Kornimate/medical-research-clean huggingface dataset:
study of oral glecaprevir/pibrentasvir tablets in participants aged 12 years or older with chronic hepatitis c to assess sustained virological response

Conditions: Hepatitis C Virus (HCV)

Summary: hepatitis c virus (hcv) infection is among the most common of all chronic liver diseases. hcv predominantly affects liver cells and causes the liver to become inflamed and damaged. this can lead to cirrhosis (scarring of the liver), liver cancer or the need for liver transplant. this study will evaluate how effective glecaprevir/pibrentasvir (gle/pib) is in participants with chronic hcv infection. effectiveness will be assessed as the achievement of sustained virologic response. gle/pib is an approved drug for the treatment of hcv. participants 12 years or older with chronic hcv infection will be enrolled. this is a prospective (conducted in future) study in therapy of direct-acting antiviral (daa) treatment-experienced participants with chronic hepatitis c genotype 1. around 67 participants will be enrolled at multiple sites in russian federation. participants will receive oral gle/pib tablets as prescribed by the physician in accordance with local clinical practice, international guidelines and/or label. prescription is independent from this study and is decided before providing opportunity to the participate in the study. there is expected to be no additional burden for participants in this trial. all study visits will occur during routine clinical practice and participants will be followed for 12 weeks.


Eligibility criteria:
inclusion criteria: * direct-acting antiviral treatment-experienced participants with confirmed chronic hepatitis c (chc) genotype 1, receiving combination therapy with the all oral glecaprevir/pibrentasvir (gle/pib) regimens according to standard of care, international guidelines and in line with the current local label. * participants can enroll up to 4 weeks after starting treatment exclusion criteria: - participating or intending to participate in a concurrent interventional therapeutic trial.

Keywords: hepatitis c virus (hcv) chronic hepatitis c infection glecaprevir/pibrentasvir gle/pib choice chronic hepatitis c genotype 1
the effect of early wbvt on neuromuscular control after aclr

Conditions: Rupture of Anterior Cruciate Ligament

Summary: to investigate the effect of early wbvt on neuromuscular control after aclr.

the knee joint position sense, postural control, muscular strength and functional ability after anterior cruciate ligament construction (aclr) are distorted, and even after a period of rehabilitation. previous studies had demonstrated that there was improvement in knee joint, postural balance, muscle strength and functional outcome in elderly, stroke and spastic patients already. it has also been concluded that the balance in elderly, postmenopausal women, parkinson's disease, multiple sclerosis, stroke and spastic patients were all significantly improved. some studies showed that the proprioception in osteoarthritis patients significantly improve. knee strength is also one of the aspect being improved. however, no studies focus on the early effect of wbvt on knee joint proprioception, postural control, muscle strength, knee joint stability and functional ability in aclr cases. this study is to answer this research gap.

Eligibility criteria:
inclusion criteria: * aclr with a single-bundle approach * no complication such as wound infection after the aclr * able to walk with a pair of elbow crutches independently at one month post operation exclusion criteria: * concomitant posterior cruciate ligament, lateral collateral ligament, and medial collateral ligament injury in the same knee * previous operation on either lower limbs * medical problems such as pregnancy, acute thrombosis, serious cardiovascular disease, pacemaker, acute hernia, discopathy, spondylolysis, severe diabetes, epilepsy, recent infections, severe migraine, tumors or kidney stones etc * neurological conditions such as guillain-barre ́ syndrome, myasthenia gravis, and postpolio syndrome * prior experience of wbvt

Keywords: aclr
development of sensory based narrative intervention

Conditions: Autism Spectrum Disorder

Summary: the goal of this study is to develop a sensory based narrative intervention and see its effect on vocabulary development in children with autism spectrum disorder. sensory based narrative intervention will be developed, and participants of experimental group will be given this treatment for 6 weeks. control group participants will be given only narrative intervention. vocabulary improvement will be documented pre-post testing in both groups.

the present study aims to bridge an existing gap in the literature in pakistan, as there are no evidence based therapeutic intervention tools available for narratives in urdu. the study further aims to provide a interventional resource pack for bilingual population who has urdu as their first and dominant language. there is no therapeutic tool available for intervention that has incorporated multimodal sensory input for language intervention. since tools developed internationally and from other countries cannot be incorporated due to cultural sensitivity and linguistic complexity, therefore, the current study will be able to incorporate these limitations. this study will provide a novel resource for intervention in the context of pakistan.

Eligibility criteria:
inclusion criteria: * participants with mild to moderate asd aged between 6-11 years as assessed by ados (already diagnosed). * cars score 30-37 (mild to moderate) * both male and female participants. * asd participants at 2 information carrying word-level receptively and at blank level 1 expressively. (will incorporate nouns, verbs and adjectives as per individual linguistic level). * participants with urdu as their first language (home language) and english as a second language. exclusion criteria: * individuals with any co-morbidity with autism spectrum disorder, such as hearing impairment, cleft lip and palate, visual impairment etc. * individuals with a mild to moderate diagnosis but severe behavioral difficulties * participants with any known sensory difficulties restricting use of certain sensory props.

Keywords: autism spectrum disorder language disorders in children narrative therapy
multiple drug hypersensitivity syndrome

Conditions: Drug Allergy

Summary: background: multiple drug hypersensitivity syndrome (mdh) is defined as confirmed drug hypersensitivity reactions (dhrs) to at least 2 chemically and pharmacologically unrelated drugs. reports of mdh are scarce and poorly specified and studies which diagnose mdh on the basis of positive allergy tests are lacking. objective: to evaluate retrospectively the frequency and characteristics of mdh patients in a large database. methods: all the patients who consulted and were tested in our allergy unit between september 1996 and february 2018, with confirmed mdh will be included. clinical history and allergy work-up results will be extracted from our drug allergy and hypersensitivity database (dahd). the frequency of mdh will be calculated, mdh patients will be described, the most frequent associations of dhrs will be identified and analysed.


Eligibility criteria:
inclusion criteria: * patients who consulted at our allergy clinic (university hospital of montpellier, france) * between september 1996 and february 2018 with a clinical history suggestive of dhr * who completed a tailored drug allergy work-up, (including a drug allergy questionnaire, skin tests (sts) and drug provocation tests (dpts)) and were diagnosed with mdh. exclusion criteria: * the dhr was due to a single component contained in 2 different drug formulations * in composed drugs; * there was possible cross-reactivity between the responsible drugs; (iv) the patient had positive but non standardized nor validated (i.e. possibly irritant) * these sts were followed by a negative dpt; * dpts with placebo were positive; (vii) doubtful tests were repeated and eventually considered negative; * a single dhr was associated with one or more non-drug related contact allergies; * dpts elicited subjective manifestations (i.e., isolated pruritus, headache, isolated abdominal pain); * non-specific histamine release was suspected (e.g., chronic spontaneous - desensitization, rather than a diagnostic work-up was preferred in order to meet the urgent therapeutic needs of individual patients (hiv infected patients, cardiac patients).

Keywords: multiple drug hypersensitivity drug hypersensitivity antibiotics drug provocation tests skin tests
investigation of the acute calming effects of drinks containing herbal extracts in healthy adults

Conditions: Cognitive Function and Mood

Summary: the primary objectives of this study are to assess the effects of three investigational drinks containing three botanicals in differing combinations versus a placebo control, on mood, psychological state, physical response, and cognitive performance during and after exposure to an observed multi-tasking stressor.


Eligibility criteria:
inclusion criteria: * aged 18 to 49 years * self-report of good health * are not excluded on the basis of the following exclusion criteria exclusion criteria: * are a smoker * have food allergies or sensitivities to any of the ingredients contained in the investigational product or any other foodstuff * currently take medication except the contraceptive pill * have habitually used dietary supplements within the last month (defined as more than 3 consecutive days or 4 days in total) * have sleep disturbances and/or are taking sleep aid medication are employed in a job that includes night shift work * have a body mass index (bmi) outside of the range 18-35 kg/m2or weigh less than 50kg or more than 85kg. * have high blood pressure (systolic over 139 mm hg or diastolic over 89 mm hg) * have a history of neurological, vascular or psychiatric illness including epilepsy or seizures (excluding depressive illness and anxiety) * have a history of anxiety or a current diagnosis of anxiety or depression * are pregnant, trying to get pregnant or breast feeding * have a recent history of (within 12 months of screening visit) or strong potential for alcohol or substance abuse. alcohol abuse is defined as more than 60g (men) / 40g (women) pure alcohol per day (7 / 5.5 units) * have learning difficulties or dyslexia * have visual impairment that cannot be corrected with glasses or contact lenses * have frequent migraines that require medication (more than or equal to 1 per month) * have disorders of the blood (e.g. anaemia, hemophilia, thrombocytosis) * have a heart disorder or a history of vascular illness * have a respiratory disorder that requires regular medication (note: participants with asthma who only take their medication occasionally/as required are eligible for this study) * have a diagnosis of type i or type ii diabetes * have a history of renal or hepatic disease, or other severe diseases of the gastrointestinal tract (e.g. iron accumulation, iron utilization disorders, hypercalcaemia, hypercalciuria), that are likely to interfere with metabolism/absorption/secretion of the product under investigation * have any health condition that would prevent fulfillment of the study requirements * are currently or have in the past 8weeks participated in other clinical or nutrition intervention studies * have participated in the bpnrc's recent stress study * do not have a bank account (required for payment)
external validation of delirium prediction models for intensive care patients

Conditions: Delirium

Summary: delirium is frequently observed among critically ill patients and is associated with detrimental outcomes. currently, no evidence-based prevention or treatment exists for delirium, and especially, the inability to identify effective preventive measures of delirium has increased the focus on identifying patients with a high risk of delirium through prediction models. two prediction models have been developed to estimate the risk of delirium in icu patients: the prediction model for delirium (pre-deliric) and the early prediction model for delirium (e-pre-deliric). these robust and well-calibrated prediction models have the potential of assisting in identifying patients with the highest risk for delirium and thereby to focusing preventive strategies on the most vulnerable group. however further validation is needed in a danish population.

adult icu patients admitted to the participating icus in the region zealand are included according to eligibility. eligible patients will be assessed with e-predeliric at admission to the icu and predeliric 24h after admission to the icu. patients will be screened twice daily with cam-icu until icu discharge, death, transferal to non-participating icu or for a maximum observation period of 14 days. central screening via epic pdm and registration in central database (redcap, zuh) by the principal investigator. the following are registered: age, sex, history of cognitive impairment, history of alcohol abuse, admission category, urgent admission, mean arterial blood pressure at the time of icu admission, use of corticosteroids, respiratory failure, blood urea nitrogen/carbamide, apache-ii score, administered morphine does, use of sedatives, metabolic acidosis, coma, presence of infection, delirium status by cam-icu, time of ventilation, length of icu and hospital stay, mortality.

Eligibility criteria:
inclusion criteria: * acute admission to an icu and * age \> 18 of years exclusion criteria: * total admittance to the icu less than 24 hours * delirium assessment nonapplicable (hearing or visual disabilities, language barriers, or mentally incompetent

Keywords: critical illness icu delirium prediction observational
ef5 in treating patients with solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: diagnostic procedures using the drug ef5 to detect the presence of oxygen in tumor cells may help to plan effective treatment for solid tumors. this phase i trial is studying how well ef5 works in detecting the presence of oxygen in tumor cells in patients with solid tumors that can be biopsied or removed by surgery

primary objectives: i. determine the optimal dose of etanidazole derivative ef5 that is safely tolerated and provides optimal signal-to-noise ratio in patients with solid tumors. ii. determine the toxic effects of ef5 in this patient population. iii. determine the pharmacokinetics of ef5 in this patient population. iv. determine the dose of ef5 that provides a mean signal-to-noise ratio (maximum binding in anoxia to minimum binding) of 75. v. determine the relationship between tumor oxygenation by ef5 binding and needle electrode measurements. vi. compare the levels of ef5 binding in regions of low and high blood flow. outline: this is a dose-escalation study. patients receive etanidazole derivative ef5 iv over 1-2 hours beginning approximately 24 hours prior to surgery. tumors are then resected or biopsied after eppendorf needle electrode measurements. cohorts of 6 patients receive escalating doses of ef5 until the maximum tolerated dose (mtd) or optimal dose is determined. the mtd is defined as the dose preceding that at which 2 or more patients experience dose-limiting toxicity. the optimal dose is defined as the dose level at or below the mtd and results in a signal-to-noise ratio of 75 or greater. thirty additional patients are treated at the optimal dose. patients are followed at 30-45 days post ef5 infusion. projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed tumor or highly suspicious cancerous mass based on imaging and clinical signs but not indicative of a direct biopsy/cellular diagnosis preceding surgery * must have a clinical condition or physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection * performance status - ecog 0-2 * life expectancy not specified * wbc greater than 2,000/mm\^3 * platelet count greater than 100,000/mm\^3 * bilirubin less than 2.0 mg/dl * creatinine less than 2.0 mg/dl * creatinine clearance greater than 50 ml/min * no significant cardiac disease that would preclude the safe use of general anesthesia * no significant pulmonary disease that would preclude the safe use of general anesthesia * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 1 month after study * no history of grade iii or iv peripheral neuropathy * see disease characteristics
a study of imr-687 in subjects with beta thalassemia

Conditions: β Thalassemia

Summary: a study to evaluate the safety and tolerability of imr-687 in subjects with beta thalassemia

a phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pk, and pd of imr-687 (phosphodiesterase (pde) 9 inhibitor) administered once daily (qd) orally for 36 weeks in 2 populations of adult subjects with β-thalassemia: population 1 (transfusion dependent thalassemia (tdt) subjects) and population 2 (non-transfusion dependent thalassemia (ntdt) subjects).

Eligibility criteria:
inclusion criteria: 1. documented diagnosis of β-thalassemia or hbe/ β-thalassemia in their medical history. concomitant alpha gene deletion, duplication, or triplication is allowed. 2. documentation of the dates of transfusion events and the number of all prbc units per event within the 12 weeks prior to the baseline (day 1) visit. . 3. must be willing and able to complete all study assessments and procedures, and to communicate effectively with the investigator and site staff. 4. tdt subjects: subjects must be regularly transfused, defined as \>3 to 10 prbc units in the12 weeks prior to baseline (day 1) visit and no transfusion-free period for \>35 days during that period. 5. ntdt subjects: subjects must be transfusion independent, defined as 0 to ≤3 units of prbcs received during the 12-week period prior to the baseline (day 1) visit, must not be on a regular transfusion program, must be rbc transfusion-free for at least ≥ 4 weeks prior to randomization, and must not be scheduled to start a regular 6. hematopoietic stem cell transplantation within 9 months. 7. ntdt subjects: subjects must have hb ≤10.0 g/dl at screening; the screening hb sample must be collected 7 to 28 days prior to randomization. hb values within 21 days post-transfusion will be excluded. 8. ecog performance score of 0 to 1 9. female subjects must not be pregnant, or breastfeeding and be highly unlikely to become pregnant. male subjects must be unlikely to impregnate a partner. exclusion criteria: 1. diagnosis of α-thalassemia (e.g., hemoglobin h \[hbh\]) or hemoglobin s (hbs)/ β thalassemia. 2. body mass index (bmi) \ 35 kg/m2 3. subjects with known active hepatitis a, hepatitis b, or hepatitis c, with active or acute event of malaria, or who are known to be positive for human immunodeficiency virus (hiv). 4. stroke requiring medical intervention ≤24 weeks prior to randomization. 5. platelet count \>1000 × 109/l. 6. participated in another clinical study of an investigational agent (or device) within 30 days or 5-half-lives of date of informed consent, whichever is longer, or is currently participating in another study. 7. for subjects on iron chelation therapy (ict) at the time of icf signing, initiation of ict less than 24 weeks before the predicted randomization date. 8. prior exposure to sotatercept or luspatercept, imr-687, or gene therapy within 6 months prior to randomization (day 1). 9. subjects who have major organ damage

Keywords: transfusion tdt ntdt
inhaled steroids and control of severe asthma

Conditions: Severe Persistent Asthma

Summary: investigational device: akita 2 device versus conventional metered-dose inhaler (mdi) objectives: to explore if inhalative fluticasone application by means of the akita technology would result in a better symptom control in patients with severe persistent asthma as compared to inhalative application of fluticasone by a conventional mdi. study design: open label, cross-over (one akita, one mdi arm) patients: 20 patients with severe persistent asthma


Eligibility criteria:
inclusion criteria: * severe persistent asthma bronchiale with diagnosis according to the criteria of the global initiative for asthma (gina) executive summary * treatment with at least inhaled corticosteroids (ics) and long acting b agonists (laba) * evidence of inflammatory triggered form of asthma with at least one of the following: * sensitization to typical aerogenous allergens * increased serum ige levels * eosinophilia in peripheral blood * proven eosinophilia in sputum differential (\> 3%) in the previous 2 years * at least 2 exacerbations of asthma within the previous 24 months leading to unscheduled presentation at a health care provider and/or systemic corticosteroid * signed informed consent * requirements of the local ethics committee are met exclusion criteria: * acute exacerbation of asthma within the last 6 weeks rtot \> 350% predicted capillary po2 \ 50mmhg near fatal asthma or anaphylaxis in history * age ≤ 18 and \> 80 years * active smoking or \> 15 pack-years former smoking * oral steroid treatment with a prednisolon-equivalent dose exceeding 10 mg per day * pregnancy, nursing females * female without use of effective contraceptive method * treatment with investigational drugs over the past 30 days or during the course of the trial * severe and uncontrolled gastroesophageal reflux disease * ongoing psychiatric disorder * treatment with systemic corticosteroids for any reason other than asthma * other active lung diseases * medical history of other uncontrolled diseases 3 months prior randomization (e.g. infections, coronary heart diseases and metabolic diseases) * any history of malignancy requiring ongoing treatment and/or limiting life-expectancy * clinically significant abnormalities in electrocardiogram (ecg) or laboratory exams * asthma related to non-steroidal anti-inflammatory drug (nsaid) * insulin dependent diabetes mellitus * cataract

Keywords: asthma inhalation