linjc16/ctgov huggingface dataset:
Stroke Imaging Package Study

Study Overview
=================
Brief Summary
-----------------
Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.

Detailed Description
-----------------
Patients with acute ischemic stroke within 4.5-72h after onset were prospectively enrolled in our study and underwent standardized clinical and new imaging technique package assessment. New imaging technique package mainly includes conventional cranial MRI （T1,T2,T2 FLAIR,DWI, and ADC), cranial magnetic resonance angiography (MRA), and intracranial vessel wall imaging (High-Resolution Magnetic Resonance Imaging,HRMRI) as well as susceptibility weighted imaging (SWI). The neurofunctional fluctuation during hospitalization as well as 90-day outcomes were carefully assessed. Patients were followed up for 90-days after stroke onset. Our study aims to explore the value of new imaging technique package in predicting early neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute ischaemic stroke.

Official Title
-----------------
Stroke Imaging Package Study

Conditions
-----------------
Acute Ischemic Stroke, Intracranial Arteriosclerosis, Cerebral Small Vessel Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with ischemic stroke and hospitalized during 4.5-72 hours after onset , confirmed by diffusion weighted imaging (DWI). patients with stable vital signs. patients who have underwent thrombolytic/intravascular therapy are allowed to enroll in the study. Exclusion Criteria: patients with absolute/relative contraindication to MRI (including but not confined to metal in the body and claustrophobia). patients who is extremely agitated, and cannot comply with MRI exam. patients who declined the consent.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| early neurological deterioration within 3 weeks after stroke onset (END-3 weeks) | END-3 weeks is defined as a significant neuro-functional decline [increment of the National Institutes of Health Stroke Scale (NIHSS) ≥ 2 points ] within 3 weeks after admission. | 3 weeks after stroke onset | 
| 90-days prognosis | 90-days prognosis included two parts :1) stroke recurrence with new lesion on DWI;2) the modified Ranking Score (mRS) at 90-days after stroke onset. | 90-days after stroke onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AIS, ICAS, CSVD
Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System (G030265)

Study Overview
=================
Brief Summary
-----------------
To demonstrate the safety and efficacy of the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System using a composite clinical success (CCS) primary endpoint.

Detailed Description
-----------------
The results from the Cormet Large Diameter Metal on Metal (LDMOM) Total Hip System cohort will be compared to the historical results from a ceramic on ceramic (CoC) hip system cohort. The primary endpoint clinical composite success (CCS) criterion at 24 months postoperative is based on a Harris Hip Score ≥ 80 and the absence of any revision,replacement, or modification of any study component.

Official Title
-----------------
Large Diameter Metal-on-Metal Total Hip System IDE

Conditions
-----------------
Osteoarthritis, Rheumatoid Arthritis, Avascular Necrosis

Intervention / Treatment
-----------------
* Device: Large Diameter Metal on Metal


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA: Patient: is skeletally mature is mentally capable of completing follow-up forms will be available for follow-up out to 2 years has a preoperative Harris Hip Score <70 points has been deemed a candidate for hip replacement by diagnosis of the investigator. EXCLUSION CRITERIA: Patient: has active joint infection has had previous hip arthrodesis (fusion) has had above knee amputation of either extremity has active neoplastic disease has a need for a structural bone graft in the operative side has an ipsilateral hemi or total arthroplasty of any kind has a nonunion or malunion of any part of the femur on operative side has severe osteoporosis of the pelvis and/or femur as noted on standard radiograph is a prisoner is pregnant is known to be allergic to implant materials is morbidly obese.

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: Large Diameter Metal on Metal<br> | Device: Large Diameter Metal on Metal<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite clinical criterion | Based on Harris Hip Score ≥ 80, and absence of any revision, replacement, or modification of any study component | 24-months postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthritis
Hyperfibrinogenemia After Major Trauma

Study Overview
=================
Brief Summary
-----------------
Assessment of the evolution of fibrinogen plasma level within the first ten days after major trauma in order to determine prevalence of hyperfibrinogenemia (Fg > 4 g/L) and its time to onset.

Detailed Description
-----------------
In this study, investigators daily investigate fibrinogen plasma levels and fibrinogen antigen in severe trauma patients (Injury severity score > 15) within the first ten days. Investigators then modelize hyperfibrinogenemia profiles according to severity of injuries and physiopathologic mechanisms. Finally, investigators determine predisposing risk factors to develop hyperfibrinogenemia and assess the impact of fibrinogen replacement therapy in initial phase of management of major trauma.

