linjc16/ctgov huggingface dataset:
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and feasibility of the NeuroFlo™ catheter in treating patients with ischemic stroke whose last time symptom-free was between 8-24 hours prior to treatment. The NeuroFlo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

Detailed Description
-----------------
The study is a prospective, single arm treatment feasibility trial to determine the baseline safety and feasibility of the NeuroFlo device in acute ischemic stroke patients whose last known time symptom-free is between 8-24 hours. A maximum of 25 patients at 5 US sites and 25 patients at 10 Canadian & European sites may be enrolled in this initial study phase. An independent data safety and monitoring board will assess the safety of the treatment on a routine basis.

Official Title
-----------------
Safety and Efficacy of NeuroFlo in 8-24 Hour Stroke Patients

Conditions
-----------------
Cerebrovascular Accident

Intervention / Treatment
-----------------
* Device: NeuroFlo™ Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic stroke NIHSS between 4-20 Time from symptom onset between 8 and 24 hours Exclusion Criteria: Hemorrhagic stroke Certain types of heart disease Kidney disease Other conditions the doctor will assess

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: NeuroFlo™ Catheter<br>* 45 minute Treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of all adverse events from baseline to 30 days post-treatment. |  | 30 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Potential benefit will be assessed through collection of neurological indices at baseline, post-procedure, 24 hours, day 4 (or discharge), 30 and 90 days. |  | 90 Days | 
| Cerebral perfusion changes associated with device therapy will be assessed using MRI perfusion studies acquired at baseline and ≤ 4 hours post-procedure. |  | ≤ 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute, ischemic, stroke, device, treatment
Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses

Study Overview
=================
Brief Summary
-----------------
The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. French neurologists treat such patients with intravenous corticosteroids. The aim of the study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is symptom recovery within 28 days after inclusion.

Official Title
-----------------
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses

Conditions
-----------------
Multiple Sclerosis, Relapsing-Remitting

Intervention / Treatment
-----------------
* Drug: methylprednisolone PO
* Drug: methylprednisolone IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 to 55 informed written consent multiple sclerosis (Mc Donald criteria, relapsing-remitting EDSS before relapse : 0 to 5 relapse : increase of 1 point or more for 1 or more functional systems of Kurtzke, with SF score most affected > 1 for all functions except for sensory (> 2); duration of symptoms > 24 h Exclusion Criteria: fever previous relapse, and/or corticosteroid treatment < 1 month before present relapse first symptoms of the present relapse appeared > 15 days before inclusion under mitoxantrone of cyclophosphamid or natalizumab treatment diabetes infection not under control liver or kidney failure psychiatric symptoms not under control pregnancy hypersensibility to methylprednisolone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: methylprednisolone PO<br> | Drug: methylprednisolone PO<br>* 10 capsules Methylprednisolone 100 mg and 50 ml IV NaCl 0,9% (syringe pump 30 mn to 2 h, every day during 3 days<br>|
| Active Comparator: methylprednisolone IV<br> | Drug: methylprednisolone IV<br>* IV Methylprednisolone 1 g in 50 ml NaCl 0,9% (syringe pump 30 mn to 2 h) and 10 capsules of placebo, every day during 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At least 1 point-reduction on Kurtzke functional scale |  | 28 days after beginning of corticotherapy |
Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ability of PET/MRI (Positron Emission Tomography/Magnetic Resonance Imaging) to give physicians preoperative information about specific sites in the body that the endometrial cancer may be present. If the PET/MRI is accurate and successful in providing this information, then women in the future may be able to have less extensive surgery for their endometrial cancer after evaluation with PET/MRI.

Detailed Description
-----------------
PET/MRI has recently become available at the institution and reports of its sensitivity, specificity, NPV (Negative predictive value) , PPV (Positive predictive value), and accuracy in endometrial cancer are not found in the literature to date, to the best of the investigator's knowledge. The GE PET/MRI recently obtained here at Mayo, Rochester has the potential to improve the sensitivity of detection of metastatic disease, compared to other imaging modalities, because of its superior PET technology and updated Q Clear software. For these reasons it is reasonable to expect improved sensitivity to detect metastatic disease in endometrial cancer, possibly proving PET/MRI to be a superior modality for preoperative screening and potentially allowing for less morbid surgical management for patients with high risk endometrial cancer.

