Kornimate/medical-research-clean huggingface dataset:
does 3 months therapy with vitamin d + peg + ribavirin improve sustained virologic response (svr) in genotype 2, 3 chronic hepatitis c patients?

Conditions: Chronic Hepatitis C

Summary: standard therapy for chronic hepatitis c virus (hcv) is (peg/rbv) combination therapy obtaining sustained virologic response (svr) in 80% of naïve patients with genotype 2,3. studies rarely address the issues of improving host factors. the current study examines 1. does 3 months therapy with vitamin d+ peg + ribavirin could improve viral response and shorten treatment duration (from 24 weeks to 12 weeks) 2. whether vitamin d levels predicts negative treatment outcome.

standard therapy for chronic hepatitis c virus (hcv) is (peg/rbv) combination therapy obtaining sustained virologic response (svr) in 80% of naïve patients with genotype 2, 3. studies rarely address the issues of improving host factors. the current study examines whether adding vitamin d, a potent immunomodulator, for 3 months therapy could improve viral response. the working hypothesis is that 3 months therapy with vitamin d + peg + ribavirin significantly improves rvr, evr, and svr.

Eligibility criteria:
inclusion criteria: * 18 to 65 years of age * chronic genotype 2,3 hcv infection * treatment naive negative sero for hbv, hdv and hiv viral infections * absolute neutrophil count of \>1500 per cubic millimeter * a platelet count of \>90,000 per cubic millimeter normal hemoglobin level exclusion criteria: * decompensated liver disease (cirrhosis with cp score \>9) * another cause of clinically significant liver disease hepato cellular carcinoma * psychiatric disorder * chronic heart failure * pregnant women * uncontrolled diabetes with retinopathy arrhythmia active cad * positive sero for hbv, hdv and hiv viral infections or other autoimmune liver disease

Keywords: svr vitamin d hepatitis c genotype 2,3 naive rvr
lidocaine before esophageal manometry and ambulatory ph monitoring

Conditions: Pain, Acute

Summary: a randomized controlled trial comparing esophageal manometry and ambulatory ph monitoring test tolerance in the presence versus in the absence of topical lidocaine.

conventionally, topical nasopharyngeal anesthesia is applied to improve the tolerance of esophageal manometry and ambulatory ph monitoring. however, there is currently no data to support this practice. this randomized controlled trial of lidocaine versus placebo applied before these tests will evaluate the benefit of topical lidocaine anesthesia.

Eligibility criteria:
inclusion criteria: adult patients undergoing esophageal manometry or ambulatory ph monitoring at our center who are able to read and consent to participate in the study. exclusion criteria: * patients \< 18 years * incapacity to provide consent * history of lidocaine allergy * current pregnancy * previous esophageal manometry or ambulatory ph monitoring in the last 14 days * previous participation in the study * severe cirrhosis (child-pugh c) * severe chronic kidney disease (egfr\<30 ml/min/1.73m2) * severe heart failure (new york heart association functional classification 3-4) * severe respiratory failure (dyspnea or oxygen-dependent at rest) * any active severe incapacitating chronic or acute medical disease * active hospitalization * ulcerated, atrophic, infected or recently burned (in the last 30 days) nasopharynx * recent surgery involving the nasopharynx (in the last 30 days) * severe chronic pain (ex. regular daily use of opioids) * previous stroke or any neurological lesion with resulting current sensory deficit * major neurocognitive disorder * any active severe incapacitating chronic or acute psychiatric disease

Keywords: manometry ph monitoring lidocaine
a randomized phase ii trial to compare the safety and neutralizing activity of cl184 in combination with rabies vaccine vs. hrig or placebo in combination with rabies vaccine in healthy adult subjects

Conditions: Rabies

Summary: the aim of this study is to evaluate the safety of the monoclonal antibody cocktail cl184 in combination with rabies vaccine compared with human rabies immune globulin (hrig) or placebo in combination with rabies vaccine in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * subjects free of obvious health-problems or with stable condition * male or female subjects aged ≥19 to ≤65 years * bmi between ≥18 and ≤30 kg/m2 exclusion criteria: * prior history of active or passive rabies immunization * clinically significant acute illness or infection within 2 weeks before first dosing based on the clinical judgment of the investigator * history and/or family history of clinically significant immunodeficiency or auto-immune disease * any clinically significant history of known or suspected anaphylaxis or hypersensitivity reaction * chronic administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of investigational medicinal product

