linjc16/ctgov huggingface dataset:
SSNHL in Head & Neck Cancer Patients

Study Overview
=================
Brief Summary
-----------------
A sound dosimeter will be used to measure noise level to which a population of head and neck patients on the otolaryngology ward are exposed to. The device is the EXTECH 407764 type II sound level meter (IEC 651 RS232). The device will be configured to OSHA and ISO standards, and calibration confirmed in a sound booth with a sound level calibrator. The dosimeter captures A-weighted sound levels between 30 and 130 dB. Specifically, participants included in the study will be head and neck cancer patients on the otolaryngology floor at VG site. Measurements will be taken three times a day at random intervals. Each measurement will be taken in a similar manner. The dosimeter will be placed on the head side of the bed at the level of patient's ear one inch away from the ear and kept there for ten seconds to get a representative level. The overall measurements will be averaged (Leq) for statistical analysis. Investigators will randomly select 50% of the patients and give them protective ear plugs to be used while the participants are inpatients, and the other 50% will not provide them with ear plugs (like what is being done now). Investigators will obtain a baseline hearing test prior to admission and 7 days after admission and then a repeat hearing test at 3 weeks after discharge. The goal is to establish if there is a temporary or a permanent threshold shift.

Official Title
-----------------
Randomized Controlled Trial Evaluating the Impact of Noise Exposure in Otolaryngology Floor Among Head and Neck Cancer Patients

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

Intervention / Treatment
-----------------
* Device: ear plugs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnoses of head and neck disease requiring surgery. Must be expected to be admitted to ENT floor. Must be able to conduct a hearing test. Exclusion Criteria: a diagnoses of SNHL. participants with low mental capacity.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: wearing ear plugs<br> | Device: ear plugs<br>* giving half of the patients ear plugs<br>|
| No Intervention: Not wearing ear drops<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hearing loss | investigators will measure the level hearing loss during the patients stay using a hearing test done by an audiologist. the rate level of hearing loss will be measured by dB using an audiogram. | 6 months |
Molecular Endotypes of Chronic Idiopathic Urticaria

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about why some people with Chronic Idiopathic Urticaria (CIU) respond to treatment with omalizumab (Xolair). It will test people before they receive treatment with omalizumab as part of standard of care, to see if there are differences in their blood and skin that can predict who responds to treatment.

Official Title
-----------------
Molecular Endotypes of Chronic Idiopathic Urticaria

Conditions
-----------------
Chronic Urticaria, Idiopathic

Intervention / Treatment
-----------------
* Drug: Omalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CIU as defined as frequent urticarial lesions for ≥ 6 weeks Symptoms not controlled with standard dose antihistamines (loratadine 10mg daily, desloratadine 5mg daily, fexofenadine 180mg daily, cetirizine 10mg daily, or levocetirizine 5mg daily) Planned initiation of treatment with omalizumab (Xolair) as part of standard of care for antihistamine-refractory urticaria Exclusion Criteria: Use of immunomodulatory drugs in the past 1 month prior to beginning the study Use of systemic steroids in the past 1 month prior to beginning the study Use of omalizumab in the past 3 months prior to beginning the study Use of any investigational agent in the past 30 days Untreated intercurrent illness Severe Asthma Primary diagnosis of flushing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Omalizumab<br> | Drug: Omalizumab<br>* omalizumab 300mg SQ every 4 weeks as part of standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responders | The number of participants who meet the definition of Responder to omalizumab. Responders are defined as having a UAS7 of 6 or less after 16 weeks of treatment. | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline expression of innate immune markers | Baseline expression of innate immune markers in peripheral blood between eventual responders and nonresponders to omalizumab. 5 significant markers will be reported. Results will be stratified between groups determined by the pre-specified arms and by the classification of participants as responders versus non-responders to omalizumab. | Baseline |
A Phase 3 Study in Patients With Chronic Kidney Disease and Hyperphosphatemia on Peritoneal Dialysis

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-labeled, non-comparative study to examine the safety and efficacy of ASP1585 in chronic kidney disease and hyperphosphatemia patients on peritoneal dialysis.

Official Title
-----------------
A Phase 3 Study in Patients With Chronic Kidney Disease (CKD) With Hyperphosphatemia on Peritoneal Dialysis

Conditions
-----------------
Chronic Kidney Disease, Renal Dialysis, Renal Insufficiency

Intervention / Treatment
-----------------
* Drug: ASP1585


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic kidney disease patients on peritoneal dialysis Hyperphosphatemia Patients on a phosphate binder or phosphate lowering drug for 28 days or longer, and that, those for whom the dose has not changed within 28 days. Written informed consent Exclusion Criteria: Patients with gastrointestinal surgery or enterectomy Patients with severe cardiac diseases Patients with severe constipation or diarrhea Patients with a history or complication of malignant tumors Patients with uncontrolled hypertension Patients treated with parathyroid intervention

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP group<br> | Drug: ASP1585<br>* oral<br>* Other names: AMG223;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum phosphorus level at treatment discontinuation |  | During the 12-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of the patients meeting the target range of serum phosphorus levels |  | During treatment | 
| Time-course changes in serum calcium levels |  | During Treatment | 
| Changes in serum Ca x P |  | During Treatment | 
| Changes in intact PTH levels |  | During Treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperphosphatemia, Peritoneal dialysis, CKD, ASP1585
DF4 Master Study (Safety and Efficacy Study)

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to proof the safety and efficacy of the new ICD sytem (Iforia/Ilesto). The devices are available with DF-1 and DF4 connection. A special focus is set on the ICD system with DF4 connection.

Official Title
-----------------
Master Study of the BIOTRONIK DF4 System

Conditions
-----------------
Ventricular Tachycardia, Ventricular Fibrillation, Sudden Cardiac Death, Heart Failure

Intervention / Treatment
-----------------
* Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has provided written informed consent. Patient has standard ICD/CRT-D indication. Patient accepts Home Monitoring concept. Patient is able to attend the planned hospital follow-up visits. Patient has legal capacity and ability to consent. Exclusion Criteria: Patient has a standard contra-indication for ICD/CRT-D therapy. Age < 18 years Patient is pregnant or breastfeeding. Patient is expected to receive ventricular assist device or heart transplantation within the next 12 months. Life expectancy of less than 12 months. Participating in any other clinical study of an investigational cardiac drug or device.

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 |
| --- | --- |
| ICD system with DF4 connection<br>Iforia/Ilesto ICD with DF4 connection and Linox smart DF4 lead/ Protego | Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego<br> <br> |
| ICD system with DF-1 connection<br>Ilesto/Iforia ICD with DF-1 connection | Device: Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serious adverse device effect (SADE) rate related to the ICD with DF4 connection |  | until 3 month follow-up | 
| SADE rate related to the Linox smart DF4 lead (ICD shock lead) |  | until 3 month follow-up | 
| Shift rate of the painless shock impedance measurement |  | between 3 and 6 month follow-up | 
| Pacing threshold comparison between Linox smart DF-1 and Linox smart DF4 lead |  | 3 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of automatic atrial pacing threshold test vs. manual measurement |  | 3 month follow-up |
Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)

Study Overview
=================
Brief Summary
-----------------
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.

Official Title
-----------------
Clinical Pharmacological Study of FYU-981 Administered to Hyperuricemic Outpatients With or Without Gout

Conditions
-----------------
Hyperuricemia With or Without Gout

Intervention / Treatment
-----------------
* Drug: FYU-981


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serum urate level: >= 7.0mg/dL in patients with gouty nodule or with history of gout, or >=8.0mg/dL in patients with hypertension, diabetes or metabolic syndrome, or >= 9.0mg/dL Disease type in the classification of hyperuricemia: Uric acid-overproduction type or Uric acid-underexcretion type Outpatients Exclusion Criteria: Gouty arthritis within 14 days before randomized allocation

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Uric acid-overproduction Type<br> | Drug: FYU-981<br>* Oral daily dosing for 14 weeks<br>|
| Experimental: Uric acid-underexcretion Type<br> | Drug: FYU-981<br>* Oral daily dosing for 14 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics (Amount of uric acid excreted in urine) |  | 2-week | 
| Pharmacodynamics (Amount of uric acid excreted in urine) |  | 6-week | 
| Pharmacodynamics (Amount of uric acid excreted in urine) |  | 10-week | 
| Pharmacodynamics (Amount of uric acid excreted in urine) |  | 14-week |
MPP Programming Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.

