Kornimate/medical-research-clean huggingface dataset:
inter-rater reliability of the clinical frailty scale in a swedish emergency department setting

Conditions: Frailty

Summary: frailty is a common clinical syndrome in older adults, which may be assessed through various assessment tools. one frequently used tool is the clinical frailty scale (cfs) which potentially can be adopted for daily use in the emergency department and has been appraised for reliability to some extent, but have so far not been evaluated in the swedish emergency care context. the purpose of this study is to evaluate the inter-rater reliability of the clinical frailty scale (cfs) in a clinical swedish emergency department (ed) setting. members of multidisciplinary emergency care teams will conduct the assessments individually.

the cfs is introduced and tested as part of a quality-improvement process regarding elderly people within the emergency departments (eds) of region östergötland (östergötland county) in sweden. cfs is a 9-point scale developed within the canadian study of health and aging. it comprises of a pictograms and a clinical description to help assign scores ranging from very fit to terminally ill. cfs enables clinicians to rapidly stratify the degree of frailty in the elderly with the help of questions and clinical assessment. however, since the assessment is judgement based, it is important that the inter-rater reliability is satisfactory. this study is part of a larger project where all eligible patients who visit the ed (24/7) for a period of four weeks will be enrolled and then subsequently assessed with cfs by one of their responsible health-care professionals (i.e. physician, registered nurse or nurse assistant). for this study, each professional on the team will individually assess each patient. first, a clinical judgement is performed (frail/not frail) without any instrument, and then the patient is assessed by using the cfs. this will take place during work shifts when someone from the research team is present and can arrange the assessments, as well as ensure that they are conducted independently. these work shifts will be selected using the online application research randomizer, to randomly include all hours of the day as well as eligible health-care professionals. the research-team member will collect the assigned cfs-scores and information on the age, gender, profession, position (emergency physician or intern/resident from other specialities) and the number of years in the profession of each assessor. informed consent will be obtained from all health-care professionals who participate. no data that can identify any patient will be collected. sample size is determined to be 100 patients, which would be more than sufficient with a power of 90% and α 0,05.

Eligibility criteria:
inclusion criteria: health-care professionals: - working in the ed, as part of the emergency-care team that are responsible for a patient ≥65 years patients: - ≥65 years exclusion criteria: health care professionals: - unwilling to provide informed consent patients: - ≤65 years

Keywords: inter-rater reliability clinical frailty scale frailty assessment frailty observer variation emergency service
efficacy and safety of tamsulosin/solifenacin combination therapy in patients with voiding symptoms and moderate to severe storage symptoms due to benign prostate hyperplasia

Conditions: Benign Prostate Hyperplasia

Summary: efficacy and safety of tamsulosin/solifenacin combination therapy in patients with voiding symptoms and moderate to severe storage symptoms due to benign prostate hyperplasia : a randomized, double blinded, parallel design, active controlled, multi-center, phase 3 clinical trial


Eligibility criteria:
inclusion criteria: 1. healthy male aged 45 years old or older 2. subjects with benign prostatic hyperplasia diagnosed by digital rectal examination 3. subjects with lower urinary tract symptom suggestive of benign prostate hyperplasia, who spontaneously agree to join and sign to the consent form exclusion criteria: 1. subjects who have a history of the lower urinary tract cancer, including prostate cancer and bladder cancer within the past 5 years 2. subjects who have acute urinary retention within 4 weeks before screening 3. subjects who have clinically significant severe cardiovascular disease(unstable angina, myocardial infarction or arrhythmia) within 6 months before screening 4. subjects who have hypersensitivity to investigational product or sulfa medications 5. subjects who were suspected or confirmed calculus of lower urinary tract, calculus of bladder (except for complete recovery,) 6. subjects who have myasthenia gravis, narrow angle glaucoma or autonomic neuropathy 7. subjects who have cataract or glaucoma scheduled to be operated in the study duration. 8. subjects who have hereditary problems of galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption 9. subjects who are judged by the investigators to be unsuitable to participate in the clinical trial.
treatment for migraines with an implantable device

Conditions: Migraine

Summary: the purpose of this study is to evaluate the safety and effectiveness of an implantable device for difficult to treat migraine. there are a significant number of patients who have drug refractory migraine and alternative therapies are needed.


Eligibility criteria:
key inclusion criteria: * be diagnosed with multiple migraines per month of moderate to severe intensity; * be refractory to medication; * be an appropriate candidate for the surgical procedures required for this study; * be willing and able to comply with all study related procedures; * be capable of reading and understanding patient information materials and giving written informed consent. key exclusion criteria: * have onset of migraine after age 50; * have a significant psychiatric disorder; * have previously been treated with occipital nerve stimulation; * have had an injection of botulinum toxin in the head or neck within 6 months prior to enrollment; * have previously undergone destructive ganglionectomy affecting c2/c3 occipital and/or trigeminal distribution or have an occipital blockade or radio frequency procedure currently in effect; * have a condition currently requiring or likely to require the use of mri or diathermy; * have an active implantable device; * have participated in any drug or device trial in the last 4 weeks or plan to participate in any other study.

Keywords: headache migraine refractory chronic pain
bone resistant tuberculosis

Conditions: Bone and Osteoarticular Infection Due to MDR M. Tuberculosis Strains

Summary: the recommendations for the treatment of mdr tuberculosis are based on pulmonary tuberculosis since there is a lack of specific recommendations for tb bone and osteoarticular disease, including those due to multi drug resistance strains (mdr ioatb). given the lack of data regarding mdr ioatb, it may be helpful to study the diagnosis, medical treatment, surgical indications and prognosis of a cohort of mdr ioatb patients.

due to the lack, in the guidelines regarding bone and osteoarticular infections due to mdr m. tuberculosis strains, this study aims to characterize the diagnosis, management and outcome of patients with osteoarticular infection due to mdr m. tuberculosis in france (mdr ioatb). aim: descriptive study of diagnosis, therapeutics and outcome of patients with bone and osteoarticular infection with mdr ioatb in france. set up: patients registered in the database of the national reference center (cnr) for mdr ioatb in france, treated for mdr ioatb between january 1, 2007 and december 31, 2018 will be included and analyzed. study design: retrospective study on historical cohort

Eligibility criteria:
inclusion criteria: * any patient with an mdr ioatb whose sample and / or strain has been referred to the national reference center (cnr) for mycobacteria in france, will be included. exclusion criteria: * patient refusing to have their data used. * patients under guardianship or curators, patients under legal protection will not be included.

Keywords: mycobacterium tuberculosis multi drug resistance bone osteoarticular
aersosolization during upper endoscopy

Conditions: Infectious; Gastro-Intestinal Disorder; Safety Issues

Summary: given the current covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic patient face-masks reduces the level of aerosolized particles. the protocol includes the use of a commercially available particle counter the investigators are employing for the measurement of aerosols before, during, and after anesthesia assisted upper endoscopic procedures. the investigators are recruiting patients undergoing these procedures with a target of 30 patients undergoing endoscopy without a facemask and 30 patients undergoing endoscopy with one.


Eligibility criteria:
inclusion criteria: * all patients undergoing elective upper endoscopic procedures (upper endoscopy, ercp, endoscopic ultrasound) with monitored anesthesia care at main campus cleveland clinic inpatient endoscopy unit. exclusion criteria: * any patient requiring endotracheal intubation * pregnant patients * emergency procedures * patients who require use of a facemask before or during the procedure due to medical necessity * patients under the age of 18 * non-english speaking individuals * patients unable to provide consent. * any procedure done outside the designated procedure room. * if in the opinion of the anesthesiologist, a subject who was randomized to the control arm requires placement of the procedural mask to augment oxygenation, the subject will be removed from the study
factor xa inhibitor ym150 for the prevention of blood clot formation in veins after scheduled hip replacement (onyx-2)

Conditions: Thromboembolism

Summary: the purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of ym150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.


Eligibility criteria:
inclusion criteria: * scheduled for elective primary hip replacement * age 18 years or over * written informed consent obtained exclusion criteria: * documented history or considered at increased risk of venous thromboembolism * subjects considered at increased risk of bleeding * surgery planned for contralateral hip at the same time or within 10 weeks after enrolment * concomitant use of anticoagulants/ antiplatelet agents

Keywords: hip replacement arthroplasty prevention thromboembolism treatment outcomes arthroplasty, replacement, hip
a safety and efficacy study evaluating ctx001 in participants with transfusion-dependent β-thalassemia

Conditions: Beta-Thalassemia; Thalassemia; Genetic Diseases, Inborn; Hematologic Diseases; Hemoglobinopathies

Summary: this is a single-arm, open-label, multi-site, single-dose phase 1/2/3 study in participans with transfusion-dependent β-thalassemia (tdt). the study will evaluate the safety and efficacy of autologous crispr-cas9 modified cd34+ human hematopoietic stem and progenitor cells (hhspcs) using ctx001.


Eligibility criteria:
key inclusion criteria: * diagnosis of transfusion-dependent β-thalassemia (tdt) as defined by 1. documented homozygous β-thalassemia or compound heterozygous β-thalassemia including β-thalassemia/hemoglobin e (hbe). participants can be enrolled based on historical data, but a confirmation of the genotype using the study central laboratory will be required before busulfan conditioning 2. history of at least 100 ml/kg/year or ≥10 units/year of packed rbc transfusions in the prior 2 years before signing the consent or the last rescreening for patients going through re-screening * eligible for autologous stem cell transplant as per investigator's judgment key exclusion criteria: * a willing and healthy 10/10 human leukocyte antigen (hla)-matched related donor is available per investigator's judgement * prior allo-hsct * participants with associated α-thalassemia and \>1 alpha deletion or alpha multiplications * participants with sickle cell beta thalassemia variant * clinically significant and active bacterial, viral, fungal, or parasitic infection as determined by the investigator * white blood cell (wbc) count \<3 × 10\^9/l or platelet count \<50 × 10\^9/l not related to hypersplenism other protocol defined inclusion/exclusion criteria may apply.

Keywords: crispr-cas9 beta-thalassemia hemoglobinopathies
a study to assess the pharmacokinetics and safety of co-administered oral galicaftor, navocaftor, and abbv-576 in healthy adults for the treatment of cystic fibrosis

Conditions: Healthy Volunteers

Summary: cystic fibrosis (cf) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. the main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor/navocaftor/abbv-576.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the tenths decimal. * a condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ecg). exclusion criteria: * history of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * history of any clinically significant sensitivity or allergy to any medication or food. * history of any clinically significant condition listed in the protocol.

Keywords: galicaftor navocaftor abbv-576 cystic fibrosis
prediction of the patient pathway in emergency room in an exceptional sanitary situation

Conditions: Covid19; Emergencies

Summary: the covid-19 outbreak leads to optimize the pathway in emergency departments. the length of time spent in the emergency department is linked to the morbi-mortality and the risk of covid-19 transmission. the amiens-picardy university hospital has developed an application (3p-u) that optimizes patient flow. it identifies the need of hospitalization and problems on the care path. patients are categorized in high risk or not high probabilty of hospitalization. the main goal of this project is to evaluate the impact on the patient flow of the 3p-u application. early lookup of bed for high probability hospitalization should be linked to a reduced time of length. this study will compare the time of length between this both groups.


Eligibility criteria:
inclusion criteria: * every patient that consults in the adult emergency department exclusion criteria: * patients directly transferred to intensive care units

Keywords: covid19 patient flow emergency overcrowding
prognosis of cerebral small vessel disease

Conditions: Cerebral Amyloid Angiopathy; Small Vessel Cerebrovascular Disease; Cadasil; CAA - Cerebral Amyloid Angiopathy

Summary: prognosis of small vessel disease (svd) depends on the underlying type of svd and index manifestation. the aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with svd according to the type of index presentation.


Eligibility criteria:
inclusion criteria: * hypertensive deep perforator arteriolopathy (dpa), clinically symptomatic with either ich, ischaemic stroke, cognitive impairment or severe radiological manifestation (fazekas ≥ii) * cerebral amyloid angiopathy (caa according to modified boston or edinburgh criteria), clinically symptomatic with either ich (including csah), amyloid spells, cognitive impairment or severe radiological manifestation (cmb≥2) * other svd (i.e. cadasil or other sporadic or genetic svd) exclusion criteria: * life expectancy of \<6 months due to not-svd related causes (i.e. cancer) * patient is unlikely to attend follow-up visits

Keywords: small vessel disease caa cerebral amyloid angiopathy hypertensive arteriopathy deep perforator arteriopathy cadasil
blood pressure treatment in icu patients with subarachniodal haemorrhage.

Conditions: Blood Pressure; Subarachnoid Hemorrhage; Aneurysm Cerebral

Summary: an mri study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.

subarachnoidal hemorrhage (sah) is a type of stroke with high mortality rates and often requires care at the intensive care unit. cerebral blood flow (cbf) needs to be ensured so that the brain receives optimal nourishment, and this is largely controlled by regulating blood pressure (bp) using medications that affect the heart and blood vessels. approximately 3-7 days after sah onset, vasospasm (sah-v) can occur. treatment usually includes maintaining blood pressure (bp) above a certain threshold to achieve adequate cerebral blood flow (cbf). an important component of raising bp is increasing vascular resistance using vasoconstrictive medications, which paradoxically can decrease cbf. the study objective is to investigate the correlation between bp changes and their impact on cbf in patients with suspect or verified sah-v using mri. to achieve this purpose, the investigators plan to examine the relationship between bp and cbf in patients with sah-v who require neuro-intensive care. to measure cbf, two techniquis will be used: phase-contrast mri and arterial spin labeling. flow measurement with mri: 1. baseline images will be acquired at baseline blood pressure. 2. mean arterial pressure (map) will be increased using norepinephrine. new images will be acquired when map is increased by approximately 20-30% from the baseline. all bp levels will be maintained within clinically acceptable ranges. all data will be recorded in the patient's medical record, and mri images will be processed at a later stage.

Eligibility criteria:
inclusion criteria: * coiled or clipped aneurysm * suspected or confirmed vasospasm exclusion criteria: * bmi \>30 * pregnancy * pacemaker or other mri contraindications * severe congestive heart failure (nyha iii-iv) or cardiac arrhythmia. * severe respiratory failure or fio2 \>0.6 * severe kidney failure

Keywords: magnetic resonance imaging norepinephrine blood flow
treatment with recombinant human growth hormone genotonorm (registered) in children with short stature secondary

Conditions: Growth Hormone Deficiency; Growth Retardation

Summary: to assess the effect of long-term treatment by genotonorm on linear growth


Eligibility criteria:
inclusion criteria: * all the patients who have benefit during one year of a treatment by genotonorm during the study 94-8123-014 * all patients who have stopped during one year will be included if a signed written informed consent exclusion criteria: * endocrine disease, except well substituted hypothyroidism * other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)
validation of 99mtc- edda - hynic -toc kits for diagnosis of neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: evaluation of the properties of the image capture test using 99m tc - hynic -toc edda (octreotide labeled with 99mtc) for the diagnosis of neuroendocrine tumors compared to the 111in - dtpa-octreotide.


Eligibility criteria:
inclusion criteria: * patients with histological diagnosis of neuroendocrine tumors * patients with indication for the staging exam with 11in * patients diagnosed in any tumor stage * patients with \> 18 years * male and female patients * patients not receiving somatostatin analogues for at least 1 month before image capturing exclusion criteria: * pregnant women * patients with previous tumor resection of the primary tumor without metastatic disease
an exploratory study to evaluate the tolerability and safety of mwav201 in subjects with wilson disease

Conditions: Wilson Disease

Summary: the primary objective of this study is to evaluate the tolerability and safety of mwav201 in patients with wilson disease.

this is an open-label, dose escalation study to evaluate the tolerability, safety, and preliminary efficacy of mwav201 in patients with wilson disease. participants will receive a single, peripheral intravenous (iv) infusion of mwav201. the dose escalation plan and the number of dose levels may be adjusted during study period.

Eligibility criteria:
inclusion criteria: * male or female aged 18 and 65 years inclusive; * confirmed diagnosis of wilson disease; * low copper diet and standardized medication for ≥ 1 year; * stable wilson disease for ≥ 1 year; * able to understand and willing to follow study procedures. exclusion criteria: * significant hepatic inflammation as evidenced by liver function test. * liver biopsy or liver stiffness measurement show progressive liver fibrosis. * laboratory tests or clinical symptoms indicate decreased liver reserve function. * other chronic liver disease (such as hepatitis b). * any signs of decompensated liver function (such as ascites). * history of liver transplant or plan to receive liver transplant. * other diseases with clinical significance, such as cardiovascular and cerebrovascular diseases, kidney diseases, respiratory system diseases, neurological diseases, mental illnesses, active infections, etc. * body mass index ≥ 30 kg/m2. * other conditions that, in the investigator's opinion, may not be suitable for the subject to be enrolled.