linjc16/ctgov huggingface dataset:
Follow-up Data of Patients Treated With XIGRIS® in France

Study Overview
=================
Brief Summary
-----------------
The transparency commission wishes that the laboratory Lilly France sets up a follow-up study describing the conditions of use of Xigris® in France. The purpose of this study is to describe the characteristics of the treated patients, the conditions of drug use, in particular the conditions of treatment initiation and the clinical development of the patients during normal clinical practice, in particular rate and cause of mortality within one month.

Detailed Description
-----------------
The objectives of the study as defined by the specific requirements of Transparency Commission are as follows: To describe the characteristics of the patients treated with Xigris® socio-demographic characteristics, clinical profile To determine the conditions of use of Xigris® To describe previous treatments, To observe delay before Xigris® initiation, To describe dose, duration of treatment, To study the concomitant treatments and the associated treatments To describe the clinical evolution of the patients To observe mortality after 1 month To describe reasons of death

Official Title
-----------------
Follow-up Data of Patients Treated With XIGRIS® DROTRECOGIN ALFA (ACTIVATED) in France

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Patients are eligible to be included in the study if they meet the following criteria Patients treated with Xigris® during the study period in intensive care units in France Patients with a minimum age of 18 years Patients who are presenting in the normal course of care

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 |
| --- | --- |
| Retrospective cohort<br>Patient treated with Xigris between January 2006 and November 2008. | |
| Prospective cohort<br>Patient treated with Xigris between November 2008 and November 2009. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 28 and 31 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe bleeding events |  | 28 and 31 days | 
| Length of hospital stay |  | 28 and 31 days |
Follow-up Study on the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens 1 Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in NeisVac-C Study 216

Study Overview
=================
Brief Summary
-----------------
The primary aim of the study is to show that the antibody response to hepatitis B, acellular pertussis toxin and inactivated poliovirus antigens after the 4th vaccination with Hexavac® is not influenced by the concomitant administration of NeisVac-C.

Official Title
-----------------
Open-label Multicenter Phase 3B Follow-up Study to Investigate the Antibody Response to Hepatitis B, Acellular Pertussis Toxin and Inactivated Poliovirus Antigens One Month After the 4th Hexavac® Vaccination in Healthy Children, Who Participated in the NeisVac-C Non-interference Study 216

Conditions
-----------------
Meningococcal Meninigitis, Serogroup C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study subjects who completed study 216 will be eligible for participation in this study if: they received all 3 vaccinations with Hexavac during study 216 and the 4th Hexavac vaccination outside the study the subject's parent(s)/legal guardian(s) understands the study and has provided written informed consent for his/her child's study participation; a blood draw was performed after the 3rd vaccination during study 216. Exclusion Criteria: Study subjects will be excluded from participation in this study if: they have received any vaccination containing hepatitis B, poliovirus or acellular pertussis toxin antigens other than Hexavac they have received a blood transfusion or immunoglobulins during the period from 28 days prior to the 4th Hexavac vaccination until study entry they have received another vaccine during the period from 28 days prior to the 4th Hexavac vaccination until study entry they are concurrently participating in or have participated in a clinical trial with an investigational medicinal product since the completion of study 216 they suffer from a disease (e.g. autoimmune disease) or were undergoing a form of treatment that may be expected to influence immunological functions since the completion of study 216 they have received systemic corticosteroids during the period from 28 days prior to the 4th Hexavac vaccination until study entry.

Ages Eligible for Study
-----------------
Minimum Age: 5 Months
Maximum Age: 22 Months

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
-----------------
Meningococcal Vaccine, Meningococcal Meningitis, Serogroup C, Neisseria Meningitidis
Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.

