linjc16/ctgov huggingface dataset:
Inpatient Blood Glucose Control in Taichung Veterans General Hospital

Study Overview
=================
Brief Summary
-----------------
This study will be conducted in the ward of Taichung Veterans General Hospital. The patient with hyperglycemia in hospitalization will be enrolled by glucose management team.

Detailed Description
-----------------
This study will be conducted in the ward of Taichung Veterans General Hospital. The type 2 diabetic patient with hyperglycemia in hospitalization are candidates. The glucose will be controlled using the insulin protocal based on the glucose monitor systems. We will assess the effects of insulin protocal and glucose monitor system on the inpatient with hyperglycemia.

Official Title
-----------------
The Effects of Glucose Control and Monitor on Inflammation in the Hospitalized Patients With Hyperglycemia

Conditions
-----------------
HYPERGLYCEMIA

Intervention / Treatment
-----------------
* Device: CONTINUE GLUCOSE MONITOR
* Procedure: Insulin protocal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic inpatient Fasting glucose >140 mg/dl or random glucose >180 mg/dl Exclusion Criteria: incooperative for glucose monitor refusal of insulin pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin protocal with CGM<br>Insulin protocal with continue glucose monitor | Device: CONTINUE GLUCOSE MONITOR<br>* Continue glucose monitor<br>Procedure: Insulin protocal<br>* Using insulin protocal based on glucose monitor<br>|
| Active Comparator: Insulin protocal<br>Insulin protocal with convential glucose monitor | Procedure: Insulin protocal<br>* Using insulin protocal based on glucose monitor<br>|
| No Intervention: Convential treatment<br>Convential insulin treatment and glucose monitor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose target | The ratio of glucose less than 180 mg/dl | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting glucose target | the ratio of fasting glucose less than 140 mg/dl | 6 days | 
| Hypoglycemia | symptoms or less than 70 | times | 
| Vascular Cell Adhesion Molecule 1 (VCAM-1) | Inflammation | 6 days | 
| Brain-Derived Neurotrophic Factor (BDNF) | Psychological assessment | 6 days | 
| Orexin-A | Psychological assessment | 6 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, inpatient, glucose control, continue glucose monitor
High Resolution 3D Diffusion-weighted Breast MRI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how well a new MRI technique called High resolution 3D diffusion-weighted breast MRI detects breast cancer.

Detailed Description
-----------------
The objective of this study is to assess the diagnostic accuracy of a new non-contrast MRI method for breast cancer detection. The study design is a single arm observational study. The new technique will be added on to the standard sequences that a women undergoes during a breast MRI. The resulting images will be compared with her standard breast MRI images, and with results of subsequent pathology.

Official Title
-----------------
High Resolution 3D Diffusion-weighted Breast MRI

Conditions
-----------------
Breast Cancer, Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Device: Magnetic Resonance Image Scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Patient scheduled for contrast-enhanced breast MRI to image possible breast cancer. 2. Female 3. Age >18 Exclusion Criteria:1. Lactation 2. Pregnancy 3. Patient undergoing chemotherapy. These patients are excluded because chemotherapy changes the biology of breast cancers. Since the ultimate objective of the research is to develop a new imaging method for breast MRI screening (detection of previously unknown tumors), results in treated tumors would not be relevant. Including treated tumors could yield a misleading assessment of the performance of the new method since treated tumors have different imaging characteristics than de novo tumors. 4. Patient scheduled for pre-operative chemotherapy. These patients are excluded if they are going to be treated only on the basis of fine needle aspiration. The project seeks to correlate all tumors detected with standard histopathology of their untreated neoplasm. This exclusion criteria will be very unusual because most patients planning neoadjuvant chemotherapy do so on the basis of a pre-chemo core needle biopsy, which provide adequate histopathologic proof necessary for enrollment.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Magnetic Resonance Image Scanner|Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the new MRI method |  | 8 weeks | 
| Lesion detection rate of the new MRI method |  | 4 weeks |
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells. This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.

Official Title
-----------------
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes

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

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with documented rheumatoid arthritis by ACR criteria Disease duration < 5 years May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination Tender joint count >= 6, swollen joint count >= 6, and one must be a knee Corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks Patients must consent to 2 arthroscopic synovial biopsy procedures Exclusion Criteria: History of severe allergic or anaphylactic reactions to monoclonal antibodies Previous treatment with Rituximab Previous treatment with Arava Injected with steroids within 4 weeks of day 1 of study Treatment with any investigational agent within 4 weeks of day of study Any severe or significant medical condition or disease or known active infection Pregnancy or nursing at present

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab<br> | Drug: Rituximab<br>* Rituximab 1000 mg Intravenously day 1 and day 15<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis |  | Biopsies of inflamed joint at beginning and at week 8 of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells |  | Collected at beginning of study and week 8 |
Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for organ transplant patients, studies have shown that the standard inactivated influenza vaccine has poor immunogenicity in this population. The investigators plan to test the humoral response to vaccination and look at HLA upregulation

Detailed Description
-----------------
OBJECTIVE AND HYPOTHESIS To test the specific humoral response of the influenza vaccine after islet cell transplantation To test the production of HLA alloantibodies after vaccination.

Official Title
-----------------
Humoral Immune Response To Influenza Vaccine In Islet Cell In Transplant Recipients

Conditions
-----------------
Transplant

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult islet cell transplant recipients Able to provide informed consent Exclusion Criteria: Egg allergy Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome) Febrile illness in the past two weeks Unable to provide informed consent

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| islet cell transplant recipients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Seroprotection rate | defined as a post-vaccination titer of ≥1:40 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| •Seroconversion rate | defined as a 4-fold increase in titer from pre- to post-vaccination. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
flu shot, islet cell transplant recipients
A Comparison of Epivir Plus Crixivan Combined With Zerit or Retrovir in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

Study Overview
=================
Brief Summary
-----------------
To evaluate the tolerance, and comparative virologic and immunologic effects of the two combination regimens.

Detailed Description
-----------------
100 patients will be randomized to receive Zerit (Stavudine) + Epivir (Lamivudine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir). Patients will be treated for 48 weeks.

Official Title
-----------------
An Open Label, Randomized, Comparative Study of Zerit (d4T) + Epivir (3TC) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700 Cells/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Indinavir sulfate
* Drug: Lamivudine
* Drug: Stavudine
* Drug: Zidovudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV infection. CD4 cell count of 200 - 700 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: AIDS defining condition within 1 month of study entry. Prior Medication: Excluded: Patients with any history of antiretroviral therapy treatment.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Indinavir sulfate|nan|
|Drug: Lamivudine|nan|
|Drug: Stavudine|nan|
|Drug: Zidovudine|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
-----------------
Anti-HIV Agents, Drug Therapy, Combination, Zidovudine, Stavudine, HIV Protease Inhibitors, CD4 Lymphocyte Count, Lamivudine, Indinavir, Reverse Transcriptase Inhibitors, Viral Load
The Accuracy of Smartphone Pulse Oximetry in Patients Visiting an Outpatient Pulmonary Function Lab for a 6-Minute Walk Test

Study Overview
=================
Brief Summary
-----------------
The primary aim of this research is to determine the accuracy of smartphone pulse oximeters in detecting blood oxygen saturations, episodes of desaturations, and heart rate by comparing results to a Masimo© hospital-grade pulse oximeter.

Official Title
-----------------
The Accuracy of Smartphone Pulse Oximetry in Patients Visiting an Outpatient Pulmonary Function Lab for a 6-Minute Walk Test

Conditions
-----------------
Oximetry

Intervention / Treatment
-----------------
* Device: iPhone with Kenek Edge and Samsung S8


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory 18 years and older Visiting the pulmonary function laboratory at Rush University Medical Center for a 6-minute walk test that agree to participate. Exclusion Criteria: Under the age of 18 years High blood pressure above 180/90 mm Hg or pressure below 70/50 mm Hg Dizzy, lightheaded or have severe headaches at time of enrollment SpO2 at or below 85% on supplemental oxygen On oxygen greater than 4 liters per minute Gait issues that may result in a fall or patient walks with a walker and did not bring the device to this visit

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: iPhone with Kenek Edge and Samsung S8|Smartphones with pulse oximetry and heart rate monitoring capabilities|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of smartphone pulse oximeters |  | through study completion, an average of 1 year |
Stretching vs Foam-rolling

Study Overview
=================
Brief Summary
-----------------
The study aims to compare the acute effects of the aplication of foam-rolling and stretching over the hamstrings flexibility. The secondary objective is to determine which time can permit the obtention of better results.

Official Title
-----------------
Comparison of Acute Effects of Stretching and Foam-rolling

Conditions
-----------------
Muscle Relaxation

Intervention / Treatment
-----------------
* Other: Foam-Roller
* Other: Neuromuscular stretching
* Other: Pasive stretching


Participation Criteria
=================
Eligibility Criteria
-----------------
Exclusion Criteria: Pregnant women Musculoskeletal disorder in the last 3 months Surgical interventions in lower limbs in the last 6 months Psychological or nervous alterations Uncomprehension of the indications.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Foam-Roller<br> | Other: Foam-Roller<br>* Application of foam roller in the posterior part of thigh.<br>|
| Experimental: Neuromuscular Stretching<br> | Other: Neuromuscular stretching<br>* Use of a neuromuscular stretching applied to the hamstring muscles<br>|
| Experimental: Pasive stretching<br> | Other: Pasive stretching<br>* Use of a pasive stretching applied to the hamstring muscles<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamstring flexibility change | Measurement of the hamstring muscles flexibility change by the use of the Sit-and-Reach test | 0 seconds, 30 seconds and 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Triceps surae flexibility change | Measurement of the triceps surae flexibility change by the use of the Lunge test | 0 seconds, 30 seconds and 2 minutes | 
| Fatigue perception | Measurement of the fatigue sensation by the use of the Modified Borg Scale | 0 seconds, 30 seconds and 2 minutes |
Study to Investigate the Safety and Efficacy of K-321 in Patients With Fuchs Endothelial Corneal Dystrophy (FECD) Following Descemetorhexis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to investigate the effect of K-321 in patients with Fuchs endothelial corneal dystrophy (FECD) after descemetorhexis.

Official Title
-----------------
A Double-Masked, Randomised, Placebo-Controlled, Parallel-Group, 12 Week, Phase 2 Study to Investigate the Safety and Efficacy of K-321 Eye Drops After Descemetorhexis in Patients With Fuchs Endothelial Corneal Dystrophy

Conditions
-----------------
Fuchs' Endothelial Corneal Dystrophy

Intervention / Treatment
-----------------
* Drug: K-321 Solution
* Drug: Placebo Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 18 years old at the screening visit (Visit 1). Has a diagnosis of FECD at Visit 1. Meet all other inclusion criteria outlined in clinical study protocol. Exclusion Criteria: Has a study eye with a history of cataract surgery within 90 days of Visit 1. Has a study eye with a history of any previous ocular surgery other than for cataract. Meet any other exclusion criteria outlined in clinical study protocol.

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-321 QID<br>K-321 Ophthalmic Solution Dose A | Drug: K-321 Solution<br>* K-321 solution drops<br>|
| Experimental: K-321 BID<br>K-321 Ophthalmic Solution Dose B | Drug: K-321 Solution<br>* K-321 solution drops<br>Drug: Placebo Solution<br>* Placebo solution drops for K-321<br>|
| Placebo Comparator: Placebo<br>Vehicle Solution Dose | Drug: Placebo Solution<br>* Placebo solution drops for K-321<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal Central ECD Measure at 12 weeks | Change in Central Endothelial Cell Density | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Number of participants with at least one adverse event | 52 Weeks |
Infertility Markers in Serum, Urine, and Follicular Fluid

Study Overview
=================
Brief Summary
-----------------
This study is only collecting specimens from current patients of PENN Fertility Care. The purpose of this investigation is to assess if markers of oxidative stress that are known to be associated with other medical conditions can be detected in women undergoing infertility treatment and normal women of similar age. Oxidative stress may affect a woman's eggs or the follicular cells that surround and nurture them. Other markers of to be investigated include markers of cellular aging and DNA structural changes. Presence of these markers will be compared in blood and urine samples taken during infertility treatment, and follicular fluid at the time of IVF (if applicable).

Official Title
-----------------
Markers in Women Undergoing Infertility Treatment

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women aged 18-50 Infertility patients only: Women undergoing infertility treatment (with or without in-vitro fertilization) at the University of Pennsylvania's PENN Fertility Care Verified infertility diagnosis of any of the following: Endometriosis (minimal or mild) Endometriosis (moderate or severe) Tubal factor Hypogonadotrophic hypogonadism Polycystic ovary syndrome Diminished ovarian reserve Male factor Unexplained Healthy normal volunteers only: Not undergoing infertility treatment Not using hormonal contraception Exclusion Criteria: Currently pregnant or breastfeeding Post-menopausal Concurrent participation in investigational trial Other health problems which, in the opinion of the investigator, may affect participation

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, Oxidative stress