linjc16/ctgov huggingface dataset:
Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status

Study Overview
=================
Brief Summary
-----------------
GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state

Detailed Description
-----------------
As a treatment for type 2 diabetesGlucagon like peptide -1 (Glucan-like peptide-1, GLP-1) receptor agonists plays the role of promoting insulin secretion, inhibiting glucagon secretion，and also has the central and peripheral effects,it can inhibit appetite,reduce weight.GLP-1 receptor agonists promote fat redistribution in obese women with type 2 diabetes, reduce liver fat content, improve the inflammation state

Official Title
-----------------
Effects of GLP-1 Receptor Agonist on Fat Redistribution and Inflammatory Status in Female Patients With Type 2 Diabetes and Obesity

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: Exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of overweight and type 2 diabetes mellitus Exclusion Criteria: Poor body condition (severe liver and kidney dysfunction) Unknown causes of pancreatitis, chronic pancreatitis, pancreatic resection, stomach operation, malignant tumor, previous use of systemic corticosteroids (local or inhalation of exceptions) heart function or niacin, incomplete serious endocrine disease genetic disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exenatide<br>exenatide, 5ug, bid, 3months | Drug: Exenatide<br>* 5ug bid,Subcutaneous injection<br>* Other names: Byetta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dual energy X-ray absorptiometry | fat distribution | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lab testing | inflammation | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity; fat distribution; inflammation
Expanded Access for Apixaban

Study Overview
=================
Brief Summary
-----------------
This is an expanded access designed to provide access to apixaban for eligible participants.

Intervention / Treatment
-----------------
* Drug: Apixaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention Previously participated in the CV185-362 study and was on apixaban for 1 year or until treatment was no longer required Exclusion Criteria: Weight less than 5 kg or greater than 35 kg Other inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 28 Days
Maximum Age: 17 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Apixaban|Administered as directed by treating physician|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Efficacy and Safety of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Disease Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of administration of AFQ056 in combination with L-dopa, in reducing the number of L-dopa related dyskinesias in Parkinson's disease patients.

Official Title
-----------------
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multiple Oral Dose Study to Assess the Efficacy and Tolerability of AFQ056 in Reducing L-dopa Induced Dyskinesias in Parkinson's Patients With Severe L-dopa Induced Dyskinesias

Conditions
-----------------
Parkinson's Disease, L-dopa Induced Dyskinesia

Intervention / Treatment
-----------------
* Drug: AFQ056
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Parkinson's Disease Patients with L-dopa induced dyskinesia for at least 3 months Patients with L-dopa treatment for at least 3 years, stable for 1 month minimum Exclusion Criteria: History of severe allergy to food or drugs Very low or high body weight. Prior surgery for Parkinson's Disease Smokers Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: AFQ056<br> <br> |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of Dyskinesias and the safety and tolerability of administering AFQ056 in combination with L-dopa |  | 20 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of administration of AFQ056 in combination with L-dopa |  | 20 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's, L-dopa, dyskinesia
Reasons for Prehospital Delay in Patients With Acute Ischemic Stroke

Study Overview
=================
Brief Summary
-----------------
Ischemic stroke is the leading cause of acquired disability among adults, and one of the main causes of death. In Switzerland, the approved time window for stroke treatment with intravenous thrombolysis after symptom onset is 4.5 h. Even within the 4.5 h time-window, however, the benefit of treatment strongly decreases as time passes. Moreover, only around 10% patients receive thrombolytic treatment, since patients with stroke arrive too late to the hospital (prehospital delay). Despite efforts to educate the community on the symptom of stroke, prehospital delay did not decrease over time, and the reasons remain incompletely understood. Prehospital delay reduces the proportion of patients with ischemic stroke treated with thrombolysis, and reduces the odds of favorable outcome among the minority treated with thrombolysis. This prospective cohort study aims at understanding the causes of prehospital delay among patients with acute ischemic stroke. Trained study-nurses will interview, at the bedside, patients and proxies along a standardized questionnaire on prehospital delay. Avoiding modificables causes of prehospital delay may increase the thrombolysis rate and improve outcomes after stroke.

