Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of allogeneic mesenchymal stem cells in patients with rapidly progressive interstitial lung disease

Conditions: Idiopathic Interstitial Pneumonia; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Summary: the study evaluates the safety and the efficacy of the addition of intravenous transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease, which have actively progressing disease with rapid loss of pulmonary function on the background of routine treatment.

despite significant progress in the treatment of interstitial lung disease, achieved thanks to new drugs, such as pirfenidone and nintedanib, there are many patients for whom these drugs are not available or poorly tolerated. in addition significant evidence of their effectiveness and safety is valid only for idiopathic pulmonary fibrosis. the transplantation of allogeneic stem cells is a promising direction in the modern medicine with the proven safety for different diseases. but the effectiveness of this therapy is still under research. we believe that in most severe cases of a rapidly progressive interstitial lung disease the transplantation of mesenchymal stem cells may be an effective technology due to their immunomodulatory properties.

Eligibility criteria:
inclusion criteria: * male and female patients 20-80 years old * diagnosis of idiopathic interstitial pneumonia or secondary to connective tissue diseases interstitial lung disease, based on: * clinical symptoms \> 12 months duration, * histologically diagnosed or diagnostic chest hrct features of interstitial pneumonia * forced vital capacity (fvc) ≥ 40% predicted and diffusing lung capacity (dlco) ≥20% * loss more than 10% of fvc (l) and dlco during the last 12 months * signed informed consent. exclusion criteria: * diagnosis of an interstitial lung disease other than idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease (sarcoidosis, pulmonary alveolar proteinosis, lymphangioleiomyomatosis, pulmonary amyloidosis, exposure-related lung disease etc) * obstructive lung disease: fev1/fvc \< 0.70 * clinically significant medical condition, in the opinion of the investigator, may compromise the results of the study * evidence of active infection within 4 week prior to enrollment * history of malignancy \< 5 years prior to enrollment * unable to cooperate with any study procedures * pregnant or breast-feeding * treatment with antiinflammatory or antifibrotic drugs including oral steroids, cytostatic drugs, pirfenidone, d penicillamine, colchicine, tumor necrosis factor α blockers, imatinib, interferon γ, monoclonal antibodies \< 6 months prior to randomization. * active listing for transplant of any organ. * known history of alcohol abuse within 1 year prior to enrollment * participation in another clinical trial

Keywords: interstitial lung disease idiopathic interstitial pneumonia idiopathic pulmonary fibrosis stem cells
pain neuroscience education in patients with fibromyalgia

Conditions: Pain, Chronic; Fibromyalgia

Summary: many patients with fibromyalgia have little understanding of their condition, leading to maladaptive pain cognitions and coping strategies. current research has suggested the use of physiotherapy and rehabilitation in addition to cognitive patient education in the treatment of fibromyalgia syndrome. this study aimed to explore the effectiveness of pain neuroscience education in patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * have fibromyalgia as defined by the criteria of the 1990 acr * have turkish as their native language * between 18 and 65 years of age exclusion criteria: * having cognitive impairment * receiving psychotherapy * illiterate people * patients with significant hearing loss

Keywords: pain neuroscience education patient education
thalidomide on left ventricular morphology and function in congestive heart failure

Conditions: Congestive Heart Failure

Summary: several studies have shown that inflammation and matrix degradation have pathogenic effects on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling process. the sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of congestive heart failure (chf). previous, small investigations have shown an improvement in left ventricular ejection fraction and a favorable cardiac remodeling during thalidomide therapy.

purpose several studies have shown that inflammation and matrix degradation have pathogenic effects on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling process. the sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of congestive heart failure (chf). previous, small investigations have shown an improvement in left ventricular ejection fraction and a favorable cardiac remodeling during thalidomide therapy. purpose the primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on left ventricular morphology and function in patients with chf

Eligibility criteria:
inclusion criteria: * left ventricular ejection fraction \< 50% * signs and symptoms of stable chf * nyha iii or iv functional class exclusion criteria: * women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before ct * clinical instability

Keywords: left ventricular function
e.v.o.l.v.e. trial™: evaluation of cinacalcet hydrochloride (hcl) therapy to lower cardiovascular events

Conditions: Secondary Hyperparathyroidism; Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the effects of cinacalcet (cinacalcet hcl or sensipar®/mimpara®) on cardiovascular events and death in chronic kidney disease (ckd) patients with secondary hyperparathyroidism (hpt) who are receiving dialysis.

