linjc16/ctgov huggingface dataset:
Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm)

Study Overview
=================
Brief Summary
-----------------
Insulin therapy requires monitoring and frequent review of glucose levels to optimize dosing. Effective presentation and data analysis are essential. We examined HbA1c changes using the OneTouch(R) UltraSmart(R) System (Test Group), an integrated glucose meter and electronic logbook, compared to established meters with paper logbooks (Control Group).

Official Title
-----------------
Self-Monitoring of Blood Glucose Study#1: The Ability of People With Diabetes to Use OneTouch(R) Ultrasmart(tm) to Improve Glycemic Control Through Behavioral and Therapeutic Changes

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: OneTouch(r) UltraSmart(r)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects with type 1 or type 2 insulin-treated diabetes mellitus with a baseline HbA1c greater than or equal to 8.0%. The lower age limit for pediatric subjects was at the discretion of the pediatric investigators and their Institutional Review Board (IRBs). The upper age limit for pediatric subjects was 20 years (i.e., not having reached their 21st birthday on date of enrollment). Subjects must have monitored blood glucose at least 2 times per day. - Subject's current blood glucose meter has download capability, however, the subject did not routinely use this capability on his/her own. Exclusion Criteria:
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: OneTouch(r) UltraSmart(r)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1c (HbA1c) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measured hypoglycemia |  |  |
A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls

Study Overview
=================
Brief Summary
-----------------
This study is designed to develop and test a gender-specific, web-based drug abuse prevention program. Study participants will be adolescent girls aged 13 and 14 years who will complete all measures online. Randomly assigned girls will also interact online with a skills-based program and subsequent annual booster sessions. The study's primary hypothesis is that rates of 30-day alcohol and drug use will be lower among girls assigned to receive the intervention.

Official Title
-----------------
A Web-Based Intervention to Prevent Drug Abuse Among Adolescent Girls

Conditions
-----------------
Drug Abuse Prevention

Intervention / Treatment
-----------------
* Behavioral: RealTeen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: resident of USA speaks English have private computer with Internet Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 14 Years

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

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 |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Intervention<br>RealTeen | Behavioral: RealTeen<br>* A web-based, gender-specific program intended improve girls' cognitive and behavioral skills. Each of the 9 sessions requires approximately 20 minutes. After initial intervention, girls will receive two annual booster sessions (i.e., a 20-minute review of previously learned material indexed to new age).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day alcohol and drug use | Measures will ask girls to report, for the past 30 days, the number of: drinks of alcohol consumed, cigarettes smoked, puffs of marijuana, and times they consumed four or more drinks within 2 hours. Girls will also report past 30-day use of: inhalants, ecstasy, club drugs, prescription drugs for recreational use, heroin, and hallucinogens. | Up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gender-specific, web-based, drug abuse, prevention
Oral Tolerance in Cow's Milk Allergy in the Infant

Study Overview
=================
Brief Summary
-----------------
This study aims to determine if there is a link between cow's milk allergy in infants and regulatory T cells dysfunction that should be transient in infant acquiring oral tolerance after 12 month avoiding food and persistent in others. Cow's milk allergy is evaluated by basophils activation test, T cells activation test, specific humoral response (IgA, IgE, IgG) in allergic infants before and after 12 month avoiding food, before and after low dose milk exposure, before and after oral challenge. Number and function of regulatory T cells and microflora composition are measured at the same time. Allergic infants are compared to age matched control group.

Official Title
-----------------
Oral Tolerance in Cow's Milk Allergy in the Infant: Role of CD4+CD25+ T Cells and Intestinal Microflora

Conditions
-----------------
Cow's Milk Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female, age before 6 month, cow's milk allergy with positive prick or patch test for cow's milk Control group: male or female, age before 6 month or within 12 and 18 month, eating cow's milk every day Exclusion Criteria: immunodeficiency syndrome, lactose intolerance Control group: other food allergy, atopic dermatitis.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 15 Months

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cow's milk allergy,, food allergy, oral tolerance,, infant,, regulatory T cells,, intestinal microflora
Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto

Study Overview
=================
Brief Summary
-----------------
Treatment of patients with beta thalassemia in North America has altered dramatically during the past 40 years, with improvements in transfusion therapy and introduction of iron chelation therapy. Thalassemia patients now enjoy an increased life expectancy to the fifth and sixth decades of life, with fertility and childbearing becoming important issues. Data regarding this important topic remain limited, without clear data regarding iron control including serial assessment of hepatic iron concentration, the need for assistance in becoming pregnant, and use of iron chelating agents during pregnancy. As the life expectancy increases and overall health improves in thalassemia, clear data on fertility, pregnancy complications, and the effect of pregnancy on maternal health in thalassemia patients are necessary since these will have a direct impact on patient care, quality of life, and patient expectations.

Official Title
-----------------
Factors Promoting Increased Rate and Success of Pregnancy in the Thalassemia Population in Toronto

Conditions
-----------------
Thalassemia, Fertility, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thalassemia, thalassemia intermedia or E-thalassemia patients in Toronto Subject has attempted conception Exclusion Criteria: Subject has any other form of blood disease Subject has not attempted conception

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
Effect of Helicobacter Pylori Treatment on Idiopathic Central Serous Chorioretinopathy (ICSCR)

Study Overview
=================
Brief Summary
-----------------
Etiology of ICSCR is not known however recent studies regard the role of immunologic and infectious processes in the pathogenesis of ICSCR.one of these hypothesis is the role of helicobacter pylori in the pathogenesis of ICSCR so perhaps treatment of h pylori have positive effect on the remission of ICSCR.

Detailed Description
-----------------
we will choose 50 cases of patients with ICSCR who are infected with h.pylori.25 cases will receive anti h.pylori regiment and 25 cases as controls will receive no medication.then we will compare the time of submacular fluid resorption and macular thickness and visual acuity among these two groups.

Official Title
-----------------
Effect of Helicobacter Pylori Treatment on Remission of Idiopathic Central Serous Chorioretinopathy (ICSCR)

Conditions
-----------------
Central Serous Chorioretinopathy

Intervention / Treatment
-----------------
* Drug: omeprazole, Amoxicillin, metronidazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the persons who are infected with helicobacter pylori and have ICSCR Exclusion Criteria: history of previous eye surgery ,to have indication of laser therapy,corticosteroid therapy,pregnancy,

Ages Eligible for Study
-----------------
Minimum Age: 28 Years
Maximum Age: 40 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oral Amoxicillin Capsule Metronidazole Tablet Omeprazole Capsule | Drug: omeprazole, Amoxicillin, metronidazole<br>* we will evaluate the effect of medication(anti h.pylori) on the remission of ICSCR<br>* Other names: treatment of Central serous chorioretinopathy;|
| No Intervention: 2<br>No medical treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subretinal fluid level |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time of sub macular fluid absorption |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CSR, Helicobacter pylori
The Preemptive Analgesic Efficacy of Nefopam

Study Overview
=================
Brief Summary
-----------------
Nefopam is administered as a preemptive analgesic drug to the patient undergoing breast cancer surgery. It will be evaluated whether postoperative acute and chronic pain can be reduced.

Conditions
-----------------
Breast Neoplasm

Intervention / Treatment
-----------------
* Drug: Nefopam
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with breast cancer Lumpectomy with axillary lymph node dissection or Lumpectomy with sentinel lymph node biopsy American Society of Anesthesiologists physical status I or II Exclusion Criteria: Refusal Seizure Cardiac disease Monoamine oxidase inhibitor user Urologic disease Glucoma Preoperative analgesic drug medication Pregnancy Recurred breast cancer patient

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nefopam<br>20 mg nefopam in 100 ml normal saline is infused before starting operation. | Drug: Nefopam<br> <br> |
| Placebo Comparator: Control<br>100 ml normal saline is infused before starting operation. | Drug: Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of pain numerical rating score from postoperative 30 min until postoperative 3 month |  | Postoperative 30 min, postoperative 1 day, postoperative 1 week, postoperative 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dose of ketorolac administered to the patient. |  | postoperative 1 day |
A Study of Overall Survival in Participants With Metastatic Colorectal Cancer (mCRC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the overall survival (OS) for US participants diagnosed with metastatic colorectal cancer (mCRC) by using Flatiron Health's individual patient level data.

Official Title
-----------------
Overall Survival for Metastatic Colorectal Cancer Patients Matched to CHECKMATE-142

Conditions
-----------------
Metastatic Colorectal Cancer (mCRC)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic Colorectal Cancer (CRC) participants in the Flatiron database as defined by: Diagnosed with CRC (ICD-9 153.x or 154.x or ICD-10 C18x, or C19x, or C20x, or C21x) Pathology consistent with CRC At least two documented clinical visits on or after January 1, 2013 Evidence of Stage IV or recurrent metastatic CRC diagnosed on or after January 1, 2013 Participants with high levels of microsatellite instability (MSI-H) and/or mismatch repair (MMR) protein deficiency (dMMR) Participants who received 2L therapy of interest on or after the initial mCRC diagnosis date Participants who had at least 1 month medical data during the prior to and post periods; however, participants who died within 1 month after the index date will not be excluded from the study Exclusion Criteria: Participants <18 years of age at index date Participants who received clinical trial drug during the prior or post periods

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 |
| --- | --- |
| Cohort 1<br>Participants diagnosed with metastatic colorectal cancer (mCRC) selected from the Flatiron Electronic Health Record database | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | Up to 6 years | 
| Duration of Systemic Treatment | Durations were reported for the first line of therapy prior to the second line (2L) therapy of interest, the 2L therapy of interest, the third line of therapy, and the at least fourth line of therapy. | Up to 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mCRC, Checkmate-142, Nivolumab
Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to collect peripheral blood and bone marrow aspirate samples from thalassemia patients in Tehran, in a collaborative effort to develop an erythroid lineage specific chimerism assay applicable to patients with thalassemia. Development of such an assay would be useful both for identification of the exact mutation causing the disease, as well as for providing a direct method to measure and monitor the kinetics of donor erythropoiesis in this patient population following transplant.

Detailed Description
-----------------
In the first phase of the study we will develop a panel of reagents designed to identify predominant thalassemia mutations in the Iranian population, as well as alternative highly variable erythroid specific polymorphisms. To determine how informative this panel is, these reagents will be applied to samples collected from patients homozygous for the disorder, and compared to patients with thalassemia trait and normal Iranian donors. In the second phase, we propose to serially measure and compare erythroid lineage chimerism with overall genomic chimerism following transplant. Samples will be collected from participants before and at 1, 2, 3, 6 and 12 months following transplant and cryopreserved. Peripheral blood from the stem cell donor will also be collected and cryopreserved. Participants will undergo myeloablative or nonmyeloablative transplant.

Official Title
-----------------
Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major

Conditions
-----------------
Thalassemia Major

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thalassemia patients being treated at Shariati Hospital in Tehran.

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?
-----------------
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
-----------------
chimerism, allogenic hematopoietic transplantation, assay
Effect Mobility During Induction of Labor on Time to Delivery. A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
this is a andomized controlled trial the evaluates the effect of enhanced mobility, controlled via electronic pedometers, during induction of labor by extra amniotic balloon on time to delivery.

Official Title
-----------------
The Effect of Enhanced Mobility, Controlled Via Electronic Pedometers, During Induction of Labor by Extra Amniotic Balloon on Time to Delivery. A Randomized Controlled Trial

Conditions
-----------------
Labor Onset and Length Abnormalities

Intervention / Treatment
-----------------
* Other: feedback


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women low risk pregnancies singlelton vertex position undergoing labor induction with extra amniotic catheter no contraindication for enhanced mobility Exclusion Criteria: medical recommendation for limited mobility status post cesarean delivery twin pregnancy premature rupture of membranes severe preeclampsia maternal comorbidity

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br> | |
| Experimental: feedback<br> | Other: feedback<br>* feedback by electronic pedometers regarding patient mobility while undergoing labor induction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to delivery | time from extra amniotic catheter placement till delivery | labor ( catheter placement till delivery completion) |
Impact of Positive End Maximum Voluntary Ventilation and Dyspnea Index in Patients After Valvular Heart Surgery

Study Overview
=================
Brief Summary
-----------------
Pulmonary mechanics are further disturbed after cardiothoracic surgery that manifests like restrictive pathology, which may persist for weeks to months postoperatively. This experimental aimed to investigate the efficacy of a positive end-expiratory pressure device on maximum expiratory pressure, maximum voluntary ventilation, and dyspnea index in patients who underwent valve surgery.

Detailed Description
-----------------
Thirty male and female adolescent patients who underwent valve surgery aged 12-18 years old, recruited from the national heart institute enrolled in this experimental. They were assigned into two matched groups: Experimental group consisted of 15 patients, received positive end-expiratory pressure (PEEP) with a mouthpiece in addition to routine chest physiotherapy (postural drainage, percussion, vibration, and deep breathing exercises). Control group consisted of 15 patients, received routine chest physiotherapy alone. The program continued for four weeks.

Official Title
-----------------
Comparison Between the Manual Respiratory Exercises and Respiratory Pressure Meter

Conditions
-----------------
Respiration Disorders

Intervention / Treatment
-----------------
* Other: respiratory exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients underwent valve surgery (repair or replacement) for mitral valve stenosis; hemodynamically stable, ages ranged from 12 to 18 years old- BMI ranges from 18.5 to 24.9 reduced MEP, MVV and complaining from shortness of breath with exertion. Exclusion Criteria: Patients with previous cardiac surgery congenital heart disease neurological disorders type1 diabetes mellitus smoker pacemaker implantation atrial fibrillation utilization of mechanical ventilation longer than 24 hours.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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 |
| --- | --- |
| Active Comparator: manual respirtory exercises<br>Using manual traditional respiratory exercises. | Other: respiratory exercises<br>* Manual respiratory exercises versus respiratory exercises with pressure meter<br>|
| Active Comparator: Respiratory exercises with respiratory pressure meter<br>Using pressure respiratory meter in exercises. | Other: respiratory exercises<br>* Manual respiratory exercises versus respiratory exercises with pressure meter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory muscle strength | By respiratory pressure meter | 3 month |