Kornimate/medical-research-clean huggingface dataset:
throwing device tracker for youth injury prevention

Conditions: Overuse Injury

Summary: the primary objective of this study is to collect motion-capture data on movements common to baseball play in order to develop an algorithm for a wearable device for the prevention and rehabilitation of sports-related overuse injuries. secondary objectives include evaluating the feasibility of wearing the throwing device during simulated baseball play.

with the rise in competitive sports participation in pediatric and adolescent populations, there has also been an increase in overuse injuries. current methods of overuse injury prevention, such as pitch-counting, fail to account for differing techniques or effort and often ignore the elevated risk for children participating in two or more sports emphasizing the same body part. this wearable device seeks to more accurately monitor overuse to prevent and aid rehabilitation of overuse injuries. subjects will be asked to fill out a short survey about their athletic activities. they will wear a prototype of a minimal risk throwing device during simulated baseball play in a sports medicine session or at the human motion laboratory. various motion data from the device and from the motion lab analysis will be collected to create and refine an algorithm to quantify workload and throwing movements. the primary endpoint of this study is to quantify motion capture data on movements common to baseball play. the secondary endpoints include quantifying injury associated with different baseball movement using the proposed system, development of algorithms to quantify workloads associated with injury during common baseball movements and validation of basic device measurements (pilot phase).

Eligibility criteria:
inclusion criteria: pilot phase: 1. males or females age 8 to 14 years 2. presenting to the children's hospital of philadelphia (chop) physical therapy clinic for rehabilitation of injury that does not impede their ability to perform basic throwing movements. phase 1: 1. males or females age 8 to 14 years 2. involved in official baseball team and primarily plays as the pitcher exclusion criteria: pilot phase 1. injury of any aspect of the throwing arm 2. unwillingness to perform all requested motions 3. parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study procedures. phase 1 1. injury or disability impeding ability to perform normal baseball-related movements 2. inability/unwillingness to schedule and/or travel to the human motion laboratory 3. parents/guardians or subjects who, in the opinion of the investigator, may be non-compliant with study schedules or procedures.

Keywords: healthy subjects athletes baseball sports research overuse injuries
protein quality on appetite control, reward-driven eating, & subsequent food intake

Conditions: Appetite and General Nutritional Disorders

Summary: to determine whether the consumption of a beef-rich lunch improves appetite control, satiety, and energy intake regulation while reducing food reward and food cravings compared to the consumption of a soy-rich lunch when matched for macronutrients and fiber content or when match for serving size. the mechanisms of action surrounding the differential responses of beef versus soy proteins were also explored.

a randomized, crossover design, acute study was completed in 21 healthy adults (age 23 ±1 y; bmi: 23.8 ± 0.6 kg/m2) to compare 400 kcal lunch meals varying in protein quality. two separate comparisons were performed. the first comparison consisted of macronutrient and fiber-matched lunches which varied in protein quality: 24 g beef protein vs. 24 g soy protein. the second comparison matched serving size only: 1 serving of beef (24 g protein with 0 g fiber) vs. 1 serving of soy (14 g protein; 5 g fiber). for each treatment, the participants completed 2 testing days per lunch treatment. during the "appetite assessment days," each participant reported to the lab to consume one of the lunch meals. pre and 7-h post-lunch appetite and cravings questionnaires were completed throughout each testing day along with plasma, hormonal responses, and plasma amino acid concentrations through repeated blood sampling. ad libitum dinner energy intake was also measured. during the "reward assessment days," the participants reported to our facility to again consume one of the lunch meals. pre and post-lunch neural responses to food stimuli, through functional magnetic resonance imaging (fmri), occurred followed by ad libitum consumption of a lunch dessert.

Eligibility criteria:
inclusion criteria: * age range 18-30 y * normal to overweight (bmi: 18-29.9 kg/m2) * no metabolic, psychological, or neurological diseases/conditions * not currently/previously on a weight loss or other special diet (in the past 6 months) * not a vegetarian * right-handed (necessary for the fmri analyses) * not pregnant * meets the mu-brain imaging center screening criteria * have not given blood (for the american red cross in the past 6 months) exclusion criteria: * age \>30 y and \<18y * under weight or obese (bmi: \ 29.9 kg/m2) * clinically diagnosed with diabetes (type i or type ii), having an eating disorder, or having any other metabolic, psychological, or neurological diseases/conditions that would influence the study outcomes. * currently/previously on a weight loss or other special diet (in the past 6 months) * left-handed * claustrophobic (≥ 2 past bouts of claustrophobia when exposure to small spaces) * do not meet the fmri criteria established by the mu-bic (regarding metal implants, etc.) * pregnant * does not meeting the mu-brain imaging center screening criteria * have given blood (for the american red cross) in the past 6 months or plan to give blood in the following 6 months
bioavailability, safety and tolerability of diazepam nasal spray versus diazepam rectal gel (diastat®)

Conditions: Refractory Epilepsy

Summary: this is a multi-center, open-label, crossover, pharmacokinetic, bio-availability study involving adolescents and adults with refractory (drug-resistant) epilepsy. cohort 1 comprises the subjects used to determine the relative bioavailability of dzns versus drg (diastat)

to determine the bioavailability of diazepam nasal spray versus diazepam rectal gel (diastat®) under conditions of use in adolescent and adult persons with epilepsy (pwe) meeting the definition of refractory epilepsy.

Eligibility criteria:
inclusion criteria: * diagnosis of refractory epilepsy * body weight 26 to 111 kilogram (kg) inclusive * other inclusion criteria apply exclusion criteria: * male or female subject who is not surgically sterile or female subject who is less than 2 years postmenopausal, and does not agree to use a highly effective birth control method during the study and up to 3 months after the last dose of investigational product * female subject who is pregnant, breastfeeding, or planning to become pregnant * presence or history of any abnormality or illness that may affect the absorption, distribution, metabolism or elimination of diazepam * other exclusion criteria apply

Keywords: seizures epilepsy
a study of the effectiveness of peginterferon alfa-2a (pegasys) and ribavirin treatment in slovenian hepatitis c (hcv) patients

Conditions: Hepatitis C, Chronic

Summary: in this slovenian, multi-center, observational study, the effectiveness of standard of care peginterferon alfa-2a + ribavirin treatment in adult patients with chronic hepatitis c (chc) is examined. patients were treated for 24- or 48-weeks, as prescribed by the treating physician, followed by a 24-week follow-up period.


Eligibility criteria:
inclusion criteria: * male and female patients \>/= 18 years * positive test for hcv * effective contraception as specified by the peginterferon alfa-2a and/or ribavirin labels exclusion criteria: * concomitant infection with hiv or hepatitis b * participation in a clinical trial within 30 days prior to study start * any contraindications specified in the peginterferon alfa-2a and ribavirin product labels
virtual reality as a perioperative teaching tool for families

Conditions: Surgical Procedure, Unspecified; Tonsil Hypertrophy

Summary: commonly, families and providers have turned to internet-based resources to provide insight as to the perioperative experience. though there is a large amount of information that is available on the internet, medical information on the internet is of highly variable quality and the information may be conflicting or inaccurate. it is hard for even the savvy well-educated patient and family to navigate and sift through all the information available. therefore, generic web-based information does not necessarily decrease patient and caregiver anxiety. as an alternative, the investigators propose an interactive teaching tool utilizing virtual reality that may provide a cost-efficient, content-rich supplement to the traditional phone or internet-based patient education. virtual reality (vr) will be provided to families of patients undergoing ambulatory pediatric surgery. vr will provide personalized education to patients and their families about the entire continuum of the child's surgical experience. this will range from the hospital registration, the peri-operative experience, including the separation of the child from the parent in the pre-operative area and the anesthetic induction process, and the post-operative hospital ward. the virtual reality (vr) tool will also review the in-hospital post-operative recovery process. the patient will be shown this either via an oculus headset or using their own smartphone device. in addition to improving a parent's comprehension of what their child will experience, the investigators expect that the virtual reality tool may also improve patient and caregiver satisfaction with the overall perioperative experience.