Official Title
-----------------
Efficacy of PET/MRI in Detecting Metastatic Disease in Endometrial Cancer

Conditions
-----------------
Endometrial Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy-proven high-risk endometrial cancer (type 2 or grade 3 endometrioid histology) BMI of at least 18.5 kg/m2 and less than 35 kg/m2 or axial diameter less than 25 cm Patients who pass standard clinical MRI screening procedures Receiving preoperative clinical evaluation at Mayo Clinic, Rochester, MN Undergoing surgical staging and/or debulking at Mayo Clinic in Rochester, MN Exclusion Criteria: Allergy to FDG or gadolinium Contraindication to MRI scanning (Extreme claustrophobia preventing PET/MRI completion, patients who are unable to lay quietly for an additional 60 minutes of imaging Known kidney disease or poor renal function Pregnant

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

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

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 |
| --- | --- | --- |
| Detection of distant metastasis of endometrial cancer by PET/MRI | Preoperative PET/MRI will be read by a radiologist and compared to final pathologic evaluation of metastatic specimens in high risk endometrial cancer patients. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging
Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see if fetal head circumference can be used as a predictor for who will experience a sphincter laceration while delivering.

Detailed Description
-----------------
Even though much work has been invested in trying to identify risk factors that can predict which population will suffer from sphincter tears and other pelvic floor trauma, the epidemiology is still poorly understood. Factors that have been implicated to include operative vaginal delivery, birth weight, and primaparity. Up to this point little focus has been placed on antenatal factors that would help predict and prevent sphincter disruptions. At the time of birth the infant's head is the largest part of the body. Thus, head circumference of the infant may be able to predict which subjects is more likely to suffer from sphincter disruption. Thus, this study aims to determine whether or not fetal head circumference measured antenatally is predictive of pelvic floor trauma.

Official Title
-----------------
Does Antenatal Fetal Head Circumference Predict Anal Sphincter Injury, a Prospective Study

Conditions
-----------------
Anorectal Sphincter Laceration, Pelvic Floor Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous subjects at least 18 years of age Gestational age greater than or equal to 36 weeks and upto 42 weeks gestation Subjects must have give written informed consent to participate in this study Subjects must be planning to deliver at UCI Exclusion Criteria: Subjects less than 18 years of age Subjects with a previous delivery Subjects with previous colorectal surgery or hemorrhoidal surgery Subjects with a history of irritable bowel syndrome, ulcerative colitis, or Crohn's disease Subjects with a history of colon or rectal cancer Gestational age less than 36 weeks Cesarean section

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

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

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 |
| --- | --- | --- |
| Fetal head circumference and position, maternal pelvis, infant weight, maternal weight, length of the second stage, the incidence of sphincter tears as diagnosed by transvaginal ultrasound as well as the incidence of fecal urgency and incontinence. |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The magnitude of the effect of other factors such as maternal obesity, maternal age, duration of labor and pelvimetry on the risk of anorectal lacerations will be examined. |  | 6 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorectal sphincter laceration, Pelvic floor dysfunction, Sphincter tear
The Potential Role of Testosterone on Target Organ Damage in Postmenopausal Hypertensive Women

Study Overview
=================
Brief Summary
-----------------
The incidence of CVD-related deaths is generally higher in women than men. Postmenopausal changes in estrogen/androgen ratio that induce a relative androgen excess have been proposed as important factors in the higher prevalence of hypertension. Therefore, the investigators hypothesize that testosterone has potential role between hypertension and target organ damage in postmenopausal hypertensive women. And the objective is to evaluate the effects of testosterone between hypertension and target organ damage in postmenopausal hypertensive women.

Official Title
-----------------
The Potential Role of Testosterone Between Hypertension and Target Organ Damage in Postmenopausal Hypertensive Women

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of hypertension Women are all postmenopausal Men are matched with women. Exclusion Criteria: Secondary hypertension Coronary disease Heart failure Arterial fibrillation Previous myocardial infarction Previous stroke Malignant disease Kidney failure Liver failure Neoplastic disease Severe neurological diseases Severe metabolic or organic decompensation Refuse to sign the informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| postmenopausal hypertensive women<br> | |
| mached hypertensive men<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative indexes of myocardial remodeling | Cardiac structure (left ventricular mass index in grams for square meter) measurement. | Baseline | 
| Ambulatory blood pressure monitoring | Non-invasive ambulatory blood pressure monitoring (ABPM) was performed for every enrolled patient with an ABPM equipment. | Baseline | 
| The level of testosterone (T) | Blood samples used to analyze the levels of sexual hormones were collected between morning 8:00 and 9:00 after an overnight fast. Testosterone (T) units on nanogram per deciliter. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypertension, female
Steroid Before Thyroidectomy

Study Overview
=================
Brief Summary
-----------------
We evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. Postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.

