Kornimate/medical-research-clean huggingface dataset:
single ascending dose study of biib037 in participants with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary objective of the study is to evaluate the safety and tolerability of a range of biib037 doses administered as single intravenous (iv) infusions in participants with mild to moderate alzheimer's disease (ad). secondary objectives of this study in this study population are to assess the pharmacokinetics(pk) and to evaluate the immunogenicity of biib037 after single-dose administration.

biib037 is an investigational product being developed as a treatment for alzheimer's disease (ad). biib037 is a fully human immunoglobulin gamma 1 (igg1) monoclonal antibody that is selective for the fibrillar form of beta amyloid (aß).

Eligibility criteria:
key inclusion criteria: * must be ambulatory * must have a clinical diagnosis of alzheimer's disease (ad) consistent with the following: 1. probable alzheimer's disease (ad), according to national institute of neurological and communicative disease and stroke and alzheimer's disease and related disorders association (nincds-adrda) criteria \[mckhann et al. 1984\]. 2. dementia of alzheimer's type, according to diagnostic and statistical manual of mental disorders-text revision (dsm iv tr) criteria \[american psychiatric association 2000\] * subject (or subject's permanent caregiver) has the ability to understand the purpose and risks of the study and provide signed and dated informed consent (or assent) and authorization to use protected health information (phi) in accordance with national and local subject privacy regulations. * must have a mini mental state examination (mmse) score of 14 to 26 inclusive. key exclusion criteria: * any medical or neurological condition other than alzheimer's disease (ad) that in the opinion of the investigator could be a contributing cause of the subject's dementia (e.g., medication use, vitamin b12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, diffuse lewy body disease, head trauma). * history within the past 6 months or evidence of clinically significant psychiatric illness (e.g., major depression, schizophrenia, or bipolar affective disorder). * subject currently lives in a nursing home. * blood donation (1 unit or more) within the 1 month prior to screening * participation in any other drug, biologic, device, or clinical study or treatment with any investigational drug or approved therapy for investigational use within 30 days (or 5 half lives, whichever is longer) prior to screening, and/or participation in any other clinical study involving experimental medications for ad within the 60 days (or 5 half lives, whichever is longer) prior to screening. * any contraindications to having a brain magnetic resonance imaging (mri) e.g., pacemaker; non-magnetic resonance imaging (mri)-compatible aneurysm clips, artificial heart valves, or other metal foreign body; claustrophobia). note: other protocol defined inclusion/exclusion criteria may apply.
bioimpedance analysis in chronic heart failure

Conditions: Heart Failure

Summary: the aim of this study is to investigate whether the objective measurement of fluid overload by bioimpedance analysis (body composition monitor-bcm) in patient with acute decompensated heart failure would improve the diuretic therapy.


Eligibility criteria:
inclusion criteria: * patients with known or newly discovered chronic heart failure admitted to hospital because of the clinical signs of acut cardiac decompensation exclusion criteria: * high level of fatigue (the patient cannot stand on a scale) * amputated upper and/or lower limb(s) * the bcm analysis is not possible technically (e.g. open wounds on the limbs) * severe obesity (\>130 kg) * patients on chronic hemodialysis or peritoneal dialysis * severe fluid volume in the transcellular space * patients with a unipolar pacemaker whose sensitivity threshold is very low * pregnancy, lactation

Keywords: heart failure bioimpedance analysis fluid overload
regional blood saturation levels in gastroschisis

Conditions: Gastroschisis; Intestinal Ischemia

Summary: gastroschisis is one of the most common neonatal surgical conditions, and is increasing in incidence. postnatal bowel ischemia leading to necrosis, bowel loss and short-bowel syndrome, occurs in a few instances, with significant impact. intestinal gangrene occurs in up to 37%. the cause of the gangrene can be multifactorial. contributing factors can be volvulus; venous engorgement with ensuing arterial compromise; constriction of the gut mesentery at the defect; and contribution of the hydrostatic effect of the column of bowel within a silo. theoretically, the increased hydrostatic pressure incurred by the bowel in a preformed silo, may decrease blood flow to the apex of the bowel and contribute to ischemia. however, this does not seem to be the norm, as most cases do well in the silo. cases of intestinal ischaemia within the silo have been described in patients. any objective measure of bowel perfusion and therefore viability which can aid clinical assessment and management may benefit patient outcome. near-infrared spectroscopy (nirs) is used to noninvasively measure and monitor changes in the approximate regional haemoglobin oxygen saturation (so2) in the blood. measurement of oxygen saturation using nirs is already in clinical application in other neonatal and paediatric medical and surgical diseases. nirs has been recommended as a good trend indicator of changes in neonatal tissues oxygenation. nirs-measured duration of cerebral oxygen desaturation is an accurate predictor of postoperative neurological injury in children undergoing cardiac surgery. the investigators propose to use nirs to measure so2 in the intestinal bed in patients with gastroschisis and to ascertain if there is any clinical advantage to routine monitoring in these patients. the aim of the study will be to: 1. measure gastrointestinal so2 (gso2) of the bowel within the silo of gastroschisis patients 2. identify the clinical progress of patients with gastroschisis in the postnatal period 3. identify any association of the measured gso2 with the clinical outcome and any gastrointestinal complications


Eligibility criteria:
inclusion criteria: * gastroschisis diagnosed antenatally or at birth exclusion criteria: * associated congenital condition affecting respiratory system , cardiovascular system or global development * generalised sepsis
comparison between a standard tube and the ultra-thin tritube for intubation of the trachea and for maintaining access to the trachea after anaesthesia, in patients with an expected difficult direct laryngoscopy

Conditions: Oral Neoplasm; Pharynx Cancer; Larynx Cancer

Summary: the investigators compare the ease of intubation between a new ultra-thin endotracheal tube, "tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. furthermore the investigators compare the acceptance of leaving the tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter.

in patients scheduled for surgery and anaesthesia in the head-/neck/ear/nose/throat -region the investigators compare the ease of tracheal intubation between a new ultra-thin endotracheal tube, "tritube", and a standard endotracheal tube in patients with predictors of difficult laryngoscopy. the intubation is performed with an angulated video laryngoscope. furthermore the investigators compare the acceptance of leaving the tritube in trachea after end of anaesthesia, with the use of a tube exchange catheter. the latter continues into the post-operative recovery-ward.

Eligibility criteria:
inclusion criteria: * patients for anaesthesia for surgery in the head-/neck/ear/nose/throat * planned for oral intubation with video-laryngoscopy * with risk factors for difficult direct laryngoscopy exclusion criteria: * patient with increased secretions in the airway (pneumonia, bronchitis, productive cough) * patients planned for awake intubation * patients where mask-ventilation is judged to could become impossible * patients where access to the cricothyroid membrane is judged to be difficult or impossible * patients in asa (american society of anaesthesiologists) physical classification status \>3 * patients who are scheduled for rapid sequence induction (rsi) due to risk of aspiration * patients with stridor * patients with hypoxemia (saturation \< 90 % in room air) * operation duration planned to \> 2.5 hours * patients with the need for a nerve-stimulation-tube during surgery
extension study of imo-8400 in patients with waldenström's macroglobulinemia who completed study 8400-401

Conditions: Waldenstrom's Macroglobulinemia

Summary: an extension study for patients who complete 24 weeks of imo-8400 on study 8400-401.

patients who had no evidence of disease progression or toxicity while participating in study 8400-401 (nct02092909) will continue to receive imo-8400 until disease progression, adverse event or the investigator deems the goals of extended treatment with imo-8400 have been met.

