Kornimate/medical-research-clean huggingface dataset:
interaction with hiv antiretroviral agents

Conditions: HIV-DDI

Summary: to investigate the pharmacokinetic drug-drug interaction potential of fixed dose antiretroviral therapies, i.e. atripla, complera, stribild, triumeq, or any approved antiretroviral protease inhibitor in combination with (preferably) triumeq, on the exposure to riociguat in hiv patients on a stable dose of one of these therapies. • to assess the safety and tolerability of riociguat treatment in combination with these fixed-dose antiretroviral therapies.


Eligibility criteria:
inclusion criteria: * male or female patients aged \>=18 to \<65 years with a confirmed diagnosis of hiv receiving a stable regimen of atripla, complera, stribild, triumeq, or any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir in combination with (preferably) triumeq consistent with the most recent prescribing information documents for at least 6 weeks before concomitant administration of a single oral dose of 0.5 mg riociguat * no clinical evidence of pulmonary hypertension * written informed consent exclusion criteria: * severe diseases for which it can be assumed that the pharmacokinetics or effects of the study drug will not be normal * history of coronary artery disease * symptomatic postural hypotension (e.g. dizziness, lightheadedness) * history of bronchial asthma or any other airway disease * renal impairment with creatinine clearance \<15 ml/min * severe hepatic impairment (child-pugh class c) * systolic blood pressure below 100 mmhg

Keywords: single-dose, open-label, non-blinded, non-placebo- controlled, stratified design
enhancing attention in adults with compulsive hoarding

Conditions: Hoarding Disorder

Summary: available data suggest that compulsive hoarders have cognitive deficits, particularly with sustaining attention that might contribute their hoarding symptoms.

compulsive hoarders perform significantly worse than healthy controls on standard attention tasks. these data suggest that the inability to sustain focus may interfere with hoarders' ability to organize, categorize and make decisions about discarding possessions. stimulants are first-line treatments for adhd, improve cpt performance in people with adhd and enhance school performance in children with adhd. extended release formulations, such as methylphenidate er, are associated with better medication compliance. together, these data suggest that adjunctive methylphenidate er might be a novel way to improve attention in compulsive hoarders which might improve hoarding symptoms. the investigators hypothesis is that adjunctive methylphenidate er will improve attention in compulsive hoarders aged 18-55. the investigators will also explore the safety of methylphenidate er administration in compulsive hoarders.

Eligibility criteria:
inclusion criteria: * clinically significant compulsive hoarding (proposed dsm-v criteria) that is principal (i.e. currently most severe and needing of treatment) and has been present for at least one year. * at least moderate attentional difficulties. * able to provide consent. * patients can be on or off of serotonin reuptake inhibitors (sris) or serotonin and norepinephrine reuptake inhibitors (snris) but dose must be stable for 12 weeks prior to study. exclusion criteria: * currently taking any psychotropic medications other than sris or snris. * presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder or other psychotic disorder. * current major depression is permitted if clearly secondary in importance to the hoarding. * judged clinically to be at risk of suicide (suicidal ideation, severe depression or other factors) * any cardiovascular abnormality that increases the risk of participation, including significant history of cardiovascular disease or family history of sudden death. * any medical or neurological disorder that increases the risk of participation or that is a medical contraindication for taking methylphenidate (e.g. glaucoma or tourette's syndrome). * current use of any drug that is contraindicated with methylphenidate (e.g. monoamine oxidase inhibitors). * female patients who are pregnant or nursing. * current or previous treatment with methylphenidate or cbt for hoarding. * current etoh/drug abuse or dependence disorder of dependency in the past 6 months. * individuals with mild cognitive impairments, dementia, or significant intellectual deficits.

Keywords: hoarding
phase i study to investigate the safety and efficacy of hbv dna vaccine

Conditions: Chronic Hepatitis B

Summary: this study will evaluate the safety and immunogenicity of a novel mixed plasmid dna (hb-110) combined with an antiviral agent (adefovir) for the patients with chronic hepatitis b infection.


