linjc16/ctgov huggingface dataset:
Beginning a Randomized Evaluation of the AGE Breaker Alagebrium in Diastolic Heart Failure (BREAK-DHF-I)

Study Overview
=================
Brief Summary
-----------------
This study is being done to evaluate the safety and effectiveness of alagebrium in subjects diagnosed with diastolic heart failure. The primary assessment for effectiveness is the assessment of exercise tolerance.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Effects of Alagebrium on Exercise in Subjects With Diastolic Heart Failure

Conditions
-----------------
Diastolic Heart Failure

Intervention / Treatment
-----------------
* Drug: alagebrium
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of diabetes or hypertension requiring therapy EF >/= 45% via echo within 1 year and evidence of diastolic heart failure via echo measurement of E/E'>/= 12 determined by echo within 1 year previous hospitalization for heart failure or previous BNP >100 pg/mL. Exclusion Criteria: Clinically significant valvular disease history of stroke/TIA or reversible ischemic neurological defect w/i 6 mths history of acute MI within 6 months severe COPD active or treated malignancies (except basal cell carcinoma) significant systemic illnesses that would prohibit completion of the study or compliance

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Experimental: 1<br> | Drug: alagebrium<br>* 200 mg (two 100 mg tablets) two times daily for 24 weeks<br>* Other names: ALT-711;|
| Placebo Comparator: 2<br> | Drug: placebo<br>* placebo tablets - two tablets taken twice daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy measure will be exercise tolerance as assessed utilizing the 6 Minute Walk Test |  | Assessed at baseline, week 12 and week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL as assessed by the Kansas City Cardiomyopathy Questionnaire |  | baseline, week 12 and week 24 | 
| To assess New York Heart Association Classification |  | Baseline, week 12 and week 24 | 
| To evaluate cardiovascular death or hospitalization for heart failure |  | Will be assessed during the entire 24 wk trial | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diastolic heart failure
A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status

Study Overview
=================
Brief Summary
-----------------
Patients may have actual or relative intravascular volume depletion in a number of different disease states, particularly with sepsis syndrome. However, it is clinically difficult to determine volume status without invasive monitoring, which may cause unintended complications. Our hypothesis is that we can accurately estimate central venous pressure, which is a surrogate marker of volume status, with a noninvasive portable ultrasound device.

Official Title
-----------------
A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older. Healthy, euvolemic volunteers and critically ill patients who are already in an intensive care unit and who will have a central venous catheter placed as part of their planned medical treatment. Exclusion Criteria: Inability to use ultrasound to measure jugular vein (neck brace or bandage), code situation.

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Healty volunteers who are euvolemic. | |
| 2<br>Critically ill patients who will be having a central venous catheter with a monitor to measure central venous pressure placed as part of their planned care independent of this study. | |

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
-----------------
Sepsis, Intravascular volume, Ultrasound, Noninvasive measurement
Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery

Study Overview
=================
Brief Summary
-----------------
Ketamine added to intravenous patient-controlled analgesia may be effective on prevention of postoperative nausea and vomiting by reducing opioid requirement after surgery.

Official Title
-----------------
Effect of Ketamine Added to Intravenous Patient-controlled Analgesia on Postoperative Pain, Nausea and Vomiting in Patients Undergoing Lumbar Spinal Surgery

