linjc16/ctgov huggingface dataset:
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma

Study Overview
=================
Brief Summary
-----------------
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.

Detailed Description
-----------------
Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.

Official Title
-----------------
Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study

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

Intervention / Treatment
-----------------
* Other: Bladder EpiCheck


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma Has all urothelial cell carcinoma tumor resected within the past 12 months Has a plan for cystoscopic surveillance Exclusion Criteria: Planning to undergo radical cystectomy or chemotherapy-radiation for UCC

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 100 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bladder EpiCheck<br>Urine sample will be tested with the Bladder EpiCheck in conjunction with cystoscopy and cytology | Other: Bladder EpiCheck<br>* Urine test for the monitoring of bladder cancer recurrence<br>|
| No Intervention: Practice of medicine<br>Practice of medicine including cystoscopy and cytology | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity (the proportion of positives that are correctly identified as such by the gold standard) | the proportion of positives that are correctly identified as such by the gold standard | Day 1 | 
| Specificity (the proportion of negatives that are correctly identified as such by the gold standard) | the proportion of negatives that are correctly identified as such by the gold standard | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bladder cancer, Urine, Methylation
Effects of Comorbid Personality Disorder on the Treatment of Bipolar I Disorder

Study Overview
=================
Brief Summary
-----------------
This study will examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar I disorder.

Detailed Description
-----------------
The major aim of this proposal is to examine the impact of comorbid personality disorder on the outcome of treatment among patients with bipolar I disorder. The specific aims are to create a research and supervisory team and to identify potential moderators of treatment response and mediators of outcome over the course of treatment. Members of the team will meet weekly to begin a treatment development process for enhancing Interpersonal Social Rhythm Therapy (IPSRT) for these patients. Additional assessment measures will be utilized to examine the proposed mediators and moderators of treatment.

Official Title
-----------------
Treatment of Primary Mood Disorders in the Comorbidly Ill

Conditions
-----------------
Bipolar I Disorder, Borderline Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: Interpersonal Social Rhythm Therapy (IPSRT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar I Disorder with Comorbid Borderline Personality Disorder, currently manic or depressed Exclusion Criteria: Unstable Medical illness

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Interpersonal Social Rhythm Therapy (IPSRT)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression (HRSD-25) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raskin Severity of Depression and Mania Scales |  |  |
Antiphospholipid Syndrome Collaborative Registry (APSCORE)

Study Overview
=================
Brief Summary
-----------------
Antiphospholipid Syndrome (APS) is an autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. Patients with these antibodies may experience miscarriages and blood clotting disorders, including heart attacks and strokes. APS may occur in people with systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy individuals. The Antiphospholipid Syndrome Collaborative Registry (APSCORE) is a national registry and tissue repository for patients with APS. This registry will collect clinical information and blood samples from people with APS.

Detailed Description
-----------------
Registry participants will have a blood sample drawn and will be interviewed about their medical histories. Participants will be asked to return for a follow-up visit after two years. Clinical, demographic, and laboratory data will be collected. Registry resources will be made available to researchers and medical practitioners to support a broad range of research on the causes, diagnosis, mechanisms, and treatment of APS. The University of North Carolina at Chapel Hill is the coordinating center and an enrollment site for the registry. There are seven other enrollment sites: Ball Memorial Hospital, Muncie, IN; Duke University, Durham, NC; Hospital for Special Surgery, New York, NY; Johns Hopkins University, Baltimore, MD; Morehouse School of Medicine, Atlanta, GA; University of Texas Health Science Center, San Antonio, TX; and University of Utah Health Science Center, Salt Lake City, UT.

Official Title
-----------------
Antiphospholipid Syndrome Collaborative Registry (APSCORE)

Conditions
-----------------
Antiphospholipid Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Antiphospholipid antibodies with or without associated clinical manifestations
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
-----------------
Antiphospholipid
Feasibility and Safety of a Virtual-Reality Based Job Interview Training Tool in Teenagers With High-Functioning Autism

Study Overview
=================
Brief Summary
-----------------
The current project involves the application of a VR job training software. We propose to use an interactive VR job interview practice system, Virtual Reality Job Interview Training (VR-JIT), in youths with ASD at the highschool level. This system was developed to bolster job interview practice skills and to help reduce anxiety in adults with ASD. However, it has never before been used in individuals under the age of 18. Our hope is that if this program is utilized in individuals while they are still in highschool, we can target those persons before the window for which risk of unemployment appears to be highest for ASD youths, immediately after high school graduation.

