Kornimate/medical-research-clean huggingface dataset:
an ascending multiple dose study evaluating amg 167 in healthy men and postmenopausal women with low bone mineral density

Conditions: Osteopenia

Summary: the purpose of this study is to assess the safety, tolerability, and potential immune response of amg 167 following multiple subcutaneous (sc, injection under the skin) dose administrations in healthy men and postmenopausal women with low bone mineral density.


Eligibility criteria:
inclusion criteria: * low bone mineral density as determined at the time of screening \[as defined by bone mineral density (bmd) t-scores of the lumbar spine (l1-l4), or total evaluable vertebrae (if fewer than l1-l4); or femoral neck between -1.0 and -2.5, exclusive\] * 25-hydroxyvitamin d ≥ 20 ng/ml * willing and able to take ≥ 1,000 mg elemental calcium and ≥ 800 iu (but ≤ 1,000 iu) vitamin d daily upon enrollment exclusion criteria: * osteoporosis, as defined by bmd t-scores of the lumbar spine (l1-l4) or total evaluable vertebrae (if fewer than l1-l4); or femoral neck ≤ 2.5 * history of vertebral fracture, or fragility fracture (a fracture resulting from no or minor trauma; ie, fall from standing height or less) of the wrist, humerus, hip, or pelvis after age 50 * diagnosed with any condition that will affect bone metabolism * diagnosis of clotting factor deficiency or history of bleeding or coagulation disorder * history of spinal stenosis * history of facial nerve paralysis exclusion criteria for cohort 7 sub-study (transition to alendronate): * contraindicated or intolerant of alendronate therapy

Keywords: amgen phase 1b postmenopausal bone mineral density
salivary bacterial profiles in relation to periodontal treatment

Conditions: Periodontitis

Summary: the purpose of the present investigation is to record and compare bacterial compositions in subgingival plaque samples and saliva samples in subjects receiving periodontal treatment. the hypothesis is that the composition of the salivary microbiota might reflect local bacterial alterations in relation to periodontal treatment.

in this study we plan to enroll 35 subjects with manifest periodontitis, which will be treated according to national and international guidelines. clinical registration and collection of subgingival plaque samples and saliva samples will be performed at baseline and 2, 6 and 12 weeks after treatment.

Eligibility criteria:
inclusion criteria: - manifest chronic periodontitis according to international classification exclusion criteria: * other treatment requiring oral conditions * systemic antibiotics within the latest 6 months * systemic diseases and medications with known associations to periodontitis * pregnancy and breastfeeding

Keywords: periodontitis saliva bacteria
post-thrombotic syndrome after deep venous thrombosis (dvt) in patients treated according to the nopho all2008 protocol

Conditions: Acute Lymphoblastic Leukemia; Post Thrombotic Syndrome

Summary: acute lymphoblastic leukemia (all) is the most common malignant disease in childhood. today more than 90% of children and 75% of adults (18-45 years) survive all. the enzyme asparaginase (asp) is an indispensable part of the multiagent treatment of all. treatment related severe acute toxicities are common. especially in teenagers and adults, thromboembolism is one of the most common acute toxicities and may result in post thrombotic syndrome (pts) or pulmonary hypertension. the knowledge about these late effects is limited, including for all patients.


Eligibility criteria:
inclusion criteria: * treated on the all2008 protocol for all. had a dvt on treatment. exclusion criteria: * death
a study of a vaccine in combination with beta-glucan in people with neuroblastoma

Conditions: Neuroblastoma; High-risk Neuroblastoma; Metastatic Neuroblastoma

Summary: the purpose of this study is to test which treatment schedule of β-glucan with bivalent vaccine is more effective for participants with high-risk neuroblastoma that is in complete remission.


Eligibility criteria:
inclusion criteria: * diagnosis of nb as defined by international criteria,102 i.e., histopathology (confirmed by the msk department of pathology) or bm metastases plus high urine catecholamine levels, or positivity in mibg scan. * hr-nb as defined by risk-related treatment guidelines and international criteria,102 i.e., metastatic/non-localized disease with mycn amplification (any age), metastatic disease \>18 months old, mycn-amplified localized disease (any age), or disease resistant to standard chemotherapy. * hr-nb (as defined above) and in 1) first cr at ≥ 6 months from initiation of immunotherapy using anti-gd2 antibody, or 2) second or subsequent cr (achieved after treatment for pd). cr is defined according to the international neuroblastoma response criteria. patients with positive mibg scan but negative fdg-pet scan, and cr in bm, are eligible. * patients with grade 3 toxicities or less using the common toxicity criteria (version 5.0) developed by the national cancer institute of the usa (ctcae v5.0) related to hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam. plus: * absolute neutrophil count (anc) ≥ 500/mcl * absolute lymphocyte count ≥ 500/mcl * \>21 and \<180 days between completion of systemic therapy and 1st vaccination. * a negative pregnancy test is required for patients with child-bearing capability * signed informed consent indicating awareness of the investigational nature of this program. exclusion criteria: * patients with grade 4 hematologic, cardiac, neurological, pulmonary, renal, hepatic or gastrointestinal function as determined by blood tests or physical exam, using the common toxicity criteria (version 5.0) developed by the national cancer institute of the usa. * history of allergy to klh, qs-21, opt-821, or glucan * prior treatment with this vaccine. * active life-threatening infection requiring systemic therapy. * inability to comply with protocol requirements.

Keywords: neuroblastoma high-risk neuroblastoma metastatic neuroblastoma hr-nb memorial sloan kettering cancer center 23-198
nanoparticles analysis in lung and bronchi during various pulmonary interstitial diseases and relationships with their aetiology

Conditions: Interstitial Lung Diseases

Summary: nanoparticles (np) are particles whose length, width and height are less than 100 nanometres. over the past decade, industrial applications of np have increased dramatically. despite their widespread use, their true impact on human health remains unknown and poorly studied. np exposure in humans primarily occurs via inhalation through the respiratory system. the aim of this study is to estimate the relationships between the nanoparticle load in the lung and bronchi and some interstitial lung diseases. in the aftermath of human exposure to asbestos, the pathological consequences of environmental exposure to nanomaterials could be evaluated upon a mineralogical analysis of pulmonary samples.


Eligibility criteria:
inclusion criteria: * patients with an interstitial lung disease assessed on clinical signs and ct scan, requiring a flexible bronchoscopy with a broncho-alveolar lavage. these patients suffer from: * idiopathic interstitial lung diseases such as idiopathic pulmonary fibrosis or sarcoidosis or * interstitial lung diseases of known aetiologies such as hypersensibility pneumonitis, infectious or cancerous interstitial diseases and interstitial diseases caused by drug reactions. written consent exclusion criteria: * flexible bronchoscopy or bal not possible. * pregnant women * patients under legal protection. * patients with contagious disease (hiv infection, tuberculosis, viral hepatitis)

Keywords: interstitial lung diseases nanoparticles lung broncho-alveolar lavage bronchial washings
acute effect of strength training on blood pressure in cardiac patients

Conditions: Heart Failure; Ischemic Heart Disease; Heart Transplant Recipients

Summary: moderate and heavy strength training exercise and the acute blood pressure rise in cardiac patient, how high?

12 heart transplant recipients 12 heart failure patients 12 patients with ischemic heart disease

Eligibility criteria:
inclusion criteria: * 18 years * no strength training \> 3 month * speak and understand danish exclusion criteria: * cancer * serum creatinin above 200 mmol/l * re-transplantation * ejection fraction \> 35

Keywords: acute rise of systolic and diastolic bloodpressure
clinical performance of bioclia ro60

Conditions: Systemic Lupus Erythematosus; Sjogren's Syndrome

Summary: the study is to evaluate the clinical performance of bioclia ro60 for measuring the autoantibody in autoimmune disease patients.

100-200 clinically-diagnosed disease samples, as well as approximately 300 samples of various control diseases, will be used in the study. the specimen will be collected as the clinically leftover samples that have been used for routine clinical diagnosis purpose or research purpose, and with de-identification methods. each set of samples will also be tested on a control serologic anti-ro60 detection kit, quanta flash ro60. clinical sensitivity and clinical specificity will be analyzed for, also a method comparison conclusion will be drawn by comparing the two methods.

Eligibility criteria:
inclusion criteria: * diagnosed with relevant diseases, including systemic lupus erythematosus (sle) and sjogren's syndrome (ss) * or diagnosed with other control diseases, including rheumatoid arthritis (ra), infectious diseases and others exclusion criteria: * treatment with medicine that submerge the autoantibody concentration to non-detectable range * co-diagnosed with multiple relevant diseases (e.g., sle / ss) and/or control diseases * hemolyzed sample.
evaluation study for the chef anchor 3.0 program

Conditions: Mild Cognitive Impairment; Dementia

Summary: objectives: 1. (primary)to estimate the potential effects of the cooking program on the people with mci/dementia and their informal caregivers; 2. to investigate if the potential effects can be maintained after the completion of the program. study design and participants: a convenience sample of 68 pair older adults with mci/dementia and their informal caregivers from the chef anchor 3.0 programme will be referred to the research team. overall, participants will be assigned to intervention group and waitlist control group in a ratio of 1:1. allocation will take into account the participants' availability and the programme capacity. assessors of outcomes and data analyst will be blinded throughout the whole study. during the first 10 weeks, the intervention group will undergo the 10-week programme in the "chef anchor 3.0", while no activity for the waitlist control group. then, from week 10 to 20, the waitlist control group will attend the same 10-week programme. measurements: main outcome measures for people with mci/dementia will include confidence in cooking (primary), cooking capability, satisfaction with autonomy in cooking, satisfaction with meal choices, worried about future cooking ability and meal choices, cognitive function, self-reported appetite, psychological well-being, family harmony and satisfaction, as well as self-rated health. outcome measures for informal caregivers will include confidence in care recipient' s cooking, worried about future cooking ability and meal choices of care recipient, caregiver burden, psychological well-being, family harmony and satisfaction, as well as self-rated health. other measures will include attendance rate, home practice rate, drop-out rate, programme satisfaction, and recommendation to others. hypotheses 1. the confidence in cooking, cooking capability, satisfaction with autonomy in cooking, satisfaction with meal choices, worried about future cooking ability and meal choices, cognitive function, self-reported appetite, psychological well-being, family satisfaction, and self-rated health of older adults with mci/dementia would improve after the programme; 2. the confidence in care recipient's cooking, worried about future cooking ability and meal choices of care recipient, psychological well-being, family satisfaction, caregiver burden, and self-rated health of informal caregivers would improve after the programme; 3. the 10-week programme is acceptable for the most of older adults with mci/dementia and their informal caregivers.


Eligibility criteria:
inclusion criteria: i. aged 60 or above; ii. diagnosed by medical doctor has having mci/dementia as reported by the older adults or their informal caregivers, or with reported subjective decline of cognitive function and with 5-min moca score ≤7th age- and education-specific percentile (wong et al., 2015); iii. ability to follow simple instructions; iv. adequate physical strength to attend cooking workshops. exclusion criteria: i. without caregiver
efficacy of 400 mg versus 800 mg imatinib in chronic myeloid leukemia in chronic phase patients - tops (tyrosine kinase inhibitor optimization and selectivity)

Conditions: Leukemia, Myeloid, Chronic Phase

Summary: this study investigated the safety and efficacy of 400mg versus 800mg imatinib in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase (cml-cp) using molecular endpoints.


Eligibility criteria:
inclusion criteria: * patients within 6 months of diagnosis (date of initial diagnosis is the date of first cytogenetic analysis) * diagnosis of chronic myelogenous leukemia (cml) in chronic phase with cytogenetic confirmation of philadelphia chromosome of (9;22) translocations and presence of breakpoint cluster region gene-abelson proto-oncogene (bcr-abl) * documented chronic phase cml * adequate end organ function as defined by: * total bilirubin \< 1.5 x upper limit of normal (uln) * serum glutamic oxaloacetic transaminase (sgot) and serum glutamate pyruvate transaminase (sgpt) \< 2.5 x uln * creatinine \< 1.5 x uln exclusion criteria: * patients in late chronic phase, accelerated phase, or blastic phase are excluded * patients who have received other investigational agents * patients who received gleevec/glivec for any duration prior to study entry, with the exception of those patients successfully completing \[csti571a2107 (nct00428909)\] study immediately prior to the participation in this study * patient received any treatment for cml prior to study entry for longer than 2 weeks with the exception of hydroxyurea and/or anagrelide * patients with another primary malignancy except if the other primary malignancy is neither currently clinically significant or requiring active intervention * patients who are: (a) pregnant, (b) breast feeding, (c) of childbearing potential without a negative pregnancy test prior to baseline and (d) male or female of childbearing potential unwilling to use barrier contraceptive precautions throughout the trial (post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential). * patient with a severe or uncontrolled medical condition (i.e., uncontrolled diabetes,chronic renal disease) * patient previously received radiotherapy to ≥ 25% of the bone marrow * patient had major surgery within 4 weeks prior to study entry, or who have not recovered from prior major surgery * patients with an eastern cooperative oncology group (ecog) performance status score ≥ 3 * patients with international normalized ratio (inr) or partial thromboplastin time (ptt) \> 1.5 x uln, with the exception of patients on treatment with oral anticoagulants * patients with known positivity for human immunodeficiency virus (hiv); baseline testing for hiv is not required * patients with identified sibling donors where allogeneic bone marrow transplant is elected as first line treatment other protocol-defined inclusion/exclusion criteria applied.

Keywords: cml philadelphia positive bcr-abl imatinib mesylate chronic myeloid leukemia (cml) in chronic phase
optimal duration of antimicrobial susceptibility test (ast) guided rescue therapy for helicobacter pylori infection

Conditions: Therapeutic Duration; Helicobacter Pylori; Antimicrobial Susceptibility Test; Eradication

Summary: strongly evidence supports that h. pylori eradication is an effective approach to reduce the incidence of those pathologies. however, due to the increasing resistance rates to antibiotics, failures of h. pylori eradication get more and more common. thus, rescue therapy for persistent h. pylori infection is becoming a grand challenge the investigators have to face.


Eligibility criteria:
inclusion criteria: * patients require upper endoscopy owing to persistent h. pylori infection despite one or more treatment attempts. exclusion criteria: * age younger than 18 years; * patients with gastrectomy, acute gi bleeding and advanced gastric cancer; * known or suspected allergy to study medications; * inability to provide informed consent and other situations that could interfere with the examination or therapeutic protocol.
effect of lactobacillus probiotic on healthy adults

Conditions: Antibiotic-associated Diarrhea

Summary: diarrhea is a common side effect of antibiotics; it may prolong hospital stay, increase the risk of other infections, develop into more serious forms of disease, and lead to premature discontinuation of the needed antibiotic. the purpose of this study is to examine the safety and effectiveness of a capsule containing lactobacillus rhamnosus gg in the prevention of diarrhea associated with antibiotic use.


Eligibility criteria:
inclusion criteria: * participants (male or female inpatients) 18 to 64 years of age who are prescribed antibiotics (single or multiple antibiotics, oral or intravenous) will be recruited from the fargo vamc primary care clinic area. * participants must be able to swallow a capsule. exclusion criteria: * exclusion criteria include diarrhea on admission or within the preceding week * reported recurrent diarrhea * antibiotics in the past four weeks * significant underlying conditions (e.g. diabetes, structural cardiac defects including valvular defects, history of infective endocarditis, poor cardiac function, immunosuppression, impaired gut integrity, moderate or serious intestinal disorders, malignancies, pancreatitis, indwelling catheters, recent surgery, recent prolonged hospitalization) * previous bowel surgery * nutritional restrictions that preclude participation * hypersensitivity to penicillin g, ampicillin, or erythromycin * persons who have been prescribed their antibiotic for a duration longer than 3 weeks
a comparative study of jns013 in participants with post-tooth-extraction pain

Conditions: Pain; Postoperative Pain

Summary: the purpose of this study is to evaluate the efficacy and safety of jns013 with single oral dose administration in participants with pain after tooth-extraction of mandibular impacted wisdom tooth.

this is a multi-center (conducted in more than one center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug assigned by chance), parallel-group (each group of participant will be treated at the same time) and comparative study in participants having pain intensity of at least 50.0 millimeter (mm) (on visual analog scale, score ranging from 0 mm \[no pain\] to 100 mm \[worst possible pain\]), following extraction of an impacted mandibular wisdom tooth. the study consists of 3 parts: pre-observation (7 days before study commences on day 1); treatment (day 1, consists of single oral dosing of either tramadol plus acetaminophen and placebo; or tramadol and placebo; or acetaminophen and placebo) and follow-up (day 2 and 8). all the eligible participants will be randomly assigned to 1 of the 3 study treatments. efficacy of the participants will primarily be evaluated through total pain relief, which will be evaluated on numerical rating scale. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participants planned to receive a tooth extraction of one mandibular impacted wisdom tooth * participants who require bone removal and separation of the crown at tooth extraction * participants whose intensity of pain associated with tooth extraction within 2 hours after tooth extraction is greater than or equal to 50.0 millimeter on the visual analog scale (vas) * participants who did not undergo general anesthesia or sedation at tooth extraction * participants without an abnormality (including laboratory test values) corresponding to grade 3 in the "criteria for severity classification of adverse drug reactions" during the pretreatment observation period exclusion criteria: * participants with conditions for which tramadol is contraindicated * participants with conditions for which acetaminophen is contraindicated * participants with history of convulsions or the possibility of convulsive seizures * pregnant participants or those who may be pregnant, lactating mothers, and those who wish pregnancy during the study period * participants with concurrent, previous, or possible alcohol dependence, drug dependence or narcotic addiction

Keywords: pain tooth extraction oral surgery postoperative pain jns013 tramadol hydrochloride acetaminophen
radiomics-based non-invasive classifier research for hcc-related liver transplantation

Conditions: Hepatocellular Carcinoma; Liver Transplantation; Magnetic Resonance Imaging

Summary: the purpose of this study is to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population

hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. liver transplantation is the most effective treatment for hcc and is in high demand in china. however, recurrence of hcc among liver transplantation recipients is still a great challenge and threat to the survival of recipients. so it is of great significance to establish a non-invasive way to filter high liver transplantation recipient population before transplantation. based on large scales of pre-treatment mr images, the investigator's study aims to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population. this study will contribute to the precise selection of hcc-related liver transplantation recipients.

Eligibility criteria:
inclusion criteria: * all patients had postoperative pathological diagnosis of hcc * all patients had underwent contrast-enhanced mri scan within 2 weeks before liver transplantation exclusion criteria: * patients whose pathological diagnosis is not hcc * patients whose ct images were affected by strong imaging artifacts, i.e. artifacts obscuring more than 10% of whole volume of interest * patients whose clinical data or ct images were missing