linjc16/ctgov huggingface dataset:
Use of Topical Benzocaine for Analgesia in Lingual Frenotomy of the Newborn

Study Overview
=================
Brief Summary
-----------------
Frenotomy of tongue-tie is commonly performed to resolve breastfeeding difficulties, eg maternal nipple pain and infant's latching difficulties. The procedure carries minor discomfort for the infants. It is not known whether the use of topical benzocaine, a very bitter tasting material' applied to the tongue-tie would decrease the length of cry. We will measure the duration of crying in infants treated with topical benzocaine to the duration in those not treated with the mediation.

Official Title
-----------------
Time of Cry After Lingual Frenotomy in Infants With Lingual Frenulum and Breastfeeding Difficulties, With or Without Use of Topical Benzocaine Analgesia

Conditions
-----------------
Neonatal Tongue-tie, Maternal Nipple Pain Upon Breastfeeding, Neonatal Latch Difficulties

Intervention / Treatment
-----------------
* Drug: Topical Benzocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full term Newborn infant Tongue-tie upon physical examination Maternal complains of nipple pain or difficult latch Exclusion Criteria: Abnormal oral or nasopharyngeal anatomy Any known congenital malformations Prematurity

Ages Eligible for Study
-----------------
Minimum Age: 12 Hours
Maximum Age: 7 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Topical Benzocaine<br>For infants treated with topical benzocaine prior to the procedure | Drug: Topical Benzocaine<br>* Topical administration of a drop of benzocaine to the lingual frenulum<br>|
| No Intervention: no benzocaine<br>No benzocaine applied | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of cry after lingual frenotomy |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tongue-tie, Ankyloglossia
Expanded Access for IMMU-132

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to IMMU-132.

Official Title
-----------------
Expanded Access for IMMU-132

Conditions
-----------------
Metastatic Triple-Negative Breast Carcinoma

Intervention / Treatment
-----------------
* Drug: IMMU-132


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IMMU-132|IMMU-132 will be administered as an intravenous infusion on Days 1 and 8 of 21-day treatment cycles|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome

Study Overview
=================
Brief Summary
-----------------
Context: Adiponectin is an adipose tissue-derived hormone with an insulin sensitizing effect, and has been related to obstructive sleep apnea syndrome. In addition, children with Prader-Willi syndrome (PWS) suffer from excessive daytime sleepiness and the abnormality of rapid eye movement (REM) sleep. Objective: To determine if the sleep stages are related to the plasma levels of adiponectin, resistin, and RBP4 (retinol binding protein-4), and whether these relationships are influenced by age, obesity and insulin resistance.

Detailed Description
-----------------
This comparative study was carried out in 28 PWS children and 18 controls. The enrolled PWS children were volunteers out of a pool of approximately 100 PWS children followed at Samsung Medical Center [median age 8.0 years, interquartile range (7.0-10.5 years), BMI: median 24.2 kg/m2 (23.0-27.5 kg/m2)] and 18 obese healthy children [median age 9.0 years interquartile range (7.0-11.0 years), BMI: median 24.2 kg/m2 interquartile range (23.1-27.6 kg/m2)].

Official Title
-----------------
Plasma Adiponectin Level and Sleep Structures in Children With Prader-Willi Syndrome

Conditions
-----------------
Prader-Willi Syndrome, Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Prader Willi syndrome healthy children Exclusion Criteria: history of seizure, mental or brain illness, adenoidectomy, tonsillectomy, craniofacial anomalies and any treatment at the time of the study.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
REM sleep, Adiponectin, Prader-Willi syndrome
Zenith® p-Branch® OTS Multicenter Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).

Official Title
-----------------
Zenith® p-Branch® Multicenter Study

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

Intervention / Treatment
-----------------
* Device: p-Branch®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation Exclusion Criteria: Age <18 years Life expectancy <2 years Pregnant, breast-feeding, or planning on becoming pregnant within 60 months Inability or refusal to give informed consent by the patient or a legally authorized representative Unwilling or unable to comply with the follow-up schedule Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) Additional medical restrictions as specified in the Clinical Investigation Plan Additional anatomical restrictions as specified in the Clinical Investigation Plan

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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: p-Branch®<br> | Device: p-Branch®<br>* Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.<br>* Other names: Stent-graft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations. | Within 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
A Study of Capecitabine (Xeloda) in Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy, safety, and pharmacoeconomics of oral capecitabine in patients with metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months, and the target sample size is 28 individuals.

Official Title
-----------------
An Open-label Study of the Safety, Tolerability, and Response Rate of Xeloda in Treatment-naïve Patients With Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients greater than or equal to (>=) 18 years of age Metastatic colorectal cancer Exclusion Criteria: Previous cytotoxic chemotherapy or immunotherapy for advanced or metastatic disease Central nervous system and bone metastases Moderate or severe renal impairment Clinically significant cardiac disease Lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication Malignancy within the last 5 years, except cured basal cell cancer of skin and cured cancer in situ of uterine cervix

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>Participants will receive oral capecitabine 1250 milligrams per square meter (mg/m^2) twice daily for 14 days followed by 7 day rest period for 6 cycles. | Drug: Capecitabine<br>* Participants will receive 1250 mg/m^2 capecitabine administered twice daily as oral tablets for 14 days followed by a 7 day rest period for up to 6 treatment cycles.<br>* Other names: Xeloda;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | up to approximately 1.5 years | 
| Response rate, ie, percentage of participants with complete, partial, and overall response |  | up to approximately 1.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacoeconomic analysis: Treatment-related and AE-related spending/savings\n |  | up to approximately 1.5 years |
Clinical Evaluation of the iMOST-X1 Hematology Analyzer - Matrix Study

Study Overview
=================
Brief Summary
-----------------
This is a method comparison study for an in vitro diagnostic device. The device is a point of care automated hematology analyzer which measures CBC parameters with a small drop of venous or capillary, e.g., fingerstick blood. The study compared the CBC results from the test device, the Essenlix iMOST X-1 to the predicate laboratory based Horiba Pentra 60C+ analyzer. The CBC parameters were hemoglobin, White Blood Cells (WBC) and the WBC Differential for Granulocytes, Neutrophils, Lymphocytes and Monocytes. The study subjects were patient donors (age 18 and older) attending the hospital clinic from whom Informed Consent had been received.

Detailed Description
-----------------
These studies demonstrate that the iMOST X-1 system yields equivalent results to the Horiba predicate system when using either capillary and venous blood specimens. Furthermore, there are three alternative methods of capillary blood sampling for the iMOST and all have direct applicability to the iMOST system. As has been published in the peer reviewed literature, different fingerstick sample collection methods yield slightly different CBC results, specifically the WBC and the WBC Differential. The iMOST employs an integrated software algorithm with which the use can employ site specific calibration constants to correctly match the selected capillary blood specimen to the venous specimen for the WBC test results. All three methods of blood collection are thus described in the Instructions for Use.

Official Title
-----------------
Clinical Evaluation of the iMOST Analyzer - Matrix Study Comparing Capillary and Venous Whole Blood

Conditions
-----------------
Hematologic Tests

Intervention / Treatment
-----------------
* Diagnostic Test: iMOST X-1 Hematology Analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all clinic attendees Exclusion Criteria: unable to provide a venous and fingerstick blood specimen

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: iMOST X-1 Hematology Analyzer|The X-1 is a point of care automated hematology analyzer|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Method Comparison of CBC Results | Blood Diagnostic Tests for CBC | October- December 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CBC, WBC, Hemoglobin
Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a drug interaction study with NS2359 and cocaine in cocaine experienced volunteers.

Detailed Description
-----------------
This is a single-center, double-blind, placebo-controlled, randomized, single dose, fixed order, dose escalating inpatient design that will study oral NS2359 in cocaine experienced volunteers.

