louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02969954: Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Diabetes
Official title: Stories for Change: Digital Storytelling as a Tool for Engagement in Facilitated Discussion for Reduction of Diabetes-Related Health Disparities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Racial and ethnic minorities with type II diabetes in the US are more likely to develop complications and die from the disease than the general population. The foreign-born subset of this population is less likely to adhere to diabetes care recommendations than US-born patients, thereby placing them at higher risk for complications. In our previous pilot project, eight stories were assessed through preliminary multi-site intervention for acceptability and efficacy in diabetes management among Latino and Somali patients with poorly controlled type II diabetes. The goal of this project is to evaluate a new format for delivery of a culturally tailored digital storytelling intervention by incorporating a facilitated group discussion following the videos, for management of type II diabetes in Latino communities.


Eligibility criteria: Inclusion criteria:

1. Self-identify as Hispanic/Latino
2. Are Spanish-speaking
3. Receive primary care at one of the participating clinical sites
4. Self-reported diagnosis of type II diabetes

Exclusion criteria:

1. Not able to give informed consent
2. Not able to participate in a group discussion

Primary outcomes:
measure: Self-efficacy for diabetes management
timeFrame: Assessment will be done immediately after participants watch the intervention video
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jane W Njeru
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06145854: Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP
Official title: Real World Clinical Outcomes in Cisgender Female Patients Who Start on Long Acting Cabotegravir for PrEP: An Observational, Multisite Prospective 2 Year Study in the Southern U.S.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hiv
Lead sponsor: Midway Specialty Care Center
Sponsor class: OTHER
First posted: 2023-11-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 100 cisgender females (including 15 cisgender females with history of substance use and 15 cisgender females with unstable housing)

Brief summary: Oral PrEP regimens (FTC/TDF have been the mainstay of HIV prevention however patients now have more options for HIV prevention. In addition to oral PrEP regimens, the FDA approved the use of long acting Cabotegravir (CAB-LA) as the first long-acting medication for HIV prevention. This study will evaluate real world clinical outcomes of cisgender female patients who start CAB-LA for PrEP.


Eligibility criteria: Inclusion Criteria:

1. Cisgender females, ages 18 years and older
2. Negative HIV test at baseline
3. Negative Pregnancy test at baseline
4. Weigh at least 35 kilograms
5. Already Prescribed CAB-LA (Apretude)

Exclusion Criteria:

1. Transgender females or males
2. Cisgender males
3. Cisgender female who is actively breastfeeding
4. Severe hepatotoxicity
5. Evidence of Hepatitis B Infection
6. History or presence of allergies to cabotegravir or its components

Primary outcomes:
measure: Describe the percent of cisgender females persistent on CAB-LA over 44 weeks.
timeFrame: 44 Weeks
Secondary outcomes:
measure: Describe incidence of bacterial STIs through weeks 20, 44 and 92
timeFrame: Weeks 20, 44 and 92
measure: Describe satisfaction of cisgender female patients while being on CAB-LA through weeks 20, 44 and 92 with the use of satisfaction surveys
timeFrame: Weeks 20, 44 and 92
measure: Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females
timeFrame: Weeks 20, 44 and 92
measure: Describe percentage adherence to CAB-LA injection schedule at weeks 20, 44 and 92 for cisgender females with substance use and/or unstable housing.
timeFrame: Weeks 20, 44 and 92
measure: Describe percentage of cisgender female patients with HIV prevention failure while on CAB-LA, with detection of HIV, at weeks 20, 44 and 92.
timeFrame: Weeks 20, 44 and 92
measure: Describe percentage of cisgender female patients with weight gain > 10% from baseline on CAB-LA at weeks 20, 44 and 92
timeFrame: Weeks 20, 44 and 92
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Midway Specialty Care Center
state: Florida
city: Temple Terrace
country: United States
facility: Midway Specialty Care Center
state: Florida
city: West Palm Beach
country: United States
facility: Midway Specialty Care Center
state: Florida
Study officials:
References:
Clinical trial NCT00093054: Cranberry Juice for Treatment of Urinary Tract Infections
Official title: Cranberry Juice and Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Urinary Tract Infections
Keywords: Vaccinium macrocarpon
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-10-01
Enrollment: 319
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether daily consumption of cranberry juice lessens the symptoms and prevents the recurrence of urinary tract infections (UTIs). This study will also determine whether drinking cranberry juice for 6 months selects for less virulent bacteria in the rectal, vaginal, and urethral areas.

