Kornimate/medical-research-clean huggingface dataset:
comparison of allows measurement of cardiac output between clearsight system and transpulmonary thermodilution

Conditions: Shock; Cardiac Output, Low

Summary: correlation study between the data provided by two measurement systems, trans- pulmonary thermodilution and clearsight © (non invasive), to determine the interest in routine use (cardiac output, cardiac index, stroke volume and blood pressure).

since 2014, edwards society has developed a completely non-invasive monitoring device for measurement of blood pressure and continuous cardiac output without inserting foreign intravascular bodies in the patient. initially tested on healthy volunteers cardiac disease -free, the correlation with the other devices seems to be good. if this clearsight © system show a relevant accuracy in measuring blood pressure and cardiac output with a specific icu hospitalized population, it could justify its place in the therapeutic arsenal of monitoring in intensive care. this is a common care ,prospective observational single center study , concerning the results of blood pressure , cardiac output values and their variations.

Eligibility criteria:
inclusion criteria: * age\>18 * hospitalized in surgical icu, with hemodynamic instability or vaso-active drugs * no opposition formulated exclusion criteria: * impossibility of establishment of one of the cardiac output measurement devices * pregnant woman * refuse to participate
the dementia symptom management at home program hospice edition

Conditions: Dementia

Summary: alzheimer's disease and related disorders (dementia) poses a significant challenge to our public health. while many persons with dementia are cared for by friends and family in the community with the assistance of home healthcare and hospice, most clinicians and agencies are ill prepared to care for this population and therefore have difficulty assisting patients and caregivers in maintaining quality of life leading to adverse patient outcomes, increased caregiver stress and burnout, and healthcare utilization. this study will utilize a cluster randomized controlled design with 6 care teams at a single study site to examine the ability of a multi-component evidence-based practice hospice care quality improvement program for registered nurses, social workers and chaplains to improve the quality of life and reduce healthcare utilization for persons with dementia and their informal caregiver.


Eligibility criteria:
inclusion criteria: * pwd over the age of 65 * admitted to mjhs hospice agency * the patient and family caregiver speak english and/or spanish. * the informal caregiver is ≥18 years of age and spends at least 8 hours per week with the patient. * patients who score ≥6 on the quick dementia rating scale (at least mild impairment). exclusion criteria: * patients with a separate axis 1 diagnosis other than forms of dementia, depression or anxiety. * pwd residing in assisted living facilities, nursing homes or board and care homes * pwd solely receiving infusion or home health aide services.
modeling outcome in patients with acquired brain injuries

Conditions: Brain Injuries

Summary: acquired brain injury (abi) is the leading cause of death and disability worldwide. the degree of severity varies according to a combination of numerous demographics, etiological, clinical, cognitive, behavioral, psychosocial and environmental factors, which can interfere with the effectiveness of rehabilitation interventions and, therefore, with the final outcome. the most important goal of the modern clinic is to predict in time the progression of possible recovery after the brain injury event in order to provide more effective treatment, but the high heterogeneity and clinical variability and the unpredictability of the onset of comorbidities makes this a hard target to reach. in recent years, artificial intelligence algorithms have been applied to more precisely define the role of critical variables that can help clinical practice to predict the final outcome. the classical approach of these algorithms provides only probabilistic values on the final outcome, without considering the typology of clinical interventions and overall complications that may appear throughout the hospitalization period. the objective of this multicentric study is to define a new statistical approach that can describe the dynamics of individual clinical changes occuring during the inpatient intensive rehabilitation care period. the proposed approach combines a principal component analysis (pca) for dimension reduction (capturing the maximum amount of information and reducing the dimensionality problem) and a nonlinear mathematical modeling for describing the evolution of the clinical course in terms of the resulting new pca dimensions. by using this approach, we may determine the individual patient's temporal trajectories while examining particular clinical factors. the secondary objective of this study is to validate a new version of the early rehabilitation barthel index (erbi), a well-known clinical scale used to measure functional changes in patients with severe acquired brain injury.


