linjc16/ctgov huggingface dataset:
One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to a Marketed 1 Day Contact Lens

Study Overview
=================
Brief Summary
-----------------
The objective of this one-day study will be to evaluate the clinical performance of SofLens Daily Disposable lenses compared to that of a marketed 1 Day Contact Lens.

Official Title
-----------------
One-Day Dispensing Clinical Evaluation of SofLens Daily Disposable Lenses Compared to 1-Day Acuvue TruEye Lenses

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: SofLens Daily Disposable
* Device: Marketed 1 Day Contact Lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings. Have no active ocular disease or allergic conjunctivitis. Not be using any topical ocular medications. Exclusion Criteria: Participating in a conflicting study. Considered by the Investigator to not be a suitable candidate for participation.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SofLens Daily Disposable<br>SofLens Daily Disposable Lenses | Device: SofLens Daily Disposable<br>* Lenses to be worn for 8-16 hours<br>|
| Active Comparator: Marketed 1 Day Contact Lens<br>Marketed 1 Day Contact Lens | Device: Marketed 1 Day Contact Lens<br>* Lenses to be worn for 8-16 hours<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Performance | Comfort of lens wear compared at insertion of lens, 4 hours after insertion, and end of day (8-16 hours of wear-time). Score was a number on a scale 0-100, graded by the participants, and included lens edge awareness, scratchiness/grittiness, foreign body sensation, and general lens awareness. | Insertion, 4 hours & End of Day |
Evaluation of Thoracic Impedance Tomography During Robotic Surgery

Study Overview
=================
Brief Summary
-----------------
the evaluation of distribution of mechanical ventilation during robotic surgery

Official Title
-----------------
Evaluation of Two Types of Mechanical Ventilation During Robotic Surgery With the Thoracic Impedance Tomography

Conditions
-----------------
Atelectasis

Intervention / Treatment
-----------------
* Other: mechanical ventilation during robotic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 informed consent robotic surgery Exclusion Criteria: age<18 no consent for the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: protective<br> | Other: mechanical ventilation during robotic surgery<br>* protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg<br>|
| Active Comparator: conventional<br> | Other: mechanical ventilation during robotic surgery<br>* protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| distribution of tidal volume |  | at the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| driving pressure |  | at the end of surgery |
Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether progesterone hormone levels differ following egg retrieval with a single lumen needle compared with a double lumen needle. These levels will be measured on several days before and after egg retrieval. The progesterone levels in each IVF group will also be compared to the group of women who are having IUI. In addition, these progesterone levels will be correlated with pregnancy outcomes.

Detailed Description
-----------------
This is a prospective randomized trial consisting of 3 groups of patients. Following a long lupron protocol IVF cycle there is a need for supplemental progesterone. The purpose of this study is to determine what range of serum levels should be observed when differing methods of egg aspiration have been administered and whether or not there is a correlation with outcomes or pregnancies.

Official Title
-----------------
Examination of Serum Progesterone Levels in an IVF Population Following Two Types of Egg Aspiration

Conditions
-----------------
Infertility, Female

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages between 21-37 Cycle Day 3 FSH between 2-12 History of regular menstrual cycles between 24-34 days Exclusion Criteria: Previous IVF failure Severe male factor Severe obesity, BMI > 40 More than 20 follicles on ultrasound prior to retrieval

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 37 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 |
| --- | --- |
| IVF population<br>Long Lupron IVF Population | |
| IUI patients<br>Patients undergoing IUI | |

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
-----------------
Infertility
Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the injection of triamcinolone and lidocaine is effective in relieving chronic abdominal wall pain.

Official Title
-----------------
Lidocaine and Triamcinolone vs Saline Trigger Point Injection for Treatment of Chronic Abdominal Wall Pain

Conditions
-----------------
Chronic Abdominal Wall Pain, Abdominal Cutaneous Nerve Entrapment Syndrome

Intervention / Treatment
-----------------
* Drug: Triamcinolone
* Other: Placebo
* Drug: Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of chronic abdominal wall pain Prior ultrasound or cross-sectional imaging of the abdomen to exclude other causes Baseline Brief Pain Inventory score ≥ 5 Exclusion Criteria: Multiple trigger points Abdominal wall hernia on exam Weight loss Rectal bleeding Recent change in bowel habits Decompensated cirrhosis or recurrent ascites Allergy or contraindication to study medications Known thrombocytopenia with platelet count < 50,000 Other diagnosis of chronic pain syndromes including fibromyalgia Unable to provide informed consent Pregnancy

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: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Injection of 3.5mL of normal saline into the point of maximal tenderness in the abdomen | Other: Placebo<br> <br> |
| Experimental: Treatment<br>Injection of 20mg triamcinolone and 1% lidocaine into the point of maximal tenderness in the abdomen | Drug: Triamcinolone<br> <br> Drug: Lidocaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Questionnaire to assess change in pain score | Baseline and 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Questionnaire to assess change in pain score | Baseline and 1 week | 
| Pain score | Questionnaire to assess change in pain score | Baseline and 2 months |
A Study of Duration of Maintained Efficacy in Rheumatoid Arthritis (RA) Patients Off Treatment With MRA(a Development Code of Tocilizumab, an Anti IL-6 Receptor Monoclonal Antibody.)

Study Overview
=================
Brief Summary
-----------------
A 52-week follow up study to investigate the duration of maintenance of efficacy in patients with RA and achieved low disease activity in clinical trials of MRA and stopped the treatment

Official Title
-----------------
A Study to Investigate the Duration of Maintained Efficacy in Patients With Rheumatoid Arthritis Who Had Treated With MRA

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies. Exclusion Criteria: Patients who receive DMARDs or immunosuppressants between the last observation in a previous studies and the first observation in this study

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Ⅰ<br>Subject who have participated in previous studies and achieved DAS28 of < 3.2 at the last observation and at least one time point among the two previous assessment time points in a previous studies. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who maintained efficacy during 52-weeks after the last infusion of MRA in the previous studies. |  | every 4th week up to the 48th week | 
| Relationship between serum IL-6 concentration at the last observation of the previous studies and the duration of maintenance of efficacy |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Proportion of patients who maintained efficacy among patients whose DAS28 was <2.6 at the last observation of the previous studies. |  | throughout study | 
| Efficacy: Time course of DAS28 during the treatment-free period in the present study |  | throughout study | 
| Efficacy: Relationship between serum IL-6 concentration at the last observation of the previous studies and the time course of DAS28 during the treatment-free period in the present study. |  | throughout study |
Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature

Study Overview
=================
Brief Summary
-----------------
A single visit & single arm study in 80 subjects with diabetes to determine if a short educational experience with a new blood glucose meter feature improves the ability of each subject to better classify glucose results into acceptable glucose ranges.

Official Title
-----------------
Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: Education with new meter feature.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Type 1 diabetes Mellitus (T1DM) or Type 2 diabetes Mellitus (T2DM) for ≥ 3 months Currently performing self monitoring of blood glucose (SMBG) at home Aged ≥16 years Exclusion Criteria: Previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education with new meter feature.<br>Subjects experience a computer stimulation of a new meter feature ( colour range indicator) to help subjects interpret whether blood glucose results are low, in-range or high based on accepted guidance. | Behavioral: Education with new meter feature.<br>* The blood glucose meter has default settings for the colour range indicator which can be customized by the subjects and/or their healthcare professional. This colour range indicator will be presented to the subjects as a computer simulation to show subjects a range of typical blood glucose values and how this new feature would classify these results as being low (blue), in-range (green) or high (red).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate to categorize blood glucose values into accepted ranges. |  | On average within 30 mins post intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Actual time taken to categorize blood glucose values into accepted ranges on the questionnaire provided. |  | On average within 30 mins post intervention. |
A Study of Blosozumab (LY2541546) in Postmenopausal Female Participants

Study Overview
=================
Brief Summary
-----------------
The purpose(s) of this study is to measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it when given in multiple doses, subcutaneously (SC) (by inserting a needle just under the surface of the skin in the lower abdominal area), to postmenopausal (PMP) female participants. Information about any side effects that may occur will also be collected. This study will also be looking for special markers called biomarkers that can be used to study osteoporosis and/or the effects of the study drug. There will be 2 parts to this study. The first part will last approximately 6 weeks and the second part will last approximately 7 weeks.

