Kornimate/medical-research-clean huggingface dataset:
study of the abuse liability of oxycodone hcl/niacin in subjects with a history of opioid abuse

Conditions: Opioid Abuse

Summary: the purpose of this study is to assess the abuse liability of 4 times (8 tablets) the usual recommended dose of acurox (oxycodone hcl 40 mg plus niacin 240 mg) versus oxycodone hcl 40 mg alone in subjects with a history of opioid abuse.

in the treatment phase, subjects randomly received oxycodone hcl 40 mg administered in combination with niacin 240 mg and oxycodone hcl 40 mg alone in crossover design. 15 subjects were randomized to receive oxycodone/niacin first followed by oxycodone with a 48 hour washout between doses. 15 subjects randomized to receive oxycodone before the oxycodone/naicin dose with a 48 hour washout between doses. the purpose of the treatment phase was to assess the abuse liability and abuse deterrence potential of 4 times the recommended 2-tablet dose of acurox® tablets 5/30 mg versus oxycodone hcl 40 mg alone (8 tablets per dose). all 30 subjects received a single dose of each study treatment. subjects were fasted prior to dosing on all dose days.

Eligibility criteria:
inclusion criteria: * subject is male or female between 18 and 55 years of age * subject meets dsm-iv criteria for the diagnosis of opioid substance abuse and subject is unlikely to experience an idiosyncratic reaction or respiratory depression after ingesting 40 mg of oxycodone * body weight is not more than 20% above or below ideal body weight * subject agrees to abstain from any rx or otc drugs (except as authorized by the investigator) or alcohol * subject is in generally good health * subject is reliable, willing, cooperative, able to communicate effectively, and has a minimum of a 6th grade reading level * subject has an acceptable score on the mmse for cognitive impairment * for women of child-bearing potential: woman is not pregnant and not nursing, and is practicing an acceptable method of birth control exclusion criteria: * subject has a disease that may endanger the subject or the validity of the data * subject is currently physically dependent on opiates or alcohol * subject was exposed to any investigational drug within 30 days prior to the inpatient phase * subject has a history of hypersensitivity to any drug, or a known allergy to any component of the study drug formulation * subject has a positive urine drug screen for a non-opiate drug * subject has a predisposing condition that may place the subject at risk for receiving niacin or oxycodone, or confound the study analyses * subject ingested niacin at doses higher than sdi within 14 days prior to the inpatient phase * subject has an abnormal bleeding tendency

Keywords: abuse liability abuse prevention abuse resistance abuse deterrence
absolute bioavailability of bms-791325

Conditions: Hepatitis C Virus Infection

Summary: the purpose of this study is to determine the absolute bioavailability of 150 mg oral dose of bms-791325 relative to 100 µg iv infusion of \[13c\]-bms-791325.

primary purpose: other: protocol is designed to assess the absolute bioavailability of 150 mg (2x75 mg tablets) bms-791325 administered orally

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: 1. healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations 2. men and women ages 18 to 49 years, inclusive 3. women of childbearing potential (wocbp) must not be pregnant or breastfeeding * wocbp and men who are sexually active with wocbp must agree to follow protocol mandated instructions for method(s) of contraception during and after the study exclusion criteria: 1. any significant acute or chronic medical illness 2. any current or recent gastrointestinal disease or surgery that could impact upon the absorption of study drug 3. inability to tolerate oral medication 4. inability to be venipunctured and/or tolerate venous access 5. use of tobacco-containing or nicotine-containing products within 6 months 6. recent (within 6 months of study drug administration) drug or alcohol abuse as defined in diagnostic and statistical manual of mental disorders (4th edition)(dsm iv), diagnostic criteria for drug and alcohol abuse 7. any of the following on 12-lead electrocardiogram (ecg) prior to study drug administration at screening or day -1, confirmed by repeat i)pr ≥ 210 msec ii)qrs ≥ 120 msec iii)qt ≥ 500 msec iv)qtcf ≥ 450 msec v)second or third degree heart block h) positive urine screen for drugs of abuse i) positive blood screen for hepatitis c antibody, hepatitis b surface antigen, r hiv-1, -2 antibodies j) any of the following screening or day -1 laboratory results outside the ranges specified below as defined by the laboratory, confirmed by repeat analysis: i)serum creatinine \> upper limit of normal (uln) ii)alanine aminotransferase (alt) \> uln iii)aspartate aminotransferase(ast) \> uln iv)total bilirubin \> uln k) history of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
the k-map study, global prevalence of kc

Conditions: Keratoconus

Summary: keratoconus is a ocular disease classified under ectatic diseases which often results in bilateral and asymmetrical corneal distortion. it usually affects patients at young age and can cause severe visual loss. the overall goal of this study is to assess the prevalence of keratoconus (kc) in children and adolescents in various regions of the world based on modern tomographic imaging methods, and to verify whether the occurrence rates reported from literature should be corrected. our hypothesis is that the prevalence of the disease is much higher than that traditionally reported. at each site, corneal tomography examinations (pentacam) will be performed bilaterally in children and adolescents, who are not ill or with any ophthalmological symptom. the population to be studied will be composed of children and adolescents on medical visits for non-ophthalmologic reasons, aged between 6 and 20 years. multiple cities, from different continents (north america, south america, asia and europe) will participate.


Eligibility criteria:
inclusion criteria: * male or female, 6-23 years of age. * subjects seen for a non-ophthalmic appointment * provide signed and dated patient consent form (signed by parents / legal guardians). * willing to comply with all study procedures and be available for the duration of the study exclusion criteria: * patients with a preexisting ocular disease / condition * pregnancy or breastfeeding

Keywords: keratoconus prevalence
evaluation of clinical parameters on admission and medications in covid-19 pneumonia (corona virus disease 2019)

Conditions: Covid-19

Summary: investigators will recruit patients diagnosed with covid-19 pneumonia between march 11th, 2020 and april 15th, 2020 in emergency, internal medicine and cardiology outpatient clinics, retrospectively and analyze their clinical and demographic features on admission in regard to their medications used for chronic diseases regularly.

covid-19 infections demonstrated a pandemic spread after january 2020 and their associations with patient characteristics and comorbidities are intensely studied. investigators also want to find out potential relations between major medications taken for chronic diseases and clinical parameters of patients with covid-19 pneumonia. for the study, investigators will recruit patients diagnosed with covid-19 pneumonia between march 11th, 2020 (the date at which the first case of covid-19 in turkey officially declared) and april 15th, 2020 in emergency, internal medicine and cardiology outpatient clinics, retrospectively. all of the demographic features, complaints on admission, reports of computed tomography (ct) scans of the chest without intravenous contrast issued by the staff radiologist, c-reactive protein (crp) and complete blood count (cbc) values on admission will be recorded retrospectively. their polymerase chain reaction (pcr) test results will be derived from the hospital records based on public health covid-19 database notifications and list of medications taken regularly for more than 8 weeks before the diagnosis of covid-19 pneumonia from the national pharmacy database. information about other systemic diseases and major medical conditions of patients will be procured from the medical histories gained by relevant physicians. patient taking each drug group will be compared to those not taking that drugs in terms of clinical and demographical features mentioned above. statistical analysis will be performed by using spss software.

Eligibility criteria:
inclusion criteria: * covid-19 pneumonia at least with typical infiltration on ct +/- positive pcr. exclusion criteria: * no typical infiltration and negative pcr results. * not newly diagnosed.

Keywords: covid-19 pneumonia medication comorbidity
the association between age-related peripheral blood components and treatment efficacy in breast cancer

Conditions: Breast Cancer; Age

Summary: this study is a single-center, prospective/retrospective, observational clinical research designed to compare the differences in peripheral blood components between young and elderly hr+her2- breast cancer patients, and to identify peripheral blood components that may affect the prognosis of young hr+her2- breast cancer patients. the study population consists of early-stage hr+her2- breast cancer patients receiving neoadjuvant therapy. eligible patients who require neoadjuvant treatment will be enrolled in the study. retrospective data and samples will be collected based on existing patient medical records and tissue biobank samples. prospective data collection will be based on routine clinical treatment during the study period and will continue until the patient completes neoadjuvant therapy and undergoes primary tumor surgery, or until the study is prematurely terminated. hr+her2- breast cancer patients receiving neoadjuvant therapy will be divided into young and elderly groups. peripheral blood samples will be collected at baseline (t0, prior to treatment) and after two cycles of neoadjuvant therapy (t1). paired baseline tumor biopsy samples and/or surgical tumor samples will also be collected. peripheral blood and tumor samples will undergo appropriate tests. the study respects the investigator's choice of treatment, without specifying which drugs should be used, the dosage, the administration mode (including monotherapy, combination therapy, or sequential therapy), or the duration of treatment.


