Kornimate/medical-research-clean huggingface dataset:
posaconazole plus pembrolizumab and chemotherapy vs pembrolizumab and chemotherapy in neoadjuvant therapy for triple negative breast cancer

Conditions: Breast Cancer

Summary: triple-negative breast cancer (tnbc) is as sociated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane-based systemic chemotherapy. neoadjuvant therapy is now also recognized as the standard treatment for patients with high-risk tnbc. the keynote-522 study demonstrated that the application of pembrolizumab has raised the pathological complete response (pcr) rate in tnbc to over 60%, but nearly 40% of patients still do not achieve pcr. how to further improve the pcr rate in tnbc patients has become a hot topic of current research. posaconazole is an antibiotic used to prevent invasive aspergillus and candida infections and to treat oropharyngeal candidiasis. our preclinical studies have found that posaconazole can inhibit immune cell-mediated steroidogenesis to restrict tnbc tumor progression. the investigators design and begin a a prospective randomized controlled clinical study to explore the effectiveness of posaconazole in the neoadjuvant treatment of tnbc.

objectives: on the basis of chemotherapy combined with immunotherapy, posaconazole was used to further improve the pathological complete response (pcr) rate of high-risk triple-negative breast cancer (tnbc), and to explore biomarkers. outline: from february 1st, 2025 to june 30th, 2026 the investigators will recruit 40 patients with first-time diagnosed early-stage tnbc. enrolled patients were randomly divided into experimental group and control group on a 1:1 basis. both groups received standard neoadjuvant chemotherapy combined with immunotherapy. the experimental group was treated with posaconazole (day 1: 300 mg po bid, from day 2, start maintenance dose at 300 mg po qd, q21d). standard surgical treatment was performed after 8 cycles and the surgical specimens were pathologically tested to compare the differences in pcr rates between the two groups.

Eligibility criteria:
inclusion criteria: 1. female, aged ≥ 18 and ≤ 70 years old; 2. first-confirmed tnbc; 3. ct1cn1-3m0 or ct2-4n0-3m0; 4. ecog score 0-1 points. exclusion criteria: 1. stage i or iv; 2. history of previous breast cancer; 3. patients with a history of other tumors who have received systemic therapy or local radiotherapy; 4. no immune system disease or connective tissue disease; 5. no history of hormone therapy; 6. pregnant/lactating.

Keywords: triple-negative breast cancer pathological complete response neoadjuvant therapy posaconazole
treatment of early childhood overweight in primary care: pilot study

Conditions: Obesity

Summary: childhood overweight continues to increase at an alarming rate and the need exists to find effective, accessible intervention strategies to prevent and treat children who are at risk for being overweight or are already overweight. the primary care setting provides an attractive option for families wishing to receive treatment, yet little is known about the feasibility, acceptance or efficacy of this intervention setting. the purpose of this study was to test two different primary care treatments that were intended to increase fruit and vegetable intake, increase physical activity, and reduce sedentary activity in children ages 4-8, who are overweight or at risk for becoming overweight. both treatments involved the child and a parent/caregiver and both were conducted over a four month period. the parent/child dyads were selected from the pool of families who receive their primary care within the geisinger medical center geographic area and who have been identified by their pediatrician as being overweight or at risk for becoming overweight (bmi \>85th percentile for age). one group received weekly mailings which focused on healthy eating, promotion of fruit and vegetable intake and physical activity, and methods to reduce tv viewing time. the second group received a group-based intervention at one of the geisinger pediatric clinic sites using specific behavioral strategies for increasing fruit and vegetable intake, reducing tv viewing and encouraging physical activity. changes in overweight percentage, child bmi, lipid profile, glucose/insulin levels, and anthropometric measurements were analyzed, as well as treatment satisfaction and acceptance. the investigators hypothesized that children who receive family behavior modification (fbm) in the primary care setting will show greater reductions in body mass index (bmi), bmi z-score, percent overweight and waist circumference, and that children receiving fbm will show greater improvements in dietary intake, increased physical activity, reduced sedentary activity, and improvements in cardiovascular outcomes.


Eligibility criteria:
inclusion criteria: * 4-8 year old children * overweight or obese (bmi≥85th percentile, based on age and sex) * parent/primary caregiver willing to attend sessions with child exclusion criteria: * failure to meet bmi criteria * child with elevated internalizing or externalizing behavioral problems, as assessed through child behavior checklist (cbcl) * elevated parent distress, as measured by symptom checklist-90 (scl-90) * child on medications with any weight-altering effect * inability to participate in moderate physical activity or attend study visits * residing \>1 hour from study site

Keywords: pediatric obesity
a study of abt-806 in subjects with advanced solid tumor types

Conditions: Advanced Solid Tumors

Summary: this is an open-label study designed to determine the recommended phase 2 dose (rptd) and evaluate the safety and pharmacokinetics of abt-806 in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * subject has a solid tumor of a type known to either over-express wild-type egfr or to express variant iii mutant egfr (e.g., head and neck squamous cell carcinoma, non small cell lung cancer (nsclc), colorectal carcinoma) or a tumor known to be egfr positive. * subject must have disease that is not amenable to surgical resection or other approved therapeutic options with curative intent. * subject has an eastern cooperative oncology group (ecog) performance status of 0 to 2. * subject must have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1. * inclusion criteria for expand safety cohort b - subject has histologically confirmed supratentorial glioblastoma multiforme (gbm) . exclusion criteria: * subject has uncontrolled metastases to the central nervous system. subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease for at least 1 month after definitive therapy. subjects with glioblastoma multiforme (gbm) are excluded from the dose escalation portion of the study, but may be enrolled in the expanded safety cohort. * subject has received anticancer therapy including chemotherapy, immunotherapy, radiotherapy, hormonal, biologic, or any investigational therapy within a period of 21 days prior to the first dose of abt-806. * subject has had any adjustments of an ongoing steroid medication during the 14 days prior to the first dose of abt-806. * subject has received a prior egfr-directed monoclonal antibody within a period of 4 weeks prior to the first dose of abt-806. * subject has unresolved clinically significant toxicities from prior anticancer therapy, defined as any common terminology criteria for adverse events (ctcae) grade 2 or higher.
measurement of retinal venous pressure under short-term low-oxygen environment

Conditions: Healthy

Summary: the hypothesis is that the pressure in the retinal veins increases under a short-term lack of oxygen and leads to a decreased blood circulation. on the basis of measurements in the hypobaric chamber this hypothesis should be verified.

conduct a pilot study to describe and quantify the retinal venous pressure (rvp) in healthy volunteers under conditions of controlled, reduced ambient and oxygen partial pressure in the pressure chamber of the aeromedical institute fai in dübendorf, switzerland. obtaining evidence of the adaptation behavior of the retinal vascular system in controlled, short-term hypoxic changes.

Eligibility criteria:
inclusion criteria: * healthy exclusion criteria: * eye diseases * systemic diseases * term medication (except contraceptives) * pregnancy * allergies to the ingredients alcain, tropicamide and phenylephrine * blood pressure levels except standard (\ 140 mmhg) * oxygen saturation (so2) \<90%

Keywords: retinal venous pressure reduced ambient pressure oxygen partial pressure short-term hypoxic changes
a randomized, placebo-controlled study to evaluate the efficacy and tolerability of asenapine with flexible dosing from 5mg to 20mg in adults with developmental stuttering

Conditions: Stuttering

Summary: the purpose of this research study is to find out the potential benefits and safety of asenapine (saphris®) in adults who suffer from the developmental form of stuttering. it is hypothesized that individuals who are randomly assigned to asenapine will have an improvement in speech as compared to a placebo.


Eligibility criteria:
inclusion criteria: subjects can be enrolled in the study only if they meet all of the following criteria: 1. subjects must satisfy dsm-iv criteria for stuttering. 2. the nature of stuttering must be developmental in origin with the onset prior to ten years of age. 3. subjects must have a score of moderate or higher on the ssi-iv. 4) women of child-bearing potential are eligible to participate as long as they are practicing a medically accepted form of contraception (i.e. condom with spermicide or diaphragm, oral or depot contraception, or an intrauterine device). 5)subjects will be male or female from the ages of 18-70. 6)subjects will be of only english speaking. exclusion criteria: subjects will be excluded from the study for any of the following reasons: 1. stuttering related to a known neurologic cause (e.g. head trauma, stroke). 2. unstable medical or psychiatric illness. 3. active substance abuse within three months prior to study inclusion. 4. any illness that would require the concomitant use of a cns active medication during the course of the study. 5. subjects with parkinson's dementia or other degenerative neurologic illness. 6. subjects who are pregnant or nursing an infant. 7. no minors (under the age of 18) will not be enrolled in this study as the research with this compound in children and adolescents has not been fully performed. 8. subjects who suffer from seizures, irregular heartbeat or an elevated blood sugar level (glucose).

Keywords: stuttering
efficacy study of extended-release niacin/lovastatin versus usual care

Conditions: Hyperlipidemia; Mixed Hyperlipidemia; Dyslipidemia

Summary: the purpose of this study is to investigate the benefits of combination niacin er/lovastatin in patients receiving standard care who are not at ldl goal per atp iii guidelines.

both ldl and hdl are important contributors in the pathophysiology of atherosclerosis and coronary artery disease (cad); however, hdl is often ignored in primary care. the combination of niacin extended-release (er)/lovastatin in a single tablet formulation (advicor®) may be the most effective therapeutic option for simultaneously correcting both of these lipoprotein abnormalities to reduce cad risk. the purpose of this study is to investigate the benefits of combination niacin er/lovastatin in patients receiving standard care who are not at ldl goal per atp iii guidelines.

Eligibility criteria:
inclusion criteria: 1. \>18 years old with cad or risk factors for cad 2. under standard care at family medical care of tulsa 3. not at ldl goal per atp iii guidelines exclusion criteria: 1. pregnancy/lactating 2. liver disease 3. allergies to statin or niacin 4. active peptic ulcer disease 5. previous treatment with combination therapy for dyslipidemia

Keywords: hyperlipidemia dyslipidemia niacin hydroxymethylglutaryl-coa reductase inhibitors combination lipid therapy lovastatin
a study of roactemra/actemra (tocilizumab) in patients with active rheumatoid arthritis who have an inadequate response to current non-biologic and/or biologic dmards

Conditions: Rheumatoid Arthritis

Summary: this single arm, open-label study will evaluate the efficacy and safety of roactemra/actemra (tocilizumab) in patients with active, moderate to severe rheumatoid arthritis who have an inadequate response to non-biologic and/or biologic disease-modifying antirheumatic drugs (dmards). patients will receive intravenous roactemra/actemra at a dose of 8 mg/kg every 4 weeks. anticipated time on study treatment is 96 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, \>/=18 years of age * active moderate to severe rheumatoid arthritis * inadequate response to \>/=3 dmards (non-biologic and/or biologic) * current treatment at stable dose for \>/=8 weeks * etanercept discontinued \>/=2 weeks, anakinra \>/=1 week, infliximab, adalimumab, abatacept, golimumab, certolizumab \>/=4 weeks, prior to baseline visit. patients have discontinued mabthera/rituxan or ocrelizumab \>/=16 weeks, and must have proven b-cell repletion exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline * rheumatic autoimmune disease other than ra * functional class iv (american college of rheumatology classification) * prior history or current inflammatory joint disease other than ra * oral corticosteroids at a dose of \>10 mg/day prednisone equivalent * positive hepatitis b surface antigen (hbsag) and / or total hepatitis b core antibodies (hbcab) or hepatitis c virus (hcv) antibody * current or history of recurrent bacterial, viral, fungal or mycobaterial infection * history of or currently active primary or secondary immunodeficiency
pitcher (peritoneal carcinomatosis heterogeneity)

Conditions: Secondary Peritoneal Cancers; Colorectal Cancer; Ovarian Cancer

Summary: how epigenetic deregulation affects gene expression patterns in subclones of the same tumor is poorly known. peritoneal carcinomatosis (pc) is a condition in which multiple metastases of the same abdominal tumor develop in the peritoneal cavity and intra-peritoneal organs, thus defining different ecosystems of the same cancer. pitcher addresses the variations in epigenetically regulated gene expression between different subclones of pc in relation with cell mechanoresponses, providing insights on how cancer epigenetic landscapes evolve under environmental pressures and on strategies used by cancer cells to adapt to the transition from one ecosystem to the other. pitcher is a network of 10 teams from lyon, grenoble and marseille, based on data and specimen collection of patients who have undergone a surgery for a peritoneal carcinomatosis of ovarian or colorectal origin. pc lesions and eventually matched specimens of primary tumors will be collected in the same patients at the time of the surgery or eventually retrieved from already existing samples. epigenetic landscapes will be analyzed by a bioinformatics pipeline combining exome sequencing, transcriptome and methylome to identify "epigenetic hotspots", and their variations across lesions will be evaluated. these analyses will be realized in fresh (when available) or pre-existing samples. when possible, organoid cultures and animal models will be derived from multicellular structures in peritoneal fluids and membrane, cytoskeletal and nucleoskeletal mechanoresponses will be characterized using atomic force microscopy. the role of tumor axonogenesis, a process of neo-formation of axon fibers in tumors, will be addressed. experimental studies of cell responses to therapy will be performed to derive mathematical predictive models. all components will be integrated in a systems biology map of pc.


Eligibility criteria:
inclusion criteria: * patients who accept to participate to the study * men / women aged over 18 years * patients with cancer management and care for peritoneal carcinomatosis of digestive or ovarian origin * patients had histologic/radiologic confirmation of peritoneal disease * serology negative hiv, hepatitis exclusion criteria: • none

Keywords: peritoneal carcinomatosis tumor heterogeneity epigenetic landscape
assessment of novel sound changing principles in hearing instruments to determine their application - 2020_09

Conditions: Hearing Loss

Summary: participants will perform two different listening tasks: (1) listening to, and repeating back, sentence lists presented in noise, and (2) subjective rating of effort \& performance following each condition. during this study, continuous, non-invasive physiological measurements (skin conductance, changes in pupil dilation) will be recorded from participants. using this paradigm we will be assessing the effect of different hearing aid processing algorithms on listening effort. the study takes the form of a one factor (algorithm), within-subjects design. each participant performs the speech perception task with each algorithm (reference, noise reduction i, noise reduction ii, noise reduction iii), at two individualized signal-to-noise ratios (srt90 and srt50). additionally subjective performance ratings in real-life will be collected.


Eligibility criteria:
inclusion criteria: * healthy outer ear (without previous surgical procedures) * ability to fill in a questionnaire conscientiously * informed consent as documented by signature * minimum 1 year hearing aid experience * moderate-severe (n3-n5) hearing loss or normal hearing exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * known central hearing disorders
the effect of tdcs on motor learning and neural network in stroke patients

Conditions: Stroke

Summary: this study is to investigate the effect of transcranial direct current stimulation (tdcs) simulation on motor learning to stroke patients compared to sham stimulation


Eligibility criteria:
inclusion criteria: * unilateral stroke including basal ganglia lesion patients * chronic patients over 6 months after onset * patients with the movement of fingers exclusion criteria: * history of psychiatric disease * significant other neurological diseases except for stroke * difficult to perform this experiment * patients who are deemed difficult to participate in this research by the investigator * patients with metal implants and medical devices * history of epilepsy * pregnancy * skin defect at the site of electrode attachment
crystallized phenol versus transposition flaps for treatment of pilonidal disease: a prospective study

Conditions: Pilonidal Sinus

Summary: although surgical techniques such as limberg flap. modified limberg flap and karydakis are currently most popular treatment methods for pilonidal disease, crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. we believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.

pilonidal sinus disease (psd) is usually located at sacrococcygeal region of the body and mostly effect young males causing loss of labor and school time. its incidence is reported 26 per 100000 in a norwegian study. although there are many treatment modalities either surgical or conservative, ideal treatment is still a matter of debate. surgical techniques such as limberg flap, modified limberg flap and karydakis are most popular treatment methods for pilonidal disease crystallized phenol application is also successfully used for pilonidal sinus treatment by different centers. we would like to compare flap techniques and crystallized phenol application for complications, recurrence, patient comfort, duration of recovery and return to work. we believe crystallized phenol application could become a good alternative to popular surgical interventions using transposition flaps.

Eligibility criteria:
inclusion criteria: * patients with pilonidal disease exclusion criteria: * previous history of pilonidal disease treatment * pregnant or breast-feeding women * systemic diseases that would affect wound healing * diabetes * chronic renal failure * autoimmune diseases * malignant diseases

Keywords: pilonidal sinus crystallized phenol limberg flap modified limberg flap karydakis recurrence complications recovery duration time to return to work
critically ill icu patients under casirivimab- and/or tocilizumab application

Conditions: COVID-19; Outcome, Fatal; Tocilizumab; Interleukin 6; Critically Ill

Summary: in a retrospective observational study, critically ill covid-19 patients admitted to the icu with the cov-2 delta-variant between august 2021 and february 2022 were evaluated (ethics application nr. 129/22 of the ethics commssion of the university ulm.

according to the recommendations, igg seronegative sarscov2-spike antibody (\ 75 mg/l or il-6 \> 75 ng/l were treated with one dose of intravenous tocilizumab 8 mg/kg body weight. 28-day mortality and 30-day time course of leukocyte counts and serum concentrations of c-reactive protein (crp), procalcitonin (pct), interleukin 6 (il-6) and ferritin in 4 patient groups, i. e., treated without (n) or with casirivimab / imdevimab (c) or tocilizumab (t), solely, or in combination of both (c + t), were evaluated.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of covid-19 * cov-2 delta-variant * critically ill patients * icu exclusion criteria: * tuberculosis * active hepatitis * hiv

Keywords: covid-19 critically ill icu casirivimab imdevimab tocilizumab interleukin 6 c-reactive protein ferritin procalcitonin mortality