linjc16/ctgov huggingface dataset:
SAPIEN 3 Ultra EU PMS

Study Overview
=================
Brief Summary
-----------------
This study will evaluate real-world outcomes for the SAPIEN 3 Ultra Transcatheter Heart Valve System in transcatheter aortic valve implantation centres that are implementing minimalist periprocedural practices and facilitating early discharge home.

Detailed Description
-----------------
This is a prospective, observational, single-arm, multicentre, post-market study.

Official Title
-----------------
SAPIEN 3 Ultra EU Post-Market Observational Study

Conditions
-----------------
Aortic Stenosis, Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Device: Transcatheter Aortic Valve Implantation (TAVI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Will undergo TAVI with the Edwards SAPIEN 3 Ultra System Less than 80 years of age at time of the procedure Low surgical risk Meets clinical and procedural requirements for early discharge The subject or subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent Exclusion Criteria: Medical, social, or psychological conditions that preclude appropriate consent and follow-up, including subjects under guardianship Considered to be part of a vulnerable population Active SARS-CoV-2 infection (Coronavirus-19 [COVID-19]) or previously diagnosed with COVID-19 with sequelae that could confound endpoint assessments Cannot tolerate an anticoagulation/antiplatelet regimen Active bacterial endocarditis Participating in a drug or device study that has not reached its primary endpoint

Ages Eligible for Study
-----------------
Maximum Age: 79 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter Aortic Valve Implantation (TAVI)|Subjects will undergo TAVI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of index hospitalization | Number of days in hospital after the procedure | Discharge, expected to be within 1-5 days post-procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Transcatheter aortic valve implantation (TAVI), SAPIEN 3 Ultra THV, Edwards Lifesciences
Reliability, Validity and Responsiveness of the Upright Motor Control Test in Patients With Stroke

Study Overview
=================
Brief Summary
-----------------
Impaired motor function is common after stroke. Individuals with stroke often exhibit synergic pattern that disturb daily function. It is crucial to identify the movement impairment in the clinical settings. Upright Motor Control Test (UMCT) is one of the tests developed to assess the selective movement control and functional strength in people with central nervous disorders. It can be used to reflect the impairment of motor function and evaluate changes of performance after treatment. Yet is little to know the clinimetrics of the UMCT on clinical utility. To date, only few researches explore that UMCT has some construct and criterion validity. Therefore, this study aims to 1) establish the inter-rater reliability to administer the UMCT. 2) explore the correlation between the Fugl-Meyer Assessment of Motor Recovery after Stroke (FMA) and UMCT. 3). investigate whether the UMCT is able to predict the walking ability in patients with stroke.

Official Title
-----------------
Reliability, Validity and Responsiveness of the Upright Motor Control Test in Patients With Stroke

Conditions
-----------------
Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First-ever, unilateral cerebral stroke within one month Being able to maintain standing for more than 10 seconds Exclusion Criteria: Could not follow commands Deformity or fracture of lower limb Less than 20 years old

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- | --- |
| Upright Motor Control Test | 6-18; higher score means better isolated joint control. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment of Motor Recovery after Stroke | UE scale:0-66; LE scale:0-34; higher score means better motor function. | 1 month |
Long Term Cornea Graft Survival Study

Study Overview
=================
Brief Summary
-----------------
Corneal transplantation have been performed for several decades, follow-up time in some centers now exceeds 30 years. Published long term (10 years and up) graft survivals vary considerably from center to center. These variations may be explained by differences in case-mix and surgical techniques used. The investigators aim to better understand the factors associated with long term graft survival.

Official Title
-----------------
Long Term Cornea Graft Survival Study (Étude Bisontine d'Estimation de la Survie à Long Terme à Partir Des données de Suivi Internes au CHRU : Evaluation Epidémiologie Clinique)

Conditions
-----------------
Keratoconus, Fuchs' Endothelial Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who underwent one or more keratoplasties since january 1983. Age 18 and older

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 |
| --- | --- |
| Keratoplasty patients<br>All patients who underwent one or more keratoplasties since january 1983. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival |  | 20 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal Transplantation
Self-collected Swabs for HPV Testing in 18-24 Year Old Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare methods for transporting self-collected swabs for HPV testing in 18-24 year old women and to look at risk factors for HPV infection in 18-24 year old women.

Detailed Description
-----------------
We propose a cross-sectional study among 150 women in the United States who have used Internet dating sites in the past year in order to examine risk factors for high-risk HPV infections in 18-24 year old online daters, and evaluate strategies for transporting and storing self-collected samples for HPV testing. We will ask participants to complete a written questionnaire on their health, sexual behavior, and attitudes toward self-collecting vaginal swabs, HPV vaccination, and cervical cancer screening. Also, we will ask the women to self-collect two sequential vaginal swab samples that will be transported and stored according to the two strategies described above. Each sample will be tested for type-specific HPV DNA using a PCR-based assay.

