linjc16/ctgov huggingface dataset:
Longitudinal Outcomes in Pediatric rTMS and CIT

Study Overview
=================
Brief Summary
-----------------
Track behavioral and qualitative longitudinal outcomes in children with hemiparesis who previously participated in a randomized, controlled trial (RCT) of intensive therapy combined with repetitive Transcranial Magnetic Stimulation (rTMS)

Detailed Description
-----------------
This longitudinal study will evaluate the subjective and behavioral outcomes of a previous randomized controlled study (RCT) rTMS/CIT (Pediatric Hemiparesis: Synergistic Treatment using rTMS and CIT (NIH Grant Number: 1RC1HD063838-01; PI: Dr. James Carey). The previous rTMS/CIT study evaluated the safety and efficacy of 5 treatments of 6-Hz primed low-frequency rTMS applied to the non-stroke hemisphere combined with constraint induced therapy (CIT) to promote recovery of the paretic hand in children and adolescents. CIT has shown improved behavioral outcomes as well as cortical reorganization in representation of the affected limb. The previous RCT was a rTMS-Sham/CIT study design (real rTMS n=10 and sham rTMS n=9). Our research question, 'What is the medical status and perception of previous participants concerning their involvement in an intensive rTMS/CIT RCT specific to symptom monitoring, the TMS experience, and their current functional status'.

Official Title
-----------------
Longitudinal Outcomes in Pediatric rTMS and CIT

Conditions
-----------------
Congenital Hemiparesis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participants in a RCT on rTMS/CIT. Exclusion Criteria: Participants who do not wish to participate.

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 |
| --- | --- | --- |
| TMS Symptom Checklist | This checklist assists in monitoring children who have had TMS for side effects. | Adminstered at testing session, 2-4 years after intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assisting Hand Assessment | This assessment evaluates how well a child can use his/her hands during every day two handed activities. | at testing session, 2-4 years after intervention. |
Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients

Study Overview
=================
Brief Summary
-----------------
Primary Objective: Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression Secondary Objective: Describe treatment patterns Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others Describe economic and patient-reported outcomes

Official Title
-----------------
Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Progression During or After a First-line Docetaxel-based Regimen

Conditions
-----------------
Prostatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy Patient who have given their written consent Exclusion criteria: Current participation in a clinical trial for the second-line treatment of prostate cancer Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity Patients having already started a second line treatment The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRPC patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | At Month 12 or death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sequence of treatment in second-line, third-line |  | At Month 6 (+/- 2 months), Month 12 or death | 
| Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others |  | At baseline, Month 6 (+/- 2 months), Month 12 or death | 
| Indicators of health care resource utilization |  | At baseline, Month 6 (+/- 2 months), Month 12 or death | 
| Quality of life |  | At baseline, Month 6 (+/- 2 months) or Month 12 |
Optimizing Preoperative Disinfection of Eyes

Study Overview
=================
Brief Summary
-----------------
Topical povidone-iodine (PI) is widely used as ocular antiseptic before and after surgery. The standard dose of 5% PI is however, associated with ocular irritation. We therefore want to test if a lower concentration of PI can be similarly efficacious in reducing bacterial growth while reducing ocular irritation.

Official Title
-----------------
Optimizing Preoperative Disinfection of Eyes

Conditions
-----------------
Eye Infections

Intervention / Treatment
-----------------
* Drug: Povidone-Iodine 0.3%
* Drug: Povidone-Iodine 5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients remitted to intravitreal injections at St. Olavs hospital. Patients competent to give written consent Exclusion Criteria: Infectious disease Known epitheliopathy Contact lens wear Use of prescription ophthalmic medications Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Both eyes of the participants are tested; one eye randomised to receive the intervention and the second eye to receive the standard disinfection.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Povidone-Iodine 0.3 %<br>A tampon is soaked in diluted PI 0.3% and placed on the inside of the lower eyelid of one eye, where it will release iodine molecules for 20 minutes before being removed. | Drug: Povidone-Iodine 0.3%<br>* Low concentration iodine<br>|
| Active Comparator: Povidone-Iodine 5 %<br>Eye drops of 5% PI is the standard disinfection before eye surgery. The drops will be dripped in one eye and allowed to work for 2 minutes. | Drug: Povidone-Iodine 5%<br>* Standard concentration iodine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conjunctival bacterial culture | Change in colony-forming units (CFU) per milliliter (ml) | 1 hour. Bacterial sample is taken before and immediately after disinfection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient pain score | Verbal numeric rating scale, from 0 to 10. | During disinfection and after 1 hour when the anesthetic no longer is effective | 
| Ocular staining score (OSS) | Modified OSS using fluorescein dye | 1 hour after disinfection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Disinfection, Pre-operative, Povidone Iodine, Eye surgery
Pulmonary Hypertension Biorepository and Registry

Study Overview
=================
Brief Summary
-----------------
Establish a pulmonary hypertension registry and biorepository to lead towards a further understanding of the disease.