Official Title
-----------------
A 20-week, Multi-centre, Open-labelled, Non-comparative Evaluation of the Safety and Efficacy of Insulin Detemir in Combination With Oral Anti-diabetic Drug(s), in Subjects With Type 2 Diabetes Mellitus Who Were Inadequately Controlled on Current Therapy in Korea

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

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes (diagnosed more than 12 months ago) HbA1c greater than 7.0 and less than 12.0% at screening Currently on any OAD in more than 3 months ago BMI (Body Mass Index) less than 35kg/m2 Exclusion Criteria: Previous treatment with insulin in more than 7 days within the last 3 months Uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmHg and/or diastolic blood pressure less than 110mmHg)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: insulin detemir<br> | Drug: insulin detemir<br>* Treat-to-target dose titration scheme, once daily, injected s.c. (under the skin).<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 | Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline to week 20 | week 0, week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 | Change in Glycosylated Haemoglobin A1c (HbA1c) at week 12 from baseline | week 0, week 12 | 
| Change in Fasting Plasma Glucose (FPG) | Change in fasting plasma glucose (FPG) from baseline to week 12 and week 20 | week 0, week 12, week 20 | 
| Percentage of Subjects Achieving Glycosylated Haemoglobin A1c (HbA1c) Less Than 7.0% | Percentage (%) of subjects achieving Glycosylated Haemoglobin A1c (HbA1c) treatment target levels less than 7.0% | week 12, week 20 | 
| Occurence of Hypoglycaemic Episodes | Occurence of hypoglycaemic episodes - diurnal and nocturnal - over 20 weeks of treatment. | weeks 0-20 |
Sirtuin Mediated Effects of 36 Hour Fast and 1 Hour Exercise

Study Overview
=================
Brief Summary
-----------------
Hypothesis: during fasting and exercise will there be an activation of sirtuins (Sirt1). Primarily the investigators will investigate Sirt1 activity in muscle- and fat-biopsies after fasting for 36 hours and after 1 hour of ergometer-cycling at 50 Vo2max. In addition to this the investigators will investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover.

Official Title
-----------------
Sirtuin Mediated Effects of 36 h Fast and 1 h Exercise

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

Intervention / Treatment
-----------------
* Other: fast and exercise
* Other: exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men Body mass index (BMI) 20-26 age 18-45 years Exclusion Criteria: any kind of disease any use of medicine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fasting and exercise<br>36 h fast and 1 h ergometer cycling 50% VO2max | Other: fast and exercise<br>* fasting 36 h and exercise 1 h 50% VO2max<br>|
| Experimental: exercise<br>1 h ergometer cycling 50% VO2max | Other: exercise<br>* exercise 1 h 50% VO2max<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sirt1 activity |  | 60 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary will we investigate the effect of fasting and exercise on the velocity of carbamide synthesis, aminoacid rate of turnover and glucose rate of turnover. |  | 4 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sirt1 activity
Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients?

Study Overview
=================
Brief Summary
-----------------
Proton pump inhibitors (PPIs) are one of the most frequently prescribed classes of drugs in the world and the most effective drugs available to reduce gastric acid secretion. However, studies have shown that PPIs are not always prescribed with a clear indication. Indeed, between 25% and 86% of older individuals taking a PPI have been overprescribed these medications. In older patients, overprescribing of a PPI is associated with increases in morbidity, adverse drug events, hospitalization, and mortality. The hypothesis is that overprescription of PPIs is associated with the individual multimorbidities in older patients evaluated using the multimorbidities group criteria included in the CIRS. The aim of the present study was to establish a relationship between overprescribing of PPIs and multimorbidities in older patients.

Official Title
-----------------
Inappropriate Prescribing of Proton-pump Inhibitor is it Associated With the Burden of Comorbidities in Older Patients Over 75 Years Old ?

Conditions
-----------------
Geriatric Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of 75 years or more Patients hospitalized in geriatric short stay Patients with an inhibitor therapy proton pump short geriatric entry Patients who have given their written consent Exclusion Criteria: Patients who have expressed their inability or refusal to sign an informed consent

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- | --- |
| Burden of comorbidities | Burden of comorbidities is assessed by the CIRS (Cumulative Illness Rating Scale) | 48 hours after the entry into acute geriatric medicine |
Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical efficacy of transfusions with platelets stored in platelet additive solution II compared to plasma storage.

