Kornimate/medical-research-clean huggingface dataset:
nightime niv initiation in amyotrophic lateral sclerosis in an outpatient setting

Conditions: Amyotrophic Lateral Sclerosis

Summary: in patients with amyotrophic lateral sclerosis (als), non-invasive mechanical ventilation (niv) is usually initiated in an in-hospital regime. the investigators evaluated if niv initiated in an outpatient setting can be as effective as regards patients' adherence. the investigators also evaluated factors predicting niv adherence and disease progression.

all patients with a definite als diagnosis, aged \> 18 years, referred to the als outpatient clinics of the fondazione salvatore maugeri institute of lumezzane (brescia) and istituto don gnocchi onlus (milano), italy, for respiratory functional assessments for the purpose of early initiation of niv were considered. patients who were in clinically stable condition and without chest infections during the previous 3 months were considered eligible for the study. between march 2011 and march 2014, during an outpatient visit, the patients were randomized 1:1 to two groups for niv initiation: outpatient vs. inpatient protocol. in both groups a diurnal niv initiation trial was performed using pressure-support ventilators in spontaneous/timed mode with a preset tidal volume (300 ml/kg) and a fixed back-up respiratory rate (12 breaths/min). the trial included: choice of the mask, setting of ventilator pressure, at least 2 hours of niv under supervision. then, the patients underwent the nighttime niv initiation trial for a maximum of 20 nights according to the outpatient vs. inpatient protocol. niv trial was stopped when: 1) patients used niv \> 4 hours/night for 3 consecutive nights, 2) patients and caregivers were able to manage with ventilator, 3) patients failed after 10 consecutive educational sessions. at enrollment (t0), the end of niv initiation trial (t1) and after 3 months from the end of the trial (t2) respiratory function tests, blood gas analysis, and sleep study were performed. at t1 the investigators assessed niv acceptance (as a minimum of 3 consecutive days \>4 h/night), and dyspnea symptoms by vas (day/night), staff and patients' satisfaction. at t2: niv adherence (\>120 h/month) and patients' satisfaction.

Eligibility criteria:
inclusion criteria: * consecutive patients * definite als diagnosis * aged \> 18 years * in clinically stable condition * referred to the als outpatient clinics of the fondazione salvatore maugeri institute of lumezzane (brescia) and the istituto don gnocchi onlus (milano), italy for respiratory functional assessment for the purpose of early initiation of niv * no chest infections during the previous 3 months. exclusion criteria: * cognitive impairment * refusal to participate * severe comorbidities and contraindications to niv (arrhythmias, cardiac failure, history of pneumothorax) * distance from hospital \> 40 km, travel problems to attend the outpatient clinic
measuring quality of life of poly-amide complete dentures

Conditions: Denture, Complete

Summary: polymethyl methacrylate have been used since 1937 as a gold standard for a denture base material because of its several advantages as; good esthetics, adequate strength, easy repair and simple processing techniques. as any material it has some problems as polymerization shrinkage, low impact and flexural properties and low fatigue resistance2. so polyamide was introduced into dentistry to be used as a denture base material in order to solve these problems. polyamide denture base materials have some superior properties than pmma as; high impact \& flexural strength, excellent esthetics and less release of residual monomers4. although being an advantage from the point of patient satisfaction, flexural property considered to be a contraindication for a denture base material. the invistigators' trial is done in order to improve rigidity of a polyamide material as well as to improve oral health related quality of life in comparison to heat cured polymethyl methacrylate.


