linjc16/ctgov huggingface dataset:
EEG Data Collection to Evaluate New Patient State Index Performance

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-center, cohort study in patients undergoing surgical procedures to collect data using Masimo SedLine EEG device in order to evaluate a newer version of PSI measurement against an older version of PSI measurement.

Official Title
-----------------
EEG Data Collection to Evaluate New Patient State Index Performance

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Device: PSI Rev 1.X
* Device: PSI Rev 2.X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA status of I, II, or III. Subjects undergoing general surgery. neurologically intact patients (e.g. no history or presence of traumatic brain injuries, neurological diseases, etc.). Exclusion Criteria: subjects with any deformities, diseases, or for any other reason that may present proper fit and application of SedLine sensors. inability to obtain subject's physiological, vital, demographics, and real time anesthesia data. Subjects who are pregnant. known history of drug abuse. subjects deemed not suitable for study at the discretion of the Principal Investigator.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of care (baseline)<br>Subjects will receive the Sedline sensor. The anesthesiologist will be blinded to the PSI Rev 1.X score and the raw EEG data from the Masimo device. Anesthesia management will be in accordance with standard of care protocols and procedures. | Device: PSI Rev 1.X<br>* PSI Rev 1.X is an older version of the PSI measurement.<br>|
| Experimental: PSI Rev 1.X<br>The anesthesiologist will be monitoring subjects using an old version of PSI (Rev 1.X). | Device: PSI Rev 1.X<br>* PSI Rev 1.X is an older version of the PSI measurement.<br>|
| Experimental: PSI Rev 2.X<br>The anesthesiologist will be monitoring subjects using a new version of PSI (Rev 2.X). | Device: PSI Rev 2.X<br>* PSI Rev 2.X is a newer version of the PSI measurement.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wake up Times, PSI 1.X vs. PSI 2.X | Compare the length of time from when the anesthesia has ended to the time of Return of Consciousness (ROC) between the PSI 1.X group and the PSI 2.X group. | From the end of anesthesia to the time of Return of Consciousness |
ADRCs in The Treatment of Hand Dysfunction Due to Scleroderma

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

Detailed Description
-----------------
The primary objective of this study is to assess the safety and efficacy of the Celution Device in the processing of an autologous graft consisting of adipose derived regenerative cells (ADRCs) in the treatment of hand dysfunction due to scleroderma.

Official Title
-----------------
Scleroderma Treatment With Celution Processed Adipose Derived Regenerative Cells - A Randomized, Double-Blind, Placebo-Controlled Study - The STAR-II Trial

Conditions
-----------------
Scleroderma, Diffuse

Intervention / Treatment
-----------------
* Device: ADRCs
* Other: Standard Care
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Diffuse cutaneous scleroderma (duration > 5 years) Cochin Hand Function Scale ≥ 20 units Symptoms consistent with Raynaud's Phenomenon Ability to safely undergo liposuction Key Exclusion Criteria: Active infection Contracture(s) of any finger Sympathectomy within 6 months of Screening Visit Rheumatoid Arthritis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Interventional Model Description: Prospective Randomized Parallel Group Placebo-Controlled Safety and Efficacy Trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADRC Arm<br>Subjects in the ADRC arm will receive standard care and active treatment (ADRCs) | Device: ADRCs<br>* Adipose Derived Regenerative Cells (ADRCs) processed with Celution System<br>Other: Standard Care<br>* Standard care<br>|
| Placebo Comparator: Standard Care Arm<br>Subjects in the Standard Care arm will receive standard care and Placebo | Other: Standard Care<br>* Standard care<br>Other: Placebo<br>* Placebo visually indistinguishable from ADRCs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cochin Hand Function Score | Cochin Hand Function Score | 26 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand Dysfunction, Scleroderma, Scleroderma, Diffuse
Treatment of Immunoglobulin A (IgA) Nephropathy by Angiotensin-Converting Enzyme (ACE) Inhibitor

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of the ACE inhibitor ramipril in the treatment of early IgA nephropathy.

Official Title
-----------------
Treatment of Early Immunoglobulin A Nephropathy by ACE Inhibitor - a Randomized Controlled Trial

