linjc16/ctgov huggingface dataset:
A Retrospective Chart Review of Thirty Three Children Who Have Received Clinical Treatment With Either Romiplostim or Eltrombopag From 2009-2013

Study Overview
=================
Brief Summary
-----------------
This is a retrospective analysis of children (≤21years old) who received clinical treatment with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children included in this study were from Weill Medical College of Cornell University, New York, New York and Children's Hospital Orange County, Orange, California

Official Title
-----------------
A Retrospective Chart Review of Thirty Three Children Who Have Received Clinical Treatment With Either Romiplostim or Eltrombopag From 2009-2013

Conditions
-----------------
Immune Thrombocytopenia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. All patients in this study had received prior treatments before the start of TPO treatment including corticosteroids, IVIG, IV anti-D, and/or Rituximab. Exclusion Criteria: 1. Children who do not have ITP

Ages Eligible for Study
-----------------
Minimum Age: 19 Months
Maximum Age: 21 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 |
| --- | --- |
| Romiplostim group<br> | |
| Eltrombopag group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet count greater than or = to 50,000 |  | on two consecutive weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| An increase in platelets greater than or = to 20,000 over baseline. |  | On two consecutive weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immune Thrombocytopenia (ITP), Thrombopoietin (TPO) agents, children, romiplostim and eltrombopag
Human Photoallergy Test

Study Overview
=================
Brief Summary
-----------------
To evaluate the potential of a test material to produce a photoallergic response.

Official Title
-----------------
Human Photoallergy Test

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Other: Bain De Soliel - Solid
* Other: Untreated skin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be male or female between the ages of 18 and 60 inclusive Be lightly pigmented (Fitzpatrick Skin Type I, II, III) Have read and signed the written Informed Consent Form and have completed a Health Insurance Portability and Accountability (HIPAA) Authorization Form in conformance with 45CFR Parts 160 and 164 Be in general good health as determined by the subject's medical history and in the discretion of the investigator Exclusion Criteria: Have a visible sunburn Have a history of sun hypersensitivity/photosensitivity or photosensitive dermatoses Have a known hypersensitivity or allergy against any of the active and non-active ingredients of the investigational products Subjects who are employees of the Contract Research Organization (CRO) and/or Bayer or is a household member of an employee

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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 |
| --- | --- |
| Experimental: Bain De Soliel - Solid<br>All subjects are patched with the same product | Other: Bain De Soliel - Solid<br>* 0.05gm/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.<br>Other: Untreated skin<br>* One site is patched without treatment as control<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of skin reactions is evaluated by 5 point scale |  | Up to 72 hours |
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Mexiletine for Painful Diabetic Neuropathy

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Assess the efficacy and toxicity of mexiletine in the management of paresthesias and pain in patients with diabetic neuropathy.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. The first group receives oral mexiletine 3 times a day for 6 weeks. The dose is increased after the first week if there are no side effects. The second group receives a placebo. Patients cross to the alternate treatment after a 1-week washout.

Conditions
-----------------
Pain, Diabetic Neuropathies, Paresthesia

Intervention / Treatment
-----------------
* Drug: mexiletine


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with painful diabetic neuropathy

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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: mexiletine|nan|

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
-----------------
diabetic neuropathy, disease-related problem/condition, neurologic and psychiatric disorders, pain, rare disease
How to Learn Cardiopulmonary Resuscitation

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to evaluate two methods of teaching cardiopulmonary resuscitation in the context of chest compression quality. We will evaluate the usefulness of the application cpr feedback device (CPRMeter) for quality of chest compression.

Official Title
-----------------
A Comparison of Two Chest Compression Techniques Among Laypersons. A Prospective, Randomized Simulation Study

Conditions
-----------------
Resuscitation, Chest Compression, Quality

Intervention / Treatment
-----------------
* Device: CPRMeter
* Other: Manual chest compression


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: give voluntary consent to participate in the study no medical experience Exclusion Criteria: not meet the above criteria wrist or low back diseases pregnancy

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chest compression without cpr feedback device<br>teaching resuscitation without application of cpr feedback device | Other: Manual chest compression<br>* Manual chest compression<br>|
| Experimental: Chest compression with cpr feedback device<br>teaching resuscitation with application of CPRMeter - cpr feedback device | Device: CPRMeter<br>* teaching resuscitation with application of cpr feedback device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| chest compressions effectiveness | the percentage of correct chest compressions relative to the total number of chest compressions | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| depth | correct depth according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation | 1 day | 
| pressure point | correct pressure point according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation | 1 day | 
| Complete pressure release | Complete pressure release measure by manikin software | 1 day | 
| Rate of chest compression | correct chest compressions rate according to European Resuscitation Council 2015 guidelines for cardiopulmonary resuscitation | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary resuscitation, medical simulation, basic life support, chest compression, feedback device
A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide

Study Overview
=================
Brief Summary
-----------------
This is a single-centre, prospective, non-randomised volunteer study to be undertaken in the MediCentre, Heath Park, Cardiff, UK

Detailed Description
-----------------
This is a single-centre, non-randomised, prospective study involving at least 120 participants. The data collected in this study will augment the data collected in IU2019_AG_03 Volunteers will be enrolled sequentially until at least 120 scans have been recorded. Ideally, between 120 and 150 scans will be recorded. Phase I Data collected from up to the first 80 participants in each of the six peripheral nerve block areas will be used as a training/verification set. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images. Phase II The remaining 40 videos in each area (total minimum 120 participants) will be used for validation of these models. The validation videos will be fed into the models created during Phase I of the study and the output anatomy highlighting will be recorded as a separate video, overlaid on the original ultrasound image. The overlay video will then be further split into 30-second segments. A panel of three independent expert anaesthetists will be convened to review and score the segments for accuracy and performance to the endpoints agreed in Phase I of the study.

Official Title
-----------------
A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide

Conditions
-----------------
Ultrasound Imaging of Anatomical Structures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 18 years of age; Able to comprehend and sign the Informed Consent prior to enrolment in the study. Exclusion Criteria: Aged <18 years of age; Unwilling or unable to provide informed consent.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Model development and verification | Collection of ultrasound scans. The collected scans will be assessed and used in the development and verification of deep-learning models that identify the target structures using a training dataset. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Model validation | Estimation of performance and accuracy (e.g. success/failure of highlighting of target structures, average distance of highlighting from target, time spent highlighting correct structure as a proportion of time target visible) | 4 months |
Influence of Bovine Milk Consumption on Hormonal Profile in Males

Study Overview
=================
Brief Summary
-----------------
50 men will be recruited to this study. Participants will be asked to ingest commercially available bovine milk. Hormonal profile will be analyzed before and after consumption.

Official Title
-----------------
Influence of Bovine Milk Consumption on Hormonal Profile in Males

Conditions
-----------------
Gonadotrophin and Sex Hormone Changes

Intervention / Treatment
-----------------
* Other: water
* Other: bovine milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy, non infertile males Exclusion Criteria: lactose intolerance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control<br> | Other: water<br> <br> |
| Active Comparator: experimental<br> | Other: bovine milk<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sex hormone profile | gonadotropin levels (Testosterone, Estradiol) | 4 hours after consumption |
Health Coaching for Glaucoma Patients

Study Overview
=================
Brief Summary
-----------------
The study will be conducted to examine the feasibility of using a Health Coach for improving the ophthalmic care of glaucoma patients. Patients taking glaucoma medications will have a coaching intervention and adherence to glaucoma drops will be monitored using a dose-recording device. The dosing data will be analyzed to examine the effect on adherence and qualitative interviews at the conclusion of the study will be used to examine which elements of the coaching experience were most helpful in the glaucoma patient population.

Detailed Description
-----------------
Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage.

