Kornimate/medical-research-clean huggingface dataset:
touchscreen-based cognitive tests in healthy volunteers

Conditions: Cognitive Symptom; Schizophrenia

Summary: this phase ib study aims to evaluate applicability of touchscreen-based cognitive test battery for assessment of ketamine-induced schizophrenia-like cognitive deficits in healthy volunteers. additionally, the study aims to assess whether ketamine-induced cognitive deficits are reversed by modafinil using touchscreen-based test battery for testing of cognition.

ketamine-induced schizophrenia-like cognitive deficits in healthy volunteers are measured by using touchscreen-based cognitive tests. in addition, the study aims to assess whether ketamine-induced cognitive deficits detected by touchscreen-based cognitive tests are reversed by modafinil.

Eligibility criteria:
inclusion criteria: * healthy caucasian men aged 20-40 years * body weight 50-100 kg * body mass index 19-26 kg/cm2 * normal physical examination including heart rate (hr; 50-90/min) blood pressure (bp; diastolic 65-90 and systolic 110-140) normal haematological and clinical chemistry variables normal ecg as judged by the investigator exclusion criteria: * visual disability or red-green color blindness * history of mental health disorders as determined by self-reported a) physician-determined diagnoses of mental health disorders, except for nicotine and caffeine dependence, or history of suicide attempt; b) medications for mental health disorders * history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, or neurological disorder * history of orthostatic syncope * history of head injury with sequelae * first-degree relative with a history of psychosis or epilepsy/seizure disorder or of a condition with risk of seizures * current regular medication * vaccination 2 weeks prior to study or during the study * known or suspected allergy/hypersensitivity to any drug * history of regular alcohol consumption * current substance dependence (excluding nicotine and caffeine). * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day * use of any medication or alcohol 24 hours before each study visit * education less than high school * clinically relevant symptoms of depression, anxiety or sleep disturbances * donation of blood within 1 month prior to study * participation in any study with an investigational product within 2 months prior to study * clinical signs of suicidal or violent behaviour or psychotic symptoms

Keywords: schizophrenia cognitive symptom healthy volunteer cognitive testing
perioperative parathormone measurement and sodium bicarbonate infusion test after total thyroidectomy

Conditions: Hypoparathyroidism

Summary: in the study will be included patients that have undergone total thyroidectomy and do not display obvious clinical or laboratory hypoparathyroidism. on the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. three months after the operation, if the study conditions are still met, the patient will undergo an additional parathyroid hormone (pth) measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again.

each patient will undergo a thorough preoperative examination for the presence of abnormalities in calcium, phosphate or magnesium metabolism as a consequence of a primary or a secondary disease. blood samples will be taken right before the beginning of the thyroidectomy, and 20 minutes after the end, to measure the pth levels and to evaluate the variation rate. on the third postoperative day and before the patient's exit from the hospital, the patient will undergo an intravenous infusion test with 35ml/m2 dilution of 8.4%(w/v) sodium bicarbonate in two minutes. blood samples will be collected from a different vein at 0, 3, 5, 10, 30 and 60 minutes after infusion to measure pth, calcium, phosphate and magnesium. three months after the operation, if the study conditions are still met, the patient will undergo an additional pth measurement and sodium bicarbonate infusion test and the parathyroid function will be evaluated again. in addition, the test will be performed on 50 healthy volunteers, in order to assess the response to the test of normal individuals.

Eligibility criteria:
inclusion criteria for the patient group 1. patient is over 18 years old 2. patient scheduled for total thyroidectomy 3. patient signs and dates a written informed consent form (icf) and indicates an understanding of the study procedures exclusion criteria the patient group: 1. primary hyperparathyroidism 2. primary hypoparathyroidism 3. diabetes mellitus 4. chronic renal failure 5. hypoalbuminemia 6. systematic diseases (e.g., infections, neoplasmas) 7. thyroid or parathyroid cancer 8. osteoporosis 9. drugs that influence calcium metabolism (vitamin d analogues, oral calcium supplements, biphosphonates, teriparatide, thiazide diuretics) 10. osteomalacia 11. neck irradiation inclusion criteria for the control group 1. participant is over 18 years old 2. participant signs and dates a written informed consent form (icf) and indicates an understanding of the study procedures exclusion criteria of the control group: 1. all the above mentioned, in addition to prior thyroid surgery.

