linjc16/ctgov huggingface dataset:
Xeroderma Pigmentosum Patient Experiences

Study Overview
=================
Brief Summary
-----------------
Xeroderma Pigmentosum (XP) is a rare skin condition that causes extreme sensitivity to the sun and an increased incidence of skin cancers. The purpose of this study is to find out more about XP patient experiences and their quality of life.

Official Title
-----------------
Xeroderma Pigmentosum: A Survey of Patient Experiences

Conditions
-----------------
Xeroderma Pigmentosum

Intervention / Treatment
-----------------
* Other: Survey Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of xeroderma pigmentosum Any age Access to a public or private computer Exclusion Criteria: Patients who do not have a confirmed diagnosis of XP Patients under 18 who do not have a parent/guardian able to read or speak English Patients who are unable to read or speak English
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Xeroderma Pigmentosum patients<br>Xeroderma Pigmentosum patients who attend Camp Sundown, a camp for children with this condition. | Other: Survey Study<br>* Survey regarding quality of life<br>|

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
-----------------
xeroderma pigmentosum, quality of life, DLQI, CDLQI
Radiation Induced Cardiopulmonary Injury in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the time, dose dependence, and fraction-size dependence of radiation (RT)-induced changes in regional lung and heart perfusion/function/structure following thoracic RT delivered using newer IMRT/conformal/radiosurgery techniques. The PI hopes to develop models to better relate and predict RT-induced changes in regional lung and heart perfusion/function/structure with changes in global cardiopulmonary function. Patients will undergo pre- and serial post-RT lung and heart assessments to better understand RT-induced regional heart/lung changes.

Official Title
-----------------
Radiation Induced Cardiopulmonary Injury in Humans

Conditions
-----------------
Thoracic, Pulmonary Injury, Heart Injuries

Intervention / Treatment
-----------------
* Procedure: SPECT Lung Perfusion Scan
* Procedure: SPECT Heart Perfusion Scan
* Procedure: Pulmonary Function Tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Patients who are to receive 3D-planned RT for tumor within and around the thorax. Patients receiving incidental RT to portions of the heart are eligible. Estimated minimum expected life expectancy of one year Able to undergo the required study-related tests for regional lung injury and regional heart injury Patients of child bearing potential age must have a negative pregnancy test and must agree to use appropriate birth control measures while in the study. Patients must be able to give informed consent. Informed consent will be obtained prior to enrollment. Exclusion Criteria: Patients who are anticipated to have thoracic surgery post-RT are ineligible. Patients with large mediastinal/hilar tumors compressing the airways/vessels, and negatively impacting on cardiovascular function Pregnant or nursing women.

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: SPECT Lung Perfusion Scan|nan|
|Procedure: SPECT Heart Perfusion Scan|nan|
|Procedure: Pulmonary Function Tests|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Regional Lung Function |  | Up to 4 years post CRT | 
| Changes in Regional Heart Function |  | Up to 4 years post CRT | 
| Relating RT-Induced Changes in Regional injury to Global Cardiopulmonary Changes |  | Up to 4 years post CRT | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiation Therapy
A Study of SA-001 to Treat Pancreatic Exocrine Insufficiency

Study Overview
=================
Brief Summary
-----------------
This study is to verify the efficacy of 3.0 g/day of SA-001 in patients with pancreatic exocrine insufficiency caused by chronic pancreatitis in the non-compensatory stage or by pancreatectomy as compared with placebo under a double-blind design using the change in a coefficient of fat absorption as a primary endpoint.

Official Title
-----------------
A Double-blind, Placebo-controlled, Parallel-group, Comparative Study to Confirm the Safety and Efficacy of Oral 1.5 g/Day and 3.0 g/Day of SA-001 in Patients With Pancreatic Exocrine Insufficiency Caused by Chronic Pancreatitis or by Pancreatectomy

Conditions
-----------------
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis

Intervention / Treatment
-----------------
* Drug: SA-001
* Drug: SA-001
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects with chronic pancreatitis in the non-compensatory stage or pancreatectomy Subjects whose CFA is 80% or less Subjects who are able to be hospitalized Exclusion Criteria Subjects who are judged to be difficult to have at least 40 g/day of fat intake during course of the study Subjects who have a known allergy to porcine protein and/or any component of digestive enzyme preparations Subjects who are in the acute phase of chronic pancreatitis Subjects with non-pancreatic malabsorption syndrome Subjects with acute pancreatitis or ileus

