linjc16/ctgov huggingface dataset:
A Comparison Between Pupillometry, Heart Rate Variability and Metaiodobenzylguanidine Scintigraphy for the Diagnosis of Early Diabetic Autonomic Neuropathy in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study will examine if one of the following methods: pupillometry, spectral analysis of heart rate variability and metaiodobenzylguanidine scintigraphy, is more capable to detect early diabetic autonomic neuropathy in patients with type 1 diabetes mellitus

Conditions
-----------------
Autonomic Neuropathy

Intervention / Treatment
-----------------
* Radiation: metaiodobenzylguanidine scintigraphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes mellitus Exclusion Criteria: Type 2 diabetes mellitus Severe cardiac autonomic neuropathy Medications other than insulin Ocular disease other than refractive eye disorders History of neurologic disease History of cardiovascular disease Thyroid disease Vitamin B insufficiency Other possible cause for autonomic failure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 49 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 |
| --- | --- |
| Patients with type 1 diabetes mellitus<br>Metaiodobenzylguanidine scintigraphy, Autonomic function tests, Pupillometry, Holter monitoring | Radiation: metaiodobenzylguanidine scintigraphy<br> <br> |
| Healthy controls<br>Autonomic function tests, Pupillometry, Holter monitoring | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with abnormal results |  | 1 day (at time of examination) |
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

Study Overview
=================
Brief Summary
-----------------
A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.

Official Title
-----------------
Open-label, Randomized, Crossover Study to Compare the Bioavailability of One Coated Tablet of Opxion® (Levonorgestrel 1.5 mg From Bayer de Mexico) vs. Two Tablets of Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers

Conditions
-----------------
Contraception, Contraception, Postcoital

Intervention / Treatment
-----------------
* Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
* Drug: Levonorgestrel (Postday)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis. Exclusion Criteria: History of illnesses or any organic abnormalities that could affect the results of the study. History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs. Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)<br>* Single dose of 1.5 mg coated tablet<br>|
| Active Comparator: Arm 2<br> | Drug: Levonorgestrel (Postday)<br>* Single dose of two 0.75 mg tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least square estimator of average maximum plasmatic concentration (log transformed) |  | After 2 months | 
| Least square estimator of area under the pharmacokinetic curve (log transformed) |  | After 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which maximum concentration is reached |  | After 2 months | 
| Area under the pharmacokinetic curve from time=0 to time of last blood sample |  | After 2 months | 
| Clearance constant of plasmatic concentration of study drug |  | After 2 months | 
| Half life of plasmatic concentration of study drug |  | After 2 months | 
| Adverse events collection |  | Up to 8 weeks |
Post-marketing Surveillance of Ventilat® in Long-term Therapy in Chronic Obstructive Pulmonary Disease

Study Overview
=================
Brief Summary
-----------------
Study to obtain further information on the tolerability and efficacy of Ventilat® metered dose inhaler in long-term treatment of Chronic Obstructive Pulmonary Disease under conditions of daily practice

Official Title
-----------------
Post-marketing Surveillance (as Per § 67(6) AMG [German Drug Law]) of Ventilat® in Long-term Therapy in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Ventilat® - metered dose inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both genders older than 40 years, who suffer from Chronic Obstructive Pulmonary Disease Only patients who have not been treated with Ventilat® within the last year are to be considered for inclusion Exclusion Criteria: Contraindications listed in the Instructions for Use/Summary of Product Characteristics for Ventilat® metered dose inhaler

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Chronic obstructive pulmonary disease patients<br> | Drug: Ventilat® - metered dose inhaler<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the clinical picture |  | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on a 4-point scale |  | after 12 months | 
| Assessment of efficacy by patient on a 4-point scale |  | after 12 months | 
| Number of patients with adverse drug reactions |  | up to 12 months | 
| Assessment of tolerability by investigator on a 4-point scale |  | after 12 months | 
| Assessment of tolerability by patient on a 4-point scale |  | after 12 months |
Bipolar Versus Unipolar Hemiarthroplasty for Patients With a Hip Fracture

Study Overview
=================
Brief Summary
-----------------
Insertion of a hemiarthroplasty is a well established treatment for a dislocated medial hip fracture in elderly patients. The purpose of this study is to compare unipolar and bipolar hemiarthroplasty as a treatment for patients aged 70 years or above with a dislocated medial femoral neck fracture. The study is prospective and randomised, and will be based on questionnaires, clinical examinations, registration of complications and radiographic evaluation at follow up at 3 months, 1 and 3 years postoperatively.

