linjc16/ctgov huggingface dataset:
N6 Input Processing in Traditional CI Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the enhanced signal processing features of the Nucleus 6 Sound Processor on existing Nucleus cochlear implant recipients currently using the Nucleus 5 Sound Processor.

Official Title
-----------------
Investigation of Nucleus 6 Sound Processor Input Processing in Cochlear Implant Recipients.

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: Nucleus 6 Sound Processor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 12 years Unilateral cochlear implant recipient (CI24RE, CI500, CI422) Minimum of 3 months experience with the N5 sound processor Prior documentation of sentence recognition testing in noise at a difficulty of +10 dB SNR or better Native English speaker Willingness to participate in and comply with all requirements of the protocol Exclusion Criteria: Unrealistic expectations Unwillingness to comply with investigational requirements of the protocol Additional handicaps that would prevent or restrict participation in the evaluations

Ages Eligible for Study
-----------------
Minimum Age: 12 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: N6 Input Processing Features<br> | Device: Nucleus 6 Sound Processor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoint 1: Evaluation of Signal to Noise Ratio - Noise Reduction | Speech understanding in noise using AzBio sentences with and without the SNR - noise reduction algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off. | Visit 2, 1 month after baseline testing | 
| Endpoint 2: Evaluation of SCAN | Speech understanding in noise using AzBio sentences with and without SCAN algorithm enabled. Speech understanding at a fixed +10 dB signal to noise level in each condition (on/off) is scored as percent correct and then subtracted to demonstrate the percent difference (benefit) in performance of having the algorithm on vs off. | Visit 2, 1 month after baseline testing |
Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.

Official Title
-----------------
Prospective Study of Stereotactic Radiosurgery Using Diffusion-Weighted Abnormality Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-line Chemotherapy

Conditions
-----------------
Recurrent or Progressive Glioblastoma

Intervention / Treatment
-----------------
* Drug: Bevacizumab
* Drug: Chemotherapy
* Radiation: Fractionated radiosurgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma History and physical exam, including neurologic examination, within 4 weeks prior to registration Exclusion Criteria: • Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fractionated Radiosurgery and Bevacizumab<br>FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression | Drug: Bevacizumab<br> <br> Drug: Chemotherapy<br> <br> * Other names: Either irinotecan or temozolomide or carboplatin or etoposide;Radiation: Fractionated radiosurgery<br> <br> |
| Active Comparator: Bev with Chemo<br>Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression | Drug: Bevacizumab<br> <br> Drug: Chemotherapy<br> <br> * Other names: Either irinotecan or temozolomide or carboplatin or etoposide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Tumor Control |  | 2 months | 
| Overall Survival |  | 12 months | 
| Progression Free Survival |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glioblastoma
Preferences in Pain Treatment: A Discrete Choice Experiment in Patients With Peripheral Neuropathic Pain (pNP)

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to identify and weight attributes of topic and systemic pain treatment options relevant from the patients' perspective with peripheral neuropathic pain. The study will use a discrete choice experimental design to reach its objective.

Official Title
-----------------
Preferences in Pain Treatment: A Discrete Choice Experiment in Patients With Peripheral Neuropathic Pain (pNP)

Conditions
-----------------
Neuralgia Peripheral, Neuropathic Pain, Patient Preference

Intervention / Treatment
-----------------
* Other: Discrete Choice Experiment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diagnosed peripheral neuropathic pain (pNP) as assessed by study sites Exclusion Criteria: Patients with no sufficient knowledge in written or oral German as assessed by study sites

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 |
| --- | --- |
| Stated-Preferences Observational Group<br>A discrete choice experiment will be conducted with participants with peripheral neuropathic pain in the stated-preferences observational group. The instrument will measure patient preferences for topical versus systemic pain treatment. | Other: Discrete Choice Experiment<br>* An online-based Discrete-Choice Experiment (DCE) using a survey for stated treatment preferences and socio-demographics. Furthermore, the neuropathic pain component will be assessed in all patients with the Numeric Pain Rating Scale instrument.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient preferences for topical and systemic pain treatment attributes | Utility values obtained via multinominal logit estimates from discrete choice experiment | 20 minutes after survey start | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relevance of attributes attributed with topical and systemic pain treatment | Derived from Likert scale | 5 minutes after survey start | 
| Marginal rate of substitution against pain reduction | Derived from discrete choice experiment | 20 minutes after survey start | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Discrete Choice Experiment
Effects of NUTRIOSE®FB Dietary Fiber Supplementation on Satiety, Body Fat, and Metabolic Syndrome in Overweight Adult Men

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effects of NUTRIOSE® supplementation on body composition, satiety, and determinants of metabolic syndrome in overweight men.

Detailed Description
-----------------
Previous trials of fiber supplementation have yielded equivocal results on body composition, satiety, and determinants of metabolic syndrome. This double-blind, randomized, placebo-controlled study was conducted to determine the effects of a proprietary soluble dextrin dietary fiber supplement (NUTRIOSE®) on these parameters in overweight males.

Official Title
-----------------
The Effects of NUTRIOSE®FB Dietary Fiber Supplementation on the Satiety, Body Fat Distribution, and Metabolic Syndrome Biomarkers of Overweight Adult Chinese Men 20-35 Years of Age.

Conditions
-----------------
Overweight, Metabolic Syndrome X

Intervention / Treatment
-----------------
* Dietary Supplement: NUTRIOSE
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males 20-35 years body mass index of 24-28 kg/m2 current employment and residence at one of three manufacturing plants with a controlled setting and with similar regimented working conditions 7 days a week Exclusion Criteria: current or recent dietary fiber supplementation use of lipid-lowering/hypertension medication current insulin injection use contraindication to fiber supplements, e.g. Crohn's disease allergy to wheat products recent or current antibiotic use

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutriose<br>17 g NUTRIOSE consumed twice daily for 12 weeks | Dietary Supplement: NUTRIOSE<br>* 17 grams of NUTRIOSE consumed twice daily for 12 weeks<br>|
| Placebo Comparator: Placebo<br>17 g maltodextrin consumed twice daily for 12 weeks | Dietary Supplement: Placebo<br>* 17 g maltodextrin consumed twice daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determinants of metabolic syndrome |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fiber, metabolic syndrome, overweight, satiety
Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage

Study Overview
=================
Brief Summary
-----------------
Patients mechanically ventilated using an endotracheal tube with a subglottic secretion drainage lumen and a polyurethane cuff may develop lower ventilator-associated pneumonia than using a conventional endotracheal tube

Detailed Description
-----------------
Subglottic secretions accumulated above the endotracheal cuff may progress, descending along the channels within folds of the cuff wall, to the lower respiratory tract causing VAP. Subglottic secretion drainage (SSD) appears to be effective in preventing VAP, primarily by reducing early-onset pneumonia; but it may not prevent late-onset pneumonia. We set out the hypothesis that using an endotracheal tube incorporating, besides of a subglottic secretion drainage lumen, a polyurethane cuff (which reduces channel formation and fluids leakage from the subglottic area) it should be also possible to reduce the incidence of late-onset VAP.

Official Title
-----------------
Influence of an Endotracheal Tube With Polyurethane Cuff and Subglottic Secretion Drainage on Ventilator-Associated Pneumonia

Conditions
-----------------
Mechanical Ventilation

Intervention / Treatment
-----------------
* Procedure: tube with subglottic drainage and polyurethane cuff


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients expected to require mechanical ventilation for more than 24 hours Exclusion Criteria: Age <18 years, Pregnancy, HIV, Blood leukocytes counts <1000 cells/mm3, Solid or haematological tumour, Immunosuppressive therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: tube with subglottic drainage and polyurethane cuff|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator-associated pneumonia |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late-onset ventilator-associated pneumonia |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventilator-associated pneumonia, endotracheal tube, polyurethane cuff, polyvinyl cuff, subglottic secretion drainage
Pediatric Boot Camp Program

Study Overview
=================
Brief Summary
-----------------
An intensive 13 weeks program that aims to improve glucose control in children with type 1 diabetes.

Detailed Description
-----------------
Our new PeDi-BoCa Program aims to help children with type 1 diabetes achieve better diabetes control by interacting weekly with their doctor/nurse practitioner (NP) and also by using a smart pen that can facilitate the burden of daily calculations with the use of an app on the phone. Your child's doctor/NP will be able to remotely monitor your child's glucose every week (Dexcom) and make recommendations for changes, discuss solutions to possible obstacles and offer intensive diabetes education.

