linjc16/ctgov huggingface dataset:
Quality of Life Intermittent Catheter Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.

Official Title
-----------------
Quality of Life Intermittent Catheter Study - A Prospective, Randomized, Cross-over, Multicenter Study Comparing Quality of Life Using Compact Versus Standard Urinary Intermittent Catheters

Conditions
-----------------
Neurogenic Bladder Dysfunction Nos

Intervention / Treatment
-----------------
* Device: SpeediCath Compact
* Device: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 18 years of age Has given written informed consent Has neurogenic bladder dysfunction Has used coated intermittent catheter as primarily bladder emptying method for at least 6 months Is able to self-catheterise Is able to use SpeediCath® compact catheters If spinal cord injury subject, injury must have occurred more than 12 months ago Covered by Social security system Exclusion Criteria: Has used SpeediCath® compact catheters (not including screening for this investigation) Is admitted to rehabilitation centre Subjects using primarily catheter sets Is pregnant or breast-feeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Compact catheter<br>Compact intermittent catheter | Device: SpeediCath Compact<br>* The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.<br>* Other names: SpeediCath®Compact Female, for female participants;|
| Active Comparator: Standard Care<br>Standard Care: Coated intermittent catheter normally used by subject | Device: Standard care<br>* The coated intermittent catheter normally used by subject<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (0-100 Point) | Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life. | 6 weeks |
Prevalence of Angle Closure in Caucasian Hyperopes

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the prevalence of asymptomatic chronic angle closure in high risk Caucasian individuals, namely those with hyperopia. A secondary purpose is to assess whether specific demographic or ocular-anatomic parameters in this population are associated with a higher risk for angle closure.

Detailed Description
-----------------
Caucasian subjects aged > 40 years with hyperopia will undergo complete eye examination including subjective refraction and gonioscopy. In addition we will measure axial length, anterior chamber depth and lens thickness using ultrasound biometry.

Official Title
-----------------
Prevalence of Chronic Angle Closure in Caucasian Hyperopic Subjects

Conditions
-----------------
Chronic Angle Closure Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 40 years Hyperopia greater then +1.00 D spherical equivalent Exclusion Criteria: Any identifiable eye disease or previous eye surgery that can affect the anatomy of the irido-corneal angle

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- | --- |
| prevalence of chronic angle closure in Caucasian hyperopes |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative risk for chronic angle closure measured for demographic and ocular-anatomic parameters |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic angle closure hyperopia
Stress Analysis of Hip Dysplasia

Study Overview
=================
Brief Summary
-----------------
The main objective of this study is to predict cartilage contact pressures in the hip after periacetabular osteotomy (PAO).

Detailed Description
-----------------
PAO was designed as a joint preserving surgical procedure to compensate for a shallow acetabulum by re-orienting the acetabulum into a position that provides better coverage of the femoral head. Although the overall theory that increasing load bearing area (improving coverage of the femoral head) results in reduced joint stress is intuitive, the complex bony surface may not behave in this manner. It is possible that joint stress may increase when the acetabulum is reoriented into a position that increases load bearing area if post-operative joint congruency is worse than pre-operative.

Official Title
-----------------
Stress Analysis of Hip Dysplasia After Corrective Surgery

Conditions
-----------------
Hip Dysplasia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-40 years Patients who have undergone periacetabular osteotomy by Dr. Peters for treatment of hip dysplasia. Patients who have previously participated in IRB #10983 Comparative Stress Analysis of Hip Dysplasia. Exclusion Criteria: Persons with a history of allergies to lidocaine or seafood. Children under the age of 18. Persons incarcerated, on trial, or parole. Women who are pregnant. Subjects who do not have high quality pre-operative images available or have not been surgically treated by periacetabular osteotomy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- | --- |
| To predict cartilage contact pressures in the hip joint during simulated daily activities before and after periacetabular osteotomy (PAO) for correction of traditional dysplasia/retroversion. |  | 1 year post surgery |
Ultrasound-Guided Intercostal Nerve Block for Postoperative Pain Relief in Percutaneous Nephrolitotomy

Study Overview
=================
Brief Summary
-----------------
Percutaneous nephrolitotomy (PCNL)is an endourological procedure for the management of patients with renal calculi. Postoperative pain around the surgical area and the nephrostomy tube can being a problem. We hypothesized that intercostal nerve block at 11th and 12th rib level would alleviate postoperative pain and reduce analgesic consumption.

Detailed Description
-----------------
Patients admitted for the removal of renal stones by PCNL will included in this study.Primary outcome measure will be analgesic (tramadol )consumption and visual analog scale (VAS).

