Kornimate/medical-research-clean huggingface dataset:
molecular analysis of ige antibodies in walnut allergic patients

Conditions: Food Allergy

Summary: accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). the proposed study intends to investigate and compare the pattern of ige antibody sensitisation in walnut allergic subjects from three different regions of europe (south (seu) and central/north (c/neu), to evaluate the diagnostic utility of a panel of novel allergen reagents.

accurate diagnosis of food allergy depends on the identification of the causative allergenic molecule(s). thus, full characterization of the major allergens of walnut and their clinical importance is an important undertaking. the proposed study intends to investigate and compare the pattern of ige antibody sensitisation in walnut allergic subjects from three different regions of europe (south (seu) and central/north (c/neu), to evaluate the diagnostic utility of a panel of novel allergen reagents. with a view towards improved in vitro diagnostic methods, we intend to evaluate the diagnostic potential of recombinant walnut allergens in patients with walnut allergy confirmed by a positive provocation or supported by a convincing history of anaphylactic reaction(s) to walnut in the past, patients with pollinosis but no symptoms of walnut allergy and non-atopic control subjects.

Eligibility criteria:
inclusion criteria: * signed informed consent * group a: positive case history of allergic reaction(s) to walnut * group b: positive case history of allergy to birch, grass or olive pollen and no case history of allergic reaction(s) to walnut * group c: no case history of atopic disease exclusion criteria: * known pregnancy * breast-feeding of infant * treatment with the following drugs (or shortest interval between last treatment and food challenge or spt): * corticosteroids (2 weeks): applied systemically, to the nose or locally on the skin test area. * antihistamines (3 days) except hydroxyzine (10 days) * betablocker agents (1 day) * angiotensin converting enzyme inhibitors (2 days) * any major organic or infectious disease

Keywords: food allergy walnut components allergens
spleen-arfi-assisted-portal-hypertension-evaluation-study (saphes)

Conditions: Hypertension, Portal

Summary: this study evaluates correlation in changes of hvpg-pressure values and stiffness values (arfi) for spleen and liver and flow-volume values in portal vein in patients with liver cirrhosis/portal hypertension, respectively, after new-admission of beta-blocker therapy.

portal hypertension is the most important risk factor for development of liver cirrhosis-linked complications (e.g. ascites, variceal bleeding, hepatocellular carcinoma, etc.). the invasive hvpg-technique is the standard-of-care investigation for evaluation of portal hypertension. administration of beta-blocker-therapy results in dropping of the elevated portal vein pressure values so overall-survival rate and incidence of liver-cirrhosis-linked complications can be ameliorated. ultrasound-based investigation of liver and spleen-stiffness and of portal-vein-flow-volume, respectively, are the non-invasive methods for evaluation of portal hypertension. but the cut-off values for detection of significant portal hypertension by the ultrasound investigation strongly vary depending on the study performed. this study evaluates the changes in arfi-assisted elastography measurements of liver and spleen and in portal vein flow values, respectively, compared with the recorded delta in invasive hepatic vein pressure gradient (hvpg)-values for patients with portal hypertension and new administered beta-blocker-therapy. the aim of this study is to evaluate value drop in liver- and spleen-stiffness and portal-vein-flow required in corelation to a significant drop in hvpg-pressure after new-administered beta-blocker therapy.

Eligibility criteria:
inclusion criteria: * liver cirrhosis * portal hypertension * indication to beta-blocker-therapy exclusion criteria: * contraindication to beta-blocker-therapy * hvpg-measurement not feasible * portal vein thrombosis * hematologic underlying disease as the source for enlarged/stiff spleen or liver

Keywords: hvpg portal hypertension arfi portal vein flow advanced liver chronic disease (acld)
antibiotic prophylaxis for peg in children

Conditions: Infection

Summary: the aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before peg can reduce the incidence of peristomal wound infection in the paediatric population.

percutaneous endoscopic gastrostomy (peg) is a common endoscopic procedure, performed to avoid malnutrition in various pathological conditions. gastrostomy tube placement is associated with intra and postoperative complications both in the adult and in the paediatric population. local infection is the most common complication following peg. antibiotic prophylaxis is a well-established strategy to reduce peristomal wound infection rate in adult population. the aim of this study is to evaluate if a single i.v. dose of co-amoxiclav before peg can reduce the incidence of peristomal wound infection in the paediatric population.

Eligibility criteria:
inclusion criteria: * all pediatric patients (0-18 years) who will refer for peg placement to the endoscopy unit exclusion criteria: * controindications for peg * ongoing antibiotic treatment * antibiotic use within the past 4 days * illness too severe to allow the patient to participate * allergy to penicillin

Keywords: peg percutaneous endoscopic gastrostomy antibiotic prophylaxis
postoperative nausea and vomiting and acupuncture/acupressure

Conditions: Postoperative Vomiting; Nausea

Summary: postoperative nausea and vomiting (ponv) remain a significant challenge in the investigators practice. however, pharmaceutical prophylaxis can imply unpleasant adverse effects. it would therefore be appropriate to consider the use of non-pharmacological methods in preventing ponv. acupuncture and acupressure are reported to be effective preventive treatment for ponv, and the adverse effects are minimal. consequently, the investigators will investigate if acupuncture and acupressure can be implemented as a supplementary to the ordinary treatment in children undergoing surgery for tonsillectomy and/or adenoidectomy. the study will also focus on the feasibility for acupuncture and acupressure in the operation theatre. the study and inclusion/exclusion decisions are conducted after the "intention-to-treat" principle. 126 patients are included, divided into two groups: 1. treatment group - standard treatment and acupuncture performed after induction of anaesthesia, acupressure administered before awakening 2. control group - standard treatment the primarily endpoints in this study are nausea, retching and vomiting. the effect of acupuncture/acupressure will be studied with regard to any association with possible factors of predisposition to ponv, as well as with other factors registered during the study. adverse effects from the acupuncture site and wristband will be registered.


Eligibility criteria:
inclusion criteria: * children scheduled for tonsillectomy and/or adenoidectomy * informed consent from the parents/guardians exclusion criteria: * asa grade greater than or equal to iii (patients with severe systemic disease) * rash or local infection over an acupuncture point * emesis during the previous 24 hours * use of medication with antiemetic effect and/or other antiemetic therapy within the 24 hours before surgery * gastric or intestinal diseases

Keywords: pov tonsillectomy adenoidectomy acupuncture acupressure child effectiveness of acupuncture on
cap'onco : psychological and social consultation of professional accompaniment in oncology

Conditions: Cancer

Summary: this patient support system is designed to help patients regain their professional activity after their treatment. it's a 3-axis neuropsycho-social synergy on 3 axes: * a weekly pluridisciplinary consultation in tandem (social worker + psychologist / neuropsychologist) * monthly information meetings and workshops (tic'onco reunions: collective information times and cogit'onco workshops: cognitive workshops * an information booklet "prepare the work return" the aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction. the aim of this research is to evaluate efficiency in term of quality of life improvement linked to work status, utility, feasibility and patients' satisfaction.

unmet need characterize in 4 points: * cancer and survival: challenges for cancer patients who want to work while being treated * cancer and career: job instability for cancer patients * difficulties and isolation of patients due to a lack of coordination between healthcare professionals and colleagues/management * post-treatment cognitive troubles stress and hindered patient return to employment: chemo brain this research-action will propose and evaluate a concrete device: to maintain a professional activity with the support of cap'onco during treatment, to balance between quality of life, managing the "cancer event" and the psychosocial consequences for professional experience, to provide an early, durable and multimodal support to improve work keeping and anticipate return to employment

Eligibility criteria:
inclusion criteria: * patients attending the institut bergonié * informed consent signed. * patients affiliated to a french social * living in gironde * professional activity at the time of diagnosis * treated for - breast cancer, hodgkin's or non-hodgkin's lymphoma (non-cerebral), testicular cancer * curative support * at any time during treatment (chemotherapy or radiotherapy, or immunotherapy) exclusion criteria: * patient deprived of liberty or subject to a legal protection measure * history of cancers * cerebral pathology and / or brain metastasis

Keywords: oncology work keeping social difficulties cognitive disorders
gc1118 in recurrent glioblastoma patients with high egfr amplification

Conditions: Glioblastoma, Adult; EGFR Amplification

Summary: this study is a phase 2 trial of gc1118, an egfr monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation.

this study is a phase 2 trial of gc1118, an egfr monoclonal antibody, for recurrent glioblastoma patients who were treated with standard concurrent chemoradiation. gc1118 (4mg/kg) will be administered by iv infusion once per week for 4 weeks(28-day cycle) up to 6 cycles.

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. 19 years or older 3. patients who experience recurrence following the standard therapy (ccrt, adjuvant temozolomide) 4. high egfr amplification 5. available archive tumor sample(s) 6. karnofsky performance status (kps) \> 70 7. life expectancy \> 3 months 8. adequate end-organ function 9. patients who recovered from previous therapy (nci ctcae v4.03 gr 1) exclusion criteria: 1. patients who had egfr target agent(s) before screening 2. patients who have clinically significant cardiopulmonary dysfunction (cardiovascular disease (\> 2grade, nyha), myocardial infarction within previous 3 months, unstable angina, unstable arrythmia, clinically significant interstitial lung disease) 3. patients who had major surgery, open biopsy, or clinically significant trauma within previous 4 weeks 4. patients who had investigation drug(s) within previous 4 weeks 5. patients who had other malignancy(ies) within previous 3 years (except malignancies with low tendency to metastases or mortality for example, treated cervical intraepithelial neoplasia, skin cancer except melanoma, localized prostate cancer) 6. patients who had severe infection within previous 4 weeks 7. hiv infection 8. patients who had anti-cancer therapy (surgery, chemo-radiation, chemotherapy, radiation therapy) within previous 4 weeks 9. clinically significant liver disease (active hepatitis b viral (hbv) or hepatitis c viral (hcv) infection, alcoholic liver disease etc) 10. pregnancy or breast-feeding
a multi-center, non-interventional, prospective study of durvalumab in unresectable locally advanced nsclc in routine clinical practice in russia

Conditions: NSCLC, Non-small-cell Lung Carcinoma

Summary: durvalumab was approved in the russian federation for use after both concurrent and subsequent crt until disease progression. currently, there is no real-world data regarding the safety and real world effectiveness of durvalumab in this indication. moreover, generation data on the safety and real world effectiveness of durvalumab after concurrent chemo-radiation therapy (ccrt) and subsequent chemo-radiation therapy (scrt) in routine practice in the russian federation will be of high relevance. the other important question that needs to be addressed is the duration of treatment with durvalumab and its' influence on the relevant outcomes. according to the russian label, it is possible to continue treatment with durvalumab until disease progression, although current data from the pacific trial provide the results on 12 months duration of durvalumab treatment. the real-world data about the duration of treatment with durvalumab in the russian population and its' influence on various outcomes would be very important. among other goals, the current study is aimed to analyze factors influencing the effectiveness of durvalumab therapy in the real-world setting (e.g. duration of treatment, delays in the start of treatment with durvalumab after crt over, early discontinuation due to any factors including aes, etc.). the study also aims to elucidate treatment approaches after discontinuation from durvalumab (post-progression outcomes and treatment in case of discontinuation due to aes). this study will support the understanding of described factors and will take and an attempt to optimize the treatment process to improve outcomes for patients


Eligibility criteria:
inclusion criteria: patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply: * written informed consent obtained from the patient prior to performing any protocol-related procedures * age ≥18 years at time of study entry * patients must have histologically or cytologically documented diagnosis of nsclc with a locally advanced, or locally recurrent, unresectable (stage iii) disease (according to american joint committee on cancer \[ajcc\] lung cancer edition 8) * patients must have completed a platinum-based chemotherapy with radiation therapy (concurrent or sequential) without evidence of disease progression * patients must have been treated with at least one dose of durvalumab exclusion criteria: any subject who meets any of the following criteria will not qualify for entry into the study: * absence or missing of written informed consent form * patients treated with durvalumab in clinical studies * absence of essential data to obtain all necessary information * confirmation that the subject was already included in this study before
a personalized approach to effects of affective bias modification on symptom change and rumination

Conditions: Major Depressive Disorder

Summary: this study evaluates the effect of a computerized intervention for depressive symptoms called affective bias modification (abm). a third of the patients will receive active abm, a third will receive sham abm and a third will undergo assessment only. the study will investigate if rumination mediates the effect of the intervention and investigate if specific symptom profiles affect the effect of the intervention.

a main aim of the project is to investigate how the effects of an abm intervention on depressive symptoms are mediated by transdiagnostic rumination and how characteristics of the symptom network moderate these effects. the affective bias modification task (abm) will be applied in a randomized controlled, double blind clinical trial with 6 months follow-up. personalized networks are generated from prospective assessment of depression-related processes at baseline and follow-ups. patients (n = 150) will be recruited from out-patient clinics at diakonhjemmet hospital, and randomized into one of three conditions: active, sham and assessment only. patients aged 18-65 with depression (major depressive disorder) or bipolar disorder 2, with or without comorbid anxiety and/or alcohol use disorder will be included. the main hypothesis is that subjects who are in the active abm group will exhibit less tendency for stress related (state) rumination compared to those in the placebo group. active vs placebo abm will decrease depressive symptoms (6 months) and this effect will be mediated by the change in state rumination. densely connected symptom network and high strength centrality of rumination at baseline will moderate the effect of abm. by combining mechanisms research with a personalized symptom network approach, this study will be in the forefront of understanding how a drug-free treatment option works and for whom it works best.

Eligibility criteria:
inclusion criteria: - current or remitted major depressive disorder, with or without anxiety, with or without alcohol use disorder exclusion criteria: * neurological disorder, mania, and/or psychosis.

