Kornimate/medical-research-clean huggingface dataset:
relative bioavailability study of nirmatrelvir/ritonavir oral powder relative to the commercial tablets and estimation of the effect of food on bioavailability of the nirmatrelvir/ritonavir oral powder in healthy participants.

Conditions: Biological Availability

Summary: the purpose of this study is to estimate the relative bioavailability (rba) of nirmatrelvir/ritonavir oral powder in 3 different food vehicles relative to the paxlovid® tablets under fasted condition in healthy adult participants, and to estimate the effect of food on the rba of the nirmatrelvir/ritonavir oral powder formulation. the study will also assess the safety, tolerability, and palatability of nirmatrelvir/ritonavir oral powder in healthy adult participants.


Eligibility criteria:
inclusion criteria: * participants who are overtly healthy as determined by medical evaluation including medical history, physical examination (pe), laboratory tests, vital signs and standard 12 lead ecgs. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). * participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures exclusion criteria: * positive test result for sars-cov-2 infection at the time of screening or day -1. * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). * clinically relevant abnormalities requiring treatment (eg, acute myocardial infarction, unstable ischemic conditions, evidence of ventricular dysfunction, serious tachy or brady arrhythmias) or indicating serious underlying heart disease (eg, prolonged pr interval, cardiomyopathy, heart failure greater than new york heart association (nyha) 1, underlying structural heart disease, wolff parkinson-white syndrome). * any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c; positive testing for hiv, hepatitis b surface antigen (hbsag), or hepatitis b surface antibody (hcvab). hepatitis b vaccination is allowed. * use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. * participant who have received a covid-19 vaccine within 7 days before screening or admission, or who are to be vaccinated with a covid-19 vaccine at any time during the study confinement period. * a positive urine drug test.

Keywords: coronavirus disease 2019 (covid-19) severe acute respiratory syndrome coronavirus 2 (sars-cov-2) nirmatrelvir paxlovid
effect of neuromuscular warm-up on injuries in female athletes

Conditions: Knee Injuries; Anterior Cruciate Ligament Injuries; Ankle Injuries; Lower Extremity Injuries

Summary: the goal of the study is to determine effect of coach-led neuromuscular warm-up on non-contact, lower extremity (le) injury rates among female athletes in a predominantly non-white public high school system. the investigators hypothesized the warm-up would reduce non-contact le injuries.

we will recruit basketball and soccer coaches and their athletes from chicago public high schools. we will randomize teams to intervention and control groups. we will train intervention coaches to implement a 20-minute neuromuscular warm-up and tracked training costs. control coaches will use their usual warm-up. all coaches will report weekly athlete exposures (aes) and injuries resulting in a missed practice/game. research assistants will interview injured athletes. we will compare injury rates between control and intervention groups.

Eligibility criteria:
inclusion criteria for high school students (initial part of study - completed) * plays basketball or soccer for a chicago public high school team * coaches basketball or soccer for a chicago public high school team * female, age 14-20 inclusion criteria for coaches (current part of study): * willing to implement a new warm-up before their team's practices and games * willing to complete a pre- and post-season survey before and after using the warm-up program for one season (surveys are attached). * willing to complete a pre- and post-workshop test before and after the workshop (tests are attached). * willing to allow study personnel to observe their implementation of the warm-up at up to three team practices or games. exclusion criteria for coaches (current part of study) there are no separate exclusion criteria for coaches.

Keywords: knee injury ankle sprain anterior cruciate ligament adolescent soccer basketball prevention
utility of liposomal bupivacaine transversus abdominal plane block for open myomectomy

Conditions: Fibroid Uterus

Summary: the study team will be randomizing patients presenting for open myomectomy to either received transversus abdominal plane blocks with either liposomal bupivacaine or standard bupivacaine. the study team will be analyzing the impact of local anesthetic on opiate consumption as the investigator's primary endpoint with other secondary endpoints.

after consent, patients will be randomized to either liposomal bupivacaine transversus abdominal plane (tap) vs standard bupivacaine tap. blocks will occur post induction and pre incision. only the block team (not the anesthesia team nor the care team) will be unblinded and they will not have any impact on the data collection. the entire care team and the patient will be blinded. a standardized anesthetic regimen will be employed followed by a prescriptive post-operative pain management plan aimed at enhanced recovery. patients will be followed for up to 96 hours and asked about their opiate consumption, pain scores, side effects, and recovery.

Eligibility criteria:
inclusion criteria: * not pregnant * weight over 50kg presenting for open myomectomy * no history of allergy to any study medication * no history of malignant ventricular dysrhythmia, epilepsy, seizure disorder, or chronic pain syndrome other than pain from myomas * no history of drug or alcohol use or abuse disorder or pre-existing liver disease.

Keywords: fibroid uterus myomectomy abdominal myomectomy
investigation of the blood-brain and blood-dura barrier durin migraine attacks using mri

Conditions: Migraine With Aura; Migraine Without Aura; Chronic Migraine

Summary: substudy 1 blood-brain barrier breakdown has been proposed in migraine patients. our hypothesis that we will test in this study is that the blood-brain barrier breaks down during migraine attacks but not out side attacks using mri. substudy 2 altered cerebral resting-state functional connectivity networks have been reported in migraine patients outside migraine attacks. what happens during migraine attacks has never been investigated. the hypothesis we will test is that pain related networks are affected during spontaneous attacks using functional mri. substudy 3 old studies report that cerebral blood flow (cbf) is altered in patients with migraine with aura, but not in those without aura. we hypothesize that cbf is altered regionally during attacks, which we will investigate in this study using arterial spin labeling (asl). substudy 4 structural changes using voxel-based morphometry (vbm) of the brain have been suggested but never investigated during migraine attacks. our hypothesis is that pain related structures show altered vbm during spontaneous migraine attacks.

brain mri during and outside migraine attacks. up to 600 patients will be recruited, who will be given a phone number that they can call when they get migraine attacks. the study will continue until 20 patients with migraine with aura, 20 patients without aura, 20 patients with chronic migraine have completed the study.

Eligibility criteria:
inclusion criteria: * diagnosis of migraine with aura, migraine without aura, or chronic migraine according to the international headache society. * written informed consent. * use of anticonceptive method by women in childbearing age. exclusion criteria: * tension type headache more than 5/month during last year. * tension type headache on the experimental day. * use of antimigraine medication or pain-killer on the experimental day before mri. * pregnant or breastfeeding women. * contraindications against mri. * history or clinical sign of cardio- or cerebrovascular disease. * untreated severe mental disorder or drug abuse. * other diseases or disorders interpreted, by the examining doctor, to interfere with participation in the study. * not accepting information about potential accidental finding during experiment.
current outpatient cardiac rehabilitation in austria

Conditions: Cardiovascular Diseases

Summary: aim of this study is to give evidence to outpatient cardiac rehabilitation in austria. the database created in this context is supposed to pave the way as instrument to document and comprehend quality of outpatient cardiac rehabilitation in austria as a key for quality management. analyses of the created database should be made on a regular basis.


Eligibility criteria:
inclusion criteria: any patient who meets inclusion criteria for outpatient cardiac rehabilitation in austria - exclusion criteria: * medical conditions which prevent patients from complying with the exercise program * acute infections * hypertrophic cardiomyopathy * pulmonary artery embolism or phlebothrombosis within the previous 6 months * unstable angina pectoris * heart failure (nyha iv) * hemodynamically unstable arrhythmia

Keywords: outpatient cardiac rehabilitation, exercise training,
pulmonary hypertension inspiratory training

Conditions: Pulmonary Hypertension

Summary: this study is examining the effects of six weeks of inspiratory muscle strength training (imst) on outcomes related to pulmonary hypertension. this study leverages previous cardiopulmonary exercise test (cpet) results and a pre-existing upcoming cpet to examine the effects of imst on cardiopulmonary pressures and exercise tolerance and ability.

ph is a condition characterized by abnormally high blood pressure in the lungs (i.e., pulmonary arterial pressure), which impacts heart function and reduces exercise tolerance. this study will assess whether six weeks of a breathing exercise called imst can improve heart and lung function as well as exercise capacity for individuals with ph. for this study, patients will be asked to perform imst for the six weeks prior to their next scheduled clinical standard of care assessment of their ph. the goal of this study is to determine whether imst reduces pulmonary arterial pressure and improves exercise tolerance in individuals with ph. this study will be minimally invasive, as it simply adds a safe, well-tolerated, non-invasive respiratory training to the participants' standard of care and leverages their existing ph assessment data to evaluate the impact of imst on ph.

Eligibility criteria:
inclusion criteria: * diagnosed with ph defined by clinical guideline criteria * must already be scheduled for a clinical assessment of their ph within 8 weeks of enrolling in the study. * must have undergone an assessment of their ph in the last 18 months with no major changes in ph management or medication within that period. exclusion criteria: * current smoker or have smoked in the last 10 years * unable or unwilling to undergo routine functional testing of their ph (i.e., 6-minute walk distance). * presence of significant cardiovascular or respiratory conditions other than ph, including but not limited to: * chronic obstructive pulmonary disease * severe asthma * severe ischemic heart disease * left-sided heart failure * history of a major cardiovascular event, such as a myocardial infarction or stroke, within the last 6 months * individuals with an implanted pacemaker or other significant cardiac devices * history of neurological, respiratory, head and neck, or thoracic surgeries, or conditions such as a collapsed lung or perforated eardrum * pregnant individuals or those actively trying to become pregnant * individuals with any of the following: chronic laryngitis, chronic bronchitis, emphysema, pneumonia, tuberculosis, chronic cough, extremely high blood pressure (\>170/100), neurological problems, scoliosis, organ transplants, hiv or other immunocompromising conditions, or autoimmune disease.

