Kornimate/medical-research-clean huggingface dataset:
safety, pharmacokinetics, and pharmacodynamics of mk-2248 in participants with hepatitis c (mk-2248-002)

Conditions: Hepatitis C

Summary: the objective of this study is to identify a safe dose of mk-2248 in participants with hepatitis c virus (hcv) that mediates at least a 3 log10 reduction in viral load (vl) from baseline. it is anticipated that once-daily administration of a safe and well tolerated dose of mk-2248 will reduce vl by at least 3 log10 iu/ml.

in this phase 1b study, the pharmacokinetic (pk), pharmacodynamic (pd), and safety profile of mk-2248 in hcv-infected participants will be evaluated as follows: part i will assess sequentially ascending mk-2248 doses from 200 mg to ≤800 mg over 4 panels (a, b, c, and d). part ii will assess sequentially ascending mk-2248 doses from 200 mg to ≤800 mg over 4 panels (e, f, g, and h). part iii will assess sequentially ascending mk-2248 doses ranging up to ≤800 mg in 2 panels (i and j). the potential relationship between plasma mk-2248 levels and vl reduction will be determined.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic hcv defined by positive serology for hcv or positive hcv rna for at least 6 months and detectable hcv rna in peripheral blood ≥10\^5 iu/ml at screening * body mass index (bmi) ≥18 to \<37 kg/m\^2 * in good health other than hcv infection with normal laboratory values exclusion criteria: * history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting hcv infection), immunological, renal, respiratory, genitourinary, or major neurological abnormalities or disease * history of cancer other than adequately treated non-melanomatous skin carcinoma, malignancies which have been successfully treated ≥10 years prior with no recurrence, or cancer that is unlikely to sustain a recurrence for the duration of the trial * history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food * positive for hepatitis b surface antigen or human immunodeficiency virus * had major surgery or lost 1 unit of blood within 4 weeks prior to screening * qtc interval ≥470 msec (males) or ≥480 msec (females) * received prior treatment with other hcv inhibitors * clinical or laboratory evidence of decompensated liver disease
exercise effects on atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) significantly affects quality of life and increases the demand for medical care of those affected. it is very important to identify triggering factors, such as oxidative stress or n-terminal pro-b-type natriuretic peptide (nt-probnp), as well as to identify potential biomarkers through plasma analysis. at the same time, it is essential to establish adequate training and rehabilitation programs, which would result in a decrease in hospitalizations and the health care costs associated with the pathology. current cardiac rehabilitation programs based on physical exercise, especially moderate intensity continuous training (mict), have demonstrated effectiveness. mict improves cardiorespiratory fitness and quality of life in patients with af. however, high-intensity intervallic training (hiit) has shown superior benefits in these variables. although hiit traditionally has an aerobic focus, a variant called high-intensity functional training (hift) is suggested that incorporates muscle strengthening exercises recommended in the guidelines for af management. this innovative modality seeks to achieve cardiovascular and neuromuscular adaptations simultaneously, with a high transfer to daily activities. despite its potential, the effects at the functional, molecular and clinical levels in patients with af are unknown. the purpose of the study is to determine the benefits of hift on molecular, functional and clinical variables in patients with af, and to compare these benefits with those achieved with hiit and the usual care and recommendations in current clinical practice.


Eligibility criteria:
inclusion criteria: * paroxysmal or persistent atrial fibrillation. * age between 18 and 80 years. * sedentary lifestyle. * signed informed consent. exclusion criteria: * permanent atrial fibrillation. * moderate to severe left ventricular dysfunction. * moderate to severe left valvulopathy. * severe pulmonary hypertension. * ischemic heart disease with incomplete revascularization. * arrhythmogenic cardiomyopathy.

Keywords: hift hiit intervallic training arrhythmia
early intervention efficacy in copd

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this study aims to evaluate the time to escalation to triple therapy among the japanese chronic obstructive pulmonary disease (copd) patients newly initiating therapy with a combination of olodaterol and tiotropium (herein referred to as tio/olo) using real world data.


Eligibility criteria:
inclusion criteria: the study cohort will include all patients who initiate tiotropium/ olodaterol (tio/olo) or tiotropium (tio) during the patient selection period. exclusion criteria: the following exclusion criteria will then be applied to generate the unmatched cohort: * aged \<40 years on cohort entry. * any lama, laba, or ics maintenance therapy (alone or in combination) during the 180-day baseline period prior to cohort entry for maintenance treatment and duration \>30 days, or any prescription within the 30 days prior to cohort entry. * patients without continuous enrolment (days since first inpatient/ outpatient encounter in the data) during the baseline period. * no prior diagnosis of copd \[international classification of diseases (icd)-10: j41\*, j43\*, j44\* and doubt (utagaiflg) = 0 (no)\] * patients without a second prescription claim of their index medication within 60 days after the cohort entry date. * diagnosis of asthma \[icd-10: j45\* and doubt (utagaiflg) = 0 (no)\] during the baseline period. * diagnosis of lung cancer \[icd-10: c34\*, d02.2, z80.1, z85.1 and doubt (utalaiflg) = 0 (no)\] or lung transplant (health claim code: 150317670, 150322510, 150322610, 150336510, 150336610, 150336710, 150399270) prior to the cohort entry date using all available data. * patients who initiate both tio/olo and tio simultaneously on the cohort entry date. * any use of triple therapy (lama + laba + ics) during the baseline period or between the cohort entry date and 1 day prior to the start of follow-up.
modafinil for smoked cocaine self-administration

Conditions: Cocaine Dependence

Summary: modafinil has been reported to reduce cocaine use in a clinical sample of infrequent users (2 days/week), but the effects of modafinil on cocaine self-administration in the laboratory have not been studied. the present study investigated the effects of modafinil maintenance on cocaine self-administration by frequent users (4 days/week) under controlled laboratory conditions. during this 48-day double-blind, crossover design study, the effects of modafinil maintenance (0, 200, and 400mg/day) on response to smoked cocaine (0, 12, 25, and 50 mg) were examined in nontreatment seeking cocaine-dependent individuals (n = 8).


Eligibility criteria:
inclusion criteria: 1. smokes cocaine 2. has patterns of smoked cocaine use in terms of frequency and amount which parallel or exceed those administered in the study. 3. age 21-50. 4. able to give informed consent, and comply with study procedures. 5. normal body weight within normal weight range (for appropriate frame) according to 1983 metropolitan weight tables - exclusion criteria: 1. current seizure disorder, heart disease or a history of serious adverse effects due to cocaine. 2. dependence on substances (other than cocaine or nicotine) or a history of dependence on alcohol 3. request for drug treatment 4. judged to be noncompliant with study protocol. 5. current use of any psychotropic medication. 6. clinical laboratory tests outside normal limits that are clinically unacceptable to the study physician (bp \> 140/90; bun, creatinine, lfts \> 3x uln; hematocrit \< 34 for women, \< 36 for men; pseudocholinesterase deficiency) 7. history of myocardial infarction or ischemia, clinically significant left ventricular hypertrophy, angina, clinically significant arrhythmia, or mitral valve prolapse 8. currently meeting dsm-iv criteria for all major psychiatric/psychotic disorders other than transient psychosis due to drug abuse 9. current parole or probation self-report during interview -

Keywords: cocaine modafinil self-administration drd4
test semiquantitative prostate specific antigen (psa)

Conditions: Prostate Cancer; Prostatic Neoplasms; Prostatic Diseases

Summary: the aim of the study is to compare the diagnostic performances of a simple and rapid psa assay on whole blood to the standard plasma psa assay.

screening and surveillance of prostate cancer typically involves sensitive laboratory techniques for the quantification of plasma prostate specific antigen (psa). in this study, we determine the sensitivity and specificity of a simple test strip based psa assay using only a few drops of whole blood as compared to a standard plasma psa assay. blood samples will be taken from hundred patients who are followed for a prostatic disease needing psa surveillance. before decantation of the samples, a few drops of blood will serve for the rapid test on strips. plasma psa levels will be determined with the trace ("time resolved amplified cryptate emission") technology in homogeneous liquid phase. the results from the rapid test can then be compared to the plasma levels obtained by trace.

