Kornimate/medical-research-clean huggingface dataset:
effects of gaseous cryotherapy on knee rom after tka: a feasibility study

Conditions: Osteoarthritis, Knee

Summary: a pilot study was performed to investigate the feasibility of a large randomized controlled trial (rct) to assess the effects of hyperbaric gaseous cryotherapy (hgc) on the change in knee flexion range of motion in the first two days after total knee arthroplasty.

background: after total knee arthroplasty (tka), patients can be discharged from hospital as early as two days after surgery. however, patients often do not achieve functional knee flexion range of motion (rom) in the first postoperative days. early application of hyperbaric gaseous cryotherapy (hgc) at the operated knee within an hour after surgery and the next postoperative days might increase rom by reducing inflammation, edema and pain. however, it is unclear whether such early application of hgc is feasible. moreover, there is no data to allow calculation of the sample size required to conduct a randomized controlled trial to compare the effects of hgc to those of conventional cryotherapy on the increase of knee flexion in the first two days after tka. objectives: to investigate the feasibility of applying hgc within an hour after tka and twice a day the next postoperative days. to collect data on changes in knee flexion rom in the first two postoperative days to calculate the sample size required for a large randomized controlled trial. to compare the effects of hgc to those of conventional cryotherapy on changes in knee flexion rom in the first two postoperative days. design: a prospective, single-blinded, randomized, controlled pilot trial. setting: orthopedic postoperative unit in an acute care hospital. interventions: patients were randomly allocated to either hyperbaric gaseous cryotherapy (intervention group) or the ice bag cryotherapy (control group). in each group, participants received the specific cryotherapy intervention at the operated knee within an hour after the surgery (day 0) and twice the next two postoperative days (day 1 and day 2). outcome measures: feasibility measures included the rate of eligible patients who were willing to participate, attrition, adherence to interventions and presence of adverse effects. active and passive knee flexion range of motion (rom) and knee pain intensity at rest were evaluated on postoperative days 1 and 2. change in active and passive knee flexion rom and in knee pain intensity at rest from postoperative day 1 to day 2 were assessed. length of hospital stay was collected.

Eligibility criteria:
inclusion criteria: * planned unilateral tka done at verdun hospital. * capacity to communicate in french or english. exclusion criteria: * complications during or after the surgery. * inability to perform the tests due to other diseases. * contraindications to cryotherapy such as raynaud's disease, cryoglobulinemia, hemoglobinopathy, polyneuropathy associated with temperature sensitivity deficits or allergy to cold.

Keywords: total knee replacement cold neurocryostimulation co2 cryotherapy mobility
alexander technique neck pain

Conditions: Chronic Non-specific Neck Pain

Summary: this study aimed to test the efficacy of five alexander technique lessons compared to the same period of heat pad application and guided imagery in patients with chronic non-specific neck pain.

see above

Eligibility criteria:
inclusion criteria: * chronic non-specific neck pain * at least 3 months * 40mm pain intensity on visual analog scale exclusion criteria: * neck pain as consequence of disc protrusion or prolapse, whiplash, congenital deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease, neurological disorder, * active oncologic disease * affective disorder * addiction * psychosis. * pregnancy * invasive treatment of the spine within the previous three weeks * spinal surgery * previous experiences in alexander technique * ongoing application for disability pension * simultaneous participation in other clinical trials on neck pain
impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis

Conditions: Cirrhosis; Kidney Injury; Sarcopenia; Frailty

Summary: the aim of this prospective observational study is to evaluate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis.

the aim of this prospective study is to collect data on patients with liver cirrhosis and to investigate the impact of acute kidney injury on sarcopenia and frailty in patients with liver cirrhosis. if patients agree to participate in this clinical trial, the patients' data (such as age, sex, height, weight, nutrition status \[rfh-npt\], history of medication, laboratory findings, endoscopic findings, and radiologic findings) will be collected in a research database. renal injury was measured using conventional and novel serum biomarkers (serum creatinine, cystatin-c, neutrophil gelatinase-associated lipocalin, kidney injury molecule 1, and interleukin-18. sarcopenia was evaluated using skeletal muscle index on abdominal computed tomography. frailty was measured using liver frailty index. the research database will be updated to include data on patients' disease outcomes and follow-up care.

Eligibility criteria:
inclusion criteria: * liver cirrhosis * aged over 20 years exclusion criteria: * serum creatinine \>1.5 mg/dl * on dialysis * liver transplant
thrombectomy in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: the purpose of the study is to determine whether thrombus removal with aspiration thrombectomy for acute myocardial infarction reduces the infarct size.

acute myocardial infarction is caused by an abrupt occlusion of coronary vessel or severe reduction of coronary flow. it has been shown that the reperfusion therapy significantly improves the clinical outcome. currently the optimal strategy is the primary angioplasty with stent implantation. the treatment is recommended by aha/acc and esc if can be performed within 90 minutes from the first medical contact. however there is still a certain percentage of procedure failure. to further improve the outcome new techniques and devices are tested . aspiration thrombectomy may facilitate the reperfusion by reducing thrombus burden. the aim of the study is to assess if adjunctive thrombectomy may improve clinical outcome in patients with an acute st segment elevation myocardial infarction.

