Kornimate/medical-research-clean huggingface dataset:
prospective observational study of 1st and 2nd line vectibix® use in ras-wt mcrc pts to evaluate pattern of use and orr

Conditions: Metastatic Colorectal Cancer

Summary: the study will shed additional light on the impact of vectibix® under the current, standard clinical conditions of mcrc treatment in greece. it will provide data on the duration and the outcomes of vectibix® treatment in real-life setting.

this is a single-arm, multi-center, prospective, observational, descriptive, noninterventional study in patients with mcrc in greece who receive vectibix®in 1st or 2nd line according to approved indication. the aim of the study is to obtain a clear understanding of the current practices concerning real-life treatment of mcrc patients with vectibix® in first-line in combination with chemotherapy or second-line in combination with chemotherapy in greece. this setting will also provide the opportunity to observe in a non-selected patient population with ras wt mcrc the real-life habits of mcrc treatment, and in particular the duration and the outcomes of vectibix® treatment. the data generated by this study may be used for reimbursement purposes, as it becomes an increasingly common need in greece to provide locally generated data for use of drugs in the real-life setting to regulatory agencies and/or payors. furthermore, this study could address the existing data gap in the treatment of anti-egfr therapy beyond progression in the real-life setting. primary objective(s): to describe the pattern of use of vectibix® in combination with chemotherapy in 1st line or in 2nd line mcrc treatments as per approved vectibix® indication. secondary objective(s): to investigate the rate of objective response (orr, defined as either a complete response or a partial response) and the rate of stable disease as best response in 1st line or in 2nd line chemotherapy regimens of mcrc including vectibix®.

Eligibility criteria:
inclusion criteria: * adult patient (age ≥18 years) at enrollment * histological documentation of mcrc diagnosis * ras wt tumor documented before study enrolment as per routine laboratory finding * subjects whose care will be managed primarily by the enrolling physician and/or all records will be available * measurable disease at baseline (preferably according to the response evaluation criteria in solid tumors version 1.1 (recist v1.1) if routinely used) * currently under (begin up to 8 weeks before informed consent) a 1st or 2nd line treatment regimen, including vectibix® as per indication * tumor assessment (i.e. ct/mri) within 16 weeks prior to first vectibix® infusion * signed informed consent exclusion criteria: * participation in any interventional clinical study (currently or during the three previous months from enrollment). * compromised ability to give informed consent (defined per clinical judgment). * unknown or mutant ras tumor type

Keywords: metastatic colorectal cancer, wild type ras, panitumumab, vectibix, greece
cohort of hiv associated lymphomas

Conditions: HIV Infection

Summary: the incidence of lymphomas is increased among hiv infected patients. in 70 % of cases, those are non hodgkin's lymphomas (nhl) and hodgkin lymphomas (hl) in 30% of cases. in france, their incidence is estimated to 100 cases per year (data from the "base de données hospitalière française sur l'infection à vih" (fhdh)). the main mechanisms involved in lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (epstein-barr (ebv) and hhv8) and molecular oncogenic events. a better understanding of these different pathways, give the possibility to design specific treatments. the treatment of these lymphomas is not standardized. a prospective study of patients with hiv associated lymphoid malignancies is an innovating tool to answer epidemiological, physiopathological and therapeutic questions. we propose a prospective multicentric study of these patients. the main objectives of this prospective study are to: * evaluate the incidence, characterise clinically and histologically nhl and hl cases associated to hiv * perform an observational study of the treatment and outcome of these patients out of the context of clinical trials, * study the differentiation and activation of b-cell populations, * better understand the role of specific t cell responses in the control of ebv infection, * allow other biological studies from the anrs group " lymphome et vih ". the recruitment of 40 cases per year is expected. the length of inclusions is 7 years. the follow-up will be of 2 years. clinical, pathological and biological data at diagnosis and during follow-up will be collected. this will allow characterizing the lymphoma, the hiv infection, the antitumoral treatments and the outcome of lymphoma. biological samples will be centralized to collect cell, dna, rna, plasma, serum and tumour collections (y.taoufik, s prevot\* ). to better understand the ebv infection and lymphomagenesis in hiv infection, we propose to follow the viral load and the molecular characteristics of ebv in pbmc, plasma and tumour (p.morand\* , v.boyer\* ), to investigate the ebv-t cell responses (g.carcelain) and the presence and reactivation of ebv in peripheral b cells (c.amiel\* , jc nicolas) and in tumoral samples (m.raphael\* , i.joab\* ). the other mechanisms of lymphomagenesis in hiv infection will be studied by the analysis of the sub-populations of b-cells in terms of activation and differentiation (y.taoufik) and by the characterization of msi tumours (a.duval).


Eligibility criteria:
inclusion criteria: * male and female patients over 18 years of age * patients with hiv-1 or 2 infection * with non hodgkin's lymphomas (nhl) or hodgkin lymphomas (hl) in the diagnosis or in relapse * sign an informed consent exclusion criteria: * patients who suffered from acute leukemia * patients treated for lymphoïd blood disease * patients whose lymphomas treatment was stopped for less than 3 months * unaffiliated to the social healthy security french system
early versus delayed rehabilitation intervention in patients with lung cancer

Conditions: Lung Cancer

Summary: in italy, the incidence of lung cancer for the year 2020 has been estimated at about 41.000 new diagnoses. patients with lung cancer experience debilitating symptoms caused by the disease itself and cancer treatments, such as dyspnea and fatigue, which reduce physical function and quality of life (qol). it is estimated that 90% of patients undergoing chemotherapy and 57% of patients undergoing lung resection suffer of cancer-related fatigue (crf). previous studies have shown that educational interventions and aerobic and resistance exercise are effective in improving crf and qol in patients with lung cancer. however, to date the optimal dose, mode and timing to deliver the intervention during the care pathway for lung cancer patients is unknown. tolerability and frequency of cancer treatment could be a barrier to adherence to the intervention. therefore, this study aims to evaluate the feasibility of a rehabilitation intervention aimed at improving crf with respect to timing of delivery: early vs delayed rehabilitation in lung cancer patients.

the primary outcome of the study is to evaluate the feasibility of the experimental pulmonary rehabilitation (rp) program combining the exercise component with the educational component for patients with lung cancer undergoing chemotherapy and/or radiotherapy and/or immunotherapy, delivering rp at different points in the course of their care pathway. the secondary outcome is to evaluate the impact of the intervention on several health outcomes (crf, physical performance, and qol) by assessing any differences between early and delayed rp. the early rp intervention will be delivered in the first three months of cancer treatment, while the same delayed rp intervention will be delivered three months after the start of treatment. finally, considering the potential beneficial role that exercise on survival of patients with cancer, this study also aims to evaluate this outcome at 12 months after enrollment.

Eligibility criteria:
inclusion criteria: * newly diagnosed of stage ii and iii lung cancer (nsclc) candidates for anticancer therapies (chemotherapy, radiotherapy, immunotherapy, or combinations thereof), associated or not with surgery. in the last case, patients will be included at least 30 days after surgery. * prognosis ≥ 12 months * at least 18 years old * recruited from the pneumology, oncology, radiotherapy, and physical medicine and rehabilitation unit of the azienda unità sanitaria locale - irccs of reggio emilia * willing and able to give written informed consent exclusion criteria: * clinical disorders that contraindicate participation in a moderate exercise program (e.g. preexisting severe physical disabilities, major cognitive or sensory deficits, severe psychiatric disorders, language barrier, etc.). * nsclc stage iv * patients who are candidates for surgery alone * patients who are candidates for neoadjuvant therapy
the effect of olfactory mental imagery and cardiovascular surgery

