louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06732076: The Effect of a Web-Based Breastfeeding Education Program for Adolescent Pregnant
Official title: The Effect of a Web-Based Breastfeeding Education Program for Adolescent Pregnant Women in the Third Trimester on Breastfeeding Practices: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 90
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: It is crucial to prepare adolescent mothers-who represent a vulnerable group where the importance of breastfeeding is increasingly emphasized-for the breastfeeding process. One potential method for promoting breastfeeding is through web-based education interventions. The aim of this study was to evaluate the effect of a web-based breastfeeding education program, developed by the researchers, on breastfeeding outcomes among adolescent pregnant women in the postpartum period. This randomized controlled study involved a sample of 100 pregnant adolescents, aged 15-19 years, who were in their third trimester of pregnancy. The study commenced after obtaining ethical approval and permissions from the hospital where the research was conducted.

A web-based breastfeeding education program was administered to the experimental group. Data were collected using a Socio-Demographic Data Form, the Breastfeeding Self-Efficacy Scale Short Form (Antenatal Version), the Breastfeeding Self-Efficacy Scale Short Form (Postnatal Version), and the LATCH Breastfeeding Diagnosis and Assessment Scale. Data collection occurred during the third trimester (pretest) and the 1st and 8th postnatal weeks (posttest).


Eligibility criteria: Inclusion Criteria:

* Aged between 15 and 19 years
* Had not previously received planned breastfeeding education
* Were between 28 and 37 weeks gestation (third trimester)
* Gave birth at term
* Had no health issues preventing breastfeeding
* Could read, write, and respond to questions
* Had access to a computer, tablet, or smartphone, and had regular internet access.

Exclusion Criteria:

* Participants were excluded if they had multiple pregnancies
* Physical or mental health problems, communication disabilities
* A history of breast surgery
* İf their newborns were considered high-risk.

Primary outcomes:
measure: Breastfeeding self-efficacy scale
timeFrame: pre-test post-test (approximately six month)
Secondary outcomes:
Other outcomes:
Locations:
city: VAN
country: Turkey
facility: Van Yüzüncü Yıl University
state: Tuşba
city: VAN
country: Turkey
facility: Van Yüzüncü Yıl University
Study officials:
References:
Clinical trial NCT05140876: Supporting Treatment Adherence for Resilience and Thriving (START)
Official title: Supporting Treatment Adherence for Resilience and Thriving
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adherence, Medication
HIV-1-infection
Stimulant Use
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-12-02
Enrollment: 286
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This Phase II randomized controlled trial is testing the efficacy of a cell phone application called START for helping men who use stimulants like methamphetamine to get the most out of their HIV treatment.


Eligibility criteria: 1. Assigned male at birth;
2. Identifies as male;
3. Age 18 or older;
4. Reads and speaks English;
5. Continental US residency;
6. Reports ever having had anal sex with a man;
7. Self-reported HIV diagnosis for 3 or more months and currently taking anti-retroviral therapy (ART)
8. Reports a detectable viral load during past year OR no viral load test in the past 10+ months OR reports \< 90% adherence to ART;
9. Screens positive for a moderate or severe stimulant use disorder in the past 3 months with an abbreviated version of the National Institute on Drug Abuse (NIDA)-modified Alcohol, Smoking and Substance. Involvement Screening Test (ASSIST);
10. Has an iPhone or Android smartphone;
11. Is willing to participate in an mHealth intervention

Exclusion Criteria:

1. HIV-negative or never tested for HIV;
2. HIV-positive men without a current ART prescription;
3. Does not return a viable DBS specimen at baseline for viral load testing
4. Not a sexual minority man

