Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of am712 in patients with namd

Conditions: Neovascular Age-related Macular Degeneration

Summary: the purpose of this phase 1 study is comprised of multiple ascending-dose component (part 1) and high concentration component (part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of am712 in patients with neovascular age- related macular degeneration (namd).

the part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of am712 in subjects with namd. subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (mtd) or the maximally administered dose (mad) has been reached. the part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of am712 in treatment-naïve patients with namd.

Eligibility criteria:
inclusion criteria: 1. male or female subjects with 50 years of age or older 2. active sub-foveal cnv lesion secondary to namd including juxta or extra-foveal lesions that partially affect the fovea 3. the area of cnv must occupy at least 50% of total lesion 4. total lesion area ≤ 12 da 5. etdrs bcva letter score measured at screening and baseline 6. clear ocular media and adequate pupil dilation to permit good quality photographic imaging in study eye exclusion criteria: 1. any previous systemic anti-vegf treatment 2. any systemic treatment or therapy to treat neovascular amd 3. continuous use of systemic corticosteroids 4. diseases that affect intravenous injection and venous blood sampling 5. presence of cnv due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia in study eye 6. history or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of ip or require medical or surgical intervention. 7. the area of fibrosis occupies ≥ 50% of total lesion area in study eye 8. evidence of myopia degeneration, diagnosis supported by the axial length examination in study eye 9. history or any concurrent macular abnormality other than amd in study eye 10. current vitreous hemorrhage or history of vitreous hemorrhage in study eye 11. history of recurrent inflammation in study eye 12. history of treatment for namd 13. subject having out of range laboratory values defined as: alt or ast \> 2 x uln, total bilirubin \> 1.5 x uln serum creatinine \> 1.5 x uln, bun \> 2 x uln hba1c \> 7.5% at screening

Keywords: namd
retaane® in age-related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: the treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. with visual loss threatening, there are only very few therapeutic options. while these patients are neither suitable for laser therapy nor for photodynamic therapy with verteporfin, antiangiogenic drugs applied intravitreally are now available. some patients however reject this therapeutic option because of potential complications such as endophthalmitis and the frequency of necessary injections. 20 patients who rejected intravitreal therapy were treated with anecortave acetate (retaane®) which was applied as a juxtascleral depot injection.


Eligibility criteria:
inclusion criteria: * rejection of intravitreal injections * presence of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration exclusion criteria: * conditions precluding judgement of the fundus
healthy transitions: menopause effect on obesity, energy balance, and insulin

Conditions: Menopause

Summary: the purpose of this study is to determine the effect of menopause on obesity, energy balance, and insulin in postmenopausal, obese women.

the effect of menopause on body composition and cardiovascular risk in healthy caucasian women has been the subject of much study. in contrast, there are few data available on menopause in african-american women. since menopause is associated with potentially preventable health risks in women, this proposal is aimed at characterizing the perimenopausal period in terms of body fat, energy balance, and insulin action in both caucasian and african-american women. the study will address 4 general hypotheses: * menopause increases both total and visceral abdominal fat * changes in body composition and body weight at menopause are mediated, at least in part by changes in 24-hour energy expenditure and/or food intake * menopause results in decreased insulin sensitivity that may predispose certain women to develop diabetes later in life * african-american women may respond to the shifts in reproductive hormones at menopause differently than caucasian women.

Eligibility criteria:
inclusion criteria: * age 47-52 yr, at time of enrollment * body mass index 25-40 * normal oral glucose tolerance test by national diabetes data group criteria * premenopausal, defined by fsh levels \<30miu/ml and at least 5 menstrual periods in the last 6 months * able to confirm ethnic heritage of past 2 generations in family exclusion criteria: * hypertension or hypercholesterolemia requiring medication * regular use of medications that influence glucose tolerance * use of oral contraceptives within the past 6 months * history of myocardial infarction or significant coronary vascular disease or stroke * history of endocrine, kidney, or liver disease or malignancy * any psychopathology, including eating disorders, substance abuse, and major depression * unable to complete longitudinal study commitment, including anticipating moving out of the area within the next 5 years.

