Kornimate/medical-research-clean huggingface dataset:
is univalving or bivalving of long arm casts for forearm fractures necessary?

Conditions: Fracture of Shaft of Radius and/or Ulna; Metaphyseal Fracture of Bone of Upper Limb; Fracture of Upper Limb, Level Unspecified

Summary: this study aims to examine the need for univalve or bivalve splitting of casts in pediatric patients with forearm fractures following closed reduction and cast application in a randomized, prospective fashion.

following cast application, little is known regarding the need to split the cast, either in a univalve (a split along a single side of the cast) or bivalve (a split along both sides of the cast) fashion. theoretically, the splitting of the cast allows for expansion and soft tissue swelling. however, review of the literature yields a paucity of evidence demonstrating the efficacy of splitting a cast. in a study by nietosvaara et. al, a retrospective examination of 109 pediatric patients initially treated with closed cylindrical casting for closed forearm fractures were evaluated. of these 109 patients, one-sixth required the initial cast to be split, trimmed, or removed secondary to post-traumatic swelling. however, the splitting of a cast is not without risks in itself. once the initial swelling dissipates, a univalved or bivalved cast can become excessively loose. this loosening has been associated with a loss of reduction. if the loss or reduction is substantial, it may require a re-reduction or operation to correct. in addition, with every use of the cast saw a patient is placed at risk for iatrogenic cast saw injury. thermal burns and abrasions from cast saws can cause lifelong emotional and physical scars for a patient. they can also be an inciting event for litigation against the hospital and or provider, with settlements averaging greater than $12,000 per centimeter of cast saw injury.

Eligibility criteria:
inclusion criteria: * a closed isolated radial and/or ulna fracture of the forearm inclusive of metaphyseal and/or shaft level fractures. * forearm fractures that require closed reduction (with or without conscious sedation) * patients between the ages of 3 and 12 years old exclusion criteria: 1. specific exclusions * age less than 3 or greater than 12 * patients presenting with an associated neurological or vascular injury caused by the fracture * patients presenting with an open fracture * patients requiring operative treatment following the initial fracture evaluation * ipsilateral upper extremity fracture * patients intubated or with a pre-existing condition that prevents them from verbalizing symptoms of discomfort 2. generic exclusion: "subjects not meeting all inclusion criteria."

Keywords: fracture of the upper limb
scandinavian multicentre acute subdural hematoma (smash) study

Conditions: Acute Subdural Hematoma

Summary: in a multi-national population-based cohort, the investigators want to compare the clinical course and clinical outcome of elderly patients (≥70 y/o) compared with younger patients (\< 70 y/o) with acute subdural hematoma treated surgically. an improved understanding of the clinical outcome and the prognostic factors of acute subdural hematomas would allow physicians to make better decisions about treatment options in traumatic asdh in the elderly population.

primary endpoint: in a population based study to evaluate 30-day mortality (perioperative death) in younger versus elderly (≥70 years) patients with asdh. secondary endpoint(s): 1. describe pattern of care in younger versus the elderly 2. clinical outcome (glasgow outcome scale at 6-months (range, 3-12) follow-up in younger versus elderly (≥70 years) patients with asdh: * good outcome predefined as gos 4-5 * unfavourable outcome predefined as gos 1-3 3. 30-day morbidity (according to the ibanez classification) in younger versus elderly (≥70 years) patients with asdh. 4. to assess the effect of age as an independent prognostic factor in traumatic asdh for outcome (gos) in the elderly (≥70 years) using a three-step approach 1. match elderly (cases) with younger (controls) patients with respect to 1. gcs at admission to treating hospital according to severity - mild (gcs 14-15), moderate (gcs 9-13), severe (gcs 3-8) 2. midline-shift (with a cut off of \> 10 mm) 3. dilated pupil(s) (yes/no) 2. using a multivariable approach with all patients including age (continuous model) to identify independent predictors of an unfavourable outcome (gos 1-3) 3. using a multivariable approach including age as a continuous variable within the elderly population (≥70 years) to identify independent predictors of an unfavourable outcome among the oldest (gos 1-3)

Eligibility criteria:
inclusion criteria: * surgically treated asdh patients exclusion criteria: * post-operative asdh (i.e. inclusion criteria post-traumatic) * intracranial surgery within 6 months prior to trauma * permanent intracranial device (i.e dbs electode, vp shunt etc.)
the effect of postoperative therapy on the quality of life of patients with early cervical cancer research

Conditions: Uterine Cervical Neoplasms

Summary: the purpose of this study is to assess the women's quality of life, who accepted chemotherapy,radiotherapy, concurrent radiochemotherapy or who didn't accept therapy, after operation.

the study projects to follow up 180-200 early stage cervical cancer patients after operation and assess the women's quality of life by the scales: ecog, functional assessment of cancer therapy, euroqol-5 dimensions, and kupperman index.

Eligibility criteria:
inclusion criteria: * ≮ 18 years, cervical cancer verified by pathology， * iia stage, accepted the operation ( piver iii and pelvic lymph node dissection) as initial therapy， obtained the patient's agreement exclusion criteria: * the patient had accepted chemotherapy or radiotherapy before operation
redirected hbv-specific t cells in patients with hbv-related hcc (safe-t-hbv)

Conditions: Hepatocellular Carcinoma

Summary: this is a single center, single arm and open-label study to determine the safety of mrna modified hbv-tcr redirected t-cells and to analyze the changes in tumor microenvironment caused by these hbv-tcr redirected t-cells in subjects with hbv-related hcc who are not amenable to/failed conventional treatment.


Eligibility criteria:
key inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status ≤1 2. presence of primary hepatocellular carcinoma in the liver with presence of measurable tumour by recist 1.1 criteria, that is not amenable to, or failed, conventional treatment options 3. serum hbsag positivity 4. non-cirrhotic or compensated cirrhosis child-pugh a (5 - 6 points) 5. life expectancy of at least 3 months 6. hla class 1 profile matching hla-class i restriction element of the available t cell receptors (restricted by either hla-a\*02:01 or hla-a\*24:02). key exclusion criteria: 1. brain metastasis 2. second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or stage i uterine cancer and superficial bladder tumors 3. use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (tki) within 5 half-lives of the drug prior to baseline liver biopsy procedure 4. alterations of concomitant medications which could potentially cause drug induced liver injury and affect liver biopsy result within 3 months of baseline liver biopsy procedure. 5. likelihood to require any immunosuppressive treatments during the period of the clinical trial. 6. 7. last rfa/tace treatment within 3 months prior to first liocyx-m infusion; last y90 therapy treatment within 6 months prior to first dose of mrna hbv/tcr t-cells 7. decompensated cirrhosis child-pugh b or c (7 - 15 points) 8. concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy. 9. use of any investigational product (ip) or investigational medical device within 30 days of study drug administration 10. serum hbv dna levels ≥ 200 iu/ml at screening 11. serum hbsag levels ≥ 10,000 iu/ml at screening 12. lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples 13. any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation 14. women who are pregnant or breast-feeding

Keywords: hepatitis b virus hepatocellular carcinoma
acceptance and commitment therapy versus cognitive therapy for the treatment of major depressive disorder

Conditions: Major Depressive Disorder

Summary: the study will investigate the effectiveness of cognitive therapy and acceptance and commitment therapy in a randomized controlled trial among patients with major depressive disorder in routine clinical practice. furthermore, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism.

the current study aims at investigating the effectiveness of cognitive therapy and acceptance and commitment therapy in a randomized controlled trial among patients with mdd in routine clinical practice. further, the study will investigate whether each specific treatment approach is mediated by its proposed theoretical mechanism. patients have to meet diagnostic criteria for nonpsychotic mdd as determined by the structured interview for dsm-iv. each client will receive either cognitive therapy or acceptance and commitment therapy that will last between 16 to 20 sessions. based on previous results, it is expected that both treatment forms will prove beneficial for the patients.

Eligibility criteria:
inclusion criteria: 1. meeting dsm-iv criteria for mdd 2. between the ages of 18 and 65-years-old 3. having sufficient fluency in dutch to complete treatment and research protocol exclusion criteria: 1. dsm-iv criteria for bipolar disorder (past or present) 2. psychotic disorders 3. substance dependence disorders (current or within the past 6 months), or 4. organic brain syndrome. 5. borderline or antisocial personality disorder
the effect of soursop supplementation on blood pressure, serum uric acid and kidney function in prehypertensive patients

Conditions: Blood Pressure; Prehypertension; Uric Acid

Summary: this study was a randomized controlled trial study. the aim of this study was to determine the effect of soursop fruit supplementation on blood pressure (bp), serum uric acid (sua), and kidney function. the definition of prehypertension and hypertension was accepted as delivered in the seventh report of the joint national committee (jnc 7) as the systolic bp was 120 - 139 mmhg and diastolic bp was 80 - 89 mmhg for prehypertension, while systolic bp ≥ 140 mmhg or diastolic bp ≥ 90 mmhg for hypertension. based on the study by sja'bani (2014), the cut-off point of (sua) was divided into 3 categories, which are normal (\< 5 mg/dl), high-normal (5 - \<7 mg/dl), and high (≥ 7 mg/dl). a number of 143 people with essential prehypertension and high normal uric acid level were assigned as subject in this study. subjects were randomly assigned into two groups which are treatment and control group. for a 3 months period, the treatment group was given 2x100 g soursop fruit juice per day and the control group was left without treatment. blood pressure was measured by medical team using omron hem-907 (digital automatic blood pressure monitoring) every 2 weeks (3 times readings for each) in each subject's home. subjects were examined in sitting position. evaluation of laboratory examination was taken at week 0, 7 and 13.


Eligibility criteria:
inclusion criteria: 1. pre-hypertensive patients in accordance with jnc 7 (joint national committee 7) criteria, 2. male or female resident in mlati, sleman with or without family history of hypertension, 3. age 30-59 years, 4. high normal uric acid levels (≥ 5 and \< 7 mg/dl) and 5. agreed to follow the study by giving their informed consent. exclusion criteria: 1. have a history of diabetes, chronic renal failure, 2. using hormonal contraceptive, 3. in pregnancy, 4. taking uric acid-lowering drugs (allopurinol, probenecid), 5. positive urine reduction, positive proteinuria, creatinine \> 1.5 g/dl, blood glucose \> 126 g/dl.

Keywords: soursop supplementation prehypertension uric acid randomized controlled trial
a study of the safety and efficacy of tacrolimus inhalation aerosol in subjects with persistent asthma

Conditions: Asthma

Summary: the purpose of this study is to determine the safety and effectiveness of tacrolimus inhalation aerosol in subjects with persistent asthma.

the purpose of this randomized, double-blind, placebo-controlled, parallel-group, multi-center designed trial is to determine the safety and efficacy of tacrolimus inhalation aerosol in subjects with persistent asthma.

Eligibility criteria:
inclusion criteria: * diagnosis of persistent asthma for at least 6 months * require use of beta-agonists at least four times per week exclusion criteria: * diagnosis of chronic obstructive pulmonary disease (copd)

Keywords: treatment effectiveness treatment efficacy investigational, therapies asthma antiasthmatics antiasthmatic agents
paroxysmal atrial fibrillation in patients with acute ischemic stroke

Conditions: Ischemic Stroke; Paroxysmal Atrial Fibrillation; Premature Atrial Complexes

Summary: the purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of premature atrial complexes and new diagnosed atrial fibrillation. furthermore to evaluate the prognostic significance of brief runs of premature atrial complexes in relation to develop atrial fibrillation, recurrent stroke/transient ischemic attack and death.

stroke is the second leading cause of death worldwide and it is well known that atrial fibrillation(af) is a major risk factor for ischemic stroke. paroxysmal af can be difficult to detect because many cases are asymptomatic. in recent years prolonged cardiac rhythm monitoring of patients with ischemic stroke has showed an underestimated prevalence of af. however, no optimal monitoring strategy is implemented in the clinic yet. this is the reason why research currently is focused on finding predictive risk markers of af. cohort studies of healthy individuals and stroke patients have shown that excessive premature atrial complexes (pacs) and brief runs of pacs are an emerging risk marker in helping to identifying patients in risk of having or developing af. despite this brief runs of pacs less than 30 s are today in everyday clinical practice perceived to be of no clinical significance. the study population of ischemic stroke patients have all without known af underwent ecg and 48 hours' inpatient cardiac telemetry as a clinical routine. in the medical record it is registered if patients had runs of pacs or new diagnosed af. all patients are registered in the danish stroke registry, and all the baseline data on patients will be obtained from the registry. the follow-up end august 2015 and information on af, recurrent stroke and death will be obtained from medical records and the funen patient administrative system, which is linked to the national civil registration system. the purpose of this study is to estimate the clinical relevance of monitoring patients with acute ischemic stroke with 48 hours' inpatient cardiac telemetry in relation to evaluate the presence of brief runs of pacs and new diagnosed af. furthermore to evaluate the prognostic significance of brief runs of pacs in relation to develop af and the prognostic significance of brief runs of pacs and af in relation to recurrent stroke and death.

Eligibility criteria:
inclusion criteria: * admitted with ischemic stroke from august 2008-april 2011 * registered in the danish stroke registry exclusion criteria: * hemorrhagic stroke * no danish civil registration * no permanent address in denmark during follow-up. * patients with lack of telemetry data

Keywords: stroke ischemic stroke recurrent stroke atrial fibrillation premature atrial complexes heart rhythm monitoring cardiac telemetry
influence of two different preloaded intraocular lens (iols) on posterior capsule opacification

Conditions: Cataract

Summary: studies showed that a sharp posterior optic edge of an intraocular lens (iol) inhibits migration of lens epithelial cells in between posterior capsule and optic of the iol and therefore reduces the rate of posterior capsule opacification (pco). in present time most iols implanted have a sharp posterior optic edge. due to differences in iol production different iols have different rates of pco. progression in cataract surgery technique allow phacoemulsification through micro-incisions. therefore there is need for iols that can be implanted through incisions of about 2.5 mm. this study investigates the effect of two different hydrophobic acrylic iols with a sharp posterior optic edge on the rate of pco after implantation through a micro-incision. the results will be compared intraindividually.

prospective, randomized, bilateral study with intraindividual comparison, implantation of a polylens y10 iol in one eye and implantation of a polylens y30 in the contralateral eye. pco rate will be detected at 1 year and 2 years.

Eligibility criteria:
inclusion criteria: * bilateral age-related cataract * age 55 to 80 years * expected postoperative visual acuity of at least 0.5 exclusion criteria: * amblyopia * corneal scars * diabetes * pseudoexfoliation-syndrome * earlier ocular surgeries or laser treatments * intraocular tumors

Keywords: posterior capsule opacification micro incision sharp optic edge
development and feasibility testing of an advanced practice physiotherapy role in chronic pain management

Conditions: Chronic Pain

Summary: the current study is intended to evaluate the feasibility of conducting a future trial to evaluate the effects of implementing an advanced practice physiotherapist (app) role within a chronic pain clinic setting.

this line of research ultimately seeks to assess the impact of integrating an app as the first point of contact within interprofessional chronic pain clinics on patient health outcomes, care provided to patients, chronic pain clinic flow, and cost-utility in comparison to usual physician or nurse practitioner-led care. the primary objectives of the feasibility study are: 1. to determine the feasibility of implementing the trial methods by evaluating participant recruitment rates, retention, and assessment completion at each of four follow-up time-points over a 12-month period. 2. to determine the feasibility of implementing the new app model of care by monitoring the care provided and treatment fidelity. 3. to explore the perspectives of participants and health care providers related to the acceptability of the app role; barriers, facilitators, and strategies for refining implementation; and perceived impact on clinic processes and outcomes.

Eligibility criteria:
inclusion criteria: * chronic musculoskeletal pain (pain \> 3 months in duration) (e.g., neck pain, thoracic pain, limb pain, low back pain) -or- * chronic widespread pain (e.g., fibromyalgia, myofascial syndrome) -and- * 18 years of age or older -and- * must be able to read, write, and speak english exclusion criteria (as identified in referral package): * primary reason for referral stated as medication change or interventional pain management (e.g., injections, nerve block) * primary reason for referral is stated as headache or migraine. * reason for referral is chronic pelvic pain * referral includes information that patient has an untreated addiction, mental health disorder, or substance use disorder * referral indicates cancer-related pain * referral indicates medical "red flags" suggestive of non-musculoskeletal etiology of symptoms (e.g., unexplained symptoms, sudden weight loss, urinary retention, saddle anesthesia, evidence of upper motor neuron lesion, or fever) * referral states visceral pain or abdominal pain.

Keywords: feasibility study
the accuracy of pediatric air test as a non-invasive atelectasis diagnostic tool

Conditions: Lung Collapse; Lung Diseases; Atelectasis; Atelectasis Without Respiratory Distress Syndrome; Atelectases, Resorption; Air Test; Pediatric Disorder

Summary: hypothesis: during anesthetic pre-oxygenation with high fio2, pulmonary atelectasis occur, especially in patients \< 6 years old, where frc and pulmonary closing volume may overlap. new borns and children \<1 year old are especially vulnerable. objectives: 1. validate "air test" as a individualized and non-invasive diagnostic method of clinically significant atelectasis in pediatrics. 2. determine what other factors contribute to atelectasis development in pediatrics methods: 30 pediatric patients will be studied with ages ranged between 45 postconceptional weeks and16 years old. baseline spo2 and lung ultrasound will be performed for each patient upon arrival at the operating theatre before preoxygenation with fio2 of 1.0 spo2 will be measured 15 min after intubation during a 5 min long "air test" trial (fio2 0.25). lung collapse will be verified by lung ultrasound at the end of the 15 min trial. lung collapse will be eventually granted upon lung us verification by a blind researcher.


Eligibility criteria:
inclusion criteria: * general anesthesia * perioperative risk classification (asa) i, ii, iii * newborns (postconceptional age\> 45 weeks) to 16 years * need for oral / nasotracheal intubation exclusion criteria: * asa \> iii * basal spo2 \< 97% on air in supine position * preoperative need for oxygen therapy and / or high-flow nasal cannulas * expected difficult airway * presence of craniofacial disorders that may compromise ventilation * hemodynamic instability and / or need for inotropics * history of untreated heart disease * presence or history of pneumothorax * presence of untreated congenital pulmonary disorders * refusal to participate in the study

Keywords: air test atelectasis pediatric non-invasive lung collapse
the effectiveness and safety of dupilumab in children with asthma in china: a real-world study

Conditions: Asthma in Children

Summary: observe the changes of type ii inflammation markers, lung function, and symptom scores in asthmatic patients aged 6 to 14 during the use of dupilumab to analyze its efficacy.


Eligibility criteria:
inclusion criteria: enrolled patients were required to have been on regular ics-laba therapy for at least 3-6 months without adequate control. the attending physician evaluated these patients as having type 2 inflammatory asthma based on factors such as feno (fractional exhaled nitric oxide) levels ≥ 20, sputum eosinophils (eos) percentage ≥ 2%, and/or blood eos count ≥ 300/μl. all children were prescribed with dupilumab during the study period. exclusion criteria: patients with conditions other than asthma receiving treatment with dupilumab, individuals currently using other biologics or undergoing sublingual or subcutaneous immunotherapy, active parasitic infections, and children with immunodeficiency were excluded.

Keywords: type 2 inflammation asthma dupilumab