Primary outcomes:
measure: Unsuppressed HIV Viral Load
timeFrame: 6 Months
Secondary outcomes:
measure: Unsuppressed Viral Load
timeFrame: 12 Months
measure: Self-Reported Stimulant Use Severity
timeFrame: 12 Months
measure: Self-Reported Anti-Retroviral Therapy (ART) Adherence
timeFrame: 12 Months
measure: Positive Affect
timeFrame: 12 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Adam W Carrico, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01121276: A Trial Investigating NN1218 in Subjects With Type 1 and Type 2 Diabetes
Official title: A Trial Investigating the Pharmacodynamic Properties of NN1218 in Subjects With Type 1 and Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe and in the United States of America (USA). The aim of this trial is to investigate the absorption and effect in the body of NN1218 in subjects with type 1 and type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Type 1 or type 2 diabetes mellitus for more than 12 months
* Treated with multiple daily insulin injections or continuous subcutaneous insulin infusion (CSII) for 12 months or longer for subjects with type 1 diabetes and for 3 months or longer for subjects with type 2 diabetes
* Body Mass Index (BMI) between 18.0-32.0 kg/m2 (both inclusive)

Exclusion Criteria:

* Surgery or trauma with significant blood loss (more than 500 mL) within the last 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the blood glucose concentration-time curve
timeFrame: from 0-2 hours
Secondary outcomes:
measure: Area under the blood glucose concentration-time curve
timeFrame: from 0-6 hours
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Heise T, Haahr H, Jensen L, Ericsen L, Hompesch M. Faster-acting Insulin Aspart Improves Postprandial Glycemia vs Insulin Aspart in Patients with Type 1 Diabetes Mellitus (T1DM). Diabetes 2014; 63 ((Suppl 1)): A34 (abstract 129-OR)
Clinical trial NCT01170676: Promoting Asthma Wellness in Rural Communities
Official title: Promoting Asthma Wellness in Rural Communities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: asthma
smoking
teens
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: Henry Ford Health System
name: University of Michigan
First posted: 2010-07-27
Enrollment: 700
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a research study that compares the effectiveness of a web-based program (known as Puff City) and another web-based program (of internet sites such as the American Lung Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key asthma management issues among rural youth:

1. Improving adherence to asthma controller medication use;
2. Improving compliance of carrying a rescue inhaler at all times for use at the first sign of asthma symptoms;
3. Improving inhaler technique;
4. Smoking reduction or cessation in those who are smokers; and
5. Avoidance of second-hand smoke exposure.

Detailed description: A randomized control trial across three southeastern rural high schools comparing a web-based tailored intervention (known as Puff City) to web-based traditional control education sites.

Eligibility criteria: Inclusion Criteria:

* AA ethnicity
* in 9th - 11th grade of selected rural schools
* have an asthma diagnosis and/or asthma-like symptoms by screening eligible on the Lung Health Survey
* have access to a telephone or mobile phone
* being the parent of a student meeting the above criteria with whom the student resides the majority of the time.

Exclusion Criteria:

* Not meeting the above criteria.

Primary outcomes:
measure: Days of asthma symptoms; personal cigarette smoking and cessation; and days of school missed because of asthma, measured by self report
timeFrame: baseline, end of treatment, 6 months, 12 months
Secondary outcomes:
measure: Change in exhaled nitric oxide and active and passive smoke exposure, measured by salivary cotinine.
timeFrame: baseline, end of treatment, 6 months, 12 months
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
Study officials:
affiliation: Augusta University
name: Martha S Tingen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Augusta University
name: Dennis R Ownby, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jordan DM, Bush JS, Ownby DR, Waller JL, Tingen MS. The impact of traditional literacy and education on health literacy in adolescents with asthma. J Asthma. 2019 Aug;56(8):882-890. doi: 10.1080/02770903.2018.1494191. Epub 2018 Sep 5.
Clinical trial NCT06833476: TTVR STRONG Under Coverage With Evidence Development (CED) Study
Official title: Transcatheter Tricuspid Valve Replacement (TTVR) in Patients With Severe TR ONgoing Evidence Generation (STRONG) Under Coverage With Evidence Development (CED)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Keywords: EVOQUE
Coverage with Evidence Development
CED
TVT Registry
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2025-02-18
Enrollment: 2044
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medicare eligible real-world patients with severe, symptomatic tricuspid regurgitation

Brief summary: This Coverage with Evidence Development (CED) study measures the long-term health outcomes of patients with severe, symptomatic Tricuspid Regurgitation who received a Transcatheter Tricuspid Valve Replacement procedure using the EVOQUE system.

Detailed description: This is a retrospective, non-randomized cohort study measuring 2-year effectiveness of the EVOQUE Transcatheter Tricuspid Valve Replacement (TTVR) system in the real-world.

