Kornimate/medical-research-clean huggingface dataset:
vaping and smoking project in people with schizophrenia

Conditions: Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)

Summary: the proposed research will characterize withdrawal among people with schizophrenia who vape daily compared to people with schizophrenia who smoke combustible cigarettes daily, filling critical gaps in the understanding of electronic nicotine delivery systems (ends) dependence and contributing to the development of vaping cessation interventions amongst people with schizophrenia, the leading preventable cause of death in the us.

although withdrawal is considered a key feature of nicotine/tobacco addiction that contributes to difficulty quitting smoking and likely electronic nicotine delivery systems (ends; e.g., electronic cigarettes), there is currently no research on ends withdrawal in people with schizophrenia. the proposed supplement will conduct a systematic and comprehensive characterization of withdrawal in a sample of people with scz who vape daily compared to those who smoke daily, filling gaps in our understanding of ends dependence/withdrawal for people with scz and contributing to the identification of intervention targets for ends use.

Eligibility criteria:
inclusion criteria: * 6+ months of daily/near-daily nicotine vaping or cigarette smoking * 200+ ng/ml cotinine on a commercially-available quick screen * stable antipsychotic medication dose (no changes in past 6 months). current exclusion criteria: * intention to quit daily/near-daily vaping/smoking in the next month * current (2+ days out of the past 7) use of pipe tobacco, hookah/shisha, smokeless tobacco, dissolvable tobacco, nicotine pouches. for vaping group only, current (2+ days out of past 7) use of cigars, cigarillos, or filtered cigars that are filled with tobacco or a mix of tobacco and marijuana * current use of any smoking cessation medication * current severe substance dependence other than tobacco/nicotine (including cannabis; nida modified assist of 27+) * current (past 2 weeks) suicidal ideation with intent and/or plan * pregnancy (intake urine screen) * florid psychosis or severe cognitive symptoms (score of ≥5 on panss items delusions (p1), hallucinatory behavior (p3), or unusual thought content (g9), conceptual disorganization (p2), abstract thinking (n5), or poor attention (g11) or a score ≥6 on grandiosity (p5) or suspiciousness (p6)
pharmacokinetics of injectable estradiol and progesterone microspheres suspension

Conditions: Menopause

Summary: phase i pharmacokinetic study main objective: to determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration study design: randomized, controlled, open-label, parallel, pharmacokinetic study sites: 1 subjects: 30 postmenopausal women

sites: 1 phase: 1 main objective: to determine plasmatic profiles and pharmacokinetic parameters of estradiol and progesterone on each of the formulations studied, after multiple-dose administration. secondary objectives: to determine bioavailability of each of the formulations studied, after multiple-dose-administration. describe tolerability of each of the formulations studied, after multiple-dose administration. study design: randomized, controlled, open-label, parallel, pharmacokinetic study investigational products: * estradiol and progesterone microspheres aqueous suspension (1 mg/20 mg) * estradiol and progesterone microspheres aqueous suspension (0.5 mg/15 mg) study subjects: 30 postmenopausal women 45 - 65 years old brief description: after written informed consent, 30 eligible women will be randomized to study treatments (one im injection each 28 days, for a total of 4 doses). blood samples will be obtained for pharmacokinetic study.

Eligibility criteria:
inclusion criteria: * female * 45 to 65 years old * able to read and write * postmenopausal * body mass index equal or below 34.99 kg/m2 * healthy * normal uterus * time availability exclusion criteria: * hypersensitivity to progesterone or related compounds * hypersensitivity to estrogens * hysterectomy * history or present hormone-dependent tumor * history or present uterine cervix dysplasia * abnormal and clinically-significant laboratory test results * family history of breast cancer * history of thromboembolic disease * non-controlled hypertension * history of stroke * history of cardiac valve surgery * renal failure * hepatic failure * non-controlled diabetes * history of serious neurologic disease * reduced mobility * anemia * previous or concomitant hormone therapy * previous or concomitant therapy with inhibitors or inductors of cytochrome

Keywords: estrogen progesterone microspheres menopause pharmacokinetics
safety and effectiveness of oral anticoagulants in patients with non-valvular atrial fibrillation

