Kornimate/medical-research-clean huggingface dataset:
trial on treatment with inhaled furosemide of preterm and term neonates with transient tachypnoea

Conditions: Transient Tachypnoea of the Newborn

Summary: in this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient tachypnoea.

in this study we will prospectively analyze the benefit of inhaled furosemide for preterm and term neonates with transient tachypnoea. patients received nebulised furosemide iv solution 1 mg/kg or nebulised 0,9% saline (4x/d) under blind conditions in random order so long as need a cpap-treatment but max. 3 days. 20 patient will be treating. the benefit will be measured as reduction of dyspnea, respiratory rate, oxygen demand and time on cpap.

Eligibility criteria:
inclusion criteria: * neonates with 35+0-39+0 ga on the first day of life with the clinical diagnosis of transient tachypnoea * the need for cpap \>6 h to obtain the oxygen saturation \>92% * written informed consent of parent/guardian exclusion criteria: * systemic infection * intubation and mechanical ventilation before inclusion in the trail * malformation and any other several disease with disturb of respiratory * subjects participating in other clinical trials
meta-analysis of orlistat laboratory data from placebo-controlled clinical trials

Conditions: Obesity

Summary: roche and gsk will carry out a meta-analysis of liver function data from trials of orlistat to establish whether there is any indication of liver toxicity. the motivation is a cumulative assessment of drug-induced liver injury (dili) conducted by the fda following spontaneous reports of liver toxicity in people taking xenical or alli.


Eligibility criteria:
inclusion criteria: 1. the trial must be randomized and placebo-controlled 2. the orlistat dose must be 60mg or 120mg 3. data on alt or bil must be available 4. the nominal treatment period must be 16 weeks or longer exclusion criteria: 1. if cross-over trials are found, data from other than the first period will be excluded.

Keywords: xenical alli safety meta-analysis liver-function test roche orlistat
a phase ii study of rbm-007 alone and rbm-007 with eylea® in subjects with wet age-related macular degeneration

Conditions: Exudative Age-related Macular Degeneration

Summary: this is a multicenter, active-controlled, double masked study assessing the safety, efficacy and durability of four monthly intravitreal (ivt) injections of rbm-007 monotherapy, and four monthly rbm-007 injections in combination with eylea® dosed at every other month, compared to eylea® monotherapy dosed at every other month in approximately eighty-one subjects with exudative age-related macular degeneration (amd).

rbm-007 is a novel oligonucleotide-based aptamer having potent anti-fgf2 activity and anti-vegf-expression activity

Eligibility criteria:
inclusion criteria: 1. provide signed written informed consent. 2. male or female 55 years of age or older on the date of signing the consent and able and willing to comply with all treatment and study procedures. 3. diagnosis of exudative age-related macular degeneration in the study eye, for which previous standard treatment with intravitreal anti-vascular endothelial growth factor agents (at least 4 injections over the past 8 months) has demonstrated incomplete resolution of exudation, as assessed by spectral domain optical coherence tomography. 4. presence of macular edema or subretinal fluid. 5. absence of central atrophy or retinal epithelial tear in the fovea or any condition preventing visual acuity improvement in the study eye. 6. visual acuity of 78 to 24 letters (20/32 to 20/320) in the study eye. 7. visual acuity of 24 letters (20/320) or better in the fellow eye. 8. reasonably clear media and some fixation in the study eye to allow for good quality tomography and fundus photography exclusion criteria: * ocular: 1. use of any of the following treatments or anticipated use of any of the following treatments to the study eye: 1. any intravitreal treatment within 4 weeks prior to baseline (visit 1). 2. intravitreal or periocular corticosteroid, within 90 days prior to visit 1 (day 1) and throughout the study. 3. fluocinolone acetonide intravitreal implant, within 12 months prior to visit 1 (day 1) and throughout the study. 4. visudyne® photodynamic therapy, within 90 days prior to visit 1 (day 1) and throughout the study. 2. uncontrolled or advanced glaucoma, evidenced by an intraocular pressure of \> 21 mmhg or cup/disc ratio \> 0.8 while on medical therapy, or chronic hypotony (\< 6 mmhg) in the study eye. 3. evidence of any other ocular disease other than wet age-related macular degeneration in the study eye that may confound the outcome of the study 4. history of vitrectomy in the study eye. 5. need for ocular surgery in the study eye during the course of the study. 6. yag laser capsulotomy within 30 days prior to visit 1 (day 1) in the study eye. 7. intraocular surgery, including lens removal or laser, within 90 days prior to visit 1 (day 1) in the study eye.

Keywords: fibrosis edema neovascularization
effect of functional chewing training on tongue thrust and drooling in children with cerebral palsy

Conditions: Mastication Disorder

Summary: this study examined the effect of functional chewing training(fuct) on tongue thrust and drooling in children with cerebral palsy.

children were divided into two groups: the fuct group and control group receiving classical oral motor exercises. each group received training for 12 weeks. oral motor assessment was performed. chewing performance level was determined with the karaduman chewing performance scale(kcps). tongue thrust severity was evaluated with the tongue thrust rating scale(ttrs). the drooling severity and frequency scale(dsfs) was used to evaluate drooling severity and frequency. the evaluations were performed before and after treatment.

Eligibility criteria:
inclusion criteria: * diagnosed with cerebral palsy * aged between 4-6 years * fed by orally * had tongue thrust exclusion criteria: * children who were unable the sitting position

Keywords: drooling tongue thrust
pocared diagnostics, ltd, field study protocol

Conditions: Urinary Tract Infections

Summary: this study is designed to compare the performance of the p-1000 system, pocared's rapid diagnostic system which uses optical fluorescence analysis, to standard methods of uropathogen quantification and identification.

this study will be conducted at 5 sites, 4 in the united states and 1 site in israel. 40,000 clinical specimens will be included and assessed by the laboratories using standard reference methods and the p-1000.

Eligibility criteria:
inclusion criteria: * samples arriving in the laboratory for urine culture exclusion criteria: * samples \<=2ml * specimens stored at room temperature for more than 2 hours (unless a preservative is used) * specimens refrigerated for more than 24 hours * specimens requesting low count urine culture (\<100,000 cfu/ml \[colony forming units per milliliter\]) * bloody specimens
prospective analysis of cardiac function in cirrhotic patients by echocardiography and its correlation with events

Conditions: Liver Cirrhosis

Summary: the cardiac abnormalities in patients with cirrhosis are already reported from the 50's, in studies of patients with alcoholic cirrhosis. further studies have shown that these cardiac changes were caused not only by the myotoxic effects of alcohol, but also are present in many patients regardless of etiology of cirrhosis. these changes are characterized by abnormalities of systolic contraction in patients undergoing physical or pharmacological stress, changes in diastolic function and electrophysiological changes in a clinical condition known as cirrhotic cardiomyopathy. increased qt interval and the pre-ejection time changes are common in cirrhotic patients. to date no studies have evaluated the clinical relevance of changes in the heart of cirrhotic patients, or their relationship with the prognosis of affected patients. til now, researches are based on strict echocardiographic parameters, not including several modern methods of assessment of cardiac systole and diastole. new techniques, such as two-dimensional strain, can bring new diagnostic and prognostic information, and it is not reported in the literature. therefore, the aim of this study is to determine the morphological and functional cardiac changes in patients with cirrhosis and their prognostic role by evaluating new echocardiographic parameters of systolic and diastolic readings.


