linjc16/ctgov huggingface dataset:
Medication Adherence in COPD--A Self-Regulation Study

Study Overview
=================
Brief Summary
-----------------
To test the effectiveness of a self-management program for chronic obstructive disease (COPD) patients. The program to improve adherence could be conducted by nurses or other clinic staff in settings where comprehensive rehabilitation services were not available.

Detailed Description
-----------------
BACKGROUND: In 1990, the available data on medication adherence among chronic obstructive pulmonary disease (COPD) patients consistently indicated that adherence was a significant problem. This was a particularly distressing finding, considering that pharmacological therapy was considered the backbone of COPD management in settings where comprehensive rehabilitation services were limited. Despite the importance of this issue and a large data base on how to enhance medication adherence among medical populations, there had been no empirical investigations evaluating the implementation of these strategies with COPD patients. DESIGN NARRATIVE: The prospective, controlled study randomized 230 emphysema and chronic bronchitis patients from an urban university medical center into either a usual care, control group or into a self-management skills training program for improving adherence. The training program was based on self-management procedures for enhancing adherence which had proven efficacious with diverse populations. Self-reported and objective measures of adherence were examined during the two month baseline period and the one year follow-up in the controlled study. A range of possible covariates including demographics, patient characteristics, treatment, and therapeutic outcome variables were also collected during the baseline phase and at the 6-month and 12-month follow-up visits in the controlled study to evaluate their relationship to the observed adherence levels. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Lung Diseases, Obstructive, Bronchitis, Emphysema, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Monitoring of Intubation and Ventilation During Resuscitation

Study Overview
=================
Brief Summary
-----------------
Airway control and ventilation is vital during cardiopulmonary resuscitation (CPR) in cardiac arrest. Endotracheal intubation is the gold standard for airway control, but several studies have shown high rates of unrecognized placements of the tube in the esophagus instead of in the airway out-of-hospital. This is lethal. There are no failproof technique for recognising such mistakes clinically in the cardiac arrest situation. Changes on the air volume in the lungs with ventilation changes the impedance (resistance to alternating current) through the thorax. This impedance is already measured routinely by the defibrillators used during CPR. We propose that we can measure ventilation volumes and also discover failed intubations by monitoring this impedance during CPR with the possibility of giving feedback on both to the rescuers.

Detailed Description
-----------------
On the anesthesiologist manned ambulance in Oslo ventilation volumes during CPR will be controlled with a ventilator, the tidal volume varied in random order between 500, 700 and 100 ml, and the volumes be measured continuously as will the impedance between the defibrillator electrodes. In case of failed CPR, the patient will be declared dead. Thereafter the lungs will be ventilated with 700 ml followed by removal of the endotracheal tube, placement of an endotracheal tube in the esophagus and ventilation of this tube, again with monitoring of the impedance.

Official Title
-----------------
Monitoring of Intubation and Ventilation During Resuscitation

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: endotracheal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac arrest Exclusion Criteria: <18 years old trauma pregnancy

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: endotracheal intubation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity/specificity for lung ventilation detection |  |  | 
| correlation ventilation volume - impedance change |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest, resuscitation, ventilation, impedance
Evaluation of CG-100 Intraluminal Bypass Device

Study Overview
=================
Brief Summary
-----------------
Evaluation of CG-100 Intraluminal Bypass device

Official Title
-----------------
Evaluation of CG-100 Intraluminal Bypass Device

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Device: CG-100 Intraluminal Bypass Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (pre-operative): Willing to comply with protocol-specified follow-up evaluations 22-75 (inclusive) years of age at screening Diagnosed with colorectal cancer Has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 22 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CG-100 Intraluminal Bypass Device<br>Subjects will be treated with CG-100 Intraluminal Bypass Device | Device: CG-100 Intraluminal Bypass Device<br>* Subjects will be treated with the CG-100 Intraluminal Bypass Device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the CG-100 Intraluminal Bypass Device | Assessment of Serious Adverse Events | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the CG-100 Intraluminal Bypass Device | Assessment of Serious Adverse Events | 4 weeks |
Hand Grip Test and Transradial Coronary Procedures

