Kornimate/medical-research-clean huggingface dataset:
treatment of myotonia - lamotrigine versus namuscla

Conditions: Non-Dystrophic Myotonia

Summary: in this clinical study, the aim is to investigate whether there is a difference in treatment of myotonia using two drugs. a difference there can justify the significantly higher cost when treated by namuscla versus lamotrigine. according to the current corona pandemic, the investigators designed an app to use for data collection in the study. the app also ensures that patients who live far from the clinic more easily can participate.

on 18 may 2020, the national board of health in denmark approved namuscla for the treatment of myotonia. myotonia is a congenital muscle disease that delays muscle relaxation after a muscle contraction. myotonia can be disabling, but with treatment, most are able to work. namuscla is the first registered drug to treat myotonia, however, the active part mexiletine is not new. it has been used off-label to treat myotonia for decades. the price for the new preparation is high with a daily cost (approx. 70 eu/dollar). in 2017, the investigators found evidence that treatment with lamotrigine is efficacious against myotonia. treatment with lamotrigine can reduce the price to 150 eu/dollar per year. therefore, the aim of the study is to investigate whether there is a difference in the effects om myotonia and side effects of the two drugs, which can justify the significantly higher cost when treated with namuscla in a double blinded, inferiority, cross-over study lasting 4 months. according to the current corona pandemic, the study is designed without need of physical attendance so that inclusion and collection of experimental data can take place, by phone conversations, video-guided testing, and diary registration via a study-app. it also ensures that patients who live far away more easily can participate. blood tests and ecgs can be performed locally.

Eligibility criteria:
inclusion criteria: 1. capable adult women and men (age ≥ 18 years). 2. diagnosed with myotonia congenita (becker and thomsen type), paramyotonia congenita, or hyperkalemic periodic paralysis. 3. myotonia under treatment or which significantly limits the daily activities (mbs\> 2). exclusion criteria: 1. allergy to lamotrigine, mexiletine, or the inactive ingredients in trial medication. 2. disease, which is affected by trial medication such as heart disease (ischemia and arrhythmia), epilepsy, and significant renal or hepatic failure. 3. treatment that, in the opinion of the project manager, can affect the study result - medication with significant interactions with trial medication. 4. in case of smoking, start or cessation during the study. 5. pregnant or breastfeeding during the study period. fertile women with a positive pregnancy test at the time of entry into the trial, or who do not use safe contraception during the project period.

Keywords: becker myotonia thomsen myotonia paramyotonia hyperkalemic periodic paralysis
probiotics and gut health

Conditions: Metabolic Syndrome

Summary: this study evaluates the effects of probiotic consumption on inflammatory outcomes and measures of gut health. participants will be given yogurt with probiotics for one period and yogurt without probiotics for another, with a break in between. these periods will occur in random order.


Eligibility criteria:
inclusion criteria: * bmi ≥ to 25 and less than 35 kg/m\^2 * increased waist circumference (men: ≥ 94 cm, women: ≥ 80 cm) * at least one of the metabolic syndrome criteria- * serum triglycerides: ≥ 150 mg/dl * hdl cholesterol: ≤ 40 mg/dl in men, ≤ 50 mg/dl in women * blood pressure: ≥ 130 mmhg systolic or ≥ 85 mmhg diastolic * fasting plasma glucose ≥ 100 mg/dl exclusion criteria: * allergy to dairy * smoking and/or use of tobacco products * systolic blood pressure ≥ 160 mmhg * diastolic blood pressure \> 100 mmhg * fasting glucose ≥ 126 mg/dl * history of myocardial infarction, cardiovascular disease (cvd), stroke, diabetes mellitus, liver disease, kidney disease, thyroid disease (unless controlled on medication) * use of cholesterol or lipid lowering medications * use of anti-hypertensive or glucose lowering supplements (psyllium, fish oil capsules, soy lecithin, niacin, fiber, flax, phytoestrogens, and stanol/sterol supplemented foods) * refusal to discontinue nutritional supplements, herbs, vitamins, or other probiotics * clinical diagnosis of inflammatory bowel disease (ibd) e.g. chron's disease or ulcerative colitis * use of antibiotics within the last 2 months * excessive alcohol consumption (≥ 14 standard drinks per week) * regular use of anti-inflammatory medications (e.g. aspirin, ibuprofen)

Keywords: probiotics human obesity non-pharmacologic therapy gut health microbiome inflammation
3d laparoscopy versus 2d laparoscopy

Conditions: Colorectal Cancer; Inflammatory Bowel Disease

Summary: * to compare surgical and oncological outcomes in patients underwent to colorectal resection with 3d vs 2d laparoscopic technique. * to evaluate the visual overload in surgeons using 3d laparoscopic technique.

3 dimensional (3d) camera system is a new technique introduced into laparoscopic surgery field, adding the depth perception. even if in the first 2000' the old 3d camera had negative results in terms of quality of images, thanks to technological progress the new 3d systems have reached high quality. this new technology has been widely tested in pelvic trainer, not yet in live surgery. moreover effects on surgeons visual work load are unknown. aim of the present study is to evaluate the potential superiority of 3d laparoscopic technique on 2d one in terms on postoperative complications and oncological radicality (in case of neoplastic disease). secondary aim is to study the possible major visual stress on surgeons brain caused by 3d camera rather than 2d videos. enrollment all patients affected by neoplastic or inflammatory colorectal disease are enrolled in the study. preoperative, intraoperative e postoperative data are collected dividing all the patients according the camera system used during the operation: 2d group vs 3d group. preoperative data: sex, age, date of birth, id, date of admission, past medical history intraoperative data: date of surgery, pathology, site of pathology, type of surgery and duration, intraoperative blood loss, other intraoperative problems, loop ileostomy, colostomy, drain positioning, intensive care unit admission postoperative data (at 30th postoperative day): complications according to dindo-clavien scale (dindo-clavien classification of surgical complications), type of complications, transfusion, reoperation, other treatments, histology specimen report. at the end of every operation, the 1st surgeon has to fill in the nasa (the national aeronautics and space administration) task load index and the simulator sickness questionnaire. number of participants: 350 years necessary: 2

Eligibility criteria:
inclusion criteria: * colorectal cancer with or without preoperative radio e chemiotherapy * inflammatory bowel disease affected colon and rectum that need surgery exclusion criteria: * patients under 18 years

Keywords: 3 dimensional laparoscopy visual work load nasa task load index simulator sickness questionnaire
epidemiology of iga selective deficiency - clinical manifestations and risk of transmission

Conditions: COVID-19

Summary: the management of patients with a selective iga deficiency currently consists of symptomatic treatment with treatment of infections by occasional or prolonged antibiotic therapy, immunosuppressive treatments for autoimmune pathologies, symptomatic treatment of allergic manifestations. ivig supplements are sometimes proposed in the event of recurrent infections and the demonstration of deficiencies in igg subclasses (igg1, 2, 3) often not sought for diagnosis the factors associated with the severity of clinical manifestations are not well identified and patients with iga deficiency must be monitored over the long term because of the risk of the appearance of autoimmune manifestations and neoplasia. the identification of such factors could lead to the proposal of close monitoring for these patients. iga deficiency, which is frequent, has not been identified as a risk factor for severe covid-19 infection, probably due to a lack of studies with sufficient recruitment. the therapeutic attitude concerning patients with an iga deficiency in the event of covid-19 infection is therefore not consensual. there is currently no action to be taken regarding the risk of transmission of iga deficiency.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject treated at the hus, with a primary selective iga deficiency, considered as definitive (iga concentration \< 0.07g/l or total absence of iga on immunofixation) or as probable (iga concentration lower than two standard leads to standard for age) with no other humoral immunodeficiency and no other cause of decreased gammaglobulins 01/01/2005 to 01/31/2022. * subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research. exclusion criteria: . subject who expressed their opposition to participating in the study

Keywords: covid-19 iga deficiency antibiotic therapy immunosuppressive treatments autoimmune manifestations neoplasia
vr mind and vr mind+ intervention

Conditions: Social Phobia

Summary: the aim of the study is to assess the safety and efficacy of vr mind and vr mind + interventions.

in this study, investigators will test the software developed by tomorrow sp. z o. o., named vr mind and vr mind+. the software utilizes the concept of virtual reality exposure therapy to treat social anxiety disorder. the aim of the study is to assess the safety and efficacy of vr mind and vr mind + interventions. the research consists of fourteen sessions. the first and the last session will be dedicated to participant assessment. subsequent sessions 2-13 will be performed according to the therapy protocol for each arm. control group of participants (active comparative arm) will receive standard treatment for social anxiety disorder - cognitive behavioral therapy based on the protocol developed by the principal investigator \[protocol adapted from the approach of clark and wells (mayo-wilson, dias, mavranezouli, 2014)\]. experimental group 1 will receive cognitive behavioral therapy with exposure in virtual environment. experimental group 1 and control group were designed to be as similar as possible, with the exception of the modality for the delivery of exposure. all treatment session will be led by licensed therapist. participants of the experimental group 2 will independently conducts the self-therapy process. the intervention will consist of 12 therapeutic sessions. at each of the 12 sessions, the participant will selects a specific scenario of social situations that arouse fear (e.g. public speaking, job interview or other situations from everyday life). because of the risk of simulator sickness (e.g., headaches, nausea), exposure trials will last no longer than 20 minutes for each session.

