linjc16/ctgov huggingface dataset:
Phase II Study of Pallidotomy for Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Evaluate the safety and efficacy of pallidotomy immediately following 3 preoperative assessments vs. delayed pallidotomy following 6 months of standard medical therapy in patients with Parkinson disease.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized study. One group of patients undergoes the surgical procedure pallidotomy, a precise lesioning of brain cells in the globus pallidus. The other group receives standard medical care for 6 months followed by a pallidotomy.

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Procedure: pallidotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Idiopathic Parkinson disease Hoehn and Yahr stage III or worse during off periods Responsive to levodopa by history or exam Sub-optimal clinical response to maximal medication Medication optimized for at least 4 weeks prior to entry No atypical or secondary disease, e.g.: No history of cerebrovascular accident No cerebellar involvement No severe brain atrophy on magnetic resonance imaging No Mattis Dementia Rating Scale score less than 116 No dementia meeting Diagnostic and Statistical Manual of Mental Disorders-IV criteria No Hamilton Depression Rating Scale score greater than 10 No Hamilton Anxiety Scale score greater than 14 --Patient Characteristics-- Other: No medical contraindication to surgery, e.g.: Diabetes Cardiopulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: pallidotomy|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
-----------------
Parkinson disease, neurologic and psychiatric disorders, rare disease
Study In Asthma Control

Study Overview
=================
Brief Summary
-----------------
This study will compare patients treated with a marketed medication and those who continue with their usual care to assess the proportion of patients achieving well controlled asthma after 24 weeks.

Official Title
-----------------
An Open-label, Multi-centre, Randomized, Parallel Group Clinical Effectiveness Study to Determine the Level of Asthma Control in Adolescent and Adult Patients With ADVAIR Versus Usual Care for 24 Weeks.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: salmeterol xinafoate/fluticasone propionate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: documented clinical history of asthma and receiving regular maintenance therapy. Exclusion Criteria: Using oral/parenteral or depot corticosteroids within 12 weeks of visit 1. History of heavy smoking or substance abuse. Females who are pregnant or lactating. Required emergency room treatment for their asthma 12 weeks prior to Visit 1. Serious, uncontrolled, systemic disease that may make study participation unsafe or inappropriate in the opinion of the physician. Other medical criteria will be evaluated at the screening visit.

Ages Eligible for Study
-----------------
Minimum Age: 12 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

| Intervention/Treatment |
| --- |
|Drug: salmeterol xinafoate/fluticasone propionate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving well-controlled asthma at the end of the treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving total asthma control as defined by the Canadian Asthma consensus guidelines at the end of the treatment period. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma Advair
A Long Term Roll-over Study to Investigate the Efficacy and Safety of Adalimumab Given Long-term to Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in patients with rheumatoid arthritis

Official Title
-----------------
A Multi-Centre Open Label Continuation Study With Subcutaneous D2E7 (Adalimumab) for Patients With Rheumatoid Arthritis Who Completed a Preceding Clinical Study With D2E7 (Adalimumab)

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of a previous D2E7 study Subject is in good health (Investigator discretion) with a recent stable medical history Exclusion Criteria: Former enrollment in this trial (DE018) Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study Female subject who is pregnant or breast feeding or considering becoming pregnant.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adalimumab 40mg subcutaneous (SC) every other week (EOW)<br>Adalimumab 40mg subcutaneous (SC) every other week (EOW) | Biological: Adalimumab 40 mg subcutaneous (SC) every other week (EOW)<br> <br> * Other names: Humira;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response indicators |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety parameters |  | 5 years |
Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children

Study Overview
=================
Brief Summary
-----------------
India's poor tribal communities have far worse health and social indicators than the general population. Most tribal people live in remote forested or desert areas where illiteracy, trying physical environments, malnutrition, inadequate access to potable water, and lack of personal hygiene and sanitation make them more vulnerable to disease.The aim of Chhatralaya initiatives taken by Arsha Vidya, Jaipur was to address the exclusion of the socially and economically disadvantaged children of the tribes and to provide a fair opportunity to all.

