Kornimate/medical-research-clean huggingface dataset:
dasatinib combined with quercetin to reverse chemo resistance in triple negative breast cancer

Conditions: Triple-negative Breast Cancer

Summary: this is a phase ii, open-label, single-arm study evaluating the efficacy and safety of combined treatment of dasatinib, quercetin with chemotherapy in mtnbc (triple negative breast cancer) patients who progressed during previous chemotherapy.

this is a phase ii, open-label, single-arm study evaluating the efficacy and safety of combined treatment of dasatinib, quercetin with chemotherapy in mtnbc (triple negative breast cancer) patients who progressed during previous chemotherapy. chemotherapy is the backbone drug for tnbc. how to reverse chemotherapy resistance or how to increase the sensitivity of chemotherapy efficacy, has become an urgent clinical problem to be solved. our preclinical studies have demonstrated that the combination of dasatinib and quercetin with chemotherapy can effectively eliminate chemotherapy-induced senescent fibroblasts, decrease the proliferation rate of disseminated tumor cells, and ultimately lead to a significant reduction in metastasis and recurrence, thereby enhancing the efficacy of chemotherapy. based on preclinical studies, the investigators designed this study to enroll mtnbc patients who have progressed during or following chemotherapy, and to explore the efficacy of combined treatment of dasatinib, quercetin with chemotherapy at a clinical level, providing new strategies of combined treatment for tnbc patients.

Eligibility criteria:
inclusion criteria: * ecog performance status of 0, 1 * metastatic or locally advanced, histologically documented tnbc (absence of her2, er, and pr expression) * radiologic/objective evidence of recurrence or disease progression after chemotherapy for metastatic breast cancer (mbc) * adequate hematologic and end-organ function, laboratory test results, obtained within 14 days prior to initiation of study treatment. * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm * measurable disease according to response evaluation criteria in solid tumors v1.1 (recist v1.1) * have the cognitive ability to understand the protocol and be willing to participate and to be followed up exclusion criteria: * symptomatic, untreated, or actively progressing cns metastases * active or history of autoimmune disease or immune deficiency * significant cardiovascular disease * history of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death * treatment with chemotherapy, radiotherapy,immunotherapy or surgery (outpatient clinic surgery excluded) within 3 weeks prior to initiation of study treatment. * pregnancy or breastfeeding, or intention of becoming pregnant during the study * history of allergies to the drug components of this trial * patients who have been using oral steroid hormones for a long time will need to stop for 4 weeks if they have used them occasionally in the past
outcomes following pulmonary valve replacement in adults

Conditions: Heart Disease, Congenital; Pulmonary Valve Replacement

Summary: one of the most common residual lesions in adult survivors of pediatric cardiac surgery is pulmonary valve disease, particularly regurgitation. multiple studies have demonstrated that placement of a pulmonary valve in such patients, results in improved ventricular function and resolution of symptoms. however, the optimal prosthetic valve for use in the pulmonary position has not been defined. there are essentially three alternatives available: the stented bioprosthetic valve, stentless bioprosthetic "tube" grafts used to replace the entire right ventricular outflow tract and mechanical valves. all three of these valve options have been used in adults with congenital heart disease at emory healthcare and at children's healthcare of atlanta at egleston. the goal of this study is to evaluate and compare the indications and short and mid-term outcomes for these alternative therapies.


Eligibility criteria:
inclusion criteria: adult patients who have received a pulmonary valve replacement for congenital heart disease at children's healthcare of atlanta at egleston or are in the emory healthcare system between 1976 and 2004. - exclusion criteria: -

Keywords: congenital heart disease pulmonary valve replacement
evaluation of low source of signal in scout ds

Conditions: Metabolic Syndrome; Impaired Glucose Tolerance; Gestational Diabetes

Summary: the overall objective of this study is to increase the number of dark skin tone individuals in the data set and evaluate if this increase in dark skin tone data has an impact on the accuracy of the scout ds diabetes risk score (drs).


Eligibility criteria:
inclusion criteria: 1. dark skin tone (von luschan chromatic skin color \> 35) 2. age greater than or equal to 45 years; or 3. age 18 to 44 years and a bmi \> 25 kg/m² with one or more of the following diabetes risk factors: * habitually physically inactive (less than 30 minutes of moderate physical activity most, if not all, days of the week) * has a first-degree relative with type 2 diabetes * african american, latino, native american, asian american, pacific islander * has delivered a baby weighing \> 9 lb or previously diagnosed with gestational diabetes * hypertension (≥140/≥ 90 mmhg) or being treated for hypertension * hdl cholesterol level \< 35 mg/dl and/or a fasting triglyceride level ≥ 250 mg/dl or being treated for dyslipidemia with medication * has been previously diagnosed with polycystic ovary syndrome (pcos) * had impaired glucose tolerance or impaired fasting glucose on previous testing within the last 3 years * conditions associated with insulin resistance such as severe obesity or acanthosis nigricans * history of vascular disease including heart attack, stroke, angina, coronary heart disease, atherosclerosis, congestive heart failure or peripheral arterial disease exclusion criteria: * prior participation under veralight protocols: vl-2710, vl-2711 or vl-2712 * under 18 years of age * receiving investigational treatments in the past 14 days * psychosocial issues that interfere with an ability to follow study procedures * conditions that cause secondary diabetes including cushing's syndrome, acromegaly, hemochromatosis, pancreatitis, or cystic fibrosis * diagnosed with any type of diabetes, including type 1 or 2 * taking glucose lowering medications * known to be pregnant * receiving dialysis or having known renal compromise * scars, tattoos, rashes or other disruption/discoloration on the left volar forearm. * recent (within past month) or current oral steroid therapy or topical steroids applied to the left forearm; inhaled steroid therapy is not excluded * current chemotherapy, or chemotherapy within the past 12 months * receiving medications that fluoresce\* * known to have, or at risk for, photosensitivity reactions ( e.g., sensitive to ultraviolet light, or taking medication known to cause photosensitivity) * known to have, or at risk for, sensitivity to skin lotions or shaving (creams, lotions, soap, shaving cream) * prior bariatric surgery

Keywords: impaired glucose tolerance diabetes risk factors dark skin
ipsc biobank of biomarkers diversity in cardiovascular disease

Conditions: Cardiovascular Diseases; Arrythmia; Cardiomyopathies; Heart Failure; Cerebrovascular Accident; Congenital Heart Disease; Cardiometabolic Syndrome

Summary: the investigators will create a clinical database and a biobank of stem cells derived from the blood of participants with cardiovascular disease. the investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. the investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. the stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease.

cardiovascular disease is the leading cause of morbidity and mortality. the development of cardiovascular disease includes both genetic and epigenetic factors. understanding their molecular and cellular mechanism is necessary to identify novel drug targets and treat the disease. present in vitro and in vivo models of the disease do not mimic human pathophysiology, and obtaining the primary cells from the patients for the studies relevant to the cardiovascular and pulmonary system is difficult. induced pluripotent stem cells (ipscs) are derived from a person's blood cells and facilitate the discovery of cardiovascular disease mechanisms. the investigators propose recruiting cardiovascular patients from diverse ethnic backgrounds and creating a rich clinical database using redcap. blood samples will be obtained from participants and used to create ipscs. the participant will have dna sequencing, and serum will be analyzed for protein biomarkers. the multi-omics data and reprogrammed ipscs will be stored in the cardiology and critical care (c3rp) laboratory at the robarts research institute at western university. the reprogrammed ipscs can generate a limitless supply of cardiovascular tissue. moreover, the ipsc-derived data will be correlated with clinical information, genetic sequencing, and protein biomarkers from serum analysis. the investigators expect to create an ipsc biobank coupled with a rich clinical dataset, including genetic sequencing analysis and protein biomarkers that will enable the discovery of novel biomarkers and drug targets for cardiovascular disease.

Eligibility criteria:
inclusion criteria: * adult (18 to 80 years of age) * cardiovascular disease (cvd) * cerebrovascular disease (cbd) * peripheral vascular disease (pvd) * inherited arrhythmias * cardiomyopathies * congenital heart disease (chd) * aortopathy * hypertension * cardiometabolic disease (cmd) exclusion criteria: * younger than 18 years of age. * patients not able to provide consent.
exablate treatment of metastatic bone tumors for the palliation of pain

Conditions: Pain Resulting From Bone Metastases

Summary: the purpose of this enhanced surveillance study ("ess") is to collect information regarding chronic adverse events that are possibly related to the exablate® system ("exablate") that are received by insightec ("insightec") following pma approval. this study will examine adverse events reported in patients undergoing the device procedure for the first two years of commercial experience. other relevant data may be collected as well.

this proposed registry will be performed in full compliance with all hipaa rules and their implementations at potential participating sites. all patients planned to undergo the exablate procedure in a commercial setting after pma approval will be offered a consent so they can be included in the ess. non-consenting patients will not be included in the ess. however, information regarding the total number of subjects treated at each participating site with the device will also be collected. insightec will set up a (password protected) edc database for the sites to enter the information of participating subjects treated with the exablate device from all u.s. sites using the exablate procedure for the bone metastases indication. this will occur for a total duration of 2 years following device approval. it should be noted that any adverse event that meets the medical device report ("mdr") definition will be reported as an mdr as well. there will be no control group. reporting to fda will occur at six-month intervals for the first two-years after pma approval.