Eligibility criteria:
inclusion criteria: * patients with clinical diagnosis of severe acquired brain injury of different etiology (traumatic, hemorrhagic vascular,ischemic vascular, anoxic, infectious, other etiology * interval since the acute occurrence that led to the clinical condition of ≤3 months duration * age of 18 years or older * informed consent signed by family member/caregiver/supporting caregiver exclusion criteria: * positive remote medical history of pre-existing disabling neurological or orthopedic conditions and psychiatric disorders

Keywords: acquired brain injury functional outcome modeling trajectories mathematical models
autologous stem cell transplantation for patients with al amyloidosis

Conditions: AL Amyloidosis; Plasma Cell Dyscrasia

Summary: this study mainly evaluated the efficacy and safety of autologous stem cell transplantation for the treatment of al amyloidosis, the role of induction and maintenance therapy in autologous stem cell transplantation, and the long-term efficacy and prognosis risk factors of autologous stem cell transplantation for the treatment of al amyloidosis.

this study is divided into two parts. in the first part, the investigators retrospectively analyze the data of patients with al amyloidosis who treated with autologous stem cell transplantation from july 2010 to december 2019. all patients had a biopsy-proven disease by positive congo red stain with a concomitant demonstration of plasma cell dyscrasia. organ involvement was established according to the criteria established at the 10th international symposium on amyloid and amyloidosis. the protocol of asct included mobilization with colony-stimulating factor alone and conditioning with high-dose melphalan 140 or 200 mg/m2. in addition to analyzing the efficacy and safety of all the patients, the investigators also analyzed the difference in efficacy between patients in different subgroups. for example, subgroups divided according to different induction treatment regimens; subgroups divided according to different plasma cell fish data and fcm data; subgroups divided according to the degree of organ involvement, and subgroups divided according to different maintenance treatment regimens. in the second part of the study, the investigators will conduct a prospective study to explore the best autologous stem cell transplantation treatment protocol for al amyloidosis. the protocol includes the induction therapy with bortezomib and daratumumab before asct, the maintenance treatment with lenalidomide after asct, and the treatment options for recurrence after transplantation.

Eligibility criteria:
inclusion criteria: * male or female; * aged 18-75 years; * patients with newly diagnosed al; * appropriate for autologous hematopoietic stem cell transplantation; * abnormal m protein or free light chain detected in serum and/or urine * ecog score 0-2 points; * subjects (or their legal representatives) must sign an informed consent document indicating understanding the purpose of and procedures required for the study and willingness to participate in the study. exclusion criteria: * pregnant and breastfeeding women; * subjects suffering from multiple myeloma; * hypersensitivity to any treatment drugs; * subjects have severe cardiovascular disease; * subjects have a serious physical disease and mental illnesses; * other conditions that researchers consider are not suitable for transplantation.

Keywords: al amyloidosis autologous stem cell transplantation induction therapy bortezomib lenalidomide ixazomib daratumumab melphalan
investigating the role of impella 2.5 system in acutely decompensated chronic heart failure patients

Conditions: Heart Failure

Summary: the primary objective of this study is to assess safety and feasibility of impella 2.5 in acute decompensated heart failure patients.


Eligibility criteria:
major inclusion criteria: 1. chronic heart failure patients, hospitalized due to decompensated heart failure (adhf) with nyha class iii-iv symptoms (adhf is defined by the presence of at least one of the following symptoms/signs: dyspnea w/orthopnea, jugular venous distension, peripheral edema +2, abdominal ascites, signs of chf on chest x-ray) 2. lvef ≤ 40 % within the past 3 months major exclusion criteria: 1. acute q-wave myocardial infarction or acute coronary syndrome within past 30 days 2. cardiac surgery within the past 30 days 3. implantation of cardiac resynchronization device within past 30 days or a possibility of implanting a biventricular pacer within 90 days of randomization
spot-scanning based hypofractionated proton therapy for low and intermediate risk prostate cancer

