linjc16/ctgov huggingface dataset:
Engaging Pacific Islanders in Mental Health Treatment

Study Overview
=================
Brief Summary
-----------------
This study will create and pilot test a culturally grounded intervention (Talking Story) to increase mental health treatment seeking among Pacific Islanders with mental disorders (e.g., major depressive disorder, generalized anxiety disorder).

Detailed Description
-----------------
For the clinical trial arm of this pilot/feasibility study, the investigators will conduct a pilottest of the culturally grounded Talking Story mental health treatment-seeking intervention with 48 Pacific Islander participants (24 intervention arm, 24 wait-list control) in preparation for larger R01 randomized wait-list controlled testing.

Official Title
-----------------
Engaging Pacific Islanders in Mental Health Treatment Services

Conditions
-----------------
Depression, Anxiety Disorders

Intervention / Treatment
-----------------
* Behavioral: Talking Story


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Of Pacific Islander or part Pacific Islander heritage, Must be over 18 years of age, Live in Los Angeles County or surrounding areas, Fluent (oral and reading) in English, Not have dual comorbidities in major depressive disorder, generalized anxiety disorder, and/or alcohol use disorder (they may have one of these disorders and still participate but not two or three). Exclusion Criteria: Do not meet inclusion criteria, Are unwilling to participate, Fail to provide or retracts consent, Reside outside the target communities.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Talking Story<br>Talking Story is a modular behavioral intervention intended to increase mental health treatment-seeking among Pacific Islanders through the use of narrative films and other culturally syntonic approaches. | Behavioral: Talking Story<br>* A culturally grounded modular intervention to increase mental health treatment-seeking among Pacific Islanders.<br>|
| Placebo Comparator: Wait-list control<br>The wait-list control will be administered as a control arm to the active Talking Story arm. | Behavioral: Talking Story<br>* A culturally grounded modular intervention to increase mental health treatment-seeking among Pacific Islanders.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KAP Model | Knowledge, Attitudes, and Practices related to seeking mental health treatment | Up to 12 months |
Plasma Citrulline in Preterm With NEC

Study Overview
=================
Brief Summary
-----------------
Aim of study

Detailed Description
-----------------
Introduction

Official Title
-----------------
Plasma Citrulline in Preterm With NEC

Conditions
-----------------
NEC, Citrulline

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preterm neonates < 35 weeks Preterm neonates< 2kg Preterm neonates diagnosed with necrotizing enterocolitis Exclusion Criteria: renal dysfunction Inborn error of metabolism Congenital malformation

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 30 Days

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma citrulline as a marker of Necrotizing enterocolitis diagnosis | Compare plasma citrulline in NEC and comparing it with properly matched healthy neonates | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Citrulline as a marker of intestinal recovery | Follow up plasma citrulline level after initiation of feeding | 1 year |
Registry for Advanced Sarcodiosis

Study Overview
=================
Brief Summary
-----------------
Registry with evaluation and genetic information of patients with advanced sarcoidosis and matched sarcoidosis

Official Title
-----------------
Registry for Advanced Sarcoidosis

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Other: observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Patients with diagnosis of sarcoidosis based on ATS/WASOG criteria 22 Age ≥ 18 years. Life expectancy of at least 2 years. Pulmonary function tests (spirometry) within one month of entry or willing to under pulmonary function testing on the day of study enrollment Sarcoidosis as characterized as either advanced or non-advanced (see protocol for definition of advanced disease) Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. Exclusion criteria Subjects with a medical disorder, condition, or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator Inability to comply with the protocol and/or not willing or not available for follow-up assessments. Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observation|observe patients every 6 months|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Determine how many people die during follow up | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neurosarcoidosis, pulmonary hyeprtension, infliximab, repository corticotropin
The Effect of Exercise Training Programs On Balance in Older Adults With CVD

Study Overview
=================
Brief Summary
-----------------
Individuals of advanced age with cardiovascular disease are at higher risk of fall.The aim of this study is to explore the effect of specific exercise program based on balance and coordination on stability parameters

Official Title
-----------------
The Effect of Exercise Training Programs - Stability and Coordination - On Static Balance, Dynamic Balance and Risk of Falls in Older Adults With Cardiovascular Disease

Conditions
-----------------
Aging, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Balance activity program
* Behavioral: Strength activity program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has Cardiovascular disease, under the supervision of a cardiologist Participates in a cardiovascular rehabilitation center Able to undergo physical activity for 60 minutes twice a week Exclusion Criteria: All Other