Eligibility criteria:
this study collects safety data on patient treatments performed commercially under the fda approved labeling. * eligibility is as per approved device indication. * all registry-consented patients who undergo commercial exablate procedure for bone mets palliation after device approval.

Keywords: exablate mrgfus bone metastases pain palliation
an evaluation of the safety and efficacy of fid 114657

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the safety and efficacy of fid 114657 in comparison to soothe xp in a specified population of dry eye patients.


Eligibility criteria:
inclusion criteria: * documented diagnosis of dry eye * nafl corneal staining sum score ≥ 3 in either eye exclusion criteria: * must not have worn contact lenses for 1 week preceding enrollment

Keywords: dry eye artificial tears
efficacy of serratus anterior plane block with dexmedetomidine during breast surgery

Conditions: Analgesia

Summary: this study aims to compare single level serratus block versus bilevel serratus block with and without dexmedetomidine in cancer patients undergoing modified radical mastectomy for breast cancer regarding pain control and possible side effects.


Eligibility criteria:
inclusion criteria: * patients scheduled for modified radical mastectomy, * age 18-65 years, * asa i-ii exclusion criteria: * patient refusal, * coagulation defects, * abnormal kidney or liver functions, * local infection at site of injection.
cbtpro: scaling up cbt for psychosis using simulated patients and spoken language technologies

Conditions: Psychosis; Schizophrenia; Schizo Affective Disorder; Bipolar Disorder; Depressive Disorder

Summary: the primary objective of this grant is to develop and evaluate an artificial intelligence-based clinical training tool--cbtpro--to support high-quality skills training in cbt for psychosis (cbtp). cbtpro will provide a rapid means of scaling and sustaining high-quality cbtp in routine care settings across the us.

this fast-track small business technology transfer (sttr) grant is a partnership between the university of washington and private company lyssn that includes the development and iterative testing of cbtpro, a computerized clinician support tool designed to teach behavioral health providers and students cognitive behavioral therapy for psychosis (cbtp). cbtpro uses natural language processing to provide automated speech-to-text and machine learning to score trainee's responses to simulated patients with psychosis. once technical reliability of the tool is achieved through iterative modifications based on usability and field trials, a randomized control trial will be conducted to assess cbtpro training vs. training as usual with n=100 providers / n=300 clients on clinician skills and client outcomes.

Eligibility criteria:
client inclusion: adults who speak english, meet with their provider who is participating in the study at least bi-weekly (2x a month), and do not plan to leave services in the next 6 months. qualifying diagnoses for clients include: schizophrenia; schizoaffective disorder; schizophreniform disorder; delusional disorder; other specified schizophrenia spectrum and other psychotic disorder; unspecified schizophrenia spectrum or other psychotic disorder; bipolar disorder with psychotic features; major depressive disorder with psychotic features exclusion criteria: dx of psychosis secondary to substance intoxication

Keywords: clinician training ai (artificial intelligence) machine learning nlp (natural language processing) cognitive behavioral therapy (cbt)
pac-ic-sas pilot study - central sleep apneas syndrome and ventricular function

Conditions: Central Sleep Apneas Syndrome; Heart Failure; Coronary Artery Bypass Graft Surgery or Other Coronary Reperfusion

Summary: the aim of this clinical trial is to evaluate the effect of an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient following coronary artery bypass graft surgery or other coronary reperfusion.

this clinical trial is a pilot study, on patients with central sleep apneas syndrome and heart failure, undergoing coronary artery bypass graft surgery or other coronary reperfusion, and then randomized for the adaptive servo-ventilation treatment application or not after surgery. the first objective is to evaluate the effect of an early treatment of sleep-disordered breathing by adaptive servo-ventilation in heart failure patient, in terms of ventricular recovery (ejection fraction improvement). this treatment will be instaurated just after coronary artery bypass graft surgery or other coronary reperfusion. secondary objectives : * assessment of adaptive servo-ventilation effect on the endothelial function, the systemic inflammation and oxidative stress, the insulin resistance, after the surgery in comparison with non treated patient with heart failure and central sleep apneas. * assessment of the impact of nocturnal desaturation level on the vascular reactivity and atherosclerosis of mammary vessels collected only during coronary artery bypass graft surgery. * assessment of the impact of nocturnal desaturation level on the oxidative stress, inflammation and insulin sensitivity on abdominal and epicardiac adipose tissue collected during surgery.

Eligibility criteria:
inclusion criteria: * coronary artery bypass graft surgery or other coronary reperfusion * heart failure patient: with altered left ventricular ejection fraction by ultrasonography (45%\< lvef ≤ 50% in 2d) or in 3d * patient with central sleep apneas syndrome (sas) exclusion criteria: * aortic or mitral valvular surgery * patient already treated for a central sas * patient with an obstructive sas * patient with malignant evolutive pathology * pregnant or lactating women

Keywords: central sleep apneas syndrome heart failure all coronary reperfusions adaptive servo-ventilation treatment
a study to evaluate efficacy of ramosetron on diarrhea-predominant irritable bowel syndrome (ibs) in male patients

Conditions: Irritable Bowel Syndrome

Summary: a study to verify the superiority of ramosetron hydrochloride (irribow tablets) to placebo for male patients with diarrhea-predominant irritable bowel syndrome (d-ibs) and to evaluate its safety.


Eligibility criteria:
inclusion criteria: * patients meeting the rome iii diagnostic criteria * loose (mushy) or watery stools within the last 3 months exclusion criteria: * patients with a history of surgical resection of the stomach, small intestine or large intestine * patients with a history or current diagnosis of inflammatory bowel disease (crohn's disease or colitis ulcerative) * patients with a history or current diagnosis of colitis ischemic * patients with a current diagnosis of enteritis infectious * patients with a current diagnosis of hyperthyroidism or hypothyroidism * patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study * patients with a history or current diagnosis of malignant tumor * patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Keywords: diarrhea ibs colonic disease ym060
virtual reality in plastic surgery: pain control and augmented satisfaction

Conditions: Pain; Anxiety

Summary: the study is looking at whether wearing a virtual reality device will help reduce pain and anxiety during minor procedures

patients who are undergoing minor plastic surgery procedures will be assigned to either wear a virtual reality device or to listen to music of their choice. patients will still get the standard lidocaine/novocaine numbing agent. patients will be asked questions about their anxiety level and pain level. heart rate and blood pressure will be monitored as measures of anxiety and pain.

Eligibility criteria:
inclusion criteria: * patients scheduled for minor elective plastic surgery procedure * patients without cognitive, visual or hearing impairments exclusion criteria: * patients with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay) * lesions that involve portions of the head or face that will prohibit the use of vr goggles * severe vertigo * patients with nausea, vomiting, dementia, motion sickness, stroke, seizure and epilepsy and those placed in isolation (mrsa, vre) were excluded. * patients who are pregnant * hearing or visually impaired * patients \<18 years old
a study of pertuzumab in combination with trastuzumab plus an aromatase inhibitor in participants with metastatic human epidermal growth factor receptor 2 (her2)-positive and hormone receptor-positive advanced breast cancer

Conditions: Breast Cancer

Summary: this randomized, open-label, two-arm, multi-center, phase ii study will evaluate the efficacy and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (ai) in first-line participants with her2-positive and hormone receptor-positive advanced breast cancer. participants will be randomized to one of two treatment arms; arm a (pertuzumab in combination with trastuzumab plus an ai) or arm b (trastuzumab plus an ai). participants may also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the investigator's discretion in combination with the assigned treatment arm. the anticipated time on study treatment is until disease progression, unacceptable toxicity, withdrawal of consent, or death whichever occurs first.


Eligibility criteria:
inclusion criteria: * participants with her2-positive and hormone receptor-positive advanced metastatic or locally advanced breast cancer * post-menopausal status over 1 year * her2-positive as assessed by local laboratory on primary or metastatic tumor * hormone-receptor positive defined as estrogen receptor-positive and/or progesterone receptor-positive * at least one measurable lesion and/or non-measurable disease evaluable according to response evaluation criteria in solid tumors version 1.1 exclusion criteria: * previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting * previous treatment with anti-her2 agents for breast cancer, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting * disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment * history of persistent grade 2 or higher hematological toxicity according to national cancer institute-common toxicity criteria version 4.0 * disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months * other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma * clinical or radiographic evidence of central nervous system metastases or significant cardiovascular disease
rudolph: nasal microbiota with red and sore nose

Conditions: Dermatitis

Summary: this pilot study will utilize the experimental rhinovirus infection model to study changes in skin microbiota in relation to skin erythema and soreness.


Eligibility criteria:
inclusion criteria: * self reported proneness to developing symptoms of nose redness and/or soreness * sero-negative to hrv-16 at screening exclusion criteria: * confirmed or self-reported allergic rhinitis * history of nasal or otologic surgery * use of anti-inflammatory medication, recent antibiotics or anti-histamines