Kornimate/medical-research-clean huggingface dataset:
effect of crow 3d printed sole on charcot foot ulcer

Conditions: Charcot Joint of Foot

Summary: the purpose of the study is to evaluate the therapeutic effect of the charcot restraint orthotic walker three-dimensional printed sole on charcot foot ulcer healing.

foot ulcerations, charcot neuroarthropathy, and peripheral arterial disease frequently result in gangrene and lower limb amputation. consequently, foot disorders are leading causes of hospitalization for persons with peripheral neuropathy. although not all foot complications can be prevented, dramatic reductions in frequency have been achieved by taking a multidisciplinary approach to patient management, the reduction of pressure to the charcot foot ulcer is essential to treatment. proper off-loading and pressure reduction prevents further trauma and promotes healing. this is particularly important in the peripheral neuropathy patient with decreased or absent sensation in the lower extremities. furthermore, recent studies provide evidence that minor trauma (eg, repetitive stress, shoe pressure) plays a major role in the causal pathway to ulceration. * off-loading approaches that deal with charcot neuroarthropathy will decrease the significant psychological, social and functional impact on individuals. * the need of this study is developed from the lack of controlled studies that reported the therapeutic effect of charcot restraint orthotic walker 3d printed sole on charcot foot ulcer. * so the present study is designed to evaluate the charcot restraint orthotic walker 3d printed sole on charcot foot ulcer. furthermore, the current study may help physical therapist, physicians, and clinicians to organize a protocol of treatment that would be safe, simple and economic for treating patients with charcot neuroarthropathy.

Eligibility criteria:
inclusion criteria: * the subject selection will be according to the following criteria: • the patient's ages will range from 45 to 65 years. * both sexes will be included in the study. * informed consent for participation in this study will be obtained in writing from all patients. exclusion criteria: * the potential participants will be excluded if they meet one of the following criteria: * preceding surgical procedure on affected foot. * patients on hemodialysis. * patients who had any pathological conditions which may affect the results of the study as active malignancy, osteomyelitis and pes planus.
menstrual migraine treatment with treximet (formerly known as trexima)

Conditions: Migraine; Migraine Disorders

Summary: this study was designed to determine efficacy of treximet (sumatriptan/naproxen sodium), formerly known as trexima compared to placebo for the treatment of a menstrual migraine.

a randomized, double-blind, single migraine attack, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and tolerability of trexima\* (sumatriptan succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of menstrual migraine in women with dysmenorrhea (\*treximet)

Eligibility criteria:
inclusion criteria: * at least a 6 month history of physician diagnosed migraine and typically experiences 2-6 migraine attacks per month * typically experiences moderate to severe migraine pain preceded by a mild pain phase * differentiate between mild migraine pain and other headache types * women of childbearing potential must be on adequate contraception exclusion criteria: * pregnant and/or nursing mother * history of cardiovascular disease * uncontrolled hypertension * basilar or hemiplegic migraine * history of stroke or transient ischemic attacks (tia) * history of epilepsy or treated with anti-epileptics within past 5 years * impaired hepatic or renal function * history of gastrointestinal bleeding or ulceration * allergy or hypersensitivity to aspirin or any other nsaid * allergy or hypersensitivity to triptans * participated in an investigational drug trial in the previous 4 weeks

Keywords: menstrual migraine headache early intervention dysmenorrhea
portuguese observational survey to assess drug adherence in patients with multiple sclerosis after conversion to betaferon by using elements of the betaplus program - nurse support, auto-injectors

Conditions: Relapsing Remitting Multiple Sclerosis (RRMS); Secondary Progressive Multiple Sclerosis (SPMS)

Summary: this is an observational survey to assess the factors that influence adherence to betaferon therapy in multiple sclerosis patients using elements of the betaplus support program, including the nurse support and auto-injectors. the patients were evaluated under normal clinical practice and were asked to fill out the quality of life fams questionnaire, coping processes (wcq) and depression questionnaire ces-d.