This study will retrospectively evaluate EVOQUE treated patients in the STS/ACC TVT Registry who have at least severe Tricuspid Regurgitation and can be deterministically linked with Medicare data.

This group will be compared to Medicare eligible and EVOQUE eligible patients evaluated in a standard of care setting from a commercial claims database linked with electronic health records.

We will evaluate the primary outcome measure in various subgroups.

There will be continued access enrollment after the primary completion date.

Eligibility criteria: Inclusion Criteria:

Medicare eligible patients who have received an EVOQUE device or are EVOQUE eligible and have at least severe Tricuspid Regurgitation

Exclusion Criteria:

Commercially insured patients who have received an EVOQUE device or are EVOQUE eligible or Medicare eligible patients with less than severe Tricuspid Regurgitation

Primary outcomes:
measure: Composite (All-Cause Death or Heart Failure Hospitalization)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Edwards Lifesciences
state: California
Study officials:
References:
Clinical trial NCT04745676: A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Official title: A Telehealth Advance Care Planning Intervention for Older Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Keywords: Acute Myeloid Leukemia
Myelodysplastic Syndromes
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-02-09
Enrollment: 36
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention among 20 older patients with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).

Detailed description: Older adults with AML and MDS are more likely to receive aggressive care and less likely to utilize hospice at the end-of-life. Advance care planning (ACP) intervention delivered through telehealth may improve patient-reported outcomes and end-of-life care in this population. This pilot study seeks to evaluate the usability and feasibility of a telehealth-delivered advance care planning intervention. We will adapt the Serious Illness Care Program.

Eligibility criteria: Inclusion Criteria for Patients:

* Age ≥60 years (conventional definition of older age in AML/MDS)
* AML or MDS diagnosis
* Being managed in the outpatient settings
* Able to provide informed consent
* English-speaking

Exclusion Criteria: N/A

Inclusion Criteria for Caregivers

* Age ≥21 years
* Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters"
* Able to provide informed consent
* English-speaking

Exclusion Criteria: N/A

Primary outcomes:
measure: Feasibility - Retention Rate
timeFrame: 12 Weeks
measure: Recruitment Rate
timeFrame: 12 Weeks
measure: Mean Usability of the Telehealth Advance Care Planning Intervention Using the Telehealth Usability Questionnaire (TUQ)
timeFrame: 12 Weeks
Secondary outcomes:
measure: Pre- and Post-Intervention Change of the Mean Score for the General Anxiety Disorder-7 (GAD-7)
timeFrame: 12 Weeks
measure: Pre- and Post-Intervention Change of the Mean Score for the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 12 Weeks
measure: Pre- and Post-Intervention Change of the Mean Score for the Distress Thermometer
timeFrame: 12 Weeks
measure: Pre- and Post-Intervention Change of the Mean Score for the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu)
timeFrame: 12 Weeks
measure: Post-Intervention Mean Score for the Health Care Communication Questionnaire (HCCQ)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Univ. of Rochester Wilmot Cancer Center
name: Kah Poh Loh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00862576: A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome
Official title: A Study of the Association of Sleep Dysfunction and Burning Mouth Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burning Mouth Syndrome
Keywords: Burning Mouth Syndrome
Sleep
Neuropathic pain
Glossodynia
Chronic pain
Orofacial pain
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2009-03-17
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Seen at the Oral Medicine Clinic at the University of California, San Francisco

Brief summary: This is a case control study of the association between burning mouth syndrome and sleep dysfunction. Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic. Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases. New patients as well as those presenting for follow-up visits will be eligible.

Each case and control subject will be administered the following 4 questionnaires by interview: (1) enrollment questionnaire (2) Sleep scale from the medical outcomes study (MOS), (3) current sleep status scale and (4) a numerical rating scale for measurement of oral symptoms.

Cases (BMS patients) will be followed in the clinic or by telephone contact once per month for the following 6 months and questionnaires 1 (question 6 only), 2, 3 and 4 will be administered by interview.


