linjc16/ctgov huggingface dataset:
Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation(SAPPHIRE Study)

Study Overview
=================
Brief Summary
-----------------
We propose to establish a database characterizing the presence or absence of comorbid PTSD in veterans with schizophrenia or schizoaffective disorder (SAD) receiving services at the Durham VA Medical Center. In addition to the evaluation of PTSD symptoms in veterans with schizophrenia or SAD, this database will facilitate the investigation of a number of additional specific research questions relevant to veterans with psychotic disorders.

Detailed Description
-----------------
See brief summary

Official Title
-----------------
Schizophrenia and PTSD Project: Health, Interventions, and Risk/Resilience Evaluation

Conditions
-----------------
Schizophrenia, PTSD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-72 years of age, any ethnic group, either sex. Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder. Ability to fully participate in the informed consent process, or have a legal guardian able to participate in the informed consent process. Exclusion Criteria: Unstable current medical or neurological illness. Significant suicidal or homicidal ideation. Pregnant women or women who could be pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 72 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 |
| --- | --- | --- |
| Brief Assessment of Cognition in Schizophrenia (BACS) | The Brief Assessment of Cognition in Schizophrenia (BACS) includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. | Visit 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, PTSD, Cognition
Management of Anal Fistula of Crohn Disease

Study Overview
=================
Brief Summary
-----------------
The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

Detailed Description
-----------------
Patients with anal fistula with Crohn disease and needed anal fistula drainage will be included. Medical and surgical treatments will be recorded. The management will be described and the best approaches will be identified.

Official Title
-----------------
Management of Anal Fistula of Crohn Disease

Conditions
-----------------
Anal Fistula, Crohn Disease

Intervention / Treatment
-----------------
* Other: therapeutic management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years of age Crohn's disease with fistulizing anoperineal lesion Operated at least once for this reason Exclusion Criteria: Adult person protected under the Public Health Code Minor person

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: therapeutic management|therapeutic management of anal fistula in Crohn Disease|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the therapeutic management of anal fistula in Crohn Disease | Therapeutic management of anal fistula in Crohn Disease, including medical and surgical treatments | The inclusion day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn disease, anal fistula, anal surgery
A Pilot Study Simulating Multifocal Intraocular Lenses in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Age related cataracts are responsible for about 51 percent of blindness worldwide and according to the WHO affect about 20 million people, according to the WH . As cataract surgery is firstline treatment in the western world, there is a constant attempt to improve artificial intraocular lenes (IOL). As for this study, the investigators seek to compare four different IOL designs in in a psychophysiological setting, allowing to assess the impact of these IOLs on vision and psychological processing of visual information. As these IOLs also have downsides, such as reduced light intensity or image alterations, the subjective preference and overall impression shall be investigated. The healthy subjects look through a stable spectacle frame mounted onto a table, which enables the investigator to insert the different IOLs. This would allow subjective testing of IOLs before surgery.

Conditions
-----------------
Lenses, Intraocular, Contrast Sensitivity, Visual Acuity

Intervention / Treatment
-----------------
* Drug: Cyclopentolatehydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged between 18 and 35 years Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant Normal ophthalmic findings, between -1 and +1 diopters Exclusion Criteria: > 0,5 diopters of cylinder Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study Symptoms of a clinically relevant illness in the 3 weeks before the first study day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 30 healthy male and female subjects<br>30 healthy male and female subjects aged 18-35 | Drug: Cyclopentolatehydrochloride<br>* Cyclopentolatehydrochloride 0.5% (Thilo, Alcon, Vienna), dose: 1 drop for study eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eearly Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score | To investigate the psychophysiological impact of different optical setups on visual acuity at far, intermediate and near distance. | 1 study day |
Mindfulness and Acceptance Group Therapy for Substance Use

Study Overview
=================
Brief Summary
-----------------
Randomized clinical trial comparing standard residential substance abuse treatment to standard residential treatment plus Mindfulness and Acceptance Group Therapy for substance use.

