Kornimate/medical-research-clean huggingface dataset:
protease inhibitors and combined oral contraceptive pharmacokinetics and pharmacodynamics

Conditions: Contraception; HIV

Summary: the project is a two-arm prospective cohort and pharmacokinetic study comparing levonorgestrel and ethinyl estradiol pharmacokinetics in hiv-positive women taking antiretroviral regimens that include ritonavir to those in women who take regimens known not to interact with combined oral contraceptives. in addition, the prevalence of ovulation will be measured in each group. participants will take a combined oral contraceptive containing levonorgestrel and ethinyl estradiol for 21 days, during which they will undergo twice-weekly serum progesterones. on the final day, they will complete a pharmacokinetic study. the investigators hypothesize that levonorgestrel levels, as measured by area-under-the-curve from 0 to 72 hours, will be increased in women on ritonavir, while ethinyl estradiol levels will be decreased and ovulation, defined by a serum progesterone of at least 3 ng/ml, will be unchanged. this study will be the first to evaluate the effects of ritonavir on the pharmacokinetics of a combined oral contraceptive containing the progestin levonorgestrel. in addition, no previous studies have rigorously assessed ovulation in women taking protease inhibitors and combined oral contraceptives. as a result, this study will provide new information correlating pharmacokinetic changes with effects on ovulation.


Eligibility criteria:
inclusion criteria: * hiv positive * female * age 18-45 * using any of the following medication regimens: no arv medication, entry inhibitors, nucleoside reverse transcriptase inhibitors (nrtis), integrase inhibitors, and ccr5 agonists. acceptable nrti combinations include zidovudine (zdv), lamivudine (3tc), emtricitabine (ftc), didanosine (ddl), stavudine (d4t), abacavir (abc), and tenofovir disoproxil fumarate (tdf) * ovulatory (mid-luteal progesterone \>3ng/dl) * not planning to conceive during the study period * willing to abstain from grapefruit products * if taking ritonavir, willing to use alternate non-hormonal contraception * bmi \< or = 40 * able to consent in english or spanish * no change in medication regimen for at least 21 days prior to study entry and no planned change during the study period * cd4 \> or =200, and/or not considered profoundly immuncompromised by primary hiv provider exclusion criteria: * using on the combination of zdv at d4t * platelets \<50,000 * ast or alt \> twice upper limit of normal * bilirubin \> twice upper limit of normal * use of other cyp3a4 inducing or inhibiting medications * pregnant or breastfeeding in last 30 days * use of depoprovera in last 180 days * use of any other hormonal contraception in last 30 days * undiagnosed vaginal bleeding or invasive cancer of the reproductive tract -\>50% change in tobacco use in the last month * initiation or titration of methadone therapy in the last month * uncontrolled thyroid disease * contraindication to estrogen use * inability to comply with study protocol
diabetes engagement and activation platform

Conditions: Type 2 Diabetes (T2D)

Summary: the following are hypothesized: 1. the diabetes engagement and activation platform (deap) can be integrated into primary care workflow to facilitate the care of patients with type 2 diabetes. 2. the deap intervention will be feasible and acceptable to patients with type 2 diabetes. 3. the deap intervention will enhance patient activation and improve type 2 diabetes self management and glucose control

aim 1: to evaluate how primary care practices adopt and integrate deap into routine workflow including identification of barriers and facilitators to support acceptable, feasible, and sustainable use of the system. * sub-aim 1.1: measure the proportion of clinicians and care team members who engage patients through the deap intervention as well as the types of patient support activities they address; assess the representativeness of participating clinicians and care team members in relation to all practice staff; and assess how they integrated deap into the care of type 2 diabetes patients. * sub-aim 1.2: assess how practices redesign workflow, overcome barriers, and enhance facilitators in order to integrate deap. * sub-aim 1.3: determine processes for sustaining deap beyond the project funding period . aim 2: to compare, relative to usual care, the effectiveness of the deap intervention. * sub aim 2.1: measure the proportion and representativeness of eligible patients who choose to enroll; access the deap curriculum; complete the deap curriculum; and contact care team members. . * sub aim 2.2: compare the change in the average glycosylated hemoglobin (primary outcome), body mass index, systolic blood pressure, and type 2 diabetes (t2d) medications and patient activation (secondary outcomes) from baseline to 3 months and from 3 to 6 months for patients randomized to deap versus usual care. sub aim 2.3: assess the clarity, readability and acceptability of the deap curricula materials for t2d patients enrolled in the intervention.

