Kornimate/medical-research-clean huggingface dataset:
examining rapid acting intra-muscular olanzapine in japanese patients with schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to examine the clinical therapeutic dose in japanese agitated patients with schizophrenia.


Eligibility criteria:
inclusion criteria: * male or female patients at least 20 years of age and less than 65 years old * patients must be inpatients during the study * patients must have a diagnosis of schizophrenia as per the dsm-iv, as determined by the investigator * patients must be considered by the investigator to be clinically agitated and to be clinically appropriate candidates for the treatment with intramuscular (im) medication * patients must have a minimum total score of greater than or equal to 14 on the 5 items of the panss-ec and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system, prior to the first im injection of study drug exclusion criteria: * serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. this includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases * known history of seizures; however, a patient whose etiology is identifiable and has been resolved may be enrolled * known history of diabetes mellitus, complications of diabetes mellitus, or potential diabetes mellitus as defined by patients with single blood glucose measurement based on site tests; patients with values greater than or equal to 140 mg/dl (non-fasting) or greater than or equal to 110 mg/dl (fasting) must be excluded from the study * history of allergic reaction or intolerance to olanzapine * have received treatment with psychostimulants or reserpine within 1 week prior to study drug administration
urine-dna biomarkers in detecting bladder cancer

Conditions: Bladder Cancer; Biomarker; Diagnosis; Urine

Summary: dna biomarkers in urine are important diagnostic and prognostic indicators for bladder cancer. many genetic alterations have been identified in the urinary dna. however, not all bladder tumors harbor mutations in the most commonly altered oncogenes. thus, to reach satisfactory sensitivity and specificity a new diagnostic test should include multiple biomarkers. the investigators will conduct a prospective evaluation of a panel of mutations in urine-dna test for the detection of urothelial bladder carcinoma in patients with gross hematuria for cystoscope.

urinary dna representative of the tumour genome provide a promising resource as a liquid biopsy for non-invasive genomic profiling of urothelial bladder cancers. voided urine samples will be collected prior to cystoscopy. cell free dna and cellular dna will both be extracted and analyzed. a blood sample will be taken. in patients with bladder wall findings suspicious of cancer, a bladder wall biopsy will be taken and submitted for histopathology examination, according to clinical standard practice. next generation sequencing will be applied and hotspots mutations in dna from urine, blood and tumor. logistic regression was used to analyze the association between predictor variables and bladder cancer. the investigators will confirm a couple of common mutations occured in urine-dna and blood-derived dna simultaneously and verify the specificity and sensitivity of individual variance or mutation combinations to establish an predictive model with optimal robustness in diagnosis of bladder cancer. moreover, external consistency test will be performed on subsequent patients collection.

Eligibility criteria:
inclusion criteria: * patients with gross hematuria or other clinical sympton suspected of bladder cancer. * male or female patients aged \>= 18 years. * available tumor tissue, urine and blood sample. * signed informed consent form. exclusion criteria: * prior diagnosis of cancer except bladder cancer * age under 18 years * individuals unwilling to sign the irb-approved consent form * comorbidities that would prohibit or make serial urine collection and cystoscopy examine difficult or impossible.

Keywords: bladder cancer urine dna biomarker diagnosis
a study of rilzabrutinib in adult patients with immune thrombocytopenia (itp)

Conditions: Immune Thrombocytopenia; Immune Thrombocytopenic Purpura

Summary: this is a 2 part (part a and b) adaptive, open-label, dose-finding study of prn1008 in patients with itp who are refractory or relapsed with no available and approved therapeutic options, with a platelet count \<30,000/μl on two counts no sooner than 7 days apart in the 15 days before treatment begins. the dose-finding portion of the study has been completed. part b treatment dose is 400 mg twice daily.

this is a 2 part (part a and b) adaptive, open-label, dose-finding study of prn1008 in approximately 60 patients in part a and approximately 25 patients in part b. part a enrolls patients with itp who are refractory or relapsed with no available and approved therapeutic options. eligible patients have a platelet count \<30,000/μl on two counts no sooner than 7 days apart in the 15 days before treatment begins. the active treatment period is 24 weeks and the post-treatment follow-up period is 4 weeks. in the dose-finding part of the study, each patient enrolled in the study is allowed to up-titrate their dose after 28 days of prn1008 therapy, if they do not experience a platelet response or a dose-limiting toxicity (dlt) at the last dose level. patients who respond to prn1008 per protocol may enter a long term-extension. part b of the study will include approximately 25 patients with itp who have relapsed or have an insufficient response to prior therapies. eligible patients will have a platelet count \<30,000/µl on two occasions no less than 7 days apart, within 15 days before treatment begins and a platelet count of ≤35,000/µl on study day 1 (sd1). the study consists of a 28-day screening period, 24-week active treatment period, and a long-term extension. after the last dose of prn1008 there will be a 4-week safety follow-up period.

Eligibility criteria:
inclusion criteria: * male or female patients, aged 18 to 80 years old * immune-related itp (both primary and secondary) exclusion criteria: * pregnant or lactating women * current drug or alcohol abuse * history of solid organ transplant * positive screening for hiv, hepatitis b, or hepatitis c

Keywords: itp
neuromodulation of lidocaine and capsaicin cream effects on pain experience

Conditions: Pain

Summary: the aim of this study is to use a brain stimulation tool called transcranial direct current stimulation (tdcs) to investigate the analgesic (reducing sensitivity to pain) effects of lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin cream using a neutral cream as a control. tdcs stimulation has been shown to temporarily influence the way the stimulated part of the brain functions. with this method, the involvement of specific parts of the brain can be investigated in the working of the brain as a whole.


Eligibility criteria:
inclusion criteria: * right handed healthy male and female adults aged 21-50 * no contraindications to fmri scanning * at least a 10th grade english-reading level; english can be a second language provided that the patients feel they understand all the questions used in the assessment measures. exclusion criteria: * current or past history of major medical, neurological, or psychiatric illness * claustrophobia * history of head trauma * instability of responses to experimental pain * non-fluent speaker of english * presence of any contraindications to fmri scanning. for example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy * history of alcohol/substance abuse
convalescent plasma for the treatment of covid-19

Conditions: COVID-19

Summary: this protocol provides access to investigational convalescent plasma for patients in acute care facilities infected with sars-cov-2 who have severe or life-threatening covid-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. following provision of informed consent, patients will be transfused with 1-2 units of abo compatible convalescent plasma obtained from an individual who has recovered from documented infection with sars-cov-2 (as detailed in separate protocol). safety information collected will include serious adverse events judged to be related to administration of convalescent plasma. other information to be collected will include patient demographics, acute care facility resource utilization (total length of stay, days in icu, days intubated), and survival to discharge from acute care facility.

this is an open-label expanded access program to make appropriately matched convalescent plasma available for the treatment of patients in acute care facilities infected with sars-cov-2 who have severe or life-threatening covid-19, or who are judged by a healthcare provider to be at high risk of progression to severe or life-threatening disease. covid-19 convalescent plasma will be obtained from the jefferson blood bank and will meet all regulatory requirements for conventional plasma and fda's additional considerations for covid-19 convalescent plasma (https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds).

Eligibility criteria:
inclusion criteria: * age 18 years and older * laboratory confirmed diagnosis of sars-cov-2 * admitted to an acute care facility for the treatment of covid-19 complications * informed consent provided by patient or legally authorized representative * severe or life threatening covid-19, or judged by the treating provider to be at high risk of progression to severe or life-threatening disease severe disease defined as any of the following * dyspnea * respiratory rate \> 30/minute * oxygen saturation \<94% * partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300 * lung infiltrates \>50% within 24 to 48 hours life-threatening disease defined as any of the following * respiratory failure * septic shock * multiple organ dysfunction or failure • informed consent provided by patient or healthcare proxy exclusion criteria: * receipt of pooled immunoglobulin in past 30 days * contraindication to transfusion or history of prior reactions to transfusion blood products
herpes simplex meningo encephalitis recurrence

Conditions: Herpes Simplex Meningo Encephalitis

Summary: study of risk factors and prognosis of herpes simplex encephalitis recurrence.


