Kornimate/medical-research-clean huggingface dataset:
upar-pet/mri in glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: the purpose of this study is to investigate the applicability of urokinase plasminogen activator receptor (upar) positron emission tomography (pet) / mri molecular imaging of glioblastoma.

68ga-nota-ae105 is a radioligand targeting urokinase plasminogen activator receptor (upar), which is a promising imaging biomarker of tumor aggressiveness. 68ga-nota-ae105 pet/mri will be applied in patients suspected of glioblastoma multiforme. the uptake of the radioligand 68ga-nota-ae105 will be compared and correlated with expression of the molecular target: upar using immunohistochemistry of tumor tissue samples obtained during routine stereotactic biopsies or operation. in addition, the semiquantitative uptake (standard uptake values, suvs) of 68ga-nota-ae105 in tumor tissue will be correlated with overall survival and progression free survival

Eligibility criteria:
inclusion criteria: * patients where imaging with mri or ct is suspicious of having glioblastoma multiforme, and patients, and who is referred for stereotactic biopsy, chemotherapy or surgery * the participants must be capable of understanding and giving full informed written consent * age above 18 years exclusion criteria: * pregnancy * lactation/breast feeding * age above 85 years old * weight above 140 kg * known allergy towards 68ga-nota-ae105

Keywords: urokinase plasminogen activator receptor positron emission tomography glioblastoma multiforme
gastroesophageal reflux treatment in scleroderma

Conditions: Gastroesophageal Reflux Disease; Systemic Sclerosis; Scleroderma

Summary: the investigators purposes are to define the prevalence of omeprazole resistance gastroesophageal reflux disease (gerd) in systemic sclerosis (ssc), to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the severity of reflux symptoms in omeprazole resistant gerd in ssc, and to compare the efficacy of omeprazole in combination with algycon versus omeprazole in combination with domperidone on the frequency of symptoms in omeprazole- resistant gerd in ssc.


Eligibility criteria:
phase 1 ssc patients who fit all inclusion and exclusion criteria will be eligible to phase 1 study for evaluation the prevalence of omeprazole resistant-gerd inclusion criteria: 1. ssc patients aged between 18 and 65 years. 2. clinically diagnosed as gerd and gerd-questionnaire score \>3 3. must not receive any proton pump inhibitor (ppi) or prokinetic drug within 2 weeks before baseline evaluation exclusion criteria: 1. pregnancy or lactation 2. previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis 3. present of barrett's esophagus 4. bedridden and confined to no self-care 5. evidence of active malignant disease 6. present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases 7. present of active infection that needs systemic antibiotic 8. allergic history of omeprazole 9. receiving prohibit co-medications that may have drug interaction or attenuate gerd symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate phase 2 randomized parallel study ssc patients who fit all inclusion and exclusion criteria will be eligible to phase 2 study. inclusion criteria: 1. ssc patients who completed the phase 1 study. 2. the subjects were defined as ppi-resistance. 3. the subject must be willing to continue phase 2 study. exclusion criteria: 1. pregnancy 2. present of uncontrolled or severe medical problems 3. present of active infection 4. allergic history of alginic acid or domperidone 5. receiving prohibit co-medications that may have drug interaction or attenuate gerd symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate 6. chewing difficulty

Keywords: gastroesophageal reflux disease heart burn regurgitation systemic sclerosis scleroderma proton pump inhibitor alginic acid omeprazole prokinetic
a clinical trial evaluating tg4050 in head and neck cancer

Conditions: Squamous Cell Carcinoma of Head and Neck

Summary: this is a multicenter, open-label, two arms, randomized, phase i/ii study evaluating the safety and tolerability as well as some activity parameters of tg4050 in patients with squamous cell carcinoma of the head and neck (scchn).


Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. newly diagnosed stage iii or iv, amenable to surgery (ajcc 8th edition) squamous-cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx 3. female or male patients, aged at least 18 years 4. patients in complete response after treatment of their primary tumor. 5. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. 6. adequate hematological, hepatic and renal functions exclusion criteria: 1. patients with carcinoma of the nasopharynx, squamous cell-carcinoma of unknown primary, squamous cell carcinoma that originates from the skin and salivary gland or paranasal sinus, non-squamous histologies. 2. prior exposure to anti-cancer vaccines and any antibody targeting t-cell co-regulatory proteins such as anti-pd1, anti-pdl1 or anti-ctla4 antibodies. 3. other active malignancy requiring concurrent systemic intervention. 4. patients with previous malignancies other than the target malignancy to be investigated in this trial 5. known history of positive testing for human immunodeficiency virus (hiv) or known acquired immune deficiency syndrome (aids) 6. clinical or laboratory history or evidence of hepatitis c virus (hcv) or hepatitis b virus (hbv) indicating acute or chronic infection 7. pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test (\> 10 miu/ml) 8. treatment with another investigational agent since the beginning of the screening period 9. uncontrolled intercurrent illness
comparative study of specular microscopes for endothelial and corneal cell measurements

Conditions: Corneal Endothelial Cell Loss

Summary: the primary objective of this clinical study is to collect clinical data to support an fda 510(k) submission for the topcon specular microscope sp-1p. the secondary objective is to evaluate any adverse events found during the clinical study.


Eligibility criteria:
inclusion criteria -non-pathologic young adults (18-28 years old) and non-pathologic adults (29-80 years old): * male or female subjects from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed; * subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date; * subjects who agree to participate in the study. inclusion criteria -pathologic adults (29-80 years old) * male and female subjects from 29 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed; * subjects who can follow the instructions by the clinical staff at the clinical site, and can attend examinations on the scheduled examination date; * subjects who agree to participate in the study; * at least one eye with any of the following conditions: * history of post-op surgical trauma including pseudophakic or aphakic bullous keratopathy; * history of corneal transplant; * physical injury or trauma to the cornea; * long term fuch's dystrophy/guttata (and other corneal endothelial dystrophies) * keratoconus; * long term pmma contact lens use (greater than 3 years). exclusion criteria -non-pathologic young adults (18-28 years old) and non pathologic adults (29-80 years old) * history of corneal transplant; * long term fuch's dystrophy (and other corneal endothelial dystrophies); * keratoconus; * guttata; * diabetes mellitus type i or type ii; * history of cataract, refractive or ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device; * all contact lens wearers; * fixation problems which may prevent obtaining good quality sp-1p and cellchek plus in either eye. exclusion criteria -pathologic adults (29-80 years old): * fixation problems which may prevent obtaining at least poor quality (refer to figure 1) sp-1p and konan cellchek plus images in either eye.
long-term safety and efficacy follow-up of biib111 for the treatment of choroideremia and biib112 for the treatment of x-linked retinitis pigmentosa

Conditions: Choroideremia; X-Linked Retinitis Pigmentosa

Summary: the objective of the study is to evaluate the long-term safety and efficacy of a sub-retinal injection of biib111 in participants with choroideremia (chm) who have been previously treated with biib111 and who have exited an antecedent study; these treated participants will be compared with untreated control participants who have exited the star (nct03496012) study and biib112 in participants with x-linked retinitis pigmentosa (xlrp) who have been previously treated with biib112 and who have exited an antecedent study.

this study was previously posted by nightstarx ltd. in october 2020, sponsorship of the trial was transferred to biogen.

Eligibility criteria:
key inclusion criteria: chm participants a. have participated in and exited from an interventional study that investigated the safety and efficacy of a sub-retinal injection of biib111 for chm. xlrp participants a. have received a sub-retinal injection of biib112 for xlrp and have exited an antecedent study. key exclusion criteria: participants are not eligible for study participation if they meet the following exclusion criterion. a. in the opinion of the investigator and/or the sponsor, it is not in the participant's best interest to participate in the study. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: nightstarx biogen nsr-rep1 chm gene therapy aav rep1 aav8 rpgr
dynamic changes in some facial muscles after hyaluronic acid filler injection

Conditions: Changes in Facial Muscles Following Filler Injection

Summary: assess electrophysiological changes in some facial muscle dynamics following hyaluronic acid filler injection in superficial versus deep level of injection.

participants will be subjected to injection of cross-linked hyaluronic acid fillers on both sides of the face in 3 different regions: temples, cheeks and chins. each female will undergo: 1. before injection: 1. aesthetic facial clinical analysis. 2. baseline quantitative surface electromyography. 3. baseline digital photography. 2. injection: each female will receive the injection in the particular facial region at superficial level to the muscle (subcutaneous) on one side and the same amount at deep level to the muscle (supraperiosteal) on the other side. 3. one week after injection: 1. follow up quantitative surface electromyography. 2. follow up digital photography.

Eligibility criteria:
inclusion criteria: 1. age: 20-60 years. 2. sex: females. 3. areas eligible for injection: temples, cheeks and chin. exclusion criteria: 1. active infection near the site of injection. 2. pregnant or lactating women. 3. patients suffering from any neuromuscular disorders. 4. known allergy/hypersensitivity to hyaluronic acid fillers. 5. history of botulinum toxin injection in the last 4 months. 6. history of injection of fillers in the last 2 years. 7. patients receiving any muscle relaxants. 8. coagulation disorder or anticoagulants therapy.
a renal impairment study for pf-06651600

Conditions: Renal Impairment

Summary: this is a phase 1 non-randomized, open-label, parallel cohort study of pf-06651600 in subjects with severe renal impairment and subjects without renal impairment (part 1) and in subjects with mild and moderate renal impairment (part 2).

this is a phase 1 non-randomized, open-label, parallel cohort, multi-site study to investigate the effect of renal impairment on the pharmacokinetics, safety and tolerability of pf-06651600 after multiple oral doses of 50 mg daily. subjects will be selected and categorized into normal renal function or renal impairment groups based on their estimated glomerular filtration rate. part 1: a total of approximately 16 subjects will be enrolled; approximately 8 subjects with severe renal impairment and approximately 8 with normal renal function. after statistical evaluation of results from part 1, part 2 may be conducted with approximately 8 subjects each with moderate and mild renal impairment. the total duration of participation from screening visit to day 11 will be a maximum of 39 days and from screening visit to follow-up/contact visit will a maximum of 73 days.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of \>/= 17.5 to \ 50 kg (110 lb) additional inclusion criteria for subjects with renal impairment: * meet the following egfr criteria during the screening period based upon mdrd equation: * severe renal impairment: egfr \<30 ml/min but not requiring hemodialysis * moderate renal impairment (part 2 only): egfr \>/=30 ml/min and \<60 ml/min * mild renal impairment (part 2 only): egfr between 60 and 89 ml/min * any form of renal impairment except acute nephritic syndrome (subjects with history of previous nephritic syndrome but in remission can be included) * stable drug regimen exclusion criteria: * females of child-bearing potential must use an accepted, highly effective contraceptive method * renal transplant recipients * urinary incontinence without catheterization * subjects with clinically significant infections within the past 6 months prior to first dose of study drug, evidence of active or chronic infection requiring oral treatment within 4 weeks prior, history of disseminated herpes simplex or recurrent or disseminated herpes zoster * subjects with malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of skin or cervical carcinoma in situ * hiv, hepatitis b, or hepatitis c infection additional exclusion criteria for subjects with renal impairment: * subjects requiring hemodialysis and peritoneal dialysis * screening bp \>/=180 mmhg (systolic) or \>/=110 mmhg (diastolic) * screening 12-lead ecg demonstrating qtcf \>470 msec
prevalence of fibromyalgia in israel

Conditions: Fibromyalgia

Summary: the prevalence of fibromyalgia syndrome in the israeli population is of importance fro planning resource allocation of medical expenditure as well as for identifying demographic and ethnic differences of this unique population compared with other western samples. in the current study the investigators aim at estimating the prevalence of fibromyalgia in this population. for this purpose a two - stage process will be used. first, a population survey will be conducted by telephone, screening for widespread pain and fatigue in the general population. this survey will use the london fibromyalgia epidemiology study screening questionnaire. second, a sample of patients attending the rheumatology clinic will be surveyed with this tool and will be examined in order to determine the actual proportion of patients fulfilling acr criteria for fibromyalgia. this will enable us to calculate the positive predictive value of the london fibromyalgia epidemiology study screening questionnaire in our population and hence to calculate the prevalence of fibromyalgia in the population.


Eligibility criteria:
inclusion criteria: * individuals over 18 who consent to answer the survey questions

Keywords: fibromyalgia fatigue
a study that switched patients from imatinib to nilotinib and then was followed by treatment cessation

Conditions: CML

Summary: to evaluate molecular relapse free rates 6 months after stopping nilotinib therapy in patients who achieve mr4.5

study protocol included criteria for study termination that was met when \> 2 patients lost ccyr during tfr phase (\> 1% bcr-abl); this study was terminated early as \> 2 cases of confirmed loss of complete cytogenetic response were reported despite bcr-abl monitoring during the tfr phase. all cases achieved mr4.5 after nilotinib treatment re-initiation and maintained until end of study; trial did not mandate re-initiation within 4 weeks after loss of mmr_ that was a requirement in other nilotinib tfr trials initial sample size was 300 patients with cml-cp; amendment #2 in june 2015 reduced sample size to 59 due to recruitment challenges; study endpoint analysis and interpretations of data were challenging due to small sample size for early study closure..

Eligibility criteria:
inclusion criteria: * diagnosis of cml * treated with at least 1 year of imatinib * bcr-abl level by pcr must be less than or equal to 0.1% and greater than 0.0032% by pcr reported on the international scale confirmed during screening * written informed consent obtained prior to any screening procedures performed exclusion criteria: * t315i mutation * prior imatinib failure or had accelerated phase or blast crisis cml * impaired cardiac function * pregnant or lactating women

Keywords: cml, chronic myeloid leukemia, stop, niotinib, discontinue, imatinib, switch, mr4.5, undetectable, bcr-abl
recombinant human relaxin in the treatment of diffuse scleroderma

Conditions: Systemic Sclerosis

Summary: relaxin is a naturally occurring protein prduced by the ovary or placenta in pregnancy. it has ani-fibrotic properties. previous studies have shown that relaxin is safe at concentrations upto 60 times higher than achieved in pregnancy. study is designed to see if skin improvement and improvement in functional ability can be achieved.