Conditions: Non-valvular Atrial Fibrillation

Summary: an anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular af (nvaf) patients. warfarin, a vitamin k antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin k antagonist oral anticoagulants (noacs). however, its safety and effectiveness remains unknown in real-world clinical practice in japan

an anticoagulation therapy is a critical treatment to prevent thromboembolism in non-valvular af (nvaf) patients. warfarin, a vitamin k antagonist, is the first oral anticoagulant approved for the treatment for prevention of thromboembolism and it had long been the only oral anticoagulant until the first non-vitamin k antagonist oral anticoagulants (noacs). however, its safety and effectiveness remains unknown in real-world clinical practice in japan. this study will evaluate the risk of stroke/se as well as the risk of bleeding in the real world settings in japan in patients with nvaf who initiated any of oacs (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin)

Eligibility criteria:
inclusion criteria patients must meet all of the following criteria to be eligible for the study: 1. diagnosed with af anytime in the baseline period or on the index date, also have definitive diagnosis of af anytime in the baseline period, on the index date, or post-index period. 2. prescribed one of the index oacs (apixaban, dabigatran, edoxaban, rivaroxaban or warfarin) on or after the day of af diagnosis. the first observed prescription will be used to identify the patient's index date and treatment cohort 3. no use of the any oacs during the baseline period (the 180 days before the index date) 4. age of 18 years or older on the index date. exclusion criteria patients meeting any of the following criteria will not be included in the study: 1. having a diagnosis of valvular atrial fibrillation, post-operative atrial fibrillation, rheumatic atrial fibrillation or mechanical-valvular atrial fibrillation during the baseline and post-index period 2. having a cardiac surgery procedure record during the baseline period 3. having a joint replacement procedure record during the baseline period 4. having a procedure of prosthetic heart valve during the baseline period 5. having a diagnosis of venous thromboembolism during the baseline period 6. female patients with pregnancy during the follow-up period 7. patients prescribed "off-label" doses of oacs (per japanese package insert of each oac) or patients treated with oac but in "off-label" or "contraindicated" manners. -

Keywords: non-valvular atrial fibrillation, nvaf
pharmacokinetic drug interaction study of dapagliflozin and valsartan or simvastatin in healthy subjects

Conditions: Type 2 Diabetes Mellitus

Summary: phase a - to assess the effect of simvastatin on the pharmacokinetics (pk) of dapagliflozin and to determine the effect of dapagliflozin on the pk of simvastatin, when simvastatin and dapagliflozin are coadministered in healthy subjects. phase b - to assess the effect of valsartan on the pk of dapagliflozin and to determine the effect of dapagliflozin on the pk of valsartan, when valsartan and dapagliflozin are coadministered in healthy subjects


Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m2, inclusive. bmi = weight (kg)/\[height (m)\]2 exclusion criteria: * women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 12 weeks after the last dose of investigational product * abnormal urinalysis at screening (repeat urinalysis may be allowed for positive hematuria in women) * glucosuria at screening * abnormal liver functions tests (alt, ast or total bilirubin \> 10% above uln) * presence of edema on physical exam * history of diabetes mellitus * history of heart failure * history of renal insufficiency * history of chronic or recurrent uti (defined as 3 occurrences per year) or uti in the past 3 months * history of recurrent (defined as 3 occurences per year) or recent vulvovaginal mycotic infections * positive urine screen for drugs of abuse either at screening or before dosing * positive blood screen for hepatitis c antibody, hepatitis c antibody, hepatitis b surface antigen, or hiv-1, -2 antibody * history of allergy to sglt2 inhibitors or related compounds * history of any significant drug allergy (such as anaphylaxis or hepatotoxicity) * history of allergy or intolerance to valsartan or simvastatin (or related compounds) * prior exposure to dapagliflozin, valsartan or simvastatin within 3 months of day -1 * exposure to any investigational drug or placebo within 4 weeks of day -1 * use of any prescription drugs within 4 weeks or over-the-counter acid controllers within 2 weeks prior to any study drug administration * use of any other drugs, including over-the counter medications within 1 week and herbal preparations within 2 weeks prior to admission to the study facility * use of an oral, injectable or implantable hormonal contraceptive agent within 3 months of day -1
home-based or clinic-based human papillomavirus (hpv) screening

Conditions: Atypical Squamous Cell of Undetermined Significance; Cervical Carcinoma; Cervical Intraepithelial Neoplasia Grade 2/3; Health Status Unknown; Human Papillomavirus Infection; Low Grade Cervical Squamous Intraepithelial Neoplasia; Stage 0 Cervical Cancer

