linjc16/ctgov huggingface dataset:
Biomarker in Tumor Tissue Samples From Patients With Rhabdomyosarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: 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. PURPOSE: This research trial studies biomarkers in tumor tissue samples from patients with rhabdomyosarcoma.

Detailed Description
-----------------
OBJECTIVES: To determine and quantify the degree of surface insulin-like growth factor I receptor (IGF-IR) expression in rhabdomyosarcoma (RMS) tumor tissue. To assess the feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue. OUTLINE: Paraffin-embedded tumor tissue slides are analyzed for insulin-like growth factor I receptor (IGF-1R) expression by mass spectrometry and correlated with the results obtained by IHC assay.

Official Title
-----------------
A Study to Assess and Quantify Surface Insulin-like Growth Factor I Receptor (IGF-IR) in Rhabdomyosarcoma (RMS) Tumor Tissue

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis
* Other: mass spectrometry


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of rhabdomyosarcoma Alveolar or embryonal rhabdomyosarcoma Available samples from the Cooperative Human Tissue Network (CHTN) bank PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|
|Other: mass spectrometry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Degree of surface IGF-IR expression in RMS tumor tissue |  |  | 
| Feasibility and validity of a mass spectrometry assay for IGF-IR expression on paraffin-embedded tumor tissue |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alveolar childhood rhabdomyosarcoma, embryonal childhood rhabdomyosarcoma, previously treated childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip

Study Overview
=================
Brief Summary
-----------------
This is a prospective, multicenter, single arm feasibility study of the safety and performance of the GRADION™ Hip Total Cartilage Replacement (TCR)™ in patients who require cartilage replacement.

Official Title
-----------------
A Prospective, Multicenter, Single Arm Feasibility Study of the Safety and Performance of GRADION™ Hip Total Cartilage Replacement (TCR)™ in the Treatment of Degenerative Joint Disease of the Hip

Conditions
-----------------
Degenerative Joint Disease of the Hip

Intervention / Treatment
-----------------
* Device: GRADION™ Hip Total Cartilage Replacement (TCR)™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary hip surgery for Noninflammatory Degenerative Joint Disease (NIDJD) such as osteo/degenerative arthritis, and is indicated for cartilage replacement Skeletally mature or at least 18 years of age and has normal anatomy Patient signs the Informed Consent form Failed medical management There will be size limitations on patients also - available size range is 46mm-54mm. Exclusion Criteria: Allergic to polyether urethane, sodium polyacrylate, bone cement or any of its components Previous fusion, acute femoral neck fracture and/or above knee amputation Revision of any previous hip procedure Slipped capital femoral epiphysis (SCFE) Rheumatoid arthritis AVN

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: GRADION™ Hip Total Cartilage Replacement (TCR)™<br> | Device: GRADION™ Hip Total Cartilage Replacement (TCR)™<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 6 months |
Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the tooth colour changes caused by retainers made of stainless steel wires and fiber reinforced in long term

Detailed Description
-----------------
30 patients who were planned to use lower fixed retainer after fixed orthodontic treatment, were included in the study and divided into 3 groups. (n=10) (Group 1: Bond a braid retainer, Group 2: Ribbond retainer, Group 3: EverStick Ortho retainer). Colour measurements will be made with spectrophotometer (Vita easyshade) after debonding (T1), after retainer application (T2), in 1 month, 3 month, 6 month and finally 1 year from 6 lower anterior teeth. The Commission Internationale de I'Echairage L*a*b* system will be used to determine the tooth colour. ∆E values measured at different times will be compared.

Official Title
-----------------
Effects of the Different Orthodontic Fixed Retainers on Enamel Colour Change

Conditions
-----------------
Tooth Color

Intervention / Treatment
-----------------
* Other: Bond-a braid
* Other: EverStick-Ortho
* Other: Ribbond


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with no anomalies of lower incisors and canine teeth Exclusion Criteria: patients drinking more then 3 cups of coffee per day smoker patients

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tooth color measurement<br>Tooth color changes between times (before retainer bonding, after retainer bonding, in 1 month, 3 months, 6 months and a year) | Other: Bond-a braid<br>* Stainless steel lingual retainer application<br>Other: EverStick-Ortho<br>* Fiber reinforced lingual retainer<br>Other: Ribbond<br>* Fiber reinforced lingual retainer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tooth color change | Measurement of tooth color change with spectrophotometry | before debonding, after debonding on 1st, 3rd, 6th months and 1st year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tooth color change
Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of MBP8298 compared to placebo in subjects with Secondary Progressive Multiple Sclerosis (SPMS)

