linjc16/ctgov huggingface dataset:
Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease

Study Overview
=================
Brief Summary
-----------------
Evaluate the effectiveness and acceptability of care given by nurse specialists in out patient clinics, through a randomized controlled study.

Detailed Description
-----------------
This study is part of a national multicenter study (NOR-DMARD) that aims to measure the longterm safety and effectiveness of disease modifying therapies in inflammatory arthropathies. The Nor-Dmard study is a comparative, phase IV, longitudinal, observational study. All patients starting a DMARD regime are enrolled. Patients from two clinics (different parts of Norway) will be randomised to receive follow-up care from either a clinical nurse or a rheumatologist. The primary outcome measure is patient satisfaction measured by Leeds Satisfaction Questionnaire. The secondary outcome is effectiveness measured by Coping (CORS),Health related quality of life (SF-36) and Disease activity (MHAQ, DAS-28).

Official Title
-----------------
Nursing Consultation in Out-patient Clinics for Patients With Inflammatory Rheumatic Disease

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Other: Follow up bu a nurse
* Other: Follow up by a medical doctor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with inflammatory arthropathies monitored after starting disease modifying antirheumatic drugs.

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: Follow up by nurse<br>Patient randomized for follow-up by a nurse | Other: Follow up bu a nurse<br>* Follow up bu a nurse<br>|
| Experimental: follow up by medical doctor<br>Patients randomized for follow up by a medical doctor | Other: Follow up by a medical doctor<br>* Follow up by a medical doctor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction |  | 12 mnths and 24 mnths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | 12 mnths and 24 mnths | 
| Disease activity |  | 12 mnths and 24 mnths | 
| coping |  | 12 mnths and 24 mnths | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nurse practitioner, rheumatology care, outpatient clinic, patient satisfaction
The Impact of Family CTI on Homeless Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine how services and housing provided for homeless families affect the mental health and behavior of homeless children over time.

Detailed Description
-----------------
This study is a supplement to a parent study which concentrates on the outcomes of homeless mothers who are provided with services and housing. This study will focus on the effects of housing and services on children, who may be the major beneficiaries of such assistance. Participants are randomly assigned to either receive services and permanent housing or to remain in a homeless shelter without additional assistance. Children and their parents are interviewed separately 3, 9, and 15 months after study entry. The teachers of participating children are surveyed twice during the study.

Official Title
-----------------
The Impact of Family CTI on Homeless Children

Conditions
-----------------
Mental Health

Intervention / Treatment
-----------------
* Behavioral: Critical Time Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in the parent study Homeless and living at a shelter with mother/maternal guardian at the time of study enrollment

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 16 Years

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Critical Time Intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internalizing, externalizing, school outcomes |  | 18 months post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Homeless Persons
A Study of the Safety of PAZ-417 in Healthy Elderly Adults

Study Overview
=================
Brief Summary
-----------------
This is study to determine the safety of PAZ-417 in healthy adults over 65.

Official Title
-----------------
An Ascending Multiple-Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of PAZ-417 Administered Orally to Elderly Subjects

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

Intervention / Treatment
-----------------
* Drug: PAZ-417


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: A signed and dated IRB-approved informed consent form before any study specific screening procedures are performed. Ability to read English or Spanish. Men or women greater than or equal to 65 years of age on study day 1. Women must be either surgically sterile (hysterectomy and/or oophorectomy) or postmenopausal for greater than or equal to 1 year (with estradiol less than or equal to 25 pg/mL[92 pmol/L] and FSH greather than or equal to 38 mIU/mL) and must have a negative serum pregnancy test result within 48 hours before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound. Subjects should have a hemoglobin level greater than or equal to 12 g/dL at the screening visit. Exclusion Any significant unstable or uncontrolled cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. History of vascular disorders (peripheral, coronary, venous), chronic inflammatory disorders (eg, rheumatoid arthritis), hematologic disorders, or bleeding disorders (eg, hemophilia, idiopathic thrombocytopenic purpura, VonWillebrand disease). Presence or history of symptomatic vertigo, significant cardiac valvular disease, congestive heart failure, angina pectoris significant cardiac arrhythmia, or seizures.