Eligibility criteria:
inclusion criteria: 1. signed informed consent according to local regulations; 2. age ≥ 18 years; 3. female; 4. histologically/cytologically confirmed breast cancer; 5. determined by immunohistochemistry to be er+ or pr+ (with at least 1% of cells expressing estrogen receptors) and her2-. exclusion criteria: 1. presence of distant metastasis; 2. history of other malignancies. patients with basal cell carcinoma or squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers who have been disease-free for more than 5 years after appropriate treatment may be included; 3. participation in another clinical trial within 30 days prior to starting neoadjuvant treatment for breast cancer, and receiving investigational drugs or any concomitant treatment including investigational drugs; 4. immunodeficiency or hiv infection; 5. severe heart, lung, liver, or kidney dysfunction; 6. uncontrolled infections or active infections; 7. pregnant or breastfeeding women.
ocular penetration of topical tacrolimus eye drops

Conditions: Ocular Penetration of Topical Tacrolimus

Summary: investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops. topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before cataract surgery. aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus.


Eligibility criteria:
inclusion criteria: * any age or gender * patients scheduled for routine cataract surgery * clear healthy cornea exclusion criteria: * corneal pathology * ocular surface disease * intraocular inflammation

Keywords: tacrolimus ocular penetration topical
a study to characterize the phenotype in patients with morton's neuroma and to explore the effect of local administration of xylocaine (lidocaine)

Conditions: Morton's Neuroma

Summary: to characterize the phenotype in patients with morton's neuroma and to explore the effect of local administration of xylocaine (lidocaine)

a randomised, double-blind, placebo-controlled, three-way cross-over single center study to characterize the phenotype in patients with morton's neuroma and to explore the effect of local administration of xylocaine (lidocaine)

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of morton's neuroma with symptoms of at least 3 months duration in one foot (affected foot) * visual analogue scale (vas) pain-score of = 40 mm in the painful foot at daily activities during the previous week (visit 1) exclusion criteria: * allergy to lidocaine * scars or other dermal conditions on the feet that may interfere with study procedures

Keywords: morton's neuroma, qst measurements
community-acquired pneumonia diagnosis through integrating novel microbiological techniques.

Conditions: Community-acquired Pneumonia

Summary: to evaluate novel microbiological techniques for enhanced pathogen identification, assess the speed and efficiency of the integrated approach in providing timely diagnostic results, aiming to reduce the turnaround time for cap diagnosis and subsequently improve patient outcomes and evaluate the clinical impact of enhanced precision in cap diagnosis on treatment decisions, including the potential for targeted and more effective antimicrobial therapy based on accurate pathogen identification.

community-acquired pneumonia (cap) is the term used to describe an acute infection of the lungs that develops outside the hospital setting in a patient who has not been recently hospitalized. community-acquired pneumonia (cap) is one of the most common infectious diseases and is a significant cause of mortality and morbidity globally despite preventative measures aimed at combating cap. these measures include pneumococcal vaccination of at-risk groups, yearly vaccinations for seasonal influenza viruses and since 2021, sars-cov-2 vaccination. understanding the etiology of cap is crucial for accurate empirical antibiotic treatment, updating treatment guidelines, and future vaccine cost-benefit analyses. currently, microbiological testing for cap patients does not identify the etiology of most cases. in contrast, molecular biology techniques, are rapid and sensitive for the diagnosis of pathogens. furthermore, a multitude of nascent technologies, including multiplex real-time pcr; that detect multiple respiratory pathogens including both bacteria and viruses from a single respiratory tract sample and microarray methodologies, have become accessible for employment in clinical settings. improved diagnostics may change the management of cap infections ,prompt identification of the appropriate organism would allow antibiotic de-escalation, which would decrease cost, adverse drug effects and antibiotic resistance pressure. these clinical interventions potentially translate to a reduced length of stay and financial savings for the patient, as well as an improved therapeutic outcome.