Official Title
-----------------
A Double-Blind, Placebo Controlled Multi-Center Study to Evaluate the Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis, Secondary Progressive

Intervention / Treatment
-----------------
* Drug: MBP8298


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male of female subjects, 18-65 years of age with a diagnosis of SPMS HLA DR2 and/or DR4 positive Absence of a relapse in the 3 months prior to baseline EDSS of 3.0 - 6.5 Exclusion Criteria: Therapy with Beta-interferon, glatiramer acetate within 3 months or mitoxantrone, cyclophosphamide, methotrexate, azathioprine or any immune modulating or immunosuppressive drugs within 6 months of baseline Treatment with Tysabri within 2 years of baseline Females who are breast feeding, pregnant (pregnancy test at baseline) or not using a medically approved method of contraception regularly Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MBP8298<br>* 500mg MBP8298 IV every six months for a period of two years<br>|
| Placebo Comparator: 2<br> | Drug: MBP8298<br>* 500mg MBP8298 IV every six months for a period of two years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression of disease in subjects with SPMS as measured by the EDSS after 24 months of treatment |  | 24 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of MBP8298, degree of change in the EDSS scores, effect of MBP8298 on MRI parameters, difference in relapse rates, effect on MSFC, subject's quality of life (MSQoL54) and fatigue (MFIS) after 24 months of treatment |  | 24 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Secondary Progressive Multiple Sclerosis, Multiple Sclerosis
Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia

Study Overview
=================
Brief Summary
-----------------
This study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.

Detailed Description
-----------------
There are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics.

Official Title
-----------------
Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis

Conditions
-----------------
Bacteremia, Infection, Bacterial

Intervention / Treatment
-----------------
* Drug: Ertapenem
* Drug: Carbapenems


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, either sex, ages 18 years or above Patients with 3GCRE bacteremia Patients admitted to any of the study sites Exclusion Criteria: Discontinuation of antibiotic due to transition to hospice care Polymicrobial bacteremia Empirical antibiotic after 24 hours of first evidence of bacteremia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Ertapenem<br>Patients who received ertapenem as an empirical antibiotic | Drug: Ertapenem<br>* Ertapenem injection<br>|
| Other carbapenems<br>Patients who received carbapenems other than ertapenem as an empirical antibiotic | Drug: Carbapenems<br>* Other carbapenems injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day mortality | death from any cause within 30 days after the blood culture with bacteraemia is drawn | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | death from any cause within the duration of admission with bacteraemia | 90 days | 
| 14-day mortality | death from any cause within 14 days after the blood culture with bacteraemia is drawn | 14 days | 
| 90-day mortality | death from any cause within 90 days after the blood culture with bacteraemia is drawn | 90 days | 
| • Length of stay | Duration of admission with bacteraemia | 90 days |
Effect of Food Intake on Pharmacokinetic Profiles of Z-338

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of food intake on plasma concentration of Z-338 in healthy volunteers.

Detailed Description
-----------------
The purpose of the study is to evaluate the influence of food intake on the pharmacokinetic profiles of Z-338 in healthy volunteers by a 3-way cross-over method.

Official Title
-----------------
A Pharmacokinetics Study to Evaluate the Effect of Food Intake on PK Profile of Z-338 in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Z-338


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subject Body weight: 50.0 - 80.0 kg BMI: 17.6 - 26.4 Exclusion Criteria: Receiving an investigational new drug within 120 days of the study Receiving medical treatment drugs within 7 days of the study Blood donation before the study

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. Z-338<br>3-way cross-over study (drug administration 3-times in fasted and 2 fed conditions) | Drug: Z-338<br>* oral<br>* Other names: YM443;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of Z-338 |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Z-338, YM443, healthy volunteers
High Septal Pacing for Cardiac Resynchronization Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this acute study is to perform a preliminary investigation of high septal right ventricular pacing in the vicinity of the His bundle region as an alternate or adjunctive means for cardiac resynchronization in patients with heart failure and wide QRS.

Detailed Description
-----------------
The HISTORY Study is an acute, cross-sectional, multi-center, feasibility study with a randomized within patient test sequence designed to characterize the effects of high septal right ventricular pacing in the vicinity of the His bundle region compared to conventional biventricular pacing for cardiac resynchronization therapy.