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experiment<br>A physical activity program that is based on balance and coordination exercises | Behavioral: Balance activity program<br>* Participants will take part in a biweekly, 12 week physical activity program that will include balance and coordination exercises<br>|
| Placebo Comparator: control<br>A physical activity program that is based on strength exercises | Behavioral: Strength activity program<br>* Participants will take part in a biweekly, 12 week physical activity program that will include traditional strength exercises<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Balance ability - a composite outcome | In order to assess changes in balance ability, it will be measured with the following tests: Timed Get Up and Go , Balance Error Scoring System Test, Functional Reach Test, before and after the 12 week physical activity program and the difference will be compared | 4 months |
Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections

Study Overview
=================
Brief Summary
-----------------
Daptomycin is a cyclic lipopeptide that has been proposed as an alternative therapeutic option in patients with prosthetic joint infection caused by Staphylococcus or Enterococcus species in the latest Infectious Diseases Society of America (IDSA) guidelines. The population pharmacokinetics (PK) of daptomycin have been described in various groups of patients in previous publications. However, little information exists on the PK of daptomycin in patients with bone and joint infections (BJI). Also, previous population studies did not investigate daptomycin PK over prolonged therapy, and, to our knowledge, no study has reported the intraindividual PK variability of this drug. The aim of this study is to describe the inter- and intraindividual PK variability of this drug.

Official Title
-----------------
Pharmacokinetic Variability of Daptomycin During Prolonged Therapy for Bone and Joint Infections

Conditions
-----------------
Bone and Joint Infection, Patient Treated by Daptomycin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated with daptomycin for BJI in Lyon Center in 2012 and 2013 Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Typical daptomycin clearance | Mean daptomycin plasma clearance (unit, liters per hour) Outcome measures performed regularly in those patients throughout therapy, roughly every month. | 6 months | 
| Typical daptomycin volume of distribution | Mean daptomycin volume of distribution (unit, liters) in the population | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone and Joint Infection, Daptomycin
International PMS Study - KOGENATE Bayer

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand. To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.

Official Title
-----------------
International PMS Study - KOGENATE Bayer

Conditions
-----------------
Hemophilia A

Intervention / Treatment
-----------------
* Drug: Kogenate (BAY14-2222)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII Exclusion Criteria: Exclusion criteria must be read in conjunction with the product information (SmPC)
Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Kogenate (BAY14-2222)<br>* Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemophilia A, Recombinant Factor VIII
Palliative Care Needs Assessment of the Population Living in Mayotte (French Island of Comoros)

Study Overview
=================
Brief Summary
-----------------
This qualitative study aims to explore the assessment of palliative care needs of the population living in Mayotte, French territory of the Comoros. The aim is to offer a palliative care service tailored to the needs of the population in this area.

Official Title
-----------------
What Are the Palliative Care Needs of the Mahoran Population Take Into Consideration the Socio-anthropological Specificities of This Population, But Also the Demographic, Social, Health and Geographical Characteristics of Mayotte Island

Conditions
-----------------
Palliative Therapy

Intervention / Treatment
-----------------
* Other: Interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients study: to be at the palliative stage of his illness, informed consent family study: being a family or caregiver of a patient in palliative care, informed consent care workers study: being a care worker of a patient in palliative care, informed consent Exclusion Criteria: 0
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Interview|Interview bases on the use of an interview guide, during one hour maximum|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| individual semi-structured interviews | individual semi-structured interviews to obtain a aata saturation Reliability and Validity of the research described according to Guba. | day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative care, needs assessment, Mayotte, terminal care
Anecortave Acetate Injection to Treat Steroid-responsive Intraocular Pressure Increase in Cornea Transplant Patients

Study Overview
=================
Brief Summary
-----------------
This study will investigate the use of anecortave acetate injection to reduce intraocular pressure (IOP) in corneal transplant recipients who are experiencing steroid-associated pressure control problems. Alternative methods of IOP control have been shown to entail serious risks. For example, reduction of topical steroids increases the risk of graft rejection, and use of glaucoma medications or glaucoma surgery increases the risk of graft failure. This study is designed to have sufficient power to detect whether a single injection can induce a clinically significant IOP reduction.

