linjc16/ctgov huggingface dataset:
A Safety Study of the Auditory Brainstem Implant for Pediatric Profoundly Deaf Patients

Study Overview
=================
Brief Summary
-----------------
Current treatment options for bilateral profoundly deaf children, diagnosed with inner ear anatomical abnormalities, are limited and, in the case of absent cochleas, non-existent. An auditory brainstem implant (ABI) places an electrode close to the auditory nucleus in the brainstem. Children aged 2 - 5 who are not candidates for a cochlear implant, or who did not demonstrate benefit from a cochlear implant, will be implanted with an ABI and followed for 1 year for safety and a total of 3 years for preliminary efficacy. This is a feasibility study to determine the safety of the ABI.

Official Title
-----------------
A Feasibility Study of the Placement, Use, and Safety of the Nucleus 24 Auditory Brainstem Implant in Non-Neurofibromatosis Type 2 (NF2) Pediatric Patients

Conditions
-----------------
Profound Bilateral Deafness Due to, Bilateral Cochlear Aplasia, Bilateral Cochlear Nerve Deficiency, Bilateral Cochlear Ossification Secondary to Meningitis

Intervention / Treatment
-----------------
* Device: Auditory Brainstem Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral profound deafness due to cochlear aplasia, cochlear nerve deficiency, or ossification secondary to meningitis If previously received a cochlear implant, must demonstrate lack of benefit from that device Exclusion Criteria: Medical contraindication to craniotomy/intracranial surgery Severe cognitive or developmental delays

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 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: Experimental<br>Device Implantation | Device: Auditory Brainstem Implant<br> <br> * Other names: Cochlear Corporation Nucleus 24;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary endpoint | Serious adverse event (count) per subject. Count of expected serious adverse events per subject. | 12-months post-device activation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary endpoint: Preliminary efficacy | Access to sound at a level (dB) and with the frequency range (500-4000Hz), known to be associated with speech. | 3 years post-device activation | 
| Unexpected Serious Adverse Events | Unexpected adverse events (count). | 12-months post-activation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
deafness, congenital, pediatric, device
The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study

Study Overview
=================
Brief Summary
-----------------
The aim this study will be to find out which patients are at risk of heart attacks/strokes up to several years after discharge from an ICU. This study will also investigate whether treatments and events occurring in ICU contribute to this risk.

Detailed Description
-----------------
Undertake a retrospective observational cohort study of patients admitted to intensive care units between 2006 and 2023. Study Participants: Adult patients admitted to a general adult intensive care unit at one or more of the study sites between 2006 and 1st of August 2023. Objectives: To determine the short and long-term cardiovascular consequences of critical illness and identify in-ICU factors that affect them. To identify the risk factors for new-onset atrial fibrillation/flutter occurring during critical illness. To study the association between poor cardiovascular function during critical illness and long-term cardiovascular disease. This study will provide new knowledge about the associations between baseline cardiovascular risk, the disease resulting in ICU admission and therapies / events on ICU with subsequent major adverse cardiac events (MACE), to allow the ongoing risk of these events to be determined. If clinicans can idetnify who is at risk, then risk factors can potentially be modified .

Official Title
-----------------
The Short and Long-term Cardiovascular Consequences of Critical Illness: The C3 Study

Conditions
-----------------
Stroke, Critical Illness, Myocardial Infarction, Atrium; Fibrillation, Atrial Flutter

Intervention / Treatment
-----------------
* Other: Admission to ICU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 16 years or above. Admitted to an intensive care unit at a study site from 2006 onwards Exclusion Criteria: Patients that have informed their participating site that they do not wish their electronic records would be used for future research Patients who inform us directly that they don't wish their records used in this research study

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| ICU<br>Patients treated on a general adult intensive care unit | Other: Admission to ICU<br>* Exposure is admission to an Intensive Care Unit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 5 years | 
| Major adverse cardiovascular and vascular events |  | 5 years | 
| Arrhythmia |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital re-admission |  | 5 years |
Urodynamic Effects of UK-369,003 in Men With Lower Urinary Tract Symptoms

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to generate hypotheses about the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms.

Official Title
-----------------
A Multi Center Randomized Cross Over Double Blind Third Party Open Placebo Controlled Pilot Study to Assess the Urodynamic Effects of Modified Release UK-369,003 in Men With Lower Urinary Tract Symptoms.

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: UK-369,003
* Drug: UK-369,003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects, aged 40 years and above, with documented LUTS with an International Prostate Symptom Score (IPSS) ≥13. Clinical diagnosis of BPH Qmax 5 to 15 ml/sec with a voided volume of ≥150 ml Urodynamically defined bladder outlet obstruction Exclusion Criteria: prostate cancer Post-void residual urine volume >200 ml Documented UTI History of relevant urological surgery

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

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

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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: UK-369,003<br>* UK-369,003-100 mg MR formulation for 2 weeks<br>|
| Active Comparator: UK-369,003<br> | Drug: UK-369,003<br>* 100 mg MR tablet once daily for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There is no specific primary endpoint for this study as it is not powered for that. It is mainly to generate hypotheses on the urodynamic effects of UK-369,003 in men with lower urinary tract symptoms. |  | Duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum flow rate (Qmax) |  | Duration of study | 
| Cystometric capacity |  | Duration of study | 
| Post void residual volume (PVR) |  | Duration of study | 
| Average flow rate (Qave) |  | Duration of study | 
| Volume at first unstable contraction |  | Duration of study | 
| Average detrusor pressure during micturition |  | Duration of study | 
| Detrusor pressure at maximum flow rate (PdetQmax) |  | Duration of study | 
| Bladder outlet obstruction index (BOOI) |  | Duration of study | 
| Bladder contractility index (BCI) |  | Duration of study | 
| Bladder voiding efficiency (BE) |  | Duration of study | 
| Frequency of unstable contractions |  | Duration of study | 
| International Prostate Symptom Score (IPSS) |  | Duration of study | 
| Mean amplitude of unstable contractions |  | Duration of study | 
| Patient Reported Treatment Impact (PRTI) |  | Duration of study |
Nexavar as First Targeted Therapy in Patients With Advanced Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is an observational study which will investigate the use of Nexavar as first targeted therapy in patients with advanced renal cell carcinoma.

Official Title
-----------------
NEXTAR - NEXavar® as First TARgeted Treatment for Patients With Advanced Renal Cell Carcinoma

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

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY 43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of advanced Renal cell carcinoma (RCC) for whom the decision has been taken by the investigator to prescribe Nexavar. Patients who failed cytokine therapy or who are not suitable for cytokines for whom Nexavar is the first targeted drug treatment. Exclusion Criteria: Prior targeted therapy for RCC Contraindications of Nexavar described in the Summary of Product Characteristics (SPC).
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: Sorafenib (Nexavar, BAY 43-9006)<br>* Dosage according to label or at discretion of the attending physician<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Nexavar treatment |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | 1 - 1.5 years after LPLV | 
| Health related quality of life (HRQoL) |  | up to 3 years | 
| Progression-free survival (PFS) |  | up to 3 years | 
| Tumor status, of patients will be evaluated according to the categories Complete Response, Partial Response, Stable Disease, Clinical Progression, Radiological Progression. |  | up to 3 years | 
| Incidence of Treatment-emergent Adverse Events (TEAE) |  | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal cell carcinoma, first targeted therapy, observational study
A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

Study Overview
=================
Brief Summary
-----------------
This study will compare kidney function in kidney transplant patients following treatment with various combinations of Zenapax, CellCept, corticosteroids, and Neoral (Cyclosporine). The anticipated time on study treatment is 6-12 months, and the target sample size is 500+ individuals.

Official Title
-----------------
A Randomized, Open-label Study Comparing the Effects of Low-dose Cyclosporine vs Cyclosporine Withdrawal on Renal Function in Kidney Transplant Patients Treated With CellCept and Daclizumab

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Corticosteroids
* Drug: Neoral
* Drug: Neoral
* Drug: Zenapax
* Drug: mycophenolate mofetil [CellCept]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients greater than 18 years of age recipients of primary kidney transplant single-organ recipients (kidney only) Exclusion Criteria: previous treatment with Zenapax history of malignancy (except localized skin cancer)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Corticosteroids<br>* As prescribed<br>Drug: Neoral<br>* Low dose (target trough level 50-100ng/mL)<br>Drug: Zenapax<br>* 2mg/kg iv first dose, then 1mg/kg every 2 weeks<br>Drug: mycophenolate mofetil [CellCept]<br>* 1g po bid<br>|
| Experimental: 2<br> | Drug: Corticosteroids<br>* As prescribed<br>Drug: Neoral<br>* Low dose (target trough level 50-100ng/mL)<br>Drug: Zenapax<br>* 2mg/kg iv first dose, then 1mg/kg every 2 weeks<br>Drug: mycophenolate mofetil [CellCept]<br>* 1g po bid<br>|
| Experimental: 3<br> | Drug: Corticosteroids<br>* As prescribed<br>Drug: Neoral<br>* Standard dose (target trough level 150-300ng/mL)<br>Drug: mycophenolate mofetil [CellCept]<br>* 1g po bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function (as measured by GFR) |  | 12 months post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and graft survival \n |  | 12 months post-transplant | 
| Proportion of patients with biopsy-proven rejection; treatment failure. |  | 6 and 12 months post-transplant | 
| AEs, OIs, malignancies, deaths |  | Throughout study |
A Comparison of European and Chinese Blood Sugar Responses

Study Overview
=================
Brief Summary
-----------------
This study is designed to compare the responses to an oral glucose challenge between people of European and Chinese heritage (essential participants in the European arm must have tow European parents and likewise for the Chinese participants).

