linjc16/ctgov huggingface dataset:
Evaluation of Safety and Efficacy of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence Due to Neurogenic Detrusor Overactivity or Overactive Bladder in Korea

Study Overview
=================
Brief Summary
-----------------
This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of botulinum toxin Type A to treat urinary incontinence in patients with neurogenic detrusor overactivity (NDO) or overactive bladder (OAB) not adequately controlled by anticholinergic drugs.

Conditions
-----------------
Urinary Incontinence, Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Biological: botulinum toxin Type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: -Patients with urinary incontinence due to NDO or OAB treated with BOTOX® as per local standard of care in clinical practice. Exclusion Criteria: -None.

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 |
| --- | --- |
| BOTOX®<br>Patients who receive botulinum toxin Type A (BOTOX®) treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice. | Biological: botulinum toxin Type A<br>* Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.<br>* Other names: onabotulinumtoxinA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events and Adverse Drug Reactions |  | 4 Months | 
| International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) Total Score |  | 4 Months |
Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

Study Overview
=================
Brief Summary
-----------------
To collect and analyze clinical follow-up data which can be used to assess the safety, efficacy, and durability of endovascular AAA repair with Zenith and Chuter-Gianturco stent-grafts.

Detailed Description
-----------------
We propose to analyze the data collected for clinical purposes in 453 patients who already underwent endovascular AAA repair at UCSF and SFVA, and others who will undergo this operation in the future. Most of these patients have now passed the 2-year follow-up required by the original protocol, all continue to be followed for clinical purposes, using the same studies, the same data forms and the same schedule as before, because studies of various devices of this type have shown that the potential for late problems requires continuing scrutiny of stent-graft structure and function, as a basis for timely re-intervention.

Official Title
-----------------
Follow-up After Endovascular Repair of Abdominal Aortic Aneurysm

Conditions
-----------------
Abdominal Aortic Aneurysm

Intervention / Treatment
-----------------
* Device: AAA Endovascular Bifurcated Stent-Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AAA with diameter > 4 cm or AAA with a history of growth > 0.5 cm per year treatment of AAA with Zenith Stent-Graft Exclusion Criteria: Pregnant Life expectancy less than two years Less than 18 years of age Unwilling to comply with clinical follow-up schedule Inability or refusal to give informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: AAA Endovascular Bifurcated Stent-Graft|Treatment of Abdominal Aortic Aneurysm with a Zenith Endovascular Bifurcated Stent-Graft.|

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
-----------------
Treatment with Zenith Aortic Stent-Graft for repair Abdominal Aortic Aneurysm, Stent-Graft, AAA, Abdominal Aortic Anuerysm, Zenith, Endovascular
Pharmacological and Behavioral Treatment of Insomnia

Study Overview
=================
Brief Summary
-----------------
to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to reduce its impact on psychological functioning, health, and economic sequelae.

Detailed Description
-----------------
DESIGN NARRATIVE: The study examined the relative efficacy of a pharmacologic, cognitive behavioral, and conjoint pharmacological/behavioral intervention for chronic sleep-onset insomnia. Sixty-three medication-free, chronic sleep-onset insomniacs completed evaluations, baseline sleep diaries, daytime functioning and mood inventories and home-based objective sleep assessments (OSA). Subjects were then randomized to one of four interventions: 1) six week Zolpidem intervention (D for drug); 2) six week multifactor behavioral intervention (B for behavioral); 3) six week conjoint Zolpidem and multifactor behavioral intervention (DB); and 4) placebo medication intervention (P for placebo). The main outcome measures were sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary measures of sleep efficiency and total sleep time, objective measures of sleep variables (Nightcap sleep monitor recorder), and measures of daytime functioning. 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
-----------------
Lung Diseases, Sleep, Sleep Initiation and Maintenance Disorders

Participation 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 |
| --- | --- | --- |
Clinical Validation of Molecular Triage in HR-HPV Positive Women

Study Overview
=================
Brief Summary
-----------------
Women accessing the HPV-based screening programme for primary screening, will undergo cervical sampling and clinical data recording. Samples from high-risk HPV positive women (around 2000 expected) will be aliquoted for testing with new HPV molecular test, that will allow full genotyping and viral load quantification.

Official Title
-----------------
VALidation of Tests Usable as a First Step TRIage to Manage Women Positive to High-risk Papillomavirus

Conditions
-----------------
Cervical Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women participating in a cervical cancer screening program using an HPV assay as primary screening test positivity to hrHPV; written informed consent given. Exclusion Criteria: total hysterectomy; diagnosis of CIN2+ in the last two years; hrHPV negative or inadequate.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Sensitivity of the index triage test: Pap-test | Sensitivity of the index triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage and relative sensitivity (index vs comparator) | Baseline | 
| Sensitivity of the index and comparator triage test: HPV molecular test | Sensitivity of the index and comparator triage test(s) performed at the time of reflex testing for CIN2+ and CIN3+ detected at the time of reflex triage + delayed triage; and relative sensitivity (index vs comparator). | Baseline | 
| Specificity of the index and comparator triage test | Specificity of the index and comparator triage test(s) performed at the time of reflex testing for <CIN2 considered at the time of reflex triage accepting negative colposcopy at the time of reflex testing and double negative index triage testing (reflex and delayed) as an acceptable proxy for <CIN2 and relative specificity for <CIN2 (index vs comparator). | Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
molecular HPV test, Pap-test, Triage
Effectivity and Safety of Ultrasound-guided Percutaneously Laser Ablation for Refractory Neoplasms

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of ultrasonography (US) -guided laser ablation liver, kidney, pancreas, lung and retroperitoneal tumors, the investigators used preoperative and postoperative US/CEUS/CT/MRI to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. Intraoperative US/CEUS/CT would be applied to monitor ablation lesions.

Conditions
-----------------
Refractory Neoplasms

Intervention / Treatment
-----------------
* Procedure: US-guided laser ablation for refractory neoplasms


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Patients with Child-Pugh A/B, Patients with PLT ≥ 50*10E9/L and PT ≤ 20s. Exclusion Criteria: Patients with blood coagulation dysfunction, ChildPugh ≥3, severe cardiopulmonary disease, intolerant anesthesia and upper gastrointestinal bleeding in shock.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: US-guided laser ablation for refractory neoplasms<br>The investigators used percutaneously US-guided laser ablation for patients with small hepatocellular carcinoma (single or multiple nodules of less than 3 cm in diameter), Child-Pugh A/B, PLT ≥ 50*10E9/L and PT ≤ 20s. Then the investigators estimated the safety and efficacy of this treatment through follow-up of US/CEUS/CT/MRI and the tumor markers every three months. | Procedure: US-guided laser ablation for refractory neoplasms<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 100 patients of refractory neoplasms with image-guided laser ablation-related effectivity as assessed by MRI |  | up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasonography-guided Laser Ablation
Genetic Susceptibility to Kidney Cancer

Study Overview
=================
Brief Summary
-----------------
This study will further the understanding of the genetic events leading to the development of RCC.

Detailed Description
-----------------
This study will further the understanding of the genetic events leading to the development of RCC; explore the genetic basis for genetic instability and how it affects cancer risk; and eventually provide a means of identifying a subgroup of individuals who are most likely to develop RCC. Such individuals may then be targeted for intervention programs such as chemoprevention or dietary modification.

Official Title
-----------------
Genetic Susceptibility to Renal Cell Carcinoma

Conditions
-----------------
Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients of any ethnicity or sex, who have a been diagnosed with possible Renal Cell Carcinoma within the past year. Exclusion Criteria: Must not have received chemotherapy, biological therapy or radiation therapy in the 6 months preceding enrollment will Must not have had RCC, or metastatic RCC, Must not have had a renal transplantation

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 |
| --- | --- |
| Healthy<br>Healthy adults, of any ethnicity, or sex, and with no previous history of cancer, except for non-melanoma skin cancer | |
| RCC<br>Adult patients with newly diagnosed (diagnosed within the year of enrollment) renal carcinoma (RCC) any ethnicity, or sex, who have not received prior chemotherapy or radiotherapy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To identify interindividual differences in inherited genetic instability |  | 12 months |
Computer Assisted Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether intraoperative computer-assisted navigation improves prosthetic implant positioning as compared to conventional intraoperatve instrumentation in Total Knee Arthroplasty (TKA).