Official Title
-----------------
Bipolar vs. Unipolar Hemiarthroplasty for Patients Aged 70 Years or Above, With a Dislocated Medial Femoral Neck Fracture

Conditions
-----------------
Femoral Neck Fractures

Intervention / Treatment
-----------------
* Procedure: Unipolar Hemiarthroplasty of the hip joint
* Procedure: bipolar hemiarthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ages 70 years or above Dislocated medial femoral neck fracture (garden type 3-4) Residence in the county of Northern Jutland, Denmark Exclusion Criteria: Pathologic fracture Failed formerly internally fixed fracture of the affected hip Degenerative joint disease of the affected hip or rheumatoid arthritis Dementia Terminal neoplastic disease No informed consent

Ages Eligible for Study
-----------------
Minimum Age: 70 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Patients treated with a cemented modular hemiarthroplasty, with a unipolar head | Procedure: Unipolar Hemiarthroplasty of the hip joint<br>* Unipolar Hemiarthroplasty of the hip joint<br>|
| Active Comparator: 2<br>Patients treated with a modular cemented hemiarthroplasty with a bipolar head. | Procedure: bipolar hemiarthroplasty<br>* bipolar hemiarthroplasty<br>|

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
-----------------
Fracture of Femoral Neck
Lifestyle Modification for Obesity-Related Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Dietary carbohydrate is the major determinant of postprandial glucose levels, and preliminary evidence suggests that low carbohydrate diets improve glycemic control when accompanied by weight loss. To determine if glycemic control can be improved by varying dietary carbohydrate during weight loss, we compared two weight loss diets with different carbohydrate levels for the treatment of obesity-related type 2 diabetes over 24 weeks in the outpatient setting.

Official Title
-----------------
A Randomized, Controlled Trial of a Low-Carbohydrate, Ketogenic Diet Versus a Low-Glycemic Index Diet for Obesity-Related Type 2 Diabetes

Conditions
-----------------
Obesity, Type 2 Diabetes Mellitus, Overweight

Intervention / Treatment
-----------------
* Behavioral: Low carbohydrate, ketogenic diet
* Behavioral: Low glycemic index, reduced calorie diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetes mellitus for at least one year hgba1c > 6.0 BMI from 27-50 kg/m2 Exclusion Criteria: Unstable medical condition Serious medical condition AST or ALT > 100 Serum creatinine > 1.5

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- |
|Behavioral: Low carbohydrate, ketogenic diet|nan|
|Behavioral: Low glycemic index, reduced calorie diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  |  | 
| Serum lipoproteins |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
weight loss, lifestyle modification, hyperglycemia, hypoglycemic agents
Consent for Obtaining Additional Bone Marrow Specimens at Time of Diagnostic Bone Marrow Procedure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect bone marrow samples for experimental studies.

Official Title
-----------------
Consent for Obtaining Additional Bone Marrow Specimens at the Time of a Diagnostic Bone Marrow Procedure

Conditions
-----------------
Brain Cancer, Cancer

Intervention / Treatment
-----------------
* Procedure: Bone marrow specimen banking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are having a bone marrow procedure done as part of their standard oncology work-up will be eligible to be consent on this study. Exclusion Criteria: None.

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Bone marrow specimen banking|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer Research in Future | No new information will be gained form this study. However, the specimens obtained me be used for other studies to progress cancer research in the future. | 1 time |
Topiramate for Binge Eating Disorder Among Adolescents

Study Overview
=================
Brief Summary
-----------------
This is a study of topiramate to see whether topiramate decreases binge eating behavior among adolescents and young adults. The investigators did also checked whether topiramate affected cognitive function or not.

Official Title
-----------------
Open-Label Study of Topiramate for Binge Eating Disorder and Bulimia Nervosa Among Adolescents

