Kornimate/medical-research-clean huggingface dataset:
ctdna as a biomarker for treatment response in hnscc

Conditions: Carcinoma, Squamous Cell of Head and Neck

Summary: tumours continually shed dna into the circulation, where it can be accessed. this circulating tumour dna (ctdna) directly reflects tumour burden and has great potential to be a sensitive biomarker for treatment recurrence. these "liquid biopsies" could give a more real-time picture of the genomic status and evolution of a tumour and can be easily assessed for measurement of different biomarkers. however, in head and neck squamous cell carcinoma (hnscc) patients treated with primary curative radiotherapy, data regarding ctdna kinetics and its correlation with outcome are scarce. a new or additional tool for response evaluation next to or instead of conventional imaging after treatment would be beneficial to detect recurrences in an earlier stage, thereby increasing the chances of success of salvage therapy. more importantly, an early response parameter during treatment could help to identify patients that have a good treatment response and might benefit from treatment adaptation. with this study, we aim to reveal ctdna as an effective tool for future dose (de)-escalation trials in hnscc.


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * stage ii-iv carcinoma of the larynx, hypopharynx, oral cavity or hpv negative oropharynx or stage ii-iii hpv positive oropharyngeal carcinoma, histologically confirmed according to the american joint committee on cancer (ajcc) staging manual 8th edition * indication for primary curative radiotherapy with or without concurrent radio sensitizer * who performance status 0-2 * signed written ic exclusion criteria: * metastatic disease * radiotherapy with palliative intent * diagnosis of any other malignancy within 5 years prior to start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g. surgery, radiation or castration).

Keywords: ctdna
epidemiology of sleep apnea syndrome

Conditions: Lung Diseases; Sleep Apnea Syndromes

Summary: to define the prevalence of sleep apnea syndrome (sas) in a community-based sample of hispanic adults.

background: the sleep apnea syndrome consists of sleep-induced disturbances of breathing and breathing-induced disturbances of sleep. symptoms of pathologic sleepiness and, less commonly, frequent awakenings and light sleep reflect the fragmentation of sleep by repeated respiration-related arousals. snoring, intermittent choking, and nocturnal dyspnea reflect varying degrees of upper airway obstruction associated with sleep apnea syndrome. observations of breathing during sleep show varying combinations and degrees of periodic breathing, apneas, and hypoxemia. in more severe cases, cardiovascular complications, including systemic and pulmonary hypertension and cardiac arrhythmias, occur. the clinical spectrum thus varies from the asymptomatic patient, to one with chronic cardiac and respiratory failure who is at risk of sudden death. most patients are disabled by varying degrees of pathologic sleepiness. the rapid increase of clinical activity with the sleep apnea syndrome created an urgent need for a more complete description of this condition. clinical descriptions were derived from case series of severely afflicted patients. limited epidemiologic data, however, indicated that symptoms and objective manifestations of sleep apnea syndrome occurred commonly in the population. it was unknown whether subjects with these findings were unrecognized patients, premorbid individuals at risk, or normal subjects with no special impairments. there was a need to define the frequency of signs and symptoms of sleep apnea syndrome in the general population, and to determine the health effects related to these findings. design narrative: subjects were recruited from a previous survey, the belen health study, conducted from july 1984 through november 1985. based on the data of the earlier survey, 421 subjects were identified for recruitment and 275 actually participated. the belen health study questionnaire included items directed at sleep apnea syndrome. subjects for the sleep study were selected based on responses to the initial questionnaire. for the sleep study, an additional questionnaire was used, as well as new techniques of home monitoring of breathing during sleep, and polysomnography to define the prevalence of symptoms and manifestations of sleep apnea syndrome. an assessment of the health effect of sleep apnea syndrome was made by reference to the demographic, socio-economic, and health data from the belen health study. diagnostic criteria and the utility of home monitors for clinical diagnosis were also determined.

Eligibility criteria:
no eligibility criteria
fusion rates and cost analysis of patients undergoing 1st metatarsal phalangeal joint arthrodesis

Conditions: First Metatarsophalangeal Joint Arthritis

Summary: this is a longitudinal, multi-center study to be conducted in at least five institutions from the private surgeon offices. these surgeons will collect data from x-rays, wound complications \\and hardware complications.


Eligibility criteria:
inclusion criteria: * painful hallux limitus or rigidus * painful geriatric hallux valgus * failed prior 1st mtp joint arthroplasty (hemi-total) * arthritis of any etiology other than degenerative causes exclusion criteria: * age less than 18 years * pregnant females * active or prior infection at the target joint * immunocompromised patients * patients unwilling to sign informed consent * patient's unwilling to participate the in study protocol * subject with known sensitivity to titanium implants
efficacy study of school-located influenza vaccination clinics to increase influenza vaccination rates in monroe county, new york

Conditions: Childhood Influenza Vaccination; School-located Influenza Vaccination

Summary: children in schools in which influenza vaccination clinics are held during school hours will have higher rates of influenza vaccination than children in control schools (no school-located clinics offered)


Eligibility criteria:
inclusion criteria: * enrolled in participating, randomized school exclusion criteria: * none

Keywords: influenza vaccination rates
steroid before thyroidectomy

Conditions: Thyroid Surgery for Benign Disease

Summary: we evaluated the effects of giving a single dose of steroid before thyroid surgery in a single institutional, double-blinded, randomized controlled trial. postoperative nausea, pain, and vocal function were significantly improved after steroid administration compared to controls.


Eligibility criteria:
inclusion criteria: * patients undergoing thyroid surgery for benign disease exclusion criteria: * depression * chronic pain disorder * insulin dependent diabetes mellitus * history of ponv * pregnancy * age \< 18 years * received antiemetic therapy within 48 hours

Keywords: thyroidectomy dexamethasone steroid nausea
ecg derived respiration for automated screening of sleep disordered breathing in chronic heart failure patients

Conditions: Heart Failure; Sleep Apnea Syndromes; Polysomnography

Summary: the prevalence of sleep disordered breathing (sdb) reaches more than 50% in chronic heart failure patients (chf). the main consequence is an increase risk of fatal and non-fatal cardiovascular events. a treatment by continuous positive airway pressure (cpap) or adaptative servo-ventilation (asv) reduces this risk. nevertheless, 75% of severe sdb cases remains undiagnosed and untreated especially due to cost and time delay for polysomnography examination which is the gold standard for sdb diagnosis. indeed, alternative methods are developed. some methods, based on nocturnal ecg analysis showed promising results but they are not validated and adapted for cardiac population. thus, the goal of present study is to test the accuracy of ecg derived respiration signal to screen sdb in a chf population.


Eligibility criteria:
inclusion criteria: * chronic heart failure * left ventricular ejection fraction \< 45% * new york heart association (nyha) index ≥ 2 * sleep apnea syndrom confirmed by polysomnography exclusion criteria: * chronic obstructive pulmonary disease with maximal respiratory volume \< 50% * resting oxygen saturation \< 90% * continuous positive airway pressure (cpap) or adaptive servo-ventilation treatment * life expectancy \< 1 year for other medical reasons than heart failure * cardiac surgery * percutaneous transluminal coronary angioplasty * unstable angora during the 6 last months * implantation of a pacemaker or a defibrillator during the 6 last months * cerebrovascular accident or transient ischemic attack during the 3 last months * restless legs syndrome * acute myocarditis or pericarditis during the 6 last months * valvular disease * pregnancy

Keywords: chronic heart failure polysomnography sleep apnea syndromes electrocardiogram
study of cyclodextrin (sbecd) and voriconazole blood concentrations during continuous dialysis

Conditions: Fungal Infection

Summary: this study's primary objective is to determine if continuous renal replacement therapy (crrt) can adequately remove the sulfobutylether-ß-cyclodextrin sodium (sbecd) vehicle from the blood so that intravenous voriconazole can be utilized in critically ill patients with renal dysfunction requiring dialysis. secondarily, the pharmacokinetics of intravenous voriconazole and its metabolite (uk121-265) and adverse effects of sbecd accumulation will also be evaluated. the study hypothesis is that crrt is effective at removing sbecd and allows patients to receive intravenous voriconazole without the concern of sbecd accumulation.


Eligibility criteria:
inclusion criteria: * patients who are receiving continuous renal replacement therapy and are prescribed voriconazole therapy for the treatment or prophylaxis of a fungal infection. exclusion criteria: * patients expected to be on crrt for \< 5 days, * patients with child-pugh c cirrhosis, and * patients who are pregnant.

Keywords: voriconazole sbecd pharmacokinetics renal failure
japanese study of the combined administration of docetaxel with prednisolone for metastatic hormone refractory prostate cancer

Conditions: Therapy, Prostatic Neoplasms

Summary: the purpose of this study is to evaluate the safety of docetaxel administered every 3 weeks repeatedly for 11 and more cycles and in combination with daily prednisolone for metastatic hormone refractory prostate cancer.


Eligibility criteria:
inclusion criteria: patients who completed the 10 cycles of docetaxel administrations in the preceding xrp6976j/2101 study and wish to continue docetaxel administrations,and who have no alternative therapy for hormone refractory prostate cancer according to the investigator's judgment. exclusion criteria: * continuation in the study would be detrimental to the patient's well-being * development of life-threatening and/or toxic conditions not manageable by symptomatic care, dose reduction, or delay of dosing * obvious disease progression (rising prostate specific antigen, any increase of ≥ 20 % in the sum of the measurable lesion in comparison to the nadir value, and progression in non-measurable lesion) * patients treated with anti-cancer treatment other than study therapy after completion of 10 cycles of study treatment in the xrp6976j/2101 study

Keywords: docetaxel, prednisolone, drug combination
follow-up study to evaluate long-term safety and tolerability of immunization with ad03 applied during aff005a

Conditions: Alzheimer's Disease

Summary: this is a phase ib follow-up study to evaluate long-term safety and tolerability of immunization with affitope ad03 applied during affiris 005a.


Eligibility criteria:
inclusion criteria: * written informed consent signed and dated by the patient and the caregiver. * patients having participated in affiris 005a and received ≥1 vaccination with affitope ad03 * availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits and being available for the telephone phone calls exclusion criteria: * patients having received no vaccination with affitope ad03 * history of questionable compliance to visit schedule; patients not expected to complete the clinical trial
sglt2 inhibitors and treatment of heart failure in severe renal insufficiency

Conditions: Heart Failure With Reduced Ejection Fraction; Renal Insufficiency, Chronic

Summary: in the treatment of heart failure (hf), sglt-2 inhibitor (sglt-2i) can significantly improve the clinical outcome and quality of life related to hf. the current data show that sglt-2i is effective and safe in improving hf outcomes in patients with chronic kidney disease (ckd) stage 4, but there is little clinical evidence in patients with egfr\<20 ml/min/1.73 m2. therefore, our research is designed to confirm that sglt-2i can improve the outcome of hf in patients with chronic heart failure with reduced ejection fraction (hfref) and severe chronic renal insufficiency (egfr\<20ml/min/1.73m2).


Eligibility criteria:
inclusion criteria: * age 20-75 years * patients with clinically confirmed chronic heart failure who have received treatment for heart failure according to the guidelines in the past two months, new york heart association (nyha) grade ii-iv * left ventricular ejection fraction (lvef) ≤ 40% in the past 1 year * clinically confirmed chronic renal insufficiency, egfr\<20ml/min/1.73m2 or maintenance hemodialysis exclusion criteria: * allergy to sglt-2i * alt or ast \>3 times the upper limit of normal value; or total bilirubin\>2 times the upper limit of normal value * urinary or reproductive system infection in the last month * blood potassium is greater than or equal to the upper limit of normal value * patients with acute heart failure * patients who need intravenous diuretics before randomization, and the dose is greater than 40mg furosemide, or other equivalent intravenous loop diuretics * patients who need intravenous vasodilators, including nitrates, before randomization * systolic blood pressure\<100mmhg measured during screening or at randomization * hemoglobin\<90g/l * uncontrolled serious arrhythmia * myocardial infarction, unstable angina pectoris, hemorrhagic stroke or ischemic stroke in 90 days before randomization * proliferative retinopathy or macular disease, painful diabetes neuropathy, diabetes foot, diabetes ketoacidosis, hyperglycemic hyperosmolality that needed treatment in 90 days before randomization * patients with malignant tumors * drug or alcohol addicts * patients who have donated or transfused blood within 90 days before randomization, or are expected to donate or transfuse blood during the study period * pregnant or lactating women, or patients who cannot take reliable contraceptive measures during the study period * patients with uncontrolled abnormal thyroid function * type 1 diabetes * not suitable evaluated by the investigator
comprehensive fall prevention and detection in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study is to examine whether an exercise and educational classroom program can help reduce falls in people with multiple sclerosis who fall frequently.

the investigators will recruit 94 people with multiple sclerosis, who report having fallen at least twice in the previous 2 months. participants will be randomized to be placed in either a group that receives classroom training during the study, or into a wait-listed control group that will be offered the classroom training after their participation in the study is completed. all participants will receive mobility and quality of life assessments at baseline, 9 weeks, 5 months, and 8 months. all participants will be asked to record any falls they have on falls calendars. in addition, 30 participants will be randomized to wear electronic fall detectors on their bodies for the duration of the study. these detectors will record when and where falls occur, and this data will be compared with the participants' self-reported falls as recorded on the falls calendars.

Eligibility criteria:
inclusion criteria: * multiple sclerosis of any type, * self-reported history of 2 or more falls in the previous 2 months, * expanded disability status scale of ≤ 6.0 (i.e. able to walk at least 100 meters with or without a walking aid), * be willing and intellectually able to understand and to sign an informed consent, and to adhere to protocol requirements, * have sufficient motor function to complete a written daily record of falls for 8 months, * be community dwelling. exclusion criteria: * have a self-reported musculoskeletal or neurological condition other than ms that is known to affect balance or gait and is associated with falls, such as a lower-extremity joint replacement within the past year, peripheral neuropathy, vestibular disorder, alcoholism, stroke, or seizures. * be unable to follow directions in english, * have unhealed bone fractures or other condition that may put them at risk of injury during balance training and assessments, * blind (visual acuity corrected worse than 20/200), * serious psychiatric or medical conditions that would preclude reliable participation in the study.

Keywords: mobility falls fall prevention gait and balance automatic fall detector
safety and preliminary efficacy of activated recombinant human factor vii in acute intracerebral haemorrhage

Conditions: Acquired Bleeding Disorder; Intracerebral Haemorrhage

Summary: this trial is conducted in asia, europe and oceania. the aim of this trial is to evaluate the safety and preliminary efficacy of activated recombinant human factor vii (novoseven®) in preventing early haematoma growth in acute intracerebral haemorrhage (ich).


Eligibility criteria:
inclusion criteria: * spontaneous ich diagnosed by ct (computerized tomography) scanning within 3 hours of onset * signed informed consent form, or in countries where waiver of informed consent is allowed by irb/iec, a completed waiver form exclusion criteria: * time of onset of symptoms of ich unknown or more than 3 hours prior to ct * patients with secondary ich related to infarction, haemophilia or other coagulopathy, tumour, trauma, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (avm) or severe trauma * surgical haematoma evacuation planned or performed within 24 hours of onset
study of sacituzumab govitecan-hziy and pembrolizumab versus treatment of physician's choice and pembrolizumab in patients with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer

Conditions: Triple Negative Breast Cancer; PD-L1 Positive

Summary: the primary objective of this study is to compare the progression-free survival (pfs) between sacituzumab govitecan-hziy (sg) and pembrolizumab versus treatment of physician's choice (tpc) and pembrolizumab in participants with previously untreated, locally advanced inoperable or metastatic triple-negative breast cancer, whose tumors express programmed cell death ligand 1 (pd-l1).


Eligibility criteria:
key inclusion criteria: * individuals with locally advanced, inoperable, or metastatic triple-negative breast cancer (tnbc) who have not received previous systemic therapy for advanced disease and whose tumors are programmed cell death ligand 1 (pd-l1) positive at screening. * individuals must have completed treatment for stage i to iii breast cancer, if indicated, and ≥ 6 months must have elapsed between completion of treatment with curative intent and first documented local or distant disease recurrence. * individuals presenting with de novo metastatic tnbc are eligible for this study. * tnbc status and tumor pd-l1 combined positive score (cps) will be confirmed centrally on a recent or archival tumor specimen. * individuals must have measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) as per response evaluation criteria in solid tumors (recist) version 1.1 criteria as evaluated locally. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * demonstrates adequate organ function * male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. * individuals with hiv must be on antiretroviral therapy (art) and have a well-controlled hiv infection/disease. key exclusion criteria: * positive serum pregnancy test or women who are lactating. * received prior therapy with an agent directed to another stimulatory or coinhibitory t-cell receptor. * individuals may not have received systemic anticancer treatment (with the exception of endocrine therapy) within the previous 6 months or radiation therapy within 2 weeks prior to enrollment. * individuals may not be participating in a study with an investigational agent or investigational device within 4 weeks prior to randomization. individuals participating in observational studies are eligible. * have previously received topoisomerase 1 inhibitors or antibody drug conjugates containing a topoisomerase inhibitor. * have an active second malignancy. * have active serious infection requiring antibiotics. * individuals positive for hiv-1 or 2 with a history of kaposi sarcoma and/or multicentric castleman disease. * have active hepatitis b virus (hbv) or hepatitis c virus (hcv) infection. * has an active autoimmune disease that has required systemic treatment in the past 2 years. note: other protocol defined inclusion/exclusion criteria may apply.
decision aid to technologically enhance shared decision making

Conditions: Colorectal Cancer

Summary: physicians face a challenge in promoting colorectal cancer screening (crcs) in the face of multiple competing demands. a decision aid (da) that clarifies patient preferences and improves decision quality could aid shared decision making (sdm) and be effective at increasing crcs rates. however, exactly how such da improves sdm is not clear. this 4-year r01 study funded by the national cancer institute seeks to provide detailed understanding of how an interactive da affects patient-physician communication and sdm, and ultimately crcs adherence.

this two-armed randomized controlled trial (300 patients/arm) will compare colorectal web (cw), the interactive da, to a non-interactive control website in ten practices in metro detroit. patients will be adults aged 50 years and over, not current on crcs. in the clinic before the patient-physician encounter, participants will complete a patient baseline survey. they will be randomized to cw or the control website. data will be collected after the patient reviews the respective website (post-intervention survey), during the patient-physician encounter (digital audio recording), and after it (post-encounter survey). chart audit will be performed six months after the encounter to determine whether the patient underwent crcs.

Eligibility criteria:
inclusion criteria: * 50-75 years of age * not current with colorectal cancer screening * scheduled for hme, health maintenance exam, or chronic care visit with participating physician * able to read english * current contact information exclusion criteria: * history of colon cancer or adenomatous polyps * history of dementia or psychosis * contraindication to crcs

Keywords: colorectal cancer screening prevention