louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04147897: Implementing mHealth for Schizophrenia in Community Mental Health Settings
Official title: Implementing mHealth for Schizophrenia in Community Mental Health Settings
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Schizophrenia
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-11-01
Enrollment: 303
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized control trial examining two mHealth intervention strategies.

Detailed description: The investigators will conduct a multi-site site hybrid type III effectiveness/implementation study in Washington State. The study involves a systematic head-to-head comparison between External Facilitation (EF) and Internal Facilitation (IF) implementation models applied to the FOCUS mHealth intervention.

Eligibility criteria: All participants need to be receiving clinical care at participating clinics who have partnered with the research team for this study.

Inclusion:

1. Chart diagnosis of SSD (i.e., schizophrenia, schizoaffective disorder, schizotypal disorder, delusional disorder, or schizophreniform disorder;
2. 18 years or older;
3. English-speaking;
4. Own a smartphone that can support FOCUS and active data plan.

Exclusion:

1. Used FOCUS in the past;
2. Plan to move or discontinue services at participating clinics in the upcoming 6 months.

Primary outcomes:
measure: Change in PhQ9
timeFrame: 0,3,6 months
measure: Change in GAD-7
timeFrame: 0,3,6 months
measure: Change in Insomnia Severity Index
timeFrame: 0,3,6 months
measure: Change in Green Paranoid Thoughts Scale- ideas and persecution sub-scale
timeFrame: 0,3,6 months
measure: Change in Symptom Check List SCL9
timeFrame: 0,3,6 months
measure: Change in Hamilton Program for Schizophrenia Voices Questionnaire (HPSVQ)
timeFrame: 0,3,6 Months
measure: Change in Illness Management and Recovery Scale
timeFrame: 0,3,6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chehalis
country: United States
facility: Cascade Mental Health Care
state: Washington
city: Colville
country: United States
facility: NEW Alliance Counseling Services
state: Washington
city: Everett
country: United States
facility: Compass Health
state: Washington
city: Federal Way
country: United States
facility: Valley Cities
state: Washington
city: Port Angeles
country: United States
facility: Peninsula Behavioral Health
state: Washington
city: Seattle
country: United States
facility: Sound Health
state: Washington
city: Spokane
country: United States
facility: Frontier Behavioral Health
state: Washington
city: Yakima
country: United States
facility: Comprehensive Healthcare
state: Washington
Study officials:
affiliation: University of Washington
name: Dror Ben-Zeev, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06655597: Efficacy of a Dietary Supplement Powder Formula (Daily Ultimate Essentials) in an Adult Population.
Official title: A 12-week Randomized, Controlled, Clinical Trial Evaluating the Efficacy of a Dietary Supplement Powder Formula (Daily Ultimate Essentials) in an Adult Population.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Dietary Assessment
Keywords: Dietary Supplement
Healthy Adults
Lead sponsor: Prenetics Global
Sponsor class: INDUSTRY
First posted: 2024-10-23
Enrollment: 60
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: Healthy Adult subjects

Detailed description: The study will be a prospective randomized, controlled clinical study. There will be interventional treatment for a total of 12 weeks. The subjects will attend two appointments in the clinic throughout the duration of the study.

Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 and 30 kg/m2
* Low, moderate, and high activity (self-identified) \*
* Self-identify as having fatigue, and abdominal issues (bloating, constipation etc.) \*
* Participants will be able to read, understand and sign an informed consent form (includes HIPAA and States requirements) and sign a photo release form.
* Participants are willing and able to follow all study directions, attend study visits as scheduled and must be willing to accept the restrictions of the study including but not limited to:
* Willing to refrain from introducing any new diets or dietary supplements for the duration of the study

Exclusion Criteria:

-

Primary outcomes:
measure: Body Morphology
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: 12 weeks
measure: Energy
timeFrame: 12 weeks
measure: Changes in Micronutrient blood levels
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Research Institute
state: California
Study officials:
References:
Clinical trial NCT05043597: Effectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load
Official title: Effectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: STEMI
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 3838
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study intends to evaluate thrombus on the basis of different methods for evaluating thrombus load The effect of aspiration on the prognosis of STEMI patients with high thrombotic load Provide a basis for the standardized use of aspiration; at the same time, discover the best benefit groups for thrombus aspiration


Eligibility criteria: Inclusion Criteria:

* (1) Age ≥ 18 years; (2) Voluntary signing of informed consent; (3) Onset of 12 hours STEMI patients who underwent PCI reperfusion therapy within time; (4) The guidewire passes through the lesion and the blood Heavy embolism load (TIMI thrombus classification ≥ 3).