Conditions
-----------------
Glomerulonephritis

Intervention / Treatment
-----------------
* Drug: Ramipril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: biopsy-confirmed IgA nephropathy proteinuria less than 0.5 g per day, normal blood pressure, and serum creatinine below 120 µmol/l Exclusion Criteria: pregnant or nursing mother, or women of childbearing potential without an effective method of birth control history of myocardial infarction, congestive heart failure, or any other medical indication that necessitate the use of ACE inhibitor evidence of clinically significant hepatic, gastrointestinal, autoimmune disease history of malignancy, drug or alcohol abuse participation in any previous trial on ACE inhibitor taking other investigational drugs within the past 30 days known history of sensitivity / allergy to ACE inhibitor The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ramipril | Drug: Ramipril<br>* 2.5mg and increase to 5mg if patient do not develop symptomatic hypotension<br>|
| No Intervention: 2<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of hypertension (defined as blood pressure above 140/90 mm Hg and require anti-hypertensive therapy) |  | From the beginning to the end of the study | 
| Development of proteinuria |  | From the beginning to the end of the study | 
| 20% decline in creatinine clearance, as determined by 24-hour urine collection or estimated by the Gault-Cockroft equation |  | From the beginning to the end of the study | 
| body weight, blood pressure, pulse |  | From the beginning to the end of the study | 
| Adverse effects of treatment |  | From the beginning to the end of the study |
Sorafenib to Treat FLT3-ITD AML

Study Overview
=================
Brief Summary
-----------------
It is a prospective, non-interventional, open-label study, in order to observe the safety and response in FLT3-ITD mutation positive AML patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. The duration of the study from June 2014 through May 2019, with the recruitment duration from June 2014 to May 2017. The inclusion criteria is: Definitely diagnosed as AML FLT3-ITD mutation has been confirmed Accepting the prescription of sorafenib

Official Title
-----------------
Sorafenib to Treat AML Patients With FLT3-ITD Mutation: a Non-interventional Cohort Study

Conditions
-----------------
Acute Myeloid Leukemia, FLT3-ITD Mutation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Definitely diagnosed as AML FLT3-ITD mutation has been confirmed Accepting the prescription of sorafenib Exclusion Criteria: Can not take drugs orally Can not follow the doctors' advices Other reasons that investigators considered as contra-indications for this 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 |
| --- | --- |
| Induction Group<br> | |
| Consolidation Group<br> | |
| Salvage Group<br> | |
| Maintenance Group<br> | |
| Alleviatitive Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate |  | up to 2 years | 
| Progress-Free Survival |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | up to 2 years | 
| Leukemia-Free Survival |  | up to 2 years | 
| Median time to the onset of sorafenib resistance |  | up to 2 years |
Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a First Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the real-world prescription patterns of Palbociclib in breast cancer (BC) patients who were treated with Palbociclib in combination with AI as a 1st line of therapy using the national health insurance claims data in South Korea.

Official Title
-----------------
Analysis of the Real-world Prescription Pattern of Palbociclib Combination Therapy With Aromatase Inhibitor as a 1st Line Therapy in Metastatic Breast Cancer Patients Using the National Health Insurance Claims Data in South Korea

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

Intervention / Treatment
-----------------
* Drug: Patients who received Palbociclib as first line therapy in MBC setting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were prescribed with palbociclib in combination with AI for at least 1 cycle during the index period Patients who were diagnosed with BC during the index period Exclusion Criteria: Male Prescribed with palbociclib during 12-month period preceding the index date

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Patients who received Palbociclib as first line therapy in MBC setting|Patients who received Palbociclib as first line therapy in MBC setting|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total treatment duration and cycle for Palbociclib |  | From index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the end date of last palbociclib prescription (maximum of 34.8 months from the index date) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment on dose modification of Palbociclib as first line of therapy in BC patients in real-world setting. |  | From the index date (Index date: 06 Nov 2012 to 30 Sep 2020) to the time of reduction or increase in the dose given in the subsequent Palbociclib prescription (up to 30 Sep 2020) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hormone receptor positive (HR+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-), Metastatic Breast Cancer (MBC)
Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)

Study Overview
=================
Brief Summary
-----------------
It is generally estimated that 5 % of patients with thyroid cancer will develop distant metastases, and most of them had an advanced stage of the disease at presentation. Thirty per cent of them are resistant to radio iodine therapy and are called refractory. Their long term survival is estimated to be less than 10 %. The objective of this study is to identify the factors associated with poor outcome in a cohort of patients with advanced thyroid cancer followed during 5 years. Anaplastic and medullary thyroid carcinomas were excluded.

Official Title
-----------------
Determination of Pronostics Factors for Advanced Thyroid Carcinoma (pT3 pT4 or M1 at Diagnosis)

Conditions
-----------------
Thyroid Cancer

Intervention / Treatment
-----------------
* Other: follow up visit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Man or woman ≥ 18 years. Thyroid cancer differentiated from follicular origins (papillary, vesicular or poorly differentiated carcinoma). TNM classification: stage pT3 (≥2 cm), or pT4 or M1 at diagnosis. Patient after post operative radioiodine therapy. Exclusion Criteria: Patient who can not be followed during the protocol. Patient who does not consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: follow up<br> | Other: follow up visit<br>* At least 1 follow up visit per year will be done and an additional visit if needed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Thyroid cancer evolving to refractory stage |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroid carcinoma, predictive factors, refractory, Differentiated, follicular origin
Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the benefits of continuing celecoxib through six weeks of total knee arthroplasty recovery. This is a randomized, double blind study with a group of approximately 130 primary total knee patients. All patients will receive celecoxib throughout their hospitalization as per current minimally invasive total knee arthroplasty protocol. At the time of hospital discharge, participating patients will be randomly placed on either celecoxib 200mg twice a day or a placebo twice a day. This study will determine if the continued use of celecoxib for six weeks after total knee arthroplasty hospitalization will further decrease narcotic consumption, improve knee range of motion, improve ambulatory ability, and improve patient satisfaction over patients receiving celecoxib only during the acute hospitalization.

