Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of specific immunotherapy with clustoid grass pollen

Conditions: Allergic Rhinitis

Summary: the objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.


Eligibility criteria:
inclusion criteria: * positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen * positive screening skin prick test (wheal diameter \> 3 mm) * compliance and ability of the patient to complete a diary card for self-evaluating of the symptoms and antisymptomatic medication * signed and dated patient´s informed consent, exclusion criteria: * previous immunotherapy with grass and/or rye pollen extracts within the last 3 years, * simultaneous participation in other clinical trials, * other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), * auto-immune disorders, * severe chronic inflammatory diseases, * malignancy, * alcohol abuse, * existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, * patients being in any relationship or dependency with the sponsor and/or investigator, * treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.
pilot study of the contour neurovascular systemtm

Conditions: Intracranial Aneurysm

Summary: prospective, single arm, multi centre study to evaluate the safety and performance of the contour neurovascular systemtm in the treatment of intracranial aneurysm (ia)

prospective, single-arm, multi-centre european study to evaluate the safety and performance of the contour neurovascular systemtm in the treatment of intracranial aneurysm (ia). target aneurysms are unruptured aneurysms requiring endovascular treatment in the anterior and posterior cerebral circulation.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years at screening 2. unruptured saccular ia in the anterior or posterior circulation with dimensions consistent with table 2 3. ia appears suitable for contour neurovascular systemtm device patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements patient able to understand and sign a study-specific informed consent form exclusion criteria: 1. ruptured ia 2. any other ia that requires treatment in the next year 3. ia width \>8.5 or \<2 mm 4. ia neck \>8 or \<2 mm 5. ia minimum height \<4mm 6. ia embolisation would most likely cause stroke 7. target ia contains other devices/implants (e.g., coils) 8. inability to access the target ia with the microcatheter 9. any congenital or iatrogenic coagulopathy 10. platelet count \<50,000/microliter 11. known allergy to platinum, nickel or titanium 12. known allergy to contrast agents 13. stenosis of the target ia's parent vessel \>50% 14. taking daily aspirin or other platelet inhibitor (clopidogrel or equivalent) other than for the target aneurysm 15. taking any anticoagulants (e.g., warfarin) 16. abnormal clotting parameters 17. pregnant, breastfeeding or planning pregnancy in the next 2 years 18. other medical conditions that could increase the risk of neurovascular procedures (e.g., liver failure, cancer, etc.) or ability to comply with study requirements participating in another study with investigational devices or drugs

Keywords: brain intracranial aneurysm treatment endovascular treatment brain aneurysm neurovascular diseases aneurysms cerebrovascular disorders central nervous system diseases vascular diseases
observation of the natural course of age-related macular degeneration

Conditions: Dry Age-related Macular Degeneration; Macular Degeneration, Dry

Summary: this research will study natural course of dry amd in chinese population, screen fundus imaging indicators for patients with chinese dry amd, describe the clinical features of chinese patients with dry amd, and obtain a biological sample library of dry amd mainly in china.


Eligibility criteria:
inclusion criteria: * 50-85 yrs male or female amd patients * dry-amd patients in either early, intermediate, or intermediate-to-late stage confirmed by fundus examinations. exclusion criteria: * any eye with disease that would interfere with the retinal examinations * research eye with cnv or high myopia * surgeries that may interfere with amd evaluation * long-term uses of medications that are associated with retinal or neural toxicities. * iop more than 26 mmhg * received cataract surgery in 3 months. * other conditions: diseases that causes less than 5 years survival; any condition that causes high risk of drop-out, or low compliance, for instance cognition disorder; have been involved in other trial that interfere with the current visit plan; taking other angiogenesis inhibitors drugs for treating cancer. * other conditions not suitable for the current study
daily use of jardiance® tablets in japanese elderly patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: study to investigate the safety and efficacy of daily use of jardiance® tablets in japanese elderly patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: male and female elderly patients (age 65 and over) with type 2 diabetes mellitus who have never been treated with jardiance® tablets before the enrolment and start taking jardiance® tablets within 3 months after launch in japan exclusion criteria: none
phase i, open-label, dose-escalation, safety and pk study of azd6918

Conditions: Cancer,; Solid Tumors; Advanced Solid Malignancies

Summary: the primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called azd6918 based on the side effects experienced by patients with advanced solid malignancies that receive daily azd6918 alone. it is possible that azd6918 will be administered twice daily. then maximum tolerated doses in combination with either gemcitabine or pemetrexed will also be investigated.


Eligibility criteria:
inclusion criteria: * advanced solid tumors for which standard treatment does not exist or is no longer effective. * for chemotherapy combination treatment, must be suitable for treatment with either gemcitabine or pemetrexed. * relatively good overall health other than cancer. exclusion criteria: * poor bone marrow function (not producing enough blood cells). * poor liver or kidney function. * serious heart conditions * history of uncontrolled epilepsy, parkinson's disease, alzheimer's disease, brain tumor or any uncontrolled psychiatric or nervous system condition

Keywords: phase i, cancer, solid tumors, advanced solid malignancies, dose escalation, combination treatment, trk inhibitor
young adult cardiovascular health study

Conditions: Preterm Birth; Hypertension

Summary: the purpose of this study is to understand more about why young people who were born prematurely may have increased risk of high blood pressure and lower cardiovascular exercise capacity.

young adults with a history of preterm birth are identified as having a unique risk profile for developing hypertension and having reduced exercise capacity. globally, there are 15 million annual preterm births. in europe, incidence is 6-15% of all births, with up to 6 million adults in the united kingdom having a preterm birth history. understanding the associations between early life exposures and this early cardiovascular risk is extremely important to be able to target primary prevention strategies. as yet there are no clear explanations for the reduced exercise capacity and elevated risk of hypertension reported in preterm born young adults. magnetic resonance imaging studies of young adult born premature demonstrated altered heart shape, with increased left ventricular mass, reduced cavity sizes and reduced stroke volumes. the changes in cardiac size identified from these studies is similar to those seen in other disease groups and has been equated to greater than 50% increased risk of cardiovascular clinical events in these groups. these structural changes may account for the reduced exercise capacity observed in preterm born young adults this study aims to understand the physiological determinants of limited exercise capacity and associated cardiovascular risk profile of adult preterm born populations.

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 18 to 40 years. * history of preterm birth, diagnosis of hypertension or full term birth normotensive control * able (in the investigator's opinion) and willing to comply with all study requirements. * participant is freely able to access john radcliffe hospital for study visits exclusion criteria: * aged \ 40 years * unwilling or unable to give informed consent for participation in the study. * pregnant or lactating during the course of the study. * planning to donate blood during the study duration. * any significant disease or disorder which, in the opinion of the investigator, might influence the participant's ability to participate in the study. * contraindication to magnetic resonance imaging

Keywords: preterm birth hypertension exercise capacity cardiovascular risk
perioperative heart rate variability analysis in realtime

Conditions: Individuality; Perioperative/Postoperative Complications; Heart Rate and Rhythm Disorders; Surgical Complications From General Anesthesia

Summary: this study will record patient electrocardiograms - as well as various other body signals (e.g., blood pressure, pulse wave, peripheral hemoglobin oxygen saturation) - as monitored routinely both during and immediately subsequent to surgical operations performed under general anesthesia. through retrospective analysis of patients' heart rate variability (hrv), in concert with the other abovementioned parameters, the investigators seek to forward the development of novel mathematical models and tools for on-line detection of cardiovascular and autonomic dysfunction in the perioperative setting.


Eligibility criteria:
inclusion criteria: * patients undergoing non-cardiac surgery under general anesthesia * patients aged 18-80 years * patients who are capable of giving informed consent exclusion criteria: * patients \ 80 years of age * patients with an active cardiac pace maker * patients with an absent sinus rhythm in ecg * patients presenting with a preexisting arrhythmia * patients requiring postoperative icu therapy * patients with pheochromocytoma

Keywords: heart rate variability electrocardiography observational study non-interventional study risk assessment perioperative
a phaseⅰstudy of ono-7475 in combination with ono-4538 and gemcitabine plus nab-paclitaxel (gnp), the standard of care, and ono-7475 in combination with gnp in patients with pancreatic cancer

Conditions: Metastatic Pancreatic Cancer

Summary: this study is phaseⅰstudy to examine tolerability and safety of ono-7475 in combination with ono-4538 and gemcitabine plus nab-paclitaxel (gnp), the standard of care, and safety of ono-7475 in combination with gnp in patients with metastatic pancreatic cancer as first-line treatment


Eligibility criteria:
inclusion criteria: 1. patient with metastatic pancreatic cancer 2. patients have an ecog performance status of 0 to 1 3. patients with a life expectancy of at least 6 months exclusion criteria: 1. patients are unable to swallow oral medications 2. patients with severe complication
autologous bone marrow stem cell therapy for autism

Conditions: Autistic Disorder

Summary: the aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism.

the aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in the management of autism of 24 patients at vinmec international hospital, hanoi, vietnam

Eligibility criteria:
inclusion criteria: - confirmed diagnosis of autism according to the diagnostic and statistical manual-iv (dsm-iv) diagnostic criteria for autistic disorder exclusion criteria: * epilepsy * hydrocephalus with ventricular drain * coagulation disorders * allergy to anesthetic agents * severe health conditions such as cancer, failure of heart, lung, liver or kidney * active infections * severe psychiatric disorders

