linjc16/ctgov huggingface dataset:
Observational Study of the Remodelling Process Following Myocardial Infarct

Study Overview
=================
Brief Summary
-----------------
This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.

Detailed Description
-----------------
A multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. The trial was terminated in 2002 and the results of the main trial have been published. In this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. A total of 235 patients were included from 18 centres. Blood was taken at randomisation, 1 month, 1 year and 2 years. The present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the Stavanger University Hospital. The study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction. The data collected at the 3-year follow-up visit will be compared to data from the initial study.

Official Title
-----------------
Assessment of the Relationship Between Collagen Turnover, Left Ventricular Remodelling and Myocardial Scarring Assessed by Cardiac Magnetic Resonance and Neurohumoral Activation in Patients With Previous Myocardial Infarction

Conditions
-----------------
Heart Failure, Myocardial Infarct

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in the previous neurohormonal substudy of the OPTIMAAL trial Willingness to participate in the present study and ability to understand and sign the written informed consent Exclusion Criteria: Myocardial infarction within 3 months of visit 1. Significant primary valve disease, confirmed by ECHO cardiography, Autoimmune disease likely to cause an increase in collagen turnover Active cancer disease Immunosuppressive treatment, Significantly reduced liver function Contraindications for performing a cardiac MRI scan (including claustrophobia, implanted ferromagnetic devices or known allergic reactions to Omniscan™). Inability to cooperate during the 1 month follow up period.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left Ventricle Remodelling, Collagen markers, Neurohormones, Cardiac MRI
Short Term Refractive and Ocular Parameter Changes After Topical Atropine

Study Overview
=================
Brief Summary
-----------------
In order we had designed a prospective clinical trial. Spherical equivalent refractive error (SER), axial length (AL), mean keratometric value (Mean-K), anterior chamber depth (ACD), and intraocular pressure (IOP) were measured at baseline and one week after topical use of 0.125% atropine. Postcycloplegic changes of refractive error and ocular parameters were evaluated, and their correlations were analyzed with multiple linear regression models.

Official Title
-----------------
Short Term Refractive and Ocular Parameter Changes After Topical Atropine

Conditions
-----------------
Myopia, Left Eye

Intervention / Treatment
-----------------
* Drug: 0.125% Atropine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had an SER of -0.5 diopters or less in their eyes. Exclusion Criteria: Patients who had already been undergoing cycloplegic treatment for myopia before.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum 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: 0.125% atropine group<br>patients used the 0.125 % atropine eyedrop every night before sleep for 7 days | Drug: 0.125% Atropine<br>* patients used 0.125% atropine eyedrop per night before sleep for 7 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SER | Spherical equivalent refractive error | change from SER at 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AL | Axial length | change from AL at 7 days | 
| ACD | anterior chamber depth | change from ACD at 7 days | 
| IOP | intraocular pressure | change from IOP at 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atropine, cycloplegia, refraction, axial length, anterior chamber depth
Predictors for Bronchoalveolar Lavage (BAL) Recovery Rate Derived From Quantified Computed Tomography (qCT)

Study Overview
=================
Brief Summary
-----------------
Bronchoalveolar lavage (BAL) is an important diagnostic method. The percentage of fluid extracted after instillation (recovery rate) is crucial for following diagnostic tests. The investigators aimed to compare novel quantified airway parameters from pre-interventional lung computed tomography (CT) with recovery rates to find possible predictive markers.

Official Title
-----------------
Predictors for Bronchoalveolar Lavage Recovery Rate Derived From Quantified Computed Tomography

Conditions
-----------------
Interstitial Lung Disease, Pneumonia, Malignant Neoplasm

Intervention / Treatment
-----------------
* Procedure: bronchoalveolar lavage (BAL)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: retrospective analysis of all patients undergoing BAL and complete documentation Exclusion Criteria: incomplete documentation

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 |
| --- | --- |
| BAL<br>patients undergoing elective bronchoalveolar lavage | Procedure: bronchoalveolar lavage (BAL)<br>* clinically indicated, elective BAL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recovery rate | volume of recovered volume | 30 minutes |
Efficacy Study of Metadoxine SR Formulation in Attention Deficit Hyperactivity Disorder (ADHD) Subjects

Study Overview
=================
Brief Summary
-----------------
This clinical study is designed to evaluate the safety and tolerability of a single oral administration of a Metadoxine slow release formulation to subjects diagnosed as having ADHD. Study also assess cognitive effects of such drug administration.

