Kornimate/medical-research-clean huggingface dataset:
finding wellness in the pandemic

Conditions: Mental Health Wellness 1; Addiction; Stress, Psychological; Covid19

Summary: there is an immediate need for population-level intervention research to address the impacts of the coronavirus disease 2019 (covid-19) pandemic and its containment measures on mental health and substance use (mhsu). while online programs are available to address these issues, they are often delivered in an asynchronous format with relatively low therapist or health coaching guidance. as highlighted by a recent systematic review, positive outcomes for online mental health programs are tied to the intensity of therapist or coaching guidance, which increases cost and reduces population access to more effective online options. a way to offset cost while maintaining effectiveness is to offer mhsu programs to groups online, rather than individually. in 2019, the investigators launched an rct to test gender-stratified group interventions to address mhsu among community-based indigenous and non-indigenous adults in southern alberta. the investigators implemented the interventions with more than 200 adults before the study was paused due to covid-19.

the primary objective of this project is to adapt two existing mental health and substance use interventions and rct for online delivery, covid-19 impacts, and province-wide spread. the second objective is to test if an online group body-oriented intervention (trauma-sensitive yoga) that has been designed to increase awareness of physical sensations, is superior to an online group verbal narrative intervention (mental wellness talking circle), and to control group. the investigators theorize that the body-oriented intervention may offer the opportunity to reprogram automatic physiologic hyperarousal in response to covid-19 triggers and increase positive body awareness, and mindful attention to the ways in which habitual self-protective behaviours like substance use may be impacting health. the third objective is to examine the impacts of the interventions on adults with pre-existing mhsu issues, and those with previous experiences that may make them more susceptible to mhsu problems during covid-19. the investigators will track other supports the participants engage during the study and the perceived impacts of these supports on the outcomes with the goal of shedding light on how to best match covid-19 related services to adults who need them the most.

Eligibility criteria:
inclusion criteria: * women between 18-75 years living in alberta, canada * need to have reliable access to the internet, a device with a webcam for the next 2 months * need to self-identify that they are currently struggling with at least one of: stress eating, alcohol use, drug use, tobacco use, or gambling during the pandemic exclusion criteria: * non-community dwelling * do not currently reside within alberta, canada
elba: exemestane and lapatinib in advanced breast cancer

Conditions: Breast Cancer

Summary: aromatase inhibitors are the standard treatment for hormone responsive advanced breast cancer. the combination of the aromatase inhibitor exemestane with with another breast cancer drug that blocks epidermal growth factor receptor (egfr) and erb-2 activity (lapatinib) is being studied for the possibility of improving response to therapy, and delaying resistance to endocrine therapy.

the recommended dose of lapatinib will be determined in the first part of the study. in the second part of the study, patients will receive the recommended dose of lapatinib and exemestane daily, taken orally.

Eligibility criteria:
inclusion criteria: * histological diagnosis of breast cancer * indication for hormonal therapy (er and/or pgr positive) * stage iv disease * female gender * postmenopausal status (patients treated with lhrh analogs are eligible for the phase ii part of the study) * at least one target or non-target lesion according to recist criteria * ecog performance status 0-2 * adequate bone marrow (neutrophils \> or = 1.500/mm³, platelets \> or = 100.000/mm³ and hemoglobin \> or = 9 g/dl), hepatic (got, gpt \< 2.5 e bilirubin \<1.25 times the value of upper normal limit) and renal (creatinine \< 1.25 times the value of upper normal limit) function * adequate cardiac function (fevs \> or = 50%) * able to take oral medications * life expectancy \> 3 months * signed informed consent exclusion criteria: * any previous hormone therapy for metastatic disease * more than one line of chemotherapy for metastatic disease (first line chemotherapy is permitted) * symptomatic cerebral metastases * planned concomitant radiation therapy in the first month of therapy (for those patients participating in the dose finding phase of the study) * previous therapy with exemestane, including as adjuvant therapy (previous therapy with non-steroidal aromatase inhibitors is permitted) * previous or concurrent malignancy in past 5 years (excluding adequately treated basal cel or spinocellular skin cancer and in situ carcinoma of the cervix) * treatment with experimental pharmacologic therapy within 4 weeks of enrollment in the study * unable or unwilling to provide signed informed consent * any concurrent illness that would, in the investigator's opinion, contraindicate the use of the study drugs. * active infection * assumption of cyp3a4 inhibitors or inducers (ketoconazole, itraconazole, fluconazole, macrolide antibiotics, antidepressives, calcium-antagonists, cimetidine, carbamazepine, phenytoin, barbiturates, rifampicin e glucocorticoids) * pregnancy or lactation * unable to comply with follow-up * active hepatobiliary disease (with the exception of gilbert's syndrome, asymptomatic biliary calculi, hepatic metastases or stabile chronic hepatopathy)

Keywords: advanced breast cancer hormone-responsive metastatic breast cancer
flupenthixol decanoate in methamphetamine smoking - 1

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to evaluate the safety and efficacy of flupenthixol decanoate for treatment of methamphetamine dependence. also, study will compare flupenthixol with desipramine in blocking methamphetamine self-administration.