Exclusion Criteria:

* (1) Hemodynamics is unstable or there is cardiogenic shock; (2) After thrombolytic therapy; (3) The expected survival time is less than 6 months due to non-cardiac diseases; (4) Past trips Coronary artery bypass graft patients; (5) Participate in other drug and device research within 30 days; (6) Before surgery, clear active gastrointestinal bleeding or other contraindications for taking dual antiplatelet drugs (7) Patients deemed unsuitable for enrollment by other researchers

Primary outcomes:
measure: Adverse cardiovascular events
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
Study officials:
References:
Clinical trial NCT01521897: Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)
Official title: Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumococcal Vaccine
Streptococcus Pneumoniae
Keywords: Pneumococcal Vaccine
Prevenar
7-valent
Special Use-result surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-01-31
Enrollment: 1143
Sex: ALL
Minimum age (years): 2
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants starting to receive Prevenar at the age of more than 2 and less than 7 months

Brief summary: This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice.

This surveillance will specifically focus on the occurrence of the following:

1. Local reactions at the injection site
2. Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

Detailed description: This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.

Eligibility criteria: Inclusion Criteria:

* Infants at the age of more than 2 and less than 7 months
* Infants who have been vaccinated with Prevenar for the first time
* Infants expected to complete four vaccinations with Prevenar

Exclusion Criteria:

Vaccination with Prevenar must not be given to any of the following;

* History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid
* Evident pyrexia
* Evident serious acute disease
* Any other infants or children ineligible for vaccination

Primary outcomes:
measure: Number of Participants With Adverse Reactions
timeFrame: 28 days
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events
timeFrame: 28 days
measure: Number of Participants With Injection Site Reactions
timeFrame: 28 days
measure: Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination
timeFrame: 28 days
measure: Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination
timeFrame: 28 days
Other outcomes:
measure: Number of Participants by Month of Age at Each Vaccination Time
timeFrame: 28 days
measure: Number of Participants by Vaccination Sites at Each Vaccination Time
timeFrame: 28 days
measure: Number of Participants by Pattern of Concomitant Vaccines
timeFrame: 28 days
measure: Number of Participants by Pattern of Concomitant Vaccination Sites
timeFrame: 28 days
Locations:
city: Kasuga
country: Japan
facility: Yokoyama Children's Clinic
state: Fukuoka
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00596297: Preoperative Bevacizumab for Vitreous Hemorrhage
Official title: Intra-Operative and Postoperative Intraocular Bleeding After Pars Plana Vitrectomy for Vitreous Hemorrhage in Diabetic Patients Previously Treated With Intravitreal Bevacizumab
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Diabetic Retinopathy
Vitreous Hemorrhage
Keywords: Diabetic Retinopathy
Vitreous Hemorrhage
Bevacizumab
pars plana vitrectomy
preoperative
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 16
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 purpose of this study is to determine whether preoperative intravitreal bevacizumab is effective in reducing intra-operative and postoperative bleeding in diabetic patients submitted to pars plana vitrectomy for vitreous hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Diabetic retinopathy causing significant vitreous hemorrhage with visual acuity loss lasting more than three months in patients not previously treated and four months in those previously LASER treated.

