Kornimate/medical-research-clean huggingface dataset:
humanized monoclonal antibody 3f8 (hu3f8) with granulocyte-macrophage colony stimulating factor (gm-csf) in the treatment of recurrent osteosarcoma

Conditions: Recurrent Osteosarcoma

Summary: the purpose of this study is to find out what effect an antibody called humanized 3f8 (hu3f8) and a drug called gm-csf have on the patient and whether it can keep the patient in remission longer and/or prevent recurrence of the disease.


Eligibility criteria:
inclusion criteria: * patients must have recurrent os. os must be verified by histopathology review by the site's department of pathology. (patients registered at msk must have pathology confirmed by msk department of pathology.) * patients must be in a ≥2nd complete remission as indicated by appropriate radiologic evaluations at the time of study entry. * patients must be ≥ 1 year of age and ≤ to 40 years of age at the time of enrollment. * prior therapy: ≥3 weeks should have elapsed since last cytotoxic therapy, immunotherapy or radiation therapy. more than one week should have elapsed since major surgery. note: minor surgery (e.g. minor biopsy, central venous catheter placement, shunt revision) is permitted within 1 week prior to enrollment) * adequate hematopoietic function defined as: * absolute neutrophil count ≥ 500/ul * absolute lymphocyte count ≥ 500/ul * platelet count ≥ 50,000/ul (transfusion independent) * adequate hepatic function as defined by: * total bilirubin of ≤ 1.5 times upper limit of normal (exception is made for patients with gilbert's syndrome who may be considered eligible if total bilirubin is ≤ 3 times upper limit of normal). * ast (sgot) of ≤ 3 times upper limit of normal * alt (sgpt) of ≤ 3 times upper limit of normal * adequate renal function as defined by a serum creatinine of ≤ 1.5 times upper limit of normal * adequate cardiac function as defined by a shortening fraction of ≥ 28% or an ejection fraction ≥ 50% * adequate pulmonary function as defined by no evidence of dyspnea at rest at no history of exercise intolerance * adequate performance status as defined by ecog score of ≤ 2 or karnofsky/lansky score ≥ 50% * prior treatment with other anti-gd2 antibodies is allowed (prior treatment with hu3f8 is not allowed), but haha antibody titer must be negative * women of child-bearing potential must be willing to practice an effective method of birth control while on treatment * signed informed consent indicating awareness of the investigational nature of this program exclusion criteria: * patients with os in first complete remission. * presence of overt metastatic disease at any site. * active life-threatening infection. * pregnant women or women who are breast-feeding. * inability to comply with protocol requirements.

Keywords: humanized monoclonal antibody 3f8 (hu3f8) granulocyte-macrophage colony stimulating factor (gm-csf) 15-096
hiv/aids & alcohol-related outcomes: translational evidence-based interventions

Conditions: HIV/AIDS

Summary: a clinical study for patients with hiv that investigates the best way to reduce hiv transmission risk, and to improve the overall health of people living with hiv/aids. participants will complete four assessments over the course of one year and will be randomly assigned to a five-week treatment program.

the main purpose of this research study is to investigate the best way to reduce hiv transmission risk and to improve the overall health of people living with hiv/aids. this study tests an intervention program that aims to improve knowledge, motivation, and skills. the intervention program is designed to motivate participants to take their medications routinely, improve the quality of life for those living with hiv, and decrease risky behaviors that may lead to hiv transmission.

Eligibility criteria:
inclusion criteria: * hiv positive * recent alcohol use exclusion criteria: -

Keywords: hiv aids alcohol health knowledge motivation skills behavior
balance and gait characteristics to predict accidental falls in community-dwelling stroke elderly

Conditions: Cerebrovascular Accident; Accidental Falls

Summary: background: accidental falls result in major physical and psychological morbidity in the elderly, especially stroke patients. to get optimal prevention of stroke falls, it is crucial to identify independent risk factors from multivariate analysis of related balance and gait parameters. aim: to evaluate the effects of balance and gait characteristics in determining whether or not accidental falls may happen. to investigate if the balance and gait parameters affect the time from lesion to when (and if) patients suffer from falls. to compare differences of balance and gait parameters in accidental fall patients between those with severe accidental injuries and those without severe injuries. methods: the 2-year observational cohort study will enroll 706 elderly stroke patients, who have not had a previous stroke. they will be retrieved from the inpatient department and followed-up regularly in the outpatient department when they are discharged. all subjects will be evaluated at 1 month and 6 months after stroke. these evaluations will include: mental, cognition and depression status; lower-limb muscle strength assessed by a dynamometer as well as range of motion of joints assessed by a biaxial electro-goniometry; functional independence measure; balance and gait pattern will be assessed by both clinical observation and objective laboratory examination (a dynamic posturography and computerized gait analysis system); falls and fall-related injuries during the proceeding year. differences in baseline characteristics are tested by one-way anova, mann whitney u or t tests, if appropriate. the investigators will identify the independent risk factors of accidental falls with logistic regression and use the log rank statistic of kaplan-meier survival curve to differentiate the risk of accidental falls or fall-related injuries in different groups.


Eligibility criteria:
inclusion criteria: * age\>65 * confirmed stroke by ct or mri * first-ever stroke * with walking ability after stroke onset 1 month exclusion criteria: * fall history before stroke * living in nursing home * unstable physical sign * seizure attack during study * impaired cognition

Keywords: balance gait characteristics
effect of memantine versus bupropion on smoking relapse in nicotine-dependent individuals - 3

Conditions: Tobacco Use Disorder

Summary: one of nicotine's effects on the body is at the level of the nmda receptors in the brain. memantine is a drug that also affects nmda receptors, making it a candidate for the treatment of nicotine addiction. the purpose of this study is to evaluate the effectiveness of memantine using a laboratory model of smoking relapse in nicotine dependent volunteers. investigators will compare the effects of memantine with bupropion, medication currently used to facilitate smoking cessation.

tobacco use is the leading preventable cause of death in the united states. recent research on the effects of nicotine on the brain and behavior presents an opportunity to advance medication development. neurotransmission at nmda receptors in the brain is associated with learning and memory and has been linked to many of nicotine's effects on humans. it is possible that altering nmda neurotransmission may be helpful in treating nicotine addiction. the goal of this study is to evaluate the effects of memantine, an nmda receptor antagonist, using the laboratory model of smoking relapse in nicotine dependent volunteers. the effects of memantine used in combination with bupropion, a medication currently used to facilitate smoking cessation, will be compared to a placebo. this double-blind study will consist of three phases (placebo, bupropion, and memantine). each phase will include 10 days of outpatient medication maintenance, followed by 5 days of inpatient testing. during the outpatient phase, study visits will occur every 2 to 3 days. during the first portion of inpatient stay, participants will not be permitted to smoke. during the second portion of inpatient stay, smoking reinstatement will be modeled, as participant will have opportunity to smoke. a variety of behavioral, subjective, physiological, and performance measures will be assessed throughout the study.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of nicotine dependence with psychological dependence * smokes at least 15 cigarettes per day for the three months prior to enrollment * currently not seeking treatment for nicotine dependence * medically healthy on the basis of physical examination and medical history, vital signs, ekg, and laboratory tests * females must use an effective method of contraception for the duration of the study exclusion criteria: * dsm-iv diagnosis of abuse or dependence on alcohol or drugs other than nicotine * current axis i diagnosis or current treatment with psychotropic medications within the three months prior to enrollment * history of schizophrenia or other psychotic disorders, bipolar disorder, or anxiety disorders * currently seeking treatment for nicotine disorders * on parole or probation * history of seizures or head trauma with loss of consciousness, brain contusion, or fracture * history of significant recent violent behavior * blood pressure greater than 150/90 * history of eating disorders * history of allergic reaction to any of the study medications * pregnant

Keywords: tobacco use
remote blood pressure monitoring with the wearable senbiosys photoplethysmographic device

Conditions: Blood Pressure

Summary: during the last couple of years, a growing number of wearable devices evolved to provide accurate, cheap and non-invasive monitoring of vitals parameters.this connected care technology could be helpful for treatment and care during a pandemic such as covid-19. the use of these non-invasive remote monitoring devices can help health care providers to assess patient's vital signs and symptom progression, reducing reducing patient and healthcare provider contact and exposure to covid-19 during this pandemic.

several cuff-less blood pressure monitoring devices have emerged in patient care using photoplethysmography. ppg utilizes an infrared or visible light to measure peripheral volumetric variations of blood circulation and its waveform has been proven to have a good correlation with bp waveform.nonetheless, the accuracy of these instruments is of fundamental importance. several validation procedures for assessing the precision of bp monitoring devices have been developed, including protocols by the association for the advancement of medical instrumentation, international organization for standardization and european society of hypertension. adherence to these guidelines are essential to ensure the effectiveness of bp measurement of the wearable devices. therefore, the investigators propose to test wearable low-noise, low-power senbiosys photoplethysmography signals for estimation of bp.