Detailed description: Participants in this study will be randomly assigned to consume either 8 ounces of cranberry juice or placebo juice twice a day for 6 months. Participants will have follow-up visits at 3 and 6 months, and whenever they experience a symptomatic episode. Urine, vaginal and rectal specimens will be taken at each visit to test for the presence of bacteria that cause urinary tract infections. Participants will complete a questionnaire at study entry, Day 3, Weeks 1 and 2, and monthly thereafter or whenever there is a recurrence of symptoms.

Eligibility criteria: Inclusion Criteria:

* Culture-confirmed urinary tract infection at study start

Exclusion Criteria:

* Other chronic disease
* Antibiotics within 48 hours prior to study start
* Hospitalization for any reason within 2 weeks prior to study start
* Stones in urinary tract
* Plans to leave Ann Arbor within 6 months after study start
* Allergy to cranberry or cranberry compounds
* Pregnancy

Primary outcomes:
measure: Culture
timeFrame: per visit
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Cibele T. Barbosa-Cesnik
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00210054: A Pharmacokinetic Evaluation Study in Healthy Volunteers
Official title: Pilot Single-Dose Intravenous Pharmacokinetic Evaluation of INS37217 Solution in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to characterize the pharmacokinetics of INS37217 following intravenous administration.


Eligibility criteria: Inclusion Criteria:

* are nonsmokers or those subjects whom have not smoked within 6 months
* are within 20% of their ideal body weight
* are healthy on the basis of a pre-trial physical examination

Exclusion Criteria:

* history or suspicion of recent alcohol, barbiturate, amphetamine or narcotic abuse or a positive urine drug test at study screening
* history of cardiac arrhythmias, bronchospastic or cardiovascular disease, diabetes mellitus, thyrotoxicosis, Parkinsonism, or drug allergy
* use of concomitant medication other than hormonal contraceptives and multi-vitamins
* donation of blood in the 60 days preceding the screening visit
* have been diagnosed with HIV, hepatitis B or hepatitis C

Primary outcomes:
measure: detection and characterization of plasma concentrations of INS37217
Secondary outcomes:
measure: Pilot study - not specified
Other outcomes:
Locations:
Study officials:
name: Robin Deterding, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00876954: Preoperative Hyperthermia in Major Abdominal Surgery Patients
Official title: Preoperative Whole-Body Hyperthermia in Patients Undergoing Major Abdominal Cancer Surgery: A Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colon Cancer
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: Braun Stiftung
First posted: 2009-04-07
Enrollment: 20
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: The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

Detailed description: The investigators hypothesize that preoperative hyperthermia improves postoperative complications and compare a placebo group with standard thermoregulatory management (normothermia) to a treatment group receiving 2,5 hours of hyperthermia (38.5-39.5 °C core temperature) in a randomized, single blinded, controlled trial.

Eligibility criteria: Inclusion Criteria:

* Male and female patients, age 18 - 75
* Open abdominal, curative cancer surgery \> 2 h

Exclusion Criteria:

* Pregnancy
* Chronic cortisone treatment
* Ongoing chemotherapy
* Acute infections, septic surgery
* Palliative surgery (e.g. debulking only)

Primary outcomes:
measure: Immune Status
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Oliver Kimberger M.D.
Study officials:
affiliation: Medical University of Vienna
name: Oliver Kimberger, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06825754: The Value of Serum MicroRNA-21-5p and LncRNAgadd7 Expression Levels in Predicting the Severity and Prognosis of ARDS ( Acute Respiratory Distress Syndrome )
Official title: The Value of Serum MicroRNA-21-5p and LncRNAgadd7 Expression Levels in Predicting the Severity and Prognosis of ARDS ( Acute Respiratory Distress Syndrome )
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ARDS ( Acute Respiratory Distress Syndrome)

Brief summary: By measuring the expression levels of MicroRNA-21-5p (miR-21-5p) and LncRNAgadd7 in the peripheral blood of ARDS patients, the study aims to explore the correlation between these levels and the severity and prognosis of ARDS.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years;
2. Meets the Berlin Criteria for ARDS;
3. Diagnosed with ARDS within 48 hours;
4. Signed informed consent.

