Kornimate/medical-research-clean huggingface dataset:
early administration of prothrombin concentrate complex in patients with acute hemorrhage following severe trauma

Conditions: Shock, Hemorrhagic

Summary: acute traumatic coagulopathy (atc) is common in severe trauma patients (around 25 to 30% of patients with severe trauma) and is associated with increased mortality. atc is associated with fibrinogen and clotting factors deficiencies. therefore, atc management relies on early administration of fibrinogen and blood products in case of massive transfusion with a 1:1 or 1:2 ratio between fresh frozen plasma (ffp) and red blood cells (rbc). this strategy relies on fast supply of ffp. to overcome delay for ffp ordering, transport and defrosting, the procoag study proposes to use prothrombrin concentrate complex (pcc) as alternative to treat coagulation factor deficiency. pcc is readily available upon hospital arrival. in addition to fibrinogen treatment, it is thought that pcc can be efficient in atc management, while reducing risks associated with massive transfusion. procoag is a randomized, controlled, double-blinded, parallel clinical trial aiming at showing superiority of early ppc+ fibrinogen strategy on fibrinogen only strategy for the management of patients at risk of massive transfusion. early administration of ppc should optimize patient blood management and therefore reduce blood products transfused within the first 24 hours following a severe trauma.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * primary admission for a severe trauma * out-of-hospital transfusion or rbc transfusion within the first hour following hospital admission * clinical prediction or abc score (assessment of blood consumption) ≥ 2 of massive transfusion defined by a transfusion of at least 10 cgr during the first 24 hours or 3 cgr during the first hour. * informed consent signed by a relative or emergency procedure exclusion criteria: * cardiac arrest before randomisation * secondary transfer from another hospital (a technical stop is accepted) * post-traumatic lesions out of therapeutic resources with death expected in the hour following hospital admission * anti-coagulation treatment (k anti-vitamine, new oral anticoagulant) * pregnancy * hypersensitivity to active substances or one of the excipients of kanokad® * patient treated with an experimental medicine within the last 30 days * decision of therapeutic limitation before randomisation * patient protected by article l1121-7 of the french public health code. * knowledge of a contraindication to the use of nacl 0.9% at the dose of 1 mg/kg (hyperchloremia, hypernatremia...)

Keywords: acute traumatic coagulopathy hemostasis severe hemorrhage
comparison of craniosacral therapy vs pelvic floor physical therapy

Conditions: Multiple Sclerosis; Bladder Dysfunction; Urinary Incontinence; Overactive Bladder

Summary: the purpose of this study is to determine the efficacy of cst for the treatment of luts in patients with ms and evaluate the acute effects compared to pfpt. a. objectives to examine the effect of cst as compared to pfpt on qol, semg resting biofeedback readings, and pvr ultrasonography measures in patients with ms and luts. b. hypotheses / research question(s) it is hypothesized that patients who receive cst will demonstrate improved qol, bladder control and ability to empty bladder as compared to those who receive pfpt.

the purpose of this study is to determine if craniosacral therapy is an effective therapy for treating bladder dysfunction in patients with multiple sclerosis (ms). it will be compared to standard care for the treatment of bladder dysfunction, which is pelvic floor physical therapy. bladder dysfunctions are extremely common in patients with multiple sclerosis. one of the most common symptoms of bladder dysfunction is called over-active bladder. over- active bladder can be described by increased urges to urinate and frequency of urination, especially at night. other common symptoms are: leakage of urine, with or without activity; inability to hold urine; and a decreased ability to empty bladder when urinating.

Eligibility criteria:
inclusion criteria: * diagnosis of multiple sclerosis * currently have the following symptoms for at least three (3) months or longer: frequent urination, increased urge to urinate, nighttime urination, loss/leakage of urine with or without activity, and/or problems emptying your bladder. exclusion criteria: * unable or unwilling to give consent to be treated * unable or unwilling to cover your portion of physical therapy treatment (i.e. co-pays and/or deductibles) * cannot speak or read english * have not had any urinary symptoms for at least three (3) months * do not have multiple sclerosis; or have not been diagnosed with multiple sclerosis * take medication to treat your urinary symptoms; or have taken medication in the past three (3) months to treat your urinary symptoms * use an indwelling catheter (i.e. tube inserted into your bladder for continuous urine drainage); or you require intermittent catheterization * currently are experiencing any of the following: shooting or radiating pain in your back or abdomen; pain that is not relieved with body position and/or medication; nausea; decreased appetite; pain with bowel movements or urination; and/or any symptom that is new and/or of unexplained onset (i.e. you do not know why it started or when it started) * currently have cancer/tumors (i.e. tumors in the spine, brain, pelvis, etc.) and/or aneurysms (i.e. abdominal aortic aneurysm) * received botox injections in the past three (3) months * received pelvic floor physical therapy and/or craniosacral therapy in the past three (3) months
a 4-week study of mifepristone in the prevention of risperidone-induced weight gain in healthy male volunteers

Conditions: Healthy

Summary: this is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers to determine the average change in absolute weight at day 28 compared to baseline.

this is a 28-day, single-center, double-blind, placebo-controlled inpatient study of the administration of risperidone alone or in combination with mifepristone in healthy adult male volunteers. the primary study objective is to determine the mean change in absolute weight at day 28 compared to baseline in normal healthy male volunteers treated with risperidone plus mifepristone or risperidone alone. the secondary study objectives are to determine the mean percent change in baseline body weight; and the proportion of subjects that gain less than 5% and less than 7% of their baseline body in the treatment groups.

Eligibility criteria:
inclusion criteria: * bmi ≥ 18 and ≤ 23 kg/m2 * able to provide written informed consent * routine clinical laboratory tests either within normal limits or not clinically meaningful if outside of normal limits * ast, alt, tbili within normal limits at screening * medical and psychiatric history and physical examination devoid of any significant findings that would interfere with participation or interpretation of results in this study * agree to use a barrier method of birth control for 28 days following the last dose of study medication * have maintained a stable weight for at least 6 months prior to screening exclusion criteria: * prior or current history of any psychiatric disorder, including eating disorders such as anorexia nervosa, bulimia nervosa, or binge-eating disorder * positive urine drug screen for any drug of abuse (including amphetamines, cannabinoids, barbiturates, cocaine, opiates, benzodiazepines) unless prescribed by a physician * participation in a clinical investigation of any drug, biological or other investigational therapy within 30 days prior to dosing * have a history of an allergic reaction to either mifepristone or risperidone * any other clinically significant abnormality on screening laboratory tests * qtc bazzett's ≥ 450 msec * history of or current major medical condition, which in the opinion of the investigator would place the patient at undue risk. * receiving any prescription or over-the-counter medications that could potentially affect appetite or weight * any history of a movement disorder such as tardive dyskinesia, parkinsonism * any personal or family history of neuroleptic malignant syndrome

Keywords: healthy weight gain anti-psychotic risperidone mifepristone mitigation weight loss
the effect of lifestyle-induced hepatic steatosis on glucagon-stimulated amino acid turnover

Conditions: Non-Alcoholic Fatty Liver Disease; Glucagon Resistance

Summary: many patients with type 2 diabetes exhibit elevated plasma concentrations of the glucose-mobilising pancreatic hormone glucagon; i.e. hyperglucagonaemia. this contributes to the hyperglycaemic state of the patients and is considered an important component in the pathophysiology of type 2 diabetes; but the mechanisms underlying this phenomenon remain unclear. the liver constitutes the main target organ of glucagon, and studies have shown that hyperglucagonaemia goes hand in hand with hyperaminoacidaemia and that both are associated with non-alcoholic fatty liver disease (nafld), independently of the presence of type 2 diabetes. in line with this, several recent studies support the existence of a feedback-cycle between the liver and the pancreatic alpha cells, governed by circulating glucagon and amino acids. the investigators hypothesise that the presence of hepatic steatosis results in hepatic glucagon resistance at the level of amino acid turnover, i.e. impaired glucagon-induced suppression of circulating amino acid concentrations. if this hypothesis proves correct, it would establish build-up of fat in the liver as a core mechanism underlying hyperglucagonaemia and, since the hyperglucagonemia is at least partly responsible for the fasting hyperglycaemia, as an important contributor to the hyperglycaemia of type 2 diabetes.


Eligibility criteria:
inclusion criteria: * normal fasting plasma glucose and glycated haemoglobin (hba1c) \<42 mmol/mol * body mass index (bmi) between 18.5 and 25 kg/m2 * haemoglobin \>8.3 mmol/l * habitual diet in accordance with the nordic nutrition recommendations * age between 20 and 65 years * oral and written informed consent exclusion criteria: * diabetes * first-degree relatives with diabetes * fasting plasma triacylglycerol indicating dyslipidemia (≥2 mmol/l) * nephropathy (estimated glomerular filtration rate (egfr) \<60 ml/min and/or microalbuminuria with an albumin to creatinine ratio of 30-300 μg/mg) * known liver disease and/or alanine aminotransferase (alt) and/or aspartate aminotransferase (ast) \>2 × normal values * signs of liver fibrosis and/or steatosis evaluated by fibroscan (cap value \>2380 db/m and/or kpa \>65.0) and/or fib-4 score (\>1.45) * \>5% steatosis evaluated by mri carried out before experimental day a (see methods) * use of medication * use of dietary protein supplementation or any other dietary supplements that cannot be paused during participation * excessive training habits, defined as \>2 weekly strength and/or aerobic training sessions * pregnancy and/or breastfeeding * implanted metal objects incompatible with magnetic resonance imaging (mri) * any condition that the investigator feels would interfere with trial completion
epidemiology of human cytomegalovirus excretion in the saliva of children attending nursery in france

Conditions: Healthy Volunteers

Summary: direct dna amplification, viral isolation and specific antibody measurement in saliva from children attending nursery in france sample collection will be done by the pediatrician the nurse, or one of the authorized investigators of the study.

salivary collection kit. 3 swab for dna research, 1 for antibodies research and 1 for virus isolation by cell growth.

Eligibility criteria:
inclusion criteria: * children older than 3 months and less than 6 years kept in nurseries retained, regardless of the duration of custody of the child in the manger concerned. exclusion criteria: * refusal of parents (lack of consent) * refusal of the child according to his ability to understand * uninsured social security

Keywords: children nursery cmv infection
rifamycin sv-mmx® tablets versus ciprofloxacin capsules in acute traveller's diarrhoea

Conditions: Traveler's Diarrhea

Summary: the purpose of this study is to prove the non-inferiority of rifamycin sv-mmx® versus ciprofloxacin for the treatment of adults with traveller's diarrhoea.


Eligibility criteria:
inclusion criteria: * signed informed consent, * men or women between 18 and 85 years of age, * history of arriving from their country of residence in the industrialized part of the world within the past 4 weeks, * presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours), * presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency), * women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control exclusion criteria: * residency in any country with high incidence rate of td within the past 6 months, * fever (defined as a body (oral) temperature \>100.4°f or 38.0°c; antipyretic medication should not have been administered in the 6 hours prior to this assessment), * known or suspected infection with non-bacterial pathogen, * presence of diarrhoea of \>72 hours duration, * presence of grossly bloody stool, * presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin), * history of inflammatory bowel disease or celiac disease,
histopathological changes in mycosis fungoides

Conditions: Mycosis Fungoides

Summary: patients with mycosis fungoides stage 1a disease have patch and plaque lesions less than %10 of body skin area. aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. two biopsies for each patient were taken from lesional and non-lesional skin area.

patients with mycosis fungoides stage 1a disease have patch and plaque lesions less than %10 of body skin area. aim of the study is to compare lesional and non-lesional skin of mycosis fungoides patients, and to decide if the systemic treatment is better or local treatment is better for them. two biopsies for each patient were taken from lesional and non-lesional skin area. biopsies will be taken from lesional and non-lesional skin of the patients in the dermatology clinic and sent to laboratory for histopathologic examination.

Eligibility criteria:
inclusion criteria: * histopathologically confirmed mycosis fungoides stage 1a patients exclusion criteria: * mycosis fungoides patients with other stages

Keywords: mycosis fungoides histopathology
a randomized study of daily and intermittent prophylactic regimens for the prevention of disseminated mycobacterium avium complex (mac) and fungal infections in hiv-infected patients

Conditions: Mycoses; Mycobacterium Avium-Intracellulare Infection; HIV Infections

Summary: primary: to determine the efficacy of azithromycin and rifabutin alone and in combination for the prevention of disseminated mycobacterium avium complex (mac) infection in hiv-infected patients. to determine the efficacy of daily versus weekly fluconazole for the prevention of deep fungal infections in this patient population. secondary: to determine the incidence of bacterial (including mycobacterial) infections, cryptosporidiosis, and toxoplasmosis in azithromycin versus non-azithromycin containing regimens. to determine the incidence of oropharyngeal and vaginal candidiasis in patients treated with daily versus weekly fluconazole. to compare survival and outcomes of primary endpoints in the treatment arms.

patients are randomized to receive azithromycin alone, rifabutin alone, or the two drugs in combination for mac prophylaxis. patients in each treatment group further receive one of two doses of concomitant fluconazole for deep fungal prophylaxis, unless specifically excluded for fluconazole randomization. patients are followed for 1 to 2 years.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * preventive therapy with isoniazid for m. tuberculosis. * maintenance therapy for cmv retinitis. patients must have: * hiv infection or history of an aids-defining condition by cdc criteria. * one documented cd4 count \< 100 cells/mm3 within 12 months prior to study entry. * no active mac disease, mac bacteremia, or active mycobacterial infection (tuberculous or nontuberculous). * no acute opportunistic infection. * life expectancy of more than 6 months. * consent of parent or guardian if less than legal age of consent. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: all patients - * unexplained fevers, elevation in alkaline phosphatase, pancytopenia, abnormal liver function tests, or odynophagia for which the diagnoses of mac and fungal infections have not been excluded. * serious hypersensitivity reactions to macrolides or rifampin. * unable to tolerate oral medications. for fluconazole randomization - * serious hypersensitivity reaction to fluconazole. * active fungal infection (cryptococcosis, histoplasmosis, blastomycosis, aspergillosis, candida esophagitis, thrush, vaginal candidiasis). * positive baseline urine cryptococcal culture. concurrent medication: excluded for fluconazole randomization: * maintenance therapy for deep fungal infections. * chronic therapy with ketoconazole or fluconazole.

Keywords: rifabutin mycobacterium avium-intracellulare infection mycoses drug therapy, combination fluconazole acquired immunodeficiency syndrome azithromycin
research for immunotherapy of glioblastoma with autologous heat shock protein gp96

Conditions: Glioma

Summary: rationale: heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells. purpose: this trial is studying the safety and effectiveness of autologous gp96 treatment of glioblastoma and to see how well it works in treating patients with newly diagnosed supratentoria glioma.


Eligibility criteria:
inclusion criteria: 1. able to read and understand the informed consent document; must sign the informed consent. 2. aged 18 to 75 years old , sex is not limited 3. newly diagnosed supratentoria glioma, must have undergone a at least a 80% resection 4. availability of at least 1 g tumor sample. 5. karnofsky functional status rating \> or equal to 70. 6. adequate bone marrow function including the absence of lymphopenia (anc \> 1,500/ mm3; hemoglobin \> 10g/dl ; platelet count \>100,000/mm3), adequate liver function (serum glutamic oxaloacetic transaminase/ aspartate aminotransferase \[ast\], alanine amino transferase \[alt\] \<2.5 times institutional upper limit of normals \[iulns\] ), and adequate renal function (bun and creatinine \<1.5 times iulns) 7. agree to surgical indications of heart \& lung and without the coagulation system disease 8. negative pregnancy test for female patients of childbearing potential 9. agree to use contraception or abstain from sexual activity from the time of consent through 3 month after the end of study drug administration exclusion criteria: 1. inability to comply with study-related procedures 2. patient not suitable for neurosurgery. 3. unavailability of at least 6 doses of vaccine 4. progression prior to vaccination as determined by the principal investigator 5. patient with allergic constitution 6. unstable or severe intercurrent medical conditions 7. current diagnosis of human immunodeficiency virus and patients with active uncontrolled infection. 8. patients with any systemic disease needed to be treated with immunosuppressant or corticosteroids. 9. any other clinical trials within 30 days pre-vaccination. 10. female patients who are pregnant or breastfeeding

Keywords: supratentoria glioma
bupropion alone or combined with nicotine gum

Conditions: Tobacco Dependence

Summary: focus of this study was to determine if bupropion was more effective for smoking cessation when used alone or combined with nicotine gum.


Eligibility criteria:
inclusion criteria: * smoke 10 or more cigarettes per day * motivated to quit * no physical or mental health issues that would prevent participation * not pregnant or willing to prevent pregnancy during treatment exclusion criteria: * carbon monoxide (co) breath test score below 10 parts per million (ppm) * center for epidemiologic studies depression scale (ces-d) score greater than 16 * heavy alcohol use * history of eating disorder * suicidality

Keywords: smoking cessation tobacco dependence
polysomnographic titration of non-invasive ventilation in motor neurone disease

Conditions: Motor Neuron Disease / Amyotrophic Lateral Sclerosis

Summary: a two-arm, individual participant randomised controlled, assessor-blinded trial in 7 mnd care centres across australia will be undertaken.

non-invasive ventilation (niv) is a treatment that uses positive pressure delivered via a face mask or mouthpiece to assist a person to breathe. it can be used as a long-term treatment for people whose breathing is failing - usually due to chronic conditions that produce weakness of the respiratory muscles such as motor neurone disease / amyotrophic lateral sclerosis \[mnd/als\]chronic obstructive pulmonary disease). most people with mnd/als use niv at night initially. even though niv may improve survival and function, many are unable to use it for more than 4 hours per day (which is considered a threshold amount of use in order to gain a benefit) and many others are unable to tolerate it at all. our team has recently provided evidence that specific and individualised titration of niv leads to better outcomes in people with mnd. this previous trial determined that the use of a sleep study (also called 'polysomnography') can improve the way people are initially set up with niv. this study will replicate and extend the single site study in a large, multi-centre randomised controlled trial (rct) across multiple sites this multi-centre rct will also include a 12-month follow-up period to evaluate longer-term outcomes.

Eligibility criteria:
inclusion criteria: * age \>18 years * clinical indication to commence long term niv * confirmed clinical diagnosis of underlying condition exclusion criteria: * medically unstable * hypoventilation attributable to medications with sedative/respiratory depressant side- effects * use of niv for more than 1 month in the previous 3 months * inability to provide informed consent * previous intolerance of niv

Keywords: non-invasive ventilation polysomnography sleep study amyotrophic lateral sclerosis chronic respiratory failure