Detailed Description
-----------------
The aim of this project will be to establish a broad and wide-ranging registry and biorepository of blood samples from patients with pulmonary hypertension, including all WHO groups I-V to be used for future research in these areas. This will be both a retrospective and prospective project. The registry and biorepository will be utilized to study and grow our knowledge of the cellular mechanisms and mediators of the disease and, in turn, contribute to advancements in treatment.

Official Title
-----------------
Pulmonary Hypertension Biorepository and Registry

Conditions
-----------------
Pulmonary Hypertension, Primary, 2, Pulmonary Hypertension, Primary, 3, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Hypertension Due to Left Heart Disease, Pulmonary Hypertension, Primary, Pulmonary Hypertension Due to Lung Diseases and Hypoxia, Pulmonary Hypertension, Primary, 4

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is a patient at TUKHS or has agreed to participate in a study approved by the KUMC Human Research Protection Program (HRPP) The participant has a diagnosis of pulmonary hypertension confirmed by right heart catheterization Patient is ≥ 18 years of age or older Exclusion Criteria: Participant declines to participate (living patients only) Participant is unable to provide informed consent (living patients only)

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Collect Clinical Data | Collect clinically obtained data from current and deceased patients with pulmonary hypertension to support research. | From Enrollment to 6 Months | 
| Establish a Biorepository | Establish a collection of biospecimens from patients with pulmonary hypertension. | From Enrollment to 6 Months | 
| Biospecimens Collection | Correlate biospecimens to longitudinally collected individual patient data. | From Enrollment to 12 Months | 
| Collaborate | Provide biospecimens to researchers investigating pulmonary hypertension. Separate IRB approval will be needed for these studies. | From Enrollment to 24 Months |
Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the ability of tofacitinib citrate, a Janus kinase inhibitor, to generate hair regrowth in patients with moderate to severe alopecia areata and its variants.

Detailed Description
-----------------
This study is an open-label pilot study. Participants will be treated with oral tofacitinib for 3 months.

Official Title
-----------------
Tofacitinib for the Treatment of Alopecia Areata and Its Variants

Conditions
-----------------
Alopecia Areata, Alopecia Totalis, Alopecia Universalis

Intervention / Treatment
-----------------
* Drug: Tofacitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years old Diagnosis of alopecia areata with >50% scalp involvement, alopecia totalis, or alopecia universalis Hair loss present for at least 6 months No treatment for alopecia areata in past 2 months No evidence of hair regrowth Females of childbearing potential must use birth control while taking the medication and there must be a negative pregnancy test documented prior to starting the medication Fluent in spoken and written English Exclusion Criteria: Age <18 years old Patients have received treatment known to affect alopecia areata within 2 months of enrolling in the study Patients with a history of malignancy (except history of successfully treated basal cell or squamous cell carcinoma of the skin) Patients known to be HIV or hepatitis B or C positive Patients with positive tuberculin skin test or positive QuantiFERON TB test Patients with leukopenia or anemia Patients with renal or hepatic impairment Patients with peptic ulcer disease Patients taking immunosuppressive medications, including but not limited to prednisone, methotrexate, mycophenolate mofetil, azathioprine, tacrolimus, cyclosporine, or TNH-alpha inhibitors Women of childbearing potential who are unable or unwilling to use birth control while taking the medication Women who are pregnant or nursing

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tofacitinib<br>Participants will receive tofacitinib for 3 months. | Drug: Tofacitinib<br>* Tofacitinib 5 mg tablet taken by mouth twice a day.<br>* Other names: Jakvinus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Severity of Alopecia Tool (SALT) Score | SALT score range is from 0 (no hair loss) to 100 (100% hair loss). Positive percent change from baseline corresponds to reduction in SALT score. | 0 and 3 months |
Early Parenting Intervention Comparison

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effectiveness of two parenting programs in a mental health clinic serving young children with behavior problems.

Official Title
-----------------
Comparing Two Parenting Programs for At-Risk Families

Conditions
-----------------
Behavior Problems, Child

Intervention / Treatment
-----------------
* Behavioral: Chicago Parent Program
* Behavioral: Parent-Child Interaction Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: child 2 to 5 years old parent reports reason for referral is child behavior problems parent is a biological or adoptive parent, or legal guardian of child Exclusion Criteria: parent is psychotic or actively abusing substances child is autistic or severely developmentally delayed

