linjc16/ctgov huggingface dataset:
Intraoperative Volume Management and QT Interval

Study Overview
=================
Brief Summary
-----------------
QT interval changes is measured during all phases of the operation. The protocol is focusing at intraoperative bleeding events and is also observing QT interval changes during anesthetic and operative procedures.

Detailed Description
-----------------
Prolongation of the QT interval is associated with functional torsade de points, re-entry, and sudden death (see reference). Variations of QT-interval caused by changes in the volume status of the patient during an operation remained unclear. QT interval changes will be monitored during the surgery with the focus of the influence of sudden blood loss, volume substitution by crystalloids, blood and blood products. The effect of surgical procedures on the QT-interval (e.g. clamping of kidney artery) will be observed as well as the association of intra-operative QT-interval alterations with postoperative complications.

Official Title
-----------------
Intraoperative Repolarisation - Etiology and Relevance for the Decision Making by Anesthesiologists in the Management of Volume Substitution and Transfusion

Conditions
-----------------
Blood Loss, Surgical

Intervention / Treatment
-----------------
* Procedure: intra-operative blood loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists physical status classification 2 - 3 patients after consent Exclusion Criteria: Children, pregnant women, patients not able to consent

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 |
| --- | --- |
| bleeding<br>intraoperative blood loss > 500 ml | Procedure: intra-operative blood loss<br>* surgery in the urology and orthopedics<br>|
| no bleeding<br>intraoperative blood loss < 500 ml | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in QT-time |  | during operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative incidents/disturbance rhythm of the heart | association to intraoperative repolarisation-disturbance / QT-prolongation | 2 days | 
| survival | association to intraoperative repolarisation-disturbance / QT-prolongation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrocardiography, Hemorrhage, Monitoring, Intraoperative
Smartphone-App Based Prediction of Large Vessel Occlusion

Study Overview
=================
Brief Summary
-----------------
The aim of this non-interventional study is to evaluate a German version of the triage stroke-score FAST-ED performed by ambulance service personnel in a pre-hospital setting using a smartphone app (Join-Triage, Allm).

Detailed Description
-----------------
The emergency service of the city of Essen (NRW, Germany), which is organised by the Essen fire-department, will perform a prehospital triage stroke-score using a smartphone-app (Join-Triage, Allm) when referring patients with suspected stroke to the university clinic Essen. The triage stroke-score FAST-ED (Field Assessment Stroke Triage for Emergency Destination), as well as the expected time of arrival will be transmitted by an additional smartphone-app in advance of the arrival (Join, Allm). Patients will receive emergency workup to identify stroke etiology and presence of large vessel occlusion. Final diagnosis, presence of large vessel occlusion and type of revascularisation treatment will be registered. Sensitivity, specificity and further criteria for test quality will be calculated for the stroke triage by emergency service in field using the FAST-ED.

Official Title
-----------------
Smartphone-App Based Prediction of Large Vessel Occlusion in Suspected Stroke by Emergency Medical Service Using FAST-ED

Conditions
-----------------
Acute Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
All patients above the age of 18 with suspected acute stroke transferred to the university hospital Essen. Inclusion criteria: suspected acute stroke, age above 18 years and a digitally transmitted FAST-ED by EMS prior to admission. Exclusion criteria: Known symptom onset beyond 24 Hours.

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 |
| --- | --- | --- |
| Presence of large vessel occlusion | Acute stroke due to large vessel occlusion as measured by computed tomography angiography (CT-A) | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prehospital Triage
Motivation to Exercise in People With Anorexia Nervosa

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine the importance and level of physical activity in people with Anorexia Nervosa.

Detailed Description
-----------------
A laboratory paradigm that uses a progressive ratio computerized work task will be used to determine the reinforcing value of exercise in hospitalized patients with AN, both before and after weight gain. In addition, we will examine the relationship between the reinforcing value of exercise and free-living physical activity in this population. We will also examine the relationship between the reinforcing value of exercise and measures of depression, anxiety, and cortisol, which we have found in previous studies to be associated with other measures of physical activity and exercise motivation. In order to determine whether physical activity in women with AN differs from that of non-eating disordered women, we will extend studies of physical activity to free-living control participants. All adult patients and controls will undergo body composition assessment once to measure the association between physical activity and percent body fat. Finally, to determine the impact of exercise reinforcement and physical activity on outcome in women with AN, we will conduct follow-up assessments in all patient participants for one year after discharge from the inpatient treatment unit.

Official Title
-----------------
Behavioral Assessment of the Reinforcing Effects of Exercise in Patients With Anorexia Nervosa

Conditions
-----------------
Anorexia Nervosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-IV diagnosis of Anorexia Nervosa (except amenorrhea) Female Age 18-45 Medically Stable for exercise participation At a minimum of 75% Ideal Body Weight Exclusion Criteria: Significant or current past medical illness including diabetes mellitis and heart disease Current or lifetime history or schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR Current suicidal ideation or recent suicidal behavior (within past 3 months) Drug or alcohol abuse in last 6 months Taking psychotropic medication Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| physical activity |  | Physical activity before and after weight restoration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia Nervosa, Eating Disorders, Exercise, Physical Activity
Genetic Predictors of Renal Dysfunction Following Heart Transplantation

Study Overview
=================
Brief Summary
-----------------
Kidney disease is a common problem after heart transplantation. It may be caused by anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some people develop kidney problems after a heart transplant, but other people do not, is not fully known. This study plans to learn more about the relationship between a person's genetic make-up (DNA; deoxyribonucleic acid) and the risk of kidney problems after a heart transplant. The long-term goal of this research is to identify genetic variations that may help predict the development of kidney problems after heart transplantation.

Official Title
-----------------
Pharmacogenomics of Calcineurin Inhibitor Nephrotoxicity in Cardiac Transplantation

Conditions
-----------------
Heart Transplantation, Chronic Renal Insufficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac-only transplant 18 years of age or older at the time of cardiac transplant 1 year or more post-cardiac transplant treatment with cyclosporine or tacrolimus following transplant Exclusion Criteria: combined organ transplant decisionally impaired unable to read or speak English unable or unwilling to provide written informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Cardiac transplant recipients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic renal dysfunction |  | year 2 post-transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart transplantation, chronic renal insufficiency, pharmacogenomics, cyclosporine, tacrolimus
Efficacy and Safety In Poorly Controlled Type 2 Diabetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.

Official Title
-----------------
A 24-week Randomized, Double-Blind, Parallel-Group, Multicenter Study to Demonstrate the Efficacy and Safety of Two Different Rosiglitazone Dosing Regimens, 4mg OD and 8mg OD, in Poorly-Controlled Drug Naive Patients With Type 2 Diabetes Mellitus

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Type 2 diabetes Drug-naive. Laboratory test result for HbA1c of greater than or equal to 10%. Written informed consent. Exclusion criteria: Prior use of antidiabetic medications within 3 months of screening. Fluid retention (edema). Significant liver disease. Low red blood cells (anemia). Severe or unstable angina (chest pain). Congestive heart failure. Severe high blood pressure. Alcohol or drug abuse. Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: rosiglitazone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline to Week 24. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FPG (fasting plasma glucose) from baseline to Week 24; characterize the effects of rosiglitazone on the albumin-creatinine ratio at Week 24. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes drug-naive
Diabetic Neuropathy Topical Treatment

Study Overview
=================
Brief Summary
-----------------
Comparative study of efficacy and safety of ketamine, clonidine, mixture of both and placebo in patients with diabetic neuropathic pain

Official Title
-----------------
Diabetic Neuropathic Pain Topical Treatment- Comparative Study

Conditions
-----------------
Diabetic Neuropathy, Pain

Intervention / Treatment
-----------------
* Drug: ketamine
* Drug: vehicle gel
* Drug: ketamine + clonidine
* Drug: clonidine gel 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes Mellitus type I or II Mono or polyneuropathy Treatment with Tricyclic Antidepressant, Carbamazepine during 3 weeks at least Preserved cognition Exclusion Criteria: Ulcerative or infection or vesicle lesion in pain site Pregnancy Breast feeding

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K<br>drug - ketamine 1% gel | Drug: ketamine<br>* ketamine 150 mcg/g bid<br>|
| Placebo Comparator: P<br>vehicle gel | Drug: vehicle gel<br>* bid - 12 weeks<br>|
| Experimental: M<br>association of ketamine and clonidine gel | Drug: ketamine + clonidine<br>* ketamine 150mcg/g + clonidine 1% gel bid 12 weeks<br>|
| Experimental: C<br>clonidine gel | Drug: clonidine gel 1%<br>* bid 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain evaluation by visual analogue scale |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain evaluation by amount of rescue medication required |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
neuropathic pain, ketamine, clonidine, association
Efficacy and Safety of Aspirin Therapy With CABG

Study Overview
=================
Brief Summary
-----------------
evaluate the safety of preoperative aspirin therapy when performing bypass surgery in conditions of artificial blood circulation

Detailed Description
-----------------
The hypothesis of the study was that aspirin therapy started 24 hours before CABG is safe. The effectiveness of this hypothesis will be assessed by the presence of a 30-day period after CABG myocardial infarction, ischemic stroke, repeat revascularizations

Official Title
-----------------
A Prospective Randomized Study of the Efficacy and Safety of Aspirin Therapy With CABG

Conditions
-----------------
Coronary Heart Disease

Intervention / Treatment
-----------------
* Drug: acetylsalicylic acid started for 24 hours before surgery
* Drug: acetylsalicylic acid stayed for 5 days before surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older Patient able to give informed consent Exclusion Criteria: Missing consent Urgent or emergent surgery Off-pump CABG Рatient has clear indication for anticoagulation (eg. mechanical heart valve, atrial fibrillation) or ADP receptor antagonist (eg. drug-eluting stent) History of bleeding diathesis, significant GI bleed, ICH, or liver failure Allergy to or intolerance of aspirin

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>acetylsalicylic acid started for 24 hours before surgery and determination of platelet function | Drug: acetylsalicylic acid started for 24 hours before surgery<br> <br> |
| Other: Control<br>acetylsalicylic acid stayed for 5 days before surgery and determination of platelet function | Drug: acetylsalicylic acid stayed for 5 days before surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| on discharge drains after surgery in milliliters |  | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial infarction |  | myocardial infarction by 30th day after procedure | 
| ischemic stroke |  | stroke by 30th day after procedure | 
| repeat revascularization |  | repeat revascularization within 30 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery bypass grafting
Prevalence and Outcome of Hypermetabolism in Initial Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study

Study Overview
=================
Brief Summary
-----------------
Patients in critical illness frequently present hypermetabolism， which can extremely increase the rest energy expenditure（REE）. We hypothesize that if we alleviate the extremely increased REE will improve ICU patients' outcome

Detailed Description
-----------------
This study focuses on the early changes of REE of critical ill patients when they admitted to ICU.

Official Title
-----------------
Prevalence and Outcome of Hypermetabolism in Initial Phase of Intensive Care Unit Patient: a Prospective Observational Study

Conditions
-----------------
SIRS, Sepsis, Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 year. APACHEⅡ score≥8 Exclusion Criteria: Hypercortisolism Thyroid disease Tracheoesophageal fistula FiO2>60 or PEEP>12cm H2O in mechanical ventilate 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate of 28 days |  | From ICU admission to 28th days of observation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Multiple Organ Dysfunction Syndrome（MODS）in 60 days |  | From ICU admission to 60th days of observation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rest energy expenditure,critical ill, outcome
Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Multi-centre survey of type 2 diabetic patients who are currently on anti-hypertensive treatment. Data collection for each patient will take place at one visit. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP<130/80 mmHg. To observe the proportion of diabetic patients on antihypertensive treatment reaching the BP<130/80 mmHg by treatment groups. To observe the proportion of patients achieving a therapeutic glycemic response defined as HbA1c=<7%. To observe the proportion of patients achieving fasting plasma glucose<110 mg%. To identify factors for not achieving BP<130/80 mmHg. To describe percentage of patients with positive proteinuria (including microalbuminuria) by treatment groups .

Official Title
-----------------
In Practice Survey on the Treatment of Hypertension in Patients With Type 2 Diabetes.

Conditions
-----------------
Hypertension, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of written informed consent Patient was diagnosed with type 2 diabetes Patient is on antihypertensive treatments for at least 3 months, with the same regimen for a minimum of 4 weeks prior to survey Exclusion Criteria: Patients are critically ill, had mental health problems or difficulty in communication Patients who are unwilling or unable to provide informed consent Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).

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 |
| --- | --- | --- |
| The number of patients achieving the BP<130/80 mmHg |  |  | 
| The percentage of patients achieving the BP<130/80 mmHg |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number and percentage of patients achieving the BP<130/80 mmHg by treatment groups |  |  | 
| The number and percentage of patients achieving HbA1c=<7% |  |  | 
| The number and percentage of patients achieving the FPG<110 mg% |  |  | 
| The association between unachievement of BP<130/80 mmHg and other factors (age, gender, CV risk factors, CV and diabetes history, duration of type of treatment...) |  |  | 
| The number and percentage of patients with positive proteinuria by treatment groups |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, BP, diabetes, anti-hypertensive treatment, ACE-I, ARB