Official Title
-----------------
Reasons for Prehospital Delay in Patients With Acute Ischemic Stroke: a Prospective Cohort Study

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

Intervention / Treatment
-----------------
* Other: No Intervention Foreseen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an acute ischemic stroke hospitalized in the Stroke Center of the University Hospital Basel. Exclusion Criteria: Patient not able to answer the in-person, bedside questionnaire asked by a trained study Nurse. Patient not willing to participate to the study

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Stroke Center Basel<br> | Other: No Intervention Foreseen<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prehospital Delay between between Stroke Onset and Admission to the Hospital as assessed by In-Person Interview | Prehospital delay will be assessed by asking the Patient or witnesses how long the time interval between stroke onset and Hospital Admission is. For instance, if stroke symptoms have onset today at 3:00 PM and the Patient gets admitted today at 4:00 PM, prehospital delay is 1 hour. | an average of 1 hour |
Evaluation of Skin Affix in the Emergency Room

Study Overview
=================
Brief Summary
-----------------
Effectiveness of a surgical adhesive on wounds found in Emergency Medicine.

Detailed Description
-----------------
Subjects were approached for recruitment in the ED when discussing closure options by the physician. Only subjects deemed appropriate for skin glue closures by their treating physician were approached.Subjects were followed at 48 hours post-procedure, 5-10 days, and at 14 days following the ED visit.

Official Title
-----------------
Evaluation of SkinAffix as a Topical Emergency Room Department Skin Incision Adhesive

Conditions
-----------------
Wounds

Intervention / Treatment
-----------------
* Procedure: Skin Affix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 5 years of age Requires the use of a surgical skin adhesive Informed consent signed Exclusion Criteria: Sensitivity to topical adhesive products or formaldehyde Hx keloid formation, hypotension, diabetes, blood clotting disorders Wound infections mucosal surfaces or skin exposed to body fluids

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin Affix<br>Surgical adhesive | Procedure: Skin Affix<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound Closure at Discharge | Wounds remained closed following application of Skin Affix | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Following Application | Any 1 point decrease, increase, or no change in pain was measured on a scale--0 =no pain = 5 most pain. | 15 minutes Post Application | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SkinAffix
Inflammatory Markers in Preeclampsia

Study Overview
=================
Brief Summary
-----------------
This is an investigation of inflammatory markers in women destined to develop preeclampsia.

Conditions
-----------------
Preeclampsia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Caucasian origin Exclusion Criteria: Previous diseases e.g. cardiovascular disease, diabetes, hypertension, inflammatory bowel disease, serious organ disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 43 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant women who develop preeclampsia<br>pregnant women who develop preeclampsia (n =43) compared to pregnant women fulfilling a normotensive pregnancy (n= 86). | |

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
-----------------
pre-eclampsia, inflammatory markers, serological biobank, To assess whether the inflammatory markers could be useful, in order to identify pregnant women at risk to, develop preeclampsia
Fast Reversal of Warfarin and Early Surgery in Patients With Trochanteric Hip Fracture A Case-control Study

Study Overview
=================
Brief Summary
-----------------
A retrospective case-control study. To evaluate if early surgery within 24hours of troch or subtrochanteric hip fractures using intramedullary nailing is safe in patients on warfarin treatment after fast reversal of the warfarin effect

Official Title
-----------------
Is Fast Reversal and Early Surgery (Within 24 h) in Patients on Warfarin Medication With Trochanteric Hip Fractures Safe: A Case-control Study

Conditions
-----------------
Trochanteric Hip Fractures, Warfarin Medication, Early Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Pathological fracture Late presentation to the hospital Other injuries

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 99 warfarin patients<br>warfarin patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture. All patients on warfarin were reversed if necessary to INR≤1.5 before surgery using vitamin K and/or four-factor prothrombin complex concentrate (PCC) | |
| 99 patients without anticoagulants<br>As a 1:1 ratio control group matched for age, gender and surgical implant. All patients were operated within 24 h with a cephalomedullary nail due to a trochanteric or subtrochanteric hip fracture. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transfusion rates | Hb value (g/dl) | Pre-surgery | 
| Transfusion rates | Transfusion rate (n) | Pre-surgery | 
| Transfusion rates | Hb value (g/dl) | During the surgery | 
| Transfusion rates | Transfusion rate (n) | During the surgery | 
| Transfusion rates | Hb value (g/dl) | 2-4 days after the surgery | 
| Transfusion rates | Transfusion rate (n) | 2-4 days after the surgery | 
| adverse events | Number of patients with a myocardial infarction, stroke, pulmonary embolism, deep venous thrombosis, sepsis, pneumonia, urinary tract infection, pressure ulcer, or any adverse events. | Immediately after the surgery | 
| mortality | The number of deaths | Immediately after the surgery | 
| mortality | The number of deaths | 30-days after the surgery | 
| mortality | The number of deaths | 1 year after the surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip fracture, Surgical treatment, Warfarin, Anticoagulation treatment, Intramedullary nailing
Cell Block Immunohistochemistry in Effusion Cytology

