Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of patients with x-linked retinoschisis

Conditions: X-linked Retinoschisis; XLRS

Summary: the purpose of this study is to evaluate subjects with x-linked retinoschisis in a clinical setting to collect data on disease progression.

the objective of the study is to evaluate subjects with xlrs in a clinical setting and gather data on disease progression. the data from this study will enhance the understanding of the natural history of this rare disease and will facilitate appropriately powered safety studies in a future gene therapy trial in humans.

Eligibility criteria:
inclusion criteria: main study: * clinical diagnosis consistent with xlrs * documented disease causing rs1 mutation * 7 years of age or older * able to provide informed consent/assent * male cai sub-study: • presence of maculoschisis exclusion criteria: main study: • other eye diseases that might affect the results (e.g. history of retinal detachment, glaucoma, cataracts that prohibit imaging, or any other eye pathology that in the opinion of the investigator would preclude enrollment) cai sub-study: exclusion criteria * already being treated with cais * previous documented failure to respond to cai treatment any drug-specific contraindication/precaution listed below (from www.micromedex.com): topical eye drop dorzolamide hydrochloride contraindications: • hypersensitivity to dorzolamide products, including sulfa allergies precautions: * dorzolamide is a sulfonamide that is absorbed systemically, sulfonamide hypersensitivity reactions may occur * angle-closure glaucoma * concomitant use of oral carbonic-anhydrase inhibitors * conjunctivitis and lid reactions reported with chronic administration * moderate to severe renal (crcl less than 30 ml/min) or hepatic insufficiency * ocular infection or inflammation * recent ocular surgery topical eye drop brinzolamide contraindications: • hypersensitivity to any component of the product, including sulfa allergies precautions: * concomitant use of oral carbonic anhydrase inhibitors is not recommended * contact lens use; remove contact lenses prior to administration, allow 15 minutes before reinsertion * hypersensitivity to sulfonamides; severe reaction may occur; discontinue if signs or symptoms appear * low corneal endothelial cell counts; increased risk of corneal edema * renal impairment, severe (crcl less than 30 ml/min); use not recommended

Keywords: xlrs rs1 maculoschisis
european calciphylaxis registry network

Conditions: Calcific Uremic Arteriolopathy (CUA); Calciphylaxis

Summary: observational, registry, prospective, non-interventional collection of cua patient data. patient treatment is carried out within clinical routine, at the discretion of the physicians and according to existing treatment guidelines. participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients.

calcific uremic arteriolopathy (cua, calciphylaxis) is a rare disease (orpha280062) with dramatically high mortality characterized clinically by the occurrence of painful debilitating cutaneous lesions and ulcerations. median survival time is about 1.5 years. many uncertainties still exist about risk factors and optimal therapy. cua mainly occurs in patients with severe renal insufficiency or esrd. the aim of the present initiative is to establish an international (european) observational registry for cua patients. this registry will help to reach a critical mass of cua patients, will allow novel insights into pathophysiology, and will help establishing systematically an overview upon risk factors and long-term outcome of cua patients. the design of the international registry is supposed to adopt the structure of the presently running nation-wide german calciphylaxis registry. the investigators plan to initiate a registry in which treating physicians can provide data upon demographics, clinical picture, comorbidities, medical treatments and laboratory data at the time of diagnosis and serial follow-up time points. in addition investigators will build-up a biobank for full blood, serum and plasma samples as well as tissue samples. the registry will allow investigations regarding potential subgroups of patients (proximal versus distal forms of cua), geno-phenotype correlations, description of international state-of-the-art treatment, and identification of preventive tools, risk factors and biomarkers for estimation of prognosis. furthermore, the registry will be the nidus for further scientific exchange between experts and clinicians on the field of uremic vascular calcification.

Eligibility criteria:
inclusion criteria: * diagnosed cua according to the judgement of locally treating physicians, who have the option to ask for external diagnostic advice from the country-specific sub-investigators * male or female aged \> 18 years * written informed consent prior to study participation * the subject is not mentally or legally incapacitated exclusion criteria: • the subject is not able to give informed consent

Keywords: calciphylaxis rare disease (orpha280062) renal insufficiency esrd calcification chronic kidney disease dialysis vascular disease
substance use disorder in chemsex practice

Conditions: Addiction Chemical; Use, Substance

Summary: the main aim of this descriptive cross-sectional study is to assess the prevalence of chemsex substance use disorder among chemsexers via an online self-questionnaire.

chemsex appeared in europe around 2006 and in france in 2010. it involves the use of psychoactive substances in a sexual context to enhance, initiate, facilitate or prolong sexual intercourse through the psychoactive effects of the molecules consumed. these molecules are essentially synthetic cathinones, ghb/gbl, mdma, methamphetamines, cocaine and ketamine. these products are often used in combination with erectile dysfunction treatments (side effects of the molecules). this practice is thought to affect almost 20% of msm. this use has numerous social, somatic, psychiatric and addictive consequences. studies have mainly focused on infectious risks, psychiatric complications (e.g. anxiety and depression) or the prevalence of this phenomenon. however, no study has assessed the prevalence of chemsex-related substance use disorders among these users.

Eligibility criteria:
inclusion criteria: * be 18 years of age or older. * proficiency in written french * have practised chemsex at least once in the last 12 months. * agree to participate in the study. exclusion criteria: * have not experimented with chemsex in the last 12 months * participation in other ongoing research * insufficient written comprehension of french
a pharmacodynamic study of slm0807, hkb0701 and cj30001 in healthy subject

Conditions: Diabetes Mellitus

Summary: this trial is conducted to 1. assess whether slm0807 alters pharmacodynamics of hkb0701 2. estimate the pharmacodynamics of hkb0701 after multiple administration of cj30001 and multiple co-administration of hkb0701/slm0807 in healthy subject


Eligibility criteria:
inclusion criteria: * healthy volunteers who are in age range of 20-50years and the weight range is not exceed ±20% of ideal weight. ideal weight = \[height -100\]\*0.9 * subjects with no history of any significant chronic disease * subjects with fpg\<100mg/dl and 2hr glucose after 75g ogtt\<140mg/dl * judged to be in good health on the basis of their vital sign, ecg, physical exam and routine laboratory data * available for the entire study period * willing to adhere to protocol requirements and sign a informed consent form exclusion criteria: * subjects who have taken any drugs to induce or inhibit hepatic enzyme activity within 30days prior to drug administration * subjects who have symptom of an acute illness within 4 weeks prior to drug administration * subjects with a history of clinically significant allergies including drug allergies * subjects whose clinical laboratory test values are outside the accepted normal range(especially,ast or alt \>1.25 times to normal range or total bilirubin \> 1.5times to normal range) * subjects with a history of drug, caffeine abuse(caffeine drink \>5cups/day) * subjects with a history of alcohol abuse(alcohol\>30g/day) or who have ever drank alcohol within 7 days prior to drug administration * heavy smoker ( \>10cigarettes/day) * subjects who have had a diet known to interfere with the absorption, distribution, metabolism or excretion of drugs (especially, consumption of grapefruit juice) * subjects who have donated plasma within 60days prior to drug administration * subjects who have participated in a clinical study within 90days prior to drug administration * subjects who have received any drugs that might confound the results of the trial in the opinion of principal investigator within 10days prior to drug administration (cimetidine within 7days prior to drug administration) * female subjects who are pregnant, breastfeeding or not using medically acceptable birth control
psychosocial treatment for attention deficit hyperactivity disorder in adults

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: this study will determine the effectiveness of group cognitive-behavioral therapy as compared to a problem-solving social support group in treating problems of time management, organization, and planning in adults with attention deficit hyperactivity disorder (adhd).

adhd is a chronic neurobiological condition that affects people of all ages, genders, and races. symptoms of adhd may include, but are not limited to, the following: poor attention span; physical restlessness or hyperactivity; excessive impulsivity; chronic procrastination; frequently losing things; poor organization, planning, and time management skills; and excessive forgetfulness. not every person with adhd exhibits all of these symptoms, and the severity of the disorder can range from mild to severe. while there is no cure for adhd, the condition can be managed with an accurate diagnosis and proper treatment. left untreated, individuals with adhd may experience significant impairment in social, emotional, occupational, and academic functioning. stimulant and non-stimulant medications are usually effective in alleviating symptoms of adhd in adults. however, some research suggests that medications may not effectively treat self-management functioning problems and that as many as one-third of adults with adhd have inadequate responses to medication treatment. additional research on the benefits of psychosocial treatments for adhd in adults is needed. this study will determine the effectiveness of group cognitive-behavioral therapy as compared to a problem-solving social support group in treating problems of time management, organization, and planning in adults with adhd. individuals interested in participating in this study will first undergo an assessment of their eligibility for inclusion in the study. the assessment will last approximately 6 hours, but can be broken up into as many as 4 separate visits. eligible participants will be randomly assigned to either receive group cognitive-behavioral therapy or join a problem-solving social support group. both groups will meet once a week for 12 weeks. each session will last roughly 2 hours and will focus on building time management, organizational, and planning skills. time management, planning, and organizational skill levels will be assessed at the treatment mid-point, immediately following the intervention, and at 3 and 6 months following the treatment. self-esteem and symptoms of depression and anxiety will also be measured at these visits.

Eligibility criteria:
inclusion criteria: * suspected of having or have been diagnosed with adhd * may potentially benefit from the adhd group treatment exclusion criteria: * any overt cognitive disability (e.g., alzheimer's disease, mental retardation) * deemed not to potentially benefit from the proposed adhd group treatment

Keywords: primarily inattentive hyperactive impulsive type combined type adhd adults psychological cognitive behavioral therapy cbt
risk factors for psychiatric disorders associated with adolescent idiopathic scoliosis

Conditions: Adolescent Idiopathic Scoliosis

Summary: the purpose of this pilot study is to determine the presence, frequency, and severity of mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.

this study is a cross-sectional pilot study investigating the prevalence of psychiatric illness at various time points in the course of treatment of ais. three independent sets of questionnaires will be administered during a single scheduled clinical visit. there will be no clinical visits for the exclusive purpose of completing questionnaires. the first questionnaire will be the srs outcome instrument. the second questionnaire will be the achenbach ysr, completed by the adolescents, and the parents will be asked to complete the cbcl. finally, a generic outcome measure specific to children and adolescents, the pediatric outcome data collection instrument, will be administered. the time requirement to complete these questionnaires is anticipated to be approximately 45 minutes. the achenbach questionnaires will be scored promptly after each is completed using the provided scoring templates. this data will be used to identify those at risk and make appropriate resources available. this would provide appropriate care for adolescents at high risk of mental health disorder by identifying those at risk via a non-invasive screening tool.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ais between the ages of eleven and sixteen, scheduled to undergo surgical intervention * the patient and one parent will be required to complete the questionnaires in their entirety at the predetermined time points. * there are several different methods of surgical intervention for ais, however there will be no selection on the basis of the type of intervention. * curve pattern and severity will, similarly, not be used as inclusion criteria. exclusion criteria: * all types of scoliosis besides ais will be excluded. this includes neuromuscular, congenital, infantile idiopathic, and childhood idiopathic scoliosis. * children younger than eleven years or older than sixteen years will be excluded. * those with additional chronic disease will be excluded, due to the possibility of confounding. * those unable to complete the entire questionnaire, for any reason, or those unable to complete the questionnaires at each time point will be excluded. * existence of psychiatric disorder prior to treatment will not be cause for exclusion from the study.

Keywords: scoliosis adolescent idiopathic scoliosis spine curve pediatric mental health screening
regulatory t-cells after subcutaneous immunotherapy

Conditions: Grass Pollen Allergy; Specific Immunotherapy

Summary: the primary endpoint was the induction of t-regulatory cells under s specific subcutaneous immunotherapy (scit). patients suffering from grass pollen allergy (relevant clinical symptomes during the pollen season, skin prick test diamter \>4mm or rast class ii or higher) were included. the patients were allocated to three study groups: group 1: during and directly after scit (after completion the 2nd or 3rd year of treatment) group 2: completed scit more then three years ago group 3: patients with clinically relevant grass pollen allergy without scit. the investigators analyzed the lung function parameters, exhaled no (eno) and asked the patients to record symptoms during the adjacent pollen season. a blood sample was drawn to analyze the amount of th1 and th2 and regulatory t-cells, inflammatory markers(il-2, il-5, il-10, il-12/23, tnf-alpha, ifn-gamma) and blocking antibodies (igg, igg4).


Eligibility criteria:
inclusion criteria: * informed consent, * clinically relevant grass pollen allergy, * age \> 6 and \< 28 exclusion criteria: * severe unstable asthma, * regular ingestion of antihistamine, * systemic steroid therapy, * lung funtcion vc \< 70%, * fev1 \< 65%

Keywords: t-regulatory cells th1, th2 cells specific ige specific igg specific igg4 il2 il5 il10 il12/23 y-ifn tnf-a
propensity score matched comparison of hmp vs. scs in kidney transplantation

Conditions: Delayed Graft Function

Summary: hypothermic machine perfusion (hmp) is considered superior to static cold storage (scs) in kidney transplantation, but the true benefit in the real-world experience remains incompletely understood. the aim of our study is to investigate the real-world impact of hmp on kidney graft function after deceased donor kidney transplant in an hmp cohort propensity score matched with scs. propensity score matching will be based on cit, ecd, gender mismatch, cmv mismatch, re-tx and et-senior program with a caliper of 0.05


Eligibility criteria:
inclusion criteria: * single kidney transplantation from a deceased donor at medical university of innsbruck between 08/2015 and 12/2019 exclusion criteria: * combined kidney transplantation with an other organ * living donor kidney transplantation

