Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of the mometasone nasal gel in the treatment of persistent allergic rhinitis

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.


Eligibility criteria:
inclusion criteria: * signed consent of the patient; * clinical diagnosis of moderate - severe persistent allergic rhinitis according to aria classification(allergic rhinitis and its impact on asthma); exclusion criteria: * patients with any clinically significant disease that in the investigator is opinion can´t participate in the study; * patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial; * patients with history of hypersensitivity to any of the formula compounds; * participation in clinical trial in the year prior to this study; * pregnancy or risk of pregnancy and lactating patients; * patients who were in use of drugs that can interfere with evaluation; * decongestants dependent patients or patients receiving allergen specific immunotherapy; * patients on treatment with monoamine oxidase inhibitors (maois).
a pilot study of fmt on cd patients with aiec

Conditions: Crohn Disease

Summary: the goal of this pilot study is to test whether fecal microbiota transplant (fmt) would be an effective antibacterial treatment for managing adherent-invasive escherichia coli (aiec) colonization in crohn's disease (cd) patients. it aims to assess the safety of fmt in patients with clinically inactive or mild to moderate cd and to determine the presence of aiec before and after fmt. participants will receive fmt via colonoscopy and have a follow-up colonoscopy at the end of the study.

experimental and observational data suggest that intestinal inflammation in crohn's disease (cd) arises from abnormal immune response to intestinal microbiota in genetically susceptible individuals. genes that regulate innate immune response, intestinal barrier function and bacteria killing of intracellular pathogens have been associated with an increased risk for developing cd in caucasian populations. the search for specific pathogens in cd has identified in the intestinal mucosa of patients several candidates. one with much supporting evidence is the adherent invasive escherichia coli (aiec). since its discovery in 1998, several groups have reported a higher prevalence of aiec in cd patients compared to healthy subjects and confirmed their pro-inflammatory potential. a growing body of work indicates that different host environments can select such aiec pathobiont. aiec colonization in mice leads to strong inflammatory responses in the gut suggesting that aiec could play a role in cd immunopathogenesis. faecal microbiota transplantation (fmt) represents a clinically feasible way to restore the gut microbial ecology and has proven to be a breakthrough for the treatment of recurrent clostridium difficile infection. clinical trials are being conducted to evaluate its use for other conditions including inflammatory bowel disease, irritable bowel syndrome, diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. efficacy of fmt on cd endoscopic lesions and aiec colonization remains to be demonstrated.

Eligibility criteria:
inclusion criteria: * \>18 years of age; * patients with cd history ≥ 3-month duration; * patients with no or mild-to-moderate symptoms defined as harvey bradshaw index (hbi) \< 16 ; * patients with positive total e.coli antibodies (aecab) exclusion criteria: * pregnancy; * new biological treatment or steroids use within 4 weeks; * current colorectal tumor; * active gastrointestinal bleeding; * having ulcerative colitis; * having colectomy or partial colectomy (less than ileo-transverse colonic anastomosis); * having colonic or small bowel stoma; * active perianal lesions; * receiving antibiotics within 4 weeks; * presenting psychological or linguistic incapability to sign the informed consent

Keywords: fecal microbiota transplant adherent-invasive escherichia coli
how to avoid cervical stenosis after leep in high grade cervical dysplasia?

Conditions: Stenosis Cervix

Summary: cervical stenosis may occur in up to 19% after conization. it is a cause of infertility and amenorrhea. this study will test a new device named duda device ("dispositivo uterino para dilatar canal endocervical") placed just after the conization, in order to evaluate the safety, efficacy and quality of life.

this device has the potential to improve outcomes by means of a significant stenosis reduction and maintain patency of the endocervical canal to view the squamo-columnar junction (scj) of the cervix during follow-up of this patient.