Exclusion Criteria:

1. Immunosuppressed patients: including those on immunosuppressive drugs, history of stem cell transplantation, etc.;
2. Patients with malignant tumors;
3. Pregnant women;
4. Patients discharged from the ICU within 48 hours;
5. History of chronic lung diseases.

Primary outcomes:
measure: The expression levels of MicroRNA-21-5p (miR-21-5p)
timeFrame: 28 days
measure: the expression levels of LncRNAgadd7
timeFrame: 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
References:
Clinical trial NCT01490554: Autologous Fibroblast Grafts in Facial Skin Regeneration
Official title: Effectiveness of Autologous Fibroblast Grafts in the Regeneration of Facial Ectoderm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Aging
Keywords: Skin aging
fibroblasts
transplantation
autologous
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.

Detailed description: - Analytical prospective autocontrolled study

Eligibility criteria: Inclusion Criteria:

* Women, aged between 50 to 70 years with facial wrinkles (rhytides),
* Fitzpatrick III skin type, and
* Who had reached menopause at least 3 years before entering the study were eligible for participation.

Exclusion Criteria:

* Women with uncontrolled comorbid conditions,
* Smokers,
* Alcohol and corticosteroid users,
* Who had undergone chemical peeling or skin filling in the face or neck at least 12 months prior to the study,
* Who had a keloid scar,
* Who scored below 18 on the Mini-Mental State Examination,
* Who had any psychiatric disorder or those undergoing orthodontic treatment were excluded from the study.

Primary outcomes:
measure: Regeneration of facial ectoderm
timeFrame: one year after the grafting of autologous fibroblasts.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Lydia M Ferreira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00606554: Clinical Trial of a Computer-driven Weaning System for Patients Requiring Mechanical Ventilation
Official title: A Randomized Controlled Trial of Computer-Driven Weaning Compared With Standard of Care Weaning in Medical Patients Requiring Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Respiratory Insufficiency
Keywords: Respiratory Insufficiency
Ventilators, Mechanical
Ventilator Weaning
Therapy, Computer-Assisted
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
First posted: 2008-02-04
Enrollment: 33
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: The purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (Drager Smartcare) to our current standard of care in the medical intensive care unit.


Eligibility criteria: Inclusion Criteria:

* Age greater than 18 years
* Initiated on mechanical ventilation via endotracheal tube
* Admitted to Medical Intensive Care Unit and Medical Intensive Care Unit Team (Harrison Avenue Campus, Menino Pavilion)
* Requiring mechanical ventilation for more than 48 hours
* Meets prespecified weaning criteria

Exclusion Criteria:

* Do Not Resuscitate/Do Not Intubate order
* Pregnancy
* Mechanical ventilation initiated at another hospital
* Cardiac arrest for more than 5 minutes with poor neurologic prognosis
* Tracheostomy

