Kornimate/medical-research-clean huggingface dataset:
phase 2a rdea3170 and allopurinol combination study in gout subjects

Conditions: Gout

Summary: this is a phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (pd) effects of rdea3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with gout.


Eligibility criteria:
inclusion criteria: * subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity. * subject meets one or more criteria for the diagnosis of gout as per the american rheumatism association criteria for the classification of acute arthritis of primary gout. * subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 45 kg/m2. * subject has a screening serum urate level ≥ 8 mg/dl. * subject is free of any clinically significant disease or medical condition, per the investigator's judgment. exclusion criteria: * subject is unable to take colchicine for gout flare prophylaxis. * subject has a history or suspicion of kidney stones. * subject has any gastrointestinal disorder that affects motility and/or absorption. * subject had unstable angina, new york heart association class iii or iv heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to day 1; or subject is currently receiving anticoagulants. * subject has screening laboratory parameters that are outside the normal limits and are considered clinically significant by the investigator. * subject has an estimated creatinine clearance \< 60 ml/min calculated by the cockcroft-gault formula using ideal body weight during the screening period. * subject is taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing. * subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the investigator, may interfere with participation in the study.
gene expression profiling of malignant tumor predict the therapeutic response of dc-cik immunotherapy

Conditions: Malignant Tumor

Summary: to investigate gene expression profile and immunological associated analysis relating to immunotherapy response of patients with malignant tumor after dc-cik immunotherapy.

1. the patients with malignant tumor are treated with dendritic cells (dc) plus cytokine induced killer cells (cik) . 2. venous blood (4 ml) is collected from each subject and placed into tubes containing ethylene diamine tetraacetic acid(edta) before and after each treatment. lymphocytes are sorted by fluorescence activated cell sorting(facs) and stored at -80°c until processing. 3. the t-cell receptor/b-cell receptor gene expression is detected by micro-array。 4. estimate immunotherapy response, time to disease progression, survival rates and clinical benefit response on patients. response is assessed using response evaluation criteria in solid tumor group (recist) guidelines. degree of response is used to divide the cancers into two groups: sensitive and non-sensitive to immunotherapy. 5. compare the gene expression profile between different immunotherapy response groups to explore the mechanism that predict the dc-cik immunotherapy response.

Eligibility criteria:
inclusion criteria: * histologically confirmed with malignant tumor; * age: 18-80 years; * an eastern cooperative oncology group (ecog) performance status of 0-2; * at least one measurable lesion according to the recist criteria; * adequate bone marrow, cardiac, liver, and renal function; * life expectancy ≥2 months; * not received other anti-tumor treatment * informed consent signed exclusion criteria: * previous history of other malignancies; * uncontrolled central nervous system metastases; * serious or uncontrolled concurrent medical illness.
clinical and actigraphic profile of young patients admitted for attempted suicide

Conditions: Suicide, Attempted

Summary: an excess suicide-related morbidity is observed among young people in the picardie region, as reflected by the \> 100% occupation rate of the amiens university hospital adolescent medicine unit

an excess suicide-related morbidity is observed among young people in the picardie region, as reflected by the \> 100% occupation rate of the amiens university hospital adolescent medicine unit. new approaches have been proposed to these problems that have led us to reorganize our diagnostic practices: 1) more precise characterization of suicidal behaviour by using standardized instruments such as the french version of the columbia-suicide severity rating scale developed by posner (c-ssrs); 2) new clinical entities, such as disruptive mood dysregulation disorder, are now proposed in international classifications (dsm 5 field trial); 3) investigations such as recording of the circadian rhythm of motor activity by actigraphy are being studied as a laboratory complement to psychiatric diagnosis.

Eligibility criteria:
inclusion criteria: * children/adolescents admitted after a suicide attempt exclusion criteria: * severe depression * mental retardation * pervasive developmental disorder * active psychotic episode, * drug and alcohol abuse at the time of admission * organic sleep-wake disorders (sleep-related respiratory and motor disorders, narcolepsy) * any contraindication formulated by the clinical team * patients not covered by french national health insurance, patients deprived of their freedom as stipulated in article l.1121-6 of the french public health code

Keywords: young disruptive mood dysregulation disorder actigraphic profile
rectal indomethacin as early treatment for acute pancreatitis (indomap trial)

Conditions: Acute Pancreatitis; Complication; Mortality Rate; Organ Failure, Multiple

Summary: acute pancreatitis (ap) is an inflammatory condition of the pancreas following the activated pancreatic enzymes induced by varied causes, with or without other organ(s) dysfunction. the production and release of inflammatory factors is generally considered as the key factor of pathogenesis. non-steroidal anti-inflammatory drugs (nsaids) are the most commonly applied agents for inflammatory diseases. a series studies have proved that indomethacin can reduce the risk of post-endoscopic retrograde cholangiopancreatography (ercp), but high-quality evidence is still lacking in the field of effectiveness of nsaids to treat, rather than prevent, other types of ap. majority of animal experiments showed that nsaids had protective effects for organ functions, but the results of several preliminary clinical studies were inconsistent. randomized controlled trials are eagerly awaited to elucidate its effects on ap.


Eligibility criteria:
inclusion criteria: * all patients ages 18-80 years with a diagnosis of ap based on at least 2 of the following criteria: * abdominal pain characteristic of ap * serum amylase and/or lipase ≥ 3 times the upper limit of normal * characteristic findings of ap on abdominal ct scan will be screened for study enrollment. exclusion criteria: * onset time \>24 hours * presence of renal dysfunction (serum creatinine \> 1.5 \*normal upper limit) * severe liver dysfunction * active peptic ulcer disease or gi bleeding * pregnancy or breast-feeding * hypersensitivity to nsaids * new-onset, exacerbation or uncontrolled hypertension * presence of serious cardiovascular events, including severe heart failure, myocardial infarction (mi) and stroke * mental disability * malignancy-associated acute pancreatitis * post-ercp pancreatitis * informed consent not signed

Keywords: acute pancreatitis indomethacin prognosis organ dysfunction
a pilot study of the effects of microcurrent on three sleep surveys

Conditions: Primary Insomnia

Summary: participants identified as having primary insomnia will be randomly assigned to groups receiving microcurrent stimulation or sham in a double-blind randomized controlled trial. the microcurrent device used is fda approved for the treatment of insomnia. the hypothesis is that the experimental group will have significantly improved scores on three sleep surveys after treatment while the sham group will not.


Eligibility criteria:
inclusion criteria: * student, faculty or staff * age 18 - 40 * symptoms of primary insomnia exclusion criteria: * no implanted electric devices * no local infection, injury or malignancy * no history of seizure or other neurological disorders * no current use of prescription or other substances that could effect sleep quality or quantity * pregnancy

Keywords: primary insomnia microcurrent therapy sleep surveys
combination methotrexate and infliximab

Conditions: Ankylosing Spondylitis

Summary: combination methotrexate and infliximab:influence of immunogenicity on the efficacy of infliximab in patients with ankylosing spondylitis.

forty consecutive patients will be recruited from the rheumatology clinic of the prince of wales hospital with as meeting the modified new york criteria with active disease as defined (see below). they will be randomized to receive mtx 7.5 mg/week initially with a weekly 2.5mg increment until 15mg/week dosage is reached,( i.e by week 6) or a placebo together with folic acid 5mg daily for a period of 16 week. after 16 weeks, all patients will receive infliximab at 5 mg/kg per dose, at weeks 16, 18, and 22 (3 doses), and will continue with mtx 15 mg/week or placebo. thereafter, they will be followed up at week 30, 38 weeks. mri changes in the sacroiliac joints (si) before and after infliximab treatment.

Eligibility criteria:
inclusion criteria: * fulfilled the as:meeting the modified new york criteria * active disease despite nsaid treatment defined as: * spinal inflammation ≧ 30 and a score of 30 on at least two of the other three domains * back pain * patient global assessment of disease activity * physical function * informed consent exclusion criteria: * complete ankylosis of the spine * on sulphasalazine * previous use of tnf inhibitors * multiple use of nsaids * prednisolone \> 10mg/day * changes of nsaids or dose of prednisolone within 2 weeks of baseline * little or no ability for self-care * received intra-articular,intramuscular, or intravenous corticosteroids in the 4 weeks before screening * infected joint prosthesis during the previous 5 years * serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months * any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis * active tuberculosis requiring treatment within the previous 3 years * opportunistic infections such as herpes zoster within the previous 2 months * any evidence of active cytomegalovirus; active pneumocystis carinii; or drug-resistant atypical mycobacterial infection * known hypersensitivity to murine proteins * current signs or symptoms of severe,progressive,or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, or cerebral disease * a history of lymphoproliferative disease including lymphoma or signs suggestive of disease, such as lymphadenopathy of unusual size or location (ie,lymph nodes in the posterior triangle or the neck, infraclavicular epitrochlear, or periaortic areas); splenomegaly; * any known malignant disease except basal cell carcinoma currently or in the past 5 years. * a hemoglobin level \ 150 µmol/l, serum transaminase levels 1.25 times the upper limit of normal, or alkaline phosphatase levels \> 2 times the upper limit of normal.

Keywords: ankylosing spondylitis mtx infliximab
self-perception of health status and physical condition of elderly people practitioners of hydrogymnastics

Conditions: Physical Disability

Summary: the researcher interest in self-perception of health status and physical condition of the elderly is determinant in an increasingly aging society and where one should seek to improve their quality of life.

introduction: the researcher interest in self-perception of health status and physical condition of the elderly is determinant in an increasingly aging society and where one should seek to improve their quality of life. objective: to study the self-perception of health status and the impact of a physical activity program oriented during 4 months in an elderly population practitioners of hydrogymnastics. methods: as instruments were used the questionnaire mos short health survey - 36 items version 2 (sf-36), and the battery of functional tests fitness test. the questionnaires were filled by the elderly with the presence of the investigator and the physical fitness was evaluated following the protocol of proof. the sample was constituted of 83 elderly individuals over 55 years of age. in statistical terms we used a percentage analysis in the questionnaire and in the evaluation of the physical condition after application of the kolmogorov-smirnov test, we used the non-parametric test for two paired variables wilcoxon.

Eligibility criteria:
inclusion criteria: * hydrogymnastics practitioners * participants over 55 years of age exclusion criteria: -

Keywords: hydrogymnastics physical condition physical activity and health gerontomotricity
comparing the efficacy of reverse hybrid therapy and concomitant therapy

Conditions: Helicobacter Pylori Infection

Summary: reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

a 14-day hybrid therapy invented by our study group appears very promising in h. pylori eradication, achieving excellent eradication rates of 99% and 97% according to per-protocol and intention-to-treat analyses, respectively. recently, the investigators demonstrated that the eradication rate of reverse hybrid therapy was higher than that of standard triple therapy. however, whether reverse hybrid therapy achieves a higher eradication rate than concomitant therapy remains unanswered.

Eligibility criteria:
inclusion criteria: * consecutive h pylori-infected outpatients, at least 20 years of age, with endoscopically proven peptic ulcer diseases or gastritis exclusion criteria: * previous h pylori-eradication therapy * ingestion of antibiotics or bismuth within the prior 4 weeks * patients with allergic history to the medications used * patients with previous gastric surgery * the coexistence of serious concomitant illness (for example, decompensated liver cirrhosis, uremia) * pregnant women

Keywords: helicobacter pylori eradication rate
impact of preoperative frailty and cognitive impairment on postoperative outcomes in elderly cardiac surgery patients

Conditions: Cardiovascular Diseases

Summary: this is a retrospective study of patients aged 65 years and older who underwent cardiac and aortic surgery between march 5, 2021 and october 12, 2022 in the operating room of severance cardiovascular hospital to determine the impact of physical frailty as well as nutritional status, emotional dysregulation, and cognitive dysfunction on postoperative outcomes. physical frailty will be determined by the clinical frailty scale, handgrip strength, and nutritional status, cognitive dysfunction will be determined by the k-mmse and k-moca administered at the preoperative interview, and emotional dysregulation will be determined using the sgds-k. these were measured during the pre-anesthesia evaluation and only results from patients who agreed to be tested will be used. nutritional status will be analyzed based on blood test values measured within one month of surgery.


Eligibility criteria:
inclusion criteria: * 65-year-old patients undergoing surgery for heart and aortic disease, who completed physical (clinical frailty scale, handgrip strength), cognitive(k-moca, k-mmse), and emotional (sgds-k) functioning tests at the preoperative interview exclusion criteria: * failed to complete two or more of assessments shown above
study evaluating multiple oral doses of ppm-204 in healthy japanese male subjects

Conditions: Diabetes Mellitus

Summary: a study evaluating the safety and pharmacokinetics of multiple oral doses of an investigational oral diabetic agent when given to healthy japanese male volunteers.


Eligibility criteria:
inclusion criteria: * men, aged 20 to 45 years, inclusive * body mass index in the range of 17.6 to 26.4 kg/m2 * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ecg) exclusion criteria: * history of cardiac, thyroid, muscle, and kidney abnormalities * history of nsaid induced bronchospasm or asthma * history of any clinically important allergies
assessing a medicaid randomized insurance experiment within community clinics

Conditions: Cardiovascular Disease; Cancer

Summary: this study examines the impact of a randomized insurance experiment on preventive services receipt and healthcare utilization in safety net patients using linked public insurance claims and safety net clinics' electronic health record (ehr) data.

in 2008, the oregon medicaid program used a "lottery" (oregon experiment) to allocate limited insurance resources to low income adults who did not categorically qualify for traditional medicaid coverage. thousands were randomly selected to apply for medicaid; many others were not selected. this "natural policy experiment" is the first population-level randomization of insurance coverage since rand's 1971-1982 experiment. we will use data from safety net clinics that share a common electronic health record (ehr) operated by ochin, a non-profit organization in portland, oregon. as one of the nation's largest linked community health center networks, the ochin ehr database records nearly all visits to safety net clinics in oregon with one patient chart linked across \>100 community health centers. we will link medicaid claims data and the ochin database to determine patients that had applied to participate in the oregon experiment, as well as to determine those that gained insurance via this experiment. we will test the hypothesis that public insurance coverage is associated with higher rates of receiving preventive care services and increased healthcare utilization among persons with a usual source of primary care. to that end, we will analyze preventive care and utilization patterns among the ochin clinic patients affected by oregon's medicaid experiment. this study capitalizes on two unique opportunities: an ehr database linking \>100 community health centers, and the quasi-experimental design of oregon's randomized medicaid experiment. the specific aims related to the oregon experiment are: 1) to compare post-intervention rates of preventive services receipt among ochin patients randomized to the oregon experiment group (intervention group), compared to those not in the coverage group (comparison group); and 3) to compare post-intervention rates of ambulatory healthcare utilization among ochin patients randomized to the oregon experiment group (intervention group), compared to those not in the coverage group (comparison group).

Eligibility criteria:
inclusion criteria: * must have applied for the oregon experiment in 2006 * must have been a patient in an oregon safety net clinic that is part of the ochin, inc network * for preventive services outcomes only, matched patients had to have been at a clinic with an electronic health record system by 3/11/08 exclusion criteria: * under 19 years of age * over 64 years of age * not alive at the end of the 36 month post-period * unknown/missing gender

Keywords: medicaid public insurance cardiovascular disease prevention community health centers electronic health records cancer prevention
a trial to evaluate the pharmacokinetic and pharmacodynamic properties of biochaperone® insulin lispro, fiasp® and novorapid® delivered by an insulin pump

Conditions: Type1 Diabetes Mellitus

Summary: this is a single-centre, randomised, double-blind, three-period, complete cross-over trial comparing the pharmacokinetic and the pharmacodynamic properties of biochaperone® insulin lispro and the two active comparators fiasp® and novorapid® when given as a bolus on top of basal delivery with an insulin pump in subjects with type 1 diabetes mellitus. each subject will be randomly assigned to a treatment sequence consisting of 3 dosing visits during which the subject will receive the investigational products. in a euglycaemic clamp setting, subjects will be given a bolus dose of 0.15 u/kg body weight. throughout the glucose clamp procedure, blood glucose will be stabilised at a target level of 100 mg/dl by means of an intravenous infusion of glucose. blood samples for pharmacokinetic assessment will be drawn at specified timepoints and glucose infusion rates and blood glucose concentrations will be recorded for pharmacodynamic assessment during the 10-hour clamp procedure after dosing.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus for more than 12 months. * bmi between 18.5 and 28.5 kg/m². * hba1c level \<=9.0%. * insulin treated for at least 12 months with total insulin dose \<1.2u/kg/day. exclusion criteria: * type 2 diabetes mellitus. * history of multiple and/or severe allergies to drugs or foods. * any history or presence of clinically relevant cardiovascular, pulmonary, respiratory, gastrointestinal, hepatic, renal, metabolic, endocrinological (with the exception of conditions associated with diabetes mellitus), haematological, dermatological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness as judged by the investigator. * more than one episode of severe hypoglycaemia with seizure, coma or requiring assistance of another person during the past 6 months. * proliferative retinopathy or maculopathy and/or severe neuropathy, in particular autonomic neuropathy. * females of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant or are not using highly effective contraceptive methods.
delayed 18f-fdg pet/ct in improving visualization of brain tumors in patients with glioblastoma

Conditions: Glioblastoma; Glioma

Summary: this clinical trial studies how well delayed fludeoxyglucose f-18 (18f-fdg) positron emission tomography (pet)/computed tomography (ct) works in improving visualization of brain tumors in patients with glioblastoma. radiotracers such as 18f-fdg are highly taken up by tumors in the brain and are visualized using pet/ct. increasing the interval of time between 18f-fdg administration and pet/ct scan may improve the visualization of brain tumors in patients with glioblastoma.

primary objectives: i. to improve the visualization/delineation of glioblastoma lesions using delayed 18f-fdg pet/ct imaging. outline: patients receive fludeoxyglucose f-18 intravenously (iv). patients then undergo a standard of care pet/ct scan at 60 minutes and a second pet/ct scan at 240 minutes after injection. note: standard uptake value (suv) is defined for state-of-the art pet/ct scanners as standardized uptake values = count activity per ml within region of interest (mbq/ml)/\[injected dose (mbq)/body weight (kgx1000)\]

Eligibility criteria:
inclusion criteria: * patients with histologically proven high grade glioma scheduled for 18f-fdg pet/ct exclusion criteria: * severe psychiatric illness * inability to give written consent * breast feeding/pregnancy