Conditions: Anxiety State; Symptoms and Signs; Vital Signs

Summary: this study aims to examine the effect of olfactory mental imagery on physiological parameters, anxiety and symptoms after cardiovascular surgery. this study was planned to be conducted as a prospective randomized controlled study in the cardiovascular surgery service of istanbul mehmet akif ersoy thoracic and cardiovascular surgery training and research hospital. the universe of the research; it will consist of patients who are hospitalized in the cardiovascular surgery service and who have undergone cardiovascular surgery. the sample will consist of a total of 90 patients hospitalized in the cardiovascular surgery service of the same hospital and meeting the inclusion criteria for the study. patient diagnosis form, physiological parameters monitoring form, state anxiety inventory and cardiac surgery symptom inventory will be used to collect data. data will be collected on days 1, 2, 3 and 4 after surgery. in the study, patients will be divided into two groups: intervention (n = 45) and control (n = 45). the intervention group will perform breathing exercises with the olfactory mental imagery technique.


Eligibility criteria:
inclusion criteria: * elective surgery is planned, * there is no smell problem, * no loss of visual and auditory functions, * no previous hospital history, * no serious head trauma or nasal injury, * no known psychiatric disease or history of anxiolytic drug use, * olfactory, capable of mental imagery exclusion criteria: * presence of decreased level of consciousness, * having drainage over 200 ml per hour, * ejection fraction less than 30 percent, * people with lung disease such as atelectasis and pneumonia, * systolic blood pressure is below 90 mmhg, * patients whose pain control cannot be achieved

Keywords: vital signs anxiety state cardiovascular surgery symptom mental imagery
impact of balance training in community-dwelling older adults after recovery from covid-19

Conditions: Community-dwelling Older Adults

Summary: this research investigates the impact of balance training on improving functional performance and reducing fall risk in community-dwelling older adults who have recovered from covid-19. post-covid-19, many elderly individuals experience lingering physical impairments, including muscle weakness, decreased coordination, and balance deficits, which increase their vulnerability to falls. the study evaluates whether a structured balance training program can enhance stability, mobility, and overall quality of life in this population.

older adults recovering from covid-19 frequently face persistent physical limitations due to the virus's impact on the respiratory, muscular, and neurological systems. these limitations often manifest as impaired balance, reduced functional mobility, and increased risk of falls-conditions further exacerbated by prolonged inactivity or hospitalization during illness. this research focuses on evaluating the effectiveness of a structured balance training program using the biodex stability system in older adults living independently in the community after recovering from covid-19. participants are assessed using validated tools such as the berg balance scale, timed up and go (tug) test, and the biodex stability system to measure changes in balance performance, fall risk, and confidence in daily movement.

Eligibility criteria:
inclusion criteria: * were being older adults (aged ≥60 years), recovered from infection during the last 6 month, exclusion criteria: * individuals were excluded if they have medical history of musculoskeletal trauma or surgery, systemic disease that could affect standing or walking, visual, auditory, or cognitive impairment that preclude the ability to comprehend the instructions during conduction of the study protocol.

Keywords: older adults berg balance scale covid-19 biodex
low-dose cd20 monoclonal antibody injection in preemptive treatment of ptld in patients with ebv-hlh/caebv

Conditions: PTLD; CAEBV; HLH

Summary: this is a clinical study on the efficacy and safety of low-dose cd20 monoclonal antibody injection in preemptive treatment of ebv positive lymphoproliferative diseases after allo-hsct in patients with ebv-hlh and caebv

purpose: to comprehend the efficacy and safety of low-dose cd20 monoclonal antibody injection in preemptive treatment of ebv positive lymphoproliferative diseases after allo-hsct in patients with ebv-hlh and caebv study subjects: ptld patients undergoing allo-hsct with caebv or ebv-hlh met the following conditions: (1) ebv-dna (pbmc or plasma) \> 1000 copies/ml in peripheral blood after transplantation; (2) no ptld symptoms; (3) presence of agvhd or clinicians believe that ri treatment is not suitable, or ebv-dna persists \> 1000 copies/ml after ri; (4) ebv infected lymphocytes; (4) b cell infection, or b cell copy number higher than other cell lines by 2 logs. therapeutic regimen: cd20 monoclonal antibody injection 100 mg/m2 was intravenously infused once a week. it can be discontinued after ebv-dna negative for 2 consecutive times. total dose≤ 4 applications per patient

