Kornimate/medical-research-clean huggingface dataset:
xpress maxillary balloon dilation study

Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Summary: a prospective, single-arm, post approval pilot study.

this study is evaluating transnasal sinus balloon dilation without tissue removal to treat the maxillary sinuses in patients with sinusitis. the study will be assessing symptomatic improvement post procedure.

Eligibility criteria:
inclusion criteria: 1. be at least 18 years of age. 2. must have uncomplicated sinusitis of the maxillary sinuses with or without anterior ethmoid disease. 3. meet either the anthem coverage guideline or bluecross blueshield of north carolina corporate medical policy for medically necessary functional endoscopic sinus surgery (fess) to treat uncomplicated sinusitis. 4. have a ct scan within 6 months prior to enrollment. 5. be mentally and physically capable (as per physician discretion) to participate in the investigation. 6. be willing and able to sign the study-specific informed consent prior to any study-related procedures. 7. be willing and able to undergo balloon dilation in the clinic setting. exclusion criteria: 1. have evidence of posterior ethmoid, sphenoid or frontal sinus (excludes presence of mucous retention cysts) disease requiring endoscopic sinus surgery or balloon dilatation. 2. have presence of features consistent with sinus fungal disease. 3. have evidence of gross polypoid disease within any of the sinuses or within the infundibulum. 4. require concurrent nasal surgery (eg, septoplasty, turbinate reduction, etc). 5. have previous sinus surgery (eg, sinus surgery or balloon sinuplasty). 6. have nasal surgery (eg, septoplasty, turbinate reduction) performed within 3 months prior to enrollment. 7. have any anatomical anomaly (ie, severe septal deviation) preventing transnasal access to the maxillary sinus outflow tract. 8. have a history of primary ciliary dysfunction. 9. have hemophilia. 10. be currently undergoing, or have undergone in the past 6 months, chemotherapy for cancer or radiation therapy in the head or neck region. 11. have a history of cystic fibrosis. 12. have sampter's triad (ie, defined as having all 3 of the following: aspirin sensitivity, asthma, and sinonasal polyposis). 13. have known sinonasal tumors or obstructive lesions. 14. be pregnant at the time of enrollment. 15. be unable to stop anticoagulant medication (eg, warfarin) until the international normalized ratio (inr) is below 1.5. 16. be unable to stop antiplatelet (eg, clopidogrel, aspirin, etc.) for at least 7 days prior to study procedure. 17. be currently participating in any other drug or device clinical studies excluding postapproval or marketing registry studies.

Keywords: balloon sinus dilation balloon catheters sinuplasty
bioequivalency study of zidovudine under fed conditions

Conditions: HIV Infections

Summary: the objective of this study was to assess the bioequivalence of roxane's zidovudine 300 mg tablet compared to glaxosmithkline's retrovir® 300 mg tablet under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * participation in a clinical trial within 30 days prior to study initiation. * positive blood screen for hiv or hepatitis b and c. * history of allergic or adverse responses to zidovudine.

Keywords: hiv
hpv integration testing for human papillomavirus-positive women

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer

Summary: papanicolaou (pap) triage, with high specificity, has been recommended for primary human papillomavirus (hpv) testing but is flawed by poor sensitivity and cytologist dependence. the investigators evaluated the potential role of hpv integration detection in cervical exfoliated cells in hpv-positive women from a clinic-based population.


Eligibility criteria:
inclusion criteria: women aged 30-65 years old visiting the gynecologic clinic of hospital exclusion criteria: 1. not providing informed consent 2. previously confirmed cin, cervical cancer, or other malignancies 3. previous therapeutic procedure to cervix 4. pregnancy
examining cooking as a health behavior

Conditions: Obesity

Summary: the proposed pilot study will examine cooking as an intervention target for weight control in overweight adults. the study will also examine whether interventions designed to promote cooking at home can increase participants' sense of food agency, and overcome common barriers to cooking at home such as time scarcity and budget constrictions. the study will utilize a cooking pedagogy designed to not just teach participants the basics of cooking different foods, but how to be efficient, mindful cooks. if cooking class participation positively impacts diet and health outcomes, it will bolster the case for promoting cooking at home as a health behavior for multiple populations.

a two arm randomized control trial will examine whether the addition of an active cooking lesson versus a passive observed lesson to a behavioral weight loss intervention results in significantly greater weight loss. additionally, the study will examine whether interventions designed to promote cooking at home can increase participants' sense of food agency, and overcome common barriers to cooking at home such as time scarcity and budget constrictions. overweight and obese but otherwise healthy participants (n=64) will be recruited. recruitment and study initiation will occur in two waves. wave 1 aims to recruit 32 individuals who will then be randomized to 1) a 24 week, 24 session group behavioral weight loss intervention with 12 bi-weekly cooking lessons; or, 2) the same 24 week, 24 session group behavioral weight loss intervention with 12 bi-weekly cooking demonstrations. both groups get the same intervention and the same counselor delivered intervention elements; the presence of active cooking lessons vs. passive observed cooking demonstrations is the only difference between conditions. assessments will be conducted at 0, 3 and 6 months. wave 2 (n=32) will follow the same process as wave 1 approximately two months after wave 1 is initiated.

