linjc16/ctgov huggingface dataset:
Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

Study Overview
=================
Brief Summary
-----------------
The study is designed to demonstrate the short term efficacy and safety of vildagliptin 50 mg bid in patients with Type 2 Diabetes Mellitus inadequately controlled with Metformin.

Official Title
-----------------
A 12 Week Multi Center, Open Label, Single Arm Study to Assess the Safety and Efficacy of Vildagliptin 50 mg Twice Daily in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who sign the informed consent HbA1c in the range of > 7 to ≤10.5% at Visit 1 Ability to comply with all study requirements Exclusion Criteria: Pregnant or lactating women Serious cardiovascular disorders Liver/renal disease or dysfunction Anti-diabetic other than metformin, thiazolidine, or α-GI or insulin Laboratories values abnormalities as defined by the protocol

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin 50 bid<br> | Drug: vildagliptin<br>* Drug 50mg vildagliptin bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety and tolerability of vildagliptin 50 mg bid | Efficacy of vildagliptin based on the reduction in mean HbA1c and mean fasting plasma glucose with vildagliptin treatment at 12 weeks. Safety is measured by monitoring lipids profile, liver and kidney function to assess vildagliptin safety. | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metformin, vildagliptin, T2DM
The Study of Warfarin Maintenance Dose in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
Title: Clinical study of the relationship between Pharmacogenomics and warfarin dose in Chinese patients Drug: Warfarin Design: To value the accuracy of warfarin Pharmacogenomics algorithm by the algorithm calculated dose and actual dose in the Chinese patients. Hypothesis:Pharmacogenomic algorithm guided dose can help to predict warfarin dose in Chinese patients.

Detailed Description
-----------------
For the patients who need to use warfarin, detect the Vitamin K epoxide reductase complex subunit 1 (VKORC1),cytochrome p450 2C9 (CYP2C9), and cytochrome p450 4F2 (CYP4F2) genotype. Record the demographic information: gender, age, height, and weight. Record drug combination, complications, and international normalized ratio (INR), liver function and kidney function or other biochemical test results. Put genotypes, demographic information and other clinical information into the algorithm to calculate warfarin dose for the patients, and compared with the actual dose.

Official Title
-----------------
Clinical Study of the Relationship Between Pharmacogenomics and Warfarin Dose in Chinese Patients

Conditions
-----------------
Atrial Fibrillation, Heart Valve Disease, Pulmonary Artery Embolism

Intervention / Treatment
-----------------
* Drug: Warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese patients Age >18y target INR 1.5 3.0 Patients signed informed consent Exclusion Criteria: Has hemorrhage disease, or tendency to significant bleeding Severe liver and kidney disfunction, serious infections, severe heart failure (NYHA heart function classification Ⅲ magnitude), severe pulmonary hypertension, abnormal thyroid function, respiratory failure, anemia, malignant tumor, blood disease patients with pregnancy or lactation; with cognitive impairment.

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 |
| --- | --- |
| Warfarin Using Group<br> | Drug: Warfarin<br>* Prescribe warfarin to the patients who are needed.<br>* Other names: 3mg*100;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of the pharmacogenomics algorithm for warfarin maintenance dose | The proportion of the patients whose predicted dose were within 20% of the actual maintenance dose. | one month after the initial dose of warfarin | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gene guided, warfarin dose, Chinese
Assessment of Long Term Treatment With Testosterone Undecanoate in Males With Hypogonadism

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the preparation of testosterone undecanoate under conditions which resemble real-life situations.

