linjc16/ctgov huggingface dataset:
Safety and Performance of the CAVU Medical, Inc. Attune Tubing Study

Study Overview
=================
Brief Summary
-----------------
The objectives of this clinical research project are to demonstrate the safety and feasibility of CAVU Medical, Inc.'s Attune Device.

Official Title
-----------------
A PROSPECTIVE, MULTI-CENTER CLINICAL EVALUATION TO ASSESS SAFETY AND PERFORMANCE OF CAVU MEDICAL, INC.'S ATTUNE TUBING WHEN USED WITH NEWLY-IMPLANTED LAPAROSCOPIC ADJUSTABLE GASTRIC BANDS (LAGBs)

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: CAVU Attune Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The subject is at least 18 years of age. The subject has been informed of the nature of the trial and agrees to its provisions. The subject has a pre-implantation BMI within the protocol limits. The subject agrees to the follow-up visit schedule. The subject is a candidate for a LAGB procedure. The subject agrees to comply with specified follow-up evaluations. The subject is willing to fast for 2 hours prior to each adjustment visit. Exclusion Criteria: The subject is pregnant or is not willing to use an effective method of birth control for the duration of the trial. The subject has a condition that is contraindicated for LAGB procedures. The subject is currently using weight loss medications or supplements. The subject has a concurrent terminal medical condition with a life expectancy of less than 12 months. The subject is currently participating in an investigational drug or another medical device trial. The subject had a previous LAGB procedure. The Investigator believes that the patient has physical or mental conditions that would render trial participation inappropriate.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CAVU Attune Device<br> | Device: CAVU Attune Device<br>* The CAVU Attune device is used with LAGB.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of successful placement and filling of the CAVU Medical Attune device without serious device-related adverse events. |  | 30 Days |
A Trial to Assess the Efficacy and Safety of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
This phase 2b trial is being conducted at approximately 60 sites in the US to investigate whether lacosamide (SPM 927) at different doses reduces pain in subjects with diabetic neuropathy. Approximately 360 subjects will be randomized to placebo or one of three doses of lacosamide. To qualify for this trial, subjects with symptoms of painful distal diabetic neuropathy ranging in duration from 6 months to 5 years must have an average pain intensity of ≥4 on an 11-point Likert scale (0-10 scale) during the 7 day period prior to start of treatment. To determine what effect lacosamide has on diabetic neuropathic pain, subjects will use a diary to record their daily pain intensity (morning and evening), pain interference with sleep (morning) and activity (evening). Use of rescue medication (acetaminophen) and subjects' quality of life will be investigated. In addition, safety and tolerability of the different doses of lacosamide will be investigated.

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Assess the Efficacy and Safety OF 200, 400, AND 600 mg/Day SPM 927 in Subjects With Painful Distal Diabetic Neuropathy

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

Intervention / Treatment
-----------------
* Drug: SPM 927


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful distal diabetic neuropathy Exclusion Criteria: Must have an average pain intensity of ≥ 4 on an 11-point Likert scale

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

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

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: SPM 927|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the efficacy of 200, 400, and 600 mg/day of lacosamide compared with placebo in reducing pain in subjects with painful distal diabetic neuropathy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the effect of lacosamide on subjects' perception of pain, sleep, activity, quality of life, as well as to investigate the pharmacokinetics and safety of lacosamide. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAINFUL DISTAL DIABETIC NEUROPATHY
Effect of Cranial Osteopathy on Visual Function

Study Overview
=================
Brief Summary
-----------------
It is the purpose of this study to attempt to determine if there is an immediate, measurable change in visual function as a direct result following a session of cranial osteopathic manipulation.

