linjc16/ctgov huggingface dataset:
Circulating Tumor Cells and Survival in Hormone Refractory Prostate Cancer (HRPC) Patients Receiving Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This study enrolled men with prostate cancer who had failed hormone therapy (as shown by rising prostate-specific antigen [PSA] levels) and who were about to start a new line of chemotherapy. Blood was drawn prior to the patient receiving chemotherapy and then monthly thereafter for up to 18 months or until disease progression, whichever occurred first. The blood was tested to find circulating tumor cells (CTC) and to count them. The circulating tumor cell levels were studied in relation to the patient's overall survival. Serum was also collected for PSA testing, and additional blood samples were drawn to test for circulating endothelial cells and RNA was isolated for future gene expression testing.

Official Title
-----------------
Circulating Tumor Cells and the Prediction of Overall Survival in Patients With Androgen Independent Prostate Cancer Entering Onto Chemotherapy

Conditions
-----------------
Hormone Refractory Prostate Cancer, Prostate Cancer

Intervention / Treatment
-----------------
* Procedure: Phlebotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > or = 18 years Pathological diagnosis of adenocarcinoma of the prostate First or later line of chemotherapy Serum testosterone < 50ng/mL ECOG 0-2 Serum PSA > or = 5ng/mL PSA progression (2 rises above a reference value) Bone scan within 60 days of enrollment Computed tomography (CT) scan If measurable disease, bone scans every 6-8 months Exclusion Criteria: Systemic radiation Prior history of other carcinoma within the last 5 years, except non-melanoma skin cancer Brain metastases

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>Metastatic Hormone Refractory Prostate Cancer Patients | Procedure: Phlebotomy<br>* Peripheral blood draws for evaluation of circulating tumor cells<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Up to 36 months from time of baseline draw | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | Up to 36 months after baseline draw | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hormone refractory prostate cancer
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of the project is to investigate in eyes with dry AMD, the efficacy and safety as preventive therapy of the immunomodulatory substance named copaxone which had been proven as safe and effective agent for a neurodegenerative disease, in arresting the progression as well as the conversion of dry AMD to wet AMD. The hypothesis that the immunomodulatory agent copaxone proven for a neurodegenerative disease may work in the eye is revolutionary and may open a new avenue of preventive treatment for the disease which is the major cause of legal blindness in the industrial world

Official Title
-----------------
Weekly Vaccination With Copaxone as a Potential Therapy for Dry Age-related Macular Degeneration

Conditions
-----------------
Dry Age Related Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Copaxone Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry AMD in one or both eyes Age 50 or above of either gender Signed informed consent. Exclusion Criteria: Known sensitivity to Mannitol or Copaxone. Skin disease or active infection of skin. Active fever or active treatment for infection. History of other uncontrolled systemic active disease. Premenopausal females not using reliable birth control. Sensitivity to fluorescein or iodine. Inability to comply with study procedures.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Copaxone<br> | Drug: Copaxone Injection<br> <br> |
| Sham Comparator: Sham<br> | Drug: Copaxone Injection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total drusen area reduction |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry Age Related Macular Degeneration, Dry AMD
Study to Assess the Safety and Effectiveness of Beltavac® Polymerized With Alternaria Alternata

Study Overview
=================
Brief Summary
-----------------
Non-interventional Study to Assess the Safety and Effectiveness Profile of a SCIT Therapy With Beltavac® Polymerized With Alternaria alternata in allergic patients

Detailed Description
-----------------
This prospective open multi-centre non-interventional study assess the safety and effectiveness profile of the subcutaneous allergen-specific immunotherapy with Beltavac® Polymerized in Alternaria alternata allergic patients (children and adults) in routine medical care. Patients receive a rush schedule administration every month for a year. They attend at least 4 study visits to inform about the adverse reactions, the self reported symptoms and the medication intake.

Official Title
-----------------
Observational Prospective Study to Assess the Safety and Effectiveness Profile of Beltavac® Polymerized With Alternaria Alternata

Conditions
-----------------
Rhinoconjunctivitis With or Without Allergic Asthma

Intervention / Treatment
-----------------
* Biological: Beltavac® Polymerized with Alternaria alternata


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of the age of 5 years and older suffering from a clinically relevant Alternaria alternata induced allergic rhinitis Positive skin testing or IgE determination to the relevant allergen Exclusion Criteria: Patients suffering from acute or chronic infections or inflammations Patients suffering from uncontrolled asthma Patients with a known autoimmune disease Patients with active malignant disease Patients requiring beta-blockers Patients having any contraindication for the use of adrenaline

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Beltavac® Polymerized with Alternaria alternata|Adminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numbers of treatment-related local and systemic reactions | Number of adverse reactions occurred during the treatment period and classified according to the WAO standard | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rhinoconjuntivitis medication intake | Medication intake for allergy symptons control at baseline, 6 and 12 months | 1 year | 
| Visual analogue Scale Score | Psycometric scale that assesses the global allergic disease discomfort. It is a 10 cm line representing severity from 0:no symptoms to 10 highest level of symptoms | 1 year | 
| IgE and IgG4 specific quantification | IgE and IgG4 quantification in serum measured at baseline, 6 and 12 months | 1 year |
Dexmedetomidine in Pediatric Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Dexmedetomidine is a selective α-2 receptor agonist with a sedative and cardiopulmonary profile that makes it an attractive anesthetic for pediatric patients with congenital heart disease (CHD). The aim of this study was to investigate the renal protective effect of dexmedetomidine in the perioperative setting in children with heart disease. Total 144 pediatric patients allocated dexmedetomidine (DEX) and did not receive the drug (NoDEX) group. The primary objective of this study was to assess the relationship between the use of intraoperative dexmedetomidine and the incidence of acute kidney injury in pediatric patients undergoing cardiopulmonary bypass. The secondary objective was to determine whether there was an association between dexmedetomidine use and duration of mechanical ventilation or cardiovascular ICU stay.

Official Title
-----------------
The Renal Protective Effect of the Dexmedetomidine in Pediatric Patients Undergoing Cardiac Surgery

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing congenital cardiac surgery Exclusion Criteria: history of allergy or anaphylaxis to study drug preexisting renal dysfunction (preoperative creatinine >1.5mg/dl) diabetes liver profile abnormality

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DEX<br>dexmedetomidine 1mcg/kg for 10min. loading and continuous infusion during the surgery 0.5mcg/kg/hr. | Drug: Dexmedetomidine<br> <br> |
| Active Comparator: no_DEX<br>Normal saline 1mcg/kg for 10min. and continuous infusion during the surgery 0.5mcg/kg/hr. | Drug: normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum creatinine | daily check the laboratory parameter. | immediate after surgery, until discharge from the ICU, assessed up to 1 week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glomerular filtration rate | daily check the laboratory parameter. | immediate after surgery, until discharge from the ICU, assessed up to 1 week. | 
| Urine output | daily check the laboratory parameter. | immediate after surgery, until discharge from the ICU, assessed up to 1 week. |
A Prospective, Randomized Clinical Study on the Effects of Casein Phosphopeptide-amorphous Calcium Phosphate (CPP-ACP) Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2

Study Overview
=================
Brief Summary
-----------------
Influence of CPP-ACP paste and Elmex Medical Gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.

Official Title
-----------------
A Prospective, Randomized Clinical Study on the Effects of CPP-ACP Paste on Plaque, Gingivitis and White Spot Lesions in Orthodontic Patients - Part 2

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No white spot lesion at the time of placement of fixed appliances Exclusion Criteria: White spots already present before start orthodontic treatment

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>CPP-ACP (GC Tooth Mousse) | Device: CPP-ACP (GC Tooth Mousse)<br>* Calcium and phosphate<br>|
| Experimental: 2<br>GCC-ACP (GC MI Paste Plus) | Device: CPP-ACP (GC MI Paste Plus)<br>* Calcium, phosphate and fluoride<br>|
| Experimental: 3<br>Fluoride (Elmex Medical Gel) | Device: Fluoride (Elmex Medical Gel)<br>* Fluoride<br>|
| No Intervention: 4<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of the opacity of white spots during orthodontic treatment with fixed appliances |  | After 2 years |
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of lixivaptan in the treatment of hyponatremia in patients with congestive heart failure.

Official Title
-----------------
THE BALANCE Study: Treatment of Hyponatremia Based on Lixivaptan in NYHA Class III/IV Cardiac Patient Evaluation

Conditions
-----------------
Hyponatremia

Intervention / Treatment
-----------------
* Drug: lixivaptan
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female patients 18 years of age or older with hyponatremia and hospitalized for congestive heart failure.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Lixivaptan | Drug: lixivaptan<br>* Oral Capsule<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Oral Capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether lixivaptan can effectively and safely produce an increase in serum sodium from Baseline in heart failure subjects with hyponatremia and volume overload. Effects on body weight and other clinical measures will be evaluated. |  | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyponatremia, Serum Sodium, Fluid Overload, Heart Failure, Acute Heart Failure, Vasopressin Antagonist
Effect of Arm Ergometry on Children With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
Cardiopulmonary issues are the major cause of sickness and hospitalisation in children with Down syndrome . Down syndrome children are also more likely to develop chronic lung infections, middle ear infections, and persistent tonsillitis.

