Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and pharmacodynamics evaluation of cbt-009 eye drop

Conditions: Myopia, Progressive

Summary: this is a two-stage phase 1/2 study to evaluate the safety, tolerability and pharmacodynamics of cbt-009 eye drop in healthy volunteers. cbt-009 has the active ingredient of atropine, which at low doses, has shown to be effective in slowing down myopic deterioration. current atropine products are prone to degradation once the container is open to the air. ads pharmaceutical has developed a novel atropine formulation.

type of study: stage 1: single center, open-labeled, vehicle-controlled, single ascending dose. stage 2: parallel, double-masked, randomized, vehicle-controlled with dosing once-daily in one eye. study population: male or female healthy volunteers aged 18-36 years. number of subjects and sites: stage 1: enrollment is planned for approximately 32 healthy volunteers with 8 subjects per cohort for a total of 4 cohorts. stage 2: enrollment is planned for approximately 50 healthy volunteers with 25 subjects per cohort for a total of 2 cohorts. duration of study participation: stage 1: one day. stage 2: 28 days of treatment with no follow-up observations.

Eligibility criteria:
inclusion criteria: healthy volunteer without any active ocular diseases * 18-36 years of age * able to provide written informed consent and comply with study assessments for the full duration of the study exclusion criteria: uncontrolled systemic disease * active ocular disease * any ocular surgical procedure within the last 3 months * current enrollment in an investigational drug or device study or participation in such as study within 30 days prior to entry into this study * any condition or situation which, in the investigator's opinion, may put the volunteer at significant risk, may confound the study results, or may interfere significantly with the volunteer's participation in the study. allergic or sensitive to atropine study medication or formulation excipient * smoking during the study * female patients who are pregnant, nursing, or planning a pregnancy during the study * current or anticipated use of topical ophthalmic medications are prohibited during the study. volunteers must have discontinued use of ophthalmic medications for at least 2 weeks prior to day 1 visit
effects of delayed growth on the quality of life of children treated for a chronic disease and quality of life study of their parents and siblings

Conditions: Chronic Disease

Summary: chronic childhood diseases have sometimes strong repercussions on the everyday life of patients and their families, because of strict daily treatment regimens, physical limitation or effects on social life for instance in children, chronic diseases can lead to poor growth, which can of itself affect the child's quality of life. our proposal is therefore to study the effects of short stature on the quality of life of children with chronic diseases treated in our multidisciplinary paediatrics department. the quality of life of the patients' relatives will also be considered.

chronic childhood diseases have sometimes strong repercussions on the everyday life of patients and their families, because of strict daily treatment regimens, physical limitation or effects on social life for instance. the importance of considering quality of life (an overarching concept covering the effects of the disease on physical, metal, emotional, social and behavioural well-being) in the treatment of patients with chronic conditions is now well established. quality of life studies often focus on a specific chronic condition. studies of multiple chronic pathologies are rarer. however, factors such as the severity of the disease, its prognosis, the constraints of the daily regimen, and the visibility of the disease can have a greater impact than the type of disease itself. studies of specific chronic diseases have identified several factors affecting quality of life such as age, sex, disease severity, medically unexplained symptoms, family cohesion, socio-economic status, perception of the disease, the adaptation strategies used by the child or their family... it would therefore be interesting to study the effects of these factors on chronic diseases in general, irrespective of disease type. in children, chronic diseases can lead to poor growth, which can of itself affect the child's quality of life. our proposal is therefore to study the effects of short stature on the quality of life of children with chronic diseases treated in our multidisciplinary paediatrics department. the quality of life of the patients' relatives will also be considered.

Eligibility criteria:
inclusion criteria: * age between 8 and 18 years * treated in the multidisciplinary paediatrics department of the timone hospital * with a chronic disease (icd10 definition: for at least 3 months in the current year with no curative treatment available) * for at least three months * requiring at least two hospital consultations per year * able to complete the questionnaire * able to speak french * child and parental consent exclusion criteria: * problems understanding the questionnaire (intellectual disability, low french proficiency) * no social security coverage
effect of ginger on nausea and vomiting during acute gastroenteritis in children

Conditions: Nausea; Vomiting

Summary: the acute gastroenteritis is a very common problem in children. the frequency and duration of this condition involves a high discomfort for the child and his family, and significant costs, in connection with the purchase of therapeutic aids, medical visits, days of work lost by parents, requiring hospitalization. vomiting is a typical symptom of the majority of the cases of acute gastroenteritis and is very often the cause of failure of oral rehydration use and hospitalization. to limit vomiting and facilitate oral rehydration have been proposed several pharmacological strategies. unfortunately, these therapies are unsuccessful (domperidone), expensive and side effects (ondansetron and metoclopramide) and therefore contraindicated in patients of pediatric age. the administration of some medicinal herbs is able to induce an effective anti-emetic power. among the various types of plants studied, the rhizome of zingiber officinale, commonly known as ginger is used as an antiemetic in various traditional systems of medicine for over 2000 years. there are several scientific evidence on the beneficial properties of ginger, including antioxidant, antimicrobial, anti-inflammatory and anti-allergic . it was also demonstrated that ginger is effective in resolving the post-operative nausea and vomiting and in pregnant. a recent meta-analysis has confirmed that ginger is effective in non-pharmacological treatment of nausea and vomiting in the early periods of pregnancy. to date there are several formulations of the ginger on the market in italy, and their use is fairly widespread in children for the treatment of vomiting by acute gastroenteritis in the absence of clinical evidence of efficacy. the purpose of the proposed study is to demonstrate the effectiveness of treatment with ginger in reducing episodes of vomiting associated with acute gastroenteritis in children.


Eligibility criteria:
inclusion criteria: * children, both sexes, aged 1-10 years, * diagnosis of acute gastroenteritis (duration less than 24 hours they had at least one episode of vomiting (no bile, no blood) in the previous four hours, with mild-state of dehydration moderate). exclusion criteria: * children under 12 months of age and older than 10 years, * concomitant presence of chronic diseases, * malnutrition (z score for lower 3 standard deviations weight / height), * severe dehydration, * malformations of the gastrointestinal tract, * malignancy, * neurological diseases, * metabolic diseases, * eosinophilic esophagitis or other gastrointestinal diseases, * history of functional dyspepsia or cyclic vomiting, * history of abdominal surgery, * history of food allergy ginger, * renal failure and/or hypoalbuminemia
study of one protein implicated in wegener disease

Conditions: Wegener's Granulomatosis

Summary: the investigators recently showed an abnormal expansion of nk-like cd4+ t cells in wegener's granulomatosis (wg), mainly in the diffuse vasculitis presentation. these cells expressed an assortment of activating nk cell receptors and their signaling partners, in particular dap12. the investigators hypothesize that dap12, or a downstream signaling target of dap12, is the missing link between the different cell components involved in wg (neutrophils, macrophages, cd4 t cells).

the investigators will test our hypothesis of "dap-12 gain-of-function" by quantitative (mrna and protein) and qualitative (dna, signaling and cellular activation) analysis of the dap12 signaling pathway in wg patients with localized (group 1; n=30) or diffuse wg (group 2; n=30) by comparison with patients with micro polyangitis (group 3; n=30), or with sarcoidosis ( group 4; n=30), and healthy blood donors (group 5; n=30). blood samples will be collected during a routine medical visit. these results may help to design future therapeutic strategies based on modulation of specific intra-cellular pathways involved in the disease.

Eligibility criteria:
inclusion criteria: * group 1: wg, with granulomatous lesions limited to upper airway or lungs and no evidence of generalized vasculitis ,± biopsy, ± anti-pr3 anca * group 2: wg with granulomatous lesions plus vasculitis expression (renal, neurological, skin, gut or heart involvement), ± biopsy, ± anti-pr3 anca * group 3: necrotizing vasculitis with no granulomatous lesions, ± pauci immune glomerulonephritis, ± anti-mpo anca * group 4: clinical presentation compatible with sarcoidosis, ± biopsy, ± eca elevated ± tuberculin anergy exclusion criteria: * \<18 years * pregnancy or breastfeeding * absence of signed informed consent * no affiliation to insurance

Keywords: wegener cd4+ t cells dap12 nkg2d
pudendal nerve block for post-episiotomy pain relief

Conditions: Pain, Postoperative

Summary: unilateral vs. bilateral pudendal nerve block for post-episiotomy pain relief: a randomized clinical trial


Eligibility criteria:
inclusion criteria: * term (37 to 42 weeks gestation), primigravid women with singleton vertex fetus exclusion criteria: * women with bleeding disorders, known hypersensitivity to local anesthetics, chronic use of pain medication, had previous vaginal surgery, extensive vulvovaginal infection, malposition or malpresentation were excluded from the study. also, women who failed to deliver vaginally, had extensive perineal or cervicat tears, or had instrumental delivery were excluded from the final analysis of the study
perclot compared to usual care in gynaecology procedures

Conditions: Endometriosis; Ovarian Cyst; Menorrhagia; Cancer; Uterine Fibroids

Summary: this study is a post market, multi-centre, randomised study evaluating perclot compared to usual care. perclot is a ce marked device and is currently used as a haemostat in gynaecological surgery throughout europe. the purpose of this study is to collect additional post market data on its use in this indication.

this study is a post market, multi-centre, randomised study evaluating perclot compared to usual care. all subjects in this randomized study will undergo a laparoscopic or open gynecological procedure such as hysterectomy, cystectomy, myomectomy, endometrial excision or ablation. subjects will be randomized to receive perclot or usual care. this research will utilize a multi-center, prospective, randomized controlled study. the study will be conducted in2 study sites in europe. an assumed sample of 90 subjects will be enrolled to evaluate the time to haemostasis. the enrollment of subjects to receive treatment will be based upon specific inclusion and exclusion criteria. subjects will be randomized on a 1:1 basis to receive either perclot or usual care. data collected from both arms will be compared. usual care will be at the discretion of the surgeon and may include any other haemostat or diathermy/electrocautery.

Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age * subject is undergoing gynecological procedure * subject is willing and able to comply with the protocol and follow up period * subject is willing and able to give written informed consent exclusion criteria: * • subject with a history of pelvic or abdominal radiotherapy (within 8 weeks) * subject is pregnant or actively breastfeeding * subject has a ruptured ectopic pregnancy * subject has a medical history of abnormal coagulopathy or bleeding * subject has a sensitivity to starch or starch derived materials * subject has active or potential infection at the surgical site * subject is currently enrolled in another study
high flow oxygen therapy and acute ischemic stroke

Conditions: Stroke

Summary: hypoxemia is common in acute ischemic stroke and associated with neurological deterioration and mortality. however, the benefit of oxygen therapy is controversial. severity of stroke may affect the benefit of oxygen supplementation. abnormal breathing patterns are commonly found among stroke patients and may increase the risk of hypoxemia. high flow nasal cannula (hfnc) has several advantages from controllable fraction of inspired oxygen (fio2), reduction of nasopharyngeal resistance and positive end expiratory pressure effect. in this study, we aimed to assess the therapeutic effect of hfnc on oxygen desaturation index (odi) and neurological outcomes in stroke patients with moderate and severe severities, compared with no and low flow oxygen supplementation.


Eligibility criteria:
inclusion criteria: 1. age of 18 or more 2. clinical and radiographic findings including computerized tomography of brain compatible with acute ischemic stroke 3. presentation within 72 hours after the stroke onset 4. national of health stroke scale (nihss) of 5 or more, 5. limb weakness defined as motor power grade of 4 or less, 6. able to give informed consent, or the next of kin was willing to give assent exclusion criteria: 1. recognized indications for oxygen treatment, such as oxygen saturation on room air of less than 92%, acute left ventricular failure, severe pneumonia, pulmonary emboli, and chronic respiratory failure treated with home oxygen supplementation 2. recognized contraindications for oxygen treatment including chronic hypercapnia and type ii respiratory failure 3. subjects with previous diagnosis of obstructive sleep apnea (osa) or highly suspicious of osa, screened by stopbang score of 5 or more

Keywords: high flow oxygen therapy oxygen desaturation index acute ischemic stroke
prehabilitation in gynaecological cancer patients

Conditions: Ovarian Cancer; Ovarian Cancer Stage III; Ovarian Cancer Stage IV; Endometrial Cancer; Frailty

Summary: prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. these interventions usually consist of physical activity and psychological and nutritional support. there is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients. phocus trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into arm a: control arm which will be provided with a basic information and standard of care support; arm b: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. all patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.

the objective of the trial is to evaluate the impact of intensive multimodal prehabilitation protocol on pre-operative functional capacity, postoperative morbidity, and quality of life in patients undergoing surgical treatment for gynaecological cancer. two groups of patients scheduled for postponed surgical treatment will be eligible for the trial: i) advanced ovarian cancer patients referred for neoadjuvant chemotherapy and interval debulking surgery; ii) stage i-ii endometrial cancer patients classifying as frail (according to the validated modified frailty index), who will be treated by hormonal therapy for three months, followed by surgical treatment.

Eligibility criteria:
inclusion criteria two groups of patients will be eligible for the trial: i) epithelial ovarian cancer patients referred for nact: a) figo stage iii or iv disease; b) patient is not a candidate for primary debulking surgery; c) patient is a suitable candidate for standard of care combined chemotherapy; d) patient is a candidate for interval.debulking surgery ii) stage i or ii endometrial cancer patients classifying as frail according to the validated modified frailty index: a) figo stage i or ii; b) patient is classified as frail; c) patient is suitable candidate for hormonal therapy. exclusion criteria 1. second malignant tumour (under the treatment) 2. patient is not suitable for any surgery delay 3. patient is not physically able to meet the prehabilitation intervention plan or is unable to walk

Keywords: prehabilitation epitelial ovarian cancer functional capacity quality of life multimodal prehabilitation frailty endometrial cancer
efficacy of sumatriptan with naprosyn in migraine with aura

Conditions: Migraine With Aura

Summary: this is a double-blinded placebo study, examining the efficacy of sumatriptan with naprosyn in the treatment of migraine with aura.


