linjc16/ctgov huggingface dataset:
Functional Recovery Changes in Subacute Stroke Patients

Study Overview
=================
Brief Summary
-----------------
In subacute stroke patients, dynamic time series data of brain imaging and motor function measurement were obtained from 7 days to 6 months (total 9 times) after stroke onset

Official Title
-----------------
Dynamic Time Series Data Collection for Functional Recovery Changes in Sub-acute Stroke Patients

Conditions
-----------------
Sub-acute Stroke

Intervention / Treatment
-----------------
* Other: Data acquisition of functional abilities in sub-acute stroke


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 19 years of age hemiplegic stroke patients Subacute-phase ischemic or hemorrhagic stroke patients within 7 days of onset Functional Ambulation Category Scale (FAC) of 3 or less, 7 days of onset, A person who understands and voluntarily participates in this study and signs a research agreement Exclusion Criteria: User of artificial heartbeat Patients with claustrophobia Patients with metal implants Patients who are contraindicated for other common MRI Patients with mild motor impairment with an FMA score of 80 or higher Patients whose conscious state is coma and who have no response at all Patients who can not independently gait with the Modified Rankin Scale (mRS) score of 4 or more before the onset of disease

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Sub-acute stroke<br>More than 1 week post-stroke Ischemic or hemorrhagic stroke | Other: Data acquisition of functional abilities in sub-acute stroke<br>* MRI data, motor evoked potentials, gait function and behavior data acquisition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanism of recovery of motor function according to recovery of sub-acute stroke | Mechanism of recovery of motor function calculate by repeated measurement method in physical and cognitive functions data and MRI data of brain | Through study completion, an average of 6 months | 
| Mechanism of recovery of gait function according to recovery of sub-acute stroke | Mechanism of recovery of motor function calculate by repeated measurement method in 3D motion capture system and electromyography (EMG) data and MRI data of brain | Through study completion, an average of 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Motor function, Recovery, Gait, Magnetic resonance imaging
Astigmatism Post-trabeculectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this project: Confirming the modification in corneal astigmatism after trabeculectomy with MMC and intracameral administration of bevacizumab. Medium-term follow up (6 months) of the induced corneal astigmatism. Investigating correlations between postoperative astigmatism, particularly with the postoperative IOP.

Official Title
-----------------
The Effect of Trabeculectomy on Astigmatism.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: trabeculectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary open angle glaucoma Normal tension glaucoma Pseudoexfoliation glaucoma Pigment dispersion glaucoma Exclusion Criteria: Patients who refuse to sign the informed consent. Patients with primary angle closure glaucoma (PACG). Patients younger than 18 years old. Other ocular diseases besides glaucoma. Significant corneal opacities. Refractive error more than + or -6.00 diopters. Visual acuity less than 0.05 Previous intra-ocular surgery (except cataract surgery more than six months preceding the trabeculectomy). Laser treatment for glaucoma within 6 months of the surgery.

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

| Intervention/Treatment |
| --- |
|Procedure: trabeculectomy|Filtering surgery to reduce the intra-ocular pressure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ocular cylinder and axis untill 6 months after trabeculectomy. | Comparing the change in corneal cylinder, axis and IOP before the operation and 1,3 and 6 months after the operation. We will compare these vectors by vector analyses. | pre-operative until 6 months post-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, trabeculectomy, astigmatism, intraocular pressure
Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

Study Overview
=================
Brief Summary
-----------------
The primary objective of this pilot study is to identify and quantify inflammatory and genetic markers from bronchoalveolar lavage fluid (BALF) and serum in patients with a history of chronic obstructive pulmonary disease (COPD) undergoing elective coronary revascularization (CABG) to determine the risk of developing post operative respiratory failure. To achieve this objective, this proposal outlines the following specific aims: Aim #1. To identify from BALF and serum, the change in inflammatory and genetic markers in patients with a history of COPD undergoing CABG. BALF and serum samples will be obtained at the time of intubation immediately prior to surgery and again upon skin closure immediately after the surgical procedure. Aim #2. To determine the extent to which inflammatory and/or genetic markers correlate with post-operative pulmonary complications defined as prolonged mechanical ventilation (> 24 hours), pneumonia, and/or tracheostomy. Aim #3. To inform the development and implementation of a large pivotal trial which may impact clinical decision-making during the initial pre-operative outpatient assessment of COPD patients undergoing CABG.

Official Title
-----------------
Inflammatory Biomarkers Predict Pulmonary Outcomes in Coronary Artery Bypass Grafting

Conditions
-----------------
Coronary Artery Disease, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing elective CABG Current diagnosis of COPD Ability to provide signed informed consent to participate > 18 years of age Exclusion Criteria: Concomitant valve surgery Urgent or emergent coronary surgery Current steroid therapy Active smoker and/or positive urine co-nicotine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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 |
| --- | --- | --- |
| Primary outcome measure | The identification of specific inflammatory and genetic markers associated with post-operative pulmonary complications in this population of elective CABG patients with a history of COPD. | During Hospitalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcome measure | Post-operative pulmonary complications: prolonged mechanical ventilation (defined as >24 hours), atelectasis, pneumonia, exacerbation of COPD and tracheostomy. All-cause mortality will also be assessed. | 30 Day Follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery bypass grafting, coronary artery disease, chronic obstructive pulmonary disease
123I-MIBG SPECT/CT for Assessment of Cardiac Sympathetic Innervation

Study Overview
=================
Brief Summary
-----------------
Myocardial scintigraphy with 123I-MIBG allows for visual and semi-quantitative assessment of sympathetic cardiac innervation using the hear to mediastinum ratio (HMR). Impaired cardiac MIBG clearance may occur in patients with congestive heart failure (CHF). The purpose of present study was to develop and validate a quantitative index for the assessment of cardiac MIBG uptake kinetics using SPECT/CT for diagnosis of CHF

Official Title
-----------------
Quantitative 123I-MIBG SPECT/CT Assessment of Cardiac Sympathetic Innervation

Conditions
-----------------
Cardiac Diseases

Intervention / Treatment
-----------------
* Device: SPECT/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>40 Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: SPECT/CT|GE INFINIA HAWKEYE|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact of the imaging modality on patient management |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The impact on patient management |  | 2 years |
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome

Study Overview
=================
Brief Summary
-----------------
This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers. Groups' (placebo vs. insulin) cognitive function and stress response will be compared.

Conditions
-----------------
Tobacco Abstinence Syndrome

Intervention / Treatment
-----------------
* Drug: Intranasal Insulin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: smokers (>10 cig/day) for the past 1 year normosmic olfactory function Exclusion Criteria: previous/current use of insulin current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder current pregnancy (or lactation) lifetime history of endocrine disease excessive alcohol use (>25 standard units of alcohol/week) current use of illicit drugs current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic agent local infections, inflammation, structural abnormalities, or other nasal pathology current use of any medications administered intranasally, including intranasal steroids

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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: Intranasal Insulin<br>Intranasal Insulin | Drug: Intranasal Insulin<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Episodic Memory | California Verbal Learning Task Number of Words Learned Higher Values Mean Better Outcome | 90 minutes | 
| Salivary Cortisol |  | 90 minutes |
Women Abuse and the Role of the Family Doctor.

Study Overview
=================
Brief Summary
-----------------
The study tested a training to improve recognition of abused female patients in family practice.Effect measures of the training were: number of reported cases wherein the doctor suspected and discussed partner abuse and the number of non-obviuos reasons to suspect partner abuse.We assumed that following a training would improve the recognition of abused women. Secondary to this trial we explored gender differences of family doctors in discussing partner abuse and we interviewed women recently identified by their family doctor. Medical histories of recently identified abused women were studied to assess health problems and health-care utilisation.

Official Title
-----------------
Women Abuse and the Role of the Family Doctor. Testing an Intervention in a Randomised Controlled Trial.

Conditions
-----------------
Improved Recognition of Partner Abuse, Gender Differences in Discussing Partner Abuse, Abused Women's Expectations,Experiences, Abused Women's Health Care Utilisation

Intervention / Treatment
-----------------
* Behavioral: a training to improve recognition of partner abuse.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:women consulting in family practice, age 18 years and older - Exclusion Criteria:we excluded only for the interviews: women who were assessed by their family doctor to be in danger because of the abusive situation, women with a psychiatric condition. -

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

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

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

Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: a training to improve recognition of partner abuse.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of reported cases wherein a doctor suspected and discussed partner abuse. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cases with non-obvious symptoms wherein a doctor suspected partner abuse. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intimate partner abuse, gender, education, attitude, family doctor, health care utilisation, abused women
French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

Study Overview
=================
Brief Summary
-----------------
Observational Study, French, prospective, multicenter rated using intravascular prosthesis ABSORB BVS. ABSORB BVS is a prosthesis of a new type. This study will prospectively evaluate all procedures for coronary angioplasty with implantation of at least one BVS with a clinical follow-up of all patients implanted with ABSORB BVS. This national observatory will collect all the events related to product and / or to procedure

Official Title
-----------------
French Observatory Evaluating the Use of Intracoronary Prosthesis ABSORB BVS

Conditions
-----------------
Intracoronary Angioplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient affiliated to the National Health Insurance Scheme Patient able to assess and understand the risks, benefits and alternative treatments laying of ABSORB, to agree to participate in the study (by signing the informed consent after having read the newsletter) Patients for whom a procedure is performed coronary angioplasty with implantation of at least one BVS. Patient allowing the follow-up as defined in the study Exclusion Criteria: Pregnant patient Patient that can not give informed consent Patient with in-stent restenosis or saphenous vein bypass

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 |
| --- | --- |
| ABSORB BVS<br>All patients with a coronary angioplasty procedure and the implantation of at least one ABSORB BVS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major Adverse Cardiac Events at 1 year | At 1 year of follow-up, to evaluate the rate of MACE (Major Adverse Cardiac Events) defined as follows: Death from cardiac causes Myocardial Infarction Rates of target lesion revascularization (TLR) of ischemic origin (ID-TLR) Surgery unscheduled bypass graft (CABG) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target vessel revascularization at 1 year | At 1 year of follow-up, to evaluate the rate of target vessel revascularization (TVR) | 1 year | 
| Rate of stent thrombosis at 1 year | At 1 year of follow-up, to evaluate the rate of stent thrombosis as ARC definitions : acute, subacute, late probable or undoubted | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiology, Intracoronary angioplasty, Bioresorbable stent
Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion

Study Overview
=================
Brief Summary
-----------------
Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops.

Detailed Description
-----------------
Deep Vein Thrombosis (DVT) is one of the most important complications after Peripherally Inserted Central Catheter (PICC) insertion. This study goals are to understand when and why DVT develops. Patients will be studied with ultrasound for 4 weeks after PICC insertion, one visit a week. The final outcome of PICCs will be collected.

Official Title
-----------------
Prospective Study on the Incidence of Early Deep Vein Thrombosis After Peripherally Inserted Central Catheter Insertion

Conditions
-----------------
Venous Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Peripherally Inserted Central Catheter insertion Exclusion Criteria: Pre-existing Deep Vein Thrombosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PICC insertion<br>Peripherally Inserted Central Catheter insertion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Deep Vein Thrombosis incidence assessed with weekly ultrasound examination |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors which may be correlated to Deep Vein Thrombosis development: obesity (Body Mass Index) | Body Mass Index (kg/m^2) | 4 weeks | 
| Factors which may be correlated to Deep Vein Thrombosis development: cancer | Cancer yes/no | 4 weeks | 
| Factors which may be correlated to Deep Vein Thrombosis development: previous Deep Vein Thrombosis | Previous Deep Vein Thrombosis yes/no | 4 weeks | 
| Factors which may be correlated to Deep Vein Thrombosis development: Heparin-induced thrombocytopenia | Heparin-induced thrombocytopenia yes/no | 4 weeks | 
| Overall Deep Vein Thrombosis incidence | Number of patients with Deep Vein Thrombosis/total number of patients | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripherally inserted central venous catheter
Routine or On-demand Fentanyl in Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely administered in most countries. In Norway, however, routine sedation is rare, and medication is normally given on demand, that is, if necessary during the procedure. The investigators want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of action, is better given before the procedure than during the procedure.

Official Title
-----------------
Routine Versus on Demand Administration of Fentanyl in Colonoscopy: A Multi-centre Randomized Controlled Trial

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Routine medication arm
* Drug: Fentanyl on-demand arm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-75 Referred for out-patient colonoscopy Exclusion Criteria: ASA-score 3 or higher Same day upper endoscopy Pregnancy Pacemaker Patient require medication before colonoscopy Previous resection of colon or rectum Significant psychiatric morbidity Oxygen saturation < 95% without supplementary oxygen Contra indications to fentanyl Inability to sign inform consent Inability to understand information about the trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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: Routine medication arm<br>Fentanyl is given routinely to all patients before the procedure | Drug: Routine medication arm<br>* 50 micrograms of fentanyl given before the procedure<br>* Other names: fentanyl;|
| Active Comparator: Fentanyl on-demand arm<br>Fentanyl is given during the procedure if the patient experiences pain | Drug: Fentanyl on-demand arm<br>* Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.<br>* Other names: Fentanyl;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during colonoscopy | Pain is recorded on a 4 point Likert scale and a 100 mm VAS scale. | Immediately after the procedure and after 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional medication | The investigators want to assess the need for additional medication during the colonoscopy in the routine fentanyl-arm compared to the fentanyl on-demand arm. | During the colonoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, pain