Eligibility criteria:
inclusion criteria: * all patients with clinical diagnosis of pneumonia among both sexes * age \>18 years old. exclusion criteria: * age \<18 years old. * patients who refuse to participate in the study. * patient who acquire infection after hospital admission within 48 hours.

Keywords: microbiological techniques multiplex pcr community-acquired pneumonia
acupuncture for anxiety in parkinson's disease

Conditions: Parkinson Disease; Anxiety

Summary: this is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safely and effectively manage anxiety in parkinson's disease. eligible subjects will receive either real or sham acupuncture three times weekly for a total of six weeks.


Eligibility criteria:
inclusion criteria: * patients diagnosed with parkinson's disease by authorized neurologist. * patients 40-75 years of age * patients who have significant anxiety symptom * patients must be on a stable medication regimen for the treatment of pd exclusion criteria: * patients who have had previous acupuncture within the past six months * patients with dementia, depression, or sleep disorder * patients who are currently taking medications known to affect anxiety

Keywords: acupuncture, anxiety, parkinson's disease
connective tissue massage in scleroderma

Conditions: Scleroderma

Summary: the only study in the literature that examined connective tissue massage in patients with scleroderma is by bongi et al. in this study, connective tissue massage and mc mennell joint manipulation technique were applied to the experimental group in addition to the home exercise program. the control group was offered only a home exercise program. the results of the study showed that the group in which connective tissue massage and mc mennell joint manipulation technique were applied were effective on hand functions, quality of life and mobility. the aim of our study was to examine the effects of connective tissue massage applied in addition to the exercise program.the study will include 30 patients diagnosed with scleroderma according to american college of rheumatology/european league against rheumatism criteria and followed up in fırat university rheumatology department. patients will be divided into two groups; 15 patients in the first group will be applied connective tissue massage to the hand and forearm area in addition to the exercise program for hand rehabilitation. in the second group, 15 patients will only receive an exercise program.

although there are various physiotherapy interventions in scleroderma rehabilitation, there is no definitive guideline. passive and active stretching has been shown to help maintain range of motion (rom) and optimal length of structures. home exercises form part of rehabilitation in most studies. the only study in the literature that examined connective tissue massage in patients with scleroderma is by bongi et al. in this study, connective tissue massage and mc mennell joint manipulation technique were applied to the experimental group in addition to the home exercise program. the control group was offered only a home exercise program. the results of the study showed that the group in which connective tissue massage and mc mennell joint manipulation technique were applied were effective on hand functions, quality of life and mobility. the aim of our study was to examine the effects of connective tissue massage applied in addition to the exercise program.the study will include 30 patients diagnosed with scleroderma according to american college of rheumatology/european league against rheumatism criteria and followed up in fırat university rheumatology department. patients will be divided into two groups; 15 patients in the first group will be applied connective tissue massage to the hand and forearm area in addition to the exercise program for hand rehabilitation. in the second group, 15 patients will only receive an exercise program. range of motion, skin thickness and hand mobility test will be evaluated.

Eligibility criteria:
inclusion criteria: * between the ages of 18-65 * stable on medical treatment * be able to adapt to exercise exclusion criteria: * diagnosed with juvenile onset scleroderma * accompanied by another rheumatic disease * active digital ulcer * chronic disease or trauma history that will affect hand functions

Keywords: scleroderma connective tissue massage mobility
complicated skin and skin structure infections

Conditions: Skin Infection; Abscess; Cellulitis

Summary: the purpose of this study is to demonstrate the non-inferiority of meropenem (merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.


Eligibility criteria:
inclusion criteria: * subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections * within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing * subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection exclusion criteria: * subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems * subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication * subjects with underlying infections or conditions which would interfere with evaluation of this study

Keywords: skin infections merrem primaxin iv complex abscess perirectal abscess wound infections infected ischemic/diabetic ulcers cellulitis meropenem imipenem-cilastatin