linjc16/ctgov huggingface dataset:
Quality Assessment in Acute Stroke Care

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the quality of care on a 16 bed stroke unit by using a new developed clinical pathway.

Official Title
-----------------
Quality of Acute Stroke Care Evaluated With a Clinical Pathway on a 16 Bed Stroke Unit - a Prospective Trial

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admission to the stroke unit of the university hospital in Muenster, Germany acute ischemic stroke or transient ischemic attack Exclusion Criteria: intracerebral haemorrhage neurological symptoms due to other pathology than acute ischemic stroke or transient ischemic attack intraarterial thrombolysis necessity of artificial ventilation
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 |
| --- | --- | --- |
| frequency of patients monitored according to the specific german procedure standard (OPS-code 8-981) (preset target 90 - 95 %) |  | duration of stay on stroke unit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequency of stroke been classified according to the TOAST criteria (preset target 55 - 65 %) |  | duration of stay on stroke unit | 
| frequency of initiated or improved antithrombotic secondary prevention (preset target 90 - 95 %) |  | duration of stay on stroke unit | 
| frequency of initiated or improved statin therapy (preset target 40 - 50 %) |  | duration of stay on stroke unit | 
| frequency of totally completed clinical diagnostics regarding the etiology of the stroke (preset target 60 -70 %) |  | duration of stay on stroke unit | 
| frequency of initiated or improved antihypertension therapy and reduction of systolic and diastolic blood pressure by more than 10 mmHg (preset target 60 - 70 %) |  | duration of stay on stroke unit | 
| frequency of a reduction on the NIH-SS by at least two points (preset target 50 - 60 %) |  | duration of stay on stroke unit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute ischemic stroke, clinical pathway, quality of care, secondary prevention
Study Comparing ABX-CBL (Monoclonal Antibody) Versus Atgam in Patients With Steroid Resistant Acute Graft Versus Host Disease

Study Overview
=================
Brief Summary
-----------------
Trial evaluating the improvement in survival at 180 days of two therapies (Atgam versus ABX-CBL, a monoclonal antibody) in patients with acute graft versus host disease that does not respond to steroid therapy.

Official Title
-----------------
A Phase II/III, Multicenter, Open Label, Randomized Clinical Trial Evaluating ABX-CBL When Compared to Atgam as Second Line Therapy in Patients With Steroid Resistant Acute Graft Versus Host Disease

Conditions
-----------------
Graft Vs Host Disease

Intervention / Treatment
-----------------
* Drug: ABX-CBL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipient of single allogeneic stem cell transplant from any donor type Time post transplant less than 100 days Received no treatment for GVHD other than steroids Exclusion Criteria: Recipient of second allogeneic stem cell transplant or subsequent lymphocyte product from the donor post transplant IBMTR index less than A Received any murine product in the past Diagnosed with chronic GVHD Received Atgam later than day 10 post transplant Change to prophylactic regimen for acute GVHD within 72 hours of randomization

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

| Intervention/Treatment |
| --- |
|Drug: ABX-CBL|nan|

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
-----------------
Acute graft versus host disease, Stem Cell Transplantation
Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis

Study Overview
=================
Brief Summary
-----------------
A retrospective and cross-sectional analysis of standard of care for facial paralysis involving the cross-face nerve graft in the past 20 years. Imagery analysis Questionnaires

Detailed Description
-----------------
The investigators will retrospectively and cross sectionally analyze all patients treated with a cross-face nerve graft and another nerve transfer in our institution by image analysis and sending out quality of life questionnaires.

Official Title
-----------------
Assessment of the Cross-face Nerve Graft in the Treatment of Facial Paralysis

Conditions
-----------------
Facial Palsy

Intervention / Treatment
-----------------
* Procedure: Cross-face nerve graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with one of the described procedures Exclusion Criteria: Evaluation material present
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cross-face nerve graft treated<br>People treated by a solitary cross-face nerve graft or in combination with another procedure. | Procedure: Cross-face nerve graft<br>* connecting the healthy facial nerve to the affected facial nerve<br>|
| Hypoglossal-facial treated<br>People treated with a solitary hypoglossal-facial anastomosis. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symmetry of the mouth | Symmetry of the mouth expressed as the difference in millimeters between the position of the affected and the healthy corner of the mouth on a picture. An ideal symmetry would be 0 mm. Measured with the FACE-gram software. | March 2016 - October 2016 | 
| Excursion of the mouth | Excursion of the mouth expressed as the difference in millimeters between the position of the affected corner of the mouth in repose and with smile on a picture. Measured with the FACE-gram software. | March 2016 - October 2016 | 
| Disease-specific quality-of-life | A validated self-reported disease-specific quality-of-life questionnaire was used (Facial Clinimetric Evaluation scale). On which patients can score anything between 0 and 100 points (100 being healty). | March 2016 - October 2016 |
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization

Study Overview
=================
Brief Summary
-----------------
LV pacing at various sites with recording of ECG and subsequent signal analysis at different sites.