Eligibility criteria:
inclusion criteria: * patients with cirrhosis of any etiology, diagnosed by clinical criteria and ultrasound and / or liver biopsy, which excluded patients with causes that also may affect cardiac function (hemochromatosis, wilson disease, amyloidosis). * age between 18 and 80 years. * signing of written informed consent. exclusion criteria: * history or presence of systemic arterial hypertension (treated or not) * history or presence of ischemic heart disease and peripheral vascular disease. * presence of greater than mild valvular disease. * patients who have a different rhythm in the baseline electrocardiogram, other than sinus (atrial fibrillation, atrial flutter, junctional rhythm). * presence of severe anemia (hb \<7 g / dl). * presence of shock, hepatic encephalopathy, bacterial infection or bleeding at inclusion or during the previous week. * history or presence of severe or decompensated lung disease. * presence of percutaneous intrahepatic porto-systemic shunt (tips). * pregnancy.
ucla couples counseling for combat veterans

Conditions: PTSD; Recent Era Combat Veteran; Couples Communication

Summary: a pilot intervention of an existing intervention adapted for the returning warfighter population: a couples treatment for ptsd, structured approach therapy (sat), which emphasizes reducing the ptsd avoidance/numbing symptoms that are corrosive in families.


Eligibility criteria:
inclusion criteria: * oif/oef/ ond veteran with at least one deployment * in a cohabitating relationship for 6 months or longer * cohabitating 50% of the time or more * diagnosed with ptsd or meets the diagnosis criteria for ptsd as related to deployment experience (caps) * ability to make weekly appointments * willingness to commit to change exclusion criteria: * receiving an evidence-based treatment for ptsd within the past 6 months * receiving couples therapy within the last 6 months * moderate or excessive physical violence within the past 3 months (cts) * alcohol/substance dependence (scid) * known domestic violence/abuse (cts) * symptoms of psychosis within the past 3 months * unstable psychiatric medicine usage or on regimen less than 3 months

Keywords: ptsd couples combat veteran warfighter oef oif ond structured approach therapy trauma
a lactation study in women who are breastfeeding or pumping and are receiving linaclotide therapeutically

Conditions: Breast Feeding; Constipation; Irritable Bowel Syndrome

Summary: the purpose of this study is to determine the amount of linaclotide and its active metabolite (mm-419447) excreted in breast milk after multiple, once daily doses of linaclotide (72 μg, 145 μg, or 290 μg) in lactating women receiving the drug therapeutically.


Eligibility criteria:
inclusion criteria: * be a lactating female who has been actively breastfeeding or pumping for at least 4 weeks * be already taking linaclotide therapeutically for irritable bowel syndrome with constipation (ibs-c) or chronic idiopathic constipation (cic) * weaning must not be underway * be willing to breastfeed or pump regularly during the study to maintain milk supply and discontinue breastfeeding for the 24-hour period of breast milk collection exclusion criteria: * clinically significant disease state in any body system, except for the indication being treated with linaclotide * any structural abnormality of the gastrointestinal (gi) tract, or a disease or condition that can affect gi motility * participation in any other clinical investigation using an experimental drug within 90 days

Keywords: linzess
predictive value of transabdominal intestine sonography in critically ill patients

Conditions: Gastrointestinal Dysfunction; Critical Illness; Intestine Ultrasonography

Summary: it is very important to evaluate the degree of gastrointestinal dysfunction in critical ill patients. thus the investigators conducted transabdominal intestine ultrasonography(us) in critical ill patients to evaluated the degree of gastrointestinal dysfunction under the acute gastrointestinal injury (agi)


Eligibility criteria:
inclusion criteria: * aged more than 18 years * acute physiology chronic health evaluation ii (apache ii) score \>8 exclusion criteria: * uncontrolled mesenteric vascular disease * uncontrolled chronic organ dysfunction * advanced cancer * any terminal stage disease
exercise tolerance in patients with decompensated heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to evaluate the effects of airway bilevel positive pressure on the improvement of exercise tolerance in patients with decompensated heart failure.

heart failure causes limitation of functional capacity and worsening of exercise tolerance. the airway pressure as adjuvant of cardiac rehabilitation has demonstrated improvement of functional capacity, decrease of respiratory work, increase of oxygenation and pulmonary compliance. objective: to evaluate the effectiveness of the bilevel positive airway pressure (bilevel) in the increase of exercise tolerance in patients with decompensated heart failure. method: this is a cross-over randomized clinical trial, with individuals who will undergo a submaximal progressive exercise test of the lower limbs with a cycle-ergometer using continuous positive airway pressure (cpap) and bilevel in a random order. patients will also be evaluated using a health related quality of life questionnaire, pulmonary function test, inspiratory muscle and peripheral muscle strength tests. hypothesis: the increase in exercise tolerance might be greater during the use of bilevel.

Eligibility criteria:
inclusion criteria: * subjects who has heart failure functional class ii or iii of new york heart association * over 18 years * non-smokers * without cognitive or motor deficit * without vasoactive drugs or low doses * without recent acute myocardial myocardium (\<1 year) * without recent cardiac surgery (\<1 year) * without pulmonary disease * without bronchodilators exclusion criteria: * unstable angina * atrial fibrillation and atrioventricular block third degree * frequent vomiting * respiratory instability while collecting data

Keywords: heart failure exercise tolerance noninvasive ventilation
comparison of biliary forceps biopsy and brush cytology

Conditions: Cholangiocarcinoma

Summary: cholangiocarcinomas (cccs) are malignant tumors arising from the biliary epithelium. cccs are characterised by a high mortality and the only curable therapy is complete tumor resection, if feasible, or in some cases liver transplantation. since surgery for ccc is a procedure associated with a high mortality itself it needs to be ascertained that an accurate preoperative diagnosis has been established. however, it often appears to be difficult to get a preoperative pathological diagnosis, since it is difficult to obtain tumor specimens using cytologic brushings, biopsy forceps, bile aspiration or endoscopic ultrasonography guided-fine needle aspiration. this is reflected by a nearly 100% specificity but low sensitivity rates. the aim of this study is to compare a new method of biliary biopsy using a double-balloon enteroscopy (dbe) forceps to enable a safe and reliable tissue specimen collection within the proximal biliary tract with cytology brushings in patients with suspected malignant proximal biliary strictures.


Eligibility criteria:
inclusion criteria: * biliary stenosis with suspected malignancy exclusion criteria: * no definite diagnosis available

Keywords: cholangiocellular carcinoma
a comparison of orally pilocarpine and artificial saliva in xerostomy treatment

Conditions: Primary Sjogren; Secondary Sjogren; Xerostomia

Summary: the purpose of this study is to assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by ss in a multicenter, doubleblind, controlled trial.

title: xerostomy treatment in patients with sjogren's syndrome in chile :a double blind control trial comparing orally pilocarpine drops and artificial saliva authors: cristian vera kellet, mirtha cifuentes mutinelli. affiliations: pontificia universidad catolica de chile background sjogren's syndrome (ss) is characterized by diminished exocrine secretions with the resultant xerostomia and xerophthalmia due to slowly progressive infiltration of lacrimal and salivary glands by inflamatory cells. objective: to assess and compare the safetyness and efficacy of pilocarpine drops versus artificial saliva as symptomatic treatment for dry mouth and dry eyes caused by ss in a multicenter, doubleblind, controlled trial. subjects and methods after providing written informed consent, 72 patients with primary or secondary ss and clinically significant dry mouth and dry eyes will be randomized to receive either 5-mg pilocarpine drops, or artificial saliva 3 times daily for 12 weeks. global evaluation and subjective responses of patients will be assessed by questionnaires with visual analog scales or categorical checkboxes. all patients will be submited to anxiety and psicological test before and after 12 weeks. whole-mouth salivary flow and lacrimal flow will be measured using schirmer test.

Eligibility criteria:
inclusion criteria: * patiens over 18 years, with primary or secondary sjogren's syndrome and xerostomia. exclusion criteria: * patiens with cardiac, pulmonary, renal, gastric diseases, * patients with diabetes, glaucoma, multipleesclerosis, * pregnant women.

