Kornimate/medical-research-clean huggingface dataset:
a study comparing the efficacy and safety of once-daily fuzeon (enfuvirtide) dosing versus the currently recommended twice-daily dosing in human immunodeficiency virus-type 1 (hiv-1) infected patients

Conditions: HIV Infections

Summary: this study will assess the safety and efficacy of once-daily administration of fuzeon compared with twice-daily administration in hiv-1 infected patients who have received prior treatment. patients will also receive an optimized treatment consisting of antiretroviral (arv) therapy as determined by the treating physician. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * hiv-1 infected adults or adolescents \>=16 years of age; * hiv-1 rna \>=5000 copies/ml; * prior experience or documented resistance to each of the 3 currently available classes of arv drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors). exclusion criteria: * history of prior use of fuzeon or t-1249; * female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study; * current severe illness; * currently taking drugs affecting the immune system, hiv vaccine, or investigational agents for any conditions other than hiv/aids.
asunercept for the treatment of patients with moderate to severe covid-19 disease

Conditions: COVID-19

Summary: this clincial trial is a prospective, multicenter, randomized, double-blind, placebo-controlled phase iii trial in hospitalized patients with moderate to severe covid-19 corresponding to score 5 or 6 on the who 10-point clinical progression scale (grade 0-10). the investigational drug (apg101; international nonproprietary name: asunercept) will be given at a dose of 100 mg intravenously (i.v.) once weekly for a period of 4 weeks (1 dose each on d1, d8, d15, and d22) in addition to the treatment recommended by international, national, or local treatment guidelines (soc) and will be compared with the control arm (i.e., soc + placebo).


Eligibility criteria:
inclusion criteria: * patient must be willing and able to give informed consent to participate in the trial and to adhere to the procedures stated in the protocol * ≥18 years of age * patient is admitted to a hospital (max. 72 hours prior to randomization) due to covid-19 and has a positive sars-cov-2 pcr test * clinical symptoms indicative of moderate or severe illness (corresponding to score 5 or 6 on the who 10-point clinical progression scale) with covid 19 prior to trial treatment * patient agrees to not participate in another clinical trial from screening until day 56 exclusion criteria: * patient is moribund or has an estimated life expectancy \<1 month (e.g., terminal cancer, etc.) * patient is anticipated to be discharged from hospital within 48 hours * patient requires anti-inflammatory medicines beyond soc (soc are drugs that are approved for treatment of covid-19 as well as medicines that have been recommended in treatment guidelines of national health authorities and/or professional organization) * patient requires invasive mechanical ventilation * patient is known to have active tuberculosis * patient is known to have hereditary fructose intolerance. * patient is known to have co-infection with influenza viruses or other viral respiratory infections (respiratory syncytial virus \[rsv\], parainfluenza viruses, respiratory adenoviruses).
fitness, hearing and quality of life in older adults with hearing loss. walk, talk and listen for your life

Conditions: Hearing Loss, Functional

Summary: this study examines the effect of an exercise and health education/auditory rehabilitation and socialization intervention on functional fitness, hearing handicap and psychosocial distress measures in older adults with hearing loss.

hearing loss is associated with functional fitness declines and increased risk for isolation, dementia, depression, falls, hospitalization and premature mortality. no studies have determined the effect of an exercise intervention on these measures in older adults with hearing loss. after baseline assessment of function fitness and several psychosocial measures, 60 older adults with hearing loss will be randomized into a 10 week exercise, health education, socialization and auditory rehabilitation program or auditory rehabilitation alone. the exercise program consists of 3/4 of an hour strengthening and resistance training followed by 30 minutes of group walking. the educational session content is determined by participants and is interactive and may include such topics as wills and probate, diabetes treatment, healthy exercise etc. the 3/4 of an hour auditory rehabilitation sessions are modified from an online program and will include interactive sessions on education about hearing and hearing devices/technologies, psychosocial support and enhancing communication skills. at the end of the 10 week intervention the assessments of functional fitness and psychosocial measures will be repeated. the group that was randomized to the auditory rehabilitation alone will then be offered the exercise program.

Eligibility criteria:
inclusion criteria: -gender: male and female age limits: * minimum age: 65 years of age * maximum age: 90 years of age. * self-reported diagnosis of hearing loss * must be independently ambulatory (no use of cane, walker or wheelchair) * less than150 minutes per week of self-reported physical activity * healthy enough to participate in the intervention without exacerbating any existing symptomatology * not having participated in any organized exercise program for at least 6 months * availability and willingness to attend at least 80% of the 10 week intervention sessions in addition to baseline and final assessments. -be english speaking and able to sign written informed consent * a hearing handicap in the elderly-25 questionnaire score of 25 \> 17 exclusion criteria: * dementia * depression
safety and efficacy of vilazodone in adolescent patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in adolescent outpatients (12-17) with major depressive disorder.