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

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

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: arm 1<br> | Drug: PAZ-417<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety as determined by adverse events, ECGs, vitals signs, and laboratory test results |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug distribution in the blood |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy subjects over 65, healthy subjects
Search for Prognostic Factors Associated With Better Survival in Refractory Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Through this retrospective observational study (over 4 years; period analysed: 1st January 2011 to 31st December 2014), we looked for prognostic factors associated with better survival in refractory cardiac arrest by: assessing the overall survival rate evaluating the frequency of intra et extra-hospital events and by comparing these with the survival rate studying no flow, low flow, rhythm at initial management, troponinemia, lactatemia and blood pH in the different groups.

Official Title
-----------------
Prognostic Factors in Refractory Cardiac Arrest Treated With Extracorporeal Life Support at Dijon CHU

Conditions
-----------------
Cardiac Arrest (CA), ExtraCorporeal Life Support (ECLS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with in-hospital or out-of-hospital refractory CA who underwent ECLS Exclusion Criteria: CA occurring during cardiac surgery Age > 75 years or < 18 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Survival rate |  | at baseline | 
| Death rate |  | at baseline |
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone.

Study Overview
=================
Brief Summary
-----------------
Gingival Pyogenic granuloma in the esthetic zone represents an esthetic problem. While surgical treatment may not give the premium esthetic demands, corticosteroid may acheive this balance.

Detailed Description
-----------------
In our practice, the investigators have found the use of topical steroids effectively induced regression of PGs. This protocol has been suggested by published case reports supported by the anti-inflammatory actions corticosteroid. This is a particularly valuable approach for patients who have PG in the esthetic zone allowing the surgeon to keep maximum amount of periodontal tissues.

Official Title
-----------------
Corticosteroid Intralesional Injection as an Alternative Treatment in Oral Pyogenic Granuloma in the Esthetic Zone

Conditions
-----------------
Oral Pyogenic Granuloma

Intervention / Treatment
-----------------
* Drug: Solu-Cortef


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with oral pyogenic granuloma at the esthetic zone Exclusion Criteria: Patients who were not compliant to oral hygiene instructions and can not be motivated
Sexes Eligible for Study
-----------------
All

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

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 arm<br>Surgical excision of the gingival pyogenic granuloma | Drug: Solu-Cortef<br>* A vial sol. used for intra-mascular injection<br>* Other names: Hydrocortisone;|
| Experimental: Intervention<br>Intralesional injection with corticosteroids solution (1.8 mL of 100 mg hydrocortisone) | Drug: Solu-Cortef<br>* A vial sol. used for intra-mascular injection<br>* Other names: Hydrocortisone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remaining width of the attached gingiva | Remaining width of the attached gingival it is measured using graduated probe | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of the lesion | Assessed as clinical reoccurrence of the lesion at the same site | 6 months |
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The trial is designed to show the effect of treatment with liraglutide or placebo on blood glucose control after 14 weeks in subjects with type 2 diabetes. Liraglutide or placebo is administered by injection once daily in the evening. The trial is a multi-national trial with treatment concealed to participating subjects, investigators and the sponsor. Treatment allocation is random with equal chance of being assigned to each group.

Official Title
-----------------
Effect of Liraglutide on Glycaemic Control in Subjects With Type 2 Diabetes.

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with type 2 diabetes mellitus and treated with either diet or single oral drug therapy Diet treated subjects: 7.5% < HbA1c < 10% Single oral drug therapy subjects: 7.0% < HbA1c < 9.5% Body Mass Index (BMI): max 40 kg/m^2 Exclusion Criteria: Subjects treated with thiazolidinediones or insulin Subjects with any serious medical conditions

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 14 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight after 14 weeks. |  |  | 
| Glycaemic control parameters (fasting plasma glucose, glucose profiles) after 14 weeks. |  |  | 
| Safety and tolerability |  |  |
Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
prospective cardio respiratory evaluation for patients post the Fontan palliation for single ventricle, compared to subjects post successful cardiac repaired surgery compared to healthy volunteers in order to evaluate the functional capacity and the primary etiology for reduction in functional capacity.

Official Title
-----------------
Cardio Pulmonary Exercise Testing in Patients Post the Fontan Palliation in Comparison With Patients With Repaired Congenital Heart Disease and Healthy Volunteers.