Study Overview
=================
Brief Summary
-----------------
Cytology is usually the first step in investigating serous effusions, to either detect or exclude an underlying malignancy. This study will try to answer the need for improved diagnostic yield of cytologic examination by cell block technique and immunohistochemical testing of three markers which are EZH2, Claudin-4 and MOC-31.

Detailed Description
-----------------
This is a prospective study that will be conducted at the pathology lab of Assiut University Hospital. The study will include effusion specimens (pleural, peritoneal & pericardial) and the aspirated fluid will be examined for physical characters e.g. color and appearance. The sample will be divided into 2 equal parts: one for conventional smear preparation, and the other for cell block. A minimum of 2 thin smears will be prepared and stained with Papanicolou stain. Cell block sections of 4-6 μ thickness will be prepared and stained with the hematoxylin and eosin stain (H&E). For immunohistochemistry, cell blocks will be used. Expression of claudin 4, EZH2, and MOC-31 will be evaluated in benign and malignant cells by using immunoperoxidase technique.

Official Title
-----------------
Diagnostic Value of Cell Block Immunohistochemistry in Effusion Cytology

Conditions
-----------------
Effusion Pleural, Ascites, Pericardial Effusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cases with serous effusion of unknown aetiology including ascites, pleural or pericardial effusions. Exclusion Criteria: No exclusion criteria from the histopathologist perspective, i.e. all cases that undergone diagnostic aspiration are eligible for the study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cases<br>cytology positive for malignancy | |
| controls<br>cytology negative for malignancy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of EZH2 | sensitivity and specificity of EZH2 for diagnosis of malignancy | within 48 hours | 
| Diagnostic performance of claudin4 | sensitivity and specificity of claudin-4 for diagnosis of malignancy | within 48 hours | 
| Diagnostic performance of MOC-31 | sensitivity and specificity of MOC-31 for diagnosis of malignancy | within 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of malignancy among cases presenting with effusion | percentage of cases diagnosed with malignancy among all cases presenting with effusion | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
immunohistochemistry, cytology, moc 31 monoclonal antibody, human
Postmarketing Surveillance Study of Atrovent® Inhaletten® in Chronic Obstructive Airways Disease

Study Overview
=================
Brief Summary
-----------------
To obtain further information on the tolerability and efficacy of Atrovent® inhaletten® in the treatment of chronic obstructive airways disease under conditions of daily practice

Official Title
-----------------
Postmarketing Surveillance Study (as Per § 67 (6) AMG [German Drug Law] of Atrovent® Inhaletten® in Chronic Obstructive Airways Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Atrovent® Inhaletten


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primarily patients of both gender, older than 30 years,who suffer from chronic obstructive airways disease Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion Exclusion Criteria: - Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Atrovent® Inhaletten®

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 |
| --- | --- |
| Chronic Obstructive Airways Disease<br> | Drug: Atrovent® Inhaletten<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of improvement in the clinical picture of the course on a 6-point symptoms profile |  | Up to 4 weeks after first study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator assessment of tolerability on a 4-point scale |  | Up to 4 weeks after first study drug administration | 
| Investigator assessment of efficacy on a 4-point scale |  | Up to 4 weeks after first study drug administration | 
| Number of patients with adverse drug reactions |  | Up to 4 weeks after first study drug administration | 
| Number of patients who withdrew from the study |  | Up to 4 weeks after first study drug administration | 
| Number of patients who changed the concomitant medication |  | Up to 4 weeks after first study drug administration | 
| Number of patients who continued treatment |  | Up to 4 weeks after first study drug administration | 
| Patient assessment of tolerability on a 4-point scale |  | Up to 4 weeks after first study drug administration | 
| Patient assessment of efficacy on a 4-point scale |  | Up to 4 weeks after first study drug administration |