linjc16/ctgov huggingface dataset:
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this Non-interventional study is to investigate the long-term safety and effectiveness of Ryzodeg® (insulin degludec/insulin aspart) in Japanese patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions.

Official Title
-----------------
Post-marketing Surveillance (Special Use-results Surveillance) on Long-term Use With Ryzodeg®.

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

Intervention / Treatment
-----------------
* Drug: insulin degludec/insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) The decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study Patients with diabetes mellitus requiring insulin therapy for whom the physician has decided to start treatment with Ryzodeg® Male or female, no age limitation Exclusion Criteria: Patients who are or have previously been treated with Ryzodeg® Previous participation in this study. Participation is defined as having given informed consent in this study Patients with a history of hypersensitivity to study product components Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
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 degludec/insulin aspart<br> | Drug: insulin degludec/insulin aspart<br>* Enrolled patients will be treated with Ryzodeg® under routine clinical practice.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of AEs (adverse event) |  | Year 0-1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SADRs (Serious Adverse Drug Reactions) |  | Year 0-1 | 
| Severe hypoglycaemic episodes |  | Year 0-1 | 
| Incidence of Serious allergic reactions (systemic or localized, including injection site reactions) |  | Year 0-1 | 
| Change in Glycosylated haemoglobin A1c (HbA1c) |  | Week 0, week 52 |
Human Insulin NPH and Insulin Aspart in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in South America. This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.

Official Title
-----------------
Comparative Evaluation of Human NPH Insulin + Insulin Aspart and Human NPH Insulin + Human Soluble Insulin in Type 1 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: insulin aspart
* Drug: soluble human insulin
* Drug: insulin NPH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 1 diabetes for at least 12 months Treatment with insulin NPH Body Mass Index (BMI) below 30 kg/m2 Exclusion Criteria: Total daily insulin dose greater than 1.40 IU/kg Treatment with oral antidiabetic drugs (OADs)

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: insulin aspart|nan|
|Drug: soluble human insulin|nan|
|Drug: insulin NPH|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prandial blood glucose lowering profile |  | between 1st and 2nd post prandial hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycaemic events |  |  | 
| Adverse events |  |  | 
| Serious adverse events |  |  |
The Archimedes Biodegradable Biliary and Pancreatic Stents

Study Overview
=================
Brief Summary
-----------------
This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic plastic stent positioning during ERCP. On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria. The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.

Official Title
-----------------
A Prospective, Single Arm Study to Evaluate the Feasibility of the Archimedes Biodegradable Biliary and Pancreatic Stents Placement

Conditions
-----------------
Pancreatic Diseases

Intervention / Treatment
-----------------
* Device: Biodegradable biliary and pancreatic stents placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an indication to position one ore more biliary plastic stents during ERCP Patients with an indication to position a pancreatic plastic stent during ERCP Exclusion Criteria: Age < 18 y Life expectancy < 1 m, Inability to pass a guidewire through stricture Contra-indication for endoscopy or interventional radiology Presence of partial gastric resection Unsigned informing consent form, ICF Pregnancy Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Biodegradable biliary and pancreatic stents placement|Biodegradable biliary and pancreatic stents placement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodegradation time |  | 24 Months |
Single/Multiple Dose Bioavailability Trial

Study Overview
=================
Brief Summary
-----------------
To determine the pharmacokinetic profile of an extended release tablet of naproxen sodium 660 mg relative to the established commercial Aleve 220 mg tablet following single dose administration and at steady-state following multiple dose administration for 4 days.