secondary hpt is common in people with ckd. patients with secondary hpt often have high parathyroid hormone (pth) levels and may develop large parathyroid glands in the neck. patients with secondary hpt may have bone disease (osteodystrophy). this bone disease may cause bone pain, fractures, and poor formation of red blood cells. other problems from secondary hpt may include increases in blood levels of calcium and phosphorus. these may cause calcium to deposit in body tissues. calcium deposits can cause arthritis (joint pain and swelling), muscle inflammation, itching, gangrene (death of soft tissue), or heart and lung problems. new evidence suggests that secondary hpt is associated with cardiovascular disease and increased death risk. the purpose of this study is to evaluate the effects of cinacalcet (cinacalcet hcl or sensipar®/mimpara®) on cardiovascular events (having to do with the heart and its blood vessels) and death in chronic kidney disease (ckd) patients with secondary hyperparathyroidism (hpt) who are receiving dialysis. these events include death from any reason, heart attack and episodes where the heart does not get enough oxygen, peripheral vascular disease (narrowing of vessels that carry blood to the legs, arms, stomach or kidneys), and heart failure (a condition that occurs when the heart is unable to pump enough blood to meet the need's of the body's tissues)

Eligibility criteria:
inclusion criteria: * inclusion:≥ 18 years of age * treated with maintenance hemodialysis - pth ≥ 300 pg/ml (31.8 pmol/l) * serum calcium ≥ 8.4mg/dl (2.1 mmol/l) * ca x p ≥ 45 mg2\*/dl2 (3.63 mmol2/l2) exclusion criteria: - exclusion: * parathyroidectomy in the 12 weeks before the date of informed consent * received therapy with cinacalcet within 3 months of randomization * hospitalization within 12 weeks of randomization for any of the following events: a. myocardial ischemia b. unstable angina c. heart failure (hf) (including any unplanned presentation to a health care facility that would require mechanical intervention \[i.e., unplanned dialysis treatment\]) d. peripheral vascular disease (other than dialysis vascular access revision) e. stroke * history of seizure within 12 weeks prior to randomization * scheduled date for kidney transplant from a known living donor * anticipated parathyroidectomy within 6 months after randomization * in all instances, the 2 refers to squared.

Keywords: cinacalcet hcl cinacalcet amg 073 sensipar mimpara calcimimetic hemodialysis ckd secondary hyperparathyroidism (hpt)
addition of quetiapine in obsessive compulsive disorder - westenberg study

Conditions: Obsessive Compulsive Disorder

Summary: quetiapine (seroquel ®), an atypical antipsychotic registered for use in schizophrenia, which has a very low propensity of extrapyramidal and endocrine side-effects, has also been studied as an adjunct in ocd. in an open trial, ten patients with ocd who had not responded to at least three previous treatments with a sri at maximum dose and duration were assigned to receive quetiapine in addition to a sri for 8 weeks. given the efficacy of quetiapine in treatment resistant patients, and given its rapid onset of action (4-6 weeks), it is postulated that the combination of a low dose atypical antipsychotic and a standard dosage of an sri as a treatment for patients with ocd might increase the number of responders as well as the effect size. please note: seroquel sr and seroquel xr refer to the same formulation. the sr designation was changed to xr after consultation with fda.


Eligibility criteria:
inclusion criteria: * all patients meet the dsm iv criteria for obsessive-compulsive disorder * y-bocs score \> 16 if obsessions and compulsions * y-bocs score \> 10 if only obsessions * y-bocs score \> 10 if only compulsions * male and female, aged between 18-70 years * female patients of childbearing potential must have a negative pregnancy test and use a reliable method of contraception. * written informed consent exclusion criteria: * presence of any of the following dsm iv conditions; major depression (with a hdrs\>15, \[17 item\]), bipolar disorder, schizophrenia or any other psychotic condition, tic disorder, substance related disorder during the past 6 months, epilepsy, or any structural cns disorder or stroke within the last year. * evidence of clinically significant and unstable cardiovascular, gastro-intestinal, pulmonary, renal, hepatic, endocrine or haematological disorders, glaucoma, myocardial infarction within the past year, or micturition abnormalities * patients at risk for suicide * multiple serious drug allergies or known allergy for the trial compounds * use of antipsychotics during 6 months before the screening visit * use of any other psychotropic drug during 6 months before the screening visit * cognitive and behavioural treatment 3 months prior to the screening visit * any known contra-indication against citalopram or quetiapine

Keywords: obsessive compulsive disorder
the caring study: creating and restoring health through nutrition guidance

Conditions: Type2diabetes; Type 2 Diabetes Treated With Insulin

Summary: the caring study assesses the health benefits of nutrition education for blue cross blue shield subscribers, as well as potential healthcare cost savings to subscribers and the insurance company.

among blue cross blue shield subscribers, individuals with type 2 diabetes will be randomly selected and invited to participate in an interventional trial. a control group matched for relevant variables will be selected from blue cross blue shield subscribers. the intervention group participants will be asked to attend weekly online classes on nutrition and health and to follow a low-fat, vegan diet for 16 weeks. body weight, plasma lipids, hba1c, dietary intake and adherence, and food acceptability will be assessed at baseline and at 16 weeks. their longer-term medical utilization will then be tracked for another 2 years and compared with that of a control population selected from blue cross blue shield subscribers. weekly classes will be offered for the whole 2-year follow-up period. plasma lipids and hba1c will be assessed every 6 months during the 2-year follow-up period.

Eligibility criteria:
inclusion criteria: 1. blue cross blue shield subscriber continuously enrolled for the prior 12 months 2. male or female 3. age at least 18 years 4. have a diagnosis of type 2 diabetes 5. ability and willingness to participate in all components of the study, including: 1. following a plant-based diet for the initial 16 weeks of the study; 2. attending weekly online classes for the initial 16 weeks of the study; and 3. keeping physical activity level consistent throughout the initial 16 weeks of the study. exclusion criteria: 1. diabetes mellitus type 1 or history of any endocrine condition that would affect body weight, such as a pituitary abnormality or cushing's syndrome 2. smoking during the past six months 3. alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use 4. current or unresolved past drug abuse 5. recently gave birth, pregnant, or plans to become pregnant before or during the study period 6. unstable medical or psychiatric status 7. cancer diagnosis 8. chronic kidney disease, stage 4 or 5 9. evidence of an eating disorder 10. lack of english fluency 11. bariatric surgery in the last 6 months 12. dementia 13. institutional custodial care 14. end of life 15. palliative care 16. actively engaged in specific bcbsm diabetes programs and case management programs

Keywords: diabetes type2 insulin a1c
structural heart and valve network prospective registry

Conditions: Mitral Valve Regurgitation; Heart Failure; Heart Valve Disease; Tricuspid Valve Regurgitation; Aortic Valve Stenosis

Summary: background: treatments for structural heart and valve disease are quickly changing. but treatment could be improved. researchers want to gather data from people with this disease. they want to find problems and seek new ways to make treatments better. objective: to find people with structural heart and valve disease with common features to study. to find flaws and patterns in procedures related to this disease. to share findings with other researchers. eligibility: people ages 18 and older who are receiving care from the structural heart and valve program at the participating nhlbi structural heart disease network sites that are part of the study design: participants will be screened with their consent. this will occur when they give their standard consent for medical care. participants will have their data collected in the course of standard medical care. data include: demographic data protected health data personally identifiable data medical records medical images. these could include x-rays, ct scans, and mri scans. the study could find something that would impact participants care. if this is the case, their doctors will be told. participants data may be shared with other researchers. ...

medical care is evolving rapidly for patients considered for treatment of structural heart and valve disease. despite technical advances, many shortcomings remain. this research protocol allows researchers to pool medical records and imaging studies to identify problems and seek new solutions. all patients considered for treatment at participating nhlbi structural heart and valve centers are invited to allow researchers to access their medical records repeatedly, including the results of medical procedures and imaging studies such as catheterization, ct, echocardiography, and mri. these records, which include patient identity, will be sent to a central nhlbi database and kept confidential. results will be used in medical publications but patient identity will be hidden.

Eligibility criteria:
* inclusion criteria: * adults age greater than or equal to 18 years. * receiving care from the structural heart and valve program at the participating nhlbi structural heart disease network site. * consent to participate in the protocol, directly, or through legally authorized representatives (lar). exclusion criteria: - does not consent to participate in this protocol.

Keywords: transcatheter aortic valve replacement mitral valve disease transcatheter mitral valve replacement tricuspid valve disease transcatheter mitral valve repair natural history
evaluation of the association between pre-existing endothelial dysfunction and the onset of vasoplegia during cardiac surgery with cardiopulmonary bypass

Conditions: Vasoplegia; Endothelial Dysfunction

Summary: cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension, atherosclerosis, dyslipidemia, chronic renal failure ...). it is likely that a significant number of patients suffering from a preexisting endothelial dysfunction. this endothelial dysfunction can be assessed by a molecular approach (determination of no, icam1, vcam1, il8, endothelial microparticles ...). extracorporeal circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as ischemia-reperfusion injury is. no studies have evaluated the time course of the infringement, and its association with the immediate post-operative complications (sirs, coagulopathy, vasoplegic syndrome, renal failure). only one study has regained an association between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac surgery vasoplegic syndrome. a study in noncardiac surgery has regained an association between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal failure. thus there is some data in the literature to suggest that the occurrence of postoperative complications (sirs, coagulopathy, capillary leak syndrome, acute circulatory failure vasoplegic and acute renal failure) may result from the interaction between a pre-existing endothelial dysfunction and "operative" aggression (extracorporeal circulation). the onset of complications result from an interaction that depends on the importance of endothelial dysfunction at baseline.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years. * patient operated on for cardiac surgical myocardial revascularization (cabg) or surgical correction of aortic valve. * consent signed. exclusion criteria: * standing arrhythmia. * pregnant woman. * curative anticoagulation (warfarin, nanco, heparin). * patient under guardianship. * patient refused to participate. * cardiac surgery without cpb. * bicuspid aortic valve. * participation in another study. * preoperative sepsis. * minor or major, under guardianship or trusteeship (art l1121-5, l1121-8 and l1122 1-2)

Keywords: vasoplegia endothelial dysfunction extracorporeal circulation cardiac surgery
efficacy and safety or rhythmic auditory stimulation (ras) for gait and balance disorders in parkinson's disease

Conditions: Parkinson Disease

Summary: gait deficits are among the most characteristic and most functionally debilitating signs of the motor neuropathology of parkinson's disease (pd). rhythmic auditory stimulation (ras) is a technique by which a series of auditory stimuli are presented at a fixed rhythm, so that patients have to synchronize their movements to the rhythms. in this study, auditory stimuli will be constituted by tango musical pieces, which tempo is modified to adapt to patients' walking cadence. previous results suggested that ras can increase tinetti's gait and balance and may also improve health-related quality of life. this will be a randomized, blind, controlled clinical trial to further assess ras efficacy and safety.


Eligibility criteria:
inclusion criteria: * clinically definitive or probable pd diagnosis * gait disorders (mds-updrs #2.12 =1) * patients that can be reasonably expected to remain in on-state during training sessions. exclusion criteria: * previous use of ras or kinesiology * mmse \>= 24 * bdi \>= 17 * patients having undergone pd surgical treatments. * patients with auditory or visual handicaps

Keywords: gait disorders balance disorders music tango rhythmic auditory stimulation health-related quality of life
establishing optimal peep setting for obese patients in the steep trendelenburg position

Conditions: Obesity

Summary: the purpose of this study is to determine whether the enlight 2100 electrical impedance tomography (eit) belt can optimize positive end-expiratory pressure (peep) during surgery better than standard anesthesia machines.

positive end-expiratory pressure (peep) is a measure taken intraoperatively to manage breathing during surgery. the enlight 2100 is a device that uses electrical impedance tomography (eit) to measure peep and provide a live image of the lungs while a patient is mechanically ventilated. in this study, the investigators will use the enlight 2100 eit belt to measure peep intraoperatively in order to better optimize peep settings for difficult cases.

Eligibility criteria:
inclusion criteria: 1. bmi ≥ 40 kg/m2 2. age \> 18 years 3. scheduled for elective laparoscopic abdominal surgery in the steep trendelenburg position. 4. able to provide informed consent. exclusion criteria: 1. currently pregnant. 2. presence of pacemaker, neurostimulator, spinal cord stimulator, or implantable cardioverter-defibrillator. 3. skin ulcerations on upper torso near the belt placement. 4. presence of phrenic nerve palsy or other diaphragm conditions. 5. thoracic circumference \> 134 cm. 6. tracheomalacia. 7. inability to speak and understand english.

Keywords: obesity steep trendelenburg trendelenburg peep positive end-expiratory pressure eit electrical impedance tomography
the safety and efficacy of fluoxetine for refractory primary mono-symptomatic nocturnal enuresis in children

Conditions: Nocturnal Enuresis

Summary: to determine whether there is a role for the selective serotonin reuptake inhibitors, fluoxetine, as therapy in the treatment of refractory primary monosymptomatic nocturnal enuresis in children , and whether there are side effects involved.


Eligibility criteria:
inclusion criteria: * primary monosymptomatic nocturnal enuresis * failed treatment with desmopressin. * the enuresis alarm had either been tried without effect, or deemed unfeasible because of the family situation. * all patients had either tried and failed combination therapy with anticholinergics or, because of contraindications, been unable to receive such therapy. * severe enuresis with at least seven wet nights out of 14 exclusion criteria: * underlying renal, urologic, neurologic, endocrinologic, or cardiac conditions * depression * severe psychiatric diseases * untreated constipation