Kornimate/medical-research-clean huggingface dataset:
a study to determine the pharmacokinetics (pk) of single intravenous (iv) dose of vedolizumab 300 milligram (mg) in healthy adult chinese participants

Conditions: Colitis, Ulcerative; Crohn Disease

Summary: the purpose of this study is to assess the pk of vedolizumab following a single intravenous infusion in healthy adult chinese participants.

the drug being tested in this study is called vedolizumab. vedolizumab is being tested to treat people who have ulcerative colitis (uc) or crohn's disease (cd). this study will look at the pk, safety, and tolerability of vedolizumab following a single intravenous infusion of vedolizumab iv in healthy adult chinese participants. the study will enroll approximately 16 participants. all participants will be assigned to receive a single dose of vedolizumab iv 300 mg on day 1. this single center trial will be conducted in china. the overall time to participate in this study is approximately 7 months. participants will make multiple visits to the clinic, and will be contacted by telephone, 6 months after single dose of study drug for a follow-up safety survey assessment.

Eligibility criteria:
inclusion criteria: 1. the participant weighs at least 50 kilogram (kg) and has a body mass index (bmi) from 19.0 to 26.0 kilogram per square meter (kg/m\^2) inclusive at screening. exclusion criteria: 1. has one or more positive response on the progressive multifocal leukoencephalopathy (pml) subjective symptoms checklist at screening or before dosing on day 1. 2. has had a surgical procedure requiring general anesthesia within 30 days before the initial screening visit or is planning to undergo a surgery that requires general anesthesia during the study period (through final visit/day 127). 3. for participants who are negative for hepatitis b surface antigen (hbsag) but are positive for either surface antibodies and/or core antibodies, hepatitis b virus deoxyribonucleic acid (dna) polymerase chain reaction will be performed and any result that meets or exceeds detection sensitivity will be excluded. 4. has poor peripheral venous access. 5. has a qt interval with fridericia correction method (qtcf) greater than (\>) 430 millisecond (ms) (males) or \>450 ms (females) or pr outside the range 120 to 220 ms, confirmed with 1 repeat testing within a maximum of 5 minutes, at the screening visit or check-in (day -1).

Keywords: drug therapy
hcv treatment with fluvastatin, simvastatin to improve interferon sensitivity

Conditions: Chronic Hepatitis C

Summary: objective: the goal is to improve peginterferon sensitivity in previous poor responders. "sensitivity" here means the host's ability to kill more hcv. design: twenty poor responders to prior pifn/rbv will be given 48 weeks of statin monotherapy. veterans and civilians between the ages of 18 and 70 are eligible.


Eligibility criteria:
inclusion criteria: hepatitis c positive by hcv rna within 180 days. - no anti-hcv medicine within 30 days of screening exclusion criteria: * decompensated liver disease * severe cardiac disease (ejection fraction \< 20% or uncontrolled angina) * unexplained muscle pain at time of screening * pregnancy * renal insufficiency (creatine clearance \< 50 ml/min)

Keywords: chronic hepatitis c, interferon
postprandial inflammation in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid; Inflammatory Response; Dietary Exposure; Diet, Healthy

Summary: patients with ra will be studied to see whether meals of different content will affect inflammation and metabolic variables in the postprandial state. healthy controls will also be invited to examine potentially different responses to patients with ra.

the pira study aims to evaluate the metabolic and inflammatory effects after a vegan meal or a meal containing red meat or fish in patients with ra and matched controls. the study have a cross-over design and each participant will have one of three meals every week and then be compared to themselves. in addition healthy individuals will be included for the red meat meal so that the response from this meal could be compared between patients with ra and their matched controls. blood samples will be collected before the meal (fasting) and every hour until 5h. primary outcome will be high sensitive il-6. secondary outcomes will be additional inflammation markers such as area under curve for hs-crp and gene expression in pbmc:s regarding genes related to inflammation and, glucose, blood lipids and metabolomics-profile in serum and urine.

Eligibility criteria:
inclusion criteria for patients with ra: * diagnosed with rheumatoid arthritis * bmi 18.5-30.0 kg/m2 * 2 years or more since diagnosis * no dmard changes during the last 3 months inclusion criteria for healthy controls: * absence of diagnosis of ra * bmi 18.5-30.0 kg/m2 * self-assessed as healthy exclusion criteria: * diagnosis of cancer, inflammatory bowel disease, celiac disease, diabetes * allergy or intolerance to any of the foods in the study * pregnancy or breastfeeding * use of any blood lipid lowering medication, glucocorticoids or il-6-inhibitor during the last 4 weeks prior to enrolment * smoking * hemoglobin \< 100 g/l

Keywords: postprandial inflammation rheumatoid arthritis ra diet pira
av fistula patency loss as a cause of fistula failure and hyperphosphatemia

Conditions: AV Fistula

Summary: assessment of arteriovenous fistula patency loss which leads to av fistula failure and its relation to high serum phosphate level in chronic hemodialysis patients.

end-stage renal disease is a chronic disease requiring treatment with dialysis or renal transplantation. patients require an adequate vascular access for hemodialysis (hd). autologous arteriovenous fistula (avf) is gold standard to maintain vascular access for hd . vascular access-related complications can lead to patient morbidity and reduction of patient quality of life.the complication rate related to permanent hd vascular access remains relatively high and access related problems are responsible for 50% of the hospitalization of dialysis patients. secondary failures are not rare and in need of adequate attention and care. once the avf has been placed. it is recommended that serial monitoring of the avf should be done for long term effective function. delays in preventing complications may lead to avf dysfunction. however, little is known about the factors determining long term prognosis of an avf. primary patency (intervention-free access survival) was defined as the interval from time of access placement to any intervention designed to maintain or reestablish patency or to access thrombosis or the time of measurement of patency. assisted primary patency (thrombosis-free access survival) was defined as the interval from time of access placement to access thrombosis or time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to maintain the functionality of a patent access. secondary patency (access survival until abandonment) was defined as the interval from time of access placement to access abandonment or time of measurement of patency, including intervening manipulations (surgical or endovascular interventions) designed to reestablish the functionality of thrombosed access . in patients having chronic renal failure (crf), several changes occur in bone metabolism due to the development of secondary hyperparathyroidism. there are increased calcium and phosphate release from bones to the blood, causing the deposition of calcium and phosphate in the intima-media layer of arterial wall and eventuating vascular calcification in these patients. the deposition of these electrolytes increases the risk of cerebrovascular and coronary complications as well. thus, a decrease in the quality of fistula occurs in these tracts utilized frequently at the arteriovenous fistula (avf) operations.

Eligibility criteria:
inclusion criteria: * adult patients more than 18 years old with end stage renal disease on regular hemodialysis using arteriovenous fistula exclusion criteria: * : patients less than 18 years, patients with peripheral artery diseases, access failure occurred within the first 2 months after fistula surgery, avf failure was related to an infectious complication and patients with arteriovenous grafts.

Keywords: hyperphosphatemia
prospective evaluation of the fluid rapid influenza test

Conditions: Influenza

Summary: the primary objective of this study is to evaluate the fluid rapid influenza test's ability in detecting influenza a and influenza b from individuals presenting with signs and symptoms of influenza-like illness (ili).

the primary objective of this study is to evaluate the clinical sensitivity and specificity of the fluid rapid influenza test in detecting influenza a and influenza b, as evaluated with respect to fresh samples collected prospectively from individuals presenting with signs and symptoms of influenza-like illness (ili). test results will be compared with those obtained from viral culture testing of samples using the same specimen types, obtained from the same subjects. the specimen types under evaluation in this study will be nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens. a secondary objective of this study is to evaluate the accuracy of the fluid rapid influenza test in detecting each of the h1 and h3 subtypes of influenza a, in nasal swab, nasopharyngeal swab, nasal wash and aspirate specimens.

Eligibility criteria:
inclusion criteria: 1. male or female subjects of any age; 2. subjects presenting to the investigative site within 4 days of symptom onset, with: * fever ≥ 38.0°c (100.4°f) if taken orally, or ≥ 38.5°c (101.2°f) if taken rectally; or a self-reported history of fever or feeling feverish (includes fever controlled by medication) in the absence of documented fever; * one or more respiratory symptoms of influenza-like illness which may include the following: * sore throat; * runny or stuffy nose; * cough; * one or more constitutional symptoms of influenza-like illness which may include the following: * myalgia (aches and pains); * headache; * fatigue; 3. subjects (or parent/guardian) willing and able to provide informed consent. written subject informed consent for this study protocol must be obtained prior to study enrollment. each subject (or parent or guardian) must personally sign and date the subject informed consent form prior to his/her participation in this clinical study. exclusion criteria: 1. subjects not presenting with at least three symptoms of influenza-like illness as outlined above. 2. subjects who have received influenza antiviral medication or an investigational influenza drug treatment within the previous 30 days of study enrollment. 3. subjects (children and adults) for whom the obtaining of swab samples, nasal wash or aspirate samples is contraindicated or not possible. 4. subjects with a medical condition that prevents swab samples or nasal washes or aspirate samples from being obtained. 5. active duty military personnel (participating military study sites only). 6. subjects (or parent/guardian) unwilling or unable to provide informed consent.
comparison of efficacy of oral amoxicillin versus intravenous ceftriaxone

Conditions: Community-acquired Pneumonia

Summary: the efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of iv trauma and infection, which is a major problem in developing countries. therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (iv) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

the efficacy of oral amoxicillin is considered equal to that of ceftriaxone in community-acquired pneumonia among children. also, there are some factors that contradict the usage of ceftriaxone, like antibiotic resistance, adverse reactions, drug cost, and the and the chances of iv trauma and infection, which is a major problem in developing countries. therefore, this study was planned to determine the efficacy of oral amoxicillin compared with intravenous (iv) ceftriaxone in the treatment of uncomplicated ceftriaxone in community acquired pneumonia in children less than 5 years of age.

Eligibility criteria:
inclusion criteria: * children of both gender * aged from 2 to 5 years * with fever \>37.5 c (99.5 f) * will be presented with symptoms and signs of uncomplicated community acquired pneumonia exclusion criteria: * children requiring icu care (having cyanosis spo2 \< 85% requiring intubation within first day of admission or in state of shock) * children with conditions like congenital heart disease, chronic lung disease, chronic kidney disease, severe malnutrition, asthma, foreign bodies, sickle cell disease, and immunodeficiency * children with underlying anatomical disorders of the lung like pulmonary sequestration, tracheoesophageal fistula or congenital cystic adenoid malformation * children already on antibiotics * presence of any complication of community acquired pneumonia * patients having symptoms of multi-organ involvement/sepsis * hypersensitivity to amoxicillin or ceftriaxone * other co-existing infections like dengue, malaria, or measles
phase ii clinical trial of pd-l1 in combination with vinorelbine + cyclophosphamide + capecitabine (vex) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.

Conditions: Advanced Triple-negative Breast Cancer

Summary: phase ii clinical trial of pd-l1 in combination with vinorelbine + cyclophosphamide + capecitabine (vex) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.


Eligibility criteria:
subjects are eligible to be included in the study only if all of the following criteria apply: 1. male or female who is 18 years of age or older on the day of signing the informed consent form. 2. subjects with metastatic triple-negative breast cancer, with clear clinical data records; specific reference to the "american society of clinical oncology - college of american pathologists (asco/cap) guidelines." 3. have received less than or equal to 1 line of chemotherapy for metastatic breast cancer; 4. have an eastern cooperative oncology group (ecog) performance status of 0 or 1 as assessed within 10 days before the start of study treatment; 5. subjects must have at least one measurable lesion present; specific reference to the "response evaluation criteria in solid tumors version 1.1 (recist v1.1)" guidelines; 6. subjects may have previously received treatment with anthracyclines (e.g., doxorubicin, epirubicin) and/or taxanes (e.g., paclitaxel, docetaxel) as follows: a) the subject has used anthracyclines and/or taxanes during adjuvant and/or neoadjuvant therapy before breast cancer recurrence. b) the subject has experienced treatment failure during or after chemotherapy based on anthracyclines and/or taxanes. c) according to the investigator's judgment, the subject is not suitable for anthracyclines and/or taxanes-based chemotherapy as a first-line treatment option. 7. female subjects are not pregnant, not lactating, and agree to use necessary contraceptive measures. 8. subjects are able to sign an informed consent form to participate in the study. 9. have appropriate organ function, as detailed in table 1; all screening laboratory tests should be completed within 10 days before the start of study treatment.

Keywords: advanced triple-negative breast cancer pd-l1 in combination with vex metronomic chemotherapy radiotherapy
effect of sodium lauryl sulfate on recurrent aphthous stomatitis

Conditions: Recurrent Aphthous Stomatitis

Summary: sodium lauryl sulfate (sls) is an anionic detergent that has been used as the major or sole surfactant in most dentifrices. but it is known to local irritating factor to oral mucosa and skin and results in many side effects. this study was to compare the effects of sls-free dentifrice and sls-containing dentifrice in patients with recurrent aphthous stomatitis (ras).