Eligibility criteria:
please contact site for information.

Keywords: methamphetamine dependence
nutri diet goal setting software pilot trial

Conditions: Type 2 Diabetes; Pre-diabetes; Metabolic Syndrome

Summary: the investigators will conduct a pilot cluster randomized trial of nutri, a clinical decision support software to support collaborative diet goal setting in primary care. nutri is designed within the chronic care model framework, specifically with the intention of leveraging clinical information systems to connect clinical care with patients' lives in the community setting. nutri is based on the theory of planned behavior and uses collaborative goal setting between the patient and provider to identify a behavioral intention (i.e., diet goal) and improve goal self-efficacy by improving attitudes/outcome expectations, subjective norms/social support, and perceived behavioral control. in this pilot trial, the intervention group (n=10 primary care providers \[pcps\], n=40 patients) receives collaborative diet goal setting via nutri, and the control group receives usual care(n=10 pcp, n=40 patients). before and after the appointment, patients will report food they consumed over the last 24 hours via the dietary recall tool, asa24 and respond to surveys about behavioral intention and self-efficacy. intervention pcps will be alerted when the nutri workflow is available for a patient and asked to complete it during their visit with that patient.


Eligibility criteria:
inclusion criteria: 1. provision of signed and dated informed consent form 2. diagnosed with pre-diabetes or type 2 diabetes, or at risk for type 2 diabetes 3. have a scheduled medical appointment with a study enrolled pcp within the study enrollment period 4. fluent in either english or spanish 5. access to a computer, tablet, or smartphone and reliable internet 6. stated willingness to comply with all study procedures and availability for the duration of the study 7. hipaa authorization for health information exchange exclusion criteria: 1. currently pregnant 2. diagnosed with an eating disorder

Keywords: clinical decision support dietary management
deflazacort expanded access program for children, adolescents and adults with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the expanded access program will provide access to treatment with deflazacort in children, adolescent, and adult patients with dmd in the u.s. who are ineligible, unable, or otherwise unwilling to enroll in a clinical study examining the efficacy of deflazacort while a new drug application is under preparation and review. enrollment is open to all eligible patients.

deflazacort will be supplied free of charge and shipped directly to patients or caregivers, as appropriate. treating physicians will continue to follow their standard of care activities and procedures for management of dmd. treating physicians participating in the expanded access program are required to collect/document any patient or caregiver reported safety events and report to the sponsor..

Eligibility criteria:
main inclusion criteria: * confirmed diagnosis of duchenne muscular dystrophy * the patient is ≥ 5 years old * current on all childhood vaccinations including the chicken pox vaccine main exclusion criteria: * history or current medication condition that could affect safety or poses an additional risk * hypersensitivity or allergic reaction to steroids or their formulations
effectiveness and safety of probiotics in relieving anxiety and depression

Conditions: Anxiety Depression

Summary: to evaluate the effectiveness and safety of probiotics in relieving anxiety and depression in adults, in comparison with placebo.


Eligibility criteria:
inclusion criteria: 1. voluntary, written, and signed informed consent: agreeing to participate in the study. 2. ability to complete the study according to protocol: able to meet the requirements of the study protocol. 3. age: 18-65 years old. 4. depression and anxiety scores: * hamilton depression rating scale (hamd-17) score of 20 or higher, or * hamilton anxiety rating scale (hama) score of 14 or higher. 5. no history of certain conditions: no history of heart, liver, kidney, nervous system, psychiatric disorders, or metabolic abnormalities. exclusion criteria: 1. past diagnosis of certain conditions: individuals with a history of other clearly diagnosed psychiatric disorders, intellectual disabilities, consciousness disorders, complete aphasia, bipolar disorder, treatment-resistant depression, or suicidal thoughts. 2. pregnant or breastfeeding women: individuals who are pregnant or breastfeeding. 3. use of certain medications: individuals who have used anti-anxiety, anti-depressant medications, or mood stabilizers within the past month. 4. allergy history: individuals with allergic constitutions or a history of drug allergies, or those with severe systemic diseases. 5. substance abuse history: individuals with a history of alcohol or psychoactive substance abuse within the past 3 months. 6. impact of medications on gut microbiota: individuals who have used medications affecting gut microbiota (including antibiotics, probiotics, mucosal protectors, traditional chinese medicine, etc.) continuously for more than 1 week in the month prior to screening. 7. discontinuation or addition of medications: individuals who have stopped taking the study medication or started taking other medications, making it difficult to assess efficacy or with incomplete data. 8. use of similar products: individuals who have taken items similar to the study product in the short term, affecting the evaluation of results. 9. inability to participate: research participants who cannot participate in the study due to personal reasons. 10. other exclusions: participants deemed unsuitable for the study by the researchers.
cardiometabolic risk in children with type 1 diabetes.

Conditions: Type1 Diabetes Mellitus; Metabolic Complication

Summary: to access the relationship between metabolic control of children and adolescents with type 1 diabetes and cardiometabolic risk through noninvasive imaging modalities to assess the early vasculature changes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for more than 0.5 year * age ≥ 10 years up to 25 years (inclusive) * the subject/carer is willing to follow study specific instructions exclusion criteria: * youth with maturity-onset diabetes of the young, hybrid, other, or missing type * any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study * current use of the following medications: medications that are used to lower blood glucose such as pramlintide, metformin and glp-1 analogs. beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (anticoagulant therapy e.g. plavix, lmw heparin, coumadin, immunosuppressant therapy)
effects of a physical exercise program on microcirculation and pregnancy outcomes in obese pregnant women

Conditions: Obesity; Pregnancy

Summary: this study aims to determine the effect of a physical exercise program on microcirculation and maternal and perinatal outcomes in obese women. a randomized clinical trial will be performed at imip with obese pregnant women assisted at the instituto de medicina integral professor fernando figueira (imip) prenatal service.

obesity in pregnancy is an important risk factor for adverse perinatal outcomes. obesity leads to oxidative stress and vascular damage including microcirculation inflammation. physical activity prevents cellular damage and provide a protective effect to the health of the mother and fetus. although physical activity has been recommended for obese pregnant women, studies assessing the effects on the microcirculation of these women are scarce. this study aims to determine the effect of a physical exercise program on microcirculation and maternal and perinatal outcomes in obese women. a randomized clinical trial will be performed at imip with obese pregnant women assisted at the imip prenatal service. the intervention group will be submitted to an exercise program consisting of daily post prandial, 10' after breakfast, lunch and dinner. the control group will follow the routine prenatal imip. all pregnant women will be evaluated by a questionnaire to assess physical activity. microcirculation function will be evaluated by a laser-doppler flowmetry at baseline and eight weeks after intervention. all pregnant women will be followed until the delivery and immediate postpartum period to check their perinatal outcomes. all pregnant women will be advised to use a pedometer to record their daily steps. the study meets the recommendations of the national health council. this project was submitted and approved from the ethics committee for research involving human subjets of imip. all participants will be duly informed about the aims of the study and will be included after signing the informed consent form.

Eligibility criteria:
inclusion criteria: * singleton pregnancy between 14 and 20 weeks gestation; * literate women; * sedentary lifestyle. exclusion criteria: * cognitive, auditory, visual or motor impairment, certified by a specialist; * any pregnancy disorders or previous maternal diseases: diabetes type 1 or type 2, hypertensive disorders of pregnancy, hemodynamic instability, renal disease or collagen, vaginal bleeding; * any medical or obstetric contraindication to perform physical activity.

Keywords: physical activity microcirculation pregnancy outcome obesity pregnancy
self-hypnotic relaxation therapy during invasive procedures

Conditions: Uterine Neoplasms; Leiomyoma

Summary: the purpose of this study is to determine the effectiveness of self-hypnotic relaxation on mental and physical distress during and after tumor treatment procedures.

pain relievers and sedatives may have limited effectiveness and serious side effects when given to alleviate distress during minimally invasive surgical procedures. unabated distress may interfere with the ongoing procedure and may negatively impact future interventions. studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation during invasive medical procedures significantly reduces patients' pain, anxiety, drug use, and number of complications. the long-term goal of this study is to determine whether self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive and physiologic distress associated with invasive procedures. participants in this study will be randomly assigned to one of three groups: a standard care group, an empathic control group, and a self-hypnotic relaxation group. the emphatic control group will meet with a clinician who will offer encouragement and support. the group assigned to self-hypnotic relaxation will read a standardized script prior to procedure. self-report questionnaires will be used to assess pain and anxiety.

Eligibility criteria:
inclusion criteria: * referred for transcatheter embolization for benign uterine fibroid tumor or radiofrequency ablation or chemoembolization for malignant tumors * able to hear and understand english exclusion criteria: * impaired mental function * psychosis * severe chronic obstructive pulmonary disease * intolerance of midazolam or fentanyl * weigh less than 121 lbs * pregnancy

Keywords: hypnosis analgesia embolization, therapeutic chemoembolization, therapeutic
genetic determinations for side effects and response rate for patients receiving chemotherapy with diffuse large cell lymphoma

Conditions: Lymphoma; Diffuse Large Cell

Summary: the purpose of this study is to determine whether people have genes that make them more likely to respond to chemotherapy and/or have side effects from chemotherapy for diffuse large cell lymphoma.

upon enrollment in the study, patients will have a blood sample collected for genotyping of the fcgr3a gene (immunoglobulin fc g receptor iiia), the abcb1 gene (atp binding cassette beta 1; also called mdr1), and other candidate genes. patients will be treated with r-chop for six cycles, which is standard therapy for advanced stage dlcl. response will be monitored by an fdg-pet scan performed after 2 cycles of r-chop and restaging exams performed upon completion of chemotherapy. gene polymorphisms will be analyzed to establish which polymorphisms predict response to r-chop.

