linjc16/ctgov huggingface dataset:
A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses

Study Overview
=================
Brief Summary
-----------------
The primary objective for this study is to assess the safety and tolerability of AZD8329 when given as a single dose in increasing dose strength, and also to identify the highest tolerated dose for future studies.

Official Title
-----------------
A Randomised, Single-blind, Placebo-controlled, Two-centre Phase I Study in Healthy Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of AZD8329 After Single Ascending Oral Doses

Conditions
-----------------
Healthy Men

Intervention / Treatment
-----------------
* Drug: AZD8329
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent prior to any study specific procedures Have a body mass index between 19 and 30 kg/m2 and weigh at least 50 kg Exclusion Criteria: Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject´s ability to participate Any clinically significant abnormalities in clinical chemistry, haematology or urinalysis results as judged by the investigator Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD8329<br>AZD8329 oral solution | Drug: AZD8329<br>* Oral solution, single ascending doses<br>|
| Placebo Comparator: Placebo<br>Placebo for AZD8329 oral solution | Drug: Placebo<br>* Oral solution, placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measurements (ECG's, Pulse, Blood Pressure, Safety Laboratory and Adverse Events) |  | Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK samples for AZD8329 |  | Intense PK-sampling during the 24 hours following administration of investigational product and additional samples up to 72 hours after dose. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
First time in man, Safety study, AZD8329
Specimen Collection From Pregnant Women at Increased Risk for Fetal Aneuploidy

Study Overview
=================
Brief Summary
-----------------
The specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

Detailed Description
-----------------
To collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.

Official Title
-----------------
Collection of Whole Blood Specimens From Pregnant Women at Increased Risk of Fetal Chromosomal Abnormality for Use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted From Maternal Plasma

Conditions
-----------------
Down Syndrome, Fetal Aneuploidy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant between 10 and 22 weeks gestation 18 years of age or older provides signed and dated informed consent subject is at increased risk for fetal aneuploidy subject is willing to undergo a CVS and/or amniocentesis procedure for the purpose of genetic analysis subject agrees to provide the genetic results of the invasive procedure Exclusion Criteria: Fetal demise at time of specimen sampling Previous sample donation under this protocol

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

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

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
-----------------
Down syndrome, fetal aneuploidy, trisomy, noninvasive screening test
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

Study Overview
=================
Brief Summary
-----------------
This is an acute, prospective, multi-center, non-randomized, investigational device exemption (IDE) clinical study.

Detailed Description
-----------------
The purpose of this study is to confirm the performance of new sensing circuitry, and to confirm the performance of a Ventricular Capture Management feature in subjects with implantable cardioverter defibrillator (ICD) leads connected to an external pacemaker/defibrillator.

Official Title
-----------------
D2-EPG Study: Evaluation of New Sensing Circuitry and Capture Management

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Device: Implantable Cardioverter Defibrillator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are scheduled for implantation or replacement of an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device Patients must have or receive Medtronic transvenous atrial and ventricular leads in association with the scheduled device implant or replacement. Exclusion Criteria: Patients who have 3rd degree heart block, as assessed by the investigator Patients who have a mechanical tricuspid heart valve Patients who have received an investigational new drug or device, or are currently enrolled in a clinical study for a new indication of an approved drug or device

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

| Intervention/Treatment |
| --- |
|Device: Implantable Cardioverter Defibrillator|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular fibrillation (VF) detection time |  |  | 
| Ventricular Capture Management accuracy |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sensing, Capture Management, Heart Failure, ICD Indication
Human Papillomavirus Anal Infection

Study Overview
=================
Brief Summary
-----------------
Human papillomavirus (HPV) are involved in up to 95 % of anal canal neoplastic lesions. Little is known about HPV carriage in anal canal previous to cancer occurrence in the population and pre-neoplastic lesions, and their risk factors. PAPILLAN is a prospective study that aims to study HPV infection (HPV low grade and high grade genotypes) prevalence in anal canal in a population non selected by its HIV status. In that purpose patients are prospectively recruited in a french university hospital gastroenterology unit and anal smears are collected during a colonoscopy with cytobrush.

