linjc16/ctgov huggingface dataset:
Improving Childhood Immunization

Study Overview
=================
Brief Summary
-----------------
Specific Aim: To improve childhood immunization rates by utilizing automated Electronic Health Record-derived provider-specific performance feedback reports, coupled with automated Electronic Health Record-derived trigger alerts. Hypothesis: The automated Electronic Health Record-derived provider-specific performance feedback reports will result in a 50% decrease in unimmunized children ages 0-13 years of age, when coupled with automated Electronic Health Record-derived trigger alerts, compared with trigger alerts alone.

Official Title
-----------------
Improving Childhood Immunization Compliance Using Electronic Health Records

Conditions
-----------------
Improve Childhood Immunization Rates

Intervention / Treatment
-----------------
* Other: Provider bulletins
* Other: Trigger alerts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all pediatric resident providers in Harriet Lane Clinic at Johns Hopkins University Exclusion Criteria: none

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Trigger alerts only | Other: Trigger alerts<br> <br> |
| Experimental: Intervention Group<br>Trigger alerts + provider bulletins | Other: Provider bulletins<br> <br> Other: Trigger alerts<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Receipt of missing immunization |  | Time to event analyses, with events measured across 7 quarters (21 months) |
Iron Status of Women and Young Children in the United States

Study Overview
=================
Brief Summary
-----------------
This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women.

Detailed Description
-----------------
Background: Total body iron stores (TBI), which are calculated from serum ferritin (SF) and soluble transferrin receptor (sTfR) concentrations, can be used to assess the iron status of populations in the United States. Objective: This analysis describes the distribution of TBI and the prevalence of iron deficiency (ID) and iron deficiency anemia (IDA) among toddlers, non-pregnant women, and pregnant women. Design: Investigators analyzed data from NHANES; toddlers aged 12-23 mo (NHANES 2003-2010), non-pregnant women aged 15-49 y (NHANES 2007-2010), and pregnant women aged 12-49 y (NHANES 1999-2010). Investigators used SAS survey procedures to plot distributions of TBI and produce prevalence estimates of ID and IDA for each target population. All analyses were weighted to account for the complex survey design

Official Title
-----------------
Iron Status of Toddlers, Non-pregnant, and Pregnant Women in the United States

Conditions
-----------------
Iron-deficiency, Nutritional Deficiency

Participation Criteria
=================
Eligibility Criteria
-----------------
Included: Children ages 12-23 months and Women ages 12-49 years Those who completed the MEC Excluded: - Those missing data on iron biomarkers
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 |
| --- | --- | --- |
| Iron Deficiency | Total Body Iron <0 mg/kg | 1999-2010 |
The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure

Study Overview
=================
Brief Summary
-----------------
The value of HbA1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for HbA1c are applied to all patients with diabetes regardless of their renal function. We would like to evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup of patients with diabetes and evaluate the effect of dialysis on HbA1c

Official Title
-----------------
The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure

Conditions
-----------------
Diabetes, Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients >18 years of age with type 1 or 2 diabetes who show competence in home glucose monitoring and are willing to commit to doing the testing Exclusion Criteria: Pregnancy Having received a blood transfusion with in the preceding three months Known to have any hereditary or hemolytic anemia On a medication known to interfere with HbA1c assay (opiates, acetaminophen, vitamin C, vitamin E) - we will allow patients to be on asprin as almost all patients with diabetes are on this drug. Having a blood hemoglobin <7 mg/dl Bilirubin level >20mg/dL or a triglyceride level > 250mg/dL Alcohol addiction

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Normal renal function<br> | |
| Stage 2 and 4 and 5 chronic kidney disease<br> | |
| End stage renal disease on hemodialysis<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation | The quantitative correlation between mean blood glucose and HbA1c in patients with diabetes and renal failure | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HbA1c, glycated hemoglobin, correlation, diabetes, renal failure
African-American Diabetes Intervention Project

Study Overview
=================
Brief Summary
-----------------
A controlled trial to assess the potential benefit of a home based worker in improving control in African-American children with insulin dependent diabetes.

Conditions
-----------------
Insulin-Dependent Diabetes Mellitus

Intervention / Treatment
-----------------
* Behavioral: home based worker


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Insulin dependent diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 17 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: home based worker|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
To determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in Chinese outpatient subjects

Detailed Description
-----------------
About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent has been obtained. The exclusion criteria include secondary hemifacial spasm, other involuntary facial movement disorder, history of surgery of microvascular decompression of the facial nerve and so on. The outcome measures include the percentage of the treatment methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom, concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.