Eligibility criteria:
inclusion criteria: * relapsing-remitting ms (rrms) or secondary-progressive ms (spms) * previous treatment with disease modifying drugs * adjustment of disease modifying treatment necessary at the discretion of the investigator * switch to betaferon at least 1 month but not longer than 3 months prior to inclusion exclusion criteria: * patients not fulfilling the indications in the local prescribing information * refusal to sign inform consent

Keywords: multiple sclerosis adherence interferon beta-1b coping styles
tiara™ transcatheter mitral valve replacement study

Conditions: Mitral Valve Regurgitation

Summary: to evaluate the safety and performance of the neovasc tiara mitral transcatheter heart valve with the tiara transapical delivery system.

the tiara-ii study is an international, multicenter, single-arm, prospective, safety and performance clinical study.

Eligibility criteria:
inclusion criteria: * severe mitral regurgitation * high surgical risk for open mitral valve surgery * subject meets anatomical eligibility criteria exclusion criteria: * deemed too frail by objective frailty assessments * previous cardiac procedures: any mitral valve replacement surgery and cardiac transplant * unsuitable cardiac structure * clinically significant untreated coronary artery disease (cad) * subjects on chronic dialysis * pregnant or planning pregnancy within next 12 months * documented bleeding or coagulation disorders * active infections requiring antibiotic therapy * subjects with a life expectancy less than 12 months

Keywords: mitral regurgitation heart valve transcatheter transapical functional degenerative tmvr
pilates based exercises in patients with behçet and familial mediterranean fever.

Conditions: Behcet Disease; FMF

Summary: behcet's disease (bd) is a chronic systemic inflammatory disease which is characterized by oral and genital ulcers, uveitis and skin lesions. musculoskeletal involvement such as arthritis, arthralgia, enthesitis and sacroiliitis can be seen in the course of bd. familial mediterranean fever (fmf) is the most frequent autoinflammatory disease (aid) and characterized by selflimited episodes of fever and polyserositis. it is the most common monogenic periodic fever syndrome that affects mainly the people of mediterranean descent. regular physical activity involving aerobic and strengthening programs in inflammatory rheumatic diseases has a long-term anti-inflammatory effect. eccentric exercises cause an acute increase in tnf alpha level and should be avoided especially at the beginning. it has been stated that patients should be encouraged about aerobic exercise programs where the intensity is gradually increased, starting with low intensity. pilates method is the mind and body centering technique developed by joseph hubertus pilates, based on providing lumbopelvic stability. fmf and bh have common characteristics such as ethnicity, etiopathogenetic mechanisms, symptoms, and treatment. when we look at the literature, there is no study on the effectiveness of exercise applications in fmf and behçet patients. the purpose of our study; it is the comparison of the effectiveness of physical activity in patients diagnosed with behçet and fmf and healthy individuals. in this context, with the short form of the international physical activity evaluation questionnaire, behçet's patients whose physical activity level is inactive will be group 1, fmf patients group 2 and healthy controls with similar demographic characteristics will be group 3. pilates based exercise program will be applied to all 3 groups for 8 weeks, 2 times a week.


Eligibility criteria:
inclusion criteria: * being inactive or minimally active according to the international physical activity survey * being between the ages of 18-65 * being diagnosed with fmf at least 1 year ago according to diagnostic criteria * a diagnosis of bh at least 1 year ago according to the international behçet working group * having a cooperative level that can adapt to the evaluation and exercise program exclusion criteria: * those with any central nervous system involvement that may interfere with exercise * those who do not want to participate in the study * pregnant women * having other chronic diseases * psychiatric disorders and treated * those with cognitive impairment
rescue plasma exchange in severe covid-19

