Kornimate/medical-research-clean huggingface dataset:
a study of the safety and effectiveness of levofloxacin compared with lomefloxacin in the treatment of complicated urinary tract infections

Conditions: Urinary Tract Infections; Bacterial Infections; Bacteriuria; Urologic Diseases

Summary: the purpose of the study is to compare the safety and effectiveness of oral levofloxacin (an antibiotic) with that of oral lomefloxacin in the treatment of complicated urinary tract infections in adults.

levofloxacin is an antibacterial agent used for the treatment of a broad spectrum of acute infections in adults. this is a randomized, open-label study of the safety and effectiveness of levofloxacin compared with lomefloxacin in the treatment of adults with complicated urinary tract infections. patients in one group are treated with 250 mg of levofloxacin, taken once daily for 7 to 10 days, and the other group is treated with 400 mg of lomefloxacin, also an antibacterial agent, taken once daily for 14 days. patients are followed for 5 to 9 days after completion of treatment (post-therapy) to assess clinical signs and symptoms of infection. long-term follow up (4 to 6 weeks after the end of treatment) of those patients who respond to therapy provides further evaluation of clinical signs and symptoms. the primary assessments of effectiveness include the clinical response (the resolution of signs and symptoms at post-therapy compared with those at the start of study) and the microbiological response (the eradication at post-therapy of the infectious organism identified at the start of study) an additional assessment of efficacy includes the overall clinical response, which is described as cured, improved, or failed. safety assessments include the incidence of adverse events throughout the study, clinical laboratory tests (hematology, serum chemistry, and urinalysis) and physical examinations at the start of the study and post-therapy. the study hypothesis is that levofloxacin is at least as effective therapeutically as lomefloxacin in the treatment of adults with complicated urinary tract infections. levofloxacin tablets, an oral dose of 250 mg taken once daily for 7 to 10 days. lomefloxacin tablets, an oral dose of 400 mg taken once daily for 14 days.

Eligibility criteria:
inclusion criteria: * diagnosis of a urinary tract infection with complicating factors such as anatomical or functional abnormalities * capable of taking medication by mouth * previous antibacterial therapy of less than 24 hours, or previous antibacterial therapy of greater than 24 hours that did not eliminate or stabilize the infection. exclusion criteria: * patients having any medical condition that requires antimicrobial therapy to be given intravenously or by hypodermic needle * complete obstruction of any part of the urinary tract * previous allergic or serious adverse reaction to similar antibiotics * inflammation of the prostate gland * pregnant or nursing females, or those lacking adequate contraception.

Keywords: levofloxacin urinary tract infections bacterial infections bacteriuria urinary anti-infective agents urinary infections quinolones
effects of snack types on acute glucose and insulin response

Conditions: Satiety

Summary: the purpose of the present study was to determine the effects of different type of snack consumption on postprandial satiety, glucose, insulin, antioxidant capacity and anxiety in healthy subjects.


Eligibility criteria:
inclusion criteria: * 18-55 years old exclusion criteria: * smoker * pregnant woman * required dietary supplement use * required medication of metabolic disorders * allergy to nuts or gluten (wheat)
phase 1/2, open-label, dose-escalation study of ionis-stat3rx, administered to patients with advanced cancers

Conditions: Advanced Cancers; DLBCL; Lymphoma

Summary: this is a phase 1/2, open-label, dose-escalation, dose-expansion study for the treatment of patients with advanced cancers. eligible patients with dlbcl or other advanced lymphomas will be enrolled into the dose-expansion cohort.


Eligibility criteria:
inclusion criteria: * aged 18 years or older * tumors that are relapsed or refractory to at least 1 prior anti-cancer systemic therapy and for which no standard therapy exists * expansion cohort only: advanced lymphoma confirmed by histopathology * measurable or evaluable disease according to recist for solid tumors or according to iwrc for nhl tumors * ecog performance status less than or equal to 2 * life expectancy greater than 12 weeks in the opinion of the investigator exclusion criteria: * any active or uncontrolled infection * nyha grade ii or greater congestive heart failure * history of myocardial infarction within 6 months prior to screening * prior radiation therapy, chemotherapy, hormonal therapy, or immunotherapy within 4 weeks prior to screening or 5 half-lives of the therapy, whichever is shorter

Keywords: advanced cancers dlbcl advanced lymphoma
live video mind-body treatment to prevent persistent symptoms following mtbi

Conditions: MTBI - Mild Traumatic Brain Injury; Anxiety

Summary: the investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, tor-c 1 and tor-c 2. the investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. both programs will be delivered virtually (zoom).

the investigator aims to conduct a pilot randomized controlled trial to test the feasibility of two symptom management programs for college-age individuals with recent concussions and anxiety, tor-c 1 and tor-c 2. the investigator will assess the feasibility of recruitment procedures (screening, eligibility, and enrollment) and data collection as well as the feasibility, credibility, and acceptability of the programs (adherence, retention, fidelity, and satisfaction), following prespecified benchmarks. both programs will be delivered virtually (zoom). each program will consist of four 45-minute sessions over the secure zoom platform. participants will receive a treatment manual. there are 3 assessment points consisting of self-report surveys: baseline, post program, and 3-month follow-up.