Keywords: parathyroid thyroidectomy hypoparathyroidism parathyroid function after total thyroidectomy
study to evaluate efficacy, safety, tolerability, and pharmacodynamics of entospletinib in adults with relapsed or refractory hematologic malignancies

Conditions: Chronic Lymphocytic Leukemia; Mantle Cell Lymphoma; Diffuse Large B-cell Lymphoma; Non-FL Indolent Non-Hodgkin's Lymphoma; Follicular Lymphoma

Summary: the primary objective of the study is to evaluate efficacy of entospletinib in participants with relapsed or refractory hematologic malignancies. participants with the following relapsed or refractory hematologic malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic leukemia (cll), mantle cell lymphoma (mcl), diffuse large b-cell lymphoma (dlbcl), follicular lymphoma (fl), or non-fl indolent non-hodgkin lymphomas (inhl; including lymphoplasmacytoid lymphoma/ waldenström macroglobulinemia \[lpl/wm\], small lymphocytic lymphoma \[sll\], or marginal zone lymphoma \[mzl\]).


Eligibility criteria:
key inclusion criteria: * diagnosis of b-cell inhl, dlbcl, mcl, or cll as documented by medical records and with histology based on criteria established by the world health organization * for institutions that have phase 3 or phase 4 protocols studying idelalisib (zydelig®) ; individuals with malignancies being studied in these protocols must have failed screening in the respective idelalisib protocol * prior treatment for lymphoid malignancy requiring treatment for progressive disease * presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy * all acute toxic effects of any prior antitumor therapy resolved to grade ≤ 1 before the start of study drug * karnofsky performance status of ≥ 60 * life expectancy of at least 3 months key exclusion criteria: * known histological transformation from inhl or cll to an aggressive form of non-hodgkin lymphoma (ie, richter transformation) except if the cll participant is enrolling in the bcr previously treated cohort * known active central nervous system or leptomeningeal lymphoma * presence of known intermediate- or high-grade myelodysplastic syndrome * evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug * ongoing liver injury * ongoing or recent hepatic encephalopathy * ongoing drug-induced pneumonitis * ongoing inflammatory bowel disease * ongoing alcohol or drug addiction * pregnancy or breastfeeding * history of prior allogeneic bone marrow progenitor cell or solid organ transplantation * ongoing immunosuppressive therapy * concurrent participation in an investigational drug trial with therapeutic intent note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: syk inhibitor
assessment of effectiveness ex-press surgery modification

Conditions: Glaucoma, Open-Angle; Glaucoma Secondary; Glaucoma, Primary Open Angle

Summary: the purpose of the study is to compare the effectiveness and safety profile of express implantation versus partial deep sclerectomy combined with express implantation with simultaneously phacoemulsification.

mermoud et all (1) proposed a modification of the classical surgical technique: combined deep sclerectomy (ds) with express device implantation. the goal of this modification was to enhance hypotensive effect of well known procedure, and also to simplify non-penetrating surgery, which is a procedure with a long learning curve. mermoud's idea provides the possibility of avoiding complications related to dissection of the filtering bleb and gives hope for achieve of better results in comparison to the classical procedure. thanks to this, the surgical procedure could be performed earlier, even in the case of glaucoma with low intraocular pressure (iop), where vascular factors are largely responsible for the progression of neuropathy. to demonstrate the potential of both types of procedures with the application of the express implant, the authors decided to conduct a prospective, randomized study with a 2-year observation period concerning the efficacy, safety and stability of effects achieved.

