Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the pharmacokinetics of recombinant human coagulation factor viii-fc fusion protein for injection

Conditions: Hemophilia A

Summary: primary objective: to assess the pharmacokinetics of recombinant human coagulation factor viii-fc fusion protein for injection at two dose levels in patients with hemophilia a. secondary objectives: to assess safety and tolerability by monitoring fviii recovery and adverse events in patients with hemophilia a.


Eligibility criteria:
inclusion criteria: * 12 years to 60 years, male. * the activity of the coagulation factor viii (fviii:c) \< 2%, and previously treated with fviii concentrate (s) for a minimum of 150 exposure days (eds) prior to study entry. * non-immune deficiency (cd4 \> 200/μl). * non-acute hemorrhagic state. * no history of a positive inhibitor test (\< 0.6 bu) or clinical signs of decreased response to fviii administrations. no family history of inhibitors. * platelet count \> 100,000 platelets/μl. * normal prothrombin time or inr \< 1.3. * normal thrombin time (tt). * normal previous results of vwf antigen examination. * negative lupus anticoagulant . * capable of understanding and willing to comply with the conditions of the protocol have read (patient and/or guardian). exclusion criteria: * hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins). * history of hypersensitivity or anaphylaxis associated with any fviii or igg2 administration. * current fviii inhibitor-positive or history of fviii inhibitor-positive. * other coagulation disorder(s) in addition to hemophilia a. * infusion of any products containing fviii within 4 days prior screening or within 72 h prior to administration. * patients with severe heart disease, including myocardial infarction, heart failure (iii or higher level). * clinically significant of other systematic diseases: alcoholism, drug abuse, mental disorders and mental retardation. * significant hepatic or renal impairment (alt and ast \> 2×uln; serum bilirubin level \> 3 × upper limit of normal (uln) , bun \> 2×uln, cr \> 2.0 mg/dl). * one or more clinically significant tests for human immunodeficiency virus (hiv), antisyphilitic spirulina (tpha) and hepatitis c virus (hcv) antibody. * patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials. * patients having major surgery or receiving blood or bood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study. * patients who previously participated in the other clinical trials within 1 month prior screening. * any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation. * patient who is considered by the other investigators not suitable for clinical study.

Keywords: hemophilia a pharmacokinetics factor viii-fc fusion protein adolescent and adult patients phase i safety and tolerability
phase iii clinical study of vc004 in patients with localized advanced/ metastatic solid tumors

Conditions: Locally Advanced Solid Tumor

Summary: this study is a single arm, open label, multicenter phase iii clinical trial to evaluate the safety and efficacy of vc004 in patients with locally advanced/metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * all subjects or legal representatives are willing and able to sign icf approved by the ethics committee before starting any screening procedures； * male or female, age ≥12 years old; exclusion criteria: * patients have undergone major surgery within 4 weeks prior to the first dose or are expected to undergo major surgery during the trial (excluding vascular access establishment procedures, biopsy procedures); * adverse reactions caused by previous treatment have not recovered to ≤1 grade (evaluated by the investigator); * patients had been treated with a strong cyp3a inhibitor or inducer within 7 days prior to the first administration of the study drug.
a placebo-controlled phase 3 trial of repeated lamazym treatment of subjects with alpha-mannosidosis

Conditions: Alpha-Mannosidosis

Summary: the overall objective of this trial is to evaluate the efficacy and safety of repeated lamazym i.v. treatment, compared with placebo, in subjects 5-35 years of age with alpha-mannosidosis


Eligibility criteria:
inclusion criteria: * subject or subjects legally authorized guardian(s) must provide signed, informed consent prior to performing any trial-related activities * the subject and his/her guardian(s) must have the ability to comply with the protocol * the subject must have a confirmed diagnosis of alpha-mannosidosis as defined by alpha-mannosidase activity \< 10% of normal activity (historical data) * the subject must have an age at the time of screening ≥ 5 years and ≤ 35 years * the subject must have the ability to physically and mentally cooperate in the tests * the subject must have an echo without abnormalities that, in the opinion of the investigator, would preclude participation in the trial exclusion criteria: * the subjects diagnosis cannot be confirmed by alpha-mannosidase activity \< 10% of normal activity * the subject cannot walk without support * presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-mannosidosis * history of bmt * presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the investigator, would preclude participation in the trial * any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the investigator, would preclude participation in the trial * pregnancy: pregnant woman is excluded. before start of the treatment the investigators will for women of childbearing potential perform a pregnancy test and decide whether or not there is a need for contraception * psychosis; any psychotic disease, also in remission, is an exclusion criteria * planned major surgery that, in the opinion of the investigator, would preclude participation in the trial * participation in other interventional trials testing imp (including lamazym) within the last 3 months * adult patients who, in the opinion of the investigator, would be unable to give consent, and who does not have any legal protection or guardianship * total ige \>800 iu/ml * known allergy to the imp or any excipients (sodium-phosphate, glycine, mannitol)
atrophic gastritis and olgim stage

Conditions: Intestinal Metaplasia

Summary: three clinical research coordinators recruited patients aged 40-75 who underwent screening endoscopy at the digestive endoscopy center of qilu hospital from july 1, 2022, to july 30, 2024. all participating patients provided written informed consent. baseline information such as height, weight, age, sex, smoking and alcohol consumption status, hp status, and family history of gastrointestinal tumors were recorded before endoscopy. during endoscopy, the endoscopist observed and photographed the lesser and greater curvature of the antrum, corpus, and incisura, performed the kimura-takemoto classification, and classified those with a kimura-takemoto score of c0 as non-atrophic gastritis and those with c1-o3 as atrophic gastritis. patients with atrophic gastritis received free multiple-site biopsies for pathological assessment, including targeted biopsies of suspected im areas and random biopsies from sydney classification sites. at least four biopsies were taken from the lesser and greater curvature of the antrum and corpus for pathological evaluation, and olgim staging was calculated based on the results.


Eligibility criteria:
inclusion criteria: inclusion criteria were patients aged 40-75 undergoing painless screening endoscopy exclusion criteria: 1) previous gastric surgery; 2) inability to undergo biopsy due to anticoagulant use; 3) refusal to sign informed consent; 4) history of radiotherapy or chemotherapy; 5) new diagnosis of advanced gastric cancer during endoscopy; 6) failure to complete multiple-site biopsy for atrophic gastritis; and 7) diagnosis of non-atrophic gastritis during endoscopy.
the effects of pain neuroscience education in a spanish-speaking population

Conditions: Pain; Educational Problems

Summary: pain neuroscience education (pne) has been shown to be effective to alter beliefs and decrease pain among individuals with musculoskeletal pain. additionally, pne has been shown to alter beliefs among middle school children. this study plans to assess the effects of pne within a group of spanish-speaking individuals.

chronic pain is a topic of discussion that is becoming increasingly prevalent among healthcare professionals. with the ever-growing opioid epidemic, there are a variety of discussions on different modes of treatment other than opioid prescription. pain neuroscience education, or pne, is one of these alternative treatment options. pne focuses on a patient's understanding of pain itself and relates this to the current pain they are experiencing. pne is often a discussion between provider and patient that utilizes a series of stories, metaphors, and examples where pain is described from a point of view that is not strictly medical. recent literature suggests there is a lack of knowledge regarding pain in the united states, particularly in the spanish-speaking population. this population is also less likely to seek a physician's advice for pain management. for these reasons, this study will focus on the spanish-speaking population within the winchester community. due to success within prior pne studies, this study will be conducted through a classroom lecture. the overarching purpose of this study is to examine the change in knowledge of pain in the spanish-speaking population immediately following a pne lecture composed of stories, metaphors, and examples about pain. because spanish-speaking individuals are less likely to seek out a medical provider, the study may support an additional treatment option for managing chronic pain. not only will this provide further research to support the benefits of pne, but there is the potential to modify a participant's perception of their own pain through this educational lecture.

Eligibility criteria:
inclusion criteria: * participants must speak spanish at least 50% of the time at home or spanish must be the first language learned. participants must also be willing to sit and listen to lecture and fill out quiz before and after. exclusion criteria: * any individual under the age of 18 will be excluded from the study.

Keywords: pain neuroscience education spanish-speaking
pharmacogenetic testing of patients with unwanted adverse drug reactions or therapy failure

Conditions: Adverse Drug Reaction; Therapy Failure

Summary: genetic makeup of a patient influences the efficacy and safety profile of a drug. this study is to summarize individual cases, where pharmacogenetics (pgx) has been applied during pharmaceutical care. the primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. the experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. the cases will be supplemented with information on additional parameters reported in the literature to affect efficacy or safety of the respective drug.

genetic makeup of a patient influences the efficacy and safety profile of a drug. this study is to summarize individual cases, where pharmacogenetics (pgx) has been applied during pharmaceutical care. health-related data of patients experiencing therapy failure (tf) or adverse drug reaction (adr) is collected and will then be supplemented with pharmacogenetic testing during pharmaceutical care in a study pharmacy. the patient data (diagnoses, medications and results of pharmacogenetic testing) is harmonized in order to generate a compilation of case reports. the primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. the experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. the cases will be supplemented with information on additional parameters reported in the literature to affect efficacy or safety of the respective drug.

Eligibility criteria:
inclusion criteria: * new medication with known pgx association (preemptive) * current medication with observation of adverse drug reactions probably linked to drugs with known pgx association (reactive) * current medication with observation of therapy failure probably linked to drugs with known pgx association (reactive) * current and/or new medication and a family history of adverse drug reactions/therapy failure probably linked to drugs with known pgx association * signed informed consent; for patients \< 14 years, the legal representative needs to sign the informed consent exclusion criteria: * insufficient german knowledge * not able to personally visit to the study pharmacy

Keywords: pharmacogenetics single nucleotide polymorphism absorption, distribution, metabolism and excretion (adme) genotyping pharmacogenetic testing
intervention in frailty versus usual care in frail patients after an acute myocardial infarction

Conditions: Fragility

Summary: frailty has been associated to a worse outcome in acute coronary syndromes, but the best management of frail patients after an acute coronary syndrome remains unknown. the aim was to investigate the benefit of an intervention on frailty in frail patients after an acute myocardial infarction. patients survivors after an acute myocardial infarction (with and without st-segment elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points) according to the fried's scale measured 24 hours before hospital discharge, will be included. the participants will be randomized to 2 strategies: a) intervention on frailty in addition to the usual care by the cardiologist, and b) conventional strategy consisting only of the usual care by the cardiologist. a multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty the study contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included patient. the main outcome will be the frailty status (fried's scale) at 3 months and 1 year. the secondary endpoint will be the clinical events, both cardiovascular and not cardiovascular events, including recurrent events (cumulative events analysis), for the total follow up (3 years in the case of the first included patient). the hypothesis is that an intervention on frailty will improve frailty status and the clinical outcomes in frail patients after an acute myocardial infarction.


Eligibility criteria:
inclusion criteria: * admission for acute myocardial infarction and survivors in the hospitalization phase * age =\>70 years * prefrail or frail status (fried scale =\>1 points) exclusion criteria: * cognitive impairment (pfeiffer test) * severe concomitant disease that could hamper the participation in the study * patient refusal to participate

Keywords: frailty acute myocardial infarction
study of sleep-maintenance activity of 3 doses of skp-1041

Conditions: Sleep Disorder; Primary Insomnia

Summary: skp-1041 is a new formulation of a marketed sleeping agent called zaleplon. zaleplon is currently available as sonata as well as several generic formulations. sonata and its generics induce sleep soon after ingestion. skp-1041, however, is a formulation that is designed to become active 2-3 hours after ingestion. it is intended for use in people who have no trouble falling to sleep but who often awaken in the middle of the night. this trial will determine the best dose to prevent those awakenings.

patients will participate in the study for approximately 44 to 56 days, including a 14- to 21-day screening period, 4 treatment periods each followed by washout periods, and a final follow-up visit. patients will receive their randomly assigned study medication and spend 2 nights in a sleep laboratory, subsequently returning home for a 4- to 7-day washout period between each treatment period. the fourth and final treatment period will include a third night at the site during which all patients will continue to receive the same study medication as on the first 2 nights of this treatment period. blood will be drawn from all patients for pharmacokinetic analyses at specific time intervals. patients will undergo final safety assessments 2 to 5 days after the last dose of study medication.

Eligibility criteria:
inclusion criteria: * primary insomnia characterized by chronic difficulty maintaining sleep exclusion criteria: * history of restless legs syndrome, sleep apnea, narcolepsy, or parasomnias; * any clinically relevant acute or chronic diseases which could interfere with the patient's safety during this trial or with this tablet's absorption; * pregnancy; * history of medication allergies; * use of medication that might interfere with this study; * recent travel across more than 3 time zones.

Keywords: insomnia middle of the night sleep maintenance
rosuvastatin and evolocumab for coronary artery disease

Conditions: Coronary Artery Disease

Summary: the aim of the retrospective study is to characterize the molecular mechanisms responsible for the effect of statins and evolocumab in patients with stable coronary artery disease. the research team will retrieve and review intravascular imaging and gene expression data previously collected in the catheterization laboratory during the following time-period: 8/1/2013-4/14/2015 and 5/4/2021 - 10/28/2022.

the researchers will use the previously collected transcriptomic and intravascular imaging data collected from subjects between 8/1/2013-4/14/2015 (statin group) and subjects who participated in yellow iii study (evolocumab group). the analyses will allow us detect common and unique pathways for each drug. the researchers will use intravascular imaging findings (optical coherence tomography, oct) to characterize patient's individual response to treatment as beneficial, if oct fibrous cap thickness (fct) increased at follow-up and develop machine-learning models to predict the individual response using baseline gene expression. the researchers hypothesize that the analyses will uncover unique gene panels predicting beneficial response to statin and evolocumab allowing to select the best treatment approach for an individual patient. the total number of subjects will be 195. transcriptomic profile of pbmc at baseline and follow-up will be compared between the groups to establish the common and distinctive molecular mechanisms of the effect of statins and evolocumab.

Eligibility criteria:
inclusion criteria: * subjects with coronary artery disease who underwent cardiac catheterization with or without pci * patients from 8/1/2013-4/14/2015 and yellow iii with both visits available, baseline and follow-up exclusion criteria: * patients from 8/1/2013-4/14/2015 and yellow iii lost to follow-up
personalization of immunosuppressive treatment for organ transplant recipients

Conditions: Kidney Injury; Kidney Failure; Kidney Failure, Chronic; Kidney Failure, Acute; Kidney Diseases; Kidney Transplant Rejection; Kidney Transplant Infection; Kidney Transplant; Complications; Kidney Disease, Chronic; Kidney Ischemia

Summary: long-term graft failure rates continue to be unacceptably high despite the development of immunosuppressive drugs, underscoring the unmet need for robust prognostic biomarkers of allograft injury and failure. while rates of acute rejection (ar) continue to decrease, it remains the strongest predictor of long-term allograft survival, and so having a better understanding of factors predicting ar may contribute to more individualized patient care. selecting optimum immunosuppressive dosage is another factor in personalizing kidney care. this project will study two areas of individualized kidney care: 1) assessing rejection by surveillance testing utilizing allosure, 2) developing an algorithm to select optimum immunosuppressive medication dosage.


Eligibility criteria:
inclusion criteria: * adult 18-80 year old * kidney transplant recipients (de novo or re-transplant, from living or deceased donor) * bmi over 30 * recipients with pre formed human leukocyte antigens (hla) antibodies * recipients with donor specific antibodies * recipients who have undergone blood type incompatible transplantation (abo incompatible) * recipients who have had prior kidney transplants. exclusion criteria: * multi-visceral transplant (simultaneous kidney pancreas, liver kidney, heart kidney) * contraindication to renal biopsy * refusing biopsy * kidney transplant recipient that is a monozygotic twin to the donor * when more than two genomes may be present in the recipient plasma (more than recipient + donor): pregnancy, multiple-organ transplants from different donors (kidney after heart, kidney after liver transplant etc.), recipients of allogeneic blood or bone marrow transplant who have received cells with a genome different from the recipient (e.g. non-monozygotic twin)
development of clinical method to determination triclosan retention in plaque following brushing.

Conditions: Gingival Diseases

Summary: clinical research study to determine the anti-plaque efficacy of prototype dentifrices via a 4-day brushing regiment


Eligibility criteria:
inclusion criteria: * male or female volunteers 18-65 years of age. * good general health. * must sign informed consent form. * must discontinue oral hygiene on the mornings of each appointment and between sampling periods. * no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. exclusion criteria: * medical condition which requires pre-medication prior to dental procedures/visits. * medical condition which precludes eating/drinking for 12 hrs. * history of allergy to common dentifrice ingredients. * subjects unable or unwilling to sign the informed consent form. * moderate or advanced periodontal disease. * two or more decayed untreated dental sites at screening. * other disease of the hard or soft oral tissues. * impaired salivary function (e.g. sjogren's syndrome or head and neck irradiation). * use of medications that can currently affect salivary flow. * current use of antibiotics. * use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. * pregnant or nursing women. * participation in any other clinical study within 30 days prior to enrollment into this study. * use of tobacco products. * subjects who must receive dental treatment during the study dates. * current use of antibiotics for any purpose. * immune compromised individuals (hiv,aids, immuno suppressive drug therapy).