Kornimate/medical-research-clean huggingface dataset:
oxynorm® capsules (immediate-release) pharmacokinetic (pk) study

Conditions: Pain

Summary: a single dose pk study of oxynorm® immediate-release capsules 5, 10, and 20mg, and a multiple-dose pk study of oxynorm® immediate-release capsules 10mg in chinese patients with pain.it will be a single center, open label, randomized, oral administration study.

single dose: the subjects will be randomized to receive a single dose of oxynorm® immediate-release capsules 5, 10, and 20mg. multiple dose: the subjects will take 3 days oxynorm® capsule 10mg, once every 6 hours, 10mg per dose. in the morning of the 4th day, the subjects will take single dose of oxynorm® capsule 10mg. on the 5th day, all the subjects complete the study.

Eligibility criteria:
inclusion criteria: * patients with pain, multiple dose group should enroll the patients with cancer pain; * patients aged \>≥30 to ≤ 60 years; * body weight ≥ 45kg, and bmi range ≥19, \<24; * karnofsky score ≥ 70; * the results of liver function and kidney tests must meet the following criteria: alt、ast is within the upper limit of normal value ranges by a factor 2, and tb、bun、cr is within the upper limit of normal value ranges by a factor 1.25; * the electrocardiogram examination results are normal; * patients must have given a written informed consent prior to this trial, and have the capability to complete every required test. exclusion criteria: * have hypersensitivity history to any opioids; * have known hypersensitivity to any of compositions of the study drugs; * patients who are likely to have paralytic ileus or acute abdomen or to perform an operation on abdominal region； * patients with respiratory depression, cor pulmonale, or chronic bronchial asthma; * patients who are unable to stop taking monoamine oxidase inhibitor during this trial period or time lapses less than 2 weeks since drug withdrawal; * patients with hypercarbia; * patients with biliary tract diseases, pancreatitis, prostatic hypertrophy, or corticoadrenal insufficiency; * patients with alcoholism or drug abuse history; * positive anti-hiv or syphilis antibody test result; * patients who are pregnant, or lactating; * urine screening before study is positive for opioids, barbiturates, amphetamines, cocaine metabolites, methadone, diazepam and cannabinoids; * donated 400 ml or more of blood or blood products within 3 months prior to the start of the study, or donated 200 ml or more of blood or blood products within one month prior to the start of the study; * subjects who participated in a clinical research study within one month of study entry; * patients who are currently taking opioids.
evaluation and treatment of copper/zinc imbalance in children with autism

Conditions: Autism; Pervasive Developmental Disorder

Summary: there are two phases to the study. the first will examine serum copper and zinc levels and copper/zinc ratio in children (ages 3-8) who have autism and compare them to levels from same sex and age children who are developing typically. the hypothesis is that there is a significant difference in the copper/zinc ratio between young children who have autism and their typically developing peers. the second phase of the study will evaluate the effect of dietary supplementation using zinc and vitamin c for 16 weeks on selected symptoms of autism. children with autism will be enrolled on the basis of copper/zinc ratios greater than 2.0, and as determined to be statistically higher than typically developing children. measurements of serum copper, zinc and unbound copper will be obtained prior to, at the mid-point and end of the trial. those children whose ratios have not fallen below 1.25, the top of the currently recognized range will have the zinc and vitamin c doses adjusted for the duration of the trial. detailed evaluation of language skills, and a variety of behaviors will be evaluated prior to and after supplementation. the study will be placebo-controlled and double blind. those children enrolled in the placebo arm will be offered a full trial of supplements at the end of the their participation in the study. the hypothesis to be tested is whether correction of elevated copper to zinc ratios in children with autism can be accomplished by oral supplementation with zinc and vitamin c and if these children show measurable and significant changes in receptive or expressive language or behavioral parameters associated with autism.


Eligibility criteria:
inclusion criteria: * ages 3-8 years * diagnosis of autism spectrum disorder * serum copper/zinc ratio greater than 2.0 or as determined in phase 1 of the study exclusion criteria: * known chromosomal disorder or neurological disorders other than autism
personalized lifestyle intervention and weight control

Conditions: Weight Loss

Summary: this trial aims to investigate whether tailored lifestyle consultation through snp testing leads to more effective weight loss among overweight or obese individuals compared to general lifestyle guidance for weight control.