Summary: this randomized clinical trial studies home-based hpv or clinic-based pap screening for cervical cancer. it is not yet known whether home-based screening is more effective, cost-effective, and/or acceptable than clinic-based screening for cervical cancer.

primary objectives: i. compare the sensitivity and specificity for cervical intraepithelial neoplasia (cin) of two screening approaches: * novel approach: every 3 years high risk-human papillomavirus (hr-hpv) testing of (at home) self-collected samples with in-clinic cytology of hr-hpv positive women and referral to colposcopy of women with cytology \> atypical squamous cells of uncertain significance (ascus); repeat hpv testing of hr-hpv positive but cytology negative women at one year; * currently recommended approach: for women \ ascus; retesting of those who are positive for other hr-hpv at one year. ii. compare these two approaches with respect to overall cost-effectiveness and acceptability. iii. determine the performance and cost-effectiveness of each approach in vaccinated and unvaccinated women \< 30. outline: participants are randomized to 1 of 2 arms. group i (home-based hpv screening): participants collect 2 vaginal specimens using polyester swabs. participants with a positive hpv test result will have a pap test. participants with an abnormal pap test will undergo standard of care as in group ii. group ii (clinic-based standard of care screening): participants undergo pap testing. participants with a positive pap test undergo standard of care, including colposcopy, hpv testing, cervical biopsy and/or endocervical curettage (ecc). participants with cervical biopsies showing precancerous changes requiring treatment may undergo loop electrosurgical excision procedure (leep) or are referred to appropriate care.

Eligibility criteria:
inclusion criteria: * able to provide informed consent in english exclusion criteria: * have had hysterectomy * currently pregnant * received treatment of cervical dysplasia with leep, cone biopsy, laser procedure or cryotherapy within three years * received colposcopy of cervix within two years * received pap test within one year * immunocompromised (positive human immunodeficiency virus \[hiv\] test, transplant recipient, received chemotherapy for cancer, or taking immunosuppressant drugs) * decisionally impaired adults requiring a legally authorized representative

Keywords: cervical cancer atypical squamous cells of undetermined significance stage 0 cervical cancer cervical intraepithelial neoplasia grade 1 cervical intraepithelial neoplasia grade 2 cervical intraepithelial neoplasia grade 3 human papillomavirus hpv
evaluating pyrroloquinoline quinone (pqq) for improving obese pregnancy outcomes

Conditions: Maternal Obesity

Summary: maternal obesity (mo) affects 1 in 5 women and is strongly linked to increased birth weight, childhood/adolescent obesity, life-long metabolic and inflammatory disorders, and childhood neuropsychiatric disorders. there remains a critical unmet need for developing a safe and effective non-pharmacological approach for attenuating metabolic inflammation and ameliorating the adverse effects of mo on offspring health that originate in utero and extend into the lactational period. pyrroloquinoline quinone (pqq) is a diet-derived natural food supplement with anti-inflammatory properties that, in humans and mice, improves metabolism and exerts potent immunoregulatory effects. researchers' central hypothesis is that pqq administration during mo pregnancy 1) improves maternal metabolic and inflammatory indices, 2) improves utero-placental blood flow and ameliorates placental maladaptation (oxidative stress, hypoxia, inflammation and fatty acid transporter expression) and 3) reduces neonatal adiposity.

women with a body mass index (bmi) greater than 30 will be recruited during their first trimester clinic visit up to 16 weeks of gestation. in addition to the blood draw and anthropometric measurements normally carried out at the first pre-natal visit, researchers will provide consented study subjects with pyrroloquinoline quinone (pqq) or placebo in capsules at a dose of 20 milligrams per day. there will be 15 women per group. at \~30 days after initiating the study (4-week routine follow-up visit) blood samples will be obtained. at \~24-28 weeks gestation, during the 2nd trimester visit, study subjects will undergo the standard 1-hour oral glucose screen, routine prenatal complete blood count (cbc) evaluation, study maternal blood sampling, and anthropometric measurements. during the delivery inpatient admission, researchers will again collect maternal blood as well as placental tissue, and umbilical cord blood (plasma, aperipheral blood mononuclear cells) after delivery. placental tissue (samples from four separate cotyledons) will be collected for protein (homogenate and plasma membrane isolation), ribonucleic acid (rna), quantitative polymerase chain reaction (qpcr), and histology (fixed in 4% paraformaldehyde). the neonate will undergo peapod evaluation prior to discharge, and within 72 hours after birth. pqq supplementation will continue for 30 days post-partum at which time maternal blood and breastmilk samples will be collected, as well as a follow up infant peapod evaluation and maternal dual x-ray absorptiometry (dexa) scan.