Eligibility criteria:
inclusion criteria: * documented herpes simplex recurrence exclusion criteria: * other cause
an efficacy, safety, and tolerability study of vx-880 in participants with type 1 diabetes with a kidney transplant

Conditions: Type 1 Diabetes; Kidney Transplant

Summary: this study will evaluate the efficacy, safety, and tolerability of vx-880 in participants with type 1 diabetes (tid) with a kidney transplant.


Eligibility criteria:
key inclusion criteria: * clinical history of t1d with greater than or equal to (≥)5 years of insulin dependence * taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks * consistent use of continuous glucose monitor (cgm) for at least 4 weeks before screening and willingness to use cgm for the duration of the study key exclusion criteria: * prior islet cell transplant, organ transplant (other than kidney transplant) or cell therapy * participants had greater than (\>)1 kidney transplant procedure other protocol defined inclusion/exclusion criteria may apply.
analgesic effects of gabapentin after scoliosis surgery in children

Conditions: Scoliosis

Summary: the primary aim of this study is to determine whether the use of gabapentin will improve postoperative analgesia and reduce opioid consumption and side effects in children undergoing corrective spinal surgery for idiopathic scoliosis. secondary aims are to evaluate whether use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases persisting pain and improves patient satisfaction.

surgical correction of scoliosis involves major orthopedic surgery, and can lead to severe acute postoperative pain and persistent neuropathic pain. the mainstays of treating postoperative pain are acetaminophen, non-steroidal anti-inflammatory drugs (nsaids), systemic opioids, and local anesthetic techniques. despite being effective, their use is limited by adverse side effects. acute postoperative pain involves multiple mechanisms and neural pathways, therefore a combination of different analgestic medications acting through different mechanisms, may be the most effective treatment. this strategy may also reduce the need for, and side effects of, using high doses of any one particular class of drugs. gabapentin is safe and well tolerated with few side effects and has minimal interactions with other drugs. the use of gabapentin to treat acute postoperative pain may improve quality of analgesia, result in decreased requirements for opioids and might consequently reduce the incidence of opioid induced side effects. it may also have a direct effect on postoperative nausea and vomiting, and decrease the incidence of persistent neuropathic pain. these qualities make gabapentin an attractive agent for use in management of postoperative pain in children undergoing corrective spinal injury. the primary aim of this study is to determine whether the use of gabapentin will improve postoperative analgesia and reduce opioid consumption and side effects in children undergoing corrective spinal surgery for idiopathic scoliosis. secondary aims are to evaluate whether use of gabapentin reduces pain scores, decreases postoperative nausea and vomiting, decreases persisting pain and improves patient satisfaction.

Eligibility criteria:
inclusion criteria: * 10 - 17 years of age * scheduled for elective surgical correction of scoliosis * able to operate a patient-controlled analgesia (pca) pump exclusion criteria: * unable to cooperate * unable to operate the pca pump * unable to rate pain * have a known allergy or sensitivity to gabapentin or morphine * have a history of chronic pain or daily analgesic use * have taken acetaminophen, a non-steroidal anti-inflammatory drug, or an antacid within a 24-hour period prior to surgery

Keywords: pediatrics scoliosis gabapentin
usefulness of transcutaneous capnography to assess residual hypoventilation in obesity-hypoventilation syndrom treated by non invasive ventilation at home : a prospective study

Conditions: Obesity Hypoventilation Syndrome

Summary: transcutaneous capnography (ptcco2) recently showed good agreement with blood gases to assess hypercapnia. there is no study that has evaluated the benefit to realise systematically a nocturnal ptcco2 in the follow-up of home-ventilated patient with obesity hypoventilation syndrome (ohs). the investigators will evaluate the intake bring by nocturnal transcutaneous capnography, compared to nocturnal oximetry and blood gases, to diagnose nocturnal alveolar hypoventilation in a population of patient presenting an ohs, treated by non invasive ventilation (niv) at home .

patients will be evaluated once a year in consultation with a blood gases, and then a nocturnal recording at home including a transcutaneous capnography and an oximetry. some data will be registered too : cardiovascular and neurological comorbidities, diabetes mellitus, treatment, parameters of the non-invasive ventilation, duration of compliance and apnea-hypopnea index (if available). the investigators will perform a sequential analysis of nocturnal hypoventilation with first blood gases, then nocturnal oxymetry and to finish nocturnal ptcco2. it will allow us to determine if ptcco2 catch up some nocturnal hypoventilation, undetected by the first two exams. the investigators plan that the study will last 18 months. the analysis will be descriptive. quantitative variables will be described with mean, standard deviation, minimum, maximum and median. quantitative variables are presented with number and percentage. comparison of blood gas / oximetry association with blood gas / oximetry / transcutaneous capnography using a mcnemar test

Eligibility criteria:
inclusion criteria: * obesity hypoventilation syndrom defined by a diurnal paco2\> 45 mmhg, in stable conditions, in a patient presenting an obesity (bmi \> 30 kg/m²) * treated by non invasive ventilation since at least 3 weeks, and seen in follow-up consultation exclusion criteria: * minors * refusal to participate * under guardianship or trusteeship * pregnant woman * other etiology of hypoventilation : copd, kyphoscoliosis, neuromuscular disorders, diaphragmatic pathology

Keywords: obesity hypoventilation syndrome non invasive ventilation transcutaneous capnography
immunotherapy of natural killer(nk) cells in human t lymphotropic virus type 1(htlv-1) associated myelopathy(ham)

Conditions: HAM

Summary: htlv-1 associated myelopathy is a chronic disease of the spinal cord, caused by a virus called human t lymphotropic virus type 1（htlv-1）. natural killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. in this trial, the investigators aim to study the therapeutic safety and the effect on htlv-1 virus. this in turn will improve the knowledge and understanding of the disease and should lead to better therapy.

ham is a chronic disease of the spinal cord, caused by a virus called htlv-i. natural killer cells provide rapid responses to viral-infected cells, acting at around 3 days after infection, and respond to tumor formation. in this trial, the investigators aim to study the therapeutic safety and the effect on htlv-1 virus. this in turn will improve the knowledge and understanding of the disease and should lead to better therapy. in a single-center, one year open-label trial, 5 ham patients will be treated with single intravenous injection of nk cells (0.9\~1\*10\^9). then, the the clinical effect was evaluated by dynamic analysis of osame's motor disability score and other related physiological indices, such as htlv-1 antibody titer in blood and cerebrospinal fluid.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of htlv-1 associated myelopathy exclusion criteria: * hiv infection * hepatitis b \& c viral infections * pregnant
o2 transport and utilization in health and lung disease

Conditions: COPD; Tetrahydrobiopterin Deficiency; Oxidative Stress

Summary: skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of chronic pulmonary obstructive disease (copd), which is still poorly understood. therefore, the focus of this study is on the role of a deficit in tetrahydrobiopterin and nitric oxide synthase uncoupling induced by chronic oxidative stress on metabolic and vascular abnormalities in skeletal muscle of patients suffering from copd.

the purpose of this study is to assess the efficacy of supplementation with tetrahydrobiopterin (bh4) for improving vascular and muscle function in patients with copd and healthy controls.

Eligibility criteria:
inclusion criteria: * all subjects must be between the age of 18 and 85 years; * for the copd cohort, patients with a diagnosis of stable copd (i.e., those not experiencing an acute exacerbation of symptoms) and spirometric evidence of airway obstruction (fev1 \<80% predicted, fev/fvc\<0.70); * ability to perform motor tests; * ability to provide informed consent exclusion criteria: * uncontrolled hypertension; * hyperlipidemia; * recent exacerbation; * major cardiovascular event procedure (\<3 months); * pregnancy * known significant hepatic, renal disease, active substance abuse * contraindication to mri, claustrophobia

Keywords: bh4 exercise mitochondria vascular function
icbt for mental health problems related to the coronavirus pandemic

Conditions: Depression and Quality of Life Related to the Coronavirus Pandemic

Summary: the study seeks to investigate the effects of a guided internet-based cognitive behavioral therapy (icbt) programme a on adult mental health problems related to the current coronavirus pandemic. icbt will be compared to a wait-list control group. participants will be recruited in sweden with a nationwide recruitment.

the study is set up as a randomized controlled trial. quality of life, depressive symptoms, anxiety, sleep problems and traumatic stress will be measured. given uncertainties regarding the psychological effects of covid-19 pandemic a transproblematic tailored treatment approach will be used that has been tested in several previous trials. however, the present program has been adapted for the target population of people who are affected by the societal and individual consequences of the pandemic. the study does not focus on people who have or have had the corona virus.

Eligibility criteria:
inclusion criteria: * experience mental health problems that are caused or exacerbated by the corona pandemic and/or its consequences * 18 years or older. * adequate ability to understand and speak swedish. * access to the internet and a smartphone/computer. exclusion criteria: * other ongoing psychological treatment or counselling that interfere with trial treatment. * recent (within the past 3 months) changes in the dose of psychotropic medication. * any severe psychiatric or somatic conditions that would interfere with trial treatment

Keywords: corona covid-19 internet-delivered cognitive-behavioral therapy (icbt) depression quality of life
rectal indomethacin in the prevention of post-endoscopic retrograde cholangiopancreatography (ercp) pancreatitis in high risk patients

Conditions: Post-ERCP Pancreatitis

Summary: pancreatitis (inflammation of the pancreas) is the most common complication of endoscopic retrograde cholangiopancreatography (ercp), a procedure for the diagnosis and treatment of disorders of the pancreas and bile duct. preliminary data has shown that non-steroidal antiinflammatory drugs, when administered rectally, can reduce the risk of pancreatitis after ercp. this study is intended to definitively determine whether rectally administered indomethacin (a non-steroidal antiinflammatory drug)is effective at preventing pancreatitis after ercp.

this study is a multi-center, randomized, placebo-controlled, double-blinded clinical trial of rectal indomethacin in the prevention of post-ercp pancreatitis in high risk patients.

Eligibility criteria:
inclusion criteria: included patients are those undergoing ercp and have one of the following: 1. clinical suspicion of sphincter of oddi dysfunction 2. history of post-ercp pancreatitis (at least one episode) 3. pancreatic sphincterotomy 4. pre-cut (access) sphincterotomy 5. \> 8 cannulation attempts 6. pneumatic dilation of intact biliary sphincter 7. ampullectomy or at least 2 of the following: 1. age \< 50 years old \& female gender 2. history of recurrent pancreatitis (at least 2 episodes) 3. ≥3 pancreatic injections, with at least one injection to tail 4. pancreatic acinarization 5. pancreatic brush cytology exclusion criteria: 1. unwillingness or inability to consent for the study 2. age \< 18 years 3. intrauterine pregnancy 4. breast feeding mother 5. standard contraindications to ercp 6. allergy to aspirin or nsaids 7. renal failure (cr \> 1.4) 8. active or recent (within 4 weeks) gastrointestinal hemorrhage 9. acute pancreatitis (lipase peak) within 72 hours 10. known chronic calcific pancreatitis 11. pancreatic head malignancy 12. procedure performed on major papilla/ventral panc duct in pt with pancreas divisum (no manipulation of minor papilla) 13. ercp for biliary stent removal or exchange without anticipated pancreatogram 14. subjects with prior biliary sphincterotomy now scheduled for repeat biliary therapy without anticipated pancreatogram 15. anticipated inability to follow protocol 16. endoscopist discretion: low risk (\<10%) of post-ercp pancreatitis