Kornimate/medical-research-clean huggingface dataset:
abuse potential of buprenorphine and naloxone in non-dependent opioid users

Conditions: Opioid-Related Disorders

Summary: buprenorphine is a medication used to treat opioid addiction, but individuals who use this drug are at risk of abusing it. a buprenorphine and naloxone combination may reduce the likelihood of buprenorphine addiction. this study will evaluate the potential for abuse of buprenorphine and a buprenorphine and naloxone combination in non-dependent opioid users.

opioid withdrawal symptoms are a major contributing factor for why opioid treatment programs often fail. individuals with severe opioid withdrawal may experience shaking, muscle and bone pain, nausea, depression, anxiety, and drug craving. buprenorphine, a medication that is used to treat opioid addiction, works by lessening the withdrawal symptoms. however, past research has shown that individuals who use buprenorphine are at risk for abusing the drug. naloxone, another medication, is currently used to treat substance addiction. it is also used in combination with buprenorphine to reduce the risk of buprenorphine abuse in individuals who are physically dependent upon opioids. the purpose of this study is to compare the abuse potential of buprenorphine versus a buprenorphine and naloxone combination in non-dependent opioid users. this 7-week study will enroll non-dependent opioid users. participants will take part in two medication challenge sessions per week. at each challenge session, participants will be randomly assigned to receive varying doses of either buprenorphine; a buprenorphine and naloxone combination; hydromorphone, which is a medication used to treat moderate to severe pain; or placebo. buprenorphine and naloxone will be administered as tablets that are dissolved under the tongue. hydromorphone will be injected. during the challenge sessions, participants will complete performance tasks to measure psychomotor and cognitive functioning. questionnaires and self-reports will be completed to assess medication effects. heart rate and blood pressure will be monitored throughout all sessions, and a specialized camera will be used to assess pupillary response of the eyes.

Eligibility criteria:
inclusion criteria: * current opioid abuse * not physically dependent on opioids exclusion criteria: * significant medical or psychiatric illness (e.g., insulin-dependent diabetes or schizophrenia) * seeking substance abuse treatment (will be assisted with referrals to community-based treatment programs) * pregnant

Keywords: opiate addiction opiate dependence
effect of pumpkin seed oil or pumpkin seeds on blood pressure and menopausal symptoms in postmenopausal women

Conditions: Hypertension; Dyslipidemia

Summary: the purpose of this randomized control trial is to compare the effect of pumpkin seed oil 2g/day with pumpkin seeds given as a dose of 1½ teaspoons/ 4.1 grams a day to provide 2g of lipid (equivalent to 2 grams of oil) on bp (systolic and diastolic), endothelial function, serum lipids, c-reactive protein (crp) concentrations, and menopausal symptoms in postmenopausal women.

at the onset of menopause cvd rates increase in women. a beneficial effect of pumpkin seed oil on blood pressure has been observed in postmenopausal women. more than 1 in 3 female adults have some form of cardiovascular disease (cvd), which is affected by blood pressure. pumpkin seed is a good source of phytoestrogens. phytoestrogens are compounds found in plants and are comparable to human estrogen, capable of producing estrogenic effects. studies in post menopausal women have demonstrated that pumpkin seed oil, at a dose of 2g per day for 12 weeks can decrease blood pressure and reduce menopausal symptoms.

Eligibility criteria:
inclusion criteria: * non-hypertensive with blood pressure less than140/90 mmhg * post menopausal women or had a bilateral oophorectomy exclusion criteria: * hypotensive women with bp \<90/60 * taking medications to manage blood pressure and blood lipids * taking estrogen supplements or on hormone replacement therapy * taking pumpkin seed oil supplements * consuming pumpkin seeds more than ¼ cup a month * diagnosed with depression and taking antidepressants
impact of structural and myelin abnormalities on cognitive impairments in recent-onset schizophrenia - before and after lurasidone treatment (marylu)

Conditions: Schizophrenia

Summary: the present longitudinal study aims to investigate the impact of lurasidone treatment in recent-onset psychosis patients. the effects of lurasidone will be studied primarily in terms of structural and myelin modifications, in relation to clinical outcomes, before and after treatment and in healthy controls. furthermore, neuropsychological tests will be used to evaluate changes in cognitive performance.


