linjc16/ctgov huggingface dataset:
A Drug Interaction Study of Clarithromycin and LY3502970 in Healthy Participants

Study Overview
=================
Brief Summary
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The main purpose of this study is to determine the levels of study drug called LY3502970 in the blood stream when administered alone and in combination with clarithromycin in healthy participants. This study will last up to approximately 85 days for each participant.

Official Title
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A Phase 1, Open-label, Drug Interaction Study to Investigate the Effect of Multiple Doses of Clarithromycin on the Pharmacokinetics of LY3502970 in Healthy Participants

Conditions
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Healthy

Intervention / Treatment
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* Drug: LY3502970
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation Participants with a body weight of 45 kilograms (kg) or more and body mass index (BMI) within the range of 18.5 to 35.0 kilograms per meter squared (kg/m²) Participants who have a hemoglobin level of at least 11.4 grams/deciliter (g/dL) for female participants and at least 12.5 g/dL for male participants Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential Exclusion Criteria: Participants who have a significant history of or current cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs Participants who regularly use known drugs of abuse Women who are lactating and who are of child-bearing potential Participants who have known allergies to LY3502970, related compounds, or any components of the formulation

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3502970 alone (Period 1)<br>LY3502970 administered orally. | Drug: LY3502970<br>* Administered orally.<br>|
| Experimental: Clarithromycin + LY3502970 (Period 2)<br>Clarithromycin administered orally in combination with LY3502970 given orally. | Drug: LY3502970<br>* Administered orally.<br>Drug: Clarithromycin<br>* Administered orally.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970 | PK: AUC of LY3502970 | Predose up to 120 hours postdose | 
| PK: Maximum Observed Concentration (Cmax) of LY3502970 | PK: Cmax of LY3502970 | Predose up to 120 hours postdose |
Long Term Safety and Efficacy Study of ProSavin in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The study is designed to assess the long term tolerability of ProSavin and whether it is safe and efficacious in patients administered ProSavin from the PS1/001/07 study .

Official Title
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A Multicentre, Open-label Study to Determine the Long Term Safety, Tolerability and Efficacy of ProSavin in Patients With Bilateral, Idiopathic Parkinson's Disease.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Drug: ProSavin


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: must have met all inclusion criteria for study PS1/001/07 willing to have L-DOPA dosage reduced/withdrawn at the discretion of the investigator at regular intervals to allow assessment of ProSavin in the absence of concomitant antiparkinsonian medication. affiliated with the French social security health care system (Patients enrolled in France only) signed and dated written informed consent obtained from the patient and/or the patient's legally acceptable representative, if applicable, in accordance with the local regulations must have been treated with ProSavin/Sham Exclusion Criteria: -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Long term follow up<br>Long term follow up of patient's who received ProSavin in previous study | Drug: ProSavin<br>* Long term follow up of patients who received ProSavin in a previous study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the long term safety and tolerability of ProSavin | The number and severity of any adverse event | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' responses to ProSavin administration | Assessed using Unified Parkinson's Disease Rating Score(UPDRS) Part III, evaluating percentage of time during waking day that patient is in the off state through patient diaries and activities of daily living using PDQ-39 at 36 months post administration. | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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ProSavin, Gene therapy
Magnetic Endoscope Imaging in Single-balloon-enteroscopy

Study Overview
=================
Brief Summary
-----------------
Magnetic endoscope imaging (MEI) is already used in colonoscopy in order facilitate scope navigation. In this study the use of MEI will be evaluated for small bowel enteroscopy in which scope navigation is particularly important. The MEI will be compared with x-ray which is still the current gold standard for scope navigation in small bowel enteroscopy.

Conditions
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Magnetic Endoscope Imaging in Single-balloon-enteroscopy

Intervention / Treatment
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* Procedure: Magnetic endoscope imaging (MEI)


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: indication for enteroscopy Exclusion Criteria: contraindication for enteroscopy patients with cardiac pacemaker or defibrillator pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MEI<br> | Procedure: Magnetic endoscope imaging (MEI)<br> <br> * Other names: Olympus MAJ-Y0158;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of concordance of MEI- and x-ray-images | Immediately after each examination MEI-images and x-ray-images will be analyzed for concordance | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic endoscope imaging, single-balloon-enteroscopy