Keywords: kidney transplantation
low-level laser therapy on inflammatory mediators during chemotherapy-induced oral mucositis

Conditions: Oral Mucositis

Summary: the aim of the study is to evaluate the effect of low-level laser therapy (lllt) on the severity of oral mucositis (om) and inflammatory mediators (pro- and anti-inflammatory cytokines, metalloproteinases and growth factors) levels in saliva and blood; furthermore, analyze the effect of lllt in product modulation of oxidative stress and cell damage from the oral mucosa transplant patients.

this is a randomized clinical trial in which the proposed analysis will be performed from saliva samples of patients transplanted bone marrow, divided into two different groups (control and laser) and collected at different times during the hospitalization of the patient. the group laser receive prophylactic laser therapy, in order to evaluate the effects of lllt in inflammatory mediators (cytokines pro- and anti-inflammatory) as well as their effect on modulation of oxidative stress products and cell damage (nitric oxide, myeloperoxidase, interleukin-8).

Eligibility criteria:
inclusion criteria: * schedule to receive myeloablative conditioning regimens using chemotherapy; oral mucosa lining intact on the first day of the conditioning regimen; exclusion criteria: * patients who presented with oral oral ulceration or erosion, active oral, viral, bacterial, or fungal infections on admission, or active oral bleeding which was uncontrollable during laser therapy or had required oral tracheal intubation during hospitalization in the hsct unit.

Keywords: mucositis inflammation chemotherapy hematopoietic stem cell transplant low level laser therapy oxidative stress
adenovirus initiative study in epidemiology in germany

Conditions: Viral Conjunctivitis

Summary: the objectives of this study is to assess the characteristics and frequency of adenovirus conjunctivitis in a population of male and female patients from one year of age who present signs and symptoms of acute conjunctivitis.

epidemiological, prospective, open, multicentric trial in patients suffering from acute conjunctivitis who will undergo a rapid diagnostic test for adenoviral conjunctivitis at the time of their visit to the ophthalmologist office, at the emergency room or during hospitalization. this epidemiological study will include approximately 500 patients in germany. the planned duration of the study is one year from the first patient visit to the last patient visit.

Eligibility criteria:
inclusion criteria: * male or female patients of at least one year of age presenting acute (for less than 7 days) conjunctivitis signs and symptoms. * patient or / and legal representative (if patient below 18 years of age) must be able to provide oral consent for the collection and treatment of the questionnaire data. * no history of hypersensitivity to corn starch, talcum powder or dacron (sampling fleece components). exclusion criteria: * current use or having received (within the last 7 days) local antiviral therapies such as povidone iodine or ganciclovir, or topical steroids or immunomodulators such as cyclosporine which may interfere with the test result. * previous enrolment in the present study. * any direct involvement with the study conduct at site or any family link with study site staff.

Keywords: adenoviral conjunctivitis diagnosed with adenoplus™ test
bioavailability in patient with psoriasis: metoject prefilled pen

Conditions: Psoriasis

Summary: this study is conducted to assess the relative bioavailability of mtx administered subcutaneously via a prefilled pen (50mg/ml) compared with mtx administered via im injection (25mg/ml).


Eligibility criteria:
inclusion criteria: * is able to understand and follow instructions during the study * has a diagnosis of moderate to severe psoriasis based on a dermatologic evaluation * provides written informed consent * is male or female and is aged 18 to 65 years, inclusive * has a body mass index (bmi) within the range 18 through 30 kg/m2. main exclusion criteria: * is receiving concomitant treatment for psoriasis with a biologic or conventional systemic treatments (eg, cyclosporine, azathioprine, fumaric acid esters, leflunomide), other than mtx every week * has used antibiotics within 14 days prior to screening or requires use prior to study completion * has used any of the following medications within 14 days prior to screening or requires use prior to study completion, unless on a stable, daily dose: non steroidal antiinflammatory drugs (nsaids), diuretics, folic acid, hydrochloroquine, probenicid, proton-pump inhibitors * has, other than psoriasis, any uncontrolled cardiac disease, liver disease, lung disease, hematologic disease, gastrointestinal disease, or other systemic disease, that in the opinion of the investigator, would present an unacceptable risk if he or she were to participate in the study * has ongoing acute or chronic infection within 14 days prior to screening * has renal insufficiency , hepatic insufficiency, impaired hematopoiesis, known severe, acute, or chronic infection, history of malignancy, history of or suspected abuse of drugs or alcohol * allergic reactions or serious adverse reactions to the study drug * is a female subject who is pregnant, trying to become pregnant, or breast feeding, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control * is a male subject with a female partner of childbearing potential, not had a vasectomy and not using a condom and/or cervical cap/diaphragm with spermicide