Eligibility criteria:
inclusion criteria: * the volunteers had a history of regularly recurring oral ulcerations of at least 6 months duration, with more than one episode per month exclusion criteria: * already using an sls-free dentifrice * taking medications affecting oral ulcers (e.g., corticosteroids) * having chronic oral mucosal disease (ex, lichen planus, pemphigus vulgaris, pemphigoid, and etc.) * having allergies to food or medications * being pregnant

Keywords: sodium lauryl sulfate (sls) recurrent aphthous stomatitis (ras) dentifrice pain
internet-delivered cognitive behaviour therapy (icbt) for post-secondary students

Conditions: Anxiety; Depression

Summary: post-secondary students are at an elevated risk for anxiety and depression, with approximately one in three students experiencing clinical levels of symptoms at some point during their academic career. despite the high prevalence of these mental health concerns, many students do not receive adequate treatment. internet-delivered cognitive behaviour therapy (icbt) is an alternative to face-to-face service that is effective for improving symptoms of anxiety and depression in general adult populations. recently, there has been increasing interest in the use of icbt in post-secondary populations, however high drop-out rates and small effect sizes suggest that current icbt programs are not fully meeting students' specific needs. additional research is necessary to ensure that icbt is delivered to students in a manner that is both acceptable and effective. the proposed study will be an implementation trial to examine whether the efficacy of an icbt course for post-secondary students is improved by offering a motivational interviewing component at pre-treatment and a booster session 1-month after completing treatment. follow-up assessment will be conducted as 3-month post-treatment. primary outcomes are anxiety, depression, and academic functioning. implementation outcomes will include measures of the acceptability, adoption, and fidelity (assessed by number of modules completed) of the icbt course.

the aims of the study will be to: assess the efficacy of the uniwellbeing course in reducing symptoms of anxiety and depression and increasing adjustment to academic and social responsibilities; to assess the impact of a pre-treatment motivational interviewing component on attrition, engagement, and outcomes (depression, anxiety, and academic functioning); to assess the impact of a booster session on anxiety, depression, and academic and social adjustment at three-month follow-up; and to assess the combined effect of including both a motivational interviewing component and booster session on outcomes.

Eligibility criteria:
inclusion criteria: * registered as a student at a post-secondary institution in saskatchewan; over the age of 18;endorse symptoms of depression and/or anxiety; be able to access computers and the internet and be comfortable using them; and willing to provide a physician as an emergency contact exclusion criteria: * high risk of suicide or hospitalization for mental health in previous 12 months * unmanaged alcohol or drug use problems * severe psychiatric illness that is not managed (e.g. psychosis or mania)

Keywords: anxiety depression post-secondary students internet-delivered cognitive behaviour therapy randomized controlled trial patient-centred therapist-assistance
observational study evaluating the quality of pegylated interferon alfa-2a and ribavirin treatment for chronic hepatitis c in cooperation with the bng (association of german resident gastroenterologists)

Conditions: Chronic Hepatitis C

Summary: this observational study will examine the efficacy and safety of pegylated interferon (peginterferon) alfa-2a, mostly in combination with ribavirin treatment in chronic hepatitis c (chc). quality of care will also be assessed. approximately 12% of the interferon-treated chc patient population in germany is expected to be studied over a period of 5 years.


Eligibility criteria:
inclusion criteria: * 18 years of age or over * clinically diagnosed chc with detectable virus replication * women of childbearing potential should use adequate contraception. it is important that female participants of childbearing potential and their sexual partners use 2 contraceptive methods at the same time during treatment and 4 months after treatment discontinuation. during this time pregnancy tests have to be performed monthly. particular attention is also required and pregnancy should be avoided 7 months after treatment discontinuation in female sexual partners of male participants taking ribavirin (copegus®). both should use adequate contraception. exclusion criteria: * any contraindications for peginterferon alfa-2a or ribavirin treatment * pregnant or breast-feeding
reducing breast cancer risk in korean american women

Conditions: Secondhand Tobacco Smoke Exposure Reduction

Summary: the goals of the study are to develop a culturally and linguistically appropriate intervention to reduce shs exposure for lep korean women using a family-focused intervention approach targeting korean americans ages 18 and above in the greater san francisco bay area, ca, and to evaluate efficacy of the proposed intervention. the study is a single group feasibility trial targeting a total of 4 lay health workers (lhw) and 24 dyads of lep korean women with self-reported shs exposure at home and a male household smoker. the hypothesis is: h. can a family-based intervention approach reduce shs exposure among korean american women who live with a current smoker?


Eligibility criteria:
inclusion criteria: * self-identified as korean or korean american; * korean speaking; * reside in the san francisco bay area * plan to stay in the area for the next 3 months * for women participants, the participant must report having shs exposure at home at least 1 day in the past 7 days and live in the same household as the smoker participant to form a dyad. * for the smoker participants, they must be male and have smoked at least 1 cigarette daily in the past 7 days. * provide a valid contact telephone number for pre- and post-intervention assessments