Official Title
-----------------
Drug Interaction Study With NS2359 and Cocaine in Cocaine Experienced Volunteers

Conditions
-----------------
Cocaine-Related Disorders, Drug Administration Schedule, Infusions, Intravenous

Intervention / Treatment
-----------------
* Drug: NS2359


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female, 18-45 yrs of age; females of child-bearing potential using appropriate method of birth control; be able to understand the procedure and agrees to participate via informed consent; must be cocaine dependent according to DSM-4 criteria; must be capable of providing written consent; must be able to comply with protocol requirement, CPU rules and regulations; must not be currently seeking treatment for cocaine abuse. Exclusion Criteria: Incapable of understanding the informed consent process; Additional criteria available during screening at the site.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NS2359|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter comparison |  |  | 
| plasma concentration |  |  |
Association Between CytochromeP4501A2 and CytochromeP4502E1 Gene Polymorphisms and Metabolism of Theophylline

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether common CYP1A2 and CYP2E1 gene polymorphisms effect metabolism of theophylline in chronic obstructive pulmonary disease patients.

Official Title
-----------------
Association Between CytochromeP4501A2(CYP1A2) and CytochromeP4502E1(CYP2E1) Gene Polymorphisms and Metabolism of Theophylline in a Chinese Population

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: theophylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-75 years,COPD patients, male or female; regularly visiting our hospital; taking a sustained-release preparation of theophylline continuously for at least 2 weeks Exclusion Criteria: patients with renal or hepatic dysfunction; patients with congestive heart failure; patients with hypothyroidism or hyperthyroidism; patients currently taking drugs likely to affect theophylline metabolism or who had taken such drugs in the preceding week; patients with extreme obesity patients with very severe Chronic Obstructive Pulmonary Disease(COPD)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: theophylline<br> | Drug: theophylline<br>* After oral theophylline 200mg per day for two weeks,bood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2 and CYP2E1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Theophylline clearance | Theophylline and it's metabolite(1,3-dimethyluric) blood concentration | Blood samples will be taken after receiving oral thoephylline for 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, theophylline, CYP1A2, CYP2E1
Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid

Study Overview
=================
Brief Summary
-----------------
A personal sound amplifying device (PASP) like Teo First is a wearable electronic product that is not intended to compensate for impaired hearing, but rather is intended for non-hearing impaired consumers to amplify sounds in the environment for a number of reasons, such as for recreational activities. Nevertheless, a lot of mild and moderate impaired hearing people don't want to buy and wear all day a real hearing aid. The goal of our study is to evaluate the benefit of such a device for mild and moderate presbycusis patient 60 years of age and older, with no previous hearing aid.

Official Title
-----------------
Evaluation of Efficacy and Patient Acceptance of Sound Amplifier Téo First, in Mild and Moderate Presbycusis Patient 60 Years of Age and Older, With no Previous Hearing Aid.

Conditions
-----------------
Mild and Moderate Presbycusis

Intervention / Treatment
-----------------
* Device: Use of a personal sound amplifying device = TeoFirst


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Wish to increase hearing Moral commitment to use the device Ability to understand the study Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz) Patient 60 years of age and older, No previous hearing aid Exclusion Criteria: Inability to use the device Previous use of a hearing aid local intolerance

Ages Eligible for Study
-----------------
Minimum Age: 60 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teo first<br>Mild and moderate presbycusis (20 to 50 dB average hearing loss at 500, 1000, 2000 Hz and 4000 Hz) Patient 60 years of age and older, No previous hearing aid | Device: Use of a personal sound amplifying device = TeoFirst<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audiometric tests (pure tone and speech) in silence and noise, with and without Teofirst |  | 7 to 15 days after the first use of Teofirst | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| audiometric and mental tests | Glasgow Hearing Aid Benefit Profile (GHABP) Acceptability and use questionnaire ANL (Acceptable Noise Level) test Mini Mental State Examination Instrumental Activities of Daily Living (IADL) | D7 to 15 and D 40 |