Kornimate/medical-research-clean huggingface dataset:
post-treatment surveillance in hpv+ oropharyngeal scc

Conditions: HPV; Oropharyngeal Squamous Cell Carcinoma

Summary: in this research study the investigators are examining a blood test to detect hpv dna in the blood that can possibly detect cancer recurrence earlier than with standard surveillance measures.

this research study involves blood tests to detect hpv dna at regular time points after treatment for hpv-positive oropharyngeal squamous cell carcinoma (hpv-opc). participants may undergo scans based on the results of the blood tests. study participants will also be asked to complete quality of life questionnaires periodically. participation in this study may last for up to 3 years. it is expected that about 150 people will take part in this research study.

Eligibility criteria:
inclusion criteria: * participants must have histologically or cytologically confirmed incident or recurrent squamous cell carcinoma of the tonsil or base of tongue (oropharynx) - includes biopsy of any lymph node with clinical evidence of an oropharynx tumor (unknown primary carcinoma in an involved cervical neck lymph node is permitted if high-risk hpv testing is positive on the involved node) * hpv-associated tumor as defined by one or more : positive p16 immunohistochemistry (\>70%) or in situ hybridization or pcr-based methods * age 18 years or older * will undergo oropharyngeal cancer treatment with curative intent * ability to understand and the willingness to sign a written informed consent document. * baseline positive or detectable cthpv dna result in plasma or detectable corresponding hpv dna in tumor tissue prior to treatment exclusion criteria: * distant metastatic disease (m1, ajcc 8th edition)

Keywords: hpv oropharyngeal squamous cell carcinoma hpv + oropharyngeal squamous cell carcinoma
metabolic syndrome and female breast cancer

Conditions: Breast Cancer

Summary: the role among metabolic syndrome and breast cancer risk is not well understood and must be further explored. the objective of this study is to evaluate the association between metabolic syndrome and breast cancer in southern brazil. in this case-control study, breast cancer patients and controls without malignant disease, matched for age (±5 years) and menopausal status, were interviewed and asked to make a glucose, hdl-cholesterol and triglycerides test. waist circumference and blood pressure were measured using standardized procedures. metabolic syndrome was considered by ncep atp iii (2001) and idf (2006) definitions. cases and controls were compared in relation to the presence of diagnosed mets (yes/no), number of metabolic abnormalities identified (1 to 5) for each definition, and according to each metabolic abnormality cutoff point.


Eligibility criteria:
inclusion criteria: * for cases: having newly diagnosed breast cancer without adjuvant or neoadjuvant treatment; * for controls: having no evidence of cancer; be matched for age and menopausal status with controls exclusion criteria: * women with a recidivated tumor, hiv infection, renal, heart or liver disease, hypothyroidism or hyperthyroidism, mobility or neurological limitations, chronicle use of corticosteroids, pacemakers or identified with severe edema were excluded.

Keywords: metabolic syndrome case-control study breast cancer
hiv and hepatitis care coordination in methadone treatment

Conditions: Hepatitis, Viral, Human; HIV Infections

Summary: this randomized clinical trial will examine the effectiveness of a strategy of hiv and hepatitis care coordination (hcc) consisting of testing, education, counseling and vaccination for methadone maintenance patients compared with standard testing, education, and counseling (tec).

in the hcc model, hiv and hepatitis screening, and hav and hbv vaccination will be done on site and participants receive on site theory-based hiv and hepatitis education, counseling, and case management to promote adherence to hiv and hcv evaluation; in tec hepatitis screening is done on site, but vaccination and medical care will be provided by off site referral. primary aims are to assess the impact of the hcc intervention on adherence to hepatitis a virus (hav) and hepatitis b virus (hbv) vaccination and attendance at an initial appointment with an hiv and/or hcv care provider. secondary aims include examining intervention effects on hiv and hepatitis knowledge, risky behaviors, alcohol use; follow-up with later stages of hiv and hepatitis c care; to identify psychological mediators of intervention outcomes; and to estimate the incremental cost of the hcc intervention to facilitate fuller economic evaluations of the intervention if proven effective.

Eligibility criteria:
inclusion criteria: * \>=18 years of age * be able to provide informed consent * agree to participate in hepatitis/hiv intervention * expect to be available to participate in the study for the entire duration of the study * hcv negative, of unknown hcv status, or have not received any previous medical care for hcv exclusion criteria: * have already had a formal hepatitis c evaluation * are obtaining medical care for hepatitis c * not interested in obtaining medical care for hepatitis

Keywords: hiv viral hepatitis methadone maintenance case management costs vaccination risk reduction education
mental fatigue and industrial work performance

Conditions: Healthy; Mental Fatigue; Industrial Work; Robotics

Summary: to investigate the effect of mental fatigue on industrial work performance, biomechanical determinants, (electro-)(psycho-) physiological measures and physical ergonomics. additionally, the current project wants to evaluate whether or not the laevo exoskeleton influences the aforementioned parameters when mental fatigue is acutely induced.


Eligibility criteria:
inclusion criteria: * healthy * males and females * 18-64 years exclusion criteria: * musculoskeletal disorders * neurological disorders * cardiovascular disorders * pregnancy
short term cardiovascular effects and oxidative status of calcium and vitamin d supplementation of postmenopausal hypertensive blacks women

Conditions: Hypertension; Postmenopausal Disorder

Summary: this study aims to determine the effect of calcium and vitamin d supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in yaoundé, cameroon. this study is a double-arm, double-blind, randomized and parallel clinical trial conducted at the yaoundé central hospital

aim: to determine and compare the short term effect of calcium and vitamin d supplementation on oxidative status and blood pressure profile of postmenopausal patients with high blood pressure in yaoundé, cameroon. method: a double-arm, double-blind, randomized and parallel clinical trial conducted at the yaoundé central hospital. postmenopausal hypertensive blacks women who are taking taking antihypertensives drugs since 12 months,without diabetes mellitus or any inflammatory disease or hypercalcemia, are randomize into 2 groups. depending on the group, the intervention consisted of the administration of calcium 1000 mg daily or vitamin d/calcium 1000 mg/800 ui daily for 08 weeks. the endpoints were the nycthemeral blood pressure profile, pro oxidant marker (malondialdehyde) and anti-oxidant marker (ferric reducing antioxidant). progress: recruitment for this study was completed in may 2019 with 22 patients.

Eligibility criteria:
inclusion criteria: * post menopausal hypertensive women since 12 months * on a stable antihypertensive therapies (determined by the investigator) for at least 3 months with no classes changes. * before any study-specific procedure, the appropriate written informed consent must be obtained. exclusion criteria: * diabetes mellitus or inflammatory diseases * hypercalcemia, * side effects affecting life quality of patients (determined by the data safety monitoring board). * withdrawal of consent

Keywords: blood pressure oxidative status
a study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of asc47 in combination with semaglutide

Conditions: Chronic Weight Management

Summary: this will be a phase i, randomized, double-blind, placebo-controlled. this study will be conducted in three periods: the screening period, the treatment period, and the follow-up period.


Eligibility criteria:
inclusion criteria: * subject have provided informed consent before initiation of any study specific procedures * females who are not pregnant or breastfeeding, or do not plan to become pregnant within 6 months and are willing to use effective contraceptive measures from the first dose of the investigational product until 3 months after the last dose are eligible. * no clinically significant findings from medical history, physical examination, 12-lead ecg, vital signs measurements, and other screening procedures, e.g., clinical laboratory evaluations (congenital non-hemolytic hyperbilirubinemia as assessed by the investigator (or sub-i). * stable body weight (less than 5% self-reported change within the previous 3 months) exclusion criteria: * have obesity traced to a medical cause, suggestive of genetic or syndromic obesity or obesity induced by other endocrinologic disorders, such as hypothyroidism, cushing syndrome, prader-willi syndrome and other conditions. * have a history of active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years. * have a positive alcohol or drug screen at screening or have a history of alcohol or drug abuse within the past 1 year. * have an autoimmune disease, is immunosuppressed or is in any way immunocompromised. * have received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 half-lives of the experimental agent (exception of placebo) prior to the start of the treatment.
symptom-driven referral for evaluation of chronic thromboembolic disease or pulmonary hypertension in patients with previous acute pulmonary embolism

Conditions: Chronic Thromboembolic Pulmonary Disease

Summary: aim: to investigate if a symptom driven referral for chronic thrombosis in the lungs after acute pulmonary embolism is better than the current approach. background: a number of patients with chronic thrombosis in the lungs after acute pulmonary embolism have dyspnea and reduced functional capacity without elevated pulmonary arterial pressure at rest (cted). however, current guidelines for follow-up after acute pulmonary embolism will miss all patients with cted, as referral for further examination is based on elevated pulmonary arterial pressure on echocardiography. thus, the prevalence of cted is unknown. the hypothesis is, that a symptom-driven referral of patients with previous acute pulmonary embolism is more sensitive in diagnosing cted than the current approach. methods and materials: patients diagnosed with acute pulmonary embolism in region midt (approx. 350 per year) will be screened for non-recovery or persistent pulmonary embolism related symptoms during their 3-6 months follow up at their local outpatient clinic. if the patient has persistent symptoms they will be referred to a scintigraphy. if cted is suspected from the scintigraphy, the patient will be referred for full cted work-up. the investigators expect to screen 300 patients for persistent symptoms with an expected study time of 3 years.


Eligibility criteria:
inclusion criteria: * acute pe diagnosed by ct or v/q-scan within the last year. * non-recovery or persistent pe related symptoms assessed by a mrc breathlessness score or who functional class. * age \>= 18 and \< 80 exclusion criteria: * contraindications or unable to perform 6 minutes walk distance (6mwd) and/or cardiopulmonary exercise test. * contraindications to ct pulmonary angiography. * congestive heart failure (lvef \<40%). * copd or restrictive lung disease, severe or worse (fev1 \ =1 exacerbation causing hospital admission per year (gold grade 3 and 4 class c and d)). * lactating or pregnant. * unable or unwilling to provide written informed consent. * paroxysmal or persistent atrial fibrillation. * other known cause of pe related symptoms.
a phase 1, study of bmf-500 in adults with acute leukemia

Conditions: Acute Myeloid Leukemia

Summary: a phase 1 first-in-human dose-escalation and dose-expansion study of bmf-500, an oral flt3 inhibitor, in adult patients with acute leukemia.

a phase 1 first-in-human dose-escalation and dose-expansion study of bmf-500, an oral covalent flt3 inhibitor, in adult patients with acute myeloid leukemia (aml), who may or may not be on antifungals.

Eligibility criteria:
key inclusion criteria: * age ≥ 18 years. * individuals with histologically or pathologically confirmed diagnosis of relapsed or refractory aml with documented flt3 mutation, and/or individuals with histologically or pathologically confirmed diagnosis of their malignancy with wild-type flt3 (including those with mll1-r and npm1 mutations). * ecog performance status of 0-2. * adequate liver and renal function * adhere to the cyp3a4 inhibitor concomitant therapy use requirements, as follows: * arm a: participants must not have received a moderate or strong cyp3a4 inhibitor for at least 7 days prior to enrollment and are not anticipated to require such agents in the near term (for at least 4 weeks). * arm b: participants must have received a necessary azole antifungal(s) that is a strong cyp3a4 inhibitor (excluding other strong cyp3a4 inhibitor\[s\]) for at least 7 days prior to enrollment and be able to continue such azole antifungal(s) while on bmf-500 treatment for at least 4 weeks. * arm c: participants must have received necessary azole antifungal(s) that are moderate cyp3a4 inhibitors (excluding other moderate cyp3a4 inhibitors) for at least 7 days prior to enrollment and be able to continue such azole antifungal(s) while on bmf-500 treatment for at least 4 weeks (cycle 1). key exclusion criteria: * significant cardiovascular disease including unstable angina pectoris, uncontrolled hypertension or arrhythmia, history of cerebrovascular accident including transient ischemic attack within 6 months prior to the first dose of the trial intervention. * wbc count \>50,000/µl (uncontrollable with cytoreductive therapy). * women who are pregnant or lactating or plan to become pregnant.

Keywords: flt3 flt3-itd flt-tkd aml flt3 wild-type mll-r npm1 cyp3a4
clinical study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: study to evaluate if macitentan is efficient, safe and tolerable enough to be used for treatment of inoperable chronic thromboembolic pulmonary hypertension (cteph).


Eligibility criteria:
inclusion criteria: * written informed consent * subject with cteph (who group 4) judged as inoperable due to the localization of the obstruction being surgically inaccessible (i.e., distal disease). * female of childbearing potential must have a negative pre-treatment serum pregnancy test, be advised on appropriate methods of contraception, and agree to use 2 reliable methods of contraception. exclusion criteria: * previous pulmonary endarterectomy. * recurrent thromboembolism despite sufficient oral anticoagulants. * symptomatic acute pulmonary embolism in the 6-month period prior to randomization. * known moderate-to-severe restrictive lung disease (i.e., tlc \< 60% of predicted value) or obstructive lung disease (i.e., fev1 \< 70% of predicted, with fev1/fvc \< 65%) or known significant chronic lung disease diagnosed by chest imaging (e.g., interstitial lung disease, emphysema). * acute or chronic conditions (other than dyspnea) that limit the ability to comply with study requirements in the 3-month period prior to screening visit or during the screening period.

Keywords: chronic thromboembolic pulmonary hypertension (cteph)
indicators predicting surgery in acute severe ulcerative colitis(asuc)

Conditions: Ulcerative Colitis Acute; Surgery

Summary: acute severe ulcerative colitis \[asuc\] patients have high risk of no response to medical treatments and might miss the best timing for surgery when waiting for the medical response. thus, we investigated whether biomarkers which could early predict the surgery risk of patients with asuc on admission.


Eligibility criteria:
inclusion criteria: the inclusion criterion was patients clearly diagnosed as acute severe ulcerative colitis. exclusion criteria: patients younger than 18 years-of-age, complicated with malignancy in colon and pregnant were excluded.

Keywords: acute severe ulcerative colitis predictive indicator surgery
drug-drug interaction study(ckd-501, amlodipine)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to assess the pharmacokinetic drug interaction between ckd-501 and amlodipine after oral administration in healthy male volunteers.

volunteers doses three times over the period of ckd-501 0.5mg or amlodipine 10mg alone/co-administrate, repeated doses are 10 days.

Eligibility criteria:
inclusion criteria: * between 20 aged and 45 years old in healthy males * body weight ≥ 55kg and 18.5 ≤ ibw \< 25 * agreement with written informed consent exclusion criteria: * subject has a history affects the adme of drug * hypersensitivity reactions to drugs or clinically significant hypersensitivity reactions in the history of party * inadequate subject by medical examination(medical history, physical examination, ecg, laboratory test) * ast,alt \> unl \* 1.25 or total bilirubin \> unl \* 1.5 * estimated gfr(mdrd) \< 80 * sbp \>150 mmhg, sbp \ 100 mmhg, dbp \ 100 per/min, pulse \< 50 per/min * substance abuse, or a history of drug abuse showed a positive for the party * continued to be taking caffeine (caffeine \> 5 cup/day), drinking (alcohol \> 210 g/week) or cannot stop drinking or severe heavy smoker(cigarette \> 10 cigarettes per day)during clinical trials * medication with drug-mediated induction/inhibition metabolic enzyme within 30 days or with may affect the clinical trial * medication within 2 weeks in the first professional medical, medicine, otc, vitamins taking * subject takes grapefruit within 1 month * previously participated in other trial within 60 days * previously donate whole blood within 60 days or component blood within 30 days * an impossible one who participates in clinical trial by investigator's decision including laboratory test result

Keywords: drug-drug interaction between the ckd-501 and amlodipine
vr and scrip training of pwa, randomized controlled trial

Conditions: Aphasia, Acquired; Chronic Stroke

Summary: the goal of this rct is to investigate if computerized script training may promote functional communication and nonverbal cognitive functions of cantonese-speaking pwa, and whether vr may further magnify the treatment outcomes. the main research questions are: 1. can script training promote verbal functional communication of cantonese-speaking pwa? 2. can script training enhance nonverbal cognitive functions of cantonese-speaking pwa? 3. can vr magnify verbal and nonverbal treatment outcomes of script training of pwa?


Eligibility criteria:
inclusion criteria: 1. a stroke onset more than six months, with an aphasia quotient (aq) below 96.4, as evaluated by the cantonese version of western aphasia battery (cab; yiu, 1992), 2. premorbid fluent cantonese speakers, 3. aged between 30 and 80 years, 4. no reported progressive neurogenic disorders such as dementia or parkinson's disease, 5. no motor speech disorders of moderate to severe level, and 6. normal or corrected-to-normal vision and hearing functions exclusion criteria: 1. concurrent participation in other aphasia treatment trials, and 2. incompatibility with immersive vr exposure such as complains of nausea, headache, or other severe discomforts during trial use of a head-mounted device during screening.

Keywords: functional communication randomized controlled trial script training immersive reality aphasia intervention
veracity surgical: a time/motion and quality of care study

Conditions: Cataract

Summary: this study aims to compare the time required for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

this study aims to compare the time commitment for surgical planning using these two methods and to explore whether differences in surgical accuracy can be identified in a small study of 40 patients.

Eligibility criteria:
inclusion criteria: * patients at least 18 years of age with upcoming cataract surgery. at least 25% of enrolled eyes must be post-refractive, and 25% must require astigmatic planning (arcuate incision or toric iol) * patients with otherwise healthy eyes, not exhibiting any significant ocular morbidity that would be expected to influence refractive outcome or interfere with postoperative refraction accuracy. exclusion criteria: * patients with visually significant comorbidities (corneal, retina, optic nerve disease, not including prior refractive surgery) that could significantly affect their ability to have accurate preoperative biometry or postoperative refraction. * patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered iol, cystoid macular edema, etc.) that would interfere with postoperative refraction. * patients with \> grade 2 or greater posterior capsule opacity