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking female patients undergoing elective lumbar spinal surgery Age 20-65 American Society of Anesthesiologists physical status classification I or II Exclusion Criteria: Antiemetic within 24 hrs, Taking Steroids, Opioids within 1 week Psychiatric disease, Active drug or alcohol abuse GI motility disorder, severe renal/ hepatic disease insulin-dependent DM admission to ICU after surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketamine group<br> | Drug: Ketamine<br>* ketamine 3 mg/kg mixed to intravenous patient controlled analgesia device (fentanyl 20 mcg/kg. total volume 180 ml, basal infusion 2 ml, bolus 2ml, lock-out 15 min)<br>|
| Placebo Comparator: Saline group<br> | Drug: Saline<br>* equal volume of normal saline mixed to intravenous patient controlled analgesia device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative nausea and vomiting |  | within 48 hrs after surgery |
Genetic Biomarkers in Tissue Samples From Patients With Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
This clinical trial studies genetic biomarkers in tissue samples from patients with osteosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed Description
-----------------
Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples from the COG Sampling Method: Non-Probability Sample PRIMARY OBJECTIVES: I. To use PET sequencing to analyze DNA from ten human primary osteosarcoma samples, along with matched normal tissue where available. OUTLINE: Tissue samples are analyzed for translocations and deletions and analyzed using polymerase chain reaction (PCR) or fluorescence in situ hybridization (FISH).

Official Title
-----------------
Observational - Gene Discovery in Osteosarcoma

Conditions
-----------------
Osteosarcoma

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples from the COG tissue repository
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Correlative studies<br>Tissue samples are analyzed for translocations and deletions and analyzed using PCR or FISH. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mapping and filtering of paired tags | Mapping of paired tags to reference genomes to identify aberrant pairs, caused by translocations, insertions, deletions and inversions. | Up to 2 years |
Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?

Study Overview
=================
Brief Summary
-----------------
Cardiovascular disease is the most common cause of mortality and morbidity worldwide. Recently, a growing body of evidence has identified Vitamin D deficiency as a potential risk factor for cardiovascular disease. Therefore, there is an increasing interest to explore the mechanism in which vitamin D deficiency affect the cardiovascular system. The investigators want to examine the relationship between serum vitamin D levels and the coagulation status in the subjects. The applied the calibrated automated thrombogram (CAT) to assess thrombin generation in plasma as a measure of overall thrombotic activity, and thus to suggest a mechanism that may explain the link between vitamin D deficiency and cardiovascular disease. Our study population are going to include 100 patients from the internal departments in Emek hospital, who present with chest pain but without acute coronary syndrome (ACS). The investigators will take blood samples from the subjects to measure the serum vitamin D levels and the generation of thrombin. The patients will be divided into four groups according to the level of vitamin D to evaluate the effect of vitamin D levels in the blood on coagulability and thrombotic activity in these patients.

Official Title
-----------------
Does Vitamin D Deficiency Associated With Hypercoagulability & Increased Thrombin Generation?

Conditions
-----------------
Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •hospitalized patient with diagnosed of chest pain Exclusion Criteria: •recent Myocardial ischemia - (in the last 30 days)

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 |
| --- | --- | --- |
| thrombin generation levels and endogenous thrombin potentials | measuring the thrombin generation and endogenous thrombin potential by the calibrated automated thrombogram (CAT) | 4 month |
Observational Study of the Sleuth Implantable ECG Monitoring System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain information on real-world device performance clinical assessments and clinical outcomes of patients receiving the Sleuth Implantable ECG Monitoring System.

Official Title
-----------------
Observational Study of the Sleuth Implantable ECG Monitoring System

Conditions
-----------------
Syncope, Presyncope, Fainting, Cardiac Arrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias Patients who experience transient symptoms that may suggest a cardiac arrhythmia Exclusion Criteria: Patients that have had a myocardial infarction (MI) < 30 days prior to implant
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 |
| --- | --- | --- |
| Time to diagnosis |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ILR, ECG monitoring, cardiac arrhythmia, syncope, presyncope, fainting
The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy in patients with steroid resistant Autoimmune Inner Ear Disease.