Eligibility criteria:
participants fulfilling the following inclusion criteria are eligible for the study: * age ≥ 18 years * patients referred for coronarography * patient in the intensive care unit requiring invasive blood pressure monitoring and with an arterial catheter in place at the time of inclusion to the study the presence of any of the following exclusion criteria will lead to exclusion of the participant: * unable or unwilling to provide written informed consent * coronarography in patients with myocardial infarction * patient with suspected or certified covid-infection * patients with atrial fibrillation

Keywords: blood pressure remote monitoring covid-19
effect of plugging the registration pin tract in robotic-assisted knee surgery

Conditions: Arthropathy of Knee; Complication of Surgical Procedure

Summary: introduction: complications of robotic-assisted total knee arthroplasty (tka) seem to be rare and consist mainly of infections or fractures. in the reinier haga orthopedisch centrum (rhoc), postoperative bleeding is experienced to be a complication that often occurs, mainly at the tibial wounds of the registration pins used in robotic-assisted tka. this often results in longer hospital stay and might interfere with the current fast track knee surgery by a delayed discharge. to overcome this complication, nowadays bone plugs are used in the two drill-holes. currently, it is unknown whether these bone plugs reduces the incidence of postoperative bleeding. objective: to evaluate the incidence of postoperative bleeding in patients that underwent a robotic-assisted tka and received bone plugs in the two drill-holes in the tibia, compared to patients that underwent the same operation but did not receive bone plugs. study design: retrospective, inventory study study population: all patients that underwent a robotic-assisted tka in the rhoc from december 2020 till october 2022. intervention: in the past, some patients that underwent a robotic-assisted tka received a bone plug in the two tibial drill-holes. this bone is collected from the excess bone that is removed during the operation. main study parameters/endpoints: incidence of postoperative bleeding in both groups.


Eligibility criteria:
inclusion criteria: * underwent robotic-assisted total knee arthroplasty between december 2020 and october 2022 with or without the use of bone plugs * does not object against use of medical data

Keywords: robotic-assisted surgery bone plug
autonomic failure patients for rna blood sampling

Conditions: Pure Autonomic Failure; Multiple System Atrophy; Parkinson's Plus Syndromes

Summary: the purpose of this study is to identify 15 patients with autonomic failure and obtain blood samples for rna from those participants and 15 control subjects within the same age range. the stabilized blood samples, along with a limited data set, will be shipped to western michigan university where the actual laboratory analysis (a separate study) of the samples will take place. unique genetic inscriptions, called gene expression signatures, are currently being identified for many diseases, including neurological diseases. the secondary goal of this study is to support the research being done at wmu and they try to look for msa-specific signs are present in whole blood samples of msa patients at late-stages of the disease. this is a pilot study that has a long term goal (through additional studies) a msa-specific gene expression signature for the development of a diagnostic test for this disease that can be used in the future. other patient groups with autonomic failure, characterized by significant drop in blood pressure on standing, will also be included in this study, to look for similar genetic inscriptions. this pilot study is expected to last for 2 years. the investigators at wmu will need some de-identified health information about the subjects, including their age at diagnosis, age (when sample drawn) and list of their medications

patients with one of the following autonomic problems will be recruited to participate in this study: multiple systems atrophy (msa), pure autonomic failure (paf) or parkinson's plus. the study consists of drawing 15 ml of whole blood for rna. the blood is drawn in special collection tubes to stabilize the rna material in the blood. the samples will be frozen and shipped to wmu for analysis. the patients will also be asked to provide the current list of their medications, their age and the age when they were first diagnosed with their neurologic or autonomic disorder. this information will be de-identified and sent to the investigators at wmu as a limited data set.

Eligibility criteria:
inclusion criteria for patients: * presumed or probably diagnosis of autonomic disorder characterized by orthostatic hypotension * age between 50 - 75 years * male or female * able and willing to provide consent inclusion criteria for controls: * absence of neurological disorder * age between 50 - 75 years * male or female * able and willing to provide consent exclusion criteria: * inability to provide consent

Keywords: gene expression changes in blood cells rna pure autonomic failure multiply system atrophy parkinson's plus
comparison between effect of systemic fentanyl infusion and fentanyl added as an adjuvant to lidocaine in bier block for controlling pain in patients undergoing hand surgeries

Conditions: Bier Block; Hand Surgery

Summary: injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain. various techniques of regional anesthesia are frequently used for upper extremity surgery. specifically, intravenous regional anesthesia, the bier block, is an effective anesthetic technique. this technique, developed by dr august bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. however, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome the aim of this study to evaluate the effect of systemic fentanyl infusion compared to addition of fentanyl as an adjuvant to lidocaine in bier block for controlling pain in patients undergoing hand surgeries

injury and deformity of the upper extremity can result in dysfunction to nerves, tendons and bones which can lead to disability and pain. various techniques of regional anesthesia are frequently used for upper extremity surgery. specifically, intravenous regional anesthesia, the bier block, is an effective anesthetic technique. this technique, developed by dr august bier in 1908, provides complete anesthesia, a bloodless field, and eliminates the need for general anesthesia. however, it was not until the 1960s that this technique was reintroduced and used in upper extremity surgery due to several disadvantages and reports of major complications. because of the dose of lidocaine and tourniquet time, there is potential for cardiac and neurological complications such as arrhythmias, seizures, and compartment syndrome