Eligibility criteria:
inclusion criteria: * chronic hepatitis b infected patient documented with positive hbsag for 3 months and more at screening * chronic hepatitis b infected patient with positive hbeag at screening * patient who has not treated with interferon alpha, lamivudine or adefovir within 3 months before study entry * hbv dna more than 1x10\^5 copies/ml through cobas amplicor hbv monitor assay or bdna method at screening * patient with hbv dna decrease more than 10-fold compared to the baseline after 8 weeks treatment with adefovir * patient with alt value between uln x 1.5 and uln x 5 at screening * patient given a written consent voluntarily exclusion criteria: * have uncompensated liver disease * serum creatinine \> uln x 1.5 * are positive for hepatitis c, hepatitis d or hiv infection (confirmed by elisa assay) * had a previous liver or bone marrow transplant * are currently taking any immunosuppressant or any possible immune modulatory drugs * women who are pregnant or breastfeeding * woman or man who plans a birth for study duration * any experience of severe adverse drug reaction or any medical history of severe allergic disease * patient with any severe disease (for example, heart failure, renal failure, pancreatitis, diabetes mellitus) affecting the study in discretion of investigator except liver disease * patient with any other liver disease but hepatitis b (for example, hemochromatosis, wilson's disease, alcoholic/non-alcoholic liver diseae) * patient with intrahepatic tumors confirmed by imaging (liver biopsy)and abnormally increased alpha-fetoprotein * patient with any present malignant tumor except liver or its history * other inappropriate patient in discretion of investigator
the effect of high dose clopidogrel treatment in patients with clopidogrel resistance

Conditions: Coronary Artery Disease

Summary: continuing high dose clopidogrel treatment after elective pci decreased adverse cardiac events in patients with clopidogrel resistance

aim: primary objective: * to evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective pci in patients with clopidogrel resistance secondary objective: * to evaluate the effect of continuing high dose clopidogrel treatment on adverse cardiac events after elective pci * to evaluate the effect of continuing high dose clopidogrel treatment on bleeding complications after elective pci * to evaluate the clinical effect of verifynow which use as a clopidogrel resistance kit. study central: bursa postgraduate hospital, cardiology clinic study population: we planned to enrol 180 patients. 50% of patients without clopidogrel resistance (control group: 90 patients) 50% have clopidogrel resistance. than we randomise the patients (with clopidogrel resistance) in two groups (group 1:45 patients (75mg/day), group 2:45 patients (150mg/day)) inclusion criteria: * the patients; who have planned elective pci and have had written informed consent for participation to study. * age\>18 year-old, * the native coronary artery;lesion with narrowing \>=70% exclusion criteria: * patients have allergy for asa, clopidogrel and heparin * patients who performed primary pci * patients with acute coronary syndrome * patients with have a history of pci and use clopidogrel * patients on warfarin therapy * patients who have bleeding diathesis, or have high risk for bleeding. study works: * write case report form for all patients * control for inclusion criteria. * evaluate the clopidogrel and asa resistance with verifynow kit. than randomised the patients. * demographic data (age, gender) * height, weight, bmi and gfr * risk factors * laboratory data (biochemical and hematologic) * medication history * echocardiographic data * angiographic data * pci data(vessel diameter, stent diameter, lesion and stent length, performed ptca or not, etc) * note complication (mace, bleeding, hematoma etc) 4 weeks later note the first control data and re assess the clopidogrel resistance with verifynow kit in patients groups 1 and 2. six months later note the second control data.

Eligibility criteria:
inclusion criteria: * the patients; who have planned elective pci and have had written informed consent for participation to study. * age\>18 year-old, * the native coronary artery;lesion with narrowing \>=70% exclusion criteria: * patients have allergy for asa, clopidogrel and heparin * patients who performed primary pci * patients with acute coronary syndrome * patients with have a history of pci and use clopidogrel * patients on warfarin therapy * patients who have bleeding diathesis, or have high risk for bleeding.