Exclusion Criteria:

* Previous intra-ocular surgery other than cataract surgery
* Retinal detachment
* Use of anticoagulants drugs other than aspirin
* Vitreous hemorrhage clearance at week-3 study period
* History of previous thromboembolic events

Primary outcomes:
measure: Intra- and postoperative intra-ocular bleeding
timeFrame: 12 weeks
Secondary outcomes:
measure: Visual acuity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
state: São Paulo
Study officials:
affiliation: Clinics Hospital of Ribeirão Preto, School of Medicine of Ribeirão Preto, USP
name: Daniel R Lucena, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01693497: Comparison of Cognitive Processing Therapy (CPT) and Dialogical Exposure Therapy (DET) for Posttraumatic Stress Disorder
Official title: Comparison of a Gestalt-based Approach to PTSD Therapy With Cognitive Processing Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Posttraumatic Stress Disorder
PTSD
psychotherapy
randomized trial
gestalt
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2012-09-26
Enrollment: 150
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: This study aims to compare two active psychological treatments for PTSD. One is an established therapy, Cognitive Processing Therapy (CPT) which operates as a control condition for a newly developed intervention, an integrative Gestalt-based trauma therapy, Dialogical Exposure Therapy (DET). There is no inactive control condition. We expect the two therapies to perform on a similar level, which would constitute evidence for the efficacy of DET.


Eligibility criteria: Inclusion Criteria:

* main diagnosis of posttraumatic stress disorder
* time since trauma is at least three months

Exclusion Criteria:

* acute suicidal ideation
* severe personality pathology
* substance dependence
* early childhood trauma (e.g. child sexual abuse)
* history of psychosis
* dissociative identity disorder
* neurological impairment (e.g. craniocerebral injury with functional impairment)
* severe pre-traumatic depression
* ongoing psychotherapy
* lack of motivation
* lack of German language skills

Primary outcomes:
measure: PTBS Symptom Severity
timeFrame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
Secondary outcomes:
measure: PTSD Symptom change (IES-R)
timeFrame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment). Also measured at each session (up to 24 time points between pre- and posttreatment).
Other outcomes:
measure: Brief Symptom Inventory
timeFrame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
measure: Inventory of Interpersonal Problems (IIP)
timeFrame: change from pretreatment to posttreatment (planned duration 12 weeks on average) to follow-up (six months after posttreatment)
Locations:
city: Munich
country: Germany
facility: LS für Klinische Psychologie und Psychotherapie
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Willi Butollo, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05828797: Elastography in Patients With Hemiplegia
Official title: Evaluation of Shoulder Region With Share-Wave Ultrasound Elastography in Patients With Hemiplegia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemiplegia
Elastography
Shoulder
Muscles
Lead sponsor: Sanliurfa Mehmet Akif Inan Education and Research Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients over the age of 18 who apply to our clinic and have hemiplegia complaints will be evaluated.

Brief summary: In our study, we aimed to examine the muscles and tendons of the shoulder region on the plegic side of patients with hemiplegia by elastography and to investigate whether there is a relationship between the course of the disease and the course of the lesions that will occur in the shoulder.

Detailed description: Patients over the age of 18 who apply to our clinic and have hemiplegia complaints will be evaluated. Patients' age, gender, occupation, habits, disease duration, upper extremity with complaints, dominant upper extremity, additional disease, weight and height values will be recorded. In the physical medicine and rehabilitation department examination of the patients, the patients will be evaluated with the brunnstrom staging used in hemiplegic patients. The elastography of the shoulder on the side with hemiplegia and the elastography of the shoulder on the side without complaints will be examined. Thus, the patient's side with the complaint will be checked by comparing the healthy side.

Eligibility criteria: Inclusion Criteria:

1. Volunteer patients
2. Patients over 18 years old
3. Patients with hemiplegia
4. Patients without any rheumatic disease
5. Patients without any neurological deficit and muscle disease
6. Not having received ftr treatment to the shoulder area in the last 3 months
7. No injection to the shoulder area in the last 3 months
8. Not having any surgical procedure on the shoulder area
9. Not to be pregnant

Exclusion Criteria:

1. Patients with any rheumatic disease
2. Patients with any neurological deficit and muscle disease
3. To have received ftr treatment to the shoulder area in the last 3 months
4. Being under 18 years old
5. Having an infectious disease
6. Having any benign or malignant disease
7. Any surgical procedure to the shoulder area
8. Pregnancy

