Kornimate/medical-research-clean huggingface dataset:
effect of multiple subcisions on rolling acne scars

Conditions: Acne Scars

Summary: the purpose of this study is to find out whether the use of multiple subcisions over several visits will improve the appearance of rolling acne scars compared to no treatment. this study was a pilot study designed to determine feasibility of this procedure.


Eligibility criteria:
inclusion criteria: 1. age 18 to 65 2. have bilateral rolling acne scars on each side of their face 3. no active or ongoing acne. 4. the subjects are in good health 5. the subject has the willingness and the ability to understand and provide informed consent for the use of their tissue and communicate with the investigator. exclusion criteria: 1. under 18 years of age 2. pregnancy or lactation 3. subjects who are unable to understand the protocol or to give informed consent 4. subjects with mental illness 5. recent accutane use in the past 6 months 6. subjects prone to hypertrophic and keloidal scarring 7. subjects reporting any blood diseases (hiv, hepatitis, etc.) 8. subjects reporting a history of herpes (oral or genital)
visual outcomes of functional intraocular lenses in cataracts

Conditions: Cataract; Visual Quality

Summary: this is a prospective, multi-center, randomized comparative study. the purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (iols) in patients.

analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses（bifocal, trifocal, extended depth of focus (edof), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."

Eligibility criteria:
inclusion criteria: * cataract * age \> 18 years exclusion criteria: * amblyopia; previous ocular surgery; * ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects; * requirements for further ocular surgery (other than nd:yag capsulotomy) or retinal laser treatments during the study
development of artificial intelligence models for segmentation and characterization of prostate cancer: a single-center retrospective observational study.

Conditions: Prostate Cancer

Summary: prostate cancer is the second most common cancer in the male population. this pathology represents an oncological and public health problem especially in developed countries, due to a greater presence of elderly men in the population. medical imaging plays a central role in the staging and restaging of prostate disease. magnetic resonance imaging (mri), computed tomography (ct) and positron emission tomography (pet) are among the methods commonly used in normal clinical practice for the characterization of prostate cancer. to date, the study of these images is limited to a qualitative visual analysis, however there is increasing evidence relating to the usefulness of introducing a quantitative (or semi-quantitative) analysis of biomedical images. the current increase in available imaging data, and their quality, allows the application of artificial intelligence methods also in the medical field for the automation of tasks (e.g. automatic segmentation) and classification (e.g. tumor aggressiveness). the extraction of quantitative data, and more generally the study of tumor lesions, requires manual segmentation by one or more doctors. this process requires very long times as each image must be processed individually; furthermore, the result also depends on the level of experience of the doctor carrying out the segmentation and this could create a source of heterogeneity, affecting the reproducibility of the segmentation. ai-based automatic segmentation methods can be applied to medical images for the localization of tumor lesions, thus exceeding the limits of manual segmentation.


Eligibility criteria:
inclusion criteria: * patients with histological diagnosis of prostate cancer; * patients who performed a pet exam with 68 ga-pmsa. exclusion criteria: * ct and mr images with artifacts that preclude interpretation of results.
rct comparing conventional haemorrhoidectomy with laser haemorrhoidoplasty

Conditions: Hemorrhoids

Summary: haemorrhoids or piles are the most common colorectal condition in the local population. patients often present with bleeding with bowel movement or anal discomfort, both of which causes significant anxiety and stress. for symptomatic sizeable piles, the treatment of choice still remains the conventional open excision (coh). however, this technique carries with it a significant risk of bleeding and pain immediately after the operation, leading to some period of discomfort for the patients. the laser haemorrhoidoplasty procedure (lah) has been shown in preliminary studies to have less pain, and less complications compared to coh. this study aims to directly compare these two techniques in a local asian population. the investigators would be conducting a single-centre rct simultaneously comparing the conventional open milligan-morgan haemorrhoidectomy (coh) and the laser haemorrhoidoplasty procedure (lah) for the treatment of symptomatic grade ll-lv haemorrhoids. primary outcomes will be post-operative pain while secondary outcomes include post-operative bleeding, readmission and/or reoperations, haemorrhoid-related quality of life (qol) results and recurrence of symptoms up to a year post procedure


Eligibility criteria:
inclusion criteria: 1. between 21-90 years old 2. presents with symptomatic haemorrhoids as evident from clinical assessment 3. never had any haemorrhoid-related operations performed on them before 4. fit for general anaesthesia 5. able to give informed consent 6. willing to be randomized 7. willing to fill in post-operative questionnaires and be compliant to follow up exclusion criteria: 1. are pregnant 2. are prisoners 3. intellectually, mentally or emotionally deemed not able to provide an informed consent and/or are unable to fill up the post-procedure questionnaires/vas score 4. have had previous haemorrhoid procedural treatment before (except rubber band ligation) 5. declined endoscopic evaluation 6. are on anti-coagulation 7. have history of thrombophilia 8. are on steroids 9. have haemorrhoids which are incidentally found on endoscopy/clinical examination but are asymptomatic from it

Keywords: haemorrhoid laser haemorrhoidectomy
bow015 (infliximab-epirus) and infliximab in patients with active rheumatoid arthritis: the uniform study

Conditions: Rheumatoid Arthritis

Summary: this is a prospective, randomized, double-blind, parallel group, multicentre global phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of bow015 (infliximab-epirus) compared to remicade in subjects with active rheumatoid arthritis (ra) despite methotrexate (mtx) therapy.


Eligibility criteria:
key inclusion criteria: 1. male and female, aged 18 to 80 2. diagnosis of rheumatoid arthritis (ra) according to the revised acr/ eular 2010 classification criteria for ra 3. patients must have acr/eular 2010 classification criteria score ≥ 6 4. patients must have active disease 5. patients must have been on treatment with methotrexate key exclusion criteria: 1. prior use of infliximab, adalimumab, certolizumab, golimumab, tocilizumab, rituximab, or etanercept or any other biological treatment 2. patients with any prior or current use of anakinra and abatacept 3. patients with suspected or confirmed current active tuberculosis (tb) 4. patients with latent tuberculosis must start treatment for latent tuberculosis 5. patients who have a current or past history of chronic infection with hepatitis b, hepatitis c, or infection with human immunodeficiency virus-1 or-2 6. history of completely excised and cured squamous carcinoma of the uterine cervix, cutaneous basal cell carcinoma or cutaneous squamous cell carcinoma 7. history of lymphoproliferative disease 8. history or presence of any other form of malignancy 9. current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease 10. history of congestive heart failure or unstable angina 11. history of any autoimmune disease other than ra 12. major surgery within 12 weeks and planned major surgery 13. history of serious infection 14. pre-existing central nervous system demyelinating disorders 15. administration of live or live-attenuated vaccine within 4 weeks of screening 16. clinically significant adverse reaction to murine or chimeric proteins 17. history or presence of any medical or psychiatric condition or disease, or clinically significant laboratory abnormality 18. participation in any clinical study of an investigational product within the previous 3 months prior to screening
a phase 1b study of laps-exendin in subjects of type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: a phase 1b, exploratory, randomized, partially single blinded, placebo and open label controlled, parallel group study to assess the effects of hm11260c and an active comparator on gastric emptying and beta-cell response in subjects with type 2 diabetes mellitus

primary objective - effect of multiple different weekly and monthly doses of hm11260c and liraglutide (victoza) as active control on gastric emptying secondary objectives * evaluate the pharmacodynamic (pd) effects of multiple weekly and monthly doses of hm11260c and liraglutide after a mixed meal tolerance test * evaluate the islet β-cell function after a graded glucose infusion (ggi) of different doses of hm11260c and liraglutide * evaluate safety and tolerability of different doses of hm11260c and liraglutide * evaluate the pharmacokinetic (pk) effect of multiple weekly and monthly doses of hm11260c

Eligibility criteria:
inclusion criteria: * adults ≥18 to ≤ 70 years of age at the time of the screening visit * history of type 2 diabetes * body mass index (bmi) ≥18 to ≤45 kg/m2 at the screening visit * use of approved methods of contraception * ability to provide written informed consent exclusion criteria: * type 1 diabetes * significant acute diabetic proliferative retinopathy or severe neuropathy * systolic blood pressure \>160 mm hg and/or diastolic blood pressure \>100 mm hg at screening * pregnant or lactating women * participation in an investigational study within 30 days prior to randomization * history of any major surgery within 6 months prior to screening * history of any serious adverse reaction or hypersensitivity to any of the product components. * history of renal disease or significantly abnormal kidney function tests at screening * history of hepatic disease or significantly abnormal liver function tests * history of any active infection within 30 days prior to randomization * presence of clinically significant physical, laboratory, or ecg findings at screening that, in the opinion of the investigator, may interfere with any aspect of study conduct or interpretation of results * concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator * donation or loss of \>500 ml of blood or blood product within 56 days of randomization

Keywords: diabetes mellitus diabetes mellitus, type 2 glucose metabolism disorders metabolic diseases endocrine system diseases exendin-4
zoledronic acid in rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: the progression of structural joint damage is the leading cause of disability and socioeconomic costs associated with rheumatoid arthritis (ra). remission and low clinical activity not always imply absence of progression of structural damage. the main objective of this study is to evaluate the progression of radiological damage in early ra patients currently treated with disease modifying anti-rheumatic drugs (dmards) and low disease activity to which treatment with zoledronic acid is added. the investigators propose a randomized clinical trial in 94 patients with ra of less than 2 years of evolution that, being treated with dmards, present criteria of low disease activity (das28 \< 3.2). patients will be randomized into two branches: zoledronic acid and no treatment. the primary study endpoint is the progression of radiological damage assessed in a blinded way by the difference in the sharp-van der heijde index (shi) in radiographs of hands and feet after two years; the secondary variables: radiographic progression after one year, serum bone biomarkers (opg, rankl, dkk-1 and sclerostin) and adverse effects. in a subgroup of patients, the investigators shall evaluate the change in the size of hand erosions by multislice computed tomography and the evolution of periarticular osteoporosis and systemic bone mass by dual x-ray absorptiometry (dxa).


Eligibility criteria:
inclusion criteria: 1. age equal or greater than 18 years 2. patients with ra of less than 2 years of evolution 3. dmard therapy (methotrexate alone or methotrexate, leflunomide or methotrexate within cobra strategy) on stable dose for at least 6 weeks prior to study entry 4. patients not treated with glucocorticoids or under stable dose of prednisone up to 5 mg / day or equivalent dose of another glucocorticoid 5. low disease activity (das28 \<3.2) 6. in case of premenopausal women, commitment to make contraceptive treatment up to 3 years after the last dose of zoledronic acid 7. signed informed consent exclusion criteria: 1. previous or current treatment with biological drugs used for the treatment of ra (infliximab, adalimumab, etanercept, certolizumab, golimumab, rituximab, abatacept, tocilizumab) 2. pretreatment with: 1. bisphosphonates in the 5 years prior to the onset of ra 2. calcitonin, raloxifene, bazedoxifene, strontium ranelate, teriparatide and denosumab in the year before the onset of ra 3. contraindication to treatment with zoledronic acid: 1. hypersensitivity to bisphosphonates 2. hypocalcemia 3. glomerular filtration rate \<35 ml / min 4. pregnant (negative pregnancy test) and lactating women 5. poor oral hygiene 6. pending invasive dental procedure 4. serum levels of calcidiol lower than 25 nmol/l (10 ng/ml). 5. simultaneous participation in another clinical trial
yervoy® postmarketing surveillance for patients in japan with unresectable, malignant melanoma

Conditions: Melanoma

Summary: this study is a local, prospective, non-interventional, non-controlled, multicenter, observational study (regulatory postmarketing surveillance). each physician will enroll patients who have received at least 1 dose of yervoy, and each patient will be followed for up to 12 months. all patients will be evaluated for safety and effectiveness during yervoy use (4 doses) and for 12 months from the first dose of yervoy to confirm the safety profile of yervoy under routine, daily practice


Eligibility criteria:
inclusion criteria: * all patients who are initiating treatment with yervoy exclusion criteria: * not applicable other protocol defined inclusion/exclusion criteria could apply
safety and efficacy of a new ophthalmic formulation of bimatoprost in patients with open angle glaucoma and ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: this study will evaluate the safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. at least 3 dose strengths will be evaluated based on internal data review of each cohort. the study was planned to be conducted in 2 stages. stage 1 was an open-label and stage 2 was planned to be masked; however only stage 1 was conducted.


Eligibility criteria:
inclusion criteria: * diagnosis of open angle glaucoma or ocular hypertension exclusion criteria: * uncontrolled medical conditions * anticipated wearing of contact lenses during the study
inflammation regulation in obese patients

Conditions: Obesity; Insulin Resistance

Summary: insulin resistance is one of the main mechanisms involved in metabolic diseases. inflammation has been implicated in its pathogenesis, due to innate immunity activation by free fatty acids, lipopolysaccharides (lps) and lactate. free fatty acids, lps and lactate activate innate immunity in squelettal muscle and adipose tissue via toll-like receptor 2/4, nfkb, irf3 (interferon responsive factor 3) and cytokines secretion (tnfa, ifn g, il1b, il6), chemokines secretion (mcp1) and leukotrienes (ltb4). feed back mechanisms involved in tlr signaling pathways as rli (ribonuclease l inhibitor)/abce1, have never been studied in inflammation due to obesity. rli inhibits an endoribonuclease, rnase l, which has been recently implicated in tlr signaling the purpose of this study is to analyse the role of rli and rnase l in tlr regulation, and its potential implication in the link between obesity, inflammation and insulin resistance in adipose tissue and squeletal muscle in humans.