Official Title
-----------------
Health Coaching for Glaucoma Patients, Pilot Study

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Behavioral: Health Coach


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult whose age is >18 years Diagnosed with glaucoma Patient of Duke Glaucoma Service Prescribed or using topical glaucoma eye medication for at least 6 months Primarily self-administering his or her eye drops English speaking Patient should be able to use the telephone for the coaching intervention, Patient should be available by phone to complete the coaching intervention Patient should be willing and able to use the MEMS (Medication Event Monitoring System) device for recording medication use Patient must be willing and able to come to the Eye Center for an exit interview and to return the MEMS device Patient must be able to give consent Exclusion Criteria: Patient should be excluded if he or she may need glaucoma surgery or laser during the 6 months of the study period

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Health Coach<br>Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients. | Behavioral: Health Coach<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glaucoma Medication Adherence | Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage. The average of the participants percentage of time they adhered to using the medication will be reported. | 6 Months |
A Multicenter Study to Evaluate the Cholesterol Lowering Effects of Two Marketed Products in Patients With Type 2 Diabetes Mellitus and Hypercholesterolemia (MK-0653A-077)

Study Overview
=================
Brief Summary
-----------------
The purpose of this 10-week study is to compare the reduction in cholesterol following treatment with two different marketed drugs, in patients with type 2 diabetes mellitus and hypercholesterolemia.

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Parallel Group, 6-Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Patients With Type 2 Diabetes Mellitus (T2DM) and Hypercholesterolemia

Conditions
-----------------
Type 2 Diabetes Mellitus, Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: MK0653A, ezetimibe (+) simvastatin
* Drug: Duration of Treatment: 4 wk placebo run in then 6 wk active
* Drug: Comparator: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women aged 18 to 79 years who have a confirmed diagnosis of type 2 diabetes mellitus with elevated cholesterol levels may be eligible to participate in a study to assess the efficacy and safety of the two marketed drugs. Exclusion Criteria: Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus that is poorly controlled

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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

| Intervention/Treatment |
| --- |
|Drug: MK0653A, ezetimibe (+) simvastatin|nan|
|Drug: Duration of Treatment: 4 wk placebo run in then 6 wk active|nan|
|Drug: Comparator: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent reduction in LDL-C from baseline after 6 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients attaining LDL-C <70 mg/dl after 6 weeks of treatment |  |  |
Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

Study Overview
=================
Brief Summary
-----------------
Fentanyl is expected to suppress tracheal tube-induced cough during emergence from general anaesthesia through binding to its receptors in the brainstem. However, it has not been proven if fentanyl has a complication-free, dose-dependent effect on cough suppression during emergence from sevoflurane anaesthesia. The purpose of this study is to evaluate the relationship between fentanyl doses and cough suppression during emergence from sevoflurane anaesthesia.

Official Title
-----------------
Dose-dependent Effect of Fentanyl on Cough Attenuation During Emergence From General Anaesthesia

Conditions
-----------------
Thyroid Neoplasm

Intervention / Treatment
-----------------
* Drug: fentanyl citrate
* Drug: saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the patients undergoing general anaesthesia for elective thyroidectomy due to thyroid neoplasm. ASA I-II. 20-59 years old. female only. Exclusion Criteria: signs of difficult intubation. risks for perioperative pulmonary aspiration. history of chronic respiratory disease. recent upper respiratory track infection. previous and recent smoking history

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 59 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: saline<br>control group | Drug: saline<br>* According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.<br>|
| Active Comparator: F1 group<br>F1 group : fentanyl 1 mcg/kg | Drug: fentanyl citrate<br>* According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.<br>|
| Active Comparator: F1.5 group<br>F1.5 group : fentanyl 1.5 mcg/kg | Drug: fentanyl citrate<br>* According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.<br>|
| Active Comparator: F2 group<br>F2 group : fentanyl 2 mcg/kg | Drug: fentanyl citrate<br>* According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |