Kornimate/medical-research-clean huggingface dataset:
safety, blood levels and effects of gw642444

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: gw642444 (the study medicine) is a new experimental medicine for treating asthma and chronic obstructive pulmonary disease (copd). people with asthma and copd suffer from breathlessness because the small tubes (bronchioles) that carry air in and out of the lungs become narrow. we hope that the study medicine will work by relaxing the muscles in the airways and help to keep the airways open, and make breathing easier. the study medicine might improve on available treatments by having fewer side-effects, and by working faster and for longer, so that patients could take it once daily, instead of twice daily. when a medicine is made into a form ready to be given to patients, inactive ingredients are often added. inactive ingredients might be used to help a medicine work better, to make it easier to produce the medicine, or to make it easier to get an accurate dose of medicine. in this study, the study medicine contains the inactive ingredient magnesium stearate. we need to check that the study medicine doesn't cause problems when inhaled along with magnesium stearate. so, we're doing this study in healthy people to find out the answers to these questions. 1)do repeated once-daily doses of the study medicine cause any important side effects when inhaled, along with magnesium stearate, as a fine powder? 2)how much of the study medicine gets into the bloodstream and how long does the body take to get rid of it?


Eligibility criteria:
inclusion criteria: * healthy males and females (of non-childbearing potential) aged 18-55 * body weight \>50kg with bmi 19-29.9 kg/m2 * normal ecg recording * non-smoker exclusion criteria: * high blood pressure (above 140/90 mmhg) * pulse outside range 45 - 90 bpm * history of breathing problems e.g. asthma * low haemoglobin (\<11 g/dl) * blood donation within 56 days of study start * taking regular medication * participation in another trial within 4 months of study start * history of drug or alcohol abuse * abnormal clinical laboratory tests * known allergies

Keywords: gw642444, healthy subjects magnesium stearate,
swedish external support study

Conditions: Critical Limb Ischemia

Summary: randomized study to evaluate the effect of adding external support to ptfe-grafts used for bypass to below knee arteries in patients with critical limb ischemia with respect to primary patency, secondary patency, and limb salvage.


Eligibility criteria:
inclusion criteria: critical limb ischemia need for bypass surgery exclusion criteria: can participate in follow-up has suitable saphenous vein

Keywords: ptfe bypass femoro-popliteal femoro-crural popliteal arteries crural arteries external support crtical limb ischemia
posturography-neuropathy

Conditions: Neuropathy Demyelinating

Summary: if the classification between hereditary and acquired neuropathy is often easy, there is no completely specific marker allowing the distinction between the two etiologies. clinical experience suggests that hereditary neuropathies have less impact on balance and gait than the acquired neuropathies at equivalent level of impairment, but this has never been clearly demonstrated.


Eligibility criteria:
inclusion criteria: * cmt1a for molecular-proven group 1 (pmp22 duplication) * ipdc likely or defined for group 2 * able to walk 10 m unassisted exclusion criteria: * neurological history other than neuropathy: epilepsy, stroke, dementia * pregnant women * person under guardianship or trusteeship * musculoskeletal conditions other than neuropathy impairing walking abilities * major comorbidity considered a contraindication by the investigator (cancer, unstable angor, etc.)

Keywords: gait balance posture charcot-marie-tooth chronic inflammatory demyelinating polyneuropathy
interventions to decrease financial toxicity

Conditions: Cancer, Breast; Cancer Colorectal; Cancer, Ovarian; Cervical Cancer; Uterine Cancer; Vulvar Cancer

Summary: financial distress affects 30-70% of cancer patients and describes the burden that patients experience due to the costs of care (coc). one reason may be because patients lack the appropriate information on coc that would help them better plan for and manage their coc. therefore, the investigators plan to test a proactive coc intervention which includes a discussion with a trained educator on coc information and a cost tracking tool to help patients deal with their coc.

