Kornimate/medical-research-clean huggingface dataset:
supporting patient provider communication in paediatric care

Conditions: Cancer; Congenital Heart Disease

Summary: children with cancer or congenital heart disease (chd) experience complex, physical, psychosocial and behavioural symptoms and problems due to the illness, treatment, and medical procedures. to help children cope with their problems and prevent psychological distress, the investigators developed sisom, a support system to help children with cancer or chd report their symptoms and problems in an age-adjusted manner on a touch-pad, portable computer. this quasi-experimental study with 202 children age 7-12 with chd or cancer will test the following hypotheses: when children use sisom to report their symptoms and problems, and this information is provided to their clinicians in their outpatient consultations: * children and parents will experience less anxiety. * children and parents will be more satisfied with the outpatient visit. * there will be greater congruence between children's reported symptoms and problems and those addressed by their clinicians as evidenced in documented patient care. to better understand the mechanisms by which these effects may occur, the investigators will also explore: * differences between control and experimental groups in patient-provider communication in terms of instrumental and affective behaviour, participation, initiative and person addressed; * the relationships among outcomes of patient-provider communication, congruence between patients' reported symptoms and those addressed by their clinicians and children's and parents' anxiety and satisfaction; and how these relationships differ between treatment and control conditions. finally, the investigators will investigate time requirements, ease of use and usefulness of sisom by children and clinicians. for analyses the investigators will use inferential statistics and qualitative analyses of the video-taped consultation sessions. this study will contribute to improving patient-centred care for a particularly vulnerable population, and to a better understanding of the triadic communication and interactions among child-parent and clinician.


Eligibility criteria:
inclusion criteria: * between 7 and 12 years. * ethnic norwegian. * undergoing treatment for cancer or diagnosed with a congenital heart disease. exclusion criteria: * receiving or have received radiation the brain as this may affect their abilities to use sisom and communicate during consultations. * syndromes, mental retardation, developmental disorders, language disorders, or cognitive disorders that affect their ability to report symptoms or communicate during consultations. * other ethnic origin.

Keywords: symptom management symptom assessment patient satisfaction patient-provider communication
minimally invasive flap with platelet rich fibrin or growth factor enhanced matrix in treatment of intrabony defect

Conditions: Periodontal Regeneration

Summary: twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. group і treated by mist alone, group іі treated by mist + ethylenediamine-tetraaceticacid (edta) + prf and group iii treated by mist + edta + gem 21s. the clinical parameters including probing pocket depth (ppd), clinical attachment level (cal) and bleeding on probing (bop), were recorded at baseline, 3, 6 and 9 months post-surgery. cone beam computed tomography (cbct) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density

: twenty-one intra-bony defects in fifteen systemically healthy patients with moderate to severe chronic periodontitis were randomly classified into 3 groups, 7 sites each. group і treated by mist alone, group іі treated by mist + ethylenediamine-tetraaceticacid (edta) + prf and group iii treated by mist + edta + gem 21s. the clinical parameters including probing pocket depth (ppd), clinical attachment level (cal) and bleeding on probing (bop), were recorded at baseline, 3, 6 and 9 months post-surgery. cone beam computed tomography (cbct) was performed at baseline and 9 months post-surgery to evaluate bone level and bone density.

Eligibility criteria:
inclusion criteria: • presence of at least one tooth with ppd and cal loss of ≥ 5 mm associated with an intra-bony defect of ≥ 2 mm according to cortellini and tonetti, 2007 exclusion criteria: * patients with uncontrolled or poorly controlled diabetes, life-threatening conditions, or requiring antibiotic prophylaxis were excluded. * smokers * pregnant patients. * patients with aggressive periodontitis. * patients with multiple interconnected vertical defect walls.

Keywords: chronic periodontitis intra-bony defects minimally invasive surgical technique platelet rich fibrin, growth factor enhanced matrix 21s
alpha sitagliptin add on to metformin (0431-103)

Conditions: Diabetes Mellitus

Summary: canadian physicians to experience in real life clinical practice the efficacy and tolerability of adding sitagliptin to their patients who have their glycemic levels inadequately controlled while on metformin


Eligibility criteria:
inclusion criteria: patient is currently on monotherapy with metformin for at least 10 weeks prior to study entry
temodal (temozolomide) post marketing surveillance protocol (study p05557am2)

Conditions: Glioblastoma; Glioma; Astrocytoma

Summary: the purpose of this surveillance is to evaluate the postmarketing safety and efficacy of temodal capsule (temozolomide) under actual conditions of use, and to understand some of the following points that are in question and doubt: * incidence of adverse events under actual conditions of use (serious and nonserious adverse events); * adverse drug reactions not shown in the directions for use (will be stated as unexpected adverse reaction); * adverse event caused by misuse, abuse, or drug interactions; * other information concerned with safety or efficacy.


Eligibility criteria:
inclusion criteria: * participants who are prescribed with temozolomide by local labeling: * participants with newly diagnosed glioblastoma multiforme; * participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy. exclusion criteria: * n/a
influence of an inverse pressure ramp in long-term non-invasive ventilation on dyspnea in the morning after therapy

Conditions: Noninvasive Ventilation; Dyspnea

Summary: patients being treated with non-invasive home mechanical ventilation (niv) may experience morning dyspnea after each night of niv use, when the therapy is abruptly ended. this study aims to show that dyspnea intensity can be significantly reduced by a gentle niv therapy end, delivered by a continuously decreasing pressure level (inverse pressure ramp) after therapy end in the morning, a feature called softstopp, which can configured in prismavent niv devices. this could also improve therapy adherence.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of a chronic obstructive pulmonary disease (copd) with chronic hypercapnic insufficiency * therapy with prismavent 30, firmware v 3.3 or higher, mode s/t, stable device settings at the time of inclusion without need to adapt ventilation parameters * may have co-existing obstructive sleep apnea syndrome * subjective dyspnea ≥3 (borg scale) after end of ventilation therapy in the morning * written informed consent for study participation including data protection exclusion criteria: * missing written informed consent for study participation including data protection * contraindication for positive airway pressure therapy * use of the softstopp feature before study inclusion * participation in another study, which influences niv therapy by defining device settings or titration * concomitant oxygen therapy
tourniquet use in anterior cruciate ligament repair

Conditions: ACL - Anterior Cruciate Ligament Deficiency; ACL Injury; ACL Tear

Summary: the purpose of this study is to assess the intra-operative and post-operative effects of tourniquet use during acl reconstruction. we hypothesize that: 1. limited tourniquet use will not significantly impact arthroscopic visualization nor the time it takes to complete an acl reconstruction. 2. limited tourniquet use will lead to significantly less patient pain intra-operatively and in the immediate peri-operative period. 3. patients who undergo an acl reconstruction with limited tourniquet use will have earlier return of quadriceps functions as compared to those undergoing reconstruction with the use of a tourniquet.

type of study double-blinded randomized controlled clinical trial group 1 (control): patients undergoing patellar bone-tendon-bone autograft acl reconstruction with a tourniquet used for the duration of the case. group 2 (treatment/intervention, if applicable): patients undergoing acl reconstruction with a tourniquet used only during patellar bone-tendon-bone autograft harvest, for a maximum of 20 minutes.

Eligibility criteria:
inclusion criteria: 1. patients undergoing an arthroscopic assisted aclr using a bone-tendon-bone patellar tendon autograft. 2. 18 years or older 3. english speaking exclusion criteria: 1. concomitant procedures (e.g., osteotomy or other ligamentous reconstructions) other than chondroplasty, partial meniscectomy or meniscal repair 2. medical contraindications to epinephrine or txa use. 3. hemophilia or other predisposition for bleeding 4. does not follow study protocol in regard to regional anesthesia, txa, epinephrine use in the arthroscopy fluid and post-operative rehabilitation. 5. participation in physical therapy at any facility other than the orthocarolina randolph, matthews or south park locations
a study of the safety and efficacy of ustekinumab in adolescent patients with psoriasis (cadmus)

Conditions: Psoriasis

Summary: this is a study of the safety and efficacy of ustekinumab (cnto 1275) in adolescent patients with moderate to severe psoriasis.

this is a randomized (drug assigned by chance), double-blind (a medical research study in which neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, parallel (a medical research study comparing the response in two or more groups of participants receiving different treatments), multicenter of ustekinumab in adolescent participants with moderate to severe psoriasis. the total duration of study will be 60 weeks. the study will consists of 2 parts; a screening period and a treatment period. in treatment period participants will receive either ustekinumab half standard dosage, ustekinumab standard dosage or placebo. participants receiving ustekinumab half standard dosage and ustekinumab standard dosage at week 0, will receive placebo at week 12 and participants receiving placebo at week 0 will be randomly assigned to either ustekinumab half standard dosage or ustekinumab standard dosage weeks 12, 16, 28, and 40. primarily efficacy will be evaluated by physician's global assessment (pga) score of cleared or minimal disease. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * have a diagnosis of plaque-type psoriasis with or without psoriatic arthritis (psa) for at least 6 months * are candidates for phototherapy or systemic treatment of psoriasis * have screening laboratory test results within the study parameters exclusion criteria: * currently have nonplaque forms of psoriasis * have used any therapeutic agent targeted at reducing interleukin-12 (il-12) or interleukin-23 (il-23), including but not limited to ustekinumab and briakinumab * received conventional systemic therapies or phototherapy within the last 4 weeks * received biologic therapies within the last 3 months

Keywords: ustekinumab injection cnto 1275 stelara pediatric psoriasis adolescents
local anesthetics on postsurgical analgesia following posterior colporrhaphy

Conditions: Postoperative Pain

Summary: effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. the colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to urogynecology and gynecology is limited. the investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the walter reed national military medical center (wrnmmc) urogynecology clinic to study postsurgical pain control after posterior repair. there will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. subjects will be randomized to receive either 20 milliliter (ml) of plain bupivacaine or 20ml (10ml+10ml) mixture of bupivacaine plus exparel®. the primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. all subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. the investigators hypothesize a 30% difference in post-operative pain measurements between the two groups. additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups


Eligibility criteria:
inclusion criteria: * females \>18 years of age undergoing urogynecologic surgery involving the posterior vaginal wall mucosa or muscularis including posterior colporrhaphy at walter reed national military medical center. * patients must be able to read and understand written english or have an appropriate certified medical translator available. exclusion criteria: * known allergy to amide local anesthetics. * unstable cardiac arrhythmia. * hepatic impairment (including but not limited to patients under the care of their physician for severe hepatic disease, cirrhosis or hepatic cancer). * known pregnancy at time of surgery (pregnancy test morning of surgery if applicable). * regular use of narcotic pain medication, defined as use on most days of week at any time in the three months prior to surgery. * significant history of opioid or alcohol abuse or addiction (requiring treatment). * concurrent pain management requiring the use of epidural anesthesia.
outcomes of acute kidney injury in critically ill patients

Conditions: Acute Kidney Injury

Summary: this study to evaluate the frequency of acute kidney injury in critically ill patients in intensive care units.

acute kidney injury (aki) affects approximately 20% of hospitalized patients and up to 67% of those admitted to an intensive care unit (icu), making it among the most common organ dysfunctions among the critically ill . depending on severity, acute kidney injury (aki) contributes to short-perimortality rates between 40% and 70% , and survivors are at increased risk for chronic kidney disease (ckd) and late death. the diagnosis of acute kidney injury (aki) is only considered after achieving an adequate status of hydration and after excluding urinary obstruction; acute kidney injury (aki) is defined by the sudden decrease (in 48 h) of renal function, defined by an increase in absolute serum creatinine of at least (0.3 mg/dl) or by a percentage increase in serum creatinine ≥50% (1.5× baseline value), or by a decrease in the urinary output (documented oliguria \<0.5 ml/kg/h for more than 6hours). the purpose of this study was to benchmark the outcomes of acute kidney injury in a critically ill surgical patients.we hypothesized that renal dysfunction in this population is common and is associated with a significantly higher burden of morbidity, mortality, and resource utilization

Eligibility criteria:
inclusion criteria: • all patient with acute kidney injury in critical care units in luxor international hospital exclusion criteria: * patients on chronic dialysis * previous acute kidney injury * nephrectomy * organ transplant * chronic kidney disease
verrari - "are ventricular arrhythmic episodes reduced by rate response in icds?"

Conditions: Ventricular Fibrillation

Summary: "the purpose of this study is to evaluate the influence of the rate response function of implantable cardioverter defibrillators (icds) on the frequency of ventricular arrhythmias in patients with an icd."

"background: studies have shown that bradycardia and irregular heart rates may increase the incidence of ventricular arrhythmias. regularizing the heart rate and avoiding bradycardias by rate responsive pacing may be a way to reduce these arrhythmias. this is a prospective, open-label, randomized multicenter study. inclusion criteria: patients with an indication for an icd according to the aha/acc-guidelines who get a rate response system and have more than 5 % rate adaptive pacing during a one month screening phase may be included if they have given written informed consent. rate adaptive pacing must not be contraindicated, patients must be able to perform a 6 min walk test, must not be nyha iv and should have a life expectancy of more than 18 months. patients will be randomly assigned to 6 months of rate responsive pacing followed by 6 months of no rate responsive pacing, vice versa respectively. at 6 and 12 months follow ups, icd stored data, arrhythmic episodes, medication, anamnesis, quality of life, 6 min walktest, echocardiographic parameters and optionally spiroergomatry will be evaluated and compared."

Eligibility criteria:
inclusion criteria: * indication for an icd according to acc/aha guidelines * icd with rate response function implanted * at least 5% rate response ventricular pacing during the one month screening phase * signed informed patient consent" exclusion criteria: * rate responsive pacing contraindicated * patient not able to perform 6 min walktest * heart failure nyha iv * life expectancy below 18 months"
magnetic resonance imaging in obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: there is a fundamental gap in the investigators ability to design effective surgical treatment of obstructive sleep apnea (osa) for the 30-40% of patients who cannot tolerate non-surgical treatment. osa surgery outcomes vary widely, with the chances of a successful outcome ranging from 5% to 65% for individual or combination procedures. to predict - and thereby to improve - outcomes, the investigators must determine what predicts surgical success. this project will compare findings from two evaluations: drug-induced sleep endoscopy (dise) and upper airway magnetic resonance imaging (mri). dise has demonstrated important benefits, but it has important limitations. upper airway mri is the most complete evaluation performed during wakefulness, making it conducive to broad application and less expensive than dise, but there are no studies utilizing mri as a surgical evaluation. the investigators propose a cross-sectional analysis of 40 adult subjects with moderate to severe osa. in addition to history, physical examination, and polysomnogram (sleep study), all subjects will undergo dise and mri to characterize the pattern of obstruction. the investigators will examine the association between dise and mri, focusing on specific dise findings that have been associated with surgical outcomes. the investigators multidisciplinary team has substantial expertise and experience in osa investigation, dise, and upper airway mri.


Eligibility criteria:
inclusion criteria: * age ≥ 21 years; moderate to severe osa (ahi ≥15 events/hour) * body mass index \<40 kg/m2. exclusion criteria: * prior osa surgery * known neurologic, cardiac, pulmonary, renal, or hepatic disorders * psychiatric problems except for treated depression or mild anxiety * co-existing sleep disorder other than osa * other contraindication to dise or mri such as propofol allergy.

Keywords: obstructive sleep apnea sleep apnea
safety of optimal peep in nsicu patients

Conditions: Respiratory Failure; Intracranial Hypertension

Summary: the investigators aim to demonstrate that use of transpulmonary pressure to guide peep management is safe in patients with possible elevations of intracranial pressure.

purpose: to establish safety of titrating peep based on transpulmonary pressure as measured by an esophageal balloon in mechanically ventilated neurosurgical patients. participants: adult patients admitted to the neuro icu at unc hospital and requiring mechanical ventilation who have an intracranial pressure monitoring device in place. procedures (methods): all enrolled patients will have esophageal balloons placed with measurement of transpulmonary pressures. all patients will have baseline measurements recorded of intracranial pressure, cerebral perfusion pressure, and cerebral autoregulation. peep will then be titrated based on transpulmonary pressure measurements with recording of physiological measurements over the next hour. at the conclusion of the hour, all patients will be returned to their prior ventilator settings.

Eligibility criteria:
inclusion criteria: * adult patients (age \>/= 18) admitted to the neuro icu of unc hospital requiring mechanical ventilation and with icp monitoring in place. exclusion criteria: 1. pneumothorax or pneumomediastinum 2. life expectancy \< 24 hours or expected to require mechanical ventilation for \< 24 hours 3. condition that precludes placement of an esophageal balloon \[esophageal or nasopharyngeal pathology preventing insertion of the esophageal balloon catheter (esophageal ulcerations, tumors, diverticulitis, bleeding varices or in patients with sinusitis, epistaxis or recent nasopharyngeal surgery), severe thrombocytopenia (platelet count \ 3 or on oral anticoagulants). 4. pre-enrollment icp \> 20 mm hg 5. pre-enrollment cpp \< 60 mm hg 6. planned change in the external ventricular drain set point during the pre-intervention, intervention or post-intervention periods 7. incarceration 8. variation in icp of \> 2 cm h2o in the hour prior to intervention.
abt-450 with ritonavir and abt-267 and/or abt-333 with and without ribavirin in genotype 1 hepatitis c virus infected patients

Conditions: Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 1

Summary: this is a study of combination direct-acting antiviral agents (daa) with or without ribavirin (rbv) in patients with chronic hepatitis c virus (hcv).

a study to evaluate the safety and effectiveness of experimental drugs abt-450, abt-267 (also known as ombitasvir), abt-333 (also known as dasabuvir), ritonavir, and ribavirin in participants with hcv. the study will test the safety and effects of combinations of these drugs in treatments up to 24 weeks.

Eligibility criteria:
inclusion criteria: * males and females 18-70 years old, inclusive * females must be post-menopausal for more than 2 years or surgically sterile or practicing specific forms of birth control * chronic hepatitis c virus (hcv), genotype 1 infection * treatment-naive or null-responders to previous treatment with pegylated interferon (pegifn) and ribavirin (at least 12 weeks of treatment and failure to achieve a 2 log10 hcv rna decrease at week 12) * no evidence of liver cirrhosis exclusion criteria: * significant liver disease with any cause other than hcv as the primary cause * positive hepatitis b surface antigen and anti-human immunodeficiency virus antibody * positive screen for drugs and alcohol * significant sensitivity to any drug * use of contraindicated or prohibited medications within 1 month of dosing * abnormal laboratory tests

Keywords: hepatitis c genotype 1 hepatitis c interferon-free hcv chronic hepatitis c