Kornimate/medical-research-clean huggingface dataset:
a study of the efficacy of canakinumab in prevention of acute flares in chronic gout patients initiating allopurinol therapy (core study) and a long-term study of the efficacy and safety of canakinumab in patients with gout (extension study)

Conditions: Gout

Summary: the 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy. the core study was followed by a 24-week open-label, multicenter extension study to assess the safety, tolerability, and efficacy of canakinumab in patients with gout who were given canakinumab at the time of gout flare.


Eligibility criteria:
core study inclusion criteria: * signed written informed consent before any study procedure is performed. * history of at least 2 gout flares in the year prior to screening (visit 1, based on patient history), thus, candidates for initiating uric acid lowering therapy. * confirmed diagnosis of gout meeting the american college of rheumatology (acr) 1977 preliminary criteria for the classification of arthritis of primary gout. * body mass index (bmi) ≤ 40 kg/m\^2. * willingness to initiate allopurinol therapy as urate lowering agent for their gout therapy or having initiated allopurinol therapy within ≤ 1 month before screening (visit 1) or willing to re-initiate allopurinol therapy if this was stopped \> 2 months before screening (visit 1) for reasons different to toxicity/ intolerance or lack of efficacy. exclusion criteria: * acute gout flare within 2 weeks of screening (visit 1) and during the screening period. * history of allergy or contraindication to colchicine or allopurinol. * history of intolerance to allopurinol or to oral colchicine in appropriate dose for prophylactic use. * history of bone marrow suppression. * absolute or relative contraindication to both naproxen and oral prednisolone/ prednisone. extension study inclusion criteria: * patients who completed the core study. a patient is defined as completing the core study if he/she completed the study up to and including the last visit (visit 9). * patients who have signed a written informed consent before any trial procedure is performed. exclusion criteria: * patients for whom continuation in the extension study is not considered appropriate by the treating physician. * 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 pregnancy test (serum or urine). other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: gout chronic gout gouty arthritis gout flares
detection of peripheral blood biomarkers in intermediate phase spinal cord injury: correlation with neurological and functional outcomes, and comparison to other central and peripheral neurological conditions.

Conditions: Spinal Cord Injury

Summary: this research looks for markers in the blood of people with spinal cord injury that may be a sign of injury severity, or serve as a clue to the degree of recovery. investigators would also like to compare the marker profile of these patient with that of other neurological conditions such as stroke and guillain-barre syndrome. patients participating in this trial will be those accepted to neuro-rehabilitation in sheba medical center, israel. they will join the trial at their arrival to the ward, no less than 2 week after the beginning of their condition, but no later than 3 months. patients will be examined by the research staff three times: 1. at arrival, the patients will be neurologically examined and their functional abilities will be assessed. blood will be drawn and sent to the lab. 2. at 6 months after the beginning of the neurological condition the same will be repeated: the patients will be neurologically examined and their functional abilities will be assessed, and blood will be drawn and sent to the lab. 3. the final examination will take place 1 year after the beginning of the neurological condition. this time only the neurological and functional abilities will be assessed without blood tests. the blood samples will be tested in the research lab. then investigators shall compare the clinical findings with the laboratory findings, and see if any of the markers found reflect the injury severity or predict the recovery.


Eligibility criteria:
inclusion criteria: * diagnosis of traumatic or non-traumatic spinal cord injury, guillain-barre syndrome or stroke * no more than 3 months after injury or disease onset * condition severe enough to necessitate hospital/day care unit * signed the informed consent form exclusion criteria: * psychiatric or cognitive situations that may interfere with the trial

Keywords: spinal cord injury biomarkers rehabilitation functional independence prognosis
archimedes compassionate use supplement

Conditions: Pain

Summary: the purpose of this compassionate use supplement to the ide protocol is to assure and monitor the safety of six subjects (in the united states) implanted with archimedes until all remaining implanted pumps are explanted.

pain management has been a long-standing challenge to the medical community, specifically the treatment of chronic pain. on october 3, 2002, fda approved codman's ide study of codman's implantable constant-flow infusion pump system (archimedes). the first subject was implanted on february 12, 2003. since then, ten subjects have had the archimedes implanted, with one subject, implanted twice. codman notified the fda in 2004 that it wished to discontinue enrollment into the study \& bring it to a close because of projected slow enrollment and waning physician interest. codman felt there was no readily acceptable alternate therapy that would not require a pump explant first. it is possible to replace the archimedes with another pump system, which is already approved for use in the united states. however, such an action would necessitate the removal or explant of the archimedes, thereby exposing the subjects to additional risks inherent in such a surgical procedure, including those associated with anesthesia. since these subjects have been treated with the investigational device for at least 2 years without experiencing any unanticipated adverse device effects, codman felt that the risk of explanting the pump was significantly greater than the risk of continuing treatment with the investigational device. it should also be noted that this pump does not have a battery and that replacement is dictated by the number of times the septum is punctured (500). this translates into approximately twenty years of therapy if the septum is punctured an average of 20 times. fda approved codman's compassionate use protocol in 2005.