Eligibility criteria:
inclusion criteria: 1. first acute myocardial infarction with st segment elevation within 12 hours from pain onset 2. culprit lesion in left anterior descending or right coronary artery. 3. coronary flow assessed in timi scale ≤ 2 4. presence of total coronary occlusion or angiographically visible thrombus in the culprit vessel 5. patient signed informed consent exclusion criteria: 1. cardiogenic shock. 2. culprit lesion in left circumflex coronary artery. 3. status post coronary artery by-pass grafting 4. previous myocardial infarction 5. status post percutaneous coronary intervention.

Keywords: myocardial infarction, thrombectomy, salvage index
real-time pressure volume loop monitoring as a guide for enhanced understanding of changes in elemental cardiovascular physiology during therapeutic strategies aiming for hemodynamic optimization. cohort i: veno-arterial extracorporeal membrane oxygenation (pluto-i)

Conditions: Extracorporeal Membrane Oxygenation; Cardio/Pulm: Heart Failure

Summary: invasive pressure-volume (pv) loop measurements have the potential to confirm or refute earlier computer simulations and animal studies regarding changes in cardiovascular physiology induced by (veno-arterial) ecmo. pv loop analysis could create a framework for the (icu-) clinician for va-ecmo weaning guidance, based on a patient's individual hemodynamic profile. pv loop measurements may, in future, serve as a guide for which patient would benefit most from (prolonged) va-ecmo support or which patient would require additional lv unloading. within the context of pluto-i, patients on va-ecmo support who are eligible for weaning from va-ecmo will undergo biventricular pv loop measurements on different intensities of extracorporeal support.

using va-ecmo support, physiological stability can be maintained in patients with refractory hemodynamic failure as bridge to recovery, definitive therapy or decision making. previous animal studies and computer simulations hypothesize increased lv afterload as well as rv distention during va-ecmo. decision making concerning va-ecmo weaning is largely based on bedside hemodynamic (including echocardiographic) parameters. profound details of the effects of va-ecmo on elemental cardiac physiology, including myocardial metabolic efficiency and ventricular-arterial coupling, are limited. we hypothesize biventricular pressure-volume loop (pvl) measurement will enhance understanding of elemental cardiovascular physiology including ventricular interdependence during different levels of va-ecmo support. pvl measurement will hypothetically provide opportunities in discovering novel predictors for successful weaning from va-ecmo support. for the purpose of pluto-i, patients on va-ecmo who are eligible to wean will undergo invasive pv-loop measurements on different intensities of extracorporeal flow.

Eligibility criteria:
inclusion criteria: - on va-ecmo support for any indication exclusion criteria: * age \< 18 years * re-initiation of va-ecmo during the same icu admission

Keywords: pressure-volume loop cardiac mechanoenergetics
anticoagulation on demand after percutaneous coronary intervention in high bleeding risk patients

Conditions: Ischemic Heart Disease; Atrial Fibrillation

Summary: preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists. the investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (hbr) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.

for decades now, stroke prevention in patients with atrial fibrillation has largely consisted of chronic oral anticoagulation, often with no end in sight. this strategy, however, is associate with a high incidence of bleeding complications, especially when anticoagulation is associated with antiplatelet agents, as it occurs in patients with coronary artery disease undergoing percutaneous coronary intervention. known as intermittent, on demand, or 'pill in the pocket' anticoagulation, the strategy of prescribing oral anticoagulation only when is actually needed, has gotten a feasibility boost from recent advancements in both medical therapy and rhythm monitoring technology. preliminary experiences suggest that intermittent anticoagulation guided by continuous electrocardiographic monitoring can reduce the incidence of bleeding in patients with episodes of atrial fibrillation. uncertainty about the potential implications of a strategy of intermittent anticoagulation after percutaneous coronary intervention exists. the investigators will perform a case-control study to evaluate the safety and efficacy of anticoagulation on demand in high bleeding risk (hbr) patients with paroxysmal atrial fibrillation after percutaneous coronary intervention.

