Kornimate/medical-research-clean huggingface dataset:
preventive pci or medical therapy alone for vulnerable atherosclerotic coronary plaque

Conditions: Coronary Artery Disease; Plaque, Atherosclerotic

Summary: the primary aim of the trial is to determine whether preventive pci with bioabsorbable vascular scaffolds (bvs) (early period) or everolimus-eluting stents (middle and late period) plus optimal medical therapy (omt) on functionally insignificant (ffr \> 0.80) vulnerable coronary plaque, as determined by intracoronary imaging, would result in a significant reduction of the primary composite outcome of death from cardiac causes, target-vessel myocardial infarction (mi), target-vessel revascularization (tvr), and hospitalization for unstable or progressive angina at 2 years, when compared with omt alone.

sub-analysis for each imaging test will be performed as below; * nirs(near-infrared spectroscopy) * oct(optical coherence tomography) * vh-ivus(ivus-derived virtual histology) * ivus(intravascular ultrasonography) extended follow-up: considering the nature of functionally insignificant coronary stenosis with vulnerable plaque, most subjects are watched for extended follow-up after the planned 2-year follow-up time point.

Eligibility criteria:
inclusion criteria: * patients aged ≥18 years * patients with suspected or known coronary artery disease who are undergoing invasive cardiac catheterization * patients with at least one significant stenosis (diameter stenosis \>50%) with fractional flow reserve (ffr) \>0.80 and meeting two of the following criteria: 1. mla(minimal luminal area)\<4mm2 2. plaque burden\>70% 3. large lipid-rich plaque on nirs(intracoronary near-infrared spectroscopy), defined as maxlcbi4mm\>315 4. tcfa(thin-cap fibroatheroma) defined as fibrous cap thickness \ 90° on optical coherence tomography (oct) or ≥10% confluent necrotic core with \>30° abutting the lumen in three consecutive slices on virtual-histology intravascular ultrasound (vh-ivus) * eligible for percutaneous coronary intervention with absorb bioresorbable vascular scaffold or everolimus eluting stent * reference vessel diameter 2.75-4.0 * lesion length ≤ 40mm * willing and able to provide informed written consent exclusion criteria: * patients for whom the preferred treatment is cabg(coronary artery bypass grafting) * patients with stented lesions * patients with bypass graft lesions * patients with three or more target lesions * patients with two target lesions in the same coronary territory * patients with heavily calcified or angulated lesions * patients with bifurcation lesions requiring 2 stenting technique * patients with contraindications to or planned discontinuation of dual antiplatelet therapy within 1 year * patients with life expectancy \<2 years * patients with planned cardiac or major noncardiac surgery * woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study

Keywords: coronary intervention vulnerable plaque insignificant stenosis bioresorbable vascular scaffold everolimus eluting stent
a phase iii trial of carboplatin as adjuvant chemotherapy in triple negative breast cancer

Conditions: Breast Cancer

Summary: this study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.

in neo-adjuvant period four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals. in post neo-adjuvant period randomization: at the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin auc 6 group vs. observation group. six cycles of carboplatin (auc=6) on the first day of every 21 days.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of breast cancer 1. female patients 2. histologically confirmed invasive breast cancer 1. primary tumor greater than 2cm diameter, measured by mammography and sonography 2. any n 3. er (estrogen receptor)/ pr (progesterone receptor) / her2 (negative/ negative/ negative)(er \<1%, pr\<1%, ihc 0, 1+ or fish - in case of ihc (immuno-histochemistry) 2+) 4. no evidence of metastasis (m0) 5. no prior hormonal, chemotherapy or radiotherapy is allowed. 6. no breast operation other than biopsy to make diagnosis is allowed. 7. age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ecog 0-1) 8. adequate hematopoietic function: absolute granulocyte count 1500/mm3, platelet 100,000/mm3, hemoglobin 10 g/mm3 9. adequate renal function: serum creatinine 1.5 mg/dl 10. adequate hepatic function: total bilirubin: 1.5 mg/dl, ast(aspartate aminotransferase)/alt (alanine transaminase): 2 times normal, alkaline phosphatase:2 times normal 11. written informed consent 12. normal mental function to understand and sign the consent 13. cardiac function: normal or nonspecific ekg taken within 1 mo of enrollment. 14. lvef (left ventricular ejection fraction)50% by muga (multiple gated acquisition scan) or echocardiogram taken within 1 mo of enrollment exclusion criteria: 1. patients who received hormonal, chemotherapy or radiotherapy for breast cancer 2. patients who underwent surgery for breast cancer 3. patients with a history of uncompensated congestive heart failure 4. patients with inflammatory breast cancer (t4d) 5. patients without primary tumor (t0) 6. patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer 7. known hypersensitivity to any of the study drugs

Keywords: triple negative breast cancer adjuvant chemotherapy
effects of intensive lipid lowering and omega-3 fatty acid on composition of coronary atherosclerotic plaque

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to determine whether intensive lipid lowering and omega-3 fatty acid are effective in the treatment of coronary atherosclerotic plaque.


Eligibility criteria:
inclusion criteria: * acute coronary syndrome within 48 hours of symptom onset * have de novo non-culprit coronary artery stenosis 20% to 70% by visual estimation exclusion criteria: * cardiogenic shock * st segment elevation myocardial infarction within 1 week * hematologic disorder: neutropenia (neutrophil\<3000/mm3), thrombocytopenia (platelet\<100,000/mm3) * liver enzyme elevation: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal * impaired renal function with serum creatinine \> 2mg/dl * bleeding diathesis or history of coagulopathy * pregnancy * hypersensitivity to heparin, dye, aspirin, clopidogrel, statin, or fish

Keywords: ivus-vh plaque characterization omega3-fatty acid atorvastatin
effects of portrayals of successful treatment and role fulfillment on mental illness stigma

Conditions: Mental Illness

Summary: this study aims to measure levels of mental illness stigma based on successful treatment and societal role fulfillment of the individual portrayed with mental illness.

this study aims to measure levels of mental illness stigma based on successful treatment and societal role fulfillment of the individual portrayed with mental illness. this study utilizes eight vignettes portraying two different mental illnesses (depression and schizophrenia), with one vignette giving no details about role fulfillment or treatment, another giving no details about role fulfillment but successful treatment, another giving details on role fulfillment but no treatment, and last giving details on both role fulfillment and successful treatment.

Eligibility criteria:
inclusion criteria: * all adults who consider buyende district their primary residence and who are capable of providing consent exclusion criteria: * minors younger than 18 years of age * persons who do not consider buyende district their primary place of residence
comparison of the frequency-altering ake-1 capsule and pillcam sb2

Conditions: Intestinal Diseases; Gastrointestinal Hemorrhage

Summary: capsule endoscopy has been shown to be the first-line endoscopic procedure for small bowel disease. this study was aimed to compare the performance between the frequency-altering ake-1 capsule and the pillcam sb2 in patients with suspected small bowel disease.


Eligibility criteria:
inclusion criteria: * obscure gastrointestinal bleeding * chronic diarrhea * suspected crohn's disease * chronic abdominal pain * neoplastic lesions of small bowel exclusion criteria: * patients with any contraindication to capsule endoscopy

Keywords: capsule endoscopy
phase ii trial of monoclonal antibody (j591) in combination with low-dose subcutaneous interleukin-2

Conditions: Prostatic Neoplasms

Summary: the monoclonal antibody j591 is being investigated as therapy for patients with prostate cancer, in combination with recombinant interleukin-2 (proleukin, aldesleukin). the study is an open-label, non-randomized phase ii study for patients with documented hormone refractory prostate cancer.

in this phase ii, open label study, patients will receive daily low-dose subcutaneous ril-2 (1.2 x 10\^6 iu/m\^2/day) continuously beginning on day 1. patients will receive 3 weeks of il-2, and on day 22 will receive the monoclonal antibody huj591 via i.v. (25mg/m\^2) for 3 consecutive weeks. il-2 will be continued for 2 additional weeks for a total of 8 weeks. the 8 week regimen will constitute 1 cycle of therapy. patients who have responded to therapy or have stable disease will be eligible for additional cycles of therapy.

Eligibility criteria:
eligibility criteria: * histologic diagnosis (recent or remote) of prostate adenocarcinoma * metastatic or recurrent carcinoma of the prostate defined by abnormal ct or mri and/or abnormal bone scan and/or rising psa. * rising psa on 3 serial determinations over a period of \> or equal to 2 weeks. * psa \> or equal to 1.0 at the time of entry. * if patient is being treated with an lhrh analog the drug: a. must be maintained for the duration of the study or b. must be terminated \> or equal to 10 weeks prior to entry (for 28 day depot preparations) or 24 weeks (for 3 month depot preparations). exclusion criteria: * prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of entry. * history of cns metastasis, and/or history of seizure and/or stroke. * lab values: anc\ 2.0; sgot\>2 x normal; bilirubin (total)\>1.5; serum calcium\> or equal to 11.5. * active serious infection not controlled by antibiotics. * active angina pectoris or nyha class iii-iv. * karnofsky performance status \<60. * life expectancy \< 3 months. * age\< 21y. * other serious illness(es) involving the cardiac, respiratory, cns, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study. * untreated thyroid disease, with the exception of treated and stable hyperthyroidism or hypothyroidism for at least 4 weeks prior to entry.

