louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02888236: LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
Official title: LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2016-09-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study of LEO 32731 in the treatment of psoriasis vulgaris

Detailed description: This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris

Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent
* Aged between 18 years and 65.
* Males or females of non-childbearing potential.
* Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis
* Have moderate to severe psoriasis vulgaris
* Candidates of systemic anti-psoriatic treatment and/or phototherapy

Exclusion Criteria:

* Subjects with therapy resistant psoriasis
* Previously exposed to apremilast
* Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris
* Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris

Primary outcomes:
measure: Psoriasis Area and Severity Index (PASI) at week 16
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of subjects with Physician's Global Assessment of Disease Severity (PGA) treatment success, defined as clear or almost clear at week 16
timeFrame: Week 16
measure: Itch evaluated by itch Numerical Rating Scale (NRS) at week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin, Dept. of Dermatology
Study officials:
affiliation: Charite University, Berlin, Germany
name: Sandra Philipp, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05736536: Behavior Intervention for Weight Loss for Type 2 Diabetes Mellitus Adults With Obesity Problem (BMI of ≥23kg/m2)
Official title: Health Intervention on Behaviour Change to Act for Adults With Type 2 Diabetes Mellitus and Body Mass Index of ≥ 23kg/m2: a Quasi-Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes Mellitus, Type 2
Behavior
Lead sponsor: Universiti Teknologi Mara
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 104
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This quasi-experimental study aims to determine the effectiveness of a health intervention (Chance2Act) on behaviour change to act for weight loss among overweight/obese type 2 diabetes adults.

The main question it aims to answer is:

- Is the new health intervention (Chance2Act) effective in changing overweight/obese type 2 diabetes adults from not being ready to act, to take action to lose weight?


Eligibility criteria: Inclusion Criteria:

* T2DM patients under follow-up of government health clinics Kuantan, Pahang.
* Age between 20 - 65 years old.
* Body Mass Index of more or equal to 23 kg/m2.
* In the stage of pre-contemplation, contemplation, or preparation stage of change based on the S-weights questionnaire.
* Able to understand, read and write in the Malay Language.
* Have access to smartphone devices and internet services.
* Have immediate family members (adults) who are living in the same household.

Exclusion Criteria:

* Pregnant patients.
* Patients' advanced comorbidity that will affect participation in the study protocol (e.g. vision problem, unable to walk or physically unfit to stand up, advanced heart failure, or cancer).
* Patients with mental conditions which will affect understanding of the study protocol.

Primary outcomes:
measure: Changes of readiness to change for weight loss (behaviour)
timeFrame: T0 (Week 0), T1 (Week 5), T2 (Week 9)
Secondary outcomes:
measure: Changes of self-efficacy for weight loss (behaviour)
timeFrame: T0 (Week 0), T1 (Week 5), T2 (Week 9)
measure: Changes of decisional balance for weight loss (behaviour)
timeFrame: T0 (Week 0), T1 (Week 5), T2 (Week 9)
measure: Changes in family support for healthy diet and physical activity to encourage weight loss (social support)
timeFrame: T0 (Week 0), T1 (Week 5), T2 (Week 9)
measure: Changes body mass index (anthropometric)
timeFrame: T0 (Week 0), T1 (Week 5), T2 (Week 9)
measure: Changes waist circumference (anthropometric)
timeFrame: T0 (Week 0), T1 (Week 5), T2 (Week 9)
measure: Changes in body fat composition (anthropometric)
timeFrame: T0 (Week 0), T1 (Week 5), T2 (Week 9)
Other outcomes:
Locations:
city: Kuantan
country: Malaysia
facility: Beserah Health Clinic
state: Pahang
city: Kuantan
country: Malaysia
facility: Paya Besar Health Clinic
state: Pahang
Study officials:
References:
Clinical trial NCT02071836: A Web Application to Reduce Heavy Drinking in First-time DWI Offenders
Official title: A Web Application to Reduce Heavy Drinking in First-time DWI Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Driving While Intoxicated
Driving Under the Influence
Heavy Drinking
Alcohol Abstinence
Keywords: web application
DWI intervention
DUI intervention
Experimental group: Right Turns + treatment as usual
Control group: Treatment as usual
Lead sponsor: Behavior Therapy Associates, LLP
Sponsor class: INDUSTRY
First posted: 2014-02-26
Enrollment: 58
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 overall objective of this project is to develop, evaluate, and disseminate a web application for first-time DWI offenders that will provide them with an age-appropriate brief motivational intervention (BMI) to motivate them to reduce their drinking and a cognitive behavioral intervention (CBI) for to help them achieve and maintain abstinence. The goal is to reduce heavy drinking and consequently the risk for future drunk driving.