the investigators working hypothesis is that rnase l and rli contribute to chronic inflammation regulation and to insulin response through tlr 4 pathway regulation in obesity. the investigators main purpose is to compare innate immunity activation pathway between insulin sensitive, insulin resistant obese patients and control patients. insulin sensitive and insulin resistant obese patients will be distinguish thanks to the homa ir index. the investigators second objectives are to evaluate if the degree of inflammation in adipose tissue and squeletal muscle is correlated to insulin sensitivity measured by hyperinsulinemic euglycemic clamp and to characterise inflammatory pathway and regulation pathway. a special focus will be given to the leukotrienes and their potential role in insulin resistance pathogenesis. the investigators will have two approaches:- characterisation of subjects with normal weight, of obese insulin sensitive and obese insulin resistant through a metabolic evaluation, an inflammatory characterisation and a measure of insulin sensitivity at the systemic level, in adipose tissue and in squeletal muscle.- an in vitron approach with human myoblast and adipocytes culture, extracted from the investigators patients: characterisation of inflammation, innate immunity.

Eligibility criteria:
inclusion criteria: * age between 50 and 65 years old * men/ menopausal women * bmi \ 30 kg/m2 for the obese group * non diabetic patients * homair \<3 for the insulin sensitive obese group * non smoking * without any inflammatory disease * without any first degrees relative with diabetes * without any treatment that could interfere with insulin sensitivity * without any infection

Keywords: obesity insulin resistance
a study of capecitabine (xeloda) and peginterferon alfa-2a (pegasys) in treatment-naive participants with advanced liver cancer

Conditions: Carcinoma, Hepatocellular

Summary: this study will evaluate the efficacy and safety of capecitabine (xeloda) in combination with peginterferon alfa-2a (pegasys) in participants with advanced liver cancer who have had no prior treatment. the anticipated time on study treatment is until disease progression, and the target sample size is 43 individuals.


Eligibility criteria:
inclusion criteria: * adults 18 to 75 years of age * locally advanced or metastatic liver cancer with measurable disease and not eligible for any standard therapy exclusion criteria: * previous treatment for liver cancer * main portal vein involvement * bone, brain, or leptomeningeal metastasis * clinically significant cardiac disease * malabsorption syndrome or lack of physical integrity of the upper gastrointestinal tract * history of other cancer, except basal cell skin cancer or in situ cancer of the cervix
effect of naltrexone in achieving and maintaining abstinence from alcohol in patients with cirrhosis.

Conditions: Liver Cirrhosis

Summary: the aim of the study is to study the safety and tolerability of naltrexone in patients with alcohol liver disease over a 12 week duration without liver related side effects. the project will be conducted at ilbs from march 2020 to february 2021. the concept is to estimate the usage of naltrexone and establish its safety in cirrhotics and study its effect on achieving and maintaining abstinence and in reducing lapses and relapses. thereby reducing the progression of alcoholic liver disease as continued ethanol consumption is an important predictor in increasing overall morbidity and mortality. all ald patients will be included as per inclusion and exclusion criteria, after taking informed consent from the patient or their relatives. in case of any reactions, the drug will be stopped as per the study stopping rule. after following the inclusion and exclusion criteria, ald patients will be recruited into the study. it's a double blind rct, hence both the patient and the investigator will be blinded and the drug will be issued by the trial co-ordinator after taking informed written consent and explaining the side effects. naltrexone at a dose of 50 mg per day and placebo are included in the tablets. placebo tablets will be identical in size, colour, shape, and taste. naltrexone tablets will be entrusted to a family member to administer every dose and monitor for side effects.


Eligibility criteria:
inclusion criteria: 1. all consecutive alcohol dependent cirrhotic aged between 18-60 yrs. 2. fulfilling dsm - 5 criteria for alcohol use disorder (association, 2013). exclusion criteria: 1. current hepatic encephalopathy 2. total bilirubin \> 3 mg/dl. 3. recent bleed. 4. treatment with corticosteroids within the past 60 days. 5. unwilling to participate. 6. dependence on any other substance (except nicotine). 7. psychotic disorder requiring treatment/suicidal tendency.