cyrilzakka/clinical-trials huggingface dataset:
Concurrent Induction Chemoimmunotherapy With Epirubicine, Oxaliplatin, Capecitabine and Panitumumab in KRAs Wild-type, Resectable Type II Gastric Adenocarcinoma

This is an open label, multicenter, single-arm phase II trial with primary eqirubicine-oxaliplatin-capecitabine chemotherapy and concurrent Pmab in patients with resectable, histologically proven gastric or esophageal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Untreated, histologically confirmed, KRAS wild type, resectable gastric or esophageal adenocarcinoma
* T2-4 NX M0 disease
* ECOG performance status 0-1
* adequate hematological status
* adequate renal function
* adequate hepatic function
* adequate metabolic function

Exclusion Criteria:

* pregnant or breast feeding women
* previous malignancy other than gastric cancer in the last 5 years except curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
* arterial or venous thromboembolism within 6 months before enrollment
* clinically significant cardiovascular disease within 1 year before enrollment
* history of interstitial lung disease
Provincial Scale-up of Choose to Move (CTM) Phase 4

Choose to Move (CTM) is a 3-month, choice-based health-promoting program for low active older adults being scaled-up across British Columbia (BC), Canada. In this project, the investigators will expand delivery of the optimized Phase 4 program with large and small partner organizations and will describe and assess scale-up, implementation, and impact of CTM Phase 4.

Choose to Move (CTM) a 3-month, choice-based health-promoting program for low active older adults being scaled-up in phases across British Columbia (BC), Canada. To date (Phases 1-4), CTM participants have included mostly white older women living in large urban centres. In this project, the investigators aim to expand the reach of CTM to include even more older adults living in communities across BC.

Within CTM (Phase 4), trained activity coaches support older adults in two ways. First, in a one-on-one consultation, activity coaches help participants to set goals and create action plans for physical activity tailored to each person's interests and abilities. Older adults can choose to participate in individual or group-based activities. Second, activity coaches facilitate 8 group meetings with small groups of participants either in person or online.

In this study, the central support unit (CSU) will work with community-based seniors' services (CBSS) organizations in large and small communities across BC to deliver CTM to more older adults. The investigators will then evaluate implementation of CTM programs, and the impact of the CTM program on older adults' physical and social health.

Objectives:

To assess whether CTM (Phase 4) was implemented as planned (fidelity) and investigate factors that support or inhibit its implementation at scale across BC (Part I - Implementation Evaluation).

To assess the impact (effectiveness) of CTM (Phase 4) on the physical activity, mobility, and social connectedness of older adult participants (Part II - Impact Evaluation).

Study Design:

The investigators use a hybrid type 2 effectiveness-implementation (Curran et al. 2012) pre-post study design to evaluate scale-up of CTM Phase 4. The investigators use mixed methods (quantitative and qualitative) and collect data at 0 (baseline) and 3 (post-intervention) months to assess implementation and impact of CTM.

Eligibility Criteria:
Inclusion Criteria:

* Central support unit staff member
* Activity coach hired by delivery partner organization (activity coaches must speak English to participate in the evaluation);
* English-speaking older adults (aged \>=50 years) who participate in CTM (recruited by delivery partner organizations) will be invited to participate in the evaluation;
* Non-English speaking older adults will also be invited to participate in the evaluation as long as an intermediary who has the necessary language skills to ensure effective communication/translation of the consent and surveys is present.

Exclusion Criteria:

* None
Low-dose Decitabine for the Treatment of Decreased Donor Chimerism After Allogeneic Stem Cell Transplantation

Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent graft versus host disease (GVHD) is the major complications. In this single arm prospective study, the investigator evaluate the effect and safety of low-dose decitabine alone or with DLI in patients with decreased donor chimerism after allo-HSCT.