Conditions
-----------------
Nerve Block, Intercostal Nerve

Intervention / Treatment
-----------------
* Other: İntercostal nerve block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted for the removal of renal stones by percutaneous nephrolithotomy (PCNL) ASA I-II status Exclusion Criteria: Respiratory or cardiac disfunction Neuropathy Coagulopathy BMI (Body mass index)over 30

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Control group: Group that without intercostal nerve block | |
| Experimental: nerve block<br>Group that performing intercostal block | Other: İntercostal nerve block<br>* Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Analgesic (Tramadol) Consumption | Total consumption of tramadol will be measured for the first 24 hours. | Postoperative 24th hour | 
| Total Consumption of Tramadol Will be Measured for the First 24 Hours |  | Postoperative 24th hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain Will be Evaluated. | The pain score (VAS)(visual analog scale) will be evaluated for the first 24 hours.(0 no pain, to 10, the maximum pain )Pain score less then 4 is acceptable. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
percutanous nephrolitotomy,intercostal nerve block, Ultrasound
A Repeat Dose Pharmacokinetic Study Of Paroxetine CR Tablet In Healthy Chinese Subjects

Study Overview
=================
Brief Summary
-----------------
The study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy Chinese subjects.

Official Title
-----------------
A Steady-state Study to Assess the Pharmacokinetic Profile of Paroxetine After 14 Day Repeated Daily Dosing of the Controlled Release Paroxetine Tablet (25 mg) in Healthy Chinese Subjects

Conditions
-----------------
Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Paroxetine Controlled Release Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: 19-45 years healthy Chinese subjects Body weight > 50 kg BMI between 19-25 serological negative for HIV, syphilis and hepatitis B and C no abnormalities in ECG Female with negative pregnancy and male has no plan to have a child during and 3 months after the study. Exclusion criteria: History of chronic physical/mental disease, current disease and concomitant medication

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects receiving paroxetine<br>Eligible subjects will receive single dose of paroxetine 25 milligrams controlled release formulation followed by wash-out period of 5 days. Subjects will receive multiple doses of paroxetine 25 milligrams for further 14 days. | Drug: Paroxetine Controlled Release Tablet<br>* Eligible subjects will receive paroxetine controlled release tablet with dose of 25 milligrams.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parameters |  | Up to 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety parameters(adverse events, lab test results,vital signs,electrocardiograph) |  | Up to 21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BRL029060/Paroxetine CR, pharmacokinetics, repeat dose
The Maintenance Treatment of UFT in Advanced Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and tolerability of the maintenance treatment of tegafur-uracil (UFT) after the standard first-line chemotherapy in advanced gastric cancer.

Official Title
-----------------
Phase II Study of the Maintenance Treatment of UFT (Uracil and Tegafur) After First-line

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Drug: UFT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed advanced or metastatic adenocarcinoma of the stomach ECOG PS 0-2 At least one measurable or evaluable lesion in the first-line chemotherapy (5-FU based regimen: ECF/EOF/EOX/FOLFOX/XELOX) with the efficacy evaluation of non-PD Adequate hepatic,renal,heart, and hematologic functions (platelets ≥75×109/L, neutrophil≥1.5×109/L, hemoglobin≥80 g/L, serum creatinine ≤1.5mg/dl, total bilirubin ≤1.5mg/dl, and serum transaminase≤2.5×the ULN) Exclusion Criteria: Receiving more or more than 2 regimens of chemotherapy Pregnant or lactating women Concurrent cancer History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Neuropathy, brain, or leptomeningeal involvement Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months or high risk/uncontrolled arrhythmia Uncontrolled significant comorbid conditions and previous radiotherapy

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UFT treatment<br>Uracil and Tegafur | Drug: UFT<br>* UFT 360mg/m2 qd po d1-14, q3w<br>* Other names: Uracil and Tegafur;|
| No Intervention: comparator<br>no treatment, follow-up at regular time | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) | PFS is calculated from the start of treatment to disease progression or death | six weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) | OS is calculated from the start to treatment to the death | six weeks | 
| Number of Participants with Adverse Events |  | six weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disease control survival
Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases

Study Overview
=================
Brief Summary
-----------------
Background: Anatomical (traditional) stereotactic body radio therapy(SBRT) treatment planning assumes homogenous distribution of function in the normal liver tissue. In functional treatment planning, additional information on distribution of the function derived from functional imaging of normal tissue is taken into account. by functional treatment planning it becomes possible to prioritize and spare the best functioning part of an organ. Aim: To test whether functional treatment planning based on 18-FDGal PET/CT may spare the best functioning liver tissue. Endpoints: Reduction in hepatic systemic clearance (K) in the dynamic 18-FDGal PET/CT scan one month after SBRT compared to the baseline status in sub-volumes recieving 15 Gy or higher. Secondly, the investigators will evaluate the toxicity to SBRT by a toxicity scoring system that includes biochemical measures as well as symptomatic scores.

