louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01018901: Goals of Sexual Function in Prostate Cancer Survivors and Their Partners After Cancer Treatment
Official title: Goals for Sexual Functioning of Prostate Cancer Survivors and Their Partners Following Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2009-11-24
Enrollment: 2
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: RATIONALE: Gathering information about survivors of prostate cancer and their partners may help doctors learn more about the goals for sexual functioning after cancer treatment. PURPOSE: This clinical trial is studying the goals of sexual functioning in prostate cancer survivors and their partners after cancer treatment.

Detailed description: Detailed DescriptionOBJECTIVES:

I. To collect data on the goals of sexual functioning among prostate cancer survivors and their partners following cancer treatment in order to identify specific components of interventions for future grant submissions on the psychosexual needs of prostate cancer survivors.

OUTLINE:

Patients and their partners complete surveys. Sexual function of men is assessed by the International Index of Erectile Function; sexual function of women is assessed by the Female Sexual Function Index.

Eligibility criteria: Inclusion Criteria:

* Prostate cancer survivors who are: willing and able to provide informed consent; able to read, write, and speak English; married or are in married-like relationship; completed radiation or surgery for their prostate cancer 6 months to 5 years ago
* Partners of prostate cancer survivors must be: willing and able to provide informed consent; able to read, write, and speak English

Exclusion Criteria:

* Prostate cancer survivors will be excluded if they have undergone androgen deprivation therapy within the past 6 months and if their partners refuse to participate

Primary outcomes:
measure: Goals of sexual functioning
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: James Coyne, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03472001: Reflection and Feedback in Clinical Reasoning
Official title: Effects of Structured Reflection and Immediate Feedback in Improving of Medical Students' Evaluation of Skin Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Problems
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: SMG-SNU Boramae Medical Center
First posted: 2018-03-21
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Medical students' abilities to diagnose skin lesions after dermatology electives often remain unsatisfactory despite a dermatology elective being one of the most effective ways to improve their clinical reasoning. Feedback and reflection are two basic teaching methods used in clinical settings. This study aimed to investigate the effectiveness of structured reflection and immediate feedback in improving of medical students' evaluation of skin lesions.


Eligibility criteria: Inclusion Criteria:

* Fourth-year medical students at Seoul National University College of Medicine
* Students taking 2-week dermatology elective courses

Exclusion Criteria:

* Students who do not complete the whole course

Primary outcomes:
measure: Diagnostic accuracy in the training set
timeFrame: At the end of a 2-week dermatology elective
Secondary outcomes:
measure: Diagnostic accuracy in the control set
timeFrame: At the end of a 2-week dermatology elective
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Dermatology, Seoul National University Boramae Hospital
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Hyun-Sun Yoon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bowen JL. Educational strategies to promote clinical diagnostic reasoning. N Engl J Med. 2006 Nov 23;355(21):2217-25. doi: 10.1056/NEJMra054782. No abstract available.
citation: Rourke L, Oberholtzer S, Chatterley T, Brassard A. Learning to detect, categorize, and identify skin lesions: a meta-analysis. JAMA Dermatol. 2015 Mar;151(3):293-301. doi: 10.1001/jamadermatol.2014.3300.
citation: Choi S, Oh S, Lee DH, Yoon HS. Effects of reflection and immediate feedback to improve clinical reasoning of medical students in the assessment of dermatologic conditions: a randomised controlled trial. BMC Med Educ. 2020 May 8;20(1):146. doi: 10.1186/s12909-020-02063-y.
Clinical trial NCT06768801: Web-app Based Lifestyle Physical Activity Promotion Program (WPAPP) for Middle Aged Latinas
Official title: Pilot RCT of the Web-app Based Lifestyle Physical Activity Promotion Program (WPAPP) for Middle Aged Latinas
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Middle Aged
Women
Depressive Symptoms
Physical Activity
Hispanic or Latino
Keywords: Web-based App
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2025-01-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Two group (intervention and control), random assignment, 3 data collection points
Primary purpose: OTHER

Brief summary: The purpose of the proposed project is to conduct a pilot randomized controlled trial (RCT) of the Web-App based Lifestyle Physical Activity Promotion Program (WPAPP) for middle-aged Latinas. The WPAPP is a web application (app) to promote lifestyle physical activity that was developed and tested with Korean American middle aged women. It shows promise for effectiveness with Latinas. The specific aims are:

1. To test the feasibility and satisfaction of the WPAPP modified for Latinas.
2. To examine preliminary effectiveness of the WPAPP-Latina on increasing physical activity and decreasing depressive symptoms.