Detailed Description
-----------------
Introduction: Utilization of platelet additive solutions (PASs) for storage of platelets has several advantages, however randomised studies testing the clinical efficacy are scarce. A prospective, randomised study comparing the efficacy of transfusions with platelets stored in Platelet Additive Solution II (PAS II) versus plasma showed that CCIs after transfusion with platelets stored in PAS II were significantly lower (1). Major drawbacks of this study were the exclusion of patients with clinical factors known to increase platelet consumption and a limited number of patients. A multicenter, randomised study to investigate clinical efficacy of platelets stored in PAS II versus plasma, also including patients with factors of increased platelet consumption, was performed. Methods: After consent patients > 18 years, without HLA- and/or HPA-alloantibodies, were randomised to receive pooled platelet concentrates (PC) suspended in either plasma or PAS II, leucoreduced, and stored up to 5 days. 1- and 24-hour CCI were the primary endpoints. Secondary endpoints were transfusion interval, adverse reactions and bleeding complications. An inclusion-period was defined as a maximum of 8 transfusions or 30 days after the first transfusion.

Official Title
-----------------
A Multicentre Randomised Study of the Efficacy of Transfusions With Platelets Stored in Platelet Additive Solution II Versus Plasma

Conditions
-----------------
Hemato-Oncologic Patients, Myelosuppression, Thrombocytopenia

Intervention / Treatment
-----------------
* Procedure: platelet transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:patients > 18 years expected to receive platelet transfusions and informed consent - Exclusion Criteria:HLA- and/or HPA- alloimmunization -

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
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: platelet transfusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corrected count increment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thrombopenia, Platelet transfusion, Increment, Transfusion reactions, Bleeding complication
Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium Before Office Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
The study aims to determine the efficacy of oral hyoscine butyl bromide versus diclofenac potassium on the pain scores during office hysteroscopy

Official Title
-----------------
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide Versus Diclofenac Potassium in Reducing Pain During Office Hysteroscopy

Conditions
-----------------
Endoscopy

Intervention / Treatment
-----------------
* Drug: diclofenac potassium
* Drug: hyoscine butyl bromide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that must perform a diagnostic hysteroscopy. Acceptance to participate in the study. Signed informed consent. Not taking analgesics (acetaminophen, ibuprofen, mefenamic acid) before admission. Absence of sedative use before admission Exclusion Criteria: Hypersensitivity to drugs refusal of the patient Patients are pregnant.

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diclofenac potassium<br>oral diclofenac potassium | Drug: diclofenac potassium<br>* patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure<br>* Other names: cataflam;|
| Active Comparator: hyoscine butyl bromide<br>oral hyoscine butyl bromide | Drug: hyoscine butyl bromide<br>* patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure<br>* Other names: buscopan;|
| Placebo Comparator: placebo<br>oral placebo | Drug: placebo<br>* patients will take oral placebo; 2 tablets one hour before the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score during hysteroscopy |  | intraoperative |
Pilot Study of Effects of Cold Vests on Cardiovascular Risk Markers

Study Overview
=================
Brief Summary
-----------------
Randomized trial of supplying a cold vest as compared with controls (no cold vest) on cardiovascular risk factors such as blood lipids, insulin, blood pressure and body weight and also on basal metabolic rate. Recruitment of 100 participants and 70 are randomized to being given a vest which they can use to increase basal metabolic rate during 1-2 hours (as long as the pre-cooled vest stays cool) by activating brown adipose tissue and/or shivering. The remaining 30 subjects will constitute a control group. Lab tests and anthropometrics are checked at baseline, after 2 months and after 1 year.

Official Title
-----------------
Prospective Randomized Pilot Study of the Effects of Cold Vests on Cardiovascular Risk Markers and Basal Metabolic Rate

Conditions
-----------------
Cardiovascular Risk Factors, Basal Metabolic Rate

Intervention / Treatment
-----------------
* Other: cold vest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects that have no known metabolic relevant diseases Exclusion Criteria: thyroid disease, mental disorders, language problems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cold vest<br>Participants are given a cold vest that the pre-cool in a freezer. They are encouraged to use it daily to activate metabolism through brown adipose tissue and shivering. | Other: cold vest<br>* The lowering of body temperature increases basal metabolic rate<br>|
| No Intervention: control<br>No intervention, just recording of risk factors and basal metabolic rate. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| basal metabolic rate | basal metabolic rate measured in the fasting state by indirect calorimetry | up to 1 year | 
| Composite measure of cardiovascular risk factors | Blood lipids, insulin, body weight, blood pressure | up to 1 year |