Kornimate/medical-research-clean huggingface dataset:
initiation of colon cancer screening in veterans or "start screening now"

Conditions: Colorectal Neoplasms

Summary: initiation of colon cancer screening in veterans is a theory-based stepped intervention to increase first time colorectal cancer screening (crcs) among male and female veterans age 50 and over.

colorectal cancer (crc) is the 2nd leading cause of cancer deaths in the us and risk increases with age. colorectal cancer screening (crcs) offers the possibility of both early detection and prevention. for those at average risk, crcs beginning at age 50 is recommended. however, awareness and use of crcs tests are low. we propose to conduct a randomized controlled trial to develop and test stepped interventions to increase initial uptake of crcs in a nationally-representative, ethnically-diverse sample of male and female veterans. our specific aims are to: (1) develop and pre-test stepped intervention components that are theory and evidence-informed; (2) implement and evaluate the process, efficacy, and cost-effectiveness of stepped interventions to increase an initial crcs among male and female veterans aged 50-64 years; and (3) analyze the association between predictor variables and crcs initiation and the mediating and moderating effects of the interventions, after each step. in step 1, we will evaluate a theory-based minimal cue delivered by a letter, telephone call, or automated telephone call compared with a survey-only control group to determine whether the 3 different delivery channels are equally efficacious and cost-effective. minimal cues are a cost-effective method that prompts to action those more willing to change and are easy to disseminate in real-world settings. persons who do not complete crcs in step 1 will be randomized in step 2 to more intensive interventions that address resistance. in step 2 we will determine whether a theory-based, tailored telephone intervention, using principles of motivation interviewing, is effective when delivered as part of a sequential intervention process in which early adopters have been removed from the population. step 2 also will determine whether an automated approach, telephone-linked communication (tlc), is as effective as a telephone counselor in promoting initiation of crcs. steps 1 and 2 together will address the important issue of the "dose" needed to encourage completion of crcs. after each step, we will examine the mediating and moderating effects of the intervention to identify determinants of completion. for cancer screening intervention research to have the broadest public health impact, interventions must have the potential for dissemination. we designed our trial to move us toward the goal of disseminable interventions with evidence of external validity.

Eligibility criteria:
inclusion criteria: * male or female veteran age 50 to 64 exclusion criteria: * prior crcs * history of colon or bowel cancer, crohn's disease, ulcerative colitis * history of colon polyps * currently active duty military * outside of age range

Keywords: colorectal neoplasms mass screening patient compliance intervention studies clinical trial
buccinator myomucosal flap with furlow palatoplasty and vpi

Conditions: Velopharyngeal Insufficiency

Summary: nasopharyngoscopic examination of the 20 patients with secondary vpi following 2 flap palatoplasty will be done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap and after vpi repair by buccinator myomucosal flap with furlow palatoplasty


Eligibility criteria:
inclusion criteria: * 5-6 years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic. * lip and palate repair performed by one craniofacial surgeon exclusion criteria: * patients with syndromic cleft lip. * bilateral cleft lip * patient older younger 5 years. * associated cardiac anomalies. * any systemic condition
safety study of intranasal oxytocin in frontotemporal dementia

Conditions: Frontotemporal Dementia

Summary: oxytocin is a hormone produced by the brain that appears to have important roles in social cognition and emotion in humans. in a pilot study, the effects of a single dose of oxytocin on measures of emotion recognition and behaviour in patients with frontotemporal dementia were investigated. the results from the pilot study suggested that oxytocin may be associated with a modest improvement in neuropsychiatric behaviours seen in patients with frontotemporal dementia. to further examine the safety and tolerability of oxytocin in this disorder, the present study will examine the safety and tolerability of three different doses of intranasal oxytocin administered to patients with frontotemporal dementia twice daily for 1 week.


Eligibility criteria:
inclusion criteria: * age 30-80 years * meets "neary criteria" for diagnosis of probable frontotemporal dementia * neuroimaging (ct, mri or spect scan) supports diagnosis of frontotemporal dementia * provides written informed consent and has a caregiver or legally acceptable representative who provides written informed consent. exclusion criteria: * has a history of a myocardial infarction within the last two years or congestive heart failure. * current uncontrolled hypertension * current bradycardia (rate \ 100 bpm) * current hyponatremia * current use of prostaglandin medications * females who are pregnant or breastfeeding * use of any investigational or experimental drug or device within the last 60 days prior to screening or within 5 half-lives of the experimental drug , whichever is longer.

Keywords: frontotemporal dementia oxytocin pick's disease
a study with primatrix dermal repair scaffold for the treatment of diabetic foot ulcers

Conditions: Foot Ulcer, Diabetic

Summary: the purpose of this study is to compare the clinical and economic effectiveness of primatrix and standard of care in the treatment of diabetic foot ulcers (dfus) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

subjects will be considered for screening upon meeting initial eligibility criteria. after a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. in particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. if all criteria including wound size at week 3 is met, subject will be randomized and enrolled. subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. week 24 will consist of a phone call to the subject to complete qol surveys.

Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years of age and able to give their own consent * type i or type ii diabetes with investigator-confirmed reasonable metabolic control * study ulcer has a wagner grade of 1 or 2 * study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement * a full thickness diabetic foot ulcer located on the foot or ankle * an ulcer which has been in existence for a minimum of 30 days, prior to the day of screening. exclusion criteria: * suspected or confirmed signs/symptoms of wound infection * wounds with exposed bone or tendon * hypersensitivity to bovine collagen
pharmacokinetics of dihydroartemisinin-piperaquine in the treatment of uncomplicated malaria in children in burkina faso

Conditions: Uncomplicated Malaria

Summary: this will be an open-label trial in burkina faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (dp, duocotexcin) in children. dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. we hypothesize that the disposition and pharmacokinetics of dp will be altered in children, and this will alter the efficacy and/or toxicity of dp. we will test this hypothesis in this open-label trial in burkina faso. the target population includes residents, aged 6 months to 10 years in bobo-dioulasso. children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. pharmacokinetic sampling for dp will occur on selected follow-up days.


Eligibility criteria:
inclusion criteria: 1. positive screening thick blood smear 2. fever (\> 37.5ºc axillary) or history of fever in the previous 24 hours 3. age ≥ 6 months to 10 years 4. weight \> 5 kg 5. absence of any history of serious side effects to study medications 6. no evidence of a concomitant febrile illness in addition to malaria 7. no history of antimalarial use in the previous two weeks 8. p. falciparum mono-infection 9. parasite density 2000-200,000/ul 10. provision of informed consent and ability to participate in 42-day follow-up exclusion criteria: 1. danger signs or evidence of severe malaria 2. hemoglobin levels \< 5.0 gm/dl
a safety study of imovax polio vaccine in selected cities in china

Conditions: Polio; Poliomyelitis

Summary: the aim of the study is to collect post marketing safety data on imovax polio vaccine in china. objective: to describe serious adverse events 30 days after each dose of imovax polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of china.

each study participant will receive an imovax polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.

Eligibility criteria:
inclusion criteria: * subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine. * subject's parent /legal representative showed willingness to complete the 3 primary doses fully using imovax polio according to the schedule. one injection at 2, 3, 4 months old respectively; * informed consent form obtained by the subject's parent/legal representative. * subject plan to live in the selected study sites for at least three months after inclusion. exclusion criteria: * subject with a history of serious illness (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.) * acute medical illness with or without fever within the last 72 hours. * vaccination planned in the 4 weeks following any trial vaccination (except diphtheria, tetanus, pertussis (dtp), hib vaccine or pneumo vaccine) * participation in another clinical trial at the same time. * contraindications to vaccination according to imovax polio™ leaflet. * subject plan to leave the study sites for at least three months after inclusion.

Keywords: polio poliovirus imovax polio™
bacteriological study of acute follicular tonsillitis

Conditions: Acute Follicular Tonsillitis

Summary: the objective of the study is to answer the following questions :- 1. is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? if yes, 2. what is (are) the possible reason(s) to explain it in our locality ?

tonsillitis is one of the most common diseases in the throat that occurs in the younger age group . the predominant bacteria causing tonsillitis are group a b-haemolytic streptococci (gabhs), which are highly susceptible to the penicillin group of antibiotics. it has been reported in the literature that the rate of penicillin failure has consistently increased from about 7% in the 1950s to almost 40% in the 2000s. authors propose many reasons to explain such failure rates e.g. the coexistence of oropharyngeal beta-lactamase producing bacteria . although there were no documented reports, it was observed that there are rising reports of failure in treatment of acute follicular tonsillitis by amoxicillin clavulanate.

