linjc16/ctgov huggingface dataset:
Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.

Official Title
-----------------
NovoMix® Start - A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix 30® Treatment

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 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 |
| --- | --- |
| BIAsp 30<br> | Drug: biphasic insulin aspart 30<br>* Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions (SADRs) |  | Week 26 | 
| Incidence of major hypoglycaemic events |  | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all hypoglycaemic events |  | In the 4 weeks prior to week 12 and week 26, respectively | 
| HbA1c (glycosylated haemoglobin A1c) |  | Week 26 | 
| Fasting Plasma Glucose (FPG) |  | Week 26 |
A Pharmacogenomics Study of Safety and Efficacy of Enalapril or Enalapril-Folic Acid Therapy in Hypertensive Patients.

Study Overview
=================
Brief Summary
-----------------
Dry cough is the most common adverse reaction of angiotensin converting enzyme, including enalapril, in Chinese population. Clinical observations suggest that the incidence of ACEI-induced dry cough is different between Chinese and other racial groups, however, there is still lack of research data in Chinese. Stroke is the second leading cause of death in the world and leading cause of death in China. Except the known risk factor such as hypertension, high homocysteine level, folic acid deficiency, the impact of genetics should not be ignored. In this study, we will investigate whether there are specific genotypes which may predict the incidence of (1)enalapril-induced dry cough in Chinese and (2)first stroke in hypertensive patients taking enalapril or enalapril-folic acid therapy, so as to provide a basis for developing guidelines on precision medication in enalapril therapy apply to Chinese population.

Official Title
-----------------
A Study of Genetic Variants Associated With Enalapril-Induced Adverse Drug Reaction and Impact of Pharmacogenomics on First Stroke in Hypertensive Patients Taking Enalapril or Enalapril-Folic Acid Therapy.

Conditions
-----------------
Enalapril Adverse Reaction, Pharmacogenomics, Stroke

Intervention / Treatment
-----------------
* Genetic: detection of genotype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients taking enalapril or enalapril-folic acid therapy Signed informed consent. Exclusion Criteria: Patients not taking enalapril treated Intolerance or unwillingness to blood sample collection.

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 |
| --- | --- |
| wild genotype<br>Detection of genotype will be carried out through next generation sequencing, distinguish wild genotype of enalapril | Genetic: detection of genotype<br>* detection of genotype by next generation sequencing<br>|
| mutant genotype<br>Detection of genotype will be carried out through next generation sequencing, distinguish mutant genotype of enalapril | Genetic: detection of genotype<br>* detection of genotype by next generation sequencing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of dry cough |  | At 2 years | 
| First Incidence of stroke |  | At 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype detected by next generation sequencing | Collect blood specimen before enalapril administration, then detect genotype of enalapril by next generation sequencing. | pre-dose of enalapril or enalapril-folic acid (Baseline) |
Accuracy of CGM in the ICU, Compared to Standard of Care

Study Overview
=================
Brief Summary
-----------------
To determine the performance of the Dexcom CGM device in comparison to arterial glucose samples.

Detailed Description
-----------------
The performance of the Dexcom continuous glucose sensor will be compared with the current standard of care which is arterial glucose samples analyzed on a glucose meter. Subjects will be ICU patients receiving intravenous insulin infusions.

Official Title
-----------------
Accuracy of Dexcom G6 Continuous Glucose Sensor in the Intensive Care Unit

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Continuous Glucose Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minimum age 18 years anticipated to be on an insulin infusion for 3-7 consecutive days 10 of these subjects will be on vasopressors who will be receiving large volume fluid resuscitation Exclusion Criteria: subjects not on insulin infusion

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continuous Glucose Sensor|Continuous glucose sensor results will be compared with arterial glucose samples|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Continous Glucose Sensor values (CGM) | CGM will be compared with arterial glucose values | 3 to 7 consecutive days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressor Use | 10 of the 20 subjects will be on vasopressors and large volume fluid resuscitation | 3 to 7 consecutive days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
insulin infusion, continuous glucose sensor
Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

Study Overview
=================
Brief Summary
-----------------
Improved outcome of high risk lymphoblastic leukemia (ALL) with laite high dose therapy. High dose versus conventional therapy for adult low risk T-ALL and Lymphoblastic lymphoma (LBL).