Eligibility criteria:
inclusion criteria: * overweight or obese individuals exclusion criteria: * a past history of bariatric surgery or eating disorders * currently pregnant or planning a pregnancy within 2 years
safety and efficacy of intracameral zimoxin for prevention of endophthalmitis after cataract surgery

Conditions: Endophthalmitis

Summary: intracameral injection of 0.1% moxifloxacin solution after cataract surgery to prevent endophthalmitis

subjects will receive either intracameral injection of 0.1% moxifloxacin solution or placebo after cataract surgery. they will be followed for one month to determine if there is a statistically significant difference in the incidence of endophthalmitis.

Eligibility criteria:
inclusion criteria: * visually significant cataracts exclusion criteria: * allergy to fluoroquinolones, cobalamin (b12)
nitrocamptothecin in treating patients with recurrent non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent non-small cell lung cancer.

objectives: i. determine the response rate, time to progression and overall survival of patients with recurrent non-small cell lung cancer when treated with nitrocamptothecin. ii. assess the toxicities and pharmacokinetics of this regimen in these patients. outline: patients receive oral nitrocamptothecin daily on days 1-5. treatment continues weekly in the absence of disease progression or unacceptable toxicity. patients are followed for survival. projected accrual: a total of 20-55 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed recurrent non-small cell lung cancer no more than one prior chemotherapy treatment bidimensionally measurable disease no prior radiotherapy to target lesion or progression since prior radiotherapy patient characteristics: age: 18 and over performance status: ecog 0-2 life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 2.0 mg/dl alt/ast no greater than 3 times upper limit of normal (uln) (no greater than 5 times uln in case of liver metastases) renal: creatinine no greater than 2.0 mg/dl or creatinine clearance at least 50 ml/min other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception no uncontrolled serious medical or psychiatric illness prior concurrent therapy: biologic therapy: not specified chemotherapy: see disease characteristics at least 3 weeks since prior chemotherapy and recovered no prior camptothecin endocrine therapy: not specified radiotherapy: see disease characteristics at least 3 weeks since prior radiotherapy and recovered surgery: at least 2 weeks since prior major surgery

Keywords: recurrent non-small cell lung cancer
care trial: comparing different levels of calorie reduction for weight loss

Conditions: Overweight; Obesity

Summary: this research study will compare two weight loss programs that provide different recommendations for how to reduce your energy (or calorie) intake to achieve weight loss in an effort to determine if fixed calorie reduction or varied calorie reduction is more effective for weight loss.


Eligibility criteria:
inclusion criteria: * age 21-75 * body mass index (bmi) 30-50 kg/m2 exclusion criteria: * uncontrolled hypertension (blood pressure \>160/100 mm hg) * any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; congestive heart failure; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); serious infectious diseases (e.g., self-reported hiv); chronic hepatitis; cirrhosis; chronic malabsorption syndrome; chronic pancreatitis; chronic lung diseases or orthopedic problems that limit physical activity * current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, antibiotics for hiv or tb, or chemotherapeutic drugs; prescription weight loss medications (past six months) * unwilling or unable to do any of the following: give informed consent; read english at the 5th grade level; accept random assignment; travel to the intervention site * likely to relocate out of the area in the next 2 years * participation in another randomized research project * weight loss \> 10 pounds in past six months * history of bariatric surgery * major depressive or psychiatric disorder, or excessive alcohol intake * potential participants living farther than 30 miles driving distance from uab will be excluded from the study. * potential participants (female) that are pregnant or plan to become pregnant in the next 18 months will be excluded from participation in the study. this is a weight loss study and weight gain/loss due to pregnancy and/or delivery would confound study results. additionally, weight loss is not recommended for pregnant women.

Keywords: weight loss body weight behavioral
a pilot study on effect of add-on sulforaphane to ssris and application of niacin skin flush response test in major depressive disorder

Conditions: Major Depressive Disorder

Summary: a 12-week, randomized controlled trial (rct) will be conducted to explore the effect of add-on sulforaphane (sfn) to selective serotonin reuptake inhibitors (ssris) for major depressive disorder (mdd). this study also aims to explore the value of niacin skin flush response test in mdd. one hundred adults diagnosed with mdd will be recruited. then all the patients will be randomly assigned to ssri only group and ssri plus sfn group. clinical symptoms and side-effects will be evaluated using the 17-hamilton depression rating scale (17-hdrs), the hamilton anxiety scale (hama), treatment emergent symptom scale (tess), and asberg's rating scale for side effects (sers) at baseline and weeks 2, 4, 8 and 12 after treatment. fifty healthy subjects will be recruited as control group. for all subjects, testing of niacin skin flush response and serum levels of nuclear factor erythroid-2-related factor 2(nrf-2), p-nrf2, heme oxygenase-1 (ho-1), malondialdehyde (mda) and erythrocyte glutathion peroxidase (gpx) will be performed at baseline and endpoint. the primary outcome is the reduction rate in 17-hdrs total score from baseline to the end of the study. the secondary outcomes include changes in niacin skin flush response test and levels of serum markers. all the data will be analyzed by spss software.


