Kornimate/medical-research-clean huggingface dataset:
systematic referral to alcohol use dependency treatment in patients with alcohol-related liver disease: a rct

Conditions: Liver Diseases, Alcoholic; Alcohol Use Disorder; Treatment Adherence

Summary: to evaluate the efficacy of systematically referring newly diagnosed ald patients to aud treatment on alcohol abstinence after 6 months. the investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing a) a referral to specialized aud treatment (intervention) and b) standard care (control). the primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.

the investigators have designed a randomized controlled superiority trial to investigate the effectiveness of systematically offering aud treatment in newly diagnosed ald patients to increase the proportion that are abstaining from alcohol after 6 months compared to standard care. the study will be embedded in an existing observational cohort from which already included participants will be used as controls in the rct (n = 70). please see figure 1 for the flow of participants in the study. from june 24, 2024, the investigators will start to randomize eligible participants. randomization will take place in connection with the first visit in the observational cohort study. study participants randomized as controls will receive standard care through their treating physicians, which consists of individualized education on the nature of ald as well as encouragement of alcohol use cessation. patients in the intervention group will receive standard care in addition to an offer of referral to aud treatment, which includes contact from the aud treatment center to the patients and the offer of both physical and online aud treatment.

Eligibility criteria:
inclusion criteria * age \> 18 years * newly diagnosed alcohol-related liver disease, defined as within six months from baseline visit. * a liver stiffness above 8.0 kpa with 10 successful measurements and an interquartile range of less than 30% as assessed with transient elastography. * excessive alcohol consumption defined as \>7 units/week for women and \>14 units/week for men within the previous year. * the patient is able to understand the purpose of the study and give informed oral and written consent to participate. * no ongoing or recent aud treatment defined as within 12 months. only aud treatment provided by a specialised aud treatment centre counts as aud treatment. exclusion criteria * not enough proficiency in danish to participate in interviews and questionnaires. * pregnancy
a study to assess the long-term safety of karxt for the treatment of manic episodes in bipolar-i disorder (balsam-3)

Conditions: Bipolar Disorder Type I With Mania

Summary: this is a phase 3, open-label extension study to assess the long-term safety of karxt for the treatment of mania or mania with mixed features in bipolar-i disorder (bp-i) the primary objective of the study is to evaluate the long-term safety and tolerability of karxt in the treatment of participants with mania or mania with mixed features associated with bp-i.


Eligibility criteria:
inclusion criteria: * participants who participated in double-blind placebo-controlled study (cn0120036 or cn0120037): a. participants must have completed treatment period of parent study. * de novo participants who did not participate in double-blind placebo-controlled studies: 1. participants must have primary diagnosis of bipolar-i disorder established by a comprehensive psychiatric evaluation based on dsm-5-tr criteria and confirmed by the mini international neuropsychiatric interview (mini, v7.0.2), with symptoms of mania or mixed mania. 2. participants must have young mania rating scale (ymrs) score of ≥ 14 at screening and at baseline. 3. participants must have cgi-bp score of ≥ 3 at screening and at baseline. 4. participants does not require hospitalization for acute mania. exclusion criteria: * participants who participated in double-blind placebo-controlled study (cn0120036 or cn0120037): a. discontinuation from any karxt parent studies. * de novo participants who did not participate in double-blind placebo-controlled studies: 1. all participants with a risk for suicidal behavior at baseline as determined by investigator's clinical assessment or history of suicidal behavior as assessed on c-ssrs. 2. participants must not have primary diagnosis of bp-i with rapid cycling (ie, ≥ 4 distinct mood episodes in one year). 3. participants must not have any primary dsm-5-tr disorder other than bp-i with mania or mania with mixed features within 12 months before screening (confirmed using mini version 7.0.2 at screening), including bp-i with depression, (previous 3 months only), bipolar-ii disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. 4. individual has a dsm-5-tr diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using mini version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test. 5. participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. 6. participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma. 7. other protocol-defined inclusion/exclusion criteria apply.

Keywords: bipolar-i disorder mania bipolar-i disorder with mania
efficacy of a brief behavioral intervention to treat adhd and disruptive behaviors in preschoolers

Conditions: Attention Deficit Hyperactivity Disorder; Attention Deficit and Disruptive Behavior Disorders

Summary: the purpose of this study is to test the intervention using a more rigorous randomized controlled trial design in order to demonstrate its efficacy compared to a wait-list control, thus ensuring that change in behavior does not occur due to the passage of time alone. using this design will also allow us to improve upon our prior clinical research by facilitating obtainment of post-treatment and follow-up data (as families in the clinical-only service stop attending treatment when behavior improves, and have often not followed-up for booster sessions or measure completion).

this pilot study will employ a randomized controlled clinical trial design comparing symptoms of children who complete the brief behavioral intervention to a wait-list control. children in the wait-list control will be waitlisted for four months prior to initiation of treatment, which is a typical wait for clinical care. treatment will then be offered to the children on the wait-list. all parts of the intervention and all measures of behavior and family functioning are part of standard clinical care. the parts of this protocol that are not standard clinical care are the following: 1. randomization process with half of the patients on a waitlist for four months. randomization will be block randomization stratified by gender. 2. booster sessions for problem solving at three months and six months after last treatment session. in standard clinical care this occurs only if the patient calls and requests. 3. collection of behavior and family functioning measures at three months and six months after the active treatment component.

Eligibility criteria:
inclusion criteria: * age 2-5 years * subject diagnosed with a disruptive behavior disorder * subject who has an english-speaking parent willing to take part in intervention. * subject must meet criteria for a diagnostic and statistical manual (dsm-iv) disruptive behavior disorder (adhd and/or odd) based upon history, clinical interview, and clinically significant cut-off scores on parent rating forms. parent and teacher of each child will also be involved. exclusion criteria: * parents who are not fluent in english * subjects with a diagnosed anxiety disorder, pervasive developmental disorder, intellectual disability, adjustment disorder, mood disorder or language disorder will also be excluded and referred for more appropriate services. * children with less severe behavior problems will not be included in the study but will be referred for more appropriate services. * patients taking medication to treat behavior and patients who have previously received treatment will be excluded from the study.

Keywords: attention deficit, add, adhd, odd, oppositional behavior, disruptive behavior, behavior modification, parent management training, pre-school
systemic corticosteroids in the perioperative management of chronic rhinosinusitis without nasal polyps (crssnp)

Conditions: Chronic Rhinosinusitis Without Nasal Polyps (CRSsNP)

Summary: oral corticosteroids are commonly utilized for the management of chronic rhinosinusitis with and without nasal polyps (crswnp and crssnp, respectively). although strong evidence supports the benefit of routine and perioperative oral corticosteroids for crswnp, there is limited evidence to support their utility for crssnp. the investigators intend to perform a randomized, double blind, placebo controlled clinical trial to investigate the impact of steroids used within 2 weeks prior to surgery for crssnp. patients with crssnp that present to the investigators office will be included if they have failed maximal medical management and have elected to undergo endoscopic sinus surgery (ess) after july 1, 2014. the investigators hypothesis is that oral corticosteroids given 2 weeks prior to surgery will improve subjective and objective outcome measures.


Eligibility criteria:
inclusion criteria: * adult patients (ages 18-80) with a diagnosis of chronic rhinosinusitis without nasal polyps (crssnp) that have failed a 6 week trial of maximal medical therapy and have elected to undergo endoscopic sinus surgery will be offered enrollment in this study. * diagnosis of chronic rhinosinusitis (crs) is based on the european position on rhinosinusitis (epos) 2012 guidelines. * these include a greater than 12 week history of inflammation of the nose or paranasal sinuses characterized by at least 2 symptoms. * these symptoms must include at least one of the following: * nasal obstruction * rhinorrhea * postnasal drip. * additional symptoms can include facial pain/pressure or anosmia/hyposmia. * these symptoms must be supplemented by either endoscopic signs of disease or characteristic ct changes. * the presence or absence of nasal polyps defines the subtype (with polyps: crswnp; without polyps: crssnp). exclusion criteria: * patients will be excluded if they have nasal polyps or suspected allergic fungal rhinosinusitis (afrs) based on classic endoscopy and ct findings. * additionally, patients with known immunocompromise or mucociliary disorders will be excluded. * patients that received oral corticosteroids within 6 weeks prior to the planned surgery will also be excluded.

