Kornimate/medical-research-clean huggingface dataset:
splanchnic and systemic vldl-tg and ffa balance

Conditions: NAFLD; NASH - Nonalcoholic Steatohepatitis

Summary: to determine differences between nafld and nash subjects with respect to hepatic fa metabolism (uptake, oxidation, and re-esterification) and hepatic vldl-tg secretion and peripheral kinetics (oxidation and tissue storage). 8 non-diabetic upper-body obese subjects with nafld and 8 with nash (biopsy proven) will be studied in the overnight fasted state. vldl-tg stable isotope will be used in combination with hepatic vein catherization to directly measure splanchnic vldl-tg uptake and secretion. ffa (palmitate) tracers as well as adipose tissue and skeletal muscle biopsies will be used to measure whole-body substrate turnover and flexibility as well as tissue specific substrate handling during fasting and hyperinsulinemic conditions.


Eligibility criteria:
inclusion criteria: * 8 obese subject men with nafl (mr spectroskopi, fibro scanner) (bmi \> 28). * 8 obese subject men with nash (mr spectroskopi, fibro scanner) (bmi \> 28). age between 40-70 years. written consent before the start of the study. exclusion criteria: * known current disease * fixed medical drug consumption except antihypertensive drugs and statins. however, pause statins 3 weeks before the examination date blood donation within the last 3 months prior to the study participation in experiments involving radioactive isotopes within the last 3 months alcohol abuse (over 21 items per week for men and 14 for women) smoking weight over 130 kg cancer patients large intake of medication
emotiph: e-mental health solution for patients with schizophrenia

Conditions: Schizophrenia

Summary: although the main objective of current schizophrenia intervention programs is the reduction of symptoms, its rates are around 36%, and recovery rates are 16.5%. between 30 and 50% of people with schizophrenia obtain little benefit with conventional therapy. they are considered resistant to treatment. therefore, the development of innovative evidence-based interventions adjunctive to pharmacological and psychological treatment are necessary for improving results in patients with treatment-resistant schizophrenia (trs). studies with digital solutions have shown feasibility, acceptability and even preliminary efficacy data. but no earlier published study has focused on trs. the emotiph is an innovative solution addressed to trs and born from the outcomes of the previous study emotiph part 1 (study of beliefs, needs, and limitations associated with current intervention in trs patients).

a prospective non-randomised feasibility trial will be performed. people with a diagnosis of treatment-resistant schizophrenia and their informal caregivers will test the digital mental health solution emotiph for 6 months. psychiatric treatment and psychological intervention (based on the unified protocol for transdiagnostic treatment of emotional disorders; farchione et al., 2012) will be delivered to patients. the aim of the study is to evaluate the feasibility, acceptability, usability, satisfaction and perceived quality of life after using the emotiph digital solution.

Eligibility criteria:
inclusion criteria: * age between 18-55 years old. * diagnosis of schizophrenia following the diagnostic and statistical manual of mental disorders-5 criteria. * meet criteria for treatment-resistant schizophrenia. * used to information and communication technology and with the physical capability to use them. exclusion criteria: * meet criteria for remission according to the remission of schizophrenia working group (andreasen et al., 2005). * the presence of delusions mainly related to their therapists or with new technologies. * hearing, vision or motor impairment that makes it impossible to operate a smartphone. * intellectual developmental disability.

Keywords: mhealth treatment resistent schizophrenia
a crossover study to assess the bioequivalence of hydrocodone bitartrate extended-release tablet

Conditions: Pain

Summary: the primary objective of this study is to assess the bioequivalence of two 45-mg hydrocodone bitartrate extended-release tablets and one 90-mg hydrocodone bitartrate extended-release tablet.


Eligibility criteria:
inclusion criteria: * written informed consent is obtained. * the subject can read, speak, and write in english. * the subject is a man or woman 18 through 45 years of age, with a body mass index (bmi) of 20.0 to 30.0 kg/m2, inclusive. * the subject is in good health as determined by medical and psychiatric history, physical examination, ecg, serum chemistry, hematology, urinalysis, and serology. * women must be surgically sterile, 2 years postmenopausal, or, if of child-bearing potential, be using an acceptable method of contraception, and agree to continued use of this method for the duration of the study and for 30 days after discontinuation of study drug. acceptable methods of contraception include abstinence or an intrauterine device (known to have a failure rate of less than 1% per year). * the subject has a negative alcohol test and urine drug screen. * the subject must be willing and able to comply with study restrictions and to remain at the study center for the required duration of each study drug period during the study. exclusion criteria: * the subject has any clinically significant uncontrolled medical conditions (treated or untreated). * the subject has a clinically significant deviation from normal in ecg or physical examination findings, as determined by the investigator or the medical monitor. * the subject has habitually consumed, within the past 2 years, more than 21 units of alcohol per week, or has a history of alcohol, narcotic, or any other substance abuse as defined by the diagnostic and statistical manual of mental disorder, fourth edition, text revision (dsm-iv-tr, american psychiatric association 2000). note: a unit of alcohol is equal to 1 ounce of hard liquor, 5 ounces of wine, or 8 ounces of beer. * the subject is a pregnant or lactating woman. (any women becoming pregnant during the study will be withdrawn from the study.) * the subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gi surgery; a history of appendectomy is allowed). * the subject has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the 1st dose of study drug, or in the case of a new chemical entity, 3 months or 5 half-lives (whichever is longer) before the 1st dose of study drug. * the subject has a known sensitivity or idiosyncratic reaction to hydrocodone or hydromorphone, their related compounds, or to any metabolites, or naltrexone, or any compound listed as being present in a study formulation. * other exclusion criteria apply.

Keywords: bioequivalence hydrocodone bitartrate extended-release tablets
perioperative symptom study of lung cancer (cn-pro-lung 1)

Conditions: Patient-reported Outcomes

Summary: investigators propose a multicenter prospective observational cohort study to develop and validate essential technical parameters for establishing the patient-reported outcome-based perioperative symptom management cohort in patients with lung cancer. with at least 300 patients with initial diagnosis of lung cancer and scheduled for surgery, this study will administer symptom assessments (mdasi-lc) and quality of life assessments (siqol) before surgery (typically within 3 days before surgery), daily after surgery (in hospital ≤ 14 days), and weekly after discharge, up to 4 weeks (±3 days) or the start day of postoperative oncologic treatment. in the upgraded research protocol, symptom and quality of life assessments (every 3 month for 1 year, every 6 month for 2-3 year, every 12 month for 4-5 year), as well as the follow-up of clinical outcomes will continue until 5 years after surgery.


Eligibility criteria:
inclusion criteria: 1. be pathologically or clinically diagnosed as primary lung cancer before surgery; 2. plan to undergo a surgical procedure. exclusion criteria: 1. aged younger than 18; 2. diagnosis of cognitive impairment or unable to understand the study requirements.

Keywords: utility parameter patient-reported outcome perioperative symptom management lung cancer
hba1c and neurocognitive disorders

Conditions: Neurocognitive Disorders; HbA1c

Summary: preliminary evidence suggest a possible relationship between hba1c and perioperative neurocognitive disorders (ncd). we are going to investigate whether the preoperative value of hba1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative ncd.

it is estimated that approximately 10% of elderly undergoing surgery will develop cognitive changes perioperatively, while in some reports the incidence rises up to 80%. despite the reported high prevalence of perioperative neurocognitive disorders (ncd), their exact etiology is still largely unknown. preliminary evidence suggest a possible relationship between hba1c and perioperative neurocognitive disorders (ncd). we are going to investigate whether the preoperative value of hba1c in patients undergoing elective non-cardiac surgery under general anesthesia, are related with increased risk of perioperative ncd.

Eligibility criteria:
inclusion criteria: * 1) 45 - 80 years * 2) american society of anesthesiologists physical status i to iii * 3) elective general, urological, gynecological and orthopedic surgery under general anesthesia * 4) native speakers of the greek language exclusion criteria: * 1) refused to participate or sign the informed consent form * 2) had undergone surgery or anesthesia within the last 30 days * 3) had any prior or current history involving an affliction of the central nervous system * 4) were diagnosed with severe cognitive decline based on the 16 - item informant questionnaire on cognitive decline (iqcode - 16) * 5) suffered from severe hearing or visual impairment * 6) any psychiatric disorder * 7) had a score \>5 in the geriatric depression scale (gds - 15) * 8) or a score in females \< 4 males \< 2 in the lawton - brody instrumental activities of daily living scale (i.a.d.l.) * 9) reported alcohol consumption \> 35 units/week * 10) drug dependence * 11) had undergone previous neuropsychological testing * 12) diabetes mellitus type ii with \> 10 years of diagnosis * 13) diabetes mellitus type i * 14) hemoglobin a1c (hba1c) \> 7.5% * 15) suffered from hemodynamical instability (\> 20% alterations of blood pressure perioperatively) * 16) or desaturation (one or more events of spo2 \< 80% for more than 2 minutes) peri-operatively * 17) or blood loss of more than one unit
a prospective non-concurrent controlled evaluation of open and mas® plif

Conditions: Lumbar Degenerative Disc Disease

Summary: the study is a prospective non-concurrent controlled observational evaluation of short-term operative results. as such, study sites will capture perioperative (through 6-week postoperative follow-up) case data associated with 10 standard open plif (posterior lumbar interbody fusion) procedures. after this open experience, these same sites will capture the corresponding data from 10 subsequent cases where the mas (maximum access surgery) plif variant was performed. the data from both series of cases will be compiled to identify similarities and differences between the techniques.

the objective of this evaluation is to collect and compare short-term factors related to the morbidity of approach using traditional posterior-approach interbody fusion techniques and a less invasive exposure for the same procedure. perioperative measures and early outcomes will be documented to demonstrate differences in procedural requirements, safety, and early recovery. a total of 100 subjects will be consecutively enrolled in this prospective study from as many as 8 centers. patients who, in the surgeon investigator's opinion, require instrumented lumbar interbody fusion and have consented to plif surgery for their conditions will be included. the following eligibility criteria are designed to identify existing clinic patients for whom study under this protocol is considered appropriate. all subjects must meet the inclusion/exclusion criteria in order to be considered for enrollment.

Eligibility criteria:
inclusion criteria: * subjects must meet all inclusion criteria to be eligible for enrollment into this observational study: 1. indicated for posterior lumbar interbody fusion at one or two contiguous motion segments between l1 and s1; 2. 18+ years of age at the date of written informed consent; 3. able to undergo surgery based on physical exam, medical history and surgeon judgment; 4. willing and able to return for post-treatment exams according to the follow-up called for in the protocol; 5. signed and dated informed consent form. exclusion criteria: * subjects presenting with any of the following will not be included in this observational study: 1. mental or physical condition that would limit the ability to comply with study requirements; 2. spine abnormality requiring treatment at more than two levels; 3. prior surgery at operative or adjacent level(s); 4. involvement in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested); 5. significant general illness (e.g., hiv, active metastatic cancer of any type, uncontrolled diabetes, dialysis dependent renal failure, symptomatic liver disease); 6. participating in another clinical study that would confound study data.

Keywords: open plif mas plif lumbar spine
long term clinical investigation to evaluate clinical performance, safety and patient reported outcomes of an active osseointegrated steady-state implant system

Conditions: Hearing Loss

Summary: the aim of this clinical investigation is to collect long-term safety and performance data with the active osseointegrated steady-state implant system by following subjects from the previous osia clinical investigation cbas5751. in addition, questions regarding device satisfaction, sound satisfaction, usability and health care utilisation will be asked.


Eligibility criteria:
inclusion criteria: * subject has performed hearing assessment at 3 and/or 6 months in the clinical investigation cbas5751 * willing and able to provide written informed consent exclusion criteria: * unable to follow investigational procedures, e.g. to complete quality of life scales, or unwilling to comply with the requirements of the clinical investigation as determined by the investigator * use of ototoxic drugs that could be harmful to the hearing, as judged by the investigator

Keywords: hearing loss, conductive hearing loss, mixed deafness, sensorineural single-sided
assessment of anti-inflammatory markers concentration, effectiveness and safety after spinal mesotherapy in chronic cervical pain syndrome

Conditions: Myofascial Pain Syndrome - Neck; Spondyloarthrosis; Neck Pain; Cervical Pain

Summary: the aim of the study is to assess the concentration of anti-inflammatory markers after the use of cervical spine mesotherapy in the course of pain syndrome. the study is randomized. patients will be divided into two groups: a - mesotherapy using injectable type i collagen, b - mesotherapy using 1% lignocaine. the mesotherapy procedure will be performed five times, at weekly intervals. blood will be collected before the start of mesotherapy, a week after its completion and after 3 months of follow-up. in addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed.

study aim: the aim of the study is to assess the concentration of anti-inflammatory markers after the use of cervical spine mesotherapy in the course of pain syndrome. material and methods: the study was conducted on patients aged 18 to 65 years, of both sexes, with local, chronic cervical spine pain syndrome, without radiation of symptoms to the upper limb. the study subjects were recruited at the national institute of geriatric, rheumatology and rehabilitation in warsaw. patients will be recruited according to the inclusion and exclusion criteria. the study is randomized. patients will be divided into two groups: a - mesotherapy using injectable type i collagen, b - mesotherapy using 1% lignocaine. each patient will have blood collected before starting mesotherapy (on the same day) to determine anti-inflammatory markers (tnf-alpha, interleukin-6, interleukin-12). again, a week after the end of mesotherapy (five treatments) and after 3 months of follow-up, blood will be collected to determine the same markers. in addition, the effectiveness and safety of mesotherapy of the cervical spine will be assessed. a visual analogue scale (vas) and the laitinen scale will be used.

Eligibility criteria:
inclusion criteria: * patients with chronic (\>12 weeks) cervical spine pain syndrome of muscular, myofascial nature without radiation to the upper limb * recent mri or ct scan of the cervical spine (up to 6 months) * no serious diseases: cancer, rheumatology, metabolic * no allergy to lignocaine 1% or injectable type i collagen exclusion criteria: * another cause of cervical spine pain * lack of patient consent

Keywords: mesotherapy tnf alpha interleukin 6 interleukin 12 collagen type i lignocaine
multi-center evaluation of the versant® ct/gc dna 1.0 assay (kpcr)in detecting c. trachomatis and n. gonorrhoeae

Conditions: Chlamydia; Gonorrhea

Summary: multicenter clinical study to test a new qualitative in vitro nucleic acid amplification assay based on kpcr technology. the assay is intended for the diagnosis of chlamydia trachomatis (ct) and neisseria gonorrhoeae (gc).

the study was terminated this clinical trial protocol outlines the analytical and clinical performance characteristics that will be evaluated to demonstrate equivalency of the versant ct/gc dna 1.0 (kpcr) assay for product registration. the gen-probe aptima combo 2 assay will be used as the ce-marked comparative method. the studies conducted during the clinical trial are intended to provide data to support the safety and effectiveness, as well as the labeling claims for the versant ct/gc assay. the study objectives are as follows: * to demonstrate concordance with the gen-probe aptima combo 2 assay; * to estimate the positive and negative predictive values for each specimen type included in the study; * to estimate the indeterminate rate for each specimen type included in the study; * to estimate the equivocal rate for each specimen type; and * to assess reproducibility of the versant ct/cg dna 1.0 assay (kpcr) using the versant kpcr molecular system. two (2) studies will be conducted to validate the analytical and clinical performance characteristics of the ct/gc dna 1.0 (kpcr) assay. table 1 provides an overview of these studies.

