Kornimate/medical-research-clean huggingface dataset:
arc1905 (anti-c5 aptamer) given with lucentis 0.5 mg in people with neovascular age-related macular degeneration

Conditions: Neovascular Age-Related Macular Degeneration

Summary: the objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of arc1905 intravitreous injection when administered in combination with multiple doses of lucentis® 0.5 mg/eye, or with one induction dose of lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (amd).


Eligibility criteria:
inclusion criteria: * subfoveal choroidal neovascularization (cnv) due to amd (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram. exclusion criteria: * previous or concomitant therapy with intravitreous corticosteroids. * any of the following underlying diseases including: * diabetic retinopathy * history or evidence of severe cardiac disease (e.g., nyha functional class iii or iv), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 6 months, ventricular tachyarrythmias requiring ongoing treatment. * history or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation. * clinically significant impaired renal (serum creatinine \>2.5 mg/dl or s/p renal transplant or receiving dialysis) or hepatic function. patients with results outside these ranges may be enrolled in consultation with ophthotech. * stroke (within 12 months of trial entry). * any major surgical procedure within one month of trial entry. * previous therapeutic radiation in the region of the study eye. * any treatment with an investigational agent in the past 60 days for any condition. * women who are pregnant or nursing. * known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the arc1905 formulation.

Keywords: amd
accuracy activity monitors for inhospital activity monitoring of geriatric patients

Conditions: Hip Fractures; Stroke; Abdominal Injury

Summary: the focus of this study will be to determine the accuracy of the mox, the axivity and fitbit, empatica and chill+ activity monitors (with both custom-made and available algorithms) for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in acute care for the elderly (ace) and geriatric rehabilitation units. in addition, the feasibility of the use of the activity monitors as a measurement tool in daily practice during hospitalization in the geriatric department will be investigated.

adequate physical activity and exercise throughout the day are important to maximize independence and quality of life. to be able to optimize the physiotherapeutic interventions and to monitor how much geriatric patients move during hospitalization, it is desirable to follow up their activity by means of an activity monitor. in this study the investigators will determine the accuracy of three different types of activity monitors, the "mox" placed on the thigh, the "axivity" placed on the torso and the "fitbit sense", the "empatica" and the "chill+" placed on the wrist, for the classification of lying, sitting, standing, walking and climbing stairs in hospitalized older people in the geriatric department. in this clinical study, 40 patients will participate of which 20 hospitalized in the geriatric rehabilitation unit at campus pellenberg and 20 hospitalized in the acute care of elderly units at campus gasthuisberg uz leuven, belgium. these activity monitors will remain attached for seven days so that activity can monitored during the week as well as on weekends. in an experimental test session a total of five activities (lying down, sitting, standing, walking and possibly climbing stairs) will be performed and observed, each lasting four minutes. the observations will be recorded by video where only the lower body will be in focus. there will be daily checks to see if the activity monitors on the thigh, torso, and wrist stay in place, if the skin tolerates it well, if participants experiencing subjective discomfort, and if the measurements continue. at the end of the week, a short questionnaire will be completed on the user-friendliness of the different monitors. the investigators will use the accuracy and patient satisfaction outcomes to decide the feasibility of using these activity monitors as a measurement tool in daily practice during hospitalization.

Eligibility criteria:
inclusion criteria: * admitted to the rehabilitation or acute ward of uz leuven * walking with the use of a walkingaid * a signed informed consent form * an expected stay of at least 7 days exclusion criteria: * medically unstable

Keywords: geriatric inhospital rehabilitation elderly activity monitors
epanova® for lowering very high triglycerides

Conditions: Severe Hypertriglyceridemia

Summary: the primary objective of the study is to determine the efficacy of epanova (omefas) compared to placebo in lowering serum triglycerides in subjects with severe hypertriglyceridemia.