Eligibility criteria:
inclusion criteria: * co-existing glaucoma and cataract (nc1, nc2) classified by means of the locs iii scale * patients with primary open-angle glaucoma (poag), pseudoexfoliative glaucoma (pgx) and normal tension glaucoma (ntg), in which a satisfactory iop level was not achieved despite maximum tolerable hypotensive treatment, both topical and systemic, * documented progression of loss of field of vision, * significant daily iop fluctuations, * no cooperation from patient with regard to application of anti-glaucoma treatment, * allergy to topical medication * written consent to involvement and participation in the study for a period of at least 24 months exclusion criteria: * no consent to participation in the study * prior surgical and laser procedures in the area of the eye * narrow- or closed-angle glaucoma * post-inflammatory or post-traumatic secondary glaucoma * chronic illness of the cornea or optic nerve * advanced macular degeneration * active inflammatory process * pregnancy * systemic steroid therapy
management of the infusion-associated reactions in rrms patients treated with lemtrada

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: primary objective: to assess the distribution of iars by severity grade when lemtrada is administered to rrms patients who will be medicated according to specified algorithm designed to manage infusion associated reactions.

the total duration of participation in the study per patient is approximately 13.5 months. after the end of the second course of lemtrada treatment, patients will be followed by their physician in a regular healthcare setting until 48 months safety monitoring period is completed.

Eligibility criteria:
inclusion criteria: * adult rrms patients who will be initiating treatment with lemtrada according to local approved label. * signed written informed consent. exclusion criteria: * previously treated with lemtrada. * contraindications to lemtrada according to the labeling in the country. * any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label. * currently participating in another investigational interventional study. * any technical/administrative reason that makes it impossible to enroll the patient in the study. * patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. * patient who has withdrawn consent before enrollment (starting from signed informed consent form). * despite screening of the patient, enrolment is stopped at the study level. * woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy. * pregnancy (defined as positive beta human chorionic gonadotropin (β-hcg) blood test), breast feeding. * known infection with latent tuberculosis or active tuberculosis. * known infection with hepatitis b, hepatitis c. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
approach study: quality of life and outcomes assessment in participants with chronic hepatitis c (chc) treated with pegylated interferon (peg-ifn) alfa-2a and ribavirin

Conditions: Hepatitis C, Chronic

Summary: this multi-center, observational study will examine the clinical use and outcomes of pegylated interferon (peg-ifn) alfa-2a and ribavirin combination (pegasys rbv) in participants with chronic hepatitis c (chc). study visits will be scheduled for baseline, 12, 24 and 48 weeks after baseline. an additional follow-up visit at week 72 will be required for participants with an hcv genotype other than 2 or 3. quality of life data will be collected at baseline, and at each follow-up visit.


Eligibility criteria:
inclusion criteria: * eligible for and scheduled to receive treatment with commercially available peg-ifn alfa-2a and ribavirin combination * serologic evidence of chronic hepatitis c (chc) infection * detectable serum hepatitis c virus - ribonucleic acid (hcv-rna) * negative urine or blood pregnancy test * fertile participants receiving treatment to use two forms of effective contraception during treatment and for 6 months after treatment end exclusion criteria: * women with ongoing pregnancy or who are breast feeding, or male partners of women who are pregnant * received any investigational drug less than or equal to (\</=) 6 weeks prior to enrollment * moderate hepatic failure \[child-pugh greater than or equal to (\>/=) b\] * co-infection with human immunodeficiency virus (hiv) or hepatitis b * autoimmune hepatitis * known hypersensitivity to alfa interferons, e. coli-derived products, polyethylene glycol, ribavirin and/or any ingredient in the formulation or component of peg-ifn alfa-2a or ribavirin
a phase i/ii study of the use of intensity modulated radiotherapy (imrt) in cancer of the thyroid, larynx and hypopharynx

Conditions: Locally Advanced Larynx, Hypopharyngeal Squamous Cell Cancers; Locally Advanced Thyroid Cancers