Eligibility criteria:
inclusion criteria: patients with acute follicular tonsillitis neither younger than five years nor older than 60 years old. exclusion criteria: 1. other causes of tonsillitis that do not cause suppuration . 2. age below five , and above 60 years . 3. patients who received antibiotic one week before presentation . 4. immune compromised patients . 5. patients with quinsy.
linking temporal patterns of modifiable behaviors to weight loss outcomes

Conditions: Obesity; Weight Change, Body

Summary: this study is designed as an observational trial. the objective of this study is to follow-up with participants 3 years after completion of an 18-month comprehensive behavioral weight loss intervention. outcomes of interest include change in body weight, body composition, physical activity, energy intake, and sleep. in addition, investigators will explore the associations between current physical activity, sleep, and energy intake patterns and body weight regulation.

a total of 170 participants were initially enrolled in the comprehensive behavioral weight loss intervention.in this study, investigators will conduct a follow-up visit 3 years after the completion of the intervention. only participants who completed the behavioral weight loss intervention will be enrolled in this study. participants will undergo testing of body weight, body composition, physical activity patterns, energy intake patterns, sleep patterns, resting metabolic rate, and total daily energy expenditure.

Eligibility criteria:
inclusion criteria: * previous enrollment in standard behavioral weight loss intervention (nct01985568 or nct03411356) * age 20-60 (this age range has been selected based upon the participants enrolled in the parent trial) * capable and willing to give informed consent * possess a smartphone to install and utilize the meal timing application * capable and willing to wear the actigraph, activpal and actiwatch-2 for 24 hours/day for 28 consecutive days * willing to complete the total daily energy expenditure (tdee) assessment which includes multiple urine collections and drinking stable water isotopes exclusion criteria: * being considered unsafe to participate as determined by the study physician (dr. catennaci) * new diagnosis of a medical condition (not observed in the parent trial) which may affect weight or energy metabolism (e.g. depression, cvd, diabetes, uncontrolled hypertension, untreated thyroid, renal, hepatic diseases) * women who became pregnant after completing the parent trial * current use or use within the last 6 months of prescription or over-the-counter medications known to affect appetite, weight, and sleep

Keywords: physical activity sleep eating patterns energy expenditure
gas exchange derangement physiopathology in critically ill patients with covid-19

Conditions: Respiratory Failure

Summary: the study was designed to understand the pathophysiology of gas exchange derangement in critically ill patients with covid-19. specifically we will evaluate the effect of 3 different levels of positive end-expiratory pressure (peep) and two different levels of inspiratory oxygen fraction (fio2) on gas exchange by analyzing shunt and dead space. furthermore, complete respiratory mechanics and distribution of ventilation and perfusion by electrical impedance tomography will be assessed at each level of peep.


Eligibility criteria:
inclusion criteria: * patients admitted in intensive care unit for covid-19 related acute respiratory distress syndrome (ards) requiring invasive mechanical ventilation exclusion criteria: * pregnancy * hemodynamic instability (80-90 mmhg increase or 30-40 mmhg decrease systolic arterial pressure compared to baseline value or need of vasopressors to maintain systolic blood pressure higher than 85 mmhg or electrocardiogram evidence of ischemia/arrhythmias) * presence of pneumothorax and/or pneumomediastinum * contraindications to electrical impedance tomography (pacemaker, implantable cardioverter defibrillator, thoracic drainages)
pilot study of inhaled nitric oxide to treat pulmonary insufficiency in congenital heart disease

Conditions: Pulmonary Insufficiency

Summary: inhaled nitric oxide in patients with pulmonic valve insufficiency.

pulmonic valve insufficiency (pi) is a well-defined problem after primary surgical repair of tetralogy of fallot (tof). though well-tolerated for years, long-term pi can lead to structural changes in the right ventricle, the sequelae of which include right heart failure, arrhythmia, and sudden cardiac death. the only current treatment for severe symptomatic pi is pulmonic valve replacement. we hypothesize that inhaled nitric oxide (ino), a selective pulmonary vasodilator, can acutely decrease pi as assessed by cardiac magnetic resonance imaging (cmr). methods: 22 consecutive patients with pi in the setting of corrected tof or post pulmonic valve balloon valvuloplasty will undergo a clinically indicated cmr. nitric oxide gas will be delivered via facemask through a specialized delivery device at 40ppm. after 5 minutes, flow velocity mapping and gradient echo sequences will be repeated to assess pulmonary regurgitant fraction, right ventricular volumes, and ejection fraction. nitric oxide will be discontinued after acquisition of the last picture. wilcoxon rank-sum for paired data will be used to assess effect of intervention. significance: if decreasing pulmonary vascular resistance decreases pi, medical therapy with long-acting pulmonary vasodilators may be an attractive therapeutic option with the goal of delaying or even obviating pulmonic valve replacement.

Eligibility criteria:
inclusion criteria: * known pulmonary insufficiency status * previous tetralogy of fallot repair or balloon valvuloplasty/surgical valvotomy for pulmonary stenosis * clinically indicated cardiac magnetic resonance imaging study exclusion criteria: * enrollment in another clinical trial * age less then 18 years * inability to provide informed consent * institutionalized individual * pregnant or lactating * serious claustrophobia * pacemaker/icd * aneurysm clips * internal hardware * severe obesity (\>350lbs) * residual ventricular septal defect * history of methemoglobinemia * history of blood dyscrasias * acute pulmonary infection * pulmonary edema * hypersensitivity to nitric oxide or any of its components * left ventricle dysfunction (ef\<40%) * concurrent use of nitroglycerin or prilocaine
effect of prebiotic or synbiotic on inflammatory response and indicators of nutritional status in obesity

Conditions: Morbid Obesity

Summary: the purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. study hypothesis: supplementation of 12 g/day of fructooligosaccharides (prebiotic) or 12 g/day of fructooligosaccharides + strains of lactobacilli and bifidobacteria (synbiotic) during 30 days promotes reduction of plasma/serum levels of acute phase proteins, cytokines, metabolic and anthropometric parameters in individuals with bmi ≥ 40kg/m².

the purpose of this study is to evaluate the effect of prebiotic or synbiotic supplementation on inflammatory response and indicators of nutritional status in patients with morbid obesity. adult individuals of both sexes with morbid obesity (body mass index ≥ 40 kg/m²) will be invited to participate in this randomized, placebo-controlled, triple-blind study. the participants will be divided into three groups: g1 - control group (placebo), g2 - prebiotic group and g3 - synbiotic group. the study will consist of four experimental time points: m0 - baseline and start of supplementation; m1 - after fifteen days of the first outpatient visit and fifteen days after the start of supplementation with prebiotic, synbiotic or placebo; m2 - after thirty days from the first outpatient visit and end of supplementation with prebiotic, synbiotic and placebo; and m3 - time after sixty days from the first outpatient visit. at all time points the inflammatory response will be assessed by determination of plasma cytokines (il-1, il-6, il-10, tnf) and acute phase proteins (c-reactive protein and albumin), besides the evaluation of laboratory and anthropometric indicators of nutritional status. the primary endpoint will be the reduction in concentrations of inflammatory markers (cytokines and acute phase proteins). investigators expect to contribute with new information in this field of knowledge, which may facilitate the clinical application of these results.

Eligibility criteria:
inclusion criteria: * age greater than 18 years and less than 60 years * body mass index (bmi)≥40kg/m2 exclusion criteria: * previous gastrointestinal diseases (e.g. cancer and inflammatory bowel disease) * intolerances and/or food allergies (e.g. lactose intolerance and celiac disease) * current use of anti-inflammatory drugs and/or antibiotics and/or immunosuppressants * regular use of laxatives and/or appetite suppressants * current or previous use (up to one month) of prebiotics, probiotics, synbiotics or products enriched with these food compounds * intolerance to prebiotic and/or probiotic and/or synbiotic * following a diet for weight loss in the last three months * pregnant or breastfeeding * following unusual diets (e.g. vegetarian, macrobiotic) * alcohol dependence and/or illicit drugs dependence * smokers

Keywords: obesity inflammation nutritional status prebiotic synbiotic