louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01399502: Promotion of Self-help Strategies for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Depressive Disorder
Depression
Keywords: Depression
Self Care
Lead sponsor: Orygen
Sponsor class: OTHER
Collaborators: name: National Health and Medical Research Council, Australia
name: University of Melbourne
name: Sidney Myer Fund
First posted: 2011-07-21
Enrollment: 1736
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effectiveness of health promotion emails for depression. It is hypothesised that emails containing self-help advice will improve depression symptoms more than emails containing information about depression.

Detailed description: Depression symptoms are commonly experienced and disrupt day-to-day life. Increasing depression literacy and the use of effective self-help methods could improve depression across the community. The internet is an ideal promotional medium for health messages, because it is often used to search for information about mental health issues, and health messages can be widely disseminated at little cost. An email campaign could be a low-cost approach to improving self-help behavior and knowledge about depression in adults with depression symptoms.

Eligibility criteria: Inclusion Criteria:

* Access to the internet at least once per week
* Resident of Australia, New Zealand, Canada, Ireland, United Kingdom, USA

Exclusion Criteria:

Primary outcomes:
measure: Depression symptom score on PHQ-9 at post-intervention
timeFrame: 6-weeks post baseline
measure: Depression symptom score on PHQ-9 at 6-month follow-up
timeFrame: 6-months post end-of-intervention
Secondary outcomes:
measure: Psychological distress on K10 at post-intervention
timeFrame: 6-weeks post baseline
measure: Psychological functioning on Work and Social Adjustment Scale at post-intervention
timeFrame: 6-weeks post baseline
measure: Psychological functioning on Work and Social Adjustment Scale at 6-month follow-up
timeFrame: 6-months post end-of-intervention
measure: Psychological distress on K10 at 6-month follow-up
timeFrame: 6-months post end-of-intervention
Other outcomes:
Locations:
city: Parkville
country: Australia
facility: Orygen Youth Health Research Centre
state: Victoria
Study officials:
affiliation: Orygen Youth Health Research Centre, The University of Melbourne
name: Anthony F Jorm, PhD, DSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Orygen Youth Health Research Centre, The University of Melbourne
name: Andrew J Mackinnon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgan AJ, Jorm AF, Mackinnon AJ. Self-Help for Depression via E-mail: A Randomised Controlled Trial of Effects on Depression and Self-Help Behaviour. PLoS One. 2013 Jun 21;8(6):e66537. doi: 10.1371/journal.pone.0066537. Print 2013.
Clinical trial NCT03018002: Intervention for Sustained Testing and Retention Among HIV-infected Patients
Official title: Intervention for Sustained Testing and Retention Among HIV-infected Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV
Keywords: HIV, PMTCT
Lead sponsor: University of Nevada, Las Vegas
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2017-01-11
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the comparative effectiveness of a congregation, clinic and integrated case management-based intervention for sustainable testing and retention on linkage to care, engagement, retention and viral load suppression of women and children infected with HIV.

Detailed description: Using a two-arm cluster randomized design, our proposed study will evaluate the comparative effectiveness of iSTAR, a community-based social network intervention that combines trained church-based Health Advisors and clinic-based staff and uses motivational interview skills and clinic- quality improvement approaches (Intervention Group; IG) versus a clinic-based approach (Control group; CG) on linkage, engagement, retention and viral suppression among HIV-infected women and children. Eighteen health facilities in identified local government areas in Benue state, north-central Nigeria will be randomly assigned to either the IG (N=9 health facilities) or the CG (N=9 health facilities). A total of 10,000 pregnant women will be screened and 400 HIV-infected participants will be enrolled over a 24-month period. The primary outcome will be the difference in the rate of linkage and engagement between the groups. The secondary outcome will be the difference in rate of retention and viral suppression among participants. Additionally, we will conduct network, mediation/moderation analysis to examine the roles of intermediate variables such as health team cohesion, turnovers, attitudes, leadership and dynamic adaptation on iSTAR implementation and sustainment.

Eligibility criteria: Inclusion Criteria:

* HIV-infected pregnant women identified during baby showers programs at participating worship centers.