Keywords: crssnp steroids corticosteroids endoscopic surgery perioperative
adolescent weight management study

Conditions: Protocol #1:Behavioral Therapy + Placebo or Sibutramine; Protocol #2: Behavioral Therapy + Meal Replacement or Conventional Food

Summary: protocol #1:the goals of this study was to examine whether increased weight loss in obese adolescent is induced when the weight loss medication sibutramine is added to a family-based, behavioral weight control program. protocol #2: this study aims to improve the behavioral treatment of obesity during adolescence. a behavioral program using regular foods will be compared to a behavioral program using a structured meal plan (a portion-controlled approach with liquid-meal replacements \[nutritional supplements\]). this structured approach may be better for the promotion of weight loss compared to a diet of regular foods.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 28-50 kg/m2 exclusion criteria: * severe cardiovascular problems; arrhythmias * hypertension, uncontrolled (blood pressure \>140/90 mm hg) * diabetes mellitus (fasting glucose \> 126) * other serious medical disorders that would complicate dieting such as: ulcer disease, cancer, thrombophlebitis, liver or kidney disease * current use of weight loss medications, amphetamines, steroids, or aspirin; medications affecting body weight * mental retardation or genetic syndromes associated with obesity * currently pregnant or planning a pregnancy or engaging in sexual activity without using contraceptives. all females will have a serum pregnancy test at baseline and all must agree to use contraception if they are sexually active during the study. * glaucoma * history of major depression, bipolar disorder, or psychosis * history of anorexia or bulimia * alcoholism and other substance abuse * use of anti-psychotic or anti-depressant medications in the last 6 months * highly dysfunctional family system or parental psychopathology * weight loss in the preceding 6 months of 5% or more and/or participation in another weight loss program * cigarette smoking or recent cessation * if taking medication for hypertension or hypercholesterolemia condition must be stable for at least 3 months prior to enrollment in the study * chronic use of decongestants * intolerance of slimfast

Keywords: adolescent weight management obesity treatment behavioral treatment
18f-fluciclovine pet to distinguish tumor progression from radiation necrosis

Conditions: Secondary Malignant Neoplasm of Brain and Cerebral Meninges

Summary: the purpose of this study is to evaluate whether 18f-fluciclovine pet/ct of the brain, is able to distinguish radiation necrosis from tumor progression in cases where mri is inconclusive. 18f-fluciclovine is an fda approved radioactive diagnostic agent and is injected into the participant and then taken up by cancer cells, which can then be visualized with a pet/ct scan. 18f-fluciclovine is fda approved for the detection of recurrent prostate cancer, but is still investigational for the purposes of this study.

the primary objective of this study is to estimate the accuracy of 18f-fluciclovine pet in distinguishing radiation necrosis from tumor progression. accuracy will be assessed via receiver operating characteristic curve analysis, as well as by calculating sensitivity and specificity. secondary objectives of this study are to assess which factors may influence accuracy of 18ffluciclovine pet in distinguishing radiation necrosis from tumor progression and to compare the accuracy of each of the qualitative and quantitative metrics.

Eligibility criteria:
inclusion criteria: * subjects must have a confirmed diagnosis of brain metastases. * subjects must have received prior intracranial srs at least once for brain metastases. prior wbrt is allowed. * subjects must have had a clinical tumor protocol mri of the brain including a dsc-mr perfusion sequence, which is equivocal for radiation necrosis versus tumor progression within 30 days of treatment scan. "equivocal" will be defined as being inconclusive for radiation necrosis versus tumor progression as determined by the study neuroradiologist. * physician assessed life expectancy of ≥ 6 months. * subjects must have the ability to understand and the willingness to sign a written informed consent document. * for women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required. exclusion criteria: * subjects who have experienced a prior anaphylaxis reaction to 18ffluciclovine are not eligible. * females pregnant at the expected time of 18f-fluciclovine administration are not eligible due to potential harm to the fetus from exposure to radiation. women who could be pregnant require a negative pregnancy test to be eligible. * women who are breast feeding at the expected time of 18f-fluciclovine administration are not eligible due to potential harm to the infant from exposure to radiation. * subjects contraindicated for mri. * subjects unable or unwilling to comply with study requirements are not eligible. * major medical illness or psychiatric impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent. * brain metastases from primary lymphoma, germ cell tumor, or small cell carcinoma.
transcutaneous tibial neuro-stimulation to improve voiding dysfunction in multiple sclerosis.

Conditions: Multiple Sclerosis; Lower Urinary Tract Symptoms

Summary: the present trial is designed to assess the efficacy and safety of transcutaneous tibial neuro-stimulation (ttns) in improving bladder emptying in multiple sclerosis (ms) patients. patients presenting with ms and performing clean intermittent self-catheterization (cisc) to empty the bladder in the context of voiding dysfunction, will be eligible. included patients will be randomly assigned to two distinct arms * ptns de verum : patients will be treated with transcutaneous tibial neuro-stimulation at a rate of one session of 30 consecutive minutes daily for a period of 12 weeks. * ptns placebo : patients will be treated with placebo (i.e. no current) transcutaneous tibial neuro-stimulation for 30 consecutive minutes daily for a period of 12 weeks (same treatment regimen as the experimental group). efficacy in improving voiding dysfunction will be assessed 12 weeks after randomization using the bve ratio (bladder voiding efficiency) = ratio of urine volume / total bladder volume.


Eligibility criteria:
inclusion criteria: * patient with a diagnosis of multiple sclerosis * patient with bladder-sphincter dyssinergia * patient using clean intermittent self-catheterization as exclusive bladder management * patient who has given written consent * socially insured patient * patient willing to comply with all study procedures and study duration exclusion criteria: * patient with other associated neurological pathology * patient with an expanded disability status scale (edss) score ≥ 6 * patient with recurrent urinary tract infections (\> 3 episodes / year) * patient with uncontrolled overactive bladder * patient with uncontrolled detrusor hyperactivity * patient with a bladder compliance disorder * patient with tibial neuro-stimulation in the last 3 months * patient treated with a sacral neuro-modulation * patient who has received an intradermal injection of botulinum toxin a within the last 9 -months patient who received alpha-blocker treatment within the last month patient with benign prostatic hypertrophy (prostate volume \> 40 cc) - last ultrasound scan \< 6 months. patient with one or more bladder diverticulum(s) patient with unilateral or bilateral renal patient with unilateral or bilateral vesico-ureteral reflux patient with impaired renal function (gfr according to ckd-epi \< 60 ml/min/1.73m2) patient with a metallic prosthesis on the lower limb patient with a pacemaker pregnant patient

Keywords: multiple sclerosis voiding dysfunction bladder-sphincter dyssinergia tibial neuro-stimulation
effect of different dosage of umbilical cord-mesenchymal stem cells through peripheral vein in patients with esld

Conditions: End-stage Liver Diseases

Summary: there is a rise in the prevalence of end-stage liver disease during the last decade. end-stage liver disease has become one of the leading causes of death in western countries. liver transplantation is the only curative treatment for patients with end-stage liver disease. however, the shortage of donor, high cost, and postoperative complications limit its wide application in clinical practice. at present, stem cell-based therapy has been developed as an alternative treatment for end-stage liver disease. stem cells can be differentiated into a variety of cell types, and stem cell transplantation, mainly umbilical cord-mesenchymal stem cells, has attracted more and more attention in the treatment of end-stage liver disease. the investigators therefore conduct a randomised controlled trial to investigate the efficacy and safety of human umbilical cord tissue mesenchymal stem cells for the treatment of end-stage liver disease.

twenty-two subjects with end-stage liver disease attending the department of gastroenterology of the general hospital of the northern theatre of operations are expected to be enrolled over a period of 1 year. the participants will be randomly divided into a low-dose stem cell group (1×10\^6cells/kg per infusion) and a medium-high-dose stem cell group (3×10\^6cells/kg per infusion), which are infused by peripheral vein. the investigators will observe alt, ast, alp, tbil, alb, pt, inr, meld score, and child-pugh score in patients at weeks 1, 4, 8, 12, 24, and 48 post-infusion.

Eligibility criteria:
inclusion criteria: 1. 18-80 years old 2. end-stage liver disease 3. sign informed consent exclusion criteria: 1. tumours of the liver or other organs 2. liver transplantation recipients 3. acute myocardial infarction, acute heart failure, type i and type ii respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases 4. other diseases that may seriously affect the survival 5. human immunodeficiency syndrome 6. interferon or glucocorticoid therapy within 1 year 7. treated for mental illness 8. participation in other clinical trials within 30 days 9. pregnant or breastfeeding subjects 10. allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies 11. other circumstances that are unsuitable for participation in this study

Keywords: cirrhosis end-stage liver diseases umbilical cord-mesenchymal stem cells randomized controlled trial