Eligibility criteria:
inclusion criteria: * no chronic atrial fibrillation * coronary artery disease * percutaneous coronary intervention exclusion criteria: * contraindications to anticoagulation * pregnancy

Keywords: coronary artery disease
pregnancy outcomes in congenital myasthenie syndrome

Conditions: Congenital Myasthenic Syndrome

Summary: this is a retrospective study that follows the clinical evolution, the pregnancy and the post-partum perioad of female patients with congenital myasthenic syndrome.

the aim of this study is to better understand the action of hormonal factors that are presumably incriminated for the fluctuation of the disease. the investigators would also like to better adress the issues of women with congenital myasthenic syndrome, who desire a pregnancy : the possibility of decompensation, the problems that can arise during the course of the childbearing, the risk of foetal malformations.

Eligibility criteria:
inclusion criteria: * adult women * congenital myastenic syndrome genetically confirmed or with clinical compatible and electrophysiological evidence * written consent exclusion criteria: * neurological or general pathology occurs significantly with the initiation and conduct of a pregnancy.

Keywords: congenital myasthenic syndrome pregnancy outcome
manual therapy and exercise with mixed reality with hololens® exercise protocol in chronic neck pain patiens.

Conditions: Neck Pain; Chronic Pain

Summary: currently, cervical pain is the second most frequent musculoskeletal disorder, which generates an important impact on the function and quality of life. it is estimated that its anual prevalence for the general population can reach 50%. non-specific cervical pain attends without signs or symptoms of structural or neurological pathology, its etiology is unknown. however, it is related with joint and muscular structures. it has been observed a decrease in the strength and endurace of the deep cervical flexor muscles in 70% of patients with cervical pain; as well as motor control déficit and coordination alterations in the sinergy between the activity of the superficial and deep musculature. also, phycosocial factors, as for example: behaviors of fear-avoidance, catastrophism, hypervigilancy, psychosocial stress and negative adaptative neuroplastic changes, may have an importante role in chronic musculoskeletal pain. in the last years, rv has been used in clinical rehabilitation, being a reliable and valid tool, which allows the patient distration to virtual world and they have offered results like: decreased pain and fear of movement and also improvements in motor performance and neuroplasticity processes. the aim of this single-blinded randomized novel pilot study is to observe the effects generated in motor variables, when a protocol of manual therapy combined with augmented reality as a method of exercise in subjects with non-specific cervical pain is applied; in comparaison with a protocol of manual therapy combined with conventional cervical exercises. different variables will be measured at the beginning and at the end of intervention. also, they will be measured one month after the intervention to observe the changes produced in short term. these variables are: pain, function, satisfaction, propioception, endurance, as well as phychological and somatosensory variables.


Eligibility criteria:
inclusion criteria: * - men and women. * age: 18-65 years old. * persistent neck pain for at least 3 month or intermittent neck pain for 6 month or more. * 5 points or 10% at the neck disability index questionnaire. exclusion criteria: * cervical whiplash (10 years before) * cervical fractures. * vestibular pathology. * epilepsy or other neurological condition. * systemic diseases. * cardiovascular or respiratory disorders that affect physical performance. * lasik eye surgery. * fibromyalgia * pregnancy

Keywords: virtual reality therapeuthic exercise quantitative sensory testing
measuring endoscopic activity in patients treated with vedolizumab for ulcerative colitis

Conditions: Ulcerative Colitis

Summary: describe the proportion of patients with ulcerative colitis (uc) treated with vedolizumab (vdz) who achieve mucosal healing at week 54 of treatment.


Eligibility criteria:
inclusion criteria: * age over 18 years, * established diagnosis of ulcerative colitis for at least 3 months * moderate to severe active ulcerative colitis with a mayo endoscopic sub-score ≥ 1 before vedolizumab introduction * patients receiving vedolizumab according to french drug labelling (previous exposure to anti-tnf, contraindicated or intolerant to anti-tnf), * possibility of concomitant therapy including corticosteroids and immunosuppressors, * patients naive to anti-integrin, * no contraindication to proctosigmoidoscopy exclusion criteria: * age under 18 years * ulcerative colitis not proven, crohn's disease, or inderterminate colitis * personal history of high-grade dysplasia or colorectal cancer * surgery with ileo-anal anastomosis * patients' refusal to participate in the study

Keywords: ulcerative colitis, endoscopic activity, mucosal healing, vedolizumab
chronic care management/patient relationship management proof of concept

Conditions: Diabetes Mellitus

Summary: this proof of concept study proposes to evaluate the feasibility of a communications-technology-based chronic care and patient relationship management program to improve diabetes self management among adult diabetic patients in an urban safety net population by providing between-visit reminders and chronic disease support through cell phone text messaging. the investigators hypothesize that diabetic patients enrolled in the program will be less likely to miss scheduled appointments and will have greater perceived self-efficacy and improved patient satisfaction concerning chronic disease management. no-show rates among patients enrolled in the program are expected to be lower than among patients receiving standard care.


Eligibility criteria:
inclusion criteria: * patients with diabetes * receive care at a primary care clinic in the dh system * between 18 and 76 years of age * primary language of english or spanish * ownership of a qualifying cell phone (sms text capable) * ownership of a glucometer. exclusion criteria: * life expectancy less than six months, * do not have or cannot use a phone or glucometer * do not want to participate
hip external rotation physical therapy trial

Conditions: Urinary Incontinence, Stress

Summary: this rct is a feasibility study to evaluate the lois hole hospital for women's urogynecology clinic's ability to recruit and randomize sui patients to the proposed rct, and to test the study procedures and follow-up schedule for participants. the study interventions used in the feasibility study will be training of (1) hip extension rotation (her) exercises alone, (2) her exercises in combination with pelvic floor muscle (pfm) exercises, or (3) pfm exercises alone (control/usual care) in the treatment of sui.

background: hip external rotation (her) exercises are being adopted into physiotherapy practice for the treatment of stress urinary incontinence (sui) despite little evidence compared to the proven effective standard of care treatment, pelvic floor muscle (pfm) exercises. a randomised clinical trial (rct) is needed to determine whether her exercise alone or in combination with pfm is more or less effective than pfm exercises alone. objective: before designing an rct, a feasibility study is needed to evaluate the lois hole hospital for women's urogynecology clinic's ability to recruit and randomize sui patients to the proposed rct, and to test the study procedures and follow-up schedule for participants. interventions: the interventions used in the feasibility study will be training of (1) her exercises alone, (2) her exercises in combination with pfm exercises, or (3) pfm exercises alone (control/usual care) in the treatment of sui. study design: rct in which participants are randomly allocated 1:1:1 to each intervention. outcome measures: feasibility outcomes will pertain to recruitment, adherence to training, appropriateness of outcome measures and completion rates. the design of the proposed rct will be based on these feasibility outcomes. outcome measures for the proposed rct will include pelvic floor muscle strength, external hip rotator muscle strength, diary-reported urinary incontinence, incontinence related quality of life, and (to test patient mobility) six minute walk test and timed up and go test. sample size: the proposed sample size is 30 participants. duration of study: after recruitment, each woman will undergo 12 weeks of training, with the first outcome measure at the end of that period, and a further follow up at 24 weeks from recruitment.

Eligibility criteria:
inclusion criteria: * stress urinary incontinence * attending lois hole hospital for women urogynecology clinic * referred for physiotherapy for stress urinary incontinence * able to toilet independently * able to undertake hip rotation exercises * able to speak and read english exclusion criteria: * urge urinary incontinence * using a pessary * neurological or cognitive impairment * using other treatment for incontinence * unable to complete study forms * unable to understand educational instruction
clinical trial to determine the efficacy and safety of insulin eye drops in dry eye in patients with topical hypotensors

Conditions: Dry Eye; Glaucoma

Summary: the goal of this clinical trial is to evaluate the preliminary efficacy of the use of insulin eye drops in the control of dry eye disease in patients with topical hypotensors, compared to placebo (artificial tears). the main question aims to answer whether glaucoma patients treated with topical hypotensors could benefit from the use of insulin eye drops for the treatment of dry eye. participants will be assigned to one of the two treatment arms and will be required to attend four follow-up visits (baseline, 1, 3, and 6 months).

patients will be recruited in madrid. patients with dry eye disease and topical glaucoma treatment will be identified through the ophthalmology clinic. they will be directly referred to a physician who is participating in this study.

Eligibility criteria:
inclusion criteria: * patients who provide written informed consent and who are able and willing to comply with all scheduled study visits and procedures. * patients ≥ 18 years at the screening visit. * ocular hypertension or glaucoma controlled with hypotensive treatment * diagnosis of dry eye exclusion criteria: * uncontrolled glaucoma with expected changes in antihypertensive treatment in the next 6 months * changes in topical glaucoma treatment in the last 3 months * severe dry eye requiring immediate treatment * previous eye surgery, except cataract surgery more than 12 months ago * laser procedures less than 6 months ago * other concomitant ocular pathology: scarring disease of the ocular surface, uveitis, infection in the last 90 days, trauma in the last 90 days * eyelid disorders * use of contact lenses * other topical treatment other than dry eye and glaucoma * patients with a history of allergy or hypersensitivity to the study medication or any of its excipients * modifications in systemic immunosuppressive treatment in the last 6 months * history of alcohol or drug abuse * patients who have received an experimental drug or used an experimental medical device in the 30-day period prior to the screening visit. * systemic pathology (cardiopulmonary pathology, connective tissue disorders, neurological or psychiatric pathology) or situation of the patient that does not allow examination (such as mental or psychomotor retardation). * any other disease or condition that, at the discretion of the investigator, could constitute a risk to the participant or interfere with the results of the study.