Kornimate/medical-research-clean huggingface dataset:
impact of a nurse implemented sedation and analgesia algorithm in surgical intensive care unit

Conditions: Sedation

Summary: to show that the nurse implementation of a sedation and analgesia algorithm is beneficial to the patient in terms of sedative drugs reduction and thus overall decrease in duration of mechanical ventilation and the morbidity and mortality which is associated with it, without altering patient comfort and tolerance of the environment. this, compared to the less frequent assessments by doctors and thus regular adjustments during the day as opposed to a fixed drug dose.

outcome measures : the primary objective of this non-invasive, non-interventional study is to show that the establishment of a titration algorithm for sedation and analgesia administered by nurses is more beneficial to the patient than the use of such a drug without a suitable regimen. the goal is to improve the quality of our painkillers and sedative drugs use needed in the intensive care environment in order to decrease the morbidity and mortality associated with it, without altering patient comfort and tolerance to the environment. for this we propose to collect a database including patient demographic details, pharmacological information and any possible complications during the icu stay as well as a distant assessment exploring the psychological complications (3, 6 months and 1 year). the primary endpoint will be the duration of mechanical ventilation, and secondary endpoints, the length of stay in icu and in hospital, mortality and other complications. methods: the two study populations will be in two distinct time periods, the first so-called control without any modification of practices, and the second, by introducing the algorithm with the same drugs being used. quantitative comparisons of data following a normal distribution will be done using a student's t test. otherwise quantitative data will be compared using a mann-whitney test or wilcoxon. the comparison of qualitative data will be done using a fisher exact test. to increase the power of this before / after study, we calculated the number of patients to be included by period, based on the reduction in duration of mechanical ventilation with such protocols in the literature, and the mean duration of mechanical ventilation in our unit before the study.

Eligibility criteria:
inclusion criteria: * any patient sedated, intubated, ventilated whose anticipated duration of sedation is more than 48 hours. * age greater than 18 years. exclusion criteria: * patient under guardianship or \<18. * comatose, intracranial hypertension, brain damage, acute respiratory distress syndrom, acute severe asthma (therapeutic sedation), post cardiac arrest care, pregnancy * neuromuscular blocking agents at the time of inclusion secondary exclusion criteria: * extubation \<48 hours after inclusion * deaths \<48 hours after inclusion
evaluation and treatment of patients with lung disease not participating in research

Conditions: Pulmonary Disease

Summary: this study was developed in order for the professional-staff at the pulmonary-critical care medical branch (pccmb) of the national heart, lung, and blood institute to maintain their skills and increase their understanding of lung diseases. the study will permit pccmb staff members to evaluate and treat patients with lung disease who do not meet the criteria for other research studies.

the professional staff in the cardiovascular and pulmonary branch (cpb) needs to maintain their clinical skills and to enhance their clinical knowledge. the purpose of this protocol is to permit cpb staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.

Eligibility criteria:
* inclusion criteria: patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of cpb will be eligible for participation in this protocol. only standard diagnostic procedures and conventional therapy will be performed. patients will not be subjected to any research procedures. this protocol does not commit the nih to medical or surgical treatment of protocol participants after discharge. patients will be discharged to the referring physician. consenting to pregnancy testing in minors of childbearing age: we will inform the minor during the assent process that for safety, we need to do a pregnancy test. she will also be told that if it is positive, we will counsel her and help her tell her parents. if the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end. exclusion criteria: patients without symptoms of pulmonary disease will be excluded from this protocol.

Keywords: teaching pulmonary disease routine testing medically indicated pulmonary function test
selective pde9 inhibition with imr-687 in adults with heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: this study is to evaluate whether 16 weeks of treatment with imr-687 is a safe and effective treatment for patients with heart failure with preserved ejection fraction (hfpef). the primary objective is to evaluate whether imr-687 reduces nt-probnp compared to placebo in these patients.


Eligibility criteria:
inclusion criteria: * males or females ≥45 years * weight 60 to 160 kg, inclusive * lvef ≥45% by echo within 6 months prior to screening visit * symptoms of hfpef requiring treatment with a diuretic(s) for at least 30 days prior to screening * nyha class ii to iv at the time of screening * lv hypertrophy, by echo within 6 months of screening, defined by either lv mass/bsa \>95 g/m² for females and 115 g/m² for males or lv mass/m² for males \>44 g/m2.7 for females and 48 g/m2.7 for males * nt-probnp criteria either ≥300 pg/ml if in sinus rhythm or ≥700 pg/ml if in atrial fibrillation at screening * elevated lv filling pressure criteria are defined as one or more of the following: 1. hf hospitalization within 12 months prior to screening 2. la enlargement (la width (diameter) ≥3.8 cm, la length ≥5.0 cm, la area ≥20 cm² , la volume ≥55 ml, or la volume index \>29 ml/m²) within 6 months of screening for a participant in sinus rhythm 3. cardiac catheterization with at least one of the following in the 12 months prior to screening: rest lvedp or pcwp ≥15 mm hg, exercise pcwp ≥25 mm hg, or fluid challenge pcwp ≥18 mm hg 4. echocardiogram criteria of one or more within 6 months of screening for a participant in sinus rhythm: e/e' (mean of lateral and septal) \>13, e/e' lateral \>12, or e/e' septal \>14; or for a participant in atrial fibrillation: e/e' septal \>11 * for wocbp: two negative pregnancy tests and the use of highly effective contraception up to 3 months following end of study exclusion criteria: * any prior echocardiographic imaging measurement of lvef \<40% * six-minute walk test (6mwt) distance \ 450 m at screening visit * kansas city cardiomyopathy questionnaire (kccq) overall summary score of \>80 * major cardiovascular surgery, or urgent percutaneous coronary intervention (pci) within the 3 months prior to screening visit, or an elective pci within 30 days prior to screening visit * any clinical event within 6 months prior to screening visit that could have reduced the lvef (eg, myocardial infarction, coronary artery bypass graft) unless an echocardiographic measurement was performed at least 1 month after the event confirming the lvef to be ≥45%

Keywords: heart failure hfpef preserved ejection fraction imr-687 pde9
aquatic therapy versus land-based therapy for the treatment of balance dysfunction in parkinson's disease

Conditions: Parkinson Disease

Summary: the aim of this study is to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with parkinson's disease and to evaluate the long-term effects in a 6-month follow-up period.

background: balance dysfunction (bd) in parkinson's disease (pd) is a disabling sign leading to falls which have a negative impact on the quality of life. it is known that aquatic therapy could be useful to train balance given its physical features and for reducing patients' fear of falls. many studies have evaluated the efficacy of land-based physiotherapy in treatment of bd, but few studies have investigated the efficacy of aquatic therapy on balance and none of those assessed clinical measurements in a clinically, relevant follow-up period. objective: the aim of study was to compare the effectiveness of a specific aquatic therapy program on balance with a land-based physical-treatment in patients with pd and to evaluate the long-term effects in a 6-month follow-up period. methods: thirty-four patients with pd in medium-stage of disease were randomized into two groups: 17 underwent multidisciplinary-intensive-rehabilitation-treatment (mirt) and 17 underwent mirt associated with aquatic therapy protocol (mirt-at). investigators assessed the berg balance scale (bbs), unified parkinson's disease rating scale (updrs) ii-iii, and timed up go test (tug) in both groups at admission, discharge and after a 6-months follow-up period.

Eligibility criteria:
inclusion criteria: * probable diagnosis of pd according to gelb et al * hoehn \& yahr stage 2.5-3 (h\&y), * stable pharmacological treatment for the last 8 weeks and during the hospitalization * mini-mental state examination (mmse) ≥ 24 exclusion criteria: * cardiac and pulmonary diseases * urinary incontinence * history of deep brain stimulation

Keywords: parkinson's disease, aquatic therapy, balance, mirt
a study evaluating the safety and efficacy of bgc20-0582 lice treatment gel for head lice infestation

Conditions: Pediculus Humanus Capitis; Head Lice

Summary: the main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

the main purpose of this study is to investigate the safety and efficacy of an investigational treatment for head lice infestation against a placebo.

Eligibility criteria:
inclusion criteria: 1. the subject and/or his/her parent/legal guardian have provided written informed consent, and, if appropriate, the child has provided assent. 2. male or female subjects who are between the ages of 2 years (24 months) and 70 years old when consent is signed. 3. infestation with head lice as demonstrated by the presence of live lice prior to first treatment. 4. willing and able to attend all study visits as scheduled. 5. females of childbearing potential must have a negative urine pregnancy test at screening and before receiving a second treatment, if necessary. exclusion criteria: 1. subject and/or legal guardian has not signed informed consent. 2. subject was treated for pediculosis within 2 weeks prior to the screening evaluation. 3. subject with an infestation of body lice or pubic lice. 4. subject is suffering from a condition likely to require medical attention, including administration of oral or systemic antibiotics, oral or systemic corticosteroids, or any other treatment, which in the opinion of the investigator and visiting physician could influence the results of the study. 5. subject with other diagnoses which, in the opinion of the investigator, would interfere with efficacy or safety assessments or would preclude study participation. 6. subject with very short (shaved) hair. 7. subject who will not be available for follow up visits. 8. subject has been treated with a systemic antibiotic within the previous two weeks before screening. 9. subject has been previously enrolled in any clinical study within the past 30 days; subject may not participate in another study while participating in this study. 10. subject with history of allergy/sensitivity to active ingredient or related products; or any ingredients commonly included in hair products such as shampoos, hair conditioners, or styling aids. 11. pregnant and/or nursing females.

Keywords: head lice lice infestation pediculosis pediculosis capitis
novel bioactive sleeve on pain and proms

Conditions: Meniscus Tear

Summary: a novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to assess pain outcomes, patient reported outcome measures, and effectiveness of healing based on range of motion.

this is a blinded randomized prospective study comparing two postoperative leg sleeves. the novel bioactive sleeve (reparel leg sleeve) will be compared to a regular black sleeve with a similar feel/compression. the main hypothesis for this study is that postoperative use of a novel bioactive sleeve after partial arthroscopic meniscectomy/meniscus repair will decrease pain and improve patient reported outcome scores faster and more reliably than the control non-bioactive sleeve. in order to test this hypothesis, approximately 100 patients scheduled for meniscectomy/meniscus repair will be randomized to one of the two arms in order to minimize bias. the following variables will be assessed: patient reported outcomes (vas, koos jr, vr12, and kss satisfaction), physical therapy time, motor testing. each patient will fill out a series of proms preoperatively, and post operatively at the 1-week, 2-week, 6-week, 3-month, 6-month, 1 year, and 2-year mark.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * male or female, over the age of 18, undergoing a meniscectomy or meniscus repair * in good general health as evidenced by medical history * under 45th percentile bmi * willing to adhere to the study intervention regimenregimen. * kellgren-lawrence grade 2 or less exclusion criteria: * febrile illness within 3 months * bmi over 40 * treatment with another investigational drug or other intervention within 6 months * kellgren-lawrence grade 3 or more or 4 * history of autoimmune disease, circulatory disease, or vascular disorder
ultraviolet germicidal irradiation on the new silicone half-piece elastometric respirators

Conditions: Covid19

Summary: since the innovation of our new half- elastometric half-piece respirator, this type of ffr has been used widely in our country. decontamination methods including ultraviolet c (uvc) germicidal irradiation and 70% alcohol have been implemented to decontaminate the respirator. we than examined inactivation potential for the porcine epidemic diarrhea virus (pedv), numerous bacterial strains ,mostly skin-derived after the decontamination process.to enable rigorous integrity after repeated decontamination process, fit test by the bitrex test ,tensile strength and elongation at break were also evaluated. our results showed that the uvc at the dose of 3 j/cm2 can eradicate the bacteria at 60 min and virus at 10 min.no fungus was found on the mask surface at the beginning. good fit test , tensile strength and elongation at break were still main maintained after multiple cycles of decontamination. no evidence of physical degradation by gross visual inspection was found. 70% alcohol is also an easy and effective way to eradicate microorganisms on the mask.as the current pandemic is expected to continue for months to years, the need to supply adequate reserves of ppe and develop effective reprocessing is crucial. our studies demonstrated that the novel silicone mask can be safely reprocessed and decontaminated for many cycles by uvc irradiation and help restore the shortage of the important protective devices in the covid-19 pandemic era.

this study showed that uvc irradiation at the dosage 300 uwatt-sec/cm2 for 1 minute satisfactorily decontaminated the silicone mask as measured by viral culture. the timing to eradicate bacteria was 60 minutes longer due to the tolerability of the bacteria .70% alcohol effectively decontaminate the virus and bacteria deposited on the masks and filters. good level of fit can be maintained following uvc treatment. the tensile strength of the strap was retained over multiple decontamination cycles using uvc and dry heat upto 60 cycles.given the efficacy of the disinfection by uvc and 70 % alcohol ,these types of decontamination method could potentially be used for the new type of silicone masks half-piece respirator in the setting of a crisis with inadequate supplies of ppe.

Eligibility criteria:
inclusion criteria: healthy volunteers 18 to 60 years old. exclusion criteria: * contraindications to fit test, such as asthma, congestive heart failure, anosmia, and ageusia.

Keywords: covid-19 decontamination filtering facepiece respirators uvc
effect of strength and coordination training on biomechanics and injury in new runners

Conditions: Injuries; Patellofemoral Pain Syndrome; Iliotibial Band Syndrome

Summary: the investigators hypothesize that new runners participating in an 8 week strength and coordination training program prior to beginning to run will 1) display different coordination patterns , and 2) experience fewer injuries, compared to new runners who do not perform strength or coordination training prior to running.

the study will investigate the effect of a sequenced training program - beginning with strength training, followed by running-specific coordination exercises, and finally a gradual introduction to running - on strength, coordination and injury incidence in a group of novice runners. he investigators hypothesize that runners who perform strength and coordination training prior to beginning to run will 1) demonstrate greater lower extremity strength, 2) demonstrate alters coordination patterns and 3) experience fewer injuries, when compared to a control group of novice runners who perform no physical preparation prior to a gradual introduction to running. the possible long-term benefits of this study include reduced burden of running-related injuries, increased participation in the sport of running, improved cardiovascular and metabolic health characteristics, and reduced incidence of disease such as cardiovascular events and cancer.

Eligibility criteria:
inclusion criteria: * no previous participation in running races * run less than 10km total in past year * able to run continuously (ie at least 5mph) for 5 min (so that biomechanical analysis of running form can be conducted) * female participants may not be pregnant * participants will be screened using the parq+ form, and parmed-x form completed by a physician if necessary * cleared for physical activity through screening * english-speaking exclusion criteria: * previous (at any time of life) training of 3 or months of consistently running 3 or more days per week

Keywords: running related injuries
clinical evaluation of a low protein content formula in the first months of life: a rct

Conditions: Safety Issues; Infant Nutrition Disorders

Summary: this study aimed to evaluate the tolerance and safety of a low-protein formula in healthy full-term infants by investigating effects on growth and gastrointestinal tolerance and by identifying any adverse effects.

infants were randomized to receive either a standard protein formula or a low-protein formula. the composition of the low-protein formula vs the standard formula was: energy (65 vs. 68 kcal/100 ml), protein (1.2 vs. 1.7 g/100 ml). to investigate the safety of the low-protein formula without any bias, a 4-month intervention period was selected during which the infants were fed only formula. anthropometric parameters (weight, length, and head circumference) and body composition were assessed at enrollment, at 2 and 4 months' of age. parents were asked to keep a diary on the occurrence of gastrointestinal symptoms or any other symptoms and were contacted every two weeks either by clinic visits or phone calls. the reference group was constituted by a cohort of healthy, exclusively breastfed, full-term infants.

Eligibility criteria:
inclusion criteria: * healthy * singleton * full-term infants (gestational age 37/0 to 41/6 weeks) * birth weight adequate for gestational age (\>p10 and \<p90 for gestational age) according to the world health organization growth charts. exclusion criteria: * presence of congenital diseases * presence of chromosomal abnormalities * presence of conditions that could interfere with growth, such as brain, metabolic, cardiac and gastrointestinal diseases, perinatal infections. * being born to mother affected by endocrine and/or metabolic diseases * having a family history of allergic disease

Keywords: full term healthy infants low protein content formula safety growth body composition
ambulate: cardiva mid-bore vvcs vs. manual compression for multiple femoral venous access sites, 6 - 12f id

Conditions: Surgical Wound

Summary: the objective of the trial is to demonstrate the safety and effectiveness of the cardiva mid-bore venous vascular closure system (vvcs) in sealing femoral venous access sites and providing reduced times to ambulation (tta) compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 fr introducer sheaths.

a prospective, randomized, controlled multi-center clinical trial designed to evaluate the safety and effectiveness of the study device in sealing multiple femoral venous access sites and providing reduced times to ambulation compared with manual compression at the completion of catheter-based procedures performed through 6 - 12 fr introducer sheaths. only patients with multiple access sites will be enrolled in order to support the desired indication. randomization will be stratified to account for patients with varying numbers of access sites in a 1:1 treatment device to control arm ratio to ensure treatment and control arms have the same proportion of access sites/patient, i.e. 3 access sites/patient vs. 4 access sites/patient.

Eligibility criteria:
inclusion criteria: * acceptable candidate for an elective, non-emergent catheter-based procedure via the common femoral vein(s) using a 6 to 12 fr inner diameter introducer sheath, with a minimum of 3 and maximum of 4 femoral venous access sites, and a maximum of 2 access sites/leg * anticipated prolonged bedrest (5 hours or more) and / or overnight stay exclusion criteria: * active systemic or cutaneous infection, or inflammation in vicinity of the groin * pre-existing immunodeficiency disorder or chronic use of high dose systemic steroids * know history of bleeding diathesis, coagulopathy, hypercoagulability or platelet count \< 100,000 cells/mm3 * severe co-existing morbidities with life expectancy less than 12 months * femoral arteriotomy or femoral venotomy in \< 10 days, or with any known vascular complications or residual hematoma, or with use of an intravascular closure device w/in previous 30 days * planned femoral venous or arterial access within next 30 days * history of dvt, pulmonary embolism or thrombophlebitis * significant anemia or renal insufficiency * bmi \> 45 kg/m2 or \< 20 kg/m2 * unable to routinely walk at least 20 ft. without assistance * lmwh within 8 hours before or after procedure * access site-specific eligibility criteria to exclude problems with gaining access or location of sheath; \ 12 fr inner diameter sheath use; obvious bleeding complications or tissue tract estimated to be \< 2.5 cm deep

Keywords: vessel closure venous access site femoral venotomy medium bore multiple access sites
safety and efficacy of intrapulmonary percussive ventilation in preterm infants

Conditions: Respiratory Distress Syndrome in Premature Infant

Summary: the purpose of this study is to evaluate the benefits and safety of intrapulmonary percussive ventilation in preterm infants. ipv has been demonstrated to be safe, and improve airway secretions clearance and decreased atelectasis in pediatric patients. we aim to evaluate the effects of ipv in preterm infants.


Eligibility criteria:
inclusion criteria * premature infants born before 32 weeks of gestation with birth weight less than 1500 grams. * infants requiring positive pressure ventilation by 14 days of life. exclusion criteria * infants with known or suspected chromosomal anomalies (trisomy 13, 18, 21) * infants with congenital diaphragmatic hernia * presence of air leak syndrome (pneumothorax, pneumomediastinum) * previous diagnosis of air leak syndrome.