Kornimate/medical-research-clean huggingface dataset:
first in human study of torl-1-23 in participants with advanced cancer

Conditions: Advanced Solid Tumor; Ovarian Cancer; Endometrial Cancer; NSCLC

Summary: this first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of torl-1-23 in patients with advanced cancer


Eligibility criteria:
inclusion criteria: * advanced solid tumor * measurable disease, per recist v1.1 * eastern cooperative oncology group (ecog) performance status 0-1 * adequate organ function exclusion criteria: * has not recovered \[recovery is defined as nci ctcae, version 5.0, grade ≤1\] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements * received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of torl-1-23 * progressive or symptomatic brain metastases * serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection * history of significant cardiac disease * history of myelodysplastic syndrome (mds) or aml * history of another cancer within 3 years before day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. a history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (dcis) of the breast and prostate cancer with a gleason score less than or equal to 6, are also not excluded * if female, is pregnant or breastfeeding

Keywords: claudin6
metabolic profile and anthropometric changes in schizophrenia

Conditions: Metabolic Syndrome; Diabetes; Obesity

Summary: "no clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. "

we aimed to study the effects of antipsychotics, olanzapine, risperidone and haloperidol on development of metabolic syndrome in a drug naïve population suffering from first episode schizophrenia and compared it with a matched healthy control group. we also aimed to examine the prevalence of metabolic syndrome as defined by the two most widely accepted definitions, the atp iiia and the idf.

Eligibility criteria:
inclusion criteria: * age between 18-40 years * diagnosis of schizophrenia * drug naive on admission exclusion criteria: * other psychiatric co-morbidity * history of severe physical illness * alcohol and substance abuse or dependence * history of pre-existing diabetes or hypertension * family history of hypertension or diabetes

Keywords: metabolic syndrome obesity diabetes
observational, non-interventional use of lipus to mitigate fracture non-union in patients at risk

Conditions: Mitigation of Fracture Non-union in Patients at Risk

Summary: this study is one of three separate studies of the bioventus observational non-interventional exogen studies (bones) program. eligibility for each study is determined by fractured bone.

the prospective arm of this non-interventional, observational study is designed to collect real world evidence from patients at risk of a fracture non-union across the us receiving exogen treatment. patients will be followed for 9 months post fracture. as a non-interventional study, the treating clinician will continue to provide routine care without research intervention or dictation by a protocol. a medically staffed direct-to-patient contact center will serve as a central investigational site with scheduled and structured direct-to-patient contacts via phone/email/text/web based surveys to obtain informed consent and collect data directly from the patient. for all prospective patients, primary effectiveness data will be obtained directly from the medical records of the treating physician. the comparator arm of this study will be a retrospective cohort of patients within a national health insurance claims database. an extract of this database will be taken and eligible controls derived via propensity score analysis.

Eligibility criteria:
inclusion criteria: 1. must be willing to provide voluntary informed consent 2. male or female age 21-80 on fracture date 3. must be willing to sign for release of medical insurance claim billing records from the treating clinician, pertaining to the fracture and fracture treatment 4. fluency in english and/or spanish 5. prescriptive initiation of therapy with the exogen ultrasound bone healing system (model number 71034400) for a specified fracture 6. bone specific fracture exclusion criteria: 1. patient report of treatment with an electrical bone growth stimulation device (e.g., pulsed electromagnetic field (pemf) or capacitive coupling (cc) based devices) for bone fracture in 9-months pre-index period up to baseline phone contact 2. pregnant on fracture index date 3. evidence that prescription for exogen has been written to treat a fracture non-union or mal-union (i.e, icd-10-cm code with seventh character modifier of k, p or s). 4. evidence that prescription for exogen has been written to treat a pathologic fracture (icd-10-cm code m80. or m84.) or neuropathic bone (icd-10-cm code m14.6) 5. patient with a concurrent fracture of the other bones of interest 6. patients who are or anticipate living or receiving fracture treatment outside of the us during the post-index fracture period 7. patient report of history of primary or metastatic bone cancer 8. patient report of bone infection or osteomyelitis of index fracture at baseline contact 9. patient report of prior bone specific fracture in 9-months pre-index period 10. patient prescribed exogen as part of a worker compensation claim
the nuvigil and provigil pregnancy registry

Conditions: Narcolepsy; Obstructive Sleep Apnea; Shift Work Sleep Disorder

Summary: the primary objective of the nuvigil/provigil pregnancy registry is to characterize the pregnancy and fetal outcomes associated with nuvigil and provigil exposure during pregnancy.

both the prospective and the retrospective data are captured.

Eligibility criteria:
inclusion criteria: * reported exposure to brand or generic formulations of nuvigil (armodafinil) and/or provigil (modafinil) within 6 weeks prior to becoming pregnant, or during pregnancy * patients who provide oral or written informed consent. * infant up to 1 year of age born to a female with maternal exposure to armodafinil and/or modafinil within 6 weeks prior to becoming pregnant or during pregnancy. * able and willing to provide healthcare professional and secondary contact information, and for the patient herself to be contacted periodically by registry staff. exclusion criteria: * patients who refuse to provide oral or written informed consent. * patients not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy. * infants whose mother was not exposed to armodafinil or modafinil within 6 weeks prior to becoming pregnant or during pregnancy.

Keywords: pregnancy
resistance exercise and peer support with bands/balls and digital support among women with polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome (PCOS)

Summary: the purpose of this one arm pilot was to assess the feasibility and acceptability of reps w/bands and evaluate for signals of improvement for depressive symptoms, anthropometrics, and muscular endurance. participants completed a 12-week personalized in-home resistance exercise program that was delivered in real-time via a smart home video device along with a buddy system for peer support.

research findings reveal that women with polycystic ovary syndrome (pcos) report low exercise motivation due to pcos stigma-related stress and lack of social connection, thus inhibiting exercise in public and group settings. the purpose of this study was to implement and assess the feasibility and acceptability of an in-home personalized resistance exercise (re) program delivered in real time by a smart home video device (shvd) with peer support provided by a buddy system. this theory-informed, one-arm proof-of-concept study provided participants (n=10) with an shvd, exercise equipment (exercise bands, stability ball), and 2 supervised re sessions per week for 12 weeks via the shvd's video feature and incorporated strategies from self-determination theory to meet the psychological needs of autonomy, competence, and relatedness. participants were randomly paired with a buddy. feasibility, acceptability, depressive symptoms, anthropometrics, and muscular endurance were measured using surveys, fitness testing, and interviews. quantitative data were calculated using t-tests. qualitative data were analyzed via thematic analysis.

Eligibility criteria:
inclusion criteria: * an age of 18 or older * a confirmed pcos diagnosis by a healthcare provider * physical activity readiness as determined by the physical activity readiness questionnaire (par-q) * residence within driving distance of the main university campus. exclusion criteria: * cardiorespiratory disease (e.g., congestive heart failure) * hypertension * orthopedic injury (e.g., herniated disc) * pregnancy.

Keywords: polycystic ovary syndrome motivation resistance training digital technology proof of concept study feasibility studies
a follow-up physician survey to evaluate physician knowledge of safety and safe use information for aflibercept administered by intravitreal injection in europe

Conditions: Ophthalmology, Macular Degeneration

Summary: with this follow up physician survey researcher want to collect the same data from all participants of the study using a highly structured questionnaire. the questionnaire will gather information related to physician characteristics and experience with aflibercept, as well as assess physicians' knowledge and understanding of storage and preparation, proper injection technique, and the risks associated with aflibercept injection into the eye (intravitreal injection). analysis will be done using descriptive statistics.


Eligibility criteria:
inclusion criteria: * has signed informed consent * is a licensed and practicing ophthalmologist * has prescribed and/or administered aflibercept to at least one patient in the past 6 months exclusion criteria: * none
nomograms to precisely predict conditional risk of survival for patients with laryngeal cancer

Conditions: Laryngeal Cancer

Summary: advanced laryngeal squamous cell carcinoma (scc) remains a highly morbid and fatal disease despite aggressive interventions. mortality is high in this cohort: laryngeal cancer affects over 13 000 patients in the united states, with over 3500 deaths annually.the results of the veterans affairs cooperative studies program laryngeal cancer trial and subsequent studies demonstrated similar overall survival (os) rates for organ preservation protocols involving radiotherapy (rt) or chemoradiotherapy (crt) when compared to surgery, with the benefit of preserving the larynx in a large majority of patients. as such, the use of rt or crt has become the predominant initial intervention for patients with laryngeal scc.however, the prognosis of recurrent and persistent laryngeal scc is particularly dire.in this study,the investigators sought to identify preoperative predictors of survival for patients with recurrent or persistent laryngeal scc in order to set patient expectations and address modifiable risk factors. identification of predictors of survival may also identify patients who could benefit from novel therapeutic agents in a neo/adjuvant fashion. herein,we examine a cohort of patients with recurrent or persistent laryngeal scc after definitive rt/crt who has undergone total laryngectomy in order to identify potential preoperative predictors of clinical outcomes.

demographic, clinical, and survival data were abstracted. death was verified via medical records and the social security death index. primary outcome measures were os (time from salvage laryngectomy to death from any cause), disease-specific survival (dss; time from salvage laryngectomy to death from recurrent/persistent laryngeal scc), and dfs (time from salvage laryngectomy to laryngeal scc recurrence)

Eligibility criteria:
inclusion criteria: * laryngeal carcinoma patients with radical surgery exclusion criteria: * multiple primarry malignant neo-plasms

Keywords: survival nomograms laryngeal cancer
evaluation of a mind-body based application for the treatment of chronic/persistent pain.

Conditions: Chronic Pain; Migraine; Chronic Pain Syndrome

Summary: we are investigating the effects of a mind-body based mobile application on the experience of chronic pain. participants meeting our criteria for chronic pain (confirmed via self-report) will complete an online baseline questionnaire. eligible participants will be enrolled in the study and randomized into control (usual care, waitlisted) or intervention group (6-week mind-body based mobile application intervention). randomization will be stratified by pain intensity and gender using computer-generated block randomization to create varying block sizes of 4 and 8. we will run the trial in multiple cohorts in series to obtain desired sample size. all participants will complete online questionnaires at baseline and post-intervention at 6 weeks that measure pain intensity, interference with daily living, pain perceptions, mental health outcomes, and medication use. participants will also complete weekly questionnaires on weeks 2 to 6 to gauge frequency of application usage (intervention) or other pain treatments (control). participants in the intervention group will be asked to repeat the follow-up questionnaire at 12-weeks.

see protocol for more details. (submitted at time of registration)

Eligibility criteria:
inclusion criteria: * participants aged 19 to 75 years with chronic pain. * chronic pain is defined as having non-malignant chronic or persistent pain for at least 6 months. * participants must experience pain at least half the days in the last 6 months. * pain can include bodily pain or head (migraine) pain. exclusion criteria: * individuals reporting a cognitive impairment that can interfere with completing questionnaires and using a mobile application. * individuals reporting any of the following psychiatric illness: schizophrenia, dissociative or personality disorders, bipolar disorder. * individuals reporting any of the following medical conditions: metastatic cancer, rheumatoid arthritis, lupus, scleroderma, polymyositis. * individuals reporting substance use disorder (within the last 6 months). * individuals that have previously used mind-body apps for the treatment of chronic pain.

Keywords: chronic pain mind-body mobile application
effects of dual-task and progressive wall squat training in stroke survivors

Conditions: Stroke Ischemic

Summary: to determine the effects of dual-task and progressive wall squat training on cognition, balance and functional mobility in stroke survivors.

a stroke is a neurological disorder in which clots or ruptured vessels obstruct blood vessels, causing abnormal blood flow in the brain. this may lead to the unexpected death of brain cells and aggravate illnesses like depression and dementia.it is a disease with significant health and social consequences because of its high frequency and rate. stroke is thought to affect 9.2% of the population in europe, with a rate of 191.9 per 100,000 people annually. according to estimates, between 25 and 74% of those who survive this illness need assistance or become totally reliant on their everyday activities.the primary long-term effects of a stroke are dysphagia, paralysis, motor impairments, cognitive decline, and speech difficulties. dual-task training entails doing a motor task and a cognitive task at the same time. this method's justification is that a lot of daily tasks necessitate multitasking, and dual-task training can improve both cognitive and motor abilities by promoting brain plasticity and the interaction of the two systems. in the dual task training, cognitive task (like naming animals or counting backwards) is combined with a lower limb strengthening exercise called wall squats. both tasks gradually increase in difficulty and intensity based on how well each person performs. by testing the muscle strength, endurance, and coordination of stroke survivors as well as their attention, memory, and executive function, this training seeks to improve their cognitive abilities, balance, and functional mobility.

Eligibility criteria:
inclusion criteria: * age: stroke patients aged 45 to 65 years. * individuals with a single ischemic stroke. * within the first 2 months post-stroke. (subacute stage) * medically stable without acute conditions interfering with exercise. * mini-mental state examination (mmse) score≥24 * ability to walk 10m without assistance exclusion criteria: * unstable medical conditions (cardiovascular, respiratory, or other medical conditions) * recent stroke or medical event * other neurological conditions such as presence of other neurological conditions (e.g., parkinson's disease). * uncontrolled hypertension: systolic bp \>160 mm hg or diastolic bp \>100 mm hg

Keywords: balance cognition dual-task functional mobility stroke survivors wall squat
effects of alpha blockers on prostate-specific antigen (psa) change in men with lower urinary tract symptoms (luts)

Conditions: Benign Prostatic Hyperplasia; Prostate Cancer

Summary: the correlation between the change of serum prostate-specific antigen (psa) or psa velocity (psav) and severity of lower urinary tract symptoms (luts) has been poorly understood. previous studies usually focused on the treatment efficacy or preventive role of alpha blockers (ab) for clinical progression of benign prostatic hyperplasia (bph) and ab therapy in real-life practice improved bph/luts and reduced the risk of overall clinical progression. we hypothesized that the change of psa and psa velocity would be correlated to luts severity in the groups of bph and prostate cancer.

since successful treatment with alpha-1 adrenergic antagonists, or ab was reported first in 1975, the therapeutic efficacy has been widely accepted and now ab medication is considered the first-line choice worldwide among pharmacologic options for bph-related luts. previous studies usually focused on the treatment efficacy or preventive role of ab for clinical progression of bph and ab therapy in real-life practice improved bph/luts and reduced the risk of overall clinical progression. however, the correlation between the change of serum psa or psav and severity of luts has been poorly understood. some studies showed follow-up data of psa during the study period, and they failed to show a significant change of psa in the group of ab. in contrast, some other studies demonstrated that the possibility of psa change with the presence of luts and it is early to tell conclusively that there would be no relationship between psa values and luts severity. because a psa value is considered an important factor to determine whether transrectal prostate biopsy should be performed, we hypothesized that the change of psa and psav would be correlated to luts severity in the groups of bph and prostate cancer.

Eligibility criteria:
inclusion criteria: * more than two consecutive psa measurements before the biopsy and the medication periods of ab more than 3 months in all patients exclusion criteria: * any prostate surgery during the study period, any prostate disease with evidence of prostatic inflammation, any urologic surgery before psa measurement, and medication history of anticholinergics or 5-alpha reductase inhibitors

Keywords: prostate prostate-specific antigen benign prostatic hyperplasia adrenergic alpha-antagonists
a non-interventional study for the collection of biospecimens from patients with parkinson's disease

Conditions: Parkinson Disease

Summary: this study aims to collect, analyze and preserve biospecimens from patients with or without lrrk2-associated parkinson's disease for the purpose of discovering and developing new treatments and novel biomarkers.


Eligibility criteria:
inclusion criteria: * male or female ≥40 * clinical diagnosis of parkinson's disease meeting united kingdom brain bank criteria and modified hoehn and yahr stage i, ii, or iii; * willing to undergo genetic testing for neurologic genotyping panel; -if being treated for parkinson's disease, must have been on a stable dose of anti- parkinson's disease medications for a minimum of 30 days prior to day 1; * if taking statins, fibrates, antipsychotic or anticonvulsant medications at day 1, must have been on a stable dose for a minimum of 30 days, and are not likely to require a change in dosage for the remainder of the study; exclusion criteria: * any major medical illness or unstable medical condition within 6 months of screening that, in the opinion of the investigator or sponsor, may interfere with the subject's ability to comply with study procedures or abide by study restrictions. * diagnosis of a significant central nervous system disease other than parkinson's disease(eg, huntington's disease, frontotemporal dementia, multi-infarct dementia, normal pressure hydrocephalus, multiple system atrophy, progressive supranuclear palsy, drug- induced parkinsonism, alzheimer's disease) * history of stroke; * history of epilepsy or seizure disorder other than febrile seizures as a child, or any seizure or unexpected loss of consciousness (eg, syncope) within 6 months prior to day 1; * history of traumatic brain injury with residual neurological deficit; -if taking anti-parkinson's disease medication(s)and are likely to require a change in anti- parkinson's disease medication(s) during the study; * known active infectious disease or active infections within 30 days prior to day 1; * any vaccination within 21 days prior to day 1; * currently taking, or planning to take, anti-coagulant medications or antiplatelet medications during the study; * allergy to lidocaine (xylocaine) or its derivatives or any other lp contraindications; * any other condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the investigator, unacceptably increase the subject's risk by participating in the study; -any systemic glucocorticoids taken within 14 days prior to day 1 or non-steroidal anti- inflammatory drugs taken within 4 days prior to day 1; * received blood products within 30 days prior to day 1; * donated blood within 30 days prior to day 1.
conservative surgery for placenta accreta

Conditions: Placenta Accreta

Summary: a stepwise surgical approach for conservative management of placenta previa accreta.

a stepwise surgical approach for conservative management of placenta previa accreta to preserve women's uterus and to evaluate the efficacy and safety of this approach in controlling postpartum hemorrhage including intrapartum hemorrhage associated with conservative management.

Eligibility criteria:
inclusion criteria: * any age. * any parity. * previous one or more cesarean delivery. * placenta previa accreta diagnosis confirmed by gray scale \& color flow doppler ultrasound in 3rd trimester. all participants had undergone abdominal ultrasound showing placenta previa anterior completely covering the internal os, with criteria suggestive of invasion by u/s exclusion criteria: * women with medical disorder * women with bleeding tendency