Summary: this study is a phase i/ii dose escalation trial designed to test the feasibility of delivering imrt to thyroid, larynx and hypopharynx cancer patients, and to assess the safety and possible improvement in outcome when the dose is increased. this protocol is in fact two studies running in parallel: thyroid cancer patients and larynx/ hypopharynx cancer patients. these two groups of patients are being treated differently and will be analysed separately. the primary objective of this phase i sequential cohort study was to determine the feasibility of delivering modest acceleration and dose-escalated imrt in locally advanced high-risk thyroid cancers. we report the incidence and prevalence of acute toxicities of 2 dose fractionation regimens. dl1: primary site 58.8 gy in 28 daily fractions and nodal levels 50 gy in 28 daily fractions dl2: primary 66.6 gy in 30 daily fractions and post operative nodal levels 60 gy in 30 daily fractions and elective nodal levels 54 gy in 30 daily fractions


Eligibility criteria:
inclusion criteria: 1. newly diagnosed histologically confirmed squamous cell or undifferentiated carcinoma of the head and neck. 2. newly diagnosed histologically confirmed papillary,follicular, undifferentiated or medullary carcinoma of the thyroid. 3. tumours arising from the oral larynx or hypopharynx requiring radical radiation of the primary tumour by parallel opposed lateral fields, and bilateral cervical lymph node irradiation. 4. high risk of radiation induced xerostomia with conventional radiotherapy due to the irradiation of the majority of both parotid glands (defined as estimated mean dose to both parotid glands greater than 26 gy using conventional radiotherapy technique). 5. radiotherapy either as primary therapy or post-operative (only for thyroid carcinoma). techniques to be detailed by each centre. neo-adjuvant and concomitant chemotherapy are permitted. 6. stage t1-4, n1-3, m0 disease 7. zubrod performance status 0-2 exclusion criteria: 1. previous radiotherapy to the head and neck region 2. previous malignancy except non-melanoma skin cancer 3. previous or concurrent illness which in the investigators opinion would interfere with either completion of therapy or follow-up 4. prophylactic use of amifostine or pilocarpine is not allowed 5. brachytherapy is not allowed as part of the treatment
study of alxn1830 administered subcutaneously in adults with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: this study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics (pd), immunogenicity, and efficacy of subcutaneous (sc) alxn1830 in adults with generalized myasthenia gravis (gmg).

participants have the option to enroll in an open-label extension (ole) period to receive alxn1830 up to 58 weeks (including follow-up period).

Eligibility criteria:
key inclusion criteria: * diagnosis of myasthenia gravis. * positive serologic test for anti-acetylcholine receptor antibodies. * myasthenia gravis foundation of america clinical classification class ii to iv at screening. * mg-adl profile must be ≥ 5. * participants receiving stable treatment with azathioprine; other immunosuppressive therapies. * total igg level at screening ≥ 600 milligrams/deciliter. key exclusion criteria: * history of thymectomy, thymomectomy, or any other thymic surgery within 12 months prior to screening. * any untreated thymic malignancy, carcinoma, or thymoma. * intravenous immunoglobulin within the 6 weeks, and/or use of plasmapheresis/plasma exchange prior to randomization (day 1). * use of rituximab within the 3 months (90 days) prior to screening. * participants who have received previous treatment with any biological agent or other anti-neonatal fragment crystallizable receptor therapy within 5 half-lives or 90 days after last dose (whichever is longer). * known medical or psychological condition(s) or risk factor that, in the opinion of the investigator, might interfere with the participant's full participation in the study, pose any additional risk for the participant, or confound the assessment of the participant or outcome of the study.

Keywords: generalized myasthenia gravis
revealing increased axonal loss in treated hiv patients

Conditions: HIV Seropositivity

Summary: hiv patients may suffer sooner from aging than average population, including brain aging. our hypothesis is that if brain dysfunctions are explained by a quicker loss of neurons in hiv patients, this loss could be detected earlier by a thinning down of retinal nerve fiber layer (rnfl), compared to non hiv patients of the same age.

the investigators aim to compare the thickness of the rnfl and the thickness of the rcgs measured by spectral domain oct between patients infected by hiv and patients of same age non infected by hiv.

