linjc16/ctgov huggingface dataset:
Carboplatin Plus Vincristine in Treating Children With Retinoblastoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of carboplatin plus vincristine in treating children with retinoblastoma.

Detailed Description
-----------------
OBJECTIVES: I. Estimate the objective response rate in infants and children with retinoblastoma when treated with carboplatin (CBDCA) and vincristine (VCR) every 3 weeks for 24 weeks. II. Assess the success of this regimen in delaying radiotherapy and eliminating the need for surgery by estimating the cumulative incidence function of treatment failure. III. Estimate the cumulative incidence of failure of this regimen as measured by subsequent treatment with radiotherapy or surgery. OUTLINE: All patients receive carboplatin and vincristine every 3 weeks for a maximum of 8 courses. Patients with disease progression after at least 2 courses are removed from study and considered for alternative therapy. Patients are followed every 6 weeks for 1 year, every 2 months for 1 year, every 3-4 months for 3 years, and yearly for 12 years. PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study within 4.5 years.

Official Title
-----------------
Evaluation of Chemotherapy as Initial Treatment for Retinoblastoma

Conditions
-----------------
Retinoblastoma

Intervention / Treatment
-----------------
* Drug: carboplatin
* Drug: vincristine sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Newly diagnosed retinoblastoma Bilateral or multifocal unilateral disease in children under age 10 Unilateral, multifocal tumors less than 5 dd in children under age 2 No metastatic disease Disease evidenced by ophthalmoscopic/imaging exam, ultrasound, CT, or MRI Fundus drawings and photographs required PATIENT CHARACTERISTICS: Age: 10 and under Performance status: Not specified Life Expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: Not specified

Ages Eligible for Study
-----------------
Maximum Age: 10 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: carboplatin|nan|
|Drug: vincristine sulfate|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
-----------------
intraocular retinoblastoma
Compare Efficacy Nebulized and Intravenous Magnesium Sulphate in Thai Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether nebulized magnesium sulphate is effective in the treatment of acute severe asthma when comparison with intravenous magnesium sulphate

Detailed Description
-----------------
Intervention: At randomization eligible patients were allocated to receive 2.5ml of isotonic magnesium sulphate (150 mg,245 mmol/L) on three occasional at 20 minutes interval or standard treatment 50 mg/kg intravenous magnesium sulphate. The asthma severity score was record at 0,20,40,60,120,180,240 minutes post randomization. Adverse event were assessed at each assessment point. Patients were followed up until discharge from hospital to collect secondary outcome data.

Official Title
-----------------
Comparison Efficacy of Nebulized Magnesium Sulphate to Intravenous Magnesium Sulphate in Children With Severe Acute Asthma

Conditions
-----------------
Acute Severe Asthma

Intervention / Treatment
-----------------
* Drug: isotonic magnesium sulphate
* Drug: 50% magnesium sulphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children age 2-15 years presenting with severe asthma or persistent wheeze without responding to conventional therapy Exclusion Criteria: chronic lung disease history of adverse reaction form magnesium sulphate life threatening condition

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 15 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: isotonic magnesium sulphate<br>2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) on three occasional at 20 minutes interval | Drug: isotonic magnesium sulphate<br>* 2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval<br>* Other names: magnesium sulfate;|
| Active Comparator: 50% magnesium sulphate<br>magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose | Drug: 50% magnesium sulphate<br>* magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose<br>* Other names: magnesium sulfate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma severity score |  | 60 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the hospital |  | within 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnesium sulphate nebulized
Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers

Study Overview
=================
Brief Summary
-----------------
Cross - Sectional study requiring one visit at the investigators office for the data collection. Target Group: Patients that suffer from Bipolar Disorder Type 1. YMRS - HAMILTON and GAF scales are going to be used to assess the clinical outcome. The findings are going to be based on the different scores reported by Specialists (before the patients started to use as a therapy atypical antipsychotics / at the time that the visit actually takes place for the cause of the study.) We predefine the time period that the patient should be using atypical antipsychotics at minimum (2 months). The first 9 consecutive patients that visit the Specialist and meet the entry criteria and signs the ICF will be recruited in the study.