Eligibility criteria:
inclusion criteria for the experimental arm: * patients diagnosed with schizophrenia with onset in the past 5 years, diagnosed through a structured clinical interview (scid-5 cv) * aged between 18 and 35 years * patients requiring treatment with lurasidone (independently from the inclusion in the present study) or that are being treated with lurasidone for 2 weeks maximum. * no other psychotropic treatment during the 2 weeks preceding the beginning of the study * acceptance of the informed consent form for the participation to the study * for women in childbearing age, negative pregnancy test (urine or blood beta hcg) performed before the start of the treatment and use of a highly efficient contraceptive method (such as progestin contraceptives, estrogen-progestin contraceptives, iud, ius, bilateral fallopian tube blockage, vasectomized partner, sexual abstinence) throughout the duration of the treatment. exclusion criteria for the experimental arm: * presence of other psychiatric and/or neurological diagnoses * previous antipsychotic treatment, except for patients that have been treated with other antipsychotics for less than a month and that have not been treated in the two weeks preceding the beginning of the trial, who are considered eligible. * contraindications to lurasidone treatment (as per summary of product characteristics) * intellectual disability * alcool or substance abuse in the previous 6 months * presence of absolute or relative contraindications to mri * underage patients * no negative pregnancy test or no use of a highly efficient contraceptive method * pregnancy (if a patient becomes pregnant during the course of the study, the subject will be excluded from the study) inclusion criteria for healthy controls: * aged between 18 and 35 years * acceptance of the informed consent form for the participation to the study exclusion criteria for healthy controls: * presence of psychiatric and/or neurological disorders * family history of psychiatric disorders in 1st-degree relatives * intellectual disability * other medical conditions at the time of the study * family history of hereditary neurological diseases * alcool or substance abuse * presence of absolute or relative contraindications to mri * underage patients * no negative pregnancy test or no use of a highly efficient contraceptive method * pregnancy (if a subject becomes pregnant during the course of the study, the subject will be excluded from the study)
study to assess impact of dysport injections early after stroke on upper limb spasticity progression

Conditions: Stroke; Upper Limb Spasticity

Summary: the purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of dysport® 500 u injections may delay the appearance or the progression of upper limb symptomatic spasticity.


Eligibility criteria:
inclusion criteria: * 2 to 12 weeks after first ever stroke according to the world health organisation criteria (previous transient ischaemic attack or clinically silent infarct on computerised tomography (ct)/magnetic resonance imaging (mri) are not counted as previous stroke) * stroke confirmed by ct/mri scan and classified as ischaemic/haemorrhagic stroke * presence of spasticity: * either symptomatic, based on symptomatic spasticity criteria (i.e. at least one of the following items: impacted passive/active function, involuntary movements, or pain ≥4 on a numeric pain rating scale \[nprs\]), in addition to increased muscle tone \[modified ashworth scale, mas ≥2\]) * or only increased muscle tone (mas≥2) exclusion criteria: * neuromuscular junction (nmj) diseases, or any other neurological disorders (including prior local joint, tendon, and intrinsic muscle disorders) that could potentially interfere with assessment of spasticity in the primary targeted muscle group selected by the investigator and in agreement with the subject * currently receiving drugs affecting nmj transmission e.g. aminoglycosides, aminoquinolines, cyclosporine, d penicillamine * previous surgery of the affected muscles/ ligaments/tendons * severe comorbidities (e.g. congestive heart failure, myocardial infarction, multiple organ failure, hepatic renal failures, severe infections)
medico-economic comparison of robot-assisted radical prostatectomy versus radical prostatectomy via laparotomy