Eligibility criteria: Inclusion Criteria: women aged 40-60 who self-identify as Latina or Hispanic women, are able to read and write in English or Spanish, live in the United States, and can use the app and complete online data collection using a smart phone, tablet, or computer.

-

Exclusion Criteria: pregnancy within 3 months of starting the study, having or being of high risk for cardiovascular or musculoskeletal illnesses or injuries

-

Primary outcomes:
measure: Center for Epidemiological Studies - Depression
timeFrame: from baseline to 3 months
measure: The modified Barriers to Health Activities Scale
timeFrame: from baseline to 3 months
measure: Kaiser Physical Activity Survey
timeFrame: from baseline to 3 months
measure: Questions on Attitudes Toward Physical Activity, Subjective Norm, Perceived Behavioral Control, and Behavioral Intention
timeFrame: from baseline to 3 months
measure: Physical Activity Assessment Inventory
timeFrame: from baseline to 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02051101: Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
Official title: Pathogenic Mechanisms of Port Wine Stain and Repository of Port Wine Stain Biopsy Samples
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Port-Wine Stain
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Beckman Laser Institute University of California Irvine
First posted: 2014-01-31
Enrollment: 19
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to investigate the pathogenic mechanisms of Port Wine Stain, collect biopsy samples and blood samples to characterize exosomes and metabolites from Port Wine Stain.

Detailed description: The researcher can detect the defects in nervous system innervation to cutaneous blood vessels contribute to the pathogenesis of Port Wine Stain . Unveiling the pathogenic mechanisms of PWS is crucial to the design of new therapeutic strategies and can use the results to improve current PWS therapeutic outcomes.

Eligibility criteria: Inclusion Criteria:

* Male or female of all ages.
* Not pregnant.
* Has diagnosis of port wine stain on the arms, legs, chest, bac.
* Ability to understand and carry out subject instructions.
* Subject willing to have skin biopsies on port wine stain and normal skin areas.

Exclusion Criteria:

* Pregnant women.
* Port Wine Stain on the face.
* History of skin cancer.
* Current participation in an investigational drug evaluation
* Concurrent use of known photosensitizing drugs.

Primary outcomes:
measure: Characterization of Port Wine Stain Birthmark tissue sample
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Beckman Laser Institute
state: California
Study officials:
affiliation: Beckman Laser Institute, UCI
name: John s Nelson, MD
role: STUDY_DIRECTOR
affiliation: Beckman Laser Institute
name: Winbin Tan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06497101: Effectiveness Trial of Temperament Based Therapy With Support (TBT-S)
Official title: Effectiveness of Temperament Based Therapy With Support (TBT-S): A Novel 5-day Treatment for Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2024-07-11
Enrollment: 140
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 main aim of this project is to determine the short and long-term effectiveness of an out-patient treatment for patients with anorexia nervosa. Specifically, we will measure whether TBT-S in addition to treatment as usual (TAU) will be more effective than TAU alone in reducing eating disorder psychopathology. Assessments will be conducted at four timepoints; pre and post TBT-S, and at 3 and 12 months follow-up. Primary outcome measure is eating disorder psychopathology, with the hypothesis that patients receiving TBT-S in addition to TAU will show significantly greater reduction in eating disorder psychopathology from TBT-S treatment admission to 3 month follow-up, compared to controls.

Detailed description: Participants in the intervention arm will receive five days of TBT-S in addition to treatment as usual. TBT-S is administered to three to six adult anorexia nervosa patients with up to four supports per patient. The treatment structure consists of five consecutive days of treatment, up to 7,5 hours each day. Staff requirements for TBT-S are three clinicians, one dietician and one medical staff. Adults referred to a local psychiatric centre (DPS) for out-patient anorexia nervosa treatment, and their supports, will be eligible to participate in the study.