Eligibility criteria:
inclusion criteria: * u. s. subjects implanted with constant flow pump in 2003. exclusion criteria: * n/a

Keywords: implantable pump intrathecal catheter constant flow pump
psychosocial screening for neuroendocrine tumor patients

Conditions: Neuroendocrine Tumors

Summary: this is a psychosocial screening application to usual care in a cohort of neuroendocrine tumor patients. the application involves monitoring using the nccn distress thermometer(dt), hospital anxiety and depression scale(hads), self-perceived burden scale(spbs) and connor-davidson resilience scale(cd-risc). these assessments will be completed at baseline, 3 months, 6 months, 12 months and 24 months. patients will have the option of filling out questionnaires more frequently if desired.


Eligibility criteria:
inclusion criteria: 1. sign written informed consent form; 2. age ≥ 18 years; 3. pathologically confirmed well-differentiated neuroendocrine tumors, g1-2 (ki67≤20%); exclusion criteria: 1. \<18 years; 2. neuroendocrine carcinoma; 3. history of psychiatric or psychologic illness; 4. history of previous cancers or cancer distress; 5. patients with central nervous system(cns) disorder； 6. severe, uncontrolled medical condition that would affect patients' compliance;

Keywords: dt hads spbs cd-risc psychosocial screening
pain in adults with autism spectrum disorder

Conditions: Autism; Pain

Summary: pain insensibility is often described in people with autism. the aim of this study is to test the pain perception in adults with autistic spectrum disorder without intellectual disability. an experimental model of pain is used to measure endogenous modulation systems. thermic stimulations (tonic heat pain stimulation and cold-pressor test) are used to test excitatory and inhibitory pain mechanisms. salivary cortisol and automatic nervous system (heart rate and blood pressure with an electrocardiogram (brest :system dantec keypoint natus g3 ; paris: nexfin hd®) are also tested and behavioral response to thermal stimulation assessed by an inspired behavior scale.

adults with autism without intellectual disability (iq \> 85) are matched with members of siblings and control group (sex and chronological age). pain reactivity (visual analog scale,endogenous modulation systems, salivary cortisol, automatic nervous system and behavioral responses to thermal stimulation assessed by an inspired behavior scale.) in adult with autism is tested using an experimental model of pain. excitatory and inhibitory modulation systems were elicited using a temporal summation test administered before and after activation of the diffuse noxious inhibitory control (dnic) by means of a cold-pressor test. demographic and clinical data are also collected (sensory profile, sleep disorders and depression inventory).

Eligibility criteria:
non-specific inclusion criteria: * intellectual quotient \>85 * consent form signed inclusion criteria autism group : * autism diagnosis (cim 10) from multidisciplinary evaluation (adi-r, ados) * sibling without autism or developmental disorder non-specific exclusion criteria: * chronic pain * pregnancy, breast feeding * consent form no signed exclusion criteria sibling and witness groups: - diagnosis of autism or developmental disorder

Keywords: high functioning autism endogenous modulation systems
two-part, open-label, multi-center, phase 1/2 study of biw-8962 as monotherapy in subjects with lung cancer

Conditions: Phase 1 Portion : Non Small Cell Lung Cancer(NSCLC), Small Cell Lung Cancer(SCLC), Mesothelioma; Phase 2 Portion : Small Cell Lung Cancer(SCLC)

Summary: this phase 1/2 study is designed to assess the following: safety and tolerability of biw-8962, dose limiting toxicities (dlts), maximum tolerated dose (mtd), recommended phase 2 dose (rp2d) in phase 1 in subjects with advanced/recurrent lung cancers or mesothelioma and preliminary efficacy in phase 2 in subjects with advanced/recurrent small cell lung cancer.