Official Title
-----------------
Feasibility and Safety of a Virtual-Reality Based Job Interview Training Tool in Teenagers With High-Functioning Autism

Conditions
-----------------
Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Other: VR-JIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 13 and 18 Have a diagnosis of ASD or a typically developing child Be able to speak and read English fluently Exclusion Criteria: I had a stroke, TBI, or neurologic injury or disease in the past I have a history of significant psychiatric illness (like bipolar, schizophrenia, or psychosis) I have uncontrolled seizures or other unstable medical complications

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 18 Years

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

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

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: VR-JIT<br> | Other: VR-JIT<br>* Job interview with virtual interviewer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mock job interview |  | 7 weeks |
Comparison Between Patching and Interactive Binocular Treatment (IBiTTM) in Amblyopia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of amblyopia therapy on cases who will receive Interactive Binocular Treatment (IBiTTM) without patching compared with those who will receive standard patching of the dominant eye with placebo IBiTTM. In this randomized clinical trial, 40 unilateral amblyopic children (3 to 10 years old) will be studied. All unilateral functional amblyopic children with best corrected visual acuity (BCVA) worse than 0.30 LogMAR at least in one eye or a difference of two BCVA lines of Snellen between the two eyes will be included and randomly will divide into the case (n=19) and control (n=21) groups. Cases will play I-BiT™ games, while controls will have standard patch therapy and will play with placebo IBiTTM for one month. All subjects will be underwent comprehensive ophthalmic examinations at baseline and at one-month follow-up.

Official Title
-----------------
Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences

Conditions
-----------------
The New Treatment in Amblyopia Therapy

Intervention / Treatment
-----------------
* Device: Interactive Binocular Treatment
* Procedure: Patching Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Functional amblyopia with BCVA less than 20/30 (0.3 LogMAR) at least in one eye A difference of two BCVA lines of Snellen between the two eyes Exclusion Criteria: A history of penalization one month prior to the study Bilateral amblyopia BCVA less than 20/200 Eccentric fixation Nystagmus Ocular deviation more than 10 prism diopter (pd) Organic amblyopia Uncooperative children those with Mental and physical disability Systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 10 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I-BiT group<br>Amblyopic patients will play I-BiT games without patching. | Device: Interactive Binocular Treatment<br>* The specified system which stimulate the fovea of the amblyopic eye directly by detailed and movable objects, while the fixation of the non- amblyopic eye will be focused on fixed targets.<br>|
| Placebo Comparator: Placebo group<br>Amblyopic patients will patch their dominant eye and they will play placebo I-BiT games. | Procedure: Patching Therapy<br>* Patching of the dominant eye with better best corrected visual acuity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best Corrected Visual Acuity |  | 6 months |
Making HD Voices Heard

Study Overview
=================
Brief Summary
-----------------
The Pilot Study, Making HD Voices Heard, will ask people living with HD to report what they experience and how they function.

Detailed Description
-----------------
The Huntington Study Group (HSG) myHDstory™ Platform is an online, observational research platform that will host the Pilot Study, Making HD Voices Heard. The Pilot Study will ask people living with HD to report what they experience and how they function. Participants will provide self-reported information using their own compatible smartphones, laptops, desktops, or tablets. Participants will be asked to reply to a series of questions, including open-ended questions that will be transcribed by voice (microphone voice-to-text transcription) or keyboard-entered text to record what they experience in their own words.

Official Title
-----------------
Making HD Voices Heard - A Pilot Study on the myHDstory™ Platform

Conditions
-----------------
Huntington Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults age 18 years and older Willing and able to provide informed consent electronically. Individuals answering as a participant must self-report they have been diagnosed with HD by a doctor. Ability to answer online questions or direct someone else to enter answers for them. Ability to ambulate independently and take care of some of his or her personal needs. Ability to read and understand English. Willing to create a unique identifier based on personal demographic information. Residing in the United States or its territories Owning or having access to an electronic device and secure internet connectivity Exclusion Criteria: An individual who does not meet all the inclusion criteria will be excluded from participation in this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| The ability to successfully consent and enroll at least 200 HD participants who have early to mid-stage manifest HD. | Ability to successfully consent and enroll at least 200 manifest HD participants (independent or with help of assistants) within three months as measured by the number of help line calls or emails received requesting technical or clinical support. | 3 months | 
| Participants' ability to successfully complete online self-reported questionnaires. | Participants' ability to successfully complete online self-reported questionnaires as measured by the number of completed questionnaires. | 3 months | 
| Utility and informativeness of data collected. | Utility and informativeness of capturing, extracting, curating, and analyzing verbatim responses to open-ended questions in the form of the HD-Patient Report of Problems (HD-PROP). | 9 months |
A Prospective Observational Study to Evaluate the Quality of Life and the Costs in a Real Life Setting in Patients Who Are Treated With 90Y-Zevalin

