linjc16/ctgov huggingface dataset:
Study of the Effects of Artificial Tears on the Response to the Latanoprost Punctal Plug Delivery System in Subjects With Ocular Hypertension or Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of artificial tears preserved with Benzalkonium Chloride (AT-BAK) on the IOP response to the L-PPDS and to evaluate the safety of the L-PPDS in subjects with OH or OAG following treatment.

Official Title
-----------------
An Open-Label, Randomized, Phase 2 Study of the Effects of Artificial Tears Preserved With Benzalkonium Chloride (AT-BAK) on the Response to the Latanoprost Punctal Plug Delivery System (L PPDS) in Subjects With Ocular Hypertension (OH) or Open-Angle Glaucoma (OAG)

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Latanoprost punctal plug
* Drug: artificial tears preserved with Benzalkonium Chloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 18 years with ocular hypertension or open-angle glaucoma Subjects who have a best-corrected visual acuity of 20/100 or better Exclusion Criteria: Subjects who wear contact lenses Uncontrolled medical conditions Subjects with a known sensitivity to latanoprost, BAK, or any other products required for the study Subjects requiring chronic topical artificial tears, lubricants, and/or requiring any other chronic topical medications.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Latanoprost punctal plug and use of artificial tears containing Benzalkonium Chloride | Drug: Latanoprost punctal plug<br>* Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.<br>Drug: artificial tears preserved with Benzalkonium Chloride<br> <br> |
| Experimental: 2<br>Latanoprost punctal plug only | Drug: Latanoprost punctal plug<br>* Control of IOP compared to baseline for the experimental dose of Latanoprost punctal plug for 6 weeks or until loss of efficacy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOP change from baseline |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, ocular hypertension
Study to Investigate the Safety and Efficacy of Alesion® in Japanese Paediatric Patients With Urticaria

Study Overview
=================
Brief Summary
-----------------
Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with urticaria

Official Title
-----------------
Post Marketing Surveillance of Alesion® (Epinastine Hydrochloride) Dry Syrup -Special Drug Use-Results Survey of Alesion® Dry Syrup-

Conditions
-----------------
Urticaria

Intervention / Treatment
-----------------
* Drug: Alesion®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients who: haven't treatment experience of epinastine product entered the survey; have urticaria Exclusion Criteria: Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient is hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| paediatric patients with urticaria<br> | Drug: Alesion®<br>* Dry Syrup<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions | classified by Medical Dictionary for Regulatory Activities (MedDRA) | up to 2 years | 
| Incidence of adverse drug reactions classified by patient's background/treatment factors |  | up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall assessment of efficacy by investigator on a 3-point scale |  | after 1 week |
Clinical Utility of SUDOSCAN in the Pediatric Population

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical device for the the determination of sweat gland function in the pediatric population. Primary Objective: To measure sweat gland function in a pediatric population Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland function in the pediatric population

Official Title
-----------------
Clinical Utility of SUDOSCAN in the Pediatric Population

Conditions
-----------------
Childhood Obesity, Prediabetes, Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ages 8 to 17 years Able to give assent as well as parental consent Exclusion Criteria: History of type 1 or type 2 diabetes Chronic autoimmune condition Taking chronic immunosuppressive or anti-inflammatory medications Unable to apply palms of the hands and soles of the feet on the sensor plates during a 3 minute Sudoscan test Presence of hepatitis B or C Presence of HIV Presence of known neurological disorder Pregnancy and/or breastfeeding Any open wound on the soles of the feet or palms of the hands Participation in an ongoing clinical investigational drug trial Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 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 |
| --- | --- | --- |
| Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores | Sweat gland function will be assessed within each age group Correlation with parameters associated with pre-diabetes and diabetes | Baseline |
Proof of Concept Study of Cognitive Improvement in Patients With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with mild or moderate Alzheimer's disease, to assess the safety and tolerability of ZAD3480 and to define the optimal dose(s) to be used in future trials.

Official Title
-----------------
A Multi-centre, Double-blind, Double-dummy, Placebo Controlled Parallel Group Randomized Phase IIb Proof of Concept Study With 3 Oral Dose Groups of AZD3480 or Donepezil During 12 Weeks Treatment in Patients With Alzheimer's Disease

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: AZD3480
* Drug: Donepezil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of informed consent from patient and caregiver Clinical prognosis of probable Alzheimer's disease Patient must have a caregiver visiting the patient at least three times weekly Exclusion Criteria: Significant neurologic disease or dementia other than Alzheimer's disease Major depressive disorder, other major psychiatric disorder Use of acetylcholinesterase inhibitor or memantine for treatment of Alzheimer's disease within 8 weeks prior to enrollment Impaired vision and/or hearing making cognitive testing difficult

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 85 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>Placebo | |
| Active Comparator: 2<br>donepezil | Drug: Donepezil<br> <br> * Other names: Aricept;|
| Experimental: 3<br>AZD3480 | Drug: AZD3480<br>* 3 oral doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADAS-Cog |  | assessed after 12 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADCS-CGIC, Computerized neurological test battery (CDR) and MMSE |  | assessed after 12 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Alzheimer Type, Alzheimer Disease
Common Genetic Variation and Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Type 2 diabetes is a common metabolic disorder arising from a complex interaction between genetic predisposition and the environment. The development of this disorder is preceded by impaired glucose tolerance and elevated fasting glucose which also carry adverse cardiovascular risk. To date a few common genetic variants have been reliably associated with predisposition to type 2 diabetes. However, it is uncertain how these genes interact to alter insulin secretion and insulin action prior to the development of type 2 diabetes. We propose to utilize an established population-based cohort to determine how common genetic variants associated with type 2 diabetes alter the response to an oral glucose challenge in people without overt type 2 diabetes. This will enable us to understand how common variants alone or in combination alter whole-body glucose physiology and predispose to type 2 diabetes.

Official Title
-----------------
The Effect of Diabetes-associated Gene Variation on Glucose Metabolism in Humans

Conditions
-----------------
Pre-diabetes

Intervention / Treatment
-----------------
* Other: Oral glucose tolerance test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fasting blood glucose < 126mg/dL Exclusion Criteria: Fasting blood glucose > 126mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 80 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 |
| --- | --- |
| A<br>Subjects without type 2 diabetes living in Olmsted County, MN | Other: Oral glucose tolerance test<br>* one time 75g oral glucose tolerance test for measurement of insulin secretion and action<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disposition Index | Measured by 7-sample, 2Hr OGTT | 2 hr |
The Effect of Wearing the 'Nike Free'Shoe on Isokinetic Muscle Strength of Foot and Ankle and on Proprioception.

Study Overview
=================
Brief Summary
-----------------
To evaluate the effect of wearing the 'Nike Free'Shoe on isokinetic muscle strength of foot and ankle and on proprioception the following protocol will be used. The test population consists out of students of the physical education department. They will at random be divided in three groups. One group will wear the shoe only for daily activities, the second group will wear the shoes for the warming up part of the sport classes and the control group will not wear the shoe at all. There will be two moments for evaluation: one at the beginning of the study and one after four months, during which the shoe will be used. The isokinetic strength will be measured with an isokinetic device (Biodex) and the proprioception will be evaluated with a force platform (Neurocom Balance Master).

Official Title
-----------------
The Effect of Wearing the 'Nike Free'Shoe on Isokinetic Muscle Strength of Foot and Ankle and on Proprioception.

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

Intervention / Treatment
-----------------
* Device: Wearing the Nike Free shoe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: being a physical education student of the second or third year having read and signed the informed consent being new to the Nike Free Shoe Exclusion Criteria: neurological or systemic diseases overuse injuries or orthopaedic surgery to the lower limbs during the previous six months familiar to or used to wear the Nike Free Shoe

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Wearing the Nike Free shoe|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic strength of foot and ankle muscles and on proprioception |  | 4 months after starting the data registration |
Does Testosterone Improve Function in Hypogonadal Older Men

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial of testosterone replacement therapy in hypogonadal men age > 60 years. The goal is to assess the safety and efficacy of TRT in men age > 60 years.

Official Title
-----------------
Does Testosterone Improve Function in Hypogonadal Older Men

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 60-80 yrs serum total testosterone < 300 ng/dL serum bioavailable testosterone < 70 ng/dL Exclusion Criteria: unable to provide informed consent history of prostate or breast cancer untreated sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 Years

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

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: Testosterone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical function |  |  | 
| Cognitive function |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypogonadism, testosterone, aging, Total testosterone < 300 ng/dL, Bioavailable testosterone < 70 ng/dL
Brain and Genetic Predictors of Individual Differences in Pain and Analgesia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to gain a better understanding of pain processing in the brain. Our understanding of how pain is processed in the brain is limited. We are testing for individual differences in pain perception and emotion.

