linjc16/ctgov huggingface dataset:
Deep Venous Thrombosis Screening in the ICU by Nurses

Study Overview
=================
Brief Summary
-----------------
Despite of preventive measures, the incidence of deep venous thrombosis (DVT) in ICU patients is estimated to range from 5-31%. While clinical diagnostics is unreliable, ultrasound compression test (UCT) has proven to be a highly sensitive and specific modality for the recognition of lower extremity DVT. Delegating this competence to ICU nurses can increase UCT availability and enable preventive DVT screening. Therefore, the investigators decided to conduct a clinical study to evaluate the sensitivity and specificity of UCT performed by general ICU nurse in ICU patients compared to an investigation by ICU physician certified in ultrasound. Prior to the study, each nurse-investigator participating in the study undergo one-hour training in UCT and examine 5 patients under supervision. Then, ICU patients without known DVT will be investigated by UCT in the femoral and popliteal region of both lower extremities by trained general ICU nurse-investigators. On the same day, the examination will be repeated by an ICU physician-investigator. The results of the examinations of each patient will be blinded to each other for both investigators until both tests are performed. The sensitivity and specificity of the test performed by general nurse will be calculated in comparison with the examination by a specialist.

Official Title
-----------------
Screening Ultrasound Compression Testing in Critically Ill Patients Performed by General Nurses - Validation Study

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

Intervention / Treatment
-----------------
* Diagnostic Test: Compression ultrasound testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all ICU patients without known deep venous thrombosis, hospitalised more than 72 hours Exclusion Criteria: contraindication of compression ultrasound testing end-of-life decision regimen of care

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 |
| --- |
|Diagnostic Test: Compression ultrasound testing|Compression ultrasound testing, screening technique for diagnosing deep venous thrombosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of the compression ultrasound testing in the ICU patients performed by general nurses | Validity of testing performed by nurses will be compared with investigation by the physician, specialist for compression ultrasound testing | One day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Compression Ultrasound testing, Nurse
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using MR-proADM - Pilot Study

Study Overview
=================
Brief Summary
-----------------
Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED. The rationale of this IDEAL study is to provide guidance to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will be tested in a pilot study first.

Official Title
-----------------
Identifying Patients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pilot Study

Conditions
-----------------
Patients Presenting With Suspicion of Infection to the ED

Intervention / Treatment
-----------------
* Other: MR-proADM guided


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients presenting to the ED with suspicion of infection Age ≥18 years Written Informed Consent obtained Exclusion Criteria: Recent major trauma or surgery End stage renal failure requiring dialysis Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure Patients those source of infection always requires hospital admission or never requires hospital admission. Patients who cannot be discharged for other than medical reasons Patient participates in any other interventional clinical trial Patients with active intravenous drug use Pregnant or lactating women Patients who are institutionalized by official or judicial order Dependents of the sponsor, the CRO, the study site or the investigator

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MR-proADM guided<br> | Other: MR-proADM guided<br>* MR-proADM value together with routine clinical evaluation identifies patients with a low 14 day mortality risk who do not need to be hospitalized<br>|
| No Intervention: Standard Care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients admitted to the hospital |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28 days all-cause hospital re-admission (corrected for mortality) |  | 28 days | 
| Number of patients re-presenting to the ED within 28 days |  | 28 days |
Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy

Study Overview
=================
Brief Summary
-----------------
This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA Objective: To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand To demonstrate physiological and pathological changes in treated patients with Goserelin. To assess tolerability and adverse effect of Goserelin therapy

Official Title
-----------------
Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients

Conditions
-----------------
Spinobulbar Muscular Atrophy, Kennedy's Disease

Intervention / Treatment
-----------------
* Drug: Goserelin
* Procedure: Electrophysiologic study
* Procedure: tissue biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent Males, age over 20 years, undesired fertility Have positive family history of muscle weakness with these clinical signs: bulbar involvement (difficulty in breathing, swallowing, talking) muscle atrophy with or without fasciculation decrease or normal deep tendon reflex normal Babinski response no sensory impairment mild tremor (either postural or intention) gynecomastia decrease libido and infertility Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35. Exclusion Criteria: Have weakness caused by other etiologies and have liver or kidney disease. Have currently prostatic cancer Want to have a child Participation in a clinical study during the last 30 days. Females and children age < 20 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Goserelin|Goserelin 10.8 mg SC every 3 months|
|Procedure: Electrophysiologic study|Nerve conduction study Electromyogram|
|Procedure: tissue biopsy|skin and muscle biopsy before and after treatment every year|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| muscle power |  | every 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| electrophysiologic study (Nerve conduction and Electromyogram) |  | every 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinobulbar muscular atrophy, Kennedy's disease, Goserelin, Electrophysiologic study, Inclusion body
Examining the Usage of Dopamine Blockers in OCD Patients

Study Overview
=================
Brief Summary
-----------------
We examine the usage of Dopamine blockers in OCD patients. We want to examine their frequency of usage, compare the course of the disease between those who receive and those who do not receive Dopamine blockers, and efficacy of the treatment. The study will be done in two stages: 1. Collecting information the usage of Dopamine blockers from 150 OCD patients' files. 2. interviewing 60-70 patients to see the difference those who receive and those who do not receive Dopamine blockers in their current severity of disease.

Official Title
-----------------
Examining the Usage of Dopamine Blockers in OCD Patients

Conditions
-----------------
Obsessive Compulsive Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age DSM-IV diagnosis of OCD Ability to understand patient information sheet, and consent to participate Exclusion Criteria: Current or past Psychotic or Bipolar disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
Italian Multicenter Database for Open Conversions After EVAR

Study Overview
=================
Brief Summary
-----------------
Late endovascular abdominal aneurysm repair (EVAR) complications not amenable to endovascular correction can undergo either late open conversion (LOC) or semi-conversion (SC). LOC is defined as a total or partial endograft explantation >30 days after the initial EVAR. SC is defined as open or laparoscopic surgery for endoleak (EL) correction with complete endograft preservation. The aim of this study is to collect in a prospective database the technical aspects of a multicenter experience of LOC and SC, and to analyse early and long-term outcomes of these two treatments.

Official Title
-----------------
Italian Multicenter Prospective Database for Open Conversions and SemiConversions After Endovascular Aneurysm Repair

Conditions
-----------------
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm Enlargement

Intervention / Treatment
-----------------
* Procedure: Open Conversion after EVAR
* Procedure: SemiConversion after EVAR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: open or laparoscopic surgery for EVAR complications, with or without endograft explantation Exclusion Criteria: endovascular reinterventions extra-anatomical bypass surgery (e.g. femoro-femoral crossover bypass) not associated with direct aorta/endograft 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Conversions<br>Patients undergoing total or partial endograft explantation for any EVAR complication. | Procedure: Open Conversion after EVAR<br>* See Open Conversions group description.<br>|
| SemiConversions<br>Patients undergoing open or laparoscopic surgery for any EVAR complication (mostly endoleak correction) with complete endograft preservation. | Procedure: SemiConversion after EVAR<br>* See SemiConversions group description.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Mortality | 30-day mortality after surgery | 30 days | 
| In-hospital Mortality | Mortality during in-hospital stay | 90 days | 
| Long-term survival | Long-term survival rate | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Morbidity | Major complications after surgery | 30 days | 
| Related complications | Aorta-related complications during follow-up | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal aortic aneurysm, Open surgical conversion, Endovascular repair, EVAR explantation, Failed EVAR
Gender Differences in Prevalence of Undiagnosed Diabetes in ACS

Study Overview
=================
Brief Summary
-----------------
The primary goal of this study is to measure the prevalence of undiagnosed pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (ACS) compared to men. Inpatients with confirmed ACS (and no known prior history of diabetes) are invited to return to the Yale Hospital Research Unit 6-8 weeks after hospital discharge for an oral glucose tolerance test to identify individuals with pre-diabetes and diabetes.

Official Title
-----------------
A Pilot Study of Gender Differences in the Prevalence of Undiagnosed Diabetes in Acute Coronary Syndromes (ACS)

Conditions
-----------------
Pre-diabetes, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute coronary syndrome age > 30 yrs Exclusion Criteria: previously diagnosed diabetes ACS due to substance abuse or trauma

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| 1<br>non-diabetic women with acute coronary syndrome (ACS) | |
| 2<br>non-diabetic men with acute coronary syndrome (ACS) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of undiagnosed pre-diabetes or undiagnosed diabetes |  | after hospitalization for acute coronary syndrome | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
undiagnosed diabetes, undiagnosed pre-diabetes, acute coronary syndrome, undiagnosed pre-diabetes and undiagnosed diabetes
Study to Assess the Safety and Efficacy of Multiple Doses of VB-201 on Biomarkers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of multiple doses of VB-201 administered for 4 weeks and its efficacy on biomarkers.

Official Title
-----------------
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Effect of Multiple Doses of VB-201 on Biomarkers

Conditions
-----------------
Biomarker

Intervention / Treatment
-----------------
* Drug: VB-201 or Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients, ≥18 to ≤75 years of age; Exclusion Criteria: Presence of, or history of cancer, with the exception of completely excised, non-metastatic squamous cell or basal cell carcinomas of the skin; Has a clinically significant systemic infection (e.g., chronic or acute infection, UTI, URI) within 30 days of Day 0, or a history or presence of recurrent or chronic infection (e.g. viral infections, [including hepatitis B or C, HIV], bacterial infections, systemic fungal infections, or syphilis); Subjects with a history of coronary events within the last 6 months;

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiple doses of VB-201<br> | Drug: VB-201 or Placebo<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: VB-201 or Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels

Study Overview
=================
Brief Summary
-----------------
We aimed to evaluate the effects of rosiglitazone on serum ghrelin and peptide yy levels in diabetic women.

Official Title
-----------------
Effects of Rosiglitazone on Serum Ghrelin and Peptide YY Levels in Diabetic Women

Conditions
-----------------
Type 2 Diabetes Mellitus, Obesity

Intervention / Treatment
-----------------
* Drug: rosiglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly diagnosed, drug naive women with type 2 diabetes Exclusion Criteria: presence of severe cardiovascular disease (eg, New York Heart Association class III or IV congestive heart failure or a history of myocardial infarction or stroke) presence of thyroid, pituitary, nutritional, hepatic, renal, or neoplastic disorders

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Improved ICU Outcomes With Protocolized Management of Analgesia, Sedation and Delirium

Study Overview
=================
Brief Summary
-----------------
To assess pain, agitation, and delirium experienced by critically ill patients daily and evaluate the impact of a protocol; to compare the incidence of coma and delirium, length of stay, mortality and costs of care between pre- and post-protocol groups.

Official Title
-----------------
Comparison of no Protocol vs Protocolized Approach to Pain, Sedation and Delirium Management in the ICU

Conditions
-----------------
Critical Care

Intervention / Treatment
-----------------
* Other: protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All adult patients admitted to ICU Exclusion Criteria: Repeat admission within the same hospitalisation; moribund patients

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 |
| --- |
|Other: protocol|management protocols of non-pharmacological strategies and individualized titration of analgesics, sedatives, and anti-psychotics based on observed scores to manage sedation, analgesia and delirium.|

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
-----------------
protocol, analgesia, sedation, delirium, coma
Evaluation of HEArt invoLvement in Patients With FABRY Disease

Study Overview
=================
Brief Summary
-----------------
This study evaluates predictors for the incidence of arrhythmias and sudden cardiac death as well as terminal heart failure in patients with Fabry disease.

Detailed Description
-----------------
Fabry disease is a rare disease and part of the group of lysosomal storage disorders. Natural history of Fabry disease has proven poor survival to ages >50 years outlining the importance to evaluate cardiac symptoms and outcomes of patients with Fabry disease. This study is a prospective cohort study and observes patients since 2001. Through this long-term experience and the relative high number of patients this study is suggested to help estimating the risk of cardiac arrhythmias and sudden cardiac death (SCD) as well as death or heart transplantation due to terminal heart failure. All patients in treatment in the Fabry Center Wuerzburg (FAZiT) are included in this study if informed consent is provided.

Official Title
-----------------
Prospective Monocentric Cohort Study to Evaluate Predictors for Heart Failure and Sudden Cardiac Death in Patients With Fabry Disease

Conditions
-----------------
Rare Diseases, Fabry Disease, Fabry Disease, Cardiac Variant, Hypertrophic Cardiomyopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fabry disease (genetically confirmed) Signed informed consent 18 years and older Exclusion Criteria: No informed consent Withdrawal of informed consent

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 |
| --- | --- | --- |
| Cardiac death | Patients sustaining cardiac death | From date of inclusion until the date of first documented event, up to the year 2032 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart transplantation | On the basis of severe cardiac damage heart transplantation is needed | From date of inclusion until the date of first documented event, up to the year 2032 | 
| Malign Arrhythmias | Patients suffering any malign arrhythmias | From date of inclusion until the date of death, up to the year 2032 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fabry, Fibrosis, Dialysis, Stroke, Chronic kidney disease