Keywords: autism stem cells
analgesic efficacy of trans-muscular quadratus lumborum block after unilateral inguinal hernia repair

Conditions: Postoperative Pain; Ultrasound Guided Nerve Block

Summary: a significant component of pain experienced after abdominal surgery is related to incision of the abdominal wall and adequate analgesia can be a challenge. the ultrasound-guided (usg) quadratus lumborum block qlb was first described by rafael blanco in a presentation at esra 2007 at the xxvi annual esra congress in valencia, spain. blanco described a potential space posterior to the abdominal wall muscles and lateral to the quadratus lumborum muscle where local anesthetics can be injected. this technique provide analgesia after abdominal surgery due to spread of la from its lumbar deposition cranially into the thoracic paravertebral space where lateral and anterior cutaneous branches from th7 to l1 can be blocked . this was proved by carney et al. who found traces of contrast agent in the tpvs following application of this block a novel usg ql block is the transmuscular approach which relies on clearly identifiable sonographic bony landmarks, where the needle is advanced through the ql muscle, penetrating the ventral proper fascia of the ql muscle and la is finally injected between the ql and psoas major (pm) muscle. the transmuscular ql block does not result in redundant antero-lateral spread of the injectate. this may indicate that lower volumes of la potentially can be used and yet provide extensive thoracolumbar anesthesia. this study was designed to compare the duration of analgesia provided by the original qlb and transmuscular qlb in patients undergoing surgical repair of unilateral inguinal hernia.


Eligibility criteria:
inclusion criteria: * asa physical status i or ii, scheduled for unilateral inguinal hernia repair exclusion criteria: * patients with systemic hypertension, cardiovascular disease, cerebrovascular insufficiency, coagulation abnormities, renal or hepatic insufficiency, infection at the injection site, strangulated hernia and hypersensitivity to the local anesthetics
simvastatin metabolism as a test for cd activity (irb 15-007568]

Conditions: Celiac Disease

Summary: to study the correlation between simvastatin metabolism by the enterocyte and the histologic state of the intestine in treated celiac disease.

a cross sectional design incorporating subjects with active celiac disease and healed celiac disease (based on clinically-obtained biopsies); and healthy individuals.

Eligibility criteria:
inclusion criteria: 1. gluten-free diet for at least 1 year 2. clinical endoscopy within the past month 3. biopsies must show no villous atrophy or villous blunting 4. villous height to crypt depth (vhcd) ratio measurement should be 2.5:1 or greater exclusion criteria: 1. 1st degree relative with celiac disease 2. positive ttg iga, already on simvastatin or statin agent 3. unable to stop non-steroidal or anti-inflammatory drugs 4. prior history of gi surgery other than appendectomy or cholecystectomy 5. taking drugs know to inhibit or activate cyp3a4 6. unable to avoid food known to inhibit cyp3a4 7. history of a reaction to statin drugs in the past 8. pregnant or nursing women
a study of dpp-iv inhibitor in patients with type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: this study will assess the efficacy, safety and tolerability of dpp-iv inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. the anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients 18-75 years of age; * type 2 diabetes; * stable metformin therapy for \>=3 months before screening. exclusion criteria: * women who are pregnant, breast-feeding, or not using an adequate contraceptive method; * type 1 diabetes; * any anti-hyperglycemic medication other than metformin in the last 3 months.
quality of life change in patients undergoing parathyroidectomy with end-stage renal failure

Conditions: Secondary Hyperparathyroidism; End Stage Renal Failure

Summary: the purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure.

study participants will be asked questions about age, gender, education level, clinical symptoms, intensities of depression and anxiety, etc, and they will also be questioned regarding the prior quality of life score, as measured by the health-related quality of life 36-item short-form (sf-36) survey before surgery. then, study participants will be contacted at one, three, six months, and 1 year after surgery, and asked questions about their sf-36 score, depression, and anxiety intensity.