Eligibility criteria:
inclusion criteria: * hiv infection known since at least 10 years * viral load undetectable under arv treatment since at least 5 years, whatever the type of arv * lymphocytes cd4 \> 350, whatever the cd4 nadir * signed informed consent exclusion criteria: * history of ocular pathology, eye surgery, or intraocular injection * familial history of glaucoma * ametropia (\>3 dioptres on the sphere and \>1,5 dioptres on the cylinder) * known neurological pathology, active or former * history of ethambutol or synthetic antimalarial drug consumption * history of chemotherapy * active and regular use of drugs * non-weaned chronic alcoholism * contra indication to mri * diabetes * cognitive disorders (moca\<26) * non covered by health insurance * patient under legal protection * pregnant or breast-feeding woman * non inclusion criteria for control patients: known hiv infection
study to evaluate dnl151 in subjects with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple oral doses of dnl151 in subjects with parkinson's disease.

this study was previously posted by denali therapeutics. in july, 2022, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) between 18 and 35.0 kg/m2, inclusive * clinical diagnosis of parkinson's disease meeting uk brain bank criteria and h\&y stage i, ii, or iii. * able to hold parkinson's disease medications 8 hours (overnight) prior to specific study assessments key exclusion criteria: * any history of clinically significant asthma, chronic obstructive pulmonary disease, or emphysema within 5 years of screening, or other clinically significant pulmonary disease within 6 months of screening * abnormal vitals including respiratory rate, body temperature, blood pressure, and pulse rate * pulmonary function tests (pfts) (fvc \<60% predicted, fev1 \<50% predicted, fev1:fvc ratio \<0.6, dlco \<70% predicted) * clinically significant neurologic disorder other than parkinson's disease, including history of stroke within 12 months of screening, cognitive impairment, seizure within 5 years of screening, or head trauma with loss of consciousness within 6 months of screening * montreal cognitive assessment (moca) score of \<24 at screening note: other protocol defined inclusion/exclusion criteria may apply

Keywords: lrrk2 movement disorders
long-term clinical follow-up of children enrolled in stannsoporfin clinical trial protocol no. 64,185-06-2(w)

Conditions: Hyperbilirubinemia

Summary: the purpose of this protocol is to provide a mechanism to collect long term clinical data from those babies who participated in the primary study 64,185-06-2(w)(ws)(isnhp) "an open-label study of the safety and clinical pharmacology of stanate® in infants at-risk for exchange transfusion".

the purpose of this protocol is to provide a mechanism to collect clinical data from those babies who participated in the primary study 64,185-06-2(w)(ws)(isnhp) "an open-label study of the safety and clinical pharmacology of stanate® in infants at-risk for exchange transfusion". data on long-term impact of stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after stannsoporfin administration

Eligibility criteria:
inclusion criteria: * all children who have been enrolled and received stanate® injection/placebo in study protocol 64,185-06-2(w)(ws)(isnhp) are eligible for this follow-up. exclusion criteria: -
a study of mircera for the intrapetient variability of hemoglobin levels in patients with chronic renal anemia (rival)

Conditions: Anemia

Summary: this retrospective observational study will assess the incidence of hemoglobin cycling in chronic kidney disease (stage 3, 4, and 5) patients with renal anemia treated with mircera (methoxy polyethylene glycol-epoetin beta). data will be collected from each patient from a 9-month treatment period.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * chronic kidney disease in predialysis (stage 3 and 4) and dialysis * renal anemia treated with mircera according to label for at least 9 months before date of signed informed consent exclusion criteria: * participation in an interventional clinical trial within the retrospective observation period * contraindications to mircera administration as per label or judged by the investigator