Kornimate/medical-research-clean huggingface dataset:
impact of oximetry on hospitalization in acute bronchiolitis

Conditions: Bronchiolitis

Summary: to determine, in previously healthy infants 6 weeks to 12 months of age, diagnosed with acute bronchiolitis and monitored by hourly oximetry, if the probability of hospitalization within 72 hours of arrival in those whose oxygen saturation display is manipulated 3 percentage points above the true measurements is significantly lower in comparison to those whose monitors display true saturations.

this is the first bronchiolitis study to examine the clinical and economic impact of making disposition decision on primarily clinical grounds, while blinding the physicians to oxygen saturations by providing them with either true saturation measurements or those which are 3 percentage points above the true values. although physiologically insignificant and within the measurement error of the instrument, this difference has been shown to be perceived as clinically relevant and to have a major hypothetical impact on disposition, without any evidence to support this belief. we hope to find out if children with oxygen saturations above or in the vicinity of the threshold recommended for initiation of oxygen therapy by the aap can be safely discharged based on their clinical appearance rather than to have their hospitalization dictated by a locally defined number. this study will hopefully provide much needed evidence necessary to help us interpret the oximetry results more meaningful which may in turn lead to fewer hospitalizations, shorter length of hospital stay and lower health care costs.

Eligibility criteria:
inclusion criteria: * acute bronchiolitis * age 4 weeks to 12 months * baseline respiratory disease assessment instrument (rdai) ≥ 3 points * informed consent * availability of a telephone exclusion criteria: * pre-existing pulmonary or cardiac distress, neuromuscular disease, congenital or acquired airway anomalies, hemoglobinopathies, or chronic hypoxia * severe respiratory distress, defined as the retraction component on the rdai as 8 out of possible 9 points * true baseline oxygen saturation less than 88% in room air * transfers from other institutions

Keywords: bronchiolitis hospitalization oximetry pediatrics
prospective multicentre non-interventional study of vantas® for the treatment of patients with advanced prostate cancer

Conditions: Prostate Cancer

Summary: the aim of this non-interventional (observational) study is to document, in collaboration with established urologists in scandinavia, experience gained from routine use of vantas® for the treatment of patients with advanced prostate cancer. in this observational study particular attention will be directed to treatment duration, quality of life and patient and physician acceptance of the medicinal product for long-term therapy. patient-based measurement parameters such as quality of life and degree of satisfaction will allow registration of information that extends beyond the clinical parameters. the knowledge gathered will enable patient acceptance of long-term therapy to be evaluated. clinical outcome will also be documented by measuring serum testosterone and prostate specific antigen (psa) levels.


Eligibility criteria:
inclusion criteria: * male patients for whom hormone treatment for advanced prostate cancer is indicated * age \> 18 years. * documented elevated psa levels. exclusion criteria: contraindications for vantas® (in accordance with summary of product characteristics (smpc))
zenith® tx2® low profile taa endovascular graft

Conditions: Aortic Aneurysm; Penetrating Ulcer; Vascular Disease

Summary: the zenith tx2 low profile taa endovascular graft extended study is to collect confirmatory safety and effectiveness data. the zenith tx2 low profile taa endovascular graft is indicated for the treatment of patients with a descending thoracic aortic aneurysm or penetrating ulcer and has an anatomy suitable for repair.


Eligibility criteria:
inclusion criteria: * meets one of the following * descending thoracic aneurysm with diameter ≥ 5.0 cm * descending thoracic aneurysm with a history of growth ≥ 0.5 cm per year * descending thoracic degenerative or atherosclerotic ulcer ≥ 10 mm in depth and 20 mm in diameter exclusion criteria: * life expectancy less than 2 years * pregnant of breastfeeding or planning on becoming pregnant within 60 months * unwilling to comply with the follow-up schedule * less than 30 days beyond primary endpoint for other investigative drug or device study * receiving home oxygen * myocardial infarction within the last 3 months * stroke within the last 3 months * diagnosed or suspected congenital degenerative collagen disease * systemic infection * bleeding diathesis, uncorrectable coagulopathy, or refuses blood transfusion * allergy to polyester, polypropylene, nitinol, or gold * previous placement of a thoracic endovascular graft * prior open repair involving the descending thoracic aorta

Keywords: aortic aneurysm aneurysm vascular prosthesis vascular disease blood vessel prosthesis implantation
study on the response to tetanus vaccination of people living with hiv

Conditions: HIV Infections

Summary: the response to primary tetanus immunization of hiv-infected children is lower than that of uninfected children. response to tetanus toxoid (tt) booster doses in adults living with hiv who have received primary vaccination prior to infection is not known. currently, it is recommended to have a tt booster for people living with hiv (plhiv) every 10 years. in general population, this recall is made only at 25, 45 and 65 years, then every 10 years.


Eligibility criteria:
inclusion criteria: * person aged ≥ 18 years * person infected with hiv followed in the infectious diseases department of ch niort * born in france * affiliate or beneficiary of a social security scheme * being able to give free and informed consent to participation in research exclusion criteria: * persons with a contraindication to tetanus vaccination * persons under guardianship or curatorship or without civil law
pharmacokinetics, safety & tolerability of zd4054 (zibotentan) in subjects with normal, mild, moderate and severe hepatic impairment

Conditions: Hepatic Impairment

Summary: this study is designed to compare how zd4054 (zibotentan) is taken up, how it is broken down and removed from the body in subjects with liver cirrhosis and hepatic impairment compared to healthy subjects of a similar age, sex and weight. as for all clinical trials, safety and tolerability of the drug will be evaluated as well to develop dosing recommendations for dosing of zd4054 (zibotentan) in subjects with varying stages of hepatic impairment.


Eligibility criteria:
inclusion criteria: * hepatically impaired subjects - subjects with stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study. * healthy volunteers - clinical laboratory tests within the normal reference range or results with minor deviations which are not considered by the investigator to be clinically significant exclusion criteria: * in the opinion of the investigator, any evidence of additional severe or uncontrolled systemic disease (eg, cardiac, or renal disease) or evidence of any other significant clinical disorder or laboratory finding * healthy volunteers - history or presence of hepatic disease known to interfere with absorption, distribution, metabolism or excretion of drug * hepatically impaired subjects - fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within the screening period

Keywords: hepatic impairment
a study to assess the effects of ct-868 treatment on glucose homeostasis in participants with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: this study will be conducted primarily to evaluate the effects of ct-868 on glucose homeostasis in participants with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * female or male adults with type 1 diabetes * ages 18-65 years * type 1 dm for at least 3 years * using an insulin pump or multiple daily injections (mdi) for at least 3 months * bmi 25.0 - 35.0 exclusion criteria: * significant medical history * uncontrolled diabetes * history of surgical treatment for weight loss * history of malignancy

Keywords: type 1 diabetes obesity overweight
monopolar radiofrequency ablation using a dual switching system and a separable clustered electrode (octopus®)

Conditions: HCC; Metastasis

Summary: increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (rfa). a combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study. based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group.

increasing ablative zone is an essential part to improve technical success and long term outcome in patient treated with radiofrequency ablation (rfa). a combination of dual switching system and separable clustered electrode has been reported to create large ablative zone in preclinical study. based on preclinical study, the investigators conducted a preliminary study in eligible 60 patients to measure whether this combination (dual switching system and separable clustered electrode) improves technical success rate and local tumor progression rate over a year, in comparison with historical control group using propensity score matching.

Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma (according to aasld guideline or li-rads) * histologically confirmed hcc * histologically confirmed or typical imaging feature of colorectal cancer liver metastasis in patients with colorectal cancer and * equal to or larger than 2cm, equal to or smaller than 5cm * available cross-sectional liver imaging within 30 days before rfa * signed informed consent exclusion criteria: * history of local treatment on the index tumor * more than three tumors in a patient * tumors in central portion of portal vein or hepatic vein * child-pugh class c * vascular invasion by tumors * uncorrected coagulopathy * presence of multiple extrahepatic metastases

Keywords: rfa
abdominal weight training assisted by cough assist machine on lung function

Conditions: PMV

Summary: the patients with prolonged mechanical ventilation (pmv) have the risk of ineffective coughing and infection due to diaphragm weakness, making it more difficult to wean. this study aimed to explore the intervention of abdominal weight training (awt) with/ without cough machine (cm) on lung function, respiratory muscle strength and cough ability in these patients.

methods 40 patients with pmv were randomly assigned to three groups: awt group (n=12), awt+cm group (n=14) and control group (n=14). the effectiveness on pulmonary function, respiratory muscle strength and cough ability were compared among these three groups.

Eligibility criteria:
inclusion criteria: * (1) invasive ventilator users, * (2) hemodynamically stable, * (3) intubated endotracheal tube or tracheotomy tube, * (4) clearly conscious and cooperative, * (5) vital capacity (vc) \<10ml/kg exclusion criteria: * (1) unconscious or unwilling to sign the informed consent form, * (2) no spontaneous breathing, * (3) active bleeding with unstable hemodynamics, * (4) acute infection symptoms, * (5) abdominal distension, digestion problems (including nausea and vomiting), * (6) severe heart failure (ejection fraction ≤ 30%), * (7) unhealed wounds in the chest and abdomen, * (8) bullous emphysema, * (9) sensitive pneumothorax or mediastinal pneumothorax, * (10) recent history of traumatic stress, * (11) acute head and neck injury (unless the injury site is immobilized)

Keywords: prolonged mechanical ventilation weaning ventilator abdominal weight training cough machine
plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease

Conditions: Acyanotic Congenital Heart Disease; Cyanotic Congenital Heart Disease; Pheochromocytoma; Paraganglioma

Summary: the aim of our study is to compare plasma metanephrines in patients with cyanotic and acyanotic congenital heart disease and possible association with chronic hypoxic stress.


Eligibility criteria:
inclusion criteria: * patients with congenital heart disease attending regular follow up exclusion criteria: * missing main data in medical documentation
realizing opportunities for self-supported improvement (rossi)

Conditions: Domestic Violence; Depression; Quality of Life

Summary: this is a 3-year comparative effectiveness study funded by the patient centered outcomes research institute (pcori) and will test an adapted priority-based patient navigation versus care as usual among 300 survivors of intimate partner violence (ipv) recruited from, and/or referred from, university of rochester medical center providers. the goal is to improve patient safety, depression, and health function over the course of 12 months. in the community health worker -personalized support for progress (chw-psp) arm, created and tested in our first ur pcori grant, in addition to meeting with a social worker, patients will work with a community health worker (chw) to complete a prioritization tool and meet as needed over the course of the next 6 months to navigate services and overcome barriers. in addition, patients will receive referrals to other professionals based on their prioritization and meet with the chw at the time and place of their choice. patients in the care as usual- social worker (cau-sw) arm, will do intake with a social worker, who follows hospital procedures for intake and referrals, does a needs assessment, and offers safety planning in referral.


Eligibility criteria:
inclusion criteria: subjects must be english speaking urmc patients, who are 18 years of age or older, and/or the non-offending parent on a cps report for a urmc pediatrics patient, and who have experienced an ipv or emotional abuse event within the past 3 months. ipv is defined as endorsing any of the following items: 1. slapped, kicked, pushed, choked, or punched? 2. forced or coerced to have sex? 3. threatened you with a knife or gun to scare or hurt you? 4. made you feel afraid that you would be physically hurt? 5. repeatedly used words, yelled, or screamed in a way that frightened you? 6. threatened you, put you down, or made you feel rejected? yes no additional inclusion criteria include depression based on phq-9 score of \>10. exclusion criteria: * subjects are ineligible if they have active psychosis or alcohol or substance dependence based on 3 months threshold on the mini-international neuropsychiatric interview (mini). * additionally, patients who are unable to understand the consent form or study procedures, are imminently suicidal, or are currently working with a chw will be excluded.
pet/mr versus cect scans in imaging patients with ovarian cancer or highly suspected ovarian cancer

Conditions: Malignant Ovarian Neoplasm; Ovarian Carcinoma

Summary: this trial studies how well positron emission tomography/magnetic resonance (pet/mr) versus contrast enhanced computerized tomography (cect) scans work in locating ovarian cancer tumors in patients with known or suspected ovarian cancer. pet, mr, and cect scans use different methods to create images of areas inside the body. this trial is being done to see if pet/mr scans may help doctors locate ovarian cancer tumors, predict how well these tumors may be removed during surgery, and predict how patients respond to platinum-based chemotherapies compared to standard of care cect scans.

primary objective: i. to compare pet/mr and contrast enhanced computed tomography (ct) to determine the accuracy in patients with advanced-stage serous ovarian cancer or highly suspected ovarian cancer using diagnostic laparoscopy as the gold standard with respect to lesion detection. secondary objectives (exploratory): i. correlating imaging findings such as enhancement pattern, apparent diffusion coefficient (adc) values, standardized uptake value (suv) values, and advanced image analytics such as texture with pathology and genomic analysis for those lesions evaluated as a discovery arm. ii. assess whether mr (multiparametric and functional) and pet findings predict response to platinum based chemotherapy. iii. to compare pet/mr and contrast enhanced ct to predict tumor negative (r0) resection using surgery as the gold standard. outline: patients undergo standard of care cect scan and pet-mri scan over 90-120 minutes within 30 days before laparoscopy or cytoreduction. patients who do not undergo cytoreduction based on diagnostic laparoscopy undergo additional pet-mri and standard of care cect scans after completion of chemotherapy and before cytoreduction.

Eligibility criteria:
inclusion criteria: * patients with ovarian cancer or highly suspected ovarian cancer who are eligible to undergo laparoscopic evaluation for resectability will be enrolled in the trial. * patients who have estimated glomerular filtration rate (egfr) \> 30. exclusion criteria: * patients allergic to gadolinium. * patients who have egrf \< 30. * patients with cardiac pacers. * pediatric patients. * greater than 400 pounds in weight. * blood glucose (\> 200 mg/dl). * pregnant women.
comparison of rhbssl with placebo when added to infant formula or pasteurized breast milk during 4 weeks of treatment in preterm infants

Conditions: Prevention of Growth Restriction

Summary: the purpose of this study is to demonstrate that rhbssl improves growth in preterm infants as compared with placebo.

the purpose of this study is to demonstrate that rhbssl improves growth in preterm infants as compared with placebo. the infants should be born before week 32 of gestational age. the study drug, rhbssl or placebo, will be administered during a 4 week treatment period by adding it to either infant formula or pasteurized breast milk. the study will also evaluate the safety and tolerability of rhbssl. eligible patients will be randomized in a ratio of 1:1 (rhbssl:placebo). the study consists of maximum 1 week screening period, a 4-week treatment period and a 2 year follow-up period.

Eligibility criteria:
inclusion criteria: * preterm infants born before week 32 of gestation. * preterm infant who is less than 33 weeks postmenstrual age at the time of randomization. * preterm infant who is appropriate for gestational age (aga) or small for gestational age (sga) at birth. * preterm infant who is receiving food enterally (bottle or gavage tube) at a level of at least 100 ml/kg/day at randomization. * preterm infant whose enteral feeding consists of only infant formula or only pasteurized breast milk at the time of inclusion, and who are expected to remain on only infant formula for 4 weeks, or only pasteurized breast milk for at least 2 weeks following treatment initiation. * preterm infant who is expected not to receive any fresh breast milk for 4 weeks following treatment initiation. * informed consent is obtained. exclusion criteria: * expected stay in the hospital is less than 4 weeks from the first dose of study drug. * criteria to ensure no disease or treatment affecting growth or development, e.g. brain disease, necrotizing enterocolitis. * enrolled in another concurrent clinical intervention study.

Keywords: rhbssl preterm infants swedish orphan biovitrum growth velocity prevention of growth restriction
efficacy and safety of empagliflozin (bi 10773) with metformin in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this is a pivotal phase iii study, mandatory to seek approval by regulatory authorities for bi 10773 as an anti-diabetic agent compared to an active comparator in patients with type 2 diabetes mellitus and insufficient glycaemic control.


Eligibility criteria:
inclusion criteria: * diagnosis typ 2 diabetes mellitus * male and female on diet and exercise regimen, pre-treated with metformin 12 weeks prior to randomisation * hba1c equal or greater than 7.0% and less than or equal to 10% at visit 1 * 18 years or more * bmi equal or less than 45kg/m2 exclusion criteria: * uncontrolled hyperglycemia defined as glucose more that 13.3 mmol/l after overnight fast during placebo run-in * any other antidiabetic drug within 12 weeks prior to randomisation except metformin * acute coronary syndrome (non-stemi, stemi unstable angina pectoris), stroke or transient ischemic attack within 12 weeks of informed consent * indication of liver disease * moderate to severe renal impairment * bariatric surgery within past 2 years * medical history of cancer or treatment for cancer within last 5 years * blood dyscrasias or any disorders causing haemolysis or unstable red blood cell * contraindications hypersensitivity to concomitant drugs * treatment with anti-obesity drugs
effects of pediatric aquatic therapy in children with spastic cerebral palsy

Conditions: Spastic Cerebral Palsy

Summary: aquatic intervention had been applied in children with neuromotor impairment for years, yet there has been little progress toward objective identifications of therapy goals, interventions, and outcomes. thus, we attempt to design aquatic intervention activity for children with cerebral palsy to evaluate the effect of hydrotherapy. purpose: to evaluate the effects of pediatric aquatic therapy on motor performance, daily activity and social participation in children with spastic cerebral palsy. method: the study enrolled 27 children with spastic cerebral palsy aged from 4 to 12 years old.these children were dived into two groups: traditional rehabilitation therapy (control group), and hospital based pediatric aquatic therapy program. we evaluate the motor performance, daily activity and social participation before and after the intervention and compared the difference in improvement between groups. the measurements include modified ashworth score, gross motor function measure (gmfm -66), vineland adaptive behavior scale (vabs) , and cerebral palsy quality of life questionnaire for children (cpqol). expect effect: we suppose pediatric aquatic therapy in spastic cerebral palsy children could improve motor function and daily activity.children could improve self-esteem and we hypothesize this could improve social participation.

* we conducted a well-designed study to investigate the effectiveness of pat on motor function, activities of daily living (adl),and health related quality of life(hrqol) perspectives for children with cp. * a convenience sample of 27 children was recruited for the study from the outpatient clinics of the department of physical medicine and rehabilitation of two tertiary hospitals: chang gung memorial hospital and taipei veterans general hospital. * the study was designed as a single blinded, prospective, case control study. * the pediatric aquatic therapy group got more improvementon motor performance measured by gmfm-66.

Eligibility criteria:
inclusion criteria: 1. children diagnosed as cerebral palsy, spastic type 2. gross motor functional classification (gmfcs) level ii-iv 3. age: 4-12 y/o 4. informed consent by parents 5. modified ashworth score 2 or3 6. if participant history of epilepsy ,well controlled by medication exclusion criteria: 1. history of psychiatric diseases 2. poor controlled epilepsy 3. received botox injection or surgery in recent three months 4. children diagnosed as attention deficit hyperactivity disorder(adhd) or autism 5. severe mental retardation 6. active infection (body temperature \> 100°f) 7. communication problems 8. bowel incontinence 9. bladder incontinence 10. severe cardiovascular disease 11. infectious skin conditions and open wound 12. nasogastric tubes or gastrostomy tubes 13. colostomy ,urostomy or ileostomy bags 14. acute orthopedic injury with pain and instability 15. diabetes 16. chlorine sensitivity 17. latex allergies 18. tracheostomy

Keywords: gross motor function performance pediatric aquatic therapy spastic cerebral palsy