Eligibility criteria:
inclusion criteria: * male and female outpatients, ages 18-35 * english fluency and literacy * diagnosed with a concussion in the past 10 weeks * owns a smartphone or computer with internet access * willingness and ability to participate in four 45-minute program sessions and answer remote questionnaires before, after, and 3-month following the program * free of concurrent psychotropic or have been on stable dosage for at least 6 weeks * clinically significant anxiety symptoms (score ≥ 5 on gad-7 anxiety scale) exclusion criteria: * previous history of moderate or severe tbi or concussion in the past 2 years that resulted in symptoms lasting 3 months or more * diagnosed with a medical illness expected to worsen in the next 6 months (e.g., malignancy) * lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder * current substance abuse or dependence and current substance use disorder * current active self-reported suicidal ideation * practice of mindfulness techniques for greater than 45 minutes per week within the last 3 months * participation in a mind-body or cbt treatment in the past 3 months * currently pregnant

Keywords: mtbi - mild traumatic brain injury anxiety mindfulness
effect of hypothyroidism on brown adipose tissue

Conditions: Hypothyroidism

Summary: the investigators aim to study whether hypothyroidism negatively affects brown adipose tissue (bat) function in humans and whether bat function can be restored to normal by thyroid hormone supplementation.

hypothyroidism is a frequent endocrine disorder, the prevalence of subclinical disease being 4.3% and of overt disease being 0.3%. patients suffering from hypothyroidism frequently complain of increased cold sensitivity and involuntary weight gain, indicating changes in energy expenditure and response to cold challenge. recently, brown adipose tissue (bat) has regained attention as an energy expending tissue. while it was previously thought to be of no or negligible relevance in human adults, recent studies clearly demonstrated the presence and metabolic activity of bat in human adults. upon activation of bat by the sympathetic nervous system intracellular lipid stores are rapidly depleted. the generated free fatty acids fuel beta-oxidation and the respiratory chain within the mitochondria and activate at the same time uncoupling protein 1 (ucp1). this protein acts as a protonophore, allowing the flux of protons along the electrochemical gradient into the inner mitochondrial matrix instead of transferring their energy to adenosine triphosphate (atp)-synthase. the short circuiting of the oxidative phosphorylation within the mitochondria leads to highly active cellular respiration and generation of heat. basic research highlights the importance of thyroid hormone in the development and function of bat. it has recently been shown that hyperthyroidism exerts activating effects on bat in adult humans. the investigators aim to study whether hypothyroidism negatively affects bat function in humans and whether bat function can be restored to normal by thyroid hormone supplementation.

Eligibility criteria:
inclusion criteria: * informed consent * serum thyroid-stimulating hormone (tsh) \> 4.5 milli-international unit (miu)/l * body mass index (weight/height(m)²) 17.5 to 30 kg/m² exclusion criteria: * known concomitant disease influencing thyroid hormone metabolism * chronic heart failure * liver cirrhosis * severe kidney failure * metastasized cancer, except for thyroid cancer * known hypersensitivity to cold, e.g. primary or secondary raynaud's syndrome * abuse of alcohol or illicit drugs * women who are pregnant or breast feeding * intention to become pregnant during the course of the study * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * participation in another study with investigational drug within the 30 days preceding and during the present study * previous enrolment into the current study
congenital adrenal hyperplasia: calcium channels as therapeutic targets

Conditions: Congenital Adrenal Hyperplasia

Summary: this study will test the ability of extended release nifedipine (procardia xl), a blood pressure medication, to permit a decrease in the dose of glucocorticoid medication children take to treat congenital adrenal hyperplasia (cah).

this protocol is designed to assess both acute and chronic effects of the calcium channel antagonist, nifedipine, on the hypothalamic-pituitary-adrenal axis in patients with congenital adrenal hyperplasia. the multicenter trial is composed of two phases and will involve a double-blind, placebo-controlled parallel design. the goal of phase i is to examine the ability of nifedipine vs. placebo to decrease adrenocorticotropic hormone (acth) levels, as well as to begin to assess the dose-dependency of nifedipine effects. the goal of phase ii is to evaluate the long-term effects of nifedipine; that is, can attenuation of acth release by nifedipine permit a decrease in the dosage of glucocorticoid needed to suppress the hpa axis? such a decrease would, in turn, reduce the deleterious effects of glucocorticoid treatment in cah.