Keywords: hormone-refractory
massage therapy in premature neonates

Conditions: Neonatal Prematurity; Massage Therapy

Summary: the goal of this clinical trial is to learn about the effects of neonatal touch and massage therapy on premature babies. the main questions it aims to answer are: * do babies who receive neonatal touch and massage therapy get discharged sooner from the nicu * does neonatal touch and massage therapy have a beneficial effect on weight gain, pain and stress responses, and neurodevelopmental outcomes. participants assigned to the treatment group will receive neonatal touch and massage therapy while admitted to the nicu. researchers will compare their outcomes to a control group, receiving standard nicu care, to see if there are any differences in the length of hospital stay, weight gain, pain scores, neurodevelopmental outcomes, and incidence of other common conditions associated with prematurity.

the purpose of this study is to determine the effects of neonatal touch and massage therapy on premature infants in the nicu. babies enrolled in this study will be randomly assigned to receive neonatal touch and massage or standard nicu care. babies in the therapy group will be given neonatal touch or massage therapy by certified providers 3 days per week for 5 to 15 minutes. therapy will be done for a minimum of 4 weeks. the investigators will assess pain and stress responses before and after treatment. the investigators will also review participant's medical records to collect information about weight gain, length of hospitalization, and general health status. after a participant is discharged home, information will be collected about participant's developmental assessments at regularly scheduled nicu follow-up clinic appointments. there are no significant risks with this therapy. potential benefits of therapy include increased weight gain, shorter hospitalization, decreased pain and stress, and improved developmental outcomes. information gained from this study could also help future babies.

Eligibility criteria:
inclusion criteria: * infants born or admitted to university of maryland nicu in the first 14 days of life * gestational age greater than 23 6/7 weeks and less than 32 weeks at birth * deemed medically stable by the medical care team exclusion criteria: * life limiting conditions, including genetic syndromes * cyanotic heart disease * requiring major surgery or critically ill at time of intervention * osteopenia of prematurity with an existing fracture

Keywords: prematurity massage therapy
a study of retrovir in the treatment of psoriasis in hiv-positive patients

Conditions: HIV Infections; Psoriasis

Summary: to evaluate the feasibility of retrovir (azt) in the treatment of psoriasis in hiv antibody positive patients. retrovir has been shown to be effective in the treatment of aids. in addition, the administration of azt appears to have induced a remission of psoriasis in one case study. in light of azt's antiviral activity and potential effectiveness as an agent for the treatment of psoriasis, this would be the most likely treatment for hiv positive, psoriatic patients whose disease progresses quickly.


Eligibility criteria:
inclusion criteria study participants must have biopsy-proven psoriasis with 3 distinct psoriatic lesions. (biopsy-proven reiter's syndrome patients with 3 distinct cutaneous lesions may be included.) documented hiv antibody (by federally licensed elisa test) positive patients. prior medication: allowed: * zidovudine (azt). exclusion criteria co-existing condition: patients with the following are excluded: * presence of any active opportunistic infection. * presence of any aids-defining neoplasms (excluding kaposi's sarcoma) such as central nervous system (cns) lymphoma. * known hypersensitivity to zidovudine (azt). * impaired renal function. * significant hepatic dysfunction. concurrent medication: excluded: - topical steroid, anthralin, or tar preparations. etretinate, methotrexate, or psoralen ultraviolet a (puva) therapy. psoriatic treatment such as systemic agents or topical steroids (emollients used distal to the control lesions and antipruritic shampoos are admissible). patients with the following are excluded: * presence of any active opportunistic infection. * presence of any aids-defining neoplasms (excluding kaposi's sarcoma) such as central nervous system (cns) lymphoma. * known hypersensitivity to zidovudine (azt). * impaired renal function. * significant hepatic dysfunction. prior medication: excluded: * other antiretroviral agents (e.g., suramin, ribavirin, hpa-23, dideoxycytidine). * excluded within 2 weeks of study entry: * topical steroid, anthralin, or tar preparations. * any other experimental therapy drugs which cause significant bone marrow suppression such as antifolates or pyrimethamine. * cytolytic chemotherapy. * drugs which cause significant nephrotoxicity or hepatotoxicity. * rifampin or rifampin derivatives. * excluded within 4 weeks of study entry: * etretinate, methotrexate, or psoralen ultraviolet a (puva) therapy. * excluded within 8 weeks of study entry: * immunomodulating agents, including steroids, interferon, isoprinosine, and interleukin 2.