Decreasing donor chimerism is considered as an early sign of graft failure or relapse in patients undergoing allogeneic stem cell transplantation. The treatment option included tapering or stop of immunosuppression and or donor lymphocyte infusion (DLI) which may restore a full donor chimerism but subsequent GVHD is the major complications. In this single arm prospective study, the investigator plan to evaluate the effect and safety of low-dose decitabine treatment alone in patients with decreased donor chimerism after allo-HSCT. The investigators expect an overall response rate of 80% without serious toxicity such as grade III-IV aGVHD, ext cGVHD and lethal infection event associated with low-dose decitabine (LD-DAC) treatment. In case of donor chimerism decreasing, 5-day low-dose decitabine (5mg/m2) will given every 6 to 8 weeks until full donor chimerism is achieved (\>98%). Fast withdraw of immuno-suppression or stop of immunosupression is not carried out in the study.

Eligibility Criteria:
Inclusion Criteria:

* all patients after allogeneic stem cell transplantation
* decreasing of donor chimerism to less than 97%
* providing inform consent

Exclusion Criteria:

* patients with documented relapse disease
* patients with documented positive MRD+ (\>0.1% via flowcytometry or PCR)
* patients with active infection or grade III-IV GVHD
Effects of Blood Flow Restriction During Eccentric Resistance Exercise

The purpose of this study is to compare the muscle strength and muscle soreness effects experienced following short term (acute) eccentric exercise with and without blood flow restriction (BFR) performed at low - moderate training intensities.


Eligibility Criteria:
Exclusion Criteria:

* lower body surgery or injury in the last 12 months
* have any neuromuscular disease
* height \>76 inches tall
* height \<54 inches tall
* eccentric strength greater than 725 pounds
* pregnant or plan to be pregnant in the duration of the protocol
* don't do resistance exercise at least once per week
* perform intense cardio or strength training \>4 days per week
* Present with any other significant comorbid conditions that would impair the ability to participate in the exercise-based testing

Inclusion criteria:

* 18 - 30 years old
* strength train lower body 1-3 times per week
A Study of Patupilone in Patients With Advanced Solid Tumors and Varying Degrees of Hepatic Function

Patients who participated in the core EPO2121 study and did not clinically progress may participate in this extension protocol to further evaluate the safety, tolerability, and efficacy of patupilone.


Eligibility Criteria:
Inclusion Criteria:

* Completion of the core study is required for participation in the extension.
* 18 years of age or older
* World Health Organization (WHO) Performance Status score of: 0 - you are fully active and more or less as you were before your illness; 1 - you cannot carry out heavy physical work, but can do anything else; or 2 - you are up and about more than half the day, you can look after yourself, but are not well enough to work.
* Life expectancy of 3 months or more
* Patients with measurable or evaluable disease who have histologically documented advanced solid tumor and who have progressed after systemic therapy or for whom standard systemic therapy does not exist

Exclusion Criteria:

* Severe and/or uncontrolled medical disease
* Known diagnosis of human immunodeficiency virus (HIV) infection
* Presence of any other active or suspected acute or chronic uncontrolled infection
* Severe cardiac insufficiency, with uncontrolled and/or unstable cardiac or coronary artery disease
* History of another malignancy within 5 years prior to study entry, except for curatively treated non-melanotic skin cancer or cervical cancer in situ

Other protocol-defined inclusion/exclusion criteria may apply.
A Crossover Safety Study of Ferumoxytol Versus Placebo

This crossover safety study will evaluate the safety of a single dose of ferumoxytol compared to placebo in patients with chronic kidney disease.

This is a double-blind, placebo controlled, crossover design study of the safety of ferumoxytol compared to placebo. Patients are randomized to receive either one 510 mg dose of ferumoxytol or the equivalent volume of normal saline followed by the other test article given one week later.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients \> 18 years.
* Have chronic kidney disease per K/DOQI guidelines.
* Baseline hemoglobin of \> 9.0 and \< 12.5 g/dl

Exclusion Criteria:

* Women who are pregnant or lactating.
* Received another investigational drug or device within 30 days.
* Recent parenteral or oral iron therapy.
* Patients that have other causes of anemia.
* Major surgery within 30 days or anticipated or planned surgery during the study.
* Patients with active infections.
* Recent blood transfusions.
* Patients with known allergies to iron products.
Algorithms to Improve the Accuracy of the Echocardiographic Report

This observational study aims to improve the accuracy of the report of the echocardiographic study, making it more consistent with the current international guidelines and reducing the diagnostic mistakes in patients undergoing clinically -indicated echocardiography. The main questions it aims to answer are:

* can the addition of automated diagnostic algorithms help to improve the overall accuracy of the echocardiographic report?


