linjc16/ctgov huggingface dataset:
Efficacy and Safety of Activated Recombinant Human Factor VII in Refractory Haemorrhagic Cystitis

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to assess the efficacy of activated recombinant human factor VII in the treatment of refractory haemorrhagic cystitis (HC) following chemotherapy.

Official Title
-----------------
An Open Label Pilot Study to Test the Efficacy and Safety of Recombinant Factor VIIa (rFVIIa, NovoSeven®) in the Treatment of Refractory Hemorrhagic Cystitis Following High Dose Chemotherapy

Conditions
-----------------
Other Haemostasis Disorder, Haemorrhagic Cystitis

Intervention / Treatment
-----------------
* Drug: activated recombinant human factor VII


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe haemorrhagic cystitis (HC) Exclusion Criteria: Patients with overt DIC (disseminated intravascular coagulation) Patients with known active atherosclerotic disease, such as active coronary artery disease or recent stroke in the past 3 months Central venous access device related thrombus in the last 3 months Patients with allergy to activated recombinant human factor VII or any component of its preparation

Ages Eligible for Study
-----------------
Minimum Age: 2 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Factor VII<br> | Drug: activated recombinant human factor VII<br>* If non-responding haemorrhagic cystitis to 24-hour trial of conventional therapy, 80 mcg/kg is administered i.v. for the first dose. If necessary, two additional doses of 120 mcg/kg can be administered i.v.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of hematuria that failed 24-hour standard therapy evaluated by change of urine color |  |  | 
| Reduction of hematuria that failed 24-hour standard therapy evaluated by urine haemoglobin content |  |  | 
| Reduction of hematuria that failed 24-hour standard therapy evaluated by urocrit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of venous or arterial thrombosis |  |  |
Nocturnal Parkinson's Disease Symptoms Study Group

Study Overview
=================
Brief Summary
-----------------
To study associate factor of Noctural Parkinson's Disease Symptoms and quality of life in Parkinson's disease patients and caregivers.

Official Title
-----------------
Nocturnal Parkinson's Disease Symptoms Study Group

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: Questionaire to assess Noctural Parkinson's Disease Symptoms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease patient Exclusion Criteria: Patient with Secondary Parkinsonism eg.Drug-induced Parkinsonism, Vascular Parkinsonism, exposure to toxin, Encephalitis Patient with Atypical Parkinsonial Syndromes eg. Parkinson-plus syndrome, Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD) Patient with Heredodegenerative parkinsonism eg. Spinocerebellar ataxias, Wilson's disease, Juvenile Huntington's disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Questionniare<br> | Other: Questionaire to assess Noctural Parkinson's Disease Symptoms<br>* Questionaire to assess Noctural Parkinson's Disease Symptoms and quality of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess Noctural Parkinson's Disease Symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess quality of life in Parkinson's Disease patient |  |  | 
| To assess quality of life in caregiver of Parkinson's Disease patient |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, Noctural Parkinson's Disease Symptoms
This Study Investigate the Impact of Maternal COVID-19 Infection During Birth on the Childrens' Physical and Mental Development.

Study Overview
=================
Brief Summary
-----------------
This study investigates the impact of the maternal COVID infection during birth on the children's development: physical and mental outcomes. We would like to differentiate the effect from the viral infection and effect of the pandemic period, too.

Official Title
-----------------
Long-term Followup of Children Was Born From COVID Positive Mother During Birth

Conditions
-----------------
COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: postitive maternal COVID test during the birth the newborn was cared at the Semmelweis University after birth

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 16 Months

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 |
| --- | --- | --- |
| Neurodevelopmental outcome |  | 2 years old | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurodevelopmental outcome |  | 1 year old | 
| Phsycosomatic outcome |  | 1 and 2 years old | 
| Regulation disorders |  | 1 and 2 years old | 
| Feeding |  | 1 and 2 years old | 
| Maternal mental status |  | 1 and 2 years old | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
followup, longterm outcome, child development, maternal COVID-19
Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The mechanisms of sensitivity and resistance to oncogene-targeted therapy can be determined from tumor tissue or tumor cell lines derived from available archival samples and/or from standard-of-care re-biopsy upon suspected tumor progression.

Detailed Description
-----------------
To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies.