Eligibility criteria:
inclusion criteria: * completed 24 weeks of treatment in protocol 8400-401 exclusion criteria: * grade 3 (or higher) adverse event assessed as treatment-related at any time during the course of treatment under protocol 8400-401. * has evidence of disease progression under protocol 8400-401. * has received other anti-cancer therapies other than imo-8400 since enrolling in protocol 8400-401.
capsaicin in treatment of rhinogenic headache

Conditions: Headache Disorders

Summary: description: capsaicin (8- methyl-n-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis. we hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches, in addition to the previously studied decongestive effects. this study aims to evaluate capsaicin impact on headaches attributed to v1, v2 distribution of the sinonasal cavity. this study is a randomized, double-blinded, parallel trial.

1. title: the role of capsaicin in treatment of rhinogenic headache 2. description: capsaicin (8- methyl-n-vanillyl-6-nonenamide) has been demonstrated to have a therapeutic effect in idiopathic rhinitis, migraines and cluster headaches. we hypothesize that capsaicin has a therapeutic effect on rhinogenic headaches as well. this study aims to evaluate capsaicin impact on headaches attributed to the nose and paranasal sinus distribution. 3. interventions, evaluations, and follow-up: subjects are recruited from an otolaryngology clinic, where a formal headache questionnaire is administered in-office, and standard endoscopy is performed in office to rule out confounding causes of headache and sinonasal disease. written instructions are provided and consent obtained. a symptom journal is provided. subjects are randomly selected to receive two bottles of either eucalyptol spray (placebo) or sinus buster (capsaicin) spray and are blinded to the content of the spray bottle. they are instructed to use the nasal spray one to two times daily. subjects are permitted to continue to take headache medication as needed, but it must be recorded in their symptom journal. the journal is completed daily, and includes medication use, a headache pain score, and side effect log. additionally, subjects fill out sinonasal outcome test (snot)22 at 2 weeks, 4 weeks, and 8 weeks. weekly emails are sent to remind subject to fill out their journal. a phone call is made to the subject to survey them on progress at 2 and 6 weeks. follow up visits are scheduled at 4 weeks and 8 weeks, or sooner if problems arise. a standard nasal endoscopy is performed at the first and last visit. 4. additional data that would be tracked: quality of life score as measured by snot-22 scores, treatment failure and drop-outs, and objective changes in sinus endoscopy.

Eligibility criteria:
inclusion criteria: * consenting adults aged 19-100 presenting to the otolaryngology departmentofuniversityof nebraska medical center complaining of headaches/ facial pain and pressure diagnosis of a primary rhinogenic headache disorder by the senior authors. exclusion criteria: * exclusion criteria include: pregnancy, age less than 19, active history of smoking, presence of confirmed sinonasal disease, fibromyalgia, poorly controlled chronic health problems, allergies to chili peppers or any ingredient in the nasal spray, or confirmed temporal mandibular joint (tmj) arthralgia as the etiology of primary headache.
rly-1971 in subjects with advanced or metastatic solid tumors

Conditions: Solid Tumor, Unspecified, Adult

Summary: this study is a multi-center, open-label, dose escalation and expansion study of rly-1971 in subjects with advanced or metastatic solid tumors.

dose escalation/dose expansion study to assess the mtd, safety, tolerability, pk and preliminary anti-tumor activity of rly-1971. approximately 70 patients

