Kornimate/medical-research-clean huggingface dataset:
low-dose buccal buprenorphine: relative abuse potential and analgesia

Conditions: Analgesia; Abuse Opioids; Pain

Summary: the goal of this study is to compare the abuse potential of low-dose equianalgesic buccal buprenorphine to a commonly used full mu opioid receptor (mor) agonist in a highly controlled experimental setting. this is a translational study in which healthy participants are phenotyped for psychosocial and opioid-use-disorder-risk-related metrics. in a within-subjects crossover design, 60 participants will receive a standard postoperative oral oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5 separate sessions. quantitative sensory testing (qst) will be used to evaluate alterations in pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will compare abuse potential (indexed by the standard fda drug liking metric) following equianalgesic doses of the two drugs.


Eligibility criteria:
inclusion criteria: * intact cognitive status and ability to provide informed consent * ability to read and write in english sufficiently to understand and complete study questionnaires * age 18-65 * opioid-naive status (defined as no use of full mu-opioid receptor (mor) agonist, partial mor agonist, or mixed agonist/antagonist medications for the prior 3 months by patient report exclusion criteria: * liver/kidney disease * chronic pain * current/prior substance use disorder * pregnancy (to avoid fetal drug exposure, with pregnancy tests conducted to confirm eligibility) * seizure disorder * certain psychiatric conditions (severe depression, bipolar disorder, psychotic disorders) * recent use of medications that may interfere with study drug metabolism * recent benzodiazepine or opioid use (confirmed via rapid urine screening prior to each lab session) * the presence of any medical conditions felt by the study physician to render participant unsafe * prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs (explicitly including moderate-to-severe nausea or vomiting with prior opioids) * recent use of marijuana, delta-8 thc, cbd, and similar products * recent use of kratom * severe asthma * long qt syndrome * parkinson disease * weight \<60 kg
valproate efficacy in cocaine-bipolar comorbidity

Conditions: Bipolar Disorder; Cocaine Dependence

Summary: this proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. we propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of divalproex sodium (valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.

bipolar disorder has the highest rate of association with cocaine and other substance use disorders than any other major severe psychiatric syndrome. this comorbidity represents a major treatment challenge and is associated with severe disability, morbidity, and heightened risk for suicide. the aims of this study are: 1. examine the efficacy of valproate plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use in patients with cocaine dependence and comorbid bipolar disorder. 2. determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed vs. manic/mixed) and the presence of additional substance use disorders moderate the association between treatment and cocaine use outcome. 3. assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.

Eligibility criteria:
inclusion criteria: * meet dsm-iv criteria for cocaine dependence and a concurrent bipolar disorder exclusion criteria: * schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolar major depression, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning. * current dsm-iv criteria for dependence on substances other than cocaine, alcohol, cannabis, nicotine, or caffeine * neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or documented focally abnormal eeg * medical conditions including severe cardiac, liver, kidney, or liver disease. * pregnancy * inability or unwillingness to use contraceptive methods * any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol.

Keywords: bipolar cocaine comorbidity
primary vaccination study with a pneumococcal conjugate vaccine in healthy children 6 to 10 weeks of age

Conditions: Infections, Streptococcal; Streptococcus Pneumoniae

Summary: the purpose of this study is to assess the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following primary vaccination of indian infants with pneumococcal conjugate vaccine gsk1024850a co-administered with a diphtheria, tetanus, whole cell pertussis (dtpw)-combined vaccine during the first 4 months of life. the study will be conducted in india.


Eligibility criteria:
inclusion criteria: * male or female subjects between, and including 6-10 weeks of age at the time of the first vaccination. * subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol. * written or oral, signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child/ward. where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness. * free of any known or suspected health problems (as established by medical history and clinical examination before entering into the study). exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). * chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * a family history of congenital or hereditary immunodeficiency. * any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period (with the exception of hepatitis b immunoglobulins at birth). * previous vaccination against diphtheria, tetanus, pertussis, hepatitis b, haemophilus influenzae type b and/or streptococcus pneumoniae (with the exception of hepatitis b vaccination at birth or at least 30 days before the subject's first study visit). * history of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis b, streptococcus and haemophilus influenzae type b disease. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * history of any neurological disorders or seizures. * major congenital defects or serious chronic illness. * acute disease at the time of enrolment. * babies for which birth weight is \< 2 kilogram.