Keywords: insulin sensitivity total abdominal fat visceral abdominal fat reproductive hormones menopause diabetes fat distribution sex hormones
lux-head&neck 2: a phase iii trial of afatinib (bibw 2992) versus placebo for the treatment of head and neck squamous cell cancer after treatment with chemo-radiotherapy

Conditions: Head and Neck Neoplasms

Summary: this randomised, double-blind phase iii trial will be performed in patients with head and neck squamous cell carcinoma (hnscc). the objectives of the trial are to compare the efficacy and safety of afatinib (bibw 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (hnscc), stage iii to ivb 2. unresected tumour prior to chemo-radiotherapy (crt) 3. concomitant crt completed prior to randomisation 4. after concomitant platinum-based crt, no evidence of disease (ned) on clinical and radiographic examinations 5. eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: 1. prior treatment with epidermal growth factor receptor (egfr)-targeted small molecules, egfr-targeted antibodies, and/or any investigational agents for hnscc 2. patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil 3. any other malignancy (except for simultaneous hnscc primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years 4. known pre-existing interstitial lung disease (ild) 5. pregnancy or breast feeding
gastric emptying in healthy volunteers and glp-1 agonist users

Conditions: Diabetes Type 2; Obesity and Overweight

Summary: this observational study aims to determine the gastric emptying kinetics assessed by ultrasound in healthy volunteers after a standard breakfast and the state of the stomach after a clear liquid diet for 18 /24 hours in patients on glp-1 agonist. the main questions it seeks to answer are: * is the kinetic after a standard breakfast that includes ( avocado and eggs: high fat) as fast as a standard meal that does not involve this food? * is a clear liquid diet of 18 to 24 hours enough to be an empty-stomach, assessed by ultrasound in patients on glp1 agonist? participants will be asked to do: -a baseline gastric us will be performed for healthy volunteers, and then they will have a standardized breakfast. an hourly or bihourly assessment will be done by the us.

glp-1 analogues enhance insulin secretion from β-cells, reduce glucagon secretion, have an appetite-suppressing effect, and delay gastric emptying. this last effect may make standard preoperative fasting inadequate, compromising airway safety during elective surgery and increasing aspiration risk. the main goal is to gather evidence to determine the optimal fasting period and dietary regimen to ensure safe outpatient surgery without increasing the risk of aspiration.ultrasound gastric content assessment is a highly accessible, bedside, cost-free, and low-risk tool for anesthesiologists. the increased use of these drugs in surgical patients and the lack of international consensus on their discontinuation and fasting protocols before surgery necessitate further study. our hypothesis is that glp-1 analogue users (for weight loss or diabetes) have significantly slower gastric emptying, but a 24-hour liquid regimen may be sufficient to ensure an empty stomach and safe elective surgery.

Eligibility criteria:
inclusion criteria: * 18 years old or older * healthy volunteers or semaglutide users exclusion criteria: * bariatric surgery * hiatal hernia * impairment to give consent

Keywords: agonist glp-1 perioperative fasting
targeted intensification with zbeam and autologous stem cell transplantation in patients with high-grade b-cell lymphoma

Conditions: Lymphoma, Large Cell, Diffuse

Summary: the purpose of this study is to evaluate the efficacy and the safety of a preparative regimen utilizing standard-dose yttrium-90 ibritumomab tiuxetan (zevalin) radioimmunotherapy combined with high-dose beam followed by asct after first line treatment in patients aged from 18 to 65 years with poor prognosis cd 20 diffuse large b-cell lymphoma


Eligibility criteria:
inclusion criteria: * aged from 18 to 65 years. * patient with pathologically proven, high grade b-cell lymphoma cd 20 positive (who classification) : * diffuse large b cell lymphoma. * adverse prognostic factors ipi\>1 * in complete remission, or partial response to first line treatment. * previously treated with chemotherapy regimen containing rituximab: r chop or r acvbp * chemo-sensitive disease * pet scan prior transplant * eligible for autologous stem cell transplantation * with a minimum life expectancy of 3 months. * negative hiv, hbv and hcv serologies (in the last 4 weeks except after vaccination). * having previously signed a written informed consent. exclusion criteria: * histological transformation in diffuse large b cell lymphoma, any type of low grade lymphoma * more than one line of treatment. prior transplantation. prior exposure to zevalin * central nervous system or meningeal involvement by lymphoma. * contraindication to any drug contained in the chemotherapy regimen. * any serious active disease or co-morbid medical condition (according to the investigator's decision and information provided in the idb). * poor renal function (creatinin level up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * poor hepatic function (total bilirubin level up to 30 micro mol/l, transaminases up to 2.5 maximum normal level) unless these abnormalities are related to the lymphoma. * poor bone marrow reserve as defined by neutrophils less than 1.5 g/l or platelets less than 100 g/l * large bone marrow irradiation more than 40percent. * bone marrow infiltration * lack of sufficient autologous hematopoietic stem cells for transplantation. * prior treatment with murine antibodies * known hypersensibility to murine antibodies or proteins * any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 (in situ) cervical carcinoma. * treatment with any investigational drug within 30 days before planned first cycle of chemotherapy and during the study. * adult patient unable to give informed consent because of intellectual impairment. * pregnant or lactating women.

