louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01406899: Computer-Based Training in Cognitive Behavior Therapy (CBT4CBT)
Official title: Computer-Assisted Cognitive Behavior Therapy for Veterans With Substance Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Substance-Related Disorders
Lead sponsor: VA Connecticut Healthcare System
Sponsor class: FED
First posted: 2011-08-01
Enrollment: 80
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: In this behavioral trial 80 substance abusing individuals will be randomly assigned to either treatment as usual in the substance abuse clinic of the Newington, CT VA hospital OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in substance use (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.

Detailed description: This pilot study aims to evaluate the feasibility and effectiveness of adding a computer based training program in Cognitive Behavior Therapy ("CBT4CBT") for the treatment of addictions in a VA substance abuse outpatient clinic. Key secondary aims are to assess the impact of adding CBT4CBT to standard care on treatment attendance, engagement, retention, and to investigate if certain process measures are associated with substance use outcomes. Approximately 80 patients enrolled in the Newington Outpatient Substance Abuse Treatment Program (SATP) will be randomly assigned to either (A) treatment as usual, or (B) treatment as usual plus exposure to the CBT4CBT program.

Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Recent (within 3 months) substance use
* meet current DSM-IV (Diagnostic and Statistical Manual-IV) criteria for substance use disorder
* fluent in English or at least a 6th grade reading level
* can commit to at least 8 weeks of treatment and willing to be randomized to treatment

Exclusion Criteria:

* Unstable housing situation
* Likelihood of going to prison during the intervention portion of study
* Recent opiate or benzodiazepine prescription

Primary outcomes:
measure: Reduction in substance use
timeFrame: 8 weeks
Secondary outcomes:
measure: Retention in treatment
timeFrame: 6 months
Other outcomes:
Locations:
city: Newington
country: United States
facility: Connecticut VA Healthcare System
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathleen Carroll, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00706199: The Expression of Antigens in Bone Marrow Samples From Volunteering Donors.
Official title: Analysis of Expression of Antigens in Bone Marrow Samples From Volunteering Donors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: bone marrow
antigen expression
volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Antigen expression levels in bone marrow from volunteering donors will be analyzed. The results of this analysis will be used to establish a clinical test to identify cancer patients who could qualify to receive an investigational treatment being developed by GlaxoSmithKline.


Eligibility criteria: Inclusion Criteria:

* The donor is aged \>= 18 years
* Written informed consent has been obtained prior to the performance of any specific procedure.
* The donor has a medical indication for which a bone marrow aspiration is planned.
* The donor is eligible for a bone marrow aspiration.

Primary outcomes:
measure: Number of copies of Wilms' Tumor 1 (WT1) antigen expression in bone marrow
timeFrame: At Day 0
measure: Number of copies of PRAME (Preferentially expressed in melanoma)antigen expression in bone marrow
timeFrame: At Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Ottignies
country: Belgium
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01941199: Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 and Metformin After Oral Administration in Healthy Male Subjects
Official title: A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of DA-1229 5 mg and Metformin IR 1000 mg After Oral Administration in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of DA-1229 5 mg and Metformin IR 1000 mg after oral administration in healthy male volunteers.


Eligibility criteria: Inclusion Criteria:

* Age between 20 to 45, healthy male subjects(at screening)
* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0
* FPG 70-125mg/dL glucose level(at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)
* Subject who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)
* Subject who had drug(Aspirin, antibiotics) hypersensitivity reaction
* Subject who already participated in other trials in 2 months
* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion in 1 months currently.

Primary outcomes:
measure: AUCτ,ss of DA-1229 and metformin
timeFrame: up to 168h
measure: Cmax,ss of DA-1229 and metformin
timeFrame: up to 168h
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trial Center, Seoul National University Hospital
Study officials:
References:
Clinical trial NCT05990699: Effect of Mindfulness-Based Relapse Prevention Program on Readiness for Change and Self-efficacy Among Clients With Substance Use Disorders
Official title: Effect of Mindfulness-Based Relapse Prevention Program on Readiness for Change and Self-efficacy Among Clients With Substance Use Disorders: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Mindfulness
Relapse Prevention
Readiness for Change
Self-efficacy
substance use
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The treatment process of substance addiction is applied principally by psychiatrists, psychologists, and psychiatric mental health nurses. In this respect, psychiatric mental health nurses have a crucial role to play. As they are the one who is in touch with the patients for 24 hours, psychiatric nurses can enhance the treatment process a lot through the application of a mindfulness-based relapse prevention program.

As drug abuse is such a devastating affliction, further knowledge about specific traits that may increase the chances of a successful recovery would be greatly beneficial to enhance treatment and decrease relapse rate. Accordingly, this study will be conducted to determine the effect of mindfulness-based relapse prevention program on readiness for change, and efficacy among clients with substance use disorder.

AIMS OF THE STUDY

The aim of this study is to:

Examine the effect of the Mindfulness-Based Relapse Prevention Program on readiness for change and self-efficacy among clients with substance use disorder during the rehabilitation phase.

