linjc16/ctgov huggingface dataset:
Pilot Study of Wearable Artificial Kidney

Study Overview
=================
Brief Summary
-----------------
This is a pilot study of a wearable type of kidney dialysis machine to treat patients with chronic kidney disease.

Detailed Description
-----------------
This is a pilot study to evaluate the clearances, tolerability and safety of a wearable artificial kidney device for treating patients with chronic kidney failure.

Official Title
-----------------
Preliminary Study to Assess the Safety and Efficacy of a Wearable Artificial Kidney Device for the Treatment of Patients With Endstage Renal Failure

Conditions
-----------------
Renal Failure

Intervention / Treatment
-----------------
* Device: Wearable artificial kidney


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: End stage renal failure Regular haemodialysis Cardiovascular stability Stable vascular access Exclusion Criteria: Allergy to heparin or ethylene oxide Recent cardiovascular or neurological event Unable to provide informed consent Age < 18

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

| Intervention/Treatment |
| --- |
|Device: Wearable artificial kidney|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urea, potassium, phosphate and B2M clearances |  |  | 
| safety - cardiovascular,no hemolysis, bleeding, infection |  |  | 
| no ammonia generation from sorbents, control of acid base balance |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid removal |  |  | 
| patient satisfaction questionnaire |  |  | 
| affect of treatment of cytokines |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
end stage renal failure, dialysis, wearable artificial kidney
Mapping 3D Bladder

Study Overview
=================
Brief Summary
-----------------
This is a single centre, single arm feasibility study assessing the feasibility of using computer vision methods to recreate the 3D bladder shape and to then map the cystoscopy images onto this bladder shape. If feasible, this 3D reconstructed shape would be spatially registered to radiological images (CT, MR) that are then used during radiation treatment planning. This analysis would not be used for making any clinical treatment decisions on the patient.

Official Title
-----------------
Feasibility of Spatially Registered Endoscopy for Mapping Bladder Mucosal Disease Into Radiation Planning Morphologic Imaging

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: Cystoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older. Clinical suspicion or histologic diagnosis of bladder tumour suitable for endoscopic evaluation. Intention to treat using external beam radiation therapy as part of standard of care. Ability to provide written informed consent to participate in the study. Exclusion Criteria: Prior complete or partial radiation therapy to bladder. Contraindications to radiation therapy as determined by the treating physician. Concurrent illness or condition that precludes subject from undergoing endoscopy or CT scanning.

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

| Intervention/Treatment |
| --- |
|Procedure: Cystoscopy|Standard of care cystoscopy procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Video recording of Cystoscopy | To determine the feasibility of using bladder endoscopic video images to reconstruct the three-dimensional shape of the bladder based on computer visions methods that employ feature extraction and triangulation and to map the endoscopy images onto the recreated 3D surface. | At study completion, up to 2 years | 
| Contouring of 3D bladder rendering | To determine the feasibility of contouring the mucosal disease on the 3D bladder rendering. | At study completion, up to 2 years | 
| Registering bladder shape | To determine the feasibility of registering the bladder shape to a CT/MR scan of the patient using deformable shape methods. | At study completion, up to 2 years |
Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Examine adrenal cortical function and the incidence of adrenal dysfunction in children with septic shock. II. Examine the mortality, length of stay in the PICU, and incidence of multiorgan failure in children with adrenal dysfunction and septic shock.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo a corticotropin stimulation test within 8 hours of admission to the PICU. Blood samples for plasma cortisol and corticotropin levels are drawn at time 0 followed by corticotropin 1-24 IV. Additional cortisol levels are drawn at 30 and 60 minutes. Corticotropin is measured by immunoradiometric assay and cortisol is measured by radioimmunoassay. Mean arterial blood pressure, heart rate, and respiratory rate are recorded at baseline and at 60 minutes. Patients receive routine management for septic shock and multiple organ system failure.

Conditions
-----------------
Septic Shock

Intervention / Treatment
-----------------
* Drug: corticotropin


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Patients admitted to the PICU with septic shock; Hypotension (systolic blood pressure less than 2 standard deviations below age normal) plus 3 or more of the following: temperature greater than 38 or less than 36 degrees Celsius; heart rate greater than 90th percentile for age; respiratory rate greater than 90th percentile for age; WBC greater than 12,000/mm3 or less than 4,000/mm3 or greater than 10% band forms; perfusion abnormalities including lactic acidosis, oliguria, or an acute alteration in mental status Arterial or central venous catheter in place --Prior/Concurrent Therapy-- At least one month since prior corticosteroids --Patient Characteristics-- Renal: No nephrotic syndrome requiring glucocorticoids Pulmonary: No asthma requiring glucocorticoids Other: No condition requiring glucocorticoids (e.g., adrenal insufficiency); No uncontrolled diabetes mellitus; No prior adrenal dysfunction (plasma cortisol concentration less than 19 mcg/dL 30 and 60 minutes post corticotropin stimulation); No hypersensitivity to corticotropin