Conditions: Low Risk Prostate Cancer; Intermediate Risk Prostate Cancer

Summary: this prospective study assess the effectiveness and safety of hypofractionated proton radiotherapy in the treatment of intermediate and low risk prostate cancer.

the purpose of this study is to assess the effectiveness and safety of spot-scanning based hypofractionated proton radiotherapy for the treatment of intermediate and low risk prostate cancer. the treatment effectiveness is defined as freedom from biochemical failure. treatment safety will be documented with acute and late morbidity assessments. dose volume relationships for late side effects in organs at risk surrounding the prostate will be calculated from the dose volume histogram parameters assessed during treatment planning. patient assessed quality of life data including sexual function will be collected to increase our understanding how the reduction of normal tissue irradiation with proton therapy with subsequent decrease in functional impairments will overall affect the patient's life.

Eligibility criteria:
inclusion criteria: * pathological (histologically) proven diagnosis of prostatic adenocarcinoma * clinical stage t1-t2b * prostate specific antigen (psa) ≤ 20 ng/ml * gleason score ≤ 7 * eastern cooperative oncology group (ecog) performance status 0-2 * clinically negative lymph nodes evaluated by imaging (pelvic +/- abdominal ct or mri scan) * any patient with lymph nodes \> 1.0 cm maximum diameter requires further studies to address eligibility. positron emission tomography (pet)-ct is recommended for lymph nodes \> 1.0 cm. positive pet-ct indicates malignant involvement. hence, the patient will be staged as "high-risk" and therefore declared ineligible for study participation. negative pet-ct in lymph nodes 1.0-1,5 cm indicates non-involvement and thus eligibility. negative pet-ct in lymph nodes \> 1.5 cm is equivocal and requires additional work-up, preferably by biopsy. * patients must be 18 years of age or older. there is no upper age limit. * patient must be able to provide study-specific informed consent prior to study entry. * willingness and ability to complete the expanded prostate cancer index composite (epic) questionnaire to assess quality of life. * previously initiated androgen deprivation therapy (adt) is acceptable. * patients with history of chronic bowel diseases may be included. * patients with previous transurethral resection of the prostate (turp) performed for urinary retention may be included. exclusion criteria: * prior radiotherapy to the pelvic area. * prior prostate cancer therapy such as: prostatectomy, cryotherapy or hyperthermia. * prior systemic therapy (chemotherapy) for prostate cancer. * concurrent cytotoxic chemotherapy for prostate cancer. * evidence of distant metastases. * regional lymph node involvement. * international prostate symptom score (ipss) \> 20 * hip prosthesis * second invasive malignancy (except of basal cell and squamous cell carcinoma of the skin in situ) if not controlled within last two years.
tissue and serum collection from colorectal cancer patients

Conditions: Colorectal Cancer

Summary: to establish a serum and tissue bank with specimens form patients with colorectal cancer, for subsequent immunological and biochemical analysis.


Eligibility criteria:
inclusion criteria: * patients must be undergoing surgery for resection of their primary tumor, resection of hepatic metastases, or hepatic artery catheter and pump implant for unresectable hepatic metastases. * for and tumor specimen removed at surgery ,the lesion must be large enough to allow for routine pathological analysis, with excision from residual otherwise discarded material for the tumor bank. exclusion criteria: n/a

Keywords: colorectal cancer tissue collection
health related quality of life after a self-promoting learning program for people with rheumatic diseases

Conditions: Rheumatic Diseases

Summary: randomized controlled trial including 200 subjects with rheumatic diseases. subjects will be randomized to either a self-promoting problem based learning (pbl) program or a control group with traditional care. the hypothesis is that a pbl program will improve health-related quality of life, empowerment and self-care ability.


Eligibility criteria:
inclusion criteria: * subjects should have one or several rheumatic diseases diagnosed more than a year. * subjects should have musculoskeletal pain, sleep disturbances and fatigue, overwhelming number of days during the last three months. * subjects should be registered on the waiting list to the rheumatologic clinic. exclusion criteria: * subjects with difficulties speaking and/or read swedish. * subjects with difficulties travelling to the clinic.

