Kornimate/medical-research-clean huggingface dataset:
optical quality after implantation of a spherical or aspherical intraocular lens in hypermetropic patients

Conditions: Cataract; Spherical Aberrations; Intraocular Lenses; Depth of Focus

Summary: the purpose of this study is to evaluate differences in the depth of focus after implantation of a spherical or aspheric iol in hypermetropic and emmetropic patients. after implantation of a spherical iol hypermetropic patients may achieve a better depth of focus compared to emmetropic patients due to a larger amount of spherical aberrations.


Eligibility criteria:
inclusion criteria: * cataract * dioptric power of iol \>22.0 d in hypermetropic patients and 18.0-22.0 d in emmetropic patients, respectively exclusion criteria: * uveitis, pathology of the retina or the optic nerve * corneal scarring or irregularities * astigmatism \>1.5 d * amblyopia * perioperative complications * postoperative refractive error \>2.0 d of spherical equivalent * postoperative dcva \<0.8 (etdrs)
a phase 2 study to evaluate the safety, tolerability, and immune response of afx3772 vaccine in healthy infants

Conditions: Pneumonia, Bacterial; Pneumococcal Infections; Pneumonia, Pneumococcal

Summary: this is a phase 2 clinical study to support the use of afx3772 in healthy infants for the prevention of pneumococcal disease. the purpose of this study is to determine the safety, tolerability, and immunogenicity of 3 different formulations of afx3772 compared with prevnar 13 (pcv13) and prevnar 20 (pcv). infants approximately 2 months of age will be enrolled and receive 4 doses of study vaccine over 8 protocol-defined visits spanning a duration of approximately 18 to 21 months. part 1 is the dose escalation, lead-in portion of the study in which infants at each dose level will be randomized 3:1 in sequential cohorts of increasing doses of afx3772 or pcv13. enrollment in cohorts 2 and 3 will proceed following data monitoring committee (dmc) review of cumulative safety and tolerability data from preceding cohorts. following completion of dmc review of safety and tolerability data for the cohorts enrolled in part 1, additional infants will be enrolled and randomized equally to receive either pcv20 or afx3772 at different dose levels approved for evaluation in part 2.


Eligibility criteria:
inclusion criteria: • is a full-term infant approximately 2 months of age at time of obtaining the informed consent. exclusion criteria: * had prior administration of any pneumococcal vaccine. * has a known or suspected hypersensitivity to afx3772, pcv13, pcv20 or any components of the formulations used. * has a known or suspected immunodeficiency or other conditions associated with immunosuppression that may require immunosuppressive drugs. in addition, the participant's biological mother has known hiv infection or known to be hepatitis b surface antigen positive. * has any clinically significant allergic condition or history prior to the first vaccination for primary immunization series. * has a history of microbiologically proven invasive disease caused by s. pneumoniae. * has received immunoglobulins. * has a bleeding diathesis or condition associated with prolonged bleeding that would contraindicate intramuscular injection. * has received systemic corticosteroids for a period of more than 14 days and has not completed the treatment for at least 30 days before study vaccine.

Keywords: pneumonia, pneumococcal infections streptococcal infections pneumonia
prediction models for postoperative reintubation in patients with acute aortic dissection

Conditions: Nomogram; Prediction Model; Type A Aortic Dissection; Postoperative Reintubation

Summary: reintubation is an adverse postoperative complication in patients with type a aortic dissection (aad) that correlates to poor outcomes. this study aims to analyze the risk factors associated with reintubation and to create a fully automated score model to predict the incidence of reintubation. a total of 861 patients diagnosed with aad and undergoing surgical procedures in a single institution between january 2018 and october 2023 were selected in wuhan union hospital. preoperative and postoperative informmation was used for seeking risk factors and build prediction model for postoperative reintubation. finally, 5 risk factors wasidentified and a nomogram was established for predicting postoperative reintubation in patients with aad.


Eligibility criteria:
inclusion criteria: (1) patients diagnosed with aad admitted for open surgery; (2) aged 18 years or older. exclusion criteria: (1) patients deceased during or within 24 hours after surgery; (2) patients with preoperative intubation.
rigorous assessment of p. vivax relapses and primaquine efficacy for radical cure

Conditions: Vivax Malaria

Summary: the study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. note that this will not be an investigational new drug application, as only world health organization (who)-approved drugs will be used at dosage and for conditions approved.

the study will be an open-labelled randomized clinical trial to determine therapeutic efficacy. note that this will not be an investigational new drug application, as only world health organization-approved drugs will be used at dosage and for conditions approved. eligible patients willing to participate will first be tested prior to enrolment for their glucose-6-phosphate dehydrogenase (g6pd) status by the gold standard spectrophotometric analysis. the investigators will exclude from the study any g6pd deficient (or intermediate females) patient. treatment allocation will be randomized between i) 7 days of artesunate (2 mg/kg/day for 7 days) alone (arm1), ii) same artesunate regimen + 0.25 mg/kg/day 14 days of primaquine (arm2) and iii) same artesunate regimen + 0.5 mg/kg/day 14 days of primaquine (arm3). all patients will be relocated to a no-transmission city to make sure they are not reinfected during the follow-up. follow-up will be performed every 24-48h for 90 days. at the end of the follow-up period, all patients that did not receive primaquine (arm1) will be treated according to national guidelines (14 days at 0.25mg/kg/day). patients will additionally be followed monthly for three months after the end of the relocation.

Eligibility criteria:
inclusion criteria: * age 15 and older * acute (within 10 days), symptomatic (i.e., history of fever), uncomplicated malaria caused solely by plasmodium vivax (verified by pcr) * g6pd normal (as determined by quantitative spectrophotometric assay) exclusion criteria: * pregnant, planning to become pregnant or lactating women, * received antimalarial drugs in the past month, * hb \< 8g/dl, \< 1,500 neutrophils/μl, or signs of complicated malaria (e.g., vomiting, convulsions,...), * history of primaquine, artesunate or artesunate-mefloquine allergy or intolerance, * pcr-positivity for severe acute respiratory syndrome coronavirus 2.
social incentives to encourage physical activity and understand predictors

Conditions: Obesity

Summary: this study tests the effectiveness of three social incentive-based gamification interventions to increase physical activity using a 24-week intervention period with a 12-week follow-up.

this is a four-arm randomized, controlled trial with a 24-week intervention period and 12-week follow-up period. participants are considered ready to be randomized once they have completed all surveys, established a baseline step count, and selected a step goal increase.participants in the control arm will receive no other interventions during the 24-week intervention period or the 12-week follow-up period. participants randomized to the one of the three intervention arms will have a 4-week ramp up towards their step goal. the participant will then be asked to maintain their goal during the 20-week "maintenance period" and the 12-week "follow-up period." participants in arms 2-4 will be entered into an intervention approach that has points and levels designed to incorporate insights from behavioral economics. participants in the supportive social incentive arm will be asked to identify a family member or friend to be their support sponsor. this sponsor will be encouraged to support the participant in their progress during the study. participants in the competitive social incentive arm will be in a group of three total participants.at the end of each week the participants will receive notification that ranks them on their cumulative points in the study thus far and also displays their level.this feedback may help to induce participants to compete for the top spot among the group. participants in the collaborative social incentive arm will be in a group of three total participants as a team. each day one of the members of the group will be randomly selected to represent their team for that day. in this design, each person is accountable to the others on the team and this may induce a collaborative effort to meet their daily goals.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older; 2. ability to read and provide informed consent to participate in the study; 3. self-reported body mass index (bmi) of 25 or greater. 4. smartphone or tablet compatible with application for the wearable activity tracking device. exclusion criteria: 1. conditions that would make participation infeasible such as inability to provide informed consent, illiteracy or inability to speak, read, and write english; 2. conditions that would make participation unsafe such as pregnancy or being told by a physician not to exercise; 3. already enrolled in another study targeting physical activity; 4. any other medical conditions or reasons he or she is unable to participate in a physical activity study for 36 weeks.
postprandial vldl-triglyceride metabolism in type 2 diabetes patients with and without nafld

Conditions: NAFLD; Type 2 Diabetes

Summary: non-alcoholic fatty liver disease (nafld) covers a spectrum from simple reversible hepatic steatosis to inflammation and fibrosis termed steatohepatitis (nash). the mechanisms behind why some subjects progress from nafld to nash are not clear and the responsible mechanism for storage of excess amounts of liver fat in patients with nafld are poorly understood. patients with type 2 diabetes mellitus (t2d) and abdominally obese subjects very often have accumulation of liver fat (nafld). t2d is also associated with abnormal lipid metabolism (dyslipidemia), including free fatty acids (ffa), hypertriglyceridemia and excessive postprandial hyperlipidemia which increases the risk of ischemic cardiovascular disease (cvd) and heart failure. in healthy, insulin sensitive subjects the postprandial increase in triglycerides (tg) is primarily caused by meal derived chylomicrons, whereas endogenously produced tg (vldl-tg) and decreased peripheral tg clearance only becomes quantitatively important in insulin resistant subjects .thus, postprandial lipidemia in t2d results from both chylomicronemia as well as a reduction in both insulin mediated suppression of vldl-tg secretion and lipoprotein lipase (lpl) mediated peripheral clearance. a recent study demonstrated that the ability of insulin to suppress hepatic vldl-tg after a fat-enriched meal and the duration of the postprandial hyperlipidemia was similar in patients with t2d compared with age- and bmi matched individuals without t2d, indicating that the degree of insulin mediated vldl-tg secretion and hyperlipidemia primarily depends on insulin sensitivity and not the presence of t2d diabetes per se. in these studies, the investigators want to examine the effect of a fat enriched mixed-meal on hepatic vldl-tg handling and adipose storage capacity in patients with t2d with and without nafld. investigators will address these questions using carboxyl-14c triolein labeled vldl-tg, magnetic resonance (mr) spectroscopy of liver, muscle and fat biopsies in combination with state-of-the art muscle and adipose tissue enzyme kinetics, gene- and protein expression. the overarching goals are to define abnormalities and differences between patients with t2d with and without nafld in terms of hepatic lipid metabolism.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes with and without nafld (steatosis ff% \> 5,6% on mr spectroscopy for nafld and nash groups) exclusion criteria: * active smoking * comorbidity other than hypertension and hyperlipidemia * fixed medical drug consumption (including insulin) except statins and anti-diabetic medications. however, statins must be paused 2 weeks before the examination date and other antidiabetic medication on examination date. * patients with cancer or former cancer patients * blood donation within the last 3 months prior to the study * participation in experiments involving radioactive isotopes within the last 3 months * alcohol abuse (over 21 items per week for men and over 14 for women) * pregnancy
effects of an mhealth web-based platform (happyair) on adherence to a maintenance program after pulmonary rehabilitation in patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: objective: this study aimed to assess the effects of an integrated care plan based on an mhealth web-based platform (happyair) on adherence to a 1-year maintenance program applied after pulmonary rehabilitation in copd patients. methods: copd patients from three hospitals were randomized to a control group or an intervention group (happyair group). patients from both groups received an 8-week program of pulmonary rehabilitation and educational sessions about their illness. after completion of the process, only the happyair group completed an integrated care plan for 10 months, supervised by an mhealth system and therapeutic educator. the control group only underwent the scheduled check-ups. adherence to the program was rated using a respiratory physiotherapy adherence self-report (cap fisio) questionnaire. other variables analyzed were adherence to physical activity (morisky-green test), quality of life (chronic obstructive pulmonary disease assessment test, st. george's respiratory questionnaire, and euroqol-5d), exercise capacity (6-minute walk test), and lung function.


Eligibility criteria:
inclusion criteria: * copd patient. * aged between 55 and 85 years. * degree of severity ii, iii, or iv of the global initiative for chronic obstructive lung disease (gold) scale. * stable clinical situation (no exacerbations in the last 6 weeks). exclusion criteria: * unstable cardiovascular disease or muscular, osteoarticular, auditory, visual, or central or peripheral nervous system impairment that prevents the performance of the rehabilitation program or evaluation tests. * cognitive impairment that makes it difficult to understand the education program and manage the happyair system
evaluation of the safety and efficacy of a guided bone regeneration membrane for the treatment of femoral fractures

Conditions: Proximal (Subtrochanteric)Femoral Fractures; Distal Femoral Fractures

Summary: certain types of fractures require surgical intervention that may involve the use of bone grafts or bone graft substitutes. many of the materials used as bone graft substitutes suffer from disadvantages such as soft tissue invasion of the fracture area, inadequate blood supply, failure to encourage the production of bone and ectopic bone formation. a guided bone regeneration (gbr) environment may help in solving these clinical concerns. gbr has been widely used in the field of dentistry since the 1980s to provide stable placement for dental implants the purpose of this study is to evaluate the safety, performance and initial efficacy of regenecure's, amca bone membrane, as a bone stimulating aid for orthopedic trauma applications.


Eligibility criteria:
inclusion criteria: 1. age: 18 to 65 years 2. both males and females 3. females of child-bearing potential who have a negative urine hcg pregnancy test following informed consent and prior to surgical procedure and who are not planning to become pregnant for the duration of their part in the study 4. femoral subtrochanteric fracture. the fracture is classified as one of the following: a. closed fracture b. ao 31 a3, 33b + c1 + c2, and extending to the distal third 5. proximal subtrochanteric femoral fracture will be treated with a cephalomedullary nail. 6. patients must be available for follow-up for a minimum of 12 months. exclusion criteria: 1. trauma presentation * open fractures * bilateral fractures * polytrauma with head injury * presence of periprosthetic fractures 2. patient medical history * previous malignancy (except basal cell carcinoma of the skin) * active autoimmune disease * metabolic bone disease (primary or secondary) * chronic renal insufficiency (defined by a glomerular filtration rate of \<30 ml/min) * liver function abnormality (defined by presence of alt or ast levels more than double the upper limit) * current smoker 3. concurrent medication o medications that may interfere with bone metabolism including: 4. calcitonin for 7 days or more within the last 6 months prior to study 5. bisphosphonates for 30 days or more within the last 12 months prior to study 6. bone therapeutic doses of vitamin d or vitamin d metabolites for 30 days or more within the last 6 months * previous or present immunosuppressive treatment * previous radiotherapy or chemotherapy * cumulative dose of 150mg total prednisolone or any other gluco-corticosteroid for 7 days or more within the last 6 months prior to study * previous history of or current alcohol abuse * previous history of or current drug addiction/abuse
effects of a vestibular rehabilitation maneuver

Conditions: Vertigo

Summary: rotational maneuver is a vestibular rehabilitation method, performed in a supervised manner. using a rotating chair, subjects are rotated towards the opposite direction of dominant side in order to inhibit this side and simultaneously, stimulate the subordinate side. we propose that the rehabilitative effect is the result of a decrease in the vestibular imbalance, mainly due to a decrease in the response of the dominant vestibular side. previously, we have shown the short-term effects of this maneuver on patients with recent onset vestibular imbalance. in the present study, we investigated the long-term effects of the rotational maneuver in patients with a history of peripheral vestibular vertigo for at least one year, originally confirmed by clinical tests. our results show a significant improvement which lasted for \>4 weeks after the end of rehabilitation (i.e., the last time tested). moreover, there seems to be a relationship between the decrease in dp values and a decrease in subjective symptoms. we propose that this maneuver can be used as an effective method for both short- and long-term rehabilitation.


Eligibility criteria:
inclusion criteria: * history of vertigo for at least one year * not under drug therapy for vertigo * directional preponderance \>10% measured by electronystagmography during rotation test exclusion criteria: * severe vertigo * intolerance to rotation * previously diagnosed for a central pathology (e.g., neuroma) * previously diagnosed with a fluctuating vestibular disorder (e.g., menier's)

Keywords: vestibular vertigo rehabilitation rotation balance
obalon in children with severe obesity

Conditions: Severe Pediatric Obesity (BMI > 97° pc -According to Centers for Disease Control and Prevention BMI Charts-); Altered Liver Function Tests; Glycemic Intolerance

Summary: the ongoing global rise in the prevalence of overweight and obesity among all ages and among all ethnic groups, figures into a real epidemic phenomenon. this is accompanied by a higher incidence in serious health risks, already present at an early age, "switching-on" the engine towards obesity-related co-morbid diseases and morbid obesity. weight loss is the only way to avoid systemic and cardiovascular complications of obesity. weight loss devices have been recently introduced in bariatric surgery, also in children. they mostly require invasive procedures to be applied. mini-invasive devices would be needed to obtain weight loss in the pediatric population, since the early age of involved patients. obalon intragastric balloons, are swallowable devices. they are filled with liquid or air, and have been used to induce weight loss in obese adults. the investigators aimed to perform a pilot study in pediatrics, and monitor weight loss, metabolic and cardiovascular parameters modifications, after up-to-3 obalon® gastric balloons placement.


Eligibility criteria:
inclusion criteria: * weight \> 97° pc -cdc bmi charts- exclusion criteria: * prevous abdominal surgery * functional gastrointestinal motility disorders

Keywords: obalon swallowable intragastric balloons severe obesity children
cannabis' impact on alcohol consumption

Conditions: Alcohol Drinking; Cannabis Use; Cannabis; Alcohol Use Disorder

Summary: this study employs a repeated measures experimental design to examine the effect of thc-dominant dose of cannabis and cbd-dominant dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. the study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly.

this study employs a repeated measures experimental design to examine the effect of thc-dominant (9.53% thc and 0.09% cbd) dose of cannabis and cbd-dominant (0.35% thc and 11.27% cbd) dose of cannabis, relative to placebo, on subsequent drinking in an alcohol choice task in which participants choose either to drink or receive monetary reinforcement for drinks not consumed. cannabis will be administered simultaneously with an alcohol-priming dose or alcohol placebo. the study will enroll up to 350 nontreatment-seeking heavy episodic alcohol drinkers who use cannabis weekly to obtain the final sample of 200 with complete data. participants will be tested at a baseline session, during three experimental sessions, and then during a subsequent 4-week period in the natural environment using a smart-phone application. findings have important implications for cannabis regulatory science and alcohol use disorder treatment by addressing the relative impact of specific cannabinoids as well as contextual risk in cannabis-alcohol co-use.

Eligibility criteria:
inclusion criteria: * age 21 to 50 * english-speaking * cannabis smoking in past two months * heavy drinking in past two months * in good physical health and weighing \< 250 lbs * zero breath alcohol at each visit exclusion criteria: * positive pregnancy test * nursing * positive urine toxicology screen for drugs other than cannabis * interest to quit or receive treatment for cannabis or alcohol use

Keywords: alcohol cannabis marijuana addiction cannabinoid tetrahydrocannabinol cannabidiol