Kornimate/medical-research-clean huggingface dataset:
promoting postpartum weight loss in overweight women

Conditions: Obesity

Summary: the purpose of this study is to evaluate, in a five-year randomized controlled trial, the efficacy of an intervention (amp - active mothers postpartum) to increase physical activity and promote a healthy diet (decreased calorie and fat intake) for weight loss among postpartum women who were overweight or obese prior to pregnancy. the hypothesis is that the proportion of women losing at least 10% of bmi from baseline to 12 months post-intervention will be significantly greater in the amp intervention arm than in the minimal care arm.

retention of weight gained in pregnancy contributes to the development of overweight and obesity in middle age, now at epidemic proportions in america. while interventions to reduce weight retention specifically targeting the postpartum period have been few, interventions that promote modest weight loss starting in early postpartum are safe and could be efficacious, particularly for women who were overweight prior to pregnancy. moreover, postpartum-related changes in cognitive factors (risk perceptions), behavioral factors (physical activity, diet), self concept (self-esteem) and social role (work, food preparation, child care) may make this time a "teachable moment" that could be capitalized upon by formal interventions. interventions could leverage natural weight changes to encourage adoption of a healthy diet and increase physical activity, which together could accelerate and/or increase natural weight loss in postpartum. whether the postpartum period is a teachable moment for weight loss interventions can be investigated empirically.

Eligibility criteria:
inclusion criteria: * pre-pregnancy bmi\>24 * over 18 * delivered baby in past 6 weeks * english speaking * driving distance to duke university medical center exclusion criteria: * hemodynamically significant heart disease * restrictive lung disease * severe anemia * unevaluated maternal cardiac arrythmia * chronic bronchitis * poorly controlled type 1 diabetes * poorly controlled hypertension * orthopedic limitations * poorly controlled seizure disorder * poorly controlled hyperthyroidism

Keywords: obesity postpartum period exercise diet motivation
comparison of methods to facilitate rapid sequence intubation

Conditions: Intubating Condition

Summary: in this study, methods which are known for facilitating rapid sequence intubation or accelerating rocuronium (roc)onset are compared including magnesium (mg), ketamine pretreatment, large dose rocuronium and priming.

patients are pretreated with mg, ketamine, or priming dose roc. two groups do not receive pretreatment, but are given roc 0.6 mg/kg or 0.9 mg/kg.

Eligibility criteria:
inclusion criteria: * age 18 - 65 years, * asa 1 - 2, * patients scheduled for elective surgery under general anesthesia, * bmi 18.5-24.9 kg/m2 * mallampati class i-ii exclusion criteria: * neuromuscular disorder, * cardiac/hepatic/renal insufficiency, * pregnant. * anticipated difficult airway * medications that influence neuromuscular transmission

Keywords: rocuronium magnesium priming ketamine intubation
dentofacial effects of two non-compliance appliances in the treatment of growing skeletal class iii patients

Conditions: Malocclusion, Angle Class III

Summary: early orthodontic treatment of class iii malocclusions with skeletal and dentoalveolar imbalances, represents a continuous dilemma. this difficulty starts from their meticulous diagnosis and treatment planning till reaching satisfactory results and finally stability. some appliances could be used to correct growing skeletal class iii patients, improving the skeletal and dentoalveolar relationships, creating proper conditions for final orthodontic treatment, more importantly avoiding surgery. these appliances remove patient compliance from the equation.

aim of the work: evaluate the skeletal, dentoalveolar and soft tissue effects of two different force application systems which are the pulling force (cs 2000® appliance/ cs appliance) and the pushing force (reversed forsus fatigue-resistant device/ rf appliance). materials and methods: a randomized controlled clinical trial will be conducted to address the aim of the study. thirty three growing skeletal class iii patients (9-11 years) will be recruited upon a lateral cephalometric x-ray. subjects complying with the inclusion criteria will be randomly assigned using a computer-generated list to one of the three groups group i: eleven patients treated with cs2000 appliance, group ii: eleven patients treated with reversed forsus fatigue resistant device and group iii: control group of eleven untreated patients with a ratio of 1:1:1 allocation. a cbct will be made before installing the appliances. after gaining a 2 mm positive overjet or a 6 months period, alginate impressions will be poured and dental casts will be made. photographs and cbcts will also be performed to record the dentofacial effect of the used appliances. keywords: cone beam computed tomography, growing skeletal class iii, cs 2000® appliance, reversed forsus fatigue resistant device.

Eligibility criteria:
inclusion criteria: * age range from 8 years to 11 years. * cervical vertebrae maturation index (cvmi 2 and 3) identified on the lateral cephalometric radiograph. * angle class iii molar relation. * skeletal class iii anb ranges between (-4) - (0). * wits appraisal ranges between (0) - (-5). * patients with good oral hygiene, and a healthy periodontal condition. * reversed over jet (-1) - (-6). * normal vertical growth pattern (sn/mp angle 28˚-38˚). exclusion criteria: * a discrepancy between centric relation and maximum intercuspation. * patients who underwent previous orthodontic treatment. * patients currently receiving drug therapy that may affect orthodontic tooth movement. * congenitally missing teeth or extracted teeth. * history of systemic disease or craniofacial syndromes or presence of cleft.

Keywords: cone beam computed tomography growing skeletal class iii cs 2000® appliance reversed forsus fatigue resistant device
t cell profiling in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the goal of this research study is to to learn more about the body's immune response in patients with multiple sclerosis (ms). in ms, the body's immune cells mistakenly attack an important part of the nerves of the brain and spinal cord. the immune cells responsible for attacking the nerves in ms patients is primarily the t cells. a marker was recently discovered that might specifically identify these damaging t cells from all other t cells in the body. understanding which t cells cause the damage in ms patients and understanding more about these specific t cells may help doctors better understand how ms occurs and could possibly prevent ms in the future.


Eligibility criteria:
ms group inclusion criteria -diagnosis of multiple sclerosis and present to the neurology clinic for a regular checkup or are admitted to the inpatient floor with acute symptoms. exclusion criteria * have an active infection * take t cell modulating drugs control group inclusion criteria -scheduled for elective surgery * without any immunological diseases. exclusion criteria * have an active infection.
low molecular weight heparin in recurrent implantation failure

Conditions: Infertility; Fertilization in Vitro; Recurrent Implantation Failure

Summary: recurrent implantation failure is the failure to achieve a pregnancy after multiple attempts with in vitro fertilization treatment. the reason is usually obscure. many empirical treatments have been offered without substantial evaluation. heparin is thought to play a role in the embryo implantation process beyond its anticoagulation effects. the proposed study aims to assess the effectiveness and safety of empirical administration of low molecular weight heparin in patients undergoing a new ivf treatment cycle after multiple failed attempts.


Eligibility criteria:
inclusion criteria: * history of at least two previously failed fresh embryo transfer cycles * all previously failed cycles to be performed in the american hospital of istanbul * female age ≤ 38 years * fresh ejaculate sperms to be used for icsi * no hormonal, coagulation, or immunological disorders detected * normal uterine cavity, as assessed by diagnostic office hysteroscopy or saline infusion sonography * normal female and male peripheral karyotype

Keywords: fertilization in vitro assisted reproduction recurrent implantation failure low molecular weight heparin heparin luteal phase
health evaluation and learning for total parenteral nutrition (tpn) at home patient registry

Conditions: Malnutrition; Patients Requiring Home Parenteral Nutrition

Summary: the health registry is a prospective, observational, non-interventional registry study of patients receiving home parenteral nutrition therapy in the us for a variety of indications.

the objective of the health patient registry is to establish and track therapy utilization and outcomes of patients receiving home parenteral nutrition therapy. data collected will include information on patient safety, clinical outcomes, resource utilization and health-related quality of life (qol). the goals of this registry include: * to better understand the patients and populations requiring hpn in the u.s. * to measure clinical outcomes associated with hpn * to identify areas for focused quality improvement interventions * to provide opportunity for resource allocation identification and improvement

Eligibility criteria:
inclusion criteria: * patient of any age, gender, and indication referred to coram/cvs specialty infusion services to receive hpn in an alternate site of care, such as the home or infusion suite * patient must be managed by coram/cvs specialty infusion services * the patient or the patient's caregiver must be willing to receive care and comply with the teaching and training necessary to administer treatment exclusion criteria: * patient is unable to start, or stops receiving hpn * patient is not managed by coram/cvs specialty infusion services * a patient and/or a patient's insurance will not cover cost of hpn therapy with coram/cvs, or a patient elects not to start treatment

Keywords: home hpn homecare
an investigational study to evaluate experimental medication bms-986165 compared to placebo and a currently available treatment in participants with moderate-to-severe plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to investigate the experimental medication bms-986165 compared to placebo and a currently available treatment in participants with moderate to severe plaque psoriasis.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * plaque psoriasis for at least 6 months * moderate to severe disease * candidate for phototherapy or systemic therapy exclusion criteria: * other forms of psoriasis * history of recent infection * prior exposure to bms-986165 or active comparator other protocol defined inclusion/exclusion criteria could apply
thyroid uptake quantification on a new generation of gamma camera

Conditions: Hyperthyroidism

Summary: the primary objective of this study is to evaluate the potential of a new large field czt gamma camera to estimate the thyroid uptake (tu) on single photon emission computed tomography (spect) and spect/ct images in comparison with standard planar scintigraphy. the secondary objective is to analyze the diagnostic contribution of spect/ct imaging.