Eligibility criteria:
inclusion criteria: subject is willing and able to provide written informed consent for the study prior to the performance of any study-specific procedures subject is a male or female subject ≥18 years of age at the time of consent subject must have an ecog ps ≤ 1 subject must have histologically or cytologically confirmed advanced or metastatic solid tumor subjects who are refractory to fda-approved, standard therapy or for which standard or curative therapy does not exist or is not considered sufficient or appropriate by the patient or investigator subject must have radiographically measurable or evaluable disease subject must have recovered from the reversible effects of prior anti-neoplastic therapy, except for alopecia and ≤ grade 2 neuropathy. subject has adequate end organ function subject is willing to comply with all protocol-required visits, assessments, and procedures male and female subjects of child-bearing potential are willing to use medically acceptable methods of birth control from the screening visit through 30 days after the last dose of study medication exclusion criteria: subjects with documented history of tumor mutations that may not be amenable to treatment with rly-1971, including: kras mutations: g12d, g12v, g13x, and q61x braf v600e mutation mek mutations subjects with prior antineoplastic therapy within 3 weeks of study day 1, or 5 half-lives, whichever is shorter subjects with prior palliative radiotherapy within 1 week of study day 1 subjects who have had major surgery or trauma, or incomplete recovery from surgery or trauma, within 4 weeks of study day 1 subjects with known central nervous system (cns) metastases or primary cns tumor that is associated with progressive neurologic symptoms or requires increasing doses of corticosteroids to control the cns disease. if patient requires corticosteroids for management of cns disease, the dose must have been stable for the 2 weeks preceding c1d1, or subject has new lesions appearing on follow up brain mri that require cns-directed intervention. subjects with a history or evidence of ophthalmic disease subjects with a history or evidence of significant cardiac dysfunction subjects with a history or evidence of significant gastrointestinal disease subjects with other serious concurrent medical conditions subject is pregnant, as documented by a serum beta human chorionic gonadotropin (β-hcg) pregnancy test consistent with pregnancy obtained within 7 days before the first dose of study treatment

Keywords: solid tumors advanced or metastatic solid tumors phase 1 first in human (fih) shp2 inhibition ptpn11 bypass resistance gdc-1971 ro7517834
transition to adulthood through coaching and empowerment in rheumatology

Conditions: Juvenile Idiopathic Arthritis; Juvenile Rheumatoid Arthritis; Juvenile Dermatomyositis; Juvenile Psoriatic Arthritis; Autoinflammatory Disease; Autoimmune Diseases; Lupus Erythematosus

Summary: tracer is a study aiming to investigate the feasibility of transition coaching sessions for patients moving from paediatric to adult rheumatology care.

tracer is a feasibility study investigating transition coaching for patients with rheumatic disease transferring from paediatric to adult rheumatology care. this is a vulnerable time in the patients' care and life as they are assuming more responsibility for their health and undergoing significant life transitions. there is risk for increased morbidity and mortality around this time if the patient are not well supported and if they do not stay engaged with care. this intervention aim to provide self-efficacy, self-management, coping skills and support to patients making the transition. this study aims to assess the feasibility of conducting a multi-centre randomized trial.

Eligibility criteria:
inclusion criteria: * patient with pediatic-onset rheumatic disease * at their last paediatric rheumatology appointment prior to transferring to adult rheumatology care * able to communicate in english * have a phone or device capable of participating in video conference * available over the next 8 months exclusion criteria: * cognitive impairment preventing participation in individualized education sessions (as determined by medical staff)

Keywords: transition care transition coaching
5-year clinical evaluation of cavity lining on the restoration

Conditions: Teeth; Lesion; Dental Root Caries

Summary: the purpose of this double-blind, randomized trial is to compare the clinical performance of a composite restorations in root surface carious lesions with or without resin modified glass ionomer lining.

thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. after caries removal, the depth, length, and width of the cavity were measured. lesions in the same patient was randomly divided into two groups, and the dentin surfaces were either lined with resin-modified glass ionomer liner (glass liner ii, willmann \& pein gmbh dental, barmstedt, germany) or not. all cavities were restored with nanohybrid composite resin (clearfil majesty esthetic, kuraray, tokyo, japan). a total of 100 restorations (50 lined, 50 unlined) were placed according to manufacturer's instructions. the restorations will be evaluated at baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified haveman criteria for marginal adaptation, anatomic form, marginal staining, anatomic form, caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity. statistical analysis will be conducted using the chi- square, fisher's exact, mann whitney-u and cochran q tests at a significance level of 5% (p \< 0.05).