Exclusion Criteria:

* HIV-infected women already on treatment

Primary outcomes:
measure: Linkage in care
timeFrame: 1 month
measure: Retention in care
timeFrame: 12 months
Secondary outcomes:
measure: ART Initiation
timeFrame: 1 month
measure: Viral Suppression
timeFrame: 12 months
Other outcomes:
Locations:
city: Makurdi
country: Nigeria
facility: Catholic Caritas Foundation
state: Benue
Study officials:
References:
citation: Ezeanolue EE, Obiefune MC, Yang W, Obaro SK, Ezeanolue CO, Ogedegbe GG. Comparative effectiveness of congregation- versus clinic-based approach to prevention of mother-to-child HIV transmission: study protocol for a cluster randomized controlled trial. Implement Sci. 2013 Jun 8;8:62. doi: 10.1186/1748-5908-8-62.
Clinical trial NCT06882902: Unique Electroencephalography (EEG) Markers of Habit Behaviors in Obsessive-Compulsive Disorder (OCD)
Official title: Using Forced-response Model and Drift-diffusion Model to Explore OCD's Unique Electroencephalographic Markers of Habit Formation and Expression
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Obsessive-Compulsive Disorder
Keywords: habit
cognitive flexibility
response inhibition
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study focuses on explaining the occurrence and development of compulsive behaviors from habit hypothesis. Investigators will study both OCD patients and healthy individuals using Hardwick's forced-response time task(2019), the habit Go/No-Go task, and the Intra-Extra Dimensional Set Shift task. Investigators aim to explore the cognitive abilities and differences between OCD patients and healthy controls in these three tasks. Control variables will include participants' levels of anxiety, depression, and stress, as well as sense of incompleteness and intolerance of uncertainty levels. By examining the differences in habit formation and expression abilities between OCD patients and healthy controls, and exploring the specific brain electroencephalographic activity processes in OCD patients, investigators hope to reveal the abnormal neural activity in habit-related circuits in OCD patients. This could provide new insights for the diagnosis and treatment of OCD.


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 50;
2. Y-BOCS score greater than or equal to 16;
3. Meet DSM-5 diagnostic criteria with no medication changes in the past two weeks;
4. Right-handed.

Exclusion Criteria:

1. Diagnosed with any DSM-5 disorder other than OCD;
2. Have a major physical illness;
3. Have strong suicidal ideation.

Primary outcomes:
measure: Reduction of Y-BOCS scores
timeFrame: baseline#after- intervention#1 weeks# (pre-intervention, after intervention, one weeks after intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
References:
Clinical trial NCT03450902: Chinese Herbal Therapy Combined With Acupuncture for Female Mixed Urinary Incontinence
Official title: Combination Therapy With Chinese Herbal Formula, Yiqi Suoquan Granule, and Acupuncture for Female Mixed Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urinary Incontinence
Keywords: Urinary incontinence, Chinese herb, Acupuncture
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2018-03-01
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
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 determine whether combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture is effective in the treatment of female mixed urinary incontinence.

Detailed description: This factorial, randomized, controlled trial is aimed to assess the effectiveness of combination therapy with Chinese herbal formula, Yiqi Suoquan granule, and acupuncture in the treatment of female mixed urinary incontinence (MUI). Eligible participants will be randomly allocated to receiving combination therapy with Yiqi Suoquan granule and acupuncture, Yiqi Suoquan ganule plus sham acupuncture, placebo plus acupuncture, or placebo plus sham acupuncture.

To minimize the evaluation bias, the outcome assessors and statisticians will be masked to treatment allocation besides participants.

Eligibility criteria: Inclusion Criteria:

* (1) female, leaking with urgency and with physical activity, coughing or sneezing (MUI) for more than 1 year; (2) recorded more than 1 incontinent episode per 24 hours in their bladder diary

Exclusion Criteria:

* (1) with acute urinary tract infection; (2) with bladder outlet obstruction, (3) with neurogenic bladder (4) with interstitial cystitis, (5) with pelvic organ prolapse more than stage 2 (6) previous anti-incontinence surgery or a post-void residual urine volume more than 100 mL.