Eligibility criteria:
inclusion criteria: * diagnosed with congenital adrenal hyperplasia (cah) * normal ecg during baseline evaluation exclusion criteria: * history of liver disease, or elevated liver function tests * history of cardiovascular disease
exercise and cognitive-psychosocial functions in men with prostate cancer receiving androgen depletion therapy

Conditions: Prostate Cancer

Summary: the objective of the proposed research is to determine the efficacy of a home-based walking exercise program in promoting cognitive-psychosocial functions of men with prostate cancer receiving androgen depletion therapy (adt). adt is the mainstay treatment for men with advanced prostate cancer. however, adt has a number of side effects including compromised cognitive function, depression and anxiety, which negatively impacts the quality of life of men with prostate cancer. the central question of the proposed research is to determine if exercise will have a positive impact on the quality of life of men with prostate cancer undergoing adt. hypothesis:


Eligibility criteria:
inclusion criteria: * men aged 50 or older * diagnosed with adenocarcinoma prostate cancer * will initiate and receive continuous adt (lhrh or combination of lhrh and anti-androgen for at least 6 months exclusion criteria: * severe cardiac disease (new york heart association class iii or greater) * angina * severe osteoporosis * uncontrolled hypertension * orthostastic blood pressure drop \> 20mm hg * moderate to severe aortic stenosis * acute illness or fever * uncontrolled atrial or ventricular dysrhythmias * uncontrolled sinus tachycardia (\> 120 beats per minute) * uncontrolled congestive heart failure * third-degree atrio-ventricular heart block * active pericarditis or myocarditis * recent embolism, thrombophlebitis * deep vein thrombosis, resting st displacement * uncontrolled diabetes * uncontrolled pain * cognitive impairment * history of falls due to balance impairment or lost of consciousness * severe neuromusculoskeletal conditions that limit their ability to perform walking exercise
efficacy of epiduo and treatment adherence of adolescent patients with inflammatory acne

Conditions: Acne

Summary: the purpose of this observational study is to assess the efficacy of epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy.

the objective of this observational study is to assess the efficacy of epiduo and patient adherence under daily clinical practice conditions in adults and adolescents (12 to 20 years) with moderate inflammatory acne using this drug first time in topical monotherapy. this non-interventional trial will include a larger population of teenaged acne patients in order to establish the practical contribution of a new mini-questionnaire to the evaluation of adherence for the physician in the daily clinical practice in general and in young adults topically treated with epiduo in particular. in addition safety and local tolerability profile of epiduo are to be assessed under marketed conditions.

Eligibility criteria:
inclusion criteria: * the patient has been diagnosed with moderate inflammatory acne * topical monotherapy of acne with epiduo is indicated, the decision about treating the patient with epiduo has been made independently from this study * the patient is aged between 12 and 20 years exclusion criteria: * pregnancy or breastfeeding * hypersensitivity to the medication or any of the ingredients * other contraindications mentioned in the epiduo spc

Keywords: acne epiduo adapalene/ benzoyl peroxide
importance of patient selection for treatment of infected total knee prosthesis

Conditions: Knee Infection

Summary: the infection of a total knee replacement often imposes changing implants. the change in two step is currently considered the gold standard. the change in one step is a much debated attitude: strictly contra-indicated for some professionals, but others agree to reserve these for favorable suspected cases selected. several criteria have been proposed in the literature: age, condition, duration of infection, known bacterium responsible, not virulent and sensitive to antibiotics, no fistula, no significant bone destruction. but these criteria are poorly validated, standing over an experience of surgical teams rather than high-level scientific studies. some authors have proposed to achieve change in one step systematically. the results of these cohorts on healing the infection does not seem very different from the changes in two steps. but it is most often single-center series, uncontrolled, with small numbers.


