Kornimate/medical-research-clean huggingface dataset:
the efficacy of a pseudoallergen-free diet in the treatment of chronic idiopathic urticaria and/or angioedema

Conditions: Urticaria; Angioedema

Summary: this study involves investigating the effects of a pseudoallergen-free (active) diet compared with a control (placebo) diet in the treatment of chronic idiopathic urticaria (ciu) and/or angioedema. the hypothesis is that over a four-week intervention period, the pseudoallergen-free diet will be more effective than the placebo diet in reducing the frequency and severity of ciu and/or angioedema.

the role of dietary pseudoallergens as a trigger for ciu and/or angioedema is a controversial subject. 'dietary pseudoallergy' refers to the mimicking of ige symptoms (such as rash, itch and swelling) by components of food in the absence of a true ige mediated response (as diagnosed by rast and skin prick testing). the pseudoallergen-free diet excludes a range of naturally occuring chemicals (including salicylates, amines and brewers yeast) in addition to a range of artificial preservatives and additives (for example sulphites and glutamates). the control diet is based on the general dietary guidelines for the management of diabetes (including the principles of healthy eating, low glycemic index choices and a reduced saturated fat intake). subjects recruited into the study will have a 3 month history of ciu and/or angioedema and will be randomly assigned to either the active or control arm of the study in a single blinded fashion. all subjects will be advised to cease antihistamine medication and will receive one-on-one dietary counselling by a dietitian. the diet to which each subject has been assigned (ie either active or placebo) is to be followed for a 4 week duration. the frequency and severity of ciu and/or angioedema as well as adherence to the diet are to be measured on both a daily and weekly basis by the subject via the completion of a clinical score card. the results of the score cards will be collated to determine the relative effects of each diet on these conditions.

Eligibility criteria:
inclusion criteria: * english speaking * aged between 21 to 75 years * 3 month history of chronic idiopathic urticaria and/or angioedema exclusion criteria: * age \ 75 years * non english speaking * systemic lupus erythematosis * dysproteinemias * thyrotoxicosis * vasculitis * infection

Keywords: dietary intervention pseudoallergen free diet
asthma control study 2011

Conditions: Asthma Control Level

Summary: asthma control study 2011


Eligibility criteria:
inclusion criteria: * asthmatic patients above 18 y exclusion criteria: * copd * pulmonary cancer * pulmonary tuberculosis

Keywords: asthma control level , acq
safety and efficacy of afq056 in adolescent patients with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: this phase iib study is designed to assess whether 3 doses of afq056 are safe and effective in treating the behavioral symptoms of fragile x syndrome.


Eligibility criteria:
inclusion criteria: * patients with fragile x syndrome, who are at least moderately ill based on a clinical global impression severity score of at least 4 and have qualifying scores on the abc-c and iq test at visit 1 exclusion criteria: * advanced, severe or unstable disease that may interfere with the study outcome evaluations * cancer within the past 5 years, other than localized skin cancer * current treatment with more than two psychoactive medications, excluding anti-epileptics * history of severe self-injurious behavior * weigh less than 32 kg * females who are sexually active other protocol-defined inclusion/exclusion criteria may apply

Keywords: fragile x syndrome martin-bell syndrome genetic diseases x-linked escalante's syndrome
18f-fdg pet metabolic phenotype in evaluating therapeutic response for breast cancer patients with bone metastases.

Conditions: Breast Cancer; 18F-FDG PET

Summary: this study is to evaluate the effectiveness of 18f-fdg pet in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy. primary outcome: using 18f-fdg uptake to evaluate the metastatic bone status after treatment. the pet results will be compared with the results in tc-99m mdp bone scintigraphy. secondary outcome: evaluate the relationship between the 18f-fdg uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

background: although 99mtc mdp bone scintigraphy is a sensitive tool for screening metastatic bone status, it is not a satisfactory imaging modality in evaluating residual disease after therapy. 18f-fdg pet has been an effective imaging tool for many malignancies including breast cancer, not only in diagnosis and staging, but also in monitoring response and following up disease status after therapy. purpose: this study is to evaluate the effectiveness of 18f-fdg pet in following up of metastastic bone lesions and in predicting outcome for breast cancer patients after therapy. method: breast cancer patients with bone metastases, age 20-90 year-old, will be included in this study. primary outcome: using 18f-fdg uptake to evaluate the metastatic bone status after treatment. the pet results will be compared with the results in tc-99m mdp bone scintigraphy. secondary outcome: evaluate the relationship between the 18f-fdg uptake of the metastatic bone lesions and (1) breast cancer related tumor marker, (2) patients' survival.

Eligibility criteria:
inclusion criteria: 1. age：20-90 years old 2. histological proven breast cancer, with known metastatic bone lesion(s) 3. written informed consent signed exclusion criteria: 1. pregnant or intend to be pregnant 2. other malignancies known

Keywords: breast cancer; bone metastases; 18f-fdg pet; 99mtc bone scintigraphy; therapy response monitoring; prognosis
a research study, looking at how xultophy® works in people with type 2 diabetes in local clinical practice in united arab emirates

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of the study is to collect information on how xultophy® works in patients with type 2 diabetes. the participants will get xultophy® as prescribed to them by the study doctor. the study will last for about 26-34 weeks. the participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). * the decision to initiate treatment with commercially available xultophy® has been made by the patient/legally acceptable representative and the treating physician before and independently from the decision to include the patient in this study. * male or female, age greater than or equal to 18 years at the time of signing informed consent. * diagnosed with type 2 diabetes and treated with basal insulin plus or minus oral anti-diabetic drugs (oads) or glucagon-like peptide-1 receptor agonist (glp-1 ra) plus or minus oads, except xultophy®, for at least 12 weeks prior to informed consent and initiation visit (visit 1). * available and documented glycosylated haemoglobin a1c (hba1c) value less than or equal to 12 weeks prior to initiation of xultophy® treatment. exclusion criteria: * hypersensitivity to the active substance or to any of the excipients as specified in the xultophy® local label. * previous participation in this study. participation is defined as having given informed consent in this study. * female who is known pregnant, breast-feeding or intends to become pregnant. * treated with xultophy® previously. * mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
effect and underlying immunological mechanisms of sublingual immunotherapy in allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: allergic rhinitis (ar) is a common ig-e mediated disease of nasal mucosa, induced by an immunoglobulin e (ige)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. ar could be divided into two kinds, perennial ar and seasonal ar (sar). allergen specific immunotherapy (ait) is the only etiological treatment available for ar. traditionally, ait is divided into 2 types, subcutaneous immunotherapy (scit) and sublingual immunotherapy (slit), both of which are effective and safe alternatives. the trial is a randomized, double-blind, placebo-controlled trial. 72 eligible sar patients, who were sensitized to sweet sagewort (artemisia annua), were enrolled into the trial, followed by either a 32-week slit schedule, where the maintenance dose would be reached within 5 weeks, or placebo slit schedule. standardized depot preparations of sweet sagewort (artemisia annua) extract (zhejiang wolwo bio-pharmaceutical co., ltd., china ) were administered by means of sublingual drops.


Eligibility criteria:
inclusion criteria: * male or female outpatients aged 18 to 60 years (inclusive). * with history of sar for at least two years, with/without conjunctivitis and asthma * two or more nasal symptoms scores were ≥ 2 points during july - october in the last year. * sensitised to artemisia annua (specific ige level ≥ 3.5 kilounit per liter). * patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol. * patients who are able to understand the information given and the consent and complete the daily record card. exclusion criteria: * patients whose humulus- or artemisiifolia-specific immunoglobulin e (ige) levels (immunocap) same as or higher than artemisia-specific immunoglobulin e (ige) level. * patients with oral diseases/ allergies within the run-in period. * patients accepted any kind of operations within 4 weeks of the run-in period. * patients applied for systemic glucocorticoids within 4 weeks in the run-in period. * patients with perennial ar. * patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps). * whatever the co-sensitization leading to clinically relevant ar, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study. * patients with comorbidity of severe asthma.
a study for observing severe asthma in patients treated with tezepelumab

Conditions: Asthma

Summary: a study involving primary data collection within real-world settings of participants who initiate treatment with tezepelumab for severe uncontrolled asthma. this study will complement evidence obtained from randomized controlled trials and provide new data focusing on the holistic and patient reported outcome (pro).

this is a 12-month, multi-country, multi-center, prospective, non-comparative and non-interventional (observational), post-reimbursement real-world evidence study that will assess asthma symptom control, lung function, and patient-reported outcomes including health-related quality of life after tezepelumab treatment initiation in participants with severe asthma in europe and canada. this study is planned to be conducted in several countries including but not limited to canada, germany, denmark, switzerland, and sweden. participants will be followed for a maximum period of 52 weeks after tezepelumab treatment initiation, irrespective of treatment discontinuation.

Eligibility criteria:
inclusion criteria: * male or female participants aged 12 years or older * provision of signed and dated written informed consent, including assent for minors * prescribed treatment with tezepelumab * diagnosis of asthma for at least 52 weeks prior to enrolment date and symptoms confirmed by the investigator not to be due to alternative diagnoses * received at least one prescription of medium-dose to high-dose inhaled corticosteroids (ics) during the 52 weeks prior to enrolment date * use of additional asthma maintenance controller medication(s) for at least 52 weeks prior to enrolment date * documented history of at least 1 asthma exacerbations during the 52 weeks prior to enrolment date * individuals with acq-6 score ≥ 1.5 (indicating inadequate asthma symptom control) at enrolment or up to 12 weeks before enrolment * participants currently receiving care from pulmonologists and/or allergists * participants who are able to understand and complete the epros * availability of participants medical records for asthma exacerbation and healthcare resource utilization (hcru) for the 52 weeks prior to tezepelumab initiation exclusion criteria: * any contraindication to tezepelumab * participants on concurrent biologics for asthma at the time of receiving the first dose of tezepelumab will be excluded except for stable allergen immunotherapy (defined as a stable dose and regimen at the time of enrolment) * participation in an observational study that might, in the investigator's opinion, influence the assessment for the current study, or participation in an interventional clinical trial in the last 3 months * pregnancy or lactation period.

Keywords: real-world evidence severe uncontrolled asthma inhaled corticosteroids (ics) post-authorization
comparison of the efficacy of double monopolar versus interleaving stimulation modes for pallidal deep brain stimulation

Conditions: Primary Dystonia

Summary: the aim of the study is to compare the efficacy and the safety profile of the newly introduced interleaving stimulation mode to those of the standard double monopolar stimulation mode during pallidal deep brain stimulation of primary generalized or segmental dystonia.

background: for the treatment of drug-refractory dystonia, bilateral pallidal deep brain stimulation (gpi-dbs) is proven to be an efficient option. on average, 40-55% improvement on dystonia rating scales (drs) could be achieved according to the results of multicenter trials lasting for years. however, a considerable portion (10-25%) of the patients experience minimal alleviation despite of good electrode placement. these patients can be regarded as non-responders to gpi-dbs defined as having either limited improvement (\< 25% on drs) or worsening. besides adjusting the amplitude, frequency or pulse-width of stimulation, one can change the electrode configuration from the commonly applied single monopolar stimulation mode (one contact on the electrode is negative) to either double monopolar stimulation (two -usually adjacent- negative contacts on the electrode are stimulated with same amplitude and pulse-width values) or bipolar stimulation mode (one contact on the electrode is positive) in case of unsatisfactory outcomes. although these techniques had been utilized in multicenter trials, non-responsiveness to gpi-dbs did occur. recently the investigators have reported in the movement disorders that the newly introduced interleaving stimulation mode was superior to single or double monopolar stimulation in four patients who had initially (6-12 months after implantation) limited response to gpi dbs. aims of the study: to systematically compare the efficacy and the side-effect profile of double monopolar stimulation mode to those of interleaving stimulation mode in a prospective, randomized, double-blind, and cross-over study. methods: the investigators would enroll 20-25 patients with drug refractory segmental or generalized primary dystonia undergoing bilateral gpi-dbs implantation within a 2-3 year time frame. the inclusion and exclusion criteria would follow those of the study of kupsch et al.

Eligibility criteria:
inclusion criteria: * ages of 7 and 75 years * marked disability owing to primary generalized or segmental dystonia, despite optimal pharmacologic treatment * disease duration of at least 5 years. exclusion criteria: * previous brain surgery; * cognitive impairment (\< 120 points on the mattis dementia rating scale) * moderate-to-severe depression (\> 25 points on the beck depression inventory) * marked brain atrophy as detected by magnetic resonance imaging * other medical or psychiatric coexisting disorders that could increase the surgical risk or interfere with completion of the trial

Keywords: dystonia pallidal stimulation deep brain stimulation deep brain stimulation of gpi gpi interleaving stimulation
adalimumab for inflammatory osteoarthritis

Conditions: Osteoarthritis

Summary: we will conduct a pilot study of the effectiveness of adalimumab for inflammatory osteoarthritis.

this is a 20 patient pilot open-label study of the efficacy of adalimumab in inflammatory osteoarthritis of the knee. primary endpoint is at 12 weeks and primary outcome is the oarsi responder index.

Eligibility criteria:
inclusion criteria: * patient is 40 years of age or older. * if female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control: condoms, sponge, foams, jellies, diaphragm or intrauterine device (iud) contraceptives (oral or parenteral) for three months prior to study drug administration),a vasectomized partner, total abstinence from sexual intercourse * if patient is female and of childbearing potential, the results of a serum pregnancy test performed at screening, prior to the first dose of adalimumab, must be negative. * patient has a diagnosis of oa of the index knee according to american college of rheumatology criteria, including radiological evidence of oa (kellgren-lawrence grades 2 or 3). * patient has had continual pain for at least 6 months prior to inclusion in the study. this includes pain that has persisted despite conventional treatment, defined as any one of the following medications taken daily during the preceding month:acetaminophen (2- 4 grams per day)maximum tolerated and recommended doses of an nsaid, acetaminophen/codeine combination (i.e. tylenol no 2, 3, 4) taken at least 3 times daily * patient has had daily knee pain for the month preceding study enrolment. * patient has a summed pain score of 125-400mm (visual analog scale) on the womac pain sub-scale in the index (more symptomatic) knee. * patient has clinical evidence of a knee effusion in the index (more symptomatic) knee at screening and baseline. exclusion criteria: * subject has a history of an allergic reaction or significant sensitivity to constituents of adalimumab. * patient has a history of proven systemic arthritis such as rheumatoid arthritis. * patient has a concurrent medical or arthritic condition that could confound evaluation of the index joint e.g. post-traumatic or any secondary form of knee oa * patient has predominant patellofemoral disease

Keywords: osteoarthritis adalimumab mri
improving health outcomes of migraine patients who present to the emergency department

Conditions: Migraine

Summary: collectively, evidence shows that a combination of medication and behavioral therapy is most effective for migraine care. the ed is a critical point of contact with the health care system for many migraine patients; in current practice, it is a missed opportunity to initiate and establish a comprehensive migraine management paradigm. behavioral headache treatments (e.g., progressive muscle relaxation (pmr), biofeedback, cognitive-behavioral therapy (cbt)) are effective migraine treatment options that are essentially free of side effects. pmr has also been successful as a technique that patients can do independently. studies have shown that combination pharmacological-behavioral therapy is most effective for migraine treatment. several aspects of this study are innovative, including: 1. initiation of preventive medication in a timely manner for migraineurs who present to the ed. 2. introduction of pm+pmr in the ed at a time that can serve as a teachable moment. 3. introduction of a smartphone application-based product (a minimal contact based behavioral therapy) in the ed setting to reduce headache disability, frequency, and intensity.

investigators will conduct a randomized trial to evaluate the impact of a comprehensive migraine treatment program on the quality of life for migraineurs with frequent and disabling headaches who present to the ed. the intervention (pm+pmr) will combine acute treatment, migraine preventive medication-topiramate, and the app with pmr. data from patients in the intervention group will be compared with data from an enhanced usual care (euc) group to examine the efficacy of the combined treatment effects.

Eligibility criteria:
inclusion criteria: * meets migraine criteria based on information in study manual or based on headache expert opinion -4+ migraines a month * migraine disability assessment (midas) score \>5. exclusion criteria: * patients who have had cognitive behavioral therapy, biofeedback or other relaxation therapy in the past year; * cognitive deficit or other physical problem with the potential to interfere with behavioral therapy; alcohol or other substance abuse as determined by self-report or prior documentation in the medical record; * opioid or barbiturate use 10+ days a month; * phq9 score of severe depression; * unable or unwilling to follow a treatment program that relies on written and audio recorded materials; * not having a smartphone.

Keywords: migraine emergency department
obstructive sleep apnea and genes expression

Conditions: Obstructive Sleep Apnea

Summary: obstructive sleep apnea is a multi-component disease. this study will test the hypotheses that hypoxia per se modulates gene expression in animal model of sleep apnea and these results may be translated with alterations that occur in apneic patients. thus, we aim to integrate basic and clinical research to shed light on novel candidate genes involved in sleep apnea.

twenty-four male rats were exposed to chronic intermittent hypoxia (5% o2) or normoxia for 6 wks. following chronic intermittent hypoxia, a group of 8 rats were removed from the chronic intermittent hypoxia protocol and allowed to normoxic conditions over a period of 2 wks. for the clinical protocol, the ahi measured by overnight polysomnography will be use to select individuals with sleep-related breathing disorders, and controls (30-60 years, body mass index (bmi) \< 35kg/m2). moreover, the investigators will evaluate the subjective sleep parameters (sleep disorders questionnaire, the epworth sleepiness scale, sleep diaries). after standard cpap titration, men with severe obstructive sleep apnea will be assigned for the cpap protocol for future assessment of the influence of 6 months obstructive sleep apnea treatment. a total of 84 genes are evaluated using the hypoxia signaling pathway pcr array (sa biosciences, eua).

Eligibility criteria:
inclusion criteria: * male subjects aged between 30 and 60 years old * normal range of laboratory tests complete blood count (cbc), glucose, total cholesterol, high-density lipoprotein (hdl), low-density lipoprotein (ldl) and very low-density lipoprotein (ldl), triglycerides * body mass index (bmi) \< 35kg/m2 exclusion criteria: * presence of clinical diseases (chronic obstructive pulmonary disease, asthma, interstitial lung diseases, neuromuscular diseases, heart failure, thyroid disease, rheumatologic and psychiatric) and other sleep disorders * smoking status * participants who had current or historical treatment with cpap or any other treatment for osa * presence of anatomical obstructive upper airway, tonsil grade iii and iv septal deviation and grade iii (severe) that may affect the outcome of cpap * alcoholism * use of sleep-inducing medications

Keywords: obstructive sleep apnea cpap hypoxia sleep translational science gene expression