Eligibility criteria:
inclusion criteria: * high grade cervical dysplasia, grades 2 and 3, in the biopsy cervical * patient eligible for conization * patient must consent for the appropriate surgery * patient must have gynecologic oncology group (gog) performance status of 0, 1 * patients must have signed an approved informed consent and authorization permitting release of personal health information exclusion criteria: * pregnancy * previous conization * limited comprehension of the study * the risk of the american society of anesthesiologists, iii or iv * hiv or immunodepression * patients with a history of the invasive malignancies

Keywords: cervical intraepithelial neoplasia stenosis cervix medical device inventories uterine cervix intrauterine devices intrauterine conization loop electrosurgical excision
european tauropace registry - university of schleswig-holstein prospective observational clinical study

Conditions: CIED Related Infection

Summary: university of schleswig-holstein campus kiel is sponsoring the european tauropace registry. this investigator-initiated local, prospective, non-interventional, multi-center study includes patients undergoing cardiac implantable electronic placement including and not limited to placement, revision with the aim to upgrade or downgrade, generator substitution, additional lead placement, revision or extraction (procedure) with adjunct tauropace. it is planned to include a total of at least 2300 procedures (valid for safety analysis).

this study is performed as an all-case investigation. the treatment is performed based on the sops (appendix study protocol). the standard observation period is 3 months from the 1st treatment. safety and effectiveness are evaluated at 3rd and 12th month. in addition, the extension observation is carried out once a year for 3 years at the longest to collect information on safety and effectiveness as long as cied treatment continues. when the treatment ends (extraction of all hardware), observation of a patient ends. for each patient, the investigator records data as defined in the protocol at each evaluation point by using a unique case report form (crf) system. the duration of the study is estimated at 10 years (registry).

Eligibility criteria:
inclusion criteria: * use of tauropace™ is indicated and not contra-indicated according to its current instructions for use (ifu) * participant is eligible for a cied related surgery procedure. exclusion criteria: * age\<18years * participant incapable of signing patient informed consent (mentally or physically) or does not sign.
efficacy and safety of bumetanide oral liquid formulation in children and adolescents aged from 7 to less than 18 years old with autism spectrum disorder

Conditions: Autism Spectrum Disorder (ASD)

Summary: the purpose of this study was to evaluate the efficacy and the safety of bumetanide/s95008 in the improvement of autism spectrum disorder core symptoms.

the present study (cl3-95008-001) was performed in children and adolescents from 7 to less than 18 years old presenting with asd. a 6-month double-blind treatment period was performed in which efficacy and safety of bumetanide 0.5mg bid were assessed versus placebo. this double-blind period was followed by a 6-month open label treatment period of bumetanide 0.5mg bid in which long term safety was evaluated.

Eligibility criteria:
inclusion criteria: * male and female patients from 7 to less than 18 years * out patients * primary diagnosis of asd as per diagnostic and statistical manual of mental disorders - fifth edition (dsm-5) criteria * criteria met for asd on autism diagnostic observation schedule (ados-2) and autism diagnosis interview revised (adi-r) * cgi (clinical global impression) - severity rating score ≥ 4 * childhood autism rating scale second edition (cars2-st or hf) total raw score ≥ 34 * social responsiveness scale second edition total score (srs-2 t-score) ≥ 66 * absence of known monogenic syndrome (fragile x, rett syndrome ...) * absence of any clinically significant abnormality likely to interfere with the conduct of the study according to the judgment of the investigator exclusion criteria: * patients not able to follow the study assessments defined by the protocol, with the exception of self-rating questionnaires which will be assessed by parent/legal representative/caregiver for those patients unable to complete them * patients having a high suicidal risk according to the investigator judgement * chronic renal dysfunction * chronic cardiac dysfunction * patient with unstable psychotherapy, behavioural, cognitive or cognitive-behavioural therapy * severe electrolyte imbalance that is likely to interfere with the study conduct or evaluation
role of fci in the detection of proctosigmoiditis caused by ibd

Conditions: Inflammatory Bowel Diseases; Proctosigmoiditis

Summary: the goal of this pilot study is to explore the ability of field-cycling imaging, a new scanning technology being developed at the university of aberdeen, to detect active disease in patients with proctosigmoiditis caused by inflammatory bowel disease.

field-cycling imaging (fci) is an emerging technology that is being developed at the university of aberdeen. it combines the use of a moderately high magnetic field (200mt) with the ability to probe low magnetic fields (0.2mt) so that image resolution can be preserved while also exploiting the high contrast present at low magnetic fields. this non-invasively provides quantitative data on the molecular dynamics in the tissues. fci represents a potentially new, non-invasive, way of assessing the extent and activity of inflammatory bowel disease (ibd). ibd can affect the rectum and distal sigmoid colon, this condition is called proctosigmoiditis (ps). currently, diagnosis of ibd depends on endoscopy for direct visualisation of the upper and lower gut, using ct scanning, with its attendant use of ionising radiation, and conventional mri, particularly for the small bowel. determining the activity of ibd remains a continuing challenge. in this proof-of-concept study, the investigators will explore the ability of fci to detect active disease in patients with ps.

Eligibility criteria:
inclusion criteria: * participants with a diagnosis of proctosigmoiditis, on the basis of a compatible history and previous flexible sigmoidoscopy * participants who are already under follow up in the nhs grampian ibd clinic * participants must be between 16 and 80 years old * participants who meet the safety criteria for undergoing an mri scan * participants who are able to fit inside the scanner * participants must be able to give fully informed consent * participants must be mobile enough to be positioned onto the fci scanner couch exclusion criteria: * mri-incompatible conditions, as detected in the mri safety screening sheet * participants under 16 years old * participants who are unable to communicate in english * participants who are unable to give fully informed consent * women who are pregnant * restrictions to mobility that would prevent the correct positioning in the scanner * previous major abdominal surgery * any known significant comorbid disease that might interfere with treatment * malignancy or other conditions that would significantly reduce life expectancy * participants who suffer from claustrophobia

Keywords: field-cycling imaging (fci) proctosigmoiditis inflammatory bowel disease
safety and tolerability of oat containing gluten-free diet

Conditions: Celiac Disease

Summary: the purpose of this study is to determine the safety and tolerability of oats in gluten free diet.


Eligibility criteria:
inclusion criteria: * children over 4 years and adults with celiac disease (diagnosed according to current guidelines) * subject is able to fully participate in all aspects of this clinical trial exclusion criteria: * known intolerance to oats * serious underlying disease other than cd which in the opinion of the investigator may interfere with the subject's ability to fully participate in the study

Keywords: celiac disease oat gluten free diet
study of metformin overdose

Conditions: Metformin Associated Lactic Acidosis

Summary: the objective of the metinfo study is an observational single-center retrospective and descriptive study. the main objective is to estimate the real mortality rate associated to a metformin overdose. second objectives are to estimate the real hospitalization rate related to metformin overdose and to identify the risk factors of a metformin overdose and especially the potential correlation between metformin blood concentration and overdose severity.


Eligibility criteria:
inclusion criteria: * adult patients benifiting of a metformin blood concentration determination in the period ranging from the 1st of july 2019 and the 1st of july 2021. exclusion criteria: none.

Keywords: metformin lactic acidosis causality assessment
triple brafinh/mekinh /antipd1 combined therapy in patients with braf mutated melanoma with central nervous system metastasis

Conditions: Metastatic Melanoma

Summary: currently, therapeutic options in braf mutated melanoma with brain metastasis occurring after achievement of a good control of extracerebral secondary lesions by a first line combined targeted therapy (tt) are limited. in this setting, the addition of an anti pd1 agent to tt may be proposed as a second line strategy. this observational survey aims at investigating the benefit/risk ratio of this triple combination in a small cohort of patients.