Eligibility criteria:
inclusion criteria: * only individuals who are cooking (from scratch) no more than 3 meals at home per week will be eligible. * must have a computer or smart device with internet access (at home or work) in order to track their diet and exercise behaviors, * potential participants will be required to demonstrate some ability to comply with study intervention procedures to be eligible (specifically, they must complete an online dietary self-monitoring diary for 3 days) * must be at least 18 years old and have a bmi between 25-50 kg/m2 * must agree to be randomized to either study arm and available for both scheduled meeting times in person on the university of vermont campus exclusion criteria: * pregnant or planning to become pregnant in the next 6 months or lactating * physical conditions that would preclude exercise * medication affecting weight loss * currently enrolled in another weight loss program * currently cooking more than 3 meals from scratch at home per week

Keywords: behavioral weight loss intervention, obesity
tms for suicidal crisis in active duty sms

Conditions: Suicide; Suicidal Ideation; Suicidal Impulses; Suicidal Intention; Suicidal and Self-Injurious Behavior; Suicidal Depression

Summary: the purpose of this study is to determine if the use of transcranial magnetic stimulation (tms) provides rapid reduction and sustained attenuation of suicidal crisis. tms is a treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with fewer side effects than current treatments such as electroconvulsive therapy (ect) and medication therapies. there will be 6 months of follow-up, in order to establish the ongoing and lasting therapeutic effect of tms.

the programmatic-level objective of the study is to address the goals of the army starrs program and the suicide prevention for america's veterans act through implementation of an effective acute treatment for patients psychiatrically admitted in suicidal crisis as well as other patients at high-risk for suicide. this is achieved by application of tms, which provides a treatment for suicidal crisis that is quicker, less invasive, better tolerated, and with fewer side effects and less incapacitation than current treatments such as ect and pharmacologic therapies. a recent study led by the senior consultant of this proposal demonstrated tolerance and efficacy for a new, high-dose regimen of tms in a va population with an average age of 47. the objective of the proposed study is to extend the application of tms to a younger population of active duty service members (sm) in order to demonstrate efficacy for returning veterans of the middle east wars, in particular, as well as the civilian young adult population. tms dosage in the proposed study is recalibrated to commercially-standard levels in order to provide consistency with devices currently in clinical operation. in addition, follow-up in the proposed study continues for 6 months in order to establish persistence and durability of the therapeutic effect of tms.

Eligibility criteria:
inclusion criteria: * all active duty sms (regardless of sex, ethnicity, sexual or religious orientation) who are admitted to eisenhower army medical center (eamc) inpatient psychiatric service (ips) with active suicidality or elevated risk for suicide regardless of most psychiatric diagnostic co-morbidity (see exclusion criteria). this includes in-patient admissions for suicidality and outpatient sms with a columbia-suicide severity rating scale (c-ssrs) score ≥3. * age 18 to 60 * able to speak and read english. exclusion criteria: * combative with staff. * comatose/catatonia. * incapacity owing to active mania or psychosis. * epilepsy, multiple sclerosis, or cerebrovascular accident. * non-removable metal in the head (shrapnel; plates, aneurysm coils/clips; metal tattoos etc.) * implantable devices (pacemakers, stimulators, etc.) * schizophrenic or borderline personality. * positive screen for pregnancy. * already receiving tms as a treatment for depression. * non-english reading and speaking subjects
oblique lateral interbody fusion versus minimally invasive transforaminal lumbar interbody fusion

Conditions: Lumbar Spinal Stenosis

Summary: the investigators will retrospectively study lumbar spinal stenosis patients who underwent olif or mis-tlif with percutaneous pedicle screw fixation between january 2016 and december 2019.the investigators will measure estimated blood loss, operative time, hospital stay, cost, reoperation, and complication incidence, visual analogue scale (vas), oswestry disability index (odi), japanese orthopaedic association (joa), and short form-36 (sf-36) scores, discal and foraminal height, lumbar lordotic angle, and fusion status.the investigators will conduct to evaluate postoperative improvements, complications, and reoperation rates between patients with lumbar spinal stenosis (lss) undergoing oblique lateral interbody fusion (olif) or minimally invasive transforaminal lumbar interbody fusion (mis-tlif).