Official Title
-----------------
Mindfulness and Acceptance Group Therapy for Substance Use

Conditions
-----------------
Substance Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Mindfulness + Residential Treatment
* Behavioral: Residential treatment alone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participating in inpatient substance use treatment at treatment facility Exclusion Criteria: psychosis and mental impairment

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness + residential treatment<br>Mindfulness and Acceptance Group Therapy + residential treatment | Behavioral: Mindfulness + Residential Treatment<br> <br> |
| Active Comparator: Residential Treatment<br>Residential treatment alone | Behavioral: Residential treatment alone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Substance use after discharge from treatment |  | 6 months |
Impact of LVAD Implantation on Micro- and Macrovascular Function

Study Overview
=================
Brief Summary
-----------------
End stage heart failure is characterized by a critical inability of the heart to meet the organism's blood demand even under resting conditions. Heart transplantation (HTx) is the established therapeutic approach in the treatment of end stage heart failure and still the gold standard treatment. Left ventricular assist devices (LVADs) are considered as a vital therapeutic option to temporarily or permanently assist the failing circulation. The hemodynamic vascular consequences of implanting LVADs have not been studied in detail. The aim of the study is to investigate the effect of LVAD implantation compared to heart transplant (HTx) on micro- and macrovascular function in patients with end stage heart failure.

Official Title
-----------------
Impact of LVAD Implantation on Micro- and Macrovascular Function

Conditions
-----------------
End Stage Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients after HTX patients after LVAD implantation patients with stable coronary heart disease and normal systolic left ventricular function healthy volunteers written informed consent Exclusion Criteria: acute inflammation cardiac arrhythmia renal failure malignant disease

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients after HTX<br> | |
| patients after LVAD implantation<br> | |
| patients with coronary heart disease<br> | |
| healthy volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macrovascular function measured by flow-mediated vasodilation (FMD) |  | 3 months after implantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular function assessed by non-invasive laser Doppler imaging |  | 3 months after implantation | 
| microparticles determined by Flow Cytometry |  | 3 months after implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microvascular perfusion, left ventricular assist device, endothelial function, microparticles
Effect of Low-level Laser Therapy (808nm) on Marker of Muscle Damage

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is a decreased muscle damage induced by exercises when low-level laser therapy is applied on body muscles before exercises.

Detailed Description
-----------------
The study assessed males submitted to exercise to induce muscle damage. Creatine kinase levels in blood was quantified in order to identify the magnitude of muscle damage.

Official Title
-----------------
Effect of Low-level Laser Therapy (808nm) on Marker of Muscle Damage: Randomized Double-blind Placebo-controlled Study

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: Low-level laser therapy (808nm) and exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy males, physically active, aged between 25-40 years. Exclusion Criteria: smoker, or under medicine as anti-inflammatory and/or any drug that could affect normal and physiological conditions and lesion in upper limbs.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Active Comparator: Low-level laser therapy (LLLT) on muscle damage<br>Effects of low-level laser therapy (LLLT)on muscle damage | Device: Low-level laser therapy (808nm) and exercise<br>* Use of low-level laser therapy(LLLT)or placebo-LLLT applied on biceps brachii for muscle damage recovery<br>* Other names: Muscle recovery;|
| Active Comparator: Low-level laser therapy (LLLT) placebo on muscle damage<br>Effects of low-level laser therapy (LLLT) placebo on muscle damage | Device: Low-level laser therapy (808nm) and exercise<br>* Use of low-level laser therapy(LLLT)or placebo-LLLT applied on biceps brachii for muscle damage recovery<br>* Other names: Muscle recovery;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatine Kinase analysis in blood | Evaluation of Creatine Kinase (CK) levels in blood before, immediately after and 24h, 48h and 72h after protocol of exercise to induce muscle damage | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low-level laser therapy, muscle damage
A Study to Evaluate the Safety of DA-3030 and to Explore the Efficacy for Diabetic Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
A multi-centers, placebo-controlled, randomized, double-blinded, pilot clinical trial is designed to evaluate the safety of the DA-3030 injection and to explore the efficacy for Neuropathic pain.

Official Title
-----------------
A Phase I Study of the DA-3030 Injection to Evaluate Its Safety and Explore the Efficacy for Diabetic Neuropathic Pain

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: 600㎍ of DA-3030 Injection
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20≤ Age ≤ 70 Diagnosed with Type I or Type II diabetes HbA1c ≤ 11% Patients with diabetic neuropathic pain for at least 3 months Patients corresponding to average pain level of 4 points or mor for 24 hours evaluated with 11-point Likert scale Exclusion Criteria: Neuropathic pain due to other causes Another stronger pain other than neuropathic pain Abnormality in blood pressure, weight Positive reaction in HIV, HBV or HCV A medical history of mental illness within 6 months The grade of BDI(Beck Depression Inventory) exceeds 21 points History of drug/alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 600㎍ of DA-3030 Injection<br>600㎍ of DA-3030 is injected once a day, for 5 continuous days. | Drug: 600㎍ of DA-3030 Injection<br> <br> |
| Placebo Comparator: Placebo<br>Placebo(a salin drip) is injected once a day, for 5 continuous days. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal score of vital signs measured by following methods: two-sample t-test, Wilcoxon rank sum test, Paired t- test, Wilcoxon signed rank test, McNemar test, Chi-squared test, or/and Fisher's exact test |  | 12 Weeks | 
| Number of Subjects or Incidence with Adverse Events including Adverse Drug Event and Serious Adverse Event |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average pain score | Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain) | 12 Weeks | 
| Most severe pain score | Measuring how much the subject feels pain last 24 hours on a scale of one to ten (no pain - most severe pain) | 12 weeks | 
| overnight pain score | Measuring how much the subject feels pain last night on a scale of one to ten (no pain - most severe pain) | 12 weeks |
Adult Autoimmune Myopathies (MAIA)

Study Overview
=================
Brief Summary
-----------------
This study corresponds to a monocentric prospective cohort of adult patients presenting a suspicion of idiopathic inflammatory myopathy. It will allows the constitution of an organized collection of longitudinal clinical data as well as collection of biological samples, including blood sample, urine, stool and muscle specimen.

Official Title
-----------------
Adult Autoimmune Myopathies (MAIA): Clinical and Immunological Characterization, Constitution of a Patient Library

Conditions
-----------------
Idiopathic Inflammatory Myopathies

Intervention / Treatment
-----------------
* Other: description of adult autoimmune myopathies


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical suspicion of Adult Inflammatory Myopathy Social security affiliation Exclusion Criteria: Pregnant and lactating women Patients unable to consent Patients refusing to participate in the research. Patients under legal protection

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: diagnosis and follow up of adult autoimmune myopathies
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adult Autoimmune Myopathies<br>It is a description Autoimmune Myopathie cohort | Other: description of adult autoimmune myopathies<br>* description of adult autoimmune myopathies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of lymphocytes subpopulations (B, T and TH-17) | Distribution of lymphocytes subpopulations (B, T and TH-17) according to the final diagnosis defined by a panel of experts | 6 months |
Efficacy of Selective Laser Trabeculoplasty in Pseudophakic Patients

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of efficacy of selective laser trabeculoplasty in pseudophakic patients compared to phakic patients is performed. Inclusion criterion are patients with glaucoma or ocular hypertension who underwent treatment with selective laser trabeculoplasty due to insufficient control of intraocular pressure during their routine treatment at the University Hospital Zurich / Division of Ophthalmology.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Procedure: selective laser trabeculoplasty (SLT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with glaucoma or ocular hypertension who underwent selective laser trabeculoplasty. Exclusion criteria: Optic neuropathy other than glaucoma

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 |
| --- | --- |
| phacic<br>Study patients who still have their own ocular lens | Procedure: selective laser trabeculoplasty (SLT)<br>* trabeculoplasty with an SLT-Laser to reduce intraocular pressure<br>* Other names: SLT-Laser, Tango Laser, Ellex Medical Pty. Ltd., 82 Gilbert Street, Adelaide, SA 5000 Australia;|
| pseudophacic<br>Study patients who have an intraocular lens after cataract surgery | Procedure: selective laser trabeculoplasty (SLT)<br>* trabeculoplasty with an SLT-Laser to reduce intraocular pressure<br>* Other names: SLT-Laser, Tango Laser, Ellex Medical Pty. Ltd., 82 Gilbert Street, Adelaide, SA 5000 Australia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP |  | t0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patients with glaucoma or ocular hypertension