Kornimate/medical-research-clean huggingface dataset:
pi3kβ selective inhibitor with paclitaxel, advanced gastric adenocarcinoma

Conditions: Advanced Gastric Adenocarcinoma

Summary: this is a phase ib/iia, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (pk), and clinical activity of oral gsk2636771 in combination with intravenous (iv) paclitaxel in two independent subject populations: subjects with pten-deficient, advanced gastric adenocarcinoma.

this is a phase ib/iia, open-label, non-randomized, dose-escalation, multi-center study to evaluate the safety, tolerability, pharmacokinetics (pk), and clinical activity of oral gsk2636771 in combination with intravenous (iv) paclitaxel in two independent subject populations: subjects with pten-deficient, advanced gastric adenocarcinoma. this study will be conducted in two phases: the dose escalation phase and the dose expansion phase. the dose escalation phase (phase ib) is designed to determine the maximum tolerated dose (mtd) and the recommended phase ii dose (rp2d) of gsk2636771 administered in combination with paclitaxel. the dose expansion phase (phase iia) will further evaluate the safety and clinical activity of the rp2d as determined in the dose escalation phase.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of advanced gastric adenocarcinoma 2. has a pten-deficient tumor as documented from archival or fresh (from biopsy) tumor tissue or has shown genomic alterations in pi3k pathway genes (pik3cb, pi3kr1, pten, etc.) as assessed in a local laboratory. 3. has had no prior taxane exposure (preferred) or at least 6 months since last taxane exposure. 4. eastern cooperative oncology group performance status of 0 or 1 5. measurable or evaluable disease as determined by recist 1.1. 6. is able to swallow and retain orally administered medication 7. adequate baseline organ function exclusion criteria 1. prior treatment with any akt, mammalian target of rapamycin (mtor) inhibitors or pi3k pathway inhibitors 2. has any unresolved grade 2 (per ctcae v4.0) toxicity from previous anti-cancer therapy at the time of enrollment such as neuropathy, except alopecia or grade 2 anemia (if hemoglobin is ≥9.0 g/dl) 3. has cns metastases 4. has a qtc interval \>450 msec or qtc \>480 msec for subjects with bundle branch block (bbb) 5. has a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to gsk2636771 or hypersensitivity to drug formulated in polyoxyl 35 castor oil, nf such as paclitaxel.
fortified foods in older inpatients

Conditions: Malnutrition; Dementia; Aging; Frail Elderly Syndrome

Summary: malnutrition in older inpatients is a significant problem espicially among those with dementia. a number of methods have been used to tackle this issue and oral nutritional supplements (ons) were proven to be the most effective way. however, they are limited by their poor tolerability due to lack of familiarity with these products. an alternative method is to fortify familiar food with protein, energy and micronutrient. thus, the aim of this study to test the feasibility and acceptability of delivering fortified foods to older patients whilst in hospital including those with dementia and frailty. this pilot study will compare the daily protein and energy intake in older people before and after offering fortified food. furthermore, patients' likeability and staff acceptability of these fortified foods will be assessed.

malnutrition is a significant problem amongst hospitalised older people, and can impede effective recovery. oral nutritional supplements (ons) are limited by their poor tolerability and an alternative strategy is food fortification, the addition of protein/energy/micronutrients to frequently eaten food. the aim of this pilot study is to establish the feasibility and acceptability of delivering fortified foods to older people including those who have dementia and frailty whilst in hospital and to assess whether fortified foods could increase the energy and protein intake. this is a quasi-experimental study on acute medical wards for older inpatient in two uk hospitals, with a before and after comparison. the intervention involves the provision of additional between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation. daily energy and protein intake will be assessed for three consecutive days during the baseline period and then in the intervention period. likeability of fortified food and food choices (the number, type, and frequency of fortified foods consumed) will be examined. likeability of fortified food by patients will be assessed using likeability scales. interviews or focus groups will be conducted with staff to assess the acceptability of fortified food. costs related to developing, packing and delivering the fortified foods will be calculated. the findings of this pilot study will identify whether delivering fortified food is feasible in acute elderly care wards, which foods are preferred and their acceptability. the results will inform the design of a definitive clinical trial.

Eligibility criteria:
inclusion criteria: 1. both female and male participants in each hospital. 2. patients aged 70 years and above including those who have dementia and frailty. exclusion criteria: 1. patients receiving enteral tube feeding or parenteral nutrition 2. patients with a known food allergy, eating disorder or illness, which requires a therapeutic diet incompatible with fortification. 3. patients who are receiving end of life care.
effectiveness of an online intervention targeting cancer-related fatigue

Conditions: Cancer Survivor; Malignant Neoplasm

Summary: this trial studies how well untire application intervention works in reducing cancer-related fatigue in cancer patients and survivors.the untire application focuses on themes that have been identified as causing or contributing to cancer-related fatigue. it may provide information and tips to improve lifestyle, give exercises for body and mind to increase energy levels, offer weekly reports to measure progress, and offer access to an online support community.

primary objectives: i. to assess the effectiveness of an online multidisciplinary psychological training program delivered via a smartphone-based application (the untire app) in reducing patient-reported fatigue in cancer patients and survivors. secondary objectives: i. to determine the dose-response association between use of the untire app and reduction in patient-reported fatigue severity. ii. to explore whether changes in positive and negative affect, depressive symptoms interact with the effects of the untire app on fatigue severity. iii. to explore the predictive value of genetic markers (single-nucleotide polymorphisms) and personality characteristics for effectiveness of the untire app in reducing patient-reported fatigue. outline: patients are randomized to 1 of 2 arms. arm i: patients use untire application intervention after baseline up to 6 months. arm ii: patients use untire application intervention after 3 months up to 6 months.

Eligibility criteria:
inclusion criteria: * patients who present at the cancer-related fatigue clinic or the psychiatric oncology clinic for an initial consult * patients who speak and read english * patients who are willing and able to review, understand, and provide written consent * patients who agree to comply with all study procedures * patients who are in possession of a smartphone or tablet that supports the untire app software * patients rating their current fatigue severity as moderate to severe (= or \> 4 on a 0-10 scale), assessed as part of the clinics' screening procedure exclusion criteria: * case report of diagnosis of a formal thought disorder (e.g., schizophrenia)
vascular cell activation, cell-derived microparticles and in vitro fertilisation, and in vitro fertilisation

Conditions: Infertility; Hyperstimulation Syndrome, Ovaian; Thrombosis

Summary: introduction: ovarian hyperstimulation syndrome (ohss) is an iatrogenic phenomenon, poorly understood and difficult to predict, complicating intense ovarian stimulation cycle. the most severe symptoms, which associate vascular permeability disorders and hypercoagulability, occur in 0.2 to 1% of the cases and often require intensive care. activation of endothelial, platelet, erythrocyte or leukocyte cells trigger the release of small specific vesicles, called microparticles, used as markers. classically leading to endothelial dysfunction and hypercoagulability, the endothelial activation phenomenon could constitute the main cause of ohss or help predict its severity, as established for various other diseases (cerebral stroke, infarct and lupus...). however, so far, this endothelial activation role has never been studied. objectives: evaluate the serum level of microparticles as a predictor of adverse outcomes; correlate it to hypercoagulability and changes of endothelial permeability associated with this syndrome. methodology: prospective pilote cohort study, evaluating before and throughout the ovarian stimulation cycle (6 samples/patient), the serum modulation of: * endothelial activation markers (endothelial-derived microparticles, e-selectin) * procoagulant markers (microparticles from platelet, erythrocyte or leukocyte origin, von willbrand factor, thrombin-antithrombin complex, prothrombin fragment 1+2) * endothelial disjunction marker (soluble cd 146) a group of 50 patients will be assessed techniques: flow cytometry for measurement of microparticles expressing non specific (annexin v) and cell specific surface determinants (cd 31, cd 41, cd 45 or glycophorin a). use of commercial kits for other serum markers.


Eligibility criteria:
inclusion criteria: * between 18 and 35 years old * with health insurance * scheduled for their first ovarian stimulation in an ivf or icsi program in our centre * whose blood samples will be collected in our hospital exclusion criteria: * suffering or having suffered from a disease likely to alter their vascular system and thus modulate their rates of microparticles: * auto-immune disease (systemic lupus erythematosus26, antiphospholipid syndrome) * cardiovascular risk factors: cardiovascular disease history, diabetes, arterial hypertension, dyslipidemia * tobacco addiction. * presenting a blood œstradiol rate \> 5000 pg/ml at ovulation triggering (criterion of stimulation cancellation) and more generally, every patient which ovulation has not been triggered.

Keywords: blood coagulation disorders cell-derived microparticles superovulation fertilization in vitro biomarkers
efficacy and tolerability of deucravacitinib in the management of palmoplantar pustulosis

Conditions: Palmoplantar Pustulosis

Summary: the goal of this clinical trial is to investigate the efficacy and safety of deucravacitinib in patients with moderate-to-severe palmoplantar pustulosis. approximately 25 subjects will be included in the study and receive deucravacitinib 6mg per day for four months. this study will begin june 2025 and is expected to last 14 months.


Eligibility criteria:
inclusion criteria: * men and women between ages 18 - 65 years who have suffered from palmoplantar pustulosis (ppp) for at least 6 months. * patients were required to have over 10 well-demarcated white or yellow pustules across all regions, with or without plaque psoriasis * patients were required to have a palmoplantar pustular physician's global assessment (pppga) score of at least moderate severity (≥3) and a minimum pppasi score of 12. * signed and dated written informed consent in accordance with ich gcp and local legislation prior to admission to the trial. * further criteria apply. exclusion criteria: * systemic treatment for ppp ended less than five half-lives or 12 weeks ago * topical treatment for ppp ended less 4 weeks ago * women who are pregnant, nursing, or who plan to become pregnant while in the trial. * severe, progressive, or uncontrolled condition such as renal, hepatic, haematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof. * presence or known history of anti-tnf-induced ppp-like disease. * patient with a transplanted organ (with exception of a corneal transplant \>12 weeks prior to screening) or who have ever received stem cell therapy. * known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly. * further criteria apply.

Keywords: palmoplantar pustulosis deucravacitinib
evaluation of deposits on contact lenses worn extended wear

Conditions: Myopia

Summary: the purpose of this study was to measure lipid deposits on commercially marketed contact lenses when worn on an extended wear (overnight) basis for 7 days.


Eligibility criteria:
inclusion criteria: * age 18 or older. * visual acuity correctable to 20/30 (snellen) or better in each eye at distance with contact lenses. * successfully wearing hydrogel or silicone hydrogel contact lenses. * other protocol-defined inclusion criteria may apply. exclusion criteria: * evidence or history of ocular conditions as prescribed in the protocol. * one functional eye or a monofit lens. * any slit-lamp finding score of (1) at the screening visit as defined by the protocol. * use of concomitant topical ocular prescription or over-the-counter ocular medications. * history of seasonal allergies with significant ocular side effects. * other protocol-defined exclusion criteria may apply.

Keywords: lens deposits soft contact lens wearers
laparoscopic three-dimensional versus two-dimensional sacral colpopexy and paravaginal repair

Conditions: Pelvic Organ Prolapse; Cystocele

Summary: compare operative times and complications of sacral colpopexy and paravaginal repair between two-dimensional and three-dimensional laparoscopic systems.

the purpose of this study is to compare operative times of laparoscopic sacral colpopexy (lsc) for the treatment of symptomatic vaginal vault prolapse as well as paravaginal repair (pvr) for symptomatic cystocele between two-dimensional and three-dimensional laparoscopic systems. additionally this study will evaluate postoperative complications from surgeries performed using two-dimensional versus three-dimensional laparoscopic systems.

Eligibility criteria:
inclusion criteria: * symptomatic vaginal vault prolapse (stage 2 or greater point c-1 pelvic organ prolapse quantification \[pop-q\] or grade 2 or greater baden-walker half way system) undergoing laparoscopic sacral colpopexy and/or * symptomatic cystocele (stage 2 or greater, point aa or ba \> -1 pop-q or grade 2 or greater baden-walker half way system) undergoing laparoscopic paravaginal repair exclusion criteria: * age less than 18 years * inability to comprehend questionnaires * inability to give informed consent or to return for review * vaginal vault prolapse \< stage 2 * unable to undergo general anesthesia * more than 5 previous laparotomies * prior sacral colpopexy or vaginal mesh prolapse procedure * prior surgery involving the retropubic space * vaginal length less than 6 cm
can microrna's predict multicentricity in breast cancer?

Conditions: Multicentric Breast Cancer

Summary: the aim of this study is to determine if microrna's have role in predicting multicentricity in breast cancer. if a specific microrna will be found to be related with multicentricity, it will help us to make appropriate decisions on the treatment of patients with multicentric breast cancer.

in the study that will be held at bezmialem vakif university medical faculty, general surgery department, 20 unifocal and 20 multifocal breast cancer patients will be included. tissues will be taken from both tumoral and normal breast tissues and they will be saved in microrna later solution under -80°c. then, 84 microrna's will be studied in these tissues to see if they express any of these microrna's.

Eligibility criteria:
inclusion criteria: 1. having breast cancer 2. having no other malignancy 3. female patient exclusion criteria: 1. having other malignancy 2. under 18 years old 3. male patient

Keywords: multicentric breast cancer
mind-body health in uro-oncology: research study

Conditions: Prostate Cancer; Kidney Cancer; Bladder Cancer

Summary: in this study, the researchers will examine the effects of post-mindfulness intervention email and text messages to promote maintenance of intervention effects over time in a uro-oncology sample (clinically localized prostate, kidney, and bladder cancer) of patients and spouses.

participant accrual will occur at northshore university healthsystem's john and carol walter center for urological health. during or prior to an office visit, a potential subject and possibly his/her spouse will speak with the physician or research staff to assess interest in discussing the study. all eligible participants will be enrolled into an 8-week mindfulness-based stress reduction (mbsr) course. because the course content focuses on training in mindfulness meditation (and not cancer-specific issues), the researchers will allow for mixed cancer classes. prior to the first class, all participants will complete baseline standardized patient reported outcomes (pros) of health related quality of life, and undergo blood collection via finger prick. following participation in the 8-week course, participants will complete their 8-week pro and bio-marker assessments in a similar manner, and will be randomized to either 4 months of: 1) weekly mindfulness-specific text or email messages related to course teachings, 2) weekly general/informational texts or emails about healthy living and lifestyle, or 3) no texts or emails. pro and bio-marker assessments will also be administered at 6 months, and pro measures will be collected at 12 months.

Eligibility criteria:
inclusion criteria: * diagnosed with clinically localized or locally advanced prostate, kidney or bladder cancer or the spouse/significant other (married or living together ≥ 1 year) of a person with prostate, kidney or bladder cancer * spouses/significant others will only be included if their partners with cancer diagnoses will be participating * 18 years old or older * proficient in comprehending spoken english. proficient in reading and writing english. exclusion criteria: * is not able to receive email or text messages * history of diagnosed severe mental illness or hospitalization for chronic psychiatric reasons, as identified by referring physicians, such that participation in mbsr group activities would be contraindicated. * vision- or hearing-impaired such that ability to listen to or observe mbsr course instructions is compromised. * diminished cognitive skills as to render consent meaningless * physical debilitation such that study participation would not be feasible or would create undue hardship. * participation in the intervention arm of the preceding study, "reducing stress during active surveillance" eh09-202.

Keywords: prostate cancer mindfulness ehealth kidney cancer bladder cancer caregiver
school breakfast policy initiative study

Conditions: Childhood Obesity; Hunger

Summary: the purpose of this study is to develop and evaluate the effects of a school breakfast policy initiative (sbpi) on the incidence of overweight and obesity as well as breakfast patterns (both inside and outside of school) among 4th-6th grade children. the study integrates research, education and extension to promote healthy breakfast consumption among low-income children in urban schools and will leverage ongoing snap-ed and the school breakfast program efforts.

policy makers have promoted school breakfast participation as a tool to help prevent childhood obesity. no randomized controlled trials have examined the effects of a school breakfast feeding program on obesity. we propose to develop and evaluate a school breakfast policy initiative (sbpi) that combines classroom feeding, in-school nutrition education, social marketing and parent outreach. specifically, we will promote the benefits of a healthy breakfast at school or home and deter buying "breakfast" at corner stores where purchases are high in energy, solid fats and added sugars. this intervention will be evaluated in the "real world" of urban schools that make frequent use of the snap-ed and the school breakfast program. the specific aims are: 1. to develop the sbpi intervention within the context of snap ed and the national school breakfast program in the school district of philadelphia. 2. to conduct a pilot feasibility study among 4 schools (2 intervention and 2 control) to assess feasibility and acceptability. 3. to compare participants in the intervention (n=8) and comparison schools (n=8) on the incidence of overweight and obesity. we predict that intervention schools, compared to the comparison schools, will have a significantly lower incidence rate of overweight and obesity over a 2 y period. 4. to compare participants in the intervention (n=8) and comparison schools (n=8) on eating one breakfast. we predict that intervention schools, compared to the comparison schools, will have significantly greater percentage of children eating one breakfast per day over a 2 y period.

Eligibility criteria:
inclusion criteria: * 4th-8th grade philadelphia public school students. exclusion criteria: -
hift for people with mobility-related disabilities

Conditions: Mobility Limitation; Physical Disability

Summary: investigators will examine the feasibility and health outcomes following a high-intensity functional training intervention for people with mobility-related disabilities. in addition to participant recruitment, attritions rates, and satisfaction, investigators will assess changes to both physical health outcomes (e.g., strength, body composition) and psychosocial outcomes (e.g., quality of life). the findings will provide evidence for the efficacy of hift to improve various health outcomes for a population that experiences health disparities in access to, and engagement in, community-based exercise.

the proposed study will examine the feasibility and effectiveness of a high intensity functional training (hift) pilot study for adults with mobility-related disabilities (mrd). aim 1 will explore the feasibility of a 12-week, thrice weekly hift intervention for adults with mrd. investigators will evaluate participant acceptability and satisfaction, document recruitment challenges, attrition rates, and the adaptive elements of the program for replication and improvement to future clinical trials. aim 2 will assess the effects of hift participation on participant health outcomes, including (i) fitness factors such as work capacity, strength, and energy expenditure; (ii) functional performance; (iii) body composition and weight; and (iv) variables contributing to psychological well-being such as motivation, quality of life, and life satisfaction. a relatively novel mode of exercise, hift stands out for its inclusive approach and adaptable programming, which has the potential to improve health outcomes for a novel target population. the proposed research activities will provide initial data on the feasibility and expected magnitude of change in multiple dimensions of health for people with mrd and contribute to the limited evidence of community-based programs that are adaptable and inclusive. the findings will also allow for the mobilization of this knowledge into disability and healthcare communities to increase the recommendations for exercise for this population and inform future design of clinical trials.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * have a permanent disability that affects mobility (1 year +); * never been a part of a functional fitness program before * no significant health impairment that would contraindicate exercise (physician clearance required) * serve as their own guardian exclusion criteria: * younger than 18 years of age * have a disability that was acquired within 1 year of starting the study or has a non-permanent mobility limitation (e.g., broken arm); * has previously been involved in functional fitness * unable to obtain physician clearance * are not their own guardian