Kornimate/medical-research-clean huggingface dataset:
continuous vs intermittent ketorolac for pain control in peds cv surgery

Conditions: Congenital Heart Disease in Children

Summary: the proposed study will be a prospective, randomized, double blind, placebo controlled trial to compare the use of a continuous infusion versus intermittent ketorolac on postoperative patients in the pediatric cardiovascular icu. we intend to determine if the continuous infusion leads to a decreased utilization of opiates when compared to intermittent ketorolac.

the mainstay of postoperative pain control in the cvicu remains opiate-based therapy. reliance on this class of medications can be detrimental, contributing to complications including hemodynamic instability, dependency, and withdrawal which can ultimately lead to longer hospital admissions, as well as long term and persistent neurodevelopmental effects. in addition, the opioid crisis has driven practitioners to aim for methods to reduce opioid exposure and post-operative narcotic prescriptions in pediatric and adult patients alike. there is a growing body of evidence in the adult literature showing promising results with the use of a continuous infusion of ketorolac in postoperative patients, including in a pediatric population. what the current literature has failed to show is whether a continuous infusion of ketorolac post operatively decreases the use of opiate mediations in a pediatric population compared to intermittent bolus injections, which is the current standard of care. given the sensitivity and fragility inherent in those patients with chd, working to reduce deleterious effects from excessive and prolonged opiate exposure is imperative. this study aims to examine whether the use of a continuous infusion of ketorolac can reduce the amount of opiates needed to treat postoperative pain control in the pediatric cvicu population, in comparison to patients who receive intermittent ketorolac within the first 72 hours post-operatively.

Eligibility criteria:
inclusion criteria: 1. all patients aged 3 months to 4 years 11months admitted post operatively to the cvicu during the time period in which the study will be ongoing 2. initiation of study medication within the first 12-24 hours post-operatively 3. the cardiovascular attending of record after review of the intraoperative course and post-operative laboratories determines the patient will receive ketorolac for pain control exclusion criteria: 1. patients that have acute kidney injury, as defined by the letter "i" in the prifle criteria. 2. history of allergy or sensitivity reaction to ketorolac or any nsaid medications. 3. requiring mechanical circulatory support (ecmo) or continuous renal replacement therapy (crrt) within the first 48 hours post-operatively 4. orthotopic heart transplantation 5. clinically significant bleeding 6. patients with known pre-operative medical renal disease, renal transplantation history, congenital or acquired renal abnormality or deformity

Keywords: pain control cardiac surgery pediatric opioid nsaid congenital heart disease
to evaluate the efficacy and safety of genalumab for injection in the treatment of active systemic juvenile idiopathic arthritis.

Conditions: Active Systemic Juvenile Idiopathic Arthritis

Summary: a multicenter, randomized phase ii/iii clinical study to evaluate the efficacy and safety of genakumab in the treatment of active systemic juvenile idiopathic arthritis.


Eligibility criteria:
inclusion criteria: * male and female patients, with the remaining before age 2 years old or more and \& lt; 18 years old; * 2001 ilar classification criteria for the diagnosis of confirmed sjia 2 or more months: onset age must \& lt; at 16 years of age, symptoms included: ≥1 case of arthritis, accompanied by or prior to ≥2 weeks of recurrent fever, including remittenor fever for ≥3 consecutive days (maximum daily body temperature ≥39 ° c, body temperature falling below 37 ° c between 2 heat peaks), accompanied by at least one of the following symptoms: ① a transient, non-fixed erythematous rash; ② systemic lymph node enlargement; swelling of the liver and/or spleen; ④ serositis. * agree to use effective means of contraception throughout the study period and for 6 months after the end of treatment. exclusion criteria: * pregnant or lactating female subjects * a history of allergic reactions to investigational drugs or to molecules with similar structures; those who cannot be given intramuscular injections； * history of pericarditis, myocarditis, serositis, bacterial heart valve or endocarditis within 6 months before screening; patients who had been diagnosed with mas within 6 months prior to screening, or had relevant symptoms and signs at screening, and were suspected of having mas as assessed by the investigators； * there are other rheumatic diseases such as kawasaki disease, polyarteritis nodosa and so on. history of autoinflammatory diseases such as familial mediterranean fever, high igd syndrome, nlrp3-related autoinflammatory diseases； * patients with a history of interstitial lung disease, pulmonary fibrosis, alveolar proteinosis, or pulmonary hypertension; patients with a history of repeated invasive fungal infection; in the 7 days prior to randomization, there were infections that required control with systemic antigenic microbiotics (including antibacterial, antiviral, antifungal, etc.)； * subjects with a history of tb exposure or suspected tb symptoms.
simple continuous, subcuticular and interrupted skin suturing of episiotomy and 2nd-degree perineal tears

