Kornimate/medical-research-clean huggingface dataset:
meditation for nicu moms

Conditions: Breast Feeding; Premature Birth; Stress; Depression, Postpartum; Anxiety; Self Efficacy; Behavior, Maternal; Insufficient Lactation

Summary: this project explores whether meditation increases breastmilk supply in mothers who are pumping milk for infants in the nicu. mothers will be randomly assigned to daily meditation while pumping using an app designed for meditation for new mothers, and their breastmilk volume will be measured after one week of meditation versus a control group with measurements at the same time points. investigators will also determine whether mediation improves breastfeeding confidence and reduces stress, anxiety and depression symptoms in these mothers. finally investigators will examine the effect on salivary cortisol levels.


Eligibility criteria:
inclusion criteria: * 1) mothers of all ages, including emancipated minors will be included 2) gestational age at birth of 24 completed weeks to 32 weeks 6 days 3) mothers of infants admitted to st. mary's nicu or with transfer or anticipated transfer to cardinal glennon nicu 4) mothers who intend to provide breastmilk to infants for at least 1 month. 5) recruitment within 24 hours of time of delivery in order to allow for beginning of 24 hour milk collection at 24 hours post delivery exclusion criteria: * 1) mothers of infants expected to be nippling at the breast in less than 10 days 2) infants for whom discharge is anticipated in less than 10 days 3) participation in another interventional study at screening or who plan to participate in another interventional study during the study period 4) hearing loss that would preclude participation in meditation recordings 5) inability to come for a midday (between 11am -3pm) visit on day of life #10. 6) inability or unwillingness to perform the study procedures.
imfinzi/imjudo nsclc japan pms_japan post-marketing surveillance (pms) study - cei/scei

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: to collect information of safety in patients with unresectable advanced or recurrent non-small cell lung cancer who receive combination therapy of imjudo, imfinzi and other platinum-based anti-cancer agents under actual use in the postmarketing setting.

this investigation will be conducted to collect information of safety in patients with unresectable advanced or recurrent non-small cell lung cancer (nsclc) who receive combination therapy of imjudo intravenous infusion 25mg, imfinzi intravenous infusion 120mg, 500mg and other platinum-based anti-cancer agents under actual use in the postmarketing setting. the investigation will be conducted as one of the additional pharmacovigilance activities in the japan risk management plan of imjudo and imfinzi in compliance with the ministerial ordinance on good postmarketing study practice (gpsp ordinance) and for the purpose of application for reexamination under article 14-4 of the act on securing quality, efficacy and safety of products including pharmaceuticals and medical devices. among the safety specifications defined in the japan risk management plan of imjudo and imfinzi, the following items are set as the safety specifications for this study. interstitial lung disease, colitis/severe diarrhoea/gastrointestinal perforation, hepatic function disorder/hepatitis/cholangitis sclerosing, endocrine disorders (dysfunction thyroid, adrenal dysfunction, pituitary dysfunction), type 1 diabetes mellitus, renal disorder (interstitial nephritis, etc.), myositis, myocarditis, myasthenia gravis, immune thrombocytopenic purpura, encephalitis, severe skin disorder, nerve disorder (including guillain-barre syndrome), infusion reaction, pancreatitis, rhabdomyolysis, meningitis, febrile neutropenia during combination treatment with chemotherapy, embryo-fetal toxicity, use in patients with a history of organ transplant (including haematopoietic stem cell transplant)

Eligibility criteria:
inclusion criteria: * all patients who receive imjudo, imfinzi and other platinum-based anti-cancer agents for their unresectable advanced or recurrent nsclc exclusion criteria: -
effects of a home based exercise program following total hip arthroplasty

Conditions: PHYSİOTHERAPY

Summary: the aim of this study is to examine the effects of home-based exercise on pain-related factors, postural control and early functional parameters in individuals undergoing total hip arthroplasty. forty-four individuals with hip osteoarthritis were included in current study. individuals were randomized as study group (n=23) and control group (n=21) by drawing lots. individuals in the study group were followed up with a personalized home-based exercise program for 6 weeks. individuals in the control group were followed up with an exercise training brochure. the exercise program of the individuals in the study group was checked at two-week intervals and adjustments were made in the exercise program. all individuals were evaluated before the operation, 2 weeks after the operation, and 12 weeks after the operation, and their data were recorded. range of motion was measured with an inclinometer, muscle strength was measured with a hand dynamometer, joint position sense was measured with a target angle test, pain was measured with a visual pain scale, leg length was measured with a tape measure, and finally, the q angle was measured with a goniometer. in addition to these,tampa kinesiophobia scale, oxford hip score and international physical activity scale were used. timed up-and-go test was used to evaluate functional performance. foursquare step test was used to evaluate balance, and finally, tetrax posturography device was used to evaluate postural control.

the aim of this study was to examine the patients who underwent total hip arthroplasty surgery with the diagnosis of hip osteoarthritis. home-based exercise program given individually under the control of a physiotherapist is effective in reducing pain. related factors (joint range of motion, muscle strength, kinesiophobia, physical activity), to investigate its effect on functional status, balance and postural control.

