Kornimate/medical-research-clean huggingface dataset:
bariatric surgery and pharmacokinetics of valsartan

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on valsartan are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics valsartan
bullying in youth with muscular dystrophy and congenital myopathies

Conditions: Muscular Dystrophies; Congenital Myopathy

Summary: bullying is an epidemic in canada, and rates may be underreported. youth with a disability were more likely to be bullied that those without disabilities, specifically if the disability was visible. research has been conducted on the prevalence and effects of bullying in youth with disabilities such as cerebral palsy, obesity, and chronic pain; however, there is a paucity of research involving youth with muscular dystrophy and congenital myopathies. the objectives of this study are to: (1) measure bullying frequency, (2) describe the types of bullying experiences; and (3) explore barriers and facilitators to dealing with bullying by youth with muscular dystrophy or congenital myopathies and their parents. the objectives will be met by an online survey and qualitative interviews of youth with muscular dystrophy and congenital myopathy and their parents.

bullying is an epidemic in canada. at least one in three canadian youth report having been bullied. bullying is defined as intentional aggressive behaviour with the intention to harm the victim. it is characterized by an imbalance of power between the perpetrator and the victim, and is often repetitive although it does not need to be. studies have shown that youth with chronic illness or disability were more likely to be bullied that those without disabilities, specifically if the disability was visible. research has been conducted on the prevalence and effects of bullying in youth with disabilities such as cerebral palsy, obesity, and chronic pain; however, there is a paucity of research involving youth with muscular dystrophy and congenital myopathies. the objectives of this study are to: (1) measure bullying frequency, (2) describe the types of bullying experiences; and (3) explore barriers and facilitators to dealing with bullying by youth and their parents. the objectives will be met using a cross-sectional, multi-centre, mixed methods approach. a survey will be administered online at a single time-point to youth and their parents. then, purposefully selected participants and their parents will complete a qualitative interview.

Eligibility criteria:
inclusion criteria: * muscular dystrophy or congenital myopathy diagnosis * 10-19 years old * speaks and reads english or french exclusion criteria: * n/a

Keywords: muscular dystophy congenital myopathy youth bullying cyberbullying
study evaluating the effects of avanafil on semen parameters

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to determine whether avanafil will affect different aspects of sperm production.


Eligibility criteria:
inclusion criteria: * provide written informed consent * able to produce semen samples without requiring therapy (pde5 inhibitors, over-the-counter (otc) medication, and/or herbal supplements) for erectile dysfunction * be medically healthy (no clinically significant screening results for medical history, electrocardiogram (ecg), laboratory studies, physical examination, etc.) in the opinion of the investigator * be willing and able to comply with all study requirements exclusion criteria: * an international index of erectile function (iief) erectile function domain score of less than 17; * history of infertility, vasectomy, testicular mass, testicular trauma, testicular abnormality (including size), radiation to the testis, previous pelvic surgery, cryotherapy of the prostate, known sperm defect, or retrograde ejaculation, or cryptorchidism; * resting heart rate \ 90 beats per minute at screening (3 rechecks permitted); * screening systolic blood pressure \ 140 mmhg and/or diastolic blood pressure \ 90 mmhg (3 rechecks permitted); * high serum fsh (\>18.0 miu/ml), high serum lh (\>18 miu/ml), or low serum testosterone (\< 270 ng/dl, early morning collection) on screening; * ast or alt \>2.0 x uln or other evidence of significant hepatic impairment; * prostate specific antigen (psa) level ≥4 ng/ml at screening; * individuals who perform rotating shift work during the course of the study.

Keywords: healthy male
defining the role of palliative care for patients with hematologic malignancies undergoing adoptive cellular therapy

Conditions: Hematologic Malignancy; Blood Cancer; Lymphoma; Leukemia; Multiple Myeloma

Summary: the goal of this study is to determine whether a palliative care intervention (peace) can improve the quality of life and experiences of participants with lymphoma, leukemia, or multiple myeloma receiving adoptive cellular therapy (act). after completion of an open pilot, participants will be randomly assigned into one of two study intervention groups. the names of the study intervention groups involved in this study are: * palliative care (peace) plus usual oncology care * usual care (standard oncology care) participation in this research study is expected to last for up to 2 years. it is expected that about 90 people will take part in this research study.