Keywords: pilot projects psoriasis acquired immunodeficiency syndrome zidovudine
prostate cancer prospective cohort

Conditions: Prostate Cancer

Summary: the overall purpose of this research is to determine if certain genes increase the chance of developing prostate cancer and once diagnosed increase the chance of the prostate cancer spreading to other parts of the body.

dna will be isolated from each person and then studied for the presence of certain genes that may increase the chance of developing prostate cancer. certain genes will also be studied in patients with known prostate cancer to determine if they increase the chance of cancer spreading to other parts of the body and decrease one's chance of being cured. small differences in genes can slightly affect their ability to function. while these differences are normal, they may influence the way the cancer responds to therapy. an understanding of which genes increase (or decrease) the chance of being cured of a disease, such as prostate cancer, will improve our ability to take care of patients more effectively. a second purpose of this study is to collect blood and cancer tissue for future studies. while the small differences in genes may be the best marker of bad cancer, it is also possible that proteins in blood or tumor may be a better marker.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients: 1. newly diagnosis of prostate cancer 2. untreated except for neoadjuvant systemic therapy. exclusion criteria: * newly diagnosed patients: 1. inability to give informed consent

Keywords: metastatic prostate cancer prostate cancer risk assessment
exhaled air temperature (tae) as a marker of airway inflammation in asthma

Conditions: ASTHMA

Summary: the goals : to develop and computerize equipment for measuring itae , compare the results with taep itae study the possible relationship between different markers of inflammation: sputum eosinophils , feno , the itae and taep and see the influence spirometry or a bronchodilator in measuring the itae . it has designed a line of work studying the following aspects : 1. comparison with taep itae in a group of healthy and stable asthmatics 60 patients , 30 asthma and 30 volunteers . two . study of the relationship between the number of eosinophils in sputum, feno , the itae and taep , 30 patients randomly feno , the itae and taep be measured. three . itae measurement before and after the spirometry test , 20 patients , in stable phase will be measured before and after the itae spirometry . april . itae baseline measurement and after administration of 400 micrograms of salbutamol , 20 patients diagnosed with asthma , phase stable , they measure the itae before and fifteen minutes after administration of salbutamol . may . measurement in patients itae a bronchial provocation test with methacholine was performed , 20 patients were measured and baseline itae after administration of methacholine . 6. measuring itae in patients during an asthma exacerbation and stable phase , 20 patients during an exacerbation , the itae be measured. already in clinically stable measurement is repeated.

the goals : to develop and computerize equipment for measuring itae , compare the results with taep itae study the possible relationship between different markers of inflammation: sputum eosinophils , feno , the itae and taep and see the influence spirometry or a bronchodilator in measuring the itae . it has designed a line of work studying the following aspects : 1. comparison with taep itae in a group of healthy and stable asthmatics 60 patients , 30 asthma and 30 volunteers . two . study of the relationship between the number of eosinophils in sputum, feno , the itae and taep , 30 patients randomly feno , the itae and taep be measured. three . itae measurement before and after the spirometry test , 20 patients , in stable phase will be measured before and after the itae spirometry . april . itae baseline measurement and after administration of 400 micrograms of salbutamol , 20 patients diagnosed with asthma , phase stable , they measure the itae before and fifteen minutes after administration of salbutamol . may . measurement in patients itae a bronchial provocation test with methacholine was performed , 20 patients were measured and baseline itae after administration of methacholine . 6. measuring itae in patients during an asthma exacerbation and stable phase , 20 patients during an exacerbation , the itae be measured. already in clinically stable measurement is repeated.

Eligibility criteria:
inclusion criteria: * patients diagnosed with asthma exclusion criteria: * patients unable to perform the maneuver the measurement of the tae
state-wide health approach to increase reach and effectiveness: study 3

Conditions: Obesity

Summary: the investigators have shown that adding an internet behavioral weight loss program to a statewide campaign improves weight loss outcomes. however, our follow-up data suggest that once the intervention is stopped, participants begin to experience weight regain. thus, the purpose of this project is extend this line of work and pilot test health coaches and monetary incentives for weight loss maintenance. the investigators hypothesize that coaching and incentives will improve longer-term weight outcomes.


Eligibility criteria:
inclusion criteria: 1. body mass index \>=25kg/m2 2. english speaking exclusion criteria: 1. health problems that make weight loss or unsupervised exercise unsafe 2. current pregnancy or plan to become pregnant in the next 12 months 3. planned relocation 4. previous participation in shape up rhode island research studies