Eligibility criteria:
inclusion criteria: * patients diagnosed with type 2 diabetes and a1c measure ≥ 8%; * english speaking; * enrolled in the practice ehr linked patient portal. exclusion criteria: * patients without type 2 diabetes or with type 2 diabetes who have a a1c less than or equal to 7.9%; * non-english speaking; * patients not enrolled in the practice ehr linked patient portal; * under 18 and over 75 years of age.
sleep health in preschoolers: a randomized controlled trial

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the ship study is a randomized controlled trial of an intervention for preschool children with sleep problems, in which we aim to give parents the knowledge, motivation, and skills necessary to set goals, problem-solve, and improve their child's sleep. in collecting three years of follow-up data, we will be able to determine the impact of the ship intervention on childhood sleep problems, obesity, academic achievement, and emotional and behavioral problems, as well as parental stress and daytime tiredness. this study has the dual potential to expand treatment resources for young children with behavioral sleep problems and to increase our scientific understanding of the long-term consequences of early childhood sleep problems.


Eligibility criteria:
inclusion criteria: * age 30-71 months * child behavioral sleep problem, as demonstrated by a score on the children's sleep habits questionnaire (cshq) of at least 50, or a score of 41-49 and reported weeknight sleep of 9hrs or less per night * english speaking parent or guardian exclusion criteria: * sleep disordered breathing, as demonstrated by a score on the cshq of at least 5 * currently taking prescribed sleep medications, psychostimulants, and/or systemic corticosteroids * serious medical conditions likely to affect sleep, including diabetes or cancer * major cognitive or developmental disorder, including autism spectrum disorder
a prospective, single-center study evaluating the efficacy and safety of glofitamab combined with orelabrutinib and bortezomib in patients with high-risk mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: the aim of this study is to evaluate the efficacy and safety of glofitamab combined with orelabrutinib and bortezomib in patients with high-risk mantle cell lymphoma


Eligibility criteria:
inclusion criteria: * signed informed consent form * age ≥ 18 years at the time of signing informed consent form and willingness to comply with study protocol procedures * participants with mcl * meets any of the following high-risk criteria: blastoid/pleomorphic morphology; high ki-67 (≥ 30%); tp53 aberration; del(17p); complex karyotype; mipi score ≥ 6.2; early progression after first-line treatment (\<24 months); presence of other high-risk genetic mutations (kmt2d, nsd2, notch1, cdkn2a, notch2, smarca4, ccnd1) * life expectancy ≥ 12 weeks * eastern cooperative oncology group (ecog) performance status 0, 1, or 2 * at least one bi-dimensionally measurable (≥ 1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥ 1 cm) extranodal lesion, as measured on ct scan * no bone marrow involvement: anc ≥ 1.0 × 10\^9/l; bone marrow involvement: anc ≥ 0.5 × 10\^9/l * no bone marrow involvement: plt ≥ 75 × 10\^9/l; bone marrow involvement: plt ≥ 25 × 10\^9/l * no bone marrow involvement: hgb ≥ 8 g/dl; bone marrow involvement: hgb ≥ 7 g/dl * adequate renal function, defined as measured or estimated creatinine clearance ≥ 30 ml/min exclusion criteria: * contraindication to any of the individual components of glofit-orela-borte * known active infection at the time of enrollment * positive test results for chronic hepatitis b infection (defined as positive hepatitis b surface antigen \[hbsag\] serology): patients with occult or prior hbv infection (defined as negative hbsag and positive hepatitis b core antibody \[hbcab\]) may be included if hbv dna is undetectable, provided that they are willing to undergo dna testing on day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy * positive test results for hepatitis c (hepatitis c virus \[hcv\] antibody serology testing): patients who are positive for hcv antibody are eligible only if pcr is negative for hcv rna * history of other malignancies that could affect compliance with the protocol or interpretation of results * active autoimmune disease requiring treatment * primary or secondary cns lymphoma at the time of recruitment * any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
efficacy and safety of remimazolam besylate versus propofol for sedation in critically ill patients with deep sedation

