Kornimate/medical-research-clean huggingface dataset:
hds plus pbpc transplant vs 4 more courses of frontline therapy in pts with aggressive nhl in pr after induction therapy

Conditions: High-Grade Lymphomas

Summary: the study is planned to compare the outcome of aggressive nhl patients in partial remission after four courses of front-line therapy, randomly assigned to receive either additional four courses of the same regimen or a modified hds program.


Eligibility criteria:
inclusion criteria: * newly diagnosed, untreated patients with histologically documented aggressive lymphoma; * age between 18 and 65 years; * clinical stage at diagnosis: i a bulky - iv b; * reduction of tumoral masses, after four courses of induction therapy, between 50 and 75%; * serum negativity for hiv, hbsag and hcv; * ecog performance status 0 through 4; * adequate bone marrow function; * adequate renal and hepatic functions; * left ventricular ejection fraction (lvef) \> 50%; * no previous malignant disease; * no previous chemo-radiotherapy; * no cerebral or cns involvement, assessed by clinical history, physical examination and csf examination through lumbar puncture; * written informed consent given at time of randomization. exclusion criteria: * clinical stage i no bulky, or cs iia-b with less than three sites of disease involved; * patients with cr, unconfirmed complete remission (ucr), very good pr (\>75%) and clinical response less than 50%, as defined by cheson et al., following four courses of induction therapy; * tumor involvement of cns (except patients with peridural masses without liquor involvement , who can be enrolled in this study); * indolent lymphoma transformed in more aggressive histologic type, even if never previously treated; * aggressive non-hodgkin's lymphoma in pre-transplanted patient; * clinically significant secondary cardiovascular disease e.g. uncontrolled hypertension, (resting diastolic blood pressure \> 115 mmhg), uncontrolled multifocal cardiac arrhythmias, symptomatic angina pectoris or congestive cardiac failure nyha class iii-iv; * left ventricular ejection fraction (lvef) \< 50%; * evidence of any severe active acute or chronic infection; * concurrent malignancy of history of other malignancy, except basal cell carcinoma of the skin (bcc) and in situ cervical carcinoma (cin); * myelodisplastic syndrome; * hbsag, hiv-positive, or hcv-rna-positive patients; * patient with psychiatric, or any disorder that compromises ability to give truly informed consent for participation in this study; * pregnant woman; potential child-bearing women can be enrolled if adequate contraceptive precautions are used before entering this trial and for the duration of the trial; * concerns for patient's compliance with the protocol procedures.
validation of a nutrient profiling system for reformulation

Conditions: Nutrition Poor

Summary: the objectives of the study are to assess the validity of nestlé reformulation criteria