Kornimate/medical-research-clean huggingface dataset:
breast cancer, omics, and precision medicine

Conditions: Breast Cancer

Summary: the standard tissue biopsy strategy for cancer detection is not comprehensive enough to profile the whole epi-genomic signatures of breast cancer (bc) and ensure an accurate prognosis and prediction of drug response. liquid-based assays have the potential to reduce the molecular heterogeneity of bc and a possible utility for improving disease management. in particular, genomic dna (gdna) and circulating tumor (ctdna) can be sequenced for genetic and epigenetic (dna methylation) profiling of the bc patients to enhance personalized prognosis and prediction of drug therapy. we describe a study protocol for evaluating the clinical utility of the early use of the network-oriented br(e)2astome algorithm which combine the power of liquid-based assays, advanced epi-genomics platform, and network analysis to identify improve precision medicine and personalized therapy of bc.

the br(e)2astome study will be performed at the u.o.c. patologia molecolare e clinica, university of campania "l. vanvitelli", naples (italy) with a long-standing experience in diagnosis and treatment of bc (refs.). from each study participant, total of 10 ml of pheripheral blood in edta tubes will be collected at time of bc diagnosis. blood-based assays will be performed to obtain genetic and/or epigenetic big data from ct-dna and gdna, respectively. a network-oriented algorithm combined with patient-level clinical information will be applied to big data in order to identify clusters of genes (bc-modules) harboring novel genetic mutations, in the ngs-ctdna bc-group, and differentially methylated regions (dmrs), in the rrbs-gdna group, with a potential predictive and prognostic role in bc management. in the ngs-ctdna-rrbs-gdna group, we will evaluate whether the multi-omics approach is more informative as compared to the single-omic paradigm. bc patients (males and females) will be randomized to the 2 study arms: ctdna-ngs + gdna-rrbs, and standard of care alone. no modifications of intervention assignment will be possible after randomization process of patients. the br(e)2astome study will provide evidence about the potential clinical utility of early use liquid-based assays and network-oriented biomarkers in prognosis and prediction of drug response in bc management. thus, results from br(e)2astome study will bring to identify not only new molecular mechanisms associated with bc, but also non-invasive biomarkers that can direct towards an early diagnosis, contribute to monitor the cancer progression and the response to therapeutic treatment.

Eligibility criteria:
inclusion criteria: * sporadic bc * inherited bc * 18 years old * males and females exclusion criteria: * inflammatory diseases * cardiovascular diseases

Keywords: liquid biopsy dna methylation omics biomarkers network analysis precision medicine
study of cp-461 in patients with advanced renal cell cancer

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to determine the efficacy of cp-461 given twice-daily orally in locally advanced or metastatic renal cell cancer and to evaluate the safety profile of cp-461 in this patient population.


Eligibility criteria:
inclusion criteria: 1. measurable metastatic or locally advanced disease. 2. histologically confirmed renal cell cancer. 3. no radiotherapy within 4 weeks prior to entering the study. no more than 1 prior systemic therapy for advanced disease. prior adjuvant systemic therapy is allowed. patients must have fully recovered from the acute effects of prior therapy. 4. expected remaining life span \> or = three months. 5. ecog performance status 0-2. 6. \> or = 18 years of legal age. 7. male patients, or non-pregnant and non-lactating female patients who are either using adequate birth control, surgically sterile or post-menopausal. 8. negative serum pregnancy test, if fertile female. 9. willingness and ability to sign an informed consent document. exclusion criteria: 1. uncontrolled or symptomatic brain metastases. 2. use of an investigational medication or device within one month of initiating study therapy. 3. absolute granulocyte count \ or = 2.2 mg/dl; ast/alt \> 2.5 uln. 4. any condition or any medication which may interfere with the conduct of the study. 5. current active malignancy other than renal cell cancer.

Keywords: renal renal cell cancer renal cell carcinoma kidney cancer
mastectomy flap temperature study

Conditions: Breast Cancer; Mastectomy

Summary: the purpose of this research study is to measure tissue temperatures and generate a prospective database of participants undergoing mastectomy with or without breast reconstruction at wake forest baptist hospital (wfbh) in order to enable and facilitate the evaluation of important and novel research questions - and quality improvement (qi) ideas/objectives - that may improve the care of breast surgery patients.

primary objective(s) * quantify the proportion of eligible women approached who consent to intraoperative (pre and post mastectomy) measurement of mastectomy flap temperatures in each of 4 quadrants of each relevant breast (i.e., unilateral or bilateral procedure). * quantify the proportion of patients upon whom the surgical team is able to obtain intraoperative flap measurements from each of 4 quadrants on each relevant breast pre- and post-mastectomy and pre-implant. secondary objective: to measure mastectomy flap temperatures in 4 quadrants pre-mastectomy, following mastectomy, and pre-implant, and compare average flap temperature to average core body temperature.

Eligibility criteria:
inclusion criteria: * scheduled for unilateral or bilateral mastectomy with implant based breast reconstruction within the wake forest baptist health system. * aged 18 or older. * ability to understand an irb-approved informed consent document (either directly or via a legally authorized representative). exclusion criteria: those who are male.
upstaging of alh/lcis found on core biopsy based on subsequent excisional biopsy

Conditions: Breast Neoplasms

Summary: the goal of this study is to determine how often patients who have atypical lobular hyperplasia (alh) or lobular carcinoma in situ (lcis) on core needle biopsy of an imaging (found by mammogram or breast ultrasound) abnormality will have associated breast cancer at surgical removal of the area.

patients will undergo a breast biopsy at which the area found to be alh or lcis on core biopsy will be removed surgically through a small incision in the breast. * the surgical biopsy specimen will be carefully examined by a pathologist, and may be useful in guiding further therapy if needed. * in the future, tissue from the surgical biopsy may be used to study genetic changes that may be responsible for cancer formation and prevention. the tissue will be kept for future research for up to 10 years.

Eligibility criteria:
inclusion criteria: * women 20 years of age or older * imaging abnormality necessitating a core needle biopsy * core needle biopsy revealing alh or lcis * patients may have a history of fibroadenoma and/or proliferative breast lesions with atypia exclusion criteria: * history and/or concomitant diagnosis of invasive breast cancer or ductal carcinoma in situ (dcis) * a palpable abnormality diagnosed by core needle biopsy to be alh or lcis * received tamoxifen in the past

Keywords: alh lcis dcis adjacent ipsilateral infiltrating carcinoma core needle biopsy lobular neoplasia of the breast
an evaluation of efficacy of the glidescope cobalt video baton for intubation on children weighing less than 10 kilograms

Conditions: Intubation

Summary: the purpose of this study is to collect relevant airway data using the glidescope cobalt video baton 1 and 2 for intubation in a large cohort of neonates and infants weighing 10 kg or less.

neonates and infants requiring endotracheal intubation and in which the attending anesthesiologist decided to use the cgs-cvb will be included in this observational study. data will be collected by one of the investigators or the research assistant/coordinator and recorded on a data sheet the data from these forms will be then entered by the investigator or research assistant/coordinator into a database maintained only for this study. the decision of using the gs-cvb is at the discretion of the attending anesthesiologist. consequently if consent would be required the anesthesiologist might feel compelled or biased to use the device against his will. this will also require that all possible patients's should be consented which will put a serious strain on the study personal.

Eligibility criteria:
inclusion criteria: * neonates, infants and children scheduled for surgical procedures under general anesthesia and requiring endotracheal intubation * patients age 0 - 2 years * weight up to 10 kg * american society of anesthesiologists physical status i-iii exclusion criteria: * patients at risk of pulmonary aspiration, * increased intracranial pressure * those with congenital cardiac diseases or * those with hemodynamic instability

Keywords: intubation
study confirms or refutes the hypothesis that the autologous bone marrow concentrate together with the allograft is a better alternative for the posterolateral fusion in spine surgery than the allograft alone

Conditions: Spondyloarthrosis, Spondylosis

Summary: the use of autologous mesenchymal stem cell (mscs) in form of the bmc in combination with allograft is an effective option how to enhance the posterolateral fusion (plf) healing. allograft by itself is not an effective material as a posterior onlay graft for the plf in adult surgery.

the study was prospective, randomized, controlled and blinded. eighty patients with degenerative disease of the lumbar spine underwent instrumented lumbar or lumbosacral plf. in forty cases, the plf was done with spongious allograft chips alone (group i). in another forty cases, spongious allograft chips were mixed with bmc (group ii), where the mesenchymal stem cell (mscs) concentration was 1.74 x104/l at average (range, 1.06-1.98 x104/l). patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for ct scanning at 24 months after the surgery. fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.

Eligibility criteria:
inclusion criteria: * degenerative disc disease or degenerative spondylolisthesis exclusion criteria: * vertebral fractures, * infections or spinal neoplasms, * non-rigid instrumentations, * medication affecting bone mineralization (e.g., corticosteroids), * body mass index higher than 35, * systemic diseases, * blood disease and/or immunosuppressant treatment and/or dicoumarol therapy; * immunosuppressant and/or neoplastic and/or infectious diseases.

Keywords: lumbar spine posterolateral fusion allograft bone marrow concentrate mesenchymal stem cells fusion rate
evaluation of wound drainage after knee or hip arthroplasty

Conditions: Complications; Arthroplasty

Summary: to compare side effects and complications relating to use of warfarin or rivaroxaban, tolerance and/or toxicity of these two agents such as drop in hemoglobin post operatively, extent of bruising, quantity of wound drainage, duration of drainage, wound swelling, sub and supra-therapeutic prothrombin times, need for transfusion, and patient tolerance in two randomized groups. return visits to the operating room, length of stay, and vte rates will also be compared.


Eligibility criteria:
inclusion criteria: * all patients over the age of 18 undergoing primary hip or knee replacement by dr. urquhart or dr. hallstrom. exclusion criteria: * patients with a contraindication to pharmacologic vte prophylaxis such as hemophilia, plavix use, active bleeding or prior reaction to warfarin or rivaroxaban, nursing mothers, hepatic disease, gfr \<30, use of more than 200mg of aspirin daily, and inability to continue medication or lab monitoring after hospital discharge known preoperatively.
analysis of a short assessment of post intensive care syndrome (pics)

Conditions: Postintensive Care Syndrome

Summary: to present a proposal for a set of outcome measurement instruments (omis) of post intensive care syndrome (pics) in settings of outpatient healthcare service.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years, whose intensive care treatment has already been completed * the patients were interviewed in the klinikum ernst von bergmann, peumologisches beatmungszentrum, bad belzig, as well as in the pain clinic of the department of anesthesiology and operative intensive care medicine (ccm, cvk), charité - universitätsmedizin berlin exclusion criteria: patients with a legal guardian or authorized representative
effects of saccharomyces boulardii cncm i-745 on antibiotic-associated perturbation in children treated for acute respiratory infections (restore study)

Conditions: Antibiotic Associated Diarrhea; Acute Otitis Media; ACUTE SINUSITIS

Summary: this study aims to evaluate the effect of co-administering the probiotic saccharomyces boulardii cncm i-745 with amoxicillin-clavulanic acid on the intestinal and nasopharyngeal microbiota in children diagnosed with acute otitis media or acute bacterial sinusitis. the trial will also assess the potential of the probiotic to reduce antibiotic-associated diarrhea (aad), antibiotic associated microbiota perturbation, and the spread of antibiotic resistance genes (args).


Eligibility criteria:
inclusion criteria diagnosed with acute otitis medica or acute rhinosinusitis no chronic diseases or recent antibiotic/probiotic use (past 8 weeks) parental consent obtained exclusion criteria: age \ 12 years chronic illness or gi disorders history of antibiotic allergy or immunocompromise malnutrition or obesity recent gastrointestinal surgery

Keywords: antibiotic associated diarrhea probiotic microbiota microbiome saccharomyces boulardii
acute effects of r- and s-mdma in healthy subjects

Conditions: Healthy

Summary: racemic ±3,4-methylenedioxymethamphetamine (mdma) is a psychoactive substance and prototypical empathogen acutely inducing feelings of heightened mood, empathy, trust and closeness to others. these acute subjective effects of mdma may be helpful to assist psychotherapy and mdma is currently investigated in phase 3 trials as a possible treatment in post-traumatic stress disorder.

mdma is a racemic substance containing equal amounts of the enantiomers s(+)- and r(-)-mdma. preclinical research indicates that s-mdma mainly releases dopamine, norepinephrine, serotonin, and oxytocin while r-mdma may act more directly on 5-ht2a receptors and release prolactin. animal studies also indicate that the two enantiomers act synergistically to produce the subjective effects of mdma and that s-mdma is mainly responsible for psychostimulation while r-mdma may have fewer adverse effects and have greater prosocial effects. however, acute effects of s- and r-mdma have never been validly examined in a human study. therefore, the present study compares acute responses to r-mdma, s-mdma, mdma, and placebo in a cross-over study in healthy subjects.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years. 2. understanding of the german language. 3. understanding the procedures and the risks that are associated with the study. 4. participants must be willing to adhere to the protocol and sign the consent form. 5. participants must be willing to refrain from taking illicit psychoactive substances during the study. 6. participants must be willing to drink only alcohol-free liquids and no coffee, black or green tea, or energy drink after midnight of the evening before the study session, as well as during the study day. 7. participants must be willing not to drive a traffic vehicle or to operate machines within 48 h after substance administration. 8. willing to use double-barrier birth control throughout study participation. 9. body mass index between 18-29 kg/m2. exclusion criteria: 1. chronic or acute medical condition 2. current or previous major psychiatric disorder 3. psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain. 4. hypertension (sbp\>140/90 mmhg) or hypotension (sbp\<85 mmhg) 5. illicit substance use (not including cannabis) more than 20 times or any time within the previous month 6. pregnant or nursing women. 7. participation in another clinical trial (currently or within the last 30 days). 8. use of medications that may interfere with the effects of the study medications. 9. tobacco smoking (\>10 cigarettes/day). 10. consumption of alcoholic drinks (\>15 drinks/week).
a study of the new medical device polybactum®

Conditions: Bacterial Vaginosis

Summary: the polaris trial is designed as a multicenter, open label, non-comparative, 3 months, clinical study. interventional, non-controlled, multicenter trial with a prospective design on one cohort of patients

to evaluate the efficacy of polybactum® administered for 3 cycles (one cycle/month) in reducing the rate of recurrence of bv in women cured with vaginal metronidazole and to compare the results of the treatment with the rate of recurrence reported in appropriate selected international literature. therefore, the polybactum® early administration should be able to modify the basal individual risk of bv recurrence.

Eligibility criteria:
inclusion criteria: * women above 18 years. * bv diagnosed by amsel criteria (see annex 3) in the 6-9 days before study, and cured with metronidazole vaginal formulation (gel for 5 days or ovules for 7 days). * diagnosis of rbv (at least 2 episodes of bv in the last 12 months including the bv cured before baseline). * non lactating women or lactating non amenorrheic women. * read and signed informed consent. exclusion criteria: * pregnancy. * candidiasis or mixed vaginitis. * hiv or other immunodeficiency. * known allergy to metronidazole or to polybactum® ingredients. * sex workers. * menstruation or pre-menopause/menopause. * patients concomitantly included in different interventional clinical trials. * unwillingness to provide the informed consent to the trial. * time between the last day of last menses and baseline visit \> 16 days or ≤5 days.

Keywords: recurrence of bacterial vaginosis
li-fraumeni syndrome imaging study

Conditions: Li-Fraumeni Syndrome

Summary: li-fraumeni syndrome (lfs) is a cancer predisposition disorder in which most affected individuals develop cancer during their lifetime. the majority of lfs patients carry a mutation in a gene called tp53, whose normal function is to control cell growth and prevent cells with damaged dna from becoming cancerous. there is currently no way to determine when, where or what type of tumour will develop. this project will use novel techniques utilizing magnetic resonance imaging (mri) to determine how sensitive they are at detecting very small tumors and how specific they are in terms of distinguishing malignant tumors from benign tumors.


Eligibility criteria:
inclusion criteria: * lfs kindreds who either carry a known tp53 mutation or are obligate mutation carriers exclusion criteria: * general contraindications for an mri scan (ferromagnetic prostheses, pacemaker, or other implants incompatible with the magnetic field of the mr scanner), claustrophobia.
bicalutamide implants (biolen) with radiation therapy in patients with localized prostate cancer

Conditions: Prostate Adenocarcinoma

Summary: this study will be undertaken to evaluate the feasibility of replacing systemic androgen deprivation therapy (adt) with targeted local delivery of an anti-androgen agent alone in patients in whom adt + radiation therapy is indicated for the treatment of localized prostate cancer.

this study is a prospective, single-center, single-arm feasibility study. up to 20 participants will be recruited to assess the safety and patient tolerance of biolen for the localized delivery of bicalutamide into the prostate when delivered with radiotherapy. at baseline, patients will undergo multiparametric mri of the prostate. study participants will have placement of the drug eluting biolen implants. at the 8 week timepoint, participants will undergo repeat multiparametric mri. participants will receive standard of care radiation therapy on weeks 9-11 and will be followed through 2 years post radiation. a third and fourth multiparametric mri will be performed at 6 and 24 months after completion of radiation. clinical labs and correlative sample collection and patient quality of life questionnaires will be administered at follow-up visits. following completion of follow-up or removal from protocol, patients may be offered enrollment on long-term follow up protocols.

Eligibility criteria:
inclusion criteria: * patients with biopsy proven localized prostate cancer in whom prostate radiation and adt is appropriate therapy (such as intermediate risk localized prostate cancer) * patients must have at least 1 mri detected; biopsy proven prostate cancer. * patients diagnosed as one of the following: 1. national comprehensive cancer network (nccn) intermediate risk prostate cancer, or 2. nccn high risk prostate cancer due to gleason grade 4 or 5 and refuses to receive systemic adt, or 3. nccn high risk prostate cancer due to prostate specific antigen (psa) \> 20 and refuses to receive systemic adt. * age \>18 years. exclusion criteria: * nccn high risk patients eligible for treatment with systemic adt who do not refuse systemic adt. * patients receiving prior radiotherapy or surgery for prostate cancer. * patients receiving prior or ongoing adt. * study participant unwilling or unable to undergo mri, including patients with contra-indications to mri, such as cardiac pacemakers, non-compatible intracranial vascular clips, etc. * use of 5 alpha reductase inhibitors (e.g. finasteride or dutasteride) within 3 months of screening or total use within the last two years prior to screening of \> 3 months. * prostate volume more than 80 cc at prior mri imaging. * international prostate symptom score ≥ 20.