Kornimate/medical-research-clean huggingface dataset:
atrial fibrillation ablation pilot study

Conditions: Atrial Fibrillation

Summary: this is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the ablation frontiers cardiac ablation system for the ablative treatment of symptomatic permanent atrial fibrillation.

the study shall be conducted according to iso 14155. results of this research study will be used to assess the performance and safety of the system and its components. data may be combined with similar research at additional sites to create a greater understanding of the endpoints. up to sixty (60) patients (including "roll-in" or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the ablation frontiers cardiac ablation system. further studies may be performed to gather additional data regarding the safety and efficacy of the system. patients with a history of symptomatic permanent af, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.

Eligibility criteria:
inclusion criteria: * history of symptomatic permanent atrial fibrillation * age between 18 and 70 * willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study exclusion criteria: * structural heart disease of clinical significance * any prior ablation for atrial fibrillation * prior ablation for arrhythmias other than af within the past three months * enrollment in any other ongoing arrhythmia study protocol * any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study * active infection or sepsis * any history of cerebral vascular disease including stroke or tias * pregnancy or lactation * left atrial thrombus at the time of ablation * untreatable allergy to contrast media * any diagnosis of af secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes * history of blood clotting (bleeding or thrombotic) abnormalities * known sensitivities to heparin or warfarin * severe copd (identified by an fev1 \< 1) * severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)

Keywords: atrial fibrillation
japanese study evaluating safety, efficacy and acceptability of telithromycin in children with infections

Conditions: Infections; Child

Summary: the primary objective is to assess the safety of telithromycin (hmr 3647) (20% fine granules) 1g filling sachet in children with infections (respiratory tract infections, dermatological infections, otorhinolaryngological infections, dentistry/oral surgery infections). secondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.


Eligibility criteria:
inclusion criteria: * outpatients of weight from 7.0 kg. * for respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°c) or c-reactive protein positive, clinical symptoms/signs, and laboratory findings. * for dermatological infections: subjects diagnosed with mild or moderate dermatological infection in terms of clinical symptoms/signs and laboratory findings. * for otorhinolaryngological infections:subjects with purulent / mucopurulent rhinorrhea and postrhinorrhea, subjects diagnosed with mild or moderate otorhinolaryngological infection in terms of clinical symptoms/signs and laboratory findings * for dental / oral surgical infections: subjects who have formed obstructive abscess and diagnosed with mild or moderate dental / oral surgical infection

Keywords: respiratory tract infections skin diseases sinusitis
buprenorphine facilitated access and supportive treatment --aim 3

Conditions: Opioid-related Disorders

Summary: the goal of this study is to test whether peer mentors (i.e., individuals with past opioid addiction and prior incarceration) can facilitate entrance into buprenorphine (suboxone) treatment for individuals with opioid use disorder who were recently released from jail or prison. in order to test whether it is helpful to have peer mentors paired with recently released individuals, the investigators will conduct an 18 month study, recruiting 72 formerly incarcerated individuals and assigning them by chance selection (like flipping a coin) to either a group that will receive peer mentorship or a group that will receive a referral to a community clinic.

buprenorphine facilitated access and supportive treatment (bup-fast) is a peer mentorship intervention in which trained peer mentors will link formerly incarcerated individuals with opioid use disorder to addiction treatment (i.e. buprenorphine maintenance treatment) following release from incarceration. the current study is a pilot randomized control trial evaluating the effectiveness and feasibility of the peer mentorship intervention. the investigators are conducting this study due to the high rates of relapse to opioid use following release from prison (up to 75% within 3 months) and difficulty that some formerly incarcerated individuals report in accessing effective treatments for opioid use disorder. the investigators hypothesize that having peer mentors - who themselves have experienced incarceration and have had success with buprenorphine treatment for opioid use disorder - assisting formerly incarcerated individuals in seeking treatment will result in higher rates of linkage to care in comparison to referral to a community health center for buprenorphine treatment. in this 18-month randomized control trial of the bup-fast intervention, the investigators will recruit 72 formerly incarcerated individuals with opioid use disorder; half will then be randomized to receive the bup-fast intervention (peer mentorship); and the other half (control) will receive referral to a community health center for assessment for buprenorphine treatment. medication will not be provided as part of this study. participants will only receive buprenorphine treatment if they meet appropriate medical criteria after assessment at the community health center.

Eligibility criteria:
inclusion criteria: 1. current or prior (at the time of incarceration) opioid use disorder by dsm-v criteria 2. ≥ 18 years old 3. fluent in english or spanish 4. released from incarceration in the last 4 weeks exclusion criteria: 1. current buprenorphine or methadone maintenance treatment 2. pregnancy

Keywords: buprenorphine treatment incarceration linkage intervention opioid use disorder
comparison of quadriceps-sparing minimally invasive and medial parapatellar total knee arthroplasty

Conditions: Osteoarthritis

Summary: quadriceps-sparing minimally invasive total knee arthroplasty (tka) with side-cutting instruments has been proposed to limit surgical dissection without compromising the surgical outcome. we conducted a prospective, randomized study to compare the outcomes of quadriceps-sparing tka with conventional medial parapatellar tka, with two-year follow-up. we hypothesize that the quadriceps-sparing arthrotomy would not outperform the conventional medial parapatellar arthrotomy in tka, in terms of postoperative recovery of quadriceps muscle strength, alignment of the prosthetic knee, and clinical outcome.

eighty primary tkas in sixty patients of osteoarthritis constituted this study. patients were randomly assigned to either quadriceps-sparing (qs, 40 knees) or medial parapatellar (mp, 40 knees) group. all surgeries were designed to set the prosthesis with thefemoral component alignment of 7º valgus and the tibial component alignment perpendicular to tibial shaft. outcome variables included knee function defined by hospital for special surgery knee score, quadriceps muscle strength measured by isokinetic dynamometer, pain indicated on visual analogue scale, range of motion, and post-operative alignment measured on plain radiograph.

Eligibility criteria:
inclusion criteria: * advanced osteoarthritis with radiograph-evident narrowing of joint gap, * with persistent symptoms after conservative treatment for at least 6 months, and * patients' intention to receive the prosthetic tka. exclusion criteria: * the knees with excessive deformity of femorotibial angle exceeding 15° varus or 10° valgus, * flexion contracture exceeding 15°, * active infection involving the knees, or * knees received previous surgery.

Keywords: total knee arthroplasty minimally invasive quadriceps-sparing quadriceps-sparing total knee arthroplasty
non-significant risk study of a cochlear implant headpiece

Conditions: Hearing Loss; Sensorineural Hearing Loss

Summary: this study aims to evaluate a cochlear implant headpiece.

the headpiece and magnet are expected to provide acceptable comfort and retention for existing cochlear implant users. in this study participants will report on their experience with the investigational headpiece during daily life.

Eligibility criteria:
inclusion criteria: * pre- or post-lingually deafened. * fluent in english, french, or spanish or capable of communication with a caregiver who is providing consent. * adult or child implanted with a commercially available advanced bionics cochlear implant. children and adult participants are included to ensure device retention is appropriate for all implant populations. * have (or caregivers have) the cognitive and functional capability to comply with all directions during the study * be able to remove their own headpiece * have (or caregivers have) the cognitive and functional capability to complete the questionnaire required for the study * capable (or caregivers are capable) of reading and understanding patient information materials and giving written informed consent exclusion criteria: * have any significant medical condition that, in the opinion of any of the investigators, is likely to interfere with study procedures or likely to confound evaluation of study data.

Keywords: cochlear implant
initial performance of a modified daily disposable contact lens

Conditions: Refractive Error

Summary: the purpose of this study is to evaluate the incidence of ocular discomfort device-related adverse events with dailies total1® with uv absorber (dt1 uv) contact lenses compared with current dailies total1® (dt1) contact lenses.


Eligibility criteria:
inclusion criteria: * must sign an informed consent document; * current wearers of commercial dt1 lenses (for at least 3 months), with a minimum wearing time of 5 days per week and 8 hours per day; * spherical contact lens correction within the range of -2.00 to -4.00 diopter (d) in both eyes; * manifest astigmatism less than or equal to 0.75 d (at screening); * best-corrected visual acuity (bcva) greater than or equal to 20/25 in each eye (as determined by manifest refraction at screening); * other protocol-specified inclusion criteria may apply. exclusion criteria: * eye injury in either eye within 12 weeks prior to study enrollment; * any anterior segment infection, inflammation, disease, or abnormality that contraindicates contact lens wear as determined by the investigator; * use of systemic or ocular medications for which contact lens wear could be contraindicated, including topical ocular medications and lubrication drops that would require instillation during contact lens wear; * history of herpetic keratitis; * history of refractive surgery or irregular cornea; * pathologically dry eye that precludes contact lens wear; * concurrent participation (or within the previous 30 days) in a contact lens or lens care product clinical trial; * monocular (only 1 eye with functional vision); * other protocol-specified exclusion criteria may apply.
the product surveillance registry reverse post approval study

Conditions: Heart Failure

Summary: the purpose of the reverse post approval study (pas) is to confirm the benefit observed in the reverse and raft pivotal studies in "real-world" clinical practice.

the reverse pas will estimate the 3-year survival probability of freedom from heart failure hospitalization and heart failure events in patients implanted with a medtronic crt-d device who meet the expanded indication criteria with a qrs duration ≤ 150 ms.

Eligibility criteria:
inclusion criteria: * patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements * patient has or is intended to receive or be treated with a medtronic crt-d who meets the expanded crt-d indication criteria with a qrs ≤ 150ms * patient within 30 days of implant exclusion criteria: * patient who is, or will be, inaccessible for follow-up * patient with exclusion criteria required by local law * patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
postoperative pain in total knee arthroplasty: a comparison between general and spinal anesthesia

Conditions: Total Knee Replacement Surgery

Summary: total knee arthroplasty may be conducted either under general anesthesia or spinal block. previous studies have shown that spinal block leads to less complications. the investigators aim to find whether post-operative pain is also diminished under spinal block compared to general anesthesia

patients who will be registered for a total knee replacement in meir medical center and that will agree to participate in the study will be enrolled into one of two groups: the first, which will be the default choice for all patients, will be operated under a spinal block. patients who will ask specifically for general anesthesia, or those in which the anesthesiologist will prefer general anesthesia due to medical reasons will be enrolled into the second group. for both groups the surgeon will add intraoperative peri-articular infiltration of local marcaine injections, which was previously shown to diminish postoperative pain. the postoperative pain will be evaluated with the visual analogue scale at different point during the first 48 hours following operation. physiotherapy achievements will also be recorded. the investigators will try to find whether one of the two groups suffered less pain or had achieved better results in physical therapy.

Eligibility criteria:
inclusion criteria: * all patient who will undergo total knee arthroplasty exclusion criteria: * patients who will not agree to participate in the study * patients who will die during the research timeframe
risk factors for early acute lung injury after liver transplantation in children

Conditions: Acute Lung Injury; Liver Transplantation; Risk Factors

Summary: the goal of this observational study is to identify the risk factors for early acute lung injury (ali) after liver transplantation in children .the main questions it aims to answer are what the risk factors are for early ali in children and to evaluate the predictive value for the development of ali.participants will be divided into non-ali group and ali group according to whether they had ali in a week after liver transplantation.researchers will compare the difference between the two groups and use multivariate logistic regression analysis to screen the risk factors of ali, and receiver operating characteristic(roc) curve was used to evaluate the predictive efficacy of risk factors.

the goal of this observational study is to identify the risk factors for early acute lung injury (ali) after liver transplantation in children and evaluate the predictive value for the development of ali.perioperative data of patients were obtained through electronic case information management system, anesthesia surgery clinical information system and clinical research database. basic clinical data of children were recorded, including age, gender, alanine aminotransferase (alt), aspartate aminotransferase (ast), international normalized ratio (inr), childhood end-stage liver disease score (peld) and other indicators.the expression levels of serum microrna-122, microrna-21, s100a9,s100a8 ,follistim like protein 1(fstl1), tumor necrosis factor-α (tnf-α) and interleukin-1β(il-1β) were recorded immediately after induction of anesthesia (t1), 10 min at anhepatic stage (t2), 30 min at new hepatic stage (t3) and immediately after abdominal closure (t4). intraoperative fluid intake and outflow, alt, ast, and serum bilirubin peaks in the first week after surgery were recorded.murray score was used to determine whether ali occurred one week after surgery, and the children were divided into non-ali group and ali group. multivariate logistic regression analysis was used to screen the risk factors of ali, and roc curve was used to evaluate the predictive efficacy of risk factors.

Eligibility criteria:
inclusion criteria: * patient was diagnosed with biliary atresia * american society of anesthesiologists physical status ⅱ-ⅲ exclusion criteria: * secondary liver transplantation or other important organ injury before surgery * present with congenital airway or respiratory malformation * acute respiratory infection or respiratory insufficiency was present within 1 month before surgery * incomplete data

Keywords: acute lung injury liver transplantation micrornas follistatins-like protein 1 s100a9 protein
the effect of eye mask and music on sleep quality and delirium in patients monitored in intensive care unit

Conditions: Abdominal Surgery

Summary: after abdominal surgery, most patients experience problems such as respiratory complications, surgical wound infection, cardiac problems, renal failure, delirium, and insomnia, along with surgical trauma and underlying comorbidities. postoperative delirium (pod) is an adverse postoperative complication that can occur in patients of all ages, from children to the elderly. effective non-pharmacological treatment approaches for delirium include using an orientation board, calendar, clock, ensuring hydration, improving sleep quality, therapeutic activities, providing companionship of family members, and building private rooms. this study conducted as a randomized controlled and experimental study to determine the effect of eye patch and music on sleep quality and delirium in patients followed after abdominal surgery in the surgical intensive care unit. it was planned to include a total of 34 patients who underwent abdominal surgery, 17 in the experimental group and 17 in the control group.considering possible sample loss, the study was completed with 45 patients, 21 in the experimental group and 24 in the control group. during the data collection phase, the patient information form, richard-campbell sleep scale, nursing delirium screening scale and richmond agitation-sedation scale, were used.


Eligibility criteria:
inclusion criteria: * those who have had abdominal surgery * those who volunteer to participate in the research * those who are over 18 years old * richmond agitation-sedation scale -1, 0, +1 * those who have been in intensive care for at least 3 days * no communication problems (language, hearing impairment, etc.) * no mental problems * patients who do not use sleeping pills or sedating drugs and who do not have alcohol or substance addiction will be included in the study. exclusion criteria: * those who experience blood loss and fluid electrolyte imbalance after surgery * there are contraindications to the use of eye masks (for example, head trauma), * patients with delirium before or after surgery will not be included in the study.

Keywords: abdominal surgery delirium sleep quality eye patch music
lactoferrin in treatment of fe deficient anemia in cirrhosis

Conditions: Iron Deficiency Anemia; Chronic Liver Failure

Summary: iron deficiency and altered homeostasis due to inflammation and decreased iron utilization are main factors involved in anemia in liver disease. lactoferrin is a first line defence protein for protection against microbial infections and subsequent development of systemic disease as seen with systemic inflammatory response syndrome (sirs) and sepsis. lactoferrin with iron has been shown to be efficacious with anemia in chronic disease, in pregnancy and in cancer patients with fewer side effects than oral iron alone. high exposure to iron is associated with increased inflammation which is associated with worse cardiovascular outcomes. lactoferrin can help reduce the total iron dose and hepatic inflammation.

lactoferrin is a highly conserved, monomeric 80 kda single polypeptide chain contained in most mammalian exocrine secretions, such as milk, saliva and tears, bronchial, and intestinal secretions. ltf is also found in the secondary granules of neutrophils a glycoprotein present in milk, has been demonstrated to possess a multitude of biological functions. lactoferrin in inflammation and sepsis the antimicrobial activity of ltf is well documented and consists of two mechanisms: one is iron dependent and deals with high affinity of ltf to iron (bacteriostatic), and the other one is due to ltf affinity to lipopolysaccharide (lps) to function as a direct bactericidal agent for gram-negative organisms. small changes, such as single nucleotide polymorphisms, can affect outcomes against pathogenic agents . ltf interacts with cell surface receptors involved in "danger signal" recognition \[e.g., toll-like receptor (tlr)4, cd14, and cd22\]. at the molecular level, ltf seems to reduce lps-induced monocyte activation and subsequent production of pro-inflammatory mediators. lactoferrin in anemia in liver disease the hepatic expression of the hepcidin gene is regulated by signals which reflect body iron status and erythropoietic activity. the regulation of hepcidin by iron status includes a signal from the circulating transferrin via hepatocellular transferrin receptor (tfr2). like transferrin, lactoferrin will deliver iron to hepatocytes but unlike transferrin, lactoferrin cannot deliver iron to erythroid cells. lactoferrin does not interact with tfr1 or tfr2.

Eligibility criteria:
inclusion criteria: 1. age 18-75 years 2. either gender 3. patients with chronic liver disease with iron deficiency anemia with transferrin saturation\<20% and hemoglobin in non-pregnant women (15 years of age and above) \<12g/dl and in men \<13g/dl - exclusion criteria: 1. those who do not consent to participate in the study 2. inability to obtain informed consent from patient or relatives 3. severe preexisting cardiopulmonary disease 4. renal dysfunction (s. creatinine ≥ 2mg/dl) 5. pregnancy/lactation 6. post liver transplant patients 7. hiv infection 8. patients who are on psychoactive drugs, like sedatives or antidepressants 9. patients who are too sick to carry out the protocol
conservative treatment of acute appendicitis in children

Conditions: Appendicitis; Child

Summary: this is a feasibility study that will be performed at the astrid lindgren children´s hospital, karolinska university hospital, stockholm, sweden. it will involve 50 patients, randomized to either conservative, non-operative, treatment with antibiotics or surgery. the study will test an computerized randomization system, the availability of patients willing to participate in the trial and the trial protocol. the investigators will assess the characteristics of the patients who agree to participate in the study and those who do not. the investigators will explore short term outcome and design suitable long term outcome measures.


Eligibility criteria:
inclusion criteria: * children 5-15 years old with a clinical diagnosis of appendicitis that prior to the trial would have been subjected to a surgical intervention exclusion criteria: * suspicion of perforated appendicitis on the basis of generalized peritonitis * an appendiceal mass, diagnosed either by palpation or with radiology

Keywords: appendectomy nonsurgical treatment with antibiotics