Kornimate/medical-research-clean huggingface dataset:
home based treatment for drug use in early adolescents

Conditions: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder; Conduct Disorder; Substance Abuse

Summary: this study will compare two programs to see if they are helpful in preventing the use of substances in adolescents with attention deficit-hyperactivity disorder (adhd), oppositional defiant disorder (odd), or conduct disorder (cd). one of the programs involves working with adolescents and their parent(s) in their home. the other program involves working with adolescents and their parent(s) in an office setting.

in this study phase, 36 patients with a disruptive behavior disorder (dbd - i.e., attention deficit-hyperactivity disorder, oppositional defiant disorder, conduct disorder) and use or abuse of one or more substances will be randomly assigned to treatment using either a standard treatment for dbds in this age group or the newly developed hbt treatment. treatment outcomes for the 24 patients assigned to receive hbt will then be compared to outcomes for the 12 patients assigned to receive standard dbd treatment. specific aims of phase ii include: 1. finalizing the hbt treatment manual and measures of treatment fidelity, therapist competence, and treatment satisfaction; 2. generating estimates of treatment effect sizes for substance use, disruptive behavior, and functional status outcomes, as pilot data for a larger efficacy study, and 3. comparing treatment satisfaction for the two treatment groups. we hypothesize that hbt will lead to significantly lower rates of disruptive behaviors, substance use, and suds than with standard treatment, as well as greater concomitant improvements in impairment.

Eligibility criteria:
inclusion criteria: * study participants (subjects and parents) must provide written consent and verbal assent * adolescents aged 11 through 14 of any race or ethnic background, * a dsm-iv disruptive behavior disorder diagnosis (either cd, odd, adhd or disruptive behavior disorder not otherwise specified \[dbd nos\]), * adolescents who are either using one or more substances regularly (2 or more times a month for 3 consecutive months), and * acceptable insurance coverage (i.e., participant has insurance that is accepted by the university of pittsburgh medical center \[upmc\] in the event that they are randomly assigned to the treatment-as-usual \[tau\] group). exclusion criteria: * full scale iq below 80; * history of pervasive developmental disorder, schizophrenia or other psychotic disorders, organic mental disorders or eating disorders, * diagnosis of bipolar disorder, * recent treatment for substance problems, and/or * daily use of "hard" street drugs (i.e., cocaine, methamphetamine, heroin, inhalants).

Keywords: adhd oppositional defiant disorder conduct disorder substance use drug and alcohol use
post-operative evaluation of endodontic microsurgeries done using a piezoelectric ultrasonic technique: an in vivo study

Conditions: Periapical Diseases; Endodontic Overfill; Healing Surgical Wounds

Summary: the aim of the study was to evaluate the effect of piezosurgery and trephine bur as cutting tools on post-operative sequelae including pain and swelling following guided endodontic microsurgeries.

materials and methods: twenty healthy male patients aged between 18 and 45 years old were selected in the study. mandibular first molar teeth with failed non-surgical treatment or re-treatment due to iatrogenic errors at the apical 3mm of the mesial root canal including canal ledging, zipping and transportation, root perforation, separated instrument, and canal calcification were selected. piezosurgery assisted cavity preparation and root-end resection were performed in groups i and ii, and trephine bur assisted cavity and root-end resection was performed in groups iii and iv. an apical curettage was performed and the over-extended objects such as separated instruments or gutta percha were removed. the prf clots was placed inside the bone cavity in groups i and iii while the bone cavity was kept for 2 min to allow the blood clots to be formed in groups ii and iv. the degree of pain and swelling were recorded for five days every 24, 48, 72, 96, and 120 hours postoperatively.

Eligibility criteria:
inclusion criteria: mandibular first molar teeth were selected according to specific inclusion criteria including: 1. teeth presented with failed non-surgical treatment or re-treatment. failure is due to iatrogenic errors at the apical 3mm of the mesial root canal including canal ledging, zipping and transportation, root perforation, separated instrument and canal calcification. 2. teeth presented with normal pocket depth ranges from 1 to 3mm, up to grade ii tooth mobility. 3. teeth presented without periapical radiolucency (class a) or with periapical radiolucency not more than 1 mm in diameter both mesiodistally and buccolingually (class b) according to the preoperative endodontic microsurgical classification of teeth. 4. teeth presented with non-fused mesial and distal roots and the mesial roots are range from 10 to 15 mm. in length, type iii root canal configuration (two canals run separately from orifice to apex). the root canal curvature angle was measured using the weine technique to be not less than 160° in both directions buccolingually and mesiodistally. 5. at the apical 3 mm of the mesial radiographic root apex, the distance from the outer surface of the buccal cortical plate of bone to the buccal side of the mesial root is 1.5 mm (depth i). the buccolingual dimension of the mesial root is 7 mm mm (depth ii). the distance from the lingual surface of the mesial root to the outer surface of the lingual cortical plate of bone is 3.5 mm. (depth iii).