Eligibility criteria:
inclusion criteria: * confirmed dsm-iv-tr criteria for social anxiety disorder (sad). * signing informed consent * unchanged doses of psychotropic medications within 3 months prior to baseline assessment and no change is anticipated exclusion criteria: * occurrence of sad symptoms inconsistent with dsm-iv-tr criteria and with psychiatric interview (scid-i; structured clinical interview) * psychosis, * bipolar disorder, * mental retardation * pregnancy, * drug addiction, * alcohol addiction, * psychoactive substances addiction, * participating in the experimental session while intoxicated * (current) neurological treatment of chronic disease of central nervous system, * epilepsy, * paroxysmal vertigo, * presence of suicidal thoughts, tendencies or attempts, * participant is taking drugs from benzodiazepine group, other sedatives, narcotic drugs * current cbt treatment for social anxiety disorder

Keywords: virtual reality social phobia vret virtual reality exposure therapy
sequential icotinib plus chemotherapy versus icotinib alone as first-line treatment in stage iiib/iv lung adenocarcinoma

Conditions: EGFR Positive Non-small Cell Lung Cancer; Adenocarcinoma

Summary: this randomised, controlled, multicentre trial is designed to assess the efficacy and safety of sequential icotinib plus chemotherapy versus single icotinib as first-line treatment in stage iiib/iv lung adenocarcinoma patients with egfr mutation.


Eligibility criteria:
inclusion criteria: * pathologic confirmation of lung adenocarcinoma with measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded on ct) * patients must have previously untreated locally advanced or metastatic nsclc * egfr activating mutation (exon 19 deletion, l858r) is required * eastern cooperative oncology group performance status (ecog ps) score of 0 or 1 exclusion criteria: * prior chemotherapy or treatment with gefitinib, erlotinib, or other drugs that target egfr * patients with wild-type egfr * any other investigational agents are not permitted * any evidence of interstitial lung disease
impact of co enzyme q10 as adjuvant therapy to letrozole on spermiogram

Conditions: Male Reproductive Problem; Infertility, Male

Summary: worldwide infertility affects about 15 % of reproductive-age couples. in many cases, infertility can't be treated, new treatment options with promising value were involved in the recent clinical trials.

we will evaluate the impacts of adding coenzyme q10 to letrozole on spermiogram and sex hormone in men diagnosed with idiopathic oligo/astheno/ teratozoospermia (ioat) syndrome. the study will include 67 patients which will be randomly separated into two groups, group (a) 29 patients will be treated with letrozole 2.5mg tablet orally twice a week, group (b) 38 patient will be treated with a combination of letrozole 2.5 mg tablet orally twice a week plus co-q10 400mg per day, both groups complete treatment for three months. semen sample, serum fsh, estradiol (e2), and testosterone (t) were analyzed at day one, and at the end of one, two, and three months.

Eligibility criteria:
inclusion criteria: 1. adult male patients. 2. aged 18 - 60 years. 3. confirmed diagnosis with idiopathic oligo-astheno-teratozoospermia (ioat) syndrome. exclusion criteria: 1. patients who have been found to have additional infertility causes, such as varicocele or obstruction of the ejaculatory duct. 2. those who have had surgery for male factor infertility. 3. patients with infections such as std. 4. patient with renal or liver disease 5. incomplete patient data
comparative study of ceftaroline vs. vancomycin plus aztreonam in adult subjects with complicated skin infections

Conditions: Bacterial Infections

Summary: the purpose of this study is to determine whether ceftaroline is effective and safe in the treatment of complicated skin infections in adults.

additional purpose of this study is to compare ceftaroline effectivity versus vancomycin plus aztreonam in the treatment of complicated skin infections in adults.

Eligibility criteria:
inclusion criteria: * skin and skin structure infection (sssi) that involves deeper soft tissue or requires significant surgical intervention, or cellulitis or abscess on lower extremity which occurs in subjects with diabetes mellitus or well-documented peripheral vascular disease. exclusion criteria: * prior treatment of current complicated skin and skin structure infection (csssi) with an antimicrobial. * failure of vancomycin or aztreonam as therapy for the current csssi, or prior isolation of an organism with in vitro resistance to vancomycin or aztreonam.