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare hematological toxicity, costs, health-related quality of Life (HR-QOL) and outcomes observed in real life in the Belgian Non-Hodgkin Lymphoma (NHL) population receiving 90Y-Zevalin, with model-predicted data at reimbursement on the basis of a clinical trial in heavily pre-treated NHL.

Official Title
-----------------
A Prospective Observational Study to Evaluate Quality of Life and Costs in a Real Life Setting in Patients Treated With 90Y-Zevalin

Conditions
-----------------
Lymphoma, Follicular, Non-Hodgkin Lymphoma

Intervention / Treatment
-----------------
* Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced cancer of the lymph nodes of follicular type at study inclusion The patient has relapsed or has refractory disease, after previous treatment with rituximab Treating physician has decided to treat the patient with a 90Y-Zevalin regimen The patient is >= 18 years of age Patient has given informed consent Exclusion Criteria: Patient is unwilling or unable to give informed consent Patient is participating in another clinical trial

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 |
| --- | --- |
| Group 1<br> | Drug: [90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)<br>* Zevalin was administered according to the directives in the approved package leaflet.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The medical resources consumed due to hematological adverse events that occurred following treatment with 90Y-Zevalin treatment |  | one year after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the health related quality of life prior to and following treatment (using EQ-5D and FACT-LYM) |  | baseline: before 1st administration, 8 days after baseline, 1, 2 & 3 months after baseline | 
| the clinical outcomes (survival status, response status), TTNT (time to next treatment) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of Life, Health Care Costs
Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet

Study Overview
=================
Brief Summary
-----------------
The object of the study is to investigate whether all included patients receive treatment that is effective against all bacteria that are defined as sensitive to meropenem with the current treatment regimen. Will the investigators findings motivate routine monitoring of plasma concentrations in children receiving meropenem? Up to 50 patients will be included in the study, and all participants are children.

Official Title
-----------------
Meropenem Plasma Concentration Measurements at the Pediatric Medical Ward, Oslo University Hospital, Rikshospitalet

Conditions
-----------------
Bacterial Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged from 3 months to 18 years that receive treatment with meropenem. Inclusion is independent of how long the patient has been receiving treatment. Children receiving other treatment (except hemodialysis)/other medications can be included. Exclusion Criteria: Children less than three months of age. Patients receiving hemodialysis. Lack of consent.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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 |
| --- | --- |
| Children receiving meropenem<br>Children aged from 3 months to 18 years that receive treatment with meropenem. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We will determine how many of the patients in our material that have plasma concentrations of meropenem above 8 mg/l for at least 40% and 75% of the time. |  | 1 dosing interval (8 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meropenem, child, bacterial infection, treatment evaluation
Ketoacidosis in Individuals With Type I Diabetes Mellitus (T1DM)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate individuals with type 1 diabetes who were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate.

Detailed Description
-----------------
Individuals with type 1 diabetes were disconnected from their insulin pump and insulin therapy was started again after positive ketones (U) in the urine or blood β-hydroxybutyrate with different therapy regimens after positive blood ketones.

Official Title
-----------------
Ketoacidosis in Individuals With T1DM

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Different insulin therapy at different time points


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 1 diabetes Exclusion Criteria: severe hypo- or hyperglycemia during last 6 months acute illness

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>stop after positive ketone bodies in urine | Behavioral: Different insulin therapy at different time points<br>* different insulin therapy after positive blood ketones<br>|
| Other: Arm 2<br>stop after positive ketone bodies in blood, normal therapy | Behavioral: Different insulin therapy at different time points<br>* different insulin therapy after positive blood ketones<br>|
| Other: Arm 3<br>stop after positive ketone bodies in blood, additional therapy | Behavioral: Different insulin therapy at different time points<br>* different insulin therapy after positive blood ketones<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose metabolism, time course of positive ketone bodies |  | 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
therapy after positive ketone bodies in the blood, timepoint of diagnosis, timepoint of metabolic normalisation