linjc16/ctgov huggingface dataset:
Evaluation of the Efficacy and Safety of VX-864 in Subjects With the PiZZ Genotype

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety and pharmacokinetics (PK) of VX-864 in PiZZ subjects.

Official Title
-----------------
A Phase 2, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of VX-864 in PiZZ Subjects

Conditions
-----------------
Alpha1-Antitrypsin Deficiency

Intervention / Treatment
-----------------
* Drug: VX-864
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Subjects must have a PiZZ genotype confirmed at screening Plasma AAT levels indicating severe deficiency at screening Key Exclusion Criteria: History of a medical condition that could negatively impact the ability to complete the study Solid organ, or hematological transplantation or is currently on a transplant list History of use of gene therapy or RNAi therapy at any time previously Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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>Participants received placebo matched to VX-864 in the treatment period for 28 days. | Drug: Placebo<br>* Placebo matched to VX-864 for oral administration.<br>|
| Experimental: VX-864 100 mg<br>Participants received VX-864 100 milligrams (mg) every 12 hours (q12h) in the treatment period for 28 days. | Drug: VX-864<br>* Tablets for oral administration.<br>|
| Experimental: VX-864 300 mg<br>Participants received VX-864 300 mg q12h in the treatment period for 28 days. | Drug: VX-864<br>* Tablets for oral administration.<br>|
| Experimental: VX-864 500 mg<br>Participants received VX-864 500 mg q12h in the treatment period for 28 days. | Drug: VX-864<br>* Tablets for oral administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plasma Functional Alpha-1 Antitrypsin (AAT) Levels |  | From Baseline at Day 28 | 
| Safety and Tolerability as Assessed by Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Day 1 up to Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plasma Antigenic AAT Levels |  | From Baseline at Day 28 | 
| Observed Pre-dose Plasma Concentration (Ctrough) of VX-864 |  | Pre-dose at Day 7, Day 14, Day 21 and Day 28 |
GON-block in Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study

Study Overview
=================
Brief Summary
-----------------
Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. Corticosteroids may be helpful in reducing the pain intensity and frequency in chronic migrtaine. This RCT is set up to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Detailed Description
-----------------
Infiltration of the greater occipital nerve (GON) with local anaesthetics and corticosteroids is a treatment option for cluster headache. In general, there is a marked paucity of evidence concerning GON blocks in migraine. Corticosteroids may be helpful in reducing the pain intensity and frequency in these patients. This is an RCT to assess efficacy and safety of sub-occipital steroid injections with local anesthetic in patients with chronic migraine.

Official Title
-----------------
Greater Occipital Nerve Blockade for the Treatment of Chronic Migraine: a Randomized, Double- Blind, Placebo-controlled Study

Conditions
-----------------
Chronic Migraine

Intervention / Treatment
-----------------
* Drug: Betamethasone and local anesthetic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic migraine Exclusion Criteria: Medication overuse headache

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Betamethasone and local anesthetic. | Drug: Betamethasone and local anesthetic<br>* Infiltration of the greater occipital nerve .<br>* Other names: GON block;|
| Placebo Comparator: Placebo<br>Saline with local anesthetic. | Drug: Betamethasone and local anesthetic<br>* Infiltration of the greater occipital nerve .<br>* Other names: GON block;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of migraine days | Number of days fulfilling the ICHD criteria for migraine | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days with severe headache days | Number of days with severe headache days | 8 weeks | 
| Medication use | use of medication recorded during the 8 weeks | 8 weeks | 
| Responder rate | number of patients with more than 50% reduction in migraine | 8 weeks | 
| Number of migraine attacks | Number of attacks fulfilling the ICHD criteria for migraine | 8 weeks |
Anatomic Outcomes Following Ozurdex Injections

Study Overview
=================
Brief Summary
-----------------
Ozurdex(TM) has recently been FDA approved for use in macular edema secondary to retinal vein occlusion. It remains unclear how quickly the drug works and for how long as the initial studies did not have frequent anatomic monitoring. This study will utilize frequent Spectral domain OCT imaging to better understand the onset of treatment effectiveness and duration of action on the anatomic thickness of the retina, in addition to distinguishing structural abnormalities of responders from non-responders.

Detailed Description
-----------------
Focal laser therapy has been the gold standard for the treatment of macular edema secondary to branch vein occlusion (BRVO), though it has not been shown to be effective for central vein occlusion (CRVO). Intravitreal corticosteroids have been shown in many case series to be effective at diminishing macular edema secondary to both BRVO and CRVO. Sustained drug delivery models have been sought after to relieve the need for frequent injections. Ozurdex has recently been found to be effective for the treatment of macular edema following BRVO or CRVO and has been approved by the FDA for these indications. The onset of effectiveness and duration of action on the anatomic thickness of the retina have not yet been demonstrated. In addition, it is uncertain as to when the clinician can label the patient as a responder or nonresponder. We also believe this study will help identify patients that may need more frequent dosing schedules.

Official Title
-----------------
Anatomic Outcomes Following Ozurdex Injection

Conditions
-----------------
Retinal Vein Occlusions

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with BRVO/CRVO who are otherwise eligible to receive treatment with Ozurdex (TM) Exclusion Criteria: Patients younger than 21 years of age, unwilling or unable to grant informed consent, participation in a clinical trial within the 30 days prior to enrollment. Patients receiving any other ocular therapy.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients

Study Overview
=================
Brief Summary
-----------------
Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.

Conditions
-----------------
Asthma, Bronchiolitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient is admitted to the ER with shortness of breath patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including: asthma management protocol bronchiolitis management protocol ages 0 - 15 patient's parent/guardian is able to comprehend and give informed consent for participating in the study Exclusion Criteria: patient has received any dose of inhaled bronchodilators in the hour prior to enrollment patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment ventilated patients, while ventilated chest skin lesions cystic fibrosis hemodynamic instability patient's parent/guardian objects to the study protocol concurrent participation in any other clinical study physician objection

Ages Eligible for Study
-----------------
Maximum Age: 15 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 |
| --- | --- |
| Group 1: Patients ages 0 - 3<br> | |
| Group 2: Patients ages 3 - 7<br> | |
| Group 3: Patients ages 7 - 15<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle) | Characterize the dynamic pattern of wheeze rate (increase or decrease by 50% or unchanged) within 30 minutes of onset of therapy, and to correlate pattern to clinical diagnoses, severity assessment (accessory muscle use, oxygen saturation, inspiratory/expiratory ratio, severity of wheezing), and outcome (admission versus discharge). | Duration (from beginning to end) of emergency department stay. On average, 3 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment | cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment and to correlate pattern to clinical diagnoses, severity assessment (accessory muscle use, oxygen saturation, inspiratory/expiratory ratio, severity of wheezing), and outcome (admission versus discharge). | Duration (from beginning to end) of emergency department stay. On average, 3 hours. |
Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify subjects with advanced solid tumors or lymphoma in which the methylthioadenosine phosphorylase (MTAP) protein has been lost.

Detailed Description
-----------------
Study AG270-PS-001 is a pre-screening study to identify subjects with advanced solid tumors or lymphoma in which the MTAP protein has been lost. Subjects whose tumor tissue has lost the MTAP protein may be considered for future enrollment into a Phase 1 clinical study of an experimental drug, AG-270, that is designed to inhibit the growth of tumors lacking this protein. Identification of the loss of MTAP will rely solely on the evaluation of archival tumor tissue samples by IHC. This study is therefore non-interventional

Official Title
-----------------
Identification of MTAP Deletion in Archival Tumor Tissue: A Pre-Screening Study in Subjects With Advanced Solid Tumors or Lymphoma