Eligibility criteria:
inclusion criteria: * non-hospitalized, healthy patients that were seeking dental treatment for caries lesions on the root surface exclusion criteria: * patients who were under the age of 18 years * complex medical history * severe or chronic periodontitis * extreme carious activity * heavy bruxism * very deep or superficial carious lesions * previously restored and abutment teeth

Keywords: root caries cavity lining composite resin restorations self-etch adhesive
a study of hepatitis c virus (hcv) polymerase inhibitor pro-drug in combination with pegasys plus copegus compared with pegasys plus copegus in patients with chronic hepatitis c genotype 1 infection.

Conditions: Hepatitis C, Chronic

Summary: this 7 arm study will determine the optimal treatment combination, based on efficacy and safety. patients with chronic hepatitis c (chc), genotype 1, will be randomized to one of 7 treatment groups. groups 1, 2, 4, 5 and 6 will receive triple combination treatment with hcv polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus pegasys (90 or 180 micrograms sc weekly) plus copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label standard of care (pegasys 180 micrograms sc weekly plus copegus 1000/1200mg po qd). group 3 will receive hcv polymerase inhibitor pro-drug 500mg po bid plus pegasys 180 micrograms sc weekly plus copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (rvr) will stop all medication, and non-rvr patients will remain on triple combination for an additional 24 weeks. group 7 will receive standard of care (soc) for 48 weeks. there will be a 24 week period of treatment-free follow-up for all treatment groups. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-65 years of age; * chronic hepatitis c, genotype 1; * chronic liver disease consistent with chc; * compensated liver disease. exclusion criteria: * infection with any hcv genotype other than genotype 1; * previous treatment for chc; * medical condition associated with chronic liver disease other than chc; * hiv, hepatitis a, hepatitis b infection.
fetuin-a, a promising serum biomarker for diagnosis of non-alcoholic fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: the work investigate the role of fetuin-a in the diagnosis and assessment of the severity of non-alcoholic fatty liver disease (nafld).

the prevalence of nonalcoholic fatty liver disease (nafld), which has recently become one of the most prevalent chronic liver illnesses, is about 25% worldwide. nafld is a progressive liver disease that can cause fibrosis and ultimately cirrhosis, in contrast to simple hepatic steatosis, which is considered to be a benign condition. the sole way to diagnose nafld and stage liver fibrosis has historically been a liver biopsy. there are a number of issues with this method, though. a liver biopsy is a painful and invasive diagnostic procedure that carries a risk of consequences. fetuin-a, also called the 2-heremans-schmid glycoprotein, belongs to the fetuin group of serum-binding proteins and is largely produced by hepatocytes. it is a phosphorylated glycoprotein. fetuin-a can cause insulin resistance in the target organs, including the liver and skeletal muscle, as it is an endogenous tyrosine kinase inhibitor. a strong correlation between the level of circulating fetuin-a and the onset and progression of nafld has been described by accumulating lines of evidence, but the findings have been contradictory. the investigators want to find out how fetuin-a affects the diagnosis and evaluation of the severity of non-alcoholic fatty liver disease (nafld) and to reveal the relationship between fetuin-a and the nafld fibrosis score (nfs).

Eligibility criteria:
inclusion criteria: * patients who were admitted to the university hospitals with inclusion criteria exclusion criteria: * patients who are younger than 18 years old, * patients with a history of high alcohol consumption (more than 40 g/day for men and 20 g/day for women) over the previous five years, * patients who have concurrent hepatitis b and hepatitis c viral infections * patients with hepatobiliary malignancy, wilson's disease, alpha-one antitrypsin deficiency, and autoimmune hepatitis, * pregnant women * patients who take steatogenic pharmaceuticals including amiodarone, valproic acid, antiretrovirals, methotrexate, and tetracyclines, or nafld treatments like vitamin e, metformin, and thiazolidinediones

Keywords: fetuin-a fibroscan nafld