Official Title
-----------------
Human PapillomaVirus (HPV) Anal Infection: Study of Prevalence and Risk Factors Among 1000 Patients Benefiting From a Colonoscopy

Conditions
-----------------
HPV Infection

Intervention / Treatment
-----------------
* Procedure: HPV detection in anal canal samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients > 18 years patients undergoing colonoscopy under general anesthesia for any purpose signed written consent Exclusion Criteria: age under 18 Absence of written consent. patients incapable of giving consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HPV detection in anal canal samples<br> | Procedure: HPV detection in anal canal samples<br>* Additional anal taking during the colonoscopy with cytobrush<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anal canal HPV infection |  | at inclusion (the day of colonoscopy) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy
Effects of Suspension Training on the Balance of Healthy Young Adults

Study Overview
=================
Brief Summary
-----------------
Non-specific training through the use of devices in which the subject can be suspended is a technique that has aroused a growing interest in recent years. One of its advantages may be to enhance the balance, since it induces a high level of neuromuscular stimulation. Indeed, a suspension training suppose a high demand of the core musculature, require a high degree of postural control, precise response strategies , anticipatory capacity and muscular conditioning. However, current literature targeting healthy young adults and appraising the specifics effects of suspension training on balance is scarce or non-existent to the best of our knowledge. For this reason this interventional study will primarily assess the effects of suspension training on different balance components.

Official Title
-----------------
Influencia Del Entrenamiento en suspensión en el Equilibrio de Adultos jóvenes Sanos

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

Intervention / Treatment
-----------------
* Other: Suspension training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy young adults aged between 18 and 30 Exclusion Criteria: Professional athlete Musculoskeletal injury in the last 6 months (i.e. sprain, bone fracture) Known balance disorders including vertigo, central or vestibular limitations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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: Suspension training group<br> | Other: Suspension training<br>* Nine sessions of suspension training The suspension device will be TRX (R) The intervention will be administered in work:rest intervals (2:1) A global training approach will seek to train lower limbs, upper body and core musculature<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Y-Balance test | Measure of dynamic balance | Change from baseline to four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emery test | A timed test for static-dynamic balance assessment, the participant stands on one leg over a foam with closed eyes | Change from baseline to four weeks | 
| Posturography measures | Using a T-Plate pedometer | Change from baseline to four weeks | 
| Jumping sideways test | A measure to assess motor coordination under time pressure | Change from baseline to four weeks |
Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.

Detailed Description
-----------------
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day. The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.

Official Title
-----------------
Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy

Conditions
-----------------
Painful Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: 0.75% capsaicin nanoparticle cream
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of type 2 Diabetes mellitus Peripheral neuropathy Stabilized on pain medication for at least one month No previous invasive intervention for pain relief Exclusion Criteria: Local wound or any skin abnormality in the applicable area Allergic to capsaicin Refuse to participate or give consent Has other significant disease or receive medication that may worsen neuropathy

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 |
| --- | --- |
| Placebo Comparator: Placebo<br>Matched gel base of capsaicin nanoparticle | Drug: Placebo<br>* Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks<br>|
| Experimental: Capsaicin<br>0.075% capsaicin nanoparticle gel | Drug: 0.75% capsaicin nanoparticle cream<br>* 0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief from pain score reduction, using visual analog scale (VAS) |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Painful diabetic neuropathy, Capsaicin, Nanoparticle, Quantitative Sensory Testing
Capadenoson in Angina Pectoris

Study Overview
=================
Brief Summary
-----------------
This is a multi-center and multi-national,randomized, double blind, placebo-controlled, 28-day treatment study with BAY 68-4986 taken orally or a matching placebo.