Keywords: pilocarpine artificial saliva xerostomia xerostomy primary sjogren secondary sjogren
promoting resilience in women with breast cancer

Conditions: Breast Cancer

Summary: the prism (promoting resilience in stress management) intervention is an evidence-based program that builds resilience. this program was developed in adolescent and young adult oncology and utilizes centrally administered skills-based coaching to bolster positive psychological tools known as resilience resources. these resources include stress management, goal-setting, and positive reframing. previous studies using this intervention have found prism to be successfully administered remotely and it has improved resilience, psychological distress, hope, and quality of life. among adult caregivers, prism has shown to improve resilience, self-efficacy, and engagement with medical care. while prism successfully targets distress and associated downstream consequences known to be experienced by breast cancer survivors, it has not been utilized in adults with cancer or in marginalized communities. adapting this intervention to this context will require the testing of the intervention and, importantly, tailoring to meet the needs of women with breast cancer, particularly those of marginalized populations who may uniquely benefit from this intervention.

this single-arm pilot study will (1) test feasibility, acceptability, and appropriateness of the prism intervention in individuals with breast cancer, (2) elicit patient perspectives on elements for future adaptation or expansion to meet the unique needs of women with breast cancer, (3) assess trajectory of patient-reported outcomes and biological measures of stress for patients with breast cancer receiving the prism intervention.

Eligibility criteria:
inclusion criteria: * women undergoing neoadjuvant chemotherapy with early-stage breast cancer, women undergoing treatment for metastatic breast cancer exclusion criteria: * patients who do not speak english
video laryngoscopy in newborn babies v1

Conditions: Respiratory Distress Syndrome

Summary: our research questions are 1. will the use of a video laryngoscope lead to decreased attempts 2. does this result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed.

neonatal intubation is a technically difficult, but essential, skill to learn, involving passing a plastic tube through the vocal cords, into the trachea. current practice involves using a laryngoscope to directly visualise the cords, however this technique does not allow the supervisor to witness the tube passing through the cords. video laryngoscopes have a camera at the distal end of the blade, allowing an 85% viewing angle as opposed to 15% that is seen with direct view. in addition, the image is projected onto a screen, allowing all members of the team to visualise the intubation and therefore provide real time guidance as well as increased confidence in the outcome of the attempt. video laryngoscopes are used in neonates in other specialities, for example ear nose and throat or respiratory physicians, and are becoming routinely used by neonatologists. the research questions are whether using a video laryngoscope will lead to decreased attempts, which in turn will potentially result in more successful intubations and greater confidence in the supervisor and the team that a successful intubation has been performed. the aim is to recruit 40 babies and randomly allocate the participant to either direct laryngoscopy or video laryngoscopy for elective intubations. number of attempts to successful intubation would be recorded, in addition to confidence of supervisor and the team regarding the outcome of the attempt.

Eligibility criteria:
inclusion criteria: * any baby requiring intubation on a neonatal unit exclusion criteria: * infants will not be recruited if they are in extremis requiring immediate intubation by a senior experienced operator who will use his/her own preferred method. infants who will be intubated nasally will not be included as this technique is not usually taught to registrars. any baby with a congenital airway malformation will not be included in the study
effect of capsular repair on the outcomes of direct anterior total hip arthroplasty.

Conditions: Coxarthrosis

Summary: total hip arthroplasty is a successful surgical procedure performed as a last-line treatment in primary and secondary coxarthrosis. recently, the direct anterior approach (daa) has gained popularity by maintaining abduction force and reducing dislocation rates. soft tissue stability in the anterior is increased by adding capsule repair with the preservation of the posterior structures in the daa. the degradation of the biological structure of the capsule due to degenerative changes in the end stage coxarthrosis questions the effectiveness of the capsule repair. therefore, the effect of capsule repair on stability is still controversial.


Eligibility criteria:
inclusion criteria: * elective unilateral or bilateral primary total hip arthroplasty * direct anterior surgical approach * 18 years of age or older * avascular necrosis of the hip exclusion criteria: * rheumatoid arthritis of the hip * revision hip arthroplasty * younger than 18 years of age * crowe type 3 and 4 coxarthrosis
to demonstrate the relative bioavailability of divalproex sodium 500 mg delayed release tablets under fed conditions

Conditions: Epilepsy; Bipolar Disorder

Summary: to demonstrate the relative bioavailability of divalproex sodium 500 mg delayed release tablets under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: treatment of epilepsy and bipolar disorder