Official Title
-----------------
Study of Arsha Vidya Chhatralaya Initiative on Health and Functioning of Disadvantaged Tribal Children

Conditions
-----------------
Physical Disorder, Mental Health Wellness, Social Function Disorder, Childhood or Adolescent, Malnutrition

Intervention / Treatment
-----------------
* Other: Chhatralaya


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children selected from Udaipur tribal areas as lacking parental care and basic services; Children living in Udaipur tribal areas; Children from 8 years to 16 years of age Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 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 |
| --- | --- |
| Arsha Vidya Chhatralaya<br>Chhatralaya is residential setting for children 8 to 16 years old. It provides residence,food and education opportunities along with regular practice of Yoga, Spiritual sessions and vedic practices to learn and follow. | Other: Chhatralaya<br>* Chhatralaya, home for children provide living resources along with spiritual practices.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical health and wellbeing | Measured by MacArthur Health and Behavior Questionnaire | Change from baseline to one year | 
| Mental Health and wellbeing | Measured by MacArthur Health and Behavior Questionnaire | Change from baseline to one year | 
| Social functioning | Measured by MacArthur Health and Behavior Questionnaire | Change from baseline to one year | 
| Academic functioning | Measured by MacArthur Health and Behavior Questionnaire | Change from baseline to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight | child's weight was measured by using a calibrated electronic weighing scale | Change from baseline to one year | 
| Prevalence of acute child malnutrition | To calculate WHZ scores the 2006 WHO growth reference was used | Change from baseline to one year |
Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease

Study Overview
=================
Brief Summary
-----------------
in this study the investigators will test anew technique to mange patients with morbid obesity and GERD by doing sleeve gastrectomy plus cruroplasty and omental rape around the gastroesophageal junction

Detailed Description
-----------------
in this study the patients that have morbid obesity concomitant GERD will managed by sleeve gastrectomy plus cruroplasty then stripe from the momentum is fashioned and is raped around the gastroesophageal junction

Official Title
-----------------
Sleeve Gastrectomy With Cruroplasty and Omental Rape for Treatment of Morbid Obesity With Reflux Disease

Conditions
-----------------
GERD, Obesity, Morbid

Intervention / Treatment
-----------------
* Procedure: sleeve gastrectomy+ cruroplasty+ omental rap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese patients with BMI more than 40 with or without co-morbidity or more than 35 with co-morbidity patients fit for laparoscopic surgery give approval to share in the study Exclusion Criteria: patients refused to share in the study patients unfit for surgery patients aged less than 18 and older than 60 patient with previous upper abdominal surgery either for obesity or other diseases revisional bariatric procedures

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sleeve gastrectomy+ cruroplasty + omental rape<br>sleeve gastrectomy+ cruroplasty + omental rape | Procedure: sleeve gastrectomy+ cruroplasty+ omental rap<br>* sleeve gastrectomy+ cruroplasty+ omental rap<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effect on GERD | change in GERD symptoms using either upper GIT endoscopy or GERDQ questionnaire | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss | the effect on weight loss determined by percentage of excess weight loss, percentage of total weight loss and change of BMI | 12 months | 
| comorbidities | change in comorbidities including diabetes by change in hemoglobin C level, hypertension by measuring arterial blood pressure using sphygmomanometer | 12 months |
Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release

Study Overview
=================
Brief Summary
-----------------
Characterize the steady-state pharmacokinetics of morphine after oral administration of Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to compare their pharmacokinetics to that of AVINZA.

Official Title
-----------------
A Single Dose, Three-Period, Three-Treatment, Six-Sequence, Three-Way Crossover Comparative Bioavailability Study of Morphine Sulfate Immediate Release Tablets and Solution and Controlled Release Capsules Under Steady-State Conditions.

