Kornimate/medical-research-clean huggingface dataset:
comparison of the fixed combinations of brimonidine/timolol and dorzolamide/timolol in subjects with open-angle glaucoma or ocular hypertension

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Summary: this study compares the efficacy and tolerability/comfort of brimonidine/timolol and dorzolamide/timolol in patients with open-angle glaucoma or ocular hypertension. in an investigator masked randomisation process, each subject is allocated to received either brimonidine/timolol or dorzolamide/timolol as fixed-combination monotherapy or as an adjunctive to a prostaglandin analogue for a period of 12 weeks. after screening, patient returns at baseline, month 1 and month 3 for ophthalmic evaluations.


Eligibility criteria:
inclusion criteria: * male or female over 18 years * female subjects of childbearing potential must have negative pregnancy test and practice contraception * subjects must have confirmed diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes * subjects who are or have been insufficiently responsive to iop reducing monotherapy and use of either study medication is deemed appropriate * subjects able to complete questionnaires and provide informed consent exclusion criteria: * female subjects who are pregnant, planning to become pregnant during study period, breast feeding or not practicing a reliable method of birth control * subjects wherein the study drugs are contraindicated * subjects who have had intraocular surgery with 6 months (3 months for laser) * subjects with known side effects/allergy or sensitivity to any component of study treatments * subjects with any uncontrolled systemic disease
evaluating alln-177 for reducing urinary oxalate excretion in calcium oxalate kidney stone formers with hyperoxaluria

Conditions: Hyperoxaluria; Nephrolithiasis

Summary: the purpose of this study is to evaluate the effect of alln-177 to reduce urinary oxalate excretion in patients with recurring kidney stones and enteric or idiopathic hyperoxaluria.

a multi-center, open-label, single arm study to evaluate the safety and the effect of alln-177 to reduce urinary oxalate excretion in recurrent kidney stone formers with associated hyperoxaluria. the study design includes a screening period to confirm eligibility, followed by a 3-day baseline period, 4-day open label treatment period with alln-177 and 4-day follow up period.

Eligibility criteria:
inclusion criteria: * able to provide informed consent * able to comply with study procedures * history of enteric or idiopathic hyperoxaluria and at least one calcium oxalate kidney stone * hyperoxaluria \>36mg of oxalate/24-hr * may be taking drugs for the prevention of stone disease as long as there have been no changes in these medications for at least 3 months exclusion criteria: * uric acid ≥1.5g/24-hr * estimated glomerular filtration rate of \< 60 ml/min * positive results from drug urine screen * requires daily vitamin c (defined as \>10 days of \>300 mg/day) * diagnosis of hypercalcemia or hypothyroidism * obstructive uropathy, chronic urosepsis, renal failure, renal tubular acidosis, primary hyperparathyroidism, primary hyperoxaluria, pure uric acid and cystine stones, and/or medullary sponge kidney. * auto-immune disorder requiring high dose steroids or other immunosuppressant drugs. * subjects who are pregnant. women of childbearing potential must have a negative pregnancy test prior to enrollment and must practice approved methods of birth control during the trial * history of cancer diagnosis except for within the past 5 years excluding dermal squamous and/or basal cell carcinoma or cervical carcinoma in situ. * taken investigational compound within 30 days prior to the first day of the study * treatment with cholestyramine * average daily dietary intake of \<75 mg oxalate per day calculated from diet recalls

Keywords: urine oxalate nephrolithiasis kidney stones hyperoxaluria enteric hyperoxaluria idiopathic hyperoxaluria urological diseases kidney diseases
clinicopathological profile of head and neck cancers in army hospital of nepal

Conditions: Head and Neck Cancer

Summary: this is a observational study conducted at the department of ear ,nose and throat -head and neck surgery (ent-hns) of shree birendra hospital ,a tertiary health care centre of nepal. head and neck cancers are the sixth most common cancer in the world. data was collected from the medical records of head and neck cancer patients who underwent treatment between may 2022 to april 2023.the main aim of the study was to know about the common cancers of head and neck region and their distribution according to the site. also to know the stage of the presentation with treatment modalities in the tertiary health care centre of nepal.

this is a retrospective study to know the prevalence of head and neck cancer at the department of ent- head and neck surgery of shree birendra hospital ,a tertiary health care centre of nepal .head and neck cancers are malignant neoplasms that develops in oral cavity, nasal cavities, paranasal sinuses,nasopharynx, oropharynx, hypopharynx, ear, scalp, salivary gland and neck,data was collected from the medical records of head and neck cancer patients who underwent treatment between may 2022 to april 2023. data considered of demographic details of age, sex, diagnosis, subsite specific head and neck cancers, treatment modality and histopathology. the data was analyzed using stastical package for social sciences (spss) version 22. pearson's chi-square test was applied and p value \<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * all histologically proven cases of head and neck region. exclusion criteria: * patient's record with incomplete data.

Keywords: head and neck cancer radiotherapy chemotherapy
patients seeking a visual impairment certificate

Conditions: Demographic Profiles; Impairment Certificates; Visual Impairment

Summary: this study investigates the prevalence, causes, and demographic characteristics of patients seeking visual impairment certificates at assiut ophthalmology hospital. using a prospective cross-sectional design, it aims to identify the magnitude and nature of visual impairment in this population by analyzing clinical data, performing comprehensive eye examinations, and utilizing advanced diagnostic tools.

the study is designed to explore the prevalence, underlying causes, and demographic profiles of patients requesting visual impairment certificates at assiut ophthalmology hospital. it employs a prospective cross-sectional approach, recruiting patients from ophthalmology outpatient clinics who meet the world health organization's (who) definition of blindness. blindness is defined as having best-corrected distance visual acuity (bcva) of 3/60 or less in the better eye or a visual field restricted to 10° or less in the widest diameter of vision. eligible participants undergo comprehensive eye examinations, including visual acuity measurement using snellen charts, slit-lamp biomicroscopy, dilated fundus examination, and automated perimetry for visual field assessment. advanced investigations such as oct macula imaging, vep (visual evoked potential), erg (electroretinography), ultrasound, and fundus photography are performed to identify the causes of visual impairment. demographic data-such as age, sex, marital status, occupation, socioeconomic status, education level-and systemic medical history are collected to assess contributing factors. the sample size was calculated using epi-info software with a confidence level of 95% and confidence limits of 5%, estimating a minimum of 383 cases. by analyzing clinical findings alongside demographic characteristics, the study aims to provide valuable insights into the magnitude and nature of visual impairment in this specific population. this information could help inform public health strategies and improve services for visually impaired individuals.

Eligibility criteria:
inclusion criteria: * patients requesting visual impairment certificate at assiut ophthalmology hospital having all investigations visual field, oct macula, vep, erg, us, fundus photography werepatients who fulfilled who's definition of blindness. the blind patients according to who's,were defined as patients having best corrected distance visual acuity (bcva) of 3/60 or less in the better eye or a visual field restricted to 10 or less in the widest diameter of vision. exclusion criteria: * patients unwilling to participate in the study incomplete or missing investigations

Keywords: visual impairment demographic profiles visual impairment certificates
color doppler ultrasonography evaluation of abdominal and peripheral vasculopathy in systemic sclerosis patients

Conditions: Systemic Sclerosis

Summary: in the current study we aim to assess the macrovascular involvement in ssc patients through an ultrasound (us) evaluation of radial and ulnar arteries and splanchnic vessels.

systemic sclerosis (ssc) is a connective tissue disease (ctd) characterized by diffuse cutaneous sclerosis of skin and organs, small vessel vasculopathy and immune system dysregulation associated with the production of autoantibodies. although small vessel vasculopathy can be considered a hallmark of this disease, large vessels can also be involved. accordingly, involvement of medium vessels such as the ulnar artery has been evaluated in the literature, with results showing how ulnar artery occlusion (uao) could be considered as a severity marker of vasculopathy as well as a predictive marker of digital ulcers (dus), which are typically more frequent in patients with limited cutaneous (lc) ssc. the gastrointestinal (gi) tract is one of the most frequently involved organs, affecting the majority (75-90%) of ssc patients. gi involvement is often largely asymptomatic because it is frequently subclinical until severe tissue damage occurs. once symptoms occur, ssc-related gi involvement heavily impacts morbidity and mortality, with patients experiencing significant emotional and social burdens and decreased survival in severe cases. unfortunately, the diagnosis of gi involvement is challenging because it is often delayed by the paucity of signs and symptoms early in the disease. moreover, several diagnostic investigations that are useful in defning gi involvement are either invasive, expensive or not very informative. understanding the etiology and early phases of gi involvement, therefore, remains a high priority in ssc research. the aim would be to identify patients at high risk of developing progressive gi involvement, monitor disease activity, in the vessels or other relevant tissues, and intervene before the development of signifcant damage/dysfunction. bandini et al. showed how potentially the splanchnic vessels in ssc may be non-invasively investigated with abdominal us and color doppler us, showing that some morphological and functional us parameters of mesenteric arteries of ssc patients are different from healthy controls defining a "bowel vasculopathy". abdominal ultrasound (us) is a unique tool that allows for the noninvasive assessment of the vasculature and major parts of the gi tract, including extra-intestinal features and splanchnic vessels as well as peripheral vessels.

