Kornimate/medical-research-clean huggingface dataset:
self-management of chronic depressive symptoms in pregnancy

Conditions: Depression

Summary: this study will provide information about the feasibility, acceptability, and preliminary effects of a biobehavioral self-management approach for perinatal depressive symptoms. this line of research will contribute to the body of knowledge about adjunctive therapies for depressive symptoms in pregnancy, a serious problem which contributes to poor maternal-child outcomes. ultimately, this will contribute to the development and implementation of theoretically driven depression prevention/ resiliency building interventions and measurement of appropriate biobehavioral outcomes to determine the effectiveness of interventions.

the investigators longitudinal mixed-methods study will use a one-group repeated measures intervention design coupled with qualitative methods to provide a comprehensive view of the feasibility, acceptability, and preliminary effects of the moms intervention. semi-structured interviews, recruitment and retention numbers, and participant logs will be used to evaluate feasibility and acceptability of the intervention (specific aim 1). recently collected archival comparison group data from an existing study will be used to contribute to explorations of preliminary effects of the intervention by comparing longitudinal psychobehavioral data, birth weight data (specific aims 2 and 3).

Eligibility criteria:
inclusion criteria: * ≥ age 18; * self-report of depressive symptoms prior to pregnancy; * current depressive symptoms at a moderate-to-severe level, as defined by a score ≥10 on the patient health questionnaire-9; * able to read, write, and understand english; * self-identify as black/african american (aa) or white; * absence of suicidal ideations (measured as low risk on the m.i.n.i. neuropsychiatric interview tool); * absence of pregnancy complications/physical conditions making physical activity (pa) inadvisable; * has not engaged in a consistent mindfulness-based pa routine during the pregnancy (such as yoga or similar activities more than once per month). exclusion criteria: * if individual does not meet the inclusion criteria listed above, they are ineligible for the study.

Keywords: pregnancy self-management yoga
the effect of video information on anxiety in adolescents having rrt-pcr test during corona virus pandemic

Conditions: Coronavirus

Summary: the polymerase chain reaction (rrt-pcr) test is still the gold standard in the diagnosis of coronavirus disease. health workers apply this procedure in a closed area, wearing personal protective equipment. adolescents cannot be informed about the invasive procedure and it is difficult to communicate with them. before the procedure, the effect on anxiety will be investigated by watching an informative video (containing information such as the materials used in the procedure, how long the procedure will take, how the sample will be taken, why healthcare workers wear personal protective equipment) prepared according to the developmental characteristics of the adolescents.

in the coronavirus pandemic, pcr testing is still the gold standard in the diagnosis of the disease. pcr with the right method can increase the sensitivity of the test. adolescents' anxiety and anxiety levels may increase during invasive procedures such as pcr testing. in addition, in this process, factors such as the uncertainty created by the pandemic, disruption of routines, loss of school and peer social ties, and fear of getting sick bring along many mental disorders. the fact that the tests and treatments for the disease are new and that they are not informed about the procedures to be done cause the anxiety levels of the adolescents to increase. nurses who treat adolescents with care and personal protective equipment may not be able to communicate verbally, sensorially, eye-to-eye with adolescents, and may have difficulty in conveying their voices and emotions. likewise, by wearing a mask, it prevents nurses from observing their reactions to the hospital environment and procedures. video education is one of the most effective ways for nurses to fulfill their educational roles during the epidemic when communication is limited. for this reason, it is very important to inform before the pcr sample collection process with a video prepared in accordance with the developmental stages of the adolescents. the aim of this study is to investigate the effect of the video that adolescents will watch before the procedure on their anxiety.

Eligibility criteria:
inclusion criteria: * applying to state hospital for a pcr test * being literate in turkish * not having a hearing or visual impairment, not having a mental disability. * not having had a previous pcr test sample taken * to be in good general condition (clinically) * signing the informed consent form (child and parent) exclusion criteria: * being illiterate in turkish * hearing or visual impairment, mental disability * previous pcr test sample taken * absence of parents next to the adolescent * those who did not sign the informed consent form (child and parent)

Keywords: coronavirus polymerase chain reaction adolescent anxiety information video
study in women with idiopathic menorrhagia to determine the reduction in menstrual blood loss (mbl) after treatment with the levonorgestrel-releasing intrauterine system (ius)

Conditions: Menorrhagia

Summary: the purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

acronyms in the adverse event section: * iucd intrauterine contraceptive device * meddra medical dictionary for regulatory activities this study has previously been posted by berlex, inc. and schering ag, germany. berlex, inc. has been renamed to bayer healthcare pharmaceuticals, inc., schering ag germany has been renamed to bayer healthcare ag, germany.

Eligibility criteria:
inclusion criteria: * women who have \>/= 80 ml blood loss during their menstrual cycles and desire contraception exclusion criteria: * post menopausal menstrual cycle \ 35 days * pregnancy

Keywords: idiopathic menorrhagia
sbrt in 4 fractions for prostate cancer

Conditions: Prostate Cancer

Summary: this is a prospective multicentric phase-i-ii pilot feasibility study. the main objective is to study early and late side effects of hypofractionated accelerated rt for prostate cancer with fff (free flattened filter) beam. the schedule will be \[ 4 x 9.5 gy = 38 gy \] delivered in 5 alternative days.


Eligibility criteria:
inclusion criteria: * age ≤ 85years. * who performance status ≤ 2. * psa\>10 and ≤ 20 ng/ml or gleason score 7 or t2a-t2c. * histologically proven prostate adenocarcinoma * no pathologic lymph nodes on ct/ mri scan. * no distant metastases. * no previous prostate surgery other than turp (at least 6 weeks interval before initiation of rt). * no malignant tumours in the previous 5 years. * ipss 0-7. * combined ht according to risk factors. * informed consent. exclusion criteria: * prostate size greater than 60cc. * previous turp less than 6 weeks before radiotherapy. * previous prostate surgery other than turp. * diabetes \*. * use of anticoagulants drugs \*. * chronic inflammatory bowel disease \*. * previous pelvic irradiation. * inability to obtain written informed consent.
mirror illusion training and cross-education

Conditions: Exercise Therapy; Weight Lifting

Summary: cross-education describes the transfer of motor performance to the opposite limb following unilateral training and is primarily explained by adaptations within the brain. the mirror training hypothesis suggests that illusionary mirror visual feedback may augment the cross-education of strength to the untrained, contralateral limb. the purpose of this project is to examine how the use of illusionary mirror visual feedback shapes the neuromuscular adaptations that occur for both limbs during unilateral (single-limb) strength training. our hypothesis is that mirror training will augment the level of cross-education for the untrained arm.

recent empirical evidence shows a heightened level of strength transfer with the use of illusionary mirror visual feedback, but this was shown for the small muscles of the wrist during isokinetic training. it is unknown if larger, multi-joint muscles respond favorably to mirror training in practical settings. a randomized controlled study design will allocate approximately 20 participants into two groups. one group will perform unilateral strength training with illusionary mirror visual feedback (mirror) and the other will perform the same unilateral strength training but without a mirror (no-mirror). the intervention will involve four weeks of unilateral strength training performed twice weekly at high intensities (\>80%1rm).

Eligibility criteria:
inclusion criteria: * right-hand dominance * no previous strength training of upper body last 3 months * no injuries or recent surgeries of the upper limbs * willingness to adhere to the strength training requirements of the study exclusion criteria: * current use of hormone replacement therapy * pregnancy/breastfeeding

Keywords: strength training mirror visual feedback
safety and efficacy of ohhmed treatments for the improvement of erectile dysfunction - a feasibility study

Conditions: Erectile Dysfunction

Summary: erectile dysfunction, the persistent inability to achieve or maintain an erection sufficient for satisfactory sexual performance, is estimated to affect up to 30 million men in the united states. the disorder is age-associated. the available treatments include oral therapy, vacuum-constriction devices; shockwave therapy, intracavernosal injections of vasoactive agents, including alprostadil (prostaglandin e1, transurethral delivery of alprostadil, implantation of penile prostheses. the ohhmed company has developed the vertica device that provides treatments for improvement of erectile function in patients with erectile dysfunction. this study assess the safety, efficacy, ease of use, and satisfaction of the vertica device by men with mild to moderate erectile dysfunction.


Eligibility criteria:
inclusion criteria: * iief-ef score of 11-24 with or without the use of medication (pde5 inhibitors). * erectile dysfunction for at least 3- months * steady relationship for at least 3-months. * patient without sensory disorders * patient with established organic of erectile dysfunction exclusion criteria: * investigator's impression of expected poor patient compliance or anatomic inadequacy (penile size/girth) * premature ejaculation * any psychiatric disorder * epilepsy * peyronie 's disease/ penile curvature * coagulopathy * any tumor in the pelvic or penile region within the last 3 years

Keywords: erectile dysfunction
thrombo embolic events in hospitalized patients with covid-19 serious acute pneumopathy

Conditions: COVID-19; Hemostasis; Coagulation

Summary: the understanding of haemostasis and inflammation cross-talk has gained considerable knowledge during the past decade in the field of arterial and venous thrombosis. complex and delicately balanced interaction between coagulation and inflammation involve all cellular and humoral components. elements of the coagulation system such as activated thrombin, fibrinogen or factor xa may increase inflammation by promoting the production of proinflammatory cytokines, chemokines, growth factors and adhesion molecules that lead to a procoagulant state amplifying the pathological process. recent evidence supports inflammation as a common pathogenic contributor to both arterial and venous thrombosis, giving rise to the concept of inflammation induced thrombosis. patients with infection of covid-19 and severe pneumoniae seem to have higher risk of thromboembolism. the purpose of this project is to analyze hemostasis and coagulation of every hospitalized patient with infection of covid-19. blood sample for coagulation and hemostasis analysis will be collected on every patient hospitalized in amiens hospital for covid-19 infection. thrombin time, factors v and ii, fibrin/fibrinogen degradation products, antithrombin will be assessed every week. anticardiolipin, anti-beta2 glycoprotein i and anti-annexin a2 antibodies igg and igm at day of admission and at fourth week after admission will be assessed. sars-cov2 viral load and serodiagnosis will be performed at the same time. at the same time venous ultrasound to diagnose thrombosis will be performed.


Eligibility criteria:
inclusion criteria: * all patients hospitalized in amiens hospital with covid-19 infection exclusion criteria: * patients\< 18 years

Keywords: covid-19 venous ultrasound hemostasis coagulation
effects of seven day prucalopride administration in healthy volunteers

Conditions: Molecular Mechanisms of Pharmacological Action; Depression; Depressive Disorder; Mood Disorders; Mental Disorders; Antidepressive Agents; Cognition

Summary: this study will investigate whether seven days administration of the serotonin receptor subtype 4 (5-ht4) partial agonist prucalopride has effects on emotional processing and neural activity in healthy volunteers, compared to placebo administration. using an experimental medicine approach, the effects of prucalopride on cognitive biomarkers of antidepressant action will be characterised. in a double-blind design, participants will be randomised to receive seven days administration of either prucalopride (1mg daily) or placebo. all participants will come for a screening visit, research visit one (including an mri scan) and research visit two (including measures of emotional processing and non-emotional cognition). the primary study hypothesis is that seven-day prucalopride administration will have positive effects on emotional processing and reward sensitivity. a secondary hypothesis is that seven-day prucalopride administration will alter non-emotional cognition. finally, the study will test the hypothesis that seven day prucalopride administration will alter neural activity during an emotional faces task and a memory task.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study * male or female * aged 18-40 years * sufficiently fluent english to understand and complete the task * right handed * body mass index in the range of 18-30 * not currently taking any medications (except the contraceptive pill) exclusion criteria: * not fluent in english * any past or current axis 1 dsm-v psychiatric disorder * current usage of psychoactive medication (except the contraceptive pill, the depo-provera injection or the progesterone implant) * current usage of any medication that will influence the mri scan * current or past history of drug or alcohol dependency * currently pregnant or breastfeeding * study visits due to take place during the pre-menstrual week (female participants asked details of their menstrual cycle to schedule the study outside this week) * not right handed * body mass index outside the range of 18-30 * history of cardiac, thyroid, or liver problems * an autoimmune disorder * current, or a history of, gastro-intestinal disorder or irritable bowel syndrome * epilepsy * known lactate deficiency or any other problem absorbing lactose, galactose, or glucose * participation in a study which uses the same computer tasks as those used in the present study * participation in a study that involves the use of a medication within the last three months * smoker \> 5 cigarettes per day * typically drinks \> 6 caffeinated drinks per day * any contraindication to mri scanning (e.g. metal objects in the body, pacemakers, significant claustrophobia)

Keywords: 5-ht4 prucalopride resolor functional magnetic resonance imaging (fmri) emotional processing healthy volunteers
telestroke for comprehensive stroke care in acute stroke ready hospitals

Conditions: Stroke

Summary: telestroke for comprehensive stroke care in acute stroke ready hospitals (telecast) is a prospective single-center study evaluating guideline-based acute ischemic stroke care at an acute stroke ready hospital (asrh) pre- and post-initiation of a specialist telestroke inpatient rounding service. telecast will study the following clinical endpoints: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, stroke education, inpatient complications, and stroke recurrence rates. additional relevant non-clinical data will include patient and provider satisfaction scores, transfer patterns, and a cost analysis.

telestroke is a validated intervention that improves the triage and emergent treatment of acute stroke, specifically related to the use of intravenous thrombolysis. effective urgent stroke evaluation and secondary stroke prevention is also essential to decrease the risk of recurrent stroke, however, there have been no studies to date examining the use of telestroke to improve delivery of non-emergent inpatient stroke care per american heart association (aha) guidelines. currently, access to stroke specialist expertise is limited resulting in significant disparities in stroke care. previous publications have identified that patients in rural areas may receive sub-optimal stroke care that does not follow accepted guideline recommendations. telestroke is a cost-effective mechanism to deliver specialist stroke care to hospitals that do not have in-person stroke consultation available. the aim of telecast is to determine whether specialist telestroke inpatient rounding improves guideline-based acute stroke care when compared to non-specialist stroke care. the primary outcome of telecast is a composite score comprising 4 categories: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, and stroke education. individual components of the primary outcome were primarily derived from aha stroke guidelines. additional outcome measures include individual analyses of the components of the primary outcome as well as the complication rate, stroke recurrence rate, transfer rate, patient and provider satisfaction levels, and a cost-analysis. all outcomes will be assessed at 1 year post-implementation, with data accruement beginning after a 3-month lead in phase.

Eligibility criteria:
inclusion criteria: * age 18 and above * patients with the primary diagnosis of ischemic stroke admitted to fairview ridges hospital * evidence of stroke on mri or ct or clinical diagnosis of acute ischemic stroke by the treating stroke service exclusion criteria: * patients less than 18 years old * patients who leave the hospital against medical advice * patients with goals of care that impact the stroke evaluation (i.e. comfort measures) * patients who are felt to have an alternative diagnosis * patients who are transferred for higher-level stroke care such as endovascular thrombectomy or decompressive craniectomy

Keywords: telestroke telemedicine stroke secondary stroke prevention
weekly and every 3 week administration of paclitaxel liposome injection in metastatic breast cancer

Conditions: Breast Cancer

Summary: this is a open-label study in patients with metastatic breast cancer to evaluate the antitumor activity and safety of weekly dose-dense paclitaxel liposome injection compared to 3-weekly regimen.