Eligibility criteria:
inclusion criteria: * phase 1: histopathological-documented, measurable or non-measurable unresectable, advanced primary or recurrent sclc, nsclc or mesothelioma * phase 2: measurable, unresectable advanced or recurrent sclc * a life expectancy \> 3 months * eastern cooperative oncology group (ecog) performance status score of 0-1 at study entry * echocardiogram or multigated acquisition (muga) scan with left ventricular ejection fraction (lvef) ≥ 50%, or ≥ institution's established lower limit of normal * adequate hematologic, hepatic, renal and lung function exclusion criteria: * subject received cytotoxic anti-cancer chemotherapy, orally available signaling pathway-targeted therapy, hormonal therapy, radiotherapy, immunotherapy, or investigational agents within 3 weeks prior to the first dose * subject received monoclonal antibodies within 4 weeks of the first dose * major surgery within 4 weeks prior to the first dose * known symptomatic brain metastases * clinically significant cardiovascular disease * leptomeningeal disease * uncontrolled intercurrent illness including ongoing or active infection, uncontrolled diabetes, etc * known hiv disease or acquired immunodeficiency syndrome-related illness * a psychiatric illness, disability or social situation * hypersensitivity reaction to monoclonal antibodies, other therapeutic proteins * a history of primary brain/cns malignancy * neurological paraneoplastic syndrome
brainstem and prematurity

Conditions: Very Premature Infants

Summary: although significant advances in neonatal care have increased survival rates of preterm infants born before 28 weeks gestation, a concomitant decrease in neuro developmental disorders has not been achieved. cerebral injuries, well documented during the previous years, in preterm babies are particularly deleterious since they occur in a developing brain. they affect both white and grey matter by complex mechanisms and the principal targets are the developing oligodendrocytes and neurons of the subplate. all these criteria define the encephalopathy of prematurity. nevertheless, the consequences of prematurity at the level of the brainstem are not very well known and may explain neuro-developmental disorders with normal mri. the assessment of the motor repertoire is complementary to the neurological examination and may represent a diagnostic tool for cerebral palsy, mild motor deficits and delayed acquisition in children. the newborn have a rich motor repertoire. gms play a key role in the development due to the feedback that they send to cortical neurons and reflect the maturational stage of the central nervous system (cns). lesions of the brainstem caused by prematurity may induce alterations of the motor repertoire. dysautonomic disorders, such as bradycardia, apneas, feeding problems, that occur frequently in very preterm babies reflect brainstem abnormalities. these symptoms are also described in other pathologies, in rett syndrome and sudden infant death syndrome (sids). in these pathologies deficits of the 5-ht system have been described and associated with dysautonomia. it would then be interesting to evaluate 5-hydroxytryptamine (5-ht) levels in very preterm babies. the serotonergic system develops very early during gestation and is one of the first neurotransmitter to appear in the developing brain. the main 5-ht nuclei are located within the brainstem. 5-ht plays an important role in the homeostasis and the modulation of the respiratory network. moreover, previous studies have shown that 5-ht projections to the spinal cord are involved in posture and in the coordination. it is tempting to think that 5-ht deficits may have some repercussions on the development of the cns, changing activity dependent processes, such as spontaneous activity recorded at the spinal level in rodents. in this project, the 5-ht platelet levels in preterm infants born before 28 weeks will be compared with newborns. a correlation between the levels of 5-ht with mri of the posterior fossa, gms and dysautonomia different parameters such as heart rate variability, suction-swallowing and different breathing techniques will be established


Eligibility criteria:
inclusion criteria: * birth less than 28 weeks * known gestational age * birth in born * infant without genetic syndrom, evolutive neurologic disease, chronic disorder, malformative pathology * infant without intra-ventricular haemorrhage with dilatation or intraparenchymal haemorrhage * infants without mechanical ventilation exclusion criteria: • infant with congenital cardiopathy, congenital brainstem disorder, pierre robin sequence
a combination study of pf-04449913 (glasdegib) and azacitidine in untreated mds, aml and cmml patients

Conditions: Myelodysplastic Syndrome; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia

Summary: this multi center open label phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (pk), and pharmacodynamics (pd) of glasdegib (pf-04449913) when combined with azacitidine in patients with previously untreated higher risk myelodysplastic syndrome (mds), acute myeloid leukemia (aml), or chronic myelomonocytic leukemia (cmml). this clinical study includes two components: (a) a safety lead in cohort (lic) and (b) an expansion phase with an aml cohort and an mds cohort.


Eligibility criteria:
inclusion criteria: * patients must have previously untreated mds, aml, or cmml according to the who 2016 classification. * mds patients must have intermediate (\>3 to 4.5 points), high risk (\>4.5 - 6) or very high risk (\>6 points) disease according to the revised international prognostic scoring system 2012 (ipss-r). * clinical indication for treatment with azacitidine for mds or aml. exclusion criteria: * patients with aml who are candidates for standard induction chemotherapy as first line treatment. * patients with known active cns leukemia. * prior treatment with a smoothened inhibitor (smoi) and/or hypomethylating agent.

