Kornimate/medical-research-clean huggingface dataset:
dupilumab treatment effects in an ethnically diverse population with chronic rhinosinusitis with nasal polyposis

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: the central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly ethnical and racial minority patients with crswnp

first, it will confirm the effectiveness of dupilumab in the treatment of crswnp in ethnic and racial minority patients who have traditionally been underrepresented in existing clinical trials of biologics in crswnp second, this research will establish a biomarker of therapeutic response to dupilumab identifying the biological effect of dupilumab in crswnp patients and its association with symptom improvement. finally, the investigators will measure the effect of dupilumab on asthma symptoms and lung function in patients with crswnp and comorbid asthma. there will be a screening visit, followed by a baseline visit where the medication will be given. follow-up visits will be scheduled at 2 weeks and then 16 weeks from baseline. long-term visits will take place in 36 and 52 weeks.

Eligibility criteria:
inclusion criteria: * patients with physician-diagnosed crswnp, with or without comorbid asthma that meet indication criteria for fda-approved use of dupilumab. * patients aged 18 years and older. * patient willing to provide consent to be a participant in the study. * patients with insurance that allows dupilumab coverage or dupilumab coverage obtained through "dupixent myway program" exclusion criteria: * age under 18 * suspected or diagnosed allergic fungal rhinosinusitis. * suspected or diagnosed cystic fibrosis. * dupilumab coverage denied through insurance or "dupixent myway program" * patients who required a steroid taper in the preceding 30 days. however, patients on chronic steroids less or equal to 20 mg of prednisone daily, are eligible. * patients who were on a different biologic medication in the preceding 3 months. * patients with a diagnosis of egpa/churg-strauss syndrome * pregnant patients * patients with inverted papilloma growth

Keywords: crswnp dupilumab
cytidine-phosphate-guanosine (cpg) dna in hepatocellular carcinoma combination therapy

Conditions: Hepatocellular Carcinoma

Summary: to observe the outcome of hepatocellular carcinoma patients under the combination treatment of transcatheter arterial chemoembolization (tace) and cpg dna


Eligibility criteria:
inclusion criteria: * tnm (tumor node metastasis ) staging with non distant metastasis; no other tumors exclusion criteria: * having received previous treatment for liver cancer
screening for liver cancer with ct vs. ultrasound in patients with advanced liver disease

Conditions: Cirrhosis; End Stage Liver Disease; Hepatitis C

Summary: the purpose of this study is to determine whether ultrasound or ct scanning is more effective at detecting early liver cancer in patients with advanced liver disease.

most cases of hepatocellular carcinoma (hcc) arise in patients with advanced liver disease, usually cirrhosis. most patients with clinically evident hcc are not candidates for treatment with curative intent because of large tumor size, invasion of hepatic or portal veins, or metastatic disease. for this reason, screening for hcc at an asymptomatic and potentially curable stage in patients with advanced liver disease has been recommended by some authorities. screening with various methods, of which ultrasound (us) and alpha-fetoprotein (afp) have been the most extensively studied, has become accepted practice. recently the technique of imaging the liver with or during both the hepatic arterial and portal venous phases of intravenous contrast ("liver-shuttle") has shown increased sensitivity in detecting hccs compared to us. the hypothesis of this study is that ct using a "liver-shuttle" protocol once a year is more sensitive and specific than us twice a year, both in combination with afp for identification of potentially curable hcc in patients with cirrhosis. patients will be randomized to "routine," accepted screening with hepatic us and afp testing every 6 months or afp testing every 6 months wtih triphasic ct every 12 months.

Eligibility criteria:
inclusion criteria: * liver biopsy or clinical diagnosis compatible with advanced liver fibrosis or cirrhosis * potential candidate for treatment of hcc * imaging study involving the liver in the last 12 months without evidence for hcc * must be a veteran in visn 23 exclusion criteria: * active or untreated malignancy other than non-melanoma skin cancer * patients with advanced medical conditions such as severe cardiovascular disease, copd, or severe end-stage liver disease * patients unable to receive intravenous contrast due to advanced kidney disease or severe allergy * history of liver mass identified on imaging study

Keywords: hepatocellular carcinoma liver cancer ultrasound computed tomography alpha fetoprotein cirrhosis screening advanced liver disease
sedation efficacy of dexmedetomidine versus midazolam in critically ill ventilated children

Conditions: Mechanically Ventilated, Critically Ill Children

Summary: there is a significant lack of adequately powered randomized clinical trial (rct) data to determine the comparative safety and effectiveness of sedative treatments in pediatric patients. in many centres the standard of care for sedation in pediatric critical care unit (pccu) patients includes the use of benzodiazepines despite the known negative effects of increased patient agitation and delirium, which can contribute to longer pccu and hospital length of stay (los). the use of an alternative sedative, dexmedetomidine may reduce negative effects in this population. as such, the investigators plan to conduct a well designed comparative rct to determine the most effective and safest sedative in this vulnerable population utilizing clinical assessments of sedation levels and delirium instance, electroencephalography (eeg) analysis and patient important outcomes.


