Kornimate/medical-research-clean huggingface dataset:
paracetamol vs ibuprofen for pda closure in preterm infants.

Conditions: Ductus Arteriosus Patent; Respiratory Distress Syndrome

Summary: current pharmacological options to treat an hemodynamically significant pda (hspda) in preterm infants are limited to non-selective cyclo-oxygenase (cox) inhibitors, indomethacin or ibuprofen. recently paracetamol exposure has been reported to successful closure of pda. aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard pda treatment ibuprofen versus paracetamol-experimental treatment . we hypothesize that paracetamol is more effective than ibuprofen in closing pda, perhaps ameliorating the safety profile of the pharmacological treatment.

the objective of this trial is to compare the efficacy and safety of 2 therapeutic regimens for pda treatment in a population of preterm newborns of gestational age (ga) \<31+6 weeks with respiratory distress syndrome (rds) and hspda: * group a: experimental boluses of paracetamol at 15 mg/kg four time a day for three consecutive days. * group b: standard boluses of ibuprofen at 10-5-5-mg/kg/dose once a day for three consecutive days. the primary objective of the study is: to evaluate the efficacy of paracetamol versus standard ibuprofen regimen, by comparing the rate of ductal closure after the first and second course of pharmacological treatment. (pda diagnosed by echo criteria) the secondary objective of the study is: to evaluate the safety of the above 2 therapeutic regimens in term of incidence of transient renal impairment, intraventricular hemorrhage (ivh) or other bleeding disorders, necrotizing enterocolitis (nec) and isolated bowel perforation (without signs of nec), incidence of sign of liver toxicity.

Eligibility criteria:
inclusion criteria: * inborn neonates * preterm neonates ≤ 31+ 6 days weeks gestation * newborns with hspda * parental written informed consent for participation in the study must be obtained exclusion criteria: * serum creatinine concentration greater than 1,5 mg/dl (132mmole/l) * urine output less than 1 ml/kg/h * severe ivh (\> grade ii according to volpe classification) * clinical bleeding tendency (as revealed by hematuria, blood in the gastric aspirate or in the stools, blood in the endotracheal tube aspirate) * necrotizing enterocolitis or marked abdominal distention with gastric bile residuals * thrombocyte count of less than 50.000/mm3 * proved sepsis * severe coagulopathy or liver failure * evidence of severe birth asphyxia, that is an apgar score below 5 at 5 minutes of age and/or umbilical arterial ph \< 7.0 * known genetic or chromosomal disorders * participation in another clinical trial of any placebo, drug, biological, or device conducted under the provisions of a protocol.

Keywords: patent ductus arteriosus preterm infant paracetamol ibuprofen
finding predictors of side effects to chemoradiation treatment in elderly patients with head and neck cancer

Conditions: Head and Neck Cancer

Summary: to look at what types of measures can be used to predict how an older person will tolerate chemoradiation treatment for head and neck cancer. this study uses surveys and a blood draw to look at the different measures.

purpose: to identify baseline predictors of change in function over the course of treatment with chemoradiotherapy in patients with head and neck cancer. participants: patients 65 or older who have an appointment at the north carolina cancer hospital (ncch) or other participating sites, have planned chemoradiotherapy for head and neck cancer procedures (methods): consenting subjects will complete a geriatric assessment, functional assessment of cancer therapy - head and neck and give a blood sample for cbc and p16ink4a at the start of their chemoradiotherapy, at week four, at the end and 90 days post therapy. they will also complete a health behavior questionnaire at baseline.

Eligibility criteria:
inclusion criteria * patients will be eligible for this protocol provided they have an appointment at the north carolina cancer hospital (ncch), have planned chemoradiotherapy for head and neck cancer (any histology) and consent to complete the geriatric assessment. no exclusions will be made based on gender, ethnicity, performance status or race. patient must be able to read and speak english. * signed, irb approved written informed consent. * age of at least 65 years. * enrollment in other studies, both therapeutic and observational, will not result in exclusion. exclusion criteria * inability to read and speak english. * inability to comply with study for any other reason than language

Keywords: geriatrics oncology biological markers survey instruments p16 geriatric oncology biological markers of aging symptom assessment cancer older persons head and neck cancer
a study of evolocumab on carotid artery atherosclerotic plaque morphology prior to carotid endarterectomy

Conditions: Carotid Artery Stenosis; Asymptomatic Carotid Artery Stenosis

Summary: this is a multicenter, randomized, open label study with blinded outcome assessment to evaluate the impact of additional/intensive ldl-cholesterol reduction with evolocumab on carotid artery atherosclerotic plaques in higher risk subjects with severe asymptomatic but vulnerable plaques.


