Kornimate/medical-research-clean huggingface dataset:
impact of keeping a personal recovery diary on upper extremity disability

Conditions: Acute Injury of Upper Extremity

Summary: primary null hypothesis: • keeping a personal diary has no effect on upper-extremity disability (assessed w/ promis \[patient reported outcome measurement information system\] upper extremity) 8 weeks after injury. secondary null hypotheses: * keeping a personal diary has no effect on avoidance of painful activities (assessed w/ promis pain interference) 8 weeks after injury. * keeping a personal diary has no effect on symptoms of depression (assessed w/ promis depression) 8 weeks after injury. * there are no factors associated with upper-extremity disability 8 weeks after injury.

recovery from injury can be counterintuitive and taxing. it is natural to feel protective and prepare for the worst. healthy exercises can seem unwise. it can seem like things are taking too long or getting off track. we have noticed that small improvements such as being able to resume a cherished activity (e.g. knitting or swimming) or achieving some success with exercises (e.g. obtaining full supination after fracture of the distal radius), can help patients feel like things are going to be okay. that feeling seems to make it easier to do exercises and resume function activities. we wonder if awareness of this process (mindfulness) would help patients recover more rapidly. keeping a journal is one method for encouraging mindfulness. it allows patients to express themselves and tell their stories. there is evidence that such "narrative medicine" can be healing. we anticipate that patients who perceive little or no progress will be able to look back on how they were feeling earlier on and appreciate that things are moving in the right direction. we also hope that their journal material might be useful for other patients that are having trouble seeing the "light at the end of the tunnel", so as part of this study, we will get permission to use their quotes anonymously in future patient care materials and future research. to our knowledge, research on the impact of keeping a personal diary/journal of recovery is scant, particularly pertaining to recovery from upper extremity trauma. explanatory variables: * diary or no diary * diagnosis (fracture, sprain, contusion, skin laceration, complex laceration \[tendon, nerve\]) * location (hand, wrist, forearm, elbow, arm, shoulder) * sex * age * education * work status * insurance (worker's compensation, private, public, other) * visit type * prior treatment received * other pain conditions * smoking status * marital status * physical or occupational therapy

Eligibility criteria:
inclusion criteria: * all new patients (\>18 years) with an acute injury of the upper extremity (fracture, laceration, sprain, contusion) * english fluency and literacy * able to take informed consent exclusion criteria: * pregnant women
the scanner in the coronary evaluation

Conditions: Valvular Disease; Coronary Stenosis

Summary: conventional coronary angiography is the recommended procedure in detection of coronary stenosis in patients with heart valve disease referred for surgery.the aim of this prospective study is to assess diagnostic accuracy of multislice spiral computed tomography coronary angiography in patients with heart valve disease referred for surgery.

the diagnostic accuracy of multislice spiral computed tomography coronary angiography in terms of sensitivity, specificity, negative and positive predictive value, the conventional coronary angiography being the gold standard.50 patients scheduled for valve surgery will be screened to conduct an additional multislice spiral computed tomography.

Eligibility criteria:
inclusion criteria: * patients scheduled for valve surgery who need a conventional coronary angiography * informed content * patients affiliated to the social security system exclusion criteria: * instable condition * arrhythmia including atrial fibrillation * impaired renal function * known contrast allergy * patients unable to hold an apnea during 20 seconds * pregnancy * emergency * people unable to sign the informed content such as major under supervision

Keywords: valvular surgery diagnostic accuracy of coronary angiography coronary stenosis coronary revascularisation
enhancement of brain circuit of inhibitory control in obese patients undergoing gastric banding

Conditions: Obesity

Summary: in this project the investigators aim to improve eating control and weight loss outcomes in patients undergoing lagb with an innovative brain-based intervention. specifically, the investigators will enhance the activity of the right inferior frontal gyrus, a core region of the brain circuit of inhibitory control, using transcranial direct current stimulation (tdcs).