Official Title
-----------------
Hyperfibrinogenemia Within the First Days After Major Trauma : Kinetic, Functionality, Impact of Fibrinogen Replacement Therapy and Trauma, Thrombosis Risk

Conditions
-----------------
Major Trauma

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years old. Polytrauma with ISS Score > 15 Hospitalized patients in reanimation unit < 4h after trauma Informed consent Exclusion Criteria: Patients in another study Pregnant or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Severe trauma patients<br>All severe trauma patients (ISS>15) admitted in our trauma center Blood samples (additional blood tubing) | Procedure: Blood samples<br>* Investigators analyze hematological parameters with blood sampled daily in severe trauma patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| daily fibrinogen level >4 g/L | the occurrence and delay of fibrinogen level > 4 g/L after major trauma | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessing predisposing risk factors of hyperfibrinogenemia (> 4 g/l) | Initial chock status severity, vascular filling, initial acidose, hypothermia, trauma severity (ISS scores, Sequential Organ Failure Assessment (SOFA), IGS2), numbers and sites of lesions (AIS scores), severity of initial failure of fibrinogene, administration of fibrinogene at initial hemorrhagic phase… | 10 days | 
| plasmatic fibrinogen level evolution |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibrinogen level, Hyperfibrinogenemia, Trauma, Thrombosis risk
RHODOS Follow-up Single-visit Study

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare this with the last visit from the SNT-II-003 study.

Official Title
-----------------
A Single Visit, Observational, Follow-up Study of Patients With Leber's Hereditary Optic Neuropathy Following Participation in SNT-II-003 Trial

Conditions
-----------------
Leber's Hereditary Optic Neuropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in study SNT-II-003

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 69 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 |
| --- | --- | --- |
| logMAR visual acuity | Change in best logMAR visual acuity (Best Acuity) compared to Visit 2/Baseline and Visit 5/Week 24 or last treatment visit of SNT-II-003 | measure taken at the single study visit (Week 24) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
leber's hereditary optic neuropathy, idebenone
Cascade PRFM Study: The Evaluation of Cascade Platelet-Rich Fibrin Matrix (PRFM) on Rotator Cuff Healing

Study Overview
=================
Brief Summary
-----------------
Hypothesis: The use of cascade platelet-rich fibrin matrix (PRFM) on medium and large sized rotator cuff tears will improve patient results versus the control results by 50%. The purpose of this study is to examine the effect of PRFM on rotator cuff repairs. Since locally applied platelet-derived growth factor (PDGF) has shown early promise in enhancing tendon and ligament healing in anterior cruciate ligament (ACL) and medial collateral ligament (MCL) reconstruction, the investigators believe that locally applied PRFM will enhance the quality of rotator cuff repairs.

Official Title
-----------------
The Evaluation of Cascade PRFM on Rotator Cuff Healing

Conditions
-----------------
Rotator Cuff, Tendon Injuries

Intervention / Treatment
-----------------
* Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 45 years of age and older who have failed conservative treatment for rotator cuff pathology. Patients in this study will have full thickness rotator cuff tears that are classified arthroscopically as medium (1 to 3 cm) or large (3 to 5 cm) and that are treated with arthroscopic repair. Exclusion Criteria: Patients who have undergone revision procedures, mini-open, or open procedures will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Placement of Platelet Rich Fibrin Matrix During Arthroscopic Rotator Cuff Surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L'Insalata: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively |  |  | 
| American Shoulder and Elbow Surgery (ASES) Patient Survey: preoperatively, 6 weeks, 3 months post-operatively, 12 months post-operatively |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound (power Doppler imaging): 6 weeks, 3 months post-operatively |  |  | 
| Manual muscle testing using a dynamometer: preoperatively, 3 months post-operatively, 6 months post-operatively |  |  | 
| ASES Physician Survey: preoperatively, 3 months post-operatively, 12 months post-operatively |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Full Thickness Tendon Defect of Rotator Cuff
Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Pulmonary dysfunction after cardiac surgery with CPB remains to be a problem complicating the postoperative course of the patients. The investigators hypothesized that RIPCcom, combined intervention of remote ischemic preconditioning and remote ischemic postconditioning, would confer beneficial influence on inflammatory response and resultant postoperative pulmonary dysfunction after CPB in patients undergoing complex valvular heart surgery who are at increased risk of postoperative pulmonary dysfunction.The aim of this study was to evaluate the lung-protective effect of combined remote ischemic pre- and post-conditioning in patients undergoing complex valvular heart surgery.

