linjc16/ctgov huggingface dataset:
Real Life Safety and Efficacy of Vardenafil

Study Overview
=================
Brief Summary
-----------------
In this uncontrolled, non-randomized, prospective, local post-marketed surveillance study, data are obtained on safety and efficacy of LEVITRA® in routine treatment of erectile dysfunction. The general objectives are to evaluate the product safety (primarily by recording adverse events), efficacy and patient acceptance.

Official Title
-----------------
Vardenafil in Routine Treatment of Erectile Dysfunction

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Vardenafil (Levitra, BAY38-9456)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any adult patient (>/=18 years) with erectile dysfunction treated with LEVITRA®. Patients must be able to give written informed consent for participation in the study after receiving detailed written and oral information prior to the study. Exclusion Criteria: Exclusion criteria must be read in conjunction with the product information (Package Insert).

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 |
| --- | --- |
| Group 1<br> | Drug: Vardenafil (Levitra, BAY38-9456)<br>* 5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General assessment of patients concerning efficacy and tolerability of vardenafil treatment |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first intercourse after intake of vardenafil |  | 2 months | 
| Percentage of successful second intercourse within 24 hours |  | 2 months | 
| Percentage of participants who are willing to continue treatment |  | 2 months | 
| Number of participants with adverse events |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levitra, Erectile dysfunction, Taiwan
VItamin D Metabolism in SEnescent Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Advanced age is associated with an increase in postoperative morbidity and mortality in cardiac surgery patients. In detail, compared with younger patients those aged 75 years and older have significantly higher rates of in-hospital mortality, cerebrovascular events, pneumonia, and dialysis. In addition, older cardiac surgery patients have longer mechanical ventilation times. Vitamin D exerts several beneficial effects on the cardiovascular system. Moreover, it has immuno-modulatory and anti-inflammatory properties. The hormonal form of vitamin D, 1,25-dihydroxyvitamin D, is an independent predictor of mid-term mortality in cardiac transplant recipients. 1,25-dihydroxyvitamin D also predicts mid-term and long-term mortality in patients with a high risk for cardiovascular disease. Mild renal impairment, insufficient vitamin D levels, and secondary hyperparathyroidism are common in frail elderly individuals. The present study aimed to investigate whether cardiac surgery exerts age-dependent effects on calciotropic hormones, components of the immune system, and inflammatory processes.It is hypothesized that (i) baseline 1,25-dihydroxyvitamin D levels are lower in patients <= 75 years of age compared to younger patients, (ii) cardiac surgery results in a transient decrease in circulating 1,25-dihydroxyvitamin D, and (iii) that the decrease in 1,25-dihydroxyvitamin D is probably more pronounced in older than in younger cardiac surgery patients.

Official Title
-----------------
Vitamin D Metabolism in Senescent Cardiac Surgery Patients

Conditions
-----------------
Coronary Artery Bypass Grafting, Heart Valve Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: <= 65 years and >= 75 years first elective cardiac surgery (bypass or combined bypass and heart valve surgery) written informed consent Exclusion Criteria: emergency cardiac intervention primary hyperparathyreoidism primary and secondary hypoparathyreoidism daily vitamin D supplementation > 10 micrograms

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 |
| --- | --- |
| Group 1<br>cardiac surgery patients age 65 years and less | |
| Group 2<br>cardiac surgery patients aged 75 years and over | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri- and Postoperative Time Course of Circulating 1,25-dihydroxyvitamin D in the First Postoperative Month in Cardiac Surgery Patients |  | change from baseline within 1 month after cardiac surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
age, vitamin D, cardiac surgery, inflammation, immune system
A Clinical Study to Assess the Efficacy and Safety of Dexamethasone Suspension for Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of two dose levels of dexamethasone ophthalmic suspension eye drops to determine if the drops decrease inflammation inside the eye and are safe after cataract surgery.