Ages Eligible for Study
-----------------
Minimum Age: 20 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: L<br> | Drug: SA-001<br>* 0.25 g of SA-001 pellets/capsule, 12 capsules/day for 7 days<br>|
| Experimental: H<br> | Drug: SA-001<br>* 0.25 g of SA-001 pellets/capsule, 6 capsules/day for 7 days<br>|
| Placebo Comparator: P<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CFA from baseline to the end of double-blind treatment |  | 7 days after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stool fat excretion, stool weight, stool frequency, nutritional parameters |  | 7 days after baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SA-001, Pancreatic Exocrine Insufficiency, Pancreatectomy
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody Fusions

Study Overview
=================
Brief Summary
-----------------
Introduction: Degenerative changes of the discs and facet joints in the lumbar spine can result in pain and disability from spondylosis, spondylolisthesis and stenosis. Patients who are suffering with back and/or leg pain are potential candidates for an ALIF procedure. Purpose: To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made

Detailed Description
-----------------
To assess and compare clinical outcomes and fusion rates in patients undergoing an instrumented ALIF procedure. Comparisons in all variables will be made across diagnostic categories. Comparisons between type of interbody spacer, graft type, and type of instrumentation will also be made. This study is part of a larger Continuous Quality Improvement initiative at the Columbia Orthopaedic Group. The purpose of this effort is to improve surgical and non-surgical outcomes by using rigorous statistical analysis of our outcomes to guide our treatment decisions. Through an iterative feedback process we hope to optimize patient outcomes.

Official Title
-----------------
Prospective Clinical Evaluation of the New Aegis Plate for Anterior Interbody

Conditions
-----------------
Degeneration, Spondylosis, Spondylolithesis, Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Standard of care Exclusion Criteria: Standard of care

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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 |
| --- | --- | --- |
| Intake data will include all fields traditionally associated with a detailed note. Subsequent visit instruments will include visual analog scale and oswestry disability index. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Degeneration, Spondylosis, Spondylolisthesis, Stenosis
PK and Safety of SI-722 in IC/BPS

Study Overview
=================
Brief Summary
-----------------
This study is designed randomized, double-blind, placebo-controlled trial in Interstitial Cystitis/Bladder Pain Syndrome patients.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of SI-722 Intravesical Instillation in Interstitial Cystitis/Bladder Pain Syndrome Subjects

Conditions
-----------------
Interstitial Cystitis, Bladder Pain Syndrome

Intervention / Treatment
-----------------
* Drug: SI-722
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females, ≥18 and ≤80 years of age A score of 19 or greater on the Bladder Pain/Interstitial Cystitis Symptom Score (BPIC-SS) Exclusion Criteria: Urinary tract infection ≤30 days Treatment with intravesical therapy ≤60 days Treatment with any opioid therapy ≤7 days History of bladder hydrodistension ≤3 months Has cancer or a past history of any cancer ≤5 years Body mass index (BMI) ≥40 kg/m2

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SI-722<br> | Drug: SI-722<br>* SI-722 will be intravesically instilled.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo will be intravesically instilled.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration (Cmax) for SI-722 | SI-722 concentrations in plasma were measured using collected blood samples, and plasma PK parameters for SI-722 were estimated. | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder, Intravesical Injection, Interstitial Cystitis
Clinical Application of Personal Designed 3D Printing Implants in Bone Defect Restoration

Study Overview
=================
Brief Summary
-----------------
Objective: Clinical application of 3D printing implant in bone defect treatment. Study design: multicenter randomized controlled study . Methods:patients randomly grouped according to register number into internal fixation and bone graft group and 3D printing group. Reconstruct 3D models ,evaluate models preoperatively , simulate surgery in computer,design 3D implant, and 3D print implants,perform surgery with 3D implants to achieve the greatest degree of physiological reconstruction.Evaluate surgical efficacy .

Official Title
-----------------
Shenzhen Hospital of Southern Medical University

Conditions
-----------------
Defect; Internal Prosthetic Device, Implants and Grafts, Orthopedic, Bone Graft

Intervention / Treatment
-----------------
* Procedure: 3D printing implant
* Procedure: autogenous bone grafting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open fracture with bone defect Burst fracture of spine with bone defect Bone tumor with bone defect Bone tuberculosis with bone defect Nonunion with bone defect Exclusion Criteria: Patients who can not tolerate anesthesia and surgery due to severe impairment of heart and lung function Systemic or local infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D printing implant<br>3D printing implant in bone defect | Procedure: 3D printing implant<br>* 3D printing implants in bone defect<br>|
| Placebo Comparator: Autogenous bone grafting<br>autogenous bone grafting in bone defect | Procedure: autogenous bone grafting<br>* 3D printing implants in bone defect<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operative time |  | 3 years |
Evaluation of Two Reduced Sirolimus Doses in Treatment of de Novo Coronary Artery Lesions (REDOX)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the performance and safety of two reduced sirolimus doses on the Bx VELOCITY Balloon-Expandable stent, mounted on the Raptorâ rapid exchange (RX) Stent Delivery System (SDS) in patients with de novo native coronary artery lesions.

