Kornimate/medical-research-clean huggingface dataset:
mdct of the coronary arteries in heart transplanted patients

Conditions: Coronary Artery Disease

Summary: heart transplanted patients often develop coronary artery disease and therefore have their coronary arteries examined with coronary angiography once a year.the purpose of the study is to validate computer tomography of the coronary arteries against coronary angiography and intravascular ultrasound in heart transplanted patients. additionally the association between different inflammatory markers and the development of cad specific to heart transplanted patients will be studied.

heart transplanted patients (htx) often develop coronary artery disease (cad) which is a major cause of graft failure and death in this group of patients. therefore, heart transplanted patients have their coronary arteries examined annually. at present this is being done with coronary angiography. recent development of the computed tomography (ct) technology has made it possible to examine the coronary arteries with ct angiography (cta), which is a non-invasive method. the goal of the study is to validate cta against coronary angiography. coronary artery disease lesions in heart transplanted patients differ from cad lesions in native hearts. htx patients develop diffuse intimal thickening affecting the whole length of the vessel starting in the periphery. these lesions specific to htx patients are not depicted on coronary angiography. the second aim of this study is to compare the accuracy of cta depicting such lesions with the gold-standard, intravascular ultrasound. the third aim of this study is to study the association between different inflammatory markers and the development of cad specific to heart transplanted patients.

Eligibility criteria:
inclusion criteria: * heart transplanted patient * age 18 or above. exclusion criteria: * heart transplantation less than a year ago. * renal insufficiency with estimated creatinine clearance \< 50 ml/min. * history of contrast induced nephropathy. * known allergic reaction to ct contrast. * pregnancy * atrial fibrillation * severe heart failure nyha class iv. * hypotension (systolic blood pressure (bp) \< 100 mmhg and/or diastolic bp\<50 mmhg) or hemodynamic unstable patients. * severe pulmonary disease making the patient unable to hold his/her breath in more than 10 seconds.

Keywords: coronary artery disease cardiac transplantation coronary artery disease in heart transplanted patients
depression and body image distress following mastectomy with reconstruction

Conditions: Breast Cancer; BRCA1 Mutation; BRCA2 Mutation

Summary: mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress. reconstructive breast surgery aims to improve patients' psychosocial adjustment to mastectomy, yet for some women substantial distress persists after reconstruction. however, very little is known about risk or protective factors for persistent depression or body image distress following mastectomy with reconstruction. the present study aims to address this critical gap. in women undergoing mastectomy with breast reconstruction, the investigators will assess risk and protective factors for post-surgery depression severity and body image distress.


Eligibility criteria:
inclusion criteria: 1. female adults (age 18+) who are scheduled for mastectomy with immediate breast reconstruction at the massachusetts general hospital (mgh) plastic and reconstructive surgery program 2. english language proficiency 3. ability to provide informed consent. exclusion criteria: 1. current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder 2. current active suicidal ideation 3. current treatment plan includes radiation and/or ongoing chemotherapy 4. does not have access to internet at home, required to complete study questionnaires

Keywords: breast reconstruction mastectomy
telemedicine control tower for the operating room: navigating information, care and safety

Conditions: Surgery; Surgery--Complications; Perioperative/Postoperative Complications

Summary: medical errors account for thousands of potentially preventable deaths each year. with the annual increase of surgical cases there is a need for research into the potential utility of a telemedicine-based control center for the operating room to assess risk, diagnose negative patient trajectories, implement evidence-based practices, and improve outcomes.

this will be a single center, randomized, controlled, phase 3 pragmatic clinical trial. forty-eight operating rooms will be randomized daily to receive support from the act or not. all adults (eighteen years and older) undergoing surgical procedures in these operating rooms will be included and followed until 30-days after their surgery. clinicians in operating rooms randomized to 'intervention' will receive decision support from clinicians in the act. in operating rooms not randomized to receive decision support from the act, the current standard of anesthesia care will be delivered. the intention-to-treat principle will be followed for all analyses.

Eligibility criteria:
inclusion criteria: * all patients 18 years or older undergoing surgery at barnes jewish hospital in st. louis, mo exclusion criteria: -

Keywords: telemedicine anesthesia control tower machine learning forecasting algorithms decision support randomized controlled trial
postprandial endothelial dysfunction after a high-fat meal in hiv-infected men

Conditions: HIV Infection; Cardiovascular Risk; HIV Infections

Summary: the purpose of this study is to examine the postprandial (anytime after a meal) effect of different dietary fats on endothelial function in hiv-infected and hiv-uninfected men.

this study requires two visits. once determined eligible by the study criteria, during the first visit the participant will be randomly placed to receive one of two high-fat meals. the participant will receive the other study meal during the second visit. at each visit, brachial artery ultrasounds will be performed before and 3 hours after the meal is eaten. the sample size is 50 subjects. this study will be conducted at the clinical research center at tufts medical center.