Keywords: rumination attention bias modification transdiagnostic
clinical evaluation of the effect of lanap as an adjunct treatment in management of patients with chronic periodontitis

Conditions: Periodontitis; Laser

Summary: this study evaluate the effect of lanap (laser assisted new attachment procedure) as an adjunct treatment in management of patients with chronic periodontitis and assay the effect of lanap on periodontal indexes like bop, cal, probing depth

this study evaluate the effect of lanap (laser assisted new attachment procedure) as an adjunct treatment in management of patients with chronic periodontitis and assay the effect of lanap on periodontal indexes like bop, cal, probing depth in a split mouth design before treatment and after follow up sessions.

Eligibility criteria:
inclusion criteria: * definite diagnosis of chronic periodontitis with at least two teeth with periodontal pocket depth more than 4 mm in each side exclusion criteria: * pregnant smoker systemic disease breast feeding

Keywords: lanap periodontitis
lactobacillus rhamnosus gg: interaction with human microbiota and immunity

Conditions: Gut Microbiota; Skin Microbiota; Humoral Immune Responses; Severity of Atopic Dermatitis

Summary: hypothesis: probiotics have been used as novel adjunct therapeutic approach in atopic dermatitis. in addition to balancing the gut microecology and promoting host immune defences, specific probiotics might further aid in controlling the microbial colonization of the skin, thereby reducing proneness to secondary infections which typically cause sustained symptoms. thirty-nine infants with atopic dermatitis,randomized for a three-month-period in a double-blind design to receive extensively hydrolysed casein formula (nutramigenr, mead-johnson, usa) supplemented with (n=19) or without (n=20) lactobacillus rhamnosus gg (atcc 53103) 5.0 x 107 cfu/g to achieve a daily intake of 3.4 x 109 cfu. sampling (blood and faecal samples, cotton swab from the skin) and clinical examination of the infant, including scorad assessment to determine the severity of atopic dermatitis, at each study visit (at entry and one month and three months thereafter).


Eligibility criteria:
inclusion criteria: * clinical diagnosis of atopic dermatitis * age 4 we - 18 mo exclusion criteria: * skin infection or severe infection at the time of enrollment

Keywords: atopic dermatitis barrier function gut probiotics skin
liposomal bupivacaine vs bupivacaine for pain control after sternotomy

Conditions: Pain Management; Sternotomy

Summary: researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. researchers will measure this based on how much iv pain medication is used, rates on confusion, and time to remove the breathing tube.


Eligibility criteria:
inclusion criteria: * adults over the age of 18 who present for elective open heart surgery that requires a sternotomy. exclusion criteria: * urgent and emergency procedures, * preexisting sternal infections, * prior sternotomy, * preexisting pain syndromes, * current chronic home opioid use, * anterior rib or sternal masses, * allergy to any of the components of liposomal bupivacaine and plain bupivacaine.
a feasibility study to evaluate the safety and effectiveness of implantation of flowise cerebral flow diverter (flowise)

Conditions: Intracranial Aneurysm

Summary: the purpose of this study is to evaluate the safety and short-term effectiveness of implantation of 'flowise cerebral flow diverter' for the treatment of unruptured wide-necked cerebral aneurysm in the internal carotid artery.

flowise is indicated for use in patients with unruptured wide-necked aneurysm in the internal carotid artery. consecutive subject data should be collected at discharge, 1, 3, and 6 month post flowise implantation.

Eligibility criteria:
inclusion criteria: * functional neurological state ≤2 mrs * unruptured wide-neck aneurysm in the internal carotid artery has a size \>8mm, a neck ≥4mm, or dome/neck ratio \<2 * parent artery with diameter ≥3.25mm and ≤4.5mm * patient willing to provide written informed consent and comply with follow-up requirements exclusion criteria: * intracranial hemorrhage within 30 days * untreated ruptured intracranial aneurysm * ≥1 intracranial aneurysm except the target one requires treatment within 6 months * immunosuppressive disease * active infectious disease (e.g. endocarditis, meningitis) * platelet count \< 100 x 103 cells/mm3 * female of child-bearing potential who are unable to take adequate contraceptive precautions, are known to be pregnant, or are currently breastfeeding an infant.
pharmacokinetics and pharmacodynamics study of saxagliptin in healthy subjects

Conditions: Type 2 Diabetes Mellitus

Summary: to characterize the steady-state pharmacokinetics (pk) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects


Eligibility criteria:
inclusion criteria: * men and women ages 18 to 45 inclusive * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ecgs, and clinical laboratory determinations * body mass index (bmi) of 18 to 32 kg/m², inclusive. bmi = weight (kg)/ \[height (m)\]² exclusion criteria: * wocbp who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product * any significant acute or chronic medical illness * current or recent (within 3 months) gastrointestinal disease * any major surgery within 4 weeks of study drug administration * history of allergy to dpp4 inhibitor or related compounds * prior exposure to saxagliptin