Official Title
-----------------
Phase IIa Efficacy and Safety Trial of Capadenoson in Patients With Chronic Stable Angina

Conditions
-----------------
Chronic Stable Angina

Intervention / Treatment
-----------------
* Drug: Capadenoson (BAY 68-4986)
* Drug: Capadenoson (BAY 68-4986)
* Drug: Capadenoson (BAY 68-4986)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The primary diagnosis is chronic stable angina of mild-moderate intensity as defined by the Canadian Cardiovascular Society Functional Class II-III, in the presence of definitive coronary artery disease. Male or female subjects aged 35 to 75 years (if female, only if postmenopausal or permanently sterilized) Stable angina of mild-moderate intensity (Canadian class II-III) with anti-anginal medication not changed for the last 5 weeks Exclusion Criteria: Inability to withdraw current anti-anginal therapy Inability to withdraw any concomitant therapy that would interfere with interpretation of study results

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Capadenoson (BAY 68-4986)<br>* 1mg Capadenoson, double dummy<br>|
| Experimental: Arm 2<br> | Drug: Capadenoson (BAY 68-4986)<br>* 2mg Capadenoson, double dummy<br>|
| Experimental: Arm 3<br> | Drug: Capadenoson (BAY 68-4986)<br>* 4mg Capadenoson, double dummy<br>|
| Placebo Comparator: Arm 4<br> | Drug: Placebo<br>* Placebo, double dummy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total exercise time |  | 28 days for ETT and 42 days for safety | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to angina onset |  | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenosin agonist, chronic stable angina
Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease

Study Overview
=================
Brief Summary
-----------------
This study aims to demonstrate innocuity and feasibility of deep brain stimulation with a multi-electrodes set.

Detailed Description
-----------------
Bilateral stimulation in subthalamic nucleus with the multi-electrodes set will be compared with single electrode.

Official Title
-----------------
Implantation Feasibility Study of a Multi-electrodes Set for Deep Brain Stimulation in Parkinson Disease (Smart in Vivo 2)

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Device: 32 channels Deep Brain Stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more or equal than 18 years old and less than 70 years patient affiliated to social security or similarly regime informed consent form signed parkinson disease (UPDRS III20 score up than 30/108 except for severe tremors) motor and non motor dysfunctions pre-operative cerebral MRI without lesion without chirurgical contraindications without psychiatric disease Exclusion Criteria: Pregnant women and lactating mothers Ward of court or under guardianship Adult unable to express their consent Person deprived of freedom by judicial or administrative decision Person hospitalized without their consent Person under legal protection Person with carcinological antecedent during precedent 5 years Chirurgical or MRI contraindications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-electrodes / single electrode<br>Multi stimulation / single stimulation | Device: 32 channels Deep Brain Stimulator<br> <br> |
| Experimental: Single-electrode / Multi electrodes<br>Single stimulation / Multi stimulation | Device: 32 channels Deep Brain Stimulator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, as measured by Number of Participants with Adverse Events | Number of Participants with Adverse Events | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic evaluation | Change in motor and non-motor symptoms assessment with neurologic scales | 3 months |
Post-Marketing Surveillance of the Safety and Efficacy of Orgalutran (Ganirelix)®

Study Overview
=================
Brief Summary
-----------------
The purpose of this post-marketing surveillance is to identify problems and questions regarding the safety and efficacy of Orgalutran (Ganirelix)® when used for the prevention of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

Official Title
-----------------
Post-Marketing Surveillance Orgalutran (Ganirelix)®

Conditions
-----------------
Fertilization in Vitro

Intervention / Treatment
-----------------
* Drug: Orgalutran


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be undergoing COH for ART Exclusion Criteria: Hypersensitivity to the active substance or to any of the excipients Hypersensitivity to gonadotropin-releasing hormone (GnRH) or any other GnRH analogue Moderate or severe impairment of renal or hepatic function Pregnancy or lactation
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants Treated<br>Women undergoing controlled ovarian COH for ART | Drug: Orgalutran<br> <br> * Other names: Ganirelix®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of retrieved oocytes by COH based on Per stage approach |  | Baseline to End of Study | 
| Number of Serious Adverse Events |  | Baseline to End of Study | 
| Number of Unlabeled (Unexpected) Adverse Drug Reactions |  | Baseline to End of Study | 
| Number of Labeled Adverse Drug Reactions |  | Baseline to End of Study | 
| Number of Non-serious Adverse Events |  | Baseline to End of Study | 
| Number of Adverse events by drug misuse/abuse or drug-drug interaction |  | Baseline to End of Study |