Kornimate/medical-research-clean huggingface dataset:
mepivacaine versus low-dose bupivacaine for primary total hip and knee arthroplasty

Conditions: Knee Osteoarthritis; Hip Osteoarthritis

Summary: this research is being done to see if there is a difference between two different spinal anesthetics (mepivacaine vs. bupivacaine) as it relates to reducing post-operative complications and the time it takes for subjects to regain mobility after surgery.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physiological status i-iii (patient must meet criteria of a status i-iii in the asa physical status classification system: i=normal healthy patient, ii=mild systemic disease, and iii=severe systemic disease) * unilateral primary tka or tha * 18+ years of age * able to provide informed consent exclusion criteria: * chronic pain syndromes such as fibromyalgia or complex regional pain syndrome * chronic opioid use (\>1 mos) with ome \>5 mg/day or acute opioid use (\ 30 mg/day. * body mass index (bmi) \> 45 kg/m2 * severe drug allergy\* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever) * major systemic medical comorbidities such as: * pre-existing severe renal disorder defined as glomerular filtration rate (gfr) \<50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history. * severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver * contraindication to spinal anesthesia technique (e.g., known spinal stenosis, coagulopathy, sepsis, infection at site of injection, uncooperative, refusal, anticoagulation medications not held within appropriate time frame\*). \*per asra guidelines, clopidogrel (plavix) held for at least 7 days, dabigatran (pradexa) held for at least 5 days, rivaroxaban (xarelto)held for at least 3 days, warfarin (coumadin)held for at least 5 days or recent inr of less than 1.4, enoxaparin (lovenox) with doses \> 1 mg/kg held for close to 24 hours. * known to be currently pregnant or actively breastfeeding. patients that have a previous history of menopause, hysterectomy, or tubal ligation will not be required to perform a pregnancy test. female patients that do not meet this criterion will be asked to submit a urine sample, and will require a negative urine sample in order to proceed with study protocol. urine sample be collected pre-procedurally. * impaired cognition
fetal renal artery doppler in patients with preeclampsia

Conditions: Preeclampsia

Summary: preeclampsia is a major devastating disorder affects 2:10% of pregnancies worldwide. preeclampsia may be associated with placental insufficiency which may cause fetal blood redistribution to essential organs like brain, heart, kidney.

preeclampsia is a major devastating medical condition that affects pregnant women after 20 weeks of pregnancy. it affects 2:10% of pregnancies worldwide according to world health organisation with higher incidence in developing countries. vascular endothelial dysfunction due to abnormal placentation is believed to be the main cause of multi-organ failure and uteroplacental insufficiency that occur in preeclampsia leading to major adverse effects in both mother and fetus. placental insufficiency causes a redistribution of fetal blood to essential organs ; brain, heart and adrenal glands by decreasing their vascular resistance on expense of peripheral organs such as kidney which exhibit increased vascular resistance and impaired perfusion. this is in contrast to normal pregnancies near term in which renal vascular resistance falls and increased blood flow to the kidneys is observed. doppler ultrasound examination of vasculature of selected organs such as kidneys may have a role in detection of hemodynamic rearrangements that occur in cases of placental insufficiency and preeclampsia.

Eligibility criteria:
inclusion criteria: * a) preeclampsia: * women with preeclampsia \>28 weeks of pregnancy. * singleton pregnancy. * women with intrauterine growth restriction and abnormal amniotic fluid volume to simulate real world data. b) control: * women with healthy pregnancy matched by closest gestational age. exclusion criteria: * ● multiple pregnancy. * known congenital fetal malformations. * women with other comorbidity such as ischemic heart disease, dm, autoimmune disorders, kidney disease, neurological disorders, liver or haematological disorders. * women unable to provide informed consent. * women who refuse to participate
a pilot study of motor control exercise and patient education for the management of chronic low back pain in rural nigerian community.

Conditions: Chronic Low Back Pain

Summary: the main purpose of this pilot single-blind randomized clinical trial is to assess the feasibility of implementing motor control exercise and patient education for the management of chronic low back pain (clbp) in a low resource rural nigerian community.

this study will determine whether supervised exercise training emphasizing motor control exercise (mce) approach and a designed patient education (pe) program based on the psychosocial approach will be feasible and acceptable in reducing pain intensity and functional disability among rural dwellers with clbp in nigeria. participants will be recruited and assigned to one of three intervention groups that include mce group, pe group, or mce plus pe gr using a simple random technique based on an electronic randomization table generated by a computer software program. blinded assessment of all clinical outcomes will be performed at baseline and 6 weeks after randomization. primary outcomes include pain intensity and functional disability while secondary outcomes include overall treatment satisfaction. data will be analyzed using descriptive statistics, paired t-test, and anova. all statistical analyses will be performed on spss (version 24.00) at an alpha level of 0.05.

Eligibility criteria:
inclusion criteria: * male and female between 18 and 65 years old. * primary complaint of lbp experienced at least over the previous 3-month duration. * ability to read/understand english or hausa language. exclusion criteria: * previous history of thoracic spine or lumbosacral spine surgery. * any neurological findings indicating radiculopathy. * evidence of serious spine pathology (e.g. tumor, infection, fracture, spinal stenosis, inflammatory disease). * unstable or severe disabling chronic cardiovascular and pulmonary disease. * history of serious psychological or psychiatric illness. * current pregnancy

Keywords: rural dwellers patient education exercise
trial comparing active intervention at diagnosis with usual care to improve psycho-social care in ayao

Conditions: Carcinoma; Lymphoma; Sarcoma; Cancer

Summary: adolescents and young adults (aya) patients experience significant distress in specific areas at diagnosis. the investigators hypothesize that providing developmentally-appropriate aya-specific psychosocial care, with an individualized multi-disciplinary program will alleviate this distress, as well as improve health-related quality of life (hrqol). the investigators' primary aim is to evaluate the impact of psychosocial interventions on hrqol. the secondary aims are to firstly identify the types of psychosocial distress experienced and secondly, to assess the feasibility of implementing a psychosocial screening and intervention program amongst aya patients newly diagnosed with cancer.


Eligibility criteria:
inclusion criteria: * 16 to 39 years old * newly diagnosed with any form of cancers * capable of giving informed consent (by patients or parents, whichever applicable) * ability to understand and willingness to sign a written informed consent document * able to speak and understand english * able to commit to attending the 3 info-educational sessions as well as patient-directed additional visits exclusion criteria: * patients with uncontrolled brain metastasis. * patients who are unable to commit to attend all 3 info-educational sessions * patients who are unable to communicate in english.

Keywords: adolescent and young adult oncology carcinoma lymphoma sarcoma cancer
efficacy and safety of everolimus in recipients of heart transplants to prevent acute and chronic rejection

Conditions: Graft Rejection

Summary: this trial was to examine the impact of everolimus and reduced dose of cyclosporine on efficacy and safety compared to mycophenolate mofetil and a standard dose of cyclosporine in heart transplant recipients.


Eligibility criteria:
inclusion criteria: * male or female cardiac recipients 18-70 years of age undergoing primary heart transplantation. * the graft must be functional at time of randomization. exclusion criteria: * patients who are recipients of multiple solid organ transplants or tissue transplants or have previously received organ transplants. * patients who are recipients of abo incompatible transplants. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: everolimus heart transplant heart disease transplantation heart ivus assessment at 12 months rate of graft loss acute rejection episodes survival
pkpd of rocuronium and sugammadex profile in pediatric patients

Conditions: General Anesthetic Drug Adverse Reaction

Summary: the aim of the study is to assess the pharmacokinetic and pharmacodynamic properties of rocuronium and sugammadex and their clinical effect in the terms of both the relaxation of paralysed muscles (rocuronium) and the reversal of neuromuscular blockade (sugammadex) in children over 2 years of age undergoing general anesthesia for surgical procedures needing muscle relaxation for more than 30 minutes.

the study group was divided into three subgroups depending on the different doses of sugammadex. group i received dose of 0.5 mg/kg, group ii - 1.0 mg/kg and group iii received dose of 2 mg/kg of sugammadex. general anesthesia was performed among all included patients at the same way. during general anesthesia monitoring of tof - train-of-four, was used to assess the muscle relaxation force of rocuronium as well as the reversal of neuromuscular blockade by sugammadex. for this purpose, 1.5 ml of blood samples taken 8 times, were collected to determine the pkpd of the tested drugs, according to own protocol.

Eligibility criteria:
inclusion criteria: * age 2-18 years * asa i-ii * qualification to surgival procedures requiring muscle relaxation for more than 30 minutes * parental consent of children below 16 yrs and parental and child's consent if child was older than 16 yrs of age * bioethical commission approvement no 161/17 exclusion criteria: * asa iii and more * age below 2 yrs * lack of consent * allergy to studied drugs * less than 30 minutes of relaxation required

Keywords: general anesthesia children
burden of illness in hypoparathyroidism

Conditions: Hypoparathyroidism

Summary: long-term conventional treatment of chronic hypoparathyroidism does not fully restore calcium homeostasis leading to increased morbidity, emergency events and reduced subjective health status. to further investigate general morbidity, hypocalcemic events, subjective and daily life performance in patients with chronic hypoparathyroidism a disease specific questionnaire, as well as the sf-36 are handed out.

design: in a cross-sectional trial the subjective health status and burden of illness in patients with chronic hypoparathyroidism will be evaluated by using a disease specific questionnaire as well as the sf-36. patients: patients will be recruited out of the patient population of the participating five medical centers. statistical analysis: documentation and analysis will be performed at the department of medicine i, endocrine and diabetes unit, university of würzburg, germany. data will be documented after pseudonymisation in a data base. for further analysis data will be compared to sex- and age-matched controls.