Official Title
-----------------
Subjective Well Being of Patients Receiving Atypical Antipsychotics as Monotherapy or Cotherapy With Mood Stabilizers

Conditions
-----------------
Bipolar Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are diagnosed with Bipolar Disorder Type 1 according to diagnostic criteria DSM - IV Patients that have started therapy with atypical antipsychotics as monotherapy or cotherapy with mood stabilizers the last three months, but have completed 2 full months of therapy. Patients with anxiety disorder can be recruited in the study unless it is dominant. Exclusion Criteria: Patients that use antidepressant medication Patients who were treated with depot antipsychotic in the last quarter before their enrollment in the study. Patients who are addicts of toxic substances. Patients who suffer from other serious diseases.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the scores reported in YMRS and Hamilton - D scales from baseline(start of therapy) |  | Assessment of the progress of disease 2 to 4 months after the initiation of the therapy(baseline) | 
| Assessment of functioning - Relative score reported in GAF scale |  | 2 - 4 months after the initiation of the therapy. No baseline comparison | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To depict sociodemographic characteristics and comorbidities. |  | Reported at the site visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bipolar Disorder, antipsychotics, social functioning, mood stabilizers, Bipolar Disorder Type I, atypical antipsychotics, monotherapy, cotherapy
Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects

Study Overview
=================
Brief Summary
-----------------
This study is intended to evaluate whether intravenous (iv) esomeprazole (Nexium® ) offers better intragastric acid suppression than iv lansoprazole (Prevacid ®

Official Title
-----------------
A Randomized, Open-Label, Comparative, Two-Treatment, Crossover Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects on Days 1 and 5 of Intravenous Treatment

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

Intervention / Treatment
-----------------
* Drug: Nexium
* Drug: Prevacid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be 18-70 years of age Participants can be male or female Women that are able to have children must have a negative pregnancy test. Exclusion Criteria: Involvement in or planning of this study Participation in another clinical study within 28 days of this one For women, pregnancy or attempting to become pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nexium|nan|
|Drug: Prevacid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to compare the pharmacodynamic efficacy in controlling intragastric pH of esomeprazole 40mg and lansoprazole 30mg on Day 5 of once daily IV administration to healthy volunteers. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcomes will compare additional efficacy and safety parameters. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
N/A this study is being conducted with healthy volunteers
Study of Genetic Anomalies of Complement Related Proteins in Patients With IgA Glomerulonephritis

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine whether allelic differences associated with the fourth component of complement, type-1 complement receptor expressed on erythrocytes, and Fc receptor FcgRIII contribute to the pathogenesis of IgA glomerulonephritis (IgA-N). II. Compare genetic anomalies of these key components in immune complex processing and clearance between juvenile vs adult onset IgA-N vs normal controls.

Detailed Description
-----------------
PROTOCOL OUTLINE: Participants undergo qualitative genetic analysis of complement-related proteins. Studies include: genomic re-arrangement of 4-gene unit, C4 DNA sequence and RNA expression, type-1 complement receptor DNA sequence, Fc-gamma receptor IIIA isoform analysis, classical and alternative complement activation pathway assays, plasma C4 and C4d protein levels, and immunoglobulin patterns in glomerular deposits.

Conditions
-----------------
IGA Glomerulonephritis

Participation Criteria
=================
Eligibility Criteria
-----------------
IgA glomerulonephritis

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IgA glomerulonephritis, rare disease, renal and genitourinary disorders
An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Study Overview
=================
Brief Summary
-----------------
This is an open-label protocol designed to provide continued access to maraviroc to only those subjects who have completed previous studies of maraviroc and continue to receive clinical benefit.

Official Title
-----------------
An Expanded Access Protocol for Subjects Who Have Completed Clinical Studies Involving Maraviroc

Conditions
-----------------
Infection, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: Continued Access Arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Subject has participated in a clinical trial that evaluated maraviroc and is continuing to derive clinical benefit from maraviroc treatment. Subject must agree to use an acceptable method of contraception for the duration of the study as outlined at the end of the inclusion criteria. Subject agrees to the specified study procedures. Exclusion Criteria: Subject who is an investigational site staff member or an employee of the Sponsor that is directly involved in the conduct of the trial. Other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. Contra-indications to use of maraviroc as described in the Investigator Brochure. Past documented dual/mixed or C-X-C chemokine receptor type 4 HIV tropism.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Continued Access Arm|All subjects will be on maraviroc 300 mg twice a day, unless a dose adjustment is required due to certain concomitant medications. For those subjects in South Africa and Argentina who were previously receiving Combivir along with maraviroc in Study A4001026, Combivir will be supplied as tablets containing 150 mg lamivudine and 300 mg zidovudine. One Combivir tablet will be taken orally twice a day.|