Detailed Description
-----------------
During routine cardiac resynchronization pacemaker or implantable defibrillator (ICD) implantation (including de-novo and upgrade from standard device, additional pacing within 3 different coronary veins will be performed in combination with a previously implanted right ventricular pacing or ICD lead. The resulting electrocardiogram signal will be analyzed afterwards. A time-frequency analysis (TFA) of several ECG leads at each paced site will be performed and compared. The results of the TFA analysis will not be used to select pacing lead location in this study. The patient will then receive the left ventricular pacing lead in the standard manner.

Official Title
-----------------
Survey of QRS Frequency at Various Left Ventricular Pacing Sites for Cardiac Resynchronization

Conditions
-----------------
Cardiomyopathies, Congestive Heart Failure

Intervention / Treatment
-----------------
* Device: Biotronik Vision Guidewire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Standard implantation for cardiac resynchronization ICD or PM implantation Cardiomyopathy with LVEF <35% QRS duration greater than 120 msec Exclusion Criteria: - Age less than 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?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Interventional Model Description: Nonrandomized survey of different pacing sites in the coronary veins.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coronary Sinus Branch Pacing<br>After cannulation, pacing impulses will be delivered via a Biotronik Vision Guidewire to 3 sites (apical, mid ventricular, and basal) within each coronary sinus branch receiving venous blood from the anterior, lateral and posterior regions of the ventricle. ECG signals will be saved digitally for analysis | Device: Biotronik Vision Guidewire<br>* The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QRS Frequency at Each Paced Location | Time frequency analysis performed at each location | Baseline |
Increased Physical Activity in African-American Women

Study Overview
=================
Brief Summary
-----------------
To conduct a randomized demonstration and education trial of churches in East Baltimore testing a self-help, minimal intervention compared with an intensive physical activity intervention.

Detailed Description
-----------------
BACKGROUND: The study filled an existing gap by examining how a culturally sensitive physical activity intervention conducted in a community setting was associated with increased daily energy expenditure in African American women -- a group of women who are sedentary and at risk for health problems for which regular physical activity can provide benefits. DESIGN NARRATIVE: An evaluation was conducted of the effectiveness of a six-month moderate-intensity physical activity intervention for increasing total daily energy expenditure of sedentary African-American women who were between the ages of 50 and 70 years. The goal of the intervention was to increase total daily energy expenditure by 150 kilocalories per day and time spent in moderate-intensity physical activity by 30 minutes per day. Effects of increased physical activity on selected cardiovascular risk factors (e.g., peak oxygen uptake, blood pressure, HDL cholesterol, serum insulin and plasma glucose) were also determined. Six churches were randomized into intensive or minimal intervention status, and 33 women per church were recruited, for a total of 100 women in each condition. The physical activity intervention consisted of twice-weekly aerobics classes conducted at the churches and additional group-and home-based programming. Volunteer lay leaders were trained as neighborhood exercise specialists to supplement certified aerobics instructors in conducting the intervention. 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
-----------------
Cardiovascular Diseases, Heart Diseases

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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- | --- |
Perioperative Management and Outcomes of Minimally Invasive Esophagectomy

Study Overview
=================
Brief Summary
-----------------
The investigators retrospectively reviewed the data of all patients who had undergone esophagectomy and reconstruction in 2015. Patient characteristics, the surgery performed, method of anesthesia, postoperative hospitalization course, and additional surgical interventions were reviewed and analyzed.

Official Title
-----------------
Perioperative Management and Outcomes of Minimally Invasive Esophagectomy- Experience of a High-volume Tertiary Center in Taiwan

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Procedure: esophagectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients received esophageal reconstruction in 2015. Exclusion Criteria: age <18 not malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: esophagectomy|all the included participants had received esophagectomy, either Ivor Lewis or tri-incision, or more complex procedures.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | rate of 30-day mortality | 30 day after surgery |
Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a 5-week intervention program targeted at improving balance and functional skills for people with stroke.