Official Title
-----------------
An Open-label Study of the Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Conditions
-----------------
Autoimmune Inner Ear Disease

Intervention / Treatment
-----------------
* Drug: gevokizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Autoimmune Inner Ear Disease with active deterioration in at least one ear Failure to respond to a trial of high-dose corticosteroid therapy Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct) History of active or chronic infections Currently receiving, or having received treatment for a malignancy in the past three years Hearing loss that coincides with significant, disabling episodes of vertigo History of allergic or anaphylactic reactions to monoclonal antibodies Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: gevokizumab<br>Solution for subcutaneous injection | Drug: gevokizumab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved hearing threshold, as defined by an improvement in either the PTA (Pure Tone Average) of >=5 dB (Decibel), or 12% in the WRS (Word Recognition Score) |  | Day 28 to Day 84 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autoimmune Inner Ear Disease, Inner Ear Disease, Meniere's Disease, Sudden Sensorineural Hearing Loss
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs

Study Overview
=================
Brief Summary
-----------------
To assess safety and efficacy of ONYX treatment for cAVM:

Detailed Description
-----------------
The main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at: 12 months post last embolization in case of treatment with embolization only 12 months after additional treatment with neurosurgery 36 months after additional treatment with radiosurgery

Official Title
-----------------
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study

Conditions
-----------------
Cerebral Arteriovenous Malformations

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient presents a cerebral AVM (not already treated) that can be treated by embolization with Onyx whether or not associated with a cyanoacrylate based adhesive, The patient is at least 6 years old. Exclusion Criteria: During the treatment period for his/her cerebral AVM, the patient participates in a study assessing another medical device, another procedure or a drug. The patient and/or his/her legal representative (if applicable) refuses to give his/her consent to the collection and processing of data required by the centralized follow-up. For patients who refused collection of their personal data, only, the reason for non inclusion and date of implantation will be documented. Any condition that could prevent follow-up of the patient.

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Cerebral Arteriovenous Malformations<br>Adult patients requiring endovascular treatment of Cerebral Arteriovenous Malformations. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Device or procedure Adverse Events | Device or procedure related adverse events | 1 month | 
| Healing rate | No residual early venous return 12 months after last embolization in case of complete treatment or stopping treatment; 12 months after additional intervention in case of additional treatment required by neuro-surgery; 36 months after additional intervention in case of additional treatment required by radio-surgery. | 12 or 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe funtional independence | Describe mRS scores assessed by a certified physician | 1 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cerebral arteriovenous malformations, cAVM, ONYX
An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)

Study Overview
=================
Brief Summary
-----------------
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.

Official Title
-----------------
An Observational, Non-interventional, Multi-national Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Moderate to severe rheumatoid arthritis Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011 Exclusion Criteria: RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients on RoActemra/Actemra treatment at 6 months |  | approximately 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of dose modifications/interruptions |  | approximately 2.5 years | 
| Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment |  | approximately 2.5 years | 
| Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR |  | approximately 2.5 years | 
| Efficacy: Monotherapy versus combination therapy |  | approximately 2.5 years | 
| Safety: Incidence of adverse events |  | approximately 2.5 years | 
| Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales |  | approximately 2.5 years |
An Evaluation of Psychological Parameters That May Influence the Outcome Following Arthroscopy and Arthroplasty for Temporomandibular Joint Surgery

Study Overview
=================
Brief Summary
-----------------
All patients undergoing arthroscopy or arthroplasty for temporomandibular joint dysfunction will complete a psychological questionnaire prior to surgery. The 3 month outcomes including pain and function will be examined using regression analysis to identify psychological variables that may predict outcomes.

Official Title
-----------------
Phase 4 Study of the Influence of Psychological Factors on the Outcomes Following Arthroscopy and Arthroplasty for Temporomandibular Joint Dysfunction

Conditions
-----------------
Psychological Predictors

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: require arthroscopy or arthroplasty Exclusion Criteria: age less than 18 yrs prior surgery unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| all<br>All patients requiring arthroscopy or arthroplasty | Other: Questionnaire<br>* Questionnaire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain will be recorded in a site specific matter (left and right TMJ) using a visual analogue scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Function | Function will be measured using the jaw function limitation scale which will assess overall jaw and masticatory function with a short well validated questionnaire | 3 months |