Detailed Description
-----------------
Comparison between two autograf therapeutic strategies in high risk patients Ramdomised comparison between maintenance treatment with or not interferon alpha 2 a

Official Title
-----------------
Study of Treatment High Risk and/or Low Risk Acute Lymphoblastic leukémia(ALL) Adults Stage III

Conditions
-----------------
Leukemia, Lymphocytic, Acute

Intervention / Treatment
-----------------
* Drug: interferon alpha 2a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria ALL high risk or low risk or lymphoblastic lymphoma age 15-55 years old informed consent signed Exclusion Criteria: patients previously treated with a chemotherapy or alpha-interferon ALL 3 (burkitt like)

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: interferon alpha 2a|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | time to death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of study treatments |  | time to end of treatment |
Evaluation of a New Cardiac Pacemaker

Study Overview
=================
Brief Summary
-----------------
An evaluation of a safety and performance of a new cardiac pacemaker

Conditions
-----------------
Atrial Fibrillation With 2 or 3° AV or Bifascicular Bundle Branch (BBB) Block, Normal Sinus Rhythm With 2 or 3° AV or BBB Block, Sinus Bradycardia With Infrequent Pauses or Unexplained Syncope With EP Findings

Intervention / Treatment
-----------------
* Device: Pacemaker implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have one of the following clinical indications: Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB block) ; or Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan (but at least one year); or Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings; and Subject ≥18 years of age; Subject has life expectancy of at least one year; Subject is not enrolled in another clinical investigation; Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; Subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the EC; If female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal. Exclusion Criteria: Pacemaker dependent; Known pacemaker syndrome, have retrograde VA conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing; Hypersensitivity to < 1 mg of dexamethasone sodium phosphate; Mechanical tricuspid valve prosthesis; Pre-existing pulmonary arterial (PA) hypertension or significant physiologically-impairing lung disease; Pre-existing pacing or defibrillation leads; Current implantation of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT); Presence of implanted vena cava filter; Presence of implanted leadless cardiac pacemaker; Pregnant or breastfeeding.

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: Pacemaker<br> | Device: Pacemaker implant<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate, where a complication is defined as a serious adverse device effect (SADE) |  | 90 days |
Incarcerated Right Inguinal Hernia Containing Sigmoid Colon: An Unusual Case Report

Study Overview
=================
Brief Summary
-----------------
Incarcerated inguinal hernia is an irreducible but the blood supply to the contained part is intact, but developing towards strangulation. Here the lumen of the portion of colon occupying a hernia sac is blocked with faeces.

Detailed Description
-----------------
A special data collection sheet designed to collect data regarding the diagnosis, age, sex and treatment from the profile of patient retrospectively. Data entry was performed by using Microsoft Excel and all the data were analysed by SPSS.

Official Title
-----------------
Incarcerated Right Inguinal Hernia Containing Sigmoid Colon: An Unusual Case Report

Conditions
-----------------
Incarcerated Inguinal Hernia

Intervention / Treatment
-----------------
* Procedure: surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: inguinal hernia that requires emergency operation Exclusion Criteria: hernia does not need emergency operation.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| An incarcerated right inguinal hernia containing sigmoid colon<br> | Procedure: surgery<br>* our study is observational and we use secondary data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of incarcerated right inguinal hernia containing sigmoid colon | Frequency of incarcerated right inguinal hernia containing sigmoid colon in general surgery ward of Aliabad teaching hospital, retrospectively. | 2013-2021 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incarcerated right inguinal hernia, right side, sigmoid colon
Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Smokers with serious mental illness including those with schizophrenia and bipolar disorder infrequently attempt and attain sustained smoking abstinence and have a 25-year shorter lifespan due to smoking-related illness. This study will examine whether reducing the nicotine content of cigarettes to non-addicting levels is a viable method of reducing smoking in smokers with serious mental illness. Smokers will be randomized to one of two experimental conditions: 1) very low nicotine content (VLNC) cigarettes or 2) normal nicotine content (NNC) cigarettes. Participants will be assessed for patterns of tobacco use, biomarkers of exposure, subjective responses (e.g., satisfaction, craving, withdrawal symptoms), psychiatric symptoms, cognitive performance, smoking cue reactivity and smoking topography.