Keywords: endodontic microsurgery piezosurgery trephine bur
atacicept in lupus nephritis patients taking stable regimen of mycophenolate mofetil

Conditions: Lupus Nephritis

Summary: the sponsor electively terminated the study because the risk mitigation measures, deemed necessary after an unforeseen safety event, could not be effectively implemented within this protocol while maintaining study timelines within a reasonable time frame.

this study will evaluate atacicept's effects in subjects who have lupus nephritis, at least 2 g/day of protein in the urine, and are already taking mycophenolate mofetil. the evaluations will include the concentrations of atacicept in the blood, the effects of atacicept on immunoglobulins (antibodies), and any side effects. the first subjects will be given a low dose. following periodic reviews of the trial data, subsequent subjects are planned to receive one of 2 progressively higher doses of atacicept.

Eligibility criteria:
inclusion criteria: * male or female subjects, ≥ 18 years of age, who provide written informed consent * subjects must have a diagnosis of sle satisfying ≥ 4 of 11 acr criteria, and must have had a renal biopsy during screening or within the previous 18 months demonstrating class iii (a or a/c), iv (a or a/c), v, or concomitant iii/v or iv/v ln as defined by the international society of nephrology/renal pathology society (isn/rps). * subjects must have a urine protein: creatinine ratio ≥ 2 mg/mg (≥ 226.2 mg/mmol), and either a positive test for antinuclear antibody (ana) (hep-2 ana ≥ 1:80) and/or anti-double stranded deoxyribonucleic acid (dsdna) (≥ 30 iu/ml) at screening. * subjects must have started induction therapy for ln at least 5 months prior to trial day 1, be considered to have received continuous treatment for ln during the 5 months prior to trial day 1, and have received a stable dose of mmf ≥ 1 g/day, with or without corticosteroids, for at least 8 weeks prior to trial day 1. exclusion criteria: * recent changes in immunosuppressant, acd inhibitors for arbs * use of azathioprine, cyclosporine, tacrolimus, or cyclophosphamide or other biologics within 8 weeks prior to trial day 1. * serum igg \< 6 g/l * estimated glomerular filtration rate (gfr) ≤ 30 ml/min per 1.73 m2 * history of demyelinating disease * significant hematuria and/or proteinuria due to a reason(s) other than ln. evaluation should be done according to the local standard of care * breast feed or pregnancy * legal incapacity or limited legal capacity

Keywords: open label dose escalating phase ib
bn brachyury and radiation in chordoma

Conditions: Chordoma

Summary: the goal of this study is to determine if the combination of bn-brachyury plus radiation therapy can induce objective radiographic response rate (orr) in patients, using a simon 2-stage optimal design. in stage 1, a minimum of threshold of activity is needed to proceed to stage 2.


Eligibility criteria:
inclusion criteria: * patients must have histologically confirmed chordoma * patients must have measurable disease by recist 1.1 * patients must be scheduled to have radiation therapy to at least 1 target lesion. * age ≥12 years * patients must have normal organ and marrow function * must have recovered completely from any reversible toxicity associated with recent therapy. * there should be a minimum of 2 weeks from any chemotherapy, small molecule/targeted therapy, immunotherapy and/or radiation prior to enrolment * females of childbearing potential and male partners of females of childbearing potential must agree to use effective birth control or abstinence from screening to after the last vaccination therapy exclusion criteria: * concurrent treatment for cancer, with specific exceptions noted in the inclusion criteria * chronic hepatitis b or c infection. * any significant disease, that in the opinion of the investigator may impair the patient's tolerance of trial treatment. * significant dementia, altered mental status, or any psychiatric condition that would prohibit the understanding, or rendering of informed consent. * active autoimmune diseases requiring treatment or a history of autoimmune disease that might be stimulated by vaccine treatment. this requirement is due to the potential risks of exacerbating autoimmunity. * concurrent use of systemic steroids, except for physiological doses of systemic steroid replacement or local steroid use. * patients who are receiving any other investigational agents within 28 days before start of trial treatment. * history of allergic reactions attributed to compounds of similar chemical or biological composition to mva-bn/fpv-brachyury or other agents used in trial. history of allergic reactions to aminoglycoside antibiotic or egg products. * serious or uncontrolled intercurrent illness, included but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with trial requirements. * pregnant women are excluded from this trial due to the unknown effects of the bn-brachyury on the fetus or infant. * hiv-positive patients are ineligible because of the potential for decreased immune response to the vaccine. * significant cardiovascular disease, which includes but is not limited to new york heart association heart failure class ii or greater, myocardial infarction within the previous 3 months, unstable arrhythmias, unstable angina.
computed tomography versus exercise testing in suspected coronary artery disease

Conditions: Angina Pectoris; Chest Pain

Summary: direct non-invasive coronary imaging by computed tomography (ct) has the potential to improve the workup of patients with stable chest pain complaints. the objective of the study is to compare in a randomized fashion the effectiveness and efficiency of a ct angiographic driven workup of suspected coronary artery disease in comparison to the standard workup using stress testing.


Eligibility criteria:
inclusion criteria: * men and women aged \>18 years. * stable symptoms of chest pain or dyspnea potentially caused by obstructive cad. exclusion criteria: * a history of surgical or percutaneous coronary revascularization * non-revascularized angiographic obstructive coronary artery disease (\>50% diameter reduction). * normal invasive coronary angiography or stress imaging less than 1 years ago. * inability or unwillingness to provide informed consent.

Keywords: coronary artery disease angina pectoris stable chest pain complaints
effects of duloxetine vs. escitalopram on heart rate variability in depression

Conditions: Major Depressive Disorder

Summary: low heart rate variability is a marker of increased risk of cardiac mortality, and is observed in depressed coronary artery disease patients. some antidepressants may themselves, however, decrease heart rate variability. we will test the hypothesis that greater reduction in heart rate variability will be associated with duloxetine (which has noradrenergic activity) than escitalopram (a selective serotonin reuptake inhibitor). we will also test the hypothesis that changes in heart rate variability are related to the magnitude of norepinephrine transporter occupancy.

evaluation of heart rate variability (hrv) has been shown to be a valuable tool for measuring autonomic dysfunction associated with depression and with cardiac disease. low hrv is a marker of increased risk of cardiac mortality, and is observed in depressed coronary artery disease patients and in anxious patients post-mi. treatment with sympathomimetic antidepressants, such as mao inhibitors and tricyclics, reduce hrv further, and have been associated with elevated heart rate, orthostatic hypotension, and with adverse cardiac events. although there is increasing evidence that the selective serotonin reuptake inhibitor (ssri) class of antidepressants have minimal effects on the cardiovascular system, the case is less clear with the snri antidepressants which block the reuptake of both serotonin and norepinephrine. it is possible that measures of the extent of norepinephrine transporter blockade or inhibition may relate to the hrv reduction seen with noradrenergic drugs. given these considerations, we propose a study to compare the cardiovascular profile of the ssri escitalopram (lexapro), with the most recently available snri, duloxetine, in outpatients with depression. using hrv methodology, we will test the hypothesis that greater reduction in hrv will be associated with duloxetine than escitalopram. in addition, we will measure the magnitude of serotonin and norepinephrine transporter occupancy produced by each drug. this will allow us to examine the relationship between changes in hrv to the magnitude of transporter inhibiting effects of each drug.

Eligibility criteria:
inclusion criteria: * adults 20-60 years of age * a primary diagnosis of depression using dsm-iv criteria * written informed consent * a negative serum pregnancy test for women of childbearing potential exclusion criteria: * history of cardiovascular disease * history of hypertension * history of bipolar disorder * history of schizophrenia or other psychotic disorder * alcohol or other substance abuse within the last 3 months * history of cognitive impairment
myeloma resistance and clonal evolution

Conditions: Multiple Myeloma

Summary: multiple myeloma (mm) is often associated with progression, temporary response to therapy and a high relapse rate over time resulting in a poor long-term prognosis. because mm is classified as an incurable disease, therapeutic resistance is of great interest. however, knowledge about the biological mechanisms underlying resistance associated with mm therapies and about associated predictors remains poor. the myracle cohort, a multicenter prospective cohort of patients with mm, is set up to address this limitation.

the myracle cohort study aims at including all patients (\>18 years old) who are diagnosed with mm in any stage of the disease and treated in specialized oncology centers in 2 public hospitals in northwestern france. any such patient providing a signed informed consent is included. all subjects are followed up until refusal to participate in the study, emigration or death. the myracle follow-up is continuous and collects data on socio-economic status, medical status, mm therapies and associated events (resistance, side effects). participants also complete standardized quality of life (qol) questionnaires. in addition, participants are asked to donate blood samples that will support ex vivo analysis of expression and functional assays required to uncover predictive biomarkers and companion diagnostics. if diagnostic biopsies are performed during the course of the disease, extracted biological samples are kept in a dedicated biobank.