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: morphine sulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to morphine sulfate or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: morphine sulfate|morphine sulfate 30 mg tablet, morphine sulfate 15 mg tablet, morphine sulfate controlled release 120 mg|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence determined by statistical comparison Cmax |  | 15 days |
A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of 7 days treatment with LEO 29102 in adult patients with atopic dermatitis.

Official Title
-----------------
A Safety, Tolerability and Pharmacokinetic Study of LEO 29102 in Subjects With Atopic Dermatitis

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: LEO 29102 cream
* Drug: LEO 29102 placebo cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-55 years Atopic dermatitis of 850-1700cm2 In good health Criteria for exclusion: Co-morbid conditions Hepatic dysfunction Clinical infection Immunocompromised status Clinically significant illness Use of immunomodulating treatment Medications related to respiratory system or to heart rhythm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LEO 29102 cream 0.3 mg/g<br> | Drug: LEO 29102 cream<br>* Twice daily application for 7 days<br>|
| Active Comparator: LEO 29102 cream 1.0 mg/g<br> | Drug: LEO 29102 cream<br>* Twice daily application for 7 days<br>|
| Active Comparator: LEO 29102 cream 2.5 mg/g<br> | Drug: LEO 29102 cream<br>* Twice daily application for 7 days<br>|
| Placebo Comparator: LEO 29102 placebo cream<br> | Drug: LEO 29102 placebo cream<br>* LEO 29102 placebo cream<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events, laboratory testing, ECG, vital signs |  | Day 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of LEO 29102 cream in the treatment of AD |  | Day 9 |
SBRT in 4 Fractions for Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This is a prospective multicentric phase-I-II pilot feasibility study. The main objective is to study early and late side effects of hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days.

Official Title
-----------------
Phase I-II Study of High Dose SBRT in 4 Fractions for Intermediate Risk Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Other: SBRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≤ 85years. WHO performance status ≤ 2. PSA>10 and ≤ 20 ng/ml or Gleason Score 7 or T2a-T2c. Histologically proven prostate adenocarcinoma No pathologic lymph nodes on CT/ MRI scan. No distant metastases. No previous prostate surgery other than TURP (at least 6 weeks interval before initiation of RT). No malignant tumours in the previous 5 years. IPSS 0-7. Combined HT according to risk factors. Informed consent. Exclusion Criteria: Prostate size greater than 60cc. Previous TURP less than 6 weeks before radiotherapy. Previous prostate surgery other than TURP. Diabetes *. Use of anticoagulants drugs *. Chronic inflammatory bowel disease *. Previous pelvic irradiation. Inability to obtain written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBRT in 4 fraction<br>Selected intermediate risk prostate cancer patients treated with 4 fraction SBRT | Other: SBRT<br>* hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity assessment of 4 fractions SBRT in selected intermediate risk prostate cancer patients. | Toxicity assessment: The presence and grading (CTAE v3/ EORTC-RTOG) of adverse events will be recorded. | up to 5 years | 
| Tumour response to local radiation therapy by assessing freedom from biochemical failure. | Tumour response is evaluated on ASTRO DEFINITION of PSA relapse (+2 from Nadir of PSA). | up to 5 years |
Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.

Detailed Description
-----------------
This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.

Official Title
-----------------
Randomized Comparison of Two Dose and Frequency Regimens of Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

Conditions
-----------------
Pleural Effusion, Empyema

Intervention / Treatment
-----------------
* Drug: Alteplase


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent Age greater or equal to 18 yrs Presence of empyema or CPE Exclusion Criteria: Active internal bleeding Pregnancy Prior enrollment in this study Platelet count less than 100,000/mm3 Use of warfarin sodium if INR is greater than 1.7 Use of heparin unless the PTT is less than 1.5 times baseline normal Known neurological disorders Current or pre-existing bleeding dyscrasia Known allergy to Alteplase

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: Alteplase|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for surgical intervention via thoracostomy or open decortication as a result of conservative therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  |  | 
| Hospital length of stay |  |  | 
| Daily chest tube drainage |  |  | 
| Radiographic improvement |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Empyema, Alteplase, Complicated Parapneumonic Effusion