Official Title
-----------------
Brain and Genetic Predictors of Individual Differences in Pain and Analgesia

Conditions
-----------------
Pain, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be registered in the Colorado Community Twin Sample (CTS). Exclusion Criteria: Not being registered in the Colorado Community Twin Sample (CTS). Any MRI contraindications.

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain rating scores made on a Visual Analog Scale (VAS) | Self reported pain using the VAS ranging from 0-100 (with 0 representing no pain at all and 100 representing most intense pain imaginable (in the context of the experiment)). | Measured during pain tasks at a single 4 hour experimental session (within one month of screening completion). |
Physical Condition and Self-efficacy in People With Fall Risk

Study Overview
=================
Brief Summary
-----------------
Middle-aged or older people with fall risk were assessed and invited to a multidisciplinary falls prevention program. This program consisted on an adapted exercise program. Two sessions per week were performed, during 6 weeks supervised by a physiotherapist. At the end of this program, measures of physical condition and of self-efficacy were repeated to determine its related-effect.

Official Title
-----------------
Physical Condition and Self-efficacy in People With Fall Risk - a Preliminary Study

Conditions
-----------------
Fall Risk

Intervention / Treatment
-----------------
* Other: Exercise program for fall prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fall Risk (Morse scale) Exclusion Criteria: Had no capacity to walk independently

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Protocol<br>Set of exercises for balance, endurance, muscle strength and flexibility | Other: Exercise program for fall prevention<br>* Set of exercises to improve the following parameters: balance, endurance, muscle strength, flexibility.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy moving indoors | Question 1- Self-efficacy moving indoors; (scoring: 0-not confident - 2-very confident) | 6-weeks | 
| Self-efficacy moving outside | Question 2 - Self-efficacy moving outside (scoring: 0-not confident - 2-very confident) | 6-weeks | 
| Self-efficacy walking uneven surfaces | Question 3- Self-efficacy walking through uneven surfaces (scoring: 0-not confident - 2-very confident) | 6-weeks | 
| Self-efficacy in physical activities | Question 4 - Self-efficacy participating in physical activities (scoring: 0-not confident - 2-very confident) | 6-weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
physical condition, self-efficacy, fall risk, exercise program
Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor

Study Overview
=================
Brief Summary
-----------------
Ritodrine is the conventional and the only approved tocolytics in Korea(by KFDA), although it was withdrawn from the US market more than 10 years ago. As already known well, ritodrine has many side effects such as tachycardia, hyperglycemia, pulmonary edema and so on. When such complications of ritodrine appears, clinicians consider of using MgSO4 as substitute, but its use is off-the-label yet in Korea. Facing this discrepancy, the investigators want to compare the efficacy and safety of MgSO4 with ritodrine and prove that MgSO4 is not inferior to ritodrine as tocolytics. For the singleton and twin pregnancies between 24+0weeks and 34 completed weeks whose uterine contraction is more than 4 during 20 minutes period with their cervical ripening is more than 25%, the investigators randomise them in Ritodrine group or MgSO4 group. Then, the investigators will check the change of their interval of uterine contraction, degree of pain and the appearance of any side effects or treatment failure sign.

Official Title
-----------------
Efficacy and Safety of MgSO4 as Tocolytics Compared to Ritodrine in Preterm Labor

Conditions
-----------------
Preterm Labor

Intervention / Treatment
-----------------
* Drug: MgSO4
* Drug: YTP(Ritodrine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age of 24+0 to 34+6weeks singleton and twin pregnancies preterm labor with more than 4 times of uterine contraction for 20 minutes or more than 8 times for 1 hour on external tocography cervical dilatation of 0 to 3cm and cervical ripening more than 25%, or cervical length in sonography below 2cm Exclusion Criteria: triplet etc preterm premature rupture of membrane cervical dilatation more than 3cm history of cerclage operation during this pregnancy placenta previa severe hypertensive diseases in pregnancy history of administration of any tocolytics 12 hours before enrollment fever more than 38.0'c

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

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

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: YTP(ritodrine) arm<br>who randomly assigned to have Yutopar(ritodrine) as tocolytics | Drug: YTP(Ritodrine)<br> <br> |
| Experimental: MgSO4 arm<br>who were randomised to have MgSO4 as tocolytics | Drug: MgSO4<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of MgSO4 as tocolytics : increased interval of uterine contraction, decreased maternal painful sensation, stopping the cervical change |  | 48 hours later |