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: corticotropin|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
-----------------
immunologic disorders and infectious disorders, rare disease, sepsis, septic shock
Usability of the Foresee Home in Intermediate Age Related Macular Degeneration (AMD) Patients

Study Overview
=================
Brief Summary
-----------------
The study purpose is to demonstrate that the target population can receive a packed FORESEE HOME unpack it, install and operate it to an extent that the FORESEE HOME can monitor them for changes in the visual field with good specificity. And evaluate the device usage on a small scale, at the subjects' homes before a commercial use.

Detailed Description
-----------------
Numerical output of the FORESEE HOME, output of the usability parameters provided by the FORESEE HOME device, counts of the number of subjects who successfully set up the device and conduct testing sessions.

Official Title
-----------------
Usability of the Foresee Home in Intermediate Age Related Macular Degeneration Patients

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Capable and willing to sign a consent form and participate in the study Subjects diagnosed as intermediate AMD in at least one eye (in case a patient will convert during the study period he will be excluded) Age more than 50 years VA with habitual correction better than 20/60 in the study eye Ability to speak, read and understand instructions in English or Hebrew Familiar with computer usage Exclusion Criteria: Evidence of macular disease other than AMD or glaucoma in the study eye Presence of any significant media opacity that precludes a clear view of the macular area as identified in the study eye by biomicroscopy, CFP. Any non-macular related ocular surgery performed within 3 months prior to study entry in the target eye Never been tested on the PHP device Participation in another study with the exclusion of AREDS study Patients diagnosed with geographic atrophy (GA)

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>Self trained subjects | |
| 2<br>supervised trained subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who managed to set the device |  | 6 months | 
| Proportion of subjects who managed to perform the test after dynamic tutorial/supervised training |  | 6 month | 
| Number of device malfunctions |  | 6 month | 
| Average use of the device |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HMP, CNV, AMD, PHP, HPHP, foresee
Video Education: Capitalizing on Caregiver Time Spent in the Pediatric Emergency Department Waiting Room

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if video education is an effective means of caregiver education in the waiting room of a pediatric emergency department (ED). This will be tested with the showing of a child passenger safety video.

Conditions
-----------------
Child Passenger Seat Safety

Intervention / Treatment
-----------------
* Other: Child passenger safety video


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: caregivers of patients presenting to Children's Hospital of Wisconsin for treatment family use of automobile for transportation Exclusion Criteria: non-English speaking caregivers triage level 1 or 2 or requiring immediate medical attention
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>This group of subjects will not be exposed to a video during their time in the ED waiting room | |
| Experimental: Child passenger safety video<br>This group of subjects will be exposed to a video during their time in the ED waiting room | Other: Child passenger safety video<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Difference in caregiver knowledge on a questionnaire | A knowledge questionnaire will be completed by caregivers in control and intervention groups | day 0 in the ED | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention | A knowledge questionnaire for caregivers will be given at phone follow up 4 weeks after initial enrollment | up to 4 weeks after enrollment |
Genome Scan for Obesity in a Multi-Ethnic Sample

Study Overview
=================
Brief Summary
-----------------
To scan the genome for obesity in a multi-ethnic sample.

Detailed Description
-----------------
BACKGROUND: Despite intensive efforts the genetic basis of obesity has been difficult to establish. Linkage analysis using a genome-wide scan can potentially identify genomic regions not previously thought to be associated with susceptibility to obesity and provides a comprehensive test of the consistency of previous studies. The study used the considerable resources generated by the four cooperating networks in the NHLBI-supported Family Blood Pressure Program (FBPP) to conduct a genome-wide scan data for obesity. DESIGN NARRATIVE: In the Family Blood Pressure Program, microsatellite markers were typed at a density of -10cM by the Mammalian Genotyping Service (MGS) in Marshfield, WI. The complete data set was to include 9,940 individuals representing 4 ethnic groups (white, black, Hispanic and Asian). Obesity was characterized as a weight/height ratio (body mass index) and waist/hip ratio. This data set was larger than any prior genome scan for obesity, and the inclusion of multiple ethnic groups made it possible to examine genetic heterogeneity. The specific aims of the study were to conduct linkage and association analyses to localize regions influencing obesity. Investigators worked closely with the FBPP Coordinating Center (Washington University, St. Louis) and investigators from each of the four FBPP networks. Evidence was sought for consistency between results obtained from analyses of the genome scan performed by each of the individuals, and results summarized from the literature, with those found in meta-analysis. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
An Evaluation of Use of Topical Ocular Hypotensive Medication by Compliance

Study Overview
=================
Brief Summary
-----------------
This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.