Keywords: percutaneous coronary intervention, clopidogrel resistance, asa resistance
pharmacokinetics of micafungin given twice weekly intravenously compared to micafungin given daily to patients at risk for developing an invasive fungal disease

Conditions: Acute Graft Versus Host Disease Grade II-IV; Allogeneic Stem Cell Transplant; Acute Myeloid Leucaemia; Myelo Dysplastic Syndrome

Summary: the primary objective of this trial is as follows: to determine the pharmacokinetics of micafungin given twice weekly in patients at risk for developing an invasive fungal disease (patients who are being treated for acute or chronic graft versus host disease; patients receiving reduced intensity conditioning for stem cell transplant (sct); receiving first remission induction chemotherapy for acute myeloid leucaemia (aml)/myelodysplasticsyndrome (mds)) compared to the pharmacokinetics of micafungin given daily. the secondary objective of this trial is as follows: to determine whether adequate exposure of micafungin is attained. to determine the safety of micafungin in this patient population

micafungin has been shown to be a reasonable option for treating invasive aspergillosis in hematopoietic stem cell transplantation (hsct) recipients and has proven as effective as fluconazole for prophylaxis. whilst micafungin has much to offer, little is known about its pharmacokinetic profile in specific patient populations, specifically concerning alternate dosing strategies with increased dosages over a prolonged dosing interval. sufficient data are lacking up to now for twice weekly administration of micafungin as antifungal prophylaxis. decreasing the dosing frequency to twice weekly seems a reasonable approach considering the long terminal elimination life (i.e. 10-17 h) and considering the data available from murine models that support the use of less frequent dosing with higher dosages. it will enable us to characterize both the pharmacokinetics of micafungin in the hematology cohort and directly compare the exposure to the alternate dosing strategy.

Eligibility criteria:
inclusion criteria: * patient receives immunosuppressive therapy for acute gvhd grade ii-iv or reduced intensity conditioning regimens for allogeneic stem cell transplant, or patients receiving first remission induction chemotherapy for aml/mds. * subject is at least 18 of age on the day of providing informed consent. * has no signs or symptoms of invasive fungal disease * if a woman, is neither pregnant nor able to become pregnant and is not nursing an infant. * less than 1 week of immunosuppressive therapy for grade ii-iv acute gvhd. * is managed with a central venous catheter (preferably a quadruple arrow-howes™ quad-lumen 8.5,5 french; arrow international). * subject is able and willing to sign the informed consent before screening evaluations. exclusion criteria: * documented history of sensitivity to medicinal products or excipients similar to those found in the micafungin preparation. * history of or current abuse of drugs, alcohol or solvents. * inability to understand the nature of the trial and the procedures required. * has not previously participated in this trial.

Keywords: pharmacokinetics alternate dosing micafungin
immunological profile changes in patients with advanced non-small cell lung cancer

Conditions: Non Small Cell Lung Cancer; Non Small Cell Lung Cancer Metastatic; Healthy

Summary: this is a blood collection study being conducted to better understand and describe the immunological blood profile changes in patients with advanced non small cell lung cancer undergoing treatment with checkpoint inhibitor therapy. blood will be collected from healthy volunteers and patients with non small cell lung cancer


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old at the time of informed consent 2. written informed consent and hipaa authorization for release of personal health information. 3. subjects with histologically and radiographically confirmed nsclc. 4. subjects must have stage iv disease or recurrent disease. 5. subjects should be treatment naïve (systemic therapies) or have received prior chemotherapy in the first line setting. prior radiation or surgery is permissible. 6. subjects who are eligible to receive single agent immunotherapy must have documentation of a pd-l1 tumor proportion score (tps) of at least 1%. 7. subjects with eastern cooperative oncology group (ecog) performance status of 0-2. exclusion criteria: 1. subjects with curable or potentially curable nsclc. 2. subjects should not have contraindications to treatment with immune checkpoint inhibitors per standard criteria. 3. patients with targetable mutations eligible for treatment with molecularly targeted small molecule inhibitor therapy. 4. subjects eligible for combination treatment with chemoimmunotherapy.

Keywords: blood donation lung cancer non small cell lung cancer
prevention of missed opportunities for hiv diagnosis by promoting hiv testing of patients with pneumococcal pneumonia at nice university hospital (pneumovih)

Conditions: Pneumonia, Pneumococcal; Hiv

Summary: according to usual practices, hiv testing should be performed for each patient diagnosed for pneumococcal pneumonia. unfortunately, in 2018, only 27% of patients were tested for hiv following pneumococcal pneumonia in nice university hospital. the aim of pneumovih protocol is to promote hiv testing by reminding good practices to physicians. to achieve this, the team of the bacteriology laboratory will contact physicians for each patient positive for pneumococcal antigenuria to suggest hiv testing. this prospective public health action will aim to integrate this hiv test into routine care and to evaluate benefits through the number of hiv positive patients that will be diagnosed.


Eligibility criteria:
inclusion criteria: * male or female 18 years or older with validated diagnosis of bacterial pneumococcal pneumonia. exclusion criteria: * documented history of hiv infection.
an open study to investigate the safety and efficacy of optivate® in severe haemophilia a patients.

Conditions: Haemophilia A

Summary: the main objectives of this study are to compare the first and second recovery assessments and recovery when a subject changed batch and to assess whether haemostasis was achieved with optivate® when treating a bleed. the secondary objectives are to evaluate the clinical tolerance and safety of optivate®.


Eligibility criteria:
inclusion criteria: * immunocompetent with severe haemophilia a without inhibitor to fviii, at least 12 years of age, currently receiving fviii concentrates and have more than 150 exposures. subjects who require elective surgergy within 6 months of starting on optivate® are permitted to be included in this study providing that the surgery could be performed using optivate® as fviii cover. exclusion criteria: -
post-stroke visual dependence and multisensory balance rehabilitation

Conditions: Sensory Integration Dysfunction; Stroke

Summary: stroke patients have higher levels of visual dependence, which affects orientation, balance and gait. visual adaption or habituation training aiming to decrease visual sensitivity and tolerance, is commonly used to decrease the levels of visual dependence. however, the visual adaption training often evokes unbearable vertigo, resulting in lower compliance to training program. in addition, stroke patients who have higher visual dependence may not have the symptom of dizziness. therefore, it is unclear whether visual adaption training has similar effects on stroke patients. visual dependence is considered as a sensory reweighting deficit and therefore visual dependence could be improved through multisensory balance training which comprises of visual, vestibular, and proprioceptive manipulation. this study will investigate the effects of early multisensory balance training on visual dependence, balance and gait in subacute stroke patients.

a total of 80 subacute stroke participants will be randomly assigned to either experimental and control groups. participants in the experimental group will receive multisensory balance training while those in the control group will maintain their regular care. all participants will be assessed their levels of visual dependence, motor ability, balance and gait, vertigo symptom and activities of daily living before and after intervention program as well as at 3-month follow-up.

Eligibility criteria:
inclusion criteria: * (1) first stroke with 20-80 years of age * (2) the time since onset is less than 6 months * (3) able to stand independently without any devices * (4) can understand and follow commands * (5) can give informed consent. exclusion criteria: * (1) other neurological disorders which could affect balance assessment * (2) diagnosis with dementia.