Primary outcomes:
measure: Duration of Weaning
timeFrame: Continuous (median weaning duration was 2 days)
Secondary outcomes:
measure: Duration of ICU Stay
timeFrame: from start of weaning to discharge from ICU, on average 1-2 weeks
measure: Duration of Mechanical Ventilation
timeFrame: from start of weaning to liberation from ventilator, on average 1-2 days
measure: Duration of Hospitalization
timeFrame: from start of weaning to discharge from hospital, on average 1-2 weeks
measure: Inpatient Mortality
timeFrame: 28 days
measure: Sedation Requirements
timeFrame: during weaning, on average 1-2 days
measure: Number of Spontaneous Breathing Trials Prior to Extubation
timeFrame: from start of weaning to liberation from ventilator, on average 1-2 days
measure: Complications (Death During Wean, Ventilator-associated Pneumonia During Wean, Self Extubation, Re-intubation)
timeFrame: Duration of weaning (median 2 days)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston University
name: Christine C Reardon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00780754: Prevention of Prostate Cancer With Dutasteride in Case of High Grade PIN Neoplasia
Official title: Effect of 5α Reductase Inhibitor Dutasteride on the Prevention of the Prostate Cancer in Men With High Grade Intraepithelial Neoplasia of the Prostate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: prostate cancer
chemoprevention
dutasteride
Lead sponsor: Kaunas University of Medicine
Sponsor class: OTHER
First posted: 2008-10-28
Enrollment: 200
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with diagnosis of HPIN were enrolled. Patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. According to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization.

There are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).


Eligibility criteria: Inclusion Criteria:

1. Age - 40-80 years
2. HPIN on prostate biopsy specimens
3. PSA below 20ng/ml
4. No hormone therapy or radiation in pelvic region
5. No previous treatment with 5alfa reductase inhibitors
6. Signed Subject Information and Informed Subject Consent Form.

Exclusion Criteria:

1. Not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.

Primary outcomes:
measure: rate of prostate cancer at repeated transrectal ultrasound guided biopsies in case of HPIN
timeFrame: 6, 12, 24, and 36 months
Secondary outcomes:
measure: effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (HPIN).
timeFrame: 6, 12, 24, and 36 months
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Urology dep. of Kaunas University of Medicine
Study officials:
affiliation: Kaunas Medical University
name: Daimantas Milonas, assist professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01313754: Comparison of Skin Incision Closure Material for the Transobturator Suburethral Sling Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Irritation (Physical)
Pelvic Pain
Keywords: Skin closure
dermabond
vicryl
monocryl
Suburethral sling
Transobturator Sling
Pain
Discomfort
Skin irritation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2011-03-14
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare different skin closure materials for the transobturator suburethral sling procedure. Currently the investigators are using monocryl suture material as the standard for skin closure. This material has anecdotally show to be very irritating to patients who have had this type of surgery. Our study will compare the monocryl suture material with vicryl (polyglactin 910) and dermabond (2-octyl cyanoacrylate) skin glue. The investigators believe that vicryl suture material will be superior in comfort when compared to monocryl and dermabond for this type of procedure.


Eligibility criteria: Inclusion Criteria:

* Those patients receiving a transobturator suburethral sling procedure.
* Adults (\>= 18years).

Exclusion Criteria:

* Non-English speaking.
* Allergy to monocryl, vicryl, or dermabond.

Primary outcomes:
measure: The level of severity of patient discomfort at their incision sites.
timeFrame: The patients will be assessed at their second week post operative visit.
Secondary outcomes:
measure: Cosmesis at the incision sites
timeFrame: The patients will be assessed at their 2nd week post operative visit
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center
state: California
Study officials:
name: Sam Siddighi, M.D.
role: PRINCIPAL_INVESTIGATOR
name: David B Waggonner, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02361333: Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators
Official title: Barriers to Use of Remote Monitoring in Patients With Implantable Cardioverter Defibrillators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Patients
Implantable Cardioverter Defibrillator
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2015-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether a teaching intervention can help increase the use of remote monitors in patients with implantable cardioverter defibrillators.


Eligibility criteria: Inclusion Criteria:

* Received a Medtronic implantable cardioverter defibrillator (ICD) at Yale Electrophysiology, between January 2007 and June 2012
* ICD is compatible with Carelink, Medtronic's remote monitoring system

Exclusion Criteria:

* Less than 18 years of age
* From a vulnerable population
* Incompetent/suffers from dementia
* Non-English speaking

Primary outcomes:
measure: Number of remote Transmissions of data using remote monitor made by patient
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Electrophysiology
state: Connecticut
Study officials:
References: