linjc16/ctgov huggingface dataset:
Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination

Study Overview
=================
Brief Summary
-----------------
Pediatric emergency department (PED) physicians frequently encounter children with symptoms that warrant evaluation of the optic disc for suspected increased intracranial pressure (ICP) such as headache, blurred vision, recurrent vomiting etc. Fundoscopic examination, by the PED physician, is considered an essential modality for assessment of the optic disc and the diagnosis of papilledema. Obtaining good visualization of the optic disc requires patient compliance, the ability to open the eyelids, the absence of opacities in the ocular media and a sufficiently large pupillary aperture. Hence, different levels of PED physician training, lack of cooperation, significant ocular or periorbital trauma, contraindications to mydriasis and severe photophobia may hinder direct fundoscopic evaluation. In the investigators' PED, children requiring fundoscopy are sent to a formal ophthalmologic examination. The investigators aim to evaluate the yield of optic disc height as measured with ocular point of care ultrasound to detect optic disc swelling in comparison to ophthalmologic examination as the gold standard.

Official Title
-----------------
Ocular Point of Care Ultrasound (POCUS) to Detect Optic Disc Swelling in Comparison to Ophthalmologic Examination

Conditions
-----------------
Papilledema Associated With Increased Intracranial Pressure

Intervention / Treatment
-----------------
* Device: Point of care ocular ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients from the PED, Aged 0-18 years, Who require funduscopic examination and referred to ophthalmologic evaluation. Exclusion Criteria: Direct trauma to the eye with suspicion of ruptured globe or laceration of the eyelid, History of glaucoma.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Point of care ocular ultrasound|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The yield of ocular POCUS in diagnosing optic disc swelling in comparison to ophthalmology evaluation as the gold standard. |  | Up to 24h from inclusion or until hospital discharge if admitted |
The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With MDD

Study Overview
=================
Brief Summary
-----------------
To determine if the NMDA antagonist, CP-101,606, is effective for depression

Official Title
-----------------
A Randomized, Double-Blinded, Placebo-Controlled Trial To Assess The Antidepressant Effects Of The NMDA Antagonist, CP-101,606, In Patients With Treatment Refractory Major Depressive Disorder

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: NMDA Antagonist, CP-101,606 (traxoprodil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary DSM-IV diagnosis of MDD Exclusion Criteria: Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

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

| Intervention/Treatment |
| --- |
|Drug: NMDA Antagonist, CP-101,606 (traxoprodil)|nan|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAM-D |  |  |
A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the relative bioavailability of Paddock Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets, under fasting conditions.

Official Title
-----------------
A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide 15mg/25mg Tablets (Paddock Laboratories, Inc) and Uniretic® 15mg/25mg Tablets (Schwarz Pharma)(Moexipril HCl/Hydrochlorothiazide) in Healthy Adult Volunteers Under Fasting Conditions.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.
* Drug: Uniretic® 15mg/25mg Tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening Exclusion Criteria: Positive test results for HIV or Hepatitis B or C History of allergy or sensitivity to Moexipril, Hydrochlorothiazide or related drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moexipril HCl/ Hydrochlorothiazide 15mg/25mg Tablets<br> | Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.<br>* test drug<br>|
| Active Comparator: Uniretic® 15mg/25mg Tablets<br> | Drug: Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.<br>* test drug<br>Drug: Uniretic® 15mg/25mg Tablets<br>* reference drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence specified outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Subjects, Bioequivalence
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate pharmacokinetic-pharmacodynamic property of C3G after administration of Mulberry fruit extract to 12 healthy Korean volunteers. Plasma concentration of C3G and the antioxidative markers such as total antioxidative capacity and attack of free oxygen radical will be measured. Additional objective is to investigate the multiple dose (2 weeks) safety of daily 1000mg black bean seed coat extract. This study, as an exploratory trial, does not required statistical hypothesis

Official Title
-----------------
A Study to Evaluate Pharmacokinetics of C3G and to Estimate Antioxidative Markers After Repeated Administration of Black Bean Seed Coat Extract