Official Title
-----------------
A Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Blosozumab Proposed Phase 3 Formulation in Postmenopausal Women

Conditions
-----------------
Osteoporosis, Postmenopausal

Intervention / Treatment
-----------------
* Drug: Blosozumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Part A: Overtly healthy PMP females Part B: PMP women who are currently taking oral bisphosphonates Have a body mass index (BMI) at screening of 19.0 to 35.0 kilogram per square meter (kg/m^2) Exclusion Criteria: Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies Show evidence of hepatitis C and/or positive hepatitis C antibody Show evidence of hepatitis B and/or positive hepatitis B surface antigen Have known allergies to blosozumab, its constituents, or related compounds Have an abnormality in the 12-lead electrocardiogram (ECG)

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blosozumab<br>Weekly SC injections of blosozumab for 6 weeks. | Drug: Blosozumab<br>* Administered subcutaneously<br>* Other names: LY2541546;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK): Maximum Concentration (Cmax) of Blosozumab | The mean maximum observed drug concentration of Blosozumab during 1 dosing interval was reported. | Predose and daily up through 7 days postdose | 
| PK: Area Under the Concentration Curve of Blosozumab | The mean area under the concentration of Blosozumab versus time curve during 1 dosing interval was reported. | Predose and daily up through 7 days postdose |
Validation of a Questionnaire to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The Primary Aim of this study is to validate a questionnaire as a screening tool to identify subjects with symptoms suggestive of nephrogenic systemic fibrosis (NSF). The investigators believe that there will be difference between subjects with NSF and other skin conditions and normal skin.

Official Title
-----------------
Validation of a Questionnaire as a Screening Tool to Identify Signs and Symptoms of Nephrogenic Systemic Fibrosis

Conditions
-----------------
Nephrogenic Systemic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects 18 years of age or older. Willing and able to understand and provide oral informed consent. Able to complete study and comply with study procedures. Exclusion Criteria: Subject is unable to provide oral consent. Psychiatric or other conditions which might, in the opinion of the Principal Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>subjects with a histologically-proven diagnosis of NSF | |
| 2<br>subjects with other fibrosing skin diseases | |
| 3<br>subjects with non-fibrosing skin diseases | |
| 4<br>subjects without skin diseases | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the number of yes answers between NSF subjects and subjects with non-fibrosing skin diseases or without skin diseases. |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Similarity in answers between NSF subjects and subjects with other fibrosing skin diseases. |  | 1 day | 
| Sensitivity of the questionnaire when applied to NSF subjects. |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nephrogenic Systemic Fibrosis, Screening
Ginseng in Treatment of Fatigue in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the efficacy and safety of Ginseng in treatment of fatigue and Quality of Life of MS patients.

Detailed Description
-----------------
Multiple Sclerosis (MS) is one of the most common non-traumatic causes of disability in the world. It is a chronic inflammatory and demyelinating disorder of the Central Nervous System (CNS) which affects individuals in the productive ages and causes a large burden for years to come. Fatigue is a common complaint and one of the least understood symptoms of MS

Official Title
-----------------
Study of Ginseng in Treatment of Fatigue in Multiple Sclerosis

Conditions
-----------------
Fatigue

Intervention / Treatment
-----------------
* Drug: Ginseng
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: definite diagnosis of relapsing-remitting MS (RRMS) by the MacDonald criteria with a baseline of Expanded Disability Status Score (EDSS)of less than 5.0 Exclusion Criteria: prior use of ginseng or any other tonic agents, glucocorticoids, warfarin, digoxin, aspirin, furosemide, caffeine, ephedra and anti-platelet agents within one month prior to enrollment; Pregnancy or lactation; history of renal failure; and, lack of appropriate adherence to the study protocol.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ginseng<br>Ginseng, tablet, 250 mg, twice, 3 months | Drug: Ginseng<br>* it is kind of drug<br>|
| Placebo Comparator: Placebo<br>Placebo, tablet | Drug: Placebo<br>* it is placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fatigue | Modified Fatigue Impact Scale (MFIS)is a21-item (score range of each item: 0-4) questionnaire with the total score computed from 0 (no impact of fatigue) to 84 (maximum impact of fatigue) in three subscales containing: physical (9 items), cognitive (10 items) and psychosocial (2 items) aspects. | at 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality Of Life | Quality Of Life Questionnaire (MSQOL-54) consisted of 54 questions (items), each one, assigned to a score ranging from 0 to 100. | at 3 months after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple sclerosis, Ginseng, Fatigue, Quality of life