Official Title
-----------------
Effect of Cranial Osteopathy on Visual Function

Conditions
-----------------
Visual Function

Intervention / Treatment
-----------------
* Procedure: Cranial osteopathic manipulation
* Procedure: Sham/Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Free of active ocular or systemic disease Refractive error between six diopters of myopia and five diopters of hyperopia with regular astigmatism of any amount Normal best-corrected visual acuity at 20/40 or better Normal amplitude of accommodation Willing to undergo cranial osteopathic manipulation Exclusion Criteria: Pregnancy History of previous closed head trauma or brain injury Students from the Nova Southeastern University Colleges of Osteopathic Medicine and Optometry Prior cranial manipulative treatment/craniosacral therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Assessment for cranial strain patterns, followed by indirect osteopathic treatment of dysfunctions found on assessment, followed by reassessment. | Procedure: Cranial osteopathic manipulation<br>* This treatment is performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.<br>|
| Sham Comparator: 2<br>Assessment for cranial strain patterns, followed by laying on of hands, followed by reassessment. | Procedure: Sham/Placebo<br>* A laying on of hands with no treatment being performed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accommodative system testing Visual acuity testing Stereoacuity testing Vergence system testing Pupillary testing |  | Immediately after intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cranial manipulation, Visual function
A Randomized Trial of Intracoronary Reopro to Improve Coronary Microvascular Function

Study Overview
=================
Brief Summary
-----------------
Microvascular dysfunction is a key determinant of pathogenesis and outcome in patients suffering an acute myocardial infarction. The investigators hypothesise that treatment with intracoronary abciximab, a potent anti platelet agent, at the time of coronary stent insertion, will improve microvascular function.

Detailed Description
-----------------
The index of microcirculatory resistance (IMR), an invasive measure of coronary microvascular function, correlates with clinical outcomes in patients with stable angina and ST elevation myocardial infarction. The glycoprotein IIb/IIIa receptor inhibitor, abciximab, improves coronary microvascular function and reduces major cardiac adverse events in patients with acute coronary syndromes. This study will investigate whether an intracoronary bolus of abciximab in patients with non-ST elevation myocardial infarction decreases IMR and improves microvascular function.

Official Title
-----------------
A Randomized Control Trial of Intracoronary Reopro to Improve Coronary Microvascular Function

Conditions
-----------------
Myocardial Infarction, Coronary Artery Disease

Intervention / Treatment
-----------------
* Drug: Abciximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with acute coronary syndromes Exclusion Criteria: Patient with untreated malignancy, disseminated malignancy, active inflammatory diseases, active infectious diseases patients unable to give informed consent Patients with STEMI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: Intracoronary abciximab (Reopro)<br>Intracoronary abciximab (Reopro) | Drug: Abciximab<br>* This drug will be administered intracoronary before percutaneous coronary intervention.<br>* Other names: Reopro;|
| Placebo Comparator: Control group<br>Intracoronary Reopro | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Index of Microvascular Resistance | We will assess IMR in the catheterisation laboratory immediately before PCI, then intracoronary reopro or placebo will be administered and we will re-assess IMR 15 minutes post delivery of the study drug. Finally we will perform PCI and immediately measure IMR post-procedure. | within 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of periprocedural myocardial infarction | We will assess for periprocedural myocardial infarction 8 to 24 hours post PCI | within 24 hours |
Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment. The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).

Official Title
-----------------
Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)

Conditions
-----------------
Neovascular Glaucoma

Intervention / Treatment
-----------------
* Drug: Aflibercept (Eylea, BAY86-5321)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of NVG Patients who have received IVT-AFL treatment according to Japanese labeling. Exclusion Criteria: Patients who are contraindicated based on approved label Diagnosis of other indication
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aflibercept (Eylea, BAY86-5321)<br>Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert | Drug: Aflibercept (Eylea, BAY86-5321)<br>* Administration by intravitreal injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants with adverse events (AEs) |  | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) value after study drug administration | In case of transient and/or persistent IOP elevation | Up to 6 months | 
| Mean changes in Visual Acuity |  | Up to 6 months | 
| Proportion of participants with improvement of anterior neovascularization |  | Up to 6 months |
Observational Post-Authorisation Safety Study of Asenapine (Sycrest)

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to evaluate the use and short term safety of Asenapine (Sycrest) in real-life usage in the Mental Health Trust Setting in the United Kingdom(UK) National Health Service (NHS). The study is to be carried out independently by the Drug Safety Research Unit (DSRU) in Southampton, although it is funded by Merck, the manufacturer of Sycrest.