Detailed Description
-----------------
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Official Title
-----------------
Open One-arm Study to Investigate Safety and Efficacy of Intramuscular Injections of 1000 mg Testosterone Undecanoate (TU) in Hypogonadal Men at Variable Intervals During a 136-week to 192-week Treatment Including Pharmacokinetics

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone undecanoate (TU) - NebidoTM


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypogonadal men, aged 18-75 years with low serum total testosterone (TT) levels and symptoms of androgen deficiency Exclusion Criteria: Tumors of the prostate or the male mammary gland including suspicion thereof. Past or present liver tumors or chronic hepatic disease with impairment of liver function, Severe acne.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: Testosterone undecanoate (TU) - NebidoTM<br>* Drug treatment with 14 injections of one ampoule of Nebido (1000 mg of testosterone undecanoate) at individually adjusted injection intervals<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy and Safety of long term treatment with TU under real-life conditions |  | Every 3 months during treatment and after final injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of treatment satisfaction by patient |  | 6,10, and 14 injections |
Corticosteroids for the Prevention of Atrial Fibrillation After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation is the most common arrhythmia to occur after cardiac surgery. Inflammatory response may be one etiological factor. We hypothesized that intravenous corticosteroid administration after cardiac surgery prevents AF after cardiac surgery.

Official Title
-----------------
Feasibility of Corticosteroid in the Prevention of Atrial Fibrillation After Cardiac Surgery: A Prospective, Double-Blind Randomized Multicenter Trial

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

Intervention / Treatment
-----------------
* Drug: intravenous hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled to undergo their first on-pump CABG, aortic valve replacement or combined aortic valve replacement and CABG were enrolled. Exclusion Criteria: Previous episodes of AF or flutter Uncontrolled diabetes mellitus Systemic mycotic infection Active tuberculosis Cushing's syndrome Psychotic mental disorder Herpes Simplex keratitis Serum creatinine exceeding 200 µg/ml Patients were also excluded if they had a history of previous peptic ulcer or thrombophlebitis.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study couldn´t start due to investigator<br>Study couldn´t start due to investigator | Drug: intravenous hydrocortisone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study couldn´t start due to investigator | Study couldn´t start due to investigator | Study couldn´t start due to investigator | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study couldn´t start due to investigator | Study couldn´t start due to investigator | Study couldn´t start due to investigator | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial fibrillation after cardiac surgery
Lower Laser Therapy in Orthognathics Surgery

Study Overview
=================
Brief Summary
-----------------
This study will examine the use of lower laser therapy to reduce edema and pain in orthognathics surgery.

Official Title
-----------------
Lower Laser Therapy in Orthognathics Surgery - Double Blind Study.

Conditions
-----------------
Dentofacial Deformity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dentofacial deformity Healthy Mandibular surgery no medication use
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 |
| --- | --- | --- |
| edema, pain and neurosensory disturbancy | edema, pain and neurosensory disturbancy, response to lasr therapy | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Edema, Pain, Lower laser therapy, orthognathics surgery
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

Study Overview
=================
Brief Summary
-----------------
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope.

Detailed Description
-----------------
Prospective, multicenter, observational registry designed to collect data on syncopal relapses in patients undergoing pacemaker implantation for bradyarrhythmic syncope. All consecutive patients aged ≥18 years who underwent pacemaker implantation for syncope of bradyarrhythmic aetiology (proven or presumed) at participating centers from January 2010 to December 2013 were enrolled in the registry. During follow-up the occurrence of the first syncopal relapse after pacemaker implantation is recorded.

Official Title
-----------------
Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

Conditions
-----------------
Syncope

Intervention / Treatment
-----------------
* Other: Clinic follow-up


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing pacemaker implantation for bradyarrhythmic syncope Exclusion Criteria: age <18 years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study population<br>Consecutive patients undergoing pacemaker implantation for bradyarrhythmic syncope | Other: Clinic follow-up<br>* Patients are regularly evaluated to asses the occurrence of syncopal relapses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Syncopal relapse | First syncopal relapse after pacemaker implantation | march 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Syncope, pacemaker, bradyarrhythmias
18793 - Human Photoallergy Test

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential of a test material to produce a photoallergic response.

