Kornimate/medical-research-clean huggingface dataset:
support c post-market registry

Conditions: Coronary Arteriosclerosis

Summary: to collect post marketing surveillance data on consecutive patients with coronary heart disease intended to be or treated by the drug eluting support c ptca balloon catheter when used according to the instructions for use. data will be collected in order to assess the long term safety and performance of the support c drug coated balloon (dcb) in routine clinical practice.

this multicenter, prospective registry population consists of consecutive patients with coronary heart disease who undergo percutaneous coronary intervention (pci) and are intended to be or treated by the support c drug coated balloon (dcb) according to the instructions for use as part of routine clinical care. approximately 278 patients from 8-12 centers in europe will be entered into the registry. patients in the registry are followed for three years. the registry is considered finished when all patients have completed the 36-month follow-up. a follow-up is scheduled at the following timepoints: immediately post-procedure, 30 days, 6 months, 12 months, 24 months, 36 months. follow-up is obtained by telephone contact with the patient or at a planned hospital visit.

Eligibility criteria:
inclusion criteria: * consecutive patients intended to be, or treated by support c dcb as per physicians' decision and according to instructions for use (ifu) in the setting of routine clinical care are entered into the registry. note: 1. in case of major dissection requiring bailout stenting after dcb use the patients will be included in the registry and followed as per study schedule. 2. if major dissection occurred after lesion preparation, but before dcb use and lesion was stented, the patient will not be included in the registry. exclusion criteria: * patients are excluded if any of the following additional conditions apply: * high probability of non-adherence to the follow-up requirements (due to social, psychological or medical reasons) * currently participating in another investigational drug or device study in which a routine angiographic follow-up is planned * a life expectancy of \<1year * explicit refusal of participation in the registry

Keywords: coronary artery disease coronary disease myocardial ischemia heart diseases arterioscherosis cardiovascular diseases drug coated balloon ischemic heart disease
mlc901 in hypoxic-ischemic brain injury patients; a double-blind, randomized placebo-controlled trial

Conditions: Hypoxic Ischaemic Encephalopathy Due to Cardiac Arrest

Summary: in a randomized, placebo-controlled trial, 35 patients with hibi were randomly designated to receive either mlc901 or placebo capsules over six months. we evaluated patients in two groups by modified rankin scale (mrs) and glasgow outcome scale (gos) to examine their state of disability and recovery


Eligibility criteria:
inclusion criteria: * an initial cardiac arrest leading to coma, successful return of spontaneous circulation, and persistent coma after the return of spontaneous circulation. exclusion criteria: * pregnancy, cardiogenic shock (systolic blood pressure less than 90 mm hg despite epinephrine infusion), possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident), an underlying background of known acute or chronic disease including renal failure, liver or pulmonary disorders, previous stroke, dementia, and brain injury.
evaluation of the antipsychotic efficacy of cannabidiol in acute schizophrenic psychosis

Conditions: Schizophrenia

Summary: a controlled, randomized study on the treatment of schizophrenic psychosis with cannabidiol, a phytocannabinoid is performed. this approach is based upon recent findings indicating that the human endogenous cannabinoid system is significantly involved in the pathogenesis of schizophrenia. our group has shown, for example, that δ9-tetrahydrocannabinol (δ9-thc) is able to provoke schizophrenia-like psychotic symptoms in healthy volunteers. this, as well as the capability of δ9-thc to exacerbate productive psychotic symptoms in schizophrenic patients, has recently been confirmed by others. furthermore, we found that the en-dogenous brain constituent anandamide, an endogenous δ9-thc agonist, is significantly elevated in the csf of schizophrenic patients. cannabinergic substances such as anandamide may enhance dopaminergic neurotrans-mission by increasing dopamine turnover. they may also influence the onset or course of schizophrenia by as yet unidentified mechanisms we seek to investigate the efficacy of cannabidiol in the treatment of schizophrenic and schizophreniform psy-choses, because there is evidence that cb1 antagonists such as sr141716 and cannabidiol have antipsychotic effects comparable to those of classic neuroleptic drugs. furthermore, cannabidiol is well tolerated showing few side effects in humans. cannabidiol may serve as an antipsychotic medication that is not primarily based upon an antidopaminergic but upon different mechanisms, especially anticannabinergic ones. it may therefore be an effec-tive medication in at least a subgroup of schizophrenic and schizophreniform patients and may be expected to show additional anxiolytic effects and only minor side effects. the control condition in this parallel design will be an established neuroleptic treatment with amisulpride that is primarely an antidopaminergic drug. thus, we will study not only the antipsychotic efficacy of cannabidiol, but we will also compare the effects of both treatment strategies on side effects and neuropsychological functioning.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of schizophrenia or schizophreniform psychosis according to dsm-iv. * bprs score \>36 and bprs psychosis cluster \> 12. * ability to provide written informed consent. * participants are required an adequate contraception. exclusion criteria: * any severe neurological or somatic disorder. * other psychiatric disorders including addictive disorders. * positive urine drug screening for any compound except benzodiazepines. * no pregnancy or breast feeding.
extended-release injectable buprenorphine for individuals at high risk of overdose