Keywords: pneumococcal disease pneumococcal vaccine safety primary vaccination immunogenicity
a first in human study to assess civi007 in subjects with an elevated ldl-cholesterol level

Conditions: Hypercholesterolemia

Summary: the primary objective of the study is to assess pharmacokinetics, dynamics, safety and tolerability of civi007 following single and multiple subcutaneous doses in subjects, including those on statin therapy


Eligibility criteria:
key inclusion criteria: * males or females, of any race, with fasting ldl c \>2.6 mmol/l (100 mg/dl) and fasting serum triglycerides \<4.52 mmol/l (400 mg/dl) * haematology and clinical chemistry without clinically significant abnormal values * normal renal and hepatic function * women must not be pregnant, lactating or of child bearing potential * men must be willing to use appropriate contraception during the study * able to comprehend and willing to sign an icf and to abide by the study restrictions. key exclusion criteria: * any uncontrolled or serious disease, or any medical or surgical condition * history or presence of coronary heart disease, peripheral artery disease, or cerebrovascular disease * uncontrolled hypertension * insulin dependent diabetes mellitus * secondary dyslipidemia * history of renal or hepatic diseases, acquired immune deficiency syndrome, positive human immunodeficiency virus test and/or history of viral hepatitis b or c * history of cancer within 5 years * history of high alcohol consumption or positive alcohol breath test or urinary test for drugs of abuse * participation in another clinical study within 3 months prior to screening or participation in another study * use of treatment (e.g. antibody) towards pcsk9 * history of multiple drug allergies or intolerance to subcutaneous injection.
inspace™ system over rotator cuff repair in comparison to repair alone.

Conditions: Rotator Cuff Tear

Summary: this is a post-marketing study to further assess the safety and effectiveness of the inspace™ in the study population in comparison to surgical rct repair.

the effectiveness will be assessed by comparing the scores of the ases, constant and quick dash outcome questionnaires with respect to pain reduction, improvement of activity of daily living (adl) and improvement of range of motion (rom).

Eligibility criteria:
main inclusion criteria: * age 40 or older. * positive diagnostic mri of the affected shoulder indicating full thickness large to massive rct of at least 3cm in diameter (according to cofield classification2) involving one or more tendons. (mri can be done up to 6 months prior to randomization.) * persistent pain and functional disability of the affected shoulder for at least 3 months. main exclusion criteria : * known allergy to the balloon material (copolymer of pla and -θ-caprolactone). * evidence of significant osteoarthritis or cartilage damage in the shoulder * evidence of gleno-humeral instability * previous surgery of the shoulder in the past 2 years, excluding diagnostic arthroscopy * evidence of major joint trauma, infection, or necrosis in the shoulder * partial-thickness tears of the rotator cuff

Keywords: massive rotator cuff tear, sub-acromial spacer, best repair of rotator cuff
hemodynamic measurements in women with serious preeclampsia

Conditions: Preeclampsia

Summary: this trial is examining hemodynamic measurements in women with serious preeclampsia.


Eligibility criteria:
inclusion criteria: * women with serious preeclampsia

Keywords: cardiac output preeclamptic women systemic vascular resistance blood pressure
effect of simvastatin on cardiac function

Conditions: Rheumatic Heart Disease; Congenital Heart Disease; Aneurysm; Heart Valve Disease

Summary: it is well know that statins have been used to low cholesterol to prevent and treat coronary artery disease for many years. it was also reported that statins could protect endothelial function and cardiac function during coronary artery bypass graft. however, some results were controversial. also, there is no clinical data available on statin cardiac protection during surgery in china where rheumatic heart disease is prevalent. thus, the investigators are trying to see whether statins can protect heart injury during cardiac surgery in chinese. part of patients will receive statin treatment and part of will not before surgery in the study. both patients' heart function will be measured and compared after surgery to determine whether statins can protect heart injury during heart surgery.

cardiac function is crucial for cardiac surgery. the mortality remains very high in patients with poor cardiac function preoperation, long surgical time, complicate or difficult surgical procedure or uncompleted corrected malformation currently. thus, it is necessary to search other approaches to improve cardiac function for cardiac surgery patients in order to increase the success, decrease complication and mortality in cardiac surgery. although statin has been used to low cholesterol to prevent and treat coronary artery disease for many years, it has been reported that statin could protect endothelial function and cardiac function in coronary artery bypass graft. however, some results were controversy. also, there is no clinical data available on statin cardiac protection during surgery in china where rheumatic heart disease is prevalence.thus, it is necessary to perform a double blind, randomised clinical trial in china to determine whether statin can protect heart injury during heart surgery in china and what's its mechanism.

Eligibility criteria:
inclusion criteria: * cyanotic congenital heart disease * noncyanotic congenital heart disease with pulmonary hypertension * heart valve disease, * other heart and great artery diseases need heart or great artery surgery exclusion criteria: * coronary artery disease * under 10-year-old. * noncyanotic congenital heart disease without pulmonary hypertension * poor liver function such ast elevated,hepatitis * gestation women and breast-feeding women
genomic structural variation in cancer susceptibility

Conditions: Breast Cancer; Colon Cancer; Germ Cell Cancer; Neuroblastoma; Rectal Cancer; Sarcoma

Summary: this study will look for new types of gene changes that may be related to cancer in some patients. some gene changes (mutations) are passed on from parents to offspring (child). other gene changes are new and are seen for the first time in a child. they are not seen in the parent. some of these gene changes may cause cancers in the offspring. we will look for gene changes by studying patients with cancer their parents and family members without cancer. in this study, we will be able to find gene changes that occur in the cancer patient but not in the rest of the family. knowing the role that new gene changes play in cancer risk may help us find people at a higher risk of getting cancer.


Eligibility criteria:
inclusion criteria: * proband must have living unaffected biologic mother and father available and eligible for participation in the study with one of the following (both incident and prevalent cases will be collected): * colorectal cancer diagnosed at or under the age of 50. * breast cancer diagnosed at or under the age of 45. * germ cell tumor diagnosed at or under the age of 40. * pediatric cancer of any type diagnosed at or under the age of 21 * adult cancer or pre-neoplastic condition of any type diagnosed at or under the age of 40 * cancer at any age in 2 or more siblings suggestive of a genetic etiology, such as brothers with testicular germ cell tumor or sisters with breast cancer and ovarian cancer * parents: * must be the biologic mother and biologic father of affected proband. * must have (by self-report) no history of cancer other than non-melanomatous skin cancer or cervical cancer in situ except in the case of inclusion criteria #6.. * in certain clinical situations, parent(s) with cancer may be included at the discretion of the principal investigator, if the principal investigator deems that the etiology of cancer in the parent(s) and proband are biologically unrelated. * sibling(s): * must be age 18 or older and have same biologic parents as proband. exclusion criteria: * known genetic mutation in proband or a family history that is indicative of hereditary cancer susceptibility.

Keywords: genome-wide 09-068
safety and efficacy of silk vista and silk vista baby flow diverter for intracranial aneurysm treatment

Conditions: Intracranial Aneurysm

Summary: the first study is an observational, prospective, multi-center, international, single-arm, study. the aim of the study is to collect safety and efficacy information on the use of the silk vista and silk vista baby flow diverter in order to assess clinical safety and performance of the device for treating intracranial aneurysms. all patients with intracranial aneurysm ruptured or unruptured, whatever the localization of the aneurysm, and treated with silk vista or silk vista baby, will be consecutively enrolled in the study. the patient's inclusion and follow up in the study will occur as part of their usual standard of care.


Eligibility criteria:
inclusion criteria: 1. patient with intracranial aneurysms intended to be treated with the silk vista and silk vista baby (decision of use silk vista and silk vista baby is done independently and prior to the participation of the patient in the study) 2. patients with recanalized aneurysms previously treated with coils exclusively are also eligible. 3. in case of multiple aneurysms, only treatment with silk vista and silk vista baby are allowed (between the initial index procedure to the 12 months follow up visit) 4. patient ≥ 18 years, who signed an informed consent. exclusion criteria: 1. patient presenting with contra-indications to the use of silk vista and silk vista babyaccording to the ifu (instruction for use). 2. recanalized aneurysms initially treated with stent (including stent assisted coiling)
a study of tiragolumab in combination with atezolizumab compared with placebo in combination with atezolizumab in patients with previously untreated locally advanced unresectable or metastatic pd-l1-selected non-small cell lung cancer

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of the study is to evaluate the efficacy and safety of tiragolumab plus atezolizumab compared with placebo plus atezolizumab in participants with previously untreated locally advanced, unresectable or metastatic pd-l1-selected non-small cell lung cancer (nsclc), with no epidermal growth factor receptor (egfr) mutation or anaplastic lymphoma kinase (alk) translocation. eligible participants will be randomized in a 1:1 ratio to receive either tiragolumab plus atezolizumab or placebo plus atezolizumab.