Keywords: lymphoma lymphoma diffuse b-cell lymphoma aggressive lymphoma
effects of caffeine-based supplement on physical performance

Conditions: Muscle Power

Summary: the aim of the study was to determine the acute effects of multi-ingredient pre-workout supple-ment (mips) containing: beta-alanine, taurine, caffeine, l-tyrosine, and cayenne pepper (capsaicin) on physical performance in untrained men

the aim of our study was to determine the acute effects of commercially available multi-ingredient pre-workout supple-ment (mips) containing: beta-alanine, taurine, caffeine, l-tyrosine, and cayenne pepper (capsai-cin) on physical performance in untrained men. the aerobic and anaerobic capacity was determined after ingestion of mips. a randomized, crossover, single-blind design was used to evaluate the effects of the dietary supplement on physical performance. the participants performed the exercise test twice, in random order: as a control test and after supplement administration (mips). the measurements took place over two consecutive days. somatic measurements were taken on the same day that the first all-out test was performed. twelve young healthy men, without medical contraindications to supramaximal and maximal intensity exercise, participated in the study. the exercise tests took place under medical supervision.

Eligibility criteria:
inclusion criteria: lack of neuromuscular and musculoskeletal disorders; no medication nor dietary supplements used within the previous month which could potentially affect the study outcomes and self-described good health status. an additional inclusion criterion was the small amount of caffeine consumed per day, i.e. only one caffeinated coffee drink per day or less. exclusion criteria: consumption of energy drinks

Keywords: exercise caffeine muscle power
identifying risk factors for bone tissue death in young patients with acute lymphoblastic leukemia treated on clinical trial ccg-1882

Conditions: Leukemia

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to bone tissue death. purpose: this laboratory study is looking at risk factors for bone tissue death in young patients with acute lymphoblastic leukemia treated on clinical trial ccg-1882.

objectives: * identify possible pharmacogenetic risk factors for avascular necrosis (avn) in pediatric patients who received intensive therapy for acute lymphoblastic leukemia on clinical trial ccg-1882. * compare whether thymidylate synthase 2/2 enhancer repeat genotype and vitamin d receptor c/c start site genotype are more common among patients who developed avn than among patients who did not. outline: this is a retrospective, cohort, multicenter study. patients are stratified according to gender and treatment regimen on clinical trial ccg-1882 (augmented vs regular berlin-frankfurt-munster). dna is extracted from slides of blast samples that were previously obtained from patients treated on clinical trial ccg-1882. dna genotyping is performed, and genotypes (proportion of population with variant alleles or frequency of variant alleles) are compared between patients who did and did not develop avascular necrosis. projected accrual: a total of 671 tissue samples from patients (294 females and 377 males) will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of acute lymphoblastic leukemia (all) * has diagnostic all blast sample slides available for dna extraction * previously treated on clinical trial ccg-1882 patient characteristics: age * 10 and over at diagnosis performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified prior concurrent therapy: biologic therapy * not specified chemotherapy * not specified endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: childhood acute lymphoblastic leukemia
intraocular pressure accuracy and variability of the barraquer tonometer

Conditions: Elevated Intraocular Pressure

Summary: to determine if the barraquer tonometer provides an accurate and reliable measurement of intraocular pressure. the barraquer tonometer is a device used to safely and painlessly measure intraocular pressure.

intraocular pressure will be checked using four different methods of tonometry. these four methods will include tonopen, goldmann applanation tonometry, schiotz tonometry, and barraquer tonometer. the data will then be compared to determine the reliability and accuracy of the barraquer tonometer.

Eligibility criteria:
inclusion criteria: 1. all patients of barnes retina institute who are scheduled to undergo vitreoretinal surgery. 2. all patients scheduled for routine eye examination at the washington university eye clinic or barnes jewish eye clinic. 3. all ages (patients seen at these locations are adult patients \>18 years of age). exclusion criteria: 1. any patient who is seen in the outpatient clinics for an urgent or emergency ophthalmological issue. 2. any patient who has a contraindication to routine, noninvasive methods of tonometry and/or pachymetry (ie corneal ulcer).

Keywords: barraquer tonometer intraocular pressure tonometry
development of upper limb motor scale to measure quality of movement and body awareness in stroke

Conditions: Stroke

Summary: for the breathing intervention, participants completed two experimental sessions at least two weeks apart. the experimental sessions were randomized between the slow-breathing condition (6 breaths/min) or the control breathing condition (12 breaths/min). breathing interventions were 15 minutes in length and completed with the assistance of the breathing app, breathe deep (mineev, bizi apps llc). the breathing intervention is currently completed. the reliability and validity study of afas is ongoing. this is a one-time visit for participants in which participants will undergo screening of sensation and movement as well as fill in some questionnaires.

all participants had two visits for the breathing exercise. the only planned intervention was the breathing exercise, which is now concluded. the protocol for the breathing intervention was as follows: the breathing protocol lasted 15 minutes. it was a guided breathing awareness session with a registered nurse (phd student) who is also trained in integrative therapies and yoga instruction. in parallel, during one of the visits the reliability and validity of a new scale for stroke to measure quality of movement and body awareness is tested. this part is still ongoing and thus this becomes a one-time visit.