Eligibility criteria:
inclusion criteria: * men and women 18 to 70 years of age with diffuse ssc * disease duration 5 years since the onset of the first non-raynaud sign or symptom * a baseline modified rodnan skin score (mrss) of 20 or greater, or at least 16 if truncal involvement was present. * recombinant human relaxin (10 or 25 ug/kg/day), or placebo was administered for 24 weeks as a continuous subcutaneous infusion and there was a follow-up safety visit at week 28.

Keywords: diffuse scleroderma skin score
study of transplant related anemia treated with aranesp® (strata)

Conditions: Anemia

Summary: the purpose of this study was to evaluate aranesp® administered subcutaneously (sc) to maintain hemoglobin (hb) levels in renal transplant recipients.


Eligibility criteria:
inclusion criteria: - subjects who are greater than 6 months post-renal transplant (living or cadaveric) - using adequate contraceptive precaution, if of childbearing potential - available for follow-up assessments and dosing visits - hb concentration less than 11.0 g/dl within 3 months of screening and a hemoglobin concentration less than 11.0 during the screening period exclusion criteria: - expected to initiate dialysis or transplantation or be scheduled for a kidney transplant within 6 months of study start, or have less than 1 year life expectancy - systemic hematologic disease, myeloma, hemolytic anemia, or malignancy (excluding basal cell carcinoma) - active systemic or chronic infection - uncontrolled hypertension defined as diastolic blood pressure greater than 110 mm hg on 2 separate occasions during the 2 weeks prior to screening - known hypersensitivity to aranesp® or any of the product's excipients - disorders that compromise the ability of the subject to give written informed consent and/or to comply with study procedures - use of any erythropoietic protein or androgen therapy within the 12 weeks prior to screening - females who are pregnant or breast-feeding - currently enrolled in or received treatment in an investigational drug/device trial within the past 30 days - have previously been enrolled in this study - recent history (within 12 weeks prior to screening) of severe cardiovascular events, grand mal seizure, dialysis or major surgery - have received a red blood cell transfusion(s) within 8 weeks prior to screening, or currently have active bleeding

Keywords: kidney transplant, renal transplant aranesp®, darbepoetin alfa amgen, q2w dosing, q4w dosing
pharmacokinetics study of amg 423 in healthy subjects and subjects with various degrees of renal insufficiency

Conditions: Heart Failure

Summary: a phase 1, open-label study in subjects with normal renal function and subjects with various degrees of renal insufficiency, including patients with end-stage renal disease (esrd) requiring hemodialysis. the primary objective is to evaluate the single-dose pk of amg 423 in subjects with various degrees of renal insufficiency, including patients with end-stage renal disease requiring hemodialysis.

this study was conducted by amgen as the ind holder, with cytokinetics as a collaborator. due to the termination of the collaboration agreement between amgen and cytokinetics in may 2021 and subsequent transfer of the omecamtiv mecarbil ind from amgen to cytokinetics, cytokinetics is now listed as the sponsor.

Eligibility criteria:
inclusion criteria: * men or women ≥18 years of age * laboratory test values (clinical chemistry and hematology)within normal limits, (other than test values out of the normal range for subjects with ckd \[groups 1 and 3 through 5\]), or clinically acceptable to the investigator and sponsor at screening and day -3 * free of any clinically significant disease or condition(s) (other than that consistent with ckd for subjects in groups 1 and 3 through 5) that require a physician's care and/or would interfere with the evaluations, procedures, or participation in the study per the investigator's discretion; exclusion criteria: * subjects whose second mdrd egfr result during the screening period is not within 10% of the first egfr result * subjects who have received a functioning renal transplant within the past year * subjects with esrd who do not have a functioning hemodialysis access * subjects with hemodynamic instability during hemodialysis * subjects whose renal insufficiency is due to active autoimmune renal disease * subjects with renal insufficiency or esrd requiring hemodialysis and troponin i \> upper limit of normal (uln) at screening or day -3 * subjects with history of heart disease or unstable angina within the last 3 months * subjects with uncontrolled diabetes (hb1ac \> 8%) and/or subjects who are able but unwilling to adhere to the required fasting intervals

Keywords: heart, failure, renal, insufficiency, cardiac, kidney, hemodialysis, impairment, omecamtiv mecarbil, cardiac myosin activator, ck-1827452