Eligibility criteria:
inclusion criteria: * having surgery with a diagnosis of osteoarthritis * cases have unilateral hip osteoarthritis * not having received physical therapy in the 6 months before the surgery * total hip arthroplasty surgery should only be performed on posterior or posterolateral done with initiative exclusion criteria: * presence of dementia, neurological deficit * having other diseases that may affect balance (vertigo, previous cvo, neuropathy, epilepsy) * being on medication that may affect balance (antidepressants, antiepileptics, antipsychotics) * individuals who use alcohol heavily * end stage organ failure * cancer patients under active treatment (except those in remission

Keywords: total hip arthroplasty home based exercise program balance pain function
video feedback intervention in nursing home residents with dementia and severe challenging behavior.

Conditions: Dementia; Nursing Home Resident; Challenging Behavior

Summary: the purpose of this study is to evaluate how, under what circumstances and for whom the video feedback intervention works for (the caregivers of) people with dementia and severe challenging behavior in a nursing home setting.

this mixed multiple case study focuses on the evaluation of a video feedback intervention for (the caregivers of) people with dementia and challenging behavior. the video feedback intervention focuses on understanding the person with dementia, increasing the sense of competence in caregivers and improving their communication skills when interacting with the person with dementia. this realist evaluation aims to investigate what outcomes the intervention generates, for whom and in which contexts. participants will receive care as usual.

Eligibility criteria:
inclusion criteria: * nursing home resident * dementia * severe challenging behavior * video feedback intervention is started by health care professionals as part of usual care exclusion criteria: * n/a

Keywords: video feedback intervention dementia challenging behavior nursing home
quadratus luborum block using bupivacaine versus bupivacaine-dexamethasone in laparoscopic cholecystectomy

Conditions: Post Operative Pain

Summary: the aim of the present study was to compare the effectiveness of transmuscular quadratus lumborum block using bupivacaine versus bupivacaine- dexamethasone in providing analgesia in patients undergoing laparoscopic cholecystectomy. because postoperative pain after laparoscopic surgery is complex, specialists suggest that effective analgesic treatment should be a multimodal support. quadratus lumborum block (qlb) is a new abdominal truncal block for controlling somatic pain in both the upper and lower abdomen. dexamethasone, through its anti-inflammatory and blocking effects on neural discharge, and nociceptor c fibers transmission could be used as a local anesthetic adjuvant.

the patients were randomly allocated into three groups each contains (30) patient. control group (c) received bilateral ultrasound guided quadratus lumborum block using (20 ml 0.9% normal saline + 1ml 0.9% normal saline) in each side ,bupivacaine group (b) received bilateral quadratus lumborum block using (20 ml bupivacaine hydrochloride 0.25% + 1ml 0.9% normal saline) in each side and dexamethasone-bupivacaine group (d) received bilateral quadratus lumborum block using (20 ml bupivacaine hydrochloride 0.25% + 1 ml dexamethasone "4mg") in each side. the following variables: heart rate, mean arterial blood pressure, peripheral oxygen saturation, visual analogue pain scale , time to first analgesic request, total analgesic requirement in the first 24 hours, patient satisfaction and complications were recorded and compared between groups.

Eligibility criteria:
inclusion criteria: * american physical status i or ii * elective laparoscopic cholecystectomy exclusion criteria: * patient refusal. * hematological diseases * bleeding disorders. * coagulation abnormality. * psychiatric diseases. * local skin infection * sepsis at site of the block. * known intolerance to the study drugs. * body mass index \> 40 kg/m2. * emergency laparoscopic cholecystectomy * if laparoscopic procedure converted to open.

Keywords: quadratus lumborum block laparoscopic cholecystectomy dexamethasone
pharmacist's influence on breast cancer patient quality of life

Conditions: Breast Cancer, Quality of Life

Summary: the purpose of this study is to investigate the impact of pharmacist behavioral intervention's influence on breast cancer patients' quality of life. croatian randomized controlled trial. targeted population: general population of breast cancer patients under the first adjuvant anthracycline chemotherapy. primary outcome: difference in eortc qlq-br23 questionnaire result from the baseline to after 3 week cycle.


