linjc16/ctgov huggingface dataset:
Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).

Detailed Description
-----------------
The purpose of this study is to compare the efficacy and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).

Official Title
-----------------
Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients With Dyslipidemia: A Dose-Ranging Study - SEACOAST

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Niacin extended release and simvastatin tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has primary Type II hyperlipidemia or mixed dyslipidemia If the patient is currently taking anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study. LDL-C levels and/or Non HDL-C levels above normal for patients This study will be conducted both in the USA and internationally. Exclusion Criteria: Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives HbA1c ≥ 9% in diabetic patients

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Niacin extended release and simvastatin tablets|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
-----------------
Niacin, Lipoprotein (a), Dyslipidemia, High Blood Cholesterol, Coronary Heart Disease, Hypertension, National Cholesterol Education Program, Adult Treatment Panel III, Simvastatin, Diabetes, Peripheral Vascular Disease, Cerebrovascular disease, Stroke, High-Density Lipoprotein Cholesterol, Hydroxymethyl Glutaryl Coenzyme A, High-Sensitivity C-Reactive Protein, Low-Density Lipoprotein Cholesterol, Lipoprotein A-I, Total Cholesterol, Triglycerides
Role of Tzanck Smear in Determining Pemphigus Vulgaris Disease Activity

Study Overview
=================
Brief Summary
-----------------
Aim: Pemphigus vulgaris (PV) is a rare, life-threatening autoimmune bullous disease that can involve the skin and mucous membranes, characterized by intraepidermal bullae and eroded lesions caused by rupture of the bullae. The aim of this study is to research the relationship of the findings obtained with Tzanck smear, which is an inexpensive and easy method, with disease activity and its prognostic importance in the clinical course in PV patients. Material and Methods: Pemphigus patients who visited to Goztepe Prof. Dr. Suleyman Yalcın City Hospital, Dermatology Clinic will be included in our study. Pemphigus disease area index (PDAI), Tzanck smear findings from the lesions and desmoglein levels during routine follow-up of patients with pemphigus vesicle/bulla/erosion will be evaluated. In the evaluation of Tzanck smear preparations, the entire slide will be scanned, acantholytic cell count performed and scored 1 to 4 accordingly (1 point: 1-3 cells, 2 points: 4-10 cells, 3 points:11-20, 4 points: >21 cells or cell clusters). Anti-desmoglein antibody levels will be analyzed by using enzyme-linked immunosorbent assay (ELISA) method.

Official Title
-----------------
Evaluation of the Relationship of Tzanck Smear Findings And Disease Activity In Patients With Pemphigus Vulgaris

Conditions
-----------------
Pemphigus Vulgaris

Intervention / Treatment
-----------------
* Diagnostic Test: Tzanck smear


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical, histopathological and immunological diagnosis of pemphigus vulgaris Must be active bullae or erosion at any stage of the disease Exclusion Criteria: Patients with uncertain diagnosis of pemphigus vulgaris Eroded lesions due to causes other than pemphigus vulgaris (such as herpes in the oral mucosa, candida infection)

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 |
| --- | --- |
| Patients with active pemphigus lesions<br> | Diagnostic Test: Tzanck smear<br>* The Tzanck smear is gently taken with a sterile scalpel from the ground of erosion or bullous lesions of pemphigus vulgaris. The sample taken is examined by staining the slide.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of acantholytic cells | Tzanck smear slides will be entirely scanned, acantholytic cell count will be performed and scored 1 to 4 accordingly (1 point: 1-3 cells, 2 points: 4-10 cells, 3 points:11-20, 4 points: >21 cells or cell clusters). | 1or 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pemphigus vulgaris, Tzanck smear, disease activity, prognostic factor
Treatment Use of Generex Oral-lyn™ in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
The objective of this Treatment IND protocol is to provide Generex Oral-lyn™ to patients with serious or life-threatening Type 1 or Type 2 diabetes mellitus, with no satisfactory alternative therapy available for treatment of diabetes, and who are not eligible to participate in the ongoing pivotal clinical trial (Protocol GEN-084-OL). This protocol is intended as a substitute for the Single Patient IND mechanism to obtain Generex Oral-lyn™.

Official Title
-----------------
An Open-Label Treatment Investigational New Drug (IND) for the Use of Generex Oral-lyn™ in Patients With Type 1 or Type 2 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Buccal insulin spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Study is closed
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Buccal insulin spray|Oral insulin spray absorbed in buccal mucosa|

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
-----------------
diabetes, insulin therapy
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic

Study Overview
=================
Brief Summary
-----------------
Steroid injection is the first line treatment for trigger finger. Steroid injection is sometimes mixed with a local anesthetic.