Official Title
-----------------
An Open Label, Randomized, Two-Way Crossover Trial to Determine the Pharmacokinetic Profile of an Extended Release Naproxen Sodium Tablet Relative to Aleve Tablets Following Single and Multiple Dose Administration in Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: Naproxen Sodium 660mg
* Drug: Commercial Aleve 220 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, ambulatory, male and female volunteers between 18 - 55 years of age with BMI of approximately 18 to 30 kg/m2, and total body weight >50 kg (110Ibs) Exclusion Criteria: History of hypersensitive to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products History of gastrointestinal bleeding or perforation related to previous Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy Active, or history of current peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding) Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Naproxen Sodium 660mg<br>* Extended release Naproxen Sodium (660mg) administered once a day<br>|
| Active Comparator: Arm 2<br> | Drug: Commercial Aleve 220 mg<br>* Immediate release commercial Aleve (220 mg) administered in a 2 (440 mg) plus one (220 mg) dosing schedule, 660 mg total<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters |  | Over 48 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the safety and tolerability of the investigational product |  | Over 48 Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Naproxen Sodium, Bioavailability
Brain Development Research Program

Study Overview
=================
Brief Summary
-----------------
Dr. Elliott Sherr and his collaborators at University of California, San Francisco (UCSF) are studying the genetic causes of disorders of cognition and epilepsy, in particular disorders of brain development that affect the corpus callosum, such as Aicardi syndrome, as well as two additional brain malformations, polymicrogyria and Dandy-Walker malformation. The goal of the investigators' research is to use a better understanding of the underlying genetic causes as a foundation to develop better treatments for these groups of patients.

Detailed Description
-----------------
We are studying both the genetics and clinical features of these disorders. We hope to understand the problems faced by individuals with these disorders as well as their causes. In the future, we hope to develop therapies that are geared specifically for individuals based on the underlying biology. To participate in the study, you will be asked to provide a copy of the magnetic resonance imaging (MRI) documenting Agenesis Corpus Callosum (ACC), Polymicrogyria (PMG), or Dandy-Walker malformation (DWM), clinical information, and saliva or blood samples from the affected individual and from the parents. Please see contact information and our webpage below.

Official Title
-----------------
Disorders of Cerebral Development: A Phenotypic and Genetic Analysis

Conditions
-----------------
Brain Disorders, Aicardi Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of agenesis or dysgenesis of the corpus callosum, polymicrogyria, or Dandy-Walker malformation Should be confirmed by an MRI (Magnetic Resonance Imaging) of the brain Exclusion Criteria: Fully formed but hypoplastic corpus callosum
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
-----------------
Agenesis Corpus Callosum, Polymicrogyria, Dandy-Walker, Brain Malformation, Autism, Epilepsy, Mental Retardation, MRI, Agenesis of the Corpus Callosum (complete or partial), Confirmed by a brain MRI., Aicardi Syndrome.
Risk Factors for Inadequate Bowel Preparation in Patients With Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
Chronic constipation is one of the risk factors of inadequate bowel preparation, which could influence the effect of colonoscopy. The risk factors associated with inadequate bowel preparation in constipated patients remains unclear. Here the investigators investigated the high risk factors which might have influence on bowel preparation quality in a prospective cohort of patients with functional constipation.

Conditions
-----------------
Constipation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-90 Patients undergoing colonoscopy; Patients meeting the criteria of chronic constipation of Rome Ⅳ; Exclusion Criteria: history of colorectal surgery; known of suspected colonic stricture or obstructing tumour; ulcerative colitis; Crohn's disease; irritable bowel syndrome; toxic colitis or megacolon; known or suspected bowel obstruction or perforation; pregnancy or lactation; unable to give informed consent; haemodynamically unstable.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| chronic constipation<br>patients with chronic constipation based on Rome Ⅳ | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adequate rate of bowel preparation ≥6 with each segment ≥2 | The adequacy of bowel preparation is defined as Boston Bowel Preparation Scale (BBPS), a 4-point scoring system applied to each of 3 broad regions of the colon: the right side, the transverse section, and the left side. They were summed to give the total BBPS score, which ranged from 0 to 9. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| polyp detection rate |  | 6 months | 
| insertion time |  | 6 months | 
| withdrawal time |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bowel preparation, chronic constipation, risk factor
Immune Regulation in Multiple Sclerosis: The Effect of Glatiramer Acetate on MicroRNA Expression in Antigen-Presenting Cells

Study Overview
=================
Brief Summary
-----------------
MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis.