laparoscopic adjustable gastric banding (lagb) is a minimally invasive and reversible procedure in bariatric surgery that has a good safety record. despite these advantages, success rates following lagb are quite variable across individuals. recent data suggest that complementing lagb with interventions targeting factors along the brain-behavior spectrum could enhance weight loss results following this procedure. the study will have the following three aims: aim #1: to evaluate whether enhancement of the right inferior frontal gyrus with tdcs in patients undergoing lagb can improve inhibitory control capacity. for this aim the investigators will evaluate participants' performance in a computerized test of inhibitory control. results from this aim will provide evidence for target engagement, and thus confirm that the brain circuit of interest was affected as a result of the intervention. aim #2: to examine whether enhancement of the right inferior frontal gyrus with tdcs in patients undergoing lagb can lead to improvements in a self-reported measure of eating control (disinhibition subscale of the three-factor eating questionnaire). results form this aim will provide evidence for an effect of the intervention on an intermediate, behavioral variable. aim #3: to preliminary evaluate whether enhancement of the right inferior frontal gyrus with tdcs in patients undergoing lagb can improve postoperative weight loss outcomes. this aim will provide preliminary evidence for the clinical efficacy of the intervention over a time window period of 12 months. weight loss at 12 months will be the primary outcome of the study.

Eligibility criteria:
inclusion criteria: * age: 20-55 years old * bmi: 35-60 kg/m2 * planning to undergo or having undergone laparoscopic adjustable gastric banding (lagb) within the previous week exclusion criteria: * unstable medical conditions including poorly controlled diabetes and hypertension * pregnancy or planning pregnancy during study period * personal or family history of epilepsy or other unexplained loss of consciousness * current or past medical history of skin disease or damaged skin on the scalp at site of stimulation * active psychiatric or neurological condition * prior neurological procedure * implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, tens unit, or ventriculoperitoneal shunt * intake of common medications that affect the central nervous system will be allowed if determined okay by md

Keywords: obesity gastric banding transcranial direct current stimulation
treatment of fibromyalgia with recovery factors

Conditions: Fibromyalgia; Chronic Fatigue Syndrome

Summary: treatment of fibromyalgia and cfs with recovery factors

use of a unique oral porcine peptide nutritional supplement in those meeting acr 2010(amended) diagnostic criteria for fibromyalgia or cdc criteria for cfs

Eligibility criteria:
inclusion criteria: * meet the acr 2010 amended fibromyalgia diagnostic criteria or cfs cdc criteria; score 5 or less on energy vas exclusion criteria: under 18 pregnant other severe complicating conditions -
surrogate markers for sudden cardiac death in patients with diabetes mellitus and end stage renal disease

Conditions: Diabetes Mellitus Type 2; End Stage Renal Disease

Summary: aim: patients with type 2 diabetes mellitus (t2dm) and hemodialysis due to diabetic nephropathy exhibit a high risk for sudden cardiac death (scd). preliminary data suggest that beta-blocker treatment may reduce arrhythmias and mortality in this high-risk population. however, no results from large-scale clinical outcome trials with beta-blockers exist in this patient group and a broad, scientifically unapproved use of beta-blocker treatment may not be justified due to potential harmful side-effects such as av-block or hypotension. in addition, we are lacking identified ecg surrogate parameters for scd in this high-risk population and on the occurrence of arrhythmias in temporary relationship to hemodialysis sessions. therefore, the present study will identify surrogate parameters of scd in hemodialysis patients with t2dm and in an interventional trial investigate the suppressive effect of beta-blockers on these identified ecg markers.


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus type 2 * chronic hemodialysis at least since 3 months * aged above 18 years * written informed consent * legally competent exclusion criteria: * intake of bets-blockker within the last four weeks * pregnancy and breast feeding * abuse of drugs and alcohol * missing compliance * life expectancy \< 6 month
a randomized clinical evaluation of the biofreedom™ stent

Conditions: Stable Angina; Ischemic Heart Disease Silent; ST Elevation (STEMI) and Non-ST Elevation (NSTEMI) Myocardial Infarction; In-stent Coronary Artery Restenosis; Bleeding

Summary: the purpose of this study is to demonstrate that a biofreedom™ drug coated stent is non-inferior to a bare metal stent at one year as measured by the composite safety endpoint of cardiovascular death, myocardial infarction and definite/probable stent thrombosis, and that its efficacy is superior to a bare metal stent as measured by clinically driven tlr at one year.


Eligibility criteria:
inclusion criteria: * any indication for pci-s in patients deemed at high risk for bleeding and candidates for 1 month dapt. this includes candidates with stable angina, silent ischemia, acs (stemi and non-stemi), non-native lesions and in-stent restenosis. patients must provide written informed consent. exclusion criteria: 1. pregnancy 2. patients expected not to comply with 1 month dapt 3. patients requiring a planned staged pci procedure more than one week after the index procedure 4. procedure planned to require non-study stents, or stand alone poba or stand-alone atherectomy 5. active bleeding at the time of inclusion 6. reference vessel diameter \ 4.0mm 7. cardiogenic shock 8. compliance with long-term single anti-platelet therapy unlikely 9. a known hypersensitivity or contraindication to aspirin, clopidogrel (or prasugrel, or ticagrelor if applicable), stainless steel, biolimus a9 or a sensitivity to contrast media, which cannot be adequately pre-medicated. 10. participation in another clinical trial (12 months after index procedure).

Keywords: des coronary stent bare metal stent high bleeding mi angina
effectiveness and safety of 0.5% moxifloxacin hydrochloride ophthalmic solution in perioperative sterilization in patients undergoing ophthalmic surgery

Conditions: Post Operative Endophthalmitis

Summary: this is a non-interventional, uncontrolled, prospective, multicenter, post marketing surveillance study.

the study treatment i.e., 0.5% moxifloxacin hydrochloride ophthalmic solution will be prescribed as per approved label; the assignment of the patient to the therapy will be decided within the current practice and the medical indication and will clearly be separated from the decision to include the patient in the study. the treatment period for each patient will be maximum 17 days from start of moxifloxacin treatment. study visit will be 1 day prior to surgery, day of surgery (day 0) and 1 (day of surgery / post surgery), 7, and 14 days post-op (note: since its non-interventional study, the eligibility confirmation can be 1 or 2 days prior to the surgery depending on investigator's discretion). after the patients sign the informed consent, the patients will be advised to start with moxifloxacin ophthalmic solutions 2 days prior to the surgery and will be advised to administer it 5 times a day. on the day 0, day of the surgery, the patient will be instilled 1 drop of moxifloxacin in the eye which will be operated prior to surgery and 1 drop twice post surgery. from day 1 post surgery, patient will have 1 drop of moxifloxacin instilled three times a day up to day 14 (14 days after surgery). if there are any signs and symptoms of endophthalmitis, then at the investigator's discretion, gram stain \& culture assessment of aqueous \& vitreous fluid may be performed post surgery on days 1, 7, and 14.

Eligibility criteria:
inclusion criteria: * male or female patients \> 18 years of age, who have been prescribed 0.5% moxifloxacin drops preoperatively and postoperatively for 2 weeks after ocular surgery * patient or legally acceptable representative (lar) willing to voluntarily provide signed informed consent for participation in the study exclusion criteria: * patients with known history of hypersensitivity to fluoroquinolones * patients with history of serious underlying ocular or systemic disease or complication before surgery * patients diagnosed with an extraocular bacterial, viral, fungal infection prior to surgery * patients who have been administered other topical antibacterial agents within 24 hours of moxifloxacin administration or systemic antibacterial agents within 72 hours of moxifloxacin administration * patients who have planned to undergo cataract surgery in both eyes on same day * patients who have participated in another clinical study within 30 days prior to the start of this study * pregnant women/lactating mothers/ women suspected to be pregnant

Keywords: moxifloxacin hydrochloride ophthalmic solution ophthalmic surgery antibacterial effectiveness nis india preoperative postoperative endophthalmitis perioperative sterilization efficacy safety
use of cross-linked donor corneas as carriers for the boston keratoprosthesis