Official Title
-----------------
Effect of Combined Remote Ischemic Preconditioning and Postconditioning on Acute Pulmonary Injury in Patients Undergoing Valvular Heart Surgery

Conditions
-----------------
Heart Valve Diseases

Intervention / Treatment
-----------------
* Procedure: remote ischemic pre and postconditioning (RIPC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing valvular heart surgery. Age: 20 80. Exclusion Criteria: Emergency operation. patients with peripheral vascular disease. Patients with a known history or clinical evidence of chronic obstructive pulmonary disease. Patients with hepatic or renal dysfunction Patients with acute myocardial infarction within 1 week before surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPCcom group<br> | Procedure: remote ischemic pre and postconditioning (RIPC)<br>* RIPCcom group: combined intervention of remote ischemic pre- and postconditioning consisted of three 10-minute cycles of right lower limb ischemia, which was induced with an automated cuff-inflator placed on the right upper leg and inflated to 250 mmHg, with an intervening 10 minute of reperfusion during which the cuff was deflated. This intervention were performed at 10 minutes after induction of anesthesia and then 10 min after weaning from CPB.<br>* Other names: combined intervention of remote ischemic preconditioning and remote ischemic postconditioning.;|
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of postoperative PaO2/FiO2 | Comparison of postoperative PaO2/FiO2 between RIPCcom group and Control group. | at 10 minutes after anesthetic induction |
MediGuide Registry

Study Overview
=================
Brief Summary
-----------------
The goal of this registry/observational study is to collect data on the clinical utility of MediGuide™ system in cardiac resynchronization therapy (CRT) implantation and electrophysiology (EP) procedures.

Detailed Description
-----------------
The intent of this worldwide registry/observational study is to understand the utility of the MediGuide™ technology in real world clinical practice during CRT implantation and study-specific-EP procedures. The study should provide an understanding of the effect of MediGuide™ technology on: The amount of fluoroscopy time and the radiation exposure Total procedure time Peri-procedural clinical event rate Additionally, this study will address the following Identification of procedural challenges which may aid in developing future MediGuide tools Evaluation of newly available MediGuide tools during the study Correlation between MediGuide operator experience and the radiation exposure amount and time

Official Title
-----------------
MediGuide Registry

Conditions
-----------------
Heart Failure, Cardiac Arrhythmia

Intervention / Treatment
-----------------
* Procedure: CRT implantation
* Device: MediGuide
* Procedure: EP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anybody coming for CRT or EP procedure utilizing MediGuide system and tools Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRT<br>Patients who are undergoing CRT implantation utilizing MediGuide system and tools | Procedure: CRT implantation<br>* It is a novel 3D electromagnetic navigation system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray environment<br>Device: MediGuide<br> <br> |
| EP<br>Patients who are undergoing ablation procedures for Atrial Fibrillation, Atrial Flutter, and Ventricular Tachycardia utilizing MediGuide system and tools | Device: MediGuide<br> <br> Procedure: EP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of Fluoroscopy Time | Amount of fluoroscopy time during CRT implant or EP procedure | Expected time frame is day 1 of the study | 
| Periprocedural Adverse Event | Adverse event until patients are discharged from the site center | From the day of CRT and EP procedure until patient discharge, expected stay is an average of 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
utility of MediGuide system, CRT, EP
Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus (T2DM) on Background Therapy With Pioglitazone

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and efficacy of dutogliptin in patients with type 2 diabetes mellitus (T2DM) who are receiving background treatment with pioglitazone.

Official Title
-----------------
A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Dutogliptin in Patients With Type 2 Diabetes Mellitus on Background Treatment With Pioglitazone

Conditions
-----------------
Diabetes Mellitus, Type II

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Dutogliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus, diagnosed at least 3 months prior to Screening (Visit 1) BMI 20 to 48 kg/m2, inclusive HbA1c 7.0% - 10.0%, inclusive Age 18 to 85 years, inclusive Exclusion Criteria: Currently taking more than one oral hypoglycemic agent Type 1 diabetes mellitus

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>placebo, oral tablet administered once daily on background of pioglitazone | Drug: Placebo<br>* placebo, oral tablet administered once daily on background of pioglitazone<br>|
| Experimental: 2<br>dutogliptin, oral tablet administered once daily on background of pioglitazone | Drug: Dutogliptin<br>* dutogliptin, oral tablet administered once daily on background of pioglitazone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c Level (HbA1c) |  | HbA1c is drawn at Visit 1 (Week -16 to -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Week 8 (Week 26) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Plasma Glucose Level (FPG) |  | FPG is drawn at Visit 1 (Week -16 to -4), Visit 2 (Week -4), Visit 3 (Week -2), Visit 4 (Week 0), Visit 5 (Week 4), Visit 6 (Week 10), Visit 7 (Week 18) and Visit 8 (Week 26). |
A Retrospective Molecular Epidemiology Study in Singapore Patients With Advanced Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Histology to Assess Epidermal Growth Factor Receptor (EGFR) Mutation Status

Study Overview
=================
Brief Summary
-----------------
To determine EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC. To determine the association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.

Conditions
-----------------
NSCLC

Intervention / Treatment
-----------------
* Other: EGFR mutation status in patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nil Exclusion Criteria: Nil

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EGFR mutation status in patients<br> | Other: EGFR mutation status in patients<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
-----------------
EGFR mutation status in patients with advanced stage adenocarcinoma NSCLC, The association between EGFR mutation status and demographic data in advanced stage adenocarcinoma NSCLC patients.