linjc16/ctgov huggingface dataset:
Phase II Randomized Study of Alendronate Sodium for Osteopenia in Patients With Gaucher's Disease

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the efficacy of alendronate sodium in treating osteopenia (generalized bone density and focal bone lesions) in patients with Gaucher's disease.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study. All patients receive oral calcium carbonate and cholecalciferol daily. Patients are randomized to receive oral alendronate sodium or placebo daily for 24 months. Patients are followed every 6 months for 2 years. Completion date provided represents the completion date of the grant per OOPD records

Conditions
-----------------
Gaucher's Disease, Osteopenia

Intervention / Treatment
-----------------
* Drug: alendronate sodium
* Drug: calcium carbonate
* Drug: cholecalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of type 1 Gaucher's disease enzymatically proven to have acid beta glucosidase deficiency Must have been on stable dose (8-60 U/kg/every 2 weeks) of alglucerase enzyme therapy (Cerezyme or Ceredase) for at least 24 months Lumbar spine bone density below the mean for age, sex, and race --Prior/Concurrent Therapy-- At least 6 months since prior medications that directly affect skeletal metabolism including, but not limited to, bisphosphonates, calcitonin, parathyroid hormone, or estrogen --Patient Characteristics-- Renal: No chronic renal failure; No recurrent renal stones Esophageal: No history of dysphagia; No frequent heartburn; No esophagitis requiring treatment Other: No untreated hyperthyroidism or hypothyroidism; No concurrent hyperparathyroidism; No concurrent malignancy; No history of alcohol or drug abuse; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: alendronate sodium|nan|
|Drug: calcium carbonate|nan|
|Drug: cholecalciferol|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
-----------------
Gaucher's disease, inborn errors of metabolism, rare disease, sphingolipidoses
Study About Predicting Fluid Responsiveness in Children Undergoing Neurosurgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate static and dynamic parameters, echocardiographic parameters, and pleth variability index for predicting fluid responsiveness in children. Children who need volume expansion will receive colloid 10 mL/kg. Blood pressure, heart rate, central venous pressure, systolic pressure variation, pulse pressure variation, delta down, aortic blood flow velocity variation, inferior vena cava diameter variation, and pleth variability index will be measure before and after volume expansion. Patients will be classified as responders to volume loading if stoke volume index increase by at least 15%.

Conditions
-----------------
Fluid Responsiveness

Intervention / Treatment
-----------------
* Other: volume expansion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neurosurgery under general anesthesia < 8 years old Exclusion Criteria: cardiac disease pulmonary, renal and hepatic disease infectious disease hematologic and muscular disease

Ages Eligible for Study
-----------------
Maximum Age: 8 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: volume expansion|fluid loading of 10 mL/kg colloid (voluven)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stoke volume index | Volume loading will be performed for 20 minutes. Stroke volume will be meausred before and after volume expansion | before and after volume loading (20 minutes) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pulse pressure variation, systolic pressure variation, central venous pressure, aortic blood flow velocity variation, pleth variability index
Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to compare the effects of oral roflumilast with placebo on lung function in patients with asthma.

Official Title
-----------------
A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma

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

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Persistent bronchial asthma No change in asthma treatment within 4 weeks prior to visit 1 Non-smoker or ex-smoker (for 12 months or longer) Main Exclusion Criteria: Poorly controlled asthma or seasonal asthma History of lower airway infection four weeks prior to visit 1 Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1 Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1 Patients with chronic heart failure Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in lung function from baseline to final visit. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function variables |  |  | 
| diary variables |  |  | 
| quality of life variables |  |  | 
| time to first exacerbation |  |  | 
| number of asthma exacerbations |  |  | 
| safety. |  |  |
Quality of Life in Chinese Postmenopausal HR(+) Early Breast Cancer (EBC) Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate quality of life (Qol) in postmenopausal HR (+) EBC patients during adjuvant AIs treatment in terms of: the change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. This study will recruit approximately 500 patients from 21 sites in China. The patients should be postmenopausal HR (+) EBC patients who have already start adjuvant AIs treatment but within 7 days.