Official Title
-----------------
Self-collected Swabs for HPV Testing in 18-24 Year Old Women

Conditions
-----------------
Papillomavirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have had sex with men Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website) Exclusion Criteria: Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of type-specific HPV DNA in self-collected vaginal swab samples |  | Baseline |
Lower Leg Edema Evaluation After Total Knee Arthroplasty Using Bioimpedance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the applicability and measurement properties of bioimpedance spectroscopy for postsurgical edema assessment after total knee arthroplasty

Detailed Description
-----------------
Current measurement techniques of edema are not adapted or not convenient for assessment in the post surgical environment. Developement of a convenient, quick and reliable method could be useful to facilitate edema evaluation in this context.

Official Title
-----------------
Validation of a Procedure Using Bioimpedance to Measure the Edema of Lower Leg of Patients After Total Knee Surgery

Conditions
-----------------
Edema

Intervention / Treatment
-----------------
* Device: bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: knee replacement surgery Exclusion Criteria: pacemaker cardiac defibrillator other metallic implant than knee arthroplasty

Ages Eligible for Study
-----------------
Minimum Age: 16 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

| Intervention/Treatment |
| --- |
|Device: bioimpedance spectroscopy ImpediMed SFB7 Brisbane Australia|edema evaluation using bioimpedance|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioimpedance ratio right/left |  | presurgery, 2 and 8 days post surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Physical Therapy - Therapeutics - Edema, Arthroplasty replacement knee, Treatment outcome
Efficacy of High Flow Therapy in COPD At Home

Study Overview
=================
Brief Summary
-----------------
Preliminary data show that in COPD patients, HFT substantially decreases ventilatory demand during sleep. The central hypothesis of this proposal is that lowering ventilatory demand using nasal high-flow therapy during sleep will elevate lung function, reduce dyspnea on exertion and improve quality of life. Thus, this proposal aims will determine the effects HFT over time on 1) lung function; 2) dyspnea on exertion; and 3) quality of life.

Official Title
-----------------
Efficacy of High Flow Therapy in COPD At Home

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Device: Nasal High Flow


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Consenting adults over the age of 18 with COPD Exclusion Criteria: 1. Apnea Hypopnea Index>15 events/hr 2. Use of Non-invasive positive pressure ventilation (CPAP + Bilevel) 3. Severe bilateral nasal obstruction (apparent mouth breathing at rest) 4. Documented clinical cardiovascular disease, as defined below: myocardial infarction in past 3 months revascularization procedure in past 3 months implanted cardiac pacemaker or ICD unstable arrhythmias congestive heart failure with ejection fraction < 40% uncontrolled hypertension (BP > 190/110) 5. History of end stage renal disease (on dialysis) 6. History of end stage liver disease, such as: Jaundice ascites history of recurrent gastrointestinal bleeding transjugular intrahepatic portosystemic shunt (TIPS) ; 7. Transportation industry worker (commercial truck or bus drivers, airline pilots) 8. Known pregnancy (by self report) 9. Known coagulopathy or anticoagulant use (e.g. coumadin) other than aspirin. 10. Do you take medications for any of the following reasons: Pain control (besides NSAIDs) Sleep medication Benzodiazepines Methadone

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| Nasal High Flow<br>All subjects are in this group | Device: Nasal High Flow<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Function | Spirometry will be performed before and after each sleep study | Baseline and 1 month | 
| Dyspnea score | Borg scale score before and after each sleep study | Baseline and 1 month | 
| Sleep quality | Sleep architecture assessed from sleep studies | Baseline and 1 month | 
| Quality of life | St Georges Respiratory Questionnaire Hopkins Sleep Survey MRC Breathlessness Scale UCSD Shortness of Breath | Baseline and 1 month |
Biomarkers And Neurological Outcome in Neonates (BANON)

Study Overview
=================
Brief Summary
-----------------
Validation of biomarkers in a human population for their ability to diagnose the severity of neonatal asphyxia. These biomarkers linked to asphyxia have been identified in animal studies and a preliminary human study.

Detailed Description
-----------------
The aim of the study is to validate the application of combinations of several laboratory parameters in early postnatal blood samples, for identification of infants, who will suffer from early abnormal neonatal neurological outcome, in a population at risk. The population at risk is defined as term and late preterm (>36 weeks of gestation) human infants following perinatal hypoxia-ischemia with or without postnatal resuscitation, and where the combination of laboratory parameters is derived from a preliminary study performed in Turkey (AAMBI) using a metabolomics approach.