Detailed Description
-----------------
The treatment of trigger finger involves an injection of corticosteroid. Corticosteroid treats the underlying inflammatory pathology. Some surgeons add lidocaine with epinephrine as a local anesthetic with the injection. Lidocaine with epinephrine is associated with a burning sensation and may be the primary pain associated with the injection. We hypothesize that a corticosteroid injection without lidocaine with epinephrine will be less painful, and equally effective in treating trigger finger

Official Title
-----------------
Trigger Finger Corticosteroid Injection With and Without Local Anesthetic; a Randomized, Double Blind Controlled Trial

Conditions
-----------------
Trigger Finger

Intervention / Treatment
-----------------
* Drug: Corticosteroid with lidocaine with epinephrine
* Drug: Corticosteroid with normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years old with trigger finger Exclusion Criteria: Preference for open trigger finger release Not a candidate for corticosteroid injection Contraindication to lidocaine with epinephrine

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticosteroid with lidocaine with epinephrine<br>This arm includes an injection mixture of corticosteroid and lidocaine with epinephrine | Drug: Corticosteroid with lidocaine with epinephrine<br>* Trigger finger injection<br>|
| Experimental: Corticosteroid with normal saline<br>This arm includes a mixture of corticosteroid and normal saline. The purpose of normal saline is the keep the volume and concentration similar when compared to the injections containing lidocaine. | Drug: Corticosteroid with normal saline<br>* Trigger finger injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever | Assessed 1 minute after injection (in clinic) | 
| Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever | Assessed after 24 hours after injection (by phone) |
Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation.

Study Overview
=================
Brief Summary
-----------------
This trial has the primary goal to show that BAY68-4986 can lower the ventricular rate in patients with the indication persistent atrial fibrillation.

Official Title
-----------------
Study to Investigate the Effect of the A1 Agonist Capadenoson on Ventricular HR in Patients With Persistent or Permanent Atrial Fibrillation by Administration of Capadenoson in a Dose of 4 mg Once Daily for Five Days

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Capadenoson (BAY68-4986)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and/or female (without childbearing potential) white patients History of persistent or permanent atrial fibrillation 18 to 75 years of age Exclusion Criteria: Patients with high-risk cardiovascular diseases Stroke or myocardial infarction Relevant pathological changes in the ECG or echocardiography Medication affecting ventricular response in Afib

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Capadenoson (BAY68-4986)<br>* 4 mg BAY68-4986 for five days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of capadenoson (BAY68-4986) on rate control in patients with atrial fibrillation |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate safety and tolerability of this treatment with capadenoson |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrillation, Capadenoson
Basal Bolus vs. Sliding Scale for Treatment of Diabetic Patients in Medical Wards

Study Overview
=================
Brief Summary
-----------------
A comparison of two treatment approaches for hyperglycemia in diabetic patients hospitalized in the medical department. The first approach is called basal-bolus in which 4 insulin shots are given daily ( 3 short acting before meals and one long acting before bed time). The second approach is called sliding scale in which short acting insulin alone is given before meals and before bed time according to the patient's glucose values. The aim is to keep fasting glucose between 140-180 mg/dl.

Official Title
-----------------
A Randomized, Comparative Study of Basal-bolus Insulin Versus Conventional Sliding-scale Regular Insulin Therapy in Management of Non-critically Ill Patients Hospitalized in the Medical Ward.

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

Intervention / Treatment
-----------------
* Drug: Insulin, regular - act rapid
* Drug: Insulin glulisine, Insulin glargine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to internal medicine ward with blood glucose (BG) between 140-400 mg/dl. Known history (>6months) of diabetes. Aged 18-80 years old. Previous therapy including either diet alone or any combination of oral hypoglycemia agents, glucagon-like peptide 1 (GLP-1) analogs and long acting insulin analogs or Neutral Protamine Hagedorn (NPH). Exclusion Criteria: Pregnancy Patients with ketoacidosis Patients with unknown history of diabetes Patients with type 1 diabetes mellitus Patients with clinically relevant hepatic disease or renal impairment ( serum creatinine≥2.5 mg/dl) Use of corticosteroid therapy Patient with any mental disorder preventing him to cooperate and give informed consent. Patients on multiple daily doses of insulin regimen.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: sliding scale<br> | Drug: Insulin, regular - act rapid<br>* 4 shots of regular insulin: 3 before meals and one at bedtime.<br>|
| Active Comparator: basal bolus<br> | Drug: Insulin glulisine, Insulin glargine<br>* 1 shot glargine at bedtime 3 shots glulisine before meals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Enhanced Tactile (Touch) Spatial Acuity in Upper Limb Amputees