this is a single-center, parallel-group, randomized controlled study to determine whether a palliative care intervention (peace) can improve the quality of life and experiences of participants with lymphoma, leukemia, or multiple myeloma receiving adoptive cellular therapy (act). 10 participants with planned act will be enrolled into an open pilot and will receive a palliative care intervention (peace) for the duration of treatment. once the palliative care intervention has been refined by feedback from the pilot participants, the study will enroll 80 participants and will randomly assign the participants into one of two study intervention groups. randomization means that a participant is put into a group by chance. the names of the study intervention groups involved in this study are: * palliative care intervention (peace) plus usual oncology care * usual care (standard oncology care) participation in this research study is expected to last for up to 2 years. it is expected that about 90 people will take part in this research study. the american society of clinical oncology is supporting this research study by providing funding support.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * ability to complete surveys in english or with assistance of an interpreter. * diagnosis of a hematologic malignancy. * receiving autologous adoptive cellular therapy (act) at mgh with an fda approved cellular therapy product. exclusion criteria: * impaired cognition or uncontrolled mental illness that prohibits study compliance based on the oncology clinician assessment. * already receiving palliative care (pc).

Keywords: hematologic malignancy adoptive cellular therapy palliative care intervention lymphoma leukemia multiple myeloma palliative care
adherence through home education and nursing assessment, indonesia

Conditions: HIV/AIDS; Medication Adherence; Substance Use

Summary: adherence to antiretroviral therapy (art) drops sharply after prison release. effective medication adherence training immediately before and after prison release may improve health outcomes and limit transmission of human immunodeficiency virus (hiv). athena (adherence through home education and nursing assessment) is an evidence-based medication adherence intervention, which is delivered in the patient's home by nurses and peer educators working in teams. in this study, researchers will examine the acceptability and feasibility of the athena intervention through a 2-arm randomized controlled trial conducted with hiv-infected prisoners in indonesia. eligible subjects will be \>18 years of age, hiv-infected, and may be treatment-experienced or treatment-naive. subjects randomized to the intervention arm will participate in monthly medication adherence counseling sessions within prison and home visits up to four months after prison release. subjects randomized to the control arm will receive standard care, which includes a referral for hiv care after prison release. the primary endpoint is the proportion of subjects demonstrating art adherence \>90% at 3 months after prison release. secondary endpoints are: 1) retention in hiv care, 2) art initiation, 3) hiv- rna viral load, 4) cd4+ t-cell count, 5) quality of life, 6) hospitalization, 6) substance use and sexual risk behaviors at 3 months after prison release.

the acceptability and feasibility of the adapted athena intervention will be assessed through a 2-arm randomized controlled trial conducted in two phases with hiv-infected prisoners recruited from 2 correctional facilities in jakarta, indonesia. phase 1: hiv+ prisoners who are already aware of their status will be recruited through prison clinics and randomized to receive either the adapted athena intervention or standard care as a control. uniform data collection at baseline will include measures of art adherence, hiv stigma, and drug dependence and cd4+ t-cell and viral load testing. phase 2: subjects receiving the athena intervention will participate in monthly medication adherence counseling sessions within prison, and home visits up to four months after prison release, during which intervention staff (nurses and peer educators working in teams) will deliver individualized medication adherence counseling based on the freirian educational model. phase 3: participants in both groups will be followed for 12 months after prison release, and asked to complete monthly study visits to evaluate primary and secondary outcomes.

Eligibility criteria:
inclusion criteria: * hiv infection documented by a rapid hiv test or any licensed elisa test; and confirmed by another test using a different method, including but not limited to rapid hiv tests, western blot, hiv culture, hiv antigen, or hiv pro-viral dna at any time prior to study entry; and aware of hiv status * age ≥ 18 years * karnofsky performance score \>40 * conversant in bahasa indonesia exclusion criteria: * none

Keywords: prisoner
validation of progranulin as a biomarker for sepsis

Conditions: Sepsis

Summary: progranulin blood concentrations in patients with sepsis will be analysed in relation to disease status in order to validate progranulin as a biomarker for sepsis. patients undergoing cardiac surgery will serve as controls.

single nucleotide polymorphisms with known effects on progranulin plasma concentrations will be assessed in a separate analysis. expression levels of micrornas isolated from plasma, circulating exosomes and blood cells will be determined by next-generation sequencing to characterize epigenetic influences on progranulin plasma levels.