Official Title
-----------------
A Prospective, Multicenter, Non-interventional Study to Evaluate Quality of Life in Chinese Postmenopausal HR(+) EBC Patients During Adjuvant Aromatase Inhibitors(AIs) Treatment

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postmenopausal women ≤ 70 years old, with histologically proven HR (+) early breast cancer. Undergoing upfront AIs adjuvant treatment within 7 days. Exclusion Criteria: Patients who disagree to participate this study Patients who, for whatever reason (eg, confusion, infirmity), are unlikely to comply with trial requirements. The AIs have not been approved by SFDA for the indication of upfront adjuvant endocrine therapy in early breast cancer.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 24 months. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of the trial outcome index (TOI) of the FACT-B questionnaire from baseline to 6 months, 12 months and 18 months |  | 6-18 months | 
| The change of the emotional well-being (EWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months |  | 6-18 months | 
| The change of the social well-being (SWB) subscales score of the FACT-B questionnaire from baseline to 6 months, 12 months, 18 months and 24 months. |  | 6-18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, postmenopausal HR(+), Early Breast Cancer, adjuvant AI treatment, Quality of Life in Chinese postmenopausal HR(+) EBC patients during adjuvant Aromatase Inhibitors(AIs) treatment
Daily Activity After Corticosteroids Injection Among Knee Osteoarthritis Patients

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to objectively measure daily physical activity and spatiotemporal gait pattern, as well as improvements in self reported symptoms and quality of life, before and six weeks after an intra-articular corticosteroids injection in patients suffering from knee osteoarthritis. Fourteen patients with unilateral knee osteoarthritis were recruited. The intra-articular corticosteroid injection was given at the end of the second week. Physical activity was objectively measured by an accelerometer worn by the participants for eight weeks. In addition, the Western Ontario and McMaster Universities Arthritis Index (WOMAC), the Medical Outcome Study Short Form-36 (MOS-SF36) and gait trials were completed every two weeks to assess symptoms, quality of life and spatiotemporal parameters of gait.

Official Title
-----------------
Quantification of Daily Physical Activity After an Intra-articular Corticosteroid Injection in Patients With Knee Osteoarthritis

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Corticosteroids injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 years old or more Medial knee osteoarthritis (Kellgren & Lawrence Grade I to III) Exclusion Criteria: Intra-articular injection during the last six months Isolated femoro-patellar arthritis Rheumatoid arthritis Knee instability Spinal stenosis Lower limb fracture over the last year Lower limb surgery in the last three months

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Injection<br>Corticosteroids injection | Drug: Corticosteroids injection<br>* A solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knee pain |  | Change from Baseline at 2, 4 and 6 weeks | 
| Change in physical activity |  | Change from baseline at 2, 4 and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in function and quality of life | Assessment with WOMAC and MOS-SF36 questionnaires | Change from baseline at 2, 4 and 6 weeks | 
| Change in Spatiotemporal gait parameters | Gait symmetry was verified with regards to the swing and stance phase durations and step length | Change from Baseline at 2, 4 and 6 weeks |
Determine Long-Term Safety and Tolerability of Pregabalin in Patients With Anxiety Disorders.

Study Overview
=================
Brief Summary
-----------------
Determine long-term safety and tolerability of pregabalin in patients with anxiety disorders.

Official Title
-----------------
A 1-Year Open-Label Safety Extension Study of Pregabalin in Patients With Anxiety Disorders

Conditions
-----------------
Anxiety Neuroses

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have completed the double-blind portion of the preceding trial Completed any protocol specified withdrawal phase and follow-up visits. Exclusion Criteria: Patient cannot participate if they experienced a serious adverse event or a nonserious, but medically significant adverse event during the preceding efficacy study that was judged to be related to the study medication.

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Tolerability |  |  |
IntellaTip MiFi XP Ablation Catheter Trial

Study Overview
=================
Brief Summary
-----------------
A study to assess the performance of a new catheter design for the treatment of Atrial Flutter.