Conditions: Prostatic Neoplasms

Summary: the main objective of the study is to estimate and compare the overall cost of care of patients over 60 months of follow-up between two groups: (1) patients undergoing robot-assisted radical prostatectomy using the da vinci system versus (2) patients undergoing robot-assisted radical prostatectomy via laparotomy. the time horizon of the main objective changes to 60 months (due to the opportunity to access patient care consumption from the national health data system).

the secondary objectives of this research are to compare the following between the two groups: * the actual cost of the surgical prostatectomy. * erectile function at 0, 1, 6, 12 and 24 * oncological results at 1, 6, 12 and 24 months. * functional results at 0, 1, 6, 12 and 24 months. * quality of life at 0, 1, 6, 12 and 24 months. * complication rates at 1 and 24 months.

Eligibility criteria:
inclusion criteria: * the patient must have given his informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 24 months of follow up * patient has localised prostate cancer * patient is eligible for radical prostatectomy exclusion criteria: * the patient is participating in another study * the patient is in an exclusion period determined by a previous study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * patient has a contraindication for a treatment necessary for this study * patients with psychiatric disorders

Keywords: radical prostatectomie robotic assistance laparotomy
fatty acid quality and overweight (fo-study)

Conditions: Weight Reduction and Insulin Sensitivity

Summary: the purpose of this study is to study the health effects of fatty acid quality in healthy, overweight individuals.


Eligibility criteria:
inclusion criteria: * no use of medication, healthy, 27\<bmi\<40 exclusion criteria: * pregnant and lactating women, chronic diseases.
dose escalation radiotherapy with modulation of intensity and integrated boost (sib-imrt) in the treatment of glioblastomas in adults

Conditions: Glioblastoma

Summary: the main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.


Eligibility criteria:
inclusion criteria: * histopathologically proven diagnosis of glioblastoma (who grade iv astrocytoma) * diagnosis must be obtained by a stereotactic or surgical biopsy * age between 18 and 70 * total or partial surgical resection deemed as not possible by a neurosurgeon * oms performance status 0 or 1 * adequate blood function : absolute neutrophil count \> 1.5 x 109/l, platelets count \> 100 x 109/l platelets; * adequate liver function: bilirubin \< 1.5 uln (upper limit of normal), alt and ast \< 3 uln, * adequate renal function: creatinine \< 1.5 uln * patient must have been informed and must have signed the specific informed consent form. exclusion criteria: * other malignancy histology * resection of the brain tumor complete on mri exploration * patient unable to give informed consent * patient presenting counter-indication to mri exploration * patient must not have received neither radiotherapy nor chemotherapy for that affection * concomitant malignancy * patient already enrolled in another biomedical study with an experimental molecule * pregnant, nursing woman, or without contraception * private individuals of freedom or under tutelage (including legal guardianship) * psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)

Keywords: imrt radiotherapy escalation dose glioblastoma escalation radiotherapy dose
improved analysis methods for infusion tests

Conditions: Idiopathic Normal Pressure Hydrocephalus

Summary: objective: patients with idiopathic normal pressure hydrocephalus are improved with shunt surgery. to increase the accuracy of the diagnosis, supplementary tests that characterize the cerebrospinal fluid (csf) dynamics are used. the infusion test is one of these, used for shunt surgery selection and postoperative evaluation of shunt function. forty-eight patients that had a preoperative investigation because of communicating hydrocephalus at the university hospitals in umeå and uppsala, sweden, participated in the study. the purpose of this study was to evaluate a new method, with a new infusion protocol and new analysis methods, and compare it to the current method.


Eligibility criteria:
inclusion criteria: * preoperative investigation because of communicating hydrocephalus * ventriculomegaly (evans ratio \> 0.3) * no obstruction to csf flow at visual inspection exclusion criteria: * postoperative infusion test investigations * patients that were unable to understand instructions

Keywords: new infusion test method reference method cerebrospinal fluid dynamics
master protocol for evaluating multiple infection diagnostics for ciprofloxacin-resistant neisseria gonorrhoeae

Conditions: Neisseria Gonorrheae Infection

Summary: the goal of this study is to learn if a few investigational tests can correctly find the gene mutation (mutant allele gyra 91f) that predicts ciprofloxacin resistance in clinical specimens that harbor neisseria gonorrhoeae. the main question the study aims to answer: can the investigational reflex test find the correct gene mutation (neisseria gonorrhoeae gyra 91f or gyra 91s) as compared to the sequenced result? specimens that are collected for routine clinical care and harbor neisseria gonorrhoeae will be evaluated in this study.

this is a prospective, multi-center, cross-sectional study using consecutive clinical specimens that are collected for routine clinical care and test positive for n. gonorrhoeae using an fda-cleared molecular assay. the study evaluates the diagnostic accuracy of multiple investigational reflex tests to detect the mutant allele gyra 91f that predicts ciprofloxacin resistance in n. gonorrhoeae, as compared to a reference standard of sanger sequencing of the gyra codon 91. specimens will be tested via a reference standard of sanger sequencing and one investigational reflex test. the target sample size is 311 urine specimens, 496 vaginal swab specimens, and 469 pharyngeal specimens, for each investigational reflex test.

Eligibility criteria:
inclusion criteria: * be n. gonorrhoeae-positive on an fda-cleared molecular assay * have sufficient n. gonorrhoeae-positive specimen volume for testing using the corresponding investigational reflex test and genetic sequencing * undergo proper handling and storage conditions exclusion criteria: * the n. gonorrhoeae-positive specimen media is not compatible with the investigational reflex test(s) at the laboratory site * the n. gonorrhoeae-positive specimen is not clearly labeled by the laboratory to link to basic epidemiologic data (age, sex) and source

Keywords: mutant allele gyra 91f wildtype allele gyra 91s ciprofloxacin-resistant neisseria gonorrhoeae
italian multi-center registry of self-apposing coronary stent in patients with stemi

Conditions: ST Segment Elevation Myocardial Infarction

Summary: the aim of this registry is to collect clinical data on nitinol self-expanding stentys xposition s™ in order to evaluate the efficacy and safety in patients presenting with st segment elevation myocardial infarction


Eligibility criteria:
inclusion criteria: * patients 18 years of age and older presenting with symptoms consistent with a st-elevation myocardial infarction (stemi) lasting ≤12 hrs in duration, with ≥2 mm of st-segment elevation in ≥2 contiguous leads, treated with primary stent implantation (xposition s planned per operator's assessment). exclusion criteria: * cardiogenic shock * multiple lesions requiring stenting in the target vessel. * highly calcified lesions or excessive tortuosity at target lesion site. * intrastent pathology. * subject unable to take or comply with dual antiplatelet therapy as recommended per guidelines. * female subjects of childbearing potential known to be pregnant. * co-morbidities with life expectancy less than 1 year * patient unable to provide written informed consent. * known allergies to stent component.
pronostic value of endothelial dysfunction in heart failure

Conditions: Heart Decompensation; Cardiac Failure

Summary: the main objective is to evaluate the pronostic value of endothelial dysfonction in acute heart failure on a combined criteria associating cardiovascular mortality, nex hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2 month and 1 year before acute heart failure.


Eligibility criteria:
inclusion criteria: * patients hospitalized for acute heart fialure with left ventricular ejection fraction (lvef) \< 45 % on echocardiography exclusion criteria: * informed consent form not signed * cardiogenic, septic or hemorragic shock * acute coronary syndrom with elevated troponin * valvular surgery or aorto-coronary graft during next 3 months * cancer * pregnancy * life expectancy over than 1 year * chronic renal impairment
efficacy of long pulsed 1064nm laser for facial skin tightening

Conditions: Skin Tightening; Skin Laxity; Wrinkle Reduction

Summary: we study the efficacy of 1 pass of stacking pulses of long pulse 1064nm laser on the face for skin tightening immediately post laser and 3 months follow up.

to study the efficacy on facial skin tightening and wrinkle reduction after a single pass of double stacking pulses of long pulse 1064nm laser on the face in skin types iii-v immediately post procedure and at 3 months. the study is a split-face placebo-controlled single-blind study.