Keywords: rheumatic diseases problem based learning health-related quality of life empowerment self-care
a phase iii study evaluating the efficacy and safety of satavaptan versus placebo in patients with dilutional hyponatremia

Conditions: Hyponatremia; Inappropriate ADH Syndrome

Summary: the primary objective of this study is to assess the efficacy of satavaptan versus placebo in participants with dilutional hyponatremia due to siadh. secondary objectives are to assess the safety of satavaptan, the maintenance of effect, and the clinical benefit in these participants.


Eligibility criteria:
inclusion criteria: * participants with symptomatic syndrome of inappropriate antidiuretic hormone secretion (siadh) with chronic hyponatremia exclusion criteria: * presence of clinical signs of hypovolemia (e.g. orthostatic decreases in blood pressure and increase in pulse rate, dry mucus membranes, decreased skin turgor) * presence of clinical signs of hypervolemia (e.g. generalized edema, jugular venous extension) * participants with adrenocortical insufficiency * participants with hypothyroidism * participants with known causes of transient siadh * participants with psychogenic polydipsia or beer potomania * concomitant use of thiazide diuretics during the study * presence of uncontrolled diabetes with fasting blood glucose ≥200 mg/dl (≥11.09 mmol/l) at time of screening * participants with impaired hepatic function or liver cirrhosis (child-pugh a-c) * pregnant or breast-feeding women the above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Keywords: aquaretic siadh
exercise therapy for patients with muscle dystrophies

Conditions: Muscular Dystrophies

Summary: muscular dystrophies (md) are a heterogeneous group of diseases characterised by muscle wasting that lead to progressive loss of function. although exercise training has been traditionally neglected to these patients due to concerns regarding muscle damage, research has shown that exercise therapy is safe and tolerable in this population and can lead to potential gains in endurance and muscle strength, as well as other patient-reported outcomes such as health-related quality of life.therefore, in this study, the investigators aim to examine the feasibility, tolerability and safety as well as the effects of a 12-week, exercise-training program in patients with md on functional capacity, muscle strength, and health-related quality of life.


Eligibility criteria:
inclusion criteria: * clinical or genetically diagnosis of muscular dystrophy including limb-girdle type i and type ii, myotonic dystrophy type i and type ii and facioscapulohumeral dystrophy. * age \> 18 years old * ability to walk independently for 10 or more metres exclusion criteria: * inability to understand or read spanish/catalan. * patients engaging in a similar exercise-based program in the past 12 months * patients with severe cognitive, neurological or musculoskeletal impairment unable to participate in the exercise program * unstable respiratory, cardiovascular or metabolic disease

Keywords: exercise therapy muscle strength exercise tolerance muscular dystrophies
phase 1 study of fusilev® to prevent or reduce mucositis in patients with non-small cell lung cancer receiving folotyn®

Conditions: Non-Small Cell Lung Cancer

Summary: to determine the optimal dose and schedule of fusilev to prevent or reduce folotyn-related grade 3 or higher oral mucositis in patients with non-small cell lung cancer.

this is an open-label, uncontrolled, nonrandomized, multicenter, dose-finding, single-arm, phase 1 study primarily to determine the optimal dose and schedule of fusilev to prevent or reduce folotyn-related grade 3 or higher oral mucositis.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * relapsed or refractory non small cell lung cancer (nsclc) after at least one line of therapy * eastern cooperative oncology group (ecog) performance status ≤ 2 * histologically or cytologically confirmed stage iii b/iv nsclc * adequate hematological, hepatic, and renal function * available during the first 8 weeks of the study treatment period to visit the clinic for oral mucositis assessments on scheduled days exclusion criteria: * active concurrent malignancy. if there is a history of prior malignancies other than those exceptions listed above, the patient must be disease-free for at least 5 years * congestive heart failure * uncontrolled hypertension * known human immunodeficiency virus (hiv)-positive diagnosis * previous exposure to pralatrexate * pregnant or breast-feeding women * major surgery within 14 days of enrollment * active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment * symptomatic central nervous system (cns) metastases or lesions for which treatment is required. patients who received prophylactic cns treatment are eligible
the cycling exercise with virtual reality visual stimulation for rehabilitation in cva patients