Detailed Description
-----------------
MicroRNAs regulate gene expression. The abnormal expression of microRNAs has been reported in many human diseases. The purpose of this pilot study is to determine if microRNA expression is changed in untreated and glatiramer acetate-treated patients with multiple sclerosis. The expression of microRNA will be analysed in cell subsets separated from peripheral blood mononuclear cells.

Official Title
-----------------
Immune Regulation in Multiple Sclerosis: The Effect of Glatiramer Acetate on MicroRNA Expression in Antigen-Presenting Cells

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-60 year-old healthy subjects or patients with RRMS/CIS Exclusion Criteria: Any treatment with steroids in the last 30 days prior to the blood draw or any immunosuppressive or Disease-modifying treatment (DMT) other than Glatiramer Acetate in the last 90 days Presence of other disorders that may be associated with immune-deficient or autoimmune process (e.g., HIV, lymphoma, lupus) or demyelinating disease other than MS (e.g., Lyme, B12 deficiency) Pregnancy Intermittent or unilateral constant assistance (cane, crutch, brace) required to walk about 100 meters with or without resting (Expanded Disability Status Scale (EDSS) score greater than 5.5)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy subjects<br>Self-explanatory | |
| Untreated patients<br>Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who are not on any disease-modifying treatment approved for MS | |
| Treated patients<br>Patients diagnosed with relapsing-remitting multiple sclerosis (RRMS) or clinically isolated syndrome (CIS) who were prescribed Glatiramer acetate prior to enrollment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative MicroRNA expression in B cells | Expression of multiple microRNA is being tested in B cells in three groups of subjects at one time point | 1 day |
A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate the screening potential of NT-proBNP for the identification of patients scheduled for vascular surgery who would benefit from additional pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured pre-operatively. For low-intermediate risk patients only those with abnormal values will receive further cardiac testing; all high risk patients will be referred for additional testing.

Official Title
-----------------
A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: Elecsys®proBNP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, &#8805;18 years of age Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery 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?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Elecsys®proBNP<br> <br> |
| Experimental: B<br> | Device: Elecsys®proBNP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of 30-day and 1-year postoperative cardiac events |  | 30-day and 1-year postoperation |
Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.

Official Title
-----------------
Efficacy and Safety of Symbicort ®Turbuhaler® 160/4.5 µg/Inhalation, Two Inhalations Twice Daily Plus As-needed Compared With Seretide™ Diskus™ 50/500 µg/Inhalation, One Inhalation Twice Daily Plus Terbutaline Turbuhaler 0.4 mg/Inhalation As-needed - a 6-month, Randomised, Double-blind, Parallel-group, Active Controlled, Multinational Phase IIIB Study in Adult and Adolescent Patients With Persistent Asthma (AHEAD).

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Budesonide/formoterol Turbuhaler
* Drug: Salmeterol/fluticasone Diskus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with asthma since at least 6 months prior to first visit Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit At least one asthma exacerbation more than one but less than twelve months prior to first visit Exclusion Criteria: Respiratory infection affecting asthma within 30 days before first visit Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit Any significant disease or disorder that may jeopardize the safety of the patient Additional inclusion and exclusion criteria will be evaluated by the Investigator.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Budesonide/formoterol Turbuhaler|nan|
|Drug: Salmeterol/fluticasone Diskus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first severe asthma exacerbation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of severe asthma exacerbations |  |  | 
| Mild asthma exacerbations |  |  | 
| FEV1 |  |  | 
| Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries |  |  | 
| Healthcare utilization |  |  | 
| Safety (adverse events) |  |  | 
| - all variables assessed over the 6 months treatment period |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma