linjc16/ctgov huggingface dataset:
Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
This Protocol is intended to facilitate development and testing of new cardiovascular MRI software capabilities by UC Davis Research Faculty, as well as to facilitate the evaluation of new software capabilities provided by GE and Siemens.

Detailed Description
-----------------
This protocol will permit normal subjects, as well as patients with suspected or proven medical conditions, to undergo MRI studies using the new software capabilities. This Protocol is not restricted to imaging of a particular organ system or disease. The Protocol does not involve injection of any contrast agent, or other minimally-invasive or invasive procedure. It is intended only for those cases for which the only requirement of the subject is to relax and lie still while imaging is being performed.

Official Title
-----------------
Development of New Software Capabilities for Use With Cardiovascular Magnetic Resonance Imaging

Conditions
-----------------
Abnormalities, Cardiovascular

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Ability to give informed, written consent Not Pregnant or breastfeeding Exclusion Criteria: Electrically, magnetically, or mechanically activated implants (for example, cardiac-pacemakers) Ferromagnetic implant, such as an aneurysm clip, surgical clip, or prosthesis History of uncontrolled claustrophobia

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extend or generalize certain capabilities, such as new data acquisition pulse sequences, new image processing and analysis software for structural and functional analysis of the MR images |  | Post-scanning | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improve image quality by various techniques (e.g. reducing the effects of motion) |  | Post-scanning | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI
Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure blood levels of TXA in children having cardiac surgery which requires cardiopulmonary bypass. TXA is used to reduce bleeding during surgery. This study will help determine if the current dosing of TXA results in therapeutic blood levels.

Official Title
-----------------
Pharmacokinetics of Tranexamic Acid (TXA) in Children Undergoing Repair of Congenital Heart Defects Utilizing Cardiopulmonary Bypass

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: congenital heart disease requiring surgical repair with cardiopulmonary bypass Exclusion Criteria: children weighing over 20 kg family does not want to participate in the study

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- |
| children less than 2 months old<br> | |
| children 2 months to 12 months old<br> | |
| Children > 2 months old and less than or equal to 20 kg<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine TXA blood levels in children having cardiac surgery with cardiopulmonary bypass. The current dosing recommendations will be utilized. |  | multiple times thoughout surgery |
The Prevalence of Osteoporosis in Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence and severity of osteoporosis in hemodialysis patients and to evaluate potential correlations with renal bone disease indices

Official Title
-----------------
Prevalence of Osteoporosis in Hemodialysis Patients and Relevance With Renal Bone Disease

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hemodialysis Age > 18-year old Exclusion Criteria: Prior specific osteoporosis treatment except vitamin D and calcium supplement administration; active malignancy Recent pregnancy Immobilization

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 |
| --- | --- | --- |
Comparative Bioavailability Study of Azithromycin 200mg/5mL Suspension Following a 600mg Dose Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the bioequivalence of Azithromycin 200mg/5mL oral suspension.

Official Title
-----------------
Comparative, Randomized, Single-Dose, 2-Way Crossover Bioavailability Study of Eon and Pfizer Inc. (ZITHROMAX) 200mg/5mL Azithromycin Suspension Following a 600mg Dose in Healthy Adult Volunteers Under Fed Conditions

Conditions
-----------------
Infections

Intervention / Treatment
-----------------
* Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC
* Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant findings on physical exam, medial history or laboratory tests on screening Exclusion Criteria: Positive test for HIV or hepatitis B and C Treatment for Drug or alcohol abuse Any other important criteria in the protocol

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Azithromycin for oral suspension 200mg/5mL | Drug: Azithromycin for Oral Suspension 200mg/5mL Eon Pharma, LLC<br> <br> |
| Active Comparator: 2<br>Zithromax (azithromycin for oral suspension) 200mg/5mL | Drug: Zithromax (azithromycin for oral suspension) 200mg/5mL Pfizer<br>* Subjects randomized to Zithromax received a single oral dose of Zithromax 600mg (15mL), administered with 240mL of water under fed conditions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 37 days |
Clinical Results and Restenosis Analysis of Symptomatic Ostial Vertebral Artery Stenosis Treated With Tubular Coronary Stents

Study Overview
=================
Brief Summary
-----------------
Vertebral artery stenosis (VAS) decreases posterior brain perfusion, causing vertebrobasilar insufficiency (VBI). It is also an important embolic source to the posterior brain. The most frequently involved location is the proximal part of the vessel, including the ostium. Various surgical procedures have been described for the treatment of proximal VAS with symptoms refractory to medical therapy, but all are technically difficult with high operative mortality and morbidity. Endovascular intervention has been described as an alternative to surgery. Balloon angioplasty is limited by elastic recoil and dissection. The restenosis rates reported in the literature varied, as high as 75 %. Stenting offers salvage following unsuccessful balloon angioplasty, and primary stenting have been shown to be safe and effective with lower restenosis rate. Coronary equipments are ideal for ostial VAS, considering the size of the artery and location of the lesion. Recently, Albuquerque et al. reports a relative high restenosis rate in a longer follow-up duration. Restenosis seems to become an important issue regarding the patients' quality of life. However, there is no clinical parameter to predict restenosis of VAS. The purpose of this study is to evaluate the clinical results of our series of symptomatic ostial VAS treated exclusively with tubular balloon expandable coronary stents. We sought to identify predictors of restenosis. This is a clinical observation study. Only chart review and angiographic review will be performed.

Official Title
-----------------
Clinical Results and Restenosis Analysis of Symptomatic Ostial Vertebral Artery Stenosis Treated With Tubular Coronary Stents

Conditions
-----------------
Vertebral Artery Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with symptomatic vertebral artery stenosis treated by stenting Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- | --- |
Study of STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
An open-label dose escalation study of patients with solid tumors treated with STA-9090 (ganetespib)

Official Title
-----------------
A Phase 1 Study of the HSP90 Inhibitor, STA-9090, Administered Once-Weekly in Patients With Solid Tumors

Conditions
-----------------
Solid Tumors

Intervention / Treatment
-----------------
* Drug: STA-9090


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be documented to be refractory or not candidates for current approved therapies. Must have an ECOG status 0-2. Peripheral neuropathy < or = 2. Must have acceptable organ and marrow function per protocol parameters. No clinically significant ventricular arrythmias or ischemia. Exclusion Criteria: Must not be pregnant or breastfeeding. Chemotherapy or radiation within 3 weeks. Previous radiation to >25% of total bone marrow. Previous high dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation. Primary brain tumors or active brain metastases. Use of any investigational agents within 4 weeks. Treatment with chronic immunosuppressants. Uncontrolled, intercurrent illness.

Ages Eligible for Study
-----------------
Minimum Age: 25 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ganetespib<br>Ganetespib once weekly infusion, dose escalation study, with treatment until progression | Drug: STA-9090<br>* This is a dose-escalation study. The first cohort will consist of three patients who will receive STA 9090 (ganetespib)during a 1-hour infusion once per week for three consecutive weeks followed by a 1 week dose-free interval. Subsequent cohorts will receive higher amounts of STA-9090 (gantespib) provided that the previous dose was well tolerated during cycle 1 (week 1 - 4). Dose escalation will continue until the maximum tolerated dose (MTD) is determined.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The safety and tolerability of STA-9090 (ganetespib) in cancer patients via assessment of dose limiting toxicities |  | Cycle 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
solid tumor, metastatic cancer, histologically or cytologically confirmed non-hematological, malignancy that is metastatic or unresectable for which no, standard therapy exists, STA-9090, ganetespib
A Clinical Study to Evaluate the Safety and Efficacy of Aliskiren Alone and in Combination With Ramipril in Hypertensive, Diabetic Patients.

Study Overview
=================
Brief Summary
-----------------
To demonstrate the efficacy and safety of aliskiren given to patients with both hypertension and diabetes mellitus

Official Title
-----------------
An Eight-week, Randomized, Double-blind, Parallel Group, Multicenter, Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren Administered Alone and in Combination With Ramipril in Patients With Hypertension and Diabetes Mellitus

Conditions
-----------------
Hypertension, Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential hypertension Patients with a documented diagnosis of Type 1 or Type 2 diabetes mellitus. Patients who are eligible and able to participate in the study Exclusion Criteria Severe hypertension History or evidence of a secondary form of hypertension History of hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined exclusion criteria may apply

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aliskiren|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting diastolic blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to week 4 endpoint in mean sitting diastolic blood pressure |  |  | 
| Change from baseline to week 8 endpoint in mean sitting systolic blood pressure |  |  | 
| Diastolic blood pressure less than 90 mmHg or reduction of 10 mmHg or greater from baseline after 8 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, aliskiren, blood pressure, diabetes mellitus, ramipril
Effects of DHA on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery

Study Overview
=================
Brief Summary
-----------------
Post-operative fibrosis of trabulectomy blebs is a major cause of surgical failure leading to a renewed increase in intraocular pressure. The use of anti-metabolites over many years has made it possible to improve success rates for this surgery but these drugs have numerous adverse effects as they are toxic. Alternative therapies are thus necessary, and we believe that DHA could have antifibrotic effects on fibroblasts and could thus improve success rates in this surgery.

Official Title
-----------------
Study of the Effects of Docosahexaneoic Acid (DHA) on Post-operative Fibrosis of Trabulectomy Blebs in Glaucoma Surgery

Conditions
-----------------
Trabulectomy, Deep Sclerectomy

Intervention / Treatment
-----------------
* Procedure: Samples of fibroblasts from Tenon's capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing trabulectomy or deep sclerectomy Patients informed about the study Exclusion Criteria: - Patients who refuse to take part 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>Glaucoma surgery | Procedure: Samples of fibroblasts from Tenon's capsule<br> <br> |
| Controls<br>Strabismus surgery | Procedure: Samples of fibroblasts from Tenon's capsule<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test of cell viability by MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) |  | At baseline | 
| Test migration ability by video microscopy |  | At baseline | 
| Test proliferation with immunohistochemistry (Ki67 staining) |  | At baseline | 
| Analysis of cell cycle in flow cytometry |  | At baseline |
Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide - 16

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the subjective, psychomotor, and reinforcing effects of combined alcohol and nitrous oxide intake in healthy volunteers.

Official Title
-----------------
Subjective/Psychomotor/ Effects of Combined Alcohol & Nitrous Oxide

Conditions
-----------------
Opioid-Related Disorders, Substance-Related Disorders

Intervention / Treatment
-----------------
* Drug: 30% Nitrous oxide
* Other: 0.35 g/Kg ethanol
* Other: 0.7 g/Kg ethanol
* Other: 0 g/Kg ethanol


Participation Criteria
=================
Eligibility Criteria
-----------------
Please contact site for information.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 0 g/Kg ethanol +/- 30% nitrous oxide<br> | Drug: 30% Nitrous oxide<br> <br> Other: 0 g/Kg ethanol<br> <br> |
| Active Comparator: 0.35 g/Kg ethanol +/- 30% nitrous oxide<br> | Drug: 30% Nitrous oxide<br> <br> Other: 0.35 g/Kg ethanol<br> <br> |
| Active Comparator: 0.7 g/Kg ethanol +/- 30% nitrous oxide<br> | Drug: 30% Nitrous oxide<br> <br> Other: 0.7 g/Kg ethanol<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood |  | Baseline and post inhalation | 
| Psychomotor performance |  | Baseline and post inhalation | 
| Cognitive performance |  | Baseline and post inhalation | 
| Choice of nitrous oxide vs placebo |  | after each ethanol session | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nitrous oxide, inhalant, ethanol, subjective effects, psychomotor effects, healthy volunteer
Blue Note Therapeutics Product BNT 103 Usability and User Engagement

Study Overview
=================
Brief Summary
-----------------
This test aims to explore product development-focused usability and user engagement.

Detailed Description
-----------------
Sponsor is testing an innovative peer-to-peer communication tool during this trial.

Official Title
-----------------
BNT 103 Usability and User Engagement

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Device: BNT103


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient can read, write, and speak in English Patient is between the ages of 35-55 Diagnosed with Stage I-III breast cancer In active treatment or within 3 months of ending active treatment and under the care of a clinician at time of study Apple mobile phone or tablet user Willing to participate in study protocol Exclusion Criteria: Any participant not meeting inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BNT103<br>All participants receive BNT103. BNT103 provides 10 sessions over approximately 10 weeks. | Device: BNT103<br>* BNT-103™ is a prescription digital therapeutic specifically designed to treat the symptoms of anxiety and depression related to cancer. There are 10 sessions provided over approximately 10 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients | Higher scores indicate higher ease of use / easier to use applications | Baseline up to Week 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Current Status - Anxiety (MOCS-A) | The MOCS-A is a 13-item self-report measure developed to assess participants' current self-perceived status on: the ability to relax at will, recognize stress-inducing situations, restructure maladaptive thoughts, be assertive about needs, and choose appropriate coping responses as needed, higher scores indicate greater self-perceived proficiency with these skills. | Baseline up to Week 7 |