linjc16/ctgov huggingface dataset:
Testing the Use of Prompts to Increase Adolescent Immunization Rates

Study Overview
=================
Brief Summary
-----------------
Although most US adolescents visit their primary care doctor, their immunization rates are low. Primary care practices from two networks, one in upstate New York as well as a national network of pediatric clinics were surveyed to ask what they thought was the best strategy to increase immunization rates. Point-of-care prompts (either by an electronic health record message or by a nurse) when an adolescent patient comes in for any type of visit and is due for a vaccine was chosen. This study will determine if these prompts will increase immunization rates after a 12-month intervention period.

Official Title
-----------------
Adolescent Vaccination in the Medical Home

Conditions
-----------------
Vaccine Preventable Diseases, Meningococcal Disease, Human Papillomavirus, Pertussis, Influenza

Intervention / Treatment
-----------------
* Other: Point-of-Care Prompt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents aged 11 - 18 who had a visit to their primary care provider during the 12 month intervention period Exclusion Criteria: Adolescent is pregnant during intervention time period

Ages Eligible for Study
-----------------
Minimum Age: 11 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Point-of-Care Prompt<br>A prompt, either electronically or by a nurse, will notify a provider if an adolescent is due for a vaccination. This prompt will appear at any type of visit where the patient is seen by a health provider. | Other: Point-of-Care Prompt<br> <br> |
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adolescent Immunization Rates | Bivariate analysis will measure the overall change between the control and intervention groups. Vaccination rates will be summarized using descriptive statistics. As appropriate, two sample t-test or chi-square tests will be used to summarize patient level data. Odds ratio with associated 95% confidence interval will be reported within each of the 2 networks. | One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missed Opportunities | A hierarchical logistic regression model will evaluate the intervention effect on rates of missed opportunities. | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent Immunization Rates, Provider prompts
Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder

Study Overview
=================
Brief Summary
-----------------
Phase II Trial of concurrent administration of intravesical BCG & Interferon in the treatment and prevention of recurrence of superficial transitional carcinoma of the urinary bladder.

Official Title
-----------------
Phase II Trial of Concurrent Administration of Intravesical BCG & Interferon in the Treatment and Prevention of Recurrence of Superficial Transitional Carcinoma of the Urinary Bladder

Conditions
-----------------
Transitional Carcinoma of Urinary Bladder

Intervention / Treatment
-----------------
* Drug: BCG, Interferon


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with superficial transitional carcinoma of the urinary bladder
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

| Intervention/Treatment |
| --- |
|Drug: BCG, Interferon|Chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | overall |
Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with Type 2 diabetes mellitus.

Official Title
-----------------
A Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Glimepiride Alone or in Combination With Metformin

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Comparator: Sitagliptin
* Drug: Comparator: Placebo
* Drug: Comparator: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 Diabetes Mellitus with inadequate glycemic control Exclusion Criteria: Patients with Type 1 Diabetes Mellitus

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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sitagliptin<br>Sitagliptin 10 mg tablet daily for 54 weeks | Drug: Comparator: Sitagliptin<br>* sitagliptin 10 mg tablet, once daily for 54 weeks<br>|
| Placebo Comparator: Placebo/ Pioglitazone<br>Placebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks | Drug: Comparator: Placebo<br>* Placebo oral tablet once daily for 24 weeks<br>Drug: Comparator: Pioglitazone<br>* Pioglitazone 30 mg tablet once daily for 30 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in A1C at Week 24 | Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent. | Baseline and 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in FPG at Week 24 | The change from baseline is the Week 24 Fasting Plasma Glucose (FPG) minus the Week 0 FPG. | Baseline and 24 Weeks |
Improved Language Acquisition With Levodopa

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the non-daily administration of levodopa is effective in boosting semantic language acquisition in healthy subjects.

Detailed Description
-----------------
Our prior work using a between-subject design shows that daily administration of d-amphetamine or the dopamine precursor levodopa over the course of five days markedly improves word learning success in healthy subjects. In this randomized, placebo-controlled, double-blind clinical trial, we probe whether the effect can be replicated using a within-subject design, with administration of levodopa and placebo on alternate days for a total period of 10 days. The expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions. Because of the heterogeneity of stroke patients, only a within-subject design can be used to probe the effects of pharmacological adjuncts to language therapy.

Official Title
-----------------
Improved Language Acquisition With Levodopa

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

Intervention / Treatment
-----------------
* Drug: levodopa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects 20-35 years old Right handedness Exclusion Criteria: Neurological/psychiatric/metabolic/cardiac disorders Asthma Known allergic reactions to one of the experimental drugs Other drugs affecting the central nervous system Leisure drug ingestion during the past 4 weeks (urine test) Smoking cessation during the past 2 weeks > 6 cups of coffee or energy drinks per day > 10 cigarettes per day > 50 grams of alcohol per day

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: levodopa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boost in language learning success through levodopa compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stability of language learning success after one month |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
language acquisition, plasticity, stroke recovery, associative learning
Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude

Study Overview
=================
Brief Summary
-----------------
The now widely used reference interval for pulse oxygen saturation of the neonate after 24 hours of birth has been developed relying on data from low altitude.It is not suitable for neonates at high altitude. At present, no reference interval has been established at high altitude, and the existing studies have many limitations. So this study was designed.

Detailed Description
-----------------
Knowledge of the reference interval of pulse oxygen saturation (SpO2) in neonates is crucial for accurate identification of neonatal hypoxemia. The now widely used standard was derived from low altitude data, which is not suitable neonates at high altitude. At present, many scholars have paid attention to this problem. But, previous studies still have some limitations. For example, they often only focus on a specific altitude. However, with the increase of altitude, the pulse oxygen saturation decreases in a curve, so their study results are only suitable for this specific altitude and can not be widely used.

Official Title
-----------------
A Prospective Study on Establishing the Reference Interval for Pulse Oxygen Saturation in Neonates at High Altitude

Conditions
-----------------
High Altitude

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy singleton term infants with no clinical signs and symptoms (e.g., cyanosis, respiratory distress, heart murmur, etc.). Exclusion Criteria: 1. Low birth weight (< 2500 g). 2. Need for oxygen. 3.1 or 5 minute Apgar score < 7. 4. Referred to the neonatal intensive care unit or neonatology department for various reasons. 5. Neonates discharged within 24 hours of birth. 6. Neonates diagnosed with congenital diseases in utero. 7. Refusal of consent.

Ages Eligible for Study
-----------------
Minimum Age: 24 Hours
Maximum Age: 28 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-ductal SpO2<br> | Other: no intervention<br>* It's only observational study. No interventions.<br>|
| Post-ductal SpO2<br> | Other: no intervention<br>* It's only observational study. No interventions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse oxygen saturation of healthy neonates at high altitude. | Pulse oxygen saturation of the right hand and any foot of healthy neonates born at high altitude will be measured 24 hours after birth. According to the normality of the results, the distribution range will be described by mean ± standard deviation or range interquartile. Altitude level: ≥ 2000m. | 24 hours after birth |
Efficacy and Safety of S (+) - Ibuprofen in the Treatment of Mechanical Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of S (+) - ibuprofen compared to an active treatment for pain control in individuals with at least moderate acute mechanical low back pain.

Official Title
-----------------
National, Multicentre, Randomized, Double-blind, Double-dummy Phase II Clinical Trial to Evaluate the Efficacy and Safety of S (+) - Ibuprofen for Pain Control in Individuals With At Least Moderate Mechanical Acute Low Back Pain

Conditions
-----------------
Low Back Pain, Mechanical, Low Back Pain, Acute Low Back Pain

Intervention / Treatment
-----------------
* Drug: S (+) - Ibuprofen
* Drug: Ibuflex®


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms; Patient with acute low back pain who responds to the pain period less than or equal to 3 days; Main Exclusion Criteria: Known hypersensitivity to the formula components used during the clinical trial; Previous history of alcohol or drugs abuse diagnosed by DSM-V; Current or previous history (less than 12 months) of smoking; Have clinically relevant abnormal laboratory results according to medical evaluation; Women who are pregnant, lactating, or positive for β - hCG urine test.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: S (+) - Ibuprofen<br> | Drug: S (+) - Ibuprofen<br>* S (+) - Ibuprofen + placebo of Ibuflex®<br>|
| Active Comparator: Ibuflex® - ibuprofen<br> | Drug: Ibuflex®<br>* Ibuflex® + placebo of S (+) - Ibuprofen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At least 50% of maximum pain relief score in Maximum Total Pain Relief (TOTPARmax) | TOTPAR was calculated using data from a 5-point categorical pain relief scale (none = 0, slight = 1, moderate = 2, good = 3, or complete pain relief = 4) | Change from Baseline to 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events rates between groups |  | During treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain control, Low back pain, Pain relief, Ibuprofen, Inflammation, Anti-inflammatory
Sleep Schedule Intervention Study Among Night Shift Workers

Study Overview
=================
Brief Summary
-----------------
This study will recruit 60 night shift workers with shift work disorder. They will be invited to wear actigraphy for 3 weeks. In the first week the participants will sleep at the time they used to, and their chronotype will be determined by actigraphy and Munich Chronotype Questionnaire. In the second week the participants will be randomly assigned to morning sleep or evening sleep time, and will change to the other in the third week. We will compare sleepiness, sleep quality, daytime vigilance score changes using mixed method ANOVA. We will also examine the interaction effect of chronotype and sleep schedule on sleep-related outcome.

Official Title
-----------------
Sleep Schedule Intervention Study Among Night Shift Workers

Conditions
-----------------
Shift Work Schedule

Intervention / Treatment
-----------------
* Behavioral: Morning sleep schedule
* Behavioral: Evening sleep schedule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Shift work disorder Exclusion Criteria: Neuromuscular disorder Taking hypnotics 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Morning-evening sleep schedule<br> | Behavioral: Morning sleep schedule<br>* sleep right after night shifts<br>Behavioral: Evening sleep schedule<br>* sleep before night shifts<br>|
| Active Comparator: Evening-morning sleep schedule<br> | Behavioral: Morning sleep schedule<br>* sleep right after night shifts<br>Behavioral: Evening sleep schedule<br>* sleep before night shifts<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Pittsburgh sleep quality index (PSQI), range from 0 (better) to 21 (worse) | Change from baseline score at the second and third week. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime sleepiness | Karolinska Sleepiness Scale (KSS), range from 1 (better) to 9 (worse) | Change from baseline score at the start and end of each night shift. | 
| Alertness | Psychomotor vigilance test (PVT), reaction time (longer the worse) and lapses (larger the worse) | Change from baseline score at the start and end of each night shift. |
Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
Diffusion Weighted Imaging (DWI) MRI will assist in differentiating poor prognosis bone oedema more effectively than traditional T2 weighted MRI in patients with early Rheumatoid Arthritis (RA).

Detailed Description
-----------------
Assess DWI MRI in patients with early Rheumatoid Arthritis to determine whether the MRI method will assist in differentiating poor prognosis bone oedema more effectively than traditional T2 weighted MRI. Aim 1: To compare DWI MRI with T2 weighted MRI for the discrimination of different types of bone oedema lesions in patients with early RA. Aim 2: To examine the association between the presence of different types of bone oedema lesions detected on DWI MRI and T2 weighted MRI and the development of subsequent joint bone erosion as detected on i) MRI and ii) standard plain radiographs.

Official Title
-----------------
Examination of the Effectiveness of Diffusion Weighted Magnetic Resonance Imaging for Identifying Poor Prognosis in Patients With Rheumatoid Arthritis

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has Rheumatoid Arthritis as defined by the ACR/Eular criteria Subject is able to understand and comply with study protocol Active disease as defined by DAS28> 3.0 Disease duration less than 12 months If female, subject is either not of childbearing potential, or is of childbearing potential and is practicing an approved method of birth control throughout the study subject is judged to be in good health as determined by the PI based upon results of medical history, laboratory profile and physical examination. Prednisone dose 10mg or less, dose stable for 28 days prior to baseline Exclusion Criteria: Inflammatory arthropathy other than Rheumatoid Arthritis Inactive disease as evidenced by DAS 28 CRP and / or ESR < 2.5 Prednisone dose greater than 10mg within 28 days prior to baseline Intra-articular steroid within 28 days prior to baseline visit IV Methyl-prednisone within 28 days prior to baseline visit Any contra-indication to Magnetic Resonance Imaging Permanent Pacemaker Intracerebral aneurysm clip Claustrophobia to the extent that patient cannot manage MRI investigations Implanted metallic device Cochlear implant

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
MMF Influence on HCV Viral Evolution After Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
Samples from a large clinical trial comparing three immunosuppression regimens, two of which contained MMF, are used to identify the HCV viral quasispecies behaviour after liver transplantation

Official Title
-----------------
The Influence MMF on 5UTR HCV Quasispecies Variation: A Potential Factor in the Natural History of Post-OLT x HCV Infection

Conditions
-----------------
HCV Infection, Liver Transplantation

Participation Criteria
=================
Eligibility Criteria
-----------------
All patients enrolled into - An Open Randomized, Prospective Multicenter Study to Compare the Efficacy and Safety Among Three Immunosuppressant Treatment Regimens in Patients Receiving a Liver Transplant for End-Stage Liver Disease Caused by Chronic Hepatitis C Infection

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