Kornimate/medical-research-clean huggingface dataset:
a study of the efficacy and safety of mk2578 for the treatment of anemia in patients with kidney disease (mk2578-003-am03-ext12)

Conditions: Anemia; Chronic Kidney Disease

Summary: this study will evaluate the efficacy and safety of intravenous mk2578, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously receiving erythropoietin stimulating agents.

this study consists of a 12-week base study (mk2578-003-am03) and an optional 40-week extension study (mk2578-003-ext12). participants who complete 12 weeks of treatment in the base study will enter the extension on the most recent dose administered in the base study or a newly adjusted dose, if adjustment is required to bring hg levels within range. participants' doses of mk2578 will be adjusted upward or downward during the extension study to maintain hb in the range of 10-12 g/dl.

Eligibility criteria:
inclusion criteria: base study: * patient is male or is a female who either cannot have children or who agrees to use appropriate contraceptive measures * patient has been on hemodialysis for at least 6 months when informed consent is signed * patient has received intravenous epoetin alfa or epoetin beta for a least 6 months when the informed consent is signed extension study: * patient completed the base study through week 12 * patient tolerated mk2578 and demonstrated compliance with study procedures exclusion criteria: * patient has a life expectancy of less than 6 months * patient is scheduled for a kidney transplant within the next 6 months * patient has had a blood transfusion within 12 weeks of screening * patient has had major surgery within 12 weeks of screening or plans to have surgery * patient has human immunodeficiency virus (hiv) * patient has history of blood dyscrasia, hematologic disorders or any other disease known to cause anemia * patient has severe congestive heart failure (chf) * patient has a history of malignant cancer, except certain skin or cervical cancers * patient has a history of grand mal seizures within the last 6 months

Keywords: anemia associated with chronic kidney disease (ckd) hemodialysis
18f-fmau pet/ct in imaging patients with advanced cancers

Conditions: Malignant Neoplasm

Summary: this clinical trial studies the safety and drug distribution of the radioactive drug, 2'-deoxy-2'-\[18f\]fluoro-5-methyl-1-beta-d-arabinofuranosyluracil (fluorine f 18 d-fmau \[18f-fmau\]), for imaging with positron emission tomography/computed tomography (pet/ct) in patients with advanced cancers. a pet scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is taken up. because cancer cells often take up more glucose than normal cells, the pictures can be used to find cancer cells in the body. pet/ct using the drug fluorine f 18 d-fmau, may help find cancer and find out how far the disease has spread.

primary objectives: i. to determine the radiation dosimetry of 18f-fmau in humans, confirm absence of adverse events in humans from intravenous (i.v.) injection of 18f-fmau for pet imaging, and characterize the incidence of circulating metabolites of 18f-fmau in humans. ii. to simply find out whether there is any visual uptake change of 18f-fmau in tumors post-therapy. outline: patients receive fluorine f 18 d-fmau iv followed by pet/ct prior to start of cancer treatment. patients may undergo 2 additional scans at one week prior to second course of chemotherapy and after completion of cancer treatment depending on cancer type.

Eligibility criteria:
inclusion criteria: * have been diagnosed with a malignancy/tumor/cancer, including but not limited to: brain tumor, breast cancer, lung cancer, esophageal cancer, lymphoma, or sarcoma * have one or more tumors visualized by conventional pet-ct, ct or magnetic resonance imaging (mri) prior to the pet fmau study; pet-ct should be within one week prior to 18f-fmau exclusion criteria: * have undergone chemotherapy or radiation therapy within the previous one month * women of childbearing potential, unless they have had a negative urine beta human chorionic gonadotropin (betahcg) within the previous 24 hours of the procedure * patients who have had surgery at the site of the suspected lesion within 1 month
older hiv-infected adults and drug interactions: french cross-sectional study

Conditions: HIV Infections

Summary: drug interactions between antiretroviral drugs and concomitants drugs and between antiretroviral need to be studied hiv-population is ageing. the referential of interactions is the liverpool base.

filters in the french social security system database, 2016 : * code of pathology "human immunodeficiency virus (hiv) infection" age ≥ 65 years * treatment with an antiretroviral between january 1, 2016 and december 31, 2016

Eligibility criteria:
inclusion criteria: * men and women over than 65 years with an hiv infection and insured at the french primary health insurance fund no exclusion criteria

Keywords: hiv infection antiretroviral aging population drug interactions cross-sectional study sniiram
open-label program of dideoxycytidine ( ddc ) to be used in combination with zidovudine ( azt ) for treatment of advanced hiv disease

Conditions: HIV Infections

Summary: to provide zalcitabine ( dideoxycytidine; ddc ) for use with zidovudine ( azt ) in patients with advanced hiv infection. to observe serious toxicities in this population.

patients are treated with 1 of 2 doses of ddc administered orally (po) in combination with azt administered po (patients who are unable to tolerate this dose of azt may receive a lower dose).