Conditions
-----------------
Eating Disorders, Bulimia Nervosa

Intervention / Treatment
-----------------
* Drug: topiramate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects (aged 12 to 23) were included if they Met the criteria of bulimia nervosa or eating disorder NOS with binge-eating behavior in DSM-IV-TR, Had weight > or = 100th % of expected body weight for their age, Engaged in binge eating at least once a week for 9 out of the 12 weeks prior to the study entry, and Were judged by a clinician to be stable enough to be treated for their psychiatric condition as an outpatient (i.e, no acute suicidality, hallucination, unstable vital signs or persistently abnormal laboratory results due to eating disorder). Exclusion Criteria: Subjects whose psychotropic medications had been changed within 4 weeks prior to the entry or who had started psychotherapy within 3 months prior to the entry were excluded. Subjects were also excluded if they were taking carbonic anhydrase inhibitors, carbamazepine, phenytoin, phenobarbital, valproic acid, evening primrose oil or oral contraceptives. Other exclusion criteria were: history of substance use disorders within the 6 months prior to study, IQ < or = 70, medical conditions causing weight loss (i.e., hyperthyroidism, diabetes mellitus type 1, malignancy) or that contra indicate treatment with topiramate (nephrolithiasis or glaucoma), history of non response or poor tolerance to topiramate in the past and history of non-adherence to medication treatment.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 23 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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: topiramate|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
-----------------
binge eating behavior, adolescents
COVID-19 in PID Survey

Study Overview
=================
Brief Summary
-----------------
With the emergence of SARS-CoV-2 and the COVID-19 pandemic, there is an urgent need to understand the impact of infection on immunodeficient individuals. Whilst co-morbidities (such as diabetes, cancer, arterial hypertension, heart disease...) have been documented in people infected with SARS-CoV-2, there is currently no information on the consequences and outcomes for individuals with primary immunodeficiencies (PID). Following the 1st phase of the survey (launched by Isabelle Meyts (ESID), Nizar Mahlaoui (CEREDIH & IPOPI) and Kate Sullivan with Stuart Tangye (IUIS), that gave an idea of the number of affected PID patients and the impact of SARS-CoV-2 and directly focusing on obtaining this top level of information), we are launching the 2nd phase: COPID19. COPID19 survey is a secured online GDPR compliant platform based in Paris (Imagine Institute). It has been approved by the Paris-Necker-Enfants malades IRB and Ethics Committee. However, this retrospective survey is designed for global distribution. Data can be entered by a health care professional (mostly clinicians) through a personal login and password. Each documenting person will have access to his/her own patients' data. COPID19 require a greater level of information than the 1st phase. The eCRF will be open to evolutions depending on progresses in our knowledge of this pandemic.

Official Title
-----------------
Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey

Conditions
-----------------
Primary Immune Deficiency, COVID

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with a Primary Immune Deficiency COVID-19 (proven or probable) Exclusion Criteria: Secondary Immune Deficiency Other Coronovirus infection

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients with PID affected by COVID-19 |  | Baseline | 
| Rate of admission to ICU of patients with PID affected by COVID-19 |  | Baseline | 
| Rate of oxygen therapy of patients with PID affected by COVID-19 |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequelae of patients with PID affected by COVID-19 |  | Baseline |
Naps and Pulses of Bright Light in Shift Workers

Study Overview
=================
Brief Summary
-----------------
Design: paired trials without and with naps and bright light. Setting: Real driving on a private road circuit. Environmental controlled car. Participants: 9 shift workers on tree shifts (morning-afternoon-night) Measurements: Sleepiness at the wheel was measured by ambulatory polysomnography and assessed using 30 seconds segments of recordings when the percentage of theta EEG was at least 50% (15 seconds) of the period recorded. Subjects were also called to rate their sleepiness on the 7-point Stanford Sleepiness Scale (SSS). Intervention: Participants drove the same car on two similar 24 hours periods of work, with three pilots in each shift (morning, afternoon, night), separated by three weeks. During the baseline period, the subjects were told to manage their rest as they usually do in the real life. During the second experimental period, they had to rest lied in a dark room during two naps of 20 minutes and then exposed to bright light pulse (5000 lux) during 10 minutes.

Detailed Description
-----------------
Results are submitted to publication

Official Title
-----------------
The Effects of a Combination of Napping and Bright Light Pulses on Shift Workers Sleepiness at the Wheel A Pilot Study

Conditions
-----------------
Sleep

Intervention / Treatment
-----------------
* Behavioral: naps and pulses of bright light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A professional experience of at least one year Exclusion Criteria: With an history of chronic disease,treatments (or toxic) Subjects with a suspicion of sleep disorders Snorers

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: naps and pulses of bright light|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EEG sleepiness at the wheel |  | two periods of 8 hours driving | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subjective sleepiness at the stanford sleepinesss scale |  | two periods of 8 hours driving | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
accidents, shift work, sleepiness, naps, bright light pulses, sleep