linjc16/ctgov huggingface dataset:
The Effects of r-metHuIFN-Gamma on the Lungs of Patients With AIDS

Study Overview
=================
Brief Summary
-----------------
To determine safety and tolerance of administering aerosolized recombinant interferon gamma (IFN-gamma) for 4 weeks in patients with AIDS. To examine activation of alveolar macrophages by aerosolized IFN-gamma administration. To determine if subcutaneous (SC) injection of IFN-gamma can activate alveolar macrophages in AIDS patients.

Official Title
-----------------
Activation of Alveolar Macrophages by Aerosolized r-metHuIFN-Gamma (IFN-Gamma) in Patients With AIDS

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Interferon gamma-1b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Diagnosis of AIDS with one or more opportunistic infections. Kaposi's sarcoma with prior history of opportunistic infection. Stable dose of zidovudine (AZT) therapy. Preserved pulmonary, renal and hepatic function. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: Presence of active infection. Active opportunistic infections. Cardiac disease. Central nervous system disorders. History of seizures. Irreversible airway disease. Patients with the following are excluded: Co-existing conditions and symptoms listed in Patient Exclusion Co-existing Conditions. Prior Medication: Excluded within 4 weeks of study entry: Immunosuppressive therapy. Cytotoxic therapy. Excluded: Interferon gamma therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Interferon gamma-1b|nan|

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
-----------------
Pulmonary Alveoli, Macrophage Activation, Interferon-gamma, Recombinant, Injections, Subcutaneous, Aerosols, Acquired Immunodeficiency Syndrome
Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Schizophrenia is a psychiatric disorder, affecting 600,000 patients in France. Patients with schizophrenia have life expectancy decrease from 10 to 20 years because of cardiovascular death. Cardiovascular risk factors are numerous: inadequate diet, smoking, alcohol consumption, diabetes, obesity. Primary prevention of cardiovascular risk in patients suffering from schizophrenia is difficult because of understaff in general practitioners and psychiatrists.

Detailed Description
-----------------
The aim of the study is to describe prevalence of cardiovascular disorders in patients aged 40 and more with schizophrenia.

Official Title
-----------------
Prevalence of Cardiovascular Disorders in Patients Aged 40 and More With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female aged of 40 and more with schizophrenia agreeing to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| with schizophrenia<br>with schizophrenia group : patients aged 40 and more with schizophrenia | Other: Data collection<br>* electrocardiogram<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRS morphology | variation of QRS waves according a standard 12-lead ECG | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiac rhythm | cardiac rhythm disorder according a standard 12-lead ECG | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, cardiovascular disorders, prevalence
A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 1

Study Overview
=================
Brief Summary
-----------------
Influence of CPP-ACP paste on the evolution and appearance of white spot lesions in orthodontic patients after removal of the fixed appliances.

Official Title
-----------------
A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 1

Conditions
-----------------
Early Caries Lesions

Intervention / Treatment
-----------------
* Device: CPP-ACP (GC Tooth Mousse)
* Device: CPP-ACP (GC MI Paste Plus)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one or more white spot lesion at the time of removal of fixed appliances Exclusion Criteria: white spots already present before start orthodontic treatment

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 60 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CPP-ACP (GC Tooth Mousse) | Device: CPP-ACP (GC Tooth Mousse)<br>* Calcium and phosphate<br>|
| Experimental: 2<br>CPP-ACP (GC MI Paste Plus) | Device: CPP-ACP (GC MI Paste Plus)<br>* Calcium, phosphate and fluoride<br>|
| No Intervention: 3<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amelioration of the opacity of white spots into a more natural tooth-like translucency |  | After 6 months |
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a

Study Overview
=================
Brief Summary
-----------------
The Canadian Paediatric Society recommends breastfeeding during COVID-19 infection. Human milk is the best form of infant nutrition providing significant protection against many illnesses for term and preterm infants. The impact of a pandemic on breastfeeding is unknown. This study seeks to address this public health issue. Breastmilk will be collected from mothers positive for COVID-19. Samples will be analyzed for the COVID-19 virus specific nucleic acid and antibody in real-time and results will be immediately disseminated to relevant organizations to inform local, national and international guidelines surrounding breastfeeding to protect the health of infants.