Detailed Description
-----------------
This is an open-label study in patients who are currently using either a topical prostaglandin as sole ocular hypotensive medical therapy q.d., or a topical prostaglandin plus an adjunctive topical ocular hypotensive marketed product either q.d., or b.i.d. in the same eye(s). Compliance will be measured over the two months of participation.

Official Title
-----------------
An Evaluation of Use of Topical Ocular Hypotensive Medication by Electronic Compliance Measures

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: travoprost, latanoprost, or bimatoprost
* Drug: Additional ocular hypotensive medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently using one or two topical ocular hypotensive medications Exclusion Criteria: Hypersensitivity to any component of medication

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: travoprost, latanoprost, or bimatoprost|nan|
|Drug: Additional ocular hypotensive medication|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glaucoma, Compliance
Study of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study was to assess the safety,efficacy and pharmacokinetic when combining SHR-1701 and BP102 in participants with advanced or metastatic non-squamous non-small cell lung cancer. To explore the immunogenicity of SHR-1701 and the relationship between corresponding biomarkers and therapeutic effect.

Official Title
-----------------
A Multicenter, Open-Label, Phase Ib/II Trial of SHR-1701 Plus BP102 in Subjects With Selected Solid Tumors

Conditions
-----------------
Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: SHR-1701；BP102


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer. Failed with prior systemic treatments. Measurable disease, as defined by RECIST v1.1 The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1 Life expectancy ≥ 3 months Adequate hematologic and end-organ function as defined in the protocol Exclusion Criteria: Histologically or cytologically confirmed mixed SCLC and NSCLC. Symptomatic, untreated or active central nervous system metastases. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment With any active autoimmune disease or history of autoimmune disease. Inadequately controlled hypertension. Tumor infiltration into the great vessels on imaging. History of hemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment. Uncontrolled tumor-related pain. Patients with active hepatitis B or hepatitis C Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Experimental: SHR-1701+BP102<br> | Drug: SHR-1701；BP102<br>* Drug: SHR-1701 IV infusion Drug: BP102 IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) |  | 2 years | 
| Disease control rate (DCR) |  | 2 years | 
| Duration of response (DOR) |  | 2 years | 
| Overall survival (OS) |  | 2 years |
Treatment of Acute Periprosthetic Total Hip Arthroplasty Infections

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the success rate of two treatments for infection after total hip replacement: single stage arthroplasty exchange (your surgeon will take out your original implants and replace them with a complete new set) compared to irrigation and debridement with modular exchange (your surgeon will clean your implants with a surgical solution and take out the plastic liner and replace it with a new one - the rest of your hip implants will stay in place). The goal is to see if one is better than the other for the treatment of hip infection after a total hip replacement. A successful treatment means that you did not have to have another surgery on your hip for an infection-related reason.

Official Title
-----------------
The Treatment of the Acute Periprosthetic Hip Infection After Uncemented Total Hip Arthroplasty: A Randomized Study Comparing Open Debridement Component Retention (ODCR) With Modular Exchange Versus One Stage Exchange Arthroplasty

Conditions
-----------------
Periprosthetic Infection Total Hip Arthoplasty

Intervention / Treatment
-----------------
* Procedure: open debridement with modular exchange
* Procedure: one stage exchange


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Return to the OR for a drainage procedure within six weeks of index primary uncemented arthroplasty 1a) Exam findings within six weeks of index operation: Drainage for more than 7 days Wound appearance consistent with deep infection or hematoma Persistent fever or evidence of bacteremia All patients currently deemed appropriate for irrigation and debridement Labs - Rising inflammatory seromarkers Aspiration with a positive culture Exclusion Criteria: Previous history of periprosthetic infection Prisoners Patients not willing to consent for the proposed treatment Patients with altered mental status Concurrent metastatic infection Superficial Infection

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: open debridement with modular exchange<br> | Procedure: open debridement with modular exchange<br> <br> |
| Active Comparator: one stage exchange<br> | Procedure: one stage exchange<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success | Success is defined as no subsequent revision surgery needed to treat chronic or acute periprosthetic infection | 2 year |