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 5 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Chicago Parent Program arm<br>The Chicago Parent Program is a 12-session group-based parenting skills training program | Behavioral: Chicago Parent Program<br>* The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems<br>|
| Active Comparator: Parent-Child Interaction Therapy<br>Parent-Child Interaction Therapy is an individually tailored treatment for parents and children with behavior problems | Behavioral: Parent-Child Interaction Therapy<br>* Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Child Behavior Problems | parent-report measure called The Child Behavior Checklist. Raw scores range from 0 to 198 with lower numbers being better for the child. | baseline, first follow-up (up to 2 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aggregate Cost | Combined provider (based on billing records) and parent cost (based on self-report). | through end of study (up to 2 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preschool children behavior problems, child between 2 and 5 years old
Contribution of F18-FDG PET/CT to the Early Assessment of Pazopanib Therapy Efficacy in Advanced Soft Tissue Sarcoma

Study Overview
=================
Brief Summary
-----------------
Soft Tissue Sarcoma (STS) is a rare tumor but can grow in different areas, for example, in 60% in limbs and about 20 % in retroperitoneum; and frequently is inoperable. Despite novel therapy in advanced cases survival is still short, approximately 12 month. Pazopanib oral angiogenesis inhibitor was recently shown as promising drug for advanced pretreated STS. Functional imaging especially F18-FDG PET/CT is a good modality for FDG avid tumor either for pre- / post- treatment evaluation or follow up. Early detection of treatment response to therapy by whole body FDG PET/CT allows for change of treatment as early as possible,when the tumor is non-responsive before serious side effects appear or before depletion of body resources. The aim of the study is to investigate the contribution of FDG PET/CT to assessment of treatment response.

Conditions
-----------------
Soft Tissue Sarcoma (STS)

Intervention / Treatment
-----------------
* Other: F18-FGD PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with advanced Soft Tissue Sarcoma prior to pazopanib treatment Exclusion Criteria: Other treatment FDG negative tumor

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 |
| --- | --- |
| Advanced Soft Tissue Sarcoma<br>patients with advanced Soft Tissue Sarcoma | Other: F18-FGD PET/CT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of extent and intensity (standardized uptake value - SUV) of disease demonstrated on PET/CT images before and after treatment. |  | 1 week | 
| determination of treatment efficiency by comparison of PET data (SUV) with CT changes (cm)in 3 studies and clinical information. |  | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prediction of treatment efficiency |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Soft Tissue Sarcoma, Pazopanib, F18-FDG PET/CT
RETRIeVE: ReversE TranscRiptase Inhibitor hiV Practice

Study Overview
=================
Brief Summary
-----------------
An observational retrospective study of NNRTI experienced patients who have virologically failed. The study aims to assess resistance profiling and subsequent prescription patterns of patients on NNRTIs

Detailed Description
-----------------
This is a cross-sectional study involving retrospective review of HIV-1 positive patient records who began treatment with a non-nucleoside reverse transcriptase inhibitor (NNRTI) and subsequently failed. Patients who have virologically failed previous NNRTI treatment, or have resistance to 1 drug in the NNRTI class are examined further. Such patients will have attended the clinic every 3-6 months for routine medical care. The data source for variables collected is the patient's electronic medical records. This database is located at Holdsworth House Medical Practice (HHMP), Sydney.

Official Title
-----------------
Non-nucleoside Reverse Transcriptase Inhibitor Failure in a High HIV Caseload Australian Primary Care Practice

Conditions
-----------------
HIV Positive

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented HIV infection Attended Holdsworth House Medical Practice 1999-2009. Chosen ART regime includes an NNRTI Exclusion Criteria: N/A
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV1 positive, NNRTI exposure and failure<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| resistance profiling and subsequent prescription patterns of patients on NNRTIs |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiretroviral therapy experienced, failed NNRTI regime
Study of Hemodynamics of Neonates by Echocardiography and USCOM

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the hemodynamic values of neonates that are healthy and those with various congenital heart diseases and sepsis by using echocardiography and USCOM.

Detailed Description
-----------------
Echocardiography is a diagnostic tool for congenital heart disease.However,it requires skilled specialists to perform it and is a little expensive.Besides,it is too big to move to the bedside easily.USCOM is another newly choice to evaluate hemodynamic values in recent years.This study will compare the hemodynamic values of neonates that are healthy and those with congenital heart diseases and sepsis by using echocardiography and USCOM.

Official Title
-----------------
Study of Hemodynamics of Healthy Neonates and Those With Congenital Heart Diseases and Sepsis by Echocardiography and USCOM

Conditions
-----------------
Sepsis, Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neonatal congenital heart disease sepsis Exclusion Criteria: aged more than thirty days

Ages Eligible for Study
-----------------
Maximum Age: 30 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| congenital heart disease<br>Neonates that are enrolled in the NICU and are confirmed of congenital heart diseases. | |
| sepsis<br>Neonates that are enrolled in the NICU and are diagnosed as sepsis. | |
| Health<br>Neonates that are enrolled in the NICU and have no congenital heart diseases and sepsis. | |

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
-----------------
hemodynamics, neonatal