Eligibility criteria:
inclusion criteria: * men or women, \>=18 years of age. * very high serum tg values in the range \>=500 mg/dl and \ =5.65 mmol/l and \<22.60 mmol/l) exclusion criteria: * allergy or intolerance to omega-3 fatty acids, omega-3-acid ethyl esters, or fish. * known lipoprotein lipase impairment or deficiency or apolipoprotein c-ii deficiency or familial dysbetalipoproteinemia. * unable to discontinue use of omega-3 drugs/supplements. * unable to discontinue use of bile acid sequestrants, fibrates or niacin (other than niacin-containing vitamins \<200 mg), or any supplement used to alter lipid metabolism. * women who are pregnant, lactating, or planning to become pregnant. women of childbearing potential who are not using acceptable contraceptive methods. * use of tamoxifen, estrogens or progestins that has not been stable for \>4 weeks prior to visit 1. * use of oral or injected corticosteroids or anabolic steroids. * history of pancreatitis. * history of symptomatic gallstone disease, unless treated with cholecystectomy. * uncontrolled diabetes. * uncontrolled hypothyroidism or thyroid stimulating hormone (tsh). * history of cancer (other than basal cell carcinoma) in the past 2 years. * cardiovascular event (i.e., myocardial infarction, acute coronary syndrome, new onset angina, stroke, transient ischemic attack, unstable congestive heart failure requiring a change in treatment) or revascularization procedure within six months prior to visit 1. * use of anticoagulants (e.g. warfarin \[coumadin®\], coumarin, heparin, enoxaparin, clopidogrel). * presence of an aortic aneurysm or resection of an aortic aneurysm within six months prior to visit 1. * recent history (within six months prior to visit 1) or current significant nephrotic syndrome, pulmonary, hepatic, biliary, gastrointestinal or immunologic disease. * poorly controlled hypertension. * any of the following laboratory criteria: serum alanine aminotransferase (alt) or aspartate aminotransferase (ast), glucose, glomerular filtration rate (gfr), platelet count,or hemoglobin outside of study range. * recent history (past 12 months) of drug abuse or alcohol abuse. * exposure to any investigational product, within 4 weeks prior to visit 1. * presence of any other condition the investigator believes would interfere with the subject's ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at undue risk

Keywords: dyslipidemia hyperlipidemia omega-3 carboxylic acid
catheter ablation of arrhythmias to improve crt response

Conditions: Arrhythmia, Cardiac

Summary: the purpose of this study is to test if catheter ablation is better than medication therapy at treating arrhythmias originating from the upper and/or lower chambers of the heart in order to allow the heart to beat properly.


Eligibility criteria:
inclusion criteria: * heart failure patients with crt-d or crt-p greater than 3 months * bi-ventricular pacing less than 94% of the time * 3 months after crt-d or crt-p implantation an ef improvement less than 5% * presence of one of the following arrhythmias and eligible for catheter ablation: * atrial fibrillation * atrial flutter * supraventricular tachycardia * premature ventricular contraction burden greater than 30% in a 24-hour period * ventricular tachycardia exclusion criteria: * estimated survival less than one year * patient unable to make scheduled follow up visits at treating center * participating in another investigational study
pain expression in the perioperative period of cataract surgery

Conditions: Cataract; Surgery; Eye Pain

Summary: patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. the purpose of this study is to investigate the pathogenesis of this phenomenon.


Eligibility criteria:
inclusion criteria: * age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery; * pupil dilation ≧7 mm after mydrisis; * va prognosis ≧6/12 exclusion criteria: * unable to give informed consent; * patients with history of ocular pathology or diabetic retinopathy; * patients with traumatic, subluxated and posterior polar cataract; * patients had other ocular surgery (not cataract surgery) in the past 6 months; * patients with significant intra-operative complications
stress management for irritable bowel syndrome

Conditions: Irritable Bowel Syndrome

Summary: the primary goal of this study is to test the efficacy of emotional awareness and expression training (eaet), a novel emotional processing intervention that the investigators have developed, for people with ibs. in this randomized, controlled trial, the investigators will compare eaet to a standard intervention that teaches the conceptually opposite approach-relaxation training (rt)-and test how both of these interventions compare to a wait-list control condition. the investigators hypothesize that individuals in the eaet group will demonstrate greater improvement in their ibs symptom severity, psychological functioning, quality of life, and health care utilization at 4 and 12-week follow-up time points, compared to individuals in the wait-list control group. it is also expected that both of the active interventions (eaet and rt) will be more efficacious than the wait-list control condition.


Eligibility criteria:
inclusion criteria: to be eligible to participate, individuals must meet the rome iii criteria for ibs. that is, they must report that they have had: * recurrent abdominal pain or discomfort, or * a change in stool frequency or form, * at least three days per month, in the last three months, and * that they have been given this diagnosis by a physician. they must also report having pain and discomfort of at least two days per week at time of screening. exclusion criteria: * individuals who report having post-infectious ibs, * organic gastrointestinal diseases (e.g., inflammatory bowel disease), immunodeficiency, * a current psychotic disorder, * drug or alcohol dependence within the past two years, and * those who are unable to communicate in english will be excluded.