Primary outcomes:
measure: Evaluation of Shoulder Region With Share-Wave Ultrasound Elastography in Patients With Hemiplegia
timeFrame: 02/05/2023-02/05/2024
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran University Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Şanlıurfa
Study officials:
References:
Clinical trial NCT00004697: Randomized Study of the Use of Intravenous Choline Supplementation in Long Term Total Parenteral Nutrition
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatty Liver
Keywords: gastrointestinal disorders
hepatic steatosis
rare disease
Lead sponsor: FDA Office of Orphan Products Development
Sponsor class: FED
First posted: 2000-02-25
Enrollment: 15
Sex: ALL
Minimum age (years): 16
Maximum age (years): 74
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: OBJECTIVES:

I. Determine whether intravenous choline supplementation will reverse the hepatic steatosis and improve liver function in patients who receive long term total parenteral nutrition.

Detailed description: PROTOCOL OUTLINE:

This is a randomized, double blind, placebo controlled study.

Patients receive either daily choline chloride in their total parenteral nutrition (TPN) solution or their usual TPN. The TPN is given intravenously over a 12 hour period beginning at approximately 9 PM nightly. Therapy continues for 24 weeks. Adjustments in the daily dose of choline provided may be required based on plasma free choline levels and patient tolerance. Additionally, all patients record the type and amount of their food intake on a daily basis.

Patients are followed every 2 weeks during the first 6 weeks, then every 4 weeks beginning with week 12 for the remainder of the 24 weeks, and then again at week 34.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Receiving nightly total parenteral nutrition (TPN) for greater than 70% of nutritional needs for a minimum of 8 weeks prior to study entry; Receiving no greater than 38 kcal/kg/day/ideal body weight; Receiving lipid emulsion as part of TPN regimen

Expected to require TPN for at least 34 weeks after study entry

Hepatic steatosis documented by prestudy CT scan

Consistent daily amount of intravenous amino acids, dextrose, or lipid received for 3 weeks prior to study entry

--Prior/Concurrent Therapy--

No concurrent cholinergic medications

--Patient Characteristics--

Hepatic: Albumin at least 3.5 g/dL; No hepatic failure; PT no greater than 2 times upper limit of normal

Renal: No renal failure requiring hemo- or peritoneal dialysis

Other: No AIDS; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Texas
name: Alan Lewis Buchman
role: STUDY_CHAIR
References:
Clinical trial NCT00905697: Patient Reported Outcomes in Living Donor Lung Transplantation
Official title: Analysis of Patient Reported Outcomes in Living Donor Lung Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Keywords: Living donor lung transplantation
Health-related quality of life
Prognosis
Patient reported outcome
Lead sponsor: Kyoto University, Graduate School of Medicine
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Labour and Welfare, Japan
First posted: 2009-05-20
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Kyoto University Hospital Clinic for Lung Transplantation

Brief summary: The purpose of the present study is to investigate how the health of donors in living donor lung transplantation will change after transplant operations.

Detailed description: In Japan, living donor lung transplantation has been established as an alternative therapy for brain-dead lung transplantation, as the number of organs for transplantation is absolutely short. However, how patient reported measurements including health status, dyspnea, psychological status and sleep would change after lung transplantation has not been well evaluated. Therefore, in the present study, we aim (1) to compare them before and after transplant operations and (2) to analyze how they will change for 5 years.

Eligibility criteria: Inclusion Criteria:

* New donors for living donor lung transplantation

Exclusion Criteria:

* Inability to obtain informed consent

Primary outcomes:
measure: Change in health status
timeFrame: At entry and every year for 5 years
Secondary outcomes:
measure: Change in dyspnea
timeFrame: At entry and every year for 5 years
measure: Change in psychological status
timeFrame: At entry and every year for 5 years
measure: Change in sleep quality
timeFrame: At entry and every year for 5 years
measure: Prognosis
timeFrame: At entry and every year for 5 years
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Graduate School of Medicine, Kyoto University
Study officials:
affiliation: Graduate School of Medicine, Kyoto University
name: Hiroshi Date, MD, PhD
role: STUDY_CHAIR
References: