linjc16/ctgov huggingface dataset:
Chest Pain Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of Nexium® with placebo in relief of acid related pain or discomfort in the chest.

Official Title
-----------------
A Randomized Double-Blind Placebo-Controlled Multi-Centre Pilot Study to Assess Symptom Response in Subjects With Pain or Discomfort in the Chest Receiving Oral Treatment With Esomeprazole 40 mg Bid for 4 Weeks.

Conditions
-----------------
Chest Pain, Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: Esomeprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pain or discomfort in the chest without any identifiable cause and severe enough for the patient to seek primary medical or similar care. History of pain or discomfort in the chest for at least the last two weeks prior to enrollment. Exclusion Criteria: Signs, symptoms or relevant investigations suggestion present symptomatic coronary heart disease. Patients whose pain or discomfort in the chest warrants urgent cardiac investigation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Esomeprazole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief of pain or discomfort in the chest during the last week of the 4-week treatment course. |  |  | 
| Relief of pain or discomfort in the chest is defined as no more than one day with minimal symptoms according to the patients assessment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom response during the first week is based on diary cards, days 3-7. |  |  | 
| The investigator's overall assessment of pain or discomfort in the chest during the first and fourth week. |  |  | 
| Scores from the PRO instruments measuring pain, HRQL, anxiety and depression, health status, reflux related symptoms and overall treatment evaluation. |  |  | 
| Adverse events, clinical laboratory variables and vital signs. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Gastroesophageal reflux disease, GERD
Duke Lupus Registry

Study Overview
=================
Brief Summary
-----------------
Lupus is a systemic autoimmune disease that can present with many varied symptoms, including joint pain, fevers, kidney disease, and rashes. Lupus can affect anyone, but it is most common in younger women. The Duke Lupus Registry will collect information and blood samples from patients with lupus (systemic lupus erythematosus or cutaneous lupus) seen in the Duke Rheumatology clinics. The goal of this Registry is to understand how lupus changes over time so that we can improve the treatment of patients with lupus.

Detailed Description
-----------------
The Duke Lupus Registry is a prospective cohort comprised of patients with lupus seen in the Duke Rheumatology clinic. The Duke Lupus Registry has two main purposes: Improved patient care. By following disease activity scores and medication usage, we expect to improve our care of the patients seen in clinic. Future research on lupus outcomes. This may encompass a broad array of areas, including but not limited to cardiovascular health, pregnancy and fertility, infections, medication use, quality of life, and depression. At each office visit, patients will complete a questionnaire, physicians will measure lupus activity, and patients may be asked to provide a small blood sample. Patients will not be required to make extra visits to Duke in order to participate -- all paperwork and blood draws will occur during a regularly scheduled office visit with the physician.

Official Title
-----------------
Duke Lupus Registry

Conditions
-----------------
Systemic Lupus Erythematosus, Cutaneous Lupus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Systemic Lupus Erythematosus or Cutaneous Lupus Patient of a rheumatologist at Duke University Medical Center Exclusion Criteria: Inability to travel to Duke for follow-up visits Inability to speak English Not able to provide informed consent

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus, Systemic Lupus Erythematosus, Cutaneous Lupus
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.

Official Title
-----------------
Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Sodium Ferric Gluconate Complex in Sucrose.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent. Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy. Predetermined TSAT and serum Ferritin (at the screening visit). Receiving a stable EPO dosing regimen. Exclusion Criteria: Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing. Hypersensitivity to Ferrlecit or any of its inactive components. High TSAT level. High Serum Ferritin

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sodium Ferric Gluconate Complex in Sucrose.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Ferritin | Change from baseline to 2 weeks after last Fe dose | 14 weeks | 
| Transferrin Saturation | Change from baseline to 2 weeks after last dose | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety. |  | 14 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia
Acupuncture for Shortness of Breath in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether acupuncture is effective in relieving shortness of breath among breast and lung cancer patients.

Official Title
-----------------
Acupuncture for Shortness of Breath in Cancer Patients

Conditions
-----------------
Lung Neoplasms, Breast Neoplasms

Intervention / Treatment
-----------------
* Procedure: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of local or metastatic breast or lung cancer Shortness of breath with onset after cancer diagnosis Life expectancy of at least 4 weeks Exclusion Criteria: Prior acupuncture Other conditions suspected of causing shortness of breath, such as congestive heart failure, sarcoid disease, pneumonia, or obesity No chest wall deformity Neuromuscular disorders Pulmonary vascular disease Anemia Uncontrolled pain or infection Heart valve dysfunction

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Acupuncture|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Breast cancer, Shortness of breath, Dyspnea, Metastasis, Breathlessness, Acupuncture
Safety and Exploratory Efficacy of Kanglaite Injection in Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
This study is for patients with advanced non small cell lung cancer that has progressed despite standard of care. The purpose of the study is to see if Kanglaite injection has any effect on survival.

Official Title
-----------------
An Open Label Safety and Exploratory Efficacy Study of Kanglaite Injection in Patients Having Progressive Stage IV NSCLC Who Are Not Candidates for Other Anti-cancer Treatment

Conditions
-----------------
Stage IV NSCLC

Intervention / Treatment
-----------------
* Drug: Kanglaite Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed (within last 3 months)progressive Stage IV NSCLC estimated life span of 3 months phase angle of at least 5 as measured by bioimpedance Exclusion Criteria: currently taking a lipid lowering medications has an imminently life threatening condition has pre-existing liver disease known allergy to soybeans uncontrolled diabetes or uncontrolled disturbance of lipid metabolism pregnant or lactating has a pacemaker or other implantable electronic medical device

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kanglaite injection<br> | Drug: Kanglaite Injection<br>* 30gm IV infusion 5 days a week for 3 weeks every 28 days<br>* Other names: KLTi;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | from date of enrollment until date of death from any cause assessed up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioimpedance Phase Angle |  | measured each month up to one year | 
| Palliation Response Measure | quality of life survey and performance status | each month up to one year |
Adherence to Aromatase Inhibitors: The Role of Partners

Study Overview
=================
Brief Summary
-----------------
This is a qualitative study which explores the role that partners play in breast cancer survivors adherence to aromatase inhibitors and management of their side effects. Both patients and their partners will be interviewed (separately) in order to capture multiple perspectives. The target number of subjects is 64 (32 patients and 32 partners). The primary method of data collection will be face-to-face semi-structured interviews. These interviews will be audio-recorded.

Official Title
-----------------
Adherence to Aromatase Inhibitors: The Role of Partners

Conditions
-----------------
Breast Cancer Survivors

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women and partners of women with stage I-III breast cancer who have completed primary cancer treatments (surgery, chemotherapy, radiotherapy) have experienced AI side effects live with a romantic partner. Exclusion Criteria:

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Survey|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Surveys Completed |  | 2 years |
Effects of Hip Abductor and External Rotator Strength Training in Patients With Patellofemoral Pain Syndrome

Study Overview
=================
Brief Summary
-----------------
The first purpose was to compare the difference between leg press exercise(LPE) and additional hip abductor and external rotator muscle strength training to leg press exercise(LPE+HAE) in muscle strength, hip kinematics during step down, pain severity and function for patients diagnosed with patellofemoral pain syndrome. The second one was to discover the relationship between the change in muscle strength performance and the difference of hip joint kinematics post treatment.

Conditions
-----------------
Patellofemoral Pain Syndrome

Intervention / Treatment
-----------------
* Other: Additional Hip Muscle Strengthening to Leg Press Exercise
* Other: Leg Press Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patellofemoral pain syndrome ( Bilateral or unilateral) Special tests: crepitus during compression test, patellar grind test (Clarke's sign), pain during compression test, palpation ( at least 2 ) Below 50 years old Pain :after long sitting, up/down stair, squat, kneeling, running & jumping ( at least 2 ) Pain duration at least 1 month At least 1 item of PSS score more than 3 cm Exclusion Criteria: Knee operation Central or peripheral neurological deficits Obvious knee joint or lower extremity malalignment People involved in competitive sports PSS sub-scale pain experienced last week more than 8cm Have been taking anti-inflammatory drugs , received anti-inflammatory injection or received other therapy for past 3 months

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 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: Leg Press<br>Leg Press exercise for 3 times/week and sustain for 8 weeks. | Other: Leg Press Exercise<br> <br> |
| Experimental: Hip Exercise<br>Additional hip abductor and hip external rotator strength training to leg press exercise for people in this group. All participants received exercise for 3 times per week for 8 weeks. | Other: Additional Hip Muscle Strengthening to Leg Press Exercise<br> <br> |
| No Intervention: Control<br>Education was given during 8 weeks of study period. After 8 weeks of study, exercise was given as compensation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength by hand-held dynamometry, hip joint kinematics during step down by electromagnetic motion tracking system (FASTRAK, Polhemus ), pain severity by PFPS pain severity scale (PSS), functional performance by Anterior Knee Pain Scale(AKP). |  | Pre and Post 8 weeks of exercise |
Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination

Study Overview
=================
Brief Summary
-----------------
There remains debate regarding whether small bowel cleansing is required prior to video capsule endoscopy, and if so, which method is best. This study prospectively tests cleansing with no preparation, preparation with picosalax, and preparation with polyethylene glycol.

Official Title
-----------------
Small Bowel Cleansing Prior to Video Capsule Endoscopy Examination: a Randomized, Blinded, Controlled Trial

Conditions
-----------------
Endoscopy

Intervention / Treatment
-----------------
* Drug: Clear fluids
* Drug: Picosalax
* Drug: Polyethylene glycol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing VCE. Exclusion Criteria: bowel obstruction or ileus; known stricture or fistula; previous small bowel surgery; severe gastroparesis or motility disorder renal impairment (serum creatinine over normal range within three months of study); congestive heart failure; cirrhosis; implanted cardiac pacemaker or defibrillator or other electromedical device; pregnancy.

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Clear fluids only after lunch. | Drug: Clear fluids<br>* Clear fluids only after lunch.<br>|
| Active Comparator: 2<br>Two sachets of picosalax the evening prior to Video Capsule Endoscopy (VCE). | Drug: Picosalax<br>* Two sachets the evening prior to Video Capsule Endoscopy (VCE).<br>|
| Active Comparator: 3<br>Polyethylene glycol, 2 liters the evening prior to Video Capsule Endoscopy (VCE). | Drug: Polyethylene glycol<br>* Two (2) litres the evening prior to Video Capsule Endoscopy (VCE).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| small bowel cleansing |  | during exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| yield of Video Capsule Endoscopy (VCE) in iron deficiency |  | during study | 
| tolerance of preparation |  | during preparation | 
| effect of preparation on blood chemistry |  | 24 hours after ingestion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Video Capsule Endoscopy, Small Bowel
A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective, multi-center study, with one single remote follow up contact. This study will include a minimum of 80 patients and a maximum 100 patients who have been treated with the ConforMIS iTotal PS knee product.

Detailed Description
-----------------
Patients will be contacted either by phone or email for a single remote follow-up. Retrospective data will be collected from medical records including pre-operative, operative and any follow up visits which have occurred since implantation as available. . All data will be collected from existing medical records and from single follow up call/email. Demographics and Medical History Pre & Post-Operative Data including Range of Motion Surgical Data Survivorship (phone/email or last known visit) Patient Reported Outcomes (phone/email single time point visit) Patient Satisfaction KOOS Jr.

Official Title
-----------------
A Retrospective Study to Evaluate the ConforMIS iTotal® Posterior Stabilized (PS) Knee Replacement System

Conditions
-----------------
Osteo Arthritis Knee

Intervention / Treatment
-----------------
* Device: iTotal Posterior Stabilized (PS) Knee Replacement System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously underwent surgical implantation of a ConforMIS iTotal PS knee replacement. Over 18 Years of age Exclusion Criteria: 1. BMI > 40

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 |
| --- | --- |
| ConforMIS PS Group<br>Patients who have undergone a total knee replacement with the ConforMIS iTotal PS Knee Replacement System | Device: iTotal Posterior Stabilized (PS) Knee Replacement System<br>* Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics and Medical History | Demographics and medical history gathered from medical records | 1 year | 
| Pre and Post Operative Range of Motion | Collected retrospectively through medical records, collecting range of motion from pre-operative visits and post-operative visits | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteoarthritis, knee arthroplasty, knee replacement, patient specific
Thoracic Injuries in Pediatric Polytraumatized Patients: Epidemiology, Treatment and Outcome

Study Overview
=================
Brief Summary
-----------------
The present study predicts that concomitant chest injuries in polytraumatized pediatric patients are a potential source of substantial morbidity and mortality.

Conditions
-----------------
Multiple Trauma

Intervention / Treatment
-----------------
* Other: reanimation/intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with isolated, but severe and potentially life-threatening injuries ISS ≥16 injuries to only one body cavity together with a single long bone fracture thoracic injuries Exclusion Criteria: Injury Severity Score (ISS) of < 16 age >18 no thoracic injuries

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Pediatric polytraumatized patients with thoracic injuries<br>Pediatric polytraumatized patients (age < 18), (ISS > 16) with thoracic injuries | Other: reanimation/intubation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury Severity Score |  | at least one year follow up | 
| Thoracic Injuries | Thoracic injuries and outcome ( number of participants with Thoracic Injuries, type of injury) | at least one year follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric polytrauma, thoracic injuries