Detailed Description
-----------------
30 Down's syndrome children (boys and girls). randomly separated into two groups of equal size. Both groups received traditional chest physical therapy, with the addition of arm ergometry training in Group B

Official Title
-----------------
The Effects of Arm Ergometry Training on Pulmonary Function in Children With Down Syndrome

Conditions
-----------------
EFFECT OF ARM ERGOMETRY ON RESPIRATION

Intervention / Treatment
-----------------
* Other: ARMEROMTERY


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: comprehend and follow directions AGE 10-14 Exclusion Criteria: Anomalies of the vasculature. -Participating in sports of any kind. Moderate to severe asthma

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EXPERMINTAL GROUP<br>start with cycle at a pace of 15-25 cycles per minute without resistance and end with cycle 45cycles per minute | Other: ARMEROMTERY<br>* ARMERGOMTERY TRAINING FOR UPPERLIMB<br>|
| No Intervention: CONTROL GROUP<br>selected respiratory exercise program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discovery Spirometer | measure forced expiratory volume, the means incresed mean improvement | pre and post treatment for 14 weeks at 3 times per week. | 
| Discovery spirometer | Measure peak volume,the means incresed mean improvement | Pre and post treatment for 14 weeks at 3 times per week |
Detection of Factor V Leiden G1691A and Factor II (Prothrombin) G20210A Point Mutations in DNA

Study Overview
=================
Brief Summary
-----------------
As an external validation test of the performance of the VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System, clinical trials will be conducted at three sites. This study will assess genotyping accuracy as compared to bidirectional sequencing and genotyping reproducibility across variables such as user, day, and site.

Official Title
-----------------
VeraCode Genotyping Test for Factor V and Factor II on the BeadXpress System

Conditions
-----------------
Detection and Genotyping of Factor V and Factor II Point Mutations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient samples will be leftover EDTA-anticoagulated whole blood from patients referred for Factor V and/or Factor II testing. Exclusion Criteria: There are no applicable exclusion criteria for this test, since the genomic sequence will not vary by ethnicity, gender, age or disease. Inappropriately stored blood samples will be excluded.
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Usage of Baclofen for Sleep Improvement After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Baclo-Sleep trial aims to investigate the effect of baclofen on sleep after scheduled cardiac surgery.

Detailed Description
-----------------
This is a prospective randomized single-blind study involving patients adults admitted to the University Hospital of Liege for a scheduled heart surgery. The study is based on the oral administration of baclofen (or placebo) the evening Bedrooms (10 pm). This administration begins the day before surgery and ends 5th day after. Sleep is evaluated by various questionnaires at baseline, during the protocol and the end. In addition, a 24 polysomnography is performed the day after surgery.

Official Title
-----------------
Usage of Baclofen for Sleep Improvement After Cardiac Surgery

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Drug: Baclofen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cardiac surgery Exclusion Criteria: Haemodynamic instability Epilepsy Psychotic disturbances Acute / Chronic respiratory failure Morbid obesity (BMI > 45 kg/m2) Sleep apnea (treated) Severe hepatic or renal failure Patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Baclofen<br>Baclofen 25 mg per os for 7 days at 10 pm every day | Drug: Baclofen<br>* 25 mg for 7 days at 10 pm every day<br>|
| Placebo Comparator: Placebo<br>Placebo per os for 7 days at 10 pm every day | Drug: Placebo<br>* Placebo for 7 days at 10 pm every day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnography (quantity & quality of sleep) | Sleep assessment by polysomnography | Participants will be followed for the duration of hospital stay, an expected average of 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Baclofen, Cardiac Surgery, Polysomnography, Intensive Care Units, Sleep
Evaluation of Decisional Conflict and Needs Assessment in Asthma Management

Study Overview
=================
Brief Summary
-----------------
Many patients suffering from asthma are not compliant to their treatment and consequently, are not well controlled. Shared decision making intervention has shown an improvement in the outcome of patients with chronic disease. The aim of this study is to evaluate decisional conflict and to assess decisional needs of adults with asthma.

Detailed Description
-----------------
Asthmatic patients will be recruited and asked to fill a decisional conflict scale. Patients, asthma educators and physicians will also be recruited to fill a needs assessment questionnaire about decisions taken by asthmatics.

Official Title
-----------------
Decisional Conflict and Needs Assessment in Shared Decision Making in Asthma Management

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-65 years diagnosed asthma Exclusion Criteria: received asthma education in the past 2 years

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DEcisional conflict<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring Decisional Conflict with a valid Decisional Conflict Scale | To measure the level of decisional conflict, subjects were asked to fill out a decisional conflict scale on asthma management which was developed by O'Connor adapted for our study. This questionnaire consisted of 16 questions. The answers used a Likert scale ranged from 1 - strongly agree to 5 - strongly disagree. | 6 month |