Study Overview
=================
Brief Summary
-----------------
Transradial coronary procedures are gaining in popularity worldwide. A possible complication of transradial approach is the occlusion of the radial artery that in most cases is asymptomatic. However the investigators do not know if the radial artery occlusion may impact over the muscle force of the hand or fingers. To evaluate if transradial approach for percutaneous coronary procedures may affect muscle force of the hand, thumb and index finger the investigators use a standardized hand-grip manometer and a pinch gauge before the transradial procedure, the day after the procedures and after few months.

Official Title
-----------------
Hand Grip Test After Transradial Percutaneous Coronary Procedures

Conditions
-----------------
Radial Artery Occlusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable patients who undergo elective percutaneous transradial coronary procedures Exclusion Criteria: hemodynamic instability, acute coronary syndromes, haemodialysis patients with an arteriovenous fistula, sheath diameter > 6 French, age < 18 years

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 |
| --- | --- |
| Patent radial artery<br>Patient with patent radial artery after the percutaneous coronary procedure | |
| Occluded radial artery<br>Patients with occluded radial artery after the procedure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hand grip strength | The variation in had grip strength and thumb pinch after the procedure (the day after and at 30 day follow-up) compared to baseline in patients with patent radial artery compared to occluded radial artery. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial occlusion | The rate of radial occlusion after transradial coronary procedures | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transradial approach, radial occlusion, hand grip, coronary angiography
Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia.

Official Title
-----------------
A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects. (ARIES)

Conditions
-----------------
Hypercholesterolemia, Dyslipidaemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting low density lipoprotein level as defined by the protocol. Self described African American race Fasting triglyceride level as defined by the protocol. Exclusion Criteria: The use of lipid lowering drugs or dietary supplements after Visit 1. Active arterial disease eg Unstable angina, or recent arterial surgery Blood lipid levels above the limits defined in the protocol. Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|
| Active Comparator: 2<br>Atorvastatin | Drug: Atorvastatin<br> <br> * Other names: Lipitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low density lipoproteins cholesterol levels |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other blood lipid level changes |  | 6 weeks | 
| Safety: adverse events & abnormal laboratory markers |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, low density lipoproteins, dyslipidaemia, Rosuvastatin, Crestor, Atorvastatin, Lipitor, African American
Skin Aging in Renal Transplant Patients

Study Overview
=================
Brief Summary
-----------------
Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients. Trial in the field of transplantation / xenotransplantation

Detailed Description
-----------------
Determination of collagen, pigment and haemoglobin content of sun exposed and sun protected skin by Siascopy. Immunocompromised patients (for more than seven years) compared to immunocompetent patients.

Official Title
-----------------
Skin Aging in Renal Transplant Patients

Conditions
-----------------
Photosensitivity Disorders

Intervention / Treatment
-----------------
* Device: Photosensitivity under the influence of immunocomp


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Renal transplant recipients transplanted more than seven years ago and immunocompetent probands of the same age. Exclusion criteria: Refusal of informed consent, physical or psychological inability to give informed consent.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Photosensitivity under the influence of immunocomp|Siascopy measurement of reflected light|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin aging defined by melanin, collagen and hemoglobin content | there is only one time point for measurement, there is no time frame, just one single measurement per patient at the one and only visit | One Time measurement at the one and only time point of inclusion and measurement |
A Study to Assess the Efficacy, Safety and Tolerability of Pregabalin in Patients With Symptoms of Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the efficacy, safety and tolerability for pregabalin using a flexible, optimized dose schedule compared to placebo in relieving the symptoms of neuropathic pain.