Eligibility criteria:
inclusion criteria: - i. male or female patient with age range (45-55) and in good medical condition ii. all patients have skeletal angle's class i maxillo-mandibular relationship and have sufficient inter-arch distance. iii. free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. iv. free from any tempro-mandibular joint disorder. v. the patients have good oral hygiene. exclusion criteria: - i. patients having hormonal disorders as diabetes, thyroid or parathyroid hormonal diseases were not included. ii. patient with xerostomia or excessive salivation. iii. patient with abnormal tongue behavior and/or size. iv. no intraoral soft and hard tissue pathosis
decrease of lesions induced by mechanical ventilation during ards

Conditions: ARDS, Human

Summary: modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ecmo for severe ards.

the hypothesis is that ecmo, in addition to improving gas exchange, should limit the deleterious effects of mechanical ventilation (mechanical ventilation-induced lesions, vili) by drastically reducing minute ventilation (volume reduction). current, vt, reduction of respiratory rate, reduction of mechanical power, reduction of motor pressure or driving pressure), adapting the level of peep from the data collected by monitoring oesophageal pressure and systematically performing positioning sessions in the prone position. this ultra-protective strategy could thus promote the restoration of the integrity of the alveolo-capillary membrane and thus facilitate the healing of patients. in order to verify this concept and, if necessary, to propose a study whose objectives would be more clinical (mortality, ventilator-free days), we propose to carry out a study aimed at showing that this ultra-protective multimodal strategy reduces the lesions induced by mechanical ventilation compared to usual protective ventilatory management during the ecmo as proposed in the eolia study.

Eligibility criteria:
inclusion criteria: * severe ards with a pao2 / fio2 ratio ≤ 70 mmhg (for at least 2h) measured at peep\> 10 cmh2o and fio2 = 1 * or a severe ards with a pao2 / fio2\> 70 ratio but \ 35 cmh2o and a ph \<7.20 exclusion criteria: * patients with associated hemodynamic failure requiring veno-arterial ecmo * impossibility of setting up or contraindication to the placement of an esophageal tube * impossibility of realization of ventral decubitus * patient to receive corticosteroids during the first 48 hours following venous venous ecmo. * patients assisted by veno-venous ecmo for more than 24 hours.
ultrasound-guided in-plane puncture of the femoral artery

Conditions: Vessel Puncture Site Bleeding

Summary: in germany almost 1 million cardiac catheterizations are performed each year. these procedures can be done either by a transradial or a transfemoral approach. today, the transradial approach is the recommended default strategy. nevertheless, transfemoral access ist still frequently used. the main draw-back of a transfemoral approach are potential access site complications, which can sometimes be life-threatening. to reduce vascular complications ultrasound guided vessel puncture may be helpful. in the "ultrasound guided puncture of the femoral artery"-study (us-parfem) an optimized method of ultrasound guided femoral puncture will be evaluated. in this randomized study the new puncture technique combining ultrasound and fluoroscopy will be compared with the conventional method guided by vessel palpation and fluoroscopy. primary endpoint of the study is the rate of primary successful puncture of the femoral common artery above the bifurcation and below the inguinal ligament ("first success rate").


Eligibility criteria:
inclusion criteria: * transfemoral catheterization exclusion criteria: * acute myocardial infarction

Keywords: ultrasound guided puncture
effects of gastric antral botulinum toxin injections in obese subjects

Conditions: Obesity

Summary: obesity is an important public health problem in the united states. the investigators hypothesize that stomach injections of botulinum toxin a (bta), delivered through an endoscope using endoscopic ultrasound (eus), may cause delayed gastric emptying, satiation, and reduction in body weight. this protocol is designed to study the effects and safety of gastric bta injections. subjects are randomized to receive placebo or one of two different doses of bta injected into the stomach during one endoscopy, performed via the mouth. gastric emptying, satiation, symptoms, psychological dimensions of eating behavior, and caloric intake are recorded before and after injections, and subjects are seen in follow-up for 24 weeks.

additional information regarding study interventions can be obtained by contacting study staff.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years and ≤ 60 years * bmi ≥ 35 kg /m² * no history of diabetes, gastric or small bowel surgery, known gastroparesis, prior peptic ulcer, esophagitis, or gastrointestinal stricture. * not pregnant or nursing. women of childbearing potential must have a negative urine pregnancy test within 48 hours prior to each gastric emptying study, and the botox injection procedure. exclusion criteria: * unable or unwilling to provide written informed consent * asa class iii or higher * chronic upper abdominal pain, nausea, or vomiting * allergy to botulinum toxin * delayed gastric emptying (abnormal t ½) on baseline scintigraphic gastric emptying test * active esophageal, gastric, or duodenal ulceration at time of diagnostic egd * allergic to both penicillins and quinolones * subject has taken warfarin (coumadin) or clopidogrel (plavix) in the week preceding eus

Keywords: obesity gastric emptying satiation endosonography endoscopy feeding behavior
paraneoplastic neurologic encephalitis and mature cystic teratoma

Conditions: Ovarian Dermoid Cyst

Summary: ovarian dermoid cyst, also known as benign mature teratoma, originate from germ cells in the ovary, and is the most common benign ovarian tumor (44-70%). several reports documented a secretion of nmda receptor antibodies from dermoid cyst. this receptor is found in different areas in the central nerves system (cns) and the presence of plasma antibodies has been shown as a rare cause of neurologic presentation term paraneoplastic neurologic syndrome, which can be characterized by mood disorder, psychiatric and neurologic symptoms. in several case reports on young women, first presented with nonspecific neurologic symptoms, then followed by rapid deterioration of conscious, seizures and the need for ventilation support, ovarian teratoma was diagnosed. in 2007 an association between n-methyl-d-aspartic acid (nmda) receptor antibody and encephalitis was first described. more than 50% of paraneoplastic encephalitis were related to teratomas, most often from an ovarian origin. therapy includes tumor resection, steroids, plasmapheresis and immunosuppressive drugs. the investigators recently published a retrospective cohort study analyzing 233 patients who were operated in their institution with pathology proven dermoid. in this study 2 patients presented with paraneoplastic syndrome (0.85%). no prospective study has been published to date to examine the association between antibody titer and dermoid cyst characteristics and the paraneoplastic phenomenon. the investigators wish to conduct a prospective study in which plasma samples will be obtained from patients asymptomatic for neurologic or psychiatric symptoms, undergoing surgery for ovarian dermoid cyst, due to gynecology indication (e.g size, symptoms) in order to identify antibodies against cns nmda-r in their plasma prior to cyst removal. if nmda receptor antibodies will be discovered in asymptomatic patients it may be prudent to examine all serums of women who are diagnosed with ovarian mature teratoma, and offer a surgical removal in order to prevent a possible neurologic sequela in the presence of these antibodies.

the data is collected by examining women's serum for the presence of nmda-r antibodies, using special elisa (enzyme-linked immunoabsorbent assay) kits. the analysis will be made by dyn diagnostics labs. the investigators will obtain a blood sample prior to the operation for cystectomy or oophorectomy and after a written informed consent by the patient. all specimen are sent to pathology examination and only proven dermoid cyst will eventually be enrolled.

Eligibility criteria:
inclusion criteria: 1. women admitted for surgery for removal of suspected dermoid cysts 2. no neurologic symptoms exclusion criteria: 1. no surgical specimen available 2. the cyst pathology does not show dermoid cyst characteristics
bi 671800 ed in steroid-naive asthmatic patients

Conditions: Asthma

Summary: this is a 6 week study to investigate the effectiveness and safety of bi 671800 ed in patients with asthma who do not take inhaled corticosteroids.


Eligibility criteria:
inclusion criteria: 1. signed informed consent consistent with ich-gcp 2. three month history of reversible (12% with 200 ml) asthma (according to gina) with following spirometry at randomization: fev1 60%-85%. 3. no ics previous 3 months prior to screening. 4. diagnosis of asthma prior to 40 years. 5. acq at least 1.5 at randomization. 6. male or female, 18 to 65 years. 7. non-smokers or ex-smokers ( less than 10 pack year history) with negative cotinine screen. 8. able to perform pft exclusion criteria: 1. significant diseases other than asthma or allergic rhinitis. 2. hepatic transaminases or total bilirubin greater than 1.5 uln. 3. hospitalizations for asthma or asthma related intubation within 3 months. 4. uncontrolled asthma. 5. respiratory tract infection or exacerbation within 4 weeks. 6. fev1 less than 40%, more than 12 puffs of saba on more than two consecutive days or asthma exacerbation during the run-in period. 7. participation in another interventional study. 8. pregnant or nursing women. 9. women of child bearing potential nor using appropriate methods of birth control as defined by protocol
safety and tolerability of omalizumab in patients with mild to moderate asthma

Conditions: Asthma

Summary: this study will evaluate the safety and efficacy of omalizumab against asthma attacks in mild to moderate allergic asthma


Eligibility criteria:
inclusion criteria: * diagnosis of allergic asthma \>= 1 year duration and a history consistent with step 2 or 3 clinical features from the global initiative for asthma guidelines. * eligible baseline serum immunoglobulin e (ige) levels value and body-weight combinations exclusion criteria: * documented medical history of anaphylaxis * lung disease other than mild to moderate allergic asthma such as chronic obstructive pulmonary disease (copd) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: asthma, anti-immunoglobulin e, omalizumab
evaluation of multi-organ metabolism and perfusion in nafld by total body dynamic pet scan on explorer

Conditions: Non-Alcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis (NASH)

Summary: evaluation of multi-organ metabolism and perfusion in non-alcoholic fatty liver disease (nafld) by total body dynamic pet scan on explorer

you are invited to participate in a research study that seeks to understand the effect of non-alcoholic fatty liver disease (nafld) on organs other than the liver. one of the most common organs affected in patients with nafld is the heart. we expect to have about 88 people participate in this study at university of california (uc), davis. about three-fourths (66) of the participants will be patients who have been diagnosed with nafld. the other one-fourth (22) will be healthy individuals with no known liver disease. these healthy subjects will allow researchers to compare healthy organs or body functions with those of persons with nafld. the healthy participants are called the "healthy control" group. all participants will undergo the same testing. if you agree to participate in this study, researchers will first interview you and review your medical records in order to document your medical (clinical) history. you will also have a physical examination by a doctor and a blood test. you will then undergo a series of imaging tests to determine the status of your liver, heart and other internal organs. all participants will have a pet/ct scan (positron emission tomography), and an mri (magnetic resonance imaging). all participants will also have an electrocardiogram and an echocardiogram. all electrocardiogram tests are the same, but there are two types of echocardiogram tests. one is like a standard ultra-sound imaging of your heart. the other is a "stress cardio" that will require you to increase your heart rate on a treadmill before the ultra-sound test. your study doctor will determine which test you have.

Eligibility criteria:
inclusion criteria: 1. individuals of 18 years and older 2. nafld patients with diagnosis of non-alcoholic fatty liver disease will be eligible for enrollment or healthy controls without any history of fatty liver disease or risks association with fatty liver will be eligible exclusion criteria: 1. history of other liver diseases including viral hepatitis b or c (except those cured \> 3 years), autoimmune hepatitis, cholestatic diseases, significant alcohol use or known alcoholic liver disease 2. participation in a blinded investigational study for nafld 3. pregnant women 4. prisoners 5. claustrophobic to mri and/or pet scan (explorer) 6. inability to lie or to maintain posture in the scanner for one hour 7. hgb a1c \>9% 8. underwent dynamic fdg pet as part of another study, non-invasive evaluation of liver steatosis, inflammation and fibrosis (irb 840422) within 12 months
clinical interest of the temporary urethral stent allium " bulbar urethral stent " in the treatment of detrusor sphincter dyssynergia

Conditions: Detrusor Striated Sphincter Dyssynergia (DSSD)

Summary: detrusor striated sphincter dyssynergia (dssd) is defined as the persistence or increasing of the striated sphincter activity during voiding and characterizes the spinal cord injuries located under the protuberance. the standard treatment for dssd is medical, either pharmacological or by clean intermittent self-catheterisation (cisc). some patients are unable to perform cisc and require alternative surgical techniques such as external sphincterotomy which is invasive, irreversible and with no adjustment period for the patient. urethral stents have been developed as an alternative to surgical sphincterotomy. temporary stents provide a non-definitive treatment, especially for evolutionary pathologies, for patients refusing a destructive surgery (psychosocial impact), or for patients having not defined yet their therapeutic preference. the allium company has developed the " bulbar urethral stent " (bus) system, which advantages are the possibility to perform the procedure under local anesthesia and to remove more easily the stent, with similar performances compared to the other devices. in order to quantify the interest of the bus system, the investigators propose to perform a prospective study aimed at describing its technical and clinical results in terms of efficacy and safety.


Eligibility criteria:
inclusion criteria: * male patient aged more than 18 years old * presenting detrusor striated sphincter dyssynergia in the opinion of the investigator, based on clinical data and proven urodynamically * detrusor striated sphincter dyssynergia with identified neurological origin * with contraindication or failure of the conventional treatments * accepting the principle of the prosthetic incontinentation * having given his signed consent to participate in the study * affiliated with a social security scheme or assimilated. exclusion criteria: * minor patient or protected adult according to the terms of the law * presenting contraindications to local regional anaesthesia * presenting contraindications or a previous failure to the treatment by prosthetic sphincterotomy * unable to hold a penile sheath.

Keywords: detrusor striated sphincter dyssynergia temporary urethral stent
prevention of progression of duodenal adenomas in patients with familial adenomatous polyposis

Conditions: Familial Adenomatous Polyposis; Duodenal Neoplasms; Duodenal Polyps

Summary: duodenal carcinomas are the leading cause of mortality in patients with familial adenomatous polyposis (fap) who underwent prophylactic colorectal surgery. the purpose of this study is to determine wether celecoxib combined with ursodeoxycholic acid is an effective chemoprevention strategy to influence the progression of duodenal adenomas to carcinomas in patients with fap.


Eligibility criteria:
inclusion criteria: * patients with familial adenomatous polyposis: apc-mutation identified or more than 100 colorectal polyps on diagnosis * spigelman score of duodenal adenoma equal to ii or iii exclusion criteria: * incapability of signing informed consent * active gastric or duodenal ulcer, gastrointestinal bleeding * cardiovascular disease or risk: * congestive cardiac failure: nyha class ii to iv * proven ischemic heart disease and/or cerebrovascular disease * risk factors: hypertension, hyperlipidaemia, diabetes mellitus, family history of cardiovascular events (≥2 first degree family members \<55 years) * renal dysfunction: creatinine clearance below 50ml/min * liver dysfunction: albumin below 25 g/l or child-pugh-score equal to or below 10 * known allergic reaction to sulfonamides, nsaids or ursodeoxycholic acid * use of nsaids or ursodeoxycholic acid for more than 1 week during the 6 months prior to the start of the study * use of lithium * symptomatic gallstones * inflammatory bowel disease * (possible) pregnancy or breast feeding

Keywords: familial adenomatous polyposis adenomatous polyposis coli digestive system neoplasms gastrointestinal disease intestinal disease intestinal neoplasms gastrointestinal neoplasms polyps adenoma adenomatous polyps neoplastic syndromes, hereditary digestive system diseases genetic diseases, inborn chemoprevention celecoxib ursodeoxycholic acid anti-inflammatory agents, non-steroidal cyclooxygenase inhibitors
treatment of fibromyalgia and cfs with ribose, ashwagandha, rhodiola, licorice, schisandra and green tea extract

Conditions: Fibromyalgia; CFS

Summary: is a combination of ribose, ashwagandha, rhodiola, schisandra, licorice, and green tea extract helpful in cfs and fibromyalgia?

ribose has been shown to be very helpful in cfs and fibromyalgia. many studies have also shown benefit for the symptoms of these conditions from ashwagandha, rhodiola, schisandra, licorice, and green tea extract. the study is undertaken as an early open label study to check for the efficacy of a proprietary combination of these

Eligibility criteria:
inclusion criteria: 1. be diagnosed with cfs and/or fibromyalgia 2. live in the united states 3 - be over 18 years of age exclusion criteria: 1. pregnancy 2. diabetes 3. hypertension