linjc16/ctgov huggingface dataset:
Dance Exercise as Novel Complementary Therapy for Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather data to see if so-called enriched forms of exercise programs such as dance is more effective in improving balance and quality of life in patients with idiopathic Parkinson's disease than regular exercise programs that are currently provided by physical therapists.

Detailed Description
-----------------
Comparison of traditional PT to dance in people who have parkinsons disease to measure which is better for gait, balance and QOL.

Official Title
-----------------
Dance Exercise as Novel Complementary Therapy for Parkinson's Disease

Conditions
-----------------
Parkinsons Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PD at least 3 years ago Less than 80 years of age Have gait and balance issues Exclusion Criteria: Diagnosis of PD for less than 3 years 80 years of age or older Not have gait and balance issues

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 79 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 |
| --- | --- |
| Dance Therapy Group<br>This will group will undergo dance therapy once a week for a series of 8 weeks. | |
| Physical Therapy Group<br>This group will undergo physical therapy sessions once a week for a series of 8 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Balance and Gait improvement | We seek to determine if balance and gait are improved as a result of dance therapy. This will be compared to the balance and gait data of group physical therapy. | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gait, balance, Parkinson's Disease
Bioavailability Study Comparing Modified Release To Immediate Release Apixaban Tablets In Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
To estimate the pharmacokinetics of apixaban when administered as three different modified release formulation tablets relative to that when apixaban is administered as an immediate release tablet

Official Title
-----------------
A Randomized, Open-Label, Single Dose, Four Way Cross-Over Bioavailability Study Comparing Three Modified Release Formulations Of Apixaban Tablets To Apixaban Immediate Release Tablets In Healthy Volunteers

Conditions
-----------------
Thrombosis

Intervention / Treatment
-----------------
* Drug: Apixaban IR
* Drug: Apixaban MR1
* Drug: Apixaban MR2
* Drug: Apixaban MR3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female patients Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 Exclusion Criteria: Any condition possibly affecting drug absorption History or evidence of abnormal bleeding or clotting disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Apixaban Cross-over<br> | Drug: Apixaban IR<br>* immediate release tablet, 10 mg, single dose<br>Drug: Apixaban MR1<br>* modified release tablet 1, 10 mg, single dose<br>Drug: Apixaban MR2<br>* modified release tablet 2, 10 mg, single dose<br>Drug: Apixaban MR3<br>* modified release tablet 3, 10 mg, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apixaban PK: Cmax, C24, AUClast, AUCinf, Tmax, and half-life (t½) |  | 96 hours | 
| Safety and tolerability as determined by adverse event reporting, clinical laboratory results, vital signs, physical examinations, and ECGs. |  | per treatment period of 96 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
formulation; sustained release; modified release; extended release
Hypopituitarism Following Traumatic Brain Injury or Spontaneous Subarachnoidal Haemorrhages

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the prevalence and predictors of pituitary dysfunction, as well as secondary out-come in patients with traumatic brain injury or spontaneous subarachnoidal haemorrhages.

Conditions
-----------------
Brain Injuries, Intracranial Aneurysm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of traumatic brain injury (TBI) or subarachnoidal haemorrhages (SAH) Exclusion Criteria: Alcohol or drug abuse Prior TBI or SAH Chronic use of glucocorticoids Pregnancy or breast feeding Diagnosis of psychiatric diseases or malignant neoplasms

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
CHAIN_brazilian Registry of Congenital HeArt Disease INtervention and Angiography

Study Overview
=================
Brief Summary
-----------------
Design: Observational - Cross study with followed up for 30 days. The Primary Objective is to realize a record that reflects a national overview of the role of cardiac catheterization in patients with congenital heart disease in hospitals distributed by geographic density of each region of Brazil.

Detailed Description
-----------------
Patients admitted in the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization. Participants release the data in (e-CRF) electronics system. Sample: 2000 records.

Official Title
-----------------
Phase 0 _ Brazilian Registry of Congenital HeArt Disease INtervention and Angiography

Conditions
-----------------
Congenital Heart Disease, Cardiac Catheterization, Brazilian Electronic Registration, Catheterization Diagnostic or Therapeutic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to the hemodynamic sector with diagnosed or suspected congenital cardiopathy and undergoing diagnostic or therapeutic cardiac catheterization. Exclusion Criteria: Patients undergoing hybrid approach to intervention, with the aid of cardiac surgery to realization of cardiac catheterization.