Official Title
-----------------
Molecular Analysis of Oncogenes and Resistance Mechanisms in Lung and Other Thoracic Cancers

Conditions
-----------------
Lung Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing investigation or treatment for thoracic cancers with oncogene-targeted therapies Aged 18 years or older Either a) have suspected tumor progression or other condition that dictates a standard-of-care palliative, therapeutic, or diagnostic intervention including but not limited to procedures such as bronchoscopic biopsy, computed tomography (CT) or ultra-sound (US)-guided biopsy, thoracentesis, video assisted thoracoscopic (VATS) pleurodesis, lobectomy, adrenalectomy or pleural catheter placement, providing tumor specimen appropriate molecular analysis or b) have previously had biopsy/surgical intervention with tumor tissue at University of Colorado or an outside institution available for medullar analysis. Patients must have the ability to understand and willingness to sign an informed consent document. Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify baseline and treatment-related somatic changes in the tumor tissue from patients with lung and other thoracic cancers. |  | To be determined upon funding | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the proportion of patients that subsequent therapy is altered based on the information acquired from such biopsies |  | To be determined upon funding | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oncogenes, Lung and Other Thoracic Cancers
Dynamic Splinting for Excessive Pronation Following CVA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine range of motion and lasting effects of Botox injections along with the use of the Supination Dynasplint.

Official Title
-----------------
Dynamic Splinting for Excessive Pronation Following CVA: A Randomized, Controlled Tial

Conditions
-----------------
Pronation Contracture

Intervention / Treatment
-----------------
* Device: Dynasplint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients enrolled will have been diagnosed with excessive pronation following a stroke and will display the following symptoms: Pronation Contracture Ability to provide consent and follow directions as related to the protocol Exclusion Criteria Treatment with Benzodiazepines Treatment with Baclofen (pump or oral) Treatment with Dantrolene sodium Treatment with Tizanidine

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dynasplint Group<br>Along with the standard of care Botox and manual therapy, patients will use the Supination Dynasplint every day | Device: Dynasplint<br>* Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or Experimental group will add this therapy to their standard of care regimen<br>|
| No Intervention: Standard of care<br>Patients in the standard of care group will have the standard Botox treatments and manual therapy with no additional interventions. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ROM changes with use of treatment |  | 20 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Excessive pronation, CVA, Forearm, Excessive pronation following CVA
Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Study Overview
=================
Brief Summary
-----------------
Frailty is a state of decreased physiologic reserves and vulnerability to stressors. Several tools exist to measure frailty, some based on physical tests and others on questionnaires, yet there is no agreement on which tool to recommend. This multi-center prospective cohort study is aimed at comparing various frailty assessment tools to determine which best predicts death or major complications after cardiac surgery or transcatheter intervention. The population of interest is elderly patients with severe aortic stenosis undergoing surgical or transcatheter aortic valve replacement. The frailty assessment tools under investigation include composite frailty scales, physical performance tests, muscle mass, and biomarker expression. The overall objective is to improve our ability to predict risk by measuring frailty using the optimal tool in elderly cardiovascular patients.

Official Title
-----------------
Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions

Conditions
-----------------
Aortic Stenosis, Cardiac Valve Replacement Complication, Fragility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥70 years (a site-specific substudy at the JGH will enroll ages ≥21 years) Severe AS Referred for surgical or transcatheter AVR (with or without concomitant revascularization) Signed informed consent Exclusion Criteria: Emergency surgery Clinical instability: decompensated heart failure, active ischemia, unstable vital signs Severe neuropsychiatric impairment Not English or French speaking Replacement of >1 valve or aortic surgery

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- |
| Aortic valve replacement<br>Patients aged ≥70 years referred for surgical or transcatheter aortic valve replacement. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-procedural mortality or major morbidity | Mortality is defined as death from any cause. Major morbidity is defined as an aggregate of the Society of Thoracic Surgeons (STS) and Valve Academic Research Consortium (VARC) composite endpoints. Additionally, the individual components of this composite endpoint will be examined. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 6-12 months | 
| Functional status |  | 6-12 months | 
| Length of stay |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aortic stenosis, Aortic valve replacement, Transcatheter aortic valve implantation, Frailty, Elderly, Outcomes
Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to validate the use of ultrasound sub-hertz analysis of viscoelastisty (SAVE) method to monitor tissue-fluid dynamics and stage disease severity in patients diagnosed with lymphedema.

