Kornimate/medical-research-clean huggingface dataset:
study of post operative pain in endometrial cancer robotic versus laparotomy

Conditions: Endometrial Cancer

Summary: this study is being done to evaluate the efficacy of robotic approach for staging of endometrial cancer as compared to an equivalent abdominal approach. the primary objective is to measure and compare postoperative pain at rest at several time points between two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer.

the primary objective is to measure and compare postoperative pain at rest at several time points (24 +/-4hours, 48 +/-4hours, and 72 +/-4hours) between the two groups of patients undergoing either robotic or open laparotomy approach for staging of endometrial cancer. post operative quality of life will also be collected at several time points. the total amount of post operative opioid requirements during the first 24hours between patients undergoing either robotic or open laparotomy approach surgery. the survival status every four months for the first two years will be monitored, then every 6 months for up to 5 years. the primary endpoint is the mean difference in post operative pain vas scores reported by subjects at rest at the following time points: 24+/-4, 48+/-4, and 72+/-4 hours between both groups after surgery has been completed.

Eligibility criteria:
inclusion criteria: * female subjects between ages 18-86 years old * subject provided written consent * preoperative diagnosis of stage i or ii endometrial cancer * subject scheduled to undergo robotic hysterectomy or open abdominal hysterectomy at the ohio state university * subject should be expected to be able to use and tolerate opioids for pain management * pre operative health is graded as asa i-iii * ecog(eastern cooperative oncology group)performance status 0-3 * subject willing to comply with scheduled visits exclusion criteria: * subject is prisoner, pregnant, or under age 18 or over age 85 * hypersensitivity to opioids * subject is breastfeeding * preoperative health grade asa iv-v * ecog performance status 4-5 * history of receiving prior chemotherapy or radiation therapy * subject schedule for additional procedures at the same time as the surgical staging * subject with pain related illness that to the pi discretion would interfere with study assessments. * known history of alcohol, analgesic, or narcotic abuse within 12 months. * subjects taking nsaid(nonsteroidal anti inflammatory drug medications)within 7 days prior to baseline visit. * require and/or receive chronic analgesic therapy for any pain related condition * severe acute or chronic medical or psychiatric condition that would interfere with the study results.

Keywords: endometrial pain
study of sodium bicarbonate in kidney transplant recipients

Conditions: Kidney Transplantation

Summary: the purpose of this study is to compare the effect of sodium bicarbonate versus no sodium bicarbonate treatment on urinary ammonia levels and urinary transforming growth factor-beta1 (tgf-beta1) excretion in renal transplant patients with low-to-normal serum bicarbonate levels (20 - 28 mmol/l).

renal allograft survival ten years after transplant is only about 50%. in people with non-transplant chronic kidney disease (ckd), sodium bicarbonate treatment seems to delay progressive decline in kidney function in those with low serum bicarbonate levels (metabolic acidosis). this may be because sodium bicarbonate reduces renal ammonia production and hence fibrosis. observational evidence suggests that people with ckd and low-normal serum bicarbonate levels might also benefit from sodium bicarbonate treatment. tgf-beta1 levels seem to be an important predictor of chronic allograft nephropathy, and alkalinizing agents may have an effect on tfg-beta1 excretion. retrospective analysis of participants in the african american study of kidney disease and hypertension showed the lowest risk of ckd progression was among those having baseline serum bicarbonate levels in the range of 28-30 mmol/l. recent studies in people with pre-transplant ckd have suggested that increasing low serum bicarbonate levels (\< 22 mmol/l) with alkalinizing agents such as sodium bicarbonate and sodium citrate may reduce ckd progression. design: this is an open-label randomized study testing the effect of a six-month intervention with sodium bicarbonate 650 mg orally thrice daily versus no sodium bicarbonate treatment on renal ammonia excretion and urinary tgf-beta1. visits will occur at baseline, 3 months, and 6 months. at each follow-up visit, the study coordinator or principal investigator will review a medical questionnaire with the participant and collect a sample of blood and urine for analysis of urinary tgf-beta1, metabolic panel, ph, urinary net acid excretion, urinary bicarbonate and urinary ammonia.