Eligibility criteria:
inclusion criteria: * ages 35-60 years exclusion criteria: 1. history of skin malignancy 2. patients on immunosuppression 3. patients with other known internal malignancy 4. patients with malnutrition, vitamin or mineral insufficiency 5. patients on colchicine, penicillamine 6. patients with weight loss 7.5% of usual body weight within 3 months 7. history of botulinum toxin injection within 6 months 8. history of facial filler injection within 1year

Keywords: 1064nm yag laser laxity rhytides asian
extension trial evaluating the long-term safety and efficacy of dasiglucagon in children with congenital hyperinsulinism

Conditions: Congenital Hyperinsulinism

Summary: this is an open-label, multinational, multicenter, long-term safety and efficacy extension trial in patients with congenital hyperinsulinism (chi) who completed either zp4207-17103 or zp4207-17109 (defined as lead-in trials). the primary objective is to evaluate the long-term safety of dasiglucagon administered as subcutaneous (sc) infusion in children with chi.


Eligibility criteria:
inclusion criteria: * completed treatment in either trial zp4207-17103 or zp4207-17109 * expected to continue to have a positive benefit-risk assessment for treatment with dasiglucagon (based on considerations of glycemic effect, tolerability, and nature and frequency of adverse events experienced in the lead-in trial) exclusion criteria: * the patient developed any conditions prohibited by the lead-in trial, requires medication prohibited by the lead-in trial, or has other new complications that preclude participation in the investigator's opinion.
early diagnosis and early treatment of alzheimer's disease based on senile plaque imaging

Conditions: Mild Cognitive Impairment; Biomarker; Diagnosis; Treatment

Summary: the purpose of this study is based on the flutemetamol-pet senile plaque imaging to investigate the peripheral blood biochemical and brain mri imaging biomarkers and to research completely independent intellectual property rights neuropsychological test tool for the mci due to ad. at the same time, the investigators will study the efficacy and safety of early treatment of mci due to ad by huperzine a in 52 weeks.

this is a randmized, double-blind, placebo-controll study.

Eligibility criteria:
inclusion criteria: * memory complaint, preferably corroborated by a spouse or relative. * objective memory impairment. * normal general cognitive function. * intact activities of daily living. * absence of dementia. * the positive of brain senile plaque. exclusion criteria: * more than two lacuna ischemia (of diameter \< 1 cm) as revealed by mri fluid-attenuated inversion recovery (flair) sequence. * other type of dementia except ad
a study of erlotinib in locally advanced, unresectable, or metastatic pancreatic cancer

Conditions: Pancreatic Cancer

Summary: this open-label, single-arm, multicenter trial is designed to evaluate the safety of erlotinib in combination with standard of care chemotherapy (gemcitabine) in participants with locally advanced, unresectable, or metastatic pancreatic cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed adenocarcinoma with locally advanced, unresectable, or metastatic disease * no prior systemic treatment for metastatic disease * adjuvant therapy ≥6 months prior to study entry with no residual toxic effects * eastern cooperative oncology group (ecog) performance status 0 to 3 * life expectancy ≥12 weeks * adequate hematologic, hepatic, and renal function * negative pregnancy test within 72 hours of study drug and use of effective contraception among women of childbearing potential exclusion criteria: * unstable systemic disease * prior systemic human epidermal growth factor receptor 1 (her1) or epidermal growth factor receptor (egfr) inhibitors * other malignancy within 5 years prior to study entry * significant opthalmologic abnormality * inability to take oral medication * need for iv alimentation * prior surgery affecting absorption * active peptic ulcer disease * nursing mothers