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
-----------------
Expanded access, HIV, maraviroc
REDUCE LAP-HF III Corvia Protocol 1701

Study Overview
=================
Brief Summary
-----------------
This is a post market trial to be conducted at sites in Germany. The device has CE approval in the EU. The purpose of this observational registry is to collect post market data in consecutive patients treated with the IASD System II, to further evaluate efficacy, safety and quality of life outcomes as a new treatment for patients with heart failure in a real world practice setting.

Official Title
-----------------
A Post-Market Clinical Follow-up Study to Evaluate the Corvia Medical, Inc. InterAtrial Shunt Device - IASD® System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: IASD Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
This is a post market registry so no criteria requirements (only recommendations).

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

| Intervention/Treatment |
| --- |
|Device: IASD Implant|Implantation of the IASD device using trans-septal puncture and the IASD system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious Adverse Events | Device and or procedure related serious adverse cardiac events | 30 days | 
| New York Heart Classification | Improvement in NYHA Classification | 12 months | 
| Quality of Life Improvement (KCCQ score) | Improvement in KCCQ score | 12 months | 
| Quality of Life Improvement (EQ5D) | Improvement in EQ5D score | 12 months |
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne

Study Overview
=================
Brief Summary
-----------------
To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12 weeks.

Official Title
-----------------
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne

Conditions
-----------------
Post - Adolescence Acne

Intervention / Treatment
-----------------
* Drug: 2% ketoconazole cream
* Drug: Hydrophilic Cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: regular menstrual cycle with mild degree of post - adolescence acne agree to stop topical and systemic medication for acne treatment for 2 and 4 weeks respectively. Exclusion Criteria: Pregnancy or lactation Other active rashes on faces. Allergic to ketoconazole or other ingredients of preparation. Signs of hyperandrogenism Taking anti-androgenic medications.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 Years

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2% ketoconazole cream<br>2% ketoconazole cream apply on face twice daily for 10 weeks. | Drug: 2% ketoconazole cream<br>* 2% ketoconazole cream applies twice daily<br>|
| Placebo Comparator: Placebo<br>Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks. | Drug: Hydrophilic Cream<br>* Hydrophilic cream (in-house preparation) applies twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total numbers of acne reduction | the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment) | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieve clear or almost clear after treatment | clear or almost clear scored by Adult Female Acne Scoring Tool | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post - adolescence acne, Topical 2% ketoconazole cream
Percutaneous Electric Neurostimulation of Dermatome T7 Improves Glycemic Profile in Obese and Typo 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
Percutaneous neurostimulation of dermatome T7 increases Insulin segregation by the apancreas and improves glycemic profile in diabetic patients

Conditions
-----------------
Diabetes Mellitus Type 2 in Obese, Type 2 Diabetes Mellitus With Features of Insulin Resistance

Intervention / Treatment
-----------------
* Device: Percutaneous Neurostimulation (PENS) of dermatome T7
* Other: 1200 Kcal diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI>30 Kg/m2 Type 2 diabetes mellitus Treatment with Metformin Exclusion Criteria: Under insulin treatment Endocrinological disorders causing diabetes mellitus

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diet<br>The patients follow only a 1200 Kcal diet | Device: Percutaneous Neurostimulation (PENS) of dermatome T7<br>* The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet<br>Other: 1200 Kcal diet<br> <br> |
| Experimental: Diet +PENS dermatome T7<br>The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet | Device: Percutaneous Neurostimulation (PENS) of dermatome T7<br>* The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum glucose levels (mg/dl) | Serum glucose levels will be recorded will be recorded at baseline and 12 weeks after beginning the treatment. Measurement units will be mg/dl. | Baseline and 12 weeks after beginning the therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Homeostasis model assessment (HOMA) | Insulin resistance will be recorded by the Homeostasis model assessment (HOMA). The calculation formula is: Serum Glucose x Serum Insulin / 405 | Baseline and 12 weeks after beginning the therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous neurostimulation; dermatome T7, type 2 diabetes