Eligibility criteria:
inclusion criteria: * patients age from 18 years to 40 years * both sex * patients of the american society of anesthesiologists (asa) physical status class i and ii * bmi less than 40 exclusion criteria: * • patients who refuse to participate in study. * uncooperative patients. * patient with crush injury * peripheral vascular, neurological or muscle diseases. * coagulation disorders that affect the blood's clotting activities e.g.: hemophilia. * history of hypersensitivity to the drugs being evaluated

Keywords: systemic fentanyl infusion fentanyl added as an adjuvant to lidocaine
pharmacokinetics of omadacycline in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.

omadacycline exhibits excellent activity against bacteria including methicillin-resistant staphylococcus aureus (mrsa), burkholderia cepacia, and nontuberculous mycobacteria (ntm) that are a potential source of lung infection in cf patients. as omadacycline demonstrates antimicrobial activity against a number of pathogens in cf, the investigators hope to learn the optimal dose of omadacycline necessary to treat lung infections in patients with cf in the future. the study hypothesis is that omadacycline will exhibit good oral bioavailability in patients with cf.

Eligibility criteria:
inclusion criteria: * diagnosis of cf based on positive sweat chloride or known cf mutation * age \>=18 years exclusion criteria: * presence of an ongoing acute pulmonary exacerbation defined based on clinical signs \& symptoms and an acute decline in relative fev1 of 10% or greater. * pregnancy or breastfeeding * serious past allergy to a tetracycline antibiotic * no alcohol, nicotine, or caffeine-containing products during the study period * hemoglobin \< 8 g/dl
gene polymorphisms influencing steroid synthesis and action

Conditions: Disorders of Sex Development; Congenital Adrenal Hyperplasia; Congenital Adrenal Hypoplasia; Adrenal Insufficiency; Mineralocorticoid Deficiency; Intersex

Summary: the extend of steroid biosynthesis and action is mainly dependent on underlying genetic polymorphisms and gene mutations. these sequence variations in multiple genes involved in steroid biosynthesis and action cause different diseases (for example congenital adrenal hyperplasia or disorders of sex development). in addition, sequence variations in several other genes may influence the severity of a genetically caused disease of steroid biosynthesis or action. by this, the differences in an observed phenotype may be explained. within the study all genes necessary for adrenal and gonadal steroid biosynthesis and several genes which are known to influence the action of steroid hormones will be analysed in patients with congenital disorders of adrenal and gonadal steroid biosynthesis, disorders of steroid action and disorders of sex development. the primary aim is to set up a correlation of the disease phenotype with the different genotypes detected.


Eligibility criteria:
inclusion criteria: * disorders of sex development * congenital adrenal hyperplasia * congenital adrenal hypoplasia * adrenal insufficiency * mineralocorticoid deficiency * salt-loss
a study to evaluate the safety and tolerability of arbaclofen placarbil (xp19986) in subjects with acute back spasms

Conditions: Back Pain

Summary: the purpose of the study is to evaluate safety and tolerability of arbaclofen placarbil sustained release tablets taken every 12 hours compared to placebo in subjects with acute back spasms in the lumbar region.


Eligibility criteria:
inclusion criteria: 1. acute moderate to severe muscle spasms in the lumbar region, as indicated by a minimum visual analog scale pain severity score of 4.0 cm, beginning either: * within four days prior to screening for subjects who do not require a 24-hour washout or * within three days for subjects who require a 24-hour washout 2. willing to discontinue all analgesics (e.g. nsaids, cox-2 inhibitors, acetaminophen), aspirin \>81 mg/day, short-acting muscle relaxants (i.e. carisoprodol, soma®), and herbal remedies for pain at least 24 hours prior to first dose and to refrain from use during the study (cardio-protective doses of aspirin ≤ 81 mg /day are allowed). exclusion criteria: 1. clinically significant abnormal neurological history or examination at screening (excluding back spasm), including lumbar radicular symptoms, spinal stenosis, foot drop, herniated nucleus pulposus, or other structural defects 2. subjects with back spasm related to major trauma to the region 3. subjects with muscle spasms due to a work-related injury or subjects involved in any injury-related litigation 4. subjects using any of the following medications at screening: * opioids, both short- and long-acting including but not limited to: morphine, fentanyl patch, oxycodone, tramadol) * benzodiazepines, such as valium and lorazepam * cyclobenzaprine containing drugs (e.g., flexeril, amrix) * carisoprodol (e.g., soma®) within 24 hours of screening

Keywords: acute back pain in the lumbar region