Study Overview
=================
Brief Summary
-----------------
This study will examine whether tactile (touch) abilities at the lip are more acute in people with upper limb amputation compared with healthy normal volunteers. People with an amputated upper limb have an expanded brain representation of the lip that may correlate with heightened tactile spatial acuity. Normal volunteers will be recruited for this study. Candidates will be screened with physical and neurological examinations. (Amputee volunteers will be studied at the amputee clinic at the University of Tubingen, Germany.) Participants will sit comfortably in a chair, wearing a blindfold, during the following experiments: Plastic domes with grooves are placed on parts of the lower lip on either side for a few seconds. The volunteer is then asked to identify the direction of the grooves relative to the long axis of the lip. The participant's arm is placed in a cast and the index finger is immobilized. The same test done on the lip is repeated on the distal part of the index finger. Each part of the test lasts about 20 minutes, and the entire experiment takes about 2 hours.

Detailed Description
-----------------
Upper limb amputation leads to expansion of the cortical representation of the lip into the adjacent deafferented hand representation. It is conceivable that this enlargement of the lip representation may translate into a behavioral gain. The purpose of this protocol is to test the hypothesis that upper limb amputation in humans results in higher tactile spatial acuity at the lip. This would represent the first demonstration of chronic deafferentation-induced behavioral gains within the somatosensory system.

Official Title
-----------------
Enhancement of Tactile Spatial Acuity in Upper Limb Amputees

Conditions
-----------------
Amputation

Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Normal volunteers who are willing and able to stay relaxed and collaborative for a period of up to 2 hours. Subjects with upper limb amputation more than one year before testing. EXCLUSION CRITERIA: Neurological or psychiatric disease Excessive callus at the palm of the fingers Subjects, who are unable to perform or understand the task
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Amputee, Plasticity, Somatosensory, Upper Limb Amputation, Tactile Performance, Cortical Reorganization, Healthy Volunteer, HV, Normal Control
Selection of Shock Energy in Out-Of-Hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Sudden cardiac death is the most frequent cause of death in industrialized countries. The most efficient interventiont in ventricular fibrillation is defibrillation in an appropriate timely manner. But since the intervention of defibrillation the optimal shock energy is unknown. As a too low energy is not able to terminate ventricular fibrillation a too high energy may cause asystole wich jeopardizes survival itself. We study the efficacy of different shock energies on the termination of ventricular fibrillatiion and survival.

Conditions
-----------------
Sudden Cardiac Death, Arrhythmia, Survival

Intervention / Treatment
-----------------
* Procedure: shock efficacy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: out of hospital sudden cardiac death ventricular fibrillation Exclusion Criteria: non cardiac death asystole

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

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

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 |
| --- |
|Procedure: shock efficacy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| termination of vf survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resulting rhythm CPC score |  |  |
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of this non-interventional study is to evaluate the current status of diabetes management, control, and complications in diabetic subjects in Vietnam.

Official Title
-----------------
A Cross-Sectional Survey to Evaluate Diabetes Management, Control, Complications, Psychosocial Aspects of Patients With Type 2 Diabetes in Bangladesh, Indonesia, Malaysia, Philippines, Sri Lanka and Vietnam

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

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People with type 2 diabetes mellitus (DM) who are being treated, with any of the non-pharmacological or pharmacological options, at a particular centre for at least 1 year and who have visited the centre within the last 3-6 months Patients willing to sign informed consent form Exclusion Criteria: Previous participation in this study Unable to comply with protocol requirements Confirmed or suspected pregnancy
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with diabetes mellitus (type 2)<br> | Other: No treatment given<br>* Patients will fill out a questionnaire by interview.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients having HbA1c ((Glycosylated Haemoglobin) as measured during survey) less than 7% |  | Evaluated at the first visit (only one study visit) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Fasting Plasma Glucose (FPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean Postprandial Plasma Glucose (PPG) of patients |  | Evaluated at the first visit (only one study visit) | 
| Mean HbA1c of patients |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having dyslipidemia |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having hypertension |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having cardiovascular complications |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having peripheral vascular disease |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic nephropathy |  | Evaluated at the first visit (only one study visit) | 
| Proportion of patients having diabetic eye complications |  | Evaluated at the first visit (only one study visit) |