Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of 300 mg gabapentin

Conditions: Epilepsy

Summary: the objective of this study was to confirm if two formulations of gabapentin (capsules) are bioequivalent. test product was darbetin® 300 mg (laboratorios dermatológicos darier) and reference product nerotin® 300 mg (pfizer). one capsule was the single dosage. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 26 healthy volunteers, both genders, adults between 18-55 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: males 18-55 years. healthy based on comprehensive medical history, lab tests, chest x-ray, electrocardiogram, negative tests for hepatitis b and c, and hiv. negative urine doping test. bmi 19-26.5 kg/m2. lab test in normal range +/- 10%. blood pressure 139-90/89-50, heart rate 100-55, respiratory rate 24-17, temperature 37.5-35 °c. non-smoking at least for 10 hrs before study. written informed consent. women must be not pregnant, nor breast-feeding. - exclusion criteria: hypersensitivity to study medication or other related drug. history of cardiovascular, renal, hepatic, metabolic, gastrointestinal, neurologic, endocrine, hematopoietic, psychiatric or organic condition. requiring any drug interfering with minocycline pharmacokinetics. exposed to inducers or inhibitors of hepatic enzymes. intake of possible toxic drugs 30 days before study. intake of any drug 14 days or 7 half-lives before study. hospitalization or severe disease 60 days before study. receiving investigational drug out of study center 30 days before study. blood loss or blood donation =\>450 ml 60 days before study. recent history of drug abuse including alcohol. intake of xanthine containing products 10 hrs before study. intake of grapefruit juice or hot-spice 10 hrs before study. -

Keywords: gabapentin bioequivalence pharmacokinetics mexico
parkinson's research with inclusion, diversity and equity

Conditions: Parkinson Disease

Summary: the purpose of this study is to identify the health and healthcare needs of lgbtqia+ and non lgbtqia+ communities living with parkinson's disease.

four million lgbtqia+ adults age 50+ live in the u.s. very little is known about the needs of the lgbtqia+ community living with parkinson's disease (pd). this research will work with the lgbtqia+ community to learn about the health needs of those living with pd. the researchers will also talk to caregivers about their care experiences, and ask healthcare providers about their work with lgbtqia+ communities living with pd. lgbtqia+ adults have more health and care problems. this study will test if lgbtqia+ adults with pd experience more health and care problems. this study will also see if caregivers have more problems and how providers are caring for the lgbtqia+ community living with pd. lgbtqia+ adults living with pd, caregivers and care providers will be asked to fill out a survey. some caregivers will be asked to participate in an hour interview to learn about their experiences. surveys and interviews can be done by phone or internet. the study will find ways to improve health and care of lgbtqia+ people living with pd. the study will share findings so others can help to make care better for the lgbtqia+ community.

Eligibility criteria:
inclusion criteria: * identify as lgbtqia+ or non-lgbtqia+ * aged 18+ * ability to complete the phone or online survey in english/spanish * diagnosis of parkinson's disease or a caregiver of a person with parkinson's disease * health care professional that provides care to patients living with parkinson's disease exclusion criteria: * not having a diagnosis of parkinson's disease * not currently or in the past a caregiver of a person with parkinson's disease * not currently providing care to patients with parkinson's disease * inability to complete the survey in english or spanish * inability to provide informed consent

Keywords: parkinson's disease caregiver health care provider lgbtqia+
prevalence of autism spectrum conditions in mainland china

Conditions: Autism Spectrum Conditions/Disorders

Summary: the china score study is a prevalence study of autism spectrum conditions (asc) in 14 regions in mainland china. it will include the following steps: 1. large population-based screening this study will be conducted in urban areas but not rural areas across mainland china. one city of each region will participate, and in total there will be 14 cities for screening. within each city, a number of 40 to 60 ordinary primary schools will be randomly selected from the defined region. all the students who are in 1st to 4th grade will asked to participate in order to form a sample of approximately 20,000 students. screening questionnaires the screening pack includes the chinese cast, the aq-child, the aq-adult short version (10 items), and risk factors questionnaire. an information sheet and consent form will be included in the pack as well. 2. further assessments we expect approximately 5% on the cast will score positive in ordinary school population. thus, for a 20,000 sample, we would expect 900 positives (90% response rate). all the screen-positives and a random selected 5% from borderline group will be invited for clinical assessment. the diagnosis of clinical assessment will be divided into three categories: definite asc, suspected asc, and non-asc. then all the children with clinical assessment results as definite asc and suspected asc and a randomly selected 10-20 non-asc will be invited for research diagnostic assessment using the ados and adi-r, as well as rpm as iq test. after that, the consensus diagnosis between ados/adi-r assessment and the clinical diagnosis will be the final diagnosis. 3. case identification in special schools all the children in special schools or training institutes in study region will be asked to fill in the screening pack. the children who do not attend any ordinary or special schools will be identified according to their residential id in the studied regions. all screen-positives in special education will be assessed using the ados and adi-r. then those who met the criteria of asc on ados or/and adi-r will be assessed by psychiatrists and the clinical diagnosis will be the final diagnosis. if we combine the prevalence of ordinary schools and special schools together, we will get an estimate of the prevalence of asc in school-population in china. if we combine all the cases identified from schools and from residential records, we will generate an estimate of the prevalence of asc in the general population in mainland china.


Eligibility criteria:
inclusion criteria: * all children who are in study region will be recruited for this study. * all children aged 6-11 years old. exclusion criteria: * children who are not in the study region. * children who are not found from ordinary schools, private training centres, public special schools and community household with the help of local residence records will not be included for this study.
effects of good behavior game in a swedish sample

Conditions: Problem Behavior

Summary: this project seeks to study the impact of good behavior game (gbg), a behavior management program, on classroom environment and problem behavior in k-3 classrooms. the goal of this randomized trial is to study the impact of good behavior game (gbg), a behavior management program, on classroom environment and problem behavior in k-3 classrooms in sweden. the main question it aims to answer is: • does gbg decrease problem behaviors in k-3 classrooms? teachers in the intervention group will be trained in gbg and asked to implement it in their respective classrooms. teachers in the comparison group will provide usual practice.

background: early conduct problems are prevalent and a prominent risk factor for several adverse health-related and psychosocial outcomes in later life. good behavior game (gbg) is a promising school-based behavior management program with the potential of reaching many children in their formative years. primary objective: to study the effectiveness of good behavior game in reducing problem behaviors in swedish k-3 classrooms under real-world conditions. secondary objectives: to investigate changes in problem behaviors in common school areas, classroom climate, teacher collective efficacy, on-task behavior, and behavioral management practices as a result of teacher training in gbg. the study also seeks to investigate implementation as a moderator, as well as potential barriers and facilitators in regards to implementation. type of trial: cluster-randomized controlled trial trial design and methods: recruitment of schools in a swedish municipality started early 2021. in may 2021, 5 schools were randomized to either intervention group or wait-list (service-as-usual). data collection started in august 2021 and ended in june 2022. the intervention group received training in gbg from september 2021 to may 2022 by certified trainers who also collected fidelity data through observations throughout the school year. teacher ratings and observer data was collected at baseline (august 2021), along with a first (november 2021) and second follow-up (may 2022, primary endpoint) throughout the first school year of implementation. statistical methodology and analysis: statistical analysis will primarily include frequentist intent-to-treat analysis, and comparisons of estimates with a corresponding bayesian model using weakly informative priors.

Eligibility criteria:
inclusion criteria: * eligibility is based on school or classroom level factors. schools must have at least one classroom with a group of students enrolled in grades k, 1, 2, or 3. exclusion criteria: * special education classrooms are not eligible, though inclusive classrooms with a minority of students needing special education can be included.

Keywords: problem behavior school prevention
balloon sinus dilation in office or or

Conditions: Chronic Sinusitis

Summary: endoscopic sinus surgery will be performed either in the physician's office or in the operating room (or). patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. patients treated in the or will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.

in this study, endoscopic sinus surgery will be performed either in the physician's office or in the operating room (or). patients treated in the physician's office will have endoscopic sinus surgery performed with the balloon sinuplasty devices. patients treated in the or will have endoscopic sinus surgery performed with or without balloon sinuplasty devices. both primary treatment of sinusitis as well as revision of previously treated sinuses will be allowed. resource absorption will be evaluated for both venues.

Eligibility criteria:
inclusion criteria: 1. age 18 years and greater 2. both male and female patients eligible 3. diagnosis of chronic sinusitis that is not responsive to medical management (\> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on ct scan) 4. planned endoscopic sinus surgery (recommended by investigator, consented to by patient) exclusion criteria: 1. cystic fibrosis 2. samter's triad (aspirin sensitivity, asthma, sinonasal polyposis) 3. sinonasal tumors or obstructive lesions 4. history of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium 5. ciliary dysfunction 6. pregnant females
starling registry study

Conditions: Hemodynamic Monitoring

Summary: hemodynamic optimization of critically ill patients is a goal for clinicians in order to afford the patient the best possible outcomes. being able to precisely and rapidly determine patient fluid responsiveness provides the bedside physician and nursing staff the information needed to make critical decisions in regards to the patient's fluid status and management of additional fluids and medications. as fluid management and cardiac output determination are linked to better decision-making and improved outcomes in icu, the use of a dynamic assessment of fluid responsiveness becomes a key tool for patient management. this study is designed to collect treatment and outcome data on patients that have undergone hemodynamic monitoring in a wide variety of clinical settings, involving a variety of patient diagnoses.


Eligibility criteria:
inclusion criteria: * ≥18 to 95 years of age * patient has undergone hemodynamic monitoring with the starling monitor * hemodynamic monitoring was completed no earlier than 2018 exclusion criteria: * none

Keywords: cardiac index (ci) stroke volume (sv) stroke volume index (svi) stroke volume variation (svv) heart rate (hr) ventricular ejection time (vet) total peripheral resistance (tpr) total peripheral resistance index (tpri) cardiac power (cp) cardiac power index (cpi) blood oxygenation (spo2) oxygen delivery index (do2i) electrical impedance of the chest cavity (z0) thoracic fluid content (tfc)
clinical outcomes in patients treated with sternalock blu

Conditions: Cardiac Surgical Procedures; Coronary Artery Disease; Heart Valve Diseases

Summary: the primary objective of this study is to evaluate the rate of deep sternal wound infection at 30 days post-operative following a full median sternotomy in patients treated with sternalock blu for rigid sternal fixation. this study will also provide evidence of the clinical performance of sternalock blu for up to 90 days using real world evidence methodology. sternal complications will be reported through 90 days follow up.

the primary endpoint for this study is the rate of deep sternal wound infection (dswi) at 30 days post-operative, following a midline sternotomy closed with sternalock blu. dswi is defined as deep infection involving muscle, bone, and/ or mediastinum requiring operative intervention and has all of the following conditions: 1. wound opened with excision of tissue or re-exploration of mediastinum 2. positive culture unless patient on antibiotics at the time of culture or no culture obtained 3. treatment with antibiotics beyond perioperative prophylaxis post-operative sternal wound complications occurring within 90 days post-operative. outcomes will be reported up to 90 days after surgery, including data on adverse events associated with the use of sternalock blu sternal closure system from the moment of implantation to the end-of-study.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age, no upper limit 2. undergoing a full standard midline sternotomy as part of an elective or urgent cardiac surgical procedure \[i.e., coronary artery bypass graft (cabg) and/ or valve replacement along with other cardiac surgical procedures\] and closed with the sternalock blu sternal closure system 3. willing and able to return for follow-up exclusion criteria: preoperative 4. emergent or salvage cardiac acuity i.e., patients undergoing cardiopulmonary resuscitation en-route to the operating room or prior to induction of anesthesia 5. any contraindication listed in the sternalock blu instructions for use (ifu/ appendix 3) (active infection, foreign body sensitivity, or mental/ neurologic conditions who are unwilling or incapable of following post-operative care instructions) operative 6. delayed sternal closure required for any reason 7. intra-operative conditions that, in the opinion of the operating surgeon, would preclude the use of rigid plate fixation, i.e.: insufficient quantity of sternal bone or compressible sternum indicating poor bone quality, as assessed by the operating surgeon using his or her professional judgment at the time of closure 8. use of bone wax between the sternal halves 9. intraoperative death prior to device placement

Keywords: sternotomy rigid fixation sternal fixation sternal plating
the tractor (tracking and tracing operations research) study -- zimbabwe

Conditions: HIV

Summary: this study evaluates the effectiveness of an enhanced package of support for activities described in the "standard operating procedures (sop) for patient tracing in health facilities in zimbabwe". this package is intended to increase the effectiveness of active patient tracing activities by developing tools, providing mentorship and implementing systematic review of processes to improve communication, coordination, and supervision between community health workers and facility-based staff.

this study consists of a pre-/post- intervention rapid assessment of sop implementation in study health facilities. the rapid assessment includes a facility audit, and the cross-verification of mother-baby pair service records, and scheduled appointments. following the baseline rapid assessment, the research team implements the proposed intervention package in health facilities randomly assigned to the intervention arm of the study. data collectors conduct monthly visits to study facilities in order to extract appointment attendance information from pmtct, art, pharmacy, hiv exposed infants (hei), and early infant diagnoses (eid) service registers.

Eligibility criteria:
inclusion criteria: mother-baby pair (mbp): 1. mother is hiv-positive 2. infant was born between october 1st, 2013 and march 30th, 2015, or initiates hiv exposed infant services within the first seven months of the data collection period 3. mothers and infants are assigned unique facility-issued id numbers that can be used to pair their records, and link service attendance between clinical units, and over time 4. enrolled in post-natal pmtct, art, or eid services at a study health facility 5. based on guidelines in the sop, mbp cannot be classified as lost to follow-up at beginning of data collection period community health workers (chw): 1. chw or facility-based staff working at selected study sites 2. participated in the implementation of mbp tracking and tracing activities for a minimum of three months 3. participant in district-level or selected facility-level chw meetings 4. above age of consent (18 years or above) 5. able and willing to provide informed consent to participate in the study exclusion criteria: * if inclusion criteria not met

Keywords: enhancing retention
earbud eeg feasibility study

Conditions: Epilepsy; Seizure; Sleep

Summary: the goal of this study is to characterize the ability of the nextsense ear-eeg device to detect pathologic electrographic signatures of epilepsy and physiologic signatures of sleep in subjects undergoing simultaneous inpatient continuous eeg monitoring, polysomnography, or ambulatory eeg monitoring at home.

for nearly half a century, conventional electroencephalography (eeg) has been the standard of care for monitoring cerebral activity, particularly in the clinical domains of epilepsy and sleep disorders. standard eeg involves highly time, labor, and cost intensive processes and typically requires subjects to be monitored by specially trained staff in the inpatient setting. existing ambulatory eeg options are limited to about 3 days in duration because of decline in electrode fidelity beyond that timeframe. there is a need for unobtrusive, easy to use, longitudinal monitoring solutions that can extend to the ambulatory setting. this study will assess whether novel nextsense eeg earbuds are able to 1) detect seizures of varying types/localizations as well as interictal epileptiform activity (iea) waveforms compared to simultaneously recorded conventional scalp eeg, or in some cases, intracranial eeg; and 2) detect characteristic electrographic signatures of aasm defined sleep stages compared to simultaneously recorded polysomnography.

Eligibility criteria:
inclusion criteria: * all patients 18 years of age and older admitted to the epilepsy monitoring unit at emory university hospital for long-term inpatient scalp or intracranial ceeg monitoring for diagnostic or pre-surgical evaluation, or patients 18 years and older admitted to the emory sleep center at the brain health center for polysomnography. * to enhance the likelihood of having a sufficient number of enrolled subjects with an adequate number of seizures, investigators may identify patients more likely to have epileptic rather than non-epileptic seizures based on the medical history. * all patients who are undergoing ambulatory eeg monitoring at home. exclusion criteria: * inability to safely tolerate earbuds (e.g. antecedent skin breakdown, recent injury to ear). * subjects who cannot have all 16 non-midline scalp eeg electrodes placed, since these eeg channels are required to accurately assess the performance of the seizure detection function.

Keywords: electroencephalography polysomnography
the efficacy of microfocused ultrasound technique in the treatment of facial skin laxity

Conditions: Middle and Lower Face and Submental Region Skin Laxity

Summary: this is a prospective study of 20 chinese patients with lower facial laxity treated by high intense focused ultrasound (hifu). response will be assessed via paired comparison of pretreatment and posttreatment photographs by two independent dermatologists, grading on a 5-point subject global aesthetic improvement scale (sgais) for skin laxity. quantitative analysis of submental lifting will also be performed. patient's level of "sagging" and "volume loss", satisfaction and tolerance will be documented.


Eligibility criteria:
inclusion criteria: healthy male or female, aged 30-60 years, seeking improved jawline definition, and/or reduction of submental skin laxity and were willing and able to provide informed consent. exclusion criteria: pregnancy or lactation, severe sun damage, excessive skin laxity on the lower face and neck, keloid scarring or open wounds in the treatment areas, severe or cystic facial acne, history of cosmetic treatments in the area to be treated (skin tightening procedure within the past year; injectable filler or botox within the past 6 months; ablative or nonablative resurfacing/rejuvenating laser treatment or light treatment within the past 6 months; dermabrasion or deep facial peels within the past 6 months), isotretinoin treatment within the past 6 months, and inability to understand the treatment protocol or to give informed consent.
tissue quality of integra vs. btm treated burns

Conditions: Burn Injury; Burn Scar; Burn Wounds - Partial Thickness (2nd Degree); Skin Grafting

Summary: an observational analysis of integra-treated burns and novosorb biodegradable temporizing matrix (btm)-treated burns will be undertaken 12-36 months post final skin graft application by retrospectively analyzing the patient's electronic medical record, and prospectively using a non-invasive measures of tissue quality and patient-reported outcomes. patients will be offered the option to consent for a tissue biopsy for pathological evaluation.


Eligibility criteria:
inclusion criteria: 1. patient has reviewed the irb-approved consent form, has been properly consented per the protocol and has documented their consent to participate in the study by signing the irb-approved consent form. 2. patient had a deep dermal or full-thickness burn that required skin grafting that was first treated with integra\* or btm, and at least 70% 'take' followed by an autograft 3. patient had final skin graft between 12-36 months prior enrollment in the study. 4. burn must have been ≥10% total body surface area (tbsa) and ≤70% tbsa. 5. patient is ≥ 21 years of age at the time of treatment. exclusion criteria: 1. patient had a radiation burn. 2. patient was treated with integra or btm and closed via secondary intention. 3. severe cognitive dysfunction or psychiatric disorders. 4. immunocompromised patients.