Eligibility criteria:
inclusion criteria: * adult systemic sclerosis patients fulfilling the criteria for the diagnosis by american college of rheumatology /european league against rheumatism 2013 classification criteria for systemic sclerosis, who accept to participate in the current study. exclusion criteria: * individuals with other autoimmune diseases (rheumatoid arthritis, dermatomyositis, mixed connective tissue disease). * those who refuse to participate in the current study.

Keywords: systemic sclerosis doppler ultrasound
the effect of subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery

Conditions: Arthrosis; Arthritis

Summary: the study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

major ankle and hind foot surgery causes intense postoperative pain. implementation of continuous sciatic catheters has been a great success in reducing postoperative pain following these operations, but despite an effective sciatic catheter patients still report moderate to severe pain from the anteromedial side of the ankle. according to cadaver dissection studies the saphenous nerve innervates the anterior and medial parts of the ankle and talonavicular joint, and even though a saphenous block is standard procedure in many departments of anesthesiology worldwide, scientific evidence regarding the effect of the saphenous block on postoperative pain is lacking. this study investigates the effect of a selective, ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

Eligibility criteria:
inclusion criteria: * elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis or (4) triple arthrodesis * age ≥ 18 * american society of anaesthesiology classification i-iii * informed consent both orally and in writing after the patient has fully understood the protocol and its limitations. exclusion criteria: * communication problems or dementia * allergies to any medical product used in the study * neuropathy of the sciatic or femoral nerve prior to the operation * morbus charcot-marie-tooth disease, diabetic neuropathy, peripheral vascular disease * daily use of opioids * coagulation disorders * infection at the site of injection or systemic infection
design of well being monitoring systems, application in autism

Conditions: Autistic Disorder

Summary: the worldwide prevalence of autism is constantly increasing. people with autisms have difficulties in communication and social interaction resulting from atypical perceptual and information processing, leading to the accumulation of anxiety. extreme overloading experienced internally may not be visible externally. identifying stressful situations at an early stage may avoid socially problematic behavior from occurring, such as self-injurious behavior. activation of the autonomous nervous system (ans) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of a portable device, non-intrusively and pain-free. thus, developing innovative analysis of signal perception and reaction is necessary, mainly for the non-communicative individuals with autism.

the protocol will take place in real life (home and social environments). we aim to associate modifications of ans with external events which will all be recorded in a synchrony manner through a specific design (spy glasses with video/audio recording). four phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. we will apply the statistical analyses developed by our team on continuous ans data. detection of abrupt changes will allow segmenting the data in shorter time series of few minutes with a constant mean, and estimating their persistency or antipersistency through a piecewise constant fractal index. we will disentangle classes characterizing different behaviors such as anxiety, rest and physical activity.

Eligibility criteria:
inclusion criteria: * clear autism spectrum disorder, based on the autism diagnostic interview - revised (adi-r), the autism diagnostic observation schedule - generic (ados-g), and the vineland adaptive behavior scales (vabs). exclusion criteria: * change in medical prescription in the previous 3 months and during the experiment. the same inclusion criteria will apply for the paired age and sex matched individuals with the exception of autism spectrum. the paired control will be chosen within the friends of individuals with autism. in case of difficulty to recruit controls, the psychologist referent may be served as control.
comparison of liraglutide and glimepiride on blood sugar control in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to establish the dose response relationship on glycaemic control of five dose levels of nnc90-1170.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * duration of diabetes at least 3 months * both diet treated and patients in therapy with oha (oral hypoglycemic agents) * body mass index maximum 40 kg/m\^2 * hba1c based on analysis from central laboratory: between 7.5-10.0%, both inclusive, for diet treated, or maximum 9.0% for oha treated exclusion criteria: * liver or renal disease * cardiac problems * uncontrolled treated/untreated hypertension * proliferative retinopathy * recurrent severe hypoglycaemia as judged by the investigator * known or suspected allergy to trial product or related products * use of any drug (except for ohas) which in the investigator's opinion could interfere with the blood glucose level
fecal microbiota transplant national registry

Conditions: Fecal Microbiota Transplantation; Clostridium Difficile Infection; Gut Microbiome

Summary: a national data registry of patients receiving fecal microbiota transplantation (fmt) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness

this registry will prospectively enroll 4,000 patients who undergo fmt at 75 sites throughout north america. information on fmt methodology employed (e.g., screening of donor and recipient, preparation, fmt delivery) will be collected from each site. the indication for fmt as well as baseline information on recipient will also be collected. following fmt, patients will be followed at regular intervals up to 10 years post fmt. this will include follow-up information from the patient's healthcare provider at 1 month, 6 months, 1 year, and 2 years after fmt as well as direct communication with patients at least annually up to 10 years after fmt. follow-up information collected will be designed to assess potential short-term and long-term safety and effectiveness.

Eligibility criteria:
inclusion criteria: * recipient inclusion criteria * ability to give informed consent * receiving fmt or other gut-related microbiota product within 90 days after providing consent * access to internet and/or telephone * donor inclusion * ability to give informed consent * providing stool sample for fmt exclusion criteria: * incarceration

Keywords: fmt cdi fecal matter transplant
intergenerational effects of paternal periconceptional cannabis and other drug use (epic)

Conditions: Cannabis Use; Drug Use; Development, Infant

Summary: the overall objective of this proposed project is to prospectively evaluate the epigenetic and developmental effects of paternal cannabis and other drug use in offspring.

this project involves enrollment of 40 healthy mother-father dyads that are between the ages of 18 and 40 years. urine samples for qualitative drug and cotinine testing will be collected from mother-father dyads, as well as quantitative thc (tetrahydrocannabinol) and thccooh (11-nor-9-carboxy-thc) assay. a semen sample will be collected from biological fathers. relevant birth outcome data including both infant and maternal measures will be extracted from the electronic health record (ehr). infant developmental assessments will be completed at approximately 6 months of age.

Eligibility criteria:
inclusion criteria: 1. both mother and father are between 18 and 40 years of age 2. free from significant medical conditions, as determined by medical history and examination from attending obstetrician or health care provider. 3. father is able to be contacted and consents to provide urine and sperm samples 4. both mother and father consent to participation and for the prospective enrollment of their child after birth 5. plan on delivering their baby at one of the two main duke-affiliated hospitals (duke university medical center and duke regional hospital) exclusion criteria: 1. mother or father currently prescribed any psychoactive medication; 2. mother or father unable to comply with study requirements or otherwise unsuitable for participation in the opinion of the pi.
endoscopic management of fistulas related to sleeve gastrectomy with double pigtail stents according to the bartoli technique

Conditions: Gastrostomy; Fistula

Summary: obesity is a major health problem in western countries, and sleeve gastrectomy has proven its effectiveness on weight loss and improvement of comorbidities related to obesity. the main complication is the occurrence of upper fistula (2%), and may be responsible of several deaths. there is no consensus on medical, radiological and surgical management of fistula. it depends on the resources of each center and is based on a low level evidence the inconstant efficacy of the endoscopic treatment by closing fistula (digestive stents, clips, glue) motivates a new endoscopic approach. it consists of an internal drainage of the collection by using double pigtail stents through the fistulous orifice.

partially or fully covered stents are the most used method, but are not supported by any comparative studies. their results are inconstant and the closure rate is estimated between 15 and 100%, with a hazardous median healing time. this method is associated with frequent complications, such as spontaneous migrations, impactions or ulcerations responsible for potentially fatal hematemesis. the preliminary results of using otsc clips (ovesco®) seem encouraging, but this technique requires external drainage to obtain a collection free from infection. a new approach is to perform an internal drainage of the peri-orificial collection by using double pigtail stents through the fistulous orifice and to direct the fistula closure from the outside to the inside. this endoscopic treatment, combined with nutritional support and initial antibiotic therapy, allows rapid weaning of external drainage and short healing times. ct and endoscopic evaluation are needed at the sixth week for stents removal in the event of a favorable evolution. in the opposite case, a second endoscopic treatment is performed. in case of unfavorable evolution, a radical surgical treatment, in the absence of endoscopic alternative, will be achieved.

Eligibility criteria:
inclusion criteria: * any major patient hospitalized for a symptomatic fistula after sleeve gastrectomy, outside the exclusion criteria, is eligible. * free, informed and signed consent * affiliation to the social security system exclusion criteria: * other surgery than sleeve gastrectomy * fistula located at a site other than the upper pole of the staple line * fistulization on the upper diaphragmatic floor * fistulous orifice larger than 25 mm * pregnancy * patient under guardianship or curators or deprived of public law

Keywords: sleeve gastrostomy endoscopy fistula double pig tail stents