linjc16/ctgov huggingface dataset:
Sun Protection Factor Assay (318/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

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

Intervention / Treatment
-----------------
* Drug: BAY987521
* Drug: SPF Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnosed by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-177)<br>Drug: SPF Control<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
A Study to Evaluate the Safety of an Investigational Drug (Etoricoxib) in Patients With Osteoarthritis (OA) or Rheumatoid Arthritis (RA)(0663-066)

Study Overview
=================
Brief Summary
-----------------
The study is designed to compare the risk of cardiovascular events (heart attacks, strokes) in patients receiving either etoricoxib or diclofenac. It will also compare the gastrointestinal tolerability of the two medicines. The study will be conducted in patients with either rheumatoid or osteo-arthritis.

Official Title
-----------------
A Randomized, Double-Blind, Active-Comparator-Controlled, Parallel-Group Study to Evaluate the Safety of Etoricoxib in Patients With Osteoarthritis or Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis,Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0663, etoricoxib
* Drug: Comparator: Diclofenac sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a clinical diagnosis of either Osteoarthritis or Rheumatoid Arthritis and in the opinion of the investigator will require chronic nonsteroidal anti-inflammatory or COX-2 inhibitor therapy for at least 1.5 years Exclusion Criteria: Concurrent medical or arthritic disease that could confound or interfere with efficacy evaluation. Concomitant therapy of warfarin, heparin, high-dose aspirin (>100 mg/day). Impaired kidney function, clinical gastrointestinal malabsorption, congestive heart failure with symptoms that occur at rest, unstable angina, uncontrolled high blood pressure, active hepatitis/hepatic disease

Ages Eligible for Study
-----------------
Minimum Age: 50 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: MK0663, etoricoxib|nan|
|Drug: Comparator: Diclofenac sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences based on combined data from this trial and MK0663 Protocols 061 & 072 (GI Tolerability in OA Patients and GI Tolerability Study in RA Patients ), respectively. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Confirmed Thrombotic Cardiovascular Serious Adverse Experiences from this trial alone. Gastrointestinal tolerability based on the percentage of patients that discontinue for clinical or laboratory gastrointestinal adverse experiences. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

Study Overview
=================
Brief Summary
-----------------
The purpose of this feasibility clinical investigation is to investigate a new medical device treatment for Overactive Bladder (OAB) in women.

Detailed Description
-----------------
The FemPulse System is a vaginal ring intended to provide mild electrical stimulation to nerves that regulate bladder function. It is believed that stimulation of these nerves may help relieve the symptoms of OAB.

Official Title
-----------------
Pilot Phase for an Acute Evaluation of a Non-Implantable Electrical Continence Device

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Device: The FemPulse System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal healthy women ≥ 21 years old Using contraception if of reproductive age Exclusion Criteria: Pregnant, recently pregnant or actively trying to conceive Prior hysterectomy Current or recent urinary tract or vaginal infection

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects will wear a device and will be monitored non-invasively during activation of the device.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monitoring during activation of the FemPulse System<br>Subjects will undergo non-invasive monitoring during activation of the FemPulse System. | Device: The FemPulse System<br>* Non-invasive monitoring during activation of the FemPulse System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Autonomic nervous system response | The Quantitative Sudomotor Axon Reflex Test (QSART) will be used to detect changes in autonomic nervous system activity during device activation | Up to 6 hours | 
| Evoked Potential response | Surface electrodes will be used to detect whether evoked potentials are generated during device activation | Up to 6 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overactive Bladder, Women, Neuromodulation, Bioelectronic Medicine
Time - Lapse Analysis of Frozen Embryos

Study Overview
=================
Brief Summary
-----------------
A retrospective analysis of embryo defrost cycles that were rated in the EmbryoScope system and frozen will be performed. The study will examine the possible association between the morphokinetic grading received by these embryos as fresh embryos before freezing, and their survival, the morphological grading they received after thawing, their proper rooting and live birth after thawing.

Official Title
-----------------
Is Morphokinetic Scoring by Time - Lapse Analysis of Embryos Undergoing Cryopreservation During IVF Associated With Post- Thaw Survival and Treatment Outcome: A Retrospective Analysis

Conditions
-----------------
Frozen Embryos

Intervention / Treatment
-----------------
* Other: time lapse analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All women who underwent embryo freezing and thawing between the years 2014-2019 in Carmel medical center Exclusion Criteria: Lack of proper data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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 |
| --- | --- |
| frozen embryos<br> | Other: time lapse analysis<br>* grading of the embryos before freezing using time lapse/<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth |  | 1 day | 
| embryos survival after thawing |  | 1-2 days | 
| implantation in the uterus |  | 1 week | 
| post thaw grading | post thaw grading of the embryos using time lapse analysis | 1 day |
Efficacy Study of Folinic Acid to Improve Mental Development of Children With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether folinic acid can improve developmental quotient of young Down syndrome patients, given that these present signs of folate deficiency which are known to cause reversible neurological, psychiatric and cognitive disorders.

Official Title
-----------------
One-year Double-blind Placebo-controlled Phase 2-3 Study to Evaluate the Effect of Oral Folinic Acid Treatment (1mg/kg/d) on the Psychomotor Development of Young Down Syndrome Patients

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Drug: folinic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Down syndrome without mosaicism age 3 to 30 months weight over 4 kg possible assessment by the revised Brunet-Lezine scale Exclusion Criteria: history of leukemia West syndrome or non-stable epilepsy non-stable thyroxin treatment

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 30 Months

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: folinic acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score on a psychomotor development scale after a 6 and 12 months treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Down syndrome, folinic acid therapy, cognitive functions
Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
To find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome

Official Title
-----------------
Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome

Conditions
-----------------
Down Syndrome

Intervention / Treatment
-----------------
* Other: core stability exercises with treadmill
* Other: core stability exercise without treadmill


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: able to stand and walk independently able to understand and follow a verbal command cutoff score less than 6 or 7 in functional balance in indicated Exclusion Criteria: patients have any neurological issue, Instability of atlantoaxial joint Vision and hearing loss History of fall

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: core stability exercise, treadmill<br>core stability exercises and treadmill training | Other: core stability exercises with treadmill<br>* swiss ball use patient is lying in supine position with 15 repitations and 3 sets.<br>|
| Experimental: core stability exercises<br>core stability exercises without treadmill training | Other: core stability exercise without treadmill<br>* technique used to improve stability<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Berg balance scale | berg balance scale was used to measure the functional balance in children. | 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach test | reach test is used to measure the stability in children | 8week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
core stability exercises, balance, treadmill
Disturbance of Water and Sodium Metabolism After Surgery of Sellar Lesions, and Correspond Clinical Strategy

Study Overview
=================
Brief Summary
-----------------
The fluid and electrolyte imbalance (FEI) is pretty common encountered during the clinical process of patients suffered sellar lesions. Moreover, if the patients are undergone the surgery for remove the lesion, FEI happens in all cases without exception. Hypo- and hyper-natremia is the most common electrolyte disorder, which is directly correlated to the patients' outcome. However, in clinical works, different sellar diseases cause variant features of FEI. For example, after the surgery of craniopharyngioma, the hyponatremia and hypernatremia always happen alternatively even without any precursor manifestation. Under this situation, it is quite difficult for fluid supplement. In contrast, the severe FEI will cause poor outcome, even death. So it is necessary to systematically collect and review the clinical data of sellar lesions. Through the analysis of variant FEI patterns of sellar diseases, more precise strategy for clinical fluid replacement will be proposed.

Conditions
-----------------
The Patients Suffered With Sellar Diseases, The Fluid and Electrolyte Imbalance Happened After Surgery

Intervention / Treatment
-----------------
* Biological: Chemical and physical detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Suffered with sellar disease 2. Udergone surgery 3. Have sufficient presurgical and postsurgical clinical data (Including MRI, CT, physical and chemical detection results) Exclusion Criteria: 1. Without sufficitent clincal data 2. No surgery
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diseases<br>1. Pituitary adenomas; 2. Craniopharyngioma; 3. Sellar germinoma; 4. Sellar tuberalis meningioma; 5. Hypophystis; 6. Sellar glioma; 7. Rathke's cleft cyst; 8. Hypothalamic hamartoma | Biological: Chemical and physical detection<br>* CVP, Urine volume per day, Blood electrolytes, Urine sodium per day, Pituitrin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood sodium | Normal: 135 155 | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine sodium |  | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluid and electrolyte imbalance, Hyponatremia, Hypernatremia, Electrolytes disorder
Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study

Study Overview
=================
Brief Summary
-----------------
Even though Hinchey classification requires operative intervention, yet remains the established and most universally used scoring system for acute diverticulitis. Several other classifications have been described. The American Association for the Surgery of Trauma (AAST) developed a severity scale for surgical conditions, including diverticulitis. The same was done by the World Society of Emergency Surgery, that proposed a specific classification mainly based on the CT scan findings. This is a pilot study to compare the AAST and WSES classifications for acute colonic diverticulitis with the traditional Hinchey classification. We hypothesize that all the classifications are equivalent one each other in predicting outcomes

Official Title
-----------------
Comparision Among Classifications for Acute Diverticulitis: a Multicenter Study

Conditions
-----------------
Acute Diverticulitis

Intervention / Treatment
-----------------
* Procedure: Colonic Resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute colonic diverticulitis Exclusion Criteria: Other severe conditions of end-life

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 100 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 |
| --- | --- |
| Hinchey Classification<br> | Procedure: Colonic Resection<br>* Resection of the colonic tract which has been interested by the acute diverticulitis<br>|
| AAST classification<br> | Procedure: Colonic Resection<br>* Resection of the colonic tract which has been interested by the acute diverticulitis<br>|
| WSES classfication<br> | Procedure: Colonic Resection<br>* Resection of the colonic tract which has been interested by the acute diverticulitis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for procedural intervention (operation or percutaneous drainage) |  | 30 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU requirement |  | 30 day | 
| Overall morbidity |  | 30 day | 
| Length of stay |  | 30 day | 
| in-hospital morbidity |  | 30 day |
ATEM (Alvesco Non-interventional Study)

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the efficacy of Alvesco in patients with persistent asthma including or excluding allergic components over 3 months, especially in the spring season. Alvesco will be inhaled by a metered-dose inhaler. The study will provide further data on safety and tolerability of Alvesco .

Official Title
-----------------
Alvesco for the Therapy of Persistent Asthma With or Without Allergic Component

Conditions
-----------------
Asthma, Allergy

Intervention / Treatment
-----------------
* Drug: Alvesco


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Asthma with or without allergic components Main Exclusion Criteria: Hypersensitive to compounds of Alvesco Other criteria as defined in the Summary of Product Characteristics, Chapter 4.3

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 |
| --- | --- |
| ATEM<br>A prospective one-arm non-interventional study with asthma patients treated with Alvesco. | Drug: Alvesco<br>* This is an observational study. Therefore, the physician decides about dosage according to individual needs.<br>* Other names: Ciclesonide;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success with Alvesco | Pre-/ post comparison of FEV1, Quality of life, Patient Questionnaire | after 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asthma, Allergy, Ciclesonide, Alvesco, Inhaled steroids