Conditions: Critically Ill; Deep Sedation

Summary: the purpose of this study is to evaluate the efficacy and safety of remimazolam besylate compared to propofol for sedation in critically ill patients with deep sedation.

this is a single-center, prospective, randomized, controlled study using remimazolam besylate and propofol for sedation in critically ill patients with deep sedation. subjects are randomized to remimazolam group and propofol group in a 1:1 ratio. remifentanil is administered as the analgesic. efficacy and safety profiles of remimazolam besylate are to be evaluated.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 80 years; * expected to require deep sedation ≥8 hours; * requirement for deep sedation (a narcotrend index between 13 and 64). exclusion criteria: * body mass index (bmi) \ 30 kg/m2; * acute severe neurological disorder and any other condition interfering with rass assessment; * systolic blood pressure less than 90 mm hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors; * heart rate less than 50 beats/min; * second- or third-degree heart block in the absence of a pacemaker; * unstable angina; * acute myocardial infarction; * left ventricular ejection fraction less than 30%; * contraindicate or allergic to study drugs; * moribund state; * acute hepatitis or serious hepatic dysfunction (child-pugh class c); * chronic kidney disease with glomerular filtration rate (gfr) \< 60 ml/min/1.73m2; * alcohol abuse; * myasthenia gravis; * expected to have a general anesthesia within 8 hours; * pregnancy or lactation.

Keywords: remimazolam besylate propofol intensive care unit deep sedation
assessment of functional capacity, pain, cognitive and respiratory functions in lung cancer survivors

Conditions: Lung Neoplasm; Survivorship

Summary: serious side effects occurs with disease and treatments in survival after lung cancer. for this reason, functional capacity, cognitive status, pain perception and respiratory functions may be affected in lung cancer. the purpose of this study was to evaluate respiratory function, respiratory muscle strength and endurance, functional capacity, pain, cognitive status level, and physical activity in lung cancer patients and compare with the findings of healthy subjects

this study was participated lung cancer patients survivors. patients' pulmonary function test, functional capacity, respiratory muscle strength and endurance, pain and cognitive status was assessed and recorded. pulmonary function testing (pft), mouth pressure measurement (mip- maximal inspiratory pressure and mep- maximal expiratory pressure), respiratory muscle endurance test, six minute walk test (6mwt) and pain threshold and tolerance test were used. in addition to physiological measurements, the montreal cognitive assessment (moca) scale was used to evaluate cognitive status, the international physical activity questionnaire (ipaq) was used to determine the level of physical activity.

Eligibility criteria:
inclusion criteria: * cooperation * lung cancer patients who had a stable condition exclusion criteria: * active cancer treatments * brain metastasis story * any orthopedic disease impairs walking, balance

Keywords: respiratory muscles pain cognitive dysfunction
preventing alcohol use disorders and alcohol-related harms in pacific islander young adults

Conditions: Alcohol Use Disorder; Alcohol; Harmful Use

Summary: this study will: (1) refine and finalize the spear intervention manual for preventing alcohol use disorders (aud) and associated harms for pacific islander young adults; and (2) test spear for efficacy by conducting a pretest-posttest randomized controlled trial (rct).

pacific islander young adults bear elevated risk for alcohol use disorders (aud) and alcohol-related harms, yet lack effective interventions to reduce their risk. grounded in the social development model, this study will: (1) refine and finalize the spear intervention manual for preventing alcohol use disorders (aud) and associated harms for pacific islander young adults from existing evidence-based aud prevention strategies; then (2) test spear for efficacy by conducting a pretest-posttest randomized controlled trial (rct) with at-risk pacific islander young adults across multiple pacific islander communities in the us.