Eligibility criteria:
inclusion criteria: * females and males ages 18-99 years of age * people with stroke who are medically stable with one or more ischemic or * hemorrhagic stroke(s) * left or right hemiplegia * willing and able to attend a one-time behavioral testing session * willing and able to sign consent to participate * able to hear, read and comprehend instructions given during the study * english speaking (or willing to work with a (student) translator) exclusion criteria: * cognitive impairment (mini-mental state exam-brief version, \<13/16) * contractures in the tested arm that would hinder testing arm movements * adults lacking capacity to consent * severe neglect, aphasia, apraxia * other medical conditions that preclude participation

Keywords: stroke
rotigotine effect on nocturnal hypokinesia compares to placebo control: a quantitative assessment by wearable sensors

Conditions: Nocturnal Hypokinesia

Summary: parkinson's disease (pd) is the neurodegenerative disease which is caused by lewy bodies deposition in central and peripheral nervous system. the mains symptoms include both motor and non motor symptoms such as bradykinesia, rigidity, rest tremor, postural instability, autonomic dysfunction or neuropsychiatric symptoms. moreover, the pd symptoms not only occur in the daytime, but also in the nighttime. the nighttime symptoms or nocturnal symptoms can make the patients disabling as well as the daytime symptoms. the bradykinesia that occurs in the nighttime is called nocturnal hypokinesia which also make many serious consequences such as bedsore, falling or aspiration or death. in this study, the investigators aim to study the effects of rotigotine transdermal patch compare to placebo on mainly the aspect of nocturnal hypokinesia.

the investigators recruited pd patients who had history of nocturnal hypokinesia and randomized by running number (blind) into 2 groups including active and placebo group. baseline demographic, disease characteristics, nocturnal questionnaires and wearable nocturnal sensors data were collected before drug titration. in active group, participants received the rotigotine transdermal patch titration from 2 mg/day to maximum dosage which participants had no side effect or 16 mg/ day every week. in placebo group, participants would get the placebo patch titration as the active group. after participants got maintenance dosage, participants would get the physical examination, nocturnal questionnaires and wearable nocturnal sensors as before study.

Eligibility criteria:
inclusion criteria: * patients: pd patients (age ≥ 18 years) who have history of nocturnal hypokinesia * patients not taking levodopa were eligible for study * patients who taking immediate- released levodopa,they had been on a stable dose for 28 days prior to baseline assessment and during the study * patients did not use control-released l-dopa at bedtime exclusion criteria: * history of narcolepsy, excessive daytime sleepiness, sudden onset of sleep * history of hallucination, dementia and psychosis * evidence of icds * clinical relevant to cardiovascular disorders (including prolonged qtc ≥ 500 ms, recent mi) * history of seizure or stroke in the past 1 year * patients had participated in other clinical trial in the past 28 days

Keywords: parkinson's disease rotigotine transdermal patch nocturnal hypokinesia
fu-zheng-qu-zhuo oral liquid improves renal function in patients of ckd stage 3 and 4

Conditions: Stage 3 Chronic Kidney Disease; Stage 4 Chronic Kidney Disease

Summary: a prospective, multicenter (outpatient clinics of the three participating hospitals in beijing), double blinded and randomized placebo-controlled study. the study consisted of a 2-week run-in period and a 12-month treatment period.


Eligibility criteria:
inclusion criteria: (1) signed informed consent and aged from 18 to 75 years old. (2) chronic renal diseases with glomerular filtration rate (gfr) estimated using the ckd epidemiology collaboration (ckd-epi) equation between 15 and 59 ml/min per 1.73 m2 on at least 2 dates separated by at least 90 days but no more than 6 month (the ckd defining window period). (3)not received other tcm treatment for at least 2 weeks. exclusion criteria: (1) 50% increase in serum creatinine occurring within 2 month before screening. (2) immediate need for dialysis. (3) myocardial infarction or cerebrovascular accident in the 6 month preceding the trial. (4) connective-tissue disease, obstructive uropathy and renal transplantation. (5) patients with severe disease in other organs or cancer, psychotic diseases, and active tuberculosis. (6) treatment with corticosteroid and immunosuppressive agents in recent 3 month. hemoglobin (hb) less than 80 g/l. (7) diabetes mellitus with uncontrolled blood sugar ( glycated hemoglobin （hba1c） \>8.0%). (8) enrolled in other trials. (9) women in pregnancy or lactation.

Keywords: chronic kidney disease egfr slope herbal medicine fu-zheng-qu-zhuo oral liquid