planar and spect/ct scintigraphy will be performed on a new generation large field czt gamma camera and thyroid uptake (tu) value will be calculated on planar acquisition for 23 consecutive patients referred in our department for hyperthyroidism. with a quantitative approach using attenuation, scatter correction and iterative algorithm with resolution recovery we will have the possibility to calculate the tu value with spect or spect/ct acquisitions. our primary objective will be to evaluate the potential of a new large field czt gamma camera to estimate the thyroid uptake on spect (tomography without attenuation correction) and spect/ct (tomography with attenuation correction) acquisitions compared with standard planar scintigraphy as a gold standard. the secondary objective will be to analyze the diagnostic contribution of spect/ct images. to established this study it will be necessary to introduce cross-calibration factors performed from a thyroid phantom, for planar and spect acquisitions, to estimate the thyroid uptake values.

Eligibility criteria:
inclusion criteria: * hyperthyroidism confirmed by blood test (tsh) and thyroid ultrasound exclusion criteria: * pregnant women

Keywords: thyroid uptake quantification czt planar spect/ct
effects of perioperative intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy

Conditions: Postoperative Pain

Summary: open nephrectomy is one of the most common surgical procedures in urologic practice. pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. the open approach represents a major physical trauma including postoperative pain and discomfort in the convalescence period. adequate control of postoperative pain facilitates earlier mobilization and rehabilitation. patient-controlled analgesia (pca) is effective to treat pain at rest, but seems to be inadequate for dynamic analgesia and may also elicit side effects that may delay hospital discharge. preventing early and late postsurgical pain is an important challenge for anesthesiologists and surgeons. ketamine (n-methyl-d-aspartate receptor antagonist) and lidocaine (sodium channel blocker) are popular analgesic adjuvants for improving perioperative pain management. the investigators designed this double-blind, placebo controlled study to test and compare the preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic pain after elective open nephrectomy. the investigators propose a double-blind placebo-controlled study of patients undergoing elective open nephrectomy. all patients will receive normal "patient-controlled analgesia morphine" in addition to study drugs or placebo. research will be conducted at charles nicolle teaching hospital.

participants will be randomized into one of three study groups: group l: intravenous lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. group k: ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. control group c: an equal volume of saline. the anesthetic technique will be standardized, and the postoperative assessments included pain scores, opioid consumption, recovery of bowel function and 6-minute walk distance (6-mwd) on the fourth postoperative morning. at 3 months, patients will be questioned for chronic postoperative pain using the neuropathic pain 4 questionnaire.

Eligibility criteria:
inclusion criteria: 1. adult (\>/=18) 2. male or female 3. undergoing elective open nephrectomy 4. general anesthesia 5. subject is american society of anesthesiologists (asa) physical status 1 or 2. exclusion criteria: 1. pregnancy and breastfeeding 2. cognitively impaired (by history) 3. subject with a history of psychosis 4. subject known to have significant hepatic disease 5. history of previous cardiac arrhythmia 6. subject for whom opioids or ketamine are contraindicated

Keywords: ketamine lidocaine nephrectomy chronic pain
evaluate the safety and pharmacokinetics of ricolinostat

Conditions: Peripheral Nervous System Diseases

Summary: this study is an open-label, phase i clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy chinese adult subjects.

this study is an open-label, phase i clinical study to evaluate the safety and pharmacokinetics of ricolinostat in healthy chinese adult subjects. 12 subjects are planned to be enrolled, both male and female, and all will receive the investigational drug.

Eligibility criteria:
inclusion criteria: * only patients who meet all of the following inclusion criteria can be enrolled in this study: 1. healthy adult male or female subjects aged 18 to 55 years; 2. body mass index of 19 - 26 kg/m2 (including the boundary value); the weight of male subjects should not be lower than 50 kg, and the weight of female subjects should not be lower than 45 kg; 3. subjects have no pregnancy plan and voluntarily take effective contraceptive measures during the study to 3 months after the last dose and have no sperm or egg donation plan. 4. subjects who fully understand the objective, nature, method and possible adverse reactions of the study, volunteer to be subjects and sign the informed consent form; 5. able to complete the study according to the protocol requirements. exclusion criteria: * subjects who meet any of the following exclusion criteria are excluded: 1. allergic to ricolinostat (including excipients) and other similar drugs; 2. have had a history of drug abuse in the past five years or have used drugs three months before screening, or who have positive result for drug abuse screening at screening; 3. smokers (people who smoked tobacco products in the past 3 months), or habitual use of nicotine-containing products, or those who are tested positive for nicotine at screening; 4. drinking more than 14 units of alcohol per week within 6 months before screening (1 unit of alcohol = 360 ml of beer or 45 ml of spirits with 40% alcohol content or 150 ml of wine) or have taken alcoholic products 48 hours before dosing, or tested positive for alcohol breath test; 5. diseases or factors judged by the investigator to be abnormal and clinically significant, including but not limited to neurological, mental, cardiovascular, blood, liver, kidney, gastrointestinal, respiratory, metabolic, endocrine, immune, skeletal system diseases or other factors;
adaptive support ventilation in acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: the purpose of this protocol is to compare standard of care lung protective ventilation settings with an automated ventilator setting, called adaptive support ventilation (asv), in patients with acute respiratory distress syndrome (ards). this study will compare measurements (i.e. tidal volumes, driving pressure, respiratory rate (rr), compliance, peak airway pressures, plateau pressures, peep) with each ventilator technique, and will measure esophageal pressures to compare transpulmonary and respiratory system mechanics.

this study will compare two different modes of mechanical ventilation: standard lung protective controlled mandatory ventilation and adaptive support ventilation. the investigators will enroll adult patients with ards who are mechanically ventilated and admitted to intensive care units, capturing a population with respiratory failure and significant critical illness. patient mechanics during each ventilation strategy will be compared before and after crossover. after obtaining informed consent, the investigators will place an esophageal balloon which will be used for simultaneous measurements of airway pressures (pao) and esophageal pressures (pes), to estimate transpulmonary pressures (pl = pao - pes), while also measuring flow and volume. use of esophageal balloon catheters is common practice in the icus, and standard of care at beth israel deaconess medical center is to use these balloons in patients with ards. both the respiratory therapy and physician staff are very comfortable with placement and use. the esophageal balloon will be left in place until extubation. if the balloon is dislodged or removed for clinical purposes, it will not be replaced solely for research purposes unless it occurs on the first day of study measurements. patients will then be randomized to be switched to asv immediately or to be maintained on their current lung protective ventilation settings.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age 2. receiving mechanical ventilation in an intensive care unit 3. ards, as defined by the berlin definition: 1. hypoxemic respiratory failure with pao2 / fio2 ratio \< 300 mmhg 2. bilateral alveolar/interstitial infiltrates on chest x-ray, with opacities not present for more than 7 days 3. respiratory failure not fully explained by cardiac failure or fluid overload 4. intubation on mechanical ventilation and receiving peep ≥ 5 cm h2o 4. receiving mechanical ventilation from a hamilton ventilator, on a controlled mode of ventilation. exclusion criteria: 1. clinical team refusal 2. esophageal injury or contraindication precluding placement of the esophageal balloon

Keywords: adaptive support ventilation ards esophageal pressure mechanical ventilation transpulmonary pressure
effect of patient cost sharing on treatment discontinuation among rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the impact of patient cost sharing on treatment discontinuation of biologic agents in patients with rheumatoid arthritis (ra)


Eligibility criteria:
patients diagnosed with rheumatoid arthritis (ra) who newly initiated a biologic dmard (bdmard) during a study timeframe of 1/01/06 to 3/31/09. inclusion criteria: * 18 to 64 years of age at index date * diagnosis of ra during the study period (icd-9cm 714.xx) * evidence of at least one biologic dmard of interest during the study timeframe * continuous enrollment during the study timeframe * both medical and pharmacy benefits * no evidence of a claim for a bdmard in the 6-month pre-period exclusion criteria: * patients are excluded if they have a diagnosis of psoriasis, psoriatic arthritis, ankylosing spondylitis, crohn's disease, or ulcerative colitis at any time during the study timeframe; have a claim for rituxan, iv etanercept, or iv adalimumab; or have medicare or medicaid during the study timeframe
sanctura muscarinic receptor antagonist resists transport (smart) trial

Conditions: Elderly; Pharmacokinetics; Overactive Bladder

Summary: this study evaluates the penetration through the blood-brain-barrier of trospium chloride at plasma steady state (day 10) in elderly subjects with overactive bladder symptoms. trospium levels in cerebrospinal fluid (csf) and peak and trough plasma levels will be measured. baseline and day 10 post-dose neurocognitive testing will be compared using a reliable change index to assess if any study subject shows evidence of a clinically and statistically significant change in memory.


Eligibility criteria:
inclusion criteria: * male or female, 65-75 years of age without evidence of memory impairment * subject has overactive bladder symptoms but otherwise healthy * non-smoker (refrained from any tobacco usage, including smokeless tobacco, nicotine patches, etc., for 6 months prior to the screening visit) * weight within normal range * ability to follow study instructions and likely to complete all required visits exclusion criteria: * residual urine within bladder greater than 4 ounces * moderate or severe memory impairment * bleeding disorder * blood-thinning agents * concurrent overactive bladder medication * concurrent dementia drugs: aricept (donepezil), namenda (memantine), cognex (tacrine), exelon (rivastigmine), razadyne (galantamine), galantamine or similar drugs for dementia * chronic kidney failure * abdominal bypass surgery for obesity