Eligibility criteria:
inclusion criteria: * sepsis or septic shock defined according to sepsis-3 criteria - age \> 18 years exclusion criteria: * no informed consent * age \< 18 years * pregnancy * immunosuppression (including transplantation) * charlson comorbidity index \> 0 (healthy volunteers)

Keywords: postoperative dysfunction following cardiac surgery
artificial tears study in mild to moderate dry eye patients

Conditions: Dry Eye

Summary: the mean change in the subjective comfort score from baseline of the test group is at least 2.0 units less than that of the control group.


Eligibility criteria:
inclusion criteria: * mild to moderate dry eye * over 18 exclusion criteria: * no concurrent ocular disease or meds

Keywords: dry, eyes amelioration of dry eye symptoms
effects of ketogenic diet in divers breathing enriched air nitrox

Conditions: Overweight and Obesity; Exertion; Excess; Oxygen Toxicity

Summary: overweight divers face a challenging activity such as immersions, starting from a higher levels of circulating cytokines and oxidative stress. ketogenic diet (kd) is described as effective in weight loss, in countering inflammation and oxidative stress, and used in the control of drug-refractory seizures. the aim of our pilot study was to evaluate if a ketosis state induced by a specific dietary regime, may have a protective effect on oxidative stress damages and inflammatory status, that accompanies both overweight and diving activities. blood and urine samples from six overweight divers were obtained a) before (ctrl) and after a dive breathing enriched air nitrox and performing light underwater exercise (ntrx), b) after a dive (same conditions) performed after 7 days of kd (k-ntrx). we measured urinary 8-isoprostane and 8-oh-2-deoxyguanosine evaluating lipids peroxidation and dna oxidative damages. plasmatic il-1beta, il-6 and tnf-alpha levels were measured to investigate the inflammatory status.


Eligibility criteria:
inclusion criteria: * to be in an overweight state (bmi ≥ 25 kg/m2) and no history of orthopedic, cardiovascular, renal or metabolic disorders. exclusion criteria: * not to be in an overweight state (bmi ≥ 25 kg/m2) and a history of orthopedic, cardiovascular, renal or metabolic disorders.
evaluation of aortic aneurysms with focus on wall stress and wall rupture risk

Conditions: Aortic Aneurysm

Summary: retrospective study to evaluate the impact of computational wall stress analysis based on computed tomography (ct) of ruptured and not-ruptured aortic aneurysms as an additional predictor for rupture with dedicated software.

in patients with known aortic aneurysm who received clinically indicated ct during a time period from 01/2004-12/2013 the ct data was evaluated with dedicated software, a4clinics, vascops gmbh, graz, austria. the following parameters will be evaluated: exterior and luminal diameter, intraluminal thrombus (ilt) thickness, vessel-, luminal- and intraluminal thrombus volume, peak wall stress (pws), peak wall rupture risk (pwrr), von mises-stress and rupture risk-index in the ilt.

Eligibility criteria:
inclusion criteria: clinical indicated ct data from patients with known aortic aneurysms. clinical indication was: * follow up ct examination by known aortic aneurysm * patient with known aortic aneurysm with new acute clinical symptoms * patients with clinical suspicion of aortic aneurysm exclusion criteria: * known exclusion criteria for ct examination as known allergy to iodine or contrast media * known pregnancy
study of safety & tolerability of opc-34712 as adjunctive therapy in treatment of adult patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to assess the long-term safety, tolerability and efficacy of oral opc-34712 as adjunctive therapy in the treatment of adult patients with major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * male or female subjects between 18 and 65 years of age, with a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by dsm-iv-tr criteria and confirmed by the mini international neuropsychiatric interview (m.i.n.i.) which is equal to or greater than 8 weeks in duration. * subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the baseline visit). * subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four adequate antidepressant treatments. exclusion criteria: * females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug. * subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration. * subjects with a current axis i (dsm-iv-tr) diagnosis of: delirium, dementia,amnestic or other cognitive disorder schizophrenia, schizoaffective disorder, or other psychotic disorder bipolar i or ii disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress disorder. * subjects with a clinically significant current axis ii (dsm-iv-tr) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
use of construal level theory to inform messaging to increase vaccination against covid-19

Conditions: Covid19; Vaccine Refusal

Summary: this study aims to increase uptake of the covid booster vaccine through messaging informed by construal level theory. patients in the mass general brigham (mgb) health system aged 18 and older who are eligible for the covid booster vaccine, but who have not yet received a dose at the time of an upcoming primary care clinic visit, will be randomized to one of three messaging arms: 1) "why" messaging, 2) "how" messaging, or 3) standard of care ("usual care"). messages will be sent via the electronic patient portal a few days in advance of their office visit. the primary outcome will be the rate of booster vaccination at the targeted visit. the secondary outcome will be the rate of receipt of a covid booster vaccine within 6 weeks of the targeted visit. subgroup analyses to assess for any association of patient characteristics with intervention responsiveness will be exploratory.