Eligibility criteria:
inclusion criteria: * hiv-positive white male aged \>18 years * under one of the following treatment categories: * treatment naive or have never taken any hiv medications * taking kaletra * taking sustiva * taking atripla exclusion criteria: * smoker * pre-existing diagnosis or treatment for the following: * lipid disorder * cardiovascular disease * high blood pressure * diabetes * acute opportunistic infection or malignancy within last 3 months or current therapy for either * active iv drug use

Keywords: brachial artery ultrasound brachial artery reactivity hiv human immunodeficiency virus cardiovascular risk omega three saturated fat sustiva atripla kaletra treatment naive
comparison between internal jugular vein versus axillary vein for implantable ports

Conditions: Catheter Complications; Cancer

Summary: comparison between internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. investigators are recruiting 240 patients and randomizing 120 for each arm. primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. the follow-up is 12 months.

prospective and randomized trial comparing internal jugular vein versus via axillary vein with single-incision for placement of implantable ports in cancer patients. investigators are recruiting 240 patients and randomizing 120 for each arm in a single center study at ac camargo cancer center. every surgery is assisted by ultrasound and radioscopic and the catheter is districath®, 8.5 french. clinical assessment will be at 10 days and every 3 months after surgery. primary outcome is early complications, until 30 days and secondary outcome late complications, between 30 days and 6 months. the follow-up is 12 months.

Eligibility criteria:
inclusion criteria: * catheter due to chemotherapy. * cancer patients. * ecog (performance status) from 0 to 2. * signed informed consent form. exclusion criteria: * non compliance. * anticoagulant therapy. * coagulopathy (platelet count below 50,000 and/or protrombin time above 18s). * death within 30 days after the procedure. * another catheter in superior vena cava. * previous long term catheter in superior vena cava. * obesity (ibm\>40 kg/m2).

Keywords: implantable port
a prospective study of the kidney protective effect of aliskiren in hypertensive patients with iga nephropathy

Conditions: Glomerulonephritis, IGA; Hypertension

Summary: the purpose of this study is to evaluate the effect of aliskiren, a novel direct rennin inhibitor, on renal function and progress of renal disease in hypertensive patients with iga nephropathy.


Eligibility criteria:
inclusion criteria: * iga nephropathy confirmed by renal biopsy * hypertension (\<= 125/75 mmhg) exclusion criteria: * patients who have been treated with angiotensin type 1 receptor blocker or angiotensin-converting enzyme inhibitor within 4 weeks * severe hypertension (\<= 180/110 mmhg) or secondary hypertension * patients with history of allergy or adverse effect for aliskiren * renal dysfunction (estimated glomerular filtration rate \< 60 ml/min/1.73m2) * pregnancy * patient treated with cyclosporine * hyperkalemia (serum potassium \>= 5.6 mmol/l) * autoimmune disease including systemic lupus erythematosus * patients inadequate for the study

Keywords: aliskiren albuminuria angiotensinogen collagen type iv transforming growth factor beta aldosterone renin prorenin receptor des-angiotensin i renin substrate oxidative stress advanced glycosylation end-product receptor n,n-dimethylarginine
xeltis hemodialysis access graft: axess pivotal study

Conditions: End-stage Renal Disease

Summary: a prospective, single arm, non-randomized pivotal study to evaluate the safety and performance of the xeltis hemodialysis access graft in subjects older than 18 years with end-stage renal disease, who plan to undergo hemodialysis for at least the first 6 months after study access creation.


Eligibility criteria:
inclusion criteria: 1. subjects with end-stage renal disease (esrd) who require placement of an avg in the upper extremity to start or maintain hemodialysis therapy 2. at least 18 years of age at screening 3. suitable anatomy (e.g. a target vein with a minimum diameter of 5mm) for the implantation of an axess graft 4. the patient, or legal representative, has been informed about the nature of the study, agrees to its provisions, and has provided written informed consent 5. the patient has been informed and agrees to pre- and post- procedure follow-up 6. life expectancy of at least 12 months exclusion criteria: 1. history or evidence of severe cardiac disease (nyha functional class iv and/or ef \<25%), myocardial infarction within six months of study enrolment, ventricular tachyarrhythmias requiring continuing treatment, or unstable angina 2. uncontrolled or poorly controlled diabetes 3. abnormal blood values that could influence patient recovery and or/ graft hemostasis 4. reduced liver function, defined as: \>2x the upper limit of normal for serum bilirubin, international normalized ratio (inr) \>1.5 or prothrombin time (pt) \>18 seconds 5. any active local or systemic infection 6. known heparin-induced thrombocytopenia 7. known active bleeding disorder and/or any coagulopathy or thromboembolic disease 8. allergies to study device (nitinol) or agents/medication, such as contrast agents or aspirin, that can't be controlled medically 9. anticipated renal transplant within 6 months 10. known or suspected central vein obstruction on the side of planned graft implantation 11. previous dialysis access graft in the operative limb unless the axess graft can be placed more proximally than the previous failed graft 12. previous enrolment in this study 13. subject is participating in another study 14. pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives 15. any other condition which, in the judgement of the investigator would preclude adequate evaluation for the safety and performance of the study conduit intra-operative exclusion criteria: 1. unsuitable anatomy to implant the axess graft (e.g. target vein and/or artery diameter smaller than anticipated; severe calcification)
randomized customized adjuvant chemotherapy (gecp-scat)

Conditions: Non-small-cell Lung Cancer

Summary: randomized study of customized adjuvant chemotherapy based on brca1 mrna levels in completely resected stages ii-iiia non-small-cell lung cancer patients.

randomized, phase iii, predictive pharmacogenomic, open, prospective, international, multicenter study in patients with non-small-cell lung carcinoma (nsclc) after complete resection and with n1 or n2 involvement

Eligibility criteria:
inclusion criteria: * patients with histological confirmation of non-small-cell lung carcinoma. * complete surgical resection of the disease. * tumoral tissue available for molecular analysis. * n1 (stage ii) or n2 (stage iiia) lymph node involvement in the study of the operative piece. * men or women age 18 years or older. * patients with a performance status of 2 or less according to the ecog classification. * patients with the following laboratory results: anc \< 1500/l, hb \< 10 g/dl, platelets \<100,000/l, bilirubin \< 1.0 mg/dl, ast and alt \< 1.5 upper limit of normality, creatinine clearance \< 60 ml/min. * complete recovery from surgery within 6 weeks. * patients who have given written informed consent before initiating any specific study screening procedure. exclusion criteria: * patients who have received previously chemotherapy or radiotherapy for the study disease. * impossibility of complying with chemotherapy treatment due to cultural or geographic circumstances. * patients with active infection, heart disease, or any other serious disease, in the judgment of the investigator. * women who are pregnant or in the period of lactation. * patients with a previous diagnosis of malignant disease in the last five years except for carcinoma in situ of the uterine cervix or skin cancer other than melanoma. * patients under treatment with investigational agents.

Keywords: scat brca1 brca1 mrna levels adjuvant lung gecp-scat
personalized hiv and sti testing tool

Conditions: Risk Reduction; HIV; Sexually Transmitted Infections (Not HIV or Hepatitis)

Summary: the phastt study is focused on understanding of facilitators and barriers to mhealth use among young black men who have sex with men (msm), and testing a novel mobile app to increase hiv/sti testing and prep uptake.

the sex pro mobile application (app) being tested facilitates home hiv-testing, home sexually transmitted infection (sti) test self-collection, and pre-exposure prophylaxis (prep) uptake. the app integrates a personalized hiv risk assessment with home hiv and sti testing options for young, black msm.

Eligibility criteria:
inclusion criteria: * self-identify as black. * self-report being hiv negative. * report anal sex with at two or more male sex partners in the prior 12 months. * own an ios or android mobile phone. * willing and able to give written informed consent to participate in all activities outlined by the protocol. exclusion criteria: * inadequate contact information for follow-up * in a mutually monogamous sexual relationship for the past 12 months * currently taking prep * does not have reliable access to the internet * does not live, work or play in the san francisco bay area * currently enrolled in another hiv intervention study * prior enrollment in an hiv vaccine trial with receipt of experimental vaccine product * any medical, psychiatric, or social condition, or occupational, or other responsibility that, in the judgment of the investigator, would make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Keywords: mhealth hiv prevention
single dose study of pf-06815345 in healthy subjects

Conditions: Hypercholesterolemia

Summary: the current study is the first clinical trial proposed with pf-06815345. it is designed to evaluate the safety, tolerability, and pharmacokinetics (pk) following administration of single oral doses of pf-06815345 to healthy adult subjects.


Eligibility criteria:
inclusion criteria: * healthy males and female of non-childbearing potential; * age of 18-55, inclusive; * body mass index 17.5-34.9 kg/m2, inclusive; * body weight \>50 kg; * not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose. exclusion criteria: - evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)

Keywords: healthy subjects single ascending dose hyperlipidemia dyslipidemia
imaging of traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: this project aims to study the prognostic ability of various mri imaging markers in the evaluation of tbi patients. cognitive, social, and occupational recovery will be measured at each time point, and compared to mri findings. healthy volunteers will serve as a comparison to the tbi patients. it is hypothesized that novel mri markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.

the goal of this study is to identify advanced magnetic resonance imaging markers that can serve as a prognostic marker in the evaluation and management of traumatic brain injury patients. magnetic resonance imaging and cognitive testing (when possible) will be performed in the acute (within 10 days following injury), and recovery stages (about 1 month, about 6 months,and about 18 months). the relationship between the advanced magnetic resonance imaging markers and the clinical condition of the patient will be evaluated at each time point to determine which combination of imaging markers best describe the current clinical status of the patient and which markers best predict a patient's outcome status.

Eligibility criteria:
inclusion criteria: * age 18 or older * evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status. * residence within 90 minutes driving time of university of maryland medical center, and willingness to attend follow-up appointments. exclusion criteria: * history of white matter disease or neurodegenerative disorders including multiple sclerosis, huntington's disease, alzheimer's disease, or pick's disease. * history of stroke * history of treatment or diagnosis of psychiatric conditions: major depressive disorder (mdd), bipolar disorder (bpd), schizophrenia, or dementia of any type. * history of brain tumor * status post trauma due to asphyxiation * preexisting contraindications for magnetic resonance imaging (mri) * active duty military status * police custody or prisoner status * pregnant women

Keywords: diffusion tensor imaging magnetic resonance spectroscopy traumatic brain injury metabolite changes cerebral perfusion hemorrhagic burden
strategies for improving linkage-to-care after eye disease screening

Conditions: Age Related Macular Degeneration; Diabetic Retinopathy; Glaucoma

Summary: the goal of this randomized, parallel-group, controlled trial is to compare methods of enhancing linkage-to-care for participants in the village integrated eye worker ii (view ii) trial who are referred to the eye hospital following eye disease screening. participants who are referred to the hospital at an eye screening visit will be randomized to three different linkage-to-care interventions: (1) text message reminders, (2) reminders from community health workers, or (3) no intervention. the primary outcome of the trial will be whether or not the participant presented to the eye hospital for a referral visit by 21 days following screening.


Eligibility criteria:
inclusion criteria: - participant of the view ii study referred to the eye hospital at their eye screening visit. exclusion criteria: * residence in a community without reliable mobile connectivity

Keywords: eye diseases mass screening patient compliance retention in care
the impact of food order on glycemic excursions in type 2 diabetes assessed by continuous glucose monitoring

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to explain the effect of food order/nutrient sequencing on glycemic excursions over a 2 week period, utilizing a device known as a continuous glucose monitor (cgm), for people who have been diagnosed with type 2 diabetes mellitus and treated with metformin. this research study is being done because recent studies demonstrate that besides carbohydrate amount and type, the sequential order of macronutrient consumption during a meal has a significant impact on post-meal glucose levels.


Eligibility criteria:
inclusion criteria: * metformin-treated type 2 diabetes of less than 10 years duration * must be on a stable dose of metformin for at least 1 month * hba1c ≤8.5 percent exclusion criteria: * relevant food allergies * oral steroid therapy within 90 days of enrollment * anti-diabetic medications other than metformin * history of bariatric surgery * pregnant women * any participant deemed unsuitable in the investigator's opinion

Keywords: diabetes nutrient sequence food order continuous glucose monitoring cgm t2dm glycemic excursion glp-1 ghrelin insulin cck pyy c-peptide metformin diet
g-csf+dac+bucy vs g-csf+dac+bf conditioning regimen for secondary acute myeloid leukemia undergoing allo-hsct

Conditions: Secondary Acute Myeloid Leukemia Evolving From MDS; Allogeneic Hematopoietic Stem Cell Transplantation; Conditioning

Summary: allo-hsct is the most effective way to cure saml patients. at present, the best conditioning regimen for saml patients undergoing allo-hsct remains in discussion. in this prospective study, the safety and efficacy of g-csf+dac+bucy and g-csf+dac+bf conditioning regimens in saml patients undergoing allo-hsct are evaluated.

allo-hsct is the most effective way to cure secondary acute myeloid leukemia evolving from mds (saml) patients. at present, the best conditioning regimen for saml patients undergoing allo-hsct remains in discussion. our previous study has showed that g-csf+dac+bucy conditioning regimen could reduce the relapse and improve the survival compared with bucy conditioning regimen, while the two conditioning regimens both have high non-relapse mortality (nrm). several retrospective and prospective studies including ours have demonstrated that bf conditioning regimen has a lower nrm compared with bucy conditioning regimen, while the relapse and survival are similar in patients undergoing bf and bucy conditioning regimens. based on the above, we design the prospective randomized controlled study to evaluate the safety and efficacy of g-csf+dac+ bucy and g-csf+dac+bf conditioning regimens in saml patients undergoing allo-hsct.

Eligibility criteria:
inclusion criteria: * had a diagnosis of saml * age 18 to 65 years old * ecog performance status of 0-2 * hct-ci of 0-2 * were willing to undergo allo-hsct exclusion criteria: * therapy-related mds * previous allo-hsct * uncontrolled infections * liver or renal dysfunction * severe concomitant conditions not suitable for the trial