Eligibility criteria:
inclusion criteria: * subject is 18 years of age or older. * subject signed an irb approved informed consent form. * subject is able to follow verbal and written instructions. exclusion criteria: * subject has been on antibiotic therapy within 21 days prior to study enrollment. * subject urinated within one hour prior to sample collection.

Keywords: ct gc ng chlamydia gonorrhoeae
prevention of akute kidney injury, hearttransplant, anp

Conditions: Acute Kidney Injury

Summary: prospective, blinded, placebo-controlled trial. patients: adult patients (\>18 years of age) undergoing de novo htx, with a preoperative gfr \> 30ml/min, not receiving an abo-incompatible organ with an ischemia time of \> 6 hours. a donor age \> 70 years is an exclusion criteria. intervention: infusion of h-anp fore five days, starting at the induction of anesthesia. outcome: kidney function, evaluated with serum creatinine day 1-7 and kidney clearance, 4-5 days after htx plus after 3 and 12 months.


Eligibility criteria:
inclusion criteria: * de novo htx. * preoperative gfr \> 30ml/min/1,73m2. * \>18 years old. * written consent. exclusion criteria: * multi organ transplantation or previous heart transplant. * ecmo * donor age \> 70 years. * dialysis. * abo-incompatible organ. * donor heart ischemia time \> 6 tim. * known kidney disease. * other planed study within 2 mounth.
tofacitinib for treatment of chronic pouchitis

Conditions: Pouchitis; Ileal Pouchitis; Ileal Pouch

Summary: a phase 2 pilot study to evaluate the effectiveness of tofacitinib in subjects with chronic pouchitis

the proposed study is a phase 2, open-label study of tofactinib in treatment of patients with chronic pouchitis. subjects with chronic active pouchitis will be screened and recruited if they meet eligibility criteria. eligible subjects will undergo baseline clinical evaluation, laboratory testing and a pouch endoscopy. they will then receive oral tofacitinib 10 mg twice daily for 8 weeks. clinical and laboratory data will be collected at week 4 and week 8, and all subjects will undergo a end of treatment pouch endoscopy at 8 weeks. clinical, laboratory and endoscopic data at 8 weeks will be compared to the baseline data to evaluate study outcomes.

Eligibility criteria:
inclusion criteria: 1. male or female subjects ages 18 to 80 2. subjects with a history of proctocolectomy with ileal pouch anal anastomosis (ipaa) for uc at least 6 months prior to screening. 3. subjects with pouchitis that is chronic, defined by a mpdai score ≥5 assessed as the average from 3 days immediately prior to the baseline study visit and a minimum endoscopic sub-score of 2 (outside the staple or suture line) with either (a) ≥ 3 recurrent episodes within 1 year prior to the screening treated with ≥2 weeks of antibiotic or other prescription therapy, (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline study visit 4. women of childbearing potential must have documentation of a negative pregnancy test at screening and must agree to use two highly effective methods of birth control during the study and for at least 1 month after completion of study drug dosing. exclusion criteria: 1. subjects with ipaa surgery done for crohn's disease (cd) or familial adenomatous polyposis (fap) indications. 2. subjects with primary cd of pouch, isolated or predominant cuffitis or mechanical complications of the ileal pouch. 3. subjects with prior exposure to tofacitinib. 4. subjects with a diverting stoma. 5. subjects with a prior history or risk factors for venous thromboembolism. 6. subjects with active bacterial, parasitic, fungal, mycobacterial, or viral infection. 7. subjects with a history of latent or active tuberculosis. 8. subjects positive for hepatitis b virus (hbv) surface antigen, hepatitis b virus core antibody with a negative hepatitis b surface antibody or with detectable serum hepatitis b dna. 9. female subjects who are pregnant or lactating. 10. female subjects of childbearing potential who are sexually active and do not agree to using two highly effective methods of contraception during the study period. 11. subjects with clinically significant laboratory abnormalities at study screening. * other eligibility criteria apply

Keywords: chronic pouchitis tofacitinib antibiotic-refractory pouchitis antibiotic-dependent pouchitis