Eligibility criteria:
inclusion criteria: * children undergoing tonsillectomy/adenotonsillectomy ± ear tubes in the ambulatory setting exclusion criteria: * non-english speaking (vr program is currently only offered in english) * inpatient * unable to effectively use vr (blind, severe motion sickness) * history of procedure in the operating room within the past year * having a combination/additional procedure
the different response of endocrine hormones to hypoglycemia in patients with type 1 or type 2 diabetes

Conditions: Diabetes

Summary: endocrine hormones, not only blood glucose responsive hormones, but also sexual hormones, thyroid hormones, growth hormones and so on, may have response and activites in hypoglycemia. however, the different responses of endocrine hormones to hypoglycemia in patients with diabetes remain unclear.

this study will observe the changes of insulin, c-peptide, glucagon, growth hormone, igf-1, acth, cortisol, thyroid function, sexual hormone in newly diagnosed men with type 2 and type 1 diabetes mellitus using hyperinsulinaemic hypoglycaemic clamp technique

Eligibility criteria:
inclusion criteria: - patients * newly diagnosed male patients with type 1 or type 2 diabetes (diagnostic criteria of world health organization) * aged 18-50 years * has not been treated with any hypoglycemic drugs * hba1c\>9% normal subjects: healthy and had no known illness exclusion criteria: * patients with insulin allergy. * any history of hypoglycemic agent intake or were presently taking hypoglycemic agents * any abnormality in liver or kidney function on blood and urine investigations * any history of systemic corticosteroid use in 3 months * any recent infections or acute medical events * any other obvious conditions or associated diseases determined by the researcher: such as severe cardiopulmonary diseases, endocrine diseases, neurological diseases, tumors and other diseases, other pancreatic diseases, history of mental diseases.
golidocitinib in combination with sintilimab for pd-l1 selected treatment locally advanced or metastatic non-small cell lung cancer(nsclc)

Conditions: Non-Small-Cell Lung Cancer

Summary: this is a phase 2 study to investigate the safety, tolerability, and anti-tumor activity of golidocitinib in combination with sintilimab as the front-line treatment for patients with metastatic pd-l1 positive non-small cell lung cancer (nsclc)


Eligibility criteria:
inclusion criteria: 1. be able to provide a signed and dated, written informed consent. 2. adults aged ≥18 to 75 years. 3. ecog performance status 0-1. 4. predicted life expectancy ≥ 12 weeks 5. histologically or cytologically confirmed non-small-cell lung cancer (nsclc) , stage iiib/iiic (not suitable for concomitant chemoradiotherapy) or stage iv according to ajcc 8th 6. without egfr or alk mutations. 7. adequate bone marrow reserve and organ system functions. 8. patients with stable and symptomatic brain metastasis (bm) can be enrolled. part a dose escalation: patients must have relapsed after or been refractory/intolerant to ≥ 1 prior systemic therapy(ies) for nsclc part b dose expansion: 1. at least one measurable lesion according to recist 1.1. 2. previously systemic untreated for advanced disease. 3. pd-l1 tps ≥ 50% (cohort 1), pd-l1 tps 1-49% (cohort 2) exclusion criteria: 1. histopathology confirmed a mixture of nsclc and small-cell lung cancer 2. known active central nervous system (cns) metastases and/or carcinomatous meningitis. 3. prior malignancy within 5 years 4. history of organ transplantation or hematopoietic stem cell transplantation 5. sever lung function decline or interstitial lung disease that has required oral or iv steroids 6. active autoimmune disease requiring systemic therapy within 2 years 7. immunodeficiency, or being treated with immunosuppressive therapy (including systemic glucocorticoid) within 7 days prior to the first dose of study treatment. 8. active infections 9. significant cardiac disorder 10. other serious or uncontrolled systemic diseases assessed by the investigator. part a dose escalation: 1. prior systemic therapy with an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or stimulatory or synergistic t-cell receptor (ctla-4、ox-40、cd137) within 4 weeks part b dose expansion: 1. any prior systemic anti-tumor therapy 2. prior systemic immunotherapy, including anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or stimulatory or synergistic t-cell receptor (ctla-4、ox-40、cd137)
syncope-asystole latency time in tilt table test: the salt-tilt study

Conditions: Syncope; Pacemaker; Asystole; Neurally Mediated Syncope

Summary: syncope is a common presenting condition. pacemaker implantation can significantly reduce syncope recurrences in reflex syncope. however, despite careful selection, a substantial proportion of patients treated with pacemakers suffer recurrences of syncope. it is thought that a pronounced vasodepressor component may hinder the efficacy of pacing in patients, preventing adequate cerebral perfusion during the reflex, thus relativizing the anti-bradycardia function of the pacemaker to prevent syncope. it is hypothesised that the time elapsed from the actual loss of consciousness to the asystole recorded on the ecg during tilt table test may be predictive in terms of response to pacemaker therapy, so this parameter becomes the subject of the present study.

syncope is a common leading affection and is responsible for 1-3% of the presentations in emergency departments and up to 3% of inpatient admissions. syncope poses often a diagnostic and therapeutic challenge for the attending physician and is often misdiagnosed or underdiagnosed. patients can be treated with pacemaker implantation when the syncope cause is a cardioinhibition with documented asystole during the syncopal event. when accurately selected, patients benefit from pacemaker therapy with a significant reduction of syncope recurrence in the follow up. however, a substantial portion of the patients (approx. 25%) experience recurrence of syncope despite optimal pacemaker therapy. the underlying mechanism is not well understood and object of the current study. the main target of the study is to evaluate the time elapsed between the t-loc during video tilt table testing and the asystole at the ecg using a registry and to assess its predictive value in patients undergoing invasive treatment. the hypothesis is that a vasodepressive component could lessen the effect of pacing in a patient, leading to cerebral hypoperfusion and syncope despite maintaining a stable rhythm. this is a prospective, multi-center observational study with 2 year follow-up of patients. patients eligible for invasive treatment of reflex syncope are included. if after guideline-directed implantable loop recorder insertion no cardioinhibition has been recorded, the patient is included automatically in the registry.

Eligibility criteria:
inclusion criteria: * patients eligible for invasive treatment according to the esc guidelines for pacing 2021 * written informed consent exclusion criteria: * other condition which explains syncope cause other than reflex syncope * structural heart disease (valvular, ischaemic, cardiomyopathies) * pregnancy * patient denial to be recorded on video during tilt table test

Keywords: syncope pacemaker tilt table test asystole salt syncope-asystole latency time
pharmacological postconditioning during the aortic valvular surgery

Conditions: Aortic Valvular Surgery

Summary: primary objective: to evaluate the efficacy of the cyclosporin a administration to induce a cardioprotection during the valvular surgery.


Eligibility criteria:
inclusion criteria: * male or females, scheduled for an aortic valvular surgery; * 18 years of age or older. exclusion criteria: * combined valvular and coronary surgery; * significant coronary artery stenosis (upper than 70%); * left ventricular dysfunction (ejection fraction \< 40%); * emergency surgery and/or infectious endocarditis; * known cyclosporin hypersensitivity; * history of known recent immunosuppression (\< 6 months): cancer, lymphoma, positive serology for hiv, hepatitis; * renal insufficiency (creatininaemia \> 150 µmol/l); * hepatic insufficiency (prothrombin time \< 50%); * uncontrolled arterial hypertension defined by a systolic arterial pressure \> 180 mm hg; * women of child bearing potential, who are pregnant or not under efficient contraception; * patients treated with nicorandil, sulfonylurea or rosuvastatine; * patients under judicial control.

Keywords: postconditioning cyclosporine a myocardial ischemia cardiac surgery aortic valvulopathy
heart rate changes during normal activity, exercise, and seizures in subjects with epilepsy

Conditions: Epilepsy

Summary: characterization of the cardiac response (ecg) preceding an epileptic seizure.

characterization of the cardiac response (ecg) to physiologic events and comparison to changes in heart rate that precede an epileptic seizure.

Eligibility criteria:
inclusion criteria: 1. patient has a clinical diagnosis of epilepsy requiring additional evaluation in an epilepsy monitoring unit (emu). 2. patient likely requires an emu evaluation for a period of at least 3 days. 3. in the opinion of the principal investigator, the patient is likely to have 3 - 5 seizures during the emu stay. 4. patient is currently taking at least one antiepileptic medication. 5. patients must be 18 years or older and may be of either sex and of any race. 6. patient must be in good general health, fully ambulatory, and able to complete the physical aspects of testing requirements. 7. patient must be willing and able to complete informed consent and hipaa authorization. 8. patient is diagnosed with epilepsy but may also experience pseudo seizures or psychogenic seizures. exclusion criteria: 1. patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study. 2. patients experiencing status epileptic within the last 6 months. 3. patients with cardiovascular, respiratory, neuromuscular or gait disorders that in the investigator's judgment would cause unnecessary risk. 4. patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response. drugs with secondary cardiac or autonomic actions are allowed. 5. patients with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to exercise, stress, or seizure. this would include but not be limited to chronic atrial fibrillation and permanent cardiac pacemaker implantation. 6. patients currently dependent on alcohol or narcotic drugs as defined by dsm iv-r. 7. patients with a history of only psychogenic seizures or pseudo seizures. 8. women who are pregnant. women of childbearing age must take a pregnancy test.

Keywords: exercise/no active treatment
clinical outcome and toxicity data in patients with advanced breast cancer treated with cdk inhibitors combined with endocrine therapy

Conditions: Breast Cancer Stage IV

Summary: the present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with cdki in patients with hr-positive, her2-negative advanced breast cancer.

patients this will be a retrospective analysis of patients with histologically confirmed hr-positive, her2-negative advanced (recurrent or metastatic) breast cancer. the investigators will use data from patients treated at hellenic cooperative oncology group (hecog)-affiliated departments of oncology. eligible patients will be of 18 years or older, women of any menopausal status with hr-positive/her2-negative advanced breast cancer who have received treatment with cdki in combination with endocrine therapy for their advanced breast cancer. treatment combinations of cdki with any endocrine therapy will be accepted. patients will be included in the analysis if they heve received at least two months of treatment with a cdki. patient clinical data will be obtained from their medical records. toxicity data will be recorded from the clinicians' documentations during scheduled patient clinical visits. statistical analysis the primary endpoint of the study will be progression-free survival (pfs), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. secondary endpoint will be overall survival (os), defined as the time from treatment initiation to patient death or last contact. patients alive will be censored at the date of last contact. adverse events will be graded based on common terminology criteria for adverse events (ctcae, version 4.0). survival curves will be estimated using the kaplan-meier method and compared across groups with the log-rank test. the associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with cox proportional hazards model. the statistical analyses will be completed using the sas software (sas for windows, version 9.3, sas institute inc., cary, nc).

Eligibility criteria:
inclusion criteria: * 18 years or older * αny menopausal status is allowed * hr-positive/her2-negative advanced breast cancer * patients treated with cdki in combination with endocrine therapy for their advanced breast cancer * combinations of cdki with any endocrine therapy are allowed * more than two months of treatment with a cdki is mandatory exclusion criteria: • treatment with cdki as (neo)adjuvant treatment

Keywords: cdk breast cancer toxicity outcome