Kornimate/medical-research-clean huggingface dataset:
simvastatin gel with perforated resorbable membranes in treatment of intrabony defects in chronic periodontitis

Conditions: Chronic Periodontitis

Summary: modified perforated membrane (mpm) is considered as a modality that could enable participation of periosteal cells and gingival stem cells which could improve the outcomes of guided tissue regeneration more than the use of the traditional occlusive membrane (om). simvastatin (smv) modulates bone formation by increasing the expression of bone morphogenetic protein 2 and angiogenesis. ethylenediaminetetraacitic acid (edta) found to be effective as low ph etchant for smear layer removal and exposing root surface collagen. the investigators compared the clinical and radiographic outcome of smv gel combined with mpm to smv gel combined with om with and without an associated edta gel root surface etching for improving bone regeneration in intrabony defects in chronic periodontitis patients. moreover, evaluation of smv gingival crevicular fluid (gcf) levels availability for 30 days in cases with and without edta root surface etching was performed.

forty patients with 40 intrabony defects having chronic periodontitis were randomly assigned into four equal groups to receive open flap procedure, 1.2% smv gel and covering the defect with om (group i), open flap procedure, 1.2% smv gel and covering the defect with mpm (group ii), open flap procedure, 24% edta root surface etching,1.2% smv gel and then coverage of the defect by om (goup iii), or open flap procedure, 24% edta root surface etching, 1.2% smv gel and then coverage of the defect by mpm (group iv). plaque index, gingival index,probing pocket depth, clinical attachment level, defect base level, crestal bone level, and radiodensitometric measurements were measured at baseline and reassessed at 6 and 9 months after therapy. additionally, gcf was collected from group i, ii, iii and iv at 1,7,14, 21, and 30 days in order to evaluate smv availability and the effect of edta root surface etching on its availability using high-performance liquid chromatography(hplc).

Eligibility criteria:
inclusion criteria: * patients were all healthy and free from any systemic disease. * no history of antibiotic therapy or periodontal treatment for at least six months preceding the study. * patients were willing and able to return for multiple follow up visits. * periodontal defects with 1. probing depth \> 5 mm. 2. clinical attachment loss \>4 mm. 3. standardized radiographic evidence of interproximal intrabony defect using periapical radiograph. * good level of oral hygiene (plaque and gingival indices score after initial phase therapy should be less than one). exclusion criteria: * pregnancy, lactation for female patients. * smokers, alcoholics and those receiving any medication that could affect healing of soft tissue and bone as steroids and cyclosporines. * history of allergic reaction to the medications used. * vulnerable groups and handicapped.

Keywords: guided tissue membranes edta simvastatin
maternal screening and antiviral therapy in pregnant women to reduce mother-to-infant transmission of hepatitis b virus

Conditions: Hepatitis B Virus Infection

Summary: to investigate the efficacy of using antiviral therapy in third trimester of pregnancy to reduce mother-to-infant hbv transmission, and to access the safety of such treatment for mothers and infants.

this is a multi-centered study conducted in 12-16 collaborative hospitals in taiwan, using tenofovir as antiviral therapy to reduce mother-to-infant transmission. the study group recruited pregnant women at 2nd to 3rd trimester receive tenofovir disoproxil fumurate (tdf) 2011-2018, june, and receive tenofovir alafenamide (taf) 2018-2021. control group did not receive antiviral treatment. both group receive mother and infant follow-up up to 12 months after delivery.

Eligibility criteria:
inclusion criteria: * women aged 20-45 years in 28 to 32 weeks of pregnancy * positive hbsag and hbeag * serum viral load above 6 log10 iu/ml exclusion criteria: * major systemic disease of the mother or fetus * positive anti-hiv or anti-hcv * under treatment of antiviral therapy * pregnant woman whose ultrasonographic examination reveals congenital anomaly of the fetus * pregnant woman whose amniocentesis reveals any genetic abnormality
companion pharmacogenetic study to umcc 9900/9901

Conditions: Metastatic Breast Cancer

Summary: the purpose is to examine the original breast tumor material to see how much of a metabolizing enzyme (cyp3a4) is present in tumor material. the researchers want to see if this is in any way associated with how the patient responded to docetaxel. they also want to examine the genes in the tumor that are responsible for the production of cyp metabolizing enzymes, to see if they are normal or if they have polymorphisms, or change compared to 'normal' cyp metabolizing enzymes.


Eligibility criteria:
inclusion criteria: * patients who participated on umcc 9900/9901 * living patients must give written informed consent exclusion criteria: * no tumor block tissue available

Keywords: patients who participated in umcc 9900/9901 (phase ii studies of tailored-dose docetaxel in metastatic breast cancer)
pact involvement in cardiology patients

Conditions: Machine Learning; Cardiovascular Outcome; Pediatric Palliative Care; Pediatric Cardiology

Summary: the goal of this trial is to determine the effectiveness of a machine-learning (ml) model predicting a serious cardiac event within the next three months, when compared pre- versus post-deployment, in pediatric cardiac inpatients. the main questions it aims to answer are whether deployment of the ml model: 1. increases pact consultation within the next three months among admissions without pact involvement in the previous 100 days 2. increases pact consultation or visit within the next three months among those who experience a serious cardiac event during this period 3. decreases time to pact consultation or visit among those seen by pact during this period 4. decreases the incidence of death in the intensive care unit (icu) 5. increases documentation of goals of care high-risk cardiology patients will be identified by an ml model each morning. if the patient has been seen by the pact team within the past year, the update will go to the pact team members. if the patient hasn't been seen by the pact team, the email will be sent to the cardiology physician in charge of the patient. this physician will decide whether a pact consultation is necessary based on their clinical judgment. if so, a referral will be made using the usual process. outcomes of the identified patients will be compared pre- and post-deployment.

at the hospital for sick children (sickkids), the collaboration between cardiology and palliative care is much stronger than other centers, with routine involvement in patients being considered for heart transplant. despite this, earlier involvement of palliative care would be advantageous. our cardiology co-investigators identified patients who would benefit from earlier palliative care team involvement as those receiving advanced heart therapies (defined as ventricular assist device (vad) and being wait listed for heart transplant) and those who die. the study team created a clinical deployment environment named sickkids enterprise-wide data in azure repository (sedar). \[1\] sedar is a modular and robust approach to deliver foundational data that is re-usable across multiple ml projects. it offers validated ehr data in a standardized and curated schema. ml is a promising approach to identify cardiac patients at the highest risk of these serious cardiac outcomes who may benefit from earlier palliative care team involvement. to assess the effectiveness of this approach, patient outcomes will be compared pre- and post-deployment of the ml model. the pre-period will include patients admitted for a 12-month period before deployment (starting 15 months prior to deployment). the post-period will include patients admitted for a 12-month period following deployment starting 3 months post-deployment start.

Eligibility criteria:
inclusion criteria: * pediatric inpatients admitted to cardiology exclusion criteria: * expected to be discharged prior to midnight on the day of admission

Keywords: quality of life cardiovascular outcomes machine learning prediction models pediatric
lipoic acid to treat chronic inflammatory demyelinating polyneuropathy

Conditions: CIDP; Chronic Inflammatory Demyelinating Polyneuropathy

Summary: the purpose of the study is to examine if alpha lipoic acid is an effective treatment for chronic inflammatory demyelinating polyneuropathy (cidp).

chronic inflammatory demyelinating polyneuropathy (cidp) is a progressive disease leading to paralysis. cidp is an immune-mediated disorder resulting from a synergistic interaction of t cell-mediated and b cell-mediated immune responses directed against peripheral nerve antigens. these immune mediated responses in turn increase the production of reactive oxygen intermediate and cause oxidative damage of the peripheral nerve system. although corticosteroids, plasma exchange, and intravenous immunoglobulin (ivig) reduce impairment caused by cidp at least temporarily and can be used as a first-line treatments, they are not ideal for long-term treatment because of serious side effects and cost. alpha lipoic acid (la) is an antioxidant that also possesses anti-immune activity. it is effective in treating diabetic neuropathy. it is also promising in treating patients with multiple sclerosis.

Eligibility criteria:
inclusion criteria: * diagnosis of cidp * on a stable dose of immunotherapy for at least 3 months before enrolling in the study exclusion criteria: * myelopathy or evidence of central demyelination * persistent neurological deficits from stroke, cns trauma, or peripheral neuropathy from other causes (eg, diabetes mellitus, igm, paraproteinaemia, or uraemic, toxic, or familial neuropathy) * evidence of systemic disease that might cause neuropathy * heart diseases (congestive heart failure or arrhythmia) * pulmonary conditions (asthma or cipd) * rheumatoid conditions (such as rheumatoid arthritis) * renal failure

Keywords: neuropathy, lipoic acid
effects of mirror neurons stimulation on motor skill rehabilitation in children with cerebral palsy

Conditions: Children With Spastic Diplegia, Between the Ages of 2 to 10 Years; Gross Motor Function Classification System (GMFCS) Level I,II and III

Summary: this study aimed to develop video compact disc (vcd) program that applying the concept of imitative learning with mirror neurons stimulation on standard rehabilitation technique in children with cerebral palsy. the author will also examine effectiveness of the program by compare the motor function measured by the gross motor function measure (gmfm-66) between conventional physical therapy and the mirror neurons stimulation based vcd program for six months.

a randomized controlled trial was performed with thirty children with cerebral palsy recruited from thammasat university hospital and rajanukul institute. informed consent was obtained from the participants' parents before participation in this study. the participants were randomly assigned according to the randomization list to receive either the mirror neurons stimulation based vcd program and practice at home or conventional physical therapy for six months. the participants in the experiment group received the mirror neurons stimulation based vcd program and practice at home three times a day for six months. concerning the control group, the participants received conventional physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. both experimental and control groups were measured their motor functions with gross motor function measure (gmfm-66).

Eligibility criteria:
inclusion criteria: * children with cerebral palsy aged between 2-10 years old * gmfcs level of one to three * able to verbal instruction * sitting are performed without assistance * standing and walking are performed with adult assistance * no severe limitation of joint movement exclusion criteria: * the children were received orthopedic intervention or botulinum toxin injection within 6 months * seizure * other conditions that prevent children from participate in research project * severe visual and hearing deficits

Keywords: children with cerebral palsy gross motor function measure imitative learning mirror neuron action observation conventional physical therapy
a phase ii randomized, double-blind, two-period cross-over study to evaluate the pharmacokinetics, safety and tolerability of a liquid formulation of palizvizumab (medi-493, synagis)

Conditions: -Unhealthy Children With a History of Prematurity

Summary: a total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence a or b.

phase ii, double-blind, two-period, cross-over study to be conducted at 20 sites the u.s. a total of 150 children who meet the entry criteria will be randomized 1:1 to receive one of the following treatment sequence: sequence a (single dose of the liquid formulation on study day 0 and a single dose of the lyophilized formulation on study day 30) or sequence b (single dose of the lyophized forumation on study day 0 and single dose of the liquid formulation on study day 30). children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.

Eligibility criteria:
inclusion criteria: * the child must have been born at greater than or equal to 35 weeks gestation and be greater than or equal to 6 months of age at the time of randomization (child must be randomized on or before their 6-month birthday) * the child's parent or legal guardian must provide written informed consent; and * the child must be able to complete the follow-up visits on study days 30 and 60 within the protocol specified windows (±2 days) * parent/legal guardian of patient has available telephone access. exclusion criteria: * be hospitalized; * birth hospitalization \> 6 weeks duration; * be receiving mechanical ventilation at the time of study entry (including cpap); * bronchopulmonary dysplasia (bpd), defined as history of prematurity and associated chronic lung disease with oxygen requirement for \>28 days; * congenital heart disease (chd). (children with medically or surgically corrected \[closed\] patent ductus arteriosus and no other chd may be enrolled.) * known renal impairment, hepatic dysfunction, chronic seizure disorder, or immunodeficiency; * any of the following laboratory findings in blood obtained within 7 days prior to study entry: * bun or creatinine \>1.5´ the upper limit of normal for age * ast (sgot) or alt (sgpt) \>1.5´ the upper limit of normal for age * hemoglobin \<9.0 gm/dl * white blood cell count \<4,000 cells/mm3 * platelet count \<110,000 cells/mm3 * acute illness or progressive clinical disorder; * history of recent difficult venous access; * active infection, including acute rsv infection; * previous reaction to igiv, blood products, or other foreign proteins; * received within the past 120 days or currently receiving igiv, other immunoglobulin products, or any investigational agents; * have ever received palivizumab; * currently participating in any investigational study; or * previously participated in any investigational study of rsv vaccines or monoclonal antibodies.
botulinum toxin injection in epicardial fat pads to treat atrial fibrillation after cardiac surgery

Conditions: Paroxysmal Atrial Fibrillation; Indications for CABG

Summary: the aim of this prospective randomized double-blind study was to compare the efficacy and safety of botulinum toxin injection in epicardial fat pads for preventing recurrences (in early postoperative period) of atrial tachyarrhythmia in patients with paroxysmal atrial fibrillation undergoing coronary artery bypass graft (cabg) surgery.


Eligibility criteria:
inclusion criteria: * paf * indication for cabg according to the american college of cardiology/american heart association (acc/aha) guidelines for cabg surgery exclusion criteria: * previous heart surgery and af ablation procedure * emergency cabg * unstable angina or heart failure * persistent af, af at the time of screening (planned maze procedure or pulmonary vein isolation) * use of i or iii antiarrhythmic drugs within 5 elimination half-lives of the drug (or within 2 months for amiodarone) * requiring concomitant valve surgery * left ventricle ejection fraction \<35% * left atrial diameter \>55 mm * unwillingness to participate
15-day repeated-dose study with sb-649868 and its interaction with cyp3a4 isoenzyme in healthy male subjects.

Conditions: Sleep Initiation and Maintenance Disorders

Summary: subjects will be screened within 28 days, simvastatin dose and single sb-649868 dose 10 and 7 days prior to repeat dosing respectively, 15 days sb-649868 repeat dosing with safety and cognition function tests.


Eligibility criteria:
inclusion criteria: * healthy adult male subjects aged between 18 and 65 years of age inclusive. * body weight =50 kg and bmi within the range 18.5-29.9 kg/m2 inclusive. * healthy as judged by responsible physician. no clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ecg. a subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the investigator and the medical monitor considers that the finding will not introduce additional risk factors and will not interfere with the study procedures. * subjects will have blood pressure measurements within the normal range for healthy volunteers. exclusion criteria: * the subject has a positive pre-study urine drug/ alcohol urine screen. * a positive pre-study hepatitis b surface antigen, hepatitis c antibody, or hiv 1/2 result at the screening visit. * abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units. * subject complains of sleep disturbances and/ or is receiving treatment for sleep disorders.

Keywords: sb-649868, simvastatin repeated dose,
study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin to muscle depth (stmd)

Conditions: Anaphylaxis

Summary: a single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects

a single dose, open label, randomized cross-over study to explore the pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (stmd) of the thigh after injections with four different marketed auto-injectors

Eligibility criteria:
inclusion criteria: 1. healthy male and female subjects, between 18 and 54 years of age (inclusive). 2. subjects who are able and willing to give written informed consent. 3. body mass index (bmi) between 28.0 and 40.0 kg/m² (inclusive). weight on day -1 may not have changed by more than 3 kg compared to screening. 4. compressed stmd of 10 mm and above (part 1+2). 5. non-smoker for at least 6 months. exclusion criteria: 1. receipt of medication (prescription or non-prescription) within 14 days prior to the planned drug administration, except for occasional use of paracetamol or ibuprofen. 2. receipt of any of the following medications within the previous 6 months; beta adrenergic blockers, tricyclic antidepressants, monoamine oxidase inhibitors and catechol-o-methyl transferase inhibitors, methylphenidate, amphetamines, any drugs that may sensitize the heart to arrhythmias, including digitalis and quinidine. 3. history or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neuropsychological, endocrine, gastrointestinal or pulmonary diseases especially asthma bronchiale. significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the endpoint analysis if the disease/condition exacerbated during the study. history or presence of silent infections, including positive tests for hiv1, hiv2, hepatitis b or c. 4. presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs. 5. hypersensitivity to epinephrine or any of the excipients (e.g. metabisulphite).
clopidogrel reloading in patients with nsteacs undergoing percutaneous coronary intervention on chronic clopidogrel therapy

Conditions: Acute Coronary Syndrome; Myocardial Infarction

Summary: patients who developed an acute coronary syndrome despite dual antiplatelet therapy with aspirin and clopidogrel may benefit from a further dose of clopidogrel before a percutaneous coronary intervention. the aim of this study is to evaluate safety and effectiveness of clopidogrel reloading in patients on chronic clopidogrel therapy with acute coronary syndrome undergoing percutaneous coronary intervention.


Eligibility criteria:
inclusion criteria: * chronic (\> 10 days) therapy with clopidogrel (75 mg/day) * non-st-segment elevation acute coronary syndrome (acs) requiring early diagnostic angiography exclusion criteria: * primary percutaneous coronary intervention (pci) for acute st-segment elevation acute myocardial infarction * platelet count \< 70 × 10\^9/l * high bleeding risk * coronary bypass grafting in the previous 3 months
effect of n-acetylcysteine on renal functioning of chronic kidney diseases(ckd) patients after general anesthesia

Conditions: Chronic Kidney Diseases; General Anesthesia

Summary: acute kidney injury (aki) is one of the most serious and frequent complication of general anesthesia. patients suffer from chronic kidney diseases (ckd) predispose to develop aki. ckd patients often need some surgical interventions that have been done under general anesthesia; they therefore have an increased probability to develop aki. n-acetylcysteine (nac), a thiol compound with antioxidant and vasodilatory properties, reduces oxygen free radical production, decreases pump-related ischemia-reperfusion injury and the levels of pro-inflammatory cytokines. nac has been reported to protect the kidney from injury induced by contrast media, ischemia, and toxins. present study aimed to explore the efficacy of nac treatment to prevent deterioration in renal functioning in ckd patients undergoing major surgery under general anesthesia. study will include about 200 ckd (egfr (estimated glomerular filtration rate) less than 40) patients that should undergo surgical interventions under general anesthesia and will divide to 3 groups as follows: group 1- about 40 patients which should undergo major vascular surgery; group 2 - about 60 patients that suppose to undergo major orthopedic surgery (revision of total hip, revision of knee); group 3 - about 100 patients undergoing major abdominal surgery. patients from each group will randomly divide in two sub-groups (a and b). subgroup a will receive nac twice (14-16h and 2h) before surgery and 12h after surgery. subgroup b will receive placebo (saline). markers for kidney function such as egfr, creatinin, urea, electrolytes, cystatin c, ngal (neutrophil gelatinase-associated lipocalin), urine albumin will measure before and after surgery in all patients. an additional blood samples for assessment of nitric oxide and cytokine levels will be taken from each patient before and after surgery.


Eligibility criteria:
inclusion criteria: * patients suffering from chronic kidney disease that should undergo surgical interventions under general anesthesia exclusion criteria: * pregnancy * single kidney * heart failure (nyha class iii-iv) * hepatic failure * mental diseases