linjc16/ctgov huggingface dataset:
Normal Tissue Oxygenation Following Radiotherapy

Study Overview
=================
Brief Summary
-----------------
This study involves women who have had a diagnosis of breast cancer, and have had a lumpectomy with radiation treatments completed in the past year. The study will determine the level of oxygen in the skin of the breast that has been radiated, compared with the normal skin of the opposite breast. The purpose of this study is to determine if there is a decrease in oxygen levels in the skin which has been radiated, hopefully to find a treatment to limit skin damage caused by radiation treatments, for women with breast cancer in the future.

Detailed Description
-----------------
Successful completion of this study will provide data on changes in oxygenation in irradiated tissues. If changes are documented, this study would provide evidence supporting current models of tissue injury following radiotherapy. In addition, these data may provide a mechanistic rationale for clinical approaches to ameliorate the toxicities of radiotherapy. Finally, if a correlation exists between tissue oxygenation and toxicity, the rapid and simple tissue oxygenation test may provide a quantitative measure of toxicity and allow earlier and more precise assessment of both toxicity and efficacy of ameliorative therapies.

Official Title
-----------------
Normal Tissue Oxygenation Following Radiotherapy

Conditions
-----------------
Radiation Toxicity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of breast malignancy Completion of breast irradiation one year (+/- 8 weeks) prior. Surgical treatment with lumpectomy Exclusion Criteria: Inability to tolerate the 20 minute transcutaneous oxygenation measurements Allergy to adhesives Bilateral disease or absence of control breast or previous radiotherapy to control breast More than one course of radiotherapy to the breast

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue Oxygenation | Transcutaneous oxygen detector is used to measure the partial pressure of oxygen. The unit detects electrolytes ionized by oxygen. The measuring electrode also heats the skin being measured to facilitate maximal bloodflow to the area. | One visit for 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin and Soft Tissue Toxicity Will be Assessed Using the RTOG/EORTC Late Radiation Morbidity Scoring Schema When Oxygenation is Measured. |  | One visit |
Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Heavy Smokers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if noni juice reduces lipid hydroperoxide (LOOH) and malondialdehyde (MDA) derived-DNA adducts, markers of oxidative DNA damage, in peripheral blood lymphocytes of cigarette smokers.

Official Title
-----------------
Double Blind, Randomized, Placebo-controlled Clinical Trial of the Effect of Noni Juice on Lipid Peroxidation-derived DNA Adducts in Current Heavy Smokers

Conditions
-----------------
DNA Damage

Intervention / Treatment
-----------------
* Dietary Supplement: Noni juice
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 65 years in age, smoker of more than 20 cigarettes per day, a smoking history exceeding one year, and willing to complete a one month trial. Exclusion Criteria: concurrent use, or use in the previous three months, of prescription medication or antioxidant vitamins

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 59 mL noni juice<br>Ingestion of 59 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) twice daily (118 mL daily total) for 30 days. | Dietary Supplement: Noni juice<br>* Ingestion of noni juice, a source of iridoids, daily for 30 days.<br>* Other names: Thrive Adaptogenics Original;|
| Placebo Comparator: Placebo<br>Ingestion of 59 mL of placebo (mixture of grape and blueberry juices and natural cheese flavor) twice daily (118 mL daily total) for 30 days. | Dietary Supplement: Placebo<br> <br> |
| Experimental: 29.5 mL noni dose<br>Ingestion of 29.5 mL of Tahitian Noni® juice (mixture of noni juice and grape and blueberry juices) daily for 30 days. | Dietary Supplement: Noni juice<br>* Ingestion of noni juice, a source of iridoids, daily for 30 days.<br>* Other names: Thrive Adaptogenics Original;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LOOH and MDA-DNA adducts | LOOH and MDA-DNA adducts in lymphocytes immediately prior to intervention and at completion of intervention. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | Adverse health events | 1 month |
Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Clinical Trial

Study Overview
=================
Brief Summary
-----------------
This randomized trial aims to understand how effective a reminder letter is compared to a reminder phone call in improving breast, cervical and colorectal cancer screening rates and reducing screening disparities.

Official Title
-----------------
Comparing Methods of Recall for Cancer Screening in Primary Care: a Pragmatic Randomized Clinical Trial

Conditions
-----------------
Cancer, Early Detection of Cancer, Socioeconomic Status

Intervention / Treatment
-----------------
* Behavioral: Letter
* Behavioral: Phone call


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The trial will include patients who are rostered to the family practice as of March 31, 2015, are eligible and overdue for cervical, breast and/or colorectal cancer screening and are verified by their primary care physician as needing recall. Exclusion Criteria: Patients will be excluded if their primary care physician noted they should not be recalled for screening or if the patient does not have both an address and a phone number on file.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 74 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letter<br>Patients will receive a reminder letter signed by their family physician which indicates which cancer screening tests they are overdue for and encourages them to book an appointment for screening. | Behavioral: Letter<br> <br> |
| Experimental: Phone call<br>Patients will receive a phone call from a member of the practice staff. The call will inform them about which cancer screening tests they are overdue for and will encourage them to book an appointment for screening. | Behavioral: Phone call<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients in each arm who go on to receive at least one screening test for which they are due |  | 6 months | 
| The proportion of patients in each arm who are due for breast, cervical and colorectal cancer screening who go on to receive those respective screening tests (female patients may be represented in the outcome calculation of more than one cancer screening |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
income-related disparities, cancer screening, recall
Rivaroxaban Pharmacokinetics/Pharmacodynamics (PK/PD) Study in Pediatric Subjects

Study Overview
=================
Brief Summary
-----------------
The first study with rivaroxaban in pediatric subjects is a Phase I study, where the pharmacokinetic/pharmacodynamic (PK/PD) profile of rivaroxaban will be investigated to confirm that the exposure is comparable to adults. This study is a single dose study with multiple PK/PD measurements in pediatric subjects at the end of their Venous Thromboembolism (VTE) treatment.

Official Title
-----------------
Single-dose Pilot Study of Oral Rivaroxaban in Pediatric Subjects With Venous Thromboembolism

Conditions
-----------------
Venous Thrombosis, Pediatrics

Intervention / Treatment
-----------------
* Drug: Rivaroxaban (Xarelto, BAY59-7939)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric subjects > 6 months and < 18 years of age at the time of administration of study drug. Patients who have completed treatment of VTE, but are considered to have risk for recurrence of VTE Exclusion Criteria: Any major or clinically relevant bleeding during prior VTE treatment Abnormal coagulation tests within 7 days prior to study drug administration Severe renal impairment Planned invasive procedures prior to or after 24 hours of study drug administration

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Rivaroxaban (Xarelto, BAY59-7939)<br>* Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics parameters (AUC and Cmax) |  | From Day 1 to Day 2 | 
| Pharmacodynamics parameters (PT, aPTT and anti-factor Xa) |  | From Day 1 to Day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of rivaroxaban in pediatric subjects |  | Day 1, day 2 plus 7 days follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Thrombosis, Pediatrics
Transcend Auto Clinical Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the Transcend Auto is as effective in treating obstructive sleep apnea as another device that is already on the market.

Detailed Description
-----------------
This is a prospective, randomized, crossover trial. Patients will be randomized 1:1 to undergo two full night sleep studies with the Transcend Auto and a commercially available device.

Official Title
-----------------
Transcend Auto Clinical Evaluation

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: Somnetics Transcend Auto
* Device: Respironics REMstar Auto with C-Flex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult 18 years of age or older Diagnosis of obstructive sleep apnea Presently using CPAP or APAP therapy Exclusion Criteria: Central or mixed apnea

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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Transcend followed by REMstar<br>The patient will receive treatment with Transcend during the first night sleep study, followed by treatment with the REMstar on the second night. | Device: Somnetics Transcend Auto<br> <br> Device: Respironics REMstar Auto with C-Flex<br> <br> |
| Active Comparator: REMstar followed by Transcend<br>The patient will receive treatment with REMstar during the first night sleep study followed by treatment with Transcend on the second night. | Device: Somnetics Transcend Auto<br> <br> Device: Respironics REMstar Auto with C-Flex<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean apnea hypopnea index during treatment | Apnea hypopnea index will be measured during treatment with each of the devices. | first and second night sleep study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| unanticipated adverse device effects | Patients will be monitored for unanticipated adverse device effects during each sleep study. Patients will not be followed after the second sleep study. | first and second night sleep study | 
| Mean apnea index and hypopnea index during treatment | Mean apnea index and hypopnea index will be measure during treatment | first and second night sleep study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OSA, obstructive sleep apnea, AutoPAP, PAP, sleep disordered breathing, CPAP, Apnea hypopnea index, AHI
The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of prolotherapy on balance and lumbar flexibility in the patients with a sacralized L5 vertebra. Evaluations for ability on balance include sensory organization test (SOT,) rhythmic weight shifting (RWS) and limits of stability (LOS.)

Detailed Description
-----------------
Lumbosacral transitional vertebra (LSTV) is a congenital variety of vertebral bony construction, which is most frequently presented as sacralized L5 or lumbarized S1. LSTV would alter the kinetics of the spine thus induce inadequate mobility and dynamic compensation. Patients with LSTV were commonly found when they visited clinicians for treatment of low back pain. Prolotherapy is a technique that stimulates the body to repair the painful area by assistance of injecting an otherwise non-pharmacological and non-active irritant solution into the body.

Official Title
-----------------
The Effect of Prolotherapy on Balance and Lumbar Flexibility in the Patients With a Sacralized L5 Vertebra

Conditions
-----------------
Lumbosacral Transitional Vertebra

Intervention / Treatment
-----------------
* Procedure: Prolotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with a sacralized L5 vertebra confirmed by X-ray images Exclusion Criteria: neuromuscular injury visual deficit vestibular deficit cannot recognize the marks on the screen

Ages Eligible for Study
-----------------
Minimum Age: 16 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Prolotherapy|inject normal saline and 50% glugose water with 1:1 ratial in volumn|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory organization |  | 30 minutes | 
| rhythmic weight shifting |  | 30 minutes | 
| limits of stability |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prolotherapy
Visualization in Shoulder Arthroscopy With and Without Epinephrine

Study Overview
=================
Brief Summary
-----------------
Adequate visualization during shoulder arthroscopy is of great importance for the procedure to be efficiently and effectively performed. The use of dilute epinephrine in irrigation fluid has been historically utilized to help with visualization. Given the potential safety issues documented in the literature related to epinephrine use, as well as the significant improvements in technique and instrumentation over the last decade, the need for this additive should be reexamined. The objective of the current study was to compare surgeon determined visualization in shoulder arthroscopy using irrigation fluid with and without epinephrine.

Official Title
-----------------
Surgeon Determined Visualization in Shoulder Arthroscopy: A Randomized, Blinded, Controlled Trial Comparing Irrigation Fluid With and Without Epinephrine

Conditions
-----------------
Visualization in Shoulder Arthroscopy

Intervention / Treatment
-----------------
* Other: visualization in shoulder arthroscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients requiring shoulder arthroscopy Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: With Epinephrine<br>Patients undergoing shoulder arthroscopy with epinephrine in their irrigation as standardly performed | Other: visualization in shoulder arthroscopy<br>* Evaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization<br>|
| Experimental: Without Epinephrine<br>Patients undergoing shoulder arthroscopy without epinephrine in their irrigation fluid as typically done | Other: visualization in shoulder arthroscopy<br>* Evaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization | surgeon determined visualization during shoulder arthroscopy as judged by a VAS | November 1, 2012- April 1, 2013 (5 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid Use | fluid used during arthroscopy | November 1, 2012-April 1, 2013 (5 months) | 
| Operative time | operative time | November 1, 2012-April 1, 2013 (5 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
shoulder arthroscopy, epinephrine, visualization
A Clinical Assessment Study in X-Linked Myotubular Myopathy (XLMTM) Subjects

Study Overview
=================
Brief Summary
-----------------
This is a pre-Phase 1 prospective, non interventional clinical assessment study to evaluate XLMTM subjects aged 3 years and younger. Many of these clinically relevant measures have not yet been routinely assessed in this population and may provide important insight on the natural history of XLMTM and for future evaluation of potential therapies.

Official Title
-----------------
INCEPTUS: A Prospective, Non-Interventional Clinical Assessment Study in X Linked Myotubular Myopathy (XLMTM) Subjects Aged 3 Years and Younger

Conditions
-----------------
X-linked Myotubular Myopathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a diagnosis of XLMTM resulting from a confirmed mutation in the MTM1 gene Subject is male Subject is aged less than 4 years Subject requires some mechanical ventilatory support (eg, ranging from 24 hours per day full time mechanical ventilation, to noninvasive support such as continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BiPAP] during sleeping hours) Access to subject's medical records Signed informed consent by the parent(s) or legally authorized representative(s) (LAR) (when applicable) Subject and parent(s) or LAR are willing and able to comply with study visits and study procedures Exclusion Criteria: Subject is participating in an interventional study designed to treat XLMTM Subject born <35 weeks gestation who is still not to term as per corrected age Subject has a clinically important condition, or life-threatening disease other than XLMTM, in the opinion of the investigator Subject has received pyridostigmine or any medication to treat XLMTM within 30 days of enrollment

Ages Eligible for Study
-----------------
Maximum Age: 3 Years

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

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 |
| --- | --- | --- |
| Characterize the disease course and natural history of XLMTM using respiratory assessment of strength as measured by PImax |  | 3 months to 2 years | 
| Characterize the disease course and natural history of XLMTM using neuromuscular assessments, as measured by CHOP INTEND/MFM-20 |  | 3 months to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize quality of life as measured by PedsQL |  | 3 months to 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MTM, XLMTM