Eligibility criteria:
inclusion criteria: * chronic hypoparathyroidism (\>12 months) under established therapy * chronic pseudohypoparathyroidism (\>12 months) under established therapy * written informed consent exclusion criteria: * age \<18 years * no detailed documentation of hypo- or pseudohypoparathyroidism

Keywords: hypoparathyroidism parathyroid disease burden of illness sf-36 quality of life
retroviral insertion site methodology study

Conditions: Immune System Diseases

Summary: adenosine deaminase (ada) is an enzyme involved in the development and functioning of the immune system. deficiency of ada results in severe combined immunodeficiency (scid), a fatal inherited immune disorder. strimvelis is a gene therapy that aims to insert ada function into blood cells and halt or reverse the conditions caused by decreased ada enzyme levels, such as impaired immune function. it is important to consider long term follow-up of patients who have received strimvelis, including evaluation of the risk of insertion near certain genes that may lead to unexpected activation of those genes (oncogenesis). the objective of this study is to evaluate the use of a new technique to identify where strimvelis has become inserted in the genetic sequence, and potential implications for patient care. this new technique is known as sonication linker mediated polymerase chain reaction (slim-pcr) for retroviral insertion site (ris) analysis. the study will recruit at least 15 pediatric or adult patients with ada-scid who have been treated with strimvelis, either in previous clinical trials or as a registered product. recruitment for the study may remain open for up to 2 years even if 15 subjects are recruited sooner. study participation will last for up to 5 years. a total of 5 blood samples will be collected from each subject at approximately annual intervals.


Eligibility criteria:
inclusion criteria: * male or female, pediatric or adult, subjects with ada-scid, who have been previously treated with strimvelis. * capable of giving signed informed consent or signed informed consent provided by the subject's parent or legal guardian. exclusion criteria: * presence of concomitant condition(s) that in the investigator's opinion makes participation in the study unsuitable or may prevent compliance with the protocol requirements. * unlikely to comply with the requirements of the protocol (i.e. attendance for blood sampling on an approximately annual basis). * transportation of viable samples to the european union (eu) central laboratory from the subject's home country is not possible.

Keywords: sonication linker medicated polymerase chain reaction previously gsk2696273 gene therapy adenosine deaminase deficiency retroviral insertion site severe combined immunodeficiency strimvelis
pacemaker implantation following transcatheter tricuspid valve replacement

Conditions: AV Block Complete; Tricuspid Regurgitation (TR)

Summary: transcatheter tricuspid valve replacement (ttvr) is associated with a high risk of third-degree atrioventricular block (avb). however, the optimal pacemaker management following ttvr remains unclear. this study aims to identify an optimal therapeutic approach for pacemaker implantation in patients undergoing ttvr.


Eligibility criteria:
inclusion criteria: * transcatheter tricuspid valve replacement exclusion criteria: * no defined exclusion criteria
cpap survival study in ghana

Conditions: Pneumonia; Acute Respiratory Infection

Summary: the purpose of this study is to determine if the use of a continuous positive airway pressure (cpap) machine (a device that blows air into the lungs) decreases the chance of a child dying from difficulty breathing.

acute respiratory infections, malaria, and sepsis remain leading causes of death in children throughout the world.these conditions may lead to respiratory distress and eventually failure if not adequately managed. in developing countries with limited resources, advanced airway management and support can be challenging and needs to be approached in a different manner than is done in developed nations. for example, the use of invasive mechanical ventilation for respiratory distress is not an option in many resource-limited countries due to the lack of available technology, infrastructure, and trained personnel. other alternatives should be utilized in order to support children with reversible conditions during their acute respiratory distress stage. one such alternative is non-invasive positive pressure. prior research demonstrated that nasal bubble cpap can be successfully introduced and utilized in a developing country's emergency ward. nurses in four ghanaian district hospital emergency wards (kintampo, mampong,nkoranza, and wenchi) were able to safely apply cpap and monitor the patient's response. the investigators demonstrated that patients receiving cpap had a significant decrease in respiratory rate compared with those that did not with a mean difference of 14 breaths per minute. there were no major side effects associated with the use of cpap. now that cpap has demonstrated to decrease respiratory rate in a non-specific disease population presenting with respiratory distress it is important to determine if it also improves survival. therefore, the purpose of the study is to determine if the use of cpap in children 1 month to 5 years of age with respiratory distress decreases mortality.

Eligibility criteria:
inclusion criteria: * one month to five years of age * respiratory rate (rr) greater than 50 breaths per minute in three months to one year of age, and greater than 40 breaths per minute in one to five years of age * presence of sub costal, intercostal, supraclavicular retractions or nasal flaring exclusion criteria: * age less than one month or older than five years * skin breakdown around nose/mouth or facial trauma * unable to protect airway * uncontrollable emesis * unresponsiveness * poor respiratory effort requiring positive pressure ventilation or invasive mechanical ventilation for respiratory failure * known or suspected pneumothorax

Keywords: continuous positive airway pressure controlled trial pneumonia children
research on equity in abortion care by telehealth

Conditions: Abortion in First Trimester; Abortion Early; Abortion; Attempted

Summary: this study will examine the ways in which telehealth for reproductive healthcare affects timing, costs, and follow-up care; whether telehealth reaches people in areas with greater health inequities; and the attributes of telehealth that patients want. study surveys will be administered to interested, eligible participants: 2,000 patients seeking abortion care will complete the study, comprising of 2 groups: patients seeking medication abortion care either (1) in-person or (2) via telehealth. this project will address how telehealth services can be optimized for people of color, low-income people, and immigrants to increase digital inclusion and health equity.

given the novelty of telehealth abortion services and new abortion bans, there is a critical need for research on the role of telehealth for abortion to expand equitable abortion access among groups historically marginalized in healthcare. outside of abortion care, telehealth appears to 1) bridge geographic disparities,2) facilitate language translation,3) provide privacy and safety for immigrants with varying legal statuses, 4) decrease patient costs, and 5) require less time off work or school. at the same time, telehealth services could exacerbate inequities if patients lack technology, internet connectivity, or digital literacy. because abortion is overregulated and highly stigmatized, research on telehealth for abortion is vital. the investigators hypothesize that telehealth is associated with several benefits compared to in-person abortion care, but is not yet reaching people in areas with greater health inequities who need these innovations most. this research can also inform the policies in states that are considering ways to support people in banned states.

Eligibility criteria:
inclusion criteria: * must be currently or about to be obtaining medication abortion care through in-person or telehealth services exclusion criteria: * not currently or about to be obtaining medication abortion care through in-person or telehealth services

Keywords: health equity medication abortion telehealth
phase 4: investigational study to evaluate metformin xr monotherapy versus metformin ir monotherapy in subjects with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is determine if metformin xr monotherapy in subjects with type 2 diabetes is non-inferior to metformin ir monotherapy


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * men and women, aged ≥18 years old at time of enrollment * treatment naive subjects with type 2 diabetes mellitus with inadequate glycemic (hba1c ≥7.0% and ≤9.2% obtained at screening visit) control on diet and exercise alone * women must have a negative serum or urine test within 24 hours prior to start of investigational product exclusion criteria: * history of ketoacidosis, lactic acidosis or hyperosmolar non-ketonic coma * symptoms of poorly controlled diabetes, including but not limited to marked polyuria and polydipsia with \>10% weight loss during last 3 months * serum creatinine ≥1.50 mg/dl (133 μmol/l) for male subjects; serum creatinine ≥1.40 mg/dl (124 μmol/l for female subjects)
renal mass registry

Conditions: Renal Cell Carcinoma

Summary: collect valuable risk factor and quality of life data from renal cell carcinoma patients and harness the latest technology to organize and analyze data.

rcc is a cancer that is poorly understood. the increase in both incidence and mortality rates for rcc, coupled with the lack of effective therapies for rcc beyond surgical excision, underscore the need for a better understanding of rcc tumor biology, immunology, and epidemiology. such improved understanding could then be directly translated into new prevention strategies as well as improved patient care. recently, the national cancer institute's kidney cancer progress review group identified as top priorities for future research the need to better understand the mechanisms underlying known risk factors for kidney cancer; and examine tumor tissue to identify predictors of patient outcome and targets for therapy. in addition, the review group stressed that the leaders in renal cancer research over the next decade would be those institutions that could enroll large numbers of patients, collect valuable risk factor and quality of life data from these patients and harness the latest technology to organize and analyze data.

Eligibility criteria:
inclusion: * patients with a renal mass or a suspected metastatic lesion from a renal primary who have been treated or are going to be studied and or treated surgically at mayo clinic arizona * patients must be 18 years of age or older * patients must be capable of and willing to sign an informed consent exclusion: none