Keywords: mds aml cmml
second 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 additional 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, or other corneal endothelial dystrophies * keratoconus; * long term polymethyl methacrylate 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 post-op surgical trauma including bullous keratopathy; * history of corneal transplant; * evidence of physical injury or trauma to the cornea; * long term fuch's dystrophy, guttata or other corneal endothelial dystrophies; * keratoconus; * long term pmma contact lens use (greater than 3 years); * 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; * fixation problems which may prevent obtaining good quality sp-1p and cellchek plus in either eye. exclusion criteria - pathologic adults (29-80 years old): * 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; * fixation problems which may prevent obtaining good quality sp-1p and cellchek plus in either eye.
behavioral therapy plus naltrexone for alcoholism

Conditions: Alcoholism; Alcohol Dependence

Summary: this study will compare cognitive behavioral therapy with a time-limited motivational enhancement therapy to which naltrexone (revia) or placebo medication is added. in this randomized clinical trial, 160 alcohol-dependent outpatients, after 5 days of abstinence, will receive one of the two psychosocial therapies and either naltrexone (revia) or placebo for a 12-week treatment period. abstinence rates, alcohol use, and time to alcohol relapse will be evaluated in all four groups along with measures of alcohol craving, biological measures of alcohol consumption, drinking consequences, changes in self-confidence for avoiding alcohol, and medication compliance. all study participants will be assessed for measures of outcome variables at 3 and 6 months after completing the treatment protocol.


Eligibility criteria:
inclusion criteria: * meets criteria for alcohol dependence, has not had more than one previous inpatient medical detoxification. * consumes on average five standard drinks per day. * able to maintain sobriety for five days (with or without the aid of detoxification medications) as determined by self-report, collateral report, and breathalyzer measurements. * able to read and understand questionnaires and informed consent. * lives within 50 miles of the study site. exclusion criteria: * currently meets criteria for any other psychoactive substance dependency disorder. * ever abused opiates. * used psychoactive substance abuse, except marijuana, within the last 30 days as evidenced by patient report, collateral report, and urine drug screen. * meets criteria for disorders of major depression, panic disorder, obsessive-compulsive disorder, post-traumatic stress syndrome, bipolar affective disorder, schizophrenia, or any other psychotic disorder or organic mental disorder. * meets criteria for dissociate disorder or eating disorders. * has current suicidal or homicidal ideation. * need for maintenance or acute treatment with any psychoactive medication including antiseizure medications. * current use of disulfiram (antabuse). * clinically significant medical problems that would impair participation or limit medication ingestion. * hepatocellular disease. * sexually active females of child bearing potential who are pregnant, nursing, or who are not using a reliable form of birth control. * have current charges pending for a violent crime. * does not have a stable living situation and a reliable source of collateral reporting. * has taken an opiate antagonist drug in the last month.

Keywords: alcoholism alcohol dependence naltrexone cognitive behavioral therapy
study assessing vagus nerve stimulation in covid-19 respiratory symptoms

Conditions: Covid-19

Summary: the purpose of this study is to asses the efficacy of the gammacore device reducing the need for mechanical ventilation in patients diagnosed of covid-19


Eligibility criteria:
inclusion criteria: 1. has been tested positive or suspected/presumed positive for covid-19 2. patients with cough, shortness of breath or respiratory compromise (rr\>24/min, increased work of breathing.) 3. o2 saturation less than or equal to 96% on room air or sensation 4. agrees to use the gammacore®-sapphire device as intended and to follow all of the requirements of the study including recording required study data 5. patient is able to provide signed and witnessed informed consent exclusion criteria: 1. on home/therapy oxygen (i.e. for copd patients) at baseline prior to development of covid-19 2. is already enrolled in a clinical trial using immunotherapeutic regimen for covid-19 3. already gammacore for other medical conditions 4. a history of aneurysm, intracranial hemorrhage, brain tumors, or significant head trauma 5. known or suspected severe atherosclerotic cardiovascular disease, severe carotid artery disease (eg, bruits or history of transient ischemic attack or cerebrovascular accident), congestive heart failure, known severe coronary artery disease, or recent myocardial infarction 6. uncontrolled high blood pressure (\>140/90) 7. current implantation of an electrical and/or neurostimulator device, including but not limited to a cardiac pacemaker or defibrillator, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant 8. current implantation of metal cervical spine hardware or a metallic implant near the gammacore stimulation site 9. belongs to a vulnerable population or has any condition such that his or her ability to provide informed consent, comply with the follow-up requirements, or provide self-assessments is compromised (e.g. homeless, developmentally disabled and prisoner) 10. compromised access to peripheral veinous for blood) 11. pregnant women