Conditions: Stroke

Summary: background: hemiplegia is one of the main reasons why stroke survivors lose their walking and balancing ability. many studies point out that cycling is an effective means for lower limb rehabilitation. however, during training, the unaffected limb may compensate for the affected one resulting in suboptimal rehabilitation. to address this issue, the investigators developed the virtual reality-cycling training system (vrcts) which can acquire force and speed signals in real-time through a cycling module. the system then analyzes the acquired data and uses a 3d vr rehabilitation program to help patients to train their affected side. the aim of the study was to develop the vrcts, verify its function and test system function on both normal subjects and stroke patients. methods: in this system, the investigators designed a cycling device that is embedded with load cell and encoder sensors to detect cycling force and angle in real-time. a cycling graph user interface control and data recode system (cycling cr system) was applied for signal analysis and feedback control. the investigators designed a 3d interactive vr rehabilitation program that can guide and train the users through visual feedback. each user performed a pre-test to examine determine condition, left-right balance and other parameters, which allows the system to be customized.


Eligibility criteria:
inclusion criteria: * single stroke with unilateral hemiplegia (brunnstrom stage iii); * hypertonia in the affected leg, modified ashworth scale (mas) grade ≦ 2; * no significant perceptual, cognitive, or sensory deficits; * no history of osteoarthritis, severe cardiopulmonary disease, or vascular disease in lower limbs * lack of a fixed contracture in the affected lower limb

Keywords: stroke, rehabilitation, leg cycling, feedback, virtual reality
apatinib in advanced non-squamous，nsclc

Conditions: Non-squamous Non-Small Cell Lung Cancer

Summary: to explore the efficacy and safety of apatinib in non-squamous non-small cell lung cancer in the real-world.

this is a multi-center, non-interventional clinical study. the number of patients that planned to be recruited is: from may 2017 to april 2019, the actual number of cases recruited into this study. if the clinicians thought the patient is suitable to take apatinib treatment, and give the patient apatinib treatment, the patient can be recruited into this study. clinicians chose the initial dose of apatinib according to the patient's physical condition. besides the clinicians adjusted the dose according to the patient's tolerance during the medication. the dosage was demanded not higher than 750 milligram (mg) per day. the patients received apatinib continuously, 28 days for a period, until intolerance, no longer getting benefits or patient wanted stop. during the course of the study, the researchers will not intervene the treatment of the patients, but only record the efficacy and adverse reactions. main evaluation criteria: pfs secondary evaluation criteria: os,dcr and orr (according to recist1.1). main safety indicators：ae, sae (according to nci ctcae v4.0) and qol scores (quality of life questionnaire-lung cancer).

Eligibility criteria:
inclusion criteria: 1. age: ≥ 18 years old; 2. histologically or cytologically confirmed, locally advanced or stage iv non-squamous, non-small cell lung cancer; 3. regardless of the past anti-tumor treatments (no limited to the number of past treatment lines), the doctors believe that apatinib can bring benefits to patients; 4. the patient is voluntarily to join the study, and signed informed consent, good compliance, with follow-up. exclusion criteria: if any of the following criteria is met, the subject shall be excluded: 1. squamous cell carcinoma and/or small cell lung cancer patients; 2. there are contraindications to apatinib (active bleeding, thrombosis, ulcers, intestinal perforation, intestinal obstruction, uncontrollable hypertension, grade iii-iv cardiac insufficiency, major surgery within 30 days, severe liver and kidney dysfunction, etc.); 3. allergic to apatinib and / or its excipients; 4. pregnant or lactating women; 5. according to the researcher's judgment, there are other situations that may increase the risk associated with participating in this study or the drug, which may lead to patients not being eligible for enrollment in the study.

Keywords: apatinib lung cancer angiogenesis inhibitors efficacy safety