Official Title
-----------------
Does a Single Dose of Steroid Before Thyroidectomy Improve Postoperative Nausea, Pain and Vocal Function?

Conditions
-----------------
Thyroid Surgery for Benign Disease

Intervention / Treatment
-----------------
* Drug: Dexamethason Helvepharm ®
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing thyroid surgery for benign disease Exclusion Criteria: Depression Chronic pain disorder Insulin dependent diabetes mellitus History of PONV Pregnancy Age < 18 years Received antiemetic therapy within 48 hours

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A, 1<br>Placebo 45 minutes prior to surgery | Drug: Placebo<br>* 100 ml sodium chloride i.v. 45 minutes prior to surgery<br>|
| Active Comparator: A, 2<br>8 mg Dexamethasone 45 minutes prior to surgery | Drug: Dexamethason Helvepharm ®<br>* 8 mg Dexamethason i.v. 45 minutes prior to surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nausea |  | 0-72 hours postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, vocal function |  | 0-72 hours postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thyroidectomy, dexamethasone, steroid, nausea
Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. Interstitial lung disease (ILD) concerns almost 50 % of SSc patients and represents the main cause of mortality. SSc-ILD is variable: from limited forms (with asymptomatic patients) to extensive lesions. Disease course in SSc-ILD is also highly variable: patients can experience stable disease, slow or fast progression. Investigators performed unsupervised clustering analysis to classify SSc-ILD according to elementary radiological lesions on HRCT scan.

Official Title
-----------------
Unsupervised Clustering Evaluation of HRCT Patterns in Systemic Sclerosis-associated Interstitial Lung Disease

Conditions
-----------------
Systemic Sclerosis, Interstitial Lung Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with systemic sclerosis according to 2013 ACR/EULAR criteria Patients with interstitial lung disease on HRCT chest Exclusion Criteria: Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

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 |
| --- | --- |
| SSc-ILD patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRCT scan variables | HRCT scan variables included in hierarchical agglomerative clustering (HAC) analysis | baseline (J0) |
Gyeongsang National University Hospital Registry

Study Overview
=================
Brief Summary
-----------------
The G-NUH registry is a two-center, real-world registry of percutaneous coronary intervention in patients with significant coronary artery disease. From January 2010, PCI-treated patients from Gyeonsang National University Hospitals (Jinju & Changwon) were enrolled in this registry. The aim of this registry is to investigate long-term clinical outcomes and predictors of adverse outcomes after percutaneous coronary intervention from the academic hospitals.

Detailed Description
-----------------
In the G-NUH registry, the investigators have collected and measured multiple hemostatic, physiologic and laboratory measurements (on-admission & 1-month) and questionnarred from PCI-treated patients. This registry will focus on the impacts of these parameters on long-term clinical outcomes from East Asian patients.

Official Title
-----------------
G-NUH (Gyeongsang National University Hospital) Registry

Conditions
-----------------
Percutaneous Coronary Intervention, Hemostatic Disorder, Blood Clot

Intervention / Treatment
-----------------
* Device: stent, ballooning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Significant coronary artery disease Treated with PCI Multiple hemostatic or physiologic measurements Exclusion Criteria: Medically treated cases

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

| Intervention/Treatment |
| --- |
|Device: stent, ballooning|DES, BMS, BRS, DEB, and POBA can be used for PCI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | the composite of cardiovascular death, myocardial infarction or stroke | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular death | Mortality related with cardiovascular events | up to 10 years | 
| Myocardial infarction | Fatal & non-fatal myocardial infarction | up to 10 years | 
| Stroke | Ischemic & hemorrhagic stroke | up to 10 years | 
| Revascularization | target-lesion, target-vessel vs. nontarget-vessel | up to 10 years | 
| Major bleeding | BARC type 3-5 | up to 10 years | 
| Stent thrombosis | Thrombotic events in & near to stent | up to 10 years | 
| ISR | in-stent restenosis | up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
East Asian Paradox