Eligibility criteria:
inclusion criteria: 1. aged 18-60 years; 2. diagnosed with moderate or severe depressive disorder according to the criteria of the dsm-5; 3. total score of 17-hdrs≥17; 4. never receiving electroconvulsive therapy (ect)/modified ect (mect)/rtms or other treatments in the past month; 5. having sufficient audio-visual ability and comprehension; 6. signed informed consent statements. exclusion criteria: 1. serious or active somatic illness (abnormal index values were more than twice the limit of normal); 2. a history of mania/hypomania; 3. current high risk of suicide (score of item 3 of 17-hdrs ≥ 3); 4. pregnant or lactating women, or planning pregnant women; 5. taking immunosuppressants or vitamins recently.

Keywords: major depressive disorder sulforaphane niacin skin flush response marker add-on
efficacy study of holep and turp on luts secondary to bph

Conditions: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Summary: the purpose of this study is to compare of efficacy and safety between holmium laser enucleation of the prostate (holep) and transurethral resection of the prostate (turp) on the lower urinary tract symptoms (luts) secondary to benign prostate hyperplasia (bph).


Eligibility criteria:
inclusion criteria: * 50 yrs or greater * international prostatic symptom score \>= 12 * bladder outlet obstruction confirmed by pressure-flow study (booi \> 20) * able to give fully informed consent exclusion criteria: * patients with urologic malignancies such as prostate cancer and bladder cancer * patients underwent urethral, prostate surgery * patients with urethral stricture or bladder diverticulum or bladder neck contracture * patients with histories of bacterial prostatitis within 1 year * seems not to be appropriate to this study by the decision of investigators because of any other reasons
preventive care system application effectiveness study on the treatment of diabetic patients in bandung

Conditions: Diabetes Mellitus, Type 2

Summary: randomized, unblinded, controlled, two arms parallel group, prospective intervention study

the objective of the study is to compare the progression of hba1c in diabetic patients after applying a medwell digital application in addition to regular diabetes treatment (treatment arm) with regular diabetes treatment of diabetic subjects alone (control arm). the primary endpoint will be measured as the difference between 3 months hba1c relative to baseline in eligible subjects. normally, hba1c in each subject is expected to either stable or slightly increase overtime. in this study we are interested in measuring the difference in hba1c 3 months post randomization. it is expected that in the experimental arm, hba1c will slightly decrease, while in the standard arm, hba1c will either remain the same or will slightly increase after 3 months in the study. previous study shows that the standard deviation of the difference in hba1c within 1 year is 0.97%.

Eligibility criteria:
inclusion criteria: * subjects are in the diabetes type 2 status (based on perkeni standard) hba1c is ≥6.5% * aged 18 - 60 years old * have compatible smartphone (minimum android 8 or ios 13) and internet connection * receiving regular diabetes treatment * giving consent and commitment to participate in the study until finish * located in bandung area within the treatment period (up to 3 month after receiving the treatment) * subject is determined to be able to complete daily physical activities. exclusion criteria: * pregnant (based on test pack) * participation in other weight loss program * use of other tracking application * having any abnormalities that affecting blood erythrocyte age defined by laboratory examination * have other severe diabetic complications that prevent subjects from participating in the prescribed program (such as stroke, cardiac diseases (chf stage iii-iv), copd or asthma with acute exacerbation and other respiratory diseases, peripheral artery disease, ckd stage 3-5) and other severe diseases that by the investigator's judgment, could not participate in this study
effects of physical exercise in type 2 diabetics

Conditions: Type 2 Diabetes Mellitus

Summary: the aim of this study is to evaluate the improvement in skeletal muscle energetic capacity, endothelial dysfunction and glycemic control induced by physical training in 20 sedentary patients with a type 2 diabetes.the protocol consists in a physical training program with 3 sessions of 30 minutes per week during six consecutive weeks. a skeletal muscle biopsy, a cardiac and humeral artery ultrasounds, a glycemic and tensional holters will be performed before and at the end of the physical training program.