Official Title
-----------------
Sub-Hertz Analysis of Viscoelasticity of Limbs in Patients With Lymphedema

Conditions
-----------------
Lymphedema

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (18+ years of age) Ability to provide written consent Has been diagnosed with Lymphedema Exclusion Criteria: Under the age of 18 years old Inability to provide written consent Previous lymphovenous bypass or lymph node transfer surgery

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: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The unaffected arm will be used to serve as control for the affected extremity.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Affected (Lymphedema)<br>Subjects affected lymphedema extremity will have elastic and viscoelastic parameters collected by ultrasound procedure | Diagnostic Test: Ultrasound Procedure<br>* Ultrasound technique that uses a compression device integrated with ultrasound imaging to perform in vivo ramp-and-hold uniaxial creep-like test on upper extremity lymphedema (UEL) in vivo.<br>|
| Active Comparator: Unaffected (Control)<br>Subjects unaffected extremity will have elastic and viscoelastic parameters collected by ultrasound procedure | Diagnostic Test: Ultrasound Procedure<br>* Ultrasound technique that uses a compression device integrated with ultrasound imaging to perform in vivo ramp-and-hold uniaxial creep-like test on upper extremity lymphedema (UEL) in vivo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viscoelasticity parameters with lymphedema as obtained using the SAVE method | Defined as the difference in viscoelastic parameters between the arm affected with lymphedema and the unaffected extremity (affected minus unaffected) using the sub-hertz analysis of viscoelasticity method | Baseline |
Safety of GANFORT® Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
A study to evaluate the long-term safety of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) in Chinese patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to topical beta-blocker or prostaglandin analogues.

Official Title
-----------------
Evaluation of the Safety of GANFORT® (Bimatoprost 0.03% Plus Timolol 0.5%) Ophthalmic Solution in Chinese Patients With Open-angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.03% plus timolol 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of open-angle glaucoma or ocular hypertension that is insufficiently responsive to topical beta-blockers or prostaglandin analogues in one or both eyes Is willing to stop other intraocular pressure (IOP)-lowering medications and switch to GANFORT® as a single agent in affected eye(s). Exclusion Criteria: Reactive airway disease including bronchial asthma or a history of bronchial asthma or severe chronic obstructive pulmonary disease Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block, not controlled with pacemaker. Overt cardiac failure, cardiogenic shock.

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 |
| --- | --- |
| Other: GANFORT®<br>One drop of GANFORT® (bimatoprost 0.03% plus timolol 0.5%) instilled in each affected eye once daily in the evening for 24 weeks. | Drug: bimatoprost 0.03% plus timolol 0.5%<br>* 1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily.<br>* Other names: GANFORT®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events |  | 24 Weeks |
External Validation of Models for Predicting Inadequate Bowel Preparation

Study Overview
=================
Brief Summary
-----------------
In order to obtain the risk level of patients with intestinal insufficiency through simple indicators, many foreign scholars have studied and developed their own prediction models. However, the current guideline indicates that there is insufficient evidence to recommend the use of a specialized predictive model for clinical practice.There are few studies on external validation of existing prediction models.

Official Title
-----------------
External Validation of Two Prediction Models for Adequate Bowel Preparation in Asia: A Prospective Study

Conditions
-----------------
Colonoscopy, Predictive Model, External Validation

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing colonoscopy. patients older than 18 years. Exclusion Criteria: Emergency colonoscopy. Have a serious medical condition, such as heart failure, acute liver failure, severe kidney disease (dialysis or predialysis patients) or New York heart association class iii-iv. Pregnant or breastfeeding. No bowel preparation or poor compliance (no bowel preparation as instructed or laxatives < 90% of prescribed dose). Refuse to sign informed consent. The patient was rescheduled after the previous colonoscopy due to insufficient bowel preparation. Temporarily change to colonoscopy for other reasons. Incomplete colonoscopy due to insufficient parenteral preparation. Lack of complete data.

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 |
| --- |
|Other: no intervention|no intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discrimination | Compare the area under the curve (AUC) between predictive models and acutal bowel preparation. | cross-sectional analyses in 2020 |