Official Title
-----------------
Type 1 Diabetes Boot Camp Program: An Intensive Program to Improve Glycemic Control in Adolescents With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes, Children, Only

Intervention / Treatment
-----------------
* Other: telehealth visits


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 11-18 years old HbA1c > 8.5% Duration of type 1 diabetes >1 year Child uses Dexcom and has a phone that is compatible with the InPen app and Dexcom Clarity app. Exclusion Criteria: Not able to attend telehealth visits

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard of care<br>standard of care will be given as per usual care | Other: telehealth visits<br>* intensive visits with doctor<br>|
| Experimental: intensive monitoring<br>intensive monitoring every week will be given to participants | Other: telehealth visits<br>* intensive visits with doctor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c |  | 3 months |
Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop the technology infrastructure for a mobile Web-based cognitive and neuropsychological assessment of substance abusers, and to perform a pilot trial using neurocognitive tasks designed to demonstrate that our system is statistically comparable to current clinical practice. The primary hypotheses are that results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions, that methamphetamine (MA) dependent participants will have worsened neurocognitive performance compared to healthy volunteers, and the platform will be acceptable to participants.

Official Title
-----------------
Comparison of Methamphetamine-Dependent and Healthy Volunteers Using a Web-Enabled Cognitive Neuropsychological Evaluation System

Conditions
-----------------
Methamphetamine Dependence

Intervention / Treatment
-----------------
* Device: Web-Enabled Cognitive Neuropsychological Evaluation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged 18 to 55. Ability to give informed consent. Exclusion Criteria: Unwilling or unable to access the web over a cell phone or living in an area with no cell phone service. Any medical, psychiatric, or other condition that, in the opinion of the investigator, would preclude safe, consistent, or useful participation in the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Web-Enabled Cognitive Neuropsychological Evaluation System<br> | Device: Web-Enabled Cognitive Neuropsychological Evaluation System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of neurocognitive task results | Results collected using a web-based data collection platform will be comparable (but not necessarily equivalent) to data collected under controlled laboratory conditions. | 2 weeks |
Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids

Study Overview
=================
Brief Summary
-----------------
In this placebo-controlled randomized parallel study the effects of a butyrate enema on plasma short-chain fatty acids (SCFA) concentrations and fluxes from portal drained viscera, liver and the splanchnic area are investigated

Detailed Description
-----------------
Patients undergoing upper abdominal surgery are included. During surgery they receive a butyrate enema or placebo enema. Before and after rectal administration, plasma samples are taken from several veins and arteries to analyse SCFA concentrations and fluxes from portal drained viscera, liver and the splanchnic area.

Official Title
-----------------
Effect of a Butyrate Enema on the Systemic Concentration of Short Chain Fatty Acids

Conditions
-----------------
SCFA Metabolism

Intervention / Treatment
-----------------
* Dietary Supplement: Sodium butyrate
* Dietary Supplement: NaCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing open liver resection or pancreaticoduodenectomy Exclusion Criteria: known parenchymal liver disease presence of ileostomy or colostomy patients with inflammatory bowel disease antibiotics, prebiotics or probiotics 2 months prior to surgery

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butyrate<br>Enema containing sodium butyrate | Dietary Supplement: Sodium butyrate<br>* Patients recieved an enema containing butyrate or a placebo during upper abdominal surgery.<br>|
| Placebo Comparator: Placebo<br>Enema containing NaCl | Dietary Supplement: NaCl<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma SCFAs |  | 0, 5, 15, 30 min after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Butyrate, Interorgan metabolism, Short-chain fatty acids, Gut production
Topical Antifungal Treatment for Tinea Cruris

Study Overview
=================
Brief Summary
-----------------
To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris

Official Title
-----------------
A Randomized, Multi-Center, Double-Blind, Vehicle-Controlled Study Evaluating the Efficacy and Safety of Product 33525 in Subjects With Tinea Cruris

Conditions
-----------------
Tinea Cruris

Intervention / Treatment
-----------------
* Drug: 33525
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate erythema, mild scaling, and moderate pruritis Exclusion Criteria: pregnancy and allergies

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Product 33525 | Drug: 33525<br>* Daily dosing<br>|
| Experimental: Placebo<br>Product 33525 Placebo | Drug: Placebo<br>* Daily dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving complete clearance | Signs and Symptoms Severity Score and negative Potassium Hydroxide (KOH) and Culture | 3 weeks post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients achieving effective treatment | Clinical Cure and Mycological Cure | 1 week Post Treatment, 2 weeks Post Treatment, and 3 weeks Post Treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tinea Cruris, antifungal