Eligibility criteria:
inclusion criteria: * patients followed for prostate cancer or symptomatic benign prostatic disease, and for who a psa assay is indicated. * patients must have given informed consent. exclusion criteria: * patients followed for a disease other than prostatic.

Keywords: prostate-specific antigen prostate cancer cancer assay
mr/pet in the evaluation of patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: in this prospective study, we will recruit newly diagnosed esophageal cancer patients and perform mr/pet before and after chemoradiation therapy. in mr, new image sequences will be added to the conventional sequences, such as high resolution image, dwi, dce, cine imaging.

total 80 patients will be recruited and followed after treatment complete for at least two years. we will compare the staging accuracy of mr/pet and pet/ct, and also analyze parameters that are predictive of disease recurrence and patient survival.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed esophageal cancer patient 2. age older than 20 years exclusion criteria: 1. for the safety reason, patients with the following conditions are contraindicated to enter magnetic resonance imaging (mri) machine due to the high magnetic field, including: cardiac pacemaker, metallic artificial valve, intracranial and mediastinal vascular clips, cardiac defibrillator, nerve stimulator, implanted drug deliver system, metallic foreign body in the eye globe, cochlear implant, metallic fragments in the dangerous body part, swan-ganz catheter, and other metallic implants within 8 weeks: such as cardiac valve, stent, coil, filter, and clips. 2. patient who will receive endoscopic local therapy alone 3. unable to finish the standard surgical or radiation treatment 4. history of surgery or radiotherapy to the mediastinum 5. renal insufficiency, contraindication to mr imaging and contrast injection patient who have the severe allergic reaction the gadollium contrast agent 6. patient who have the claustrophobic symptoms are also not suitable for this mr examination 7. pregnancy or lactating women

Keywords: mr/pet in the evaluation patients
adjuvant furmonertinib in stage ia with high risk factors and stage ib non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage ia with high-risk factors and stage ib non-small cell lung cancer. a total of 114 patients would be enrolled. the primary endpoint is the disease-free survival rate at 3 years.


Eligibility criteria:
inclusion criteria: * received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy. * histologically diagnosed non-small cell lung cancer based on the judgement of at least 2 pathologists. * stage ia with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; stage ib with or without high-risk factors. the pathological stage is based on the 8th edition of ajcc lung cancer staging. * egfr mutation positive according to ngs testing by tissue, including deletions in exon 19, l858r, s768i, g719x, l861q, t790m mutations et al. * ecog performance status 0-1. * sufficient organ function in liver, renal, kidney and hematology. * with written signed informed consent form, ability to report adverse events, and good adherence to clinical study. exclusion criteria: * lung cancer with small cell or neuroendocrine cancer cell. * egfr exon 20 insertion positive. * concurrent with other diver mutations including alterations in alk, ros1, met et al. * women who are pregnant or breastfeeding. * use of cyp3a4 strong depressant within 7 days or cyp3a4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional chinese medicine within 14 days before enrollment. * concurrent with other malignancies excluding carcinoma in situ. * with uncontrolled systematic diseases such as active bleeding, unstable angina, heart infarction within 1 year, chronic heart failure and uncontrolled hypertension and diabetes mellitus; with active infection of hbv, hcv or hiv, or other infections requiring injection of antibiotics. * gastrointestinal disorders which may affect drug taking or absorption. * with history of qt prolongation or relative risk factors including heart failure, hypokalemia, congenital long qt syndrome, family history of long qt syndrome et al. * with history of interstitial lung disease or relative risk. * allergic to any component of furmonertinib tablet. * mental illness or drug abuse. * live vaccination within 30 days before enrollment. * other situation judged by investigator such as failure to follow the rules of study. * attending another study of investigational drug, or received other study drugs or medical devices with 4 weeks before enrollment.
68ga-ny104 pet/ct for the detection of clear cell renal cell carcinoma in presurgical patients with renal masses

Conditions: Clear Cell Renal Cell Carcinoma

Summary: this is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. the goal is to determine the sensitivity and specificity of 68ga-ny104 pet/ct in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.

this is a prospective, single-center, single-arm, diagnostic phase 2 study in patients with renal masses scheduled for surgical resection. each patient will receive one dose of 68ga-ny104 by intravenous route. dedicated whole-body pet/ct imaging will be performed. additionally, prior to resection of the tumor, contrast-enhanced ct imaging of the abdomen, and if clinically warranted, or as part of the local standard of care, of the chest, will be performed. both imaging modalities will be performed prior to resection of the kidney(s). pet/ct studies will be interpreted by two readers and diagnostic ct will be interpreted by one reader, all of whom will provide independent and blinded interpretations. imaging interpretations and histopathologic evaluation data will be used to estimate the sensitivity, specificity, and predictive value (primary and secondary objectives) of each modality. the exploration into the detection of metastases by 68ga-ny104 pet/ct in comparison to diagnostic ct will also be performed. the pathologist will identify representative tumor tissue for the determination of histology, grading, and caix expression. 63 patients will be recruited in peking union medical college hospital. this study will be conducted according to local regulations and laws, the ethical principles that have their origin in the declaration of helsinki, and the principles of good clinical practice.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 y 2. presence of a renal mass 3. scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique) 4. expected survival of at least 3 months 5. ecog ≤ 2 6. written informed consent provided for participation in the trial 7. in the opinion of investigator, willing and able to comply with required study procedures. exclusion criteria: 1. on vegf tki treatment less than 1 week before 68ga-ny104 pet/ct. tki is known to affect girentuximab binding in patients with ccrcc and is expected to have the same effect on 68ga-ny104. if patients were on vegf tki treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68ga-ny104 pet/ct is required. 2. intercurrent medical condition that renders the patient ineligible for surgery. 3. pregnancy or breastfeeding. 4. severe claustrophobia.

Keywords: 68ga-ny104 pet/ct renal mass
a study using imaging technology to measure changes in bone structure after treatment with teriparatide

Conditions: Osteoporosis, Postmenopausal

Summary: the purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.

as teriparatide is approved for up to 24 months of treatment in the us, patients will be given the option to continue in a 6-month extension phase upon completion of 18 months of teriparatide treatment. this extension will allow for collection of additional bone quality data. in canada, the use of teriparatide is currently approved for 18 months. patients in canada may be given the opportunity to participate in the 6-month extension phase, contingent upon health canada approval of the use of teriparatide treatment for 24 months.

Eligibility criteria:
inclusion criteria: * postmenopausal (after the "change of life") women with osteoporosis * between the ages of 45-85 * have low bone mass as determined by a bone density test * have at least one prior atraumatic vertebral or nonvertebral fracture(with a t-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a t-score of -3.0 or lower at these same sites) * could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate exclusion criteria: * have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study * have a metal implant or have had a hip replacement in either hip which might affect results of study * have an increased risk of osteosarcoma; includes paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton * currently have active or suspected diseases that affect the bone, other than osteoporosis * have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values

Keywords: osteoporosis, teriparatide, postmenopausal, mri, finite element analysis
neuromuscular mechanisms of specific trunk interventions in children with cp

Conditions: Child Behavior

Summary: determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with cp.

we will determine whether repeat exposure to pelvis perturbation during sitting astride will induce functional improvements in trunk postural control and locomotion in children with cp.

Eligibility criteria:
inclusion criteria: * children with a diagnosis of bilateral spastic cp attributed to complications of prematurity, intracranial hemorrhage and periventricular leukmalacia according to the definition of bax. * children aged 4 to 12 years old without botulinum toxin treatment within 6 months, and without surgeries (such as selective dorsal rhizotomy) within 12 months before the onset of the training. * subjects will be able to remain seated without help for ≥10s. * gmfcs levels will be i to iv. * children must be able to signal pain, fear or discomfort reliably. * children with mild scoliosis (cobb angle \< 20 °). * children with cp who have no prior hippotherapy experiences within 6 months. exclusion criteria: * severe lower extremity contractures, fractures, osseous instabilities, osteoporosis. * severe disproportional bone growth. * unhealed skin lesions in the lower extremities. * thromboembolic diseases, cardiovascular instability. * aggressive or self-harming behaviors.