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

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 |
| --- | --- | --- |
| Occurrence of serious complications of cardiac catheterization in congenital heart | Occurrence of serious complications of cardiac catheterization in congenital heart procedure-related (occurring within 7 days after the procedure or until hospital discharge, whichever occurs first, and following 30 days), such as embolization of the prosthesis, cardiac arrhythmias, trauma vascular intracardiac injury, death, etc | December 2014 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
congenital heart disease, cardiac catheterization, brazilian electronic registration
Restricted Useful Field View as a Risk Factor in Older Adults

Study Overview
=================
Brief Summary
-----------------
The relationship between Useful Field of Vision (UFOV) and falls taken by the elderly will be investigated. UFOV is a test which measures visual attention. The test has been used in correlating the visual attention in the elderly with their driving safety record. The test is administered using a computer and consists of three parts: a) subject views figures which appear in the center of the computer screen and identified them as quickly as possible; b)the subject has to identify figures in the center of the screen while at the same time point to another symbol which will appear in one of eight places on the outer portion of the screen; c) the third section is similar to the second except while the subject is identifying and pointing there is a background noise.

Official Title
-----------------
Restricted Useful Field View as a Risk Factor in Older Adults

Conditions
-----------------
Vision Impairment

Intervention / Treatment
-----------------
* Procedure: Prevention of Falls


Participation Criteria
=================
Eligibility Criteria
-----------------
Vision impaired adults at risk for falls

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 |
| --- |
|Procedure: Prevention of Falls|nan|

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
-----------------
Aging adult, attention, falls, vision
Comparison of Creatinine Clearance Calculation for Estimation of GFR in Patients Receiving HD Methotrexate

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma.

Detailed Description
-----------------
We intend to perform a retrospective chart review to identify a serum creatinine-based equation that gives the best estimate of CrCl as compared with an equation derived from a 24-hour urine collection. Study subjects will be identified using the Brigham and Women's Hospital and Dana-Farber Cancer Institute's Adult Pharmacy systems to identify patients who received high-dose methotrexate. Data will be collected starting with December 31, 2010 and proceeding chronologically backwards until the target enrollment of 40 patients is reached.

Official Title
-----------------
Comparison of Creatinine Clearance Calculation Methods for Estimation of Glomerular Filtration Rate in Patients Receiving High-Dose Methotrexate

Conditions
-----------------
CNS Lymphoma, CNS Involvement of Systemic Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >/= 18 years Received high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma Available timed urine collection within 1 week of HDMTX Exclusion Criteria: Receiving high-dose methotrexate for indications other than primary CNS lymphoma or CNS involvement of systemic lymphoma Documented viral hepatitis

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 |
| --- | --- |
| CNS lymphoma patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula. | Serum creatinine-based equations to be included in that analysis are: Cockcroft-Gault with the following weight descriptors; ideal body weight, actual body weight, and adjusted body weight; Modified MDRD; CKD-EPI. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To further compare each formula in a different subset of patients. | To further compare each formula in a different subset of patients: Age < 65 years and >/= 65 years; body mass index < 25, 25-30, 30-35, and > 35; serum creatinine <1.5 mg/dL and >/= 1.5 mg/dL. | 1 year |
Institut Paoli Calmettes Ovarian Cancer Database

Study Overview
=================
Brief Summary
-----------------
Database of Institut Paoli-Calmettes patients diagnosed with ovarian cancer

Conditions
-----------------
Ovarian Neoplasms

Intervention / Treatment
-----------------
* Other: Data collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with a diagnosis of ovarian cancer Exclusion Criteria: Diagnosis of fallopian tube cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with ovarian cancer diagnosis<br> | Other: Data collection<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of patients | Overall survival of all patients who come in the center | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of patients characteristics | Collection of characteristics of patients treated at Institut Paoli Calmettes in order to set up prospective and retrospective studies | 10 years |
Femoral Arterial Cannulation

Study Overview
=================
Brief Summary
-----------------
Many children undergoing surgery for congenital heart disease have had prior operations. Re-operative sternotomy carries with it the risk of cardiac injury and the need for emergent peripheral cannulation. Our first aim is to demonstrate that peripheral arterial cannulation may be lifesaving in cases of complicated sternal re-entry in children and that angio-catheters can be utilized when vessels are too small for standard cannulas. Our secondary aim is to present a case report of successful femoral cannulation in a 5 kg child.

Detailed Description
-----------------
In children, many of the standard operative sites are either occluded, stenosed, or too small for the smallest manufactured cannulas. In these instances, it may be feasible to utilize angio-catheters for arterial access until central cannulation can be achieved safely. In an in vitro model, we have simulated a cardiopulmonary bypass circuit and arterial cannulation with angio-catheters. It appears that angio-catheters may be used with acceptable flow hemodynamics for blood vessels too small for standard cannulas. We have performed this successfully in a 5 kg child. We have completed the cardiopulmonary bypass model and are ready to submit the hemodynamic data. We would like to submit to a national meeting and hopefully for publication thereafter.