Eligibility criteria:
inclusion criteria: * patients over 18 years * patient having surgery for the management of knee infection after change in one step of a knee replacement prothesis in the participating services between 2000 and 2010. exclusion criteria: * patients under 18 years

Keywords: infection knee knee replacement
the use of metformin in early breast cancer patients pre-surgery

Conditions: Breast Cancer

Summary: the study will test metformin in patients with early breast cancer. blood and tissue will be collected before and after the use of metformin.

patients will take metformin twice a day for 3 weeks before surgery. the hypothesis is that metformin will reduce cell proliferation rates (ki67) and increase apoptoses (tunel)in tumor tissue. the study will collect and analyze pre- and post-treatment blood specimens for: * serum glucose * insulin levels * estradiol * homa test * glycosylated haemoglobin

Eligibility criteria:
inclusion criteria: * invasive breast cancer t1 or t2, nx * knowledge of the investigational nature of the study and ability to provide consent for study participation exclusion criteria: * diabetes or baseline glucose or glycosylated haemoglobin upper limit of normal for the institution * recent use of corticosteroids * ast \> 1.5 times upper limit of normal for the institution * pregnancy * serious clinical illness * prior or concurrent systemic neoadjuvant breast cancer therapy.

Keywords: breast cancer metformin pre-surgery
toddler milk intervention trial

Conditions: Healthy

Summary: to assess growth of children (enrolled between 11.5 and 13.5 months) fed with two iso-energetic, young-child formulas with different protein content during the second year of life

this study is designed to investigate in a randomized double-blind parallel-group trial the growth and metabolic effects of different contributions of protein to total energy intakes in healthy children during the second year of life

Eligibility criteria:
inclusion criteria: * having obtained his/her parents' (or his/her legally accepted representative \[lar's\] written informed consent and having evidence of personally signed and dated informed consent document indicating that the child's parents/lar have been informed of all pertinent aspects of the study * child was born full term (≥ 37 weeks of gestation) * age at enrollment: between 11.5 months and 13.5 months of age * 2.5 kg ≤ birth weight ≤ 4.5 kg * born from a singleton pregnancy * child's parent(s)/lar is of legal age of consent, has sufficient local language skills to complete the informed consent and other study documents, is able to be contacted directly by telephone throughout the study, and is willing and able to fulfill the requirements of the study protocol. exclusion criteria: * diagnosed disorder considered to interfere with nutrition or growth (e.g. malabsorptive disorders as short bowel syndrome, inflammatory bowel disease; neurological and congenital disorders that may delay growth as cerebral palsy, agenesis of the corpus callosum, spina bifida, down syndrome, cri du chat; disorders that may lead to obesity: prader willi syndrome, angelman syndrome, etc.) * cows' milk allergy * lactose intolerance * participation in any other interventional clinical trial during the 4 weeks prior to enrollment * infant who is being breastfed at the time of enrollment * infant who does not usually drink 300ml of cow's and/or formula milk per day * institutionalized children * child or child's family who in the investigator's judgment cannot be expected to comply with the protocol or study procedures
application of thoracic epidural scs for managing fog in patients with advanced parkinson's disease

Conditions: Parkinson Disease; Freezing of Gait; Spinal Cord Stimulation

Summary: spinal cord stimulation (scs) has proven to be effective for pain that is unresponsive to medication. this technique involves an anesthesiologist or a neurosurgeon placing stimulation electrodes at the thoracic vertebrae to provide pain relief. although scs is not currently a standard treatment for patients with parkinson\&#39;s disease, recent studies have shown that parkinson\&#39;s patients who experience intolerable pain and undergo scs treatment not only experience pain relief but also show improvements in gait and other parkinson\&#39;s symptoms. therefore, the investigators aim to use temporary, minimally invasive scs electrodes to help patients with nrfog (non-responsive freezing of gait) improve their stability and reduce their risk of falls.


Eligibility criteria:
inclusion criteria: * age:40-85 years old. * patients with primary parkinson\&amp;#39;s disease who have been diagnosed by a movement disorder specialist for more than 5 years. although they have a clear response to drugs, they have a frozen gait that cannot be controlled by drugs. lower limb pain may be present with or without parkinson\&#39;s non-motor symptoms. * no other secondary gait problems. exclusion criteria: * atypical parkinson's disease. * patients with spinal cord injuries. * medication-controlled frozen gait. * it is expected that there are lesions near the implantation area causing spinal canal stenosis or myelopathy (can be ruled out by mri). * it is expected that the implantation area has undergone previous surgery or there is infection near the implantation area, which may affect the success rate of implantation or increase concerns about complications (such as severe extraspinal adhesion, or spinal cord damage in previous surgeries). * people with abnormal coagulation function (such as hemophilia patients) or those who have been controlled by long-term use of antithrombotic drugs and cannot stop taking them in a short period of time. * cdr (clinical dementia rating scale) ≧2. 8. those who are allergic to developer.

Keywords: spinal cord stimulation, freezing of gait parkinson disease