Eligibility criteria:
inclusion criteria: * eastern cooperative oncology group (ecog) performance status of 0 or 1 * histologically or cytologically documented locally advanced or recurrent nsclc not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic stage iv non-squamous or squamous nsclc * no prior systemic treatment for metastatic nsclc * high tumor tissue pd-l1 expression * measurable disease per response evaluation criteria in solid tumors, version 1.1 (recist v1.1) * adequate hematologic and end-organ function * for participants enrolled in the extended china enrollment phase: current resident of mainland china or taiwan and of chinese ancestry. exclusion criteria: * known mutation in the egfr gene or an alk fusion oncogene * symptomatic, untreated, or actively progressing central nervous system metastases * active or history of autoimmune disease or immune deficiency * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis * malignancies other than nsclc within 5 years, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * severe infection within 4 weeks prior to initiation of study treatment * positive test result for human immunodeficiency virus (hiv) * active hepatitis b or hepatitis c * treatment with investigational therapy within 28 days prior to initiation of study treatment * prior treatment with cd137 agonists or immune checkpoint blockade therapies, anti-ctla-4, anti-tigit, anti-pd-1, and anti-pd-l1 therapeutic antibodies * treatment with systemic immunostimulatory agents within 4 weeks or 5 drug elimination half-lives prior to initiation of study treatment.
cognitive enhancement in depression (the cog-d study)

Conditions: Aging; Depression; Cognitive Symptom

Summary: this study will investigate whether transcranial direct current stimulation (tdcs) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime episodes; either current or within past 3 years).

the purpose of this study is to determine whether the addition of active tdcs to computerized cognitive remediation (nccr) enhances brain activity and cognitive functions in older adults with recurrent depression to a greater degree than nccr with sham stimulation. the investigators will randomize 20 elderly depressed outpatients to either double-blinded active or sham bifrontal tdcs plus daily nccr over 4-weeks. multimodal mri (focused on the cognitive control network; ccn) and psychiatric and neuropsychological evaluations will be obtained at baseline and following intervention completion. long-term ccn cognitive effects will be explored 3-months post-intervention via cognitive assessments.

Eligibility criteria:
inclusion criteria: * age 60+ years * diagnosis of a current or past (within last 3 years) depressive episode (e.g., major depressive disorder (mdd), persistent depressive disorder (pdd)) using diagnostic and statistical manual of mental disorders, fifth edition (dsm-5) criteria * in total, participants must have 2 or more lifetime depressive episodes to be considered "recurrent" * either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment * evidence of subjective cognitive complaints on the everyday cognition scale (ecog) * english fluency exclusion criteria: * other axis i psychiatric conditions via the dsm-5, except for anxiety symptoms occurring in a depressive episode * acute suicidality on clinical evaluation * acute grief * history of alcohol use disorder or substance use disorder in last 12 months * currently taking medications that would significantly interact with tdcs effects (such as sodium channel blockers or anticonvulsants) * neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury, parkinson's disease) * montreal cognitive assessment (moca) score \< 23 * primary amnestic cognitive profile (\>1.5 standard deviations (sds) below demographically-adjusted mean on national alzheimer's coordinating center (nacc) memory measures in context of otherwise normal cognitive profile) * any physical or intellectual disability affecting ability to complete assessments * unstable medical illness needing urgent treatment * mri contraindications * electroconvulsive therapy (ect) or transcranial magnetic stimulation (tms) in last 2 months * current involvement in psychotherapy * current involvement in other research studies (including but not limited to: neuromodulation \[tms or tdcs\] or investigational drug studies)

Keywords: geriatrics aging elderly cognition memory depression tdcs cognitive training cognitive remediation