Eligibility criteria:
inclusion criteria: * adult women * body mass index \>30 kg/m2 * currently pregnant with gestational age up to 16 wks exclusion criteria: * women with pregestational diabetes (type 1 or type 2) * smokers * women with other risk factors for placental insufficiency or preterm delivery * advanced maternal age (age ≥40 yrs) * pre-existing chronic hypertension * renal disease * thrombophilias * substance use * human immunodeficiency virus (hiv) * hepatitis c * autoimmune disorders
intermittent fasting in prostate cancer patients receiving androgen deprivation therapy

Conditions: Prostate Cancer

Summary: this is a a pilot study to assess the feasibility of intermittent caloric restriction (plus a plant-enriched diet optionally) in prostate cancer patients receiving androgen deprivation therapy. study feasibility measures will include enrollment rate, drop-out rate and compliance with diet measured by self-reports.


Eligibility criteria:
inclusion criteria: * in order to be eligible for participation in this trial, the subject must: * be willing and able to provide written informed consent for the trial. * be male at birth and least 18 years of age on day of signing informed consent. * have measurable prostate cancer disease and be eligible for androgen deprivation therapy. * have a performance status of 0-2 on the eastern cooperative oncology group (ecog) performance scale. * demonstrate adequate organ function (all screening labs should be performed within 10 days of treatment initiation). * subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment. * subjects must have a life expectancy of at least 6 months. exclusion criteria: * has an ecog performance of 2 or higher. * is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the beginning of the treatment. * has a known additional malignancy that is progressing or requires active treatment. * has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * has a known allergy, intolerance, or medical contraindication to receiving the contrast dye required for the protocol-specified ct/mri imaging * has any other medical intervention or condition which, in the opinion of the principal investigator, could compromise adherence with study requirements or otherwise compromise the study's objectives. * is not willing and able to provide written informed consent for the trial.
improving parental soothing by video

Conditions: Acute Pain

Summary: this study sets out to compare the effectiveness of a parent pain management coaching video that is 5-minutes in length. the investigators will be comparing an active-video to a placebo-video of equal length (and identical formatting). participants will be 6 or 18 month infants undergoing routine immunization. the investigators hypothesize the active video will result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase in the parental use of distraction, physical comfort, and rocking.

our goal is to determine if a video instructing parents on the principles of soothing their infant following immunization will influence soothing behaviours exhibited by parents, and pain reactivity and regulation in infants. we plan to present parents of young infants (6 months) and older infants (18 months) with either a treatment video instructing them on the abcd's (assess anxiety, belly breathe, calm close cuddle, distraction; copyright r. pillai riddell) of pain management or a placebo video with neutral information. there is very minimal risk because our suggestions are based on what parents deemed 'sensitive' (in our ongoing longitudinal study) were doing naturally i.e., without any intervention in their day-to-day lives. additionally, in a separate study, that already received ethics approval, parents viewed these videos without any negative side effects. participants will be adult parents from one of two clinics in the greater toronto area who bring their infant in for a routine immunization (12 or 18 months). in our cohort study (where we simply videotape dyads in the clinic). parents will be asked to complete a brief questionnaire (parent information sheet) entailing basic demographic information and preimmunization ratings of their worry about their infant's pain from the immunization. the parents will also be asked to complete the 18-item brief symptom inventory (bsi-18) and the negative affect subscale (ibq-r very short form), in addition to demographic information. the parents will subsquently be asked to view a brief video (treatment or placebo video) discussing the abcd's of pain management described above. during the infant's routine immunization procedure the parents and infant will be videotaped for approximately 10 minutes, and the parent will be asked a few brief questions post immunization including ratings of their infant's pain from the immunization procedure and the helpfulness of the video.

Eligibility criteria:
inclusion criteria: * infants must be 6 or 18 months old receiving a routine immunization injection. * parents must be fluent in english. * only one child per family can be enrolled. exclusion criteria: * no suspected developmental delays or chronic illnesses. * time spent in a neonatal intensive care unit. * born more than 3 weeks premature.

Keywords: infant immunization