Eligibility criteria:
inclusion criteria: * metastatic melanoma braf mutated * initially treated by a doubled targeted therapy anti braf/anti mek * with an intra cerebral progression of the tumor * whom we add an check point inhibitor anti pd1, combined with the double targeted therapy * between 01/2019 et 01/2022 exclusion criteria: - other condition

Keywords: initially treated by a doubled targeted therapy anti braf/anti mek immunotherapy combined tritherapy melanoma's brain metastasis with an intra cerebral progression of the tumor
study evaluating the efficacy and safety of 0.05% ingenol mebutate (picato® 500) in the treatment of basal cell carcinoma

Conditions: Carcinoma

Summary: basal cell carcinomas (bccs) are the most common form of cancer. the treatment of bcc can be surgical or topical for the low-risk subtypes. topical treatments used for bcc are imiquimod and photodynamic therapy (pdt). ingenol mebutate could provide a fast and easy topical therapy for bcc. data regarding the treatment of bcc with ingenol mebutate are still limited. the investigators propose a pilot study to investigate the efficacy of 1 or 2 courses of ingenol mebutate 0,05%, on superficial and nodular bcc


Eligibility criteria:
inclusion criteria: * age \> 18 years * histologically confi rmed, primary, previously untreated, nodular or superfi cial basal-cell carcinoma not arising on the face or scalp, measuring 1 to 4 cm (large axis) exclusion criteria: * basal cell carcinomas of the scalp * basal cell carcinomas recurrent, sclerodermiform, infiltrant, metatypic * allergic patient to treatment products * patient treated with immunosuppressants, immunomodulators, systemic cytotoxic agents or local corticosteroids applied in the cbc area during the 4 weeks prior to the screening visit

Keywords: basal cell carcinoma
a long term extension study of wa19926 (nct01007435) of tocilizumab (roactemra/actemra) in participants with early, moderate to severe rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: this open-label, single arm, multicenter long-term extension study of wa19926 (nct01007435) will evaluate the safety and efficacy of tocilizumab in participants with early, moderate to severe ra who have completed the 104-week wa19926 (nct01007435) core study. eligible participants will be those who are expected to benefit from the study medicine based on the investigator's discretion.


Eligibility criteria:
inclusion criteria: * participants who completed their last wa19926 (nct01649804) core study visit (week 104) and who may benefit from study drug treatment according to the investigator's assessment * no current or recent adverse event or laboratory finding preventing the use of tocilizumab 8 mg/kg at baseline visit * women of childbearing potential must agree to use highly reliable contraception during the treatment period exclusion criteria: * pregnant or breastfeeding females * participants who have withdrawn prematurely from the wa19926 (nct01649804) core study for any reason * treatment with any investigational agent or cell-depleting therapies since the last administration of study drug in wa19926 (nct01649804) * treatment with an anti-tumor necrosis factor (tnf) or anti-interleukin (il) 1 agent, or a t-cell costimulation modulator since the last administration of study drug in wa19926 (nct01649804) * immunization with a live/attenuated vaccine since the last administration of study drug in wa19926 (nct01649804) * diagnosis since last wa19926 (nct01649804) visit (week 104) of rheumatic autoimmune disease other than ra * diagnosis since last wa19926 (nct01649804) visit (week 104) of inflammatory joint disease other than ra * history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, including tocilizumab and its excipients * evidence of severe uncontrolled concomitant disease or disorder * known active infections or history of recurrent infections * active tuberculosis requiring treatment in the previous 3 years * history of alcohol, drug or chemical abuse since inclusion in the wa19926 (nct01649804) study
effects of allium hookeri on blood glucose

Conditions: PreDiabetes

Summary: the researchers investigated the anti-diabetic effects of allium hookeri root extract for korean prediabetic participants.

allium hookeri root is widely consumed as a vegetable and herbal medicine in asia. although the antidiabetic activities of allium hookeri have been documented in animal studies, the improved effects of allium hookeri on human are not clear. therefore, in this study, the researchers investigated whether allium hookeri root extract could be effective in reducing the risk of type 2 diabetes in individuals with prediabetes.