RESEARCH HYPOTHESIS Clients with substance use disorder who attend Mindfulness-Based Relapse Prevention program sessions exhibit higher levels of readiness for change and self-efficacy compared to those who receive conventional hospital treatment.


Eligibility criteria: Inclusion Criteria:

* Able to read and write.
* Able to communicate and willing to participate in the study.
* Male patients only Exclusion Criteria
* Patients who are only alcoholics will be excluded.
* Diagnosed with SUDs with mental illness comorbidity.

Primary outcomes:
measure: Five Factors Mindfulness Questionnaire (FFMQ)
timeFrame: 5 weeks
measure: The Stages of Change Readiness and Treatment Eagerness Scale (SOCRATES)
timeFrame: 5 weeks
measure: Drug abstinence Self-Efficacy Scale (DASE)
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Nursing
Study officials:
References:
citation: Bowen S, Chawla N, Collins SE, Witkiewitz K, Hsu S, Grow J, Clifasefi S, Garner M, Douglass A, Larimer ME, Marlatt A. Mindfulness-based relapse prevention for substance use disorders: a pilot efficacy trial. Subst Abus. 2009 Oct-Dec;30(4):295-305. doi: 10.1080/08897070903250084.
Clinical trial NCT06192199: The Diagnostic Value of APTT/Fibrinogen Ratio in Pulmonary Embolism
Official title: The Diagnostic Value of APTT/Fibrinogen Ratio in Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Pulmonary Embolism
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: From January 1, 2023 to December 30, 2023, the patients were diagnosed with suspected pulmonary embolism at the Southern Hospital of Southern Medical University and underwent enhanced pulmonary artery scanning examination. According to the 2018 edition of the Guidelines for Diagnosis, Treatment and Prevention of Pulmonary Thromboembolism, and based on inclusion and exclusion criteria, enrolled patients were divided into a pulmonary embolism group and a non pulmonary embolism group

Brief summary: From January 1, 2023 to December 30, 2023, patients who were suspected of pulmonary embolism and underwent CTPA examination at Nanyang Hospital of Southern Medical University were divided into pulmonary embolism group and non pulmonary embolism group. 1. Collect relevant data, including gender, age, primary disease, CTPA imaging and reports, BNP, troponin, electrocardiogram, cardiac ultrasound, PT, APTT, TT, fibrinogen, D-dimer, etc., and analyze demographic data, pulmonary embolism risk grading, APTT/fibrinogen ratio, and determine their cut-off values through statistical analysis of the two groups. 2. Follow up on the APTT/fibrinogen ratio after anticoagulation treatment and bleeding in the pulmonary embolism group.


Eligibility criteria: Inclusion Criteria:

1. Voluntary signing of informed consent form;
2. When signing the informed consent form, the age is equal to or greater than 18 years old, regardless of gender;
3. From January 1, 2023 to December 30, 2023, the patient was diagnosed with suspected pulmonary embolism at the Southern Hospital of Southern Medical University and underwent enhanced pulmonary artery scanning examination.

Exclusion Criteria:

1. Patients with gastrointestinal bleeding, severe trauma, acute coronary syndrome, severe liver disease (childC grade), and coagulation dysfunction;
2. Patients with pulmonary embolism diagnosed outside the hospital and regular anticoagulation;
3. Patients undergoing regular anticoagulant therapy such as atrial fibrillation and valve replacement;
4. Patients deemed unsuitable for participation in this study by the researchers.

Primary outcomes:
measure: Cutoff value of APTT/FIB between patients with and without acute pulmonary embolism
timeFrame: 2024.01-2026.12
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang hospital of Southern Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT03434899: Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
Official title: Effects of Physical Activity With Online Support for Individuals With Chronic Widespread Pain (CWP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Widespread Pain
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Sahlgrenska University Hospital
name: Vastra Gotaland Region
First posted: 2018-02-15
Enrollment: 139
Sex: ALL
Minimum age (years): 20
Maximum age (years): 62
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to evaluate a novel treatment routine where contact through a smart phone/computer is used for online support for patients suffering from chronic widespread pain (CWP). The outline is that patients are encouraged to perform physical activity during a period of 12 months with online support from a physical therapist.

Detailed description: The intervention follows principles from the theories of person-centered care and self-efficacy. The examinations performed at baseline and after six months were conducted by blinded examiners at a visit at the primary health care centers. All participants developed a person-centered health plan for physical activity together with a physiotherapist. The intervention group was supported with a digital platform for six months.

