Kornimate/medical-research-clean huggingface dataset:
a study evaluating the safety, activity, and pharmacokinetics of divarasib in combination with other anti-cancer therapies in participants with previously untreated advanced or metastatic non-small cell lung cancer with a kras g12c mutation

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the safety, pharmacokinetics (pk), and activity of divarasib combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * confirmation of biomarker eligibility * pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. representative tumor specimens must be in formalin-fixed, paraffin embedded (ffpe) blocks (preferred) or 15 unstained, freshly cut, serial slides. although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the sponsor. * eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 * histologically or cytologically documented locally advanced unresectable or metastatic nsclc that is not eligible for curative surgery and/or definitive chemoradiotherapy * no prior systemic treatment for advanced unresectable or metastatic nsclc * measurable disease, as defined by response evaluation criteria in solid tumors (recist) v1.1 exclusion criteria: * known concomitant second oncogenic driver with available targeted treatment * squamous cell histology nsclc * symptomatic, untreated, or actively progressing central nervous system (cns) metastases * prior treatment with a kras g12c inhibitor * known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (cohort b only) * history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment * history of malignancy other than nsclc within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year os rate more \>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or stage i uterine cancer * uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia
the effect of auricular acupressure on the improvement of anxiousness, depression and heart rate variability in stroke patients

Conditions: Post-stroke Depression; Auricular Acupressure

Summary: heart rate variability (hrv) in post-stroke patients are closely related to patient mortality, neurological deterioration and overall prognosis. anxiety and depression will demotivate the patients' will to undergo rehabilitation program, which would delay their functional recovery. the influence of acupressure over the auricle on the hrv, anxiousness and depressive mood have yet to be verified. the investigators aimed to study the effect on auricular acupressure treatment between the different trending of hrv, anxiety and depression and their correlations. this is a randomized control study, consisted of 70 patients with post-stroke depressive mood, from both cgh and xizhi cathay hospital in taiwan. hrv analysis is performed on the first 24 hours, and on a weekly basis for a total of 6 weeks. the included depressed patients were defined by the "hospital anxiety and depression scale" and weekly will be undertaken by the patients. a "taiwanese depression questionnaire" pre-test and after-test will be undertaken by the patients. experimental group will receive acupressure treatment by the second week, trice daily, 3\~5minutes each session for a course of four weeks. data were analyzed using spss 20.0, using generalized estimating equation, gee. the study hypothesized that the auricular acupressure treatment would improve post-stroke depression. therefore, participants would be more willing to receive rehabilitation program. our study would also help to provide future references on related studies.


Eligibility criteria:
inclusion criteria: 1. over 20 years old 2. within 24 hours of arriving at the hospital with the first symptoms of stroke 3. hemorrhagic stroke:nontraumatic hemorrhagic stroke and intracerebral hemorrhage score 0-1 4. infarct stroke:national institutes of health stroke scale less than 30 5. able to express themselves through oral or written communication 6. hospital anxiety and depression scale score equal to or greater than 11 exclusion criteria: 1. previous diagnosis of arrhythmia 2. mental illness, dementia, alzheimer's disease, or possible complete paralysis on imaging 3. subarachnoid hemorrhage, subdural hemorrhage, epidural hemorrhage 4. patients with acute myocardial infarction 5. there is a wound or lesion at the ear auricular point

Keywords: stroke heart rate variability autonomic nerve auricular acupressure depression anxiety
post-market clinical study to confirm safety and performance of purastat® for the management of bleeding in vascular surgery.

Conditions: Vascular Anastomosis Surgery

Summary: the objective of this post-market clinical follow-up study is to collect medical information on patients implanted with purastat®, according to each participating institution's procedures and standards of care.

this multicentre, single arm post-market clinical study aims to collect medical information on patients implanted with purastat®, absorbable haemostatic material, according to each participating institution's procedures and standards of care for confirming the safety and the performance of purastat®, for the management of bleeding in vascular surgery (carotid endarterectomy either by direct closure (without the use of patch), or by patch reconstruction or eversion technique).

Eligibility criteria:
main inclusion criteria: 1. male or female patient ≥18 years old 2. subject undergoing elective carotid endarterectomy 3. subject who is able to give voluntary, written informed consent to participate in this clinical study and from whom consent has been obtained 4. subject, who, in the opinion of the clinical investigator, is able to understand this clinical study, cooperate with the study procedures and is willing to return for the required post-treatment follow-up 5. intra-operative inclusion criteria: subject requiring the use of purastat® for haemostasis during elective carotid endarterectomy either by direct closure (without the use of patch), or by patch reconstruction or eversion technique when haemostasis by ligation or standard means is insufficient or impractical. main exclusion criteria: 1. presence or sequelae of coagulation disorder 2. known allergy or hypersensitivity to any component of purastat® 3. concurrent participation in another clinical trial with a medical device or a medicinal product 4. pregnant or interested in becoming pregnant during the duration of the study, or breast feeding intra-operative exclusion criteria: 5. spurting and/or gushing haemorrhage site(s) 6. contaminated or potentially contaminated surgical area 7. fibrin glue and/or topical haemostatic agent used before or concomitantly to the use of purastat® 8. persistent major bleeding after conventional haemostasis
effects of animation therapy on children with adhd

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: the aim of the study is to determine the effects of animation therapy on the main symptoms of attention deficit - hyperactivity disorder; hyperactivity, inattention and impulsivity.

attention deficit and hyperactivity disorder (adhd) is the most frequent childhood disorder, that is characterized with three main symptoms: inattention, hyperactivity, and impulsivity. animation therapy is the use of a stop-motion movie production process for therapeutic purposes. this new approach may have promising effect on attention because of its flow effect. also, there is only one study on the effectiveness of animation therapy in literature. this study is planned to investigate the effects of animation therapy on the main symptoms of the disorder.

Eligibility criteria:
inclusion criteria: * being at the age between 6-12 years. * being diagnosed with adhd by a psychiatrist. * taking prescribed medication for treatment of adhd. * having no physical, visual or mental problems. exclusion criteria: * absence in pre- and post-intervention evaluations * not completing 10-weeks of re-animation approach intervention process. * discontinuation of medical treatment for adhd.

Keywords: attention hyperactivity animation occupational therapy
analysis of the quality of life, the clinical effectiveness and cost-effectiveness of a novel educational programme in patients with psoriasis and atopic dermatitis

Conditions: Psoriasis; Atopic Dermatitis

Summary: 'onderhuids' is an educational program (department of dermatology, university hospital, gent) for patients with psoriasis and atopic dermatitis. we want to stimulate the patient to actively participate in their therapeutic approach by enhanced self care. we call the hypothesis that this program will help the patients learn to cope with their disease and to be loyal to their treatment, which will result in a better quality of life, better clinical outcome and cost effectiveness.


Eligibility criteria:
inclusion criteria: * patients who have given written informed consent * women or men of any race * patients who are 18-75 years of age * diagnosis of psoriasis or atopic dermatitis exclusion criteria: * patients with a cognitive disorder (not able to understand, speak, read or write..) * patients with a significant underlying medical cause (i.e. severe infection, haematologic disease, malignity, severe renal or hepatic disease, major depression) in the last 3 months * patients under experimental pharmaceutical medication

Keywords: moderate and severe psoriasis and atopic dermatitis
glucose trnsporter and pedf in psoriasis

Conditions: Psoriasis Vulgaris

Summary: psoriasis is a chronic relapsing cutaneous immune mediated inflammatory disease(imid). in which there are skin lesions characterized by erythema, thickness and scale formation with different size from a pinhead to 20 cm in diameter. prevalence of psoriasis is 2% to 4% worldwide. psoriasis occurs at any age with two peaks: between 15-20 years and between 55-60 years. women are presented with psoriasis at younger age than men ,but with less severity. lesions usually present on knee, elbow, scalp and sacral region this may be attributed to higher traumatic incident . psoriasis vulgaris is the most common type, and accounts 90% of cases. patients with psoriasis vulgaris present with pain, itching and bleeding from skin lesions. there are many theories for psoriasis pathogenesis: angiogenesis, decrease in apoptosis of keratinocyte, hyperproliferation , alteration of cell to cell adhesion and immune-mediated inflammation. patients with immune mediated inflammatory disease (imid) are susceptible to develop diabetes mellitus, metabolic syndrome, hyperlipidemia, and hypertension.a previous study found that psoriatic patients are more susceptible to type 2 diabetes compared to control. glucose transporter type 1(glut1) is upregulated in psoriatic patient attributed to angiogenesis and execessive cell proliferation in those patients .also expression of glut 1 is found high with hyperglycemia . a study reported that glut 1 density in placenta of women with gestational diabetes was found to be two folds higher than control. pigment epithelium derived factor (pedf) has antiangiogenic effect. topical application of pedf on mouse model of psoriatic disease helps in reduction of skin proliferation and angiogenesis. glut 1 overexpression was found to be associated with decrease in pedf expression in diabetic retinopathy. in view of that we will compare the level of glut 1 gene in psoriatic patients and psoriatic patients with diabetes, as well as healthy control, and detect the effect of pedf on glut 1 expression in vitro using human keratinocytes cell line .


Eligibility criteria:
inclusion criteria: * patients with psoriasis vulgaris patients with psoriasis vulgaris and type 2 diabetes exclusion criteria: * factors affect glut 1 expression as: tumors either benign or malignant cause increase glut 1 expression

Keywords: glut 1 pedf psoriasis vulgaris
collection and storage of blood and tissue samples from patients who are undergoing surgery for lung cancer

Conditions: Lung Carcinoma; Lung Neoplasm; Malignant Lung Neoplasm

Summary: this research studies collecting and storing tissue and blood samples from patients with lung cancer who are undergoing surgery. collecting and storing samples of tissue and blood from patients with lung cancer to study in the laboratory may help doctors learn more about changes that may occur in deoxyribonucleic acid (dna) and identify biomarkers related to cancer.

objectives: 1. to collect, catalog and store frozen samples of lung carcinoma and when possible, portions of involved lymph nodes, as well as adjacent grossly uninvolved lung tissue obtained from surgical specimens of patients undergoing surgical resection for previously untreated lung cancer as a source of quality dna, messenger ribonucleic acid (mrna) and protein for molecular analysis. 2. to collect, catalog and store frozen samples of blood pre- and post-resection from the same patients to provide a source of reference dna to assess somatic mutations associated with tumor or preneoplastic "normal" lung, and to allow assessment of levels of circulating markers. 3. to associate these specimens with historical, clinical, pathological, and outcome information. grossly viable tumor and grossly normal lung tissue are identified and removed from patient surgical specimens and cryopreserved until shipment to the cancer and leukemia group b (calgb) lung cancer tissue bank for future use in research. blood specimens are also collected prior to surgery and at 4-12 weeks post-surgery (before the start of adjuvant therapy) and shipped immediately to the tissue bank.

Eligibility criteria:
1. histologic documentation: all patients with suspected or histologically documented previously untreated lung cancer undergoing surgical resection are eligible whether or not the patient participates in a calgb-sponsored treatment trial; patients enrolled on a calgb trial of preoperative chemotherapy for lung cancer will be eligible if a pre-treatment frozen sample of tumor (e.g., a positive lymph node from mediastinoscopy) can be submitted to the bank; patients enrolled on calgb 140203, intraoperative sentinel node mapping in non-small cell lung cancer, are not eligible. 2. no patients with known infectious disease, such as human immunodeficiency virus (hiv), tuberculosis (tb), or hepatitis b, c
safety of herceptin/trastuzumab in metastatic breast cancer

Conditions: Breast Cancer, Metastatic Breast Cancer

Summary: this study was designed to evaluate safety and tolerability of herceptin as treatment for patients with human epidermal growth factor receptor 2 (her-2) positive metastatic breast cancer. frequency, characteristics and severity of adverse events (ae) and serious adverse events (sae) were followed to evaluate the safety of herceptin in patients with her2 positive metastatic breast cancer.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of metastatic breast cancer (bc) with her2-neu overexpression * left ventricular ejection fraction (lvef) by echo or multi gated acquisition scan (muga) \> 50% * good performance status: eastern cooperative oncology group (ecog) scale \ or = 12 weeks exclusion criteria: * advanced pulmonary disease and severe dyspnea * abnormal laboratory within 14 days prior to registration * peripheral neuropathy \> grade 2 * presence of central nervous system (cns) metastasis * pregnancy or lactating
objective evaluation of ocular surface lubricants in two environments

Conditions: Dry Eye

Summary: this study will evaluate ocular surface lubricants in subjects with dry eye syndrome.

this study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. the investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control). the investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.

Eligibility criteria:
inclusion criteria: * age 30-75 years * good general health * willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits * currently using an otc artificial tear for ocular comfort, at least occasionally. * at least one positive dry eye symptom. exclusion criteria: * current eye disease, infection or inflammation that requires the use of any prescription ocular medication. * recent past eye surgery. * female subjects may not be pregnant or lactating. * infectious diseases

Keywords: dry eye tear film lipid tear volume environmental chamber thermal imaging
timing of energy availability on menstrual cycle function

Conditions: Menstrual Irregularity

Summary: the primary aim of this clinical trial is to evaluate how fasted prolonged exercise may influence circulating reproductive hormones (i.e., estradiol, progesterone, luteinizing hormone) and menstrual cycle length when energy availability is maintained at or above 30 kcal/kg lean body mass/ day among women who regularly do running or cycling exercise. a secondary aim is to determine the effects of fasted prolonged exercise on serum leptin and cortisol. participants will be asked to do the following over a \~3 month enrollment period: * attend a laboratory visit at the beginning of the study to have their resting metabolic rate, aerobic fitness, and body composition tested * monitor their menstrual cycle length, urine hormones, perceived stress levels, and diet for \~3 months * complete 3, 90-minute exercise sessions on a stationary bike or treadmill either fed (consuming a carbohydrate meal 1 h prior and 0.7 g carbohydrate/ kg body mass/ h during exercise) or fasted (consuming no meal prior and no carbohydrates during exercise) during month \~3 * saliva samples will be taken prior to and after 90-minute exercise sessions for quantification of leptin and cortisol


Eligibility criteria:
inclusion criteria: * participates in structured running or cycling exercise for at least 30 minutes on 3 or more days per week * accustomed to exercising for 90 minutes or more * has regular periods every 21-35 days * have not taken hormonal contraceptives for at least the past 6 months * is not currently or trying to become pregnant or breastfeeding, and has not been pregnant or breastfeeding in the past 12 months * does not currently have a diagnosis of a major menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome \[pcos\], endometriosis, ovarian cancer, ovarian insufficiency, uterine or endometrial cancer) * does not currently have a metabolic disease (i.e., hypothyroidism, hyperthyroidism, cushing disease, addison's disease, diabetes, congenital adrenal hyperplasia) * does not currently have a major cardiovascular or respiratory disease exclusion criteria: * miss more than 7 consecutive days of aerobic activity (i.e., running, cycling, cross training) * demonstrate clinical low energy availability as defined as energy availability \<30 kcal/kg fat free mass * report menstrual cycle lengths \ 35 days in the first 2 months of at-home monitoring * do not demonstrate an anticipated rise in luteinizing hormone and progesterone in the first 2 months of at-home monitoring * begin taking a hormonal contraceptive * become pregnant * are diagnosed with a menstrual cycle disorder (i.e., amenorrhea, polycystic ovary syndrome \[pcos\], endometriosis, ovarian cancer, ovarian insufficiency, uterine, or endometrial cancer) * are diagnosed with a metabolic disease (i.e., hypothyroidism, hyperthyroidism, cushing disease, addison's disease, diabetes) * are diagnosed with a major cardiovascular or respiratory disease * are unable to follow instructions for any of the procedures

Keywords: functional hypothalamic amenorrhea menstrual cycle female athlete
breastfeeding peer counseling intervention for latine families

Conditions: Breastfeeding Self-Efficacy; Breastfeeding Continuation; Breastfeeding Duration; Breastfeeding Support

Summary: the goal of this clinical trial is to learn how to improve exclusive breastfeeding rates in the latine community. breastfeeding initiation is high in this community, but many people ultimately do not breastfeed for as long as they would like to. the main questions it aims to answer are: do latine mothers benefit from peer counseling support from peer counselors who can speak spanish and share their cultural background? are mothers more likely to continue exclusive breastfeeding if additional funds are given so that the wic exclusive breastfeeding package has the same cash value as the wic formula feeding package? researchers will compare participants in the intervention group (who receive peer counseling and additional funds) to a control group (who do not receive peer counseling or additional funds) to see if the intervention package improves breastfeeding rates. all participants (intervention and control) will complete weekly surveys about their feeding experiences ($8 per week). members of the research team will also take infant weight/length measurements at home (twice during the first month and then at 2, 4, and 6 months). participants will be recruited during pregnancy and the study will last for the first 6 months after their babies are born. participants in the intervention condition will also be matched with spanish-speaking latine peer counselors who will visit mothers at home regularly (weekly at the beginning of the study, monthly at the end of the study) and receive $150 for every month they select the wic exclusive breastfeeding package. mothers can choose to receive an electric breast pump instead of one $150 payment.


Eligibility criteria:
inclusion criteria set 1 (determined at prenatal recruitment): 1. confirmation of latine origin 2. receives or eligible for wic 3. 18 years or older 4. singleton pregnancy 5. intend to breastfeed. inclusion criteria set 2 (determined after infants are born): 1. infant gestational age 37 weeks or more 2. normal infant birth weight (i.e., \> 5 lbs 8 oz.) 3. breastfeeding has been initiated 4. no congenital or other health issues (such as cleft palate) identified that require specific accommodations for feeding. exclusion criteria: 1. mothers below 18 years of age. 2. mothers do not plan to breastfeed. 3. mothers not eligible to participate in the wic program due to high household income 4. non-singleton pregnancy.