Conditions: Opioid-Use Disorder; Opioid Overdose

Summary: this pilot study will evaluate the feasibility and clinical utility of extended-release injectable buprenorphine (xr-bup) for the treatment of opioid use disorder (oud) among individuals at high-risk for overdose (od).

faster-bup is a 24-week observational pilot study evaluating the feasibility and clinical utility of xr-bup (brand name: sublocade) for the treatment of oud among individuals at high-risk of od. forty participants with moderate to severe oud starting treatment with xr-bup as part of standard of care will be followed.

Eligibility criteria:
inclusion criteria: participants must meet all the following criteria to be eligible to participate for the study: 1. be above 19 years of age; 2. be diagnosed with moderate or severe oud as evidenced by their approval for treatment with xr-bup (sublocade); 3. be at high-risk for recurrent overdose, defined as having experienced a recent non-fatal overdose within the past 6 months (e.g., admission to the emergency department for an overdose or self-reported od that required naloxone administration or had an overdose where an ambulance arrived at the scene); 4. have a new prescription for xr-bup, but have not yet initiated treatment; 5. be able and willing to follow study procedures; 6. be able to provide adequate locator information (e.g., phone number and at least one emergency contact); 7. be able and willing to provide written informed consent; 8. be able to understand, communicate and speak with the research staff. non-english speaking individuals will require a translator to be present during all study visits and during all study activities. the translator will be independent (e.g., not known to the participant to prevent the risk for coercion or misrepresentation). exclusion criteria: participants will be excluded from the study if any of the following criteria are met: 1. be on oat other than buprenorphine/naloxone in the 7 days prior to screening; 2. be on a stable buprenorphine/naloxone dose for more than 27 days prior to screening; 3. use of an investigational drug in the 30 days prior to screening; 4. incarcerated, pending legal action or other reasons that might prevent completion of the study.
a phase 3 study of rusfertide in patients with polycythemia vera

Conditions: Polycythemia Vera

Summary: the study is designed to evaluate the safety and efficacy of rusfertide in subjects with polycythemia vera (pv) in maintaining hematocrit control and in improving symptoms of pv.

phase 3 study in approximately 250 subjects previously diagnosed with polycythemia vera (pv) who require phlebotomy on a routine basis. there is a 32-week period during which rusfertide or placebo will be added-on to each subject's ongoing therapy for polycythemia vera which may include phlebotomy only or phlebotomy plus stable doses of either of hydroxyurea, interferon and/or ruxolitinib. all subjects who successfully complete the double blind 32-week portion of the study will receive rusfertide for 124 weeks. approximately 6 and 12 months after their last dose of rusfertide, subjects will have a post-study contact (e.g. by phone) for safety.

Eligibility criteria:
main inclusion criteria: all subjects must meet all of the following inclusion criteria to be enrolled. there are additional inclusion criteria. * male and female subjects aged 18 (or the country specific minimum age of consent \>18) years or older. * meet revised 2016 world health organization (who) criteria for the diagnosis of polycythemia vera. * at least 3 phlebotomies due to inadequate hematocrit control in 6 months before randomization or at least 5 phlebotomies due to inadequate hematocrit control in 1 year before randomization. * cbc values immediately prior to randomization: 1. hematocrit \<45%, 2. wbc 4000/μl to 20,000/μl (inclusive), and 3. platelets 100,000/μl to 1,000,000/μl (inclusive) * subjects receiving cytoreductive therapy at randomization must be on a stable pv therapy regimen. * subjects treated with phlebotomy alone at randomization must have stopped cytoreductive therapy 2 to 6 months before screening. main exclusion criteria: subjects must meet none of the following exclusion criteria to be enrolled. there are additional exclusion criteria. * clinically meaningful laboratory abnormalities at screening. * subjects who require phlebotomy at hematocrit levels lower than 45%. * clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) within 2 months prior to randomization. * active or chronic bleeding within 2 months prior to randomization. * history of invasive malignancies within the last 5 years, except localized cured prostate cancer and cervical cancer. * subjects with in situ or stage 1 squamous cell carcinoma of the skin, in situ or stage 1 basal cell carcinoma of the skin, or in situ melanoma of the skin identified during screen unless the cancer is adequately treated before randomization. * received busulfan, pipobroman or 32phosphorus within 7 months prior to screening.

Keywords: polycythemia vera pv
obstructive sleep apnea and endothelial function in patients with resistant hypertension

Conditions: Obstructive Sleep Apnea; Secondary Hypertension

Summary: the purpose of this study is to determine the prevalence of obstructive sleep apnea and associate it with the endothelial function behavior in patients with resistant hypertension. two groups will be evaluate, one presenting uncontrolled high blood pressure, and other, with controlled blood pressure by drugs.

introduction: obstructive sleep apnea (osa) is considered an independent risk factor for cardiovascular disease. there is evidence that individuals with osa may have increased inflammatory mediators, changes in the metabolic profile, increased sympathetic activity with consequent elevation of blood pressure (bp) and endothelial dysfunction. resistant hypertension (rh) is defined as uncontrolled blood pressure (bp ≥ 140/90mmhg) despite the current use of three hypotensive drugs at full doses, including a diuretic, or the need for \>3 medications to control bp. osa has been reported as the most common secondary cause of high blood pressure maintenance. objective: to determine the prevalence of osa and associate it with the endothelial function behavior in patients with resistant hypertension comparing to those with bp controlled by medication. methods: a cross-sectional study involving 40 hypertensive patients (20 with resistant hypertension and 20 with controlled bp), irrespective of race or gender, with ages between 18 and 75 years. bp was measured by oscillometric method on automatic device. endothelial function was assessed by peripheral arterial tonometry (pat) by endopat2000® and the osa diagnosis also through pat, using the portable device watchpat200®. anthropometric evaluation was performed through measurements of waist, hip and neck circumference, body mass index, waist to height ratio (whtr), and body composition assessed by bioelectrical impedance. statistical analyzes were performed by graphpad prism software.

Eligibility criteria:
inclusion criteria: * ages between 18 and 75 years * previous hypertension diagnosis exclusion criteria: -

Keywords: obstructive sleep apnea resistent hypertension endothelial function blood pressure
feasibility of providing computerized cbt in the black church

Conditions: Substance Abuse

Summary: the investigator will conduct a pilot study evaluating the feasibility and acceptability of providing a computer-based program (cbt4cbt), used for the treatment of substance use disorders, in a church setting.

the investigator will conduct a pilot study evaluating the feasibility and acceptability of providing a computer-based program (cbt4cbt), used for the treatment of substance use disorders, in a church setting. forty black adults with a current dsm-5 alcohol or substance use disorder will utilize the 'cbt for cbt' program over a period of 8 weeks. primary outcomes will be acceptability and feasibility of providing the treatment in a church setting. if found to be acceptable and feasible, with preliminary promise for reductions in substance use, the next step would be to adapt the computer intervention for this population and conduct a randomized controlled trial.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * has at least one sud diagnosis as defined by the dsm 5 exclusion criteria: * are unable provide informed consent or participate in the study procedures as proposed in the consent * active suicidal or homicidal ideation * current engagement in substance use treatment * have a current legal case pending, such that incarceration during the 8 week protocol is likely * are in need of detoxification from alcohol, opioids or benzodiazepines
evaluation of the efficacy of different drugs in the treatment of the pain in patients with temporomandibular disorder

Conditions: Temporomandibular Disorder

Summary: the most important step in the treatment of tmj (temporomandibular joint) disease in clinical dentistry is diagnosis and planning. the clinical findings, drug requirement and biological risk of the patients determine the examination methods to be used in the treatment of temporomandibular joint disorders. in this context, it is thought that studies in the field of dentistry should be increased in order to increase the success in the treatment of tmj disorders. the aim of the study is to evaluate the efficacy of of different pain relievers as dexketoprofen trometamol + thiocolchicoside, dexketoprofen trometamol + paracetamol and dexketoprofen trometamol in the treatment of pain in tmj disorders.

the study was carried out on 200 patients aged 18 and over, who applied to van yuzuncu yıl university, faculty of dentistry, department of oral and maxillofacial surgery, with complaints of pain due to temporomandibular disease. when patients first applied to the clinic, their anamnesis were taken and they were directed to mr (magnetic resonance) imaging after clinical evaluation. patients who meet the inclusion criteria and volunteer were included in the study. patients were randomly divided into 4 groups. medications were given to patients by auxiliary staff and the study was double-blind. medicines were given as follows. dexketoprofen trometamol + thiocolchicoside (25mg + 4mg, 2x1) in the 1st group, dexketoprofen trometamol + paracetamol (25mg + 300mg, 2x1) in the 2nd group, only dexketoprofen trometamol (25mg, 2x1) in the 3rd group and paracetamol 500 mg in the 4th control group (4x1) were given. in addition, patients in each group used occlusal plate for a minimum of 8 hours per day (at night). medicines were used regularly for 2 weeks. paracetamol 500 mg was used only if needed for the next 2 weeks. the pain values of the patients was evaluated with the vas scale, and the amount of mouth opening was evaluated by measuring the distance between the incisal edges of the lower and upper central teeth. evaluations have been done at the beginning of the treatment and at the 1st week, 2nd week, 1st month and the 3rd month and the findings were recorded. after the 1st month, the patients were followed up to the 3rd month and the treatment of those who need additional treatment were continued. obtained data will be analyzed and evaluated statistically.

Eligibility criteria:
inclusion criteria: 1. individuals aged 18 and over 2. individuals without any systemic disease 3. individuals without missing teeth 4. individuals who have not used any medication in the last week 5. individuals with normal tmj mr imaging 6. patients who applied to our clinic and had pain due to temporomandibular disease. exclusion criteria: 1. individuals who do not come to their check-ups regularly 2. individuals allergic to any of the study drugs 3. pregnant and lactating individuals
memory modulation by pain during anesthesia

Conditions: Amnesia; Pain; Anesthesia

Summary: the purpose of this study is to determine the effects of pain on facilitating long-term auditory memory in the presence and absence of distinct intravenous anesthetics. the ability to identify previously presented words from a list assessed the degree of memory formation. in a subset of subjects, functional magnetic resonance imaging was used to identify the neural correlates of memory inhibition or facilitation by the combination of pain and anesthetic used.

this study adds specific details to the current incomplete body of knowledge examining the effect of pain on memory formation under the influence of anesthetic agents. pain and anesthetic agents were administered as experimental variables in this study. healthy adult subjects were played repeated lists of words and performed several decision-making tasks that encourage memory encoding. some words were consistently paired with painful electric shock, and was anticipated to improve subsequent memory performance specifically for those items. the same experiment was repeated in all subjects during the administration of 1-2 possible agents that reduce memory formation: dexmedetomidine, a predominantly sedative agent, and midazolam, a well-known amnestic agent, and ketamine, a well-known dissociative analgo-sedative. the extent to which pain modulates memory performance under the effects of the anesthetic agents was the primary outcome of interest. further, a subset of the subjects performed the same experimental procedures while undergoing functional magnetic resonance imaging, which continuously reflects neuronal activity throughout the brain. classic memory areas were predicted to be activated by the auditory processing task, but how these neural circuits change under the two anesthetic agents with the concomitant experience of pain were of interest. it was anticipated that pain recruits a parallel memory pathway using limbic structures, known for their involvement in fear conditioning. additionally, stronger and more diffuse cortical processing likely occurs with concomitant pain, as level of sedation was reduced by this strong stimulus. discovering the anatomic correlates specific to each experimental variable (pain and anesthetic), and their interplay, may help refine our model of brain function during the dynamics of pain and sedation.

Eligibility criteria:
inclusion criteria: * healthy adult volunteers, with normal memory and hearing, whose native language is english exclusion criteria: * pregnancy * significant memory or hearing loss * sleep apnea * chronic pain * metal or electronic implants * claustrophobia * currently taking: antidepressants, anti-psychotics, antihistamines, anti-anxiety medication, stimulants, sleep-aids, or pain medication

Keywords: midazolam dexmedetomidine memory ketamine
yoga on qol physiological distress&fatigue, on patients affected by breast cancer in adjuvant radiotherapy

Conditions: Female Breast Cancer; Fatigue; Quality of Life; Physiological Stress; Radiotherapy; Complications

Summary: the study aims to investigate, through serial measurements of some biomarkers, the potential mechanisms through which yoga impacts on qol and fatigue.

the study aims to assess qol, fatigue and physiological distress (cortisol and proinflammatory markers) with blood sampling on day 1,15 and last of radiotherapy, at 1-3-6 months after the end of radiotherapy. patients with breast cancer who will undergo radiotherapy will be randomly assigned to the yoga group (yg) or the control group (cg). patients in the yg will participate in 2 weekly yoga classes during the 5 weeks of radiation therapy. the classes will be coordinated with the treatment program and will be held in the vicinity of the radiation therapy center.

Eligibility criteria:
inclusion criteria: * women with stage 0-iii breast cancer who have undergone adjuvant daily radiotherapy for 5 weeks in istituto scientifico romagnolo per lo studio e la cura dei tumori (irst) department of radiation oncology of meldola. exclusion criteria: * patients with documented diagnosis of mental disorders (eg schizophrenia) * patients with stage iv disease * patients with active or non-canalised deep vein thrombosis * patients not undergoing surgery for the basic oncological disease * patients with mobility problems (eg unable to get up from the chair) * patients who have practiced yoga or are practicing yoga in the 6 months before the cancer diagnosis. * patients diagnosed with lymphedema

Keywords: female breast cancer fatigue quality of life physiological stress radiotherapy; complications