Keywords: abscess antibacterial antibiotic antimicrobial bacterial infection, skin ceftaroline ceftaroline acetate cellulitis cephalosporin complicated skin and skin structure infection (csssi) csssi intravenous methicillin-resistant staphylococcus aureus (mrsa) ppi-0903 prodrug skin disease, bacterial skin infection staphylococcal skin infection staphylococcus aureus streptococcal skin infection surgical site infection tak-599
online support groups for depression and anxiety

Conditions: Depression; Anxiety

Summary: the purpose of this study is to determine the effectiveness of online support groups for anxiety and depression.

in recent years the number of online support groups for conditions like depression and anxiety has grown rapidly. millions of people are thought to be using them around the world. this research aims to help find out whether the use of online support groups is beneficial and to learn more about what happens in these groups. this research will compare online support groups with expressive writing. expressive writing involves people writing about their thoughts and feelings, often upsetting ones, for a short period of time. in online support groups giving and receiving support from others can be helpful while expressive writing about emotional issues can be cathartic. 1,000 participants will be recruited online from the uk, usa and canada and randomly assigned to either an existing online support group or to an expressive writing condition.

Eligibility criteria:
inclusion criteria: * self-defined depression \& anxiety * resident in the uk, us or canada * access to the internet exclusion criteria: -
vienna hypothermic oxygenated machine perfusion study

Conditions: End Stage Liver Disease; Hepatocellular Carcinoma

Summary: in this observational cohort study data on all patients undergoing liver transplantation after hypothermic oxygenated machine perfusion at medical university of vienna will be prospectively recorded. investigation of short- and long-term outcome in this cohort will be conducted.


Eligibility criteria:
inclusion criteria: * patients undergoing liver transplantation with the use of hypothermic oxygenated machine perfusion * age ≥ 18 years exclusion criteria: * pregnancy * partial grafts * the anatomical integrity of the liver is not preserved in a way that makes the perfusion of the liver possible

Keywords: liver transplantation hypothermic oxygenated machine perfusion
effectiveness of diacutaneous fibrolysis in painful shoulder

Conditions: Shoulder Pain

Summary: while diacutaneous fibrolysis (df) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. the investigators hypothesized that the use of df in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. to test the hypothesis a double blind (patient and investigator) randomized clinical trial was carried out in two public primary health care centres. fifty patients were randomly allocated to two groups: the intervention group, who received a real df session, and the control group, who received a placebo df session.

background and objectives: diacutaneous fibrolysis (df) is a manual technique to treat the mechanical pain of the musculoskeletal system. while this technique has achieved promising results empirically, its effectiveness has not been tested in clinical trials. we aimed at evaluating the effectiveness of a single session of df on pain and mobility in patients suffering from painful shoulder. subjects and methods: this clinical trial took place in two public primary health care centres. fifty patients were randomly allocated to two groups: the intervention group, who received a real df session, and the control group, who received a placebo df session. the degree of active mobility (flexion, abduction, extension, external and internal rotation), the pain in the hand behind back position and the participant's perception of the technique in terms of comfort and results obtained were measured.

Eligibility criteria:
inclusion criteria: * over 18 years of age * being referred for treatment of painful shoulder (except for adhesive capsulitis) * not having been previously treated with df exclusion criteria: * damaged skin and/or cutaneous lesions in the shoulder area * history of shoulder surgery * vascular abnormalities * platelet antiaggregant therapy * acute inflammatory condition of the shoulder (\<1 week) * patients with a pending litigation or court claim

Keywords: physiotherapy manual therapy painful shoulder diacutaneous fibrolysis
evaluating treatment efficacy in oral lichen planus: the role of salivary biomarkers

Conditions: Oral Lichen Planus; Oral Lichen Planus Related Stress

Summary: lichen planus, a chronic autoimmune mucocutaneous disorder, affects 0.5% to 2.2% of diverse populations. the treatment for oral lichen planus (olp) includes a range of options, both topical and systemic therapies. recent research has highlighted the potential of hyaluronic acid as a drug alternative, potentially offering effective management for olp and alleviating the discomfort of this chronic condition. the objective was to assess the impact of topical hyaluronic acid on salivary oxidative stress markers in individuals suffering from oral lichen planus

interventional (clinical trial) actual enrollment : 60 participants allocation: randomized intervention model: parallel assignment masking: double (care provider, outcomes assessor) masking description: the clinical outcomes were assessed by an investigator masked about the treatment modality that has been used primary purpose: treatment pain , quality of life the study on oral lichen planus, three treatment groups were established: group i: received a combination of 0.1% hyaluronic acid and 0.2% triamcinolone acetonide. group ii: was treated solely with 0.2% triamcinolone acetonide. group iii: received only 0.1% hyaluronic acid. these groups were designed to evaluate and compare the efficacy of different treatments in patients with oral lichen planus.

Eligibility criteria:
inclusion criteria: patients with diagnosis oral lichen planus. patients with no history of taking corticosteroids for the last 6 months patients who agrees to take medication. exclusion criteria: pregnant and lactating ladies. patients with recent dental filling associated with the lesion or associated with recent drug administration. patient with uncontrolled diabetes, uncontrolled hypertension,

Keywords: treatment saliva stress oral lichen planus