Eligibility criteria:
inclusion criteria: 1. age is 1 month to 18 years inclusive 2. the patient is intubated and is expected to remain intubated for at least the next 48 hours 3. the patient has not been receiving mechanical ventilation for more than 72 hours 4. the patient must already be receiving an opioid infusion per pccu guidelines for sedation \& analgesia for procedures outside o.r. and need additional sedation. exclusion criteria: 1. admission is a consequence of suspected or proven drug overdose 2. patient is receiving dialysis 3. known pregnancy or lactation 4. neuromuscular blockade other than for intubation 5. general anesthesia in the 24 hours prior to study initiation 6. an acquired central nervous system (cns) condition (i.e. encephalitis, traumatic brain injury) resulting in ongoing dysfunction or an acquired condition resulting in ongoing dysfunction 7. acute hepatitis or severe liver disease 8. known history of sensitivity to midazolam and/or dexmedetomidine or their constituents 9. systolic blood pressure (sbp) below 5th percentile for two consecutive measurements 10. heart rate (hr) below 5th percentile for two consecutive measurements 11. death is deemed to be imminent or inevitable during the admission and either the intensivist or substitute decision maker is not committed to full active resuscitation 12. previous enrollment into the study

Keywords: sedation, delirium, pediatric, critical care
efficacy, safety and acceptability of the new pen needle 34gx3,5mm.

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to determine the non-inferiority of a new pic insupen 34gx3,5mm needle vs. a 32gx4mm needle in terms of metabolic control, safety and acceptability in patients with diabetes treated with insulin.


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes * age \>= 18 years * multiple daily injections of insulin for at least 6 months * signed informed consent exclusion criteria: * pregnancy or or breast feeding * inability to fill in the questionnaire * combined therapy for diabetes (oral drugs associated with insulin injections) * any medical condition that could interfere with the study according to the investigator's opinion

Keywords: insulin therapy needle
clinical evaluation of a restorative glass ionomer and a bulk-fill composite resin

Conditions: Tooth Disease

Summary: the clinical performance of a restorative glass ionomer and bulk-fill resin composite in class ii restorations will be evaluated and compared. after recruiting participants with at least 2 approximal caries lesions, all restorations will be placed by a single clinician. all caries lesions will be removed before restoring. cavities will be divided into two groups: a restorative glass ionomer \[equia forte ht, gc, tokyo, japan (eht)\] and bulk-fill composite resin \[sonicfill2, orange, ca, usa (sbf)\] all restorative procedures will be conducted according to manufacturers' instructions. restorations will be scored using modified united states public health service (usphs) criteria after a week (baseline) 6, 12, 24, 36 and 48 months. descriptive statistics will be performed using chi-square tests.


Eligibility criteria:
inclusion criteria: * age range will be 18 to 65 * patients should have at least 2 approximal caries lesions require restoration * healthy periodontal status * a good likelihood of recall availability exclusion criteria: * poor gingival health * adverse medical history * potential behavioral problems
improvement of fertilization rate and embryo quality by treating calcium ionophore in ivf patients: a sibling oocyte control study

Conditions: IVF; Infertility; Artificial Oocyte Activation

Summary: gm508 cultactive is a bicarbonate buffered reagent and ready-to-use designed to investigate oocytes of patients with failed fertilization after previous intracytoplasmatic sperm injection cycles. the investigators hypothesize that gm508 cultactive will improve the fertilization rate and embryo development of such ivf patients (a history of poor fertilization, a history of poor embryo quality, and over 40 years old expected challenging to conceive).


Eligibility criteria:
inclusion criteria: * low fertilization rate in previous ivf cycle (\<30%), or * poor embryo developmental problems in previous ivf cycle, or * diminished ovarian reserve (amh\<1.2 or afc\<5) and/or more than 40 y/o. exclusion criteria: * without or just one oocyte picked up

Keywords: artificial oocyte activation calcium ionophore ivf poor responder
comparing ohrqol: one or two sessions for wisdom teeth removal

Conditions: Impacted Third Molar Tooth; Impacted Tooth

Summary: this single-center prospective cohort study includes patients aged 18-30 years aimed to compare the effects of bilateral extraction of wisdom teeth at a single appointment (group a) versus two separate appointments (group b) on patients' oral health-related quality of life (ohrqol). the primary outcome is oral health impact profile 14 score, while secondary outcomes included postoperative pain and maximum interincisal opening.