Conditions
-----------------
Fontan Palliation, Congenital Heart Disease

Intervention / Treatment
-----------------
* Other: Cardio Pulmonary Exercise Testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children at age of 8-25 post fontan palliation Patients With Repaired Congenital Heart Disease without chronic lung disease Healthy patients ate age of 8-25 Exclusion Criteria: Patients with chronic lung disease Pregnant women Patients with acute active disease or chronic disease that may affect the exercise function

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 25 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 post Fontan palliation for single ventricular hear<br>Cardio Pulmonary Exercise Testing | Other: Cardio Pulmonary Exercise Testing<br>* Cardio Pulmonary Exercise Testing<br>|
| Subjects post surgical correction of congenital heart disease<br>Cardio Pulmonary Exercise Testing | Other: Cardio Pulmonary Exercise Testing<br>* Cardio Pulmonary Exercise Testing<br>|
| Healthy patients<br>Cardio Pulmonary Exercise Testing | Other: Cardio Pulmonary Exercise Testing<br>* Cardio Pulmonary Exercise Testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing Cardio Pulmonary Exercise function between the three groups in the study |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Repaired Congenital Heart Disease, Cardio Pulmonary Exercise Testing, Fontan, Fontan Palliation, functional capacity
Impact Evaluation of the Steps to Success Program

Study Overview
=================
Brief Summary
-----------------
The evaluation will examine whether the Steps to Success enhanced home visits are more effective at delaying repeat pregnancies than are traditional Healthy Families home visits.

Official Title
-----------------
Impact Evaluation of the Steps to Success Program

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Behavioral: Steps to Success
* Behavioral: Traditional Healthy Families


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 14 to 21 Pregnant, or have delivered a child in the last three months

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Steps to Success<br>Steps to Success enhanced home visits-including instruction for both young mothers and fathers on contraception, comprehensive sex education, and the importance of adequate birth spacing, and accompanied by group sessions on adulthood preparation topics. | Behavioral: Steps to Success<br> <br> |
| Active Comparator: Traditional Healthy Families<br>Traditional Healthy Families home visits which cover topics of parenting and child development | Behavioral: Traditional Healthy Families<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsequent pregnancy |  | 2-years post random assignment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subsequent pregnancy |  | 1-year post random assignment |
Optical Coherence Tomography Angiography and Choroidal Osteoma

Study Overview
=================
Brief Summary
-----------------
This study evaluates the vessel density of choriocapillary vascular network in eyes affected by choroidal osteoma and in eyes complicated by choroidal neovascularization, using optical coherence tomography angiography.

Detailed Description
-----------------
The choroidal osteoma is a rare benign tumor of choroid, it is bilateral in 10%-25% of cases, affecting usually young women. Previous studies evaluated the morphologic characteristics of tumor-related vasculatures, described as a seafun vascular networks, but none focused on study of vessel density of coriocapillary. The aim of this study is to investigate the potential role of the optical coherence tomography angiography (OCTA) in evaluating the choriocapillary vessel density in order to individuate the changes of this vascular network that may influence the onset of choroidal neovasculariztion. Therefore, OCTA could be useful in the clinical management of the choroidal osteoma

Official Title
-----------------
Optical Coherence Tomography Angiography in Choroidal Osteoma: a Quantitative Evaluation of Choriocapillary Vessel Density

Conditions
-----------------
Choroidal Osteoma, Bilateral

Intervention / Treatment
-----------------
* Diagnostic Test: Optical coherence tomography angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 50 years diagnosis of choroidal osteoma absence of history of vitreoretinal and vascular retinal diseases Exclusion Criteria: age younger than 50 years no diagnosis of choroidal osteoma presence of history of vitreoretinal and vascular retinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Optical coherence tomography angiography|To evaluate the vessel density in choriocapillary vascular networks, using optical coherence tomography angiography|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of vessel density of the choriocapillary in patients affected by choroidal osteoma . | To evaluate the role of optical coherence tomography angiography in evaluating the features of the choriocapillary, using optical coherence tomography angiography (OCTA) in patients with choroidal osteoma and in patients with choroidal osteoma complicated by choroidal neovascularization. The parameter analyzed by OCTA was the vessel density of choriocapillary (percent) | 7 years |