Eligibility criteria:
inclusion criteria: 1. age ≥ 40 years old 2. significant (70-99%) carotid artery stenosis on one side, as measured by duplex ultrasound or angiogram 3. asymptomatic carotid stenosis (no history of ipsilateral stroke or tia within 180 days) 4. deemed to be fit for carotid endarterectomy 5. at least one of the following high-risk features: (a) prior stroke \>6months prior to randomization; (b) peripheral artery disease; (c) current smoker; (d) type 2 diabetes; (e) egfr ≥ 30 ml/min/1.73m2 and \ 2mg/l in the absence of alternative known causes of hscrp elevations including autoimmune diseases or active infections. 6. on a moderate to high intensity statin therapy (defined as atorvastatin 40-80mg daily, rosuvastatin 20-40mg or simvastatin 40mg daily) unless a lower dose, or another statin or non-statin therapy is clinically justified exclusion criteria: 1. contraindications for mri (pacemaker; neurostimulator; non-removable metal fragments in the eye; etc.) 2. patients in whom additional lowering of ldl-c with evolocumab is deemed to be clinically inappropriate 3. currently taking simvastatin \>40mg/day 4. high risk comorbidities such as severe heart failure, severe copd, severe renal disease, known severe hepatic impairment, unstable coronary syndrome, and/or advanced dementia 5. egfr \<30 ml/min/1.73m2 6. current, prior within past year, or known planned use of pcsk9 inhibition treatment 7. known intolerance or allergy to evolocumab or other pcsk9 inhibitors 8. known latex allergy 9. women who are pregnant or breastfeeding 10. women of child bearing potential who are unwilling to use proper family planning or birth control methods to avoid pregnancy. women are considered post-menopausal and not of childbearing potential after 12 months of natural (spontaneous) amenorrhea or have had a surgical procedure such as hysterectomy which makes pregnancy impossible 11. inability to comply with protocol-required study visits or procedures, including administration of study drug 12. severe concomitant disease that is expected to reduce life expectancy to less than 5 years 13. participation in another investigational device or drug study which is likely to affect the primary outcome, within 30 days of planned initiation of study drug additional inclusion criteria if all eligibility criteria listed above are met, participants with only one high risk feature will undergo a time-of-flight mr angiogram, where one additional inclusion criteria will be assessed to confirm eligibility: 1. evidence of iph on mri

Keywords: cea carotid endarterectomy evolocumab carotid artery
the effect of cold application to the sacral area on labor comfort:

Conditions: Birth

Summary: purpose: cold application is considered as an effective alternative treatment for labor comfort because of its low side effects and easy availability. this study aims to determine the effect of cold application to the sacral area in the transition phase of labor on labor comfort. materials and methods: the study was done as a randomised controlled experimental study. while the women in the experimental group received cold application for 10 minutes every 20 minutes after 8 cm of cervical dilatation, the women in control group received routine care protocol of the unit.


Eligibility criteria:
inclusion criteria: * the inclusion criteria were having a full-term pregnancy (pregnancies between 37th and 42nd weeks), * having a single fetus, having a cephalic presentation, * fetal weight of 2,5- 4 kg, * pregnant women's having normal body mass index and receiving no antenatal trainings, * having an 8 cm cervical dilation. exclusion criteria: * the women who had any kind of pregnancy complications (placenta previa, preeclampsia, * premature rupture of membranes, oligohydramnios and polyhydramnios, presentation disorder, * intrauterine growth retardation, intrauterine dead fetus, * macrosomia babies, fetal distress, etc.), * who had any systemic or neurologic diseases * contraction anomalies (hypotonic or hypertonic contractions), * who had induced labor, * who received narcotic analgesics, * who had occiput posterior, * who were in the latent and active phases of labor, * who had irregular contractions were excluded from the study
positional distraction and stabilization exercises in adults with lumbar radiculopathy.

Conditions: Lumbar Radiculopathy

Summary: this study evaluate the addition of positional distraction to stabilization exercises in the treatment of lumbar radiculopathy in adults. half of the patients will recieve positional distraction and stabilization exercises in combination, while the other half will recieve stabilization exercises only.

in positioanl distraction making use of the body position to produce traction at an isolated spinal level to maximally open the affected neuroforamen. it is an alternative to lumbar mechanical traction. the spinal level of vertebral level requiring traction is palpated and a soft roll is placed and the patient side lies on the unaffected side. for further distraction both hips are flexed until movement is noted at the spinal level needing traction. further, distraction applied by rotating upper trunk to opposite side of pain. stabilization exercises are mainly used for the stability of joints and for improving muscle strength. the first step of lumbar stabilization exercises are to maintain functional back positions during all activities. the second step is to improve strength and endurance of the core muscles.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of lumbar radiculopathy * age limit 30-50 years * both males and females * pain history more than 12 weeks but less than one year * patient having lumbar disc bulge at maximum two adjacent levels exclusion criteria: * any type of tumor and infection in the spine * spondylolisthesis at l4- l5, l5-s1 * fracture of the lumbar spine * sciatica other than lumbar region (piriformis syndrome) * acute cardiopulmonary conditions * morbid obesity (bmi \&gt; 30)
randomized, single-masked, long-term, safety and tolerability study of vegf trap-eye in amd

Conditions: Macular Degeneration

Summary: rollover study for subjects in prior vegf trap-eye phase i and ii studies. primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

randomized, single-masked phase ii study for subjects previously enrolled in phase i and ii studies for wet age-related macular degeneration with vegf trap-eye intravitreal injection as treatment.long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of vegf trap-eye on best corrected visual acuity (bcva).

Eligibility criteria:
inclusion criteria: * prior participation in vegf trap-eye phase i and ii studies exclusion criteria: * any ocular or systemic adverse events that would preclude participation * presence of any condition that would jeopardize subject's participation

Keywords: vegf trap-eye macular degeneration amd neovascular age-related macular degeneration
study of tibial shaft fractures in children

Conditions: Tibial Shaft Fractures in Children

Summary: tibial shaft fracture is one of the most common fractures in children and adolescents. it encompasses approximately 15 % of all long-bone fractures and is third behind only fractures of the femur and both bones of the forearm. (2). although most authorities agree that closed tibial shaft fractures are best treated by immobilization in a long-leg cast, there is no clear consensus as to when to allow weight bearing on the injured extremity. while most recent articles have recommended long-leg casts with the knee bent in flexion of 30-60 degrees to preclude weight-bearing(1,2,3,4), other authors have recommended much less flexion, 0-5 degrees, to encourage early weight bearing.(5). the purpose of this randomized controlled prospective study is to determine if the position of immobilization of the knee influences the rate of healing, delayed union, and nonunion as well, we will assess if the type of immobilization affects the function of the patient during the period of treatment using the activities scale for kids - performance (ask-p) child self-report musculoskeletal outcome measure . a minimum of 36 patients in each group for a total of 72 patients between 4 and 14 years of age (open physis) with closed fractures of the tibia, with or without fracture of the fibula, will be included in the study


Eligibility criteria:
inclusion criteria: * patients between 4 and 14 years of age (open physis) * patients seen at the los angeles orthopaedic medical center within 7 days of the original injury * all closed tibia and tibia and fibula shaft fractures regardless of fracture pattern exclusion criteria: * fractures with greater than 2 cm of initial shortening * open fractures * patients that have other orthopaedic medical issues such as hemophilia

Keywords: tibia shaft fracture children
day long prevention of oral malodor with a palatal patch (smellx) containing a herbal formula

Conditions: Halitosis; Gingivitis

Summary: in a previous study the prevention of halitosis by the herbal formula and delivery system (smellx), were established both in vitro and clinicaly. the duration of relief was established as long as 8 hours. in this study the investigators intend examine the day long efficacy of smellx.

oral malodor is a common complaint among dental patients. this condition derives in most cases form the putrefactive activities of oral microorganisms, primarily anaerobic gram negative bacteria. these bacteria reside on various locations within the oral cavity (e.g. tongue dorsum, interdental space, periodontal pockets, faulty and leaky restorations and tonsils) and breakdown salivary and oral proteins into their amino acid building blocks. some of these amino acids (e.g. methionine and cysteine) are further metabolized yielding malodorous volatile sulfide compounds (vsc) such as methylmercaptan and hydrogen sulfide.the tongue dorsum and especially its posterior portion are considered the key location for this process. therefore, the treatment regiment includes in most cases a daily use of tongue scrapers and mouthwashes. indeed, a recent cochrane systematic review found tongue scrapers to have short-term efficacy in controlling halitosis. however, the use of tongue scrapers is unpleasant and induces in many cases a strong gag reflex, and apparently has very little effect on bacterial load of the tongue. furthermore, some mouthwashes have been shown to cause adverse side effects such as tooth staining. in a previous study we performed a set of related experiments on a new sustained release delivery system in the form of an adhesive tablet containing an herbal formulation. the adhesive tablet is applied to the palate. this places it right above, and in direct contact with the tongue dorsum, thus allowing a sustained release of the active ingredients directly to the target site. the ingredients of the herbal formulation have been previously shown to reduce malodor production in a salivary incubation assay. we tested the effect of this system on oral malodor production and vsc levels in a young healthy population, and the antimicrobial effect of its active ingredients on three known oral pathogens (streptoccocus mutans, porphyromonas gingivalis and candida albicans. in this study we intend to examine a day long protocol to achieve a relief from oral halitosis for 24 houres.

Eligibility criteria:
inclusion criteria: * random gender * age * healthy people exclusion criteria: * used antibiotics in the last three months * suffer from systemic disease

Keywords: smellx malodor halitosis herbal formulation natural medicinals slow release delivery system gingivitis bad breath
safety and pharmacokinetics study of naldemedine in paediatric participants receiving opioids

Conditions: Opioid-Induced Constipation (OIC)

Summary: the primary objective of this study is to evaluate the pharmacokinetic (pk) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.


Eligibility criteria:
inclusion criteria: disease characteristics * participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids. * participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment. * able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point. weight * body mass index within approximately the 3rd to 97th percentile for their age according to the world health organization child growth standards. exclusion criteria: medical conditions * history of a gastrointestinal (gi) neoplasm or an ongoing gi-related issue or any recent (within last 1 year) or planned gi tract surgery. * signs or symptoms of gi obstruction or participants with recurrent obstruction who may be at increased risk of gi perforation. * inability to eat/swallow or have need of a nasogastric tube. * no bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (study day 1). * history of more than 1 week of common terminology criteria for adverse events (ctcae) grade 3 neutropenia or thrombocytopenia with clinical sequelae. * participants who need mechanical ventilation. * severe ctcae grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator. * progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia. prior/ongoing medications * currently receiving the first cycle of chemotherapy. * previously received naldemedine. other exclusions - positive pregnancy test for females of childbearing potential. note: other protocol-defined inclusion/exclusion criteria may apply.
study of fibromyalgia treated with milnacipran

Conditions: Fibromyalgia

Summary: the purpose of this study is to examine the characteristics of the nerves and the small veins in the skin of people with fibromyalgia. this information will then be used to identify possible processes in the skin that may help explain why some people feel pain relief with the study drug (milnacipran) and others do not. the investigators expect to learn more about the pathophysiology of fibromyalgia and the way in which milnacipran acts on these patients. the investigators hypotheses are: 1. the pathophysiologic basis of fibromyalgia in some patients may be due to a biochemical and/or morphological pathology among the sensory innervation. 2. fibromyalgia patients may have different sites of innervation. 3. milnacipran may have a therapeutic effect on some fibromyalgia patients. 4. abnormalities in fibromyalgia patients may predict the likelihood of a good response to milnacipran.


Eligibility criteria:
inclusion criteria: * female age 18-70 * fulfill the acr criteria for fma (wide spread pain for a least 3 months and pain in at least 11 or 18 tender point sites. * vas score greater that 40mm at screening and randomization visits. exclusion criteria: * history of clinically significant liver disease, serious peripheral vascular disease, a blood clotting disorder, or any other medical condition felt to be exclusionary by the investigator. * allergy to lidocaine * unwillingness to sign informed consent or any other reasons for which the investigator feels the subject cannot complete the study * women who are pregnant, breastfeeding or trying to become pregnant * active cancer with the previous two years except treated basal cell carcinoma of the skin. * presence of dermatological or neurological condition that could interfere with the interpretation of the skin biopsy or qst * co-existing conditions that can produce chronic widespread pain * presence of uncontrolled or severe depression * patients with worker's compensation, pending worker's compensation, * any ongoing litigation or disability claims due to fibromyalgia or any other source of pain, or currently receiving monetary compensation as a result of any of the above. * presence of uncontrolled narrow-angle glaucoma

Keywords: female age 18 to 70