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * concomitant use of investigational compounds for prophylaxis or treatment of opportunistic infections or other treatments provided use of those compounds with ddc-azt is considered safe. patients must have: * documented hiv infection or documented aids-defining opportunistic infection or neoplasm. * previous aids-defining opportunistic infection, neoplasm, or condition or cd4 lymphocyte count equal to or less than 300 cells/mm3 if symptomatic orcd4 lymphocyte count equal to or less than 200 cells/mm3 if asymptomatic. * patients must not be currently enrolled in or must be unable to enter an aids clinical trials group (actg), community programs for clinical research on aids (cpcra), or other controlled clinical program because of patient ineligibility, distance from trial site, or patient refusal. * patients currently enrolled in any controlled clinical trial of an anti-hiv compound may enter this program only if they have met the end points required for termination of that trial. * patients may be co-enrolled in clinical programs of investigational compounds being tested for prophylaxis or treatment of opportunistic infections or other treatments provided that program allows ddc-azt combination use, and concomitant administration of the other investigational drug and ddc-azt is considered safe by the investigator. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * any clinical or laboratory toxicity or abnormality, particularly the presence or history of moderate to severe peripheral neuropathy, that would pose an undue risk to the patient upon initiation of ddc-azt treatment. * pregnancy.

Keywords: zalcitabine acquired immunodeficiency syndrome aids-related complex zidovudine
the effect of pre-operative use of finasteride versus cyproterone acetate on blood loss with transurethral resection of prostate

Conditions: Prostate Hyperplasia

Summary: perioperative bleeding is the most common complication related to transurethral resection of prostate, the aim of the study is to compare the effect of pre-operative use of finasteride versus cyproterone acetate on blood loss with mono polar turp

this prospective randomized controlled study to compare the effect of pre-operative use of finasteride versus cyproterone acetate on blood loss with mono polar turp

Eligibility criteria:
inclusion criteria: * patients with benign prostatic hyperplasia with prostate size (60-100) grams * lower urinary tract symptoms (luts) not responding to medical treatment * recurrent prostatic bleeding * recurrent acute urinary retention * chronic urinary retention exclusion criteria: * patients with coagulation disorders * previous prostatic surgery * previous finasteride administration * bladder pathology (urinary bladder stones - bladder mass) * suspected or proved cancer prostate * hepatic or renal impairment * patients unfit for operation eg. decompensated heart failure, poor chest condition
pharmacokinetics and safety of ceftobiprole in neonates and infants up to 3 months treated with systemic antibiotics

Conditions: Bacterial Infections

Summary: this study characterized the pharmacokinetics and safety of a single dose of ceftobiprole in neonates and infants aged ≤ 3 months.


Eligibility criteria:
inclusion criteria: * neonates and infants ≤3 months, with gestational age ≥28 weeks * documented or presumed (or at risk of) bacterial infections, and currently receiving antibiotic treatment * expected to survive beyond the first 7 days after enrollment * sufficient vascular access to receive study drug, and to allow blood sampling at a site separate from the study drug infusion site * parent's / legally acceptable representative's informed consent to participate in the study exclusion criteria: * major birth defect or malformation syndrome * proven presence of an immunodeficiency * hiv or other congenital viral or fungal infection * significant laboratory abnormalities including: hematocrit \ 3 times the age-specific upper limit of normal * impaired renal function or known significant renal disease * any condition which would make the subject or caregiver, in the opinion of the investigator, unsuitable for the study
prodromal markers in recurrent dream enactment behaviors without rem sleep without atonia

Conditions: REM Sleep Behavior Disorder

Summary: rem sleep behavior disorder is a novel and distinct parasomnia characterized by recurrent dream enactment behaviors (debs) and rem sleep without atonia (rswa) during polysomnographic assessment, with a male predominance and typical onset age at early 60's. the majority of patients with idiopathic rbd (irbd) will eventually develop α-synucleinopathy, for instance parkinson's disease (pd). thus, irbd has been considered as a highly specific precursor of α-synucleinopathy-related neurodegeneration. recently, increasing studies have found that some participants present with only rswa or debs (but without sufficient rswa), which does not meet the diagnostic criteria for rbd. it has been suggested that these participants with subclinical features (either debs or rswa) might represent a condition known as prodromal rbd. several emerging evidence, including our own study, have implied a link between isolated rswa (rswa without debs) and markers of α-synucleinopathy-related neurodegeneration. however, it is still unclear whether the other condition related to rbd, i.e. recurrent debs but without sufficient rswa, is related to a certain degree of α-synucleinopathy. in this regard, the novel concept of recurrent debs but without sufficient rswa, also termed as prodromal/isolated rbd by some researchers, requires validation by further evidence in terms of clinical feature and neurodegenerative prodromal markers perspectives.