Official Title
-----------------
An Evaluation of Two Reduced Sirolimus Doses on the BX VELOCITY Balloon-Expandable Stent in the Treatment of Patients With de Novo Native Coronary Artery Lesions(REDOX)

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Device: Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or non-pregnant female patient minimum 18 years of age No significant (>50%) untreated stenoses proximal or distal to the target lesion that will not be treated during the procedure and may require revascularization or impede runoff; Target lesion is 18mm in length (visual estimate); Target lesion is 3.0mm and 3.5mm in diameter (visual estimate); Target lesion stenosis is >50% and <100% (visual estimate); Exclusion Criteria: A Q-wave or non-Q-wave myocardial infarction within the preceding 72 hours unless the CK and CK-MB enzymes are back to normal; Ejection fraction 30%; Stent placement of target lesion covers a side branch >2.0mm in diameter;

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

| Intervention/Treatment |
| --- |
|Device: Bx VELOCITY Stent containing 45% and 70% of Sirolimus dose|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late loss measured by quantitative coronary angiography at four-months and twelve-months post-procedure. |  | four-months and twelve-months post-procedure | 
| NIH volume as measured by intravascular ultrasound (IVUS) at four-months and twelve-months post-procedure. |  | four-months and twelve-months post-procedure | 
| Volumetric plaque burden as measured by IVUS at four-months and twelve months post-procedure. |  | four-months and twelve months post-procedure | 
| Four and twelve month target vessel failure (TVF). |  | Four and twelve month |
The Role of Ophthalmologic Tests and EEG Imaging in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
Alzheimer's disease (AD) is a prevalent, long-term progressive degenerative disorder with great social impact. It is currently thought that, in addition to neurodegeneration, vascular changes also play a role in the pathophysiology of the disease. Meantime, EEG resting state has also demonstrated significant change in patients with AD in neuroscience research area. Thus, the combination of these sensitive biomarkers would lead to a potential new biomarker for detection of AD, which has higher specificity and sensitivity.

Official Title
-----------------
The Combination of Ophthalmologic Tests and EEG Imaging as a New Biomarker for Alzheimer's Disease

Conditions
-----------------
Mild Cognitive Impairment

Intervention / Treatment
-----------------
* Diagnostic Test: observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Alzheimer's Disease Exclusion Criteria: neurologic disorders psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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 |
| --- | --- |
| mild cognitive impairment (MCI)<br>observational | Diagnostic Test: observational<br>* No intervention<br>|
| Patients with mild to moderate AD<br>observational | Diagnostic Test: observational<br>* No intervention<br>|
| Normal controls<br>observational | Diagnostic Test: observational<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT retinal and choroidal thickness | retinal structural anatomy | 2 days | 
| Retinal Photography vascular caliber | use Retinal Photography to detect vascular caliber | 2 days | 
| functional connection strength in the brain network | record resting-state EEG, use graph theory to calculate the functional connection strength | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AD EEG OCT biomarker
Hangover and Residual Zopiclone Effect on Spatial Perception

Study Overview
=================
Brief Summary
-----------------
Hangover after recreational alcohol use, residual effect of zopiclone and placebo compared in terms of spatial perception, psychomotor tests and simulated driving ability. Three recording visits plus screening included.

Official Title
-----------------
The Effect of Alcohol Hangover and Night-time Zopiclone on Next-morning Spatial Perception in Healthy Young Volunteers

Conditions
-----------------
Healthy, Alcohol Drinking

Intervention / Treatment
-----------------
* Drug: Zopiclone
* Behavioral: hangover
* Drug: Placebo oral capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: weight >45 kg likely to experience and predict alcohol hangover within the next five weeks no childbearing potential of negative pregnancy test at screening a valid driving license Exclusion Criteria: breastfeeding infection with HCV, HBV or HIV a medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation suspected or current drug or alcohol abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zopiclone|Oral, single dose, 7.5 mg|
|Behavioral: hangover|as per subjects choice to consume alcohol|
|Drug: Placebo oral capsule|oral|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving error rate | Driving error rate | Day 1 | 
| Number of erroneous responses to peripheral visual stimuli during driving | Number of erroneous responses to peripheral visual stimuli during driving | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| digit symbol substitution | digit symbol substitution test | Day 1 | 
| drug concentration | concentration of zopiclone in plasma | Day 1 |