Eligibility criteria:
inclusion criteria: * renal transplant recipients * age 21-75 years * six months since the time of the most recent transplant * serum bicarbonate 20-28mm on the two most recent serum measures with the last six months * stable creatinine exclusion criteria: * systolic blood pressure \> 140mmhg * diastolic blood pressure \> 90mmhg * known ejection fraction \<50% * clinical diagnosis of heart failure * use of \>3 antihypertensive agents * \> 1+ edema * use of alkali in the preceding 3 months * history of noncompliance with clinic visits

Keywords: bicarbonate chronic allograft nephropathy urinary tgf-beta urinary acid excretion
onsite versus referral models of primary care for substance abusing patients

Conditions: Substance Abuse; Primary Medical Care

Summary: veterans presenting for treatment of substance use disorders (suds) often have multiple and serious comorbid medical conditions that affect functional health status and health care costs. prior studies show higher rates of medical follow-up when onsite primary health care was provided to patients with suds within an addictions clinic (onsite care). however, no data are available on differences between onsite versus referral models of primary care delivery in terms of clinical outcomes and total health care costs.

background: veterans presenting for treatment of substance use disorders (suds) often have multiple and serious comorbid medical conditions that affect functional health status and health care costs. prior studies show higher rates of medical follow-up when onsite primary health care was provided to patients with suds within an addictions clinic (onsite care). however, no data are available on differences between onsite versus referral models of primary care delivery in terms of clinical outcomes and total health care costs. objectives: the objectives of this study are to compare patients with suds who receive onsite primary care in a va outpatient addictions clinic to those referred for primary care to the general internal medicine clinic on: 1) medical outcomes and quality of life; 2) sud treatment outcomes; and 3) overall health care costs. this information will assist in identifying practice guidelines for providing preventive services and treatment for acute and chronic medical conditions to individuals in sud treatment. methods: this study is a randomized clinical trial with two treatment conditions: 1) onsite primary care in the addictions treatment center (atc; experimental); or 2) referral primary care in the general internal medicine clinic (gimc; control). subjects are assessed at baseline and at 3, 6, and 12-month time points. the sample includes 720 veterans, newly presenting or returning to sud treatment, who exhibited a chronic medical condition at screening, did not have a primary care provider; and did not present with a serious medical condition requiring ongoing care in three or more organ systems. medical status outcome measures include scores on the sf-36, and total emergency room visits and medical or surgical inpatient admissions. substance abuse outcomes are measured by treatment retention, changes in addiction severity index (asi) scores, and self-reported alcohol use. lastly, overall va health care costs per subject per the 12-month period following randomization are compared across groups. the main analysis involves intent-to-treat analysis of group (onsite vs. referral) by time (3, 6, 12-month) using random effects regression models. status: complete. all subjects completed study interventions as of 3/31/2004. currently data analysis is ongoing.

Eligibility criteria:
inclusion criteria: enrolling in addictions treatment, has no primary care provider currently and has some ongoing medical concern that would benefit from primary care. exclusion criteria:
fondaparinux population pharmacokinetic to morbid obese patients in post-operatory bariatric surgery

Conditions: Morbid Obesity; Obesity; Surgery

Summary: after bariatric surgery , thromboembolics complications are major cause of mortality. however, in obese patients, thromboprophylaxia is a controversy. fondaparinux' efficacy is superior to hbpm, and is a good treatment for this population. pharmacokinetics information with fondaparinux in this population are rare.

we proposed a bicentric study cohort of obese patients (bmi \> 40 kg/m2) treated by 1 day injection of fondaparinux 2.5 mg after bypass surgery. anti-xa activity of fondaparinux will be measured 4 times during hospitalisation for each patient to realise a pharmacokinetic modelisation of fondaparinux. haemorrhage and thromboembolics events will be collected.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * requiring a bariatric surgery * requiring an antithrombotics prophylaxis * having a morbid obesity based on a bmi \>40 kg/m2 * having signed the inform consent form exclusion criteria: * contra-indication to fondaparinux * history of heparin induced thrombopenia (hit) * platelets \< 100 g/l * requiring an effective antithrombotic treatment

Keywords: obesity fondaparinux surgery anti-xa activity
the effect of surgery on central aortic pressure & haemodynamics study

Conditions: Abdominal Aortic Aneurysm; Pulse Wave Analysis; Risk

Summary: the present study will investigate the effect of artificially stiffening the aorta by means of an aortic stent on central aortic haemodynamics (cah). this study will determine whether aortic stenting inadvertently adversely impacts on cah, thereby providing the rational for subsequent therapeutic intervention to reduce the associated cardiovascular risk.

increased pulse pressure and pulse-wave velocity are recognized indices of arterial stiffness (laurent, boutouyrie, asmar et al., 2001; qiu, winblad, viitanen et al., 2003). an increased pulse pressure (indicative of increased central aortic pressure) is independently associated with an increased incidence of postoperative neurological and cardiac complications (fontes, aronson, matthew et al., 2008). pulse pressure has been identified as an independent predictor of cerebrovascular events after cardiac surgery (benjo, thompson, fine et al., 2007). moreover, many studies have demonstrated that pulse-wave velocity is an independent predictor of morbidity and mortality in a range of study populations (for a review see vlachopoulos, aznaouridis, stefanadis, 2010). an increasing body of evidence suggests that brachial artery pressure, although representative, is not an accurate reflection of central aortic pressure. the conduit artery function evaluation study, for example, revealed that certain drugs preferentially reduce central aortic pressure, whilst having similar effects on brachial artery pressure. moreover, in this study central aortic pulse pressure was demonstrated to be an independent predictor of clinical outcomes (williams, lacy, thom et al., 2006). other studies support the finding that markers of cap are more closely related to surrogate measures of cardiovascular risk such as left ventricular mass (haider, larson, franklin et al., 2003) and carotid intima-media thickness (kostis, davis, cutler et al., 1997). one inadvertent effect of stenting is the introduction of a semi rigid conduit into the circulation. this could potentially increase pulse wave velocity and adversely affect central aortic pressures and haemodynamics. the investigators thus aim to investigate the effect of aortic aneurysm of surgery on central aortic pressures and haemodynamics

Eligibility criteria:
inclusion criteria: * all participants undergoing abdominal aortic aneurysm repair, with non-atheromatous common carotid arteries. exclusion criteria: * atheromatous carotid arteries
safety study of gnbac1 monoclonal antibody in healthy male volunteers

Conditions: Healthy Volunteers

Summary: in this clinical study, the safety and tolerability of gnbac1 as a treatment for ms patients will be evaluated in healthy male volunteers.

the monoclonal antibody, gnbac1, targets the envelope protein (env) of the human endogenous retrovirus (herv), also called multiple sclerosis associated retrovirus (msrv), which is considered as a critical factor in the development of multiple sclerosis. this study will assess the pharmacokinetics, safety and tolerability of gnbac1 following single ascending doses (6, 18, and 36 mg/kg) administered via iv infusion.

Eligibility criteria:
inclusion criteria: * healthy male subjects as determined by past medical history, physical examination, vital signs, ecg and laboratory tests at screening and confirmed at day -1 who have signed the informed consent. * aged from 18 to 55 years, both inclusive. exclusion criteria: * history of serious adverse reactions or hypersensitivity to any drug. * presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis that requires no treatment may be tolerated). * need of any prescription medication within 15 days prior to the administration of the study drug and/or non-prescription medication within 7 days prior to the administration of the study drug or anticipated need for any concomitant medication during the study. * participation in a clinical trial during the previous 3 months, i.e. from completion of the previous trial to the planned first administration of the current trial. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: gnbac1 multiple sclerosis multiple sclerosis associated retrovirus (msrv) msrv-envelope protein monoclonal antibody temelimab
evaluation of endothelial dysfunction during aortic valvular replacement by bioprosthesis with and without extracorporeal circulation

Conditions: Endothelial Dysfunction; Aortic Valve Disease

Summary: patients with aortic stenosis present many risk factors for endothelial dysfunction (arterial hypertension, arteriosclerosis, dyslipidemia, chronic renal insufficiency, etc.). it is likely that a significant number of patients suffer from pre-existing endothelial dysfunction that can be evaluated by a molecular approach. to date, the replacement of the aortic valve can be performed by surgery with extracorporeal circulation (cec) or percutaneous (transcatheter aortic valve implantationtavi) without cec. two recent studies have demonstrated a sustained improvement in endothelial function with tavi. on the contrary, studies have demonstrated that post-operative complications (coagulopathy, capillary leak syndrome, acute vasoplastic disorder and acute renal failure) after surgery with extracorporeal circulation (cec) could be the result of the interaction between pre-existing endothelial dysfunction and the "operative" aggression associated with the cec. thus, patients with preexisting involvement of endothelial function would develop vascular dysfunction after valvular replacement due to "endothelial activation" related to cec. this phenomenon would not exist in tavi, and would explain the absence of so-called vascular dysfunction complications (systemic inflammatory response syndrome, vasoplastic syndrome, disseminated intravascular coagulation).


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years. * patient operated on aortic valvular replacement by bioprosthesis in surgery + cec or tavi * signed consent. * affiliation to social security exclusion criteria: * any other cardiac surgery * mechanical aortic valve replacement * permanent ac / fa. * pregnant woman. * curative anticoagulation (avk, nanco, heparin). * patient under tutelage or curatelle. * refusal of the patient. * participation in another study. * preoperative sepsis * minor or adult, under guardianship or curatorship
registry study for optimal management of liver failure in the chinese population

Conditions: Liver Failure

Summary: liver failure is the most severe form of liver damage caused by viral, alcoholic, drug-related and ischemia-reperfusion factors, often combined with extrahepatic organ damage, resulting in a high mortality rate. this study intends to construct a real-world case registry database of inpatients with liver failure based on an electronic clinical data collection system through a multicenter collaborative network to study the clinical characteristics, epidemiology of bacterial and fungal infections, the impact of sarcopenia on clinical prognosis, and optimization of treatment strategies such as antiviral and artificial liver in chinese inpatients with liver failure. the cohort and experience generated from this study will be used as a support for a series of future studies to focus on clinical issues such as infection, end-stage liver disease combined with organ failure, and early warning of critically ill patients.


Eligibility criteria:
inclusion criteria: patients with a diagnosis consistent with liver failure and pre-liver failure: * extreme weakness with significant gastrointestinal symptoms such as anorexia, vomiting and abdominal distention; * elevated alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) with progressive jaundice (tbil≥85.5 μmol/l); * bleeding tendency with pta ≤ 60% or inr ≥ 1.5. exclusion criteria: * an event or complication that, in the judgment of the investigator, significantly affects the assessment of clinical status.
et-blockade and exercise induced blood flow in t2dm

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to establish the effect of et blockade on the acute exercise induced blood flow and endothelial function in subjects with t2dm. we hypothesize that combining et - blockade with exercise training leads to an acute increase of exercise induced blood flow when compared with exercise alone. we expect that this will lead to an optimization of vascular training effect in t2dm.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus (\>2 years since diagnosis) or controls exclusion criteria: * \<40 years of age * \>65 years of age * smoking * cardiovascular disease * diabetes related manifest vascular complications * type 1 diabetes mellitus * use of glibenclamide * use of hiv drugs * use of calcineurin inhibitors * use of drugs that interfere with cyp3a4 and cyp2c19

Keywords: diabetes endothelial function exercise blood flow bosentan
titanium elastic nailing versus hip spica cast in treatment of femoral fractures in children

Conditions: Femoral Shaft Fracture

Summary: the purpose of this study is to determine which method is better for treatment of femoral fracture in children in outcomes.

there is no consensus on treatment of closed femoral shaft fractures in children 6-12years old. we aimed to compare hip spica cast with titanium elastic nailing (ten) in the treatment of femoral shaft fractures in children.

Eligibility criteria:
inclusion criteria: * patients 6-12 years old with femoral shaft fracture without exclusion criteria exclusion criteria: * segmental, winquist type iii and iv comminuted fractures, previously diagnosed neuromuscular disease (e.g., cerebral palsy), metabolic bone disorders (e.g. osteomalacia), or pathological fractures.

Keywords: spica cast ten femoral shaft fracture children
integrative cognitive-affective therapy for binge eating disorder

Conditions: Binge Eating Disorder

Summary: the purpose of the study is to test a newly developed individual psychotherapy treatment for binge eating disorder in adults. this treatment is a type of individual psychotherapy called integrative cognitive-affective therapy (icat) that focuses on helping people change their behaviors, feelings, thoughts about themselves, and relationships. this new treatment is being compared to an existing treatment called cognitive-behavior therapy-guided self help (cbtgsh), which focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist. the primary hypothesis of this investigation is that icat will be associated with greater reductions in binge eating at end of treatment and follow-up compared to cbtgsh.


Eligibility criteria:
inclusion criteria: * binge eating disorder (dsm-5) exclusion criteria: * history of gastric bypass surgery * medical condition acutely affecting eating and/or weight * current medical and/or psychiatric instability (e.g., acute suicidality) * psychosis and/or bipolar disorder * severe cognitive impairment or developmental disability * inability to read english * current substance use disorder * current participation in psychotherapy and/or commercial weight loss program * change in dosage and/or frequency of psychotropic medication in the past 6 weeks * pregnant or breast feeding * bmi \< 21

Keywords: binge eating disorder binge eating eating disorders obesity psychotherapy cognitive behavioral therapy
multi-centre, open-label, first-in-man study with epipad used in adult patients

Conditions: Wound

Summary: the main objective of the trial is to confirm safety of a new product - epipad. the main impact of the device is to provide good environment for the healing of chronic wounds and wounds in the last healing phase (granulation and epithelisation).


Eligibility criteria:
inclusion criteria: * patient suffered from superficial wound of different etiology * wounds in terminal phase of healing * wounds without visible sign of infection * max. size of the wound: 10 x 20 cm (i.e. two pieces of the product) * duration of wound treatment of at least 6 weeks * subject willing and able to provide written informed consent * ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study exclusion criteria: * sloughy or necrotic wound bed * severely contaminated or infected wound * age \< 18 years * pregnant or lactating woman * subject in terminal stage of living * subject with cancer disease * subject with known hypersensitivity or allergy to any component of the investigational device * subject participating in other interventional clinical trial * alcohol and/or drug abuse
evaluation of diagnostic methods and dietary treatment of diabetic gastroparesis

Conditions: Diabetic Gastroparesis

Summary: the objective of the study is in subjects with insulin treated diabetes mellitus type 1 or 2 and gastroparesis: * validate radiopaque markers with fluoroscopy with gastric scintigraphy method * study the difference of metabolic control including the frequents of hypoglycaemia, gastrointestinal symptoms, quality of life and nutrition state during dietary treatment of food of small particle size compared with food of large particle size * validate the radiopaque markers method and measurement of the blood glucose and gastrointestinal symptoms after a test meal, against the gastric scintigraphy * determine if the function of gastric emptying can be improved after intervention


Eligibility criteria:
inclusion criteria: * diabetes type 1 or 2 and gastroparesis * must be able to understand oral and verbal instructions exclusion criteria: * gastrointestinal surgery * other gastrointestinal disease * s-creatinine \>150 umol/l * mental disease * cerebral disease * collagen disease * untreated endocrine disease * anticholinergic drugs * psychopharmacologic drugs * opiates * addiction to drugs as alcohol and narcotics * vegetarian

Keywords: diet dietary treatment particle size gastroparesis diabetes mellitus