Official Title
-----------------
Validation of Biomarkers of Adverse Neurologic Outcome in Newborns Who Required Resuscitation or Are Suspected to be at Risk for Perinatal Brain Injury and Long-term Adverse Neurological Outcome A Prospective Multicenter Observational Study for Development of a Diagnostic Test

Conditions
-----------------
Asphyxia Neonatorum

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Need for resuscitation after birth: For >1 min. after birth, positive pressure respiratory support with face mask or endotracheal tube (but not only CPAP), or cardiac compressions 5 min APGAR-score ≤ 5. Perinatal hypoxia-ischemia defined as a perinatal acidosis indicated by a pH≤7.1 in arterial umbilical cord blood or early postnatal blood collected at <30min of age Perinatal hypoxia-ischemia indicated by a base deficit ≥ 12mmol/l in umbilical cord blood or early postnatal blood collected at <30min of age. Exclusion Criteria: Age >1.5h gestational age < 36 weeks birth weight <2000g congenital malformation missing valid written informed parental consent unsuccessful resuscitation infant considered not-viable decision for palliative care only

Ages Eligible for Study
-----------------
Minimum Age: 0 Minutes
Maximum Age: 90 Minutes

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of diagnostic algorithm | The best combinations of biomarkers from the preliminary study will be used and sensitivity and specificity as well as positive and negative likelihood ratios and their 95%-confidence limits will be calculated. | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers
Respiratory Mechanics and Metabolic Changes During Low Pressure Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate the differences between deep continuous muscle relaxation and moderate blockade during low-pressure (8 mmHg) laparoscopic cholecystectomy in respect to metabolic changes and respiratory mechanics.

Official Title
-----------------
The Impact of Deep Versus Moderate Neuromuscular Block on Respiratory System Mechanics and Metabolic Changes During Laparoscopic Cholecystectomy a Double-Blind Randomized Clinical Trial.

Conditions
-----------------
Laparoscopic Cholecystectomy

Intervention / Treatment
-----------------
* Drug: Rocuronium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: more than 18 years undergoing elective laparoscopic cholecystectomy Exclusion Criteria: previous surgeries, a history of venous or arterial diseases, BMI (≥30 kg/m2), Allergy to rocuronium. Significant liver dysfunction. Significant renal dysfunction (S-creatinine > 200 umol/l). Neuromuscular disease that might impair neuromuscular blockade Pregnant or breastfeeding. Indication for rapid sequence induction. Inability to informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group D<br>deep neuromuscular block by rocuronium defined :post tetanic (PTC) >1 but no response to a train of four (TOF) stimulation. | Drug: Rocuronium<br> <br> |
| Active Comparator: group I<br>intermediate neuromuscular block by rocuronium defined as TOF count of 1-3. | Drug: Rocuronium<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| respiratory mechanics (Dynamic compliance) | Dynamic compliance | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgeon satisfaction (scale from 1 to 5) | scale from 1 to 5 | intraoperative | 
| postoperative pain (VAS score) | VAS score | postoperative for 6 hours | 
| postoperative nausea and vomiting |  | postoperative for 6 hours | 
| completion of surgical procedure | yes or no | intraoperative | 
| metabolic changes (blood lactate) | blood lactate | intraoperative |
Doppler and AFV for Outcome Prediction ın FGR

Study Overview
=================
Brief Summary
-----------------
The investigator contrived a prospective study of AUCR to compare its association to adverse perinatal outcomes with other established doppler parameters, such as CPR and UCR within a population of suspected FGR fetuses at term.

Official Title
-----------------
Combination of Doppler Measurements With Amniotic Fluid Volume for the Predicition of Perinatal Outcome in FGR

Conditions
-----------------
Fetal Growth Retardation

Intervention / Treatment
-----------------
* Diagnostic Test: Doppler measurement in combination with amniotic fluid volume


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SİNGLETON PREGNANCİES WİTH FGR FETUSES AFTER 37th GESTATİONAL WEEKS Exclusion Criteria: SİNGLE OR MUTİPL FETAL ANOMALİES EVİDENCE OF İNTRAUTERİNE ENFECTİON

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fetal Growth Retardation Group<br> | Diagnostic Test: Doppler measurement in combination with amniotic fluid volume<br>* Ultrasonographic evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the prediction power of adverse perinatal outcome with new doppler parameters ( such as AUCR) | enterence to neonatal intensive care unit and severe fetal acidemia ( pH: >7.10) | 1 year |
Efficacy and Safety of Cilostazol for the Indication of CSPS

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label, prospective study of cilostazol use for prevention of recurrence in patients with cerebral infarction.

Detailed Description
-----------------
This is a multicenter, open-label, prospective study of cilostazol use to prevention of recurrence in patients with cerebral infarction. Qualified patients will be treated with cilostazol by physician's assessment. This study will be continued for 4 years. More than 600 patients for 4 years.

Official Title
-----------------
Post Marketing Surveillance of Efficacy and Safety of Cilostazol for the Indication of CSPS

Conditions
-----------------
Cerebral Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with an experience of cerebral infarction and having a purpose for prevention of recurrence of cerebral infarction. Age: more than 18 years of age Exclusion Criteria: Unqualified patients judged by study investigator(s)

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cilostazol<br>Cilostazol Treatment Patients who were in stable states after the occurrence of cerebral infarction (except cardiogenic cerebral embolism) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1)Efficacy:Recurrence of cerebral infarction 2)Safety:Adverse Event |  | 3M | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cerebral Infarction Prevention, Cilostazol