Eligibility criteria:
inclusion criteria: * age: ≥18 years old; * patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure exclusion criteria: • patients refuse to participate
novel single wave assessment in measuring cardiac dysfunction and metabolic syndrome in patients with cancer

Conditions: Malignant Neoplasm

Summary: this clinical trial studies a novel single wave assessment in measuring cardiac dysfunction and metabolic syndrome in patients with cancer. the novel single wave assessment is a hand held device that can report left ventricular ejection fraction, which measures how well the heart is pumping blood (by giving a percentage) and measures how stiff the arteries are in the heart (pulse wave velocity). a novel single wave assessment may help identify patients at increased risk for type ii diabetes and metabolic syndrome (disease where patients have increased blood pressure and high blood sugar level and excess body fat around the waist and abnormal cholesterol levels).

primary objectives: i. to determine the relationship between insulin resistance (delta omega) as measured by the single wave application and inflammation markers associated with insulin resistance and metabolic syndrome (mets) in cancer patients, and to estimate the mean and standard deviation (sd) of delta omega in cancer patients with and without mets for designing future, larger studies. ii. to determine the degree of agreement between the single wave measure of left ventricular ejection fraction (lvef) in cancer patients and that measured by the routine 2-dimensional (2d) echocardiography (standard of care). outline: patients undergo placement of a single wave application near the carotid region of the neck.

Eligibility criteria:
inclusion criteria: * adult patients undergoing 2d echocardiogram at city of hope (coh) * patients with a current or past diagnosis of cancer * ability to sign a written informed consent exclusion criteria: * inability to provide informed consent * patients who have known "carotid sinus hypersensitivity" * patients who do not consent to blood draw * patients who have not fasted for the instructed time prior to blood draw
cross-education and mirror therapy for upper limb in post-stroke patients

Conditions: Stroke

Summary: this randomized controlled trial will investigate the potential synergistic effects of combining cross-education training with mirror therapy on strength and motor function in the more affected upper limb of post-stroke patients.


Eligibility criteria:
inclusion criteria: * post-stroke patients with upper limb motor impairments * aged 30 years to 60 years old * at least 3 months post-stroke * able to participate in the intervention exclusion criteria: * severe cognitive impairments * visual impairments * any contraindications to the intervention
epidyolex® in lennox gastaut, dravet syndrome and tuberous sclerosis complex: an observational study in italy

Conditions: Lennox Gastaut Syndrome; Dravet Syndrome; Tuberous Sclerosis Complex

Summary: this is a prospective, observational study on approximately 70-100 real world participants affected by lgs, ds, or tsc treated with epidyolex® as prescribed in the summary of product characteristics. the eligible participants are expected to participate in the study for a duration of 52 weeks of treatment.

this observational study evaluates a real-world population of children and adult participants affected by lgs, ds, and tsc and the effect of therapy with epidyolex® administered according to clinical practice on epileptic symptoms. the study will assess specific scales, questionnaires, and the satisfaction of the caregivers and the participants/tutors.

Eligibility criteria:
inclusion criteria: * adult patients, and minor patients ≥ 2 years old diagnosed with lgs, ds or tsc. * clinical decision, taken by the physician, to initiate epidyolex® * adult participants, parents or legal representatives must be willing and able to give informed consent/assent for participation in the study. exclusion criteria: * participants currently using or have used recreational, medicinal cannabis, or cannabinoid-based products within the three months prior to study entry and are unwilling to abstain from these products for the duration of the study. * any reason, according to investigator's judgment, able to compromise compliance with procedures outlined in the study there will not be any other specific exclusion criteria; however, contraindications, special warnings, and precautions for use as detailed in the summary of product characteristics (smpc) (particularly related to raising of aspartate aminotransferase \[ast\], alanine aminotransferase \[alt\], and total bilirubin) will have to be considered by the treating physician.

Keywords: seizures epidyolex cannabidiol oral solution
pharmacokinetic analysis of bupivacaine in the presence and absence of perineural dexamethasone in axillary blockade

Conditions: Analgesia; Acute Pain; Upper Extremity Injury

Summary: the investigators will conduct a prospective, randomized, double-blinded study using an axillary brachial plexus block in patients undergoing elective surgery of the distal forearm and hand to characterize and describe the pharmacokinetics of bupivacaine associated with perineural dexamethasone. the pharmacokinetic analysis will be performed by measuring bupivacaine plasma levels at different time intervals after the blockade (15, 30, 45, 60, and 90 minutes), allowing comparison between 2 different groups: bupivacaine (b) and bupivacaine-dexamethasone (bd). thus, the hypothesis is that plasma levels of bupivacaine during the first 90 minutes after a blockade are lower in the presence of perineural dexamethasone, suggesting a decrease, at least initially, in systemic absorption from the injection site.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists classification 1-2 * real weight between 80 and 100 kg * body mass index between 20 and 30 exclusion criteria: * adults who are not capable of giving their own consent * medical history or physical findings of pre-existing neuropathy * coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, international normalized ratio ≥ 1.4 or prothrombin time ≥ 50) * renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100) * hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100) * allergy to local anesthetics (las) * pregnancy * previous surgery in the axillary region of the surgical side

Keywords: dexamethasone nerve block adjuvant pharmacokinetic analysis