Conditions: Chemical Injuries; Unspecified Complication of Corneal Transplant; Autoimmune Diseases; Ocular Cicatricial Pemphigoid; Stevens Johnson Syndrome; Lupus Erythematosus, Systemic; Rheumatoid Arthritis; Other Autoimmune Diseases

Summary: the purpose of the pilot study is to test the efficacy and safety of riboflavin/ultraviolet a (uva) cross-linked human donor corneas as carriers for the boston keratoprosthesis (boston kpro) in patients with higher risk for corneal melting (keratolysis).

the corneal cross-linking technique has been shown to strengthen the cornea and resist degradation by the body's own enzymes. the use of highly-resistant donor corneas is meant to eliminate the serious post-operative complication of corneal melting (keratolysis) that repeatedly occurs in boston kpro patients with severe ocular burns, autoimmune and cicatrizing diseases.

Eligibility criteria:
inclusion criteria: 1. ability to provide written informed consent and comply with study assessments for the full duration of the study. 2. age \> 18 years. 3. a negative urine pregnancy test. 4. candidate for a boston keratoprosthesis/corneal transplant. 5. generally good stable overall health. 6. patients with an eye at risk for a cornea sterile ulcer which includes: * chemical injuries. * autoimmune diseases (ocular cicatricial pemphigoid, stevens johnson syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases). * history of previous sterile corneal ulceration requiring a cornea transplant. exclusion criteria: 1. age \< 18 years. 2. inability to provide written informed consent and comply with study assessments for the full duration of the study. 3. pregnant or lactating women. 4. no or minimal tear production. 5. ocular or periocular malignancy. 6. inability to wear a contact lens due to lid abnormalities or shortened fornix. 7. signs of current infection, including fever and current treatment with antibiotics. 8. participation in another simultaneous medical investigation or trial

Keywords: keratoprosthesis sterile cornea ulcer
intensive versus traditional voice therapy

Conditions: Dysphonia

Summary: the purpose of this study is to determine if there are differences in treatment outcomes between traditional voice therapy, performed weekly for a maximum of 6 weeks versus intensive voice therapy, consisting of 4-6 therapy sessions performed within one day.

the goal of voice therapy is optimal long-term vocal quality and communication function with minimal recurrence. traditional voice therapy for dysphonia typically consists of one to two therapy sessions each week with a single clinician for about 8 weeks. another approach of voice therapy is intensive short-term therapy also known as "boot camp." this approach, borrows from the disciplines of neurobiology, exercise physiology, motor learning, and psychotherapy which describe desirable learning and behavior changes influenced by practice that involves high-intensity overload, variability, and specificity of training. a few studies have showed that "boot camp" model of intensive therapy resulted in comparable gains in voice quality and vibratory mechanics and may promote better patient satisfaction and attendance. while such findings support the notion that intensive voice therapy may enhance voice therapy outcomes, no study to date has examined patient response to the "boot camp" approach to voice therapy. the investigators will compare the outcomes of traditional, weekly voice therapy and intensive voice therapy with multiple sessions in one day.

Eligibility criteria:
inclusion criteria: * diagnosed with a voice disorder * diagnosed with benign vocal fold lesions and/or hyper-function * first/primary propose treatment modality is voice therapy * patients who are appropriate for either standard of care treatment modality (traditional or intensive voice therapy) * willingness to participate in either standard of care treatment modality * all races * males and females * english speaking exclusion criteria: * younger than 18 * inability or unwillingness to participate in one of the standard of care treatment modalities * laryngeal surgery or procedures during course of study * prisoners

Keywords: voice disorder hoarseness phonation disorders speech disorders
extension study of the efficacy and safety of oral scio-469 in relapsed, refractory patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: the main objective of this study is to assess the long-term effectiveness of scio-469 as monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple myeloma (mm) who have previously demonstrated clinical benefit in the scios b003 study.

the main objective of this study is to assess the long-term efficacy of scio-469 as monotherapy, or in combination with bortezomib in relapsed, refractory patients with multiple myeloma (mm) who have previously demonstrated clinical benefit in the scios b003 study. patients took by mouth two capsules (60 mg) three times a day alone or in combination with bortezomib, for 168 days.

Eligibility criteria:
inclusion criteria: * patients who did not have disease progression on day 73 of study b003 * patients fully understand all elements of, and have signed and dated, the written informed consent form (icf) before initiation of protocol-specified procedures exclusion criteria: * patients who have an active uncontrolled infection * any condition, including laboratory abnormalities, that in the opinion of the investigator places the patient at unacceptable risk to participate in the study * pregnant or lactating women, or who are not using adequate contraception * sexually active women of childbearing potential (wcbp) who do not agree to use at least two forms of medically accepted birth control, including one barrier method, for the duration of the study * men who do not agree to use an acceptable method for contraception throughout the study

Keywords: multiple myeloma scio-469 bortezomib p38 map kinase
quality of life in daxas-treated patients older than 18 years with severe copd

Conditions: Severe COPD

Summary: daxas (roflumilast) is the first oral anti-inflammatory phosphodiesterase inhibitor (pde-4) for patients with severe chronic obstructive pulmonary disease (copd) experiencing chronic cough and sputum and with a history of exacerbations as add-on to bronchodilator treatment. with its mode of action daxas can reduce exacerbations rates and improve lung function parameters which may result in a better health-related quality of life and an improved long-term management of copd. the aim of this non-interventional study is to evaluate data on quality of life in copd patients in germany in a real life medical setting. evaluation is based on two copd specific questionnaires to assess the patient's health status over six months. during the study, socio-demographic data and cost-of-illness data will be recorded. daxas (tablet) will be administered once daily. the study will provide further data on the safety and tolerability of daxas.


Eligibility criteria:
main inclusion criteria: * severe copd main exclusion criteria: * child pugh (classified b and c)

Keywords: copd quality of life sociodemographic data cost-of-illness data roflumilast daxas
tocilizumab for sars-cov2 (covid-19) severe pneumonitis

Conditions: SARS Pneumonia

Summary: in a phase 2 simon's optimal two-stages design intravenous tocilizumab will be administered as single 8mg/kg dose in patients affected by severe multifocal interstitial pneumonia correlated to sars-cov2 infection. aim of the study is to test the hypothesis that an anti-il6 treatment can be effective in calming the virus-induced cytokine storm, blocking deterioration of lung function or even promoting a rapid improvement of clinical conditions, preventing naso-tracheal intubation and/or death.


Eligibility criteria:
inclusion criteria: * sars-cov2 infection diagnosed by rt-pcr * ct-scan confirmed multifocal interstitial pneumonia * need of oxygen therapy to maintain so2\>93% * worsening of lung involvement, defined as (one of the following criteria): * worsening of oxygen saturation \>3 percentage points or decrease in pao2 \>10%, with stable fio2 in the last 24h * need of increase fio2 in order to maintain a stable so2 or new onset need of mechanical ventilation in the last 24h * increase in number and/or extension of pulmonary areas of consolidation exclusion criteria: * age \ 90 ys * severe heart failure * bacterial infection * haematological neoplasm * neutrophil count below 1000/mcl * platelet count below 50000/mcl * alt\> x5unl * inability to give informed consent

Keywords: tocilizumab
turkish montreal children's hospital feeding scale

Conditions: Feeding Disorders

Summary: the purpose of this study is to test the reliability and validity of the turkish montreal children's hospital feeding scale.

the purpose of this study is to test the reliability and validity of the turkish montreal children's hospital feeding scale. the internal consistency, test-retest reliability, and criterion validity of turkish montreal children's hospital feeding scale will be investigated. the internal consistency will be assessed using cronbach's alpha. intraclass correlation coefficient (icc) value with 95 % confidence intervals will be calculated for test-retest reliability. the criterion validity of the scale will be determined by assessing the correlation between the turkish montreal children's hospital feeding scale and behavioral pediatrics feeding assessment scale.

Eligibility criteria:
inclusion criteria: * children with cerebral palsy * children with typical development * aged between 18 months- 6 years exclusion criteria: * who aged under the age of 18 months and above the age of 6 years.