Kornimate/medical-research-clean huggingface dataset:
refine and assess the readability of patient, carer, and clinician treatment preference in myelodysplasia questionnaire

Conditions: Myelodysplastic Syndrome (MDS)

Summary: the primary goal of this study is to use qualitative interviews to elicit and confirm concepts related to treatment preferences and understandability of the ptpmq, ctpmq, and mtpmq. the information gathered will be used to support the appropriateness of the questionnaires as a patient-reported, caregiver-reported and clinician-reported outcome measure (prom) in the population of interest.


Eligibility criteria:
inclusion criteria: potential subjects must satisfy all of the following criteria to be enrolled in the study: a. adult patients with myelodysplastic syndrome meeting any one of the following criteria: 1. they are currently being treated with azacitidine or 2. they have recently been treated with azacitidine or 3. they have been deemed eligible for treatment with azacitidine, but have not yet commenced treatment b: primary caregiver of a patient meeting all of the inclusion criteria (i.e. a patient who meets criteria defined above in a). c. clinician treating patients meeting all of the inclusion criteria (i.e. treats patients who meet criteria defined above in a). exclusion criteria: potential subjects who meet any of the following criteria will be excluded from participating in the study: exclusion criteria a. patients meeting any of the following criteria are excluded: 1. they have lower risk disease (international prognostic scoring system low or intermediate-1 risk) 2. cognitive or physical impairment of a nature that makes it infeasible for them to effectively participate in a structured interview. 3. deemed appropriate for stem cell transplantation and are being pre-treated or will be treated with azacitidine 4. they were treated, are being treated, or will be treated with azacitdine as part of a clinical trial 5. they are a relative of an employee of the investigational clinic, sponsor or research organization (e.g., investigator, coordinator, technician, interviewer). b. carers meeting any of the following criteria are excluded: 1. they are a caregiver of a patient who meets any of the exclusion criteria listed above in a 2. they are a relative of an employee of the investigational clinic, sponsor or research organization (e.g., investigator, coordinator, technician, interviewer). c. clinician will be excluded from participating in the study if a relative of an employee of the sponsor or research organization (e.g., investigator, coordinator, technician, interviewer). d. participants who are not fluent in english, or who cannot read or write in english will be excluded from the study
modified constraint induced movement therapy in children with obstetric brachial plexus injury

Conditions: Obstetric; Injury

Summary: the aim of this study was to increase and improve the use of affected extremity in obstetric brachial plexus palsy children while restricting the use of less affected arm and the purpose was to improve the function, range of motion and disability in affected arm of children with brachial plexus injury.


Eligibility criteria:
inclusion criteria: * 3 to 10 years * both genders will be included * deficiency of shoulder abduction and external rotation * who can follows command exclusion criteria: * uncontrolled seizures * orthopedic and/or neurological surgery. * a visual impairment interfering with treatment/testing. * unable to actively engage in assessment process

Keywords: birth injuries therapy arm function constraint induced movement therapy brachial plexus neuropathies
trial to evaluate the use of pomegranate concentrate (pomx) for the prevention of experimental rhinovirus infection

Conditions: Common Cold

Summary: pomegranate has a long history of use in folk medicine. there is vast data on the health benefits of pomegranate fruit and juice. multiple studies have established the strong antioxidative effects of pomegranate polyphenols (primarily the ellagitannin punicalagin) and their health effects. a vast number of animal and human clinical studies have provided evidence on effect of pomegranate products on reducing symptoms of common cold, reducing blood pressure, improving endothelial function, anti-tumor activity, and its anti-atherosclerotic activity. this study will evaluate the protective effect of a pomegranate concentrate (pomx) in decreasing the incidence and duration of the common cold among healthy adults.


Eligibility criteria:
inclusion criteria: * nonsmoker * no recent history of respiratory disease exclusion criteria: * serum positive for rhinovirus * pregnant or breastfeeding * recent immunization

Keywords: punicaceae pomegranate
phase ii trial for patients with loco-regional esophageal carcinoma

Conditions: Loco-regional Esophageal Cancer

Summary: the purpose of this study is to determine whether bevacizumab can improve the outcome of treatment for patients with esophageal cancer whose disease is confined to the esophagus or the closely surrounding lymph nodes.

standard treatment is pre-operative chemotherapy and radiation, followed by surgery. in this study, bevacizumab will be added to the pre-operative chemotherapy and radiation, and then bevacizumab will also be administered for a year after surgery. bevacizumab is a humanized monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer) produced by genentech, inc. using recombinant dna technology. bevacizumab has been approved by the fda for the treatment of metastatic colorectal cancer in combination with chemotherapy. bevacizumab is experimental in the treatment of esophageal cancer and has not been approved by the fda for the treatment of esophageal cancer. bevacizumab is an antibody directed against vascular endothelial growth factor, or vegf. vegf is a growth factor with a well defined role in normal and abnormal blood vessel formation. it is present in a wide variety of normal tissues, but is produced in excess by most solid cancers (tumors). in the setting of cancer, vegf promotes the growth of blood vessels that bring nutrients to tumor cells. in studies with laboratory animals, bevacizumab inhibits the growth of several different types of human cancer cells, including colon cancer cells, by blocking the effects of vegf. by blocking vegf, your doctors hope that bevacizumab may decrease blood supply to the tumor, and therefore decrease the ability of the tumor to grow and come back after chemotherapy, radiation, and surgery.

Eligibility criteria:
inclusion criteria: 1. no prior treatment for esophageal cancer 2. no prior radiation to the chest or upper abdominal area 3. no prior treatment with an egfr inhibitor or an anti-angiogenic agent 4. disease should be limited to the esophagus and regional lymph nodes - exclusion criteria: 1. history of stroke 2. history of heart attack 3. inadequately controlled high blood pressure
journey™ uni post market clinical follow-up

Conditions: Non-inflammatory Degenerative Joint Disease

Summary: this is a retrospective/prospective, open-label single cohort, multicenter study to collect relevant clinical data from 147 subjects with unicompartmental degeneration of the knee in whom the journey uni uks was previously implanted.

the purpose of the current investigation is to assess the safety and effectiveness of the journey uni unicompartmental knee system (uks) in patients with non-inflammatory degenerative joint disease (nidjd) of the knee who previously had the journey uni uks implanted. this clinical study will prospectively evaluate the 36 and 60-month safety and performance of the journey uni uks in patients with nidjd of the knee who required lateral or medial knee compartment replacement.

Eligibility criteria:
inclusion criteria: 1. between 12 and 48 months previously, subject had unicompartmental knee replacement implanted for unicompartmental, nidjd including oa, traumatic arthritis, avascular necrosis, for correction of functional deformity, or to repair a fracture that was unmanageable using other techniques. 2. subject received a journey uks implant (consisting of a femoral component, tibial baseplate, and a tibial insert). 3. subject was considered skeletally mature at the time of surgery and was at least 18 years of age. 4. subject is willing to have retrospective data collected and to participate in required prospective follow-up visit(s) at the investigational site and to complete study procedures and questionnaires. 5. subject has consented to participate in the study by signing the institutional review board (irb)/ethics committee (ec)-approved informed consent form (icf). exclusion criteria: 1. subject has body mass index (bmi) \> 40 within 1 month of surgery. 2. subjects who have received the journey uni uks as part of a revision surgery. 3. subject has a condition that may interfere with the unicompartmental knee arthroplasty (uka) survival or outcome (e.g. paget's or charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease). 4. subject has a known allergy to study device or one or more of its components. 5. subject, in the opinion of the principal investigator (pi), has an emotional or neurological condition that would preempt his/her ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse. 6. subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product in the past 30 days. 7. subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

Keywords: osteoarthritis traumatic arthritis avascular necrosis
fby pet/ct in patients with brain tumors

Conditions: Brain Tumor

Summary: this study is an open-labeled phase ii diagnostic clinical trial to explore the safety and clinical value of fby in suspected adult brain tumor patients. the investigation regarding the clinical value of fby includes 1) the metabolic characteristics of fby in suspected malignant brain tumors; 2) role of fby to differentiate tumor progression from pseudoprogression. a single dose of 0.10 mci/kg fby will be intravenously injected for pet examination. quantitative features will be extracted to analysis the pet images. cranial mri (with contrast enhancement) will also performed as diagnostic comparison with fby. for patient who took surgery after multiple examination, histopathology, molecular pathology and lat-1 immunohistochemistry will also be obtained.

fby is a new pet tracer derived from tyrosine, with the carboxyl group replaced by boron trifluoride, and is transferred across cell membrane through lat-1. lat-1 is a sodium independent amino acid transporter and is highly expressed in tumor cells. considering the significant role in cancer development as well as in nutrient delivery, fby could be a promising pet tracer to reflect altered metabolism in tumors. this study aim to observe the safety of fby, and investigate the diagnostic value of fby in the patient with suspected brain tumors. patients who meet the eligibility criteria are included in clinical trials after fully communicating the condition, explaining the benefits and risks of clinical trials, clarifying the patient's willingness to include the clinical trial, and signing informed consent. the cohort number, fby administrative dose, imaging protocols are decided based on the investigators' preliminary data. the diagnosis and post-examination treatment are based on the recommended guideline, combined with the subject's own situation for standardized diagnosis and treatment.

Eligibility criteria:
inclusion criteria: * 1. have suspected diagnosis of brain tumors, based on clinical performance and mri results. * 2. meet the indications for pet examination, show a clear indication and no contraindications; * 3. have a performance status of score ≥70 on kps scale or score 0-1 points on ecog scale, a relatively good general situation; * 4 does not appear agonal stage, deep coma, over grade 2 major organ dysfunction (heart, lung, liver, kidney and other major organ include), acute or life-threatening status of infection; * 5. be ≥ 18 years of age on day of signing informed consent. * 6. be willing and able to understand the research content and provide written informed consent/assent for the trial. exclusion criteria: * 1. have a history of imaging agent allergies; * 2. does not meet the pet-ct scan sedation requirements, or there are contraindications for pet-ct examination; * 3. be pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial; * 4. unable to adhere strictly to protocol requirements.

Keywords: brain tumor fby-positron emission computed tomography (fby-pet) glioma brain metastasis
dietary fibre and chromium picolinate efficacy in overweight and obese women

Conditions: Overweight; Obesity

Summary: obesity is one of the greatest causes of preventable morbidity and mortality worldwide with the main treatments requiring significant changes to lifestyle, particularly dieting and physical exercise. glucomannan is a dietary fibre that expands in the stomach, creating the feeling of fulness, while chromium can regulate insulin response.

the aim of this pilot study was to investigate the effect of agglomerated glucomannan, oligofructose and chromium, as part of a calorie restricted diet plan, on weight loss, satiety, satiation, mood and gut microbiome composition in a human intervention study.

Eligibility criteria:
inclusion criteria: * healthy female * aged 18-65 years * with a bmi between 25 and 35 kg/m2 * not dieting within the previous four months * not having lost \> 5% body weight in the previous year * not having increased physical activity levels in the past 2-4 weeks * intending to modify them during the study * able to eat most everyday foods exclusion criteria: * bmi \< 25 kg/m2 * \> 35 kg/m2 * significant health problems * taking any medication or supplements known to affect appetite * weight within the past month and/or during the study * pregnant, planning to become pregnant or breastfeeding * history of anaphylaxis to food * known allergies or intolerance to foods and/or to the study materials or any of their stated ingredients. * volunteers who were on specific food avoidance diets * with abnormal eating behaviour * receiving systemic or local treatment likely to interfere with the evaluation of the study parameters * smokers and those who have recently ceased smoking * volunteers who work in appetite or feeding related areas volunteers who participated in another experimental study or receipt of

Keywords: hormones microbiota mood hunger weight loss
pharmacokinetic study,ceftobiprole,healthy volunteers,healthy patients with end stage renal disease

Conditions: Staphylococcal Skin Infections; Streptococcal Infections

Summary: the purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single 250-mg intravenous (iv) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (esrd) requiring hemodialysis or healthy volunteers.

the purpose of this study is to characterize the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of ceftobiprole after a single 250-mg intravenous (iv) infusion (given directly into the vein) for 2 hours, before and after dialysis to patients with end-stage renal disease (esrd) requiring hemodialysis or healthy volunteers. this is a phase 1, open label study (all patients involved know the identity of the drug). healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with esrd on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis. plasma and urine samples will be assayed for ceftobiprole. samples will be collected over a 48 hour period of time. safety evaluations will include monitoring of adverse events, clinical laboratory tests (hematology and serum chemistry in all patients/volunteers, and urinalysis in healthy volunteers subjects), pregnancy testing, vital signs, physical examination, and recording of concomitant medications. healthy volunteers will be given a single 2-hour infusion of 250 mg ceftobiprole; patients with esrd on hemodialysis will be given a 2-hour infusion of 250 mg ceftobiprole 3 hours either before dialysis or immediately after dialysis.

Eligibility criteria:
inclusion criteria: * healthy volunteer or be a hemodialysis patient in stable physical condition with a diagnosis of esrd and requiring hemodialysis treatment 3 times per week exclusion criteria: * history of repeated severe nausea * history of infection with hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) * recent febrile illness

Keywords: renal dialysis, ceftobiprole skin and soft tissue infections staphylococcal skin infections streptococcal infection
synthetic human secretin in children with autism and gastrointestinal dysfunction

Conditions: Autism

Summary: the purpose of the study is to determine the effect of multiple doses of secretin on autism.


Eligibility criteria:
* autism * gastrointestinal dysfunction
evaluation of diagnostic capacity of eccdnas as biomarkers in indetermined biliary stricture(eccbile)

Conditions: Biliary Stricture; Bile Duct Cancer; Pancreas Cancer

Summary: biliary stricture is mainly malignant in the adults and caused by several types of fatal malignancies such as pancreatic cancer, cholangiocarcinoma, and metastatic tumor, which have poor prognosis that the overall survival of unresectable lesions is no more than 15 months. the poor outcome often relates to a lack of reliable strategies for early diagnosis, which results in most patients with malignant biliary stricture being already advanced-stage disease at presentation. therefore, it is critical to discover novel and effective strategies for the early diagnosis of malignant biliary strictures. brush cytology and biopsy during endoscopic retrograde cholangiopancreatography (ercp) are the main methods for recognizing malignant diseases of the bile duct, but their sensitivity is relatively low, 45% and 48.1%, respectively. even when combined with other biomarkers like carbohydrate antigen 19-9 (ca19-9), their sensitivity is still less than 80%. in the previous study, the investigators found that bcf-eccdna has excellent diagnostic value in predicting uncertain bile duct stricture, and the sensitivity and specificity of a related eccdna in 40 samples are 80.8% and 100%. the sensitivity and specificity of another eccdna were 92.3% and 92.9%, respectively. however, the sample size is still relatively small, and further prospective studies are needed to evaluate its diagnostic efficacy.


Eligibility criteria:
inclusion criteria: * patients is suspected indetermined biliary strictures * patients have the indication for ercp exclusion criteria: * ercp failed, or can not obtain bile * sever comorbidities * predicted overall survival less than 1 year because of other disease * patients who are unlikely to comply with the protocol, inability to return for subsequent visits

Keywords: malignant biliary stricture cell-free extrachromosomal circular dna (eccdna) liquid-biopsies assay
a study of intravenous iron isomaltoside 1000 (monofer®) administered by infusions to iron-deficient blood donors

Conditions: Iron-deficiency

Summary: the primary purpose of the study is to evaluate the effect of iv iron isomaltoside 1000 compared with placebo on hb in first-time female donors with p-ferritin below 30 µg/l

at present, clinical efficacy and safety data is available for iron isomaltoside 1000 administered to patients with ida requiring iron therapy. however, there is a need for clinical efficacy and safety data within iron deficiency without anaemia which is e.g. observed in blood donors. thus, this study is planned to compare the efficacy and safety of parenteral iron isomaltoside 1000 with placebo in female blood donors with a p-ferritin below 30 µg/l.

Eligibility criteria:
inclusion criteria: 1. women aged ≥ 18 years 2. first-time donor 3. p-ferritin \< 30 µg/l 4. willingness to participate and signed the informed consent form exclusion criteria: 1. iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 2. known hypersensitivity to any excipients in the investigational drug products 3. history of drug related allergies 4. history of severe asthma 5. decompensated liver cirrhosis and hepatitis (defined as alat \> 3 times upper limit of normal) 6. active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (wbc) and c-reactive protein (crp)) 7. rheumatoid arthritis with symptoms or signs of active inflammation 8. subjects who are pregnant or nursing. in order to avoid pregnancy, women have to be postmenopausal (at least 12 months since last menstruation), surgically sterile, or use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, vaginal devices, or hormonal injections with prolonged release) 9. participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening 10. untreated vitamin b12 or folate deficiency 11. treated with other iv or oral iron products within 4 weeks prior to the screening 12. treated with erythropoietin (epo) within 4 weeks prior to the screening 13. any other medical condition that, in the opinion of the investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study
sorafenib drug drug interaction study in healthy male subjects

Conditions: Drug Interactions

Summary: to evaluate the effect of levothyroxine on the absorption, distribution, metabolization and elimination of sorafenib and safety in healthy male subjects


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 (inclusive) and 45 years (inclusive) at the first screening visit. * body mass index (bmi) between 18.5 (inclusive) to 30.0 kg / m² (inclusive) with body weight ≥ 65kg. * normal thyroid function indicated by thyroid examination to include total and free t3 (triiodothyronine) , t4 (total and free thyroxine, levothyroxine), tsh (thyroid stimulating hormone), anti-tsh-receptor (anti-tshr) antibody, anti-thyroperoxidase (anti-tpo) antibody, anti-thyroglobulin antibody (anti-ata) as well as thyroid ultrasound. exclusion criteria: * history of clinically significant metabolic, renal, hepatic, or central nervous system disorder such as seizure, psychosis and sleep disorders. * history of cardiovascular diseases including arrhythmia, hypertension, ischemia, etc. * known or suspected cardiovascular disease including potential risk of atrioventricular (av) block, arrhythmia, etc. with or without a formal cardiologist consultation. * subjects who had received iodine containing contrast medium within 2 months before first study drug administration. * use of systemic or topical medicines or substances which might affect the study drug(s) must be avoided

Keywords: sorafenib, levothyroxine, drug interaction, pharmacokinetics, healthy volunteer