Eligibility criteria: Inclusion Criteria:

* Cases will comprise of patients diagnosed with burning mouth syndrome at the UCSF oral medicine clinic.
* Controls will include patients with leukoplakia, pigmented lesions, traumatic lesions, aphthous ulcers, reticular oral lichen planus, benign tumors, mucoceles, and pemphigoid matched on age (5 years) and gender to the cases.
* New patients as well as those presenting for follow-up visits will be eligible.

Exclusion Criteria:

* Age below 18 years
* Pregnancy
* Systemic corticosteroid therapy within the previous 2 weeks.

Primary outcomes:
measure: Sleep quality and quantity
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Nita Chainani-Wu, DMD, MS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Sol Jr. Silverman, MA, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01356576: Effect of Hemodialysis Membranes on Platelet Count
Official title: Effect of Hemodialysis Membranes on Platelet Count
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombocytopenia
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2011-05-19
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were being selected from the community where undergoing dialysis.

Brief summary: The purpose of this study is to determine if there is a drop in platelet count after hemodialysis. Hemodialysis membranes are known to activate complement and cause a drop in platelets and sometimes in white blood cells. The investigators are going to study one of the membranes which is the Fresenius Optiflux® to check if it causes a drop in platelets.


Eligibility criteria: Inclusion Criteria:

* Patients on Hemodialysis for \>=6 months

Exclusion Criteria:

* Hematological Cancers

  * Myelodysplastic syndromes
  * Baseline thrombocytopenia
  * Acute infections (patients on antibiotics)
  * Patients with Immune thrombocytopenic purpura (ITP)/Thrombotic thrombocytopenic purpura (TTP)
  * HIV
  * Liver disease

Primary outcomes:
measure: Drop in platelet counts
timeFrame: 90 minutes through hemodialysis and immediately after finishing hemodialysis
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Island Rehabilitative Service
state: New York
Study officials:
affiliation: Staten Island University Hospital
name: Edwerd Epstein, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01740076: Soy Nuts and Cardiovascular Risk in Postmenopausal Women
Official title: Effect of Soy Nuts on Blood Pressure, Lipids and Inflammation in Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopausal Women
Keywords: isoflavones, hypertension, soy, diet, nutrition, women, inflammation, hot flashes
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 84
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the effect of a whole soy food, dietary soy nuts, on blood pressure, lipid levels, inflammation and menopausal symptoms in postmenopausal women.

Detailed description: The present study examines the effect of a whole soy food, soy nuts (dry roasted soybeans), added to the Therapeutic Lifestyle Change diet on blood pressure, lipids, inflammation and menopausal symptoms in postmenopausal hypertensive and normotensive women in a randomized crossover trial during an 8-week period. We sought to determine whether dietary soy had an additional benefit to the currently recommended heart healthy diet.

Eligibility criteria: Inclusion Criteria:

* Women with absence of menses for at least 12 months or irregular periods and hot flashes.

Exclusion Criteria:

* were current cigarette smoking or smoking in the previous year;
* clinical coronary artery disease, peripheral artery disease, or cerebrovascular disease;
* known diabetes mellitus or a fasting glucose level of 126 mg/dL or greater;
* a history of breast cancer; a fasting triglyceride level greater than 400 mg/dL; systolic BP of 165 mm Hg or greater or diastolic BP of 100 mm Hg or greater;
* untreated hypothyroidism; systemic or endocrine disease known to affect lipid, mineral, or bone metabolism;
* and consumption of more than 21 alcoholic drinks per week.
* Use of lipid-lowering drugs, hormone therapy, medications for osteoporosis, and soy products was discontinued for 2 months before entering the study. Participants took a multivitamin but no additional vitamin or mineral supplements or other soy products during the study.

Primary outcomes:
measure: Blood pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: lipid levels
timeFrame: 8 weeks
measure: inflammatory markers
timeFrame: 8 weeks
measure: menopausal symptoms
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Francine Welty, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Acharjee S, Zhou JR, Elajami TK, Welty FK. Effect of soy nuts and equol status on blood pressure, lipids and inflammation in postmenopausal women stratified by metabolic syndrome status. Metabolism. 2015 Feb;64(2):236-43. doi: 10.1016/j.metabol.2014.09.005. Epub 2014 Oct 5.