Kornimate/medical-research-clean huggingface dataset:
efficacy of qax576 in asthma

Conditions: Asthma

Summary: the purpose of this study is to investigate the efficacy of 24 weeks intravenous treatment with qax576 in patients with persistent asthma not adequately controlled with inhaled corticosteroids and long acting beta2-agonists.


Eligibility criteria:
inclusion criteria: * male and female patients * female patients must be surgically sterilized or postmenopausal * male patients must use two forms of contraception * body mass index must be between 18 and 39 kg/m2 * diagnosis of asthma for at least one year, which is not adequately controlled by inhaled corticosteroids and long acting beta-2 agonists exclusion criteria: * smoking history \>10 pack-years * patients with a diagnosis of chronic obstructive pulmonary disease (copd) * patients who have experienced a severe asthma attack/exacerbation requiring systemic corticosteroids or an increase in maintenance doses, within 6 weeks of screening * patients who have had a respiratory tract infection within 6 weeks prior to screening * history of schistosomiasis, within 6 months of screening, or traveling to a country endemic with schistosomiasis within 6 months of completing the study

Keywords: asthma qax576
gait control of stroke patients using visual feedback

Conditions: Stroke

Summary: the purpose of this study is to determine the possibility of gait pattern change via visual feedback among patients with stroke. also, the optimal visual feedback would be chosen from this study.


Eligibility criteria:
inclusion criteria: * hemiplegic stroke patients \>= 18 years old * functional ambulation category \>=3 * cognitively intact enough to follow the study protocol * adults without any gait problem exclusion criteria: * quadriplegic stroke patients * orthopedic problems to affect gait * underlying other neurological or psychological disorders * spasticity or contracture which impede the gait. * uncontrolled medical problems * pregnant.
a study to investigate the safety, tolerability and pharmacokinetics of inhaled chf10073 after single and multiple doses in healthy volunteers

Conditions: Pulmonary Fibrosis

Summary: the objective of this study is to assess the safety and tolerability of single ascending doses of inhaled chf10073 (part 1 of the study) and multiple ascending doses of chf10073 (part 2 of the study). the study will also evaluate the pk profile of study drug in plasma and urine after single and repeated administrations of chf10073. in addition, this study will also investigate the metabolites profile of chf10073 in plasma, urine and faeces (part 2 of the study) and the pk profile of chf10073 in the lungs after bronchoalveolar lavage (bal) (part 3 of the study).


Eligibility criteria:
inclusion criteria: * subject's written informed consent; * healthy males aged 18-55 years; * understanding of the study procedures and the correct use of the inhalers; * bmi between 18.5 and 30.0 kg/m2; * non- or ex-smokers (\ 1 year prior to screening); * good physical and mental status; * vital signs within normal limits; body temperature \<37.5°c; * 12-lead digitised ecg in triplicate considered as normal; * lung function measurements within normal limits; * males with pregnant or non-pregnant wocbp partners must be willing to use contraception exclusion criteria: * recent participation in another clinical trial; * clinically significant abnormal 24h holter ecg (part 1 and 2); * clinically relevant and uncontrolled medical disorders ; * subjects with history of respiratory diseases ; * presence of any current or recent infection; * clinically relevant abnormal laboratory values; * abnormal liver enzymes; * positive results from the hepatitis serology results; * positive hiv-1 or hiv-2 serology results ; * recent blood donation or blood loss (≥450 ml) ; * heavy caffeine drinker ; * recent use of any kind of electronic smoking devices; * documented history of alcohol abuse within 12 months prior to screening ; * documented history of drug abuse within 12 months prior to screening ; * intake of non-permitted concomitant medications ; * known intolerance and/or hypersensitivity to any of the study excipients ; * unsuitable veins for repeated venipuncture; * part 3 only: contraindication to the bal procedure; * part 3 only: recent lower respiratory tract infections
fst-100 in the treatment of acute adenoviral conjunctivitis

Conditions: Acute Adenoviral Conjunctivitis

Summary: this randomized, double masked, multi-center study is being conducted to support the safety and efficacy of fst-100 for the treatment of acute adenoviral conjunctivitis.


Eligibility criteria:
inclusion criteria: * have a clinical diagnosis of suspected acute adenoviral conjunctivitis in at least one eye. exclusion criteria: * have a known sensitivity to any of the components of fst-100 or fst-100 vehicle.
insulin pump vs multiple daily injections of insulin and glyco-metabolic control in type 1 diabetic patients

Conditions: Type 1 Diabetes Mellitus

Summary: the transition from the pediatric clinic to the adult care is a challenging period for young adults with type 1 diabetes, due to the high risk of poor glycemic control. achieving the glycemic target without hypoglycemia and/or large glucose excursions is of paramount importance for type 1 diabetic patients, who have high variability of daily glucose levels . both insulin pump therapy and multiple daily injections of insulin are recommended strategy to achieve glycemic control in type 1 diabetes; however, no studies investigated the effects of insulin pump vs insulin injections on glycol-metabolic outcomes in the transition phase. the aim of this study was to evaluate the effects of continuous subcutaneous insulin infusion (csii) therapy, as compared with multiple daily injections of insulin (mdi), on glycemic and metabolic control, in young type 1 diabetic patients transitioned to the adult diabetes care.


Eligibility criteria:
inclusion criteria: * t1dm for at least 12 months * persistent hba1c levels ≥ 7.5% (58 mmol/mol) despite optimized education therapy, * recurrent severe hypoglycemic episodes or high glucose variability * willingness to wear the insulin pump exclusion criteria: * previous use of insulin pump * pregnancy or planning to become pregnant in the next 2 years, * lack of ability to use the study devices * history of severe chronic diseases * recent or concomitant use of corticosteroids * drug or alcohol abuse * psychiatric complaints that interfere with the correct use of the devices

Keywords: type 1 diabetes transition csii mdi glycemic control glucose variability
the effects of different tooth brushing explanations in fixed orthodontic treatment

Conditions: Orthodontic Treatment; Dental Plaque Induced Gingival Disease

Summary: the aim of this study is to investigate the effects of tooth brushing training methods on orthodontic patients and to determine the most effective oral hygiene methods for individuals receiving orthodontic treatment.

because orthodontic appliances cause food retention, a good level of oral hygiene is needed to maintain dental health. inadequate tooth brushing can lead to gingival diseases on periodontal tissue, cavities and white lesions on tooth enamel. antimicrobial agents and fluoride products are useful but it cannot replace the mechanical removal of plaque. because the mechanical plaque control is still considered the most important oral hygiene tool during orthodontic treatment. in the literature, it has been reported that the motivation to maintain oral hygiene during the orthodontic fixed treatment phase has a very positive effect on periodontal health, and in the same studies, plaque index scores increased over time in control groups that were not given repeated oral treatment. if patients are not given repeated and regular oral hygiene motivation in every session in the clinical routine, gum health may deteriorate. more invasive methods may be required to correct this condition. because poor oral hygiene, if left unchecked, can compromise the outcome of orthodontic treatment. when performing manual tooth brushing, the modified bass technique (mbt) is often recommended to provide optimum plaque reduction by protecting oral tissues from mechanical irritation. the problem with this brushing technique is that it consists of a complex sequence of movements. first of all, the toothbrush should be positioned at a 45° angle to the gingival edge. secondly, the brush should be moved back and forth with small horizontal vibrations. thirdly, debris must be removed by sweeping the brush towards the occlusal face in a vertical motion (upward in the lower jaw, downwards in the upper jaw). this sequence of movements requires dexterity and attention to technique. brushing demonstration techniques or sequences have been developed through a brochure, a model, or video.

Eligibility criteria:
inclusion criteria: * the patient with orthodontic attachments at least 4 months * with permanent dentition exclusion criteria: * impacted or atypically erupted teeth * with prosthetic restorations such as crowns or implants * open bite * deep bite * crowding more than 7 mm or polydiastema cases * individuals diagnosed with periodontitis * ndividuals with cleft lip and palate or other craniofacial anomalies

Keywords: tooth brushing fixed orthodontic treatment microbial dental plaque
dual energy cardiac ct data collection and evaluation

Conditions: Cardiovascular Diseases

Summary: this study is intended to collect clinical feasibility data using this prototype research mode for the purposes of understanding potential clinical impact, potential limitations and strengths, and to further develop the technique through development of image reconstruction and processing approaches or identification of other areas of development required.

up to 38 subjects may be enrolled to achieve the target number of 30 evaluable subjects. withdrawn or discontinued subjects who are enrolled and received the investigational scan, may be replaced. subject participation will be deemed complete once the diagnostic and investigational scans are completed. a subject is considered evaluable when images and raw data from the diagnostic single energy cardiac ct scan and raw data from the investigational dual energy cardiac ct scan have been collected successfully and demonstrate a diagnostic interpretation.

Eligibility criteria:
inclusion criteria: 1. patients \> 50 years old undergoing routine cardiac ct imaging exam; 2. patients that within last 12 months did not undergo medical procedures involving ionizing radiation; 3. signed informed consent. exclusion criteria: 1. contradictions to contrast; 2. contraindications for beta blocker; 3. bmi \>30; 4. high heart rate ≥75 bpm; 5. atrial fibrillation; 6. arrythmia or irregular heartbeats; 7. pregnant women; 8. patients lacking capacity in providing informed consent 9. patients who did participate in prior research studies with ionizing radiation in the last 12 months.
denosumab and screw fixation for osteoporotic compression fracture

Conditions: Denosumab Allergy

Summary: evaluation of bone mineral density and function at 1 year after screw internal fixation of osteoporotic vertebral compression fractures with desuzumab: a parallel double-blind randomized controlled clinical trial

conduct a single-center, double-blind, randomized controlled clinical trial according to clinical trial reporting standards (consort). bone mineral density and function were compared 1 year after screw internal fixation of osteoporotic vertebral compression fracture (ovcf) with desomumab versus placebo in shenzhen people's hospital from september, 2021 to september, 2022. the study was approved by shenzhen people's hospital and informed consent was signed

Eligibility criteria:
inclusion criteria:• must be age between 40 and 90 years old * x-ray diagnosis of 1-2 vertebral compression fractures * dual energy x ray test bone mineral density t value less than -1 * fracture history lasted within 6 weeks * mri showed bone marrow edema of injured segment * lower back pain, local spines tenderness exclusion criteria: * • must be able to have no posterior vertebral wall fracture * must be able to have no patients with intervertebral fissure * must be able to have no infection * must be able to have no malignancy * must be able to have no neurological dysfunction * must be able to have no previous use of anti-osteoporosis drugs within 6 weeks * must be able to have no inability to perform magnetic resonance imaging * must be able to have no prior back surgery * must be able to have no other established contraindications for elective surgery
blood pressure and subclinical organ damage

Conditions: Diabetes Mellitus

Summary: background: the purpose of this study is to analyze the relationship between central and peripheral blood pressure (clinic and ambulatory) with vascular structure and function, assessed by carotid intima-media thickness (imt), artery venous retinal index, pulse wave velocity (pwv) and ankle-brachial index in patients with diabetes type 2 and without diabetes type 2. develop and validate a software to measure the retinal vessels and to estimate arterio-venous index automatically. methods/design: the investigators will perform a coss-sectional study with control group, with follow-up of 4 years in primary care. the study population will be diabetic type 2 patients with a control group without diabetes mellitus. the investigators will include by consecutive sampling 300 patients between 34 and 75 and without previous cardiovascular disease, half of each group. main measurements: age, sex, height, weight and waist circumference. lipids, creatinine, microalbuminuria, blood glucose, hba1c, insulin, fibrinogen, hs-crp and markers of endothelial dysfunction. clinic and ambulatory blood pressure (mapa). ultrasonography to assess carotid imt, retinography to assess arterio-venous ratio. ecg to evaluate left ventricular hypertrophy, ankle-brachial index and morphology analysis (pwa) and pulse wave velocity (pwv) in sphigmocor system. discussion: the investigators provide information regarding various parameters derived from mapa and pulse wave analysis of with target organ damage, especially with the vascular structure and function assessed by imt and pwv and endothelial dysfunction in patients with diabetes type 2 and without this disease. the investigators also hope to demonstrate the usefulness of the tool developed for automatic evaluation of retinal vascularization in the early detection of abnormalities of vascular structure and function and the prognosis of cardiovascular disease in the medium term.


Eligibility criteria:
inclusion criteria: * patients aged 34 years or more but less than 75 years, with and without type 2 diabetes. exclusion criteria: * patients who fail to meet the requirements of the protocol (mental disorders and / or cognitive uncooperative, education and understanding limitations), * patients with ischemic heart disease, cerebrovascular disease or other atherosclerotic disease * patients who are participating or will participate in a clinical trial during the study * patients with serious comorbidity that might endanger his life in the next 12 months.

Keywords: carotid artery diseases blood pressure blood pressure monitoring, ambulatory peripheral vascular diseases retinal vessels
a trial of high power-short duration versus standard power-long duration radiofrequency ablation for treatment of atrial fibrillation

Conditions: Atrial Fibrillation; Atrial Fibrillation Paroxysmal; Atrial Fibrillation, Persistent

Summary: this study is a prospective, randomized controlled study to compare overall clinical outcomes between high power short duration (hpsd) and standard radiofrequency (rf) ablation settings for atrial fibrillation (af) ablation in the treatment of subjects with paroxysmal or persistent atrial fibrillation.

pulmonary vein isolation using radiofrequency (rf) ablation is a widely used treatment strategy for atrial fibrillation. peri-procedural complications rates are estimated at between 1.5 - 6% with the two most feared complications being stroke and atrial-esophageal fistula. the risk of these complications increases with (1) longer left atrial dwell times with greater potential for clot formation and (2) esophageal heating during delivery of radiofrequency energy. 'high-power short-duration' (hpsd) is an increasingly utilized strategy to decrease procedure duration and minimize the risk of these complications. potential mechanisms for benefit include: (1) shorter left atrial dwell times due to more efficient lesion delivery (2) rapid, but more controlled, resistive tissue heating, which avoids deeper, passive conductive heating that can reach the esophagus and cause injury. moreover, hpsd may improve lesion efficacy and durability due to less recover of excitability after ablation. despite being widely used and several retrospective studies, there have been no prospective randomized trials comparing outcomes between hpsd and standard rf ablation settings. moreover, the investigators are interested to see if a shorter procedure (less time in the left atrium) is associated with a lower rate of silent cerebral infarctions (which are occasionally seen on mri brain post rf ablation - their clinical significance is unclear).

Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years of age at their pre-operative visit. 2. patient is scheduled to have their first af ablation 3. paroxysmal or persistent af 4. written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. exclusion criteria: 1. prior af ablation 2. stroke or transient ischemic attack (tia) within the previous 6 months 3. known esophageal ulcer or gastrointestinal (gi) bleed within prior 6 months 4. intent to perform adjunctive left atrial ablation, including posterior wall isolation, left atrial appendage isolation, mitral or other linear lesions. 5. prior rheumatic heart disease or significant mitral stenosis 6. mechanical mitral valve replacement 7. long lasting persistent af \> 1 year 8. severe left ventricular systolic dysfunction, with lv ejection fraction lvef\<35% 9. prior left atrial appendage (laa) occlusion device 10. prior septal occlusion device 11. pregnancy 12. pacemaker, defibrillator or any contraindication to mri

Keywords: atrial fibrillation
cmv disease and iris in hiv-1 infected persons

Conditions: HIV Infections; Cytomegalovirus

Summary: various diagnostic methods are available for cmv infection. but none of them could be a standard and highly valuable. our first goal is to setup a series of molecular diagnostic tools for hiv-1 infected person. by using these tools, physicians can easily select cases with cmv disease or immune restoration inflammatory syndrome (iris) to enroll this study. furthermore, we will seek for a predict marker for cmv reactivation, cmv disease and iris. finally, our research will focus on the mechanism of the ie gene alternative splicing between lytic and latent stage.

at present, human cytomegalovirus (hcmv) remains a major health threat in immune compromised patients. especially hcmv will cause blind and death in hiv-1 infected person. currently, few antiviral drugs can be chosen for treatment of hcmv infection. besides, more and more drug resistant virus strains were reported and led failure in antiviral therapy. various diagnostic methods are available for cmv infection. such as shell vial assay, cmv antigen test, pp65 antigen assay and polymerase chain reaction. but none of them could be a standard and highly valuable. although cmv-pcr is very sensitive, it can't distinguish between active disease and asymptomatic infection or latency, can't predict symptomatic disease nor can't monitor the successful antiviral therapy. our first goal is to setup a series of molecular diagnostic tools for hiv-1 infected person. by using these tools, physicians can easily select cases with cmv disease or immune restoration inflammatory syndrome (iris) to enroll this study. furthermore, we will seek for a predict marker for cmv reactivation, cmv disease and iris. finally, our research will focus on the mechanism of the ie gene alternative splicing between lytic and latent stage. we may find out new therapeutic concept and prevent virus reactivation from latency.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hiv-1 disease * clinical diagnosis of cmv disease or immune restoration inflammatory syndrome (iris)

Keywords: cmv iris
covid 19 and psychological health: a cross sectional study to evaluate anxiety and depression in covid-19 patients

Conditions: Covid19; Anxiety; Depression

Summary: the covid-19 pandemic started to spread worldwide since december 2019. it promoted to an exaggerated psychological stress and anxiety in humans due to the intolerable symptoms higher than usual death of many infected patients. this study examines the corona related anxiety and if there is need for drug intervention to treat this anxiety. to answer these questions, a survey made to the hospitalized patients including sex, age, educational level, marital state, and a standardized questionnaires (gad-7 and phq-9) which has been validated and shown to possess good psychometric qualities in studies of participants from multiple populations.


Eligibility criteria:
inclusion criteria: - patients with covid19 willing to participate in the study exclusion criteria: * unwilling unable to read or interact with standardized questionnaire unconscious

Keywords: covid19 anxiety depression
efficacy of myskin patch for the healing of burn wounds: a randomised controlled trial

Conditions: Burns; Burn Injury; Hydrogel Bandage; Occlusive Dressings

Summary: evaluation of clinical efficacy of my skin (hydrogel and polyurethane film) plus best practice clinical care in subjects with burn injuries with particular regard to: 1) wound healing (complete reepithelialization), 2) the patient's pain. in the context of the study will be collected secondary outcomes related to type of lesion and its clinical evolution through the analysis of the items in the scale of the psst.


Eligibility criteria:
inclusion criteria: * presence of at least one injury burn covered by a dressing of 10x8 cm (80 cm2) * injury treated with medication in use at the center * patients assisted at the emergency care, or at the outpatient * extension of the lesion less than 80 cm2 (including dressings in cm10x8cm) * patient age greater than or equal to 18 years * patients who have given consent to enrollment in the trial and the processing of personal data * patient / lesion that has already been recruited in the study or who have previously passed a period of 10 days (washout) of "no treatment" according to the research protocol exclusion criteria: * a end-stage of disease * suspected or known allergic diathesis to the product of medication * subjects that do not give consent to data processing * dry lesion with necrosis or eschar * presence of both local and systemic infection or inflammation * injuries that to the decision of the provider of care, needs a targeted local treatment other than as provided for in the protocol * patient / lesion that has already been previously recruited into the study, before a period of 10 days (washout) of suspension from the same research protocol * patients who use alternative medicine treatments such as aloe

Keywords: myskin patch