Official Title
-----------------
Evaluation of Post Hospital Administration of Celecoxib Following Minimally Invasive Knee Replacement Surgery: A Randomized Controlled Study

Conditions
-----------------
Pain Management, Function, Minimally Invasive Total Knee Arthroplasty, Celecoxib

Intervention / Treatment
-----------------
* Drug: Celecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having undergone a minimally invasive total knee by select surgeon voluntarily enrolled independent community ambulators only patients being discharged directly home Exclusion Criteria: celecoxib allergy or intolerence Renal insufficiency (defined as serum creatine level >1.5 mg/dL or BUN level >22mg/dL History of bleeding gastic or duodenal ulceration New York Heart Association Class III or IV Congestive Heart Failure Previous myocardial infarction or cerebralvascular event Severe inflammatory bowel disease Known coagulation abnormality or hepatic disease Chronic coumadin administration Refusal by primary or cardiac physician
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial

Study Overview
=================
Brief Summary
-----------------
This is a large pragmatic multicenter trial comparing maintenance of general anesthesia with total intravenous anesthesia using propofol versus volatile agent (sevoflurane, isoflurane, or desflurane) during cancer surgery. The primary endpoint is all-cause mortality.

Official Title
-----------------
General Anesthetics in CAncer REsection Surgery (GA-CARES) Trial: Pragmatic Randomized Trial of Propofol vs Volatile Inhalational Anesthesia

Conditions
-----------------
Anesthesia, General, Surgical Oncology

Intervention / Treatment
-----------------
* Drug: Propofol
* Drug: Volatile Agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with known or suspected cancer and scheduled to undergo any of the following oncologic surgical procedures: Lobectomy or pneumonectomy Esophagectomy Radical (total) cystectomy Pancreatectomy Partial hepatectomy Hyperthermic intraperitoneal chemotherapy (HIPEC) Gastrectomy (subtotal or total) Cholecystectomy or bile duct resection Exclusion Criteria: Age less than 18 years American Society of Anesthesiologist Class 5 Projected life expectancy less than 30 days Known or suspected hypersensitivity to either propofol, e.g. egg or soy allergy, or volatile general anesthetic agents Known or suspected history of malignant hyperthermia

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propofol infusion<br>Maintenance of general anesthesia with propofol infusion | Drug: Propofol<br>* Maintenance of general anesthesia with propofol infusion<br>|
| Experimental: Volatile agent<br>Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane) | Drug: Volatile Agent<br>* Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Time to event | 2 year minimum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence free survival | Time to event | Minimum 2 years | 
| All-cause mortality as a binary outcome |  | 2 years |
Comparison of Tibial Plateau Fractures Outcomes Treated With Non-locking and Locking Plate

Study Overview
=================
Brief Summary
-----------------
this study will perform to compare the results and functional outcomes of tibial plateau fractures treated with non-locking and locking plate fixation.

Conditions
-----------------
Tibial Fracture

Intervention / Treatment
-----------------
* Device: Locking plate
* Device: Non-Locking plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral closed tibia plateau fracture Exclusion Criteria: patients who have been treated with casting or screw history of diabetes mellitus evidences of pathological fractures

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Locking plate<br> | Device: Locking plate<br> <br> |
| Active Comparator: Non-Locking plate<br> | Device: Non-Locking plate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knee society knee score |  | ten months after surgery |
The Effect of Reduced Dose of Enoxaparin on the Outcomes of Treatment With Enoxaparin

Study Overview
=================
Brief Summary
-----------------
We hypothesize that reduced dose of enoxaparin in elderly patients will result in reduced proportion of patients with therapeutic anti Xa activity and reduced clinical efficacy.

Detailed Description
-----------------
Patients treated with enoxaparin will be followed, sociodemographic , clinical and laboratory data will be collected. Clinical efficacy as well as adverse events will be monitored.

Official Title
-----------------
The Effect of Reduced Dose of Enoxaparin on the Laboratory and Clinical Outcomes of Treatment With Enoxaparin

Conditions
-----------------
Acute Coronary Syndrome, Venous Thromboembolism, Atrial Fibrillation, Hypercoagulability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: treatment with enoxaparin Exclusion Criteria: no

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleeding, anticoagulation, LMWH, Enoxaparin