Eligibility criteria:
inclusion criteria: * patients referred to the oral and maxillofacial surgery department for bilateral extraction of impacted mandibular third molars. * asymptomatic, impacted mandibular third molars. * impaction classified as class i, position a according to the pell and gregory classification. * patients with an asa (american society of anesthesiologists) physical status classification of asa 1. exclusion criteria: * local pathology associated with third molars (e.g., cysts or tumors). * diagnosis of acute pericoronitis. * usage of anti-inflammatory drugs or antibiotics within the last week. * operations requiring osteotomy. * patients with psychiatric disorders or taking drugs that may impair their mental health. * patients unwilling to undergo data collection procedures. * pregnant or lactating women. * heavy smokers. * operations lasting longer than 45 minutes for one side (from the time the first incision is made to the last suture placed).

Keywords: quality of life oral health prospective studies molar, third tooth extraction patient preference
evaluation of botulinum toxin a alone versus botulinum toxin a with hydrodistension for treatment of overactive bladder

Conditions: Overactive Bladder

Summary: the specific aim of this trial is to determine if hydrodistention at the time of intradetrusor injection of botulinum toxin a has additional benefit in patients with refractory overactive bladder (oab) and urgency symptoms compared to intradetrusor injection of botulinum toxin a alone. consented patients will be randomized to hydrodistention at a pressure of 80 cm h2o for 5 minutes, prior to the intradetrusor injection of 100 units of botulinum toxin a (hydrodistention group) or intradetrusor injection of 100 units of botulinum toxin a alone (botulinum toxin a alone group). the primary aim will be subjective improvement measured as change from baseline at 12 weeks using the oab-q bother subscale.


Eligibility criteria:
inclusion criteria: * women with refractory overactive bladder symptoms, failing a credible behavioral therapy intervention and medical therapy or not tolerating medical therapy. patients who are on medical therapy will stop the medical therapy for at least 2 weeks prior to botulinum toxin a treatment in the study * female ≥ 18 years old * desires further treatment for oab symptoms. * express understanding and ability to perform clean intermittent self-catheterization (cisc) if required. * ability to consent * ability to complete all study related items and interviews exclusion criteria: * post void residual urine volume \> 150 ml as assessed by catheter or ultrasound * history of intradetrusor botulinum toxin a injection * history of or current cancer of the genitourinary or gynecology tract * neurogenic bladder * interstitial cystitis * current urinary tract infection (can be treated and re-considered for study) * current active sacral neuromodulation device * non-english speaking * history of chronic pelvic pain * hematuria not previously evaluated
cognitive stimulation program in aids

Conditions: HIV Infections

Summary: there has been little success in treating the cognitive (thinking) problems associated with hiv/aids using medications. the purpose of this study is to determine whether an internet-based cognitive "stimulation" program might help hiv-infected individuals think more clearly. if this is true, then it means that people with mild forms of cognitive impairment may be able to help themselves to get better.

the neurocognitive manifestations of hiv/aids have long been recognized as important for the management, survival, and quality of life of affected patients and their families. following the advent of highly active anti-retroviral therapy (haart) the incidence of hiv-associated dementia (had) has fallen, but the prevalence of the milder forms of hiv-related cognitive disorders has risen. this is important because alterations in cognitive function can have significant impact on work and social activities, mood, and perceived quality of life. to date, pharmacological management of hiv-associated cognitive disorders - apart from haart - have met with limited success (e.g., peptide t, ritalin). therefore, it appears reasonable to ask whether the use of non-pharmacological tools might help alleviate or ameliorate the symptoms of the milder forms of cognitive impairment, and thus improve mood and activities of daily living. the purpose of this application is to request funds to allow us to complete a feasibility/pilot study of the merits of using an internet-based cognitive stimulation program (csp) to improve the cognitive functions and quality of life of individuals with hiv/aids, and, secondarily, to detect such changes using a computerized assessment tool designed for use in a health care practitioner's office (computer-based assessment of mild cognitive impairment (camci)).

Eligibility criteria:
inclusion criteria: * access to the internet (either from home or public access) * native language is english * hiv infected exclusion crieria: * active drug/alcohol abuse or dependence * current major depression * history of neurological disease, central nervous system opportunistic infections, tumors, or stroke * history of learning disability or attention deficit/hyperactivity disorder (by subject report).

Keywords: cognition rehabilitation cognitive stimulation human immunodeficiency virus aids
prospective study of fmt for acute intestinal gvhd after allo-hsct

Conditions: Acute Graft Versus Host Disease in Intestine

Summary: acute intestinal gvhd is the main cause of death after allo-hsct, and fmt is a new treatment method for this disease. in this prospective study, the investigators will recruit intestinal gvhd patients to demonstrate the efficacy and safety of fmt.

graft-versus-host disease (gvhd) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-hsct), of which intestinal gvhd is a particularly serious one, which is the main cause of death after allo-hsct. recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-hsct. on the basis of this theory, fecal microbiota transplantation (fmt) may be an effective method for gvhd, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. in this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.