Eligibility criteria:
inclusion criteria: * ptld patients undergoing allo-hsct with caebv or ebv-hlh met the following conditions: (1) ebv-dna (pbmc or plasma) \> 1000 copies/ml in peripheral blood after transplantation; (2) no ptld symptoms; (3) presence of agvhd or clinicians believe that ri treatment is not suitable, or ebv-dna persists \> 1000 copies/ml after ri; (4) ebv infected lymphocytes; (4) b cell infection, or b cell copy number higher than other cell lines by 2 logs. exclusion criteria: * patients with active infection except for ebv; active hepatitis b or c (positive hbv-dna or hcv-rna) ; known life-threatening allergic reactions to cd20 monoclonal antibody injection or its preparation ingredients; participate in other clinical studies.

Keywords: preemptive therapy, cd20 monoclonal antibody
nutritional prognostic factors in als

Conditions: Nutritional Deficiency; Neuro-Degenerative Disease; Gastrostomy

Summary: background. several nutritional factors have been evaluated as prognostic factors for survival in als patients at earlier stages of the disease \[body mass index (bmi), body composition expressed as fat free mass (ffm), fat mass (fm), phase angle (pha), low-density lipoprotein/high-density lipoprotein (ldl/hdl) ratio, cholesterol levels\], while only two studies have evaluated some of these parameters after peg placement. aim. bmi and cholesterol levels were evaluated as prognostic factors for survival after percutaneous endoscopic gastrostomy (peg) placement moreover, the relationship between body composition and bmi in a subgroup of als patients was evaluated.

methods. nutritional and neurological parameters were assessed at the time of peg placement (t0) in 47 consecutive patients. body composition and pha were measured in only 22 patients within 2 months from t0. survival was calculated as the time from the peg placement to tracheostomy or death.

Eligibility criteria:
inclusion criteria: * als patients who underwent peg tube placement from 2006 to 2015 and were referred to the artificial nutrition team of the gastroenterology unit exclusion criteria: * als patients without peg
exercise in insulin-resistant minority adolescents

Conditions: Insulin-Resistance

Summary: insulin resistance, often accompanied by obesity, plays a major role in the development of type 2 diabetes. this phenomenon may be related with the fact that american adolescents are now becoming less physically active in early puberty, explaining the largely pubertal and post-pubertal onset of type 2 diabetes in adolescence. although regular physical activity has been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and adolescents, the magnitude of exercise training-induced improvement in the risk factors for type 2 diabetes has been only recently studied in adults and studied very little in pediatric populations. it is clear that exercise, diet, and genetics all contribute to the development of type 2 diabetes in children. however, the few studies that have been done to dissect the relative contributions of these three risk factors have generally used only lipid profiles as the end point. there have been a number of recent advances in our understanding of the molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways modulated by exercise within muscle tissue.

insulin resistance, often accompanied by obesity, plays a major role in the development of type 2 diabetes. this phenomenon may be related with the fact that american adolescents are now becoming less physically active in early puberty, explaining the largely pubertal and post-pubertal onset of type 2 diabetes in adolescence. although regular physical activity has been suggested to attenuate obesity and prevent type 2 diabetes in high-risk children and adolescents, the magnitude of exercise training-induced improvement in the risk factors for type 2 diabetes has been only recently studied in adults and studied very little in pediatric populations. it is clear that exercise, diet, and genetics all contribute to the development of type 2 diabetes in children. however, the few studies that have been done to dissect the relative contributions of these three risk factors have generally used only lipid profiles as the end point. there have been a number of recent advances in our understanding of the molecular basis of type 2 diabetes, particularly, with regards to insulin regulatory pathways modulated by exercise within muscle tissue.