Detailed Description
-----------------
A prospective, non-blinded, single arm, single center study designed to assess the performance of the IntellaTip MiFi XP Ablation Catheter for the treatment of recurrent or sustained type I atrial Flutter.

Official Title
-----------------
IntellaTip MiFi XP Ablation Catheters First in Human Use Trial

Conditions
-----------------
Atrial Flutter

Intervention / Treatment
-----------------
* Device: IntellaTip MiFi XP Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 or older indicated for ablation for Atrial Flutter Exclusion Criteria: Thrombus Recent MI/cardiac revascularization Prosthetic Valves recent ablation for atrial flutter atrial flutter with reversible cause Class IV HF

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IntellaTip XP MiFi<br>Patients with Atrial Flutter will receive ablation treatment with the IntellaTip MiFi XP catheter | Device: IntellaTip MiFi XP Catheter<br>* Temperature controlled ablation catheter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Procedural Success | The Demonstration of bi-directional isthmus block at the end of the ablation procedure | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication Rate at procedure | Determine major complications in patients exposed to the device, which occur within 7 days of the procedure | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Flutter, Ablation, Type I Atrial Flutter, Atrial Arrhythmia
Impact of Prisma on Donor Site Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the feasibility of evaluating the use of a composite collagen, silver-oxidized regenerated cellulose matrix compared to the standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.

Official Title
-----------------
Impact of Promogran Prisma™ on Pain of Split-thickness Skin Graft Donor Sites Compared to Standard of Care Alone

Conditions
-----------------
Skin Graft Disorder, Donor Site Complication

Intervention / Treatment
-----------------
* Drug: Promogran Prisma
* Other: Standard of care (SOC) dressings


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled to undergo STSG for any reason Patient, or designated healthcare proxy, has read and signed the IRB-approved informed consent form. Exclusion Criteria: Active infection or history of radiation to the donor site Patient has a known sensitivity to Promogran Prisma™ or silver Elevated INR >3.0 Insensate at the donor site Chronic narcotic use (>6 months of daily use)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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: Promogran Prisma<br>Following standard of care split thickness skin grafting, patients randomized to the intervention group will receive Promogan Prisma as the primary contact dressing at the donor grafting site. | Drug: Promogran Prisma<br>* Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix<br>Other: Standard of care (SOC) dressings<br>* standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.<br>|
| Active Comparator: Standard of care (SOC) dressings<br> | Drug: Promogran Prisma<br>* Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Score between treatment and control arms | The primary endpoint of this feasibility study is to evaluate if using Promogran in addition to SOC is associated with a clinically meaningful difference in pain score (≥2 points on the pain scale) between the treatment and control arms on postoperative day (POD) 1. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Donor site pain after skin graft harvesting
Stroke Arrhythmia Monitoring Database

Study Overview
=================
Brief Summary
-----------------
Cardiac arrhythmia are frequently observed after stroke. They may on one hand be causative for the stroke mainly in case of atrial fibrillation but on the other hand present severe complications of the stroke. In addition, cardiac comorbidity as well as acute myocardial infarction are frequently found in acute stroke patients. Diagnostics to identify cardiac arrhythmia in the acute phase of stroke care thus have an important role not only for adjusting the correct secondary prevention but also to prevent cardiac complications potentially reducing morbidity and mortality. The aim of the SAMBA-Study is to systematically assess the prevalence of higher grade arrhythmias after stroke using a standardized reading of 72h telemetric monitoring in the first days after stroke onset. In addition, it evaluates different strategies to identify paroxysmal atrial fibrillation.

Conditions
-----------------
Acute Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated on the stroke unit Patients with telemetric monitoring Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Patients on the Stroke Unit<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of high grade cardiac arrhythmia after stroke |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of paroxysmal atrial fibrillation by different diagnostic approaches |  | 72 hours | 
| Cerebral lesion distribution in patients with cardiac arrhythmia |  | 72 hours | 
| Impact of arrhythmia on clinical outcome and mortality after 90 days |  | 90 days post stroke | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Cardiac Monitoring