Official Title
-----------------
Is COVID-19 Transmitted Through Human Milk? Implications for Breastfeeding and Human Milk Banking-Study 1a

Conditions
-----------------
SARS-CoV2, Breastmilk

Intervention / Treatment
-----------------
* Other: COVID-19


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current COVID-19 positive status or COVID-19 positive status during pregnancy Intent to breastfeed or currently breastfeeding Exclusion Criteria: - None
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 |
| --- | --- |
| Breastfeeding mothers positive for COVID-19<br> | Other: COVID-19<br>* Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of SARS-CoV-2 in breastmilk | To describe the presence of SARS-CoV-2 nucleic acid in human milk samples collected from mothers positive for COVID-19 | 2-6 months | 
| SARS-CoV-2 antibody in breastmilk | To describe the presence of SARS-CoV-2 antibody in human milk samples collected from mothers positive for COVID-19 | 2-6 months |
Dual Reinforcement Contingency Management for Alcohol Use Disorders

Study Overview
=================
Brief Summary
-----------------
Phosphatidylethanol (PEth) is a direct biomarker of alcohol that can detect moderate to heavy drinking with high sensitivity and specificity over 3-week periods. Reinforcing negative PEth results alongside attendance may increase the proportion of participants who respond to CM during and post treatment. In the proposed study, the investigators will collect PEth samples every 3 weeks for 12 weeks in 150 participants initiating outpatient treatment for alcohol use disorders. Using a two-group randomized design, participants will be assigned to standard care with PEth monitoring alone or with CM for attending treatment and submitting PEth negative samples. Compared to standard care and monitoring, the investigators expect that the CM intervention will result in greater attendance, more PEth negative samples, and higher proportions of self-reported non-drinking days, along with lower proportions of heavy drinking days, over the short term and the long term, measured throughout a 12-month follow-up. The investigators anticipate that the reinforcement intervention may decrease other drug use and sexual risk behaviors that spread HIV, reduce psychiatric symptoms, and improve quality of life as well.

Official Title
-----------------
Dual Reinforcement Contingency Management for Alcohol Use Disorders

Conditions
-----------------
Alcohol Use Disorder, Contingency Management

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: in intensive outpatient treatment DSM-5 diagnosis of an alcohol use disorder Exclusion Criteria: have a condition that may hinder study participation

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 |
| --- | --- |
| Active Comparator: Control Group<br>Standard care | Behavioral: Standard care<br>* standard treatment for substance use disorders, along with sample monitoring<br>|
| Experimental: Experimental Group<br>Standard care plus contingency management | Behavioral: Standard care<br>* standard treatment for substance use disorders, along with sample monitoring<br>Behavioral: Contingency management<br>* Participants can earn reinforcement for attending group and abstinence from alcohol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Group attendance | longest consecutive days attended groups | 12 weeks | 
| Alcohol abstinence | number of negative PEth samples | 12 weeks |
A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.

Detailed Description
-----------------
The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.The trial will be complete in 2012.

Official Title
-----------------
Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia

Conditions
-----------------
Impaired Cognition, Schizophrenia

Intervention / Treatment
-----------------
* Drug: Donepezil
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of schizophrenia as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version; Between 18 and 40 years of age; Duration of the illness must be longer than 2 year; Patient's current antipsychotic medication regimen must be stable; Must be in a stable living arrangement; Exclusion Criteria: Patient has mental retardation or severe organic brain syndromes; Treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening; Has suicidal attempts or ideation or violent behavior within the last 12 months; Patient has a history of alcohol/drug dependence;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Placebo Comparator: placebo<br>Subjects will be given with a dose of 5mg/day placebo. All drugs will be administered orally. | Drug: placebo<br>* placebo 5mg/d<br>|
| Active Comparator: donepezil<br>Subjects will be given with a dose of 5 mg/day donepezil. All drugs will be administered orally. | Drug: Donepezil<br>* 5 mg/day<br>* Other names: Donepezil hydrochloride;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in the Composite Score From the Cognition Assessment Battery After 12 Weeks of Treatment |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change From Baseline in Cognition Assessment scores After 12 Weeks of Treatment |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Impaired Cognition Schizophrenia
Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe

Study Overview
=================
Brief Summary
-----------------
Magnetic resonance (MR) spectroscopic techniques are to be developed to obtain the best data possible at 3 Tesla (3T) for the prostate.

