linjc16/ctgov huggingface dataset:
A Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting Intraocular Lenses (IOLs)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively evaluate postoperative visual and refractive parameters in a series of subjects bilaterally implanted with the AcrySof® IQ ReSTOR® +3 versus those bilaterally implanted with the Tecnis Multifocal 1-piece.

Official Title
-----------------
A Randomized, Subject-masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-correcting IOLs

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: ReSTOR +3
* Device: Tecnis MF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with bilateral cataracts candidate for presbyopic lens Exclusion Criteria: >1 Diopter (D) preoperative astigmatism by Keratometry (K)readings pre-existing conditions that could skew the results

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReSTOR +3<br>Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction | Device: ReSTOR +3<br>* Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction<br>|
| Active Comparator: Tecnis MF<br>Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction | Device: Tecnis MF<br>* Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Defocus Curve | A defocus curve is created by multiple measurements of one's visual acuity at different spherical powers (recorded as Diopters (D)). Visual Acuity (VA) is measured in logMAR. LogMAR is the logarithm of the minimum angle of resolution. | 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
presbyopia, intraocular lens
Extension Study to Assess Safety and Efficacy of Pimecrolimus in Adult Patients With Atopic Dermatitis

Study Overview
=================
Brief Summary
-----------------
Pimecrolimus, which is an ascomycin derivative, is an anti-inflammatory non-steroidal agent. In this study, the long-term safety and efficacy of pimecrolimus cream will be evaluated in Japanese adult patients with atopic dermatitis. This study is a 6-month extension study following core study. THIS STUDY IS NOT ENROLLING PATIENTS IN THE UNITED STATES

Official Title
-----------------
A Clinical Study Continued From the Confirmatory Study to Assess the Efficacy and Safety of ASM981 Cream in Adult Atopic Dermatitis Patients

Conditions
-----------------
Atopic Dermatitis

Intervention / Treatment
-----------------
* Drug: Pimecrolimus Cream 1%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had completed the core study and whose participation in this study was considered appropriate as judged by the investigator Patients who had given written informed consent to participation in this study Exclusion Criteria: Patients who failed in treatment compliance in the core study Patients who had a major violation of the protocol in the core study

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Pimecrolimus Cream 1%<br>* Pimecrolimus cream 1 %<br>* Other names: Elidel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by adverse events (AEs) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of disease flares during 26 weeks of treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atopic dermatitis, ASM981, pimecrolimus
High Intensity Light Therapy in Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether bright light improves the sleep, mood, and behavior of persons with Alzheimer's disease and related dementias (AD) who live in long-term care settings and, if so, to determine the best timing for the light therapy. The light levels being used in the study have been shown to improve depression in persons with seasonal affective disorder (SAD) and to relieve sleep problems in persons with jet lag and other body rhythm disturbances. Because persons with AD often will not remain still in front of a fluorescent panel, this project has involved renovations in the study units that provide for even, regulated, high-intensity light in all public areas of the study settings.

Detailed Description
-----------------
See Brief Summary

Official Title
-----------------
High Intensity Light Therapy in Alzheimer's Disease

Conditions
-----------------
Dementia, Alzheimer's Disease

Intervention / Treatment
-----------------
* Device: high-intensity light therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of dementia Residence on study units Exclusion criteria: Bipolar disorder Severe retinal (eye) disease

Ages Eligible for Study
-----------------
Minimum 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: high-intensity light therapy|nan|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, light therapy, long-term care, depression, sleep, agitation
Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome

Study Overview
=================
Brief Summary
-----------------
Chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome.

Detailed Description
-----------------
A retrospective, multi-center, chart review study to collect patient data from medical charts of patients who have been treated with Korlym® for the treatment of ACTH independent adrenal Cushing's Syndrome. Treatment with Korlym® will be a minimum 3 months in duration with follow-up of a minimum 3 months. Only sites that have been identified to have patients appropriate for this protocol will be invited to participate.

Official Title
-----------------
Retrospective Chart Review Study of Korlym for the Treatment of ACTH Independent Cushing's Syndrome

Conditions
-----------------
Cushing's Syndrome

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with ACTH independent endogenous Cushing's Syndrome Available adrenal imaging prior to being treated with Korlym® Treated with Korlym® and followed for at least 3 months (follow-up data should be available) Exclusion Criteria: Diagnosed with adrenocortical carcinoma Participant in any clinical trial(s) during the observational period

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|No treatment (intervention) was administered.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drug Utilization Patterns as assessed by chart review | The retrospective review would analyze the drug utilization patterns of patients treated with Korlym | up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes as assessed by chart review | The retrospective review would analyze outcomes measures (vitals, clinical assessments, etc) in patients treated with Korlym | up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cushing's Syndrome, Mifepristone, Adrenal, Retrospective, Chart Review
Knowledge About Covid-19 Infection in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
Covid 19 is a pandemic infection developed in late 2019

Detailed Description
-----------------
It developed in China Then spread worl wide

Official Title
-----------------
Knowledge About Covid-19 Infection in Pregnant Women

Conditions
-----------------
Viral Infection

Intervention / Treatment
-----------------
* Other: labs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women Exclusion Criteria: non pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 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 |
| --- | --- |
| pregnant women with abnormal labs<br>Mothers who have abnormal labs during pregnancy with abnormal coagulation profile | Other: labs<br>* A group of questions to women regarding Corona with laboratory finding suggestive of covid 19 and coagulopathy<br>* Other names: Questions and counseling;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of pregnant women who have knowledge about covid-19 | The proper knowledge about covid-19 | one month |
Research on Suicidal Ideation of University Students in Harbin City and Cognitive Behavior Therapy

Study Overview
=================
Brief Summary
-----------------
The purposes of this research are: to understand the status of suicidal ideation, suicidal behavior, and depression in Harbin University students; and to analyse the infect factors of suicidal ideation and suicidal behavior. With cognitive behavior interventions on students with suicidal ideation, suicidal behavior, and middle or high degree of depression, the researchers can provide a scientific and effective intervention to the students. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Department of Psychiatry, University of Pennsylvania, Philadelphia 19104, USA. gregbrow@mail.med.upenn.edu JAMA. 2005 Aug 3;294(5):563-70.

Detailed Description
-----------------
By using suicidal ideation scale, to assess the status of suicidal ideation and suicidal attempt in 6000 university students in Harbin city. About 300 students with suicidal ideation and depression disorder randomized into two groups (control and intervention groups) accept the cognitive behavior intervention. We will assess the depression after intervention.

Official Title
-----------------
the Research on Suicidal Ideation of University Students in Harbin City and Intervention on Them

Conditions
-----------------
Suicide

Intervention / Treatment
-----------------
* Behavioral: cognitive behavior therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suicidal ideation or the scores of Beck Depression Inventory ≧14 Exclusion Criteria: have no Suicidal ideation and the scores of Beck Depression Inventory <14

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 35 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,2<br> | Behavioral: cognitive behavior therapy<br>* cognitive behavior therapy once a week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| suicidal ideation; depression |  | half a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suicidal ideation, cognitive behavior therapy
Survey to Identify Substance Use in Teenagers and Adolescents

Study Overview
=================
Brief Summary
-----------------
This is a prospective survey study of patients 12-21 years undergoing anesthetic care. The primary objective is to determine the incidence of illicit substance use and abuse prior to anesthetic care. The secondary objective is to determine the illicit substances used and their frequency in patients presenting for anesthetic care.

Detailed Description
-----------------
The participants will be asked to complete a survey in REDCap using an iPad during the visit. The study will record any positive answers from the drug and tobacco use questions routinely asked of the parents during the on-line pre-admission testing process. These include yes/no answers regarding drug, alcohol, and tobacco use. The information collected will include only demographic data including age, weight, gender, ethnicity/race, and zip code. Survey data will be coded and will not include patient information. Completion of the survey will take approximately 15-20 minutes.

Official Title
-----------------
Expanded Preoperative Survey During Perioperative Care to Identify Substance Use in Teenagers and Adolescents

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 12-21 years of age Presenting for surgery or procedure requiring anesthesia Exclusion Criteria: Patients who are not able to complete the computerized survey due to physical or intellectual impairment Patients who are non-English speaking

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescents<br>Patients 12-21 years undergoing anesthetic care | Other: Survey<br>* Survey assessing incidence, frequency, and type of illicit substance use<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence | When subject last used illicit substance | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency | How often subject uses illicit substances | Baseline | 
| Substance | Type of illicit substances used | Baseline |
Axitinib Therapy Management Study

Study Overview
=================
Brief Summary
-----------------
The objectives of the study is to describe axitinib therapy management through use of the data to be generated by ConcertAI

Detailed Description
-----------------
not mandatory

Official Title
-----------------
Retrospective Analysis of Axitinib Treatment Optimization and Management of Selected Immune Related Adverse Events of Checkpoints Inhibitors