Official Title
-----------------
Femoral Arterial Cannulation in Infants Following Complicated Sternal Re-entry

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: case report of successful angio-catheter use on 5 kg child Exclusion Criteria: that which does not meet inclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 3 Months

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
-----------------
cannulation, infant, femoral arterial
New Non-invasive Modalities for Assessing Retinal Structure and Function

Study Overview
=================
Brief Summary
-----------------
This study investigates a new technology to assess the structure and function inside the eye. Retinal imaging of subjects with inner and outer retinal defects to detect areas of abnormal structure and function compared to other visual function tests.

Official Title
-----------------
New Non-invasive Modalities for Assessing Retinal Structure and Function:Preliminary Investigation

Conditions
-----------------
Ischemic Optic Neuropathy, Branch Retinal Artery Occlusion, Hemianopia, Leber Hereditary Optic Neuropathy, Acute Zonal Occult Outer Retinopathy

Intervention / Treatment
-----------------
* Device: LSFG-NAVI


Participation Criteria
=================
Eligibility Criteria
-----------------
Controls: Inclusion: Normal eye exam in last 2 years Exclusion: Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. Any abnormalities of the retina or optic nerve that could affect metabolism of the retina outside of normal. Subjects with Inner Retina Defect: Inclusion: Defined structural defect to include those with Ischemic optic neuropathy, branch retinal artery occlusion (BRAO), hemianopia or visual field defect that respects the vertical meridian, inherited mitochondrial optic neuropathies such as Leber's and Dominant Optic Neuropathy, other retinopathies or optic neuropathies. Exclusion: Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. Subjects with Outer Retinal Defect: Inclusion: AZOOR (acute zonal occult outer retinopathy) or other focal or diffuse outer photoreceptor loss of function Exclusion: Cataract or media opacity that would degrade the imaging of the retina. Mild cataracts are okay. The 450 total is to allow for exclusion of some subjects or in the event that the enrolled subject blinks too much or cannot fixate on a visual target adequately to maintain the same eye position during the short imaging interval. We hope to have a total of 450 (50 controls and 400 patients)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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: Laser Speckle Blood Flow Group<br> | Device: LSFG-NAVI<br>* laser-speckle blood flow of ocular arteries and veins<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Blood Flow | imaging the movement of blood through blood vessels in retina and optic nerve | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optic Neuropathy, , Retinopathy
Real World Data Collection Pediatric Neuroblastoma Treated With Lorlatinib

Study Overview
=================
Brief Summary
-----------------
The overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.

Official Title
-----------------
REAL WORLD DATA COLLECTION AMONG PEDIATRIC NEUROBLASTOMA PATIENTS TREATED WITH LORLATINIB THROUGH EXPANDED ACCESS PROGRAM

Conditions
-----------------
Neuroblastoma

Intervention / Treatment
-----------------
* Drug: lorlatinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient receives lorlatinib through Pfizer's expanded access program for treatment of ALK+ neuroblastoma. HCP documentation of at least one tumor assessment of response after patient has had at least one dose of lorlatinib Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: Any patient who does not meet any of the inclusion criteria defined in the previous section.

Ages Eligible for Study
-----------------
Minimum Age: 0 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 |
| --- | --- |
| Pediatric Neuroblastoma Patients Treated with Lorlatinib<br> | Drug: lorlatinib<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective tumor response of primary tumor (soft tissue), soft tissue metastasis, and bone metastasis |  | March 2017- December 2023 | 
| Bone marrow response |  | March 2017-December 2023 | 
| Health care professional (HCP) Reported Objective Response |  | March 2017-December 2023 | 
| Derived Objective Response |  | March 2017-December 2023 | 
| Best Overall response |  | March 2017-December 2023 | 
| Overall Response Rate (ORR) |  | March 2017-December 2023 | 
| Duration of response |  | March 2017-December 2023 | 
| Progression free survival (PFS) |  | March 2017-December 2023 | 
| Duration of treatment |  | March 2017-December 2023 | 
| Overall survival (OS) |  | March 2017-December 2023 | 
| The number of patients reporting Adverse Events (AE) |  | March 2017-December 2023 | 
| The percentage of patients reporting Adverse Events (AE) |  | March 2017-December 2023 | 
| The number of patients reporting treatment related Adverse Events (AE) |  | March 2017-December 2023 | 
| The percentage of patients reporting treatment related Adverse Events (AE) |  | March 2017-December 2023 | 
| The number of patients reporting Serious Adverse Events (SAE) |  | March 2017-December 2023 | 
| The percentage of patients reporting treatment related Serious Adverse Events (SAE) |  | March 2017-December 2023 |