Eligibility Criteria:
Inclusion Criteria:

* Having undergone a clinically-indicated echocardiographic study

Exclusion Criteria:

* Denial of the consensus to use individual clinical data for research purposes
Pilot Study to Evaluate the Effect of Aromatase Inhibitor Therapy on Pain Threshold in Breast Cancer Patients

Postmenopausal women who have hormone receptor positive breast cancer are typically treated with aromatase inhibitor medications, which substantially decrease the amount of estrogen produced by their bodies. These medications are fairly well tolerated, but can cause aches and pains which can be quite severe in some cases.

People experience pain differently. Estrogen appears to play a role in how we experience pain. Therefore, decreasing estrogen levels may lead to more pain in some women than others. The goal of this study is to evaluate perception of pain in women with breast cancer, and to determine if differences in pain perception lead to more aches and pains in some women treated with aromatase inhibitors.

In this study, we plan to enroll 55 women with breast cancer who are starting treatment with an aromatase inhibitor. Participants will undergo testing to evaluate their perception of pain, and will also complete a set of questionnaires. Testing will be conducted before starting aromatase inhibitor therapy, as well as after 3 and 6 months of therapy. We will investigate whether pre-existing differences in pain perception lead to different amounts of pain during aromatase inhibitor therapy.


Eligibility Criteria:
Inclusion Criteria:

* Female gender
* Postmenopausal, age 21 or greater
* Stage 0-III estrogen receptor and/or progesterone receptor positive breast cancer who will be receiving a standard dose of letrozole, anastrozole, or exemestane
* Performance status 0-2
* Willing to sign the consent form

Exclusion Criteria:

* Average pain \>=8/10 over the past 24 hours
* Peripheral sensory neuropathy grade 2 or higher
* Personal history of schizophrenia, or suicidal ideation or attempt within the past 2 years
* Thumbnail abnormalities on either hand that are likely to alter pain perception during testing
Open Label Study to Assess the Effect of Secukinumab in Moderate to Severe Papulopustular Rosacea

This is a study to determine whether secukinumab is a potential therapy for those with papulopustular rosacea. We will observe whether this drug decreases the size and/or amount and severity of the pustules of those who suffer from rosacea.

Rosacea is a common inflammatory skin disease affecting up to 10% of adults. Despite this, the etiology of rosacea is unclear, although there may be a genetic predisposition (Chang et al., 2015). Currently, there is no cure. Rosacea can lead to scarring, itching, burning, and is associated with anxiety and depression (Moustafa et al., 2015), significantly affecting quality of life.

Secukinumab is an antibody that binds to a protein (interleukin (IL)-17A) that is involved in inflammation. When IL-17A is bound to secukinumab, it cannot bind to its receptor, thereby inhibiting its ability to feed the inflammatory response. In clinical trials, secukinumab has been effective for moderate to severe psoriasis (Blauvelt et al., 2015). Recently, human data from all types of rosacea have shown Th1/Th17 polarization profile of the T-cell response, suggesting that anti-IL-17 therapy may be beneficial for rosacea (Buhl et al., 2015). Hence, secukinumab could be effective against rosacea. This proposal is a proof-of-concept study to use secukinumab in open label design for moderate to severe papulopustular rosacea.

Eligibility Criteria:
Inclusion Criteria:

* moderate to severe papulopustular rosacea defined clinically using the grading system of Wilkin et al. (2004) as having at least ten lesions (either papules or pustules) on face at time of enrollment
* age 18 years or greater willing and able to understand and sign informed consent form

Exclusion Criteria:

