linjc16/ctgov huggingface dataset:
Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.

Official Title
-----------------
A 12-Week, Double-Blind, Randomized, Parallel Group, Placebo Controlled Study of Two Doses of VX-702 in Subjects With Moderate to Severe Rheumatoid Arthritis

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

Intervention / Treatment
-----------------
* Drug: VX-702


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation. Exclusion Criteria: Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: VX-702|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint for the study is the ACR20 response at Week 12. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures. |  |  |
The Serotonergic Transmitter System in Dementia and Affective Disorders

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to examine the serotonergic transmitter system using functional imaging of the brain (positron emission tomography [PET]) to gain knowledge about early pathophysiological changes in Alzheimer's dementia and mood disorders.

Conditions
-----------------
Mood Disorders, Alzheimer Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe Alzheimer's disease Individuals genetically predisposed to affective disorder Healthy gender and age matched controls Exclusion Criteria: Contraindications to magnetic resonance imaging (MRI) Use of psychoactive drugs Past or present affective disorder Other systemic diseases that may affect brain function

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
-----------------
Affective disorder, Alzheimer dementia, healthy controls
Pharmacists Management of Diabetes

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that patients with poorly controlled diabetes would have greater improvement in their blood sugar control when managed by a clinical pharmacist than when managed with usual medical care. Patients with poor control are randomized to pharmacist management or to usual medical care for one year.

Official Title
-----------------
Pharmacist Management of Diabetes Mellitus: A Randomized Controlled Trial.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Pharmacist Management
* Other: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older A1c greater than or equal to 9.0 Exclusion Criteria: Not expected to live for the duration of the study Managed by an endocrinologist Unwillingness to participate and attend pharmacist visits

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pharmacist Management<br>In this arm the Pharmacist managed the Diabetes in collaboration with the primary care physician | Other: Pharmacist Management<br>* Pharmacist Managed the patient's diabetes in collaboration with their primary care physician<br>|
| Active Comparator: Usual Care<br>The patient was managed by the primary care physician | Other: Usual care<br>* Patient was managed by their primary care physician as usual<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hgb A1c change |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HgbA1c change based on ethnicity |  | one year | 
| percent of patients with a 1 point or greater decrease in A1c |  | one year | 
| Percent of patients with a 1 point decrease in A1c by ethnicity |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes Mellitus, Pharmacist
Treatment Use Study With Sunitinib (SU011248) For Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The primary objective of this protocol is to provide access to SU011248 treatment for patients with metastatic RCC who are ineligible for participation in ongoing SU011248 clinical studies and have the potential to derive clinical benefit from treatment with SU011248 based on the judgment of the investigator.

Detailed Description
-----------------
Given that an Expanded Access study does not meet the definition of a controlled clinical investigation, and as such, is not considered an applicable drug clinical trial per NIH, Basic Results for such studies are not required to be reported. Protocol A6181037 has been identified as an Expanded Access trial, and has been registered to ClinicalTrials.gov, however Basic Results will not be posted.

Official Title
-----------------
A SU011248 Expanded Access Protocol For Systemic Therapy Of Patients With Metastatic Renal Cell Carcinoma Who Are Ineligible For Participation In Other SU011248 Protocols But May Derive Benefit From Treatment With SU011248

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

Intervention / Treatment
-----------------
* Drug: Sutent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: renal cell carcinoma that is not amendable to standard therapy with curative intent Exclusion Criteria: current treatment in another therapeutic clinical trial

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sutent|Sutent, 25, 37.5. or 50 mg daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Isosorbide Mononitrate in Induction of Labour

Study Overview
=================
Brief Summary
-----------------
Induction of labor is defined as the process of artificially initiating uterine contractions, prior to their spontaneous onset, with progressive effacement and dilatation of the cervix and ultimately, the delivery of the baby.

Detailed Description
-----------------
There are many indications for induction of labor in the obstetric practice, of which prolonged gestational age stands as the most common cause.

Official Title
-----------------
Isosorbide Mononitrate and Misoprostol in Induction of Labour

Conditions
-----------------
Labor Fast

Intervention / Treatment
-----------------
* Drug: Isosorbide Mononitrate 40 MG
* Drug: Isosorbide Mononitrate 60 MG
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single vertex presentation. 2. Gestational age > 37weeks calculated from last menstrual period or U/S scanning. Exclusion Criteria: Patients with rupture of membranes. Previous uterine scar. Fetal malpresentation. Multiple pregnancies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: women receiving isosorbide mononitrates lower dose<br>women who will receive isosorbide mononitrates lower dose | Drug: Isosorbide Mononitrate 40 MG<br>* giving women isosorbide mononitrate 40 MG<br>|
| Active Comparator: women receiving isosorbide mononitrates higher dose<br>women who will receive isosorbide mononitrates higher dose | Drug: Isosorbide Mononitrate 60 MG<br>* giving women isosorbide mononitrate 60MG<br>|
| Active Comparator: Women receiving misoprostol<br>Women who will receive misoprostol | Drug: Misoprostol<br>* Giving women misoprostol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of women who will be reach active phase within 24 hours | how many women will reach active phase within 24 hours | 24 hours |
INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON GAIT IN INDIVIDUALS WITH BACK PAIN

Study Overview
=================
Brief Summary
-----------------
Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain. It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study. Gait characteristics of participants will be evaluate with treadmill. Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses. Gait speed, cadance, step lengths, time on each foot and step length variabilities will be recorded.

Detailed Description
-----------------
Sacroiliac joint dysfunction (SJD) is a common problem in individuals with lumbar herniation nucleus pulposus (LHNP) plus back pain. It is important to determine the effects of SJD on the gait characteristics in individuals with LHNP.Twelve individuals with LHNP (control group) and six individuals with LHNP plus SJD (study group) will be the participants of the study. Gait characteristics of participants will be evaluate with treadmill. Participants will walk at their self-selected speed for six minutes and data from 2nd minutes to 4th minutes were selected for statistical analyses. Gait speed, cadance, step lengths, time on each foot and step length variabilities will be record

Official Title
-----------------
INVESTIGATING THE EFFECTS SACROILIAC JOINT DYSFUNCTION ON GAIT VARIABILITY IN INDIVIDUALS WİTH LUMBAR HERNIATION NUCLEUS PULPOSUS

Conditions
-----------------
Biomechanical; Lesion

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have current back pain Have Lumbar Disc Herniation diagnosis Have sacroiliac dysfunction Exclusion Criteria: Do not want to participate Have another systemic, neurologic or orthopedic problem

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Study group<br>Individuals with lumbar back pain plus sacroiliac disc herniation | Other: No intervention<br>* No intervention<br>|
| Control Group<br>Individuals with lumbar back pain | Other: No intervention<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Step Length Variability | Covariance of variability for right and left step lenghts. | First minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biomechanical Phenomenon, Gait, Lumbar Disc Degeneration
Seasonal Allergic Rhinitis In Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the investigational drug is effective and safe in children with seasonal allergic rhinitis.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 50mcg and 100mcg for 2 Weeks in Pediatric Subjects Ages 2 to <12 Years With Seasonal Allergic Rhinitis (SAR)

Conditions
-----------------
Rhinitis, Allergic, Perennial

Intervention / Treatment
-----------------
* Drug: GW685698X


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosis of seasonal allergic rhinitis. Adequate exposure to seasonal (Spring/Summer) allergen prevalent to the geographic area. Exclusion criteria: Have significant concomitant medical conditions. Use of corticosteroids, other allergy meds during the study. Have abnormal ECG or laboratory abnormality.

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 12 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GW685698X|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in daily, reflective total nasal symptom scores after 2 weeks of treatment in subjects ages 6 to <12 years. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in AM, pre-dose, instantaneous total nasal symptom scores after 2 weeks of treatment, overall evaluation of response to therapy after 2 weeks of treatment for subjects ages 6 to <12 years. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, Seasonal allergic rhinitis
Is There a Microbiome Associated With Poor Growth in Preterm Infants?

Study Overview
=================
Brief Summary
-----------------
This study evaluates the relationship between growth and stool microbiota in premature infants.

Detailed Description
-----------------
Preterm infants often require increased caloric intake to maintain appropriate growth while in the neonatal intensive care unit (NICU). While some infants will have a clear source of need for greater calories, it is often not obvious why others require increased available calories to maintain appropriate growth. Emerging evidence suggests that patterns of gut microbiota may play a role in infant and childhood growth. We hypothesize that differences in the microbial pattern in preterm infants is related to poor growth and need for increased caloric intake. This may ultimately represent a therapeutic target to improve the growth of preterm infants in the NICU. This study aims to describe the differences in microbiome which may vary with growth pattern.

Official Title
-----------------
Is There a Microbiome Associated With Poor Growth in Preterm Infants?

Conditions
-----------------
Growth Disorders, Growth Failure, Prematurity

Intervention / Treatment
-----------------
* Other: Caloric Requirement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All infants less than 28 weeks gestation who are admitted to the Parkland Hospital NICU. Exclusion Criteria: Infants >27 weeks gestation. Infants with major congenital anomalies which may alter growth patterns.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Growth<br>Require less than or equal to 110 kcal/kg/day to maintain growth curve | |
| Slow Growth<br>Require more than 110 kcal/kg/day to maintain growth curve | Other: Caloric Requirement<br>* Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quantitative rT-PCR of stool microbiome | alpha diversity of bacterial groups in normal growth vs. poor growth | 8-10 weeks depending on length of stay in NICU |
Drug-induced Brugada Syndrome Research Database

Study Overview
=================
Brief Summary
-----------------
All patients with drug-induced Brugada syndrome who are evaluated and followed at each participating centers will be recorded in this register. Within this register a characterization of patients and therapy will be done. Prognostic factors of adefined clinical relevant endpoints will be evaluated.

Official Title
-----------------
Drug-induced Brugada Syndrome Research Database

Conditions
-----------------
Arrhythmia, Brugada Syndrome, ICD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients with drug-induced Brugada Syndrome Exclusion Criteria: Missing Informed Consent Form Missing Contact Informations for Follow up

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Sudden Cardiac Death | Unexpected death due to cardiac causes that occurs in a short time period. | 1 year | 
| Appropriate ICD Therapies | Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia | 1 year |
Carpal Tunnel Release Effects on Median Nerve Perfusion

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging to view the perfusion to the nerve.

Detailed Description
-----------------
The study will involve patients undergoing carpal tunnel release surgery at our institution, with no change in the actual procedure performed. Using the SPY Scope, we will measure blood flow prior to the carpal tunnel release, and again measure once carpal tunnel release has been performed, in order to compare the values. This may add roughly 15 minutes to the total procedure time, however, no steps in the actual operation will be altered or affected in any way.

Official Title
-----------------
Effect of Carpal Tunnel Release on Median Nerve Perfusion Using SPY Scope Imaging

Conditions
-----------------
Carpal Tunnel Syndrome

Intervention / Treatment
-----------------
* Drug: Indigocyanine green dye


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: carpal tunnel syndrome 18 years or older Exclusion Criteria: pregnant less than 18 years of age allergy to iodide or iodinated contrast agents

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Median nerve perfusion<br>Injection of indigocyanine green dye to evaluate perfusion of the median nerve with the SPY scope before and after carpal tunnel release | Drug: Indigocyanine green dye<br>* Each patient will receive 1 injection of indigocyanine green dye using 2.5 mg/mL concentration of the imaging agent. 3mL of this mixture will be injected intravenously, followed by 10mL NS bolus, just prior to imaging with the SPY scope<br>* Other names: Indigocyanine green dye (ICG);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of median nerve perfusion with carpal tunnel release | This study aims to examine the effect of carpal tunnel release on blood flow to the median nerve using SPY scope imaging. | intraoperatively |