Keywords: rabies post-exposure prophylaxis
chios mastic toothpaste and halitosis and oral hygiene in orthodontic patients

Conditions: Halitosis; Orthodontic Appliance Complication

Summary: the aim of this trial was to investigate the effect of mastic toothpaste on halitosis using as proxy the levels of the volatile sulfur compounds (vscs), and the effect on plaque and gingival indices in adolescents undergoing orthodontic treatment with fixed conventional labial appliances.


Eligibility criteria:
inclusion criteria: patients eligible for the trial must comply with all of the following at randomization: • age between 13 and 18 years for the group with conventional orthodontic appliances. this age group represents the majority of patients seeking orthodontic treatment and is homogeneous regarding occupational status (high-school and lyceum students in greece). younger patients might present with cooperation problems. * good general health. * orthodontic fixed labial appliances on the maxillary and mandibular arch, brackets at least on 20 teeth for more than 4 months before enrollment and estimated duration of the treatment more than 1 month, bands on the first molars, extraction cases patients could be enrolled at least two months after the last extraction. * total initial vscs levels above the baseline level of 150ppb. exclusion criteria: patients will be excluded for any of the following reasons: * active caries * periodontitis * dental fluorosis / dysplasia of the teeth * syndromes, mental disabilities and craniofacial deformities * smoking or use of other tobacco products * allergy to mastic * antibiotics during the last 2 months * chlorhexidine in the previous 3 weeks * participation in other trials

Keywords: halitosis mastic orthodontic appliance
a study of pro95780 in combination with cetuximab and irinotecan chemotherapy or the folfiri regimen with bevacizumab in patients with previously treated metastatic colorectal cancer (apm4187g)

Conditions: Colorectal Cancer

Summary: this is a phase ib, open-label, multicenter, dose-escalation study designed to assess if pro95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mcrc) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. this study will also make a preliminary assessment of the anti-tumor activity of pro95780 in combination with irinotecan and cetuximab or the folfiri regimen plus bevacizumab.


Eligibility criteria:
inclusion criteria: * signed informed consent * age ≥ 18 years * histologically confirmed crc with evidence of metastases and measurable tumor lesions * documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy * life expectancy \> 3 months * for patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device \[iud\], physical barrier) throughout the trial and for 6 months following their final exposure to study treatment * willingness and capability to be accessible for study follow-up exclusion criteria: * patients who have a kras mutation will be excluded from receiving cetuximab-containing regimens * prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy * recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field * recent chemotherapy, hormonal therapy, or immunotherapy * evidence of clinically detectable ascites * other invasive malignancies within 5 years * history or evidence of active central nervous system (cns) disease * current or recent participation in another experimental drug study * clinically significant cardiovascular disease * active infection requiring parenteral antibiotics * recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, or anticipation of need for major surgical procedure during the course of the study * known or suspected to be positive for the human immunodeficiency virus (hiv) * known to be positive for hepatitis c or hepatitis b surface antigen * history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment * pregnancy (positive pregnancy test) or breast feeding * serious, non-healing wound, ulcer, or bone fracture * known sensitivity to any of the products administered during the study * any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures

Keywords: crc colon cancer avastin apm4187g
bisphosphonates for the treatment of seropositive musculoskeletal complaints

Conditions: Seropositive Muskuloskeletal Complaints

Summary: seropositive rheumatoid arthritis (ra) is characterized by autoantibodies that develop prior to clinical onset, allowing identification of individuals at risk for disease development. in a unique program in stockholm, seropositive individuals presenting with musculoskeletal complains are currently identified and followed-up in a dedicated outpatient clinical program. despite significant disease burden and increased sick leave among these individuals, we lack today any therapeutic and preventive measures. we aim to (1). establish a nation-wide health program, (2). develop an algorithm for disease risk estimation and (3). test a novel strategy to delay and/or prevent disease onset in seropositive at risk individuals with musculoskeletal complains. we will perform a multicentre randomised study to treat autoantibody-positive individuals at risk for developing ra presenting with pain (population), by repurposing of bisphosphonates (intervention) as compared to placebo (control) to treat pain (primary outcome) and delay/prevent ra development during 1-year follow-up (secondary outcome)

we have recently identified a novel disease-triggering pathogenic mechanism in autoantibody-positive individuals consisting in a bone-mediated induction of pain by autoantibodies. we hypothesize that specific targeting of this new mechanism, rather than using therapies developed for already established disease (where other mechanisms are active), will be able to treat pain with arthralgia and halt disease progression in seropositive at-risk individuals. we will address this hypothesis by repurposing of bisphosphonates, currently used in clinical practice in both ra patients as well as in many individuals at risk for ra (mainly women in post-menopausal age). we will perform a multi centre, prospective, randomised, double-blind and placebo-controlled study with 2 parallel groups. patients will be randomised 1:1 to receive either one infusion aclasta (5 mg zolendronic acid, n=40) or placebo (n=40). the primary outcome is the vas pain score and the study is powered to detect a 20% difference in the primary endpoint between the active and the control arm. the study is powered to detect a 20-percentage point difference in proportions between the control and the treated group. subjects may withdraw from the trial at any time at their own or the investigators request for safety reasons.

Eligibility criteria:
inclusion criteria: age older than 18 years lack of arthritis as estimated by clinical and ultrasound examination of the joints acpa positive intermediate or high risk for ra (according to the algorithm described above) vas score of at least 20 mm exclusion criteria: a previous diagnosis of arthritis intolerance/contraindication to any of the study medications
study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of sam-531 in healthy japanese males

Conditions: Alzheimer Disease

Summary: to assess the safety and tolerability of ascending single oral doses of sam-531, an investigational drug, in healthy japanese male subjects. secondary: to obtain preliminary pharmacokinetic (pk) and pharmacodynamic (pd) profiles of sam-531 in healthy japanese male subjects.


Eligibility criteria:
inclusion criteria: * men aged 20 to 45 years (inclusive) at the time of getting informed consent. * body mass index (bmi) in the range of 17.6 to 26.4 kg/m2 and body weight ≥50 kg (bmi = \[weight (kg)\]/\[height (m)2). * healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and digital 12-lead electrocardiogram (ecg). alanine aminotransferase (alt), aspartate aminotransferase (ast), and creatinine levels must be within the upper limit of normal for eligibility. exclusion criteria * any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ecgs, or clinical laboratory test results. * consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages is prohibited from 48 hours and consumption of grapefruit or a grapefruit-containing product is prohibited from 72 hours before study day 1.
french validation of the capture case finding tool for obstructive respiratory disease

Conditions: Lung Diseases; Lung Diseases, Obstructive; Obstructive Pulmonary Disease

Summary: the objective of this multicentre prospective study is to validate capture as a french case finding tool for undiagnosed patients suffering from obstructive pulmonary disease.

a large number of healthcare professional across the country will screen participants. participants willing to participate will have a short interview, and then will have to answer the 5-item capture questionnaire. they will be assisted to perform a peak expiratory flow measurement with a portable device. the comparison will be made between the capture decision and a portable spirometry assessing the presence or not of an obstructive disorder. patient screened either by the tool or the spirometry will be addressed to a doctor. follow-up at 6 months will be set up in order to assess the entry or not of those patients to an approved health care pathway. at the end of each center's participation, a questionnaire will be sent to all healthcare professionals working on the study, to assess the ease of use of spirometry and the capture tool and its possible implementation in clinical practice.

Eligibility criteria:
inclusion criteria: * people aged 40 or more, * provision of dated and signed informed consent form, * currently being treated by a healthcare professional, * patients affiliated to the french social security system. exclusion criteria: * patients previously diagnosed with copd or asthma, * patients with any condition making them unable to perform spirometry or answer a short questionnaire, * patients unable to give free and informed consent.