Eligibility criteria: Inclusion Criteria:

* fulfilling the American Colleague of Rheumatology (ACR) 1990 criteria for chronic widespread pain (CWP)
* access to a smart phone or computer

Exclusion Criteria:

* other serious diseases that cause pain or hinder exercise, such as heart disease, neurological disease or severe osteoarthritis
* unable to speak or read Swedish

Primary outcomes:
measure: Pain during the last week
timeFrame: Change from Baseline Pain at 6 months
Secondary outcomes:
measure: Fatigue
timeFrame: Change from Baseline Fatigue at 6 months
measure: Health
timeFrame: Change from Baseline Health at 6 months
Other outcomes:
Locations:
city: Alingsas
country: Sweden
facility: Alingsas Primary Health Care
city: Göteborg
country: Sweden
facility: Göteborg Primary Health Care
city: Uddevalla
country: Sweden
facility: Uddevalla Primary Health Care
Study officials:
affiliation: Sahlgren University Hospital
name: Kaisa Mannerkorpi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Feldthusen C, Bergenheim A, Barenfeld E, Gjertsson I, Larsson A, Mannerkorpi K. Experience of co-creation of a health plan and support for sustainable physical activity among people with chronic widespread pain: a qualitative interview study in Sweden. BMJ Open. 2022 Apr 8;12(4):e059432. doi: 10.1136/bmjopen-2021-059432.
Clinical trial NCT00486499: I-125 Versus Pd-103 for Medium Risk Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Prostate Cancer
Keywords: radiation
brachytherapy
prostate
cancer
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
Collaborators: name: Dr. Gregory Merrick
name: Theragenics Corporation
First posted: 2007-06-14
Enrollment: 660
Sex: MALE
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: hypothesis: the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).

Detailed description: Objective: The objective of this study is test the hypothesis that the shorter half-life of Pd-103 versus I-125, will increase the rate of tumor eradication.

Research plan:

A total of 660 patients with AJC clinical stage T1c-T2a prostatic carcinoma (Gleason grade 7 to 9 and/or PSA 10-20 ng/ml) will be randomized to implantation with I-125 (144 Gy) versus Pd-103 (124 Gy).

Methodology:

Randomization will be accomplished by the method of random permuted blocks.

Cancer status will be monitored by yearly serial serum PSA. Treatment-related morbidity will be monitored by personal interview, using standard American Urologic Association and Radiation Therapy Oncology Group criteria at 1, 3, 6, 12 and 24 months.

Primary endpoint: Time to treatment failure. Patients with serum PSA above 0.5 ng/ml two years or more after treatment will be considered to have residual or recurrent cancer and to have failed therapy.

Eligibility criteria: Inclusion Criteria:

* PSA 4-10 ng/ml
* Gleason score 5 or 6

Primary outcomes:
measure: PSA-based cancer eradication
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Group Health Cooperative
state: Washington
city: Seattle
country: United States
facility: VA Puget Sound
state: Washington
Study officials:
affiliation: VA Puget Sound, Group Health Cooperative, U of Washington
name: Kent E Wallner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05276999: Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"
Official title: Rheumatic Heart Disease Community Streptococcal Treatment Program "RESET"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatic Heart Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Uganda Heart Institute
name: Children's National Research Institute
First posted: 2022-03-14
Enrollment: 66123
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pragmatic public health study to test an integrated strep education and treatment program to reduce echo-detected burden of RHD
Primary purpose: PREVENTION

Brief summary: The primary objective of this study is to determine the impact of a pragmatic RHD primary prevention program in Uganda.

The secondary Objective are as follow:

1. To improve guideline-based care for sore throat through frontline healthcare provider education on clinical decision rules and guideline-based primary prevention.
2. To increase health seeking behavior for sore throat thorough a multifaceted community awareness campaign.

Detailed description: Our intervention is designed as a service-oriented plan to be implemented through the primary healthcare structure and facilities of both the national health and private system. Additional support will come from the education system, with participation from schools, teachers, patients, patient families, and the public. Our intervention will focus on two of the more easily rectified impediments to primary prevention, namely (1) poor uptake of guideline-based treatments for Group A Streptococcal (GAS) pharyngitis and (2) low levels of public awareness of the importance of sore throat care and treatment.

Eligibility criteria: Inclusion Criteria:

• Has agreed to participate in the study via the study's informed consent/assent process.

Exclusion Criteria:

* Known history of ARF or RHD
* Any known co-morbid conditions (HIV, renal deficiencies, severe malnutrition,
* among others) that have resulted in prescription of regular antibiotic prophylaxis
* Structural or functional cardiac defects, other than those consistent with RHD, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus).

Primary outcomes:
measure: Determination of Echocardiography prevalence of RHD among children 5-15 years old
timeFrame: 2 year endpoint
Secondary outcomes:
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Uganda Heart Institute
Study officials:
affiliation: Cincinnati Chidren's hospital
name: Andrea Z Beaton
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04178499: Smoking: Cytokines in Vitreous and Aqueous Humor
Official title: Smoking: Cytokines in Vitreous and Aqueous Humor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients scheduled for vitrectomy at the Medical University of Graz/Austria

Brief summary: Smoking is a risk factor for ophthalmologic diseases. Inflammation might play a role in their pathogenesis.

This study elucidates intraocular cytokine profiles in smokers and non smokers.


Eligibility criteria: Inclusion Criteria:

* scheduled vitrectomy and/or cataract surgery
* signed informed consent

Exclusion Criteria:

* diabetes
* uveitis
* rheumatologic disease
* anti-inflammatory/immunomodulatory medications
* st.p. intravitreal injections
* st.p. glaucoma surgery
* cataract surgery on the eye to be examined within the past 6 months

Primary outcomes:
measure: cotinine
timeFrame: At the time of vitrectomy procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: