linjc16/ctgov huggingface dataset:
Vascular Endothelial Protection Effects of Dextromethorphan

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.

Detailed Description
-----------------
Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can prevent vascular remodeling and neuron injury in animal models of carotid ligation and cerebral ischemia injuries, respectively. It was believed that its action was through the anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual effect on human vascular protection remained unclear. To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers, this prospective study will be conducted to treat subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the improvement of endothelial function.

Official Title
-----------------
Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker

Conditions
-----------------
Atherosclerosis, Smoking, Inflammation

Intervention / Treatment
-----------------
* Drug: Dextromethorphan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male volunteers who are currently smoking Exclusion Criteria: personal history of hypertension or diabetes mellitus family history with documented premature cardiovascular events cardiovascular-associated sudden death total cholesterol > 240 mg/dL triglyceride > 200 mg/dL low-density lipoprotein > 160 mg/dL.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Dextromethorphan<br>* 120 mg/day, single once daily dose taken after breakfast by oral route<br>* Other names: medicon for DM;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function |  | 1, 2, 3 and 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surrogate end-points of the study: hs-CRP, sPLA2, matrix metalloproteinase-3, interleukin-6, tumor necrosis factor-alfa receptor II, GSH-Px, and urinary excretion of 8-PGF2alfa |  | 1, 2, 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endothelial function, atherosclerosis, smoking, inflammation, antioxidant
Comparison of Two Pharmacological Treatments of Pedophilia

Study Overview
=================
Brief Summary
-----------------
Sexual abuse committed on children is a major public health problem because of its frequency and its severe consequences on the mental health of victims. Objective: to compare the therapeutic efficacy of cyproterone acetate (CPA) and leuprolide, with the hypothesis that leuprolide will be more effective.

Official Title
-----------------
Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia

Conditions
-----------------
Pedophilia

Intervention / Treatment
-----------------
* Drug: leuprorelin
* Drug: Cyproterone acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of pedophilia high frequency of sexual urges and deviant behavior as demonstrated by a score equal to 8 on the scale of Rösler & Witztum (Rösler & Witztum, 1998) ; age: 18-60 years informed consent Exclusion Criteria: IQ<70 schizophrenia, schizoaffective disorder, or delusional disorder already receiving one of the tested drugs contraindication for one of the tested drugs no current or planned incarceration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: leuprorelin<br>* Subcutaneous injection, 3.75 mg every 4 weeks<br>* Other names: Enantone;|
| Active Comparator: 2<br> | Drug: Cyproterone acetate<br>* 2.0 mg/kg/day, tablet, per os<br>* Other names: Androcur;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire on sexual behavior |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recidivism |  | Prospective | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pedophilia, antiandrogens, gonadotropin releasing hormone agonists
Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This phase I study will evaluate the feasibility and toxicity of weekly bortezomib in the treatment of relapsed or refractory multiple Myeloma and determine whether a twice-weekly schedule of bortezomib is effective in producing responses in patients with stable disease or progression after weekly bortezomib

Detailed Description
-----------------
Upon determination of eligibility, patients will be receive: Bortezomib

Official Title
-----------------
Phase I Trial of Weekly Bortezomib (Velcade) in the Treatment of Patients With Refractory Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Bortezomib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Multiple Myeloma Received no more than 2 previous treatment regimens for multiple Myeloma ECOG performance status 0, 1, or 2 Serum creatinine < 2.0mg/dL calculated or measured creatinine clearance > 30ml/minute Measurable or evaluable disease Provide written informed consent prior to receiving protocol therapy. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Moderate or severe peripheral neuropathy Other serious medical conditions Other active malignancies history of treatment for other invasive cancers Women who are pregnant or lactating Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Bortezomib|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| objective response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  |  | 
| overall survival |  |  | 
| Safety |  |  |
Safety and Tolerability of a Novel Malathion Formulation in Infants and Toddlers With Head Lice

Study Overview
=================
Brief Summary
-----------------
In a previous phase II study, the safety and efficacy of a novel formulation of malathion 0.5% was evaluated in patients 2 years of age and older. Based on the results of that study, this formulation is currently in a phase III study for that population. The current study will use blood markers and clinical evaluations to determine the safety and tolerability of this formulation when used in children 6-24 months of age.

Official Title
-----------------
Phase II, Multi-center, Open-Label, Safety and Tolerance Study of a Novel Malathion Formulation in Infants and Toddlers With Pediculosis Capitis

Conditions
-----------------
Lice Infestations

Intervention / Treatment
-----------------
* Drug: MALG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed active head lice infestation Parent or guardian must be able to apply treatment Exclusion Criteria: Allergy to pediculicides or hair care products Scalp conditions other than head lice Previous head lice treatment within the past 4 weeks Current antibiotic treatment

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 24 Months

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MALG | Drug: MALG<br>* 30 minute application<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cholinesterase level |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evidence of cholinesterase inhibition |  | 1 day | 
| Local tolerability |  | 1 day | 
| Cure of head lice 14 days after last treatment |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediculosis, Head Lice
Genotype-Phenotype Correlations in Patients With Alport Syndrome

Study Overview
=================
Brief Summary
-----------------
Alport syndrome (AS) is caused by pathogenic variants in the type IV collagen genes COL4A3, COL4A4, and COL4A5. This study aims to enroll families and patients with a history of renal hematuria in 27 hospitals and detect these three genes for AS screening. This study also aims to analysis the effect of COL4A3/COL4A4/COL4A5 genotype on the development of kidney disease.

Detailed Description
-----------------
Alport syndrome (AS) is a genetically and phenotypically heterogeneous disorder caused by the mutations in the type IV collagen genes COL4A3, COL4A4, and COL4A5. In this study, next generation sequencing is used to screen AS on 8165 participants enrolled from families and patients with a history of renal hematuria in 27 hospitals of China Huadong Region. Genotype (variants in COL4A3/COL4A4/COL4A5)-phenotype (onset age of hearing loss, nephroticrange proteinuria, decline of eGFR, kidney survival and onset age of CKD5) correlations in AS were evaluated.

Official Title
-----------------
Association Analysis Between Variants of COL4A3/COL4A4/COL4A5 and Alport Syndrome in the Han Chinese Population

Conditions
-----------------
Alport Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: up to 99 Years (Child, Adult, Older Adult) Sex: All; Families and patients with a history of renal hematuria; Those who signed the informed consent. Exclusion Criteria: Polycystic kidney disease, hypertensive nephropathy, etc.; Kidney biopsy is diagnosed as other primary/secondary kidney disease without type IV collagen-related kidney disease, including IgA nephropathy, membranous nephropathy, lupus nephritis, etc. Incomplete medical history or clinical data.
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 |
| --- | --- | --- |
| Identification COL4A3/COL4A4/COL4A5 variants of Alport Syndrome | To characterize the variants of COL4A3/COL4A4/COL4A5 in patients with Alport syndrome over the course of up to 240 weeks | Up to 240 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification genotype-phenotype correlations of Alport Syndrome | Exploring correlations between variants of COL4A3/COL4A4/COL4A5 and the clinical robustness including onset age of hearing loss, nephroticrange proteinuria, decline of eGFR, kidney survival and onset age of CKD5 in Alport syndrome patients | Up to 240 weeks |
Study of NPL-2003 in Adolescents With Obsessive Compulsive Disorder (OCD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of NPL-2003 on the symptoms of Obsessive Compulsive Disorder (OCD) in an adolescent population.

Official Title
-----------------
Open-Label Exploratory Investigation Of NPL-2003 In Adolescents With Obsessive Compulsive Disorder

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Minocycline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets DSM-IV criteria for Obsessive Compulsive Disorder. CY-BOCS score of greater or equal to 16 at screening. NIMH Global OC Scale score of 7 or higher at screening. Exclusion Criteria: Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment. Autistic Disorder or Pervasive Developmental Disorder. Moderate or severe mental retardation. Severe renal insufficiency. Other protocol-defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Minocycline|Capsules|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in OCD symptoms using CY-BOCS |  | Throughout the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) |  | Throughout the study | 
| NIMH Global OC Scale |  | Throughout the study | 
| Clinical Global Impressions of Improvement (CGI-I) |  | Throughout the study | 
| The Children's Depression Rating Scale (CDRS-R) |  | Throughout the study | 
| Columbia Suicide-Severity Rating Scale (SSRS) |  | Throughout the study | 
| Multidimensional Anxiety Scale for Children (MASC) |  | Throughout the study | 
| Global Assessment Scale for Children (CGAS) |  | Throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obsessive Compulsive Disorder, Neuropharm, NPL-2003
Training Therapists to Administer Contingency Management-Patient Phase - 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to train therapists to administer contingency management (CM). This project will train up to 42 community-based treatment providers about the rationale for and the specifics of administering CM. Initial training will occur in 2-day workshops, followed by weekly supervision in delivery of CM with test cases. We expect that the majority of therapists will achieve high levels of competence and adherence in administering CM treatment within 3-5 test cases, as measured by ratings of audiotapes. To examine the efficacy of CM, each therapist who achieves adherence and competence in delivering CM will administer standard treatment alone or standard treatment plus CM to substance-abusing outpatients. In the CM condition, patients will have the opportunity to win prizes for submission of negative samples, and the treatment will be in effect for 12 weeks. In total, up to 200 patients will be randomly assigned to one of the two conditions. A research evaluator will conduct follow-up assessments, scheduled for 3, 6 and 9 months after treatment initiation.

Official Title
-----------------
Training Therapists to Administer Contingency Management-Patient Phase

Conditions
-----------------
Substance Abuse

Intervention / Treatment
-----------------
* Behavioral: Contingency management


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: age 18 years or older meets DSM-IV criteria for cocaine abuse or dependence English speaking (est. >90% of patients) For those in drug-free programs, they must have initiated treatment within the past week. For methadone patients, they must be stabilized on a dose of methadone, defined as being on the same dose for at least 30 days and not currently requesting or being considered for a dose modification. Methadone patients must also have submitted at least 30% cocaine positive urine samples in the past 3 months. Exclusion criteria: acute uncontrolled psychiatric disorder (psychosis, suicidality) as determined by the SCID dementia (<23 on the Mini Mental State Exam; Folstein & Folstein, 1975) in recovery for pathological gambling

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Contingency management|Rewards (prizes) for abstinence|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug use |  | baseline and each follow-up | 
| Retention |  | each follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contingency Management, Substance Abuse Treatment
The Collection and Transmission of Electrocardiogram Using a Wearable Device

Study Overview
=================
Brief Summary
-----------------
A multi-center clinical trial to explore the status of collection and transmission of electrocardiogram using a wearable device

Detailed Description
-----------------
The collection and transmission of electrocardiograms to a central data server using a wearable device were evaluated.

Official Title
-----------------
A Multi-center Clinical Trial to Explore the Status of Collection and Transmission of Electrocardiogram Using a Wearable Device

Conditions
-----------------
Arrhythmia

Intervention / Treatment
-----------------
* Device: Vital Patch(TriBell Lab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult male volunteers who can use an Android smartphone. The subjects who voluntarily agree to participate and give written informed consent. Exclusion Criteria: The subjects who have hypersensitivity to adhesives, such as medical bandages, or have clinically significant skin lesions. The subjects who are judged to be inappropriate for the clinical trials to participate.
Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single arm<br>Electrocardiograms were measured by VP-100 for more than 6 hours and transmitted to a central server. | Device: Vital Patch(TriBell Lab)<br>* Electrocardiograms were recorded using VP-100 for more than six hours and transmitted to a central data server located in Seoul National University Hospital. The data on a central server was confirmed and evaluated.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of data collected | Compare actual monitored and server collected times | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The comparison of ventricular rate | Compare actual monitored and server collected ventricular rate | 6 hours | 
| The comparison of abnormal events | Compare patient-reported adverse events with abnormal beats collected by a central server | 6 hours |