Kornimate/medical-research-clean huggingface dataset:
a study of incb123667 in participants with platinum-resistant ovarian cancer with cyclin e1 overexpression

Conditions: Ovarian Cancer

Summary: this study will evaluate the safety and efficacy of incb123667 in participants with platinum-resistant ovarian cancer (proc) with cyclin e1 overexpression.


Eligibility criteria:
inclusion criteria: * histological diagnosis of a high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer. * have platinum-resistant disease: * participants who have only had 1 line of platinum-based therapy must have received at least 4 cycles of a platinum-containing regimen. * participants who have received 2 to 4 lines of platinum-based therapy must have progressed on or within 6 months after the last dose of platinum. * archival ffpe tumor tissue block or slides from a specimen no older than 5 years must be available. if not available, participant must be willing to undergo a pretreatment tumor biopsy. * received at least 1 and no more than 4 prior lines of systemic therapy following the initial diagnosis, after which single-agent therapy is considered an appropriate next therapeutic option. * must have received bevacizumab unless there was a contraindication for its use. * if the tumor tests positive for frα, participants must have received mirvetuximab soravtansine unless there is an exception for its use on medical grounds. exclusion criteria: * have endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of these histologies, or low-grade/borderline ovarian cancer. * have primary platinum-refractory disease: either did not respond (cr or pr) to first-line platinum-containing therapy or progressed on or within 3 months after the last dose of the first line platinum-containing therapy. * the tumor tests positive for frα but the participant has not received mirvetuximab soravtansine for any reason other than medical contraindication. * clinically significant or uncontrolled cardiac disease within 6 months before the first dose of study drug. * known active cns metastases and/or carcinomatous meningitis. * known additional malignancy that is progressing or requires active treatment. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: incb123667
ensartinib in the treatment of alk positive or met exon 14 skipping anvanced solid tumors excluded lung cancer

Conditions: Solid Tumors

Summary: in lung cancer, ensartinib is effective in improving the prognosis of alk positive /met exon 14 skipping patients. however, patients with alk positive /met14 exon skipping non-lung cancer solid tumors have limited treatment options in the absence of standard treatment. we hope to bring a new effective and safe treatment option to these patients more efficiently.


Eligibility criteria:
inclusion criteria: * advanced/metastatic solid tumors other than primary lung cancer * alk-positive or met14 exon skipping mutation by ihc\\fish\\ngs\\rt-pcr * have no standard treatment after mdt discussion, or could not tolerate the standard treatment, or the patient refused the standard treatment * adequate liver and kidney function * adequate bone marrow function * ecog ps 0-3 * female subjects should not be pregnant. all human subjects should able to comply with the required protocol and follow-up procedures, and able to receive oral medications written informed consent provided exclusion criteria: * active viral, bacterial, or fungal infection detected 2 weeks before enrollment * pregnancy or lactation * receiving medications or herbal supplements with potent inducers of cyp3a4 (at least 3 weeks prior) * any severe or uncontrolled systemic illness, including uncontrolled hypertension and active bleeding, any nonadherence that the investigator considered to be detrimental to study participation or adherence to the protocol, or active infections including hepatitis b, hepatitis c, and human immunodeficiency virus (hiv) * ineligible cardiac function * interstitial lung disease, drug-induced interstitial lung disease, previous history of radiation pneumonitis requiring steroid therapy, or any evidence of active interstitial lung disease * lack of adequate bone marrow reserve or organ function
clinical exploration of adeno-associated virus (aav) expressing human acid alpha- glucosidase (gaa) gene therapy for patients with infantile-onset pompe disease

Conditions: Infantile-onset Pompe Disease

Summary: this study is being conducted to evaluate the safety and effectiveness of gc301 adeno-associated virus vector expressing codon-optimized human acid alpha-glucosidase (gaa) as potential gene therapy for pompe disease. patients diagnosed with infantile-onset pompe disease who are younger than 6 months old will be studied.


Eligibility criteria:
inclusion criteria: * the patient's legal guardian(s) must be able to understand the purpose and risks of the study and voluntarily provide signed and dated informed consent prior to any study-related procedures being performed; * the patient must be no older than 6 months; * the patient must be diagnosed with infantile-onset pompe disease. exclusion criteria: * class iv patient based on modified ross heart failure classification for children; * aspartate aminotransferase (ast), alanine aminotransferase (alt) \> 3x upper limit of normal (uln), alkaline phosphatase (alp) \> 2x uln (with the exception of liver abnormalities related to pompe disease); * patient has severe organ dysfunction, such as liver and kidney failure (liver failure: patients may have liver failure syndrome, including fatigue, severe gastrointestinal symptoms; clinical examination found prolonged prothrombin time, prothrombin activity less than 40%; neuropsychiatric symptoms, such as restlessness, changes in personality and behavior, lethargy, coma, etc.; toxic tympanic bowel, ascites, multiple organ dysfunction, etc.; hyperalbuminemia exceeding 171 μmol/l, hypoalbuminemia. renal failure: creatinine exceeding 110 μmol/l, or glomerular filtration rate less than 100 ml/min), congenital/acquired encephalopathy, etc.; * patient with congenital organ absence; * patient with primary immunodeficiency; * patient who is positive for human immunodeficiency virus (hiv) antibody, hepatitis b surface antigen, hepatitis c antibody, or treponema pallidum antibody; * patient with a history of glucocorticoid allergy； * patient who has participated in a previous gene therapy research trial; * patient who has any concurrent clinically significant major disease or any other condition that, in the opinion of the investigator, makes the subject unsuitable for participation in the study.
pharmacogenomics of antiplatelet response

Conditions: Atherosclerosis

Summary: this clinical trial will examine with effect of 2-week aspirin therapy on platelet gene expression in persons at high-risk of developing heart attacks due to family history of early-onset coronary artery disease

in this clinical trials we will select individuals from genestar cohort based o their platelet function. equal number of individuals will be selected from each race and gender and from low or high platelet aggregation. we will have baseline platelet functions performed and baseline platelet gene expression examined. participants will be given 2-week supply of aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation studies and a repeat platelet gene-expression (using rna-seq). the ultimate goal is to examine platelet gene expression differences due to aspirin and across different gender, race, platelet-aggregation groups.

Eligibility criteria:
inclusion criteria: * 45-75 years * genestar participant * no personal history of coronary artery disease * women who are post-menopausal * women who are using a reliable method of contraception, such as history of tubal ligation, iud or taking ocp exclusion criteria: * taking aspirin prescribed by physician * weight \< 60 kg * history of recent or current bleeding * allergy to aspirin or history of adverse events to aspirin * serious comorbid conditions (such as aids, active cancer) * high blood pressure (\>160/95) * history of gastrointestinal ulcer/bleeding * mental incompetence to make decision to participate.

Keywords: aspirin, atherosclerosis
impact of spontaneous breathing on ventilation distribution in obese patients

Conditions: Obesity; Hip Arthroplasty; General Anesthesia; Spinal Anesthesia; Atelectasis

Summary: general anesthesia (ga) and paralysis are factors which facilitate atelectasis formation, especially in obese patients. spontaneous breathing can reduce the amount of atelectasis. in this study, the investigators are comaparing obese patients undergoing hip arthroplasty in ga versus spinal anesthesia. distribution of ventilation during and after anesthesia is assessed by eletrical impedance tomography (eit).


Eligibility criteria:
inclusion criteria: * bmi \>30 * age 18-85 * elective hip arthroplasty in general anesthesia or spinal anesthesia exclusion criteria: * pregnancy/breastfeeding * allergies against drugs used for the anesthesia * contraindications for eit * severe cardiac or pulmonary comorbidities * unable to consent or understand/follow study
effects of epicatechin on statins for mitochondrial dysfunction and impaired exercise capacity

Conditions: Statin Intolerance

Summary: the purpose of this study is to gain insight into the side-effects of statin consumption, and assess the ability of epicatechin (a compound in dark chocolate) to counteract or reverse these changes. the investigators' prior research has shown that epicatechin can improve skeletal muscle structure and mitochondrial (which gives us energy) structure.

patient inclusion criteria: 1. must be between 30-75 years of age. 2. must have a vo2max greater than 18 ml/kg/min(non-sedentary individuals). 3. subjects with ldl\>100mg/dl (or on drug treatment) 4. subjects without a prior cerebrovascular event (example: stroke) 5. subjects without a prior cardiovascular event (example: heart attack) patient exclusion criteria: 1. liver, thyroid, or kidney disease. 2. currently taking drugs that interfere with statin metabolism (calcium channel blockers, colchicine etc.). 3. acute or chronic infectious disease; autoimmune/inflammatory disease, cancer, copd, anemia, diabetes, psychiatric illness. 4. non-smokers, prior smokers, or illicit drug users with abstinence \>1 year. 5. subjects taking blood thinners (coumadin, xarelto, pradaxa, plavix, effient, apixiban, etc) will be excluded. if subjects are taking aspirin for routine prevention they will be asked to hold aspirin for 7 days prior to biopsy. routine prevention means that the patients are taking aspirin to reduce their risks, but do not have established cardiovascular disease. 6. history of previous knee surgery and active history of knee pain or neuromuscular disease are exclusions as they are known to affect muscle structure and function. the study will be a double blind placebo controlled study where subjects will be randomized to either of two groups: 1. simvastatin 40 mg + placebo once daily (statin only group) for 3 months 2. simvastatin 40 mg + epi 50 mg once daily (statin + epi group) for 3 months

Eligibility criteria:
patient inclusion criteria: * must be between 30-75 years of age * ldl\>100mg/dl (or on drug treatment) * vo2 max greater than 25 ml/kg/min patient exclusion criteria: * liver or kidney disease * currently taking drugs that interfere with statin metabolism * currently taking blood thinners * acute or chronic infectious disease; autoimmune/inflammatory disease, cancer, copd, anemia, psychiatric illness, insulin-dependent diabetes * smokers or illicit drug users * adverse cardiovascular event (ex: heart attack) * history of knee surgery or active history of knee pain

Keywords: myopathy muscular weakness cramping fatigue
sleeping for two: rct of cbt-insomnia in pregnancy

Conditions: Insomnia; Sleep Disturbance

Summary: cognitive-behavioural therapy for insomnia (cbt-i) has been shown to be an effective treatment for insomnia in multiple populations, including women during pregnancy and postpartum. online cbt-i has also been shown to be effective and comparable to in-person cbt-i, and shows promise as an accessible treatment alternative to in-person cbt-i for pregnant women experiencing insomnia. as the harmful consequences of insomnia or sleep disturbances have been well documented during late pregnancy, this randomized-controlled trial will compare the efficacy of both in-person and online cbt-i on pregnant women with insomnia to a wait-list control group.

the primary aim of the current project is to evaluate the impact of a 6-week in-person cbt-i, versus online cbt-i, versus a wait-list in reducing symptoms of insomnia (assessed subjectively by self-report and objectively with actigraphy) experienced in pregnancy. the investigators hypothesize that participants who receive a 6-week program of either in-person cbt-i or online cbt-i (versus a wait-list) will report fewer insomnia symptoms and have improved objectively assessed sleep measured at one-week post-treatment. based on previous research findings, the investigators do not expect that there will be a difference between in-person cbt-i and online cbt-i administration. the secondary aim is to investigate if cbt-i versus a wait-list will reduce symptoms of depression at one-week post-treatment. the investigators hypothesize that participants who receive in-person cbt-i and online cbt-i (versus a wait-list) will report fewer depressive symptoms measured at one-week post-treatment.

Eligibility criteria:
inclusion criteria: * age: 18 years or greater * gestation: 12 - 30 weeks * identifying as experiencing sleep disturbances * language: english-intermediate or above * have access to internet exclusion criteria: * experiencing symptoms of sleep disorders other than insomnia * currently taking prescribed medications for sleep problems * history of untreated, serious psychiatric illness * substance-use during pregnancy
observation of side effects and effectiveness of desloratadine (aerius) syrup in filipino children (study p05634)

Conditions: Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria

Summary: the purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in filipino children. the participants will take desloratadine syrup for 14 days. at the end of treatment, side effects will be recorded, as well as how the participants tolerate the medication. effectiveness will also be rated at the end of treatment.

physicians who commonly prescribed desloratadine treatment as standard care of treatment were selected enroll participants.

Eligibility criteria:
inclusion criteria: * outpatient pediatric participants, male or female, aged 6 months to 11 years * diagnosis of allergic rhinitis or chronic idiopathic urticaria exclusion criteria: * known hypersensitivity to desloratadine
a study of risk factors for the covid-19 virus infection

Conditions: COVID-19 Infections in Cancer Patients

Summary: the purpose of this study is to collect information that will help the reasearchers learn more about covid-19 infections in cancer patients, and to find out about the effects of these infections on cancer treatment and outcomes. the research study involves asking people to complete a series of online questionnaires that include questions about their medical history, lifestyle, and risk factors related to the covid-19 infection. the study will enroll both msk patients and their household family members.


Eligibility criteria:
inclusion criteria: msk patients * all individuals who have had at least one point of contact since january 1st 2019 as a patient, including visiting an msk facility for treatment, clinical evaluation, follow-up or screening, covid-related screening, or a telehealth visit. household members of msk patients * individuals aged 18 or older * currently reside in the same household of msk patients enrolled onto this protocol * have an email account exclusion criteria: * impaired decision-making capacity as noted in ehr * current msk employee

Keywords: sars-cov-2 infection questionnaires 20-418
addressing treatment nonresponders

Conditions: Language Development Disorders

Summary: the goal of this clinical trial is to see if providing late talking toddlers who are not responding to the vocabulary acquisition and usage for late talkers (vault) treatment with a different way of communicating will help them improve their word learning. participants will start with vault word learning treatment. if, in the first few sessions, it looks like they won't respond well, they will be provided with a big mack augmentative and alternative communication device (a button that says a word when you press it) to use for their responses. the investigators will see if this modification will help with word learning.

children will begin vocabulary acquisition and usage for late talkers (vault) word learning treatment. if, after three sessions, they do not show an initial response to treatment, they will be provided with a big mack augmentative and alternative communication device which will allow them to 'say' the treatment words with the device. treatment will continue until the children have had 8 total weeks of treatment (2x/wk for 30 minutes per session). the investigators will measure word learning across time tracking both spoken productions and productions made with the device.

Eligibility criteria:
inclusion criteria: * native english speaking * pass pure tone hearing screening or medical report of normal hearing * 2-3 years at start of study * macarthur-bates communicative development inventories (mcdi) expressive scale \<10th percentile exclusion criteria: * parental report of other diagnoses * enrolled in concurrent treatment elsewhere * nonverbal iq \<75 as measured by the bayley scales * parents unable to consistently bring child to treatment sessions.

Keywords: late talkers
test of target engagement of ambiguity aversion

Conditions: Intolerance of Uncertainty; Anxiety; Intolerance of Uncertainty; Anxiety; Depression, Anxiety

Summary: the present work aims to test whether a single session intervention alters ambiguity aversion, both in terms of people's decision making and their brain responses to ambiguous choices.

in this trial, participants will be randomized to one of two single session interventions (ssi). they will complete a decision making task before and after the ssi to measure their behavioral and brain responses to ambiguity, all on the same day. they will also complete a brief measure of hopelessness before and after the ssi. the main analysis will compare changes in ambiguity aversion before and after the interventions. participants will also be asked to complete questionnaires before completing the task and ssi. the questionnaires will be about the participant's emotions and symptoms of depression and anxiety, personality, and avoidance/tolerance of uncertainty.

Eligibility criteria:
inclusion criteria: 1. ages 25 to 60 2. right-handed 3. ability to read and write english 4. capacity to provide informed consent 5. intolerance of uncertainty score ≥ -0.5 standard deviation below the mean (31st percentile) exclusion criteria: 1. personal history of psychosis, mania, or hypomania 2. personal history of autism spectrum disorder 3. iq \< 80 as determined by the wechsler test of adult reading 4. head injury with greater than 120 seconds loss of consciousness 5. neurological condition (e.g., epilepsy, parkinson's, cerebral palsy, history of stroke) 6. currently pregnant 7. use of any implanted electrical device (e.g., pacemaker, spinal stimulator, vagal nerve stimulator, inspire sleep apnea device, etc.).

Keywords: ambiguity aversion intolerance of uncertainty computational modeling eeg/erp
the urinary microbiome and its relationship to the urinary and serum metabolome in healthy peri- and postmenopausal women

Conditions: Urinary Tract Infections

Summary: the presented project aims to characterize the microbiome of healthy peri- and postmenopausal women and its correlation with the metabolome of urine and serum.

at the beginning of their visit to the blood center of the university hospital ostrava, blood and plasma donors will be approached by one of the authorized members of the team with information about the possibility of participating in this study. the course of the study will be explained to them in detail, including the sampling methodology, their processing, and further handling. if the subject is interested in participating in the study, they will give written informed consent to participate in the study. subsequently, the inclusion and exclusion criteria for participation in the study will be verified. if these are not met, the subject will be excluded from the study. furthermore, the criteria for current valid blood and urine sampling will be verified. if the conditions for valid sampling are not met and the participant is still interested in participating in the study, she will be offered a new sampling date. if the study subject fulfills the conditions of valid sampling, she will fill out a simple questionnaire, which will be used to obtain data on basic demographic characteristics. their knowledge is essential for the correct interpretation of urine and serum test results. blood and serum will then be collected. in justified cases, sampling can also be carried out at the urology department of the university hospital ostrava. after submitting the first sample, the participant will be asked to submit another urine and serum sample in 3-6 months. by submitting the 2nd urine and serum sample, the participant ends her participation in the study.

Eligibility criteria:
inclusion criteria: * women over 50 years old * consent to participate in the study * willingness to take urine and blood samples according to the protocol exclusion criteria: * known congenital developmental defects of the urinary tract (congenital hydronephrosis, vesicoureteral reflux, renal agenesis, and hypoplasia, multicystic and polycystic kidneys) * recurrent urinary tract infections (more than 3 episodes in the last 12 months) * presence of any lower-urinary tract symptoms (urgency, frequency, incontinence, stranguria, urge to urinate, weak urine stream, the feeling of post-micturition residue) * the presence of a foreign body in the urinary tract - urolithiasis, urinary catheter, ureteral stent * acute or chronic diseases with possible influence on lower-urinary tract function * medications with possible influence on lower-urinary tract function * rheumatoid arthritis * diabetes mellitus

Keywords: microbiome urinary metabolome urinary bladder menopause
endothelial dysfunction in subjects with history of premature coronary artery disease

Conditions: Coronary Heart Disease

Summary: the aim of this prospective study is to investigate the prevalence of endothelial dysfunction in subjects with family history of premature coronary heart disease. at the same time, the effect of atorvastatin in treating subclinical endothelial dysfunction in those patients will be evaluated.


Eligibility criteria:
inclusion criteria: * within 1 year * the siblings of premature coronary heart disease(male\<55years old, female\<65years old: framingham heart study)patients admitted relevant hospital exclusion criteria: * documented coronary heart disease * any woman of childbearing potential who is pregnant, seeking to become pregnant or suspects that she may be pregnant.

Keywords: subjects with family history of coronary heart disease