Eligibility criteria:
* inclusion criteria: to be included in this study, subjects must meet the following conditions: sedentary (regular aerobic exercise less than or equal to 2 times/wk and less than 20 min/session): nonsmoker; impaired glucose tolerance (fasting plasma glucose greater than or equal to 100 mg/dl but less than 126 mg/dl or/and 2 hour plasma glucose greater than or equal to 140 mg/dl but less than 200 mg/dl; bmi-for-age is 95% or greater. exclusion criteria: not pregnant; and not have any other medical condition that would preclude regular exercise. if taking medication known to affect metabolism. history of chronic illness known to affect metabolism.

Keywords: insulin sensitivity moderate intensity insulin resistance exercise intervention
medication adherence with telehealthcare medication therapy management

Conditions: Uncontrolled Asthma; Young Adults

Summary: improving medication adherence with telehealthcare medication therapy management to change health outcomes in adolescents and young adults with asthma (match) is a multi-center, randomized parallel group study targeted to an at-risk population of adolescents and young adults (aya) with uncontrolled asthma who have poor adherence with prescribed inhaled corticosteroid (ics) therapy.

the study evaluates a medication therapy management (mtm) video telehealthcare intervention to address poor medication adherence. in addition, it employs a novel method to track and provide feedback to participants on adherence by using propeller sensors. 300 adolescents and young adults will be randomized to medication therapy management (mtm) video telehealthcare plus electronic adherence self-management \[mtm eam\] or electronic adherence self-management alone (eam). due to the hierarchal design of the trial, two primary outcomes to be tested in a sequential manner are specified, adherence and time to first asthma exacerbation.

Eligibility criteria:
inclusion criteria: * age 12 through 35 years * speaks english or spanish * physician diagnosed asthma (without any other co-morbid pulmonary disease) * prescribed ics treatment for at least 3 months prior to screening * adherence to refills and medication scale (arms) 7-item questionnaire score of \>8 (low or moderate adherence) * current use of albuterol metered dose inhaler (mdi) for rescue: proair, ventolin, albuterol sulfate (from prasco or teva) * uncontrolled asthma: * symptomatic asthma defined as 3 of the following in the past 4 weeks: * daytime symptoms of asthma more than twice per week * any night awakening due to asthma * rescue inhaler use for symptoms more than twice per week * any activity limitation due to asthma; or * asthma control test score ≤19 * has iphone or android smart phone with short message service (sms) * has access to reliable wifi service and a device with capability for telemedicine study visits * ability to understand and willingness to sign consent documents * evidence of propeller sensor connection in the 4-week run-in period exclusion criteria: * use of an investigational treatment in the previous 30 days. * previous enrollment in match structured interviews ( aim 1) * currently enrolled in an intervention trial * currently uses an ics not compatible with the propeller sensor * inability to comply with study procedures, including: * inability or unwillingness to provide informed consent (or assent in the case of a minor). * inability to perform study measurements. * inability to be contacted by phone via calls and /or text messaging * not willing to have video chat * any condition(s) in the opinion of the physician that puts the participant at risk from participating in the study

Keywords: bronchial diseases respiratory tract diseases lung diseases obstructive lung diseases
long term follow-up study of type-1 gaucher subjects post flt201 dose (galileo-2)

Conditions: Gaucher Disease, Type 1

Summary: this is a multicenter, long-term, follow-up trial of participants with gaucher disease type 1 who received flt201 treatment in a preceding clinical trial. participants will be followed for 5 years post-treatment.


Eligibility criteria:
inclusion criteria: * 1. participants who have previously received flt201 (including those who may have required recommencement or initiation of ert/substrate reduction therapy \[srt\]). * 2. participants able to give full informed consent and able to comply with all requirements of the trial. exclusion criteria: * n/a