Eligibility criteria: Inclusion Criteria:

* Age ≥18, all genders
* A Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed anorexia nervosa disorder (F50.0, F50.01, F50.02, also including F50.9 - atypical anorexia nervosa)
* Willingness to have Support(s) participate in treatment
* Medically stable

Exclusion Criteria:

* Developmental, intellectual or psychotic disorder
* Diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study
* Receiving in-patient treatment at time of study entry
* Presence of other psychopathology that might interfere with ability to participate in the study

Primary outcomes:
measure: Eating Disorder Psychopathology
timeFrame: Baseline, after 1 week and at 3 and 12 months follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital, Regional Department for Eating Disorders
Study officials:
References:
Clinical trial NCT06333301: Translational Initiative to Map Epigenetics in Sleep
Official title: Translational Initiative to Map Epigenetics in Sleep
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Biological Aging
Keywords: Sleep
Chronotype
Lead sponsor: Elysium Health
Sponsor class: INDUSTRY
Collaborators: name: University of Oxford
First posted: 2024-03-27
Enrollment: 10000
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: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: The primary aim of TIME-ZZZ is to explore the relationship between chronotype, incidence of depression and biological age, and whether individuals working "out-of-phase" with their chronotype are more likely to exhibit signs of depression and accelerated biological aging.

Detailed description: Understanding the relationship between chronotype, depression, and biological age is important in the field of sleep research and mental health. Sleep patterns and their alignment with an individual's internal body clock, or chronotype, have been increasingly recognized as influential factors in various aspects of well-being, including mental health and overall physiological aging. By conducting a study that investigates the potential correlation between chronotype, incidence of depression, and biological age, along with the impact of working "out-of-phase" with one's chronotype, the investigators can shed light on crucial aspects of sleep, mental health, and their interplay with biological aging.

Eligibility criteria: Inclusion Criteria:

* Has taken an INDEX test within the last 3 months
* Has registered at least 1 INDEX kit via the Elysium Health website
* Able and willing to provide digital consent to the RSCF, and the TIME-ZZZ Research Subject Consent Form

Exclusion Criteria:

* Consent to participate not given

Primary outcomes:
measure: Effect of being "out of phase" with chronotype on biological age
timeFrame: At baseline
Secondary outcomes:
measure: Effect of Chronotype Alignment and Depression Risk in Relation to Rate of Aging
timeFrame: At baseline
measure: Identification of DNA methylation markers associated with chronotype
timeFrame: At baseline
measure: Identification of DNA methylation markers associated with depression
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
affiliation: Elysium Health
name: Dayle Sampson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Russell Foster, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03080701: Financial Incentives to Increase Colorectal Cancer Screening in Priority Populations
Official title: Systems of Support (SOS) to Increase Colon Cancer Screening Disparities Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Behavioral: Automated Mailing
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: University of Texas
First posted: 2017-03-15
Enrollment: 898
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The investigators propose to build on the success of the Systems of Support to Increase Colorectal Cancer trial (SOS, R01CA121125, Green) and focus on disparity groups who are less likely to be current for colorectal cancer (CRC) screening. We will test whether financial incentives increases screening uptake and decreases screening disparities. The investigators hypothesize that CRC screening rates will be higher in patients offered mailed fecal kits and financial incentives than those offered mailed fecal kits alone.

Detailed description: Study staff will send invitation letters and a questionnaire to 5,000 patients aged 50-75 not current for CRC screening, two-thirds who are identified in the electronic data as being from a non-White race, ethnicity, or who have Medicaid coverage. Those returning the survey and remaining eligible (estimated N = 1150) will be randomized to either (1) Mailed fecal kit only, or mailed fecal kit plus one of 2 types of financial incentives for completing testing: (2) a guaranteed Monetary incentive or (3) a probabilistic Lottery incentive.

Eligibility criteria: Inclusion Criteria:

* No evidence in electronic data of FIT screening in past year or a colonoscopy in the prior 9 years.
* Continuously enrolled in Group Health Cooperative (GHC) for at least one year.
* Patients who have Medicaid coverage or are non-white race or Hispanic any race.