Eligibility criteria:
inclusion criteria: * early breast cancer * first adjuvant chemotherapy * chemotherapy protocol: anthracycline x 4 exclusion criteria: * cardiovascular comorbidities * regular nausea or vomiting during six months before enrollment * unable to answer the quality of life questionnaire on their own
pharmacogenomics of asparaginase induced hepatotoxicity

Conditions: Acute Lymphoblastic Leukemia

Summary: this pilot trial studies the impact of genetic information on developing liver damage caused by asparaginase in participants with newly diagnosed acute lymphoblastic leukemia. testing saliva samples may help doctors find certain genetic markers that may predict whether participants will tolerate asparaginase, which is given as part of clinical care for acute lymphoblastic leukemia.

primary objectives: i. to establish the association between the sod2 rs4880 genotypes and asparaginase-induced hepatotoxicity in hispanic patients. ii. to identify novel single nucleotide polymorphisms (snps) that are associated with asparaginase induced hepatotoxicity. outline: participants' sod2 rs4880 snp genotype (based on saliva from buccal swabs) will be classified. participants with the cc genotype will be compared to participants with the ct or tt genotype. buccal swabs of prospective participants' saliva will be collected when participant achieves complete remission (during regular clinical visit). retrospective participants will be identified through search of pharmacy records for those who received asparaginase within the last 5 years (2012-2017). recurrent patients will be consented during their regular clinical visits and samples will be collected.

Eligibility criteria:
inclusion criteria: * newly diagnosed with acute lymphoblastic leukemia (all) - no prior treatment for all * receiving asparaginase as part of the primary treatment regimen * ability to understand and the willingness to sign a written informed consent * for retrospective recruitment, those who have received asparaginase between 2012 and 2017; and are current patients of university of southern california (usc) exclusion criteria: * patients who are unable to give informed consent
predictive parameters for efficacy of sitagliptin and metformin combination

Conditions: Diabetes

Summary: it is well established that inhibition of dipeptidyl peptidase (dpp)-iv reduces glucose levels in both fasting and postprandial states and preserves pancreatic beta cell function in patients with type 2 diabetes. their mechanism of action is derived from increased incretin (glp-1) levels, which stimulate insulin secretion as well as insulin biosynthesis and inhibit glucagon secretion from pancreas. recent studies reported that combination therapy with dpp-iv inhibitors and metformin have additive or synergistic effects in lowering glycose level, preserving beta-cell mass and function as well as enhancing insulin sensitivity. however, there have been few studies about the difference of glucose lowering effect of combination therapy of dpp-iv inhibitors and metformin according to the secretory capacity of pancreas. the researchers hypothesized that combination therapy with dpp-iv inhibitor and metformin may have more favorable glucose lowering effect in type 2 diabetic patients who have preserved pancreatic secretory function. the researchers plan to investigate the difference of glucose lowering effect of 24 weeks treatment with sitagliptin (dpp-iv inhibitor) in combination with metformin according to basal c-peptide and glucagon level in type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c ≥ 7% * age ≥ 18 exclusion criteria: * contraindication to sitagliptin or metformin * pregnant or breast feeding women * reproductive-age women who refuse contraception * type 1 diabetes, gestational diabetes, or diabetes with secondary cause * chronic hepatitis b or c (except healthy carrier of hbv), liver disease (ast/alt \> 3-fold the upper limit of normal) * renal failure (cr \> 2.0) * cancer within 5 years (except squamous cell cancer, cervical cancer, thyroid cancer with appropriate treatment) * not appropriate for oral antidiabetic agent * medication which affect glycemic control * disease which affect efficacy and safety of drugs * other clinical trial within 30 days

Keywords: diabetes sitagliptin c-peptide glucagon
vaginal estrogen with pessary treatment

Conditions: Vaginal Infection; Urinary Tract Infection; Quality of Life

Summary: patients presenting with pelvic organ prolapse will be offered the use of a pessary. vaginal estrogen cream treatment with the pessary will be randomized amongst the patients and patient satisfaction and complication rates will be assessed during follow-up.

this will be a double-blinded, placebo-controlled, randomized controlled trial. eligible patients presenting to the urogynaecology clinic with pelvic organ prolapse will be offered management with a pessary and participation in the study patients who agree to participate in the study will be given a consent form patients in the study and thus those who have opted for pessary use will be randomized between two groups: 1. treatment group - will be given instructions for use and prescription for premarin vaginal cream 2g at bedtime twice weekly 2. control group - will utilize pessary with an inactive placebo cream both the patient and the investigators will be blinded to patient treatment. if a patient has expressed willingness to participate in the study over the phone, the research assistant will issue a study number to the patient and pick up the corresponding cream from the lhsc pharmacy to give to the patient at their next clinic visit. the cream will be provided to the patient once they have read the letter of information and signed the consent form. for follow-up visits, the research assistant will monitor appointment bookings to ensure that the cream is ready in the clinic when the patient has their next follow-up visit. patients of both groups will be fitted with a pessary. pessary fitting will be individualized due to differences in pelvic size and shape and degree of prolapse. patients may return to the clinic for subsequent fittings until a successful fit has been achieved. an unsuccessful fitting is defined as discontinued pessary use due to discomfort or expulsion. patients will be assessed for satisfaction and complications 6 wks, 18 wks, 36 wks and 60 wks after the successful fitting. to determine patient satisfaction and complications, patients will complete a compilation of validated questionnaires assessing urinary symptoms, sexual function and quality of life at each follow-up. at each follow-up, a vaginal exam will be done and a vaginal swab and urine sample (for urinalysis and culture and sensitivities) will be taken to assess vaginal bleeding and infections.