Detailed Description
-----------------
Primary data to be obtained is to determine whether mechanical axis of the limb malignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation. Three months after surgery follow-up radiographic data will provide evidence on the initial implant position as determined with a series of x-rays including: full length standing, standard AP weight bearing, lateral, patellar, kneelingfilm views and CT evaluation. In addition, a correlation betweeen the CT measures and the kneeling x-ray can be performed at this time. Clinical (Knee Scale Society, WOMAC, and SF-36) data will also be obtained at the three month interval.

Official Title
-----------------
Computer Assisted Navigation in Total Knee Arthroplasty

Conditions
-----------------
Total Knee Arthroplasty, Osteoarthritis

Intervention / Treatment
-----------------
* Procedure: Computer Assisted Navigation Knee Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Study participants must: Be over 18 years of age. Require a TKA and is considered by the investigator to be a suitable candidate for the specific knee prosthesis identified in protocol. The subject has given consent to the transfer of his/her information to the sponsor.

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Computer Assisted Navigation Knee Replacement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine whether mechanical axis of the limb malalignment differs between patients whom have computer-assisted TKA and those treated with conventional intraoperative instrumentation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the frontal alignment of the femoral and tibial components from full length standing radiographs |  |  | 
| To compare sagittal alignment of the femoral and tibial components from lateral radiographs |  |  | 
| To compare the rotation of the femoral and tibial components from CT Scan. |  |  |
Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists)

Study Overview
=================
Brief Summary
-----------------
Evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion.

Official Title
-----------------
Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists): The TOTEM Study

Conditions
-----------------
Vitreomacular Traction, Subretinal Edema

Intervention / Treatment
-----------------
* Drug: Eplerenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years of age Symptomatic VMA, VMT, or macular hole BCVA 20/30 - CF 3' Snellen equivalent Willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments JETREA® treatment naïve Exclusion Criteria: Patients who are pregnant, planning to become pregnant, or breastfeeding a child Uncontrolled ocular hypertension or glaucoma in study (defined as IOP ≥ 25mm Hg or a cup to disc ratio (CDR) > 0.8 despite treatment with anti-glaucoma medication) Active malignancies within the last 12 months except appropriately treated carcinoma in situ of the crevices, melanoma, and prostate cancers treated with a curative intent Inability to comply with study or follow-up procedures Women who may become pregnant or lactating or intend to become pregnant during the study Known drug allergy to ocriplasmin or eplerenone Patients with known contraindications Eplerenone as outlined in the package insert

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Treatment<br>Eplerenone | Drug: Eplerenone<br>* Following intravitreal ocriplasmin therapy<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Central Foveal Thickness (CFT) over time | Changes as assessed via SD-OCT from the lowest CST measurement in the study, due to disease activity | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in Best Corrected Visual Acuity (BCVA) over time | Changes as assessed using the visual acuity chart at a starting distance of 4 meters | through study completion, an average of 1 year |
Evidence of Haloperidol Absorption After Topical Administration

Study Overview
=================
Brief Summary
-----------------
This will be a blinded study to compare the absorption of topical haloperidol with placebo

Official Title
-----------------
Topical Haloperidol: Evidence of Absorption After Topical Administration

Conditions
-----------------
Nausea, Vomiting

Intervention / Treatment
-----------------
* Drug: Haloperidol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age: patient must be 18 years or older and less than 70 years of age. Provision of informed consent No previous adverse reaction to haloperidol No current use of haloperidol Good health No alcohol within 24 hours of the study No significant cardiovascular, gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease. Normal neurologic exam Exclusionary Criteria Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study Recent cerebral trauma Study will exclude women who are pregnant and/or nursing Women who are of child bearing potential must have a negative urine pregnancy test. History of seizures Taking medications that can interact with haloperidol Subjects with significant cardiovascular (cardiac conduction deficits), gastrointestinal, hematologic, neurologic, renal, hepatic or pulmonary disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: intravenous haloperidol<br>intravenous haloperidol pharmacokinetics | Drug: Haloperidol<br>* 0.5 mg iv x one dose<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 0.5 mg iv , one dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the pharmacokinetics levels of haloperidol after topical administration compared with intravenous administration. | Measuring either the presence of absence of haloperidol | baseline to 240 minutes after administration. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nausea, vomiting, gastrointestinal symptoms, palliative care