Eligibility criteria:
inclusion criteria: * patients in the mass general brigham system * aged 18 and older * are eligible for the covid booster vaccine but have not received a dose at time of upcoming primary care clinic visit exclusion criteria: * documented allergy to a covid vaccine or its components * home address outside of massachusetts * did not receive full set of primary covid-19 vaccination series
effect of cartoons on preoperative anxiety in paediatric patients.

Conditions: Anxiety

Summary: preoperative anxiety is a major problem in anesthesia management. paediatric patients are a special group who need special attention. some studies have shown that cartoons are a very good tool for distraction in the preoperative period for children. our hypothesis is that children watching cartoons in the preoperative period will have less anxiety and will be fit with preparation.

after local ethics committee approval 60 patients scheduled for various types of surgery will be included. on the operation day patients are going to be evaluated in the preoperative preparation room. for anxiety evaluation the modified yale preoperative anxiety scale will be used. after this first evaluation patients are going to be separated randomly into two groups; group r (routine) and group c (cartoon). all patients are going to be premedicated with midazolam. the first group will receive their premedication straight after the first evaluation and their response will be recorded as easy, moderate, difficult, does not accept. group c will choose a cartoon movie (5 different movies are recorded and will be shown through a tablet pc)) and will begin to watch it. after 5 minutes they will receive their premedication and their response will also be recorded. after 30 minutes a physician will try to insert an iv line and the response of the child will also be evaluated and recorded as easy, moderate, difficult and does not allow. afterwards the patient will be transported into the operation room. in the operation room anesthesia will be induced via sevoflurane and the response to mask anesthesia will be evaluated with the mask score as it is described before in previous studies. patients in group c will continue to watch the cartoon movie until the induction of anesthesia. and the modified yale score will also be reevaluated and recorded. the family anxiety will be evaluated with the state trait anxiety inventory scale. the family and the child will also be interviewed separately, 4 prepared standard questions will be asked in order to understand how the family described the operation.

Eligibility criteria:
inclusion criteria: * family approval * age between 3-9 * scheduled for surgery under general anesthesia exclusion criteria: * history of physiatric disease * regular medication * previous history of anesthesia/sedation

Keywords: preoperative anxiety paediatric patients cartoon
effect of weight loss on breast density using digital mammography and mri in women who are at increased risk for breast cancer

Conditions: Healthy, no Evidence of Disease

Summary: diagnostic procedures, such as digital mammography and mri, may help measure how weight loss affects breast density in women who are at increased risk for breast cancer.

objectives: i. to determine if weight loss in patients undergoing roux en y gastric bypass procedures has any effect on breast density as measured by mammography and breast mri. outline: group i: participants undergo mammography and mri at baseline and 1 year. participants also undergo gastric bypass surgery. group ii: participants undergo mammography and mri at baseline and 1 year. after completion of study treatment, patients are followed up at 1 year.

Eligibility criteria:
inclusion criteria: * women eligible for gastric bypass surgery * pre-menopausal women * all women will have signed an informed consent form prior to participating in study procedures exclusion criteria: * women with a history of breast cancer * women currently taking exogenous hormone replacement therapy * women currently taking a serm * women currently taking an aromatase inhibitor * pregnant or lactating women * women who have been pregnant or lactating in the past 2 years * women who have metallic or other surgical implants * all subjects will have a determination of their estimated glomerular filtration rate (egfr) within 24 hours of undergoing any study where gadolinium based contrast agents will be administered * subjects should not have a known history of recent onset acute renal dysfunction * subjects with a history of stable chronic renal dysfunction may participate in studies using gbca based on their egfr, as outlined below * subjects should not have severe liver dysfunction, particularly when associated with kidney disease * subjects should receive gbcas in the perioperative period (i.e. within 4 weeks) after renal or liver transplantation