Conditions: Therapeutic Plasma Exchange; Covid19

Summary: the spectrum of coronavirus disease 2019 (covid-19) ranges from asymptomatic infection to acute respiratory distress syndrome ("ards") and patient death. severely affected patients may develop a cytokine storm-like clinical syndrome with high mortality. laboratory tests in these patients show an excessive and uncontrolled immune response with consecutive multi-organ failure. in addition, there is evidence for the development of prothrombotic autoantibodies as an epiphenomenon of "severe acute respiratory syndrome coronavirus 2" (sars-cov-2) infection. therapeutic plasma exchange ("tpe") is being discussed as a therapeutic alternative in patients with severe, refractory covid-19. the idea is that plasma exchange eliminates both endogenous and exogenous inducers of an exuberant inflammatory response as well as prothrombotic factors, thus breaking the secondary vicious circle of sars-cov-2 infection. in general, tpe is a safe procedure with known efficacy in other severe viral diseases as well as in cytokine storm-like diseases and ards of other geneses. moreover, initial data, mostly derived from case studies, demonstrate promising therapeutic efficacy of tpe in severe covid-19 courses with previously lacking treatment options. to further evaluate the therapeutic efficacy of tpe in severe covid-19, a prospective randomized controlled trial of tpe in severe sars-cov-2 infection is being conducted at our center. patients will be randomized to a control group (standard therapy according to center standards) and a therapy/intervention group (standard therapy + tpe).


Eligibility criteria:
inclusion criteria: * written informed consent by the study participant or their legally appointed representative. * age ≥ 18 years * evidence of acute sars-cov-2 infection, confirmed by pcr testing * invasive ventilation * fever ≥ 38.5°c, confirmed by a total of 3 consecutive measurements or ongoing renal replacement therapy and temperature ≥ 37.5°c * d-dimers ≥ 2mg/l * dexamethasone ≥ 6mg/day or equivalent dose on at least 2 days exclusion criteria: * age \> 85 years * pre-existing treatment limitations * pregnancy * confirmed pulmonary arterial embolism with hemodynamically relevant right heart strain * st-segment elevation myocardial infarction (stemi) * participation in an intervention study elsewhere

Keywords: plasma exchange covid19
should colorectal cancer patients be followed after five years? study of recurrence in a population cohort

Conditions: Colorectal Cancer

Summary: the results of this study will make it possible, thanks to better understanding of the natural history of colorectal cancer, to define new treatment and surveillance strategies for colorectal cancers resected with curative intent, so as to improve management and thus improve patient survival. these data will also make it possible to calculate the prevalence of patients who require treatment or surveillance because of their disease.


Eligibility criteria:
inclusion criteria: * with adenocarcinoma of the colon or rectum (icd-o: c18, c19 and c20) * residing in the département of côte-d'or (501,000 inhabitants according to the 1999 census) or calvados (511, 012 inhabitants) at the moment of diagnosis * recorded by either registry between january 1985 and december 2000 * treated by resection with a curative intent. exclusion criteria: will be excluded other morphologic tumours and initially metastatic colorectal cancers, anal cancers.
validation of a simulated clinical evaluation of ventilators

Conditions: Respiratory Diseases; Chronic and Acute Respiratory Failure

Summary: the purpose of this study is to evaluate the ability of a device reproducing patients' respiratory characteristics to select in-vitro the most appropriate ventilator for a given pathology.

context : mechanical ventilation is an essential element in the management of chronic as well as acute respiratory failure allowing an improvement of both mortality and morbidity. however, considering the wide choice of ventilators available on the market, it has become increasingly difficult to choose the most appropriate ventilator according to the pathology presented by a patient, patients being able to try only a limited number of devices. patient-ventilator synchronization is a crucial part of ventilation efficacy and its success. it depends on both the physiopathological characteristics of patients and specific properties of the ventilation device. objective : to evaluate the ability of a device reproducing patients' respiratory characteristics to select in-vitro the most appropriate ventilator for a given pathology. method : multi-center transversal study. selection, after an initial bench-evaluation, of three ventilators. clinical evaluation of their efficacy and synchronization between patient and ventilator and establishment of a classification. second bench evaluation of the studied ventilators while the bench is simulating the ventilation characteristic of previously studied patients in order to compare the results obtained in vitro to the results obtained in vivo. selection criteria : patients requiring mechanical ventilation for management of either chronic or acute respiratory failure. patients, centers : 4 groups of 14 patients presenting chronic respiratory disease followed in the icu of raymond poincare hospital in garches and in the pulmonary departments of the armand trousseau hospital and the pitie salpetriere in paris; 1 cohort of 12 patients admitted in the icu of henri mondor in creteil in paris for acute respiratory failure. study duration : 33 months (bench study : 3 + 6 months, clinical study : 24 months) perspectives : developing an evaluation tool allowing the rapid assessment of any new available ventilator according to the specific characteristics (and needs) of a patient and to a given pathology. selecting the most appropriate ventilator for a given patient.