Conditions
-----------------
Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Inlyta
* Drug: Bavencio
* Drug: Keytruda


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of aRCC (Stage III, Stage IV (M0) or Stage IV (M1)) at any point Age 18 years or older at the time of aRCC diagnosis Received a qualifying IO-containing combination (nivolumab and ipilimumab, axitinib and pembrolizumab, or axitinib and avelumab) in the first regimen after aRCC diagnosis or axitinib monotherapy in any line Exclusion Criteria: none

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

| Intervention/Treatment |
| --- |
|Drug: Inlyta|axitinib|
|Drug: Bavencio|avelumab|
|Drug: Keytruda|Pembrolizumab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe type of immune related adverse events and adverse events related to axitinib | describe type of immune related adverse events and adverse events related to axitinib | during treatment period | 
| To describe the percentage of patients with documentation of dose modifications | describe dose modifications | during treatment period | 
| To describe the percentage of patients with usage of concomitant high-dose corticosteroid | descriptive assessment | during treatment period | 
| To describe the percentage of patients alive at pre-specified time points (6 months, 12 months, 18 months, 24 months) from start of the index therapy | calculation of overall survival time | during study period | 
| To estimate the best overall response (partial response, complete response, progressive disease, or stable disease | description of overall response | during treatment period | 
| To estimate time to treatment discontinuation | calculation of duration of treatment | during treatment period | 
| To estimate PFS | calculation of progression free survival | during treatment period |
Inflammatory Responses in Solitary and Multiple Erythema Migrans

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate differences in host immune responses (levels of cytokines and chemokines, representative of innate, Th1, and Th17 immune responses) in acute sera from adult patients with solitary or multiple erythema migrans.

Official Title
-----------------
Inflammatory Responses in Borrelia Afzelii Culture Positive Patients With Early Disseminated or Early Localized Lyme Borreliosis

Conditions
-----------------
Erythema Migrans

Intervention / Treatment
-----------------
* Other: antibiotic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: erythema migrans in patients > 18 years Borrelia afzelii isolated from skin Exclusion Criteria: pregnancy or immunocompromising conditions taking antibiotic with antiborrelial activity within 10 days

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 |
| --- | --- |
| erythema migrans<br>patients with erythema migrans | Other: antibiotic treatment<br>* Patients were treated with: ceftriaxone intravenously 2 g OD for 14 days or doxycycline orally 100 mg bid for 10 to 14 days or cefuroxime axetil orally 500 mg bid for 14 days or amoxicillin orally 500 mg tid for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| inflammatory proteins in erythema migrans patients | The inflammatory immune profiles will be assessed using Luminex to measure the expression of cytokines and chemokines representative of innate and adaptive TH1, TH2, TH17, and B cell responses in serum of patients at enrollment (during active infection). | at enrollment |
Effect of Changing Diet on Fasting and Post Fat Load Lipoproteins

Study Overview
=================
Brief Summary
-----------------
The study examines the effect of two diets on fasting and post fat load lipoproteins of subjects with type 2 diabetes with moderate hypertriglyceridemia.

Official Title
-----------------
Effect of Changing the Diet to Low Fat/High Carbohydrate or High Monounsaturated Fat/Low Carbohydrate on Fasting and Post Fat Load Lipoproteins of Diabetics With Moderate Hypertriglyceridemia

Conditions
-----------------
Hypertriglyceridemia, Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Low Fat/High Carbohydrate
* Other: High Monounsaturated Fat/Low Carbohydrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female, 18 - 75 years of age Type 2 diabetes Fasting triglycerides 300 -800mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Low Fat/High Carbohydrate | Other: Low Fat/High Carbohydrate<br>* Low Fat/High Carbohydrate for 6 week period<br>* Other names: Diet;|
| Active Comparator: 2<br>High Monounsaturated Fat/Low Carbohydrate | Other: High Monounsaturated Fat/Low Carbohydrate<br>* High Monounsaturated Fat/Low Carbohydrate for 6 week period<br>* Other names: Diet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paired t-test or Wilcoxon signed rank test will be used to evaluate the change in fasting triglycerides with the diets. |  | At the beginning and end of each of the two diet regimens | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-prandial lipids will be evaluated by t-test or Wilcoxon signed rank test for AUC of triglyceride and remnant lipoprotein measured by immunoseparation. |  | At the beginning and end of each of the two diet regimens |