The specific objectives of this Phase II are:

* Completing the development of the Right Turns prototype based on feedback from the Phase I pilot study participants. This includes: providing more structure and guidance as participants work in the Tool Box section of the program; simplifying the content of the Tool Box; further R\&D in the text messaging feature for 2nd and 3rd tier cellular providers; implement a customized pdf report function for progress reports from the program to users' probation officers (under control of the user); developing a follow-up component and outcome reports; and revising the videos in the Tool Box to reflect greater diversity and a younger population of drinkers.
* Conducting a randomized clinical trial of the program with first time DWI/DUI offenders who are recruited locally, collecting follow-up data, analyzing the data, and reporting the results.


Eligibility criteria: Inclusion Criteria:

* be a first-time DWI offender
* have a 5th grade reading level
* has a computer with Internet access at home
* own a cell phone with text messaging

Exclusion Criteria:

* age less than 18
* recent history of uncontrolled psychotic or bipolar behavior
* evidence of significant cognitive impairment from brain dysfunction (e.g., head injury)

Primary outcomes:
measure: Quantity/frequency of alcohol use: Form 90
timeFrame: 3 months
measure: Inventory of Drug Use Consequences (InDuC)
timeFrame: 3 months
Secondary outcomes:
measure: Self-efficacy
timeFrame: at enrollment
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Behavior Therapy Associates, LLC
state: New Mexico
Study officials:
affiliation: Behavior Therapy Associates, LLC
name: Reid K Hester, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02847013: The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section
Official title: The Use of Liposomal Bupivacaine in TAP Blocks for Women Undergoing Cesarean Section
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Pain
Keywords: Postcesarean Section
Postoperative
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2016-07-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This present investigation aims to determine whether a transversus abdominous plane(TAP) block, utilizing liposomal bupivacaine (Exparel), at the conclusion of a cesarean section decreases post-operative pain. The hypothesis is that performance of the TAP block with liposomal bupivacaine will decrease post-operative narcotic use.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years of age
* Scheduled cesarean section with or without bilateral tubal ligation
* Planned performance of a Pfannenstiel incision
* Patients are schedule to have a cesarean section with a member of the Women's Health or Maternal and Fetal Medicine Departments at Penn State University Hershey S. Medical Center

Exclusion Criteria:

* History of opioid use
* History of chronic pain syndrome
* Use of general anesthesia during cesarean delivery
* Postoperative SICU admission
* Postpartum hemorrhage (defined as an Estimated Blood Loss of greater then 1,000mL upon completion of the cesarean section)

Primary outcomes:
measure: Postoperative narcotic use
timeFrame: initial 48 hours postoperatively
Secondary outcomes:
measure: Subjective pain scores using 1-10 VAS system
timeFrame: initial 48 hours postoperatively
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Jaimey Pauli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01271413: Cognitive Stimulation
Official title: Effects of Cognitive Training in Methadone Maintenance Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Substance Use Disorders
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-01-06
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research is being done to learn if computer tasks that challenge the brain (cognitively stimulating tasks) can improve memory and other types of thinking. The study will compare the effects of different versions of the computer tasks. It also will compare the task performance of different groups of people.


Eligibility criteria: Inclusion Criteria:

* age 18-55
* in methadone maintenance or healthy volunteers
* healthy

Exclusion Criteria:

* Axis I disorder (except substance abuse and dependence in methadone maintenance patients)
* severe cognitive impairment
* serious untreated medical condition

Primary outcomes:
measure: Working Memory
timeFrame: baseline, 7 weeks
Secondary outcomes:
measure: Episodic Memory
timeFrame: baseline, 7 weeks
measure: Trail-making
timeFrame: baseline, 7 weeks
measure: go/No-go
timeFrame: baseline, 7 weeks
measure: Addiction Severity Index
timeFrame: baseline, 7 weeks
measure: Delay Discounting
timeFrame: baseline, 7 weeks
measure: Digit Symbol Substitution Test
timeFrame: baseline, 7 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: BPRU, Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Miriam Z Mintzer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rass O, Schacht RL, Buckheit K, Johnson MW, Strain EC, Mintzer MZ. A randomized controlled trial of the effects of working memory training in methadone maintenance patients. Drug Alcohol Depend. 2015 Nov 1;156:38-46. doi: 10.1016/j.drugalcdep.2015.08.012. Epub 2015 Aug 24.
Clinical trial NCT02771613: Impact on the Adverse Event (AE) Incidence of Two Types of Experience Feedback on AE Analyzed During Local Morbidity Mortality Reviews
Official title: Impact on Adverse Events (AE) Occurrence of Two Types of Experience Feedback on AE Analysed During Local Morbidity Mortality Reviews (MMR), (by Multi Professional Simulation Education Versus Simple Diffusion of MMR Decisions)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hospital Adverse Event
Keywords: Morbidity Mortality Review
medical simulation
in situ simulation
multi professional simulation
hospital adverse event
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 144000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any stage of patients in the involved departments during the two-years intervention's period

Brief summary: After implementing a French version of a trigger tool validated for computerized detection of adverse events in patient's medical record, the study will be performed in three parallel randomized arms of three identical departments (each steaming from 6 types of medical, surgical or obstetrical departments with a total of 18 departments involved). This three arms will be: no intervention, education of department's staff by multi professional in situ simulation (adapted to the discovered adverse events), or simple but large diffusion of results and decisions of Morbidity Mortality Reviews.

The interventions will be performed during a two-years period.


Eligibility criteria: Inclusion Criteria:

* patients aged \> 18 years old
* patients hospitalized in the involved departments during the two-years intervention's period

Exclusion Criteria:

* patient aged \< 18 years old
* no other exclusion criteria

Primary outcomes:
measure: Occurence of adverse events related to medical care
timeFrame: During patient hospitalization, up to 2 years
Secondary outcomes:
measure: Severity of adverse events related to medical care
timeFrame: During patient hospitalization, up to 2 years
measure: Contributive factors identification
timeFrame: During patient hospitalization, up to 2 years
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon - Direction DOQRU
Study officials:
affiliation: Hospices Civils de Lyon
name: Bernard BUI-XUAN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Michel N, Bui-Xuan B, Bapteste L, Rimmele T, Lilot M, Chollet F, Favre H, Duclos A, Michel P. Implementation of an in situ simulation-based training adapted from Morbidity and Mortality conference cases: effect on the occurrence of adverse events-study protocol of a cluster randomised controlled trial. Trials. 2022 Feb 2;23(1):106. doi: 10.1186/s13063-022-06040-2.
Clinical trial NCT02445313: Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device
Official title: Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration (AMD)
Lead sponsor: Doheny Image Reading Center
Sponsor class: OTHER
First posted: 2015-05-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort A will consist of patients with AMD, recruited by PI when they come in to the clinic, with whom we will conduct medical record review and imaging procedures, using one of the research devices.

Cohort B will consist of control subject with no ocular problems, with whom no record review will be conducted, but imaging will be conducted with study devices.

Brief summary: The investigators would like to know if different imaging devices can improve the quality of images and visualization of imaged tissues. Also, the investigators would like to find out whether these changes are useful in the diagnosis and treatment of eye diseases. Using images of previous participants will allow us to demonstrate the advancement of different technologies, as well be used to allow comparisons between current technologies.

Detailed description: To test the quality of images from the Nidek MP-3 device and to measure Geographic Atrophy (GA) in patients with Age-related Macular Degeneration (AMD).

Eligibility criteria: Inclusion Criteria:

* Normal, healthy participants and patients with AMD

Exclusion Criteria:

1. Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging
2. Participants who are unable to maintain retinal fixation on a specified target
3. Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place
4. Patients with media opacity which preclude high quality imaging will be excluded.
5. Exclusion criteria include vulnerable patients; patients under 18, pregnant, economically and educationally disadvantaged, decision impaired, or homeless people. We exclude pregnant women because pregnancy often can alter eye anatomy.

Primary outcomes:
measure: Geographic Atrophy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Doheny Eye Centers UCLA
state: California
Study officials:
affiliation: Doheny Eye Institute
name: Srinivas Sadda
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00872313: Risk Factors for Postpartum Psychosis
Official title: Potential Risk Factors for Postpartum Psychosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postpartum Period
Psychosis
Keywords: Labor
Psychology
Postpartum Psychology
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2009-03-31
Enrollment: 4000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Parturients undergoing spontaneous or induced labor or cesarean delivery

Brief summary: A range of psychological disorders occur in women in the postpartum period. These include "the blues", which occurs in the first days after birth and which is very common and self-limiting; severe psychoses often associated with mania or bipolar illness, occurring in the first weeks after birth; and mild to moderate depression, occurring weeks to months after birth. Studies have been done focused on postpartum psychosis using a retrospective investigation, which gave only a limited material on the prevalence of psychological disorders in postpartum women. The investigators hypothesized that different pathways to psychosis function as the risk factors which may be overlapped, truly independent, mediating, or moderating, in new mothers who are at high risk and/or during the early period of delivery. In addition, the investigators purposed that the temporal sequence of biological, social and demographic variables are also the potential factors contributing to the development of postpartum psychosis.


Eligibility criteria: Inclusion Criteria:

* Pregnant women
* Chinese

Exclusion Criteria:

* Age \< 18 years or \> 50 years
* Gestational age \< 32 weeks

Primary outcomes:
measure: Incidence of psychoses
timeFrame: 3 months and 6 months postpartum
Secondary outcomes:
measure: Antepartum economic level
timeFrame: One year before labor and delivery (recorded by antepartum communication)
measure: Antepartum social status
timeFrame: One year before labor and delivery (recorded by antepartum communication)
measure: Antepartum psychological level
timeFrame: 1 day before birth
measure: Intrapartum complications
timeFrame: 1 day after birth
measure: Baby characteristics
timeFrame: One minute, 5min, 15min after baby was born
measure: Maternal characteristics
timeFrame: One day after birth
measure: Medical caregiver characteristics
timeFrame: One day before and after the labor completion
measure: Parturient family characteristics
timeFrame: One week before labor and delivery, recorded by investigators through patients' antepartum communication
measure: Intrapartum medical procedures
timeFrame: One day after birth
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternal and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: XiaoFeng Shen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00183313: Improving Primary Care in Patients With Mental Disorders
Official title: Improving Primary Care in Patients With Mental Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mental Disorders
Keywords: Mental Health
Primary health care
Case management
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2005-09-16
Enrollment: 407
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study will determine the effectiveness of medical case management in improving the medical care of people with mental disorders or substance abuse problems.

Detailed description: Poor quality of care may contribute to impaired health status and increased mortality in individuals with serious mental disorders and substance abuse problems; interventions designed to improve medical care for this population need to be developed. This study will develop a population-based medical case management model for improving the primary medical care of patients at an inner city community mental health center.

This study will last 2 years. Participants will be randomly assigned to receive medical case management or standard of care (typically drug and behavioral therapy) for 2 years. Participants in the case management group will receive help in overcoming barriers to receiving primary care. Participants will also undergo 5 interviews over the 2-year study duration, and have annual chart reviews. Results of the interviews will be used to assess quality of primary care, service use, health outcomes, psychiatric symptoms, and substance use.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of mental illness or substance abuse
* Patient at Florida Hall (Grady Health Systems)

Exclusion Criteria:

* Current use of medical case management

Primary outcomes:
measure: Quality of primary medical care
timeFrame: Measured over 2 years
Secondary outcomes:
measure: Health status
timeFrame: Measured over 2 years
measure: Psychiatric symptoms
timeFrame: 2004-2009
measure: Costs
timeFrame: 2004-2009
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health Systems
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Benjamin G. Druss, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Silke A. von Esenwein, MA
role: STUDY_DIRECTOR
References:
citation: Druss BG, von Esenwein SA, Compton MT, Rask KJ, Zhao L, Parker RM. A randomized trial of medical care management for community mental health settings: the Primary Care Access, Referral, and Evaluation (PCARE) study. Am J Psychiatry. 2010 Feb;167(2):151-9. doi: 10.1176/appi.ajp.2009.09050691. Epub 2009 Dec 15.