Eligibility criteria:
inclusion criteria: * subjects must be 18 to 50 years of age, inclusive. * patients will meet the international headache society (ihs) classification criteria for migraine with aura. * subjects must carry the diagnosis of 1-2 migraine with aura per month for at least three months before study inclusion. and migraine with aura were included in the study * subjects must have an onset of a visual aura that occurs 15-30 minutes before a migraine headache. * subjects must be able to understand and complete a migraine diary. * subjects must be able to distinguish a migraine with aura from other types of headache. * subjects must be in generally good health as confirmed by medical and medication history, baseline physical and neurological exam and vital signs. * female subjects must be either a) postmenopausal for one year, b)surgically sterile, c) practicing acceptable birth control for at least one month prior to screening and throughout study, or d) practicing abstinence and agree to continue same throughout study. exclusion criteria: * subjects who have a significant systemic disease other than migraine that is equally painful or more painful. * subjects who have other progressive neurological disorders. * subjects who have more than 8 migraines or 15 headache days per month. * subjects who have previously taken treximet and failed due to lack of efficacy or adverse side effects. * subjects who carry the diagnosis of chronic tension type headache or cluster headache based on the international headache society criteria. * subject should not have received any other investigative drug within 3 months prior to enrollment in the study. * subject who have the diagnosis of seizure disorder, chronic daily headache, uncontrolled hypertension, cardiovascular disease, history of stroke, basilar or hemiplegic migraine, hepatic disease, or active peptic ulcer disease. * subjects currently taking or in 3 months prior to study, use of prophylactic migraine medications. * subjects who have a known allergy to sumatriptan or naprosyn. * subjects who in the opinion of dr. mechtler have a condition for which they should not be enrolled in the study.

Keywords: migraine migraine with aura headache
naloxone to treatment entry in the emergency setting

Conditions: Opioid Dependence; Opioid Intoxication; Substance Use Disorders

Summary: the study tests a structured referral process for opioid overdose survivors, from pre-hospital emergency care to long-term treatment of the individual's substance use-related disorder.

randomized controlled trial. subjects are included if they are being treated by an ambulance in the malmö uptake are for an opioid overdose requiring naloxone antidote administration, and if they sign informed written consent to the study. subjects are randomized by ambulance staff to either an active intervention, or a control condition: intervention: a telephone alert signal is sent from ambulance staff after successful naloxone reversal of an opioid overdose, leading to an active outreach effort from the staff of the addiction research facility, where staff locate the individual and offer her/him formal inclusion in the study. control: no telephone alert signal is sent, and the active outreach procedure is not carried out. ambulance staff hand over written information to the individual about how she/he can apply actively for treatment. primary outcome is entry into formal assessment and treatment of the substance use disorder.

Eligibility criteria:
inclusion criteria: * survivor of opioid overdose requiring antidote naloxone administration by ambulance staff, and provision of written informed consent exclusion criteria: * patients unable to understand study information and to provide informed consent
diabetic retinopathy candesartan trials

Conditions: Type 2 Diabetes

Summary: the primary objective is to determine whether candesartan, compared to placebo reduces the progression of diabetic retinopathy in normoalbuminuric type 2 diabetic patients with retinopathy. the secondary objective is to determine whether candesartan, compared to placebo, reduces the incidence of clinically significant macular oedema (csme) and/or proliferative diabetic retinopathy (pdr) and beneficially influences the rate change in urinary albumin excretion rate (uaer). this study is part of the direct programme also including a primary prevention study of diabetic retinopathy in type 1 diabetes and a secondary prevention study in type 1 diabetes. the primary objective for all three pooled studies is to determine whether candesartan, compared to placebo, reduces the incidence of microalbuminuria in type 1 and type 2 diabetic patients.


Eligibility criteria:
inclusion criteria: * male or female aged 37 - 75 years with type 2 diabetes diagnosed at age of 36 years or thereafter. * duration of diabetes for \> 1 year and \< 20 years with stable diabetic therapy within last 6 months. * patients with untreated resting mean sitting sbp \ 20/10 up to \< 47/47 (on etdrs severity scale). exclusion criteria: * patients with the following conditions are excluded from participation in the study: * cataract or media opacity of a degree which precludes taking gradable retinal photographs * angle closure glaucoma, which precludes pharmacological dilatation of the pupil * history of or presence of proliferative retinopathy * history or presence of clinical significant macular oedema (csme) * history or evidence of photocoagulation of the retina * other retinal conditions which may mask assessment, eg, retinal vein occlusion * positive micral dipstick test * presence of secondary diabetes * pregnant or lactating women or women of child bearing potential not practicing an adequate method of contraception * need of treatment with ace-inhibitor * haemodynamically significant aortic or mitral valve stenosis * known renal artery stenosis or kidney transplantation * hypersensitivity to study drug * severe concomitant disease which may interfere with the assessment of the patient, eg, malignancy, as judged by the investigator

Keywords: diabetes mellitus type 2