Conditions
-----------------
Advanced Solid Tumors, Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be ≥18 years of age. Have a histologically confirmed diagnosis of an advanced solid tumor (other than a primary CNS malignancy) or lymphoma. Have archival tumor tissue that can be provided for assessment of MTAP deletion status. Have given written informed consent to participate in this study. Exclusion Criteria: Have a primary CNS malignancy (eg, GBM). Have a medical or psychological condition deemed by the Investigator likely to interfere with the subject's ability to give informed consent or participate in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Determination of MTAP status in tumors | Number of tumor tissue samples found to have or not have MTAP deletion, as assessed by IHC | From initiation of the Pre-Screen study until the Phase 1 study of AG-270 is activated at each study site, up to 9 months |
TVMR With the Innovalve System Trial - Early Feasibility Study

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Detailed Description
-----------------
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Official Title
-----------------
TVMR With the Innovalve System Trial - Early Feasibility Study

Conditions
-----------------
Mitral Valve Regurgitation (Degenerative or Functional)

Intervention / Treatment
-----------------
* Device: Innovalve MR system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically significant, symptomatic mitral regurgitation High risk for open-heart surgery Meets anatomical criteria Exclusion Criteria: Unsuitable anatomy Patient is inoperable EF<25%

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: Treatment<br>MV replacement with Innovalve MR system | Device: Innovalve MR system<br>* Innovalve MR system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of implant or delivery related serious adverse events at 30 days | Absence of implant or delivery related serious adverse events | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success |  | Procedure | 
| Procedural success |  | 30 days | 
| NYHA functional class |  | 30 days, 6, 12 months and annually up to 5 years | 
| Six-minute walk test |  | 30 days, 6, 12 months and annually up to 5 years | 
| Quality of life improvement (KCCQ-12) |  | 30 days, 6, 12 months and annually up to 5 years | 
| Reduction in MR grade |  | 30 days, 6, 12 months and annually up to 5 years |
Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development

Study Overview
=================
Brief Summary
-----------------
This is a study to collect blood from volunteers to assist in assay development.

Official Title
-----------------
Blood Collection In Healthy Adult Volunteers To Obtain Serum For Use In Serum Bactericidal Activity Assay Development

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Procedure: Blood Collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers aged 18-64 Exclusion Criteria: Bleeding disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br> | Procedure: Blood Collection<br>* Blood Collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No outcome measures. Blood collected for assay development. |  | 1 hour |
The Effect of Intermittent Theta Burst Stimulation on Motor Learning in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
This study investigates the effect of different application frequencies of intermittent theta burst stimulation on motor learning in healthy adults.

Official Title
-----------------
The Effect of Intermittent Theta Burst Stimulation on Motor Learning in Healthy Adults

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

Intervention / Treatment
-----------------
* Other: neuromodulation
* Other: motor learning training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being at the age of 40-75 years Exclusion Criteria: visual disability cognitive or psychiatric problems such as dementia, depression, etc.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Finger Taping Task + iTBS intermittent group<br>Finger Taping Task + iTBS Daily application group: the group receives these applications every other day for 5 sessions. | Other: neuromodulation<br>* neuromodulation: Neuromodulation is technology that acts directly upon nerves. It is the alteration-or modulation-of nerve activity by delivering electrical or magnetic stimulus/current.<br>|
| Active Comparator: Finger Taping Task intermittent Group<br>Finger Taping Task intermittent application group: the group receives the application every other day for 5 sessions. | Other: motor learning training<br>* motor learning training requires performing a sequential training called finger taping task<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Finger Taping Task | The total right answers and the mean response time in the finger taping task will be recorded | 5 minutes |
Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and Gemfibrozil.

Official Title
-----------------
An Open-Label, Nonrandomized Study To Evaluate The Potential Pharmacokinetic Interaction Between SAM-531 and Gemfibrozil, A Cytochrome P-450 2C8 Inhibitor, When Coadministered Orally To Healthy Young Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: SAM-531 and gemfibrozil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings. Exclusion Criteria: Presence or history of any disorder that may prevent the successful completion of the study. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>SAM-531_gemfibrozil | Drug: SAM-531 and gemfibrozil<br>* 2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | 24 days | 
| Time to maximum plasma concentration (tmax) |  | 24 days | 
| Area under the concentration-time curve (AUC) |  | 24 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests |  | 24 days | 

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