Eligibility criteria:
inclusion criteria: 1. of full or part self-reported pacific islander heritage; 2. fluent (oral and reading) in english 3. for young adult participants: 18 - 30 years of age 4. current drinking (1+ drink in past 30 days) 5. high aud risk (audit-c score # 4 for men, # 3 for women) 6. not currently in alcohol treatment (medication, therapeutic). exclusion criteria: 1. do not meet inclusion criteria 2. are unwilling to participate 3. fail to provide or retracts consent 4. reside outside the target pacific islander communities
irreversible electroporation (nanoknife) for the treatment of pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma; Interventional Imaging

Summary: the aim of the study is to evaluate the use of irreversible electroporation in the treatment of locally advanced cancers of the head of pancreas with vascular spread. this technique would allow to treat the unresectable part of the tumor to make it more accessible for a secondary surgery.


Eligibility criteria:
inclusion criteria: * patients with histologically proven adenocarcinoma of the head of the pancreas (fine needle aspiration or biopsy) * pancreatic adenocarcinoma locally advanced on imaging at diagnosis * tumor of less than 7 cm in largest diameter * no chemotherapy or abdominal radiotherapy within five years before the inclusion in the study exclusion criteria: * pancreatic adenocarcinoma of more than 7 cm of diameter or immediately operable on imaging data * patient with contraindication of nanoknife use * patient with neurostimulator * epileptic patient or with a myocardial infarction lasting less than 2 months * presence of visceral or lymph node metastases or peritoneal carcinosis at the initial workup * patient who cannot be treated with muscle blockers (curare) * patient with a metallic stent or a medical device implanted near the area treated by electroporation

Keywords: locally advanced pancreatic carcinoma irreversible electroporation interventional radiology
electroencephalogram and attention deficit hyperactivity disorder study

Conditions: Attention Deficit Hyperactivity Disorder; Healthy Controls

Summary: the purpose of this research is to assess and determine brain oscillations or "brain signatures" of adult participants with attention deficit hyperactivity disorder (adhd) relative to adult participants without adhd using the technique electroencephalogram (eeg). electroencephalogram is entirely non-invasive way of tracking brain activity.the main goal of this study is to establish biological factors for determining the diagnosis of attention deficit hyperactivity disorder (adhd).


Eligibility criteria:
inclusion criteria for all: * right-handedness inclusion criteria for attention deficit hyperactivity disorder (adhd) group: * currently unmedicated adults with adhd. to be given a full diagnosis of adult adhd, the participant must have full diagnostic and statistical manual of mental disorders (dsm-iv-r) criteria: (1) described a chronic course of adhd symptomatology from childhood to adulthood, and (2) endorsed a moderate or sever level of impairment attributed to the adhd symptoms. exclusion criteria for all: * currently taking psychoative medications * any clinically significant neurological problem (e.g., tics, seizures, serious head injury) * alcohol or substance abuse (current or in the past 2 years) * any current axis i psychiatric diagnosis (other than adhd) as verified by clinical interview
optimizing timing of cabg in patients presenting with acs and treated with ticagrelor