Keywords: visual dependence multisensory balance training
a drug-drug interaction study of ctl0901 and ctl0902 compared to coadministration in healthy adult volunteers

Conditions: Health, Subjective

Summary: this is a two-arm, open-label, single-sequence, multiple-dose, cross-over phase 1 study to evaluate the interaction between two investigational drugs by comparing and analyzing the pharmacokinetic interaction and safety of ctl0901 and ctl0902 at steady state when administered alone or in combination with repeated oral doses in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * a subject who weighs 50 kg or more (45 kg or more for women) * a subject who does not have clinically significant congenital or chronic diseases * a subject who is judged to be eligible to participate by the results of diagnostic tests by the principal investigator * a subject and their partner who agree to use a medically appropriate method of contraception to exclude potential of pregnancy and not to provide sperm or ova from the first dose to 7 days after the last dose of the investigational drug * a subject who voluntarily signs the consent form after hearing and understanding the purpose and content of this study, the characteristics of the investigational drugs, and expected adverse reactions exclusion criteria: * a subject who has a known digestive system, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and genitourinary system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmic system or has any past history of them * a subject who has a history of gastrointestinal surgery that may affect drug absorption (except simple appendectomy or hernia surgery) or has gastrointestinal diseases * a subject who has taken drugs that induce or inhibit drug metabolizing enzymes such as barbiturates within 1 month of the first administration or has taken drugs that may affect the study within 10 days of the first administration (however, participation can be possible considering pharmacokinetic·pharmacodynamic characteristics such as interaction with concomitant drugs and half-life of concomitant drugs etc) * a subject who has participated and administered other investigational drugs in other clinical trials or bioequivalence studies within 6 months of the first administration * a subject who is judged ineligible for participation in this study by the principal investigator * a female volunteer who is pregnant or lactating
effectiveness of suprachoroidal injection in diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: it will investigate a novel treatment approach for diabetic macular edema (dme), which causes vision impairment in diabetic patients. it will focuse on the efficacy and safety of administering triamcinolone acetonide via suprachoroidal injection, targeting the space between the sclera and choroid.

this method aims to enhance drug delivery to the retina, potentially improving outcomes compared to conventional treatments. participants receive suprachoroidal injections, and the study measures changes in macular thickness and visual acuity. the study's findings could offer a promising alternative to existing dme treatments, aiming to provide better management of the condition and improved patient quality of life.

Eligibility criteria:
inclusion criteria: * above 30 years old patients male and female * diabetic patient * diabetic patient for more than 2 years * macular thickness of more than 280um exclusion criteria: * patient below 30 years * patients having media opacity * patients with other systemic problems * uncooperative patients
in utero repair of myelomeningocele: atosiban versus terbutaline

Conditions: Myelomeningocele; Terbutaline Adverse Reaction; Pregnancy; Malformation Central Nervous System

Summary: myelomeningocele is a malformation with high incidence, and it consists in a neural tube defect. fetal intrauterine surgery is an alternative for correction, and it improves the prognosis of the fetus, but has an increased risk of maternal complications and premature labor, as it can occur due to uterine stimulation. it is therefore essential that tocolysis is performed before, during and after surgery, and the most commonly used tocolytics are terbutaline and atosiban. terbutaline has no specificity and may have several adverse effects such as maternal acidosis.

the objective of the study was to evaluate maternal blood gas alterations among cases that used atosiban tocolytic agent and cases with terbutaline in in utero repair of myelomeningocele. it consists of a retrospective cohort study. it included 25 patients, who were divided into two groups, depending on which agent they received as main tocolytic agent during the intrauterine fetal myelomeningocele repair: terbutalineor atosiban. the primary outcome was maternal arterial ph at the end of surgery.

Eligibility criteria:
inclusion criteria: * pregnant women over 18 years * single fetus pregnancy * fetus with myelomeningocele * gestational age from 19 to 26 * fetus with normal karyotype exclusion criteria: * multiple pregnancy * fetal abnormality not related to myelomeningocele * kyphosis greater than or equal to 30 degrees * placenta previa * maternal disease that increases the risk of pregnancy (insulin-dependent dm, hypertension poorly controlled) * history of incompetent cervix * carrier of hiv, hepatitis b or hepatitis c * maternal-fetal isoimmunization * uterine alteration * obesity (imc greater than 30)