Official Title
-----------------
A Phase 1/2 Dose-Ranging, Open-Label, Randomized, Clinical Study to Assess the Efficacy and Safety of Dexamethasone Ophthalmic Suspension Eye Drops for the Treatment of Inflammation Associated With Cataract Surgery

Conditions
-----------------
Inflammation Eye

Intervention / Treatment
-----------------
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients at least 40 years of age scheduled for unilateral cataract surgery by phacoemulsification with posterior chamber intraocular lens implantation. Exclusion Criteria: Patients who have received a periocular corticosteroid injection in the study eye in the 3 months prior to screening. Patients who anticipate requiring treatment with any corticosteroids by any route, except inhalation, during the study. Patients who are known steroid responders

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Arm 1<br>Dexamethasone suspension dose level 1 | Drug: Dexamethasone<br>* Drop<br>|
| Experimental: Arm 2<br>Dexamethasone suspension dose level 2 | Drug: Dexamethasone<br>* Drop<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anterior Chamber Cell | Number of cells in the anterior chamber | 30 days |
Diagnostic Study of Gene Alterations in Children Who Have Been Treated for Relapsed Acute Lymphocytic Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Diagnostic procedures, such as genetic testing, may improve the ability to detect acute lymphocytic leukemia and determine the extent of disease. PURPOSE: Diagnostic study to try to detect changes in the genes of children who have been treated for relapsed acute lymphocytic leukemia.

Detailed Description
-----------------
OBJECTIVES: Determine the incidence of p16/p15 homozygous deletions and p15 promoter hypermethylation in acute lymphocytic leukemia cells of children treated on protocol CCG-1941. Determine the prognostic importance of p16/p15 abnormalities in these children. Determine the presence or absence of p16/p15 abnormalities in the dominant clone at diagnosis if present at relapse in these patients. OUTLINE: Frozen cells are obtained from samples collected on protocol CCG-1941. DNA is isolated and examined using Southern blot analysis to assay for deletions and promoter hypermethylation of p16 and/or p15. PROJECTED ACCRUAL: Approximately 100 samples will be obtained for this study.

Official Title
-----------------
The Incidence and Prognostic Significance of P16 INK4A/ P15 INK4B Gene Alterations in Children With Relapsed ALL Treated on CCG-1941

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute lymphocytic leukemia and treated on protocol CCG-1941 Material cryopreserved in the CCG cell bank PATIENT CHARACTERISTICS: Age: Children 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: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified Other: See Disease Characteristics

Ages Eligible for Study
-----------------
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|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
-----------------
recurrent childhood acute lymphoblastic leukemia
Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities

Study Overview
=================
Brief Summary
-----------------
Power-assisted therapeutic electrical stimulation (TES) or conventional TES to upper extremities in acute stroke patients were performed in a randomized controlled trial. The changes in finger and hand function will be evaluated. The hypothesis is that a power-assisted TES is more effective than a conventional TES.

Official Title
-----------------
Power-Assisted Therapeutic Electrical Stimulation to Upper Extremities in Acute Stroke Patients. A Randomized Controlled Trial.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Procedure: therapeutic electrical stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute or subacute phase of stroke Exclusion Criteria: chronic phase of stroke

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 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

| Intervention/Treatment |
| --- |
|Procedure: therapeutic electrical stimulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Perioperative Dexmedetomidine Administration on Outcome in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
Investigation of effect of perioperative Dexmedetomedine administration on mortality, length of ICU and hospital stay, delirium onset, major adverse cardiac and cerebrovascular events, acute kidney injury in cardiac surgery patients.

Official Title
-----------------
The Effect of Prophylactic Dexmedetomidine Administration on the Outcome in Patients Undergoing Surgery With Cardiopulmonary Bypass

Conditions
-----------------
Patient Outcome Assessment

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed agreement Elective surgery Use of CPB Exclusion Criteria: Previous prolonged immobilization Reoperation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexmedetomidine<br> | Drug: Dexmedetomidine<br> <br> * Other names: Dexdor;|
| No Intervention: No Dexmedetomidine<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30DM | 30-day mortality | 30 days after surgery | 
| Delirium | Postoperative delirium | 30 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VIS | Vasoactive- Inotropic Score | 5 days after surgery | 
| MACCE | Major adverse cardiac and cerebrovascular events | 30 days after surgery | 
| Subsyndromal delirium | Subsyndromal postoperative delirium | 30 days after surgery | 
| AKI | Acute kidney injury | 7 days after surgery | 
| ICU-LOS | Length of ICU stay | 7 days after surgery | 
| H-LOS | Hospital length of stay | 30 days after surgery |
Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.

Official Title
-----------------
Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale

Conditions
-----------------
Systemic Sclerosis

Intervention / Treatment
-----------------
* Other: Endoscopic capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Systemic sclerosis based on the ACR diagnostic criteria Exclusion Criteria: Patients with other connective tissue diseases Pregnancy Absence of contraception in women Patients with pace maker Patients with intestinal pseudo-obstruction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 81 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Endoscopic capsule|Endoscopic capsule|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms |  | 1 year | 
| to assess a correlation between small intestinal mucosal abnormalities and nutritional status |  | 1 year | 
| to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis |  | 1 year |
High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study

Study Overview
=================
Brief Summary
-----------------
A refractive error is the most common reason for reduced visual acuity. Myopia, hyperopia, astigmatism and presbyopia belong to the four basic refractive errors and, unfortunately, cannot be prevented. There are different tools to correct them, like spectacles, contact lenses, and refractive surgery. Many different contact lenses are available, the two large groups create rigid contact lenses and soft contact lenses. It is a common knowledge that the presence of a contact lens in the eye divides the tear film into the prelens and postlens tear film layers. In the present study we want to investigate the variability and reproducibility of prelens and postlens tear film thickness measurements.

Official Title
-----------------
High-resolution Imaging of Tear Film Thickness in Contact Lenses Wearers With Optical Coherence Tomography (OCT). A Pilot Study

Conditions
-----------------
Contact Lens, Tear Film Thickness

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Men and women aged over 18 years Soft or rigid contact lenses wearers Schirmer Test ≥ 10 mm/5 min Tear Breakup Time (TBUT) ≥10 seconds Exclusion Criteria: Participation in a clinical trial in the previous 3 weeks Presence of any abnormalities preventing reliable measurements as judged by the investigator Pregnancy, planned pregnancy or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Soft Contact Lenses<br>healthy subjects wearing soft contact lenses | Device: Optical Coherence Tomography<br> <br> |
| Rigid Contact Lenses<br>healthy subjects wearing rigid contact lenses | Device: Optical Coherence Tomography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre lens and post lens tear film thickness |  | 2 months |
Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)

Study Overview
=================
Brief Summary
-----------------
This work aims to use wearable sensors to record the return towards normal physical activity after breast surgery. It will build on current evidence by using objective measures of activity and arm movements rather than patient reports.

Official Title
-----------------
Breast: Recovery After Axillary Node Clearance - Evaluating Limbs With E-Technology (the BRACELET Study)

Conditions
-----------------
Breast Cancer, Mobility Limitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast or axillary surgery Exclusion Criteria: Other diagnosed movement disorder Cannot consent due to language or capacity
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 |
| --- | --- | --- |
| Arm movements | Arm movements as measured by wearable sensor | Post-operative for 2-4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Technology, Rehabilitation, Wearables, Breast surgery, Physical activity, Enhanced recovery after surgery
A Dose Ranging Study To Investigate The Efficacy And Safety Of SB-742457 In Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if SB-742457 is a safe treatment and what effects it has on the symptoms of mild to moderate Alzheimer's disease. SB-742457 is a new treatment which is thought to increase the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.

Official Title
-----------------
A Phase IIa/b Double-blind, Randomised, Placebo-controlled, Linear Trend Design Dose-ranging Study to Investigate the Effects of 24 Weeks of Monotherapy With SB-742457 on Cognition in Subjects With Mild to Moderate Alzheimer's Disease

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: SB-742457


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Clinical diagnosis of probable mild-to-moderate Alzheimer's disease as determined by the NINCDS-ADRDA and DSM-IV criteria with an MMSE score of 12-24. Subjects and their caregivers must provide informed consent prior to study entry. Adequate blood pressure and laboratory values. Exclusion criteria: Females of child-bearing potential. Have other causes of dementia such as vascular damage, depression, bipolar affective disorder, schizophrenia, syphilis, vitamin B12 deficiency or thyroid deficiency. Subjects taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes. Subjects taking agents for which there is a theoretical risk of interaction with SB-742457. Subjects with known hypersensitivity to sunlight or seizures.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: SB-742457|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cognition and function after 24 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in behavioural symptoms, activities of daily living and caregiver burden after 24 weeks. Changes in all symptoms at 8 and 12 weeks. Safety and tolerability. PK and dose response profiling. Efficacy related to ApoE status. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, cognition global functioning, symptomatic, B-742457