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Other: Black bean seed coat extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight >55 kg for male, >45 kg for female (within 80-120% of Ideal body weight) Give written informed consent and voluntarily decide participation Exclusion Criteria: Acute or chronic disease symptom on screening Existing active and clinically significant disease involving more than one organ system Known allergy to Mulberry or other berries Positive drug or alcohol screening Smokers of 10 or more cigarettes per day Participation in a clinical trial during last 2 month prior to the start of the study Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Black bean seed coat extract<br>Daily 1000 mg oral Black bean seed coat extract is given to each subject for 2 weeks from Day2 after measuring antioxidative marker without intervention on Day1. | Other: Black bean seed coat extract<br>* 1000 mg oral daily dose for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax - Maximum Observed Concentration - C3G in Plasma |  | Blood samples collected over 6 hours | 
| AUC0-inf - Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated) - C3G in Plasma |  | Blood samples collected over 6 hours | 
| Antioxidative markers |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events |  | for 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
C3G, Oxidative stress, Antioxidant, Black bean
MESS-study MRSA Eradication Study Skåne

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether systemic antibiotic treatment with rifampicin and clindamycine or trimethoprim-sulfa in addition to topical treatment with mupirocin is more effective than only topical treatment to eradicate MRSA in throatcarriers

Official Title
-----------------
MESS- MRSA Eradication Study Skåne. A Comparison Between Systemic Antibiotic Treatment in Combination With Topical Mupirocintreatment With Only Topical Mupiroicintreatment to Eradicate MRSA in Throat Carriers

Conditions
-----------------
Throatcarriers of MRSA

Intervention / Treatment
-----------------
* Drug: Mupirocin
* Drug: Rifampin+Clindamycine or Trimehoprimsulfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Colonized with MRSA in the throat Older than 5 years MRSA-bacteria sensitive for Rifampicin and Clindamycine or Trimethoprimsulfa - Exclusion Criteria: Allergy to the studymedication Healthcareworkers Pregnancy Active infection with MRSA Immunosuppression Treatment with other antibiotic during the studyperiod

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mupirocin<br>Topical treatment | Drug: Mupirocin<br>* Topical in the nose 3 times daily for 5 days<br>Drug: Rifampin+Clindamycine or Trimehoprimsulfa<br>* Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3 Trimethoprimsulfa 400mg/80mg 2x2<br>|
| Active Comparator: Rifampicin+Clindamycine or Trimethoprimsulfa<br>Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3xVII Trimethoprimsulfa 400mg/80mg 2x2 | Drug: Rifampin+Clindamycine or Trimehoprimsulfa<br>* Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3 Trimethoprimsulfa 400mg/80mg 2x2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture for MRSA |  | after 6 months |
Exploratory Study of Pagoclone in Men With Premature Ejaculation.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.

Detailed Description
-----------------
The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time (IELT) male patients with primary premature ejaculation.

Official Title
-----------------
A Four-arm, Randomized, Double-blind, Parallel, Placebo-controlled Exploratory Study of Pagoclone 0.15mg, 0.30mg, and 0.60mg in Men With Primary Premature Ejaculation.

Conditions
-----------------
Premature Ejaculation

Intervention / Treatment
-----------------
* Drug: pagoclone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A male regularly experiencing premature ejaculation 18 to 55 yrs old In a Stable relationship with one woman for at least 6 months

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0.15 mg<br> | Drug: pagoclone<br> <br> |
| Experimental: 0.30 mg<br> | Drug: pagoclone<br> <br> |
| Experimental: 0.60 mg<br> | Drug: pagoclone<br> <br> |
| Placebo Comparator: PBO<br> | Drug: pagoclone<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravaginal ejaculation latency time (IELT) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
investigational drug, ejaculation
Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe Medical Center

Study Overview
=================
Brief Summary
-----------------
Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. Reviewing the data collected until now may reduce the need for poist natal echography.

Detailed Description
-----------------
Cardiac echogenic foci are common finding on prenatal follow-up. At hillel Yaffe medical center a post natal echography is performed to all newborns with prenatal cardiac echogenic foci. The investigator will review all echographies performed in the last ten years. Reviewing the data collected until now may reduce the need for poist natal echography.

Official Title
-----------------
Postnatal Managemant of Prenetal Cardiac Echogenic Foci in Hillel Yaffe

Conditions
-----------------
Prenatal Diagnosis

Intervention / Treatment
-----------------
* Other: No intervension


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newborns who had a cardiac echogenic focus during prenatal pollow-up. Exclusion Criteria: Newborns who did not had postnatal echocardiography due to technical reasons.

Ages Eligible for Study
-----------------
Maximum Age: 14 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prenetal cardiac echogenic focus<br>Newborn infants who had prenatal cardiac echogenic focus | Other: No intervension<br>* There is intervention at all.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any sonographic cardiac pathologic finding exists | Any sonographic cardiac pathologic finding exists, as defined by the cardiologist who performs the postnatal echocardiography. | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac echogenic focus
A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging, placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post operative pain after undergoing third molar extraction.

Official Title
-----------------
A Randomized,Double Blind, Parallel Group, Placebo Controlled Dose Ranging Study to Assess the Analgesic Efficacy, Tolerability, Safety and Pharmacokinetic/Pharmacodynamic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: ketamine 25 mg
* Drug: ketamine 35 mg
* Drug: ketamine 50 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* placebo<br>|
| Active Comparator: ketamine 25 mg<br>ketamine | Drug: ketamine 25 mg<br>* ketamine<br>|
| Active Comparator: ketamine 35 mg<br>ketamine | Drug: ketamine 35 mg<br>* ketamine<br>|
| Active Comparator: ketamine 50 mg<br>ketamine | Drug: ketamine 50 mg<br>* ketamine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of Pain Intensity Difference | The primary objective of this study is to demonstrate the dose-response relationship for analgesia of three dose levels of ketamine sublingual wafer compared with placebo, using the summed pain intensity difference from baseline over the first 3 hours (SPID3) in subjects with acute moderate to severe pain following third molar extraction. | 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of Pain Intensity Difference | SPID 6 | 6 hours | 
| Safety and tolerability | Safety and tolerability of ketamine sublingual wafer as evaluated with physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs, and incidence of Adverse Events (AEs) and Serious AEs (SAEs) | 6 hours |
Best Treatment Modality of Frozen Shoulder

Study Overview
=================
Brief Summary
-----------------
This study will compare between the effect of three treatment modalities of shoulder adhesive capsulitis to hilight the best technique to improve pain and range of motion outcome measures .

Official Title
-----------------
Shoulder Adhesive Capsulitis ; Comparison Between Three Theraputic Approaches

Conditions
-----------------
Shoulder Adhesive Capsulitis

Intervention / Treatment
-----------------
* Procedure: Local injection of shoulder joint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gross limitation of passive shoulder movement pain interfering with daily activities painful restiction of active and passive movement of shoulder Exclusion Criteria: presence of degenerative pathology fracture contraindication to steroid injection deformity affecting upper limb history of previous shoulder injection in the past 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Suprascapular nerve block<br>This group will include will under go suprascapularnerve block as following :10 ml of .5% bupivacaine and 2 ml of methylpradnisolon 40mg/ml | Procedure: Local injection of shoulder joint<br>* Under ultrasound guidance , local shoulder joint injection will be done<br>|
| Active Comparator: Hydrodilatation of shoulder capsule<br>This group will undergo intraarticular hydrodilatation by injection of :first lidocaine10ml%followed by 1ml of methylprednisolon 40mg/ml and finally 20ml of .9 % sodium chloride slowly in the gleno humeral joint | Procedure: Local injection of shoulder joint<br>* Under ultrasound guidance , local shoulder joint injection will be done<br>|
| Active Comparator: Hydrodilatation of shoulder interval<br>This group will undergo interval hydrodilatation by injection of :first mepivacaine 10ml folowed by 20ml of sterile water slowly in the shoulder interval | Procedure: Local injection of shoulder joint<br>* Under ultrasound guidance , local shoulder joint injection will be done<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in range of motion of shoulder joint | Improvement will be measured by measuring active and passive range of motion | 12 weeks efter intervention | 
| Improvement in pain | Improvement will be measured by VAS ( visual auditory assessment ) | 12 weeks after intervention |