Eligibility criteria:
inclusion criteria: * male or female outpatients between 12-17 years of age * primary diagnosis of major depressive disorder (mdd) * children's depression rating scale-revised (cdrs-r) score of 40 or greater * clinical global impressions-severity (cgi-s) score of 4 or greater exclusion criteria: * current (past 3 months) principal diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) based diagnosis of an axis disorder other than major depressive disorder (mdd) that is the primary focus of treatment. * history of suicidal behavior, or requires precaution against suicide * not generally healthy medical condition * seizure disorder
experimental validation of the long-term accuracy of blood pressure measurement using a smartwatch

Conditions: Hypertension; Blood Pressure

Summary: the aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the samsung galaxy smartwatch

blood pressure is one of the basic vital signs monitored and is one of the most important indicators of a patient's health status. cardiovascular disease is one of the leading causes of death worldwide. one of the major risk factors for cardiovascular disease is hypertension, which is globally attributed to one third of deaths in the world population. to improve the prevention of hypertension, self-monitoring of blood pressure is increasingly recommended. this project involves an experimental validation of the long-term accuracy of blood pressure measurement using the samsung galaxy smartwatch compared to a medical grade digital tonometer with a cuff placed on the arm.

Eligibility criteria:
inclusion criteria: * healthy volunteer exclusion criteria: * post-traumatic conditions of the upper limbs * tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands * cardiac arrhythmias * circulatory or peripheral varcular disease * aortic valve disease * myocardiopathy * other cardiovascular diseases * pregnancy * kidney disease * diabetes * neurotic disorder * haemostatic disorders * use of blood-thinning drugs

Keywords: smartwatch blood pressure heart rate
comparison of two techniques for placement of perineural femoral catheters.

Conditions: Postoperative Pain; Anterior Cruciate Ligament Reconstruction

Summary: the purpose of this study is to assess the efficacy of the hydrolocalization technique for placement of femoral perineural catheters in comparison with stimulating catheters. a non inferiority trial.

the investigators will randomize patients that will undergo anterior cruciate ligament reconstruction. each patient will receive a subgluteal single shot nerve block and a continuous femoral nerve block with placement of a catheter either with the hydrolocalization technique (group hloc) or a neurostimulating catheter (group ns).

Eligibility criteria:
inclusion criteria: * adults * bmi less than 30 exclusion criteria: * known allergies to local anesthetics or other drugs used * patient refusal * any local or systemic contraindication to the use of popliteal block
study of the effect of differing platelet transfusion times in neonates

Conditions: Thrombocytopenia

Summary: to evaluate changes in platelet counts and hemodynamics between "rapid" and "long" platelet infusion groups.

1. it is our hypothesis that the change in post-transfusion platelet counts of babies who receive platelets over 30 minutes (short transfusion group) will be significantly different from the change in babies who receive platelets over two hours (long transfusion group) when platelets are checked immediately after transfusion and 6 hours after the completion of transfusion. 2. we also expect there to be significant differences in the platelet counts drawn thirty minutes after transfusion compared to the counts drawn 6 hours after the completion of the transfusion in either group.

Eligibility criteria:
inclusion criteria: * infants with significant thrombocytopenia requiring a transfusion of platelets. exclusion criteria: * infants requiring extracorporeal membranous oxygenation. * infants with congenital heart disease (other than patent foramen ovale or patent ductus arteriosus). * babies diagnosed with neonatal alloimmune thrombocytopenia.

Keywords: platelets transfusion thrombocytopenia
comparison manufactured rib splint with hand-made rib splint

Conditions: Pain, Acute

Summary: a pilot study for a prospective randomized clinical trial was conducted to compare subjects using the cco (group-a) with those using the er-splint (group-b) before and after the intervention. the primary outcome was difference in the level of pain based on the visual analogue scale (vas) between before and after intervention in each group during forceful and resting respiration. vas : visual analogue scale cco : chrisofix® chest orthosis

investigators performed vas assessments to determine the level of pain in the subjects with rfs during resting and forceful respiration. investigators applied either the cco rib splint or the er splint to the rf subjects in a randomized order. at 30 minutes after splint application, investigators repeated the vas assessments during resting and forceful respiration. subsequently, additional pain control was provided via intravascular drug injection. rf : rib fractures vas : visual analogue scale cco : chrisofix® chest orthosis

Eligibility criteria:
inclusion criteria: * subjects who have rib fractures and age was over 18 years old exclusion criteria: * investigators excluded subjects with cardiopulmonary dysfunction, poly-trauma, flail chest, damage to an internal organ, or alcoholism and subjects who did not consent to participate.
effect of sedation on intra-abdominal pressure

Conditions: Intra-abdominal Hypertension

Summary: the purpose of this study is to evaluate the effect of deepening of sedation on intra-abdominal pressure in mechanically ventilated adult patients with intra-abdominal hypertension.

the importance of intra-abdominal pressure (iap) in critically ill patients has been addressed increasingly. several studies have shown that elevated mean iap is associated with adverse icu outcomes. the prevalence of intra-abdominal hypertension (iah) among critically ill patients is as high as 50% if defined according to maximal iap and half of it if defined according to mean iap. development of iah during icu period is an independent risk factor for death. considering such significant impact on patients' outcome, international conference of experts has agreed and published recommendations for treatment of iah and abdominal compartment syndrome. among others, deepening of sedation is suggested as treatment option. the recommendation is based on expert opinion; there are no controlled clinical studies available to support this approach. importantly, recent studies have shown that deep sedation itself may be associated with worse outcome to patients. treggiari et al suggest that a strategy of light sedation affords benefits with regard to reduction of intensive care unit stay and duration of ventilation without negatively affecting subsequent patient mental health or patient safety. others have shown reduced icu mortality as well as reduced incidence of ventilator-associated pneumonia in conjunction with light sedation. this is a prospective, interventional, multicentre study. there will be no control group. study subjects: adult, mechanically ventilated patients with iap between 12 and 20 mmhg in at least two consecutive measurements, spontaneous breathing activity of at least 6 breaths/minute, rass score between 0 and -4, if no contraindications to propofol administration are present and no other interventions to reduce iap are planned. study intervention: sedation deepening will be achieved with a bolus of propofol 1 mg/kg followed by continuous infusion of propofol 3 mg/kg/h for one hour. patients previously receiving propofol infusion will receive supplemental propofol per protocol up to a maximum infusion rate of 5 mg/kg/h. series of measurements of iap will be performed before (once) and after (repeatedly) intervention (deepening of sedation). deepness of sedation will be assessed with rass score.

Eligibility criteria:
inclusion criteria: * age 18 years or older * mechanical ventilation * iap between 12 and 20 mmhg in at least two consecutive measurements within 1-12 h * spontaneous breathing activity of at least 6 breaths/minute * rass score between 0 and -4 * physician-led sedation (if sedated; as opposed to nurse-led protocol) exclusion criteria: * contraindication for propofol administration * contraindication for iap measurement in supine position with head-of-bed at 0° * other intervention for reduction of iap planned * previous propofol infusion rate \>4 mg/kg/h

Keywords: intra-abdominal pressure intra-abdominal hypertension
magnesium nutrition and sleep behavior in older adults

Conditions: Nutritional Deficiency; Insomnia

Summary: insomnia is not a natural part of aging but is higher in older adults because of a variety of factors common in later life. one of these factors may be a deficient magnesium status. this study will look at whether or not magnesium supplementation will improve sleep.

insomnia affects approximately one-third of older americans. more than half of all people aged 65 and older experience sleep problems. the prevalence of insomnia and other sleep disorders is not a natural part of aging but is high in older adults because of a variety of factors common in late life. one of those factors may be a deficient magnesium status. there is a close association between sleep architecture, especially slow wave sleep, and activity in the glutamatergic and gamma-aminobutyric acid (gaba) system. because magnesium is a natural n-methyl-d-aspartate (nmda)antagonist and gaba agonist, magnesium apparently plays a key role in the regulation of sleep. such a role is supported by supplementation, correlation, and animal studies showing that magnesium intake or status affects sleep organization.

Eligibility criteria:
inclusion criteria: * have sleep complaints * score greater than 5 on pittsburgh global sleep quality index exclusion criteria: * taking medications that affect sleep * taking 100 milligrams or more of magnesium * body mass index of 40 or higher * abnormal breathing conditions

Keywords: magnesium nutritional requirements sleep
hbv/hcv/hiv in belgian prisons

Conditions: Hepatitis C; Hepatitis B; HIV Infections

Summary: to assess the prevalence of blood-borne viral infections in prisons in belgium, screening will be executed in several prisons in flanders, brussels and wallonia to obtain a geographical representative distribution. upon informed consent screening will be performed using whole capillary blood (finger prick testing) with three different tests for hcv ab, hbsag and hiv. screening will be performed first. while awaiting the test result (15-20min), the participant can fill out a questionnaire (together with the study nurse), concerning risk factors for hcv, hbv and hiv infection. this questionnaire is filled out directly online, and will be immediately implemented in the encoded database. the database is set-up according to the rules of good clinical practice. (castor edc software). the results will be filled out immediately by the prison staff in this database after it is filled out by the participant, minimizing the risk of displacement of test results.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * imprisoned in one of the predefined prisons in flanders brussels or wallonia participating in this trial * written informed consent obtained exclusion criteria: * written informed consent not possible: (language barrier, illiteracy) * already participated in the study: re-entry within inclusion period in one of the prisons
decremental esophageal catheter filling volume titration for transpulmonary pressure measurement

Conditions: Pediatric Acute Respiratory Distress Syndrome (PARDS); Acute Respiratory Failure; Acute Respiratory Distress Syndrome

Summary: mechanical ventilation is a critical intervention in the management of pediatric patients with respiratory distress. during this process, accurate measurement of transpulmonary pressure (pl) is essential to ensure the safety and efficacy of ventilation. pl is defined as the difference between alveolar pressure (palv) and pleural pressure (ppl). while the direct measurement of ppl is possible, it poses a risk to tissue integrity. thus, the primary surrogate for ppl measurement today is esophageal pressure (pes). however, the measurement of pes is not without challenges. this abstract outlines the pitfalls associated with pes measurement, emphasizing the importance of employing well-defined procedures to mitigate potential errors. these errors can range from underestimation of pes due to underfilled catheters to overestimation resulting from overfilled catheters. to address these challenges and optimize pes measurement, various methods have been proposed for titrating the filling volume of the esophageal catheter. in this study, investigators aim to assess a faster decremental filling method and compare it to the traditionally accepted mojoli method in the context of pediatric patients. this research seeks to enhance the intensivists' understanding of the most efficient and accurate approach to pes measurement during mechanical ventilation in the pediatric population, ultimately contributing to improved patient care and outcomes


Eligibility criteria:
inclusion criteria: * pediatric patients between 1 months and 18 years * patients need mechanical ventilation support without modification of ventilation settings within the upcoming 2 hours * informed consent was signed by next of kin * requiring esophageal catheter application exclusion criteria: * patients eligible for extubation or modification of ventilation settings within the upcoming 2 hours * patient included in another interventional study in the last 30 days * patients unable to undergo esophageal catheter insertion due to congenital or acquired pathologies * patient included in another interventional research study under consent * patient already enrolled in the present study in a previous episode of acute respiratory failure

Keywords: acute respiratory failure (arf) esophageal catheter transpulmonary pressure
pregnancy exposure registry for tysabri®

Conditions: Crohn's Disease; Prenatal Exposure; Multiple Sclerosis; Pregnancy

Summary: the primary objective of the registry was to evaluate the outcomes of pregnancy in women with multiple sclerosis (ms) or crohn's disease (cd) who were exposed to tysabri® at any time within 90 days prior to first day of last menstrual period (lmp) or during pregnancy.

this study was conducted in coordination with the tysabri® global observational program in safety (tygris) observational study in the united states (us), canada, and rest of world (row). the coordinating center (cc) monitored participants throughout their pregnancies and monitored the infants until 8 to 12 weeks of age in the us and canada, and within 4 weeks after the estimated date of delivery (edd) in the row.

Eligibility criteria:
key inclusion criteria: females who become pregnant while they are taking tysabri® as part of the tygris program, during a clinical trial with tysabri® that is sponsored by biogen-idec, or in the post-marketing setting may enroll in this registry, as follows: 1. documentation that the patient was exposed to tysabri® within 90 days prior to first day of last menstrual period (lmp) or during pregnancy. (if exposure dates are unknown, the reporter must be able to specify or estimate trimester of exposure). 2. the outcome of the pregnancy must not be known at the time of enrollment. for pregnancies for which the outcomes are known at the time of enrollment, the information will be collected as retrospective reports and analyzed separately. 3. for us patients, verbal informed consent must be collected at the time of enrollment. the coordinating center (cc) obtains verbal informed consent (if verbal consent has not already been obtained by the physician). the cc then mails the patient a release of medical information form to sign and return. if the patient is a minor, verbal consent must be obtained from the parent or legal guardian and verbal assent must be obtained from the patient. 4. for canadian patients, a written informed consent must be collected by the tygris investigator at the time of enrollment. a release of medical information form will also be signed by the patient and returned to the cc. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: pregnancy tysabri