Official Title
-----------------
Human Photoallergy Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517
* Other: Untreated skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be male or female between the ages of 18 and 60 inclusive be lightly pigmented (Fitzpatrick Skin Type I, II, III) have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form (Health Insurance Portability and Accountability Act) in conformance with 45CFR Parts 160 and 164 be in general good health as determined by the subject's medical history and in the discretion of the investigator Exclusion Criteria: have a visible sunburn have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products subjects who are employees of the CRO (Contract Research Organization) and/or Bayer or is a household member of an employee

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987517<br>All subjects are patched with the same product | Drug: BAY987517<br>* 50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. Forty-eight (48) hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.<br>Other: Untreated skin<br>* One site is patched without treatment as control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions is evaluated by 5 point scale |  | Up to 72 hours |
Reducing Anxiety in Pediatric Dental Patients Through Passive Music Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if passive music listening decreases anxiety in patients undergoing dental procedures and if the effects of music therapy are influenced by gender, age, and amount or type of dental treatment needed.

Official Title
-----------------
Reducing Anxiety in Pediatric Dental Patient Through Passive Musical Therapy

Conditions
-----------------
Anxiety, Dental

Intervention / Treatment
-----------------
* Behavioral: Music


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists Physical Status Classification System I (ASA I) I and American Society of Anesthesiologists Physical Status Classification System II (ASA II) Patient needs restorative procedure (with or without local anesthesia or nitrous oxide) Received previous dental restorative treatment (detected via visual or radiographic evidence of previous restoration - no additional radiographs will be exposed for this study; exposed radiographs will be previously obtained, as needed,for comprehensive or periodic dental reasons) Exclusion Criteria: Patients with hearing impairments Uncooperative patients at examination appointment (detected by Frankl behavior score of 1 or 2)

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 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 |
| --- | --- |
| Experimental: Music Group<br>Patients listen to music | Behavioral: Music<br>* Patients in the music group will listen to classical music during their dental procedure.<br>|
| No Intervention: No Music group<br>Patients do not listen to music | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety as assessed by the Pediatric 7 question survey | The total score ranges from 7-49, with lower scores indicating less anxiety. | baseline | 
| Anxiety as assessed by the Pediatric 7 question survey | The total score ranges from 7-49, with lower scores indicating less anxiety. | immediately after the dental procedure (within 5 minutes after procedure) | 
| Parent's prediction of child's anxiety in the dental office as assessed by survey | The total score ranges from 0-10. A lower score indicates less anxiety. | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Anxiety, Pediatric dentistry
Swiss Primary Biliary Cholangitis Cohort Study

Study Overview
=================
Brief Summary
-----------------
Research project in which biological material is sampled and health-related medical data is collected. In addition, already existing health-related medical data are used for further research. Coded data are used.

Detailed Description
-----------------
Enrolment visit and one follow-up visit at least once a year are planned. Whole blood is collected for biobanking once a year. Optionally, if available and collected during normal clinical procedures, liver fragments are obtained. To collect high quality prospective data on a rare disease in order to elucidate epidemiology, natural history, response to treatment and outcome. In addition, the biobank allows addressing specific scientific issues on a variety of open questions. The cohort will provide a platform for carrying out scientific research projects on PBC. In addition, the cohort will allow collaboration with reference networks on PBC abroad.

Official Title
-----------------
Swiss Primary Biliary Cholangitis Cohort Study

Conditions
-----------------
Liver Cirrhosis, Biliary

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnose of Primary biliary cholangitis (according to EASL Clinical Practice Guidelines: management of cholestatic liver diseases). Subjects with isolated anti-mitochondrial antibodies and/or isolated PBC-specific anti-nuclear antibodies are also included Patients/subjects aged at least 18 years and living in Switzerland are included Exclusion Criteria: N/A

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 |
| --- | --- | --- |
| Disease course | Observing disease course | 3 years | 
| Disease features | Observing disease features in Swiss population and see if they are similar to other countries' | 3 years | 
| Response to treatment | Observing response to treatment | 3 years | 
| Overall survival | Observing overall survival | 3 years | 
| Transplantation-free survival rate | Observing transplantation-free survival rate | 3 years |