Eligibility criteria:
inclusion criteria: * fasting glucose 100\~126 mg/dl exclusion criteria: * significant variation in weight (more 10%) in the past 3 months * treatment by hypoglycemic and hypolipidemic drug therapy within the past three months * type 1 diabetes or hba1c\>9.0% * cardiovascular disease * hypoglycemic agent, obesity medicine, and lipid lowering agent within past 6 months or blood sugar, obesity, and lipid improvement functional foods within past 2 monts * pregnancy or breast feeding
information, follow-up and early diagnosis of children at risk for type 1 diabetes

Conditions: Type 1 Diabetes Mellitus; Stage 2 Type 1 Diabetes; Stage 1 Type 1 Diabetes; Stage 3 Type 1 Diabetes

Summary: the aim is to investigate whether screening for islet autoantibodies, regular follow-up, and increased knowledge in families about the progression of the disease in children at high genetic risk or with single or multiple islet autoantibodies (stage 1 or 2 type 1 diabetes) ensures an earlier diagnosis of stage 3 type 1 diabetes compared to no screening or follow-up. risk factors studied in relation to disease progression are the impact of higher-than-average weight gain, insulin resistance, and physical activity, both individually and in combination, on the risk of developing autoantibodies and disease progression. an alternative diagnostic method, continuous glucose monitoring (cgm), will be evaluated for its for usefullness in early diagnosis of stage 2 and 3 type 1 diabetes as alternatives to oral glucose tolerance tests. another aim is to investigate the psychological impact of being aware that the children are at a higher risk of type 1 diabetes. when a child in the study develops stage 3 type 1 diabetes, the psychological impact and metabolic control during the first five years after diagnosis will be compared to children not followed before the diagnosis.


Eligibility criteria:
inclusion criteria: * children 0 -10 years with high or moderate genetic risk of type 1 diabetes, measured by a combined analysis of hla and non-hla snps. moderate genetic risk is defined as 8-10% risk of developing multiple islet autoantibodies before 6 years of age, and high genetic risk as over 10% risk of developing multiple islet autoantibodies before 6 years of age. * children 0-18 years of age screened in other research studies or tested at a clinical site and found to have a single autoantibody (before stage 1 type 1 diabetes) or multiple islet autoantibodies without or with impaired glucose tolerance (stage 1 or 2 type 1 diabetes, respectively). * children will be invited to participate in the current study if they have moderate or high genetic risk and 1) have participated in a prevention trial but have dropped out or the trial has ended 2) are not willing to participate in prevention trial. * children screened and found to be positive for islet autoantibodies in other studies (teddy, trialnet, innodia etc) or in clinical settings but which have not progressed to stage 3 type 1 diabetes can also be invited to participate in the current study. exclusion criteria: * stage 3 type 1 diabetes * currently participating in a prevention study

Keywords: type 1 diabetes genetic risk islet autoantibodies staging of type 1 diabetes islet autoimmunity children follow-up autoantibody screening
mental health and well-being of people who seek help from their member of parliament

Conditions: Common Mental Disorders; Alcohol Use Disorder

Summary: this is an observational study to assess the prevalence of common mental disorders and alcohol use disorders in a population of individuals seeking help from their member of parliament (mp) in the uk.

members of parliament (mp) in the united kingdom (uk) represent the interests of their constituents. constituents may contact their mp for assistance if they feel that they have been treated unfairly by a government department or agency, have concerns relating to their local area, or are wanting support from their mp for a campaign they are involved in. in order to fulfil their duty to constituents, mps hold regular surgeries which allow anyone with a concern to meet with them to discuss the issue in question further. given the role of the mp in representing people who may be in the midst of stressful events, such as a dispute, it is possible that mental health problems may be more prevalent in this population. however, at present mps are not given any additional training in recognising mental distress, and may not know how to appropriately sign-post people to appropriate supportive services, nor do mps receive advice in supporting such individuals. to the best of the investigator's knowledge, there have been no prior studies in this area. the findings of this study will inform initiatives to improve mp working practices, to and raise awareness of the mental health challenges faced by their constituents, with the aim of better meeting the mental health needs of constituents who attend mp surgeries in the future.

Eligibility criteria:
inclusion criteria: * attending selected mp surgeries (e.g. in central suffolk \& north ipswich) * over the age of 18 * must be able to complete paper or online questionnaires. * have consented to take part in the study exclusion criteria: - unable to complete questionnaires on their own/ unaided.