Eligibility criteria:
inclusion criteria: * any patient presenting to the clinic with pelvic organ prolapse will be offered management with a pessary and will be offered participation in the study. exclusion criteria: * have a contraindication to the use of estrogen cream or products * have any allergy to the use of estrogen cream or products * have a past medical or family history of breast cancer * have a past medical history of thromboembolism, myocardial infarction and stroke or are pregnant * have previously used premarin vaginal cream * are currently using oral estrogen * are not competent to consent

Keywords: pessary patient satisfaction estrogen cream
clinical trial of creatine in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the objective of this study is to determine whether creatine slows disease progression in subjects with amyotrophic lateral sclerosis (als). als is a progressive uniformly lethal neurodegenerative disorder for which there is no known cure. recent genetic and biochemical studies implicate free radical toxicity, glutamate excitotoxicity and mitochondrial dysfunction as possible causes of familial als (fals) and sporadic als (sals). it has been hypothesized that in als there may be involvement of oxidative free radical damage and impaired mitochondrial energy metabolism that could in turn lead to excitotoxic cell death. creatine, an agent that improves mitochondrial function, has been shown to be neuroprotective in animal models of als and huntington's disease. this study is a double-blind, randomized, placebo-controlled trial of the safety and efficacy of creatine in patients with als enrolled at sites distributed throughout the united states, including northeast als (neals) sites. the study will provide preliminary data on the safety and efficacy of creatine in als. if creatine slows disease progression in als and is well tolerated, a phase 3 study with survival as the primary outcome measure will be initiated. 114 eligible subjects will be randomized to receive treatment for 6 months of (1) active creatine or (2) placebo. after randomization, subjects will be followed prospectively for 6 months. the primary outcome measure for the study is the change in upper extremity motor function after 6 months of experimental therapy as tested with the tufts quantitative neuromuscular exam. strength in eight arm muscles will be measured (bilateral shoulder and elbow flexion and extension). secondary outcome measures include grip strength, motor unit number estimates (mune), the als functional rating score-revised (alsfrs-r), and rate of change of a well established biochemical marker of oxidative damage to dna (8oh2'dg levels in urine), and the safety and tolerability of creatine.


Eligibility criteria:
inclusion criteria: * als * fvc \>=50% * abnormality in upper and/or lower extremity motor function * not pregnant * disease duration \<5 years

Keywords: als
phase i: safety and efficacy of an injectable follistatin plasmid gene therapy in humans

Conditions: Frailty; Aging

Summary: this study examines the safety and effects of an injectable plasmid gene therapy. plasmids are circular pieces of dna which have been widely studied as a non-permanent \& non-heritable method for transferring genes and inducing gene expression. in this study the plasmid is a gene vector which contains the human fst344 gene intended to express and secrete bioidentical human follistatin into serum circulation. follistatin is a myostatin and activin inhibitor that has demonstrated improved functional outcomes in mouse models of neuromuscular disease. participants will undergo dual energy x-ray absorptiometry scans before and after the treatment's administration to compare change from baseline and rates of change in fat vs muscle tissue and bone density. participants will also undergo metabolic and epigenetic blood panels to observe any changes. participants will be monitored at the clinic site for a short time period after receiving the therapy and participants will be able to report any adverse events through an online form. lastly, participants will have blood drawn just prior to, and three months after, the gene therapy's administration in order to assess circulating levels of follistatin. this study is administered at the global alliance for regenerative medicine clinical research site on the island of roatan and is sponsored by minicircle. the main contact for this study is mac davis.


Eligibility criteria:
inclusion criteria: * openness to morphological change * will practice contraception for the duration of trial (if female) exclusion criteria: * women who are pregnant, nursing or of childbearing potential who are unwilling or unable to maintain contraceptive therapy for the duration of the study * life expectancy \< 6 months due to concomitant illness * pre-existing joint, ligament, or heart issues * systolic blood pressure (supine) ≤90 mmhg; * resting heart rate \> 100 bpm * unwilling or unable to give written informed consent.