Conditions
-----------------
Hemifacial Spasm

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.Clinically diagnosed primary hemifacial spasm Tonic and clonic contractions of muscles innervated by the unilateral facial nerve. No other neurological disorder. 2.Male or female 18 to 80 years old 3.Informed consent has been obtained Exclusion Criteria: Secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on. Other involuntary facial movement disorder: facial synkinesia after facial palsy, tics, myokymia and focal motor seizures. History of surgery of microvascular decompression of the facial nerve. Participation in another clinical study currently. Not able to understand and answer questionnaire. Investigator's opinion that the subject has a concurrent condition(s) that may confound the study results.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of the treatment methods of HFS in outpatient subjects |  | November, 2012 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of onset age of hemifacial spasm patients |  | November, 2012 | 
| Analysis of aggrevated and relieved factors of HFS symptom |  | November, 2012 | 
| Analysis of concomitant symptoms of hemifacial spasm |  | November, 2012 | 
| Adverse events of botulinum toxin treatment in hemifacial spasm |  | November, 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemifacial spasm, observational study, clinical manifestation, treatment, Chinese
Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates

Study Overview
=================
Brief Summary
-----------------
Acute respiratory distress syndrome (ARDS) in neonates has been defined in 2017. The death rate is over 50%.There are no special treatments for acute respiratory distress syndrome.

Detailed Description
-----------------
Acute respiratory distress syndrome (ARDS) is one of the serious complications in critically ill neonates. It can result in severe hypoxemia refractory to mechanical ventilation. There are few options for mechanical ventilation for such situations such as high frequency oscillation ventilation and extracorporeal membrane oxygenation. The aim of the present study is to determine whether transfusion of red blood cells can decrease the mortality in neonate with ARDS.

Official Title
-----------------
Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates: A Randomized Controlled Trial

Conditions
-----------------
Red Blood Cells(RBC), Acute Respiratory Distress Syndrome (ARDS)

Intervention / Treatment
-----------------
* Other: conventional treatment with RBC transfusion
* Other: conventional treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosed with neonatal ARDS. informed parental consent has been obtained Exclusion Criteria: major congenital malformations or complex congenital heart disease transferred out of the neonatal intensive care unit without treatment

Ages Eligible for Study
-----------------
Minimum Age: 30 Minutes
Maximum Age: 1 Month

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: RBC transfusion with conventional treatment<br>Besides conventional treatment,neonates diagnosed with ARDS is treated with RBC transfusion. | Other: conventional treatment with RBC transfusion<br>* Besides conventional treatment, neonates is given RBC transfusion.<br>|
| Active Comparator: conventional treatment<br>neonates diagnosed with ARDS is treated with conventional treatment. | Other: conventional treatment<br>* neonates is treated with conventional treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death rate | neonate died due to respiratory failure | within 100 days |
Harmonic Scalpel Vs. Electrocautery in Breast Reduction Surgery

Study Overview
=================
Brief Summary
-----------------
Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery. The three metrics are: the time taken to complete the operation drainage volume in the days immediately following surgery, patient pain in the days immediately following surgery.

Official Title
-----------------
A Randomized Clinical Trial Comparing the Harmonic Scalpel to Electrocautery in Breast Reduction Surgery

Conditions
-----------------
Hyperplasia

Intervention / Treatment
-----------------
* Device: Harmonic Scalpel
* Device: Electrocautery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are eligible for enrollment if they agree to provide informed consent, can read and speak English, are at least 18 years of age, and are in generally good health. Exclusion Criteria: under 18 years of age

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

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

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 |
| --- | --- |
| Experimental: Harmonic Reduced Breast<br>harmonic scalpel used to reduce breast on that side | Device: Harmonic Scalpel<br>* harmonic scalpel used to reduce breast on this side<br>|
| Active Comparator: Electrocautery Reduced Breast<br>Electrocautery (current practice = control) used to reduce breast on that side | Device: Electrocautery<br>* Electrocautery used to reduce breast on this side<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for Operation | Time to complete the breast reduction per breast. | day of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Drainage in Surgical Drains | An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour. | within one week of surgery | 
| Pain Level in Surgical Sites | An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable. | first week after surgery | 
| Hematoma | A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery. | first day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Electrocoagulation, Mammaplasty, Breast
Telomere Parameters in Patients With Nonalcoholic Fatty Liver

Study Overview
=================
Brief Summary
-----------------
Telomerase, through its regulatory function on telomere length may play an important role in immune function, cellular replicative life span, and carcinogenesis. Non-alcoholic fatty liver disease (NAFLD) is considered a benign condition, but in some cases, it may progress to cirrhosis and hepatocellular carcinoma. The risk factors for that evolution are not fully understood. Our group showed in a previous study, that hTERT mRNA expression is lower in peripheral lymphocytes of patients with fatty liver, compared to healthy controls. This finding could explain the telomere shortening found previously in these patients by our group [20] and others [21]. Furthermore, we found higher rates of TC in these patients, probably due to an attempt to counteract the shortening of the telomeres and to stabilize them. This is through a different mechanism that is not telomerase-mediated. Telomere capture is considered an alternative way to maintain telomere length and chromosomal stability [3]. It is a more common mechanism for chromosome stabilization and repair, in contrast to the telomerase-mediated process of chromosome healing and elongation This study aimed to evaluate mechanisms of telomere homeostasis like telomere shortening, telomerase activity, telomere capture and aneuploidy in patients with NAFLD in order to explain previous findings of telomere shortening in these patients.

Official Title
-----------------
Telomere Parameters Like Telomere Length, Telomerase Expression, Telomere Capture and Aneuploidy in Patients With Nonalcoholic Fatty Liver

Conditions
-----------------
FATTY LIVER, NO MALIGNANCY, NO DECOMPENSATED ILLNESS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age over 18 diagnosis of fatty liver Exclusion Criteria: no malignancy no eligible to sign the consent paper

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
Study The Effects Of Different Doses Of UK-369,003 In Men With Overactive Bladder

Study Overview
=================
Brief Summary
-----------------
This is a 12 week study in which different doses of UK-369,003 will be administered to patients with a diagnosis of overactive bladder. Patients will complete a series of questionnaires before treatment, during treatment and after treatment, to assess whether UK-369,003 has improved their symptoms of overactive bladder and erectile function.

Official Title
-----------------
A Multi-Center, Randomised, Parallel Group, Double-Blind, Placebo Controlled Estimation Study To Assess The Efficacy And Safety Of Modified Release UK-369,003 In The Treatment Of Men With Storage Lower Urinary Tract Symptoms (LUTS) With And Without Erectile Dysfunction (ED).

Conditions
-----------------
Urinary Bladder, Overactive

Intervention / Treatment
-----------------
* Drug: UK-369,003
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male subjects aged 18 years and above documented clinical diagnosis of overactive bladder with urinary frequency >= 8 times / 24 hours and number of urgency episodes > 1 episode / 24 hours. Exclusion Criteria: Neurological diseases known to affect bladder function. Urinary tract infection.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Drug: UK-369,003<br>* UK-369,003 100mg, 50mg, 25mg and 10mg doses in addition to placebo.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| This is an estimation study with no primary endpoint. There are efficacy endpoints. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported treatment impact questionnaire. |  | 12 Weeks | 
| Lower urinary tract symptoms diary. |  | 12 Weeks | 
| International prostate symptom score questionnaire. |  | 12 Weeks | 
| OAB-q short form questionnaire. |  | 12 Weeks | 
| Patient perception of bladder control questionnaire. |  | 12 Weeks | 
| International index of erectile function questionnaire. |  | 12 Weeks | 
| International consultation on incontinence questionnaire. |  | 12 Weeks | 
| Quality of erection questionnaire. |  | 12 Weeks |
Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling

Study Overview
=================
Brief Summary
-----------------
All existing medical literatue regarding axial length (AL) changes after scleral buckling surgery for retinal detachment, descibes changes after solid silicone buckling. In this hospital, the investigators use only silicone sponge buckling, which has different properties and a different buckle profile. there are no studies in the literature describing tha AL changes after sponge buckling, or whether the AL change is less or more than with solid silicone buckles. The investigators wish to determine whether the AL change profile with their silicone sponge is significantly different, and if so, whether this is clinically important in determining the better choice of buckle material to be preferred.

Official Title
-----------------
Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling.

Conditions
-----------------
Rhegmatogenous Retinal Detachment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 6 months after succesful retinal detachment surgery with silicone sponge scleral buckling currently attached with IOL Master pre-surgery Axial Length measurement Exclusion Criteria: patients with failed surgery and currently detached patients with vitreos silicone oil tamponade patients with radial or other non-circumference buckles patients with unclear media not amenable to IOL Master exam

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length in eye as measured by Zeiss IOL Master. |  | Single non-invasive measurement at 1 time point. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retinal detachment, scleral buckle, silicone sponge, axial length, surgery included silicone sponge scleral buckling, retina currently attached, at least 6 months after surgery