Detailed Description
-----------------
Primary outcome measure is the safety and tolerability of study drug after a single dosing. Additional outcomes include commission error rate from the TOVA test. The result is measured as standard score in % compared to the values of the normal population. Exploratory outcome measures include: TOVA measures like response time , variability, omissions etc. Subtests from Wechsler: digit memory, digit-number signs etc

Official Title
-----------------
Efficacy Study of Metadoxine SR Formulation in ADHD Subjects

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Extended Release Metadoxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-45 diagnosed as ADHD Exclusion Criteria: PDD patients head injured patients patients suffering from heart, lung, liver, kidney, intestinal, endocrine an neurological diseases and patients who are sensitive to vitamin B

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Metadoxine SR<br>Metadoxine is a pyrolate salt of Pyridoxine | Drug: Extended Release Metadoxine<br>* one oral 1400mg dose (2 tablets)<br>* Other names: Metadoxine, Metadoxil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Subjects were evaluated for general safety and tolerablity measures, including number of AEs and AEs related (possibly or likely) to study drug | 24 hours after drug adminstration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADHD, ADD, TOVA, METADOXINE
ACRIPAB- Trial: Anti Coagulation Regimen In High Risk PAtients for Bleeding

Study Overview
=================
Brief Summary
-----------------
To determine the safety/efficacy of Bivallirudin Vs unfractionated heparin (UFH) on top of dual antiplatelet therapy in patients with high tendency for bleeding during urgent and elective PCI.

Conditions
-----------------
Hematologic Diseases

Intervention / Treatment
-----------------
* Drug: Bivalirudin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria (any of the following): ≥75 years Creatinin clearance rate < 60 ml per minute Anemia (Hb 9-11 mg%) Hypertension: BP > 180/95 mmHg but less than 210/110 m Hg Diabetic Pts Steroid treated Pts Recent (within 6 weeks) non major surgery Pts with hematological disorders associated with tendency for bleeding like Thrombocytopenia (platelets 50000-150000) included TTP; Exclusion Criteria: Exclusion criteria: Age < 18 year Acute STEMI (Primary PCI)* Rescue angioplasty <12h after lytic therapy* Active bleeding S.C LMWH < 8 hours or UFH < 4 hours before PCI Using IIb /IIIa as an upstream therapy before PCI PCI which will be involved with obligatory IIb /IIIa therapy: (thrombotic complication, occlusive dissection) INR>1.5 on day of cathetrization Bolus of 600mg of Clopidogrel before PCI Current pregnancy or women in reproductive age without contraceptives Hypersensitivity to heparin or bivalirudin or its components *(possible using IIB/IIIA)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bivalirudin<br> | Drug: Bivalirudin<br>* Bivalirudin: loading dose 0.75mg/kg bolus During procedure: 1.75mg/kg/hour. UFH: loading dose 60 Units /kg During procedure: keeping ACT < 250<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End points: Primary :Major & minor bleeding Port of entry related complications |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End points: Secondary: 30 days MACE |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, efficacy
AMIStem-H Radiological Assessment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate radiological performance of the cementless femoral stem AMIStem H at 1 and 5-year follow-up. All the patients operated at the investigational sites between April 2009 and April 2012 will be reviewed at 1, 5 and 10 year according to standard practice

Official Title
-----------------
Etude rétrospective et Prospective, Multicentrique, Non contrôlée, Non randomisée, Ouverte évaluant la Performance et la sécurité de l'Implant AMIStem

Conditions
-----------------
Hip Replacement Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who underwent total hip arthroplasty at the investigational sites between April 2009 and April 2012 patients bearing an AMIStem-H cementless femoral stem Exclusion Criteria: patients who refuse to give consent for the treatment of data

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of radiolucencies |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between the presence of radiolucencies and patient/implant characteristics |  | 5 years, 10 years | 
| evaluation of radiolucent lines progression |  | 1 years, 10 years | 
| evaluation of radiolucent lines progression |  | 5 years, 10 years | 
| Record of adverse events |  | 1, 5 years and 10 years |
Cycled Light and Crying of Preterm Infants

Study Overview
=================
Brief Summary
-----------------
This study shows that cycled light during neonatal care reduces infant's fussing and crying behavior at 5 and 11 weeks corrected age and improves growth during neonatal care.

Official Title
-----------------
Cycled Light Exposure Reduces Fussing and Crying in Very Preterm Infants

Conditions
-----------------
Crying, Sleep

Intervention / Treatment
-----------------
* Other: Cycled light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: very preterm infants (≤ 32 0/7 weeks gestational age, GA) Exclusion Criteria: major cerebral injuries such as intraventricular haemorrhage grade III (according to Papile 16) or periventricular leukomalacia or venous infarction (according to Govaert and de Vries 17) diagnosed by cranial ultrasound retinopathy of prematurity grade III and IV congenital malformations small for gestational age (birth weight < 3rd percentile) prenatal infections intrauterine drug exposure
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dim light<br>Day and nighttime dim light conditions | Other: Cycled light<br>* lights on at daytime, lights off at nighttime<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean duration and change over time for total duration per 24 hours for crying variables | mean duration per 24 hours for following variables: content, fussing, crying, unsoothable crying change over time, measured at 5 and 11 weeks corrected age measured by diary | 5 and 11 weeks corrected age | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean sleep duration per 24 hours and change over time | mean sleep duration per 24 hours measured by sleep diary measured at 5, 11 and 25 weeks corrected age, for adressing change over time | 5,11 and 25 weeks corrected age | 
| mean weight gain per day | mean weight gaing per day during hospital stay. | during hospital stay | 
| mean activity count per 24 hours and change over time | mean activity count per 24 hours measured by actigraph recordings measured at three time points, 5, 11 and 25 weeks corrected age to adress change over time | 5, 11, and 25 weeks corrected age | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cycled light, dim light, circadian rhythm, actigraphy, sleep, premature infant
Acute Psychological Effects of High Intensity Exercise With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the acute psychological effects in patients with schizophrenia after one session of high intensity exercise.

Detailed Description
-----------------
We will examine if there is an acute effect of one high intensity session of physical exercise (4x4 intervals) on psychological variables state mood, state anxiety, well-being and psychological distress. This possible effect will be examined in three groups, one group being the main group that the other two groups will be compared up against. Group 1: Patients with schizophrenia and other psychotic illnesses. Group 2: people with non-psychotic diagnosis. Group 3: people without any psychological diagnosis.

Official Title
-----------------
Acute Psychological Effects of High Intensity Exercise in Patients With Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: High intensity exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They will be allocated into groups by their diagnoses Exclusion Criteria: Not being able to complete the exercise

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: schizophrenic disorder<br> | Behavioral: High intensity exercise<br>* 4x4 intervals<br>|
| Experimental: other psychotic disorder<br> | Behavioral: High intensity exercise<br>* 4x4 intervals<br>|
| Experimental: no mental disorder<br> | Behavioral: High intensity exercise<br>* 4x4 intervals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive and negative affects | Positive and Negative Affect Schedule - Expanded Form (PANSS) | baseline and 2 days postintervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| state anxiety | Questionnaire, self-report. State anxiety inventory (SAI) | baseline and 2 days postintervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schizophrenia, high intensity exercise, interval training exercise
Bone Structure in Patients With Adult Onset Growth Hormone Deficiency Assessed Using High Resolution Peripheral Quantitative Computed Tomography

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess bone geometry, bone compartment specific volumetric densities and micro-architecture as well as to evaluate non-invasive estimates of bone strength in patients with adult onset growth hormone deficiency.

Official Title
-----------------
Bone Geometry, Volumetric Density, Microarchitecture and Estimated Bone Strength Assessed by High Resolution Peripheral Quantitative Computed Tomography in Patients With Adult Onset Growth Hormone Deficiency

Conditions
-----------------
Adult Onset Growth Hormone Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women diagnosed with Adult onset Growth Hormone Deficiency Age between 18-80 Informed consent Exclusion Criteria: Competing bone disease (e.g.. Mb. Paget, myelomatosis, osteogenesis imperfecta, osteoporosis, primary hyperparathyroidism) Ongoing medical treatment affecting bone metabolism (eg. osteoporosis medications) Ongoing pregnancy or breast feeding

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Growth hormone deficiency<br> | |
| healthy controls<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volumetric bone mineral density in grams per cc |  | 1 year |