Official Title
-----------------
Very Low Nicotine Cigarettes in Smokers With Schizophrenia

Conditions
-----------------
Tobacco Dependence

Intervention / Treatment
-----------------
* Other: Very low nicotine content cigarettes
* Other: standard nicotine content cigarettes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-70 Schizophrenia, schizoaffective disorder or bipolar disorder Smoke an average of at least 10 cigarettes per day for at least 1 year Breath carbon monoxide (CO) levels >8 ppm (if ≤ 8 ppm, then nicotine (NicAlert) Strip > 2) Exclusion Criteria: Pregnant or nursing Seeking treatment for smoking Medical contraindications

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.8 mg nicotine with 10.5 mg tar<br>SPECTRUM Cigarette: 0.8 (±0.15) mg nicotine yield with 9 (±1.5) mg tar (standard nicotine and tar yields of commercially-available cigarettes; control condition) | Other: standard nicotine content cigarettes<br> <br> |
| Experimental: 0.03 mg nicotine with 9 mg tar<br>SPECTRUM Cigarette: 0.03 mg (± 0.02) nicotine yield with 9 mg (± 1.5) tar | Other: Very low nicotine content cigarettes<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cigarettes smoked per day |  | End of 6 week intervention |
Cardiac T1 Mapping Enables Risk Prediction of LV Dysfunction After Surgery for Aortic Regurgitation

Study Overview
=================
Brief Summary
-----------------
To assess whether cardiac T1 mapping for detection of myocardial fibrosis enables preoperative identification of patients at risk for early left ventricular dysfunction after surgery of aortic regurgitation.

Detailed Description
-----------------
We hypothesized that a diffuse interstitial myocardial fibrosis may be present in AR patients who experience early systolic LV dysfunction after aortic valve surgery. We aimed to evaluate the association between preoperative cardiac T1 mapping for detection of myocardial fibrosis and early systolic LV dysfunction after surgery for aortic regurgitation.

Conditions
-----------------
Aortic Regurgitation

Intervention / Treatment
-----------------
* Procedure: aortic valve surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with severe aortic regurgitation referred for aortic valve surgery were prospectively enrolled in the study. Exclusion Criteria: history of coronary artery disease acute aortic valve disease (i.e., type A aortic dissection or infectious endocarditis) common contraindications for MRI such as severe obesity and metallic foreign bodies.
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 prior to aortic valve surgery<br> | Procedure: aortic valve surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Native T1 | Measured with MRI | baseline (Prior surgery) |
A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance of Telostop Plus Tab.

Detailed Description
-----------------
This study will collect clinical data, mainly focused on safety, in Korean population as per the requirement of MFDS for market authorization.

Official Title
-----------------
A Post-marketing Surveillance to Assess Safety and Efficacy of Telostop Plus Tab.

Conditions
-----------------
Hypertension, Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient who is first prescribed and administered Telostop plus Tab. Exclusion Criteria: The patients who are overreacting to this drug or its components The patients with severe renal impairment
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypertention, Dyslipidemia<br>NA (Observation study) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse event after this drug administration in general medical practice | Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. | 24 weeks | 
| Incidence of serious adverse event after this drug administration in general medical practice | Any serious adverse events occurred after this drug dosing will be recorded. Description of serious adverse event(s) including type of serious adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the serious adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be serious adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be serious adverse events. | 24 weeks |
Coronary Bifurcation Stenting (COBIS) Registry in South Korea

Study Overview
=================
Brief Summary
-----------------
The COBIS registry is multi-center, real-world registry of drug-eluting stenting in coronary bifurcation lesions in South Korea. The aim of the study was to find out the current status of bifurcation drug-eluting stenting and determine the prognostic factors for long-term outcome in South Korea.

Official Title
-----------------
Coronary Bifurcation Stenting (COBIS) Registry in South Korea

Conditions
-----------------
Coronary Bifurcation Lesion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Any type of de novo bifurcation lesion with a parent vessel >= 2.5 mm and side branch>= 2.0 mm by visual estimation Treated with drug-eluting stent Exclusion Criteria: Cardiogenic Shock ST elevation MI within 48hours Expected survival less than 1 year Left main bifurcation Allergy to the antiplatelets

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 |
| --- | --- |
| Coronary bifurcation lesion<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the composite outcome of all-cause death, MI, or any PCI/CABG |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of stent thrombosis, and periprocedural MI |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary bifurcation lesion, Drug-eluting stent