linjc16/ctgov huggingface dataset:
Observational Study to Evaluate the Safety of Levemir® in Patients With Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of the study is to observe the safety of insulin detemir (Levemir®) in patients with type 1 and type 2 diabetes patients.

Official Title
-----------------
A Multicentre, Open Label, Nonrandomised, Non-interventional, Observational, Safety Study in Patients Using Insulin Detemir for the Treatment of Type 1 or Type 2 Diabetes Mellitus: The PREDICTIVE™ Study - Predictable Results and Experience in Diabetes Through Intensification and Control to Target: An International Variability Evaluation

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient with type 1 or type 2 diabetes mellitus, including newly diagnosed patients who had never received insulin or an insulin analogue before Exclusion Criteria: Patients whom the physician considered might be noncompliant for any reason; for example, uncooperative attitude, inability to return for the final visit and similar Patients previously enrolled in this study Patients with a hypersensitivity to insulin detemir

Ages Eligible for Study
-----------------
Maximum Age: 110 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 |
| --- | --- |
| Insulin detemir users<br> | Drug: insulin detemir<br>* Administered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse drug reactions (SADRs), including major hypoglycaemic events |  | Weeks 0-26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of serious adverse events (SAEs) |  | Weeks 0-26 | 
| Number of all adverse events (AEs) |  | Weeks 0-26 | 
| Number of all hypoglycaemic events |  | In the 4 weeks preceeding week 26 | 
| Weight change |  | Week 0, week 26 | 
| Glycosylated haemoglobin (HbA1c) |  | Week 26 | 
| Variability in fasting plasma glucose (FPG) |  | Week 26 | 
| Average plasma glucose level |  | Week 26 | 
| Quality of Life as assessed by a treatment satisfaction questionnaire |  | Week 26 |
Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
This study will examine whether fasting and non-fasting lipid measures can provide similar clinical information in order to guide lipid management by primary physicians. It will compare fasting vs. non-fasting lipid measurements in patients with and without diabetes.

Official Title
-----------------
Assessment of Non-Fasting vs. Fasting Lipid Measures in Diabetes Patients

Conditions
-----------------
Diabetes Mellitus, Normal Glucose Metabolism, Hyperlipidemia

Intervention / Treatment
-----------------
* Other: fasting 12+ hours
* Other: Non-fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Park Nicollet Health Services patients due for routine lipid measures Exclusion Criteria: Unwilling or unable to provide consent

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: Diagnostic
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fasting<br> | Other: fasting 12+ hours<br>* fasting 12+ hours<br>|
| Other: Non-fasting<br> | Other: Non-fasting<br>* Non-fasting<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-Cholesterol |  | Fasting 12+ hours vs. Non-fasting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other lipid parameters |  | Fasting 12+ hours vs. non-fasting | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fasting lipid measures, non-fasting lipid measures, clinical decision-making, LDL-Cholesterol
Retrospective Study of Carotid Surgery in Dijon

Study Overview
=================
Brief Summary
-----------------
The results in carotid surgery are an indicator of the functioning of an academic surgical team, making it possible to evaluate and improve practices, as much among surgeons in training as among senior surgeons. The indications have evolved with the development of symptomatic stenosis surgery, and results analysis has allowed us to improve our practices. It would be of great use to have the statistics obtained in previous years to continue improving our practices.

Official Title
-----------------
Retrospective Study of Carotid Surgery in Dijon

Conditions
-----------------
Carotid Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients operated for carotid stenosis at Dijon University Hospital Exclusion Criteria: none

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 |
| --- | --- | --- |
| mortality rate (%) |  | Day 30 | 
| incidence of complications (%) |  | Day 30 |
Crestor RAPID (The Efficacy of RosuvAstatin for Korean Dyslipidemia PatIents With Diabetes)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of rosuvastatin in Korean dyslipidemia patients with diabetes

Official Title
-----------------
RAPID (Evaluating the Efficacy of RosuvAstatin for Korean Dyslipidemia PatIents With Diabetes in Real World Practice)

Conditions
-----------------
Dyslipidemia, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on clinical grounds and fulfil the following criteria Over 18 years of age Diagnosed with DM based on fasting or post-load glucose data and/or clinical assessment by the clinician Exclusion Criteria: Patients already taking other hyperlipidemic agents Patients who do not fulfil the indication criteria for statin therapy Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyslipidemia, rosuvastatin, diabetes, cholesterol, Naturalistic, Observational
Maastricht IBS Cohort

Study Overview
=================
Brief Summary
-----------------
To set up a cohort of at least 400 IBS patients in order to identify different patient subgroups according to phenotypical and genotypical patterns and To set up a biobank for future translational studies on the pathophysiology of IBS, in order to identify genetic factors to unravel the pathogenesis of IBS and to provide novel therapeutic targets.