Eligibility criteria:
inclusion criteria: * sedentary adult with type 2 diabetes * bmi between 25 and 35 kg/m² * hba1c \< 10 % exclusion criteria: * unstable coronary artery disease * advanced peripheral occlusive arterial disease * proteinuria \> 3 g/d and / or creatinine clearance \< 30 ml / mn * advanced diabetic neuropathy
quality control of ce-certified phonak hearing aids - 2016_37

Conditions: Hearing Loss, Bilateral Sensorineural, Progressive

Summary: a methodical evaluation of new ce-labelled phonak hearing systems is intended to be conducted on hard of participants with a hearing loss to grant quality control prior to product launch. the aim of the investigation series is to ensure zero-defect overall performance of the new hearing systems as well as maximum benefit for the participant with the devices in comparison to previously outstanding phonak hearing systems.

phonak hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner. if the benefit is proven, their performance is then investigated regarding interdependency between all available algorithms, features and functions running in parallel in a hearing aid (pivotal/pre-validation studies) and, as a result, they get optimized. afterwards, and prior to product launch, the phonak hearing systems undergo a final quality control in terms of clinical trials in the way as planned for this study ("phase of final inspection"). this will be a controlled, single blinded and randomised active comparator clinical evaluation which will be conducted mono centric at sonova ag headquarters based in stäfa (switzerland).

Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids * good written and spoken (swiss) german language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * informed consent as documented by signature exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments in stäfa (switzerland) * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * central hearing disorders
effect of the computer aided diagnosis with explainable artificial intelligence for colon polyp on optical diagnosis and acceptance of technology

Conditions: Colon Polyp

Summary: the goal of this clinical trial is to learn if computer-aided diagnosis with deep learning and computer-aided diagnosis with explainable ai work to optical diagnosis performance and acceptance of technology in endoscopists. the main questions it aims to answer are: do computer-aided diagnosis with deep learning and computer-aided diagnosis with explainable ai improve optical diagnosis performance in endoscopists? does experience using deep learning-based computer-assisted diagnosis and explainable ai-based computer-assisted diagnosis improve endoscopists' acceptance of computer-aided diagnosis as a technology? participants will: conduct a survey on acceptance and use of technology about computer-aided diagnosis. perform a test to estimate the pathologic diagnosis on 200 nbi still images without the aid of computer-aided diagnosis. more than 1 month later, perform a same test to estimate the pathologic diagnosis on 200 nbi still images with computer-aided diagnosis with deep learning or explainable ai. conduct a survey on acceptance and use of technology about computer-aided diagnosis.


Eligibility criteria:
inclusion criteria: * endoscopists with colonoscopy experience exclusion criteria: * who can not perform colonoscopy

Keywords: colon polyp optical diagnosis computer-aided diagnosis
visual outcomes after cataract surgery: multifocal acrysof® iq restor® intraocular lenses versus monofocal intraocular lenses

Conditions: Cataract

Summary: the purpose of this study is to assess and compare visual outcomes of the acrysof® iq restor® +3.0 d intraocular lens (iol) to a commercially available monofocal iol in cataract patients.

this study included subjects with bilateral age-related cataracts and either no preoperative corneal astigmatism, or preoperative regular corneal astigmatism confirmed by autokeratometry of ≤2.5 d.

Eligibility criteria:
inclusion criteria: * willing and able to understand and sign an informed consent; * willing and able to attend post-operative examinations as per protocol schedule; * diagnosis of bilateral, age-related cataracts; * planned cataract removal via phacoemulsification with implantation of an iol; * available to undergo second eye surgery within 6 weeks of the first eye surgery; * fulfill the recommendations of the "warnings" and "precautions" sections of the acrysof iq restor iol and monofocal iol package inserts; * no preoperative corneal astigmatism or preoperative regular corneal astigmatism ≤2.5d; * qualify in both eyes for either acrysof® iq restor® iol model sn6ad1 or acrysof® iq restor® toric iol models snd1t2 through snd1t5 as indicated by the acrysof iq restor multifocal toric web-based calculator; * able to read and understand one of the following languages: dutch, french, german, italian, spanish, english or catalan. * other protocol-defined inclusion criteria may apply. exclusion criteria: * previous corneal surgery and/or reshaping; * any abnormality, disease and/or conditions of the cornea (ie, keratoconus, corneal dystrophy, severe keratitis, corneal scar, etc.), which would clinically contraindicate the implantation of a toric iol; * planned multiple procedures during cataract/iol implantation surgery; * planned limbal relaxing incisions, excimer laser treatment or similar procedures prior to or during the course of the study; * pregnant, lactating, or planning pregnancy during the course of study; * other protocol-defined exclusion criteria may apply.

Keywords: intraocular lens