Eligibility criteria:
inclusion criteria: * patient with diagnosis of multiple myeloma according to standard criteria * age \>18 exclusion criteria: * minor patient * patient under guardianship * protected patient

Keywords: myeloma cohort resistance quality of life
identification of tongue involvement in late-onset pompe disease

Conditions: Myopathy; Neuropathy; Glycogen Storage Disease Type II (Late-onset Pompe Disease)

Summary: this purpose of this study is to determine if tongue strength and tongue ultrasound measurements differentiates patients with untreated late-onset pompe disease (lopd) from patients with acquires/hereditary myopathies or neuropathies. it is hypothesized that abnormalities in tongue function and structure in patients with lopd may be useful in discriminating this condition from others that have similar presentations.


Eligibility criteria:
inclusion criteria: * age ≥ 12 years * confirmed diagnosis of lopd and naïve to enzyme-replacement therapy (ert) * acquired/hereditary myopathy (e.g., dermatomyositis, polymyositis, inclusion body myositis, limb-girdle muscular dystrophy, distal myopathy, myotonic muscular dystrophy, and other myopathy) * neuropathy (e.g., peripheral neuropathy, cranial neuropathy, autonomic neuropathy, focal neuropathy) exclusion criteria: * current use, history within the past two years of use, or eligible but declined use of lumizyme® enzyme replacement therapy (applicable to lopd group) * history of stroke, parkinson's disease, oculopharyngeal muscular dystrophy, head and neck cancer or radiation treatment to head/neck, or other conditions that commonly affect lingual strength * inability to follow directions for study participation
rct for electroconvulsive treatment followed by cognitive control training

Conditions: Depressive Episode; Electroconvulsive Therapy; Cognitive Remediation

Summary: major depressive disorder (mdd) is worldwide one of the most prevalent and disabling mental health conditions. electroconvulsive therapy (ect) is a safe and effective treatment even though 6-month relapse rates are high. cognitive side effects of ect, such as reduced cognitive control, might trigger mechanisms that increase relapse in patients. as such, cognitive control training (cct) holds promise as a non-pharmacological strategy to improve long-term effects of ect (i.e., increase remission, and reduce depression relapse).

eighty-eight participants aged between 18-70 years with major depressive disorder who start electroconvulsive treatment (ect) will be included in this randomized controlled trial (rct). following (partial) response to ect treatment (at least a 25% reduction of clinical symptoms), participants will be randomly assigned to a computer based cct or active placebo control. a first aim of this rct is to assess the effects of cct compared to an active placebo condition on depression symptomatology, cognitive complaints, and quality of life. secondly, participants will be monitored every two weeks for a period of six months following cct/active placebo, allowing the detection of potential relapse of depression. thirdly, the investigators will assess participant evaluation of the addition of cognitive remediation to ect using qualitative interview methods (satisfaction, acceptability and appropriateness). finally, in order to further advance our understanding of the mechanisms underlying effects of cct, exploratory analyses may be conducted using facial video footage collected during the cct/active control phase of the study.

Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years old * current major depressive episode with treatment resistance * eligibility and consent for ect treatment * ability to provide consent to study exclusion criteria: * neurodegenerative disorder or moca \< 18 * catatonia * schizophrenia * alcohol use disorder in previous year * prior ect treatment * insufficient computer knowledge or analphabetism

Keywords: cognitive control training
post-market clinical survey of clareon® iol autonome™ in japanese subjects

Conditions: Cataract

Summary: this purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (iol) delivery performance of clareon® iol autonome™ when used in daily practice.

this study will enroll subjects who underwent prior cataract surgery with phacoemulsification and were implanted with clareon intraocular lenses (iols) using the clareon® iol autonome™ automated preloaded delivery system. subjects will be enrolled post-operatively and followed for one year.

Eligibility criteria:
inclusion criteria: * able to comprehend and willing to sign informed consent. * prior diagnosis of age-related cataracts. * prior cataract surgery with implantation of clareon iol in the capsular bag by autonome™. * no ophthalmic disease which might affect visual acuity. exclusion criteria: * none.

Keywords: cataract surgery intraocular lens iol clareon autonome
liver health and metabolic function in people with obesity

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: this project aims to determine the effect of significant weight loss on rates on hepatic fibrogenesis in people with obesity.

non-alcoholic fatty liver disease (nafld) affects approximately 70% of those with obesity and if left untreated can progress to cirrhosis and liver failure. nafld stages progress from the stage of simple steatosis to steatohepatitis, and fibrosis the stage of nafld is currently best determined using histology from a liver biopsy, however this provides a static depiction of the state of the liver. therefore, this project aims to determine fibrogenesis in the liver of obese humans in vivo, before and after weight loss.

Eligibility criteria:
inclusion criteria: * body mass index ≥35 kg/m2 * scheduled for bariatric surgery exclusion criteria: * significant organ disfunction/disease * tobacco use * previous bariatric surgery * pregnancy * excessive alcohol use * liver disease other than nafld