an PFT, stress test or other functional exploration.
* Person with tremors at the time of clinical examination (Parkinson, spasms...)
* People who cannot present the palms of both hands (amputation).
* Woman of childbearing age who does not have effective contraception.
* Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the Public Health Code: Pregnant woman, parturient or nursing mother, Minor (non-emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice), Person of full age unable to express consent
* Persons deprived of their liberty by a judicial or administrative decision, persons undergoing psychiatric treatment under Articles L. 3212-1 and L. 3213-1.

Primary outcomes:
measure: Caducy's heart rate measurement compared to standard
timeFrame: through study completion, an average of 6 month
Secondary outcomes:
measure: Caducy's SpO2 measurement compared to standard
timeFrame: through study completion, an average of 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05895279: Assessment of Research Digest Impact for Minority with Prostate Cancer, MiCAP Phase III Study
Official title: Minority Prostate Cancer (MiCaP) Phase III (Aim 3): Assessment of Research Digest Impact
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 220
Sex: MALE
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This phase III trial determines how well the Minority Prostate Cancer (MiCaP) Research Digest works in providing information to black men about the latest prostate cancer research. MiCaP Research Digest may be an effective method to help people learn about prostate cancer.This goal of this trial is to create educational programming that helps Black men make informed decisions about their prostate healthcare since Black men are diagnosed with prostate cancer more than any other race or ethnicity.

Detailed description: PRIMARY OBJECTIVE:

I. To develop a research dissemination program, the Minority Prostate Cancer (MiCaP) Research Digest, which will spread information about CaP scientific discoveries, evidence-based interventions, and open clinical trials instantly among black males (BM).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants watch MiCaP Research Digest video on study. Participants complete a survey throughout the trial.

ARM II: Participants watch an alternative video on study. Participants complete a survey throughout the trial.

Eligibility criteria: Inclusion Criteria:

* Identify as a Black male
* Between the ages of 35 and 70
* For virtual data collection, have access to the internet and Zoom (if joining study online)
* For virtual data collection, reside anywhere in the U.S.
* For in-person data collection, reside in one of the nine (9) catchment areas of the Mayo Clinic Cancer Center: Baker, Duval, Nassau, Clay, St. John's, Putnam, Flagler, Volusia and Brevard

Exclusion Criteria:

* Identify as a race or ethnicity that is not Black
* Identify as female
* Be younger than age 35 and older than age 70
* Lack access to internet and Zoom (if joining study online)

Primary outcomes:
measure: Change in perception of access to medical services and general health
timeFrame: Baseline, 1 hour after video intervention
measure: Change in perception in participation with clinical trials about prostate cancer
timeFrame: Baseline, 1 hour after video intervention
measure: Change in perception of familiarity with prostate cancer research
timeFrame: Baseline, 1 hour after video intervention
measure: Change in perception of familiarity with a research study protocol
timeFrame: Baseline, 1 hour after video intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Folakemi T. Odedina, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04926779: Study Utilizing BIOZEK COVID-19 Antigen Rapid Test
Official title: Open Label, Single-Center Study Utilizing BIOZEK COVID-19 Antigen Rapid Test: Comparison of Biozek COVID-19 Antigen Rapid Test Results Performed on Self-collected Samples by the Subjects, to Results of COVID-19 RT-PCR as a Standard of Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19 Testing
Keywords: Covid-19
Antigen
Rapid
Test
Lead sponsor: Mach-E B.V.
Sponsor class: INDUSTRY
First posted: 2021-06-15
Enrollment: 185
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: This is a research study to evaluate the Sensitivity and Specificity of BIOZEK COVID-19 Antigen Rapid Test (Saliva) and BIOZEK COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) on samples that are self-collected; and to perform analysis to compare results. In addition, to obtain RT-PCR test results, performed prior to enrollment, and compare all three results.


Eligibility criteria: Inclusion Criteria:

* Subjects must be ≥18 years of age and have had an RT-PCR test performed prior to enrollment.
* Subjects must be able to understand and willingly sign a written informed consent. Additionally, participants need to meet at least 1 of the criteria listed below:

  * Currently experiencing symptoms of COVID-19.
  * Be clinically diagnosed or suspected to have COVID-19.
  * Recent past (3 weeks) exhibited symptoms of COVID-19.
  * Be capable of performing a self-collection of a nasopharyngeal sample with use of nasal swab kit.
  * Be capable of performing a self-collection of an oral fluid sample with use of oral fluid collection kit.
  * Interacted with a COVID-19 positive individual.

Exclusion Criteria:

Subjects who meet any of the following exclusion criteria may not be enrolled in this study:

* Cannot perform self-collection of a nasopharyngeal sample with use of nasal swab kit.
* Cannot perform self-collection of an oral fluid sample with use of oral fluid collection kit.
* Have a deviated nasal septum.
* Cognitively impaired individuals resulting in the inability to provide informed consent

Primary outcomes:
measure: Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Saliva)
timeFrame: 6 months
measure: Sensitivity and Specificity of Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Flushing
country: United States
facility: Mobile Covid Services LLC
state: New York
city: Southampton
country: United States
facility: Quality Research and Invention LLC
state: New York
Study officials:
References:
Clinical trial NCT00918879: Evaluate Saxagliptin in Adult Indian Patients With Type 2 Diabetes Inadequate Glycemic Control
Official title: A 24-Week National, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled, Phase IIIb Study in India to Evaluate the Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Who Have Inadequate Glycaemic Control With Diet and Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: DPP-4 inhibitors
HbA1c
Incretins
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-06-11
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult Indian patients with inadequate glycaemic control with diet and exercise.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with Type 2 diabetes
* Patients should be drug naïve ie, not received medical treatment for diabetes
* HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

Exclusion Criteria:

* Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
* Type 1 diabetes,history of ketoacidosis or hyperosmolar non-ketonic koma

Primary outcomes:
measure: Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
timeFrame: Baseline , Week 24
Secondary outcomes:
measure: Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
timeFrame: Baseline , Week 24
measure: Proportion of Patients (Expressed in Percentage of Total Participants) Achieving a Therapeutic Glycemic Response Defined as HbA1c < 7.0% at Week 24
timeFrame: Baseline , Week 24
Other outcomes:
Locations:
city: Gujarat
country: India
facility: Research Site
state: Ahmedabad
city: Karnataka
country: India
facility: Research Site
state: Bangalore
city: Tamil Nadu
country: India
facility: Research Site
state: Chennai
city: Tamil Nadu
country: India
facility: Research Site
state: Coimbatore
city: Andhra Pradesh
country: India
facility: Research Site
state: Hyderabad
city: Madhya Pradesh
country: India
facility: Research Site
state: Indore
city: Haryana
country: India
facility: Research Site
state: Karnal
city: Kerala
country: India
facility: Research Site
state: Kochi
city: Maharashtra
country: India
facility: Research Site
state: Pune
Study officials:
affiliation: AstraZeneca, Wilmington, USA
name: Peter Ohman, MD, PhD
role: STUDY_DIRECTOR
affiliation: AstraZeneca, Wilmington, USA
name: Deborah Price, MSc
role: STUDY_CHAIR
References:
citation: Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11.