Detailed Description
-----------------
Aim of the present study is to set up a large cohort of IBS patients in order to identify different disease characteristics as well as aetiological and pathophysiological factors in (sub)groups of patients with this heterogeneous disorder. Various phenotypical and genotypical markers will be evaluated. For this purpose, blood and faecal samples as well as symptom questionnaires will be collected and visceral perception and intestinal permeability will be measured. In order to increase the sensitivity of the barostat procedure, a pilot study will be performed by measuring patients and healthy controls under meal stimulated and fasting conditions. We aim to set up a biobank for studies on the pathophysiology of IBS, in order to identify genetic factors that may help unravel the pathogenesis of IBS and provide novel therapeutic targets. Consent will be asked to collect data from questionnaires, to store serum samples, DNA, stool and, when endoscopy is performed for clinical reasons, also biopsy specimens.

Official Title
-----------------
Maastricht IBS Cohort: Phenotypical and Genotypical Characterization of Patients With Irritable Bowel Syndrome.

Conditions
-----------------
Irritable Bowel Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: IBS-patients Exclusion Criteria: Severe co-morbidity hindering a rectal barostat procedure, according to the gastroenterologist's perception. Abdominal surgery, except for uncomplicated appendectomy, laparoscopic cholecystectomy or hysterectomy. Inability to stop medication that can influence gastrointestinal motility or perception (like loperamide, butylscopolamine, psylliumsead (metamucil), duspatal, metoclopramide, domperidon, erytromycin and serotonin reuptake inhibitors), for at least 3 days before tests.

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

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 |
| --- | --- | --- |
Exercise Training and Plasma Lipoproteins in Man

Study Overview
=================
Brief Summary
-----------------
To determine the effects in moderately obese subjects of weight loss by combined dieting and exercise training on risk factors for coronary artery disease including lipoprotein lipids, apoproteins and blood pressure.

Detailed Description
-----------------
BACKGROUND: Evidence appears to be fairly conclusive that obesity has adverse effects on health and longevity when the relative body weight is 40 percent above desirable weight based on insurance industry tables of weights. The close association between obesity, hypertension, hypercholesterolemia, non-insulin dependent diabetes mellitus, an excess of certain cancers and other medical problems makes it imperative that interventions be directed to change the lifestyles and behaviors of individuals who are overweight. The Stanford Weight Control Project (SWCP) trial examined the effects of weight loss on cardiovascular disease risk factors. The Stanford Weight Control Project (SWCP) randomized 155 overweight, sedentary, non-smoking men, aged 30-59 years, to one of three groups. Fifty-one were assigned to weight loss through dieting, 52 to weight loss through exercise, and 52 to a control, non-intervention group. Follow-up continued through July 1989. DESIGN NARRATIVE: Subjects were randomized to a control group, a hypocaloric National Cholesterol Education Program (NCEP) diet, or to a hypocaloric NCEP diet with exercise. One hundred nineteen of the men and 112 of the women returned for testing after one year.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Hypertension, Myocardial Ischemia, Obesity

Intervention / Treatment
-----------------
* Behavioral: diet, reducing
* Behavioral: exercise
* Behavioral: diet, fat-restricted


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women, ages 25-49. Subjects were overweight with blood pressure less than 160/95 mm Hg and total cholesterol less than 260 mm/dl.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 49 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, reducing|nan|
|Behavioral: exercise|nan|
|Behavioral: diet, fat-restricted|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Iron in Congestive Heart Failure

Study Overview
=================
Brief Summary
-----------------
The hypothesis to be tested is whether treatment with intravenous iron (ferric carboxymaltose) will improve left-ventricular ejection fraction in patients with heart failure and iron deficiency as determined by cardiac magnetic resonance imaging.

Official Title
-----------------
Randomized, Double-blind, Placebo-controlled Trial of Ferric Carboxymaltose Versus Placebo in Patients With Congestive Heart Failure

Conditions
-----------------
Heart Failure, Iron Deficiency, Anemia

Intervention / Treatment
-----------------
* Drug: ferric carboxymaltose
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congestive heart failure At least 18 years of age Iron deficiency Dyspnea class II or III according to New York Heart Association Left-ventricular ejection fraction ≤ 45% Exclusion Criteria: Known sensitivity to any of the products to be administered during dosing Immediate need of transfusion Patients presenting with an active infection Thalassaemia Other forms of microcytic anemia not caused by iron deficiency History of acquired iron overload Need for revascularization, ST-segment elevation myocardial infarction or Non-ST-segment elevation myocardial infarction during the past 3 months (at time of randomization) Women who are pregnant or of childbearing age and not using medically acceptable effective contraception