Official Title
-----------------
An 8-Week Multi-Center, Randomized, Double Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety And Tolerability Of Pregabalin (150mg-600mg/Day) Using A Flexible Dosing Schedule In The Treatment Of Subjects With Symptoms Of Neuropathic Pain

Conditions
-----------------
Neuropathic Pain

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese outpatient of age 18 to 75 At screening and baseline, a score of greater than 40 mm on the visual log scale of SF-MPQ Exclusion Criteria: Neurologic disorders unrelated to neuropathic pain, which in the opinion of the investigator, might impair the assessment of pain Serum creatinine clearance greater than 60 ml/min

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy parameter is the endpoint mean pain score based on the pain scores from the subject's daily pain diaries. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy parameters include the weekly mean pain scores from the subject's daily pain diaries |  |  | 
| The Short Form McGill Pain Questionnaire |  |  | 
| The Sleep interference score (from subject pain diary) |  |  | 
| The Clinician and Patient Global Impression of Change (CGIC and PGIC) |  |  | 
| The responder rate defined as the proportion of subjects reporting a decrease of at least 30% in the weekly mean pain scores in each treatment group. |  |  | 
| Addtionally, the safety and tolerability of Pregabalin will also be evaluated. |  |  |
Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

Study Overview
=================
Brief Summary
-----------------
To observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for symptoms: dysmenorrhoea, dyspareunia and pelvic pain; to observe the effect of goserelin 3,6mg sc depot injection by assessment of the mean percent reduction scores for pelvic tenderness and indurations; to observe the reduction in the proportion of patients requiring analgesics for the relief of pelvic pain for 6 months in patients treated with Zoladex 3.6 mg.

Official Title
-----------------
Non-Interventional Study to Evaluate Effect of Zoladex In EndometrioSIS

Conditions
-----------------
Endometriosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with endometriosis that the doctors have already decided to treat with Zoladex within the last month, before inclusion in this program, according to Romanian approved goserelin 3,6 mg Exclusion Criteria: patients who have a known hypersensitivity to goserelin (Zoladex) or any of its excipients or any other GnRH analogue, pregnancy, according to Romanian approved goserelin 3,6 mg SmPC

Ages Eligible for Study
-----------------
Minimum Age: 18 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>Patients diagnosed with endometriosis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biberoglu and Bergham Scale |  | monthly/ at every clinic visit- 6 times for symptoms: dysmenorrhoea, dyspareunia and pelvic pain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biberoglu and Bergham Scale |  | twice/first and last clinic visit for pelvic tenderness and indurations | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endometriosis
Spanish Version of the Brief-BESTest in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to adapt and validate the Spanish version of the Brief-BESTest in stroke patients

Detailed Description
-----------------
Balance disorder is a major risk factor for falls. The population that has suffered a cerebrovascular accident (CVA) or stroke has balance disorders. Over the last few years the assessment of balance has taken on special importance, carrying out the development, adaptation and validation of various tools that assess it. The Brief-BESTest has 6 items, it has demonstrated comparable reliability to the Mini-BESTest and potentially superior sensitivity. This version represents all dimensions based on the original BESTest theory. The purpose is to adapt and validate the Spanish version of the Brief-BESTest in stroke patients in order to have a brief tool, appropriate to the clinical environment and to the characteristics and limitations of these patients.

Official Title
-----------------
Adaptation and Validation of the Spanish Version of the Brief-BESTest in Stroke Patients

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

Intervention / Treatment
-----------------
* Diagnostic Test: Spanish version of the Brief-BESTest in stroke patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years old Diagnosis of stroke Exclusion Criteria: Cognitive impairment Physical disability that prevents them from completing the assessment No cooperation and communication problems

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single group<br>Instrument validation in stroke patients | Diagnostic Test: Spanish version of the Brief-BESTest in stroke patients<br>* Adaptation and validation of the Spanish version of the Brief-BESTest in stroke Patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BESTest |  | Baseline | 
| Mini-BESTest |  | Baseline | 
| Berg Balance Test |  | Baseline | 
| Time Up and Go Test |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Validation Study, Postural Balance