Official Title
-----------------
Evaluation of Programming Strategies for MultiPoint™ Pacing in Cardiac Resynchronization Therapy Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Hemodynamic measurements for CRT device programming
* Device: CRT device implant with MultiPoint Pacing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system with approved standard indication by ESC/EHRA Guidelines Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule Exclusion Criteria: Have high ventricular rate (>90 bpm) during persistent or permanent atrial fibrillation despite available treatment Be in NYHA IV functional class Have a recent myocardial infarction within 40 days prior to enrollment Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months Have had a recent CVA or TIA within 3 months prior to enrollment Have had intravenous inotropic support in the last 30 days Be less than 18 years of age Be pregnant or planning to become pregnant during the duration of the investigation.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MultiPoint Pacing programming based on hemodynamics<br>CRT device implant with MultiPoint Pacing Hemodynamic measurements for CRT device programming | Procedure: Hemodynamic measurements for CRT device programming<br> <br> Device: CRT device implant with MultiPoint Pacing<br> <br> |
| Experimental: MultiPoint Pacing programming without hemodynamics<br>CRT device implant with MultiPoint Pacing CRT device programming without hemodynamics | Device: CRT device implant with MultiPoint Pacing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end-systolic volume |  | 6 months |
Obalon in Children With Severe Obesity

Study Overview
=================
Brief Summary
-----------------
The ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. This is accompanied by a higher incidence in serious health risks, already present at an early age, switching-on the engine towards obesity-related co-morbid diseases and morbid obesity. Weight loss is the only way to avoid systemic and cardiovascular complications of obesity. Weight loss devices have been recently introduced in bariatric surgery, also in children. They mostly require invasive procedures to be applied. Mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients. Obalon intragastric balloons, are swallowable devices. They are filled with liquid or air, and have been used to induce weight loss in obese adults. The investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 Obalon® Gastric Balloons placement.

Official Title
-----------------
Tolerance and Efficacy of the Swallowable Obalon® Gastric Balloons System in Children With Severe Obesity

Conditions
-----------------
Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-), Altered Liver Function Tests, Glycemic Intolerance

Intervention / Treatment
-----------------
* Device: Swallowable Obalon® Gastric Balloon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight > 97° pc -CDC BMI charts- Exclusion Criteria: Prevous abdominal surgery Functional gastrointestinal motility disorders

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Obalon Arm<br>Children swalowed up to 3 intragastric balloons | Device: Swallowable Obalon® Gastric Balloon<br> <br> |
| No Intervention: Dietary and lifestyle changes Arm<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss (Kg) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obalon swallowable intragastric balloons, Severe obesity, Children
Risk Factors for Primary Cesarean Section in Egypt

Study Overview
=================
Brief Summary
-----------------
women in their first pregnancy evaluated till delivery for associated risk factors for cesarean delivery

Detailed Description
-----------------
Evaluation of maternal , fetal, delivery place and health care provider rules to determine route of delivery in women during their first pregnancy

Official Title
-----------------
Evaluation of Risk Factors for Primary Cesarean Section in Egypt

Conditions
-----------------
Cesarean Section

Intervention / Treatment
-----------------
* Procedure: vaginal delivery
* Procedure: Cesarean section


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women in their first pregnancy Delivery between 37 and 42 weeks Singleton pregnancy _ cephalic presentation Exclusion Criteria: women asked for CS on demand

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vaginal delivery<br>woman who terminate their pregnancy by vaginal delivery | Procedure: vaginal delivery<br>* pregnancy ended by vaginal delivery<br>|
| Cesarean delivery<br>woman who terminate their pregnancy by cesarean delivery | Procedure: Cesarean section<br>* pregnancy ended by cesarean delivery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| route of delivery in primigravida |  | at delivery |
Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this prospective cohort study is to develop a simplified risk model for post-discharge nausea and vomiting (PDNV) in adult same-day surgery patients in the US that will allow clinicians to identify those patients who would benefit from prophylactic antiemetic strategies.

Official Title
-----------------
Development of a Predictive Model for Post-Discharge Nausea and Vomiting (PDNV)

Conditions
-----------------
Nausea, Postoperative Nausea and Vomiting, Postdischarge Nausea and Vomiting, Postoperative Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older scheduled for an elective outpatient surgical procedure understands the nature and purpose of this survey and has signed an informed consent form willing and able to complete daily components of the Patient Diary from the day of surgery until the end of the 48 hour assessment undergoing general anesthesia requiring a tracheal tube or laryngeal mask airway Exclusion Criteria: planned inpatient surgery inability to communicate in English regional anesthesia alone without general anesthesia, as PONV in this setting is known to be significantly lower [18, 19] persistent or recurrent nausea and/or vomiting before anesthesia due to other etiologies, unless clearly related only to the anxiety due to impending surgery minors (< 18 years of age) current pregnancy by self-report (potentially confounding for etiology of nausea)

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 |
| --- | --- |
| 1<br>Adult same-day outpatients scheduled for general anesthesia | |

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
-----------------
nausea, postoperative nausea and vomiting, postoperative pain