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Iron<br>ferric carboxymaltose | Drug: ferric carboxymaltose<br> <br> * Other names: Ferinject;|
| Placebo Comparator: Placebo<br>Sodium chloride 0.9% | Drug: Placebo<br> <br> * Other names: Sodium chloride 0.9%;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint of the study is the change from baseline to week 12 in left-ventricular ejection fraction as determined by cardiac magnetic resonance imaging. |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Iron Deficiency, Anemia, Ferric Carboxymaltose
Ultrastructure of Atrial Myocytes in Patients in Sinus Rhythm and With Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The aim of this work is to study the prevalence of T-tubular system in left and right myocytes from patients in sinus rhythm and whether this is altered in paroxysmal and permanent atrial fibrillation. Furthermore, since current information is lacking on the key Ca2+-handling proteins RyR, NCX, and SERCA-2a from patients in Atrial Fibrillation (AF), it will be investigated whether a regulation of these proteins could be an underlying cause of the disease. Mitochondrial function will also studied. The investigators hypothesize that both structure of sarcolemma and localization of key Ca2+-handling proteins are altered in patients with atrial fibrillation compared with patients in sinus rhythm. The investigators hypothesize that mitochondrial function is altered in patients with atrial fibrillation compared with patients in sinus rhythm.

Official Title
-----------------
Ultrastructure of Sarcolemma, Immunofluorescence of Calcium Handling Proteins and Mitochondrial Function in Atrial Myocytes of Patients in Sinus Rhythm and With Atrial Fibrillation

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sinus rhythm, permanent atrial fibrillation or paroxysmal atrial fibrillation selected for open heart surgery informed consent Exclusion Criteria: not given informed consent

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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 |
| --- | --- |
| stable sinus rhythm<br> | |
| permanent atrial fibrillation<br> | |
| paroxysmal atrial fibrillation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| structure of sarcolemma |  | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, atrial cells, myocardial tissue, t-tubules, immunofluorescence
Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine for HPV E6/E7 mRNA in tampon self-tests, and compare with the cytological and histological diagnoses. Study Hypothesis: Expression of HPV E6/E7 mRNA in Tampon self-tests are a suitable alternative to the routine cervical smear.

Official Title
-----------------
Expression of Oncogenic Human Papillomavirus E6/E7 Protein in Tampon Self-Tests

Conditions
-----------------
Normal Uterine Cervical Cytology, Uterine Cervical Dysplasia, Uterine Cervical Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women with cervical dysplasia been referred to conisation. Women invited to cervical screening program and with only normal smear and normal smears in their history. Exclusion Criteria: Women not performing the tampon self-test before conisation. Women not performing the tampon self-test at least 3 month after having a normal PAP-smear taken.

Ages Eligible for Study
-----------------
Minimum Age: 23 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 |
| --- | --- |
| A<br>Women with at least moderate dysplasia in biopsies from cervix uteri | |
| B<br>Women with only normal PAP-smears | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of the HPV test of the material from the tampon self-test |  | Spring 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, self test, PAP smear, tampon test, E6/E7, mRNA
Abu Dhabi Sleep Apnea (ADSA) Study

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnoea (OSA) is a common medical problem which, despite increasing awareness, remains under-diagnosed. There is a close association between OSA and obesity; 60-70% of patients diagnosed with OSA are either obese or overweight [1]. OSA is also very common among patients with type 2 diabetes. Type 2 Diabetes Mellitus (T2DM) has reached epidemic status in the Gulf region. OSA worsens insulin resistance and leads to weight gain through sleep disturbance [2]. Several mechanisms have been proposed for the associations of OSA with diabetes and obesity [3]. At present there is little available information regarding the prevalence of OSA in the UAE, the relationship with T2DM and obesity, and the impact of OSA on health outcomes in the Emirati population. This research will explore these relationships and inform public health decisions regarding diagnostic pathways, service provision and treatment protocols.

Official Title
-----------------
Abu Dhabi Sleep Apnea (ADSA) Study

Conditions
-----------------
Sleep Apnoea

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants aged between 18-64 years old. Both Gender male and female. Exclusion Criteria: Paediatrics below the age of 18. Any participant who is unable to take part

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal glucose tolerance<br>Patients with normal fasting glucose. Blood glucose less than 5.6mmol/L | Other: Questionnaire<br> <br> |
| Impaired fasting glycaemia<br>Patients with blood glucose between 5.6mmol/L - 7mmol/L | Other: Questionnaire<br> <br> |
| Type 2 diabetes<br>Patients with blood glucose higher than 7mmol/L and negative IA2 and GAD antibodies. | Other: Questionnaire<br> <br> |
| Type 1 diabetes<br>Patients on insulin and with positive IA2 and/or GAD antibodies. | Other: Questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective (Establishing the prevalence of OSA in the study population.) | Establishing the prevalence of OSA in the study population. | 3 months |