Keywords: copd asthma case finding
the effect of glp-1 on the inhibition of glucagon secretion

Conditions: Type 2 Diabetes; Type 1 Diabetes

Summary: diabetes(both types) are recognized by high levels of glucagon in the circulation. glucagon is known to increase blood glucose, and might therefore contribute to the respective diseases. under some circumstances the gut hormone glp-1 inhibits the glucagon secretion. the investigators aim to identify the impact of glp-1 on the glucagon secretion, at increasing blood glucose levels in healthy subjects, in patients with type 2 diabetes, and in patients with type 1 diabetes. the investigators think that the effect of glp-1 on the glucagon secretion might be dependent of blood glucose levels.


Eligibility criteria:
inclusion criteria: patients with t2dm * above the age of 35 years, treatment with diet or oral anti-diabetic medication. diagnosed with t2dm in at leat three months in advance(who criterion) * normal hemoglobin * informed content patients with t1dm * t1dm (who criterion) * plasma-c-peptid negative due to arginin-test * normal hemoglobin * age\> 18 years * informed content healthy subjects * normal fasting plasma glucose and normal glucose tolerance (who criterion) * normal hemoglobin * age \>18 years * informed content exclusion criteria: patients with t2dm * treatment with glitazones and/or gliptins * inflammatory bowels disease * previous bowel resection with or without stomy * nephropathy (serum creatinin \>150 µm and/or albuminuria) * liver disease (serum alanine-aminotransferase (alat) and/or serum aspartate-aminotransferase (asat) \>2×normal values) * medical treatment impossible to break for 12h. * age \>80 years patients with t1dm * overweight (bmi \>30 kg/m2) * inflammatory bowels disease * previous bowel resection with or without stomy * nephropathy (serum creatinin \>150 µm and/or albuminuria) * liver disease (serum alanine-aminotransferase (alat) and/or serum aspartate-aminotransferase (asat) \>2×normal values) * medical treatment impossible to break for 12h (except treatment with insulin). * age \>80 years healthy subjects * diabetes * prediabetes (impaired glucose tolerance and/or impaired fasting plasma glucose) * first order relatives with diabetes * overweight (bmi \>30 kg/m2) * inflammatory bowels disease * previous bowel resection with or without stomy * nephropathy (serum creatinin \>150 µm and/or albuminuria) * liver disease (serum alanine-aminotransferase (alat) and/or serum aspartate-aminotransferase (asat) \>2×normal values) * medical treatment impossible to break for 12h. * age \>80 years

Keywords: glucagon-like peptide-1 glucagon normal physiology t2dm t1dm
rapid identification and phenotypic susceptibility testing for gram-negative bacteremia

Conditions: Gram-negative Bacteremia

Summary: rapids-gn is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (gnb): 1. standard culture and antimicrobial susceptibility testing (ast); or 2. rapid identification and ast using the accelerate phenotest™ bc kit, performed on the accelerate pheno™ system (axdx)

rapids-gn is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (gnb): 1. standard culture and antimicrobial susceptibility testing (ast); or 2. rapid identification and ast using the accelerate phenotest™ bc kit, performed on the accelerate pheno™ system (axdx) patient specimens with positive blood culture with gram stain showing gnb identified during local laboratory business hours will be enrolled by the microbiology laboratory technologist if they do not meet any exclusion criteria. subject specimens will be randomized 1:1 to standard culture and ast or rapid identification and ast using the fda approved accelerate pheno tm system. both groups will receive standard antimicrobial stewardship (as). the primary service, including the prescribing provider, will be unaware of group assignment at the time of randomization, so initial antibiotic choice will not be affected by group assignment. once rapid results become available and/or as interventions are made, treating providers may become aware of group assignment. the goal of this study is to determine the impact of rapid bacterial identification and phenotypic antimicrobial susceptibility testing (ast) on antimicrobial usage and clinical outcomes.

Eligibility criteria:
inclusion criteria: * positive blood culture with gram stain showing gnb identified during local laboratory business hours. exclusion criteria: * identification of gnb outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing) * positive blood culture for gnb at the same institution within prior 7 days (if known at the time of randomization). * deceased at the time of randomization. * gnb plus gram-positive organism, gram-negative cocci, and/or yeast detected on gram stain * previous enrollment in this study * no minnesota research authorization (rochester site only)

Keywords: gram-negative bacteremia icu critically ill intensive care unit rapid identification rapid susceptibility accelerate phenotest™ bc kit accelerate pheno™ system (axdx) antimicrobial stewardship antimicrobial use