Keywords: inspiratory muscle strength training
an observational study of patients with coronavirus disease 2019

Conditions: COVID-19; Coronavirus

Summary: this is an observational study of patients with covid-19 designed to specifically address important clinical questions that remain incompletely answered for coronavirus disease 2019.

data from up to 5,000 adult patients in the us will be captured from eligible patients enrolled following admission to the hospital. participants will have de-identified medical records collected from hospital admission to discharge, including but not limited to critical care monitoring, details on mechanical ventilation, laboratory data, imaging reports, medications, and all procedures. diagnosis and patient management will follow each hospital's standard of care and no specific treatments, procedures or laboratory tests will be dictated by enrollment in target-covid-19.

Eligibility criteria:
inclusion criteria: * adults (age ≥18 years) who are or have been hospitalized and diagnosed with severe acute respiratory syndrome coronavirus (sars-cov-2) infection. * sars-cov-2 confirmed diagnosis (e.g. polymerase chain reaction \[pcr\] or other clinically utilized test). exclusion criteria: n/a
a study of different donanemab (ly3002813) dosing regimens in adults with early alzheimer's disease (trailblazer-alz 6)

Conditions: Alzheimer's Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Summary: this study will investigate different donanemab dosing regimens and their effect on the frequency and severity of aria-e in adults with early symptomatic alzheimer's disease (ad) and explore participant characteristics that might predict risk of aria. approximately 300 additional participants will be enrolled per addendum. the study will last approximately 91 weeks and include up to 26 visits in the main study.


Eligibility criteria:
inclusion criteria: * gradual and progressive change in memory function reported by the participant or informant for ≥6 months. * a mini mental state examination (mmse) score of 20 to 28 (inclusive) at screening. * have an amyloid pet scan result from central read, consistent with the presence of amyloid pathology. exclusion criteria: * have significant neurological disease affecting the central nervous system other than ad, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, parkinson's disease, multiple concussions, or epilepsy or recurrent seizures, except febrile childhood seizures. * has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than ad), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study. * a life expectancy of \<24 months. * contraindication to mri or pet scans * have had prior treatment with a passive anti-amyloid immunotherapy. * have a presence or history of malignant neoplasms within the past 5 years prior to visit 1. exceptions: * non-metastatic basal- or squamous-cell skin cancer * stage 0 non-invasive carcinoma of the cervix * stage 0 non-invasive prostate cancer, or * other cancers with low risk of recurrence or spread
novel determinants and measures of smokeless tobacco use: study 1

Conditions: Smokeless Tobacco Use; Tobacco Dependence

Summary: the extent of toxicity varies considerably across different brands of smokeless tobacco (st) products and data suggest that greater toxicity may result in greater health risks. however, little is known about the actual extent of exposure to toxicants from current smokeless tobacco products and factors that might moderate the extent of this exposure. the goals of this project are to address the following questions: 1. what are the characteristics of the range of smokeless tobacco products in current use and how do these products impact user behavior; 2. what are novel and the best measures of smokeless tobacco use, behavior and exposure; and 3. what are some of the determinants of smokeless tobacco use.

study 1 is a multi-site descriptive study assessing tobacco toxicants in various smokeless tobacco products and tobacco toxicant exposure found in 600 subjects in three sites: university of mn twin cities, oregon research institute in eugene or, and at west virginia university in morgantown, wv (200 subjects per site). the study will examine the relationship between brands of u.s. smokeless tobacco products that contain different levels of tobacco-specific nitrosamines (tsnas), other carcinogens and nicotine, and biomarkers of exposure and effects on health (e.g., cardiovascular risk factors). additionally, the study will examine factors that influence the extent of toxicant exposure and effect besides the levels of toxicants in the product. subjects will attend an orientation where they will sign a consent form and then return for one clinic visit where they will provide blood (umn only), urine samples, buccal samples and expectorated chews to be examined for nicotine levels, toxicant exposure and potential for tobacco-related health risks. a subsample of subjects (10 per brand of smokeless tobacco) will be asked for a tin of their unused product for testing (they will be reimbursed for the cost of their tin) and will be asked for three samples of expectorated chews that will be collected, frozen and shipped to the cdc where they will be analyzed for tobacco constituents. subjects will complete several questionnaires on their tobacco use history, alcohol, diet, physical and mental health. subjects will also keep a daily diary of their tobacco and alcohol use.

Eligibility criteria:
inclusion criteria: 1. using a consistent and daily amount of st for the past year; 2. in good physical health (no unstable medical condition); 3. stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the dsm-iv criteria). exclusion criteria: 1. subjects must not be currently using other tobacco or nicotine products. 2. female subjects cannot be pregnant or nursing.

Keywords: smokeless tobacco biomarkers of tobacco exposure
sequential profiling of tumor-derived circulating cell-free dna (ctdna) in advanced ovarian cancer patients

Conditions: Ovarian Cancer

Summary: ovarian cancer (oc) is the third most common gynaecologic cancer worldwide and has the highest mortality rate among gynaecologic cancers. despite the advances in cytoreductive surgery and frontline chemotherapy, recurrence is a common event in the advanced disease setting, with more than 70% of women experiencing relapse within two years from diagnosis. new strategies to anticipate the diagnosis of recurrence have been investigated in the last years. in this context, standard serum biomarkers, such as ca-125, and radiological evaluation are commonly used for disease surveillance, however, the early identification of relapsed disease as well as the identification of patients at higher risk for recurrence are still unmetclinical needs. novel and reliable molecular biomarkers, which might also better represent the intrinsic molecular complexity of oc, could help clinicians to address this important challenge. circulating tumor dna (ctdna) analysis has recently emerged as a non-invasive tool to profile and monitor tumor evolution over time. ctdna has been extensively studied in several neoplasms in order to evaluate its ability in anticipating detection of relapse compared to common markers used in clinical practice. wehave designed a study to assess the ability of ctdna to detect recurrence and progression of disease and to provide a genomic characterization, during follow-up of patients with advanced oc. if proven effective and reliable, ctdna could be introduced into routine surveillance programme for oc.


Eligibility criteria:
inclusion criteria: 1. newly diagnosed suspicious international federation of gynecology and obstetrics (figo) stage iii a or greater ovarian, fallopian tube, or primary peritoneal cancer 2. age between 18 and 80 years 3. estimated life expectancy of at least 4 weeks 4. signed informed consent exclusion criteria: 1. any previous cancer in the last 5 years 2. previous chemotherapy or target treatments 3. diagnosis of synchronous tumors 3. pregnancy or breastfeeding 4. missed informed consent
neuromodulation effect of focused ultrasound for motor recovery in patients with stroke

Conditions: Focused Ultrasound; Stroke

Summary: transcranial focused ultrasound (tfus) can be used as a non-invasive brain neuromodulation technique. low-intensity focused ultrasound has been demonstrated to be safe and have neuromodulatory effects on the cerebral cortex in healthy human and animal experiments.this study aims to investigate the effect of tfus on cortical excitability for motor recovery in patients with stroke.

the study is a pilot study for feasibility, which aims to recruit 20 patients with subacute (within 3 months) stroke and unilateral hemiparesis. tfus stimulation will be delivered. the primary outcomes are defined as cortical excitability assessment in bilateral primary motor cortex, as well as safety analysis; the secondary outcome measures include the fugl-meyer assessment, medical research council score, national institutes of health stroke scale (nihss), barthel index, modified rankin scale and functional brain activities.

Eligibility criteria:
inclusion criteria: * patients with stroke (including hemorrhagic or ischemic stroke) diagnosed by a board-certificated physician. * occurrence of stroke within three months. * upper limb muscle strength ≤ 4 points according to the medical research council manual muscle testing scale. * no previous history of stroke, epilepsy, dementia, parkinson's disease, or other neurodegenerative diseases. * patients could maintain sitting posture for more than 15 minutes on a chair. * 18 years of age or older. exclusion criteria: * history of recurrent stroke, traumatic brain injuries, brain tumors, spinal cord injury, parkinson's disease or other musculoskeletal system diseases that may affect evaluation and treatment. * contraindications to focused ultrasound, including pregnancy, cardiac pacemaker or implantable medical device, abnormal connective tissue diseases, coagulopathy (plt\ 14 seconds, aptt\>36 seconds, inr\>1.3), implants near or in the brain, or those deemed unsuitable for this treatment by the physician. * unable to cooperate with treatment or functional assessment due to impaired consciousness or aphasia; inability to informed consent. * patient with cranial bone factor causing the inability of tfus penetration. * patient under anticoagulants with coagulopathy (plt\ 14 seconds, aptt\>36 seconds, inr\>1.3) * patients who are not suitable for undergoing ct imaging examination; * major physical illnesses and neurological disorders (such as epilepsy, brain surgery, etc.) * patients with metallic implants in their bodies; * patients taking tricyclic antidepressants, analgesics, or using antiepileptic drugs * individuals experiencing sleep disorders during tfus treatment; * individuals with history of alcoholism * patients with severe or uncontrollable intracranial pressure; * patients requiring anticoagulants; * any intracranial space-occupying lesions; * significant calcification of intracranial vessels based on pre-treatment ct imaging; * subjects with lesions/wounds on the scalp in the target region.