Exclusion Criteria:

* Known high risk for CRC
* History of CRC
* History of inflammatory bowel disease
* Current anticoagulation therapy
* Organ failure
* Serious illness
* Debilitating disease
* Dementia
* Nursing home resident

Primary outcomes:
measure: CRC Screening Within 6 Months Following Randomization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Research Institute
state: Washington
Study officials:
affiliation: Kaiser Permanente
name: Beverly B Green, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06255301: Collection of Ocular Surface Impressions Cytology of the Living Eye From Patients With Dry Eyes or Limbal Stem Cell Deficiency.
Official title: Collection of Ocular Surface Impressions Cytology of the Living Eye From Patients With Dry Eyes or Limbal Stem Cell Deficiency.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Diseases
Keywords: biomarkers
limbic stem cell deficiency
dry syndrome
EYEPRIM
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Laboratoire Biologie, Ingénierie et Imagerie de la Greffe de Cornée (BiiGC)
First posted: 2024-02-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 50 patients with limbal stem cell deficiency
* 100 patients with dry eye syndrome
* 150 patients with eye diseases other than dry eye syndrome or limbal stem cell deficiency

Brief summary: In order to develop innovative biomarkers for the diagnosis of two ocular surface pathologies, Dry Syndrome (DS) and Limbic Stem Cell Deficiency (LSCD), human cells from the ocular surface will be collected in order to test these biomarkers ex vivo.

Detailed description: To collect them, cytological fingerprints of the ocular surface are made using filter paper applied to the surface using a commercially available EC (European Conformity)-marked medical device, called EYEPRIM.

Eligibility criteria: Inclusion Criteria:

* Patient affiliated or entitled to a social security scheme
* Age 18 years or older
* Presenting a Dry Syndrome, a limbic stem cell deficiency (clinical diagnosis) or another pathology (control).
* Signature of Consent

Exclusion Criteria:

* Major blepharospasm making examination impossible
* Pregnant women
* Breastfeeding women
* Protected Persons

Primary outcomes:
measure: Ocular surface impression cytology collected from patients suffering from dry eye syndrome, limbal stem cell deficiency or other pathologies (control).
timeFrame: day one
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Gilles THURET, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05519501: Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
Official title: Randomized Controlled Clinical Investigation Evaluating the Effect of Adipose Tissue Processed With the SyntrFuge™ System in the Healing of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: Microsized Fat Tissue
Adipose Tissue
DFU
Wound Management
Lead sponsor: Syntr Health Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-29
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled multi center study on diabetic patients with the aim of evaluating the efficacy of the adipose tissue processed with the SyntrFuge™ system in diabetic patients with diabetic foot ulcers. In particular, it will be evaluated whether the microsized fat graft will be able to shorten the healing times of these wounds. Patients will be randomized to the treatment group with adipose tissue processed with the SyntrFuge™ system (injection of autologous microsized adipose tissue) or to the control group represented by the standard of care.


Eligibility criteria: Inclusion Criteria:

1. Subjects who have Diabetic Foot Ulcer located at the plantar or dorsal aspect of the foot or the heel with a surface area of 1.0cm2 - 25cm2
2. Index ulcer has been present for greater than four weeks
3. Diabetics included will be those with HbA1c ≤ 12%
4. Subjects aged 18 - 85, inclusive
5. The target ulcer has been offloaded for at least 14 days

Exclusion Criteria:

1. Subjects without decisional capacity
2. Subjects unable to give informed, written consent
3. Subjects with active infection (redness, swelling, pain, suppuration)
4. Subjects with active osteomyelitis to the index ulcer
5. Subjects with previous treatment with Negative Pressure Wound Therapy, growth factors, radiation, hyperbaric O2, or bioengineered tissue product within 30 days of Screening
6. Subjects with a previous diagnosis of HIV or Hep C
7. Subject is pregnant or breast feeding
8. Subjects receiving oncological treatments ongoing or previous (past 5 years) and/or neoplastic lesions
9. Subjects under corticosteroid therapy, unless taking dose of 5mg/dl or less
10. Subjects with any other condition that, in the opinion of the investigator, makes the subject inappropriate to take part in this study

Primary outcomes:
measure: Percent of subjects with study wound deemed closed at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Roanoke
state: Virginia
Study officials:
References: