cyrilzakka/clinical-trials huggingface dataset:
Yoga in Controlling Symptoms and Reducing Stress in Women With Ovarian Cancer or Breast Cancer

RATIONALE: Yoga may improve symptoms and quality of life and reduce stress in patients with ovarian cancer or breast cancer and may help them live more comfortably.

PURPOSE: This clinical trial is studying how well yoga works in controlling symptoms and reducing stress in women with ovarian cancer or breast cancer.

OBJECTIVES:

* Determine the feasibility of implementing a restorative yoga intervention as a complementary supportive therapy for women with ovarian or breast cancer.
* Measure changes in fatigue, psychosocial distress (anxiety, depression), psychological well-being (positive emotions), and overall quality of life from baseline to completion of the study treatment.

OUTLINE: This is a pilot study.

Patients undergo a 75-minute restorative yoga session once a week for 10 weeks.

Patients complete questionnaires regarding fatigue, psychological distress (anxiety, depression), positive affect, and quality of life at baseline, immediately after the final yoga session, and then at 2 months after the final yoga session.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast or ovarian cancer

  * Must be 2-24 months post-primary treatment (e.g., surgery) for breast cancer and/or have had a recurrence of breast cancer within the past 24 months
  * Must be 3-24 months post-primary treatment (e.g., surgery) for ovarian cancer and/or have had a recurrence of ovarian cancer within the past 24 months
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Zubrod performance status 0-3
* No medical contraindications
* Understands written and spoken English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Peer Leadership for Physical Literacy

The purpose of the proposed research is to develop, implement, and test the efficacy of a theory-driven evidence-based peer leadership program for elementary school students (Grade 6/7; age 11/12 years) in relation to (a) their own leadership skills and their leadership self-efficacy (i.e., confidence to lead), as well as (b) the physical literacy of younger (Grade 3/4; age 8/9) students with whom they are partnered.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be teachers (Grade 6/7) and students (Grade 3,4, 6 or 7) in elementary schools in the Lower Mainland of British Columbia.
* Students must have a basic working knowledge of English.

Exclusion Criteria:

* There are no exclusion criteria that would exclude anyone who otherwise meets the inclusion criteria specified above
Breast Study to Determine the Ability of Non-Invasive Optical Transillumination Spectroscopy to Predict Breast Density.

The purpose of this study is to learn more about the application of transillumination measurements in the determination of breast cancer risk. The goal is to demonstrate a correlation between non-invasive optical transillumination spectroscopy and parenchymal density pattern.

X-ray generated images, such as mammograms, rely on the density of tissue within the breast. Tissue density are believed to be associated with proliferation of stroma and/or epithelium, which result in an increase in water associated light absorption and a decrease in lipid associated light absorption. The amount of density of the breast tissue has been shown to be an indicator of cancer risk. Thus, assessing this breast tissue density is also an important tool in determining breast cancer risk.

Optical transillumination has been shown to give information about tissue composition and tissue density. Unlike x-ray mammography which uses ionizing radiation, optical transillumination uses normal white light and is deemed safe to be used frequently for women of all ages and therefore can be used for those situations where mammography is not an option.

Normal white light is shone into the tissue and the light that leaves the breast on the other side from the source is detected and analyzed. Since the same physiological conditions that contribute to dense breast tissue, as seen in mammography, also will have unique optical signatures.

We will compare the amount of this dense tissue from the mammogram, taken with 12 months, to the density measurements found through the optical procedure. The goal is to be able to duplicate the information from the mammogram using the transillumination technique. All measurements are non-invasive and no blood samples or biopsies are required.

Eligibility Criteria:
Inclusion Criteria:

* Be in good health and able to provide consent
* Be between 35 and 75 years of age
* Have no personal history of breast cancer
* Have had a mammogram at The Marvelle Koffler Breast Centre at Mount Sinai Hospital within the last 12 months

Exclusion Criteria:

* Have had breast biopsy
* Have had breast augmentation or reduction
A Study of the Effects of Amprenavir, a Protease Inhibitor, on Carbohydrate and Fat Metabolism in HIV-Infected Patients

The purpose of this study is to evaluate the effects of a 3-drug anti-HIV regimen, amprenavir (APV) plus abacavir (ABC) plus lamivudine (3TC), on the way carbohydrates (sugars) and fats are metabolized (processed by the body) in HIV-infected patients who have received little or no previous anti-HIV drug therapy.

This single-site study uses an open-label, single-arm design to evaluate the effects of APV, a protease inhibitor (PI), plus concurrent nucleoside reverse transcriptase inhibitors (NRTIs) ABC and 3TC on carbohydrate and lipid metabolism in non-diabetic, HIV-1 infected patients initiating antiretroviral therapy. Treatment duration is 24 weeks, and patients serve as their own controls. The combination therapy is evaluated for safety, tolerability, efficacy, and effects on body composition. The proportion of patients who attain plasma HIV RNA below the lower limit of quantitation of the Roche Amplicor (less than 400 copies/ml) and Ultrasensitive (less than 50 copies/ml) is measured at 24 weeks after starting therapy with APV plus ABC plus 3TC.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are at least 18 years old.
* Have very little or no anti-HIV drug experience (see below for details) and have never taken ABC.
* Have a CD4 count greater than or equal to 200 cells/mm3 within 30 days prior to study entry.
* Have a viral load (level of HIV in the blood) greater than 500 copies/ml within 30 days prior to study entry.
* Agree to use effective methods of birth control during the study.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have taken both 3TC and stavudine (d4T).
* Have taken a protease inhibitor (PI) or nonnucleoside reverse transcriptase inhibitor (NNRTI) for more than 7 days.
* Have taken a PI within 60 days of study entry.
* Have a history of diabetes.
* Have a history of untreated gonad or thyroid disorder.
* Have a stomach or intestinal disorder which may affect the way the body absorbs the study drugs, or which may make them unable to take medications by mouth.
* Have received chemotherapy or radiation within 4 weeks prior to entry, or if they will need either of these during the study period.
* Have lost or gained a significant amount of weight (greater than 5%) within the past 2 months.
* Have a serious medical condition, such as heart disease.
* Are allergic to any of the study drugs.
* Have been treated for an infection or other medical illness within 14 days prior to study entry.
* Have had a fever (over 38.5 degrees Celsius) for any 7 days or chronic diarrhea (more than 3 liquid stools per day for 15 days) within 30 days prior to study entry.
* Have an AIDS-related cancer (other than Kaposi's sarcoma).
* Abuse alcohol or drugs.
* Have received certain medications.
* Are pregnant.
Symptomatic Trial of Angina Assessment Prior to Revascularization

The principal objective of this research is to determine whether symptoms, induced by confirmed experimental ischaemia, can help us predict which patients will respond to PCI.


Eligibility Criteria:
Inclusion Criteria:

1. Angina or angina-equivalent symptoms
2. Anatomical evidence of a significant single vessel coronary stenosis on diagnostic coronary angiography indicating ≥ 70% stenosis
3. Referred for percutaneous coronary intervention for treatment of stable angina

Exclusion Criteria:

1. Age younger than 18
2. Age older than 85
3. Recent acute coronary syndrome
4. Multivessel coronary artery disease
5. Previous coronary artery bypass graft surgery
6. Significant left main stem coronary disease
7. Chronic total occlusion in the target vessel
8. Contraindication to percutaneous coronary intervention or drug-eluting stent implantation
9. Contraindication to antiplatelet therapy
10. Contraindication to adenosine infusion
11. Severe valvular disease
12. Severe LV systolic impairment
13. Severe respiratory disease
14. Life expectancy less than 2 years, pregnancy, unable to consent
Evaluating a Pharmacokinetic Drug Interaction Between LGEV1801 and LGEV1802

The purpose of this study is to evaluate the drug-drug interaction between LGEV1801 and LGEV1802 in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male
* Age between 19 and 50
* Subjects with BMI of 18\~27 kg/m2 with a weight of 55kg or more
* Subjects with SBP of 90\~150 mmHg and DBP of 60\~150 mmHg
* Signed informed consent

Exclusion Criteria:

* Presence of medical history or a concurrent disease
* Has a history of hypersensitivity to IP ingredients
Comparison Between Early Excision and Grafting Versus Dressing and Delayed Grafting in Deep Burn Mangement.

* All the patients will be included in the study will be resuscitated on arrival in our department.
* Detailed history will be taken and burn evaluation will take place in respect to TBSA according to Lund and Browder chart and burn depth.
* Dreesing will be done with topical antimicrobial agent.
* Fluid resuscitation with lactated Ringer's solution according to modified Parkland's formula.
* Injectable proton pump inhibitors, and analgesics will be started as initial drug therapy.
* Close follow up of the patients will be done then evaluation of the patients will be done in the fourth day and dividing the patients into two groups: the first group "early exicion and grafting " and the second group " dressing and delayed grafting ".
* The first group will include patients with early surgery from 4 to 10 days since burn.
* Dressing will be done for the second group every other day until spontanous eschar seperation or after surgiacl debridrment of adherent eschar then for delayed grafting more than 10 days post burn.
* Then the data will be collected and analyzed for comparison between the two groups regarding : the timing of operation and its relation to the length of stay, functional outcome and cost of treatment

* The first group will include :

  1. Patients with good general condition and hemodynamically stable that fit for early surgery.
  2. Patients that accept the option of early surgery and can give consent for it .
  3. Patients with available donor site for early grafting.
  4. Patients with burn at certain sites may be of priority for early excision and grafting to avoid long term complication of delayed wound healing such as : on joint surface, hands, feet, and face.
* The early excision will be done surgically within 4-10 days post burn by whatson knife by tangential excision of burned tissue until capillary bleeding appears to make a good bed to be covered with grafts" split thickness grafts STG" at the same time.
* The first dressing will be in the fifth day post operative.
* In the other hand the second group will include:

  1. Patients with bad general condition or hemodynamicaly unstable at the early excision period (4-10 days post burn).
  2. Patients that refuse early surgery and give no consent for early surgery.
  3. Patients with no available donner site for early excision and grafting during the fourth day evaluation .

Eligibility Criteria:
Inclusion Criteria:

1. Patients who had deep second and third degree burns.
2. patients with flame and scald burns.

Exclusion Criteria:

1. Patients who had only first or superficial second degree burns.
2. patients with high voltage contact electric burns and chemical burns.
Dose Finding Study for QAW039 in Asthma

This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.


Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy.
* Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value of 40% to 80% of individual predicted value.
* Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study.
* Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year.
* An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization.

Exclusion Criteria:

* Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/mL).
* Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.).
* Acute illness other than asthma at the start of the study
* History of life-threatening asthma, including a history of significant hypercarbia (pCO2\>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma.
* Patients who have had a respiratory tract infection within 4 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date.
* Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.
Prostatic Urethral Lift (PUL) Pre-/Post-Radiation Treatment for Prostate Cancer

The purpose of this study is to test the use of the Prostatic Urethral Lift (PUL), Urolift®, in prostate cancer (Pca) participants seeking or undergoing radiotherapy for relief of urinary obstructive symptoms.

Prostatic Urethral Lift (PUL)/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH) (also called prostate gland enlargement). This study seeks to evaluate UroLift's efficacy in a unique cohort of participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy. The primary objective of this study is to achieve urinary obstructive symptom relief in prostate cancer participants undergoing radiotherapy treatment with placement of PUL. This will be quantified using primary effectiveness endpoints:

* For PUL placement post-EBRT and post-BT: ≥ 30% or ≥ 4 point International Prostate Symptom Score (IPSS) reduction 3 months after PUL.
* For PUL placement pre-BT: ≥ 30% or ≥ 4 point IPSS reduction 3 months after Brachytherapy (BT) from pre-PUL baseline.

The team will also assess participant outcomes with regard to International Prostate Symptom Score (IPSS), peak urine flow (Qmax),post-void residual (PVR), quality of life (QOL) scores, Benign Prostatic Hyperplasia Impact Index (BPHII) scores, Men's Sexual Health Questionnaire (MSHQ) scores, and urinary incontinence at 6 and 12 months of PUL placement post-External Beam Radiotherapy (EBRT), post-BT, and pre-BT.

Eligibility Criteria:
Inclusion Criteria:

* International Prostate Symptom Score ≥ 12.
* Peak flow rate ≤ 12 ml/sec with at least 125 ml voided urine.
* Prostate volume ≤ 80 cc as measured either by trans-rectal ultrasound (US) or Magnetic Resonance Imaging (MRI).

Exclusion Criteria:

* Obstructive median lobe of the prostate.
* Active urinary tract infection.
* Neurogenic non-obstructive voiding dysfunction.
* Obstructive symptoms secondary to prostate cancer (via cystoscopy).
* Patients with prior Transurethral resection of the prostate (TURP).
* Patients with prior history of urethral stricture.
Study of Kinetics, Dosimetry & Safety of [18F]F-AraG, a Positron Emission Tomography Imaging Tracer in Healthy Humans

The goal of this study is to visualize biodistribution of a PET tracer called \[18F\]F-AraG through time in healthy human volunteers.

A positron emission tomography (PET) imaging tracer will be intravenously injected into healthy human volunteers who provide informed consent. Following injection of this tracer each volunteer will have four whole-body PET scans inside a PET scanner to obtain images of tracer biodistribution at four different time points. This will allow studying the kinetics of the tracer as well analysis of tracer dosimetry. Safety of the tracer will also be analyzed in each volunteer.

Eligibility Criteria:
Inclusion Criteria:

* Healthy human subjects without history of chronic disease or at present an acute disease will be included.
* Ability to abide by the study conditions is also a requirement for inclusion.

Exclusion Criteria:

* Individuals under the age of 18 years and pregnant women will be excluded from the \[18F\]F-AraG imaging studies.
* Women who are breast-feeding will be excluded from the study.
* Individuals unable to provide informed consent will be excluded.
Prone Position Impact in ARDS Patients on the Incidence of Central Venous Catheter Colonization

Catheter colonization, catheter-associated infection and catheter-associated bacteremia are a major challenge for resuscitation unit. This study wishes to explore the impact of the central venous catheter colonization on the ARDS patient with and without prone position.

Catheter-associated infection prevention is achieved by identification of the population at risk. Patients receiving prone position Under acute respiratory distress syndrome appear to be particularly vulnerable. This retrospective study is designed to compare the risk of catheter colonization that could be induced or worsened by prone position. Knowing that, prone position is increased into the care acute respiratory distress syndrome since few years. Unfortunately, no study has examined the prone position impact on catheter-association infection in these population.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient in the reanimation unit of the CHR Metz-Thionville or the CHRU Nancy between january 2014 and december 2015
* Patient with an acute respiratory distress syndrome, moderate or severe
* With a central venous catheter
* With or without prone position during the stay

Exclusion Criteria:

* Minor patient
* Absence of information on central venous catheter bacteriology
Post-operative Radiotherapy With Cisplatin Alone or in Combination With Iressa in Upper Aerodigestive Tract Carcinomas

This trial will be an open multicentric randomized phase II study comparing post-operative radiotherapy + cisplatin associated or not with Iressa in upper aerodigestive tract carcinomas.


Eligibility Criteria:
Inclusion Criteria:

* Patients with upper aerodigestive tract carcinomas (all sites included) having surgical resection and eligible for post-operative radiation + cisplatin.
* Patient having a tumoral biopsy (0.5 - 1 cm3) stored in liquid nitrogen at time of surgical resection (patients with small tumors located in larynx for instance will not be included)
* Patients receiving post-operative radiation (\>=60 Gy on tumor bed and/or cervical area), associated with cisplatin, 6 weeks after surgery at the latest.

Exclusion Criteria:

* previous history of cancer (except skin basal cell carcinoma)
Crohn Disease Exclusion Diet After Single Medication De-escalation

The primary objective of this study is to determine whether pediatric Crohn Disease (CD) patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet.

Crohn disease (CD) is an idiopathic, chronic, relapsing and remitting inflammatory condition of the gastrointestinal tract with a high risk for complications and need for surgical interventions, particularly in children. Immunomodulators and biologic therapies are effective at inducing and maintaining remission in pediatric CD, yet there is no proven strategy for reducing exposure to medications once sustained remission has been achieved. Diet has been proven to impact disease activity in CD and may allow for sustained drug-free remission. The primary objective of this study is to determine whether pediatric CD patients in long-standing remission remain in remission longer after stopping medications if they follow the Crohn's Disease Exclusion Diet (CDED). The hypothesis is that subjects on the CDED will have longer time-to-relapse as opposed to those on an unrestricted diet.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of Crohn Disease using the Revised Porto criteria who will be withdrawing from biologic or immunomodulator monotherapy as part of clinical care.
* Normal Growth Velocity, or Tanner 5
* Steroid-free Remission (Pediatric Crohn Disease Activity Index Score \<10 without the height component) for at least 12 months prior to enrollment
* Colonoscopy during the preceding 3 months with complete mucosal healing or only few aphthous ulcerations located in one segment
* Stool calprotectin \<250µg/g during the preceding 3 months
* Parental/guardian permission (informed consent) and, if appropriate, child assent.

Exclusion Criteria:

* Discontinuation of biologic or immunomodulator therapy by the subject without the approval of the primary gastroenterologist.
* Those subjects who in the judgment of the investigative team are unable to complete the study endpoints.