Official Title
-----------------
Compassionate Use of Anecortave Acetate: Clinical Protocol for the Treatment of Corticosteroid-induced Intraocular Pressure (IOP) Increases After Corneal Transplantation

Conditions
-----------------
Transplant, Intraocular Pressure

Intervention / Treatment
-----------------
* Drug: anecortave acetate
* Drug: 30 mg anecortave acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years of age corneal transplant recipient with intraocular pressure (IOP) greater than 24 mmHg and with relative increase in IOP of at least 10 mmHg over the pre-graft baseline Exclusion Criteria: not pregnant or lactating intraocular surgery in the study eye within 30 days before enrolling in the study use of any investigational drug or treatment within 30 days before receipt of study medication clinical evidence of scleral thinning

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 30 mg anecortave acetate<br> | Drug: 30 mg anecortave acetate<br>* anterior juxtascleral depot of 30mg anecortave acetate<br>|
| Active Comparator: 15 mg anecortave acetate<br> | Drug: anecortave acetate<br>* anterior juxtascleral depot of 15 mg anecortave acetate<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure Within Normal Limits (<24 mm Hg) | Intraocular pressure was measured by Goldmann applanation tonometry. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cornea, transplant, intraocular pressure, steroid response
CuraMed and Curamin in Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This randomized, placebo-controlled study evaluates the effects of CuraMed ® (BCM-95 ®) and Curamin ® in the treatment of osteoarthritis. One group will receive CuraMed, one group will receive Curamin and one group will receive placebo.

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Other: Placebo
* Dietary Supplement: Curamin
* Dietary Supplement: CuraMed


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of degenerative hypertrophic osteoarthritis of the knee (M17, according to International Classification of Diseases (ICD-10) of bone joints, verified by radiography (Grade 1-3 by Kellgren-Lawrence radiographic grades). Exclusion Criteria: subjects with inflammatory and any secondary arthritis moderate and severe synovitis (grades 2 and 3) tear of meniscus chronic diseases of the kidneys, liver, gastrointestinal, cardiovascular, endocrine and nervous systems allergic anamnesis and drug intolerance pregnant or nursing history of substance abuse subjects taking non-steroidal anti-inflammatory drugs and analgesics within 2 weeks prior to the study subjects taking glucosamine sulfate, chondroitin sulfate, intra-articular hyaluronate, systemic or intra-articular glucocorticoids within three months prior to the study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CuraMed (BCM-95)<br>67 patients, treatment with CuraMed (BCM-95), one capsule (500 mg) orally, three times daily for 12 weeks | Dietary Supplement: CuraMed<br> <br> |
| Experimental: Curamin<br>67 patients, treatment with Curamin, one capsule (500 mg) orally, three times daily for 12 weeks | Dietary Supplement: Curamin<br> <br> |
| Placebo Comparator: Placebo<br>67 patients, treatment with placebo, one capsule (500 mg) orally, three times daily for 12 weeks | Other: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Curamin and Curamed on joint pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |  | 12 weeks | 
| Effects of Curamin and Curamed on physical performance measures using the Osteoarthritis Research Society International (OARSI) tests of physical function |  | 12 weeks |
A European Network for the Investigation of Gender Incongruence

Study Overview
=================
Brief Summary
-----------------
The physical and psychological effects of the hormonal treatment of transsexual persons are not sufficiently described. 'Transparency' wants to answer this question in a prospective manner, in a multicenter study to describe these effects. The low prevalence of transsexualism was the stimulus to search for European partners for this Protocol. A common standardized hormonal protocol was designed.

Official Title
-----------------
A European Network for the Investigation of Gender Incongruence

Conditions
-----------------
Physical and Psychological Evaluation of Hormonal Therapy in Transsexual Persons

Intervention / Treatment
-----------------
* Other: questionnaires
* Biological: blood sampling
* Other: clinical evaluation
* Other: Dermatology evaluation
* Other: Bone evaluation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Transsexual persons older then 18 years, who are not yet treated with hormonal therapy. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transgender people starting hormone treatment<br> | Other: questionnaires<br>* a descriptive questionnaire, SF-36, , bone questionnaires, Baecke physical activity questionnaire, voice evaluation<br>Biological: blood sampling<br>* LFT (AST, ALT), CRP, creatinine, glucose, Total Cholesterol, Triglycerides, HDL-CH, LDL-CH, 25OH vitamin D, PSA if> 45 years, Hematocrit, testosterone, sex hormone-binding globulin, free testosterone , oestradiol, prolactin, luteinizing hormone, TSH, androgeengevoeligheids test (CAG RL), oral glucose tolerance test<br>Other: clinical evaluation<br>* height, weight, blood pressure, chestcircumference, waist circumference, grip strength, measuring 2 ° and 4 ° finger, and Ferriman Gallwey score<br>Other: Dermatology evaluation<br>* Evaluation of the hair pattern, using the Leeds acne classification scale, acne scars through ECCA scale (échelle d'évaluation clinique des cicatrices d'acné), androgenetic alopecia, and sebummetrie<br>Other: Bone evaluation<br>* PQCT scanner, BMD assessment<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical and psychological effects of the hormonal treatment of transsexual persons | evaluations will be done every 3 months the first year of therapy, every 6 months in the second year, and after sex reassignment surgery annually. | annually |