* known hypersensitivity to secukinumab
* topical or oral anti-rosacea medication usage for 28 days prior to enrollment
* active Crohn's disease, as secukinumab may exacerbate this disease
* active infection including tuberculosis, hepatitis B or C, human immunodeficiency virus
* participants with latent tuberculosis will need to have treatment initiated prior to starting study drug
* pregnant or lactating
* active and/or uncontrolled medical conditions that may interfere with study procedures or obscure rosacea assessment such as cutaneous lupus
* use of retinoids within past 3 months of enrollment
* use of antibiotics within 4 weeks of enrollment
* use of light based or laser treatment to face within 8 weeks of enrollment
* use of topical or systemic steroids within 4 weeks of enrollment
* acne conglobate, acne fulminans, chloracne, severe acne requiring systemic treatment
European Quality Improvement Programme for Acute Coronary Syndromes

The main hypothesis to be tested is that the use of a quality improvement programme will lead to measurable improvements in the management of care and use of evidence based treatments for patients presenting to hospital with non-ST elevation acute coronary syndromes.


Eligibility Criteria:
Inclusion Criteria:

Patients with a good clinical history of ACS and at least one of the following:

* New or transient ST or T wave changes on the ECG consistent with acute myocardial ischaemia
* Elevation of troponin or other cardiac markers to levels indicative of myocardial necrosis according to local laboratory values

Exclusion Criteria:

* Evidence of persistent ST elevation on the ECG
* Use of early reperfusion therapy
* Patients \>80 years
* Patients transferred from another hospital
Combined Effects of PNF and Electrical Muscle Stimulation on Spasticity and Hand Function in Stroke Patients.

To determine the combined effects of proprioceptive neuromuscular facilitation and electrical muscle stimulation on spasticity and hand function in stroke patients.

It will be a randomized controlled trial. The stroke patients aged between 30-70 years will be included in this study. Participants will be selected with non-probability convenience sampling technique. Participants will be randomly allocated into two groups by lottery method i.e experimental group and control group. The experimental group will receive proprioceptive neuromuscular technique (contract relax-10 repetition) (5-min) and electrical muscle stimulation(10 min) as 15 min session 3 times a week for four weeks while the control group will receive only conventional therapy. The outcome measure will be calculated by modified barthel index, modified ashworth scale and wolf motor function test.

Eligibility Criteria:
Inclusion Criteria:

* Both ischemic and haemorrhagic stroke patients
* Chronic stroke patients from 6 month to 2years
* Mini Mental Scale Examination (MMSE) more than 25

Exclusion Criteria:

* Transient ischemic attack
* Recurrent stroke
* Stroke patient with comorbidity and cardiac disease
* Myopathies
Retinal Oxygen Function After Radiation Therapy

The investigators propose using retinal oximetry to assess for abnormalities in regional retinal oxygen consumption in previously- irradiated patients, and relate these abnormalities to changes in regional retinal function (i.e. visual field abnormalities). Since different regions of retina receive different radiation doses, the investigators will assess for a dose response as well.

Radiation therapy (RT) is a common treatment for patients with cancers of the sinonasal area, orbit, skull base, nasopharynx, and brain. Because of the close proximity of these targets to the eyes, the retina is often incidentally and unavoidably irradiated. As a result, some patients develop radiation retinopathy and possibly vision loss. Clinicopathologic studies suggest similar microvascular mechanisms for both radiation- and diabetic retinopathy: small vessel occlusion and ischemia that can lead to neovascularization, increased capillary permeability, and visual loss in the regions of retina perfused by damaged vasculature. UNC has a novel, non-invasive retinal imaging technology called a Retinal Oximeter which measures hemoglobin oxygen saturation of retinal vessels. The difference in oxygen saturation between a retinal arteriole and venule pair reflects the oxygen consumption of the retinal region supplied by that vessel pair.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age at the time of radiation therapy (no upper age limit)
2. History of radiation therapy delivered at UNC-CH or Rex Hospital to the vicinity of the retina(s) ≥ 2 months prior to enrollment
3. Estimated average dose to at least one quadrant of one retina ≥ 30 Gy

Exclusion Criteria:

1. History of diabetes, retinal vascular occlusions, glaucoma, retinitis pigmentosa, occipital stroke or any other ophthalmologic or systemic problem that may confound visual field results.
2. Residual tumor within the visual pathway: retina, optic nerves, optic chiasm, optic radiations and brain.
GLP-1 CellBeads® for the Treatment of Stroke Patients With Space-occupying Intracerebral Hemorrhage

The objective of this study is to assess the safety of GLP-1 CellBeads® in patients with space-occupying intracerebral hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of intracerebral hemorrhage or subarachnoid hemorrhage in conjunction with ICH by cranial computed tomography (CCT) or Magnetic Resonance Tomography (MRT)
* Patients who need by judgement of a clinical neurologist or neurosurgeon surgical removal of the blood clot due to its space-occupying effects
* Age greater or equal 18 years for men
* Age greater or equal 18 years for women if confirmed infertility (e.g. hysterectomy or surgical sterilisation at least 3 months before study start)
* For all other women age greater or equal 50 years with last menstrual bleeding at least one year before study start
* Minimum hematoma diameter of 2 cm as measured in baseline CCT or MRT
* Signed, written informed consent of patient or consent/assertion from the patient's legally acceptable representative/affiliated if the patient is unable to provide informed consent

Exclusion Criteria:

* Participation in any other clinical trial within the past 3 months or ongoing
* Occurrence of inconsistency with initial diagnosis at baseline during surgery of the patient leading to unfulfilled inclusion criterion Hemorrhage secondary to tumour or trauma
* Patients with a cerebellar hemorrhage or extension of a supratentorial hemorrhage into the brainstem
* Patients with severe pre-existing physical or mental disability or severe comorbidity that interferes with the assessment of outcome
* Allergy to contrast media (MRT)
* Acute infection
* Muscular, neurological, or vascular insufficiency of the respective tissue
* Polypropylene incompatibility
* Acute immunosuppressive medication
* Patient after organ transplantation
* Patient with immune depression
* Patients with a high probability of spontaneous recovery or showing rapidly improving signs
* Patients with extensive intracranial hemorrhages or with deep hemispheric localisation of the clots
* Patients whose diagnosis of ICH is uncertain
The Study of Efficacy and Mechanism in Fecal Microbiota Transplantation in the Treatment of Ulcerative Colitis

The aim of our study is to investigate the efficacy and mechanism in fecal microbiota transplantation in the treatment of ulcerative colitis. About 20 Ulcerative Colitis (UC) patients will be recruited into our trial for Fecal Microbiota Transplantation (FMT) treatment,the safety and efficacy of FMT will be observed.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate UC patients
* male
* volunteered to our FMT trial

Exclusion Criteria:

* severe UC
* Hb \< 6g/dL
Omitting Sentinel Node Procedure in Breast Cancer Patients Undergoing Breast Conserving Therapy

STUDY AIM To decrease the number of breast cancer patients receiving over treatment of the axilla, in order to positively influence the axillary morbidity rate and quality of life.

PRIMARY OBJECTIVE To determine whether omitting the sentinel lymph node procedure is not inferior to the current axillary staging regimen in clinically node negative breast cancer patients undergoing breast conserving therapy, in terms of regional recurrence rate.

HYPOTHESIS The sentinel lymph node procedure can be safely omitted in clinically node negative breast cancer patients undergoing breast conserving therapy. This will lead to a decreased axillary morbidity rate, with a non-inferior regional recurrence-, distant-disease free- and overall survival rates.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 years or older
* Pathologically confirmed invasive breast carcinoma
* A clinical T1-2 tumor
* Will be treated with lumpectomy and whole breast radiotherapy
* Clinically node negative status: no signs of axillary lymph node metastases at physical examination and preoperative axillary ultrasound (or negative cyto-/histopathology)
* Written informed consent

Exclusion Criteria:

* Clinically node positive pre-operative
* Bilateral breast cancer
* Evidence of metastatic disease
* History of invasive breast cancer
* Previous treatment of the axilla with surgery or radiotherapy (except surgery for hidradenitis suppurativa or for other superficially located skin lesions, such as naevi)
* Pregnant or nursing
* Other prior malignancies within the past 5 years (except successfully treated basal cell and squamous cell skin cancer, carcinoma in situ of the cervix or carcinoma in situ of the ipsilateral or contralateral breast) or unsuccessfully treated malignancies \> 5 years before randomization
* Unable or unwilling to give informed consent