Eligibility criteria:
inclusion criteria: * lss due to neurogenic claudication; central stenosis or lateral stenosis who need surgery; single-level, low-grade (meyerding grade 1 or 2) isthmic spondylolisthesis or degenerative spondylolisthesis; and imaging findings consistent with the symptoms of lss. exclusion criteria: * trauma, active infection, malignant tumors, spinal deformity, previous lumbar fusion, multi-segment fusion, multi-level, high-grade (meyerding grade 3 or 4) isthmic spondylolisthesis or degenerative spondylolisthesis.

Keywords: lumbar spinal stenosis olif mis-tlif postoperative improvements
efficacy of rectal indomethacin in prevention of post-operative pancreatitis after pancreaticoduodenectomy

Conditions: Pancreatoduodenectomy

Summary: pancreatico-duodenectomy is one of the commonly performed procedure for periampullary/distal cholangio/head of pancreas carcinoma. post operative pancreatitis is an emerging concept, recently being studied as one of the most important contributing factor of post-operative pancreatic fistula, which is one of the major complication of pancreatoduodenectomy. rectal indomethacin, a type of non-steroidal anti-inflammatory drug, when given in a single dose has been shown to prevent pancreatitis in patients undergoing ercp. in this study, we will be administering rectal indomethacin at the time of induction of anesthesia to the experimental arm of the study and compare the results in terms of incidence of post-operative pancreatitis in the two groups.


Eligibility criteria:
inclusion criteria: * all consenting adults planned to undergo pancreatoduodenectomy, exclusion criteria: * asthma * allergic reactions to nsaids * ckd * internal hemorrhoids * anti-platelet medications
strength training using neuromuscular electrical stimulation for children with cerebral palsy

Conditions: Spastic Diplegic Cerebral Palsy

Summary: the purpose of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (nmes) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy.

the overall goal of this study is to determine if using high-intensity, short-duration, intermittent neuromuscular electrical stimulation (nmes) is better than volitional exercise in increasing quadriceps femoris and triceps surae force-generating potential and gross motor function in children with cerebral palsy. this study consists of a randomized controlled trial in which the effects of nmes applied to the quadriceps femoris and triceps surae are compared to the effects of volitional isometric exercise and a non-exercising control group. this project assesses the ability of nmes to increase muscle force generating ability, the mechanisms behind changes in force generating ability, and the effects of training on spatiotemporal parameters of gait and gross motor function in children with cerebral palsy. subjects is the nmes group will be implanted with percutaneous electrodes in the medial and lateral heads of the gastrocnemius and the quadriceps (3 electrodes in each lower extremity, implanted bilaterally). during the intervention phase, these subjects will undergo 15 electrically-elicited contractions in each of the implanted muscle groups three times/week (at home), while positioned on an exercise board to maintain good alignment and facilitate isometric contractions. subjects in the volitional group will perform 15 isometric contractions in each muscle group (quadriceps, triceps surae), while positioned on an exercise board. the non-exercise control group will continue with typical activities, but no intervention will be administered. subjects are assessed at baseline, 6 weeks into the intervention, 12 weeks into the intervention (at which point the intervention is withdrawn), and at a follow-up assessment 12 weeks after the withdrawal of the intervention.

Eligibility criteria:
inclusion criteria: * children ages 7-12 years old * diagnosis of spastic diplegic cerebral palsy * gmfcs level of ii or iii (able to walk indoors and outdoors with or without an assistive device) * prom requirements (\ 20 degrees of hip abduction, \ 45 degree popliteal angle, ankle dorsiflexion to neutral with knee extension) * sufficient cognitive/communication skills to perform volitional muscle contractions and complete data collection procedures exclusion criteria: * significant orthopedic impairments (hip migr \> 40%, significant scoliosis) * must be at least one year post orthopedic surgery * must be at least 6 months post botulinum toxin injections * uncontrolled seizure activity

Keywords: nmes cerebral palsy spastic diplegia electrical stimulation children
covid-19 disease & vaccine survey in africa

Conditions: COVID-19; Vaccine Hesitancy

Summary: the covid-19 pandemic is a public health concern; for which the who recommends protective measures and vaccination. there is inadequate data on the impact of covid-19 vaccination and control measures in africa. this survey is collecting data about people's knowledge, attitude and compliance regarding covid-19 disease and vaccines.

the coronavirus disease 2019 (covid-19) pandemic remains a major public health concern. there is inadequate data on the epidemiology of covid-19 in africa. there are emerging covid-19 variants with high transmissibility and morbidity. the world health organization (who) recommends protective measures and vaccination; for the control of covid-19. there is inadequate data on the impact of covid-19 vaccination and control measures in many nations in africa. this study is a survey of specific urban populations in sub-saharan africa. the anonymized survey is collecting data about people's knowledge and attitude regarding covid-19 disease or control measures. the survey is also collecting data about people's knowledge, attitude and compliance regarding covid-19 vaccines. the study uses a validated questionnaire to collect data. the study aims to inform and improve covid-19 management or control in africa.

Eligibility criteria:
inclusion criteria: * urban population in africa * people in sub-saharan africa town exclusion criteria: * rural population * people outside sub-saharan africa

Keywords: covid-19
feasibility of primer shot radiotherapy for non-small cell lung cancer - primer

Conditions: Patients With Non-small-cell Lung Cancer

Summary: intro/rationale: radiotherapy employs uniform, equally spaced weekday fractions that do not account for changes in tumor radiosensitivity. however, radiobiological characteristics evolve during the radiotherapy schedule as reoxygenation increases radiosensitivity. in tumor-response simulations and preclinical experiments, it was superior to prime the tumor with one radiotherapy fraction, followed by a treatment break permitting mitotic cell death and reoxygenation of tumor cells. objective: to determine the safety and feasibility of primer shot fractionation for nsclc. study design: a prospective non-randomized feasibility trial to test the safety of primer shot fractionation in a 3+3 phase with increasing treatment breaks, followed by an expansion cohort. study population: patients with nsclc stage 2-4, referred for palliative radiotherapy of the primary tumor and possibly (lymph node) metastases. patients are allowed to receive systemic treatments, except for vegfr-inhibitors. the 3+3 phase is followed by an expansion phase of 22 patients. intervention: all treatments are 5x6 gy to all targets. patients receive an increasing primer shot treatment break. in the 3+3 phase, the break between the first and the second radiotherapy fraction is: 1, 2 and 3 weeks. the maximum tolerated break length will be used for the expansion cohort. main study parameters/endpoints: the main study endpoint is the ability of patients to finish the radiotherapy schedule as planned. secondary endpoints are tumor response at the end of treatment and 3 months thereafter, and acute toxicity. nature and extent of the burden and risks associated with participation, benefit and group relatedness: based on simulations and preclinical data, primer shot treatment breaks increase tumor control. however, the increased overall treatment time could potentially increase the chance a patient drops out before the radiotherapy schedule is finished. because of the gradually prolonged break, this risk is relatively small and acceptable for this population. additionally, patients are asked to fill in pro-ctcae lung subset questionnaires at the start of treatment and during follow-up. they will also receive 1 additional ct with contrast at fraction 5.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * nsclc (either pathology proven or sufficient clinical suspicion to be treated as nsclc), referred for palliative radiotherapy of at least the primary tumor site. * stage 2-4 * who performance score 0-2. * provision of signed, written and dated ic prior to any study specific procedures. exclusion criteria: * interstitial lung disease * treatment with vascular endothelial growth factor receptor (vegfr) inhibitors * prior thoracic radiotherapy (\>20 gy eqd2 a/b 3) overlapping with the current planning target volume
a coordinated parent/child dyad weight loss intervention: dyad plus (feasibility)

Conditions: Weight Loss; Pediatric Obesity

Summary: the purpose of this research is to develop a coordinated program (dyad plus) that would help to facilitate self-monitoring, positive communication, joint problem solving, and social support to increase physical activity, healthy eating, and weight loss. participants of the brenner fit (families in training) pediatric weight management program and their parent/guardian will co-enroll in weight loss programs. parents/guardians will receive the components of by design essentials.

participation in this study will involve participation in six, one-hour sessions in addition to those required by your weight loss program. these sessions will work to facilitate an increase in self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs. joint goal setting and tracking will be enabled by commercially available devices and apps. each caregiver and child will receive an activity monitor, activity app, and a food app (digital food diary) that allows self-monitoring of consumption and "social accountability," which will allow caregivers and the brenner fit team to monitor and encourage. furthermore, two home visits will be conducted to evaluation the home food and activity environments to inform tailored feedback to families. brenner fit is a family-based pediatric weight management clinic for youth 2-18 years old referred by a physician for overweight or obesity.11-14 by design is an adult (\>18yrs) weight loss clinic that includes tailored dietary and physical activity behavioral counseling. the preliminary data suggest that most adolescent youth who enroll in brenner fit have at least one adult caregiver who is eligible and would benefit from enrollment in by design essentials.

Eligibility criteria:
inclusion criteria: * eligible for enrollment in brenner fit and/or by design essentials * caregiver who lives in the house with a bmi \> 30 * no contraindication for physical activity or caloric restriction * must be able to read and write english exclusion criteria: * over the age of 65 * bmi \< 30 * contraindication for physical activity or caloric restriction * cannot read or write english

Keywords: youth parents overweight families