Conditions: Coronary Artery Disease

Summary: the administration of ticagrelor have demonstrated superiority to clopidogrel in patients presenting with acute coronary syndrome (acs) and remains a first line therapy as an adjunct to aspirin for patients admitted with acs. the patient population treated with ticagrelor at an early time point includes non st elevation myocardial (nstemi) patients and those undergoing primary angioplasty for st elevation myocardial infarction (stemi). it is estimated that 10-15% of patients presenting with acs have advanced coronary artery disease requiring coronary artery bypass surgery (cabg). the treatment guidelines recommend a delay of 5-7 days for cabg surgery in these patients for normalization of ticagrelor induced platelet inhibition to reduce the risk of peri-operative bleeding. this delay may expose these high risk patients to adverse cardiac events while waiting for ticagrelor effect to wean off. furthermore, this empirical application of 5-7 day delay in all patients may be unnecessary due to the significant inter individual variability in response to ticagrelor. there is limited data to determine the optimum timing of cabg surgery in acs patients treated with ticagrelor. the present study will determine the optimum timing of cabg in acs patients treated with a loading and/or maintenance dose of ticagrelor.


Eligibility criteria:
inclusion criteria: * accepted for cabg surgery * treatment with ticagrelor within 48 hours exclusion criteria: * anticoagulation therapy * prior cabg. * active bleeding or at high risk of bleeding * severe liver or renal disease. * hypersensitivity to ticagrelor * history of intracranial hemorrhage
he effect of care and the use of virtual reality glasses on pain and comfort

Conditions: Care

Summary: the research will be conducted to determine the effect of comfort theory-based care and virtual reality glasses on pain and comfort levels in women who have given birth to primiparous babies. the hypotheses of the study are: h0: comfort theory-based care and the use of virtual reality glasses have no effect on pain and comfort in the postpartum period. h1-1: comfort theory-based care has an effect on pain level in the postpartum period. h1-2: comfort theory-based care has an effect on comfort in the postpartum period. h2-1: the use of virtual reality glasses in the postpartum period has an effect on the level of pain. h2-2: the use of virtual reality glasses in the postpartum period has an effect on comfort.

although pregnancy and birth are normal processes, the type of birth affects the comfort level, quality of life, and pain in the natal and postnatal period. in our country, as in many other countries, cesarean delivery rates are quite high.pain in cesarean births is more severe and lasts longer than in vaginal birth. along with many methods to reduce pain, the effectiveness of virtual reality applications is also emphasized theoretically or conceptually.in the planned randomized controlled study, the pain level and comfort of individuals will be measured by applying virtual reality glasses to one of the experimental groups and giving kolcaba's comfort theory-based care to the other. personal information form, postpartum comfort scale, visual analogue scale (vas) and virtual reality glasses form will be used as measurement tools.this study aims to reduce the pain of the mother in the short term and enable the mother to participate in self-care and baby care in a shorter period of time, and in the long term to minimize maternal and newborn deaths and eliminate deaths under the age of 5.increasing maternal comfort during the postpartum period is expected to have a direct impact on maintaining maternal health and indirectly on baby care.

Eligibility criteria:
inclusion criteria: * volunteering to participate in research * having given birth with epidural anesthesia * being between the ages of 18-35 * having given birth within 37-41 weeks of pregnancy * having a primiparous cesarean birth exclusion criteria: * having a normal birth * having given birth with general anesthesia * having a disability that limits vision, hearing or communication * having a systemic disease, hypertension, preeclampsia or uterine atony and risk of bleeding

Keywords: postpartum period pain comfort care virtual reality
transverse b-lynch in management of placenta accreta

Conditions: Decrease Maternal Morbidity

Summary: placenta accreta is considered a severe pregnancy complication that may be associated with massive and potentially life-threatening intrapartum and postpartum hemorrhage. life-threatening bleeding is the most common complication to be associated with this condition; the average blood loss at time of delivery is reported to be 3000-5500 ml, which leads to significant postoperative morbidity and death.


Eligibility criteria:
inclusion criteria: 1. all pregnant women with placenta previa as diagnosed by ultrasound with suspicion of abnormal placentation by doppler us, confirmed intraoperatively undergoing either emergent or elective cesarean exclusion criteria: 1. patients who will be managed by hysterectomy 2. patients who will be managed by conservative leaving the placenta in-situ