Eligibility criteria:
inclusion criteria: * histologically proven diffuse large b-cell non-hodgkin's lymphoma according to the who classification, with measurable or evaluable disease * no prior therapy for nhl. patient may be enrolled in this study after the first cycle of r-chop if all screening evaluations were performed prior to the first cycle of chemotherapy. * ann arbor stage 3 or 4 * age greater than or equal to 18 years * patient must give written informed consent. * a patient enrolled in another clinical trial may also enroll in this study if the other trial has an r-chop treatment arm and the patient is randomized to the r-chop only arm. registration to this study must occur after randomization in the other trial. exclusion criteria: * cns involvement * known hiv positive * t-cell lymphoma or history of indolent nhl * patients who will be treated with radiation therapy

Keywords: lymphoma rituximab chop
pilot study of clinician-supported patient self-management of hospital insulin therapy

Conditions: Diabetes Mellitus

Summary: this study will examine the feasibility of implementing a clinician-supported patient self-managed inpatient insulin intervention. it will: assess the number of eligible patients presenting over time; assess patients' willingness to enroll; assess patients' ability to successfully complete the intervention; examine occurrences of hyperglycemia and hypoglycemia; and assess patients' satisfaction with inpatient diabetes care.


Eligibility criteria:
inclusion criteria: * admitted to the hospital of the university of pennsylvania (hup) in the past 72 hours. * current hup locations are founders 12, founders 14, silverstein 11, and rhoads 1. * age 18 years or older. * type-1 or type-2 diabetes mellitus requiring home basal-bolus insulin therapy administered via subcutaneous injection (not pump). * patient manages own basal-bolus insulin therapy at home without assistance, including measuring own blood glucose (at least at mealtimes) and administering own subcutaneous insulin. * patient is willing to use the following insulin products: rapid-acting insulin aspart via insulin pen (novolog) and long-acting insulin glargine via vial and syringe (lantus). * most recent hemoglobin a1c was measured within past 6 months and was \<7.5%. * active order for in-hospital basal-bolus or sliding-scale insulin. * patient is willing and able to record their self-measured blood glucose results, doses of insulin that they self-administer, a food journal, and exercise log. * clinical care team agrees with study inclusion. exclusion criteria: * inpatient order for insulin via subcutaneous infusion (i.e., pump) or intravenous infusion (i.e., drip). * inability to perform the activities required by the trial. * primary reason for admission was hyperglycemia, hypoglycemia, diabetic ketoacidosis, hyperglycemic hyperosmolar nonketotic coma, a psychiatric condition, acute alcohol poisoning, or acute drug ingestion. * order for a newly-prescribed or increased dose of a previously-prescribed corticosteroid. * enteral or parenteral nutrition. * expected length of stay \<48h, as determined by treating physician. * at risk for self-harm, as determined by 1-to-1 status placement. * pregnant, as recorded on medical record. * cannot understand, speak, and read english. * patient does not wish to utilize novolog and lantus while in the hospital. * prior enrollment in this trial. * do not resuscitate status. * inability to give written informed consent. * clinical care team disagrees with study inclusion. * patient has limited mobility such that they cannot safely access the bedside medication lockbox.

Keywords: diabetes mellitus insulin self administration patient satisfaction glucose hypoglycemia hyperglycemia
evaluation of the cerebral edema in children having diabetic ketoacidosis

Conditions: Cerebral Edema

Summary: the purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath.

the purpose of this study is to determine cerebral edema with evaluation of measurement of diameter of optic nerve sheath. for that, if patients have fluid treatment shall be started in 4 hours in our or other emergency care, they will be included our study. if not, they will be out of our study. how we measure; 1. first measurement shall be taken in 4 hours. 2. second measurement shall be taken at 12 hours in mild and 12-18 hours measurement shall be taken for severe diabetic ketoacidosis, 3. third measurement shall be taken after fluid treatment. 4. fourth measurement shall be taken at polyclinic control. so, after all measurements will be hand and all data will be analyzed with statistical program. after that all outcome will be discussed and compared with patient at normal conditions at their polyclinic visit.

Eligibility criteria:
inclusion criteria: fluid treatment shall be started in 4 hours in our or other emergency care exclusion criteria: fluid treatment was started over four hours in other emergency care

Keywords: c10.228.140.187