The Heartland Study
Pregnancy RelatedPregnancy Complications5 moreThe Heartland Study is a prospective, observational study that will enroll up to 2,600 pregnant participants across the Heartland States in the U.S.. The objective of the Heartland Study is to address major knowledge gaps concerning the health effects of herbicides on maternal and infant health. The study is being conducted to evaluate the associations between environmental exposures to herbicides during and after pregnancy and reproductive health outcomes. The study is measuring multiple biomarkers of herbicide exposure among pregnant Midwesterners and their partners to evaluate associations with pregnancy and childbirth outcomes, epigenetic biomarkers of exposure, and child development.
Medial Displacement Calcaneal Osteotomy and FDL- Transfer - With a Human, Allogeneic Cortical Bone...
Flat FeetFlexor Tendon Rupture3 moreThe goal of this observational study is to compare the use of a screw made of human bone (Shark-Screw®, Surgebright-GmbH) with the metal/Bio-Tenodesis screw (Arthrex) in the treatment of the symptomatic flatfoot using the medializing calcaneus osteotomy with flexor digitorum longus transfer (FDL) in adult patients. The advantage of the human bone screw is that after surgery no hardware removal is necessary. The screw is transformed from the body to normal bone. The main questions it aims to answer are: Can the human bone screw achieve union rates like the metal/Bio-Tenodesis screw? Is the time to union similar between the different screws? Is the complication rate similar between the different screws? Are the activity scores American Orthopaedic Foot and Ankle Society (AOFAS), Foot and Ankle Outcome Score (FAOS) and Foot Function Index (FFI) after surgery similar in the compared patient groups? Participants will have the surgery follow-ups at 6 weeks, 6 months, 1 and 2 years. X-rays are performed at each follow up. CT-scans are performed after 6 months. activity scores are collected at the follow up after 6 months, 1 year and 2 years.
The Relationship of the Medial Longitudinal Arch Height With Clinical Features of Knee Osteoarthritis...
Foot DeformitiesPes Planus5 moreThe goal of this observational study is to investigate the relationships between the medial longitudinal arch (MLA) height of the foot and clinical and radiological characteristics of knee osteoarthritis in adult patients 50 aged and over. The main questions it aims to answer are: Is there any relationship between knee pain and disability in knee osteoarthritis and MLA height? Is there any relationship between the radiologic severity of knee osteoarthritis and MLA height? Is there any relationship between knee joint alignment in knee osteoarthritis and MLA height?
Semaglutide Improves Metabolic Abnormalities and Fertility in Obese Infertile Women With Polycystic...
PCOS (Polycystic Ovary Syndrome)SemaglutideTo investigate the efficacy of semaglutide in obese infertile women of childbearing age with polycystic ovary syndrome (PCOS), we design this prospective, randomized, open and controlled study. 75 obese infertile PCOS patients will be recruited and randomized into three groups: metformin, semaglutide and metformin+semaglutide, on the basis of calorie-restricted diet and physical exercise. All subjects will be treated for 12 weeks, and then stop taking the drug for at least 8 weeks to initiate ovulation induction or ovulation induction combined with artificial insemination. All subjects will be followed up for 24 weeks for pregnancy outcome. The primary endpoint of the study is the percentage of weight loss at 12 weeks of treatment. The secondary endpoints include HOMA-IR and androgen levels at 12 weeks of treatment, ovulation rate at 24 weeks of follow-up, clinical pregnancy rate and cumulative pregnancy rate, and depression, anxiety, diet and quality of life scores at 12 weeks of treatment.
Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA...
Lymphatic MalformationsThe main purpose of this study in participants with PIK3CA-mutated lymphatic malformations (LyM) is to assess the change in radiological response and symptom severity upon treatment with alpelisib as compared to placebo.
Biobank on Prematurity, Preeclampsia and Other Pregnancy Complications
PreeclampsiaPreterm Birth2 moreThe Biobank includes data and biological specimens of women from three original studies: 1) First-trimester Prediction of Preeclampsia (PREDICTION Study, NCT02189148), 2) Pre-Eclampsia And growth Retardation, an evaluative Longitudinal study (PEARL Study, NCT02379832), 3) Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial (NCT02280031) and 4)PREDICTION2: Prediction of Preeclampsia and other Pregnancy Complications Following Combined Iterative Screening.
Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract...
Vesicoureteral RefluxRenal Hypodysplasia3 moreThe exact role of urinary tract infection in the appearance of chronic kidney disease is unclear. Children with congenital malformations of kidney and urinary tract have the higher risk of impairment of renal function. To understand if the use of antibiotic prophylaxis can reduce the risk of urinary tract infection in children with these malformations, this study will randomize children in two groups. Group A will not take antibiotic prophylaxis, Group B will take antibiotic prophylaxis for 2 years. This study will assess if antibiotic prophylaxis reduce the risk of urinary tract infections in these children and if urinary tract infections influence the appearance of renal damage. Our hypothesis is that prophylaxis reduce the risk of infection in severe vesicoureteral reflux and that urinary tract infections, in morphologically normal kidneys, will not result in chronic renal failure.
Pelvic Fixation and Fusion During Multilevel Spinal Surgery
Spinal FusionDeformity of SpinePAULA aims to collect data on the safety, performance, and effectiveness of iFuse Bedrock Granite (GRANITE) in patients who have spinal fusion surgery with pelvic fixation/ fusion.
Clinical Study to Evaluate Adaptos®Ortho Wedge Bone Graft Substitute in High Tibial Osteotomy
Knee DeformityThe aim of this study is to obtain performance and safety data of the new investigational device, dual-part Adaptos®Ortho Wedge, for its intended use in orthopaedic surgery. The study intervention is medial open wedge high tibial osteotomy (OWHTO) with loadbearing plate fixation, where a bone graft substitute material Adaptos®Ortho Wedge is evaluated when used as a bone void filler. Investigational device is expected to support bone formation in osteotomy gap and to resorb in the body. The comparator arms are treated with medial OWHTO with plate fixation, either without a bone graft (the bone defect is left empty, non-augmented osteotomy) or by using a comparator product (chronOS® Wedge, semi-circular) as a bone void filler.
Neurocognitive Abnormalities in Stimulant Abuse Among High-Risk Women
Stimulant AbuseCriminal BehaviorSubstance use disorders and psychopathy are serious and costly mental health issues. Psychopathy is known to be associated with aberrant moral decision making and there is considerable interest in determining whether substance use disorders lead to impairments in these same cognitive processes. Recent large-scale research initiatives in forensic settings have begun to identify substance abuse and psychopathy-related disruption in the neural mechanisms involved in moral decision-making processes, and associations between these neural networks and future relapse and antisocial behavior. Here the investigators extend prior work (with incarcerated men) to examine these issues among incarcerated women in order to better understand sex differences. This project addresses the overall lack of neurocognitive research in criminal offenders with substance use disorders, thereby focusing on a major public health issue in an underserved and understudied population.