the investigators will recruit 60 patients diagnosed with gynecologic (ovarian, uterine, cervical, or vulvar cancer), breast or colorectal cancer who are starting a new line of treatment at the o'neal comprehensive cancer center. participants will be randomized to proactive coc intervention versus usual care. usual care consists of the current care processes at the cancer center where information on coc and financial assistance are only provided once a financial need is identified. the main goal is to compare the change in financial distress from baseline to 6 months to see if patients who received any of the proactive coc intervention have improved financial distress compared to those in usual care. all participants will complete two main surveys at 0 and 6 months that will ask questions to measure the study outcomes, self-efficacy (patient reported confidence managing certain situations, such as dealing with coc), depression, anxiety, and insurance knowledge. participants randomized to any of the proactive coc intervention groups will complete three additional phone interviews at 2, 4, and 6 months to check how participants utilized the materials, reasons why they have or have not, and what sections were helpful or not. this study is important to determine whether the proactive coc intervention can be successfully delivered, whether the intervention is useful to help patients decrease financial distress, and to inform the design of a future larger study that will include different cancer types and health systems.

Eligibility criteria:
inclusion criteria: * newly diagnosed ovarian cancer (i.e., stage ii-iv epithelial histology receiving surgery and chemotherapy), or newly diagnosed cervical cancer (i.e., locally advanced stage ib3-iva receiving chemoradiation), or newly diagnosed uterine cancer (i.e., high-risk histology likely to receive chemotherapy; serous/clear cell), or newly diagnosed stage i-iii breast cancer (i.e., high-risk histology), or newly diagnosed stage iii-iv colorectal cancer * receiving systemic therapy or radiation at university of alabama at birmingham o'neal comprehensive cancer center * with health insurance coverage * with reliable access to a phone, mobile device, or internet exclusion criteria: * unable to read english * does not agree to complete surveys

Keywords: financial toxicity financial distress costs of care
measurement of cardiopulmonary variables after acute exposure to high altitude

Conditions: High Altitude Effects

Summary: as altitude increases, the availability of oxygen in the air decreases, and just to compensate for this lack, the body increases cardiac and respiratory work and changes blood pressure. but that is not all: at altitude the body's ability to use oxygen is also limited. thus, there is on one hand less oxygen available, and on the other a lower capacity to use it. all this generates significant alterations at the cardiovascular level, to the point of running possible risks of heart attack, stroke and acute pulmonary edema, particularly for individuals already suffering from cardiovascular disease. the availability of modern cable cars allows an increasingly large number of individuals, including sedentary people, elderly subjects, and cardiorespiratory patients, to easily and rapidly reach high-altitude locations. data on what happens on the cardiovascular system at high altitude are relatively scarce, and most experiments in the literature are limited by low sample sizes. the primary purpose of this study is to assess the characteristics of a large population that acutely reached high altitude at punta helbronner (3,466 m above sea level), a location on mont blanc that is readily accessible by a 20-minute cableway ride from courmayeur (entreves station, 1,300 m, skyway monte bianco). we aim to create a unique database and study correlations between altitude and cardiorespiratory parameters (heart rate, blood pressure, and hb saturation) by collecting medical history data and biometric measurements in a very large population and to identify subjects most at risk of developing hypoxia at altitude. in a subset of subjects, differences in biometric variables after acute exposure at high altitude (in the transition between the downstream and the upstream measuring station) will be evaluated. two biometric multiparametric recording systems (keito k9; keito, barcelona, spain) were installed at entreves station as well as at punta helbronner. keito k9 is an automatic multiparametric recoding system for measuring peripheral oxygen saturation spo2, heart rate hr (pulse oximeter), blood pressure (bp; wrist pressure cuff, automatic), height (laser height meter), weight (scale platform), and body mass index (bmi). once initiated by the subject with the completion of a cardiology history questionnaire (self-reported), the automated keito k9 system provides a sequence of vocal and animated directions to guide subjects through the measurements (the subject may elect to abstain from some of the measurements). upon completion, the system prints a summary receipt for the subject, and the measurements are transmitted through a wi-fi network and collected in an excel sheet. it should be noted that all data collected will be anonymized or not traceable to the subject, through the use of a disposable identification card (for subjects who will perform both downstream and upstream measurement).


Eligibility criteria:
inclusion criteria: * age ≥ 18 years exclusion criteria: * age \< 18 years
omic technologies to track resistance to palbociclib in metastatic breast cancer

Conditions: Advanced Breast Cancer

Summary: this is a monocentric cohort study, prospective and interventional with minimal risks and constraints for advanced breast cancer. the planned interventions are collection of biological samples at different times. the study will aim to do a descriptive analysis of omics profiles evolution (tumor, volatile organic components) over time, before and after disease progression under palbociclib treatment with a clinical-biological database.

patients enrolled in the study will receive the following interventions: * biospecimen sample collection: before and during treatment, and at progression * tumor biopsy before treatment and at progression the aim of this study is to describe molecular changes associated with resistance to palbociclib at the individual level and describe longitudinal changes in the profile of tumor, vocs and exosomes according to treatment response. other objectives of the study include: * proportion of single or shared molecular alterations / signatures between patients at progression time * associations between tumor signatures, vocs and exosomes * compare molecular changes identified by proteomics with those observed by genomics / transcriptomics * compare the evolution of vocs and exosomes over time with evolution of liquid biopsy markers.

Eligibility criteria:
inclusion criteria: * women over 18 years old * with histologically proven breast cancer, positives hormones receptors and negative her2 * advanced disease (metastases or non-resequable locoregional disease), from the 1st to the 4th line. * with an indication for hormone therapy associated with the cdk4/6 inhibitor palbociclib * agree to the sampling of the study * signed the informed consent form exclusion criteria: * neoadjuvant or adjuvant treatment for localized breast cancer * metastatic breast cancer beyond the forth line * impossibility to give informed consent (person deprived of liberty or under guardianship)

Keywords: breast cancer omics profiles proteomics volatile organic compounds exosomes
to investigate the blood concentration of liraglutide as well as the effects on glucose and insulin after 21 days of daily subcutaneous injections of liraglutide or placebo

Conditions: Diabetes; Healthy

Summary: this trial is conducted in asia. the aim of this clinical trial is to investigate the blood concentration of liraglutide (pharmacokinetics) as well as the effects on glucose and insulin (pharmacodynamics) after 21 days of daily subcutaneous injections (injected under the skin) of liraglutide or placebo. in addition, the safety and tolerability of liraglutide will be observed.


Eligibility criteria:
inclusion criteria: * informed consent obtained before any trial related activities * healthy chinese male subjects * body mass index (bmi) between 19.0 and 27.0 kg/m2 (both inclusive) * fasting plasma glucose less than 6.0 mmol/l * non-smoker exclusion criteria: * clinically significant abnormalities on pre-study clinical examination or any laboratory measurements during screening (any abnormality should be discussed with the clinical monitor) * presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders * blood pressure in supine position at the screening, after resting for 5 min, outside the ranges 90- 140 mmhg systolic and/or 40 - 90 mmhg diastolic * pulse in supine position at the screening, after resting for 5 min, outside the range 40 - 100 times/min * hepatitis b surface antigen, hepatitis c antibodies or hiv antibodies positive.
simvastatin in patients with septic shock

Conditions: Septic Shock

Summary: the beneficial effect of statins to prevent cardiovascular events in patients at risk is well established. recent trials demonstrated that statins can exert a number of vascular actions independent of lipid lowering. short-term simvastatin therapy recently has been reported to reduce mortality in 2 different animal models of sepsis. pleiner and coworkers could demonstrate potent vasoprotective properties of simvastatin during escherichia coli endotoxin induced endotoxemia in healthy volunteers. in a population-based cohort analysis it was demonstrated that administration of statins was associated with a reduced risk of subsequent sepsis. thus, simvastatin treatment may offer a new therapeutic strategy for clinical conditions associated with inflammation like severe sepsis and septic shock. the aim of the present study is to test the hypothesis that short term treatment with simvastatin may mitigate the detrimental vascular effects of acute inflammation in patients admitted to the intensive care unit requiring treatment for septic shock.


Eligibility criteria:
inclusion criteria: * age \> 18 years * septic shock for less than 48 hours exclusion criteria: * pregnancy * unable to receive enteral medications * expected survival of less than 72 hours * treatment in the previous 3 weeks with simvastatin or other hmg-coa reductase inhibitors * history of hypersensitivity to the trial drug or to drugs with a similar chemical structure * history of known or suspected porphyria * high risk of rhabdomyolysis (multiple trauma, crush injuries, extensive burns, baseline creatinine kinase (ck) ≥ten-times upper limit of normal * hemorrhagic shock

Keywords: septic shock simvastatin
thoracic-lumbar arthrodesis- implanet jazz

Conditions: Spondylolisthesis; Spinal Stenosis; Degenerative Disease

Summary: establish a data repository of patients who have undergone single, two-, or three-level lumbar instrumented arthrodesis procedures supplemented by the implanet jazz system.

to collect and organize data into a repository from the principal investigator's and other site investigators' patients who are undergoing single, two-level, or three-level lumbar instrumented arthrodesis procedures supplemented by the implanet jazz systemtm at participating centers. this device is designed to provide a stable interface between spinal constructs and the rods; it can be secured around vertebral structures (such as the lamina, transverse or spinous processes) from t1 to l5 and is intended to provide temporary stabilization as a bone anchor during the development of a solid body fusion. of note, these patients will receive the supplemental support of the implanet jazz sublaminar band as their clinical standard of care deems necessary and separately from study participation. clinical data will be collected as indicated at 6 weeks, as well as 3, 6, 12, 24, 36, 48, and 60 months post-operatively in the database.

Eligibility criteria:
inclusion criteria: * male and female patients, 18 years of age and older * qualified candidate for hybrid thoracolumbar fixation with the implanet jazz system tm during arthrodesis surgery. exclusion criteria: * individuals who have not yet reached the age of 18.

Keywords: thoracic-lumbar arthrodesis spinal fusion back pain
analysis of a new biomarker for prostate cancer diagnosis

Conditions: Patients With Suspected Prostate Cancer

Summary: the aim of our study is to determine if the levels of the "hem" substance in seminal plasma are associated with the presence of prostate cancer in transrectal prostate biopsy.


Eligibility criteria:
inclusion criteria: * clinical or laboratory suspected of prostate cancer exclusion criteria: * inability to ejaculate
french translation/adaptation of ahemd-sr (fr-ahemd)

Conditions: Motor Disorders

Summary: the aim of this study is to develop a french translation and adaptation of the original english version of the ahemd-sr.

the ahemd-sr was developed in 2005 to assess the opportunities offered to children aged 18 to 42 months to support their motor development in the home environment. the questionnaire is reliable and valid and is regularly used by researchers and practitioners to assess and develop strategies to improve the stimulating properties of the home. to date, the ahemd-sr has been translated into eight languages, but no french translation exists. the study will include a translation of the ahemd-sr into french and a cultural validation of the french version of the questionnaire with a sample of parents of children diagnosed with delayed motor development and a panel of paediatric rehabilitation experts.

Eligibility criteria:
parents group : inclusion criteria: * parents of a child aged 18 to 42 months with a diagnosis of delayed motor development * taken in charge in one of the participating centers for an intensive motor rehabilitation training * francophone by birth exclusion criteria: * parent opposing participation in the study experts group : inclusion criteria: * professional * holding a french state diploma in the field of rehabilitation * participating in an intensive motor rehabilitation training in one of the participating centres. * proof of experience in paediatric rehabilitation (lasting 5 years). * francophone by birth non-inclusion criteria : - expert opposing participation in the study

Keywords: ahemd-sr motor development pediatric rehabilitation
a study to measure the amount of study medicine in blood in adult participants with covid-19 and severe kidney disease

Conditions: COVID-19

Summary: the purpose of this study is to learn about the side effects (safety) of the study medicine pf-07321332 (nirmatrelvir)/ritonavir for the treatment of mild to moderate covid-19 infection in adults with severe renal impairment. the study will also look at the amounts of study drug in your blood. there will be 24 participants in this study; 12 of them will have severe renal impairment and not be on hemodialysis and 12 of them will be on hemodialysis. all participants in this study will take pf-07321332 (nirmatrelvir)/ritonavir by mouth for 5 days. during this time, they will have to collect blood samples to measure the study drug levels in their blood. after taking the study drug for 5 days, the participants will have follow-up visits for about another 28 days for a total of about 34 days in the study. the study team will check how each participant is doing during regular visits at the study clinic.


Eligibility criteria:
inclusion criteria: * covid-19 infection * severe kidney disease (on hemodialysis or not on hemodialysis) exclusion criteria: * hospitalized * take medications that are not allowed * renal transplant patients * hiv infection this is not a complete list. other inclusion and exclusion criteria may apply.

Keywords: severe acute respiratory syndrome coronavirus 2 (sars-cov-2) kidney disease kidney failure renal disease renal failure dialysis renal dialysis hemodialysis coronavirus disease 2019 (covid-19) covid paxlovid antiviral nirmatrelvir mild to moderate covid-19 high risk
support tool for antibiotic allergy delabeling

Conditions: Antibiotic Allergy

Summary: antibiotic allergy labels (aal) are reported in 7% of inpatient's charts, especially for beta-lactams (86% of aal, i.e., prevalence of 6%). they are associated with increased length of hospital stay, and use of second-line and broad-spectrum antibiotics. allergy workups are able to invalidate the majority of these aal but are time-consuming and require invasive skin and provocation testing. the investigators recently evaluated, for the first time in europa, a strictly non-invasive delabeling protocol using a questionnaire, medical file search and contact with primary care health care workers in 200 adult internal medicine inpatients with a beta-lactam aal. up to half of the aal could be removed or refined, demonstrating the potential of this strategy. in this project, they aim to assess the impact of using the non-invasive 'aal-fact-check' tool in a multicenter study, on antibiotic selection, and clinical, antimicrobial, and economic endpoints, as compared with the standard of care (i.e., no aal-fact-check tool).


Eligibility criteria:
inclusion criteria: 1. hospitalized patients 2. aal for one or more beta-lactams exclusion criteria: 1. age younger than 18 2. previous enrolment in this study

Keywords: penicillin allergy delabeling beta-lactam electronic health records clinical decision support antibiotic allergy drug allergy
neuroablation versus neuromodulation techniques for treatment of secondary dystonia

Conditions: Secondary Dystonia

Summary: the disability inflected by dystonia encouraged the development of many neurosurgical procedures. this is a prospective study included 120 patients suffering from intractable secondary dystonia. they were subjected to different neurosurgical treatments and were assessed through the follow up period

background: secondary dystonia are the syndromes that have dystonic symptoms due to brain insult which can be associated with neonatal encephalopathy syndromes, trauma, vascular injury, infections, demyelinations, or hereditary disorders associated with neurodegenerative process. the disability inflected by dystonia encouraged the development of many neurosurgical procedures in order to improve the quality of life of these patients. the aim of this study was to compare the outcomes of different neuroablative and modulation techniques in treatment of secondary dystonia. patients and methods this is a prospective study included 120 patients suffering from intractable secondary dystonia. ablative techniques included the brain lesioning procedure and combined anterior and posterior lumbar rhizotomy (capr). modulation techniques included deep brain stimulation (dbs) and intrathecal baclofen therapy (itb). patients with focal dystonia were included in the botulinum toxin injection group. patients with generalized dystonia were included in either of the brain lesioning or the deep brain stimulation, and patients with predominant affection of both lower limbs were included in either of the (capr) or the (itb) groups. assessment measures included the evaluation of the muscle tone, range of motion, and the burke-fahn-marsden dystonia rating scale through a follow up period of one year.

Eligibility criteria:
inclusion criteria: * secondary dystonia of previous etiologies exclusion criteria: * patients who are not candidate for anaesthesia