Official Title
-----------------
High Septal Pacing for Cardiac Resynchronization Therapy Acute Research Study

Conditions
-----------------
Heart Failure, Left Bundle Branch Block, Heart Disease

Intervention / Treatment
-----------------
* Device: Cardiac Pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 50 years of age or older Patients willing and capable of providing informed consent, participating in all testing associated with this clinical investigation Patients undergoing a CRT implant procedure (pacemaker or defibrillator) for one of the following reasons Indicated for a new device Device upgrade Device replacement Lead revision Note: recognized indications for CRT-P and CRT-D as of October 2009 are valid for inclusion in this study. Should new indications become approved during the study conduct; those will also be applied within the inclusion criteria. Exclusion Criteria: Patients unwilling or incapable of signing the informed consent, or patients having previously withdrawn their consent Patients in AF that cannot be cardioverted for the study RBBB pattern Sustained, uncontrolled ventricular tachycardia Sinus rhythm < 30 bpm or >100 bpm Complete AV node block Second degree AV block Women who are pregnant or plan to become pregnant during the study (method of assessment upon physician's discretion); History of (hemorrhagic) cerebro-vascular accident or TIA

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| Patients with heart failure and wide QRS<br>Patients undergoing a cardiac resynchronization therapy procedure | Device: Cardiac Pacing<br> <br> |

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
-----------------
Pacing, Cardiac Resynchronization Therapy, His Bundle
Vascular Function on the First Day After Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This study examines the flow mediated dilation (FMD) of the brachial artery before and after cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved trough obstructing blood flow with a cuff around the forearm for five minutes. FMD is measured before surgery and on the first morning after the operation.

Official Title
-----------------
Vascular Function on the First Day After Cardiac Surgery

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: admitted for coronary artery bypass surgery Exclusion Criteria: Ongoing treatment with nitrates or RAAS inhibiting drugs unstable coronary syndrome unstable circulation/shock renal failure hepatic failure autoimmune or inflammatory disease untreated hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| CABG patients<br>Patients undergoing cardiac surgery for coronary artery disease with the use of heart-lung machine in St Olavs Hospital Trondheim University Hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| flow mediated dilation of the brachial artery | Transitory change in FMD as a consequence of cardiac surgery with use of extra corporal circulation. | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive hyperemia | Transitory change in reactive hyperemia after five minutes of occlusion of forearm blood flow as a consequence of cardiac surgery with the use of extra corporal circulation. | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Surgical Procedures, Heart-Lung Machine, Coronary Artery Bypass, Brachial Artery, Vasodilation, Regional Blood Flow, Ultrasonography
A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

Study Overview
=================
Brief Summary
-----------------
Objective and Principle: To evaluate whether enlarging the incision can reduce corneal complications associated with phacoemulsification with regular 2.2 mm incision. The aim of this study: To evaluate whether the technique of enlarging internal incision could reduce the incidence of descemet membrane detachment after 2.2 mm incision phacoemulsification. Secondary outcome: To evaluate whether the technique of enlarged internal incision can reduce other corneal complications such as corneal edema and astigmatism after 2.2 mm incision phacoemulsification. Study Design: A prospective randomized controlled study

Official Title
-----------------
A Randomized Controlled Study of Phacoemulsification by the Enlarged Internal Incision and the Regular 2.2mm Incision

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Procedure: enlarged internal incision
* Procedure: regular 2.2mm incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age-related cataract patients Age from 65 to 90 The diameter of pupil after mydriasis is more than 6 mm LOCS III nuclear grade ≥4 Corneal endothelial cell count > 1500 cells/mm2 Phacoemulsification and intraocular lens implantation are planned Agree to participate in this study and sign informed consent Exclusion Criteria: History of ocular trauma Anterior segment lesions (exfoliation syndrome, suspension ligament injury or relaxation, corneal and iris lesions, glaucoma) Other ocular diseases that impair visual function, such as optic neuropathy, uveitis and ocular tumors History of Ophthalmic Surgery Intraoperative and Postoperative Complications

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 90 Years

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

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

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: Enlarged internal incision<br>enlarged the internal incision about 0.4mm | Procedure: enlarged internal incision<br>* enlarging the internal incision about 0.4mm<br>|
| Placebo Comparator: Regular 2.2mm incision<br>regular 2.2mm corneal incision for microincision coaxial phacoemulsification | Procedure: regular 2.2mm incision<br>* 2.2mm microincision coaxial phacoemulsification<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| descemet membrane detachment(DMD) | DMD at the incision observed by anterior segment optical coherence tomography | postoperative 1 week |