Eligibility criteria:
inclusion criteria: * female or male \>18 years of age and \< 70years of age, if female of childbearing potential, pregnancy test is negative before first dose of study drug and agree to use an acceptable method of birth control to avoid pregnancy for the duration of the study * stage iv disease * measurable disease * eastern cooperative oncology group (ecog) performance status 0-2. * suitable for the treatment with paclitaxel as single agent regimen (first line or prior first line chemotherapy including adriamycin is allowed, if a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen and if her2+ patient, herceptin therapy will be allowed. * patient has the following values at baseline: absolute neutrophil count ≥ 1.5 x 10\^9cells/l; platelets ≥ 100 x 10\^9 cells/l; hemoglobin ≥ 10 g/dl. aspartate transaminase (ast or sgot), alanine aminotransferase (alt or sgpt) ≤ 2.5x upper limit of normal range (uln); total bilirubin ≤ 1.5uln; creatinine ≤ 1.5 mg/dl. * informed consent has been obtained. exclusion criteria: * parenchymal brain metastases. * history of other malignancy within the last 3 years * new york heart association (nyha) grade 2 or greater congestive heart failure,history of myocardial infarction or unstable angina or new occured angina within 6 months prior to study enrollment. * concurrent other anticancer therapy. * history of serious organic disorders (including active infection or cardiovascular disease), serious hepatic disease, serious blood coagulation diseases, cachexia * sensory neuropathy of \> grade 1 at baseline. * patients with prior hypersensitivity to paclitaxel * pregnant or nursing women * enrolled in a different clinical study * no psychiatric illness and other situations that would limit compliance of study
evaluation of the relative bioavailability of bosutinib capsules under fed condition and estimation of food effect on orally administered bosutinib capsule

Conditions: Healthy Participants

Summary: this study is intended to estimate the bioavailability of a single 100 mg bosutinib capsules relative to four 25 mg capsules under fed condition in adult healthy participants and to estimate the effect of a high-fat, high-calorie meal on the bioavailability of a single 100 mg capsule of bosutinib relative to fasted condition in adults healthy participants. the comparisons will be performed using the pharmacokinetic parameters that define the rate and extend of absorption (cmax, auc). statistical analyses will be performed after the administration of a single 100 mg dose under fed condition as the reference treatment and the four 25 mg capsules as the test treatment for the first comparison, and after administration of a single 100 mg dose under fasted condition as the reference treatment and the 100 mg capsule under fed condition as the test treatment for the second comparison.


Eligibility criteria:
inclusion criteria: * female participants of non-childbearing potential and/or male participants must be 18 to 55 years of age, inclusive, at the time of signing the informed consent document (icd) * participants who are overtly healthy as determined by medical evaluation including a detailed medical history, complete physical examination, vital signs which include bp and pulse rate measurement, clinical laboratory tests, and electrocardiogram (ecg). * participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease. * any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * history of human immunodeficiency virus (hiv) infection, hepatitis b, or hepatitis c; positive testing for hiv, hbsag,hepatitis b surface antigen (hbcab) or hepatitis c antibody (hcvab). * participants with any of the following abnormalities in clinical laboratory tests at screening, as assessed by the study-specific laboratory and confirmed by a single repeat test, if deemed necessary: * estimated glomerular filtration rate (egfr) (chronic kidney disease epidemiology collaboration \[ckd-epi\]) \<90 ml/min/1.73 m2; * aspartate aminotransferase (ast) or alanine aminotransferase (alt) level \>upper limit of normal (uln); * serum (total and direct) bilirubin level \> uln; participants with a history of gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is \<= uln; * amylase and lipase level \> uln.

Keywords: bioavailability food effect bosutinib maximum observed plasma concentration (cmax) area under the curve (auc)