Primary outcomes:
measure: Change in incontinence episode per 24 h
timeFrame: 8 week (post-treatment) and 12 week (follow-up)
Secondary outcomes:
measure: Change in ICIQ-SF questionnaire
timeFrame: 8 week (post-treatment) and 12 week (follow-up)
measure: Change in I-QOL questionnaire
timeFrame: 8 week (post-treatment) and 12 week (follow-up)
measure: proportion of participants with more than 50% improvement in incontinence episodes per 24h
timeFrame: 8 week (post-treatment)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital, China Academy of Chinese Medical Sciences
state: Beijing
Study officials:
affiliation: Guang'anmen hospital
name: Ran Pang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01415102: A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372.
Official title: A Double Blind (3rd Party Open), Randomised, Placebo-Controlled, Dose Escalation Study To Investigate The Safety, Toleration, And Pharmacokinetics Of Single Inhaled Doses Of Pf-05212372 In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Phase 1
Single Dose
Safety
Toleration
Pharmacokinetics
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study in healthy people is to evaluate safety, toleration and time course of plasma concentration of single inhaled doses of PF-05212372.


Eligibility criteria: Inclusion Criteria:

Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* A positive urine drug screen.
* Treatment with an investigational drug within the past 30 days (or local regulations) or 5 half-lives preceding the first dose of study medication.

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 14 days
measure: Plasma pharmacokinetics
timeFrame: up to 72 hours post dose
measure: Urine pharmacokinetics
timeFrame: up to 24 hours post dose
measure: Urine Pharmacodynamics
timeFrame: up to 24 hours post dose
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04054102: Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation in Subacute Stroke
Official title: Effects of Upper Extremity Rehabilitation Robot and Transcranial Direct Current Stimulation on Reaching Function of Upper Extremity Among Subjects With Subacute Stroke
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: stroke
transcranial direct current stimulation
upper extremity rehabilitation robot
Lead sponsor: National Rehabilitation Center, Seoul, Korea
Sponsor class: OTHER_GOV
First posted: 2019-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of real transcranial direct current stimulation (tDCS) and sham tDCS combined with robot training for upper extremity rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Hemiplegic patients secondary to first cerebrovascular accidents
* Onset ≤ 6 months
* Fugl-Meyer Assessment score ≥ 19
* Cognitively intact enough to understand and follow the instructions from the investigator

Exclusion Criteria:

* Severe upper extremity pain that could interfere with rehabilitation therapy
* Neurological disorders other than stroke that can cause motor deficits
* Uncontrolled severe medical conditions.

Primary outcomes:
measure: Change of kinematic data during scale for the assessment and rating of ataxia
timeFrame: Change from baseline at 4 weeks after baseline
Secondary outcomes:
measure: kinematic data during scale for the assessment
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Fugl-Meyer Assessment - upper extremity
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Wolf Motor Function Test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Motor activity log
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
measure: Action reach arm test
timeFrame: baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: National Rehabilitation Center
Study officials:
affiliation: National Rehabilitation Center
name: Joon-Ho Shin, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03891602: DECIDE: Developing Tools for Lung Cancer Screening Discussion Improvement
Official title: Using a Mixed Methods Approach to Understand Shared Decision-Making in Lung Cancer Screening
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Smoking, Tobacco
Smoking, Cigarette
Lung Cancer
Keywords: Smoker
Memorial Sloan Kettering Cancer Center
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Indiana University
name: University of North Carolina
name: Memorial Sloan Kettering Cancer Center
name: Kaiser Permanente
First posted: 2019-03-27
Enrollment: 654
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All recruitment will take place at Kaiser Permanente Washington.

Brief summary: The purpose of this study is to learn about discussion between clinicians and their patients related to lung screening. Survey answers will be collected from both clinicians and their patients.