Conditions: Episiotomy Wound

Summary: millions of women worldwide undergo perineal suturing after childbirth and the type of repair may have an impact on pain and healing. the skin as a barrier between the internal structures and the external environment is exceptionally susceptible to injury, either through accidental injury or planned surgical incision. today, as surgery increases in complexity, and the heightened public awareness of scar cosmesis and skin healing need to be optimized to ensure the overall success of the surgical procedure


Eligibility criteria:
inclusion criteria: * normal vaginal delivery. * at term (37 40 weeks ). * live baby. * vertex presentation exclusion criteria: * third and fourth degree perineal tear. * instrumental vaginal delivery. * previous perineal surgery. * anaemia with hemoglobin level \< 9 g/dl. * diabetes mellitus. * coagulation abnormalities. * postpartum hemorrhage. * delivery conducted outside woman healthhospital. * breech delivery. * body mass index \>35 kg/m2. * local infectious lesions. * anal fissures or hemorrhoid.
delayed versus immediate use of zoledronic acid for postmenopausal patients with early breast cancer who are using adjuvant letrozole

Conditions: Use of Zoledronic Acid in Breast Cancer

Summary: the investigators will involve about 25 patients of postmenopausal women who have er/pr positive early breast cancer in each arm. the study is a two-arm comparative, prospective, interventional, and randomized study. all patients who are on oral daily letrozole (2.5 mg), will be randomly assigned to receive either immediate or delayed zol (4 mg via 15-min infusion every 6 months) for 24 months. immediate-zol patients will receive zol immediately after randomization; delayed-zol patients will receive zol only if their t-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal x-ray at the 3- monthly assessment. all patients will receive daily supplements containing calcium (500 mg) and vitamin d (400-800 iu). baseline bone mineral density and every 3 months will be done for the enrolled patients.

the investigators will involve about 25 patients of postmenopausal women who have er/pr positive early breast cancer in each arm. the study is a two-arm comparative, prospective, interventional, and randomized study. all patients who are on oral daily letrozole (2.5 mg), will be randomly assigned to receive either immediate or delayed zol (4 mg via 15-min infusion every 6 months) for 24 months. immediate-zol patients will receive zol immediately after randomization; delayed-zol patients will receive zol only if their t-score fall below -2.0, after a nontraumatic clinical fracture, or if an asymptomatic fracture will be detected by spinal x-ray at the 3- monthly assessment. all patients will receive daily supplements containing calcium (500 mg) and vitamin d (400-800 iu). baseline bone mineral density and every 3 months will be done for the enrolled patients. -research outcome measures: 1. primary (main): the primary endpoint will be the percentage change in lumber spine (l2-l4) bmd at 12 months for immediate- versus delayed-zol patients. 2. secondary (subsidiary): secondary end points will include percentage change in total hip bmd at each assessment, fracture incidence, time to disease recurrence (local relapse or distant metastasis), dfs, and safety.

Eligibility criteria:
inclusion criteria: 1. histologic evidence of er/pr positive breast adenocarcinoma 2. postmenopausal women. 3. baseline ls and total hip bmd t-score \> -2.0. 4. no prior treatment with denosumab or iv bisphosphonates is allowed. 5. no prior treatment with radiopharmaceuticals. 6. not pregnant and not nursing. 7. good dental health. 8. ecog performance status 0-2. 9. calculated creatinine clearance \>= 30 ml/min. 10. corrected serum calcium \>= 8.0 mg/dl (2.00 mmol/l) and \< 11.6 mg/dl (2.90 mmol/l) exclusion criteria: 1. patients with dental problems. 2. patients with impaired renal functions 3. patients with osteopenia, or t- score is below -2.0 4. patients with history of serious drug hypersensitivity or drug allergy.

Keywords: breast cancer
pilot study of whole body vibration for children with cerebral palsy (cp) from 12 months of age

Conditions: Cerebral Palsy (CP)

Summary: cerebral palsy (cp) is the most common cause of physical disability in childhood. up to day the investigators have treated children diagnosed cerebral palsy with side-alternating whole body vibration (system galileo®) from the age of two years on. considering verticalisation (standing and walking) at about 12 months of age in a normal developing child the investigators suggest the introduction of verticalisation with whole body vibration to a child with cp at this early age in order to enhance motor development and participation. in this pilot study the investigators will test the feasibility and the effect on motor development of whole body vibration in children with cp from 12 months of age. the investigators will investigate the effect of whole body vibration on motor performance, independence in all day living situations, quality of life and contractures compared to a control group.


Eligibility criteria:
inclusion criteria: * children diagnosed cp * ≥ 12 months and ≤ 24 months of age (prematures corrected age) * gmfcs level ii, iii, iv * inability to stand and walk * written informed consent of legal guardian exclusion criteria: * chronic infectious disease * epilepsy not responding to therapy * additional severe congenital disorder (e.g. congenital heart disorder) * surgery in previous three months * hernia requiring surgery * treatment with botulinumtoxin * acute thromboses * implants and tendinitis in body parts to be trained * acute inflammation in the musculoskeletal system * slipped disc * rheumatoid arthritis * fractures in previous three months * intracerebral bleeding in previous three months * planned surgery in study period * participation at another interventional trial * gall stones, kidney stones and pregnancy of the person who trains with the child

Keywords: cerebral palsy whole body vibration infant motor development physiotherapy
retrospective study of bone infection due to campylobacter spp

Conditions: Campylobacter Infections; Bone Diseases, Infectious

Summary: only 24 cases of campylobacter bone and joint infection (bji) have been reported worldwide between 1955 and 2008. between 2010 and 2012, 7 cases were observed in two university hospitals in france. this increasing number of cases raises several issues. are they the consequences of better detections and reporting, or are they reflecting any epidemiologic changes? for answering these questions, we performed a 10 year (2002-2012) retrospective multicenter (6 centers) study on bji (native and implanted joints) due to campylobacter species.

methods: by browsing the microbiological database of 6 bji french reference centers, we collected all cases due to campylobacter species between 2002 and 2012, including first and relapse cases. clinical, microbiological and treatment features were analyzed using descriptive statistics. results: 14 episodes of bji due to campylobacter spp were identified in 10 patients. mean age was 76.8 y.o. (63-96). sex ratio m/f was 1.5. nine patient had hip (n=6), knee (n=2), and shoulder (n=2) implants. immunosuppression was observed in 6 patients (3 cancers, 1 cirrhosis, 1 rheumatoid arthritis, 1 corticosteroid treatment). during the 10 primary cases: all patients had fever and 2 presented digestive symptoms. campylobacter spp were isolated on per operative samples in 5 patients. one of them presented positive blood culture. 5 patients had joint punctures: all of them were positives. campylobacter species were c. fetus (n=7), c. coli (n=2) and c. spp (1). strains were resistant to nalidixic acid (=10), ciprofloxacin (n=4), erythromycin (n=3) or cefotaxime (n=2). only one c. fetus was susceptible to all antibiotics tested. surgical treatment was performed in 8 patients (2 two-stage procedure, 6 irrigation). the mean duration of adapted antibiotherapy was 77 days (26-237). 3 out of 4 relapse cases were due to c. fetus. all were resistant to more than one antibiotic classes.

Eligibility criteria:
inclusion criteria: * patient with peroperative bone samples positive to campylobacter spp. between jan 2002 and dec. 2012 * adults over 18 yo * no opposition to the study expressed by the patient exclusion criteria: * adults below 18 yo * spine infection to campylobacter spp. * outside of the timeframe of the study * no microbiologic data available * opposition to the study expressed by the patient
nipsa versus marginal approach by palatal incision and mist in periodontal regeneration

Conditions: Periodontitis; Periodontal Diseases; Periodontal Pocket

Summary: three techniques for periodontal reconstruction will be compared, in which marginal access versus apical access will be carried out.


Eligibility criteria:
inclusion criteria: * patients diagnosed with periodontitis. * plaque index and bleeding index of \< 30%. * periodontal lesions with pocket probing depth \> 5 mm. * intrabony defect \> 3 mm. * intrabony defect configuration including a 1 and/or 2-wall component, always involving the buccal wall. exclusion criteria: * patients with systemic diseases that contraindicated treatment. * third molars. * teeth with incorrect endodontic or restorative treatment.
comparative study between safety and effectiveness of high versus low power holep

Conditions: Benign Prostatic Hyperplasia

Summary: holmium laser enucleation (holep) has became a standard of treatment of large prostates that indicates surgery. holep is widely used nowadays. many settings are used but no optimal setting was world wide adopted. the aim of this trial is to assess the low-power holmium laser enucleation of the prostate (lp-holep)and compare to high-power (hp-holep) for enucleation efficiency pertaining to the advantages of lower cost and minimal postoperative dysuria, storage symptoms, and negative sexual impact.


Eligibility criteria:
inclusion criteria: * large prostate indicated for surgical intervention. exclusion criteria: * prostate cancer * recurrent adenomas * associated neurologic factors that may affect outcomes (e.g., neurogenic bladder)

Keywords: holep, enucleation, prostate
safety study of a contact lens with ketotifen in healthy, normal volunteers

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the safety of a novel contact lens in healthy normal volunteers.


Eligibility criteria:
inclusion criteria: * healthy normal, soft contact lens wearing volunteers * normal ocular health * contact lens correction from +6.00 to -12.00d in each eye and astigmatism of -1.00d or less in each eye exclusion criteria: * active ocular infection * history of ocular surgery * use of topical ophthalmic preparations (including rewetting drops) * pregnancy or lactation
interleukin-12 gene therapy in treating patients with skin metastases

Conditions: Metastatic Cancer

Summary: rationale: inserting the gene for interleukin-12 into a person's skin tumor cells may make the body build an immune response to kill tumor cells. purpose: phase i trial to study the effectiveness of interleukin-12 gene therapy in treating patients who have skin metastases.

objectives: * determine the safety and toxicity of interleukin-12 gene in patients with spontaneous skin metastases. * determine the antitumor immune response in patients treated with this regimen. * compare the toxicity of this regimen administered for 1 week vs 2 weeks in these patients. * compare the local and systemic antitumor response in patients treated with this regimen administered for 1 week vs 2 weeks. outline: patients are stratified according to number of tumor sites (1 vs 2 vs 3 or more). patients are assigned to 1 of 2 treatment arms. * group a: patients receive interleukin-12 gene intratumorally over 5 minutes on days 1, 3, and 5. * group b: patients receive il-12 gene intratumorally over 5 minutes on days 1, 3, 5, 8, 10, and 12. patients with stable or responding disease may receive 1 subsequent course beginning on day 29. patients are followed at 3, 6, and 12 months. projected accrual: a total of 12 patients (6 per treatment group) will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed solid malignancy * surgically or medically incurable disease * no standard chemotherapy or radiotherapy exists for this disease * tumor of at least 0.5 cm but no more than 2.5 cm infiltrating into or underlying the skin * cutaneous metastases, subcutaneous metastases, or tumor-involved lymph nodes that are easily palpable patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * more than 3 months hematopoietic: * wbc greater than 3,000/mm\^3 * platelet count greater than 80,000/mm\^3 hepatic: * bilirubin less than 2.0 mg/dl renal: * creatinine less than 2.0 mg/dl other: * hiv negative * no active infections requiring antibiotic, antiviral, or antifungal treatment * no other active malignancy * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy: * at least 1 month since prior immunotherapy * no concurrent colony-stimulating factors chemotherapy: * see disease characteristics * at least 1 month since prior chemotherapy endocrine therapy: * at least 1 month since prior steroids (other than intermittent use as an antiemetic or topical agent) * no concurrent steroids radiotherapy: * see disease characteristics * prior radiotherapy to vaccine site allowed provided there is documentation of progressive disease surgery: * see disease characteristics * no prior organ allografts other: * no other concurrent antineoplastic therapy * no other concurrent investigational drugs

Keywords: skin metastases
comparison of surgical versus medical termination of pregnancy between 13-20 weeks of gestation in ethiopia

Conditions: Termination of Pregnancy

Summary: the purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion

all patients with a gestational age between 13-20 weeks are fully counseled on the risks and benefits and given the option of medical or surgical abortion. those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to sphmmc 24-48 hours later for admission and misoprostol administration. those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.

Eligibility criteria:
inclusion criteria: * gestational age between 13 - 20 weeks confirmed with ultrasound, * age at or more than18 years, * having a working phone and willingness to be contacted for a follow-up questionnaire 2 weeks after the procedure. exclusion criteria * inability to give consent * complicated abortion (missed abortion, septic abortion)

Keywords: dilation and evacuation second trimester medical abortion ethiopia
gp_posit intervention for mothers of preterm infants for maternal sensitivity : randomized pilot trial

Conditions: Preterm Infant; Mothers; Parent-Child Relations; Child Development; Interaction, Mother-Infant

Summary: the aim of this study is to evaluate the acceptability, feasibility and preliminary effects a gp_posit intervention. gp_posit is an intervention where mothers will learn how to participated in their preterm infant's care and positioning while being guided by a nurse. preliminary effects will be estimated on maternal sensitivity, stress and anxiety as well as preterm infant's neurodevelopment.


Eligibility criteria:
this study will recruit mother-infant dyads. inclusion criteria for mothers: * understand, write and read french and/or english * are 18 years or older exclusion criteria for mothers: * use drugs * have an instable mental health * give their newborn infant for adoption inclusion criteria for preterm infants: * are born at 27 0/7 et 31 6/7 weeks of gestation * are hospitalized in the nicu for at least 4 weeks exclusion criteria for preterm infants: * require surgery * have intraventricular haemorrhage (ivh) \> grade 2 * have congenital malformations

Keywords: intervention maternal sensitivity neurodevelopment maternal stress maternal anxiety neonatal intensive care unit