Official Title
-----------------
Optimization of Spectroscopic Imaging Parameters and Procedures for Prostate at 3 Tesla Using an External Probe

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject 18 years of age and over

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

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

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 |
| --- | --- | --- |
Shulman Fasciitis Prevalence Study in Alsace

Study Overview
=================
Brief Summary
-----------------
Shulman fasciitis or eosinophilic fasciitis (EF) is a rare inflammatory disease, usually benign but disabling, described by Shulman in 1974. The diagnosis is suggested by the clinic, confirmed by MRI and confirmed by histology, there really no published diagnostic criteria validated for this rare disease. The low number of cases reported in the literature reflects the difficulty of studying the epidemiology of this disease, to establish and evaluate therapeutic strategies and to assess prognosis. Work on this subject are few. To our knowledge, no study has previously used to estimate the incidence and prevalence of this disease. Therefore, the investigators want to determine the prevalence of FEs in Alsace in 2016 by a study capture-recapture using several independent sources of identification of cases in order to have recent epidemiological data and learn more about this disease.

Official Title
-----------------
Shulman Fasciitis Prevalence Study in Alsace

Conditions
-----------------
Shulman Fasciitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged over 18 years Patients suffering from fasciitis Shulmande and living in Alsace at 1 January 2016 Exclusion Criteria: refusal to participate in the study

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 |
| --- | --- | --- |
| Estimation of the prevalence of Shulman fasciitis in Alsace, the calculation will be carried out using the numerator of all the cases identified and in the denominator the general population (Alsatian population of both sexes) |  | all living patients in Alsace from 1 January 2016 to december 2016 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shulman, fasciitis, Shulman fasciitis, eosinophilic fasciitis, inflammatory disease, prevalence
Effectiveness and Costs of Enhanced Cocaine Treatments

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effectiveness, economic benefits, and costs of voucher reinforcement for cocaine and alcohol abstinence, additional counseling services, and their combination in a sample of cocaine dependent patients receiving outpatient treatment as usual in a community clinic.

Conditions
-----------------
Cocaine Dependence

Intervention / Treatment
-----------------
* Behavioral: Voucher Reinforcement
* Behavioral: Extra Counseling Services
* Behavioral: Voucher Reinforcement + Extra Counseling Services


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in an intensive outpatient program (IOP) for no more than 1 month Current DSM-IV diagnosis of cocaine dependence (month prior to IOP treatment) 18-65 years of age Ability to provide names of informants to help locate subject for follow-up Exclusion Criteria: IV heroin use in last year Acute medical/psychiatric diagnosis that precludes outpatient treatment Inpatient treatment for 6 weeks or more prior to IOP treatment Incarceration for 6 months or more prior to IOP treatment

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Voucher Reinforcement|nan|
|Behavioral: Extra Counseling Services|nan|
|Behavioral: Voucher Reinforcement + Extra Counseling Services|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953

Study Overview
=================
Brief Summary
-----------------
The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese subjects.

Official Title
-----------------
A Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSI-953 Administered Orally to Healthy Japanese Male Subjects and Healthy Elderly Male Japanese Subjects.

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

Intervention / Treatment
-----------------
* Drug: GSI-953


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy males aged 20 - 40 and healthy males aged greater than 65. Body mass index range of 17.6 - 26.4 kg/m2 greater than or equal to 45 kg. Non-smokers or smoker of fewer than 10 cigarettes a day.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 120 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose of GSI-953<br> | Drug: GSI-953<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants reporting Adverse Event | Safety | 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Japanese, Healthy, Alzheimers Disease
Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury

Study Overview
=================
Brief Summary
-----------------
To observe the changes of plasma ESM-1 levels in patients with ARDS, and to explore its clinical significance.

Detailed Description
-----------------
70 patients who diagnosed as ARDS were included in this study. Then keep blood samples from these patients in the first day, the third day and the seventh day, detect ESM-1 level in plasma by ELISA. Record Severity of illness and survival status of every patient within 28 days. Objective to evaluate the correlation between the level of ESM-1 in plasma and the prognosis of the patients.

Official Title
-----------------
Endothelial Cell Specific Molecule-1 (ESM-1): a Novel Biomarker for ARDS Endothelial Injury

Conditions
-----------------
Evaluate the Correlation Between the Level of ESM-1 and the Prognosis of the Patients With ARDS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to ICU diagnosed of ARDS (Berlin definition）in 48h Patients age between 18 years old and 80 years. Exclusion Criteria： Pregnant women, Patients with malignant tumor, Immunosuppression or immunocompromised patients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| ESM-1<5ng/ml<br> | |
| ESM-1≥5ng/ml<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 28-day |