this proposed study is a case-control study, which aims to determine whether recurrent debs but without sufficient rswa represents an early stage of α-synucleinopathy. the investigators will recruit 62 participants with recurrent debs but without sufficient rswa and their age-, sex- matched controls from the community and on-going projects. all participants will undergo clinical interview, comprehensive measures of prodromal markers of neurodegeneration (including excessive daytime sleepiness, olfactory functioning, constipation, erectile dysfunction, urinary dysfunction, symptomatic hypotension, depression, and clinical motor markers) as suggested by the international parkinson and movement disorder society (mds) research criteria. in addition, a subset of the sample (n = 26 in each group) will undergo the triple-tracer positron emission tomography/computed tomography (pet/ct) imaging protocol of 18f-dopa, to determine dopamine functions in putamen. this proposed study will help to disentangle the core features of rbd and validate the concept of prodromal rbd with reference to prodromal markers related to α-synucleinopathy neurodegeneration.

Eligibility criteria:
inclusion criteria: * age between 45 and 65 years old * rbdq-hk behavior factor greater \> 8 * recurrent debs by interview and/or video analysis * absence of sufficient rswa exclusion criteria: * age- and sex- matched with cases * rbdq-hk behavior factor \< 8 * no debs by either interview or video analysis * absence of sufficient rswa

Keywords: striatal dopamine rem sleep without atonia prodromal markers
clinical study of the effects of a swalker ii and vr for hip fracture rehabilitation in the elderly

Conditions: Hip Fractures; Gait Disorders in Old Age

Summary: this project is structured in two distinct phases. the first phase deals with the recovery of the hip fracture in the acute phase up to ambulation, and the second is understood as the continuation of functional improvement of gait. in the first phase, the aim is to evaluate the effects of the use of the robotic device (swalker) on the physical improvement of the patient. while in the second phase, the objective is to evaluate the effects of virtual reality technology combined with the use of the swalker.therefore, the following specific objectives are identified: * phase i: to analyze the effects of swalker application in patients with acute hip fracture on clinical parameters of rehabilitation. * phase ii: to study the effects of the application of the swalker combined with immersive technology in people with impaired gait function after hip fracture.

in the preliminary phase, the usability and acceptance of the swalker ii system combined with virtual reality is evaluated with a group of healthy subjects. for this purpose, an exposure session and the evaluation of the system based on questionnaires are carried out. on the other hand, a gait characterization session (capture of rom and emg) is performed inside and outside the walker with different speeds and weight loads. in the first phase of the clinical study, patients with hip fractures in the early rehabilitation phase were recruited. they are randomly assigned to a control group or experiment group. and for a period of 6 weeks, both groups carry out the same rehabilitation exercise program based on strength, balance and ambulation exercise. the difference is that the experimental group performs the rehabilitation exercises with the swalker, and the control group performs these exercises with conventional parallel bars. in the second phase of the clinical study, these same patients who have passed the first pass, move on to a 6-weeks program of maintenance and improvement of gait function. again, they are divided into 2 groups, control and experimental. so the control group will perform walking exercises with the swalker and conventional balance exercises and the experimental group will perform walking and balance exercises with swalker and virtual reality.

Eligibility criteria:
inclusion criteria: * participants of both sexes over 65 years of age, * patients with a height of less than 180 cm, * patients weighing less than 90 kg, * patients who have suffered a hip fracture\* and wish to participate in the study. * in addition, they must sign and understand the informed consent form. exclusion criteria: * cognitive status insufficient to understand and execute instructions given by the physiotherapist. * patients needing rehabilitation after hip fracture may vary from a few days to a few weeks after the period of occurrence of the hip fracture, depending on the complications that could arise and the type of surgery used, with a pre-set limit of one month.
effectiveness and safety of implantable intrathecal systems for refractory pain in spain (intrathecal-renased)

Conditions: Refractory Pain

Summary: refractory pain is a prevalent condition that negatively affects patients' quality of life. intrathecal implantable systems have been proposed as a treatment option for refractory pain. however, real-world data on the effectiveness and safety of these therapies in spain are scarce. this study aims to obtain real-world data on the effectiveness and safety of intrathecal implantable systems for refractory pain treatment in spain.

all spanish hospitals that implant intrathecal systems for refractory pain will be invited to participate in the study. patients will be recruited before the procedure, and before providing data to the registry, the study will be explained to them, and they will sign an informed consent form. demographic data related to the pathology and procedure will be collected. follow-up will be conducted at three and twelve months after the procedure.

Eligibility criteria:
inclusion criteria: * chronic refractory pain patients candidates for treatment with an implantable neurostimulation system. * accept to participate in the study and sign informed consent. exclusion criteria: * patients in whom it would be difficult to complete follow-up. * insufficient understanding of the spanish language. * pregnancy.

Keywords: intrathecal drug delivery implantable infusion pump refractory pain
dissemination of sars-cov-2 (covid-19) in the environment of infected patients admitted to intensive care unit

Conditions: Covid-19; Viral Infection

Summary: the objective of this protocol is to estimate the proportion of patients hospitalized in intensive care unit for a sars-cov-2 viral lung infection and contaminating their environment at 1 meter. the contamination will be assessed by quantifying the viral rna by rt-pcr on a 600-liter air sample aspirated by a coriolis® system. this sample will be taken within 48 hours after the confirmation of sars-cov-2 infection, documented by rt-pcr. in fact, the hospital hygiene measures practiced in intensive care unit in patients with viral respiratory infection are identical to those practiced in other services. these measures are possibly insufficient as evidenced by recent data related to the covid-19 epidemic.

respiratory viruses are frequently responsible for acute respiratory failure which justifies hospitalization in intensive care unit. actually, recent epidemics of emerging viruses (including covid-19) have highlighted the possibility of air-type transmission in this specific population. despite the fact that the risk of environmental contamination has never been objectified, it is probable that in intensive care patients, this contamination is greater than in other patients because of the gravity of the patients (greater inoculum) and the use of ventilation techniques responsible for probably increased exhaled viral expression. defining the mode of transmission of respiratory viruses has major consequences in terms means of prevention. the "air" mode of transmission absolutely requires hospitalization in a single room and sometimes additional air treatment. the droplet transmission mode due to its short range requires simpler measures (wearing a surgical mask, no specific air treatment) and has also led to the discussion of the value of the individual room. indeed, the use of high flow ventilation system such as "optiflow" or non-invasive ventilation, can transform a droplet risk into "air" risk. for this reason, measuring the extent of environmental contamination around infected patients in intensive care is a major issue.

Eligibility criteria:
inclusion criteria: * patient over 18 years old. * patient admitted to intensive care unit for a low respiratory infection during which the sars-cov-2 virus is documented, with a positive rt-pcr in the 48 hours before taking samples. * information and not opposition from the patient / or family exclusion criteria: * no documentation of sars-cov-2 viral respiratory infection. * patient under guardianship / curatorship

Keywords: sars-cov-2 environmental contamination intensive care unit
efficacy and acceptability of a monkeypox curriculum for disproportionately impacted communities

Conditions: Monkey Pox

Summary: the study team will create an online module via the redcap platform. the module will include around 5 videos and several infographics covering the topics of symptoms, transmission, prevention, vaccination, and treatment of the monkeypox virus. surveys assessing the primary and secondary study endpoints will be given to participants before and after the module. the purpose of the study is to assess the efficacy and acceptability of an educational presentation on monkeypox in a cohort of individuals recruited from rainbow health and to secondarily assess participant risk perception, intention to vaccinate, and confidence in public health initiatives.


Eligibility criteria:
inclusion criteria: * individuals who are 18 years and older * individuals able to read and write in english exclusion criteria: * unable to provide informed consent
two-period 21 day cross-over study to compare the pharmacokinetics of tiotropium from two inhalers

Conditions: Healthy

Summary: the purpose of this study is to compare the absorption of a test inhalation product with the reference product in healthy volunteers.

healthy subjects will be enrolled and will receive doses of a test inhalation product and a reference inhalation product for 28 days according to a crossover design. plasma tiotropium levels will be measured predose and over 24 hours postdose on days 1 and 28.

Eligibility criteria:
inclusion criteria: * healthy volunteer * willing and able to give informed consent * willing to withhold all alcoholic beverages for 48 hours and all xanthine- containing foods and beverages for 24 hours prior to reporting to clinic * subjects must agree to use an adequate method of contraception from admission through 12 weeks after last administration exclusion criteria: * evidence or history of clinically significant abnormalities or disease or chronic respiratory disorders * any presence or history of a clinically significant allergy including any adverse reaction to study drug * history of drug or alcohol abuse within the past 2 years * smoked tobacco within the past 6 months or have a history of more than 10- pack years (number of packs smoked per day x number of years smoked) * donation or loss of greater than 400 ml of blood within the previous 3 months * have received any prescription medication within 4 weeks or investigational medication within 12 weeks of study (exception: contraceptives are permitted) * have received any non-prescription medication within 14 days prior to dosing (exception: paracetamol use within 2 days) * upper respiratory tract infection (excluding otitis media) within 14 days of the first study day, or lower respiratory tract infection within the last 3 months * if female, nursing, lactating or pregnant

Keywords: inhalation anticholinergic