linjc16/ctgov huggingface dataset:
A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.

Official Title
-----------------
A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5847 Following Oral Administration to Healthy Male Subjects and Female Subjects of Non-childbearing Potential

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

Intervention / Treatment
-----------------
* Drug: AZD5847
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18-30 Exclusion Criteria: Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes History of presence of gastrointestinal, hepatic or renal disease

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AZD5847<br>* oral suspension, 15 days<br>|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* oral suspension, 15 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry) |  | collected prior to treatment, during treatment, and follow-up for a total of 25 to 52 days(includes upto 28 days for screening) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| characterize the Pharmacokinetics of AZD9742 in blood and urine |  | PK-sampling during 14 pre-defined study days for PK profiling | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety
Real-life Efficacy of Insulia® Tool in Patients Living With Type 2 Diabetes Treated With Basal Insulin Therapy as Part of a National Telemedicine Program (ETAPES)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the INSULIA digital tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) in a single-center study. The assumption is that a better metabolic control with this tool.

Detailed Description
-----------------
Basal insulin titration in people with type 2 diabetes is of major importance to obtain the optimal dose to regulate fasting blood glucose without hypoglycemia. Significant inertia in treatment optimization has been observed among both general practitioners and diabetologists. The INSULIA tool (automation of basal insulin dose calculation in type 2 diabetes) within the framework of a French national telemedicine experimentation program (ETAPES) has been supported by the health authorities. The data collected are of a single-center cohort of adult patients with type 2 diabetes who used this tool between 2018 and 2021. It is supposed that a better metabolic control with this tool and aimed to understand factors associated with better results.

Official Title
-----------------
Effectiveness in Real Life of the Insulia® Digital Tool in Patients With Type 2 Diabetes Treated With Basal Insulin Therapy as Part of a National Telemedicine Program (ETAPES)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years old. Patients with type 2 diabetes. Initiation or adjustment of basal insulin. Prescription of Insulia® for more than 6 months (between august 2018 and june 2021) Informed patient not opposed to the research Exclusion Criteria: Patient opposed to the research

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| HbA1c | Evolution of HbA1c between baseline and 6 months after Insulia initiation | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin | Evolution of daily dose of basal insulin between baseline and 6 months after Insulia initiation | at 6 months | 
| HbA1c objective | Percentage of patients reaching the HbA1c target after 6 months | at 6 months | 
| Mean fasting glucose | Percentage of patients reaching a mean fasting glucose < 150 mg/dL for 7 days after 6 months | at 6 months |
Diagnostic and Imaging Indicators of Immunocardiomyopathic Patients

Study Overview
=================
Brief Summary
-----------------
Cardiac involvements in autoimmune diseases (AD) is common but underestimated and an early detection remains a clinical challenge for lacking of efficient imaging methods. The objective of the study was to investigate LV myocardial abnormalities in AD patients by multimodal cardiac imaging, including speckle-tracking echocardiology (STE), cardiac magnetic resonance imaging (CMRI) and positron emission tomography (PET).

Official Title
-----------------
Multimodal Imaging Evaluation of Myocardial Involvement in Immunocardiomyopathic Patients

Conditions
-----------------
Autoimmune Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is diagnosed with autoimmune diseases, including systemic lupus erythematosus (SLE), vasculitis, dermatomyositis, sjogren's syndrome, scleroderma, rheumatoid arthritis and IgG4 associated disease. Patient is capable of complying with study procedures Exclusion Criteria: Patient is pregnant or nursing Patient is complicated with congenital heart disease Patient had cardiac surgery before Patient is complicated with serious infections Patient is complicated with organ failure Patient is complicated with tumors Patient is diagnosed indefinitely Patient has been involved in other clinical trial

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in deformational parameters in echocardiography during follow-up period | global longitudinal strain (%), circumferential strain (%) and radial strain (%) measured by STE in autoimmune diseases | 6 months - 1 year - 2 years | 
| Progression of myocardial fibrosis and edema during follow-up period | Late Gadolinium Enhanced, T1 mapping and T2 mapping tested by CMRI | 1 year - 2 years | 
| Change in myocardial perfusion during follow-up period | SUVmax examined by PET | 1 year - 2 years |
A Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 study to evaluate the safety and determine maximum tolerated dose, safety & tolerability of noscapine HCl in patients with advanced multiple myeloma

Official Title
-----------------
A Phase I Open Label Study of Noscapine HCl (CB3304 ) in Patients With Relapsed or Refractory Multiple Myeloma

Conditions
-----------------
Refractory Multiple Myeloma

Intervention / Treatment
-----------------
* Drug: Noscapine HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced Multiple Myeloma. Progression after ≥ 2 lines of prior therapy, including at least one steroid, one immunomodulatory agent (iMID), one alkylator, and bortezomib (VELCADE®). ECOG performance status of either 0 or 1. Exclusion Criteria: Prior chemotherapy with antimicrotubule agents Metastasis involving the brain or spinal cord Clinically significant lung or heart disease Abnormal electrocardiogram Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria. Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

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: One<br>Noscapine HCl | Drug: Noscapine HCl<br>* Escalating doses given twice per day<br>* Other names: Noscapine HCl (CB3304);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose |  | During the first 28 day treatment cycle | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability in the study population |  | End of the study treatment | 
| To evaluate the pharmacokinetics of study drug |  | End of the study treatment | 
| To assess anti-tumor effects as classified by International Uniform Response Criteria for Multiple Myeloma |  | End of the study treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory Multiple Myeloma, CB3304, Noscapine HCl, Multiple Myeloma
PRESERVE-Zenith® Iliac Branch System Clinical Study

Study Overview
=================
Brief Summary
-----------------
The PRESERVE-Zenith® Iliac Branch System Clinical Study is a clinical trial to study the safety and effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation in combination with the Zenith® Connection Endovascular Stent/ConnectSX™ covered stent in the treatment of aorto-iliac and iliac aneurysms.

Official Title
-----------------
PRESERVE-Zenith® Iliac Branch System Clinical Study

Conditions
-----------------
Aorto-iliac Aneurysms, Iliac Aneurysms

Intervention / Treatment
-----------------
* Device: Endovascular repair for aortoiliac or iliac aneurysms.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: An aortoiliac or iliac aneurysm of appropriate size Unsuitable distal sealing site for a traditional Zenith® iliac leg graft within the common iliac artery Exclusion Criteria: Less than 18 years of age Inability or refusal to give informed consent Disease considerations that would compromise patient safety or study outcomes Unsuitable arterial anatomy

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: Device Implant<br> | Device: Endovascular repair for aortoiliac or iliac aneurysms.<br>* Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.<br>* Other names: Endovascular repair for aortoiliac or iliac aneurysm.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients That Are Free From Patency-related Intervention | Patency-related intervention is defined as: Secondary intervention to treat a > 60% stenosis of the internal iliac artery (as identified through CT, angiography, or duplex ultrasound and confirmed by core laboratory) associated with clinical symptoms. Of note, this not only includes patients with internal iliac artery stenosis following successful placement of the Zenith® Branch Endovascular Graft-Iliac Bifurcation and ConnectSX™, but also any cases of technical failure resulting in occlusion of the internal iliac artery during the initial implant procedure that require secondary intervention for associated clinical symptoms. | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Zenith aortoiliac aneurysm, iliac aneurysm, branch, connections, endovascular graft, graft-iliac bifurcation, Aneurysm, Vascular Diseases, Cardiovascular Diseases
Near-infrared Software Performance Study

Study Overview
=================
Brief Summary
-----------------
This study will look at the performance capabilities of software for VeinViewer.

Detailed Description
-----------------
This study will look at the performance capabilities of future software for VeinViewer.

Official Title
-----------------
Near-Infrared Software Performance Study

Conditions
-----------------
Vascular Access Complication

Intervention / Treatment
-----------------
* Device: VeinViewer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 18 years of age or older Must be considered to be in overall good health by investigator Must pass all prescreening questions Must be able to read and understand English Exclusion Criteria: Presence of tattoos, scarring, and/or extensive hair in the areas to be assessed for cannulation. IV cannulation in the arms or hands in the previous 4 weeks.

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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VeinViewer<br>Vascular imaging technology will be used to visualize peripheral vasculature. | Device: VeinViewer<br>* Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants for Whom Successful Visualization of Vasculature Was Achieved |  | One day |
Database Creation and Evaluation of Motor Function of Finger Tapping Measured by Magnetic Sensor System in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a database of quantified finger movements. Using the evaluation system with magnetic sensors, the movements of finger tapping are measured and assessed by various indices, such as finger tapping interval, maximum amplitude of finger taps, and so on. In this study, the investigators will accumulate the data from healthy subjects for the purpose of applying this evaluation system to diagnosis support of nervous diseases in the future.

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

Intervention / Treatment
-----------------
* Device: magnetic sensor system to measure the movements of finger tapping


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Informed consent signed Exclusion Criteria: Renal or hepatic dysfunction Severe heart disease Under medications for diabetes or hypertension Medical history of nervous disease, mental disease, muscular disease, cervical spondylosis, and/or apoplexy Feeling difficulty in daily movements Taking medicines which possibly affect the motor function of finger tapping. Implantation of pacemaker or DBS

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: healthy subjects<br> | Device: magnetic sensor system to measure the movements of finger tapping<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| movements of finger tapping |  | 1 day for measurement |
Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are diagnosed with ADHD Patients must be able to swallow capsules Patients must be of normal intelligence Exclusion Criteria: Patients who weigh less than 15 kg or more than 75 kg Patients with organic brain disease (for example, dementia or traumatic brain injury residual)

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Atomoxetine|nan|
|Drug: Placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of total score on ADHD RS-IV-JParent Version: Investigation-Administered and Scored |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between atomoxetine doses and both efficacy and safety variables |  |  | 
| Plasma concentration of atomoxetine and its metabolites |  |  | 
| Changes on ADHD RS-IV-J-School Version score |  |  |
Management of Drug Hypersensitivity in Children

Study Overview
=================
Brief Summary
-----------------
The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing HLA typing and a gene expression profile both in the acute phase of the reaction and 2 months later.

Official Title
-----------------
Improved Management Based on Pathophysiology of Drug Hypersensitivity in Childhood

Conditions
-----------------
Drug Hypersensitivity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake. Exclusion Criteria: Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy).

Ages Eligible for Study
-----------------
Maximum Age: 16 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 |
| --- | --- | --- |
| Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the diagnostic values of the different allergy tests available | Sensitivity, specificity, negative and positive predictive value | 3 years | 
| Determination of the role of viruses, HLA typing and gene expression profile both in the acute phase of the reaction and 2 months later |  | 3 years |