Kornimate/medical-research-clean huggingface dataset:
a study of doripenem in infants less than 12 weeks of age

Conditions: Bacterial Infections

Summary: the purpose of this study is to measure drug levels of doripenem in blood samples collected before and after administration of doripenem to infants less than 12 weeks of age who are hospitalized and documented, presumed to have, or are at risk for bacterial infection (s) and are undergoing treatment with intravenous (i.v.) antibiotics. safety and tolerability will also be assessed.

this is a multicenter, open-label (identity of treatment is known to patient's parent/legal guardian/caregiver and to all study staff) pharmacokinetic study (a study to observe how the drug is absorbed and distributed within the body) to measure drug levels of doripenem in hospitalized but medically stable infants (term and preterm), \ =8 weeks ca will receive an 8 mg/kg doripenem 1-hour infusion. study drug will be administerd to the patient alone at any time after the first dose of a nonstudy antibiotic is administered to the patient.

Eligibility criteria:
inclusion criteria: * must be hospitalized, medically stable, without acute decline in physical condition in the inestigator's judgement * documented, presumed to have, or are at risk for bacterial infection(s) and are undergoing treatment with i.v. antibiotics * patient's weight (kg) must be within the 5th and the 95th percentile inclusive for his or her age * parent or the patient's legally acceptable representative must have signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to allow the infant to participate in the study exclusion criteria: * clinically significant abnormal values for hematology or clinical chemistry at screening as deemed appropriate by the investigator * clinically significant abnormal physical examination or vital signs at screening, as deemed appropriate by the investigator * patients who, in the investigator's judgment, have compromised renal (kidney) function including renal failure * history of clinically significant allergies to medications, especially known hypersensitivity or intolerance to carbapenems, penicillins, or other beta lactam antibiotics * known allergy to heparin or history of heparin-induced thrombocytopenia, if an indwelling cannula (e.g., heparin lock) or central line is used * patients concomitantly treated with or having received imipenem/cilastin within 48 hours before study drug administration

Keywords: doripenem doriped1003 intravenous infection colonization prophylaxis pediatric antibiotic pharmacokinetics
effect of short-term oxygen during cpet in ild

Conditions: Interstitial Lung Disease

Summary: in a randomized, sham-controlled crossover trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with interstitial lung disease.


Eligibility criteria:
inclusion criteria: * interstitial lung disease, diagnosed by high-resolution ct * fev1/fvc \>70% and fvc \<85% predicted * stable medication for at least 4 weeks * desaturation in spo2 in 6-minute walk test of ≥ 4% to absolute values ≤ 92% * signed informed consent * male and female patients 18 to 80 years of age exclusion criteria: * severe daytime hypoxemia (pao2 ≤7.3 or \<55 mmhg at rest) * other clinically significant concomitant disease states (e.g., cardiovascular disease, hepatic dysfunction, etc) * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject, neurological or orthopaedic problems with walking disability or inability to ride a bicycle * women who are pregnant or breast feeding
impact of different dialysis on sleep apnea in patients with renal failure

Conditions: Sleep Apnea; End Stage Renal Disease

Summary: the purpose of this study is to determine whether hemodiafiltration, a new form of hemodialysis can improve sleep apnea in patients with end stage kidney disease.

sleep apnea or breathing problems during sleep are frequent, occurring in 6% of the general population. however, more than half of all patients on dialysis suffer from breathing problems related to sleep. sleep apnea is associated with high blood pressure, excessive sleepiness, fatigue, poor memory and concentration as well as depression in those with normal kidneys. hemodiafiltration is a new kind of dialysis that is more efficient at clearing toxins that accumulate in kidney failure. it has been used successfully in europe for over 15 years. however, the effects of hemodiafiltration on sleep apnea in dialysis patients have never been assessed. we are conducting a clinical trial to examine the effects of hemodiafiltration on sleep apnea in dialysis patients. fifteen patients with sleep apnea, already on dialysis will be treated with hemodiafiltration 3 times a week, instead of their regular hemodialysis treatment for a period of 3 months. we will repeat sleep studies in these patients before and after the hemodiafiltration period and assess their quality of life. we hope to decrease the severity of sleep apnea with hemodiafiltration. this could result in better sleep, improved energy level, mood, memory, concentration and blood pressure control in those afflicted by sleep apnea and on dialysis. our findings would also give us better insight into the cause of sleep apnea in patients with end stage kidney disease.

Eligibility criteria:
inclusion criteria: * patients currently stable on a thrice weekly hemodialysis regimen for a minimum of 3 months * patients with vascular access and no contraindications to anticoagulation * presence of sleep-related breathing disorder defined as a mean apnea-hypopnea per hour of recording greater than 10 based on cardiorespiratory monitoring exclusion criteria: * patients already on hemodiafiltration therapy * patients already on treatment for sleep disordered breathing. * patients with significant neuromuscular disease * patients with an expected lifespan \< 1 year * patients unable to complete sleep related quality of life questionnaires and consent forms due to language barriers or dementia * patients with known substance abuse * patients with a respiratory disturbance index greater than 30 with active cardiovascular disease defined by unstable angina, myocardial infarction within 3 months or an epworth sleepiness score greater than 15 while actively working in a stress situation (for example bus driver, taxi driver). these patients will be evaluated by a sleep specialist. * living further than 30 km from dialysis centre

Keywords: sleep apnea end stage renal disease hemodiafiltration
the effectiveness of dental health home visits on caries prevention in young children

Conditions: Dental Caries in Children

Summary: tooth decay affects 75% of malaysian preschool children, most of which remain untreated. untreated decay can cause pain, and impair nutritional status and physical growth. in 2012, nearly 4,000 children in malaysia were referred for hospital paediatric dental services because of early childhood caries. the realistic management of these children would have been treatment under general anaesthesia or sedation, at considerable cost to the state, and distress to the children and families. the amount of dental disease in young children who have been referred to the hospital children's dentistry service for severe caries is disturbing, particularly given the fact that each district has a dental clinic and that the water is very likely to be fluoridated. it is unlikely that there will ever be enough dental clinics and dental practitioners to manage the amount of disease. clearly, existing health services need to be supplemented with a population-based approach to promote child oral health. the investigators, therefore, propose a community trial study to investigate the effectiveness of a dental health visiting service for caries control in young children. it is likely that such a home-based intervention is influenced by the family dynamics in which the child lives. the investigators further propose to assess the cost-effectiveness of dental home visits (dhvs). health economic evaluation can be used to assess health services to ensure there is cost-efficient resource allocation. economic evaluation is defined as the comparative analysis of alternative courses of action in terms of both their costs and consequences. a health intervention is considered cost-effective when it produces acceptable costs and health benefits. economic data are now recognized as important due to the fact that dental disease is very common and expensive for the health care system. this study was conducted in collaboration with the national oral health of pre-school survey (nohps), in which a sub-sample will be followed up for two years. the nohps is a national survey of the oral health of 5-year-olds that takes place every 10 years. this is a randomized controlled trial to assess the cost-effectiveness of home-based dhvs with families of children at high risk of caries in caries prevention compared to children receiving oral health information in the form of an education leaflet (els) alone. a collaborative project with the oral health division (ohd) at the ministry of health is proposed. the ohd will provide access to a sub-sample from the national oral health preschool survey (nohps), with clinical dental health data.


Eligibility criteria:
inclusion criteria: * all the children age of 5 or 6-year-old with parents' consents to participate from these kindergartens will be included as the subjects of this study exclusion criteria: -

Keywords: dental caries dental health home visits young children dental decay
naloxegol drug utilization post authorisation safety study

Conditions: Opioid Induced Constipation

Summary: this post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the united kingdom (uk), norway, sweden, and germany.

the overall research questions for this study are: 1) what are the demographic, clinical, and treatment characteristics (including dose) at baseline of patients prescribed naloxegol in real-world practice (including the use of naloxegol in non-indicated populations)? and 2) what are the treatment patterns of naloxegol utilization during follow-up? primary objectives: 1. to describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics). 2. to describe any of the following treatment patterns: * discontinuation of naloxegol (permanently during the observation period) * switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (oic) * prescription of other drug(s) potentially used by patients with oic in the same period when naloxegol is prescribed (augmentation) * restart in the prescription of naloxegol (after temporary discontinuation or treatment holiday) * continuous treatment with naloxegol during the study period * change in dosing exploratory objective: 1. to identify predictors of length of naloxegol use

Eligibility criteria:
inclusion criteria: 1. the patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period. 2. the patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date) exclusion criteria: * no exclusion criteria will be applied
topical lidocaine: predictors of response in peripheral nerve injury

Conditions: Neuropathic Pain

Summary: the primary purpose is to study the predictive value of preserved nociceptors and large afferent fibers and dynamic mechanical allodynia on the effect of lidocaine patch. the primary outcome measure is the predictive role for these three measures for obtaining a response to lidocaine. a responder is defined as a person with at least a 2-point pain reduction to lidocaine (change in median pain intensity (measured on a 10 point numeric rating scale) of pain from the baseline week to the last week of lidocaine treatment). secondary effect variable will be efficacy of lidocaine on pain reduction (baseline week versus last week of each treatment) and pain relief (complete, good, moderate, slight, none, or worse) for spontaneous and evoked pain, and effect on ongoing pain, brush evoked allodynia, cold and warm allodynia, and pinprick hyperalgesia evaluated on each visit.


Eligibility criteria:
inclusion criteria: * patients aged 18 or more with neuropathic pain after a peripheral nerve injury with a pain intensity of at least 4 on a 0-10 point numeric rating scale. exclusion criteria: * pregnancy or lactation, * allergy to lidocaine, * alcohol abuse, * psychiatric disorders, * skin diseases in the area where the patches are to be applied, * treatment with class i antiarrhythmic agents, * any treatment within the past one month or concomitantly with na2+-channel blockers (e.g., mexiletine, phenytoine, propafenone), * any topical treatment with capsaicin within the last three months before entering the study, or any other topical treatment in the area of neuropathic pain, * concomitant therapy with tens or acupuncture.

Keywords: focal neuropathic pain
a clinical study of eus-rfa for inoperable pancreatic ductal adenocarcinoma

Conditions: Pancreatic Ductal Adenocarcinoma

Summary: to assess if endoscopic ultrasound-guided radiofrequency ablation application in patients with inoperable pancreatic cancer confers survival benefit when compared to patients receiving standard medical care.

the five-year survival for pancreatic ductal adenocarcinoma (pdac) is less than 5% in spite of the advances in management of cancers in the last few decades. endobiliary application of radiofrequency (rf) has been developed and used in patients with inoperable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. (1, 2) endoscopic ultrasound (eus) radiofrequency ablation (rfa) of pancreatic neoplasms has been proven to be well tolerated and safe, inducing a significant reduction in tumour size (3). various techniques of eus-guided tumour ablation have been described, including rf ablation, photodynamic therapy, laser ablation, and ethanol injection (4). kahaleh et al. have demonstrated that endoscopic ultrasound guided rf ablation (eus-rfa) of the pancreatic head using habib eus-rfa catheter (emcision ltd, uk) through a 19-gauge needle was well tolerated in 5 yucatan pigs and with minimum amount of pancreatitis (5). in a pilot clinical study, pai et al showed either a complete response or at least a 50% reduction in tumours following application of radiofrequency ablation with the habib™ eus-rfa device in a group of eight patients with pancreatic cancers (3).

Eligibility criteria:
inclusion criteria: * patients above 18 years of age. * a cytological / histological diagnosis of inoperable pdac based on multidisciplinary review of cross-sectional imaging and cytology / histology results. * patients ought to be fit enough to be considered for the study (ecog (eastern cooperative oncology group) performance status 0, 1 or 2) * patients who have commenced chemotherapy are not excluded from the study * patients capable of giving informed consent * negative blood pregnancy test for women of childbearing potential * willingness and ability to comply with all protocol requirements including scheduled visits, treatment plans, laboratory tests and other study procedures. exclusion criteria: * ecog performance status 3 or 4 * life expectancy less than 3 months (including liver metastases, carcinomatosis) * prior investigational drugs within the last 30 days * known infection with human immunodeficiency virus (hiv)
copd and cardiovascular risk in the population

Conditions: Chronic Obstructive Pulmonary Disease; Cardiovascular Disease

Summary: the prevalence of chronic obstructive pulmonary disease (copd) in patients with cardiovascular disease (cvd) is unknown, and whether or not copd is adequately diagnosed and treated in these patients has not been investigated before. we hypothesized that the prevalence of copd would be significantly higher (30%) in patients with cvd than in the general population. besides, we anticipated that copd, a potentially treatable cv risk factor, would be undiagnosed in more than 80% of cvd patients.

we aim to compare clinical and spirometric data in three groups of individuals. two of them are participants in an ongoing population-based study (corsaib) aimed at investigating the distribution of cvd risk factors in the general population of the balearic islands, spain. the design and full methodological details of the corsaib study have been published elsewhere (rigo f, et al. rev clin espa 2005). a third group will include patients with stable cvd regularly visited at the referral hospital of our community. inclusion criteria for the study are male and female individuals, aged 40 to 81 years, residents of the balearic islands, and who are willing to participate in this research.

Eligibility criteria:
inclusion criteria: * residents of the balearic islands * willing to participate in this research * able to sign the written consent form exclusion criteria: * none

Keywords: cardiovascular copd population prevalence underdiagnosis
bicuspid aortic valve replacement: evaluation of transcatheter versus surgery-pilot trial

Conditions: Aortic Valve Stenosis; Bicuspid Aortic Valve

Summary: the study protocol is a randomized trial of standard of care therapies for severe aortic stenosis (as) in patients with a bicuspid aortic valve (bav). namely, the therapies to which patients will be randomized will be transcatheter aortic valve replacement (tavr) or surgical aortic valve replacement (savr), in patients deemed clinically suitable for both following heart team review. the purpose of this study is to compare the safety and efficacy of transcatheter aortic valve replacement (tavr) versus surgical aortic valve replacement (savr) for treating patients with severe aortic stenosis (as) who have a congenital bicuspid aortic valve (bav) anatomy. patients with bav anatomy have been under-represented in previous trials and this study might provide important information to help guide future treatment options. the study patients will be followed with standard of care procedures for 10 years.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, aged \> 50 years of age * site-determined severe as deemed necessary for treatment with savr or tavr * gated contrast ct available and suitable for core laboratory analysis * bav anatomy confirmed by ct core laboratory analysis exclusion criteria: * recent cardiovascular intervention within the prior 30 days. * presence of an existing tavr or savr device * pregnancy or lactation * extreme or prohibitive tavr or savr risk, determined by site or committee active enrollment in another investigational study * disproportionate tavr vs savr risk, as determined by treating site or committee * associated aortopathy (aa≥ 45 mm by maximal cross-sectional dimension, as confirmed by ct core laboratory analysis, or aa\<45 mm but site plan for surgery of the aorta in the event of randomization to surgery * site plan for treatment of concomitant non-coronary cardiovascular disease in the event of randomization to surgery (for instance, concomitant valve surgery, septal defect or coarctation repair, aorta or root replacement or repair) * in the presence of coronary artery disease deemed necessary for revascularization in the event of randomization to savr or tavr, syntax score ≥ 32 or deemed unsuitable for pci, or deemed unsuitable for coronary artery bypass grafting (cabg).

Keywords: tavr bav savr
histopathological evaluation of the periodontal ligament subjected to laser ablation.

Conditions: Pulp Necroses

Summary: laser ablation therapy (la) using an 810nm diode laser and indocyanine green (icg) solution, which efficiently absorbs laser energy and increases the effectiveness of tissue removal. intracanal heating can potentially cause damage to structures outside the tooth root. the study was to observe possible changes in the periodontal ligament and cementum resulting outside the root using this treatment. histological and morphological examination of extracted cementum, ligament, and collagen post-exposure showed no difference in these structures vs. non-treated controls.

laser ablation therapy (la) using 810nm diode laser and indocyanine green (icg) solution which efficiently absorbs laser energy and the increased temperature results in an instantaneous flame that chars tissue and microbes. intracanal heating can potentially cause damage to cementum structure and periodontal tissues. the objective of this study is to observe possible changes in the periodontal ligament and cementum resulting from the use of la with icg as an adjuvant therapy to endodontic treatment. ten patients with lower incisors requiring extraction will be selected. before extraction, chemical-mechanical root canal preparation will be carried out with a single file reciprocating system (35/04) and 2.5% sodium hypochlorite solution. then, the canals will be dried and filled with 0.05% icg, which will remain in place for 1 minute (pre-irradiation time). for the test group, a #20 laser fiber will be inserted into the root canal to the working length. the 810 nm wavelength infrared diode laser is activated with a power of 2.5w, an interval of 300 ms, and a duration of 100 ms. after activation commences, circular movements are made for a period of 30 seconds together with the fiber removal movement. after the first activation, there is a 30-second pause and a new 30-second activation cycle will then be performed in the same way as the previous one. after treatment, the tooth element will be extracted and the apical third of the root with the periodontal ligament is processed for histological analysis using hematoxylin-eosin and picrosirius red staining to evaluate the morphological structures. two teeth extracted without treatment will be used as controls.

Eligibility criteria:
inclusion criteria: * age 18 years or older. * requiring at a least one mandibular incisor to be extracted. exclusion criteria: * evidence of periodontal disease anywhere in the mouth beyond the apical third of any tooth. * mandibular canines that do not require extraction. * presence of other dental or oral conditions of any type that require immediate intervention.
evaluation of the repeatability and reproducibility of corneal epithelial thickness mapping with ivue sd-oct

Conditions: Cornea

Summary: evaluate the repeatability and reproducibility of ivue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.


Eligibility criteria:
inclusion criteria: normal * able and willing to provide consent. * able and willing to complete required exams. corneal conditions * able and willing to provide consent. * able and willing to complete required exams. * history of refractive surgery, contact lens, dry eye or keratoconus. exclusion criteria: normal * history of refractive surgery, contact lens, dry eye or pathology. * blepharitis or meibomitis * unable to complete required exams. corneal conditions * unable to complete required exams.