Official Title
-----------------
An Observational Post-Authorisation Safety Specialist Cohort Monitoring Study (SCEM) to Monitor the Safety and Utilisation of Asenapine (Sycrest) in the Mental Health Trust Setting in England

Conditions
-----------------
Manic Disorder

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for whom a study questionnaire containing useful information has been returned Exclusion Criteria: Patients who do not provide consent Patients within selected institutions (for example prisons) Patients who commenced treatment between date of market launch (to be confirmed) and study start Enrolled patients for whom both the baseline and 12-week questionnaires are returned blank (contain no clinical information) Enrolled patients for whom the psychiatrist, designated member of clinical care team, or study facilitator from the DSRU reports that the patient did not take or was never prescribed asenapine Enrolled patients for whom there is evidence to suggest duplication of patients Enrolled patients for whom informed written or verbal notification is received by DSRU indicating that they no longer wish to participate at any stage of 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 |
| --- | --- |
| Asenapine<br>Patients prescribed asenapine for any indication. | Other: No intervention<br>* This is a non-interventional study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of selected identified risks of asenapine in the mental health care trust setting |  | 12 weeks after asenapine is first prescribed |
Paravertebral Block for Breast Surgery

Study Overview
=================
Brief Summary
-----------------
The effect of paravertebral block in combination with general anaesthesia is studied in a double blind fashion.

Detailed Description
-----------------
Patients having surgery for breast cancer receive a paravertebral blockade at C8-Th4 with either Naropin 0.5% or saline. General anaesthesia is then provided with laryngeal mask intubation, propofol infusion and fentanyl i.v. as needed. The effect on postoperative pain ([VAS] and fentanyl PCA doses taken) and postoperative nausea and vomiting is recorded.

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

Intervention / Treatment
-----------------
* Procedure: paravertebral block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast surgery Exclusion Criteria: Infections Coagulation disorder Allergy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: paravertebral block|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea and vomiting 2 hours postoperatively, and 1 and 2 days postoperatively |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dosage of analgesic |  | 1 day |
Pediatric Expanded Access Program-Oral Solution (0831-908)

Study Overview
=================
Brief Summary
-----------------
Monitor the safety and tolerability of efavirenz oral solution in combination with Antiretroviral Therapy for the treatment of patients age 3 to 16 years who have failed therapy or who are intolerant to their current therapy. This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).

Official Title
-----------------
A Noncomparative,Open, Multisite Study to Monitor the Safety and Tolerability of Efavirenz Oral Solution Given in Combination Antiretroviral Therapy (ART) in ART-naive or Experienced HIV-1 Infected Patients Age 3 to 16 Years Who Have Failed Therapy or Are Intorerant to Their Current ART Regimen

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: MK0831


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not tolerating current ART regime laboratory status is stable Able to take oral liquid medications but have difficulty swallowing capsules Weigh at least 10 kg (22 lbs) Exclusion Criteria: Has had more than 2 episodes of moderate to severe diarrhea or vomiting lasting more than 4 days within 3 months prior to taking study drug Have taken another investigational drug 30 days before starting this study Have a history of drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0831|nan|

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
-----------------
HIV, Treatment Experienced
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)

Study Overview
=================
Brief Summary
-----------------
This is a 12-Week clinical trial in patients with Primary hypercholesterolemia or mixed dyslipidemia to study the effects of ER niacin/laropiprant on lipids.

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel Group, 12 Week Study to Evaluate the Efficacy and Safety of Extended-release (ER) Niacin/Laropiprant in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia.

Conditions
-----------------
Primary Hypercholesterolemia, Mixed Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Comparator: simvastatin
* Drug: niacin (+) laropiprant
* Drug: Comparator: atorvastatin calcium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 to 80 years of age with Primary hypercholesterolemia or mixed dyslipidemia Patients will be eligible for the study if their LDL-C values are within protocol specified range and meet other entry criteria Exclusion Criteria: Patient whose LDL-C values are not within protocol specified range

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose. | Drug: niacin (+) laropiprant<br>* One tablet of ER niacin/ laropiprant (1g); titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.<br>* Other names: MK0524A;|
| Active Comparator: 2<br>Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks. | Drug: Comparator: simvastatin<br>* simvastatin (20mg to 40mg) for 12 weeks.<br>* Other names: Zocor®;Drug: Comparator: atorvastatin calcium<br>* atorvastatin calcium (20mg to 40mg) for 12 weeks.<br>* Other names: atorvastatin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low Density Lipoprotein Cholesterol at Week 12 |  | Baseline and 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12 |  | Baseline and 12 Weeks | 
| Percent Change From Baseline in Triglycerides at Week 12 |  | Baseline and 12 Weeks |