Kornimate/medical-research-clean huggingface dataset:
ranibizumab short- and log-term effects on retinal function in wamd

Conditions: Age-Related Macular Degeneration; Retinal Function

Summary: multifocal-electroretinoram (erg) and microperimetry are objective criteria to asses retinal function. no information besides visual acuity exist for the development of retinal function during the course of wet amd during therapy with lucentis. the aim of our study is to evaluate the value of multifocal-erg and microperimetry as an sensitive tool and early predictor of recurrence of the disease. the second goal will be to evaluate the neuroprotective effects of an adequate therapy on retinal function using microperimetry and multifocal-erg during the course of wet amd.


Eligibility criteria:
inclusion criteria: 1. male and female patients above 50 years of age 2. wet age-related macular degeneration (amd) 3. an available follow-up of 12 months 4. written informed consent 5. visual acuity of 0.1 or better exclusion criteria: systemic conditions or treatments 1. history or evidence of severe cardiac disease (e.g., nyha functional class iii or iv) 2. clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within the last 6 months 3. ventricular tachyarrythmias requiring ongoing treatment 4. history or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation 5. clinically significant impaired renal or hepatic function 6. stroke within 12 month before trial entry. 7. known serious allergies to the fluorescein dye use in angiography 8. known contraindications to the components of lucentis® formulation. ocular concomitant conditions/ diseases 1. active intraocular inflammation (grade trace or above) in either eye 2. any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye 3. history of uveitis in either eye 4. treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate,bevacizumab, etc.) or intravitreal corticosteroids in either eye within 3 months prior to inclusion 5. angle block glaucoma 6. phthisis 7. intraocular pressure \<10mmhg 8. macular or retinal dystrophies compliance/ administrative 1. previous participation in any clinical studies of investigational drugs (excluding vitamins and minerals) within 1 month (or a period corresponding to 5 half-lives of the investigational drug, whatever is longer) prior to inclusion. 2. patients will be excluded who were younger than 50 years according of the definition of age-related amd. 3. women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. 4. pregnant or nursing (lactating) women 5. inability to comply with study or follow-up procedures. 6. any treatment with an investigational agent in the past 3 months any condition.

Keywords: age-related macular degeneration retinal function multifocal-erg electroretinography microperimetry lucentis ranibizumab longterm effects best corrected visual acuity bcva
oxaliplatin in combination with capecitabine and concurrent radiation therapy in non-small cell lung cancer

Conditions: Carcinoma, Non-Small Cell Lung

Summary: the purpose of this study is to determine the most suitable dose of oxaliplatin that can be safely given in combination with a low fixed dose of capecitabine and a limited volume of radiation in patients with non-small cell lung cancer.

the purpose of this study is to determine the maximum tolerated dose (mtd) and the dose limiting toxicity (dlt) of oxaliplatin in combination with capecitabine and radiation in subjects with non-small cell lung cancer.

Eligibility criteria:
inclusion criteria: * histologically proven non-small cell lung cancer * inoperable stage iii a or b nsclc * must have measurable disease by recist criteria * no more than one prior chemotherapy for advanced disease * ecog performance status of 0, 1, or 2 * must be able to swallow pills or have a working gastric feeding tube and no evidence of malabsorption * negative serum beta-hcg test and under active contraception (for females of childbearing potential) * no known allergies to any of the study drugs * willingness to sign an informed consent exclusion criteria: * women who are pregnant or breastfeeding * anc of less than 1500/mm3 * platelet count of less than 100,000/mm3 * estimated creatinine clearance of less than 50 cc/min (as measured by the cockcroft-gault equation) * bilirubin of less than 2mg/dl * sgpt of greater than 2x nl * peripheral neuropathy of grade 2 or higher * more than one previous chemotherapy and previous radiation therapy to the chest * a history of chf/mi or other significant cardiac history within the last six months

Keywords: non-small cell lung cancer oxaliplatin capecitabine xelox-rt
blood sugars in children with idiopathic seizures.

Conditions: Seizures; Hypoglycemia; Hyperammonemia

Summary: the purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar).

convulsive disorders are among the most frequently occurring neurologic conditions in children. idiopathic seizures are the most common (67.6%) type of seizure seen in the 0-15 year age group. the highest incidence is in the first year of life. in the united states, 5 percent of individuals experience a seizure of some type by the age of 20. seizures have multiple etiologies. these include hypoglycemia, congenital causes, toxic/metabolic causes, infection, neoplasm, perinatal causes, and trauma. the medical evaluation often includes blood work, imaging of the brain, and performing an electroencephalogram. currently, there is no consensus as to the work-up of children presenting with unprovoked seizures. hypoglycemia presents with a wide spectrum of symptoms and severity. in children, hypoglycemia can lead to seizures and coma. in neonates and infants, however, the symptoms are even more varied and nonspecific. they can include cyanotic spells, apnea, respiratory distress, refusal to feed, and myoclonic jerks. the varied symptoms of hypoglycemia make the disorder difficult to diagnose. the study will have parents checking blood sugars for 14 days and a one time ammonia level. blood sugar checks will be first thing in the morning and one hour after a meal. if the study identifies a subset of patients with idiopathic seizures who have hypoglycemia, this finding may have implications for future glucose screening recommendations.

Eligibility criteria:
inclusion criteria: * the inclusion criteria will be patients with idiopathic seizure disorders. * the age range will be from birth to 17 years of age. * study subjects may be on anti-convulsants; the study does not alter current drug therapy. exclusion criteria: * the exclusion criteria includes patients with known causes of seizure disorders, including those with an underlying risk factor predisposing them to seizures. the risk factors are: 1. congenital causes (cns malformation, cerebral palsy) 2. cns infection toxic/known metabolic abnormality 3. cns neoplasm perinatal insults (birth trauma, asphyxia/hypoxia), 4. traumatic 5. all others who have an anatomic or known biochemical lesion.

Keywords: idiopathic seizure hypoglycemia hyperammonemia/hyperinsulinism syndrome
an open-label study of the safety, tolerability, and pharmacokinetics of oral nnz-2591 in angelman syndrome

Conditions: Angelman Syndrome

Summary: a study of the safety, tolerability and pharmacokinetics of nnz-2591 and measures of efficacy in children and adolescents with angelman syndrome

the primary purpose of this study is to investigate the safety, tolerability and pharmacokinetics of treatment with nnz-2591 oral solution, 50mg/l, in children and adolescents with angelman syndrome. the secondary purpose is to investigate measures of efficacy of subjects will receive treatment of 50mg/ml orally administered nnz-2591 for a total of 13 weeks

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of as with a documented disease-causing genetic etiology known to impact maternally derived ube3a expression in brain. 2. males or females aged 3-17 years 3. body weight of \>12kg 4. subjects with a clinical global impression - severity (cgi-s) score of 3 or greater 5. not actively undergoing regression or loss of skills, defined as no persistent loss of previously acquired developmental skills for a period within 3 months of the screening visit 6. each subject must be able to swallow the study medication provided as a liquid solution. 7. caregiver(s) must have sufficient english language skills. exclusion criteria: 1. mosaicism for disease-causing mutation. 2. clinically significant abnormalities in safety laboratory testing or vital signs at screening 3. abnormal qtcf interval or prolongation at screening. 4. positive for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) and previous covid 19 infection with last 12 months that required hospitalization. 5. unstable or changes to psychotropic treatment 2 weeks prior to screening . 6. excluded concomitant treatments 7. actively undergoing regression or loss of skills. 8. unstable seizure profile. 9. current clinically significant renal conditions and abnormalities 10. current clinically significant cardiovascular, hepatic, gastrointestinal, respiratory, endocrine disease, or clinically significant organ impairment. 11. current clinically significant hypo or hyperthyroidism, type 1 or type 2 diabetes mellitus requiring insulin (whether well controlled or uncontrolled), or uncontrolled type 1 or type 2 diabetes. 12. has planned surgery during the study. 13. history of, or current, cerebrovascular disease or brain trauma. 14. history of, or current catatonia or catatonia-like symptoms. 15. history of, or current, malignancy. 16. current major or persistent depressive disorder (including bipolar depression). 17. significant, uncorrected visual or uncorrected hearing impairment. 18. allergy to strawberry. 19. positive pregnancy test 20. subject is judged by the investigator or medical monitor to be inappropriate for the study

Keywords: angelman syndrome
the role of glp-1 receptor signalling in the glucose-lowering effect of metformin in patients with t2d

Conditions: Glucose Metabolism Disorders

Summary: delineation of the role of glucagon-like peptide-1 receptor signalling in the glucose-lowering effect of metformin during meal ingestion in patients with type 2 diabetes.

aim: to evaluate the contribution of metformin-induced glp-1 secretion on the glucose-lowering effect of metformin in patients with type 2 diabetes treated with metformin for 14 days. furthermore, the investigators aim to elucidate the mechanisms by which metformin-induced glp-1 secretion may affect glucose levels in patients with type 2 diabetes. fifteen patients with type 2 diabetes treated with lifestyle intervention and/or metformin as the only glucose-lowering drug will be enrolled in the study. the effect of a 14-day metformin treatment course on postprandial glucose tolerance will be examined with and without infusion of the glp-1 receptor antagonist exendin9-39 in 15 patients with type 2 diabetes. the double-blinded, placebo-controlled, randomised, cross-over study consists of four study days with concomitant infusions of a) placebo + placebo, b) placebo + exendin9-39, c) metformin + placebo and d) metformin + exendin9-39.

Eligibility criteria:
inclusion criteria: * type 2 diabetes for at least three months (diagnosed according to the criteria of the world health organization (who)), with a hba1c \<58 mmol/mol. * caucasian ethnicity * lifestyle intervention and/or metformin monotherapy * normal haemoglobin * age \>18 years * bmi \>23 kg/m2 and \<35 kg/m2 * informed and written consent exclusion criteria: * liver disease * gastrointestinal disease, previous intestinal resection, cholecystectomy or any major intra-abdominal surgery * hypo- or hyperphosphataemia * reduced kidney function or nephropathy * treatment with medicine that cannot be paused for 12 hours * intake of antibiotics two months prior to study * hypo- or hypercalcaemia * hypo- and hyperthyroidism * treatment with oral anticoagulants * active or recent malignant disease * any treatment or condition requiring acute or sub-acute medical or surgical intervention * lack of effective birth control in premenopausal women * positive pregnancy test on study days in premenopausal women * pregnancy * women who are breastfeeding * any condition considered incompatible with participation by the investigators * if the subjects receive any antibiotic treatment while included in the study they will be excluded

Keywords: glp-1 glucagon-like peptide-1 metformin exendin(9-39)
nb-uvb phototherapy with and without topical lcd treatment: a bilateral pilot study

Conditions: Plaque Psoriasis

Summary: the purpose of this study is to determine if combining a daily at-home regimen using an lcd solution with a 3 times weekly outpatient narrowband uvb phototherapy regimen could be a safe, effective, rapid, and, convenient treatment for plaque psoriasis.

use of coal tar with narrowband (nb) ultraviolet b (uvb) light (the goeckermen regimen) is an effective treatment for plaque psoriasis that has become impractical in outpatient care mainly due to the inconvenience and aesthetic concerns of coal tar. this study aims to evaluate the safety, efficacy, and convenience of adding a novel liquor carbonis distillate (lcd) (coal tar) solution to standard nb_uvb phototherapy in adults with chronic plaque psoriasis. patients will apply lcd solution to half the body, twice daily at home and receive outpatient full-body nb-uvb light therapy 3 times a week for up to 12 weeks. a blinded investigator will grade psoriasis severity of body halves and bilateral target lesions and monitor adverse reactions. patients will rate their psoriasis symptoms and lcd solution aesthetics. incorporating an at-home regimen with a novel lcd solution into outpatient nb-uvb light therapy is safe, convenient, and effective and can improve psoriasis more quickly than nb-uvb light therapy alone.

Eligibility criteria:
inclusion criteria: * 18 years old or older * able and willing to provide written informed consent * symmetrical plaque psoriasis * able and willing to attend phototherapy sessions and apply lcd at home * negative pregnancy test for women of child-bearing potential exclusion criteria: * current or recent other treatments for psoriasis * hypersensitivity to lcd or uvb light * current or previous skin cancer * pregnant or nursing mother * participating in another clinical trial

Keywords: psoriasis
efficacy and safety of continuous subcutaneous insulin infusion of faster-acting insulin aspart compared to novorapid® in adults with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe and the united states of america (usa). the aim of this trial is to investigate efficacy and safety of continuous subcutaneous insulin infusion of faster-acting insulin aspart compared to novorapid® in adults with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * male or female, age at least 18 years at the time of signing the informed consent * diagnosed with t1dm (type 1 diabetes mellitus) (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) equal or above 1 year prior to the day of screening * using the same medtronic pump (minimed 530g (551/751), paradigm veo (554/754), paradigm revel (523/723), paradigm (522/722)) for csii in a basal-bolus regimen with a rapid acting insulin analogue for at least six months prior to screening and willing to stay on the same pump model throughout the trial (if the model is changed the change should not exceed 7 consecutive days.) * hba1c (glycosylated haemoglobin) 7.0-9.0% (53-75 mmol/mol) as assessed by central laboratory at screening * body mass index (bmi) below or equal to 35.0 kg/m\^2 at screening * ability and willingness to take at least 3 daily meal-time insulin bolus infusions every day throughout the trial exclusion criteria: * any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening * planned coronary, carotid or peripheral artery revascularisation known on the day of screening * history of hospitalization for ketoacidosis below or equal to 180 days prior to the day of screening * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening * any condition which, in the opinion of the investigator, might jeopardise a subject's safety or compliance with the protocol
the impact of pecs blocks on postmastectomy pain syndrome

Conditions: Pain Syndrome; Pain, Postoperative; Chronic Pain; Breast Cancer; Breast Soft Tissue Neoplasm; Breast Neoplasms; Breast Cancer Female; Breast Pain; Anesthesia

Summary: the aim of the present study is to investigate the incidence of chronic pain following breast cancer surgery in cyprus, discover its associated risk factors and explore the impact of pecs blocks on the appearance of post mastectomy chronic pain symptoms

breast cancer is the commonest type of malignancy in women. chronic postoperative neuropathic pain may appear either in the early postoperative period or at a later stage, usually 3-6 months post-operatively. chronic post-operative pain syndrome of any magnitude usually involves 19-57% of patients that have undergone any kind of surgical procedure, while 5% of them experience intense symptoms. risk factors for developing post-mastectomy pain syndrome include younger age, increased body mass index (bmi), psychological profile, co-existence of other painful conditions, pre-operative radiotherapy/chemotherapy, type of surgical procedure and anaesthesia, persistent acute postoperative pain, etc. consequently, chronic post mastectomy pain syndrome results in significant psychosomatic sequelae with variable social impacts for the female patients. the aim of the present study will be to investigate the incidence of chronic pain following breast cancer surgery in cyprus, discover its associated risk factors and explore the impact of pecs blocks on the appearance of post mastectomy chronic pain symptoms. during the preoperative visit, the women will be informed about the study and will be instructed to the use of the pain numeric rating scale (nrs) graded from 0 to 10. standardized anesthesia will be administered. all patients will receive 1000 mg of paracetamol and 0.07 mg/ kg of morphine intraoperatively. in the post-anesthesia care unit (pacu), patients will receive additional morphine boluses on request, until nrs score is lesser or equal than 4. postoperative nausea and vomiting will be treated with ondansetron 4 mg iv. after discharge from pacu, patients will receive a combination of paracetamol 1 gr/6h and im pethidine 75 mg on request, as per hospital protocol. numerical rating scores (nrs) at rest and movement will be measured at 6h, 12h and 24h postoperatively. additionally, the time to first request for analgesia after surgery will be noted. all patients will also be evaluated 3 and 6 months after surgery with the use of nrs at rest and movement and additionally, via the use of douleur neuropathique (dn4) questionnaire for the occurence of neuropathic pain.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i-iii patients * breast cancer patients * patients who receive operative treatment exclusion criteria: * inability to consent to the study due to language barriers or cognitive dysfunction - * skin infection at the puncture site * contraindication to paracetamol administration * known previous hepatic or renal impairment as assessed by the patients' history and routine biochemical markers
changes of left ventricular mass and cardiac function in patients with active acromegaly during treatment with the growth hormone receptor antagonist pegvisomant

Conditions: Acromegaly; Heart Failure; Hypertrophy, Left Ventricular

Summary: the purpose of this study is to evaluate changes in left ventricular mass and cardiac function in patients with active acromegaly before and after treatment with the growth hormone receptor antagonist pegvisomant for one year.


Eligibility criteria:
inclusion criteria: * active acromegaly in adult subjects (≥ 18 years) after surgery and/or radiation therapy with elevated igf-1 levels despite treatment with somatostatin analogues or dopamine agonists * pegvisomant therapy is indicated (i. e. patients who have had an inadequate response to surgery and/or radiation therapy and/or other medical therapy, or for whom these therapies are not appropriate) * evidence of left ventricular hypertrophy (infero-lateral wall thickness ≥ 12 mm assessed by echocardiography) or * evidence of impaired diastolic function (≥ stage 2 as assessed by echocardiography) or * evidence of systolic dysfunction (ejection fraction \< 50% assessed by echocardiography) * stable medication for arterial hypertension and heart failure for 3 months * written informed consent. exclusion criteria: * pregnancy and lactation period * previous therapy with pegvisomant * suspected or known hypersensitivity to the drug or any of its components * contraindications for mri * history of malignancy during the last 5 years * suspected or known drug or alcohol abuse * patients who are neither able to self administer study medication on a daily basis nor have a caregiver who can administer study medication to the patient on a daily basis * any condition which in the opinion of the investigator makes the patient unsuitable for inclusion * participation in another clinical trial * pituitary adenoma with a distance to the optic chiasm of \< 3 mm * any other drug for treatment of acromegaly (e.g. dopamine agonists, somatostatin analogues) which would be necessary during the study or patients who apply for radiotherapy * instable heart insufficiency classified as nyha iv. * severe renal insufficiency, liver transplantation

Keywords: acromegaly heart failure hypertrophy cardiomegaly
follow up protocol to the phase i/ii study of opn-305 in second-line or third-line lower lower risk myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: this protocol is a follow-up for patients receiving continuation of opn-305 monotherapy treatment or combination treatment with azacitidine after completion of the dose confirming, dose expansion and hma naïve parts of the main study opn-305-106.


Eligibility criteria:
inclusion criteria: * completion of the opn-305-106 study * principal investigator adjudicated efficacy response defined as either transfusion independence", "stable disease", "minor hi-e response" or "major hi-e response" and in the opinion of the principal investigator the patient may benefit from continued treatment with opn-305 monotherapy or combination treatment with azacitidine. * provide written informed consent for the follow up protocol. exclusion criteria: * refusal to provide written informed consent * withdrawal from the opn-305-106 study prior to the final eot visit * plan to be included into another interventional investigational study. * progression of disease