Keywords: ibs relaxation emotional exposure emotional processing
urinary retention in orthopedic patients

Conditions: Urinary Retention; Orthopedic Patients; Spinal Anesthesia

Summary: the participants were hospitalized in orthopedic and traumatology departments in military institute of medicine, warsaw, poland. the inclusion criteria were (1) age to 40 year-old, (2) no history of urologic problems, and (3) surgery under spinal anesthesia. all the patients where (1) opioids were administered during the surgery, (2) general anesthesia was necessary, and (3) the urinary bladder catheterization was perform during the surgery were excluded from the study. the participants were randomly divided into the study and control groups. no oral premedication was administered. all the patients were asked to empty their urinary bladders before arrival to the operating theatre. when the standard monitoring (continuous electrocardiogram, noninvasive blood pressure, pulse oximetry) was started, intravenous premedication with midazolam was administered and lumbar spinal anesthesia with hyperbaric 0.5% solution of bupivacaine hydrochloride was performed. in the study group, but not in the the control one, the 40 mg of drotaverine hydrochloride was administered intramuscularly. the decresed intravascular volume was corrected with cristalloids. during the surgery the adequate, not deeper than ii grade according to ramsay scale, level of sedationt was obtained with midazolam and/or propofol. all the participants received a questionaire in which we asked the questions about (1) the duration of anesthesia, (2) the time of micturition, (3) the time when discomfort or pain appeared in the lower abdomen, (4) the incidence of the urinary bladder catheterization and time to catheterization. on the next day after the surgery the questionaires were collected. in cases, when the patient's dischaged from the hospital was planned during the weekend, he or she was asked to pass on the questionaire to the nurses.


Eligibility criteria:
inclusion criteria: * age below 40 y.o., * surgery under spinal anesthesia, * no previous history of urological problems. exclusion criteria: * opioid administration during surgery, * need for urinary bladder catheterization during surgery, * conversion to general anesthesia.
a study to examine the safety and efficacy of pf-00610355 in moderately asthmatic subjects

Conditions: Asthma, Bronchial; Lung Diseases, Obstructive; Respiratory Tract Diseases; Bronchial Diseases

Summary: this study (a7881006) is the first multiple dose study in moderate asthmatic subjects and aims to determine the safety and efficacy of pf-00610355 when subjects take pf-00610355 on a daily basis for 4 weeks in subjects maintained on inhaled corticosteroid.


Eligibility criteria:
inclusion criteria: * subjects with a physician documented history or diagnosis of persistent asthma for at least 6 months prior to screening visit 1. trough fev1 must be 50-100% of predicted at screening visit 1. subjects who have been maintained on a stable dose of ics over the previous month prior to screening. exclusion criteria: * subjects who have had a severe asthma exacerbation in the 2 months prior to screening. subjects meeting any of the criteria of 'very poorly controlled' according to the nih epr 3 guidelines. subjects with evidence or history of cardiovascular disease including angina, myocardial, infarction, clinically significant cardiac arrhythmia (eg, atrial fibrillation, atrial flutter,supraventricular tachycardia, ventricular tachycardia), systemic hypertension (sbp \> 160 mmhg or dbp \>100mmhg), pulmonary hypertension or cerebrovascular disease (including transient ischaemic attacks).

Keywords: asthma bronchial diseases
study to assess the effectiveness of abobont-a injections for adult lower limb spasticity in a real life cohort

Conditions: Adult Lower Limb Spasticity

Summary: the purpose of the protocol is to assess the longitudinal attainment of person-centered and function related goals of patients who receive abobotulinumtoxina (abobont-a) injections for adult lower limb spasticity over a period of 16 months.


Eligibility criteria:
inclusion criteria: * adult male and female subjects ≥18 years of age * primary diagnosis with unilateral adult lower limb nonprogressive spasticity. * subject able to take more than five steps with or without assistance. * decision to treat the lower limb with abobont-a by the care provider made prior to, and independently from, the decision to enroll the subject in the observational study as per country label. * previously untreated with bont-a (i.e. naïve to bont-a), or previously treated with a bont-a (i.e. non-naïve to bont-a). for those who were previously treated with bonta, they should have responded to bont-a treatment and at least 12 weeks should have elapsed from prior injection. * signed informed consent prior to participation in the study. exclusion criteria: * prior history of nonresponsiveness to bont-a therapy * previous treatment with bont-a of less than 12 weeks prior to enrolment in study. * current participation in any other clinical study or have participated within the 12 weeks prior to the inclusion visit (visit 1) of this study. * severe limitations in passive range of motion/contractures in the affected limb (mas=4 in at least one of the joints in the lower limb). * limb surgery or intrathecal baclofen therapy placement for spasticity within 3 months. * nonambulatory subject. * pregnant and lactating women. * progressive neurological conditions or diagnosis of cerebral palsy.
a study to evaluate the safety of dostarlimab in adult participants in india with recurrent or advanced endometrial cancer (ec)

Conditions: Neoplasms, Endometrial

Summary: the goal of this study is to evaluate the safety profile of dostarlimab in indian adults with recurrent or advanced endometrial cancer.