Official Title
-----------------
Phase 2 Study: Functional Treatment Planning Utilizing 18-FDGal PET/CT in SBRT for Liver Metastases

Conditions
-----------------
Liver Metastases

Intervention / Treatment
-----------------
* Other: measuring liver function by 18-FDGal PET/CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Performance status >2 liver metastases refereed for SBRT Exclusion Criteria: pregnancy claustrophobia

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 |
| --- | --- |
| Other: liver metastases<br>measuring liver function by PET/CT at patients where SBRT is planned for liver metastases | Other: measuring liver function by 18-FDGal PET/CT<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volumetric uptake values of 18-FDGal will be measured and the 18-FDGal PET/CT one month after stereotactic body radioation therapy will be compared to the baseline status in sub-volumes receiving more than 15 Gy |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate toxicity to SBRT by toxicity scoring system that includes biochemical measures as well as symptomatic scores. |  | up to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
liver function, galactose, 18-F-deoxy-galactose
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds

Study Overview
=================
Brief Summary
-----------------
This research project is testing a product called AmnioClear™ which is an amniotic membrane graft processed for Liventa Bioscience formerly AFCell Medical. AmnioClear™ allograft human amniotic membrane is regulated solely under section 361 of the Public Health Service Act. The purpose of the study is to see if this treatment works to accelerate the healing time of chronic wounds.

Official Title
-----------------
A Randomized Comparison of AmnioClear™ Human Allograft Amniotic Membrane vs. Moist Wound Dressing in the Treatment of Diabetic Wounds

Conditions
-----------------
Diabetic Foot Ulcers, Wound Care

Intervention / Treatment
-----------------
* Biological: AmnioClear™ Human Allograft Amniotic Membrane


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable Type I or II diabetes mellitus At least one chronic diabetic ulcer Full-thickness ulcer size from 1-8 cm2. Exclusion Criteria: Concurrent use of corticosteroids, NSAIDs immuno-suppressive or cytotoxic agents Bleeding disorders Ulcer with muscle, tendon, capsule or bone involvement

Ages Eligible for Study
-----------------
Minimum 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AmnioClear™<br>AmnioClear™ Human Allograft Amniotic Membrane | Biological: AmnioClear™ Human Allograft Amniotic Membrane<br> <br> |
| No Intervention: Standard of Care<br>Standard moist wound dressing (saline wet-to-moist or a hydrogel dressing) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Wound Size | Clinical assessment of wound healing in terms of the reduction in size and shape of the wound over time. | 12 Weeks |
Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement

Study Overview
=================
Brief Summary
-----------------
This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.

Official Title
-----------------
A Randomized, Placebo-Controlled, Double-Blind Study of Escalating Single Doses of ITI-214 in Healthy Volunteers to Determine Central Nervous System Engagement, Safety and Tolerability

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: ITI-214
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female, 18 - 45 years Fluent and literate in English and able to provide written informed consent BMI between 18.5 and 38.0 kg/m2 and minimum body weight of 50 kg Exclusion Criteria: Recent exposure to any investigational product Previous exposure to relevant fMRI task(s) Considered medically unsuitable for participation Has any contraindication for BOLD fMRI

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 mg ITI-214<br>Single dose | Drug: ITI-214<br>* Oral<br>|
| Experimental: 10 mg ITI-214<br>Single dose | Drug: ITI-214<br>* Oral<br>|
| Placebo Comparator: Placebo<br>Single dose | Drug: Placebo<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD MRI signals in the anterior insula during the extinction phase of a Fear Conditioning task | Changes in brain activation | 1-3 hours post-dose | 
| BOLD MRI signals in the inferior frontal gyrus during the Stop Signal Task | Changes in brain activation | 1-3 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BOLD fMRI signals elicited by fear conditioning stimulus | Changes in brain activation in amygdala, prefrontal cortex, and/or insula cortex | 1-3 hours post-dose | 
| BOLD fMRI signals elicited by the Stop versus Go signal | Changes in brain activation in dorsolateral prefrontal cortex and/or anterior cingulate cortex | 1-3 hours post-dose | 
| Number of subjects with reported or observed treatment-related adverse events | Safety and tolerability | 0-5 hours post-dose |