Eligibility criteria:
inclusion criteria: * patients requiring mechanical ventilation for management of either chronic or acute respiratory failure. * old of at least 6 years * having given his consent writes after enlightened information, him even and the parents for least than 18 years, only he for most than 18 years * realization of a preliminary medical examination exclusion criteria: * patients presenting criteria of pointed exacerbation of the respiratory disease

Keywords: ventilators bench evaluation mechanical ventilation
a study to assess pharmacokinetics (pk) of preladenant in participants with chronic renal impairment (cri) (p06512)

Conditions: Parkinson Disease

Summary: this is a two part study to compare the pk of preladenant administered to participants with cri to the pk of preladenant administered to healthy participants. part 1 will compare the pk of participants with severe cri to healthy participants. part 2 will compare the pk of participants with moderate cri and participants with mild cri to healthy participants. the primary hypotheses are that the plasma area under the concentration-time curve from time 0 to infinity after single dosing (auc0-∞) of preladenant in participants with either severe, moderate or mild cri is similar to that of matched healthy participants.


Eligibility criteria:
inclusion criteria: * has a body mass index (bmi) between 19 to 34 kg/m\^2, inclusive * has mild to severe cri and not on dialysis (participants with normal renal function are to be matched to subjects with renal impairment) * clinical laboratory tests, electrocardiogram, and vital signs within normal ranges * free of any clinically significant disease that would interfere with the study evaluations (except related to his/her renal disease and comorbid conditions) exclusion criteria: * females who are pregnant, intend to become pregnant (within 3 months of ending the study), or are nursing/breastfeeding * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug * had a renal transplant or are on dialysis * has a history of any infectious disease within 4 weeks * is positive for hepatitis b surface antigen, hepatitis c antibodies or human immunodeficiency virus (hiv) * has donated blood or had a blood transfusions in the past 60 days * has demonstrated allergic reactions (eg, food, drug, atopic reactions or asthmatic episodes) which could interfere with their ability to participate in the trial * has a history of malignancy * has evidence of suicidality or is at risk for self-harm or harm to others
quadratus lumborum block for total hip arthroplasty

Conditions: Pain, Postoperative

Summary: the quadratus lumborum (ql) block is a fascial plane block that has been described to provide analgesia from t7-l3 dermatomes. the investigators aim to evaluate the efficacy of ql blocks in patients undergoing primary total hip arthroplasty (tha).

investigators will enroll subjects planned for primary tha and allocate them into receiving a ql block with either saline or ropivacaine. primary outcome will be pain scores over the first 48 hours after surgery.

Eligibility criteria:
inclusion criteria: * adult subjects undergoing elective primary total hip arthroplasty exclusion criteria: * patients age \< 18, * documented allergy to local anesthetic * presence of peripheral neuropathy * patients with current long term opioid use defined as receiving an opioid on most days in a 90 day period * patients with a contraindication to spinal and regional anesthesia such as coagulopathy or infection at the site of the regional technique.

Keywords: quadratus lumborum nerve block, analgesia, total hip arthroplasty, postoperative outcomes
treatment with anti-sars-cov-2 immunoglobulin in patients with covid-19

Conditions: Covid19

Summary: a phase i/ii clinical trial for safety and efficacy evaluation of treatment with anti-sars-cov-2 equine immunoglobulin (f(ab')2) in hospitalized patients with covid-19 not requiring of invasive ventilation support.


Eligibility criteria:
inclusion criteria: * inpatients diagnosed with covid-19 by rt-pcr; * time between symptom onset and inclusion ≤ 10 days; * age ≥ 18 years and \<75 years * no indication of invasive ventilatory support at the time of randomization; * signature of the informed consent form. exclusion criteria: * pregnant or lactating women * severe comorbidity: severe heart disease, severe copd or o2-dependent copd, terminal cancer. * any confirmed or suspected immunosuppressive or immunodeficiency state, including hiv (regardless of treatment, cd4 count or viral load status); asplenia; severe recurrent infections and chronic use (more than 14 days) of immunosuppressive medication in the last 6 months, except for topical steroids or short-term oral steroids (cycle lasting ≤14 days); * history of anaphylaxis or severe allergic reaction; * previous use of any heterologous serum; * participation in trials of prophylactic drugs or vaccines for covid-19; * administration of immunoglobulins and / or any blood products in the previous three months.
prevention of nicotine abstinence in critically ill patients after major surgery

Conditions: Nicotine Dependence

Summary: the primary objective of this study is to determine whether the application of transdermal nicotine patches in critically ill patients after major surgery with nicotine abstinence condition is associated with a lower incidence of delirium.

patients in a group with medical intervention receive nicotine patch within 24 hours after surgery. the nicotine patch is replaced every day. delirium is evaluated every day by the confusion assessment method (cam) - icu test. the maximum length of intervention is 7 days. patients in a group with placebo receive a placebo patch within 24 hours after surgery. this patch is replaced every day. delirium is evaluated in the same way - cam - icu test. the maximum length of the placebo intervention is 7 days.

Eligibility criteria:
inclusion criteria: * patients undergoing a surgical procedure - urological, surgical, trauma surgery, orthopedic surgery, dental surgery) * age 18 years and above * patient with an assumption of nicotine abstinence (smoking a minimum 10 cigarettes/day). * ex-smokers (if they stopped smoking less than 30 days prior to surgery) * an assumption of hospitalization at the intensive care unit (icu) after surgery * signed informed consent exclusion criteria: * age ˂ 18 years * non-signing of the informed consent * patients after neurosurgical surgery, patients with traumatic brain injury, patients after a new stroke * patients with psychiatric diseases * nicotine, curapor or hydrocoll allergy * patient with a heart attack, unstable angina pectoris or patients with a serious heart arrhythmia * pregnant and breastfeeding patients * patients with nicotine treatment

Keywords: nicotine patch placebo critically ill patients delirium prevention
efficacy of telemetry-assisted care in home home vented copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study in patients suffering of chronic obstructive pulmonary disease (copd) aims to investigate whether telemonitoring of their non invasive ventilation (niv) device together with targeted, tailored intervention in case of increasing symptoms or ventilation abnormalities improves the therapy adherence and effectiveness and can reduce the need for hospitalizations.

54 niv naive copd patients will be randomized to either telemonitoring care with a data-based intervention scheme or standard care according to the guideline of the german society of pneumology. primary objective: adherence to ventilation in the intervention group versus control group. secondary objective: comparisons between the control and intervention groups, over time and against each other, in terms of: * health-related quality of life assessed by sgrq * symptomatology based on blood gas analyses, cat score, mmrc score and s3-niv score * therapy quality according to therapy parameters from device data * number of hospitalizations and physician visits * evaluation of the impact of feedback and interventions on therapy adherence, symptomatology and therapy data.

Eligibility criteria:
inclusion criteria: * niv-naive / continuation after 3 months interruption * indication for initiation of niv according to s2k guideline of the german society of pneumology * presence of the signed informed consent exclusion criteria: * absence of signed written informed consent for data protection and study participation. * contraindication to pap therapy * participation in another study that influences the setting of niv therapy through specifications regarding device settings or titration

Keywords: copd niv telemonitoring