Eligibility criteria:
inclusion criteria: * participants ≥18 years of age, at the time of signing the informed consent. * documented case of dmmr/msi-h recurrent or advanced ec that has progressed on or following prior treatment with platinum containing regimen. * eligible for dostarlimab treatment according to the approved prescribing information and the investigator's clinical judgement. * wocbp (women of childbearing potential) agree to use contraceptive from screening through at least 120 days after the last dose. * negative serum or urine pregnancy test at most 72 hours prior to the first dose of study medication. * capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (icf) and in this protocol, in accordance with applicable laws. exclusion criteria: * known active hepatic disease, end-stage renal disease (esrd) or known case of serious, uncontrolled medical disorder/active infections which precludes participant's inclusion in the study as per the investigator's judgement. * either the history of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class of the study drug. * received prior therapy with an anti- programmed death receptor 1 (anti-pd-1), anti-pd-1- ligand-1 (anti-pd-l1) agent. * has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. * received a live vaccine within 14 days of planned start of study therapy. * participation in another clinical study with a study drug administered in the last 3 months. * pregnant, breastfeeding, or expecting to conceive while receiving study treatment and for up to 120 days after the last dose of study treatment. * judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

Keywords: dostarlimab endometrial cancer dmmr msi-h
riboflavin corneal crosslinking for brittle cornea syndrome and ehlers-danlos syndrome type vi

Conditions: Brittle Cornea Syndrome; Ehlers-Danlos Syndrome Type 6

Summary: brittle cornea syndrome and ehlers-danlos syndrome (eds) type vi are rare collagen-connective tissue disorders that predispose affected individuals to the development of perforated corneas from the mildest of eye trauma or even spontaneously. clinical studies evaluating riboflavin-corneal crosslinking have found that it dramatically increases corneal rigidity. given the success and safety of riboflavin crosslinking, the investigators believe that it can increase the corneal stability in patients affected these disseases, preventing perforation. it is furthermore possible, that riboflavin crosslinking will allow corneal transplants to successfully be performed on blind eyes that have already perforated and opacified. the purpose of the study is to determine whether corneal crosslinking can be safely performed on individuals with brittle cornea syndrome or ehlers-danlos syndrome type vi.


Eligibility criteria:
inclusion criteria: adult patient with: 1. genetic diagnosis of either brittle cornea syndrome or eds-vi, and 2. either: * personal history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma or * immediate family member with history of either spontaneous corneal perforation or corneal perforation due to minor ocular mechanical trauma exclusion criteria: * any patient that is deemed to be unable to fully cooperate during the crosslinking procedure
implantation of markers for the radiotherapy of lung cancer patients

Conditions: Lung Cancer

Summary: this clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.

objectives: * to acquire experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors in patients with stage i-iiib non-small cell lung cancer. * to characterize the potential side effects involved in the use of markers in these patients. * to analyze the positional stability of lung markers in these patients over a radiotherapy series. * to acquire experience in the use of markers for treatment planning and radiotherapy in these patients. outline: patients undergo implantation of ≥ 1 small radio-opaque visicoil™ marker into or close to the primary lesion and affected lymph nodes by bronchoscopy. patients then undergo x-rays to document marker location, detect potentially dropped markers, and diagnose operation-related side effects (i.e., pneumothorax). after marker implantation, patients undergo stereotactic or conventionally fractionated radiotherapy for 30-33 daily fractions.

Eligibility criteria:
disease characteristics: * diagnosis of non-small cell lung cancer * stage i-iiib disease * no prior surgical tumor resection * respiration-induced tumor motion \> 5 mm * recruited by attending physician or research nurse at the medical college of virginia hospitals patient characteristics: * not pregnant * no insufficient lung function or other parameters prohibiting a bronchoscopy * not a prisoner or institutionalized prior concurrent therapy: * see disease characteristics * concurrent chemotherapy allowed

Keywords: stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage ia non-small cell lung cancer stage ib non-small cell lung cancer stage iia non-small cell lung cancer stage iib non-small cell lung cancer