Kornimate/medical-research-clean huggingface dataset:
a study of star-0215 in healthy adult participants

Conditions: Hereditary Angioedema

Summary: this is a first-in-human, single-center, randomized, double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single subcutaneous (sc) or intravenous (iv) administration of star-0215 in healthy adult participants.


Eligibility criteria:
inclusion criteria: * good health as determined by the investigator based upon a medical evaluation, including medical history, physical examination, vital signs, 12-lead electrocardiogram (ecg), and clinical laboratory measurements. assessments may be repeated per investigator discretion. * body mass index of 18 to 35 kilograms (kg)/square meter with a weight of at least 60 kg for men and at least 50 kg for women, with a maximum weight of 130 kg for any participant. * female participants capable of becoming pregnant must have a negative serum pregnancy test at screening, not be nursing, and must agree to use an effective method of contraception and abstain from egg donation or fertility treatment. * male participants must agree to use an effective method of contraception and abstain from sperm donation. exclusion criteria: * prior or ongoing medical condition (for example, gastrointestinal, renal, hepatic, dermatological, neurological or psychiatric, cardiovascular, respiratory, or hematological), medical history, physical examination, vital signs, ecg, or clinical laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant. assessments may be repeated once prior to dosing as needed per investigator discretion. * known sensitivity to the ingredients in star-0215. * regular use of prescription or non-prescription drugs unless investigator believes the medication(s) will not interfere with the study or compromise participant safety. * participation in a recent clinical study involving receipt of an investigational product within 30 days prior to the first dose of study drug or exposure to more than 4 investigational products within 12 months prior to the first dose of study drug.

Keywords: hae angioedema
the effects of levosimendan on haemodynamics in patients undergoing elective aortic valve replacement (avr)together with coronary artery bypass grafting (cabg) surgery

Conditions: Heart Valve Disease

Summary: patients undergoing aortic valve replacement (avr) surgery with coronary artery bypass grafting (cabg) are at risk of left ventricular dysfunction. the aim of the study is to describe the haemodynamic effects of levosimendan in comparison to placebo in patients undergoing elective aortic valve replacement (avr) together with coronary artery bypass grafting (cabg) surgery. the study is randomized, double-blinded, placebo-controlled and will be carried out in heart center. twenty four patients will be randomized into two groups of 12. the treatment group will receive 24 hour infusion of levosimendan preoperatively where as the placebo group will receive an identical infusion of thiamine coloured glucose. the splanchnic perfusion will be measured by the means of vena hepatica cannulation. circmon b202 (jr medical ltd, tallinn, estonia) is used for the measurement of whole-body impedance cardiography derived heart rate, cardiac index, left cardiac work index, systemic vascular resistance index (svri), and extracellular water (ecw). surgical procedure, anaesthesia and cardio protection will be carried out as in standard care. echo cardiography will be done pre- and postoperatively. haemodynamics will be recorded hourly and mixed venous saturation every fourth hour for 24 hours.


Eligibility criteria:
inclusion criteria: * lvef less than 50% of left ventricular hypertrophy indicated by wall thickness more than 12mm exclusion criteria: * allergy to levosimendan

Keywords: levosimendan cabg avr
staining and calculus formation after 0.12% chlorhexidine rinses

Conditions: Dental Calculus; Tooth Discoloration

Summary: the presence of plaque on tooth surfaces as a predictor of chlorhexidine side effects has not been evaluated especially because most studies utilized a previous disruption of biofilms in all dental surfaces before the beginning of rinsing. the purpose of this study is to compare staining and calculus formation after 0.12 percent chlorhexidine between previously plaque-free and plaque-covered surfaces by means of an experimental gingivitis model.

test panel the test panel will be recruited from the dental students of the lutheran university of brazil, canoas, rio grande do sul, brazil. at recruitment, subjects will be asked about their medical and dental history. written and oral explanations detailing the study purpose and design will be given for each subject. subjects that preliminarily met inclusion/exclusion criteria will be selected for a dental screening appointment. if the subject met all the inclusion/exclusion criteria, an informed consent was handed out and, upon acceptance, signed by the volunteers. the following clinical parameters were assessed in the order listed below from all teeth, excepting the third higher/lower molar. presence of calculus (c) in all teeth, at 6 sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual and disto-lingual) was scored as a dichotomous index: 0 - absence of calculus; 1 - presence of calculus. discoloration index proposed by lobene 36 and modified by macpherson et al. 2000. this involves visual stain assessment of the buccal/labial and lingual/palatal aspects of the index teeth.

Eligibility criteria:
inclusion criteria: * age between 18-35 years * male * no relevant medical conditions that could interfere on the periodontal health * probing pocket depth \< 3 mm and clinical attachment loss \< 2mm at all sites * willingness to comply exclusion criteria: * antibiotic and/or anti-inflammatory therapy within 3 months prior to baseline examination * oral mucosal lesions * smokers * need for antibiotic premedication * history of hypersensitivity to chlorhexidine * any device that could act as plaque retentive factor (e.g., carious lesions, inadequate restorations, dental implants, orthodontic appliances, fixed or removable prostheses) exclusion criteria during the study: * individuals that wanted to give up the study * any acute process like allergic reaction to the product or gingival abcess * necessity to use of any antibiotic or anti-inflammatory * use of any other rinsing product farther the chlorhexidine's rinses * individuals who did any mechanical biofilm control

Keywords: chlorhexidine adverse effects staining dental calculus dental plaque
genotype-phenotype association in hereditary hemorrhagic telangiectasia

Conditions: Hereditary Hemorrhagic Telangiectasia; HHT; Rendu Osler Weber Disease

Summary: the present project aims to study the inflammatory and endothelial responses involved in the differences in clinical events related to both genotypes (eng vs. acvrl1) in hht. accordingly, a cross-sectional study is proposed to evaluate the differences in circulating inflammatory and endothelial biomarkers, including interleukines, adhesion molecules, chemokines and immune regulatory molecules between both hht groups.

background and rationale: hereditary hemorrhagic telangiectasia (hht) is a rare disease characterized by a multisystemic vascular dysplasia with autosomal dominant inheritance, mainly caused by mutations in eng and acvrl1 genes. even though those mutations have been related to different clinical manifestations, the molecular mechanisms involved in each genetic variant have not been clarified. methods: a cohort study will be carried out to compare the incidence of clinical events after a 12-months follow-up. the ability of these biomarkers to predict the clinical events will be assessed in a multivariate analysis.

Eligibility criteria:
inclusion criteria: * age between 18 and 75 years. * confirmed diagnosis of hht, according to the curaçao criteria or genetic diagnosis. * clinically stable condition at the time of inclusion, defined as score \< 7 points on the epistaxis severity score (ess). * having signed the informed consent, after having received all the information concerning the study. exclusion criteria: * major coronary or cerebrovascular event in the 3 months prior to inclusion. * serious intercurrent illnesses, such as acute infections, outbreaks of autoimmune or inflammatory pathology, active cancer, or other pathologies that, at the investigator's discretion, could interfere with the conduct of the study. * major surgery during the 2 months prior to inclusion. * pharmacological treatment maintained during the 3 months prior to inclusion with nsaids, corticosteroids or chemotherapy. * toxic habits, including severe smoking, alcohol or drug abuse, which in the opinion of the investigator could interfere with the conduct of the study. * pregnancy or puerperium. * any other condition that limits compliance with the visits or procedures established in the protocol.

Keywords: hereditary hemorrhagic telangiectasia hht rendu osler weber disease genotype-phenotype association eng alk-1
pre-operative gefitinib in resectable egfr mutation positive lung cancer with sector sequencing for biomarker discovery

Conditions: Non-small Cell Lung Cancer

Summary: this is a pharmacodynamic study to evaluate the effect of gefitinib as induction therapy for patients who have resectable, epidermal growth factor receptor (egfr) sensitizing mutation lung cancer.

selected patients will receive 4 weeks of gefitinib before surgery. a positron emission tomography - computed tomography (pet- ct) will be performed before and after gefitinib to assess the response. circulating tumour cells (ctcs) and plasma deoxyribonucleic acid (dna) will be acquired at baseline, 2 weeks and 4 weeks after gefitinib treatment. resected tumor will be sectored in details to study the spatial heterogeneity.

Eligibility criteria:
inclusion criteria: * egfr mutation positive non-small cell lung cancer (nsclc) (regardless of smoking status), or control group may encompass other molecular subtypes of lung cancer e.g. anaplastic lymphoma kinase (alk) and kirsten rat sarcoma viral oncogene homolog (kras). * all early stage patients with nsclc who are deemed surgically resectable. * all patients must have histologically proven nsclc, with known egfr mutation * patients should be fit for either lobectomy/ pneumonectomy with or without lymph node sampling. * primary tumour should be at least 2 cm in size (tumor stage 1b). * willing to provide informed consent. exclusion criteria: * known severe hypersensitivity to gefitinib or any of the excipients of this product * any serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. * interstitial lung disease (ild) or pulmonary fibrosis; impaired pulmonary function (e.g. fev1 \<40% predicted value, artery blood gas pao2\<60mmhg) * patients with prior exposure to agents directed at the human epidermal receptor (her) axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab). * patients with prior exposure to chemotherapy, irradiation or systemic anti-cancer therapy (e.g. monoclonal antibody therapy) for lung cancer. * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within six months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the subject at high risk for treatment-related complications. * patient who has serious active infection. * patients who harbouring exon 20 t(threonine)790m (methionine) mutation. * pregnancy or breast feeding.
breathalyzer validation study

Conditions: Alcohol Drinking; Alcohol Intoxication

Summary: the proposed project will test three commercial cellphone breathalyzers against a police grade breathalyzer device.the study will test the accuracy of these smartphone breathalyzers at assessing breath alcohol content (brac) against a standard police grade breathalyzer. this study aims to fill the knowledge gap by determining the validity of smartphone paired breathalyzer devices to accurately assess brac. data collection includes collection of brac measurements, as well as survey data.


Eligibility criteria:
inclusion criteria: * age 21-39 old * less than 4 drinking days and less than 12 drinks per week on average in the past 2 months * have previously consumed four (women) or five (men) or more standard drinks without problems * a valid photo id * willing to take public transportation home, via septa or an uber rideshare credit. exclusion criteria: * desire alcohol treatment now or received it in the past 6 months * alcohol dependence with withdrawal per dsm-v criteria * non-english-speaking * individuals who have a medical condition or who are taking medication which limits or prevents the consumption of alcohol.
thoracolumbar fascia thickness in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: the aim of this study is to examine thoracolumbar fascia thickness, trunk flexibility, trunk control and upper extremity skills in parkinson's disease patients. patients between the ages of 55-80 who have been diagnosed with parkinson's disease by a neurologist and healthy individuals with similar demographic characteristics will be included in the study as a control group. demographic information of the individuals will be recorded and clinical evaluations will be made. staging of parkinson's patients will be done with the modified hoehn and yahr scale (mhrs), and disease severity will be done with the unified parkinson's disease rating scale (updrs). thoracolumbar fascia thickness of individuals in both groups will be evaluated with ultrasonography, trunk flexibility with the active trunk range of motion assessment and sit-reach test, trunk functions with the trunk impairment scale, and manual skills with the purdue pegboard test.


Eligibility criteria:
inclusion criteria: * age between 50 and 80 * mini mental state examination (mmse) score between 24 and 30 * diagnosed with parkinson's by a neurologist * mh\&y stage 2-3 exclusion criteria: * inability to communicate verbally * use of walking aids * elderly people with severe visual impairment, neurological disorders and/or congestive heart failure * older adults in whom exercise is not recommended.
transforaminal and parasagittal approach in lumbar epidural steroid injection

Conditions: Lumbar Radiculopathy

Summary: lumbar epidural injection is used in the treatment of lumbar radicular pain. there are three different application methods: lateral parasagittal, midline interlaminar and transforaminal epidural injection. investigator aimed to compare lateral parasagittal and transforaminal epidural injection methods. the purpose of the study is to determine which method is more efficient.

it was planned to recruit 60 participants in the study. interlaminar epidural steroid injection will be applied to 30 patients with midline and 30 patients with lateral parasagittal approach. all patients will receive oswestry disability index before and 2-4-12 weeks after the procedure. all patients will receive somatization amplification scale (ssas) before the treatment. the results of the patients will be compared. it will be investigated which method is more effective.

Eligibility criteria:
inclusion criteria: * unilateral low back pain, radiculopathy exclusion criteria: * malignancy * past back surgery

Keywords: epidural steroid injection transforaminal steroid injection radicular pain
effect of functional strength training of hip abductors in runners with medial tibial stress syndrome

Conditions: Medial Tibial Stress Syndrome

Summary: this study will be the first project to investigate the effect of functional strength training of hip abductors on pain, function, hip, and knee kinematics including contra-lateral pelvic drop angle (hip frontal plane projection angle) and dynamic knee valgus (knee frontal plane projection angle) in runners with medial tibial stress syndrome patients.

forty participants with medial tibial stress syndrome will be recruited from orthopedic out clinic of the faculty of physical therapy, cairo, university, and gezira youth center. they will be asked to sign the informed consent form . the selected participants will be randomly assigned to two groups using a simple randomization method to allocate participants to the groups through the available online website www.randomization.com considering the control group as active control group. a flow diagram according to the consolidated standards of reporting trials (consort) statement will be presented to illustrate the progression of this clinical trial . sample size calculation was performed using g\*power statistical software (version 3.1.9.2; franz faul, universitat kiel, germany) based on data of knee valgus angle derived from pourahmad et al., (2021) who investigated the effect of strengthening the abductor and external rotator on lower limb kinematics in volleyball players with patellofemoral complications. the sample size required for this study was approximately 15 subjects in each group. calculation is made with α=0.05, power = 80% and effect size = 1.1. the sample size increased to 18 subjects per group for possible dropout of 20%. for statistical analysis: * unpaired t-test will be conducted for comparison of the subject characteristics between groups. * chi- squared test will be conducted for comparison of sex distribution between groups. * mixed manova will be conducted to investigate the effect of treatment on pain, function, contralateral pelvic drop angle and dynamic knee valgus. * post-hoc tests using the bonferroni test were carried out for subsequent multiple comparison. * statistical measures will be performed through the statistical package for social studies (spss) version 25 for windows. * the level of significance for all statistical tests will be set at p \< 0.05.

Eligibility criteria:
inclusion criteria: * male and female athletes (runners) with a referred diagnosis of mtss for at least 1 month * participants with bilateral affection, the most affected limb will be included in measurements. * body mass index range between (18.5-25 kg /m2 ) exclusion criteria: * history of previous lower extremity surgery * neurological problems that will affect lower extremity function * recent or old fractures at lower limbs * cognitive impairment * medications (anti-inflammatory/muscle relaxant) * tumours

Keywords: recreational runners frontal plane projection angle pelvic drop height kinovea software
the impact of initiating/switching to insulin detemir on emotional well-being and treatment satisfaction

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in europe. the aim of this study is to assess the well-being of patients following treatment with insulin detemir (levemir®) in subjects with type 1 or type 2 diabetes in whom either initiation of or a switch to insulin treatment with a long-acting basal insulin analogue is needed.


Eligibility criteria:
inclusion criteria: * any subject with type 1 or type 2 diabetes not optimally controlled (hba1c above 7.5%) in whom at the discretion of the participating physicians it was decide to either initiate or switch to a treatment with a long-acting insulin analogue * subjects with type 1 diabetes should have been treated with insulin for at least 12 months * potential pre-study treatment with insulin detemir (levemir®) should have started no more than two months before baseline
safety and efficacy study of three different dosages of newgam in patients with cidp

Conditions: Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Summary: newgam (current working title for a new igiv formulation) is a newly developed human normal immunoglobulin solution ready for intravenous administration (igiv). this study will evaluate the safety and efficacy of three different dosages of newgam 10% in patients with chronic inflammatory demyelinating polyradiculoneuropathy.

this is a phase 2/3 study that will take place in 2 stages. the primary objective of stage 1 (phase 2 dose-finding part)is to determine and select one dosage from three newgam maintenance dosage arms in comparison with a placebo arm, based on the percentage of responders (response defined as a decrease, meaning improvement, in the adjusted incat disability score by at least 1 point). the selected newgam dosage and placebo will be employed and compared in stage 2. the primary objective of stage 2 (phase 3 confirmatory part) is to demonstrate superiority of the maintenance dosage regimen selected at study stage 1 over placebo in patients with cidp as assessed by the percentage of responders. the secondary objective is to evaluate the safety (measured by number of adverse events)and efficacy of newgam administration in patients with cidp compared to baseline.

Eligibility criteria:
inclusion criteria: * patients diagnosed as having cidp based on fulfilment of clinical criteria of the incat group and the definite electrophysiological criteria for cidp ; patients with madsam or pure motor cidp will be included provided they fulfil these criteria * worsening of disability and objective increase in weakness or sensory deficit during the 6 months prior to screening * \>=18 years of age exclusion criteria: * unifocal forms of cidp * pure sensory cidp * mmn with conduction block * treatment of cidp with immunoglobulins (intravenous or subcutaneous) at any time prior to study entry * steroids of any type equivalent to prednisolone or prednisone \> 10 mg/day or equivalent plasma exchange (pe) during the last 3 months prior to baseline visit * treatment with cyclosporin, methotrexate, mitoxantrone, mycophenolate mofetil, interferon or other immunosuppressive or immunomodulatory drugs during the three months prior to baseline visit * clinical evidence of peripheral neuropathy from another * known diabetes mellitus * other serious medical condition complicating assessment or treatment * thromboembolic events: patients with a history of deep vein thrombosis (dvt) within the last year prior to baseline visit or pulmonary embolism ever * known iga deficiency with antibodies to iga * history of hypersensitivity, anaphylaxis or severe systemic response to immunoglobulin, blood or plasma derived products, or any component of newgam * known blood hyperviscosity

Keywords: cidp ivig