Eligibility criteria:
inclusion criteria: 1. received allo-hsct due to a hematopoietic disease 2. corticosteroid resistant/dependent intestinal gvhd 3. ecog≤2 4. sign informed consent 5. no major organ dysfunction exclusion criteria: 1. uncontrolled or severe infections 2. patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder 3. high-risk bleeding 4. anc\<0.5×10\^9/l or plt\<20x10\^9/l 5. hepatitis b, tuberculosis, syphilis, and hiv antibody positive or acute phase of any infectious disease 6. patients participating in other clinical trials 7. patienta who suffer from mental illness

Keywords: acute-graft-versus-host disease fecal microbiota transplantation
efficacy and safety of ff-31501 in meniscus tear patients

Conditions: Meniscus Injury

Summary: a single-arm, multi-center study to verify that knee joint function at 52 weeks after injection of ff-31501 is better than at screening in patients with meniscus tear who are eligible for meniscectomy .


Eligibility criteria:
inclusion criteria: 1. patients with suspected meniscal flap tear 2. patients with knee pain 3. patients with one or more of the following symptoms * feeling stuck in the knee・instability of the knee * knee range of motion impairment * knee joint edema 4. other exclusion criteria: 1. patients with poor knee alignment 2. patients who underwent meniscus surgery or platelet rich plasma therapy 3. patients with or history of knee ligament injury 4. diabetic patients with poor glycemic control 5. patients with the following complications and poor general condition * severe cardiovascular disease * severe liver disease * severe renal dysfunction * severe anemia・uncontrolled mental illness * other diseases for which sudden change or worsening of symptoms can be expected during study participation 6. patients who are pregnant or possibly pregnant and/or breast-feeding, or patients planning to become pregnant during the study period 7. other
treatment of children with peer related aggressive behavior

Conditions: Oppositional Defiant Disorder

Summary: the efficacy of the treatment program for children with aggressive behaviour (therapieprogramm für kinder mit aggressivem verhalten, thav) which is a social competence training delivered in an individual format will be evaluated in a randomized controlled trial with children aged 6 to 12 years with peer-related aggressive behaviour.

the german treatment program for children with aggressive behaviour (therapieprogramm für kinder mit aggressivem verhalten, thav) aims at the therapy of children aged 6 to 12 years with peer-related aggressive behaviour, which results in a persistent impairment of the relationships to other children. contrary to other treatment approaches, this intervention aims at the individual treatment of problem maintaining and moderating factors of aggressive behaviour. depending on the individual problem maintaining factors the treatment aims to modify social cognitive information processing, impulse control, social problem solving, social skills and social interactions. methods: the efficacy will be tested in a partial randomized control group design with n=100 children. n=60 children will be treated for about half a year with the modules of thav in weekly sessions. the control group of n=40 children will receive alternative interventions with group play and techniques to activate resources of the child. these interventions give the children the opportunity to train pro-social interactions. outcome parameters are aggressive behaviour und comorbid symptoms as well as problem maintaining factors, psychosocial functioning, family burden and treatment satisfaction. moreover, variables of the treatment process are assessed. questionnaires, tests and individual problem checklist were used to assess these outcome and process parameters

Eligibility criteria:
inclusion criteria: * age: 6 - 12 years * iq\>= 80 * diagnoses (icd-10): f91, f92, f90.1 * high symptom score in the parent rated symptom checklist for oppositional defiant and conduct disorder (fbb-ssv) (stanine ≥ 7) at assessment 1 and assessment 2 * often conflicts with other children (clinical rating) * impaired social relationships / activities * parents agree in randomization * in medicated children no planned change of the medication exclusion criteria: * other disorder is dominating * other active psychotherapy * severe mental disorder of the parents

Keywords: social skills training, social competence training, oppositional defiant disorder peer related aggressive behavior randomized controlled trial
health2006 - an observational study of cardiovascular disease, diabetes, asthma and allergy

Conditions: Cardiovascular Disease; Type 2 Diabetes; Asthma; Hypersensitivity; Osteoporosis

Summary: the aim is to assess the population prevalence of risk factors for different chronic diseases such as cardiovascular disease, type 2 diabetes, osteoporosis, asthma, and allergy. risk factors include genetic and serologic biomarkers, questionnaire data on health and lifestyle. there are many hypotheses under study for each research field.

a population-based random sample of persons living in copenhagen is drawn from the danish civil registration system and invited for a health examination including blood sample drawing, measurement of lung function, serologic and genetic biomarkers, questionnaires on lifestyle and health. the study will form the basis for research within many different areas such as cardiovascular disease, type 2 diabetes, asthma, and allergy.

Eligibility criteria:
inclusion criteria: * persons living in 11 municipalities in copenhagen exclusion criteria: * pregnancy * non-danish citizenship

Keywords: epidemiology risk factors