Eligibility criteria: Inclusion Criteria:

CLINICIANS:

* Clinician (physician, nurse practitioner, or physician assistant)
* Practicing in a KPWA primary care clinic
* Having a patient panel with \>/= 10 lung cancer screening eligible patients

PATIENTS (Quantitative Phase):

* Age 55-80 years
* \>/= 30 pack-year tobacco smoking history
* Current smoker or former smoker who has quit within the past 15 years
* Documented SDM lung cancer screening discussion during a recent clinic visit

Exclusion Criteria:

PATIENTS:

* Significant comorbidities (Charlson Comorbidity Index \>/=3)
* Lung cancer diagnosis

Primary outcomes:
measure: Key Components of Shared Decision Making Process That Predict Patient-perceived Lung Cancer Screening Decision Quality
timeFrame: at baseline (study enrollment)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jamie Ostroff, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hackensack Meridian Health
name: Lisa Carter-Bawa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05646602: Focused Shock Wave Therapy Outcomes in Peyronie's Disease and Erectile Dysfunction
Official title: Impact of Focused Low-intensity Shockwave Therapy (LiSWT) in Penile Disorders (Peyronie's Disease, Erectile Dysfunction, or Both), With or Without Intralesional Clostridial Collagenase (Xiaflex) Injection, Compared With Radial Shock Wave Therapy or Xiaflex Therapy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Peyronie Disease
Penile Curvature
Erectile Dysfunction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Following enrollment men will be randomized based on the severity of their penile curvature. Separate randomization tables will be established for men with penile curvature (i) 30 to \< 60 degrees and (ii) 60-90 degrees. Patients will be randomized in a 1:1 ratio to CCH + LiSWT versus CCH alone within each severity cohort, with the intention to enroll a similar number of patients within each severity group
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine the pure or additional effects of penile shockwave therapy with low intensity linear shock wave machine for penile curvature (and/or erectile dysfunction) vs patients' undergoing other treatments (including Xiaflex therapy, patients that have undergone older generations of SWT, or medical treatment).


Eligibility criteria: Inclusion Criteria:

* Peyronie's Disease (PD) at any stage
* The presence of penile plaque or pain at erection or curvature
* PD therapy with or without simultaneous intralesional Xiaflex injection.

Exclusion Criteria:

* Prior penile surgery or LiSWT.
* Erective Dysfunction (ED) not responding to phosphodiesterase-type five inhibitors or intracavernosal injections.
* Unwillingness or inability to provide informed consent.
* Having active or life-threatening coagulopathies ore using anti-coagulation /anti-platelet medications

Primary outcomes:
measure: Change in penile curvature
timeFrame: Baseline, 10 weeks
Secondary outcomes:
measure: Change in Sexual function
timeFrame: Baseline, 10 weeks
measure: Change in penile length
timeFrame: Baseline, 10 weeks
measure: Li-SWL related pain at therapy sessions
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Tobias Kohler, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06687902: Value of Digital Breast Tomosynthesis in Breast Lesions
Official title: Added Value of Digital Breast Tomosynthesis in Characterization of Breast Lesions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Digital Breast Tomosynthesis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to evaluate the added value of digital breast tomosynthesis (DBT) in the characterization of breast lesions.

Detailed description: All patients enrolled in the study will undergo both 2D digital mammography and digital breast tomosynthesis (DBT), using standardized protocols. The DM plus DBT acquisition commonly referred to as "combo" mode , that has shown an improvement in specificity and sensitivity , but at approximately doubling of the radiation dose . This approach will provide a consistent framework for evaluating the diagnostic capabilities of both techniques in characterizing breast masses.

Eligibility criteria: Inclusion Criteria:

1. Patients with mammographic breast lesions of BIRADS III, IV.
2. Dense breast in patients with complaints (BIRADS 0) which needed further assessment.

Exclusion Criteria:

1. Pregnant females to avoid the hazards of ionizing radiation to the fetus.
2. Patients with known metastatic breast cancer.

Primary outcomes:
measure: Compare DBT with traditional mammography in terms of diagnostic accuracy, sensitivity, and specificity for detecting and differentiating benign and malignant breast lesions
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References: