Kornimate/medical-research-clean huggingface dataset:
prescription of intra-dialytic exercise to improve quality of life in patients with chronic kidney disease

Conditions: End-Stage Kidney Disease

Summary: the pedal study aims to evaluate the effectiveness of a 9-month intradialytic exercise training intervention designed to improve quality of life (qol) and alleviate functional limitations in patients with stage 5 chronic kidney disease (ckd) who are on haemodialysis. exercise rehabilitation will be compared against established treatment options available within uk nhs haemodialysis (hd) units. a qualitative substudy will also investigate the experience and acceptability of the intervention for both participants and members of the renal care team. in addition, we want to examine whether this type of additional exercise treatment is cost effective within the health service setting. pedal is designed as a multi centre randomised clinical trial (rct) and will recruit 380 adult patients who have been on hd for at least 3 months, from 10 hd sites located in scotland, england and wales. the type of exercise programming will consist of cycling exercise performed during each dialysis session plus a muscle conditioning programme performed twice per week. all exercise sessions will be supervised by a physiotherapy assistant. the exercise prescription will be individualised for all patients on the basis of their fitness and clinical status. the main objective is to examine the impact of exercise rehabilitation on quality of life and well being of patients. we hypothesise that the exercise training delivered during haemodialysis treatment will significantly improve the functional limitations/abilities of the patients leading to the detection of clinically beneficial improvement in quality of life outcome, as measured by the kdqol-36 physical composite score (pcs) at the primary end point.


Eligibility criteria:
inclusion criteria: 1. prevalent stage 5 ckd patients (gfr \<15 ml/min) receiving maintenance haemodialysis therapy for more than 3 months 2. male or female 3. aged \>18 years 4. able to provide written informed consent exclusion criteria: 1. patients unlikely to be on hd for \> 6 months - (this includes cachectic patients, those with severe heart failure, patients in whom dialysis withdrawal is being considered, and patients likely to receive a live-donor transplant or transfer to pd in that period of time); 2. less than 3 months after the initiation of haemodialysis (patients in this time-frame are generally less clinically stable, many having vascular access procedures performed, and rates of inter-current events, including death and hospitalisation, are very much higher in the first 3 months after commencement of chronic haemodialysis); 3. deemed to be clinically unstable by treating physician; 4. dementia or severe cognitive impairment (as will be unable to give consent and/or complete questionnaire assessments); 5. severe psychiatric disorders - except treated stable

Keywords: quality of life exercise functional capacity
metabolic surgery versus medical management for resolution of type ii diabetes

Conditions: Obesity; Type 2 Diabetes Mellitus

Summary: best medical management and gastric bypass surgery is a way to treat diabetes as part of regular medical care (standard of care). however, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care).

best medical management and gastric bypass surgery are ways to treat obesity as part of regular medical care (standard of care). best medical management is a way to treat diabetes as part of regular medical care (standard of care). however, gastric bypass surgery is not a way to treat diabetes as part of regular medical care (standard of care). but, studies suggest that diabetes gets better or goes away after gastric bypass surgery. this study is being done to find out if diabetes gets better or goes away completely after a patient has gastric bypass surgery as part of regular medical care (standard of care).

Eligibility criteria:
inclusion criteria: * age 25 to 70 * bmi 35 or greater * hba1c\>6.5% * stable weight * stable medications exclusion criteria: * coagulopathy * liver cirrhosis * c-peptide \<1 ng/ml (off insulin) * diagnosis of severe eating disorder * untreated endocrine disorder * use of medication for weight loss in the past 6 months * use of medication for weight loss in the last 6 months (with the exception of orlistat) * pregnancy * coagulopathy * liver cirrhosis * incurable, malignant, or debilitating disease * severe eating disorder * use of weight loss medication in the last 6 months, with the exception of orlistat * untreated endocrine disorder * pregnant * inability to provide informed consent

Keywords: obesity type 2 diabetes mellitus roux-en-y gastric bypass surgery
role of parasympathetic activity in mild to severe asthma with fixed airway obstruction (parasma study)

Conditions: Asthma; Airway Obstruction; Airway Remodeling; Parasympathetic Nervous System Diseases

Summary: in asthma, the significant role of pathogenesis is chronic airway inflammation, bronchial hyperresponsiveness, and variable airflow obstruction. asthma with irreversible or fixed airflow obstruction (fao) is a clinical phenotype resulting from chronic airway inflammation with having longer disease duration, suggesting that airway remodeling contributes to the decline in lung function seen in individuals with asthma. although this condition frequently occurs in patients with severe asthma, there are pieces of evidence occurring in those with mild to moderate asthma. according to previous research, low lung function, fev1 less than 60% predicted, is a robust independent predictor of subsequent asthma attacks and other asthma outcomes, including asthma control and saba use. in a recent study, the patients with mild to moderate asthma who received mild to medium dosed inhaled corticosteroid plus long-acting beta-2 agonist with or without asthma control showed evidence of fao with or without bronchodilator reversibility. therefore parasympathetic activity may be affected by fao in those patients. the autonomic nervous system plays an essential role in asthma, especially from the parasympathetic, promoting bronchoconstriction and regulating airway inflammation and remodeling. this study hypothesizes that a cholinergic mechanism may play a significant role in fao across patients with mild, moderate, and severe asthma. this might increase the fundamental evidence leading to early-step treatment with anti-cholinergic medication in early asthma severity driven by fao.


Eligibility criteria:
inclusion criteria: * asthmatic patients classified by severity mild (achieved control with using low-dose ics or as-needed ics-formoterol) or moderate (achieved controlled with using low-dose ics/laba or severe ((achieved controlled with using medium to high dose ics/laba) * post-bronchodilator (salbutamol) fev1/fvc ratio less than 0.75 or below the lower limit of normal (lln) and post-bronchodilator (salbutamol) fev1 predicted \< 80% with or without bronchodilator response * history of smoking less than 10 pack-years or current smoking * patients who able to do spirometry without contraindication * asthma control was defined by acq6 \< 1.5 exclusion criteria: * contraindication for spirometry * chest x-ray suggested any chronic lung diseased * contraindication for anticholinergic drug * history of asthma exacerbation within 12 weeks before visit 1 * history of taking lama within 6 months before visit 1

Keywords: asthma fixed airway obstruction spirometry parasympathetic activity well controlled
a study of azacitidine and venetoclax versus a stem cell transplant in people 65 years and older with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: the researchers are doing this study to find out if an allogeneic hematopoietic stem cell transplant (hsct) or maintenance therapy with azacitidine and venetoclax is more effective at keeping aml from coming back (relapsing).


Eligibility criteria:
inclusion criteria: * adult patients ≥65 years of age at the time of signing the informed consent form. * confirmed diagnosis of acute myeloid leukemia according to the eln 2017 criteria * treatment with azacitidine and venetoclax for the diagnosis of aml o the first cycle of study treatment will start 28-42 days after the start of the second cycle of soc aza/ven. in the event that patients can't be admitted for allo-hct until after day 42 due to donor related issues, an additional cycle of aza/ven will be allowed as a bridge to the transplant, and then initiation of conditioning will start no later than day 42 after the start of the third cycle. * patients with adequate organ function to be considered as candidates for allo-hct: * cardiac: asymptomatic or if symptomatic, then lvef at rest must be \>40% and must improve with exercise. * renal: crcl ≥50 ml/min (measured or calculated/estimated). * pulmonary: asymptomatic or if symptomatic, dlco \> 50% of predicted (corrected for hemoglobin) * hepatic: \< 5x uln liver function tests and \< 2x uln total serum bilirubin, unless there is congenital benign hyperbilirubinemia. * kps of ≥ 70 * patients with suitable donor for allo-hct * patients must achieve a morphologic remission \<5% blast with mrd negative status by flow cytometry (defined as one or less residual leukemic blasts per 1000 leukocytes (or 10\^3)) meeting one of the below: * complete remission (cr) defined as: \ 1000 and plt \>100k * crh defined as \ 500 and plt \>50k * cri defined as \<5% blasts with anc\< 1000 or plt \< 100k * subject is willing and able to adhere to the study visit schedule and other protocol requirements. exclusion criteria: * patients who are not considered to be transplant eligible (either due to lack of suitable donor or due to comorbidities/performance status). the reason the patient is not considered transplant eligible will be documented in the ecrf. * history of prior allo-hct * patients who underwent prior leukemia directed treatment (other than aza/ven) * patients with cns involvement at any time point prior to enrollment. * patients with previous exposure to venetoclax or an hma for the treatment of a myeloid malignancy * patients who are planned for treatment other than aza/ven * patients who are planned for treatment with hma/ven with another agent (e.g. a "triplet") * presence of any other condition that may increase the risk associated with study participation, and in the opinion of the investigator, would make the patient inappropriate for entry into the study.

Keywords: azacitidine venetoclax allogeneic stem cell transplant
evaluation of preoperative functional magnetic resonance imaging (fmri) in patients with brain tumors

Conditions: Brain Tumor

Summary: the purpose of this study is to test the accuracy of using an imaging technique called breath-holding functional magnetic resonance imaging (bh fmri) in addition to the standard imaging test described above. this study will allow the researchers to find out whether using bh fmri in combination with the standard approach is the same as, better, or worse than the standard approach used alone.


Eligibility criteria:
inclusion criteria: health volunteers * volunteers between the ages of 18 and 80 years * volunteers must be able to perform the language paradigms on cue while inside the scanner patients * patients between the ages of 18 and 80 years * patients must be able to perform the language paradigms on cue while inside the scanner * women of child bearing potential must have a negative pregnancy test prior to the study intervention (serum or urine) * patients diagnosed with primary glial neoplasm, meningioma and metastasis (from prior histology) or must be suspected to have primary glial neoplasm, meningioma and metastasis on imaging (to be confirmed by post-operative histology). * patient"s location of the tumor must involve the expected location of broca"s area (left pars opercularis and/or pars triangularis), or the expected location of the primary motor area (the pre-central gyrus). this determination will be made on the basis of a pre-operative mri by a fellowship-trained neuroradiologist exclusion criteria: healthy volunteers * volunteers who are unable to comply or complete mri exams as per the site"s standards. (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.) o msk site only - see appendix 2 * volunteers who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.) * volunteers with a history of neurological disorders, psychiatric disorders or cancer female volunteers who are pregnant or nursing. * volunteers who have mri safe pacemakers. * volunteers from the vulnerable population, as defined by 45 cfr 46 * volunteers who are unable to perform the breath hold task during practice sessions patients * patients who are unable to comply or complete mri exams as per the site"s standards. (e.g.: claustrophobia, high levels of anxiety, pacemaker etc.) °msk site only - see appendix 2 * patients who have mri safe pacemakers. * patient who are unable to perform the language paradigms on cue while inside the scanner (due to weakness, deafness, inability to understand or follow instructions etc.) * female patients who are pregnant or nursing. * patients from the vulnerable population, as defined by 45 cfr 46 * patients who are unable to perform the breath hold task during practice sessions

Keywords: functional magnetic resonance imaging (fmri) 18-331
clinical outcome comparison between medial and lateral offset reverse shoulder arthroplasty

Conditions: Rotator Cuff Tear; Proximal Humerus Fractures; Malunions; Chronic Proximal Humerus Dislocations

Summary: the purpose of this study is to prospectively evaluate two fda approved implant designs for the tornier reverse shoulder arthroplasty. the small difference in design is the amount of offset each implant has. this offset may improve clinical outcomes in the patient population. there have been no clinical comparative studies between these two designs in the literature to date. we would like to follow these patients for two years after implantation of the reverse shoulder and evaluate their radiographs, pain scores, and shoulder functional scores. this would be the first randomized prospective single blinded study of its kind.

the combination of shoulder arthritis and rotator cuff deficiency presents quite a surgical challenge. the reverse prosthesis offers a treatment option for subset of patients as previous attempts to treat with soft tissue reconstruction or conventional arthroplasty have provided sub-optimal clinical results. numerous reports in the literature have validated the effectiveness of the reverse design. patients meeting criteria must be between the ages of 50 and 95 years of age and are a candidate for a reverse shoulder arthroplasty. this is includes patients with rotator cuff tear arthroplasty, irreparable rotator cuff tears, significant proximal humerus fractures and malunions, and chronic proximal humerus dislocators. a total of 40 patients will be enrolled and randomized to either one of two groups; 20 patients will be randomized to the tornier reversed shoulder arthroplasty medial offset, and 20 will receive the lateral offset design. both implants are fda approved. the patients will be followed for 24 months and will follow-up will be at 6 weeks, 3 months, 6 months, 12 months and 24 months questionnaires will be completed at each visit, x-rays will be done at pre-op, 3 month, 6 months 12 and 24 months.

Eligibility criteria:
inclusion criteria: 1. any patient that is a candidate for reverse shoulder arthroplasty this includes: * rotator cuff tear arthroplasty, * irreparable rotator cuff tear, * significant proximal humerus fracture and malunions, * chronic proximal humerus dislocation. exclusion criteria: 1. any patient with previous arthroplasty on affected shoulder. 2. patient who will need additional procedures including: bone grafting of the glenoid and muscle transfer. 3. patients who do not want to participate or participate in follow-ups.

Keywords: irreparable rotator cuff tears
timing of dilation tracheostomy in mechanically ventilated chronic obstructive pulmonary disease (copd) patients

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is: * to evaluate the optimal time-point for percutaneous dilation tracheostomy in copd patients in terms of duration on mechanical ventilation, length of stay on icu and mortality; * to evaluate the rate of infections and infectious complications of tracheostomized copd patients; * to evaluate the spectrum of pathogens in tracheostomized and intubated copd patients; * to evaluate the amount of sedatives used in mechanically ventilated copd patients; * to assess the quality of life in copd patients tracheostomized after 3 or after 10 days.

screening of patients following inclusion and exclusion criteria on all units of the department of critical care will occur on a daily basis. randomization will be performed by blocks of sealed envelopes containing random numbers which are deposited at a central space within the department of critical care medicine. randomization is performed as permuted block randomization. collection of baseline parameters (last/current lung function test, last/current 6-min walk test, cardiac stress test - if accessible) if not accessible, current lung function test results (at least fev1 and fvc) are requested from the patient's general physician or pulmonologist to determine gold stage. patients randomized into the (early tracheostomy) study group, will undergo tracheostomy at the next possible opportunity but not later than 72 h after initiation of invasive ventilation. patients of the control group will be invasively ventilated at least until day 10. before tracheostomy a complete endoscopic inspection of the bronchial system will be performed routinely. bronchoalveolar lavage fluid (balf) will be obtained from sites of pulmonary infiltrations. in case of no radiographically or bronchoscopic detectable infiltrations balf will be drawn from the middle lobe. primary and secondary endpoints will be analyzed at given time-points.

Eligibility criteria:
inclusion criteria: * diagnosis of copd (gold stage iii or iv) * suspected long-time invasive mechanical ventilation due to arf (\> 10 days) * informed consent of the patient or legal guardian exclusion criteria: * severe neurological failure (such as stroke, cerebral haemorrhage etc.) * immunosuppressant therapy (with the exception of steroid therapy) * major risk of bleeding * intubation \> 72 h * contraindication for dilation tracheotomy * impossibility of intubation

Keywords: tracheostomy tracheotomy dilational dilatative critical care intensive care copd chronic obstructive pulmonary disease lung disease pneumonia prospective study questionnaire quality of life outcome mortality
endoscopic gastric tubulization

Conditions: Morbid Obesity

Summary: endoscopic gastric tubulization is currently proposed in the digestive surgery department of the nouvel hôpital civil, strasbourg, france, to adult patients with morbid obesity. the procedure is performed using the ce marked endoscopic suture device overstitch (apollo endosurgery, austin, tx. usa). it is standard practice since october 2016. the objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. these data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

gastric restriction is one of the fundamental principles of gastric bypass and gastric banding. despite its advantages (long term weight loss, comorbidities related to obesity improvement...), bariatric surgery is risky. in fact, complications putting the patient into a life-threatening condition can occur. endoscopic approaches are similar to current surgical methods but less invasive, safer and allow ambulatory care. nowadays, practitioners have the possibility to reduce stomach size by merging tissues through an endoscopic endoluminal suture approach without any incision. this leads to similar results (gastric restriction, weight loss, quality of life and comorbidities improvement) compared with standard surgical procedure while reducing the risk of complications. one of the major benefit of this technique is its reversibility. a new surgical or endoscopic procedure is possible at a later stage. endoscopic gastric tubulization is currently proposed in the digestive surgery department of the nouvel hôpital civil, strasbourg, france, to adult patients with morbid obesity. the procedure is performed using the ce marked endoscopic suture device overstitch (apollo endosurgery, austin, tx. usa). it is standard practice since october 2016. the objective of this study is to prospectively collect data of patients who underwent an endoscopic gastric tubulization, from last visit before procedure to 2 years after procedure. these data are usually collected during medical consultations and will enable the evaluation of weight loss, quality of life and comorbidities improvement, reproducibility and durability of the technique.

Eligibility criteria:
inclusion criteria: * patients scheduled for an endoscopic gastric tubulization in the nouvel hôpital civil, strasbourg, france

Keywords: endoscopic gastric tubulization weight loss quality of life
shared decision making for kidney transplant candidates to plan for an organ offer decision

Conditions: End Stage Renal Disease; End-Stage Kidney Disease; Kidney Transplantation; Esrd

Summary: the goal of this pilot randomized trial is to learn about shared decision making in kidney transplant candidates. the aim of this proposal is to evaluate the donor plan donor choice tool to promote high-quality shared decision making for providers and kidney transplant candidates at two transplant centers. participants will: * review an online education tool, donor plan donor choice. * discuss a kidney offer plan with a transplant provider. * answer questions about willingness to consider different donor types. researchers will compare the shared decision making group to usual care to generate pilot data and implementation outcomes for a larger trial.


Eligibility criteria:
inclusion criteria: * candidate on the kidney transplant waiting list * greater than 3 months since listing for transplant * 18 years of age or older * english-speaking exclusion criteria: * non-english speaking * \< 18 years of age * patients who choose to opt out of research. * unable to provide informed consent

Keywords: shared decision making sdm transplantation organ offer kidney offer kdpi