Kornimate/medical-research-clean huggingface dataset:
gustatory function following radiotherapy to the head and neck

Conditions: Head and Neck Cancer

Summary: the aim of this study is to assess the effect of rt or chemo-rt on chemosensory gustatory function in patients with hnc. by using detailed dosimetric data derived from the rt planning system, we will be able to calculate mean radiation doses to important structures including the anterior and posterior tongue, oral cavity, parotid and submandibular salivary glands, and correlate them with both qualitative and quantitative data for dysgeusia.

this study aims to collect data from patients with hnc undergoing rt or chemo-rt to correlate quantitative chemosensory gustatory function with * detailed dosimetric data for critical structures relevant to perception of taste * fungiform papillae density (fpd) * use of concurrent platinum based therapy * patient reported taste loss using the taste and smell survey (tss) \[14\] * patient reported toxicity and overall qol using university washington quality of life revised version 4 (uw-qol v4) \[15\]. * clinician reported acute and late toxicity using nci common terminology criteria for adverse events version 4.0 (ctcae v4) \[16\] and scale of subjective total taste acuity (stta) \[17\]. * weight (as a surrogate of nutritional status). this study hopes to demonstrate a dose dependent relationship for loss of taste and to develop a dose constraint for preservation of taste. in turn this will serve as a platform for further research to optimise the technical delivery of radiation either in the form of optimised imrt or through the use of intensity modulated proton therapy (impt).

Eligibility criteria:
inclusion criteria: * age \>/= 18 years * undergoing unilateral or bilateral rt or concurrent chemo-rt to the head and neck - region using either a conformal or imrt planning technique or * no restrictions on tumour sub-site * no restriction on tumour histology * no restrictions on radiotherapy dose and fractionation * for entry into the cross-sectional cohort; patients 12 months post completion of unilateral or bilateral rt or concurrent chemo-rt to the head and neck region using either a conformal or imrt planning technique. exclusion criteria: * patients with pre-existing olfactory or gustatory disorders either self-reported or through objective taste function testing. * patients with radiological or clinical involvement of following nerves * facial nerve * chorda tympani * glossopharyngeal nerve * lingual nerve * greater petrosal nerve * geniculate ganglion * patients who have undergone a total or partial glossectomy
phase 1 study of mpc-6827 and carboplatin in recurrent/relapsed glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: this is an open-label, dose finding, multiple-dose study in subjects with recurring/relapsing glioblastoma multiforme. three dose levels of mpc-6827 will be administered with carboplatin to three separate cohorts. study endpoints will include determination of the maximum tolerated dose, dose limiting toxicities, and evaluation of evidence of anti-tumor activity of mpc-6827 when given with carboplatin.


Eligibility criteria:
inclusion criteria: * histologically proven who grade iv glioblastoma multiforme at time of diagnosis or relapse * prior treatment with radiotherapy and temozolomide * evidence of measurable recurrent or residual primary tumor by contrast-enhanced mri * be a minimum of 4 weeks since prior surgical resection, major surgical procedure, radiation therapy or cytotoxic chemotherapy (6 weeks since prior bcnu or ccnu) * have a performance scale of karnofsky \> 60%, ecog \< 2 or who \< 2 * if steroids are needed, be on a stable or decreasing dose of steroids for at least 1 week exclusion criteria: * hypersensitivity to cremophor el * have evidence of current/active intratumor hemorrhage by mri * have greater than second relapse * have had prior treatment with platinum-based chemotherapy * have cardiovascular disease * have cerebrovascular disease * have uncontrolled hypertension * have a cardiac ejection fraction \< 50% * have troponin-i elevated above the normal range

Keywords: recurrent relapsed glioblastoma multiforme
treatment patterns of neratinib in her2+ ebc in china

Conditions: Breast Cancer

Summary: this is a multicenter, open-label, single-arm, non-interventional study to investigate the treatment patterns of neratinib in her2-positive early-stage breast cancer in china


Eligibility criteria:
inclusion criteria: * signed written informed consent approved by the reviewing ethics committee (ec). * adult patients (≥18 years of age, no upper limit). * eligible to receive neratinib for extended adjuvant treatment as per prescribing information in china, diagnosed with her2 overexpressing/amplified early-stage breast cancer regardless of hormone receptor (hr) status and clinical/radiological assessed to be negative for recurrences or metastatic disease. exclusion criteria: * presence of any contraindication with regard to the neratinib treatment. * current or upcoming participation in an interventional clinical trial. (investigational treatment within four weeks of enrolment).
an open protocol for the compassionate use of thalidomide

Conditions: Multiple Myeloma

Summary: the purpose of this study is to evaluate the use of thalidomide for the treatment of cancer. patients with many types of cancers will be enrolled because the researchers will also study how the different cancers respond and what kind of side effects patients will experience.

angiogenesis is a normal, physiological process in the growing embryo, wound healing and ovulation. progressive recruitments of blood vessels to the tumor site are thought to result in a self perpetuating loop helping to drive the growth of tumors. this new vasculature also allows competent tumor cells to find access to the vascular system and facilitate distant spread of tumor cells. neovascularization is apparently an absolute prerequisite for physical expansion of solid tumors to grow beyond the volume of about 1-2 mm in diameter. several molecular and cellular mechanisms have been identified by which tumor parenchyma may exert its angiogenic effect on host endothelial cells. there is also evidence that endothelial cells themselves, like other stromal cells, may act reciprocally to alter the behavior of adjacent tumor cells in a paracrine or cell contact mediated fashion. there is now known to be a diverse family of angiogenic growth factors, foremost among them being basic fgf and vegf. several angiogenic peptide genes have been sequenced and cloned. the degree of vascularization has acquired importance as an independent prognostic indicator in various types of solid tumors. more recently, it has been noted that increased angiogenesis may also be an important feature in hematologic malignancies, e.g. leukemia.

Eligibility criteria:
inclusion criteria * all patients must have a confirmed malignancy which can be classified as locally advanced or distant metastatic disease and must have either 1) failed on standard therapy or 2) have disease for which in the opinion of the investigator, no adequate standard +therapy exists. * patients must be 18 years of age or older. women of childbearing potential must have a negative pregnancy test and fertile women and men must use a medically acceptable means of birth control while on study and for 6 months thereafter. * patients must sign an informed consent to participate in this study. * swog performance status 0-3, unless related to cancer pain. * before starting treatment, women of childbearing potential should have a negative pregnancy test performed within 24 hours prior to beginning therapy. * pregnancy testing is not required for 1) women who have been post-menopausal for at least 2 years with no menses, 2) women who have had a hysterectomy. * patients must have adequate hematologic function as demonstrated by total white blood count \> or = 2000/mm3, adequate renal function as demonstrated by serum creatinine \< or = 3.0 mg/dl, and adequate hepatic function as demonstrated by bilirubin \< or =1.5 mg/dl and transaminases \< or =4 x uln. exclusion criteria * patients must not be eligible for any uams participating clinical trial of higher priority.

Keywords: advanced refractory plasmacytoma myeloma proteins
obinutuzumab and ice chemotherapy in refractory/recurrent cd20+ mature nhl

Conditions: Non-Hodgkin Lymphoma; Burkitt Lymphoma; Diffuse Large B-Cell Lymphoma; Primary Mediastinal B-cell Lymphoma; CD20+ Lymphoblastic Lymphoma; Follicular Lymphoma, Grade III

Summary: the purpose of this study is to determine the safety of administering obinutuzumab as a single agent alone and in combination with ifosfamide, carboplatin, and etoposide (ice) chemotherapy and determine the response rate of this treatment for children, adolescents and young adults (caya) with relapsed cd20 positive b-cell non-hodgkin lymphoma (b-nhl).


Eligibility criteria:
inclusion criteria: * patients in first relapse or primary induction failure cd20 positive b-cell leukemia/lymphoma including: * diffuse large b-cell lymphoma * burkitt lymphoma * high grade b-cell lymphoma: not otherwise specified (nos) * primary mediastinal b-cell lymphoma (pmbl) * cd20+ b-lymphoblastic lymphoma * follicular lymphoma, grade iii * karnofsky ≥ 60% for patients \> 16 years of age and * lansky ≥ 60 for patients ≤ 16 years of age. * myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study. * patients may not have received prior therapy with obinutuzumab (ga101) * radiation therapy (xrt): date of receiving prior xrt must be \> 2 weeks for local palliative xrt (small port); \> 6 months must have elapsed if prior craniospinal xrt or if \> 50% radiation of pelvis; \> 6 weeks must have elapsed if other substantial bone marrow radiation. * steroids: patients may have received prior steroid treatment, but not started greater than 7 days prior to initiation of protocol therapy. * adequate organ function. exclusion criteria: * patients with newly diagnosed, previously untreated b-nhl. * known congenital or acquired immune deficiency. * prior solid organ transplantation. * prior allogeneic stem cell transplant within 60 days or active acute graft-vs-host-disease (gvhd) grade 3 or higher. * history of grade 4 anaphylactic reactions to humanized or murine monoclonal antibodies * uncontrolled hepatitis b and/or c infection
intravenous bolus-infusion versus sliding scale of insulin for intra-operative glycemic control

Conditions: Intraoperative Complications

Summary: pre-operative blood glucose (bg) concentrations in type 2 diabetic patients undergoing elective non-cardiac surgery; have an increased incidence of in-hospital morbidity for cardiopulmonary and infectious complications. also, hyperglycemia is associated with increased production and impaired scavenging of oxygen reactive species, polymorph nuclear neutrophil dysfunction and decreased intracellular killing, resulting in poor wound healing and increased risk of infection. thus, perioperative optimal glucose management contributes to reduced morbidity and mortality. recommendations favor moderate levels of capillary blood glucose (cbg); maintaining it in the range of 140-180 mg/dl. peri-operative doses of rapidly acting insulin for glycemic control could be done by the sliding scale or the bolus-infusion approaches. the sliding scale of insulin is commonly used to manage peri-operative hyper-glycaemia. it involves administering prescribed doses of insulin when the cbg is within determined ranges and withholding insulin when the cbg is within normal range. when used as a sole therapy; it results in under-insulinisation and thus hyper-glycaemia. the use of a dynamic insulin regimen like the intravenous bolus-infusion approach; allows adjusting the blood glucose level according to the insulin sensitivity of each patient, thus, better glucose control and less variations than the intermittent intravenous bolus of short-acting insulin in the sliding scale despite the same blood glucose target.

compare the rapidly acting insulin injection via the bolus-infusion approach (study group) to the sliding scale approach (control group) as regards the intra-operative glycemic control

Eligibility criteria:
inclusion criteria: * asa physical status ii patients * aged 21-65 years * known to have type1 or 2 diabetes mellitusw * pre-operative fasting blood glucose level ˂ 350 mg/dl * scheduled to undergo elective laparotomy surgeries * expected to exceed 2 hours duration under general anesthesia exclusion criteria: * patients' refusal * diabetic ketoacidosis * hyperglycemic hyperosmolar syndrome * serum potassium ˂3.5 meq/l * hba1c \>8.5%.

Keywords: insulin intra operative sliding scale bolus- infusion
futibatinib and pembrolizumab combination in the treatment of advanced or metastatic urothelial carcinoma

Conditions: Advanced and Metastatic Urothelial Cancer

Summary: the purpose of the trial is to evaluate the antitumor activity and confirm the safety for the combination of fibroblast growth factor receptor (fgfr) inhibitor futibatinib and anti-programmed cell death-1 (pd-1) antibody pembrolizumab in patients with advanced or metastatic urothelial cancer who are not candidates to receive a platinum-based treatment regimens.


Eligibility criteria:
inclusion criteria: 1. willing and able to provide written informed consent for the trial. 2. age ≥ 18 years of age 3. histologically confirmed advanced or metastatic urothelial carcinoma who have not received systemic treatment for advanced metastatic disease. 1. cohort a: must have an fgfr3 mutation or fgfr1-4 fusion/rearrangement. 2. cohort b: all other patients with uc (including patients with other fgfr or non-fgfr genetic aberrations and patients with wild-type \[non-mutated\] tumors) 4. unfit for or intolerant to standard platinum-based chemotherapy. 5. have an eastern cooperative oncology group (ecog) performance status (ps) of 0 to 1. 6. adequate organ function. 7. have a measurable disease per recist 1.1 exclusion criteria: 1. have received prior therapy with anti-pd-1, anti-pd-l1/l2 agent or fgfr inhibitor. 2. history and/or current evidence of any of the following disorders: 1. non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the investigator. 2. ectopic mineralization/calcification considered clinically significant in the opinion of the investigator. 3. retinal or corneal disorder considered clinically significant in the opinion of the investigator. 3. has received a live vaccine within 30 days prior to the first dose of study drug. 4. have an active autoimmune disease that has required systemic treatment in the past 2 years. 5. have a history of (noninfectious) pneumonitis that required steroids or has current pneumonitis. 6. have had an allogenic tissue/ organ transplant. 7. has known human immunodeficiency virus (hiv) and/or history of hepatitis b or c infections, or known to be positive for hepatitis b antigen (hbsag)/ hepatitis b virus (hbv) dna or hepatitis c antibody or rna. 8. have known active central nervous system metastases and/or carcinomatous meningitis. 9. has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy. 10. has severe hypersensitivity (≥grade 3) to pembrolizumab and/or any of its excipients.

Keywords: futibatinib pembrolizumab urothelial cancer fgfr tas120 mk3475 b04
the effect of clopidogrel on coated-platelets in patients undergoing cardiac catheterization

Conditions: Coronary Artery Disease; Chest Pain

Summary: this study will explore the effect of clopidogrel on coated-platelets in patients who are given a loading dose before diagnostic catheterization or percutaneous coronary intervention. we hypothesis that clopidogrel will reduce the percentage of platelets that are coated and therefore more hypercoagulable.

platelet activity will be determined by light transmission aggregometry at baseline, after a 300 mg dose of clopidogrel and after the catheterization and/or angioplasty procedure. the change in the percentage of platelets that are coated platelets will be determined.

Eligibility criteria:
inclusion criteria: * patients given clopidogrel loading dose before scheduled catheterization or percutaneous intervention exclusion criteria: * acute coronary syndrome * unable to tolerate clopidogrel

Keywords: platelets, platelet aggregation inhibitors
biomarkers in acute cardiac care

Conditions: Acute Coronary Syndrome; Myocardial Infarction; Chest Pain

Summary: the primary aim of the study is to investigate new cardiac biomarkers and algorithms to diagnose acute coronary syndrome in patients with suspected acute myocardial infarction.

the primary aim of the study is to detect and evaluate new cardiac biomarkers, evaluate and improve acute coronary syndrome (acs) risk scores, which takes into account clinical, gender specific, psycho-social and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint of acute myocardial infarction. secondary study aims are : * to provide estimates for the incidence of acs in patients presenting with recent onset chest pain; * to provide accurate, quantifiable measures of precursors of acs; * dna, rna, cells, and serum/plasma for comprehensive genetic, gene expression and proteomic studies * to explore the impact of acs candidate genes on cardiovascular risk stratification by using genome-wide analyses and a biological systems approach; * to explore proteins relevant for acs; * to allow the identification of new therapeutic targets; * to evaluate the impact of socio-economic factors on acs and cad risk. patients will be followed up during the hospital stay. afterwards a telephone follow-up will take place after 30 days, 6, 24 and 48 months.

Eligibility criteria:
inclusion criteria: * symptoms suggestive of acute myocardial infarction * ability to provide written informed consent in accordance with good epidemiological practice and local legislation * individuals at least 18 years old exclusion criteria: - insufficient knowledge of the german language (able to understand and write the german language)

Keywords: troponin myocardial infarction acs ami biomarker bacc high-sensitivity
neurocognitive function after carotid thrombendarterectomy

Conditions: Carotid Stenosis; Postoperative Cognitive Dysfunction; Neurological Impairment

Summary: previous studies did not reach a consensus on the influence of the type of anesthesiologic procedure and monitoring, during carotid thrombendarterectomy, on perioperative complications and cognitive outcomes. the aim of this study is the optimization of brain perfusion during the vascular carotid clamp using multimodal monitoring. we assume that standardized monitoring techniques and a better selection of cognitive tests will allow a more accurate assessment of subclinical cognitive deficits.

abstract: aim of the study: effect of perioperative multimodal monitoring with transcranial doppler (tcd), near-infrared spectroscopy (nirs), and electroencephalography (eeg) in patients for carotid thrombendarterectomy (cea) on perioperative complications and cognitive functions. patients and methods: the prospective study will analyze 80 consecutive patients with an asymptomatic and symptomatic (transitory ischemic attack, tia, in anamnesis) stenosis of the internal carotid artery in which cea is indicated in general anesthesia. cognitive tests will be analyzed for all patients preoperatively, first and eighth day postoperatively, and after 8 weeks. breath-holding index (bhi) will be measured preoperatively and postoperatively. the first group of patients (n = 40) will have expanded intraoperative monitoring involving tcd, nirs, and eeg, and the control group (n = 40) will have only standard anesthetic monitoring. expected contribution of the study: previous studies did not agree on the influence of the type of anesthesiologic procedure and monitoring of perioperative complications and cognitive outcomes. we assume that standardized monitoring techniques and a better selection of cognitive tests will allow a more accurate assessment of the effect.

Eligibility criteria:
inclusion criteria: * patients with the north american symptomatic carotid endarterectomy trial (nascet) stenosis of more than 70% * symptomatic stenosis * asymptomatic stenosis * elective surgery patients * signed informed consent * initial moca test equal and more than 22 exclusion criteria: * who refuse to participate * previous stroke in anamnesis * patient without bone window for bhi measurements * comorbidities with aphasia and plegia, and the impossibility to solve cognitive tests

Keywords: cea aci cognitive tests bhi nirs tcd eeg
cleansing efficacy of waist-shaped interdental brushes.

Conditions: Periodontitis, Adult

Summary: the aim of the present randomized and single-blinded cross-over study was to compare the cleansing efficacy of waist-shaped interdental brushes with that of cylindric interdental brushes in interproximal sites.

brushing efficacy of cylindric and waist-shaped interdental brushes was evaluated in a randomized, controlled, examiner-blinded, two-period crossover study. 20 periodontal maintenance patients of the university hospital of dental prosthetics and restorative dentistry were recruited. each subject was asked to attend three appointments. in the first visit (day one), baseline plaque and bleeding indices were assessed. each proband was instructed by the same experienced dental hygienist with two sizes of waist-shaped and cylindric interdental brushes, respectively. primary outcome measure plaque index and secondary outcome measure papillary bleeding index were assessed by two blinded and calibrated examiners at four sites per tooth.the odds ratio and confidence interval for establishing plaque free interdental sites were calculated with logistic regression analysis.

Eligibility criteria:
inclusion criteria: * periodontitis stage 3 * completion of active periodontal treatment * maximum probing pocket depths of 5 mm * no site ≥ 4 mm with bleeding on probing * bleeding on probing \< 10% * open interproximal spaces both, in mandible and maxilla * presence of \> 23 natural teeth with no need for prosthetic rehabilitation. exclusion criteria: * oral or systemic diseases other than periodontitis * mucosal / periodontal swelling or suppuration * pregnancy * minority * need for frequent drug consumption

Keywords: biofilm interdental brushes interproximal oral hygiene periodontal disease(s)/periodontitis
zambia healthy choices project for emerging adults living with hiv

Conditions: Pre-Exposure Prophylaxis

Summary: this project will develop and implement a multi-component intervention using mobile health technology to improve hiv self-management and reduce substance use. specifically, the investigators will adapt healthy choices (hc) to develop mobile hc (mhc) and develop motivational text messaging (mtm) for zambian emerging adults living with hiv.


Eligibility criteria:
zambian emerging adults living with hiv inclusion criteria: * aged between 18 and 24 years * report visual analogue scale showing \<80% medication adherence in the last month and problematic/risky alcohol use in the last month * speak english, nyanja, or bemba exclusion criteria: * have a serious cognitive or psychiatric problem that would compromise ability to provide informed consent * currently enrolled in another hiv intervention study

Keywords: pre-exposure prophylaxis (prep) hiv prevention mhealth