Detailed Description
-----------------
100 participants (50 European and 50 Chinese) will attend a lab after an overnight fast and have a capillary finger-prick blood test to assess fasted blood glucose levels and then consume a 50 gram glucose solution. Blood test will be repeated at 15, 30, 45, 60, 90 and 120 minutes post consumption of the glucose solution. This test will be repeated on a spate occasion at least a week later than the first test. Participants will only take part in the experiment after singing informed consent and agreeing to take part in the study and after a medical screening questionnaire assessing that they are non-diabetic or haemophiliac or have blood born infections.

Official Title
-----------------
A Comparison of European and Chinese Blood Sugar Responses

Conditions
-----------------
Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: European ethnicity Chinese ethnicity age 19-59 years Exclusion Criteria: diabetics serious blood born infection haemophilia

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 59 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chinese Subjects<br>7 blood glucose tests taken over a two hour period | |
| European Subjects<br>7 blood glucose tests taken over a two hour period | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sugar response measured by 7 finger prick blood samples | 7 finger prick blood samples | 2 hours |
Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.

Official Title
-----------------
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Conditions
-----------------
Ocular Inflammation and Pain

Intervention / Treatment
-----------------
* Drug: OTX-DP (Dexamethasone punctum plug)
* Drug: Placebo Vehicle Punctum Plug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule Is greater than or equal to 21 years of age Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens Exclusion Criteria: Any intraocular inflammation in the study eye present during the screening slit lamp examination Score greater than 0 on the Ocular Pain Assessment at Screening Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone Punctum Plug<br>Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days | Drug: OTX-DP (Dexamethasone punctum plug)<br>* Sustained and tapered release of dexamethasone from hydrogel punctum plug<br>|
| Placebo Comparator: Placebo Vehicle Punctum Plug<br>Placebo punctum plug insertion | Drug: Placebo Vehicle Punctum Plug<br>* Hydrogel punctum plug without dexamethasone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of Cells in Anterior Chamber of Study Eye |  | Day 8 | 
| Absence of Pain in the Study Eye |  | Day 8 |
Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients-Pilot Study

Study Overview
=================
Brief Summary
-----------------
Fevers raise the concern for serious bacterial infections in pediatric oncology patients receiving chemotherapy. The gold standard for diagnosing bacteremia (bacterial infection of the blood) is a blood culture. However, bacterial growth may not occur for 48 hours or there can be a false negative result. Thus, the biomarker, procalcitonin, has been investigated for its predictive ability to identify bacteremia earlier than blood culture. We believe that procalcitonin can assist in differentiating bacteremia from non-bacteremia infections in febrile pediatric oncology patients. A reliable predictor of bacteremia infections in pediatric oncology patients should decrease hospitalizations for fever and unnecessary antibiotic treatment. In our study we will measure procalcitonin levels in pediatric oncology patients presenting with fever. We will measure procalcitonin at the time of admission which is part of our standard of care for febrile pediatric oncology admissions. For the purpose of our study, we will additionally measure procalcitonin levels at 12 hours and at 24 hours post admission. We will examine procalcitonin levels at these three timepoints to determine if elevated procalcitonin levels predict bacteremia in pediatric oncology patients with and without neutropenia.

Official Title
-----------------
Procalcitonin Levels as a Predictor of Bacteremia in Febrile Pediatric Oncology Patients - Pilot Study

Conditions
-----------------
Cancer, Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between the ages of birth to seventeen years. Present to Charleston Area Medical Center Women and Children's Hospital Existing pediatric oncology diagnosis. Temperature greater than 38.0 C or 100.5 Fahrenheit. Central venous access or functional port available. Exclusion Criteria: Any non-pediatric (eighteen years and above) oncology patient or a non-oncology patient. The patient does not have central venous access or a port from which the blood can be drawn.

Ages Eligible for Study
-----------------
Maximum Age: 17 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 |
| --- | --- | --- |
| Change in procalcitonin levels | Procalcitonin will be measured at the time of admission (Zero hours) and at 12, at 24 hours from admission. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of bacteremia | Blood will be cultured for bacteria | 1 week |
Timing of Optimal Platelet Inhibition After Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
Comparison of two antiplatelet strategies between months 1 and 12 after coronary stenting for ACS. Efficiency and tolerance évaluation

Official Title
-----------------
The Randomized TOPIC Study : Timing of Optimal Platelet Inhibition After Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome, Coronary Stenting, Antiplatelet Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACS and coronary stenting one month ago Exclusion Criteria: age under 18 and pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| combined ischemic and hemorragic endpoint |  | 12 months |