Detailed Description
-----------------
Many people with stroke experience a deterioration in balance and a functional decline due to hemiplegic muscle strength. This tend to restrict the persons activity in daily life and also leads to a low falls self efficacy. High intensity exercise have shown to be effective for improving strength and balance for older people in general living in residential care facilities. It is interesting to see if this high intensity exercise also is applicable in the older stroke population. Comparison: An intervention group receives three training sessions per week and one theory session per week during 5 weeks, compared to a control group that receives one theory session per week during 5 weeks.

Official Title
-----------------
Evaluation of an Intervention Program Targeted at Improving Balance and Functional Skills After Stroke - a Randomized Controlled Study

Conditions
-----------------
Cerebrovascular Accident, Musculoskeletal Equilibrium

Intervention / Treatment
-----------------
* Behavioral: high intensity functional exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 55 years of age or older stroke diagnosis 3-6 months prior to inclusion ability to walk 10 meter with or without assistive device ability to understand simple instructions Exclusion Criteria: TIA independent in walking outdoors serious visual impairment serious hearing impairment long distance to intervention station

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: high intensity functional exercise|high intensity functional exercise|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in balance |  | post, 3 & 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduced falls |  | post, 3 & 6 months | 
| Improved self-efficacy |  | post, 3 & 6 months | 
| Improved ADL |  | post, 3 & 6 months | 
| Improved walking ability |  | post, 3 & 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ADL, Self efficacy, Accidental falls, Cerebrovascular accident, Balance, Quality of Life, Gait parameters
E. Coli 83972 Induced Asymptomatic Bacteriuria (ABU) in Patients With Recurrent Urinary Tract Infections (UTI)

Study Overview
=================
Brief Summary
-----------------
This study tests the following hypothesis: Does induced asymptomatic bacteriuria (E. coli 83972) protect against symptomatic urinary tract infections in individuals with bladder emptying dysfunctions and prone to recurrent infection episodes? The study is performed using a double-blind randomized study protocol with a cross-over, with re-inoculations being patient-blinded (phase 1). After patients have fulfilled the cross-over, those who have had bacteriuria or placebo-periods < 12 months will be subjected to additional patient blinded inoculations (phase 2). During the entire study (phase 1+2) the study-team and the patients are unaware of urine culture results.

Official Title
-----------------
Induced Asymptomatic E. Coli 83972 Bacteriuria in Patients With Recurrent Urinary Tract Infections and Bladder Dysfunction- is There a Protective Effect Against Recurrent Symptomatic Infections? A Blinded Placebo Controlled Cross-over Study.

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Biological: E. coli 83972


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent UTI Bladder emptying dysfunction Optimal conservative treatment incl. clean intermittent catheterization Capable of self reporting of UTI episodes Exclusion Criteria: Malignant disease Immunosuppression Recurrent pyelonephritis Abnormalities within upper urinary tract, including renal stones and poor kidney function

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active arm<br>E. coli 83972 bacteriuria | Biological: E. coli 83972<br>* Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml). Placebo arm: Identical procedure but with saline, 30 ml.<br>|
| Placebo Comparator: Placebo arm<br>Monitoring | Biological: E. coli 83972<br>* Active arm: Intravesical inoculation (by urethral catheterization) on three subsequent days with 30 ml E. coli 83972 (100 000 cfu/ml). Placebo arm: Identical procedure but with saline, 30 ml.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to UTI |  | 12 months | 
| Number of UTI |  | During 12 months placebo or active treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Report of Urinary Tract Infection episode
Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.

Official Title
-----------------
A Phase I, Open-Label, 2-Part Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism and Excretion of DA-1229 in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: DA-1229


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males Age 18 to 55 BMI 18.0 to 30.0 kg/㎡ Exclusion Criteria: History of any drug or alcohol abuse in the past 2years Regular alcohol consumption nin males >21 units per week Current smokers and those who have smoked within the last 12months Radiation Exposure Positive drugs of abuse test result Positive HBsAg, HCV Ab, HIV results Serious adverse reaction or hypersensitivity to any drug of the formulation excipients Clinically significant allergy Donation of loss of blood within the previous 3 months Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part 1<br>Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ [14C]-DA-1229 | Drug: DA-1229<br> <br> |
| Experimental: Part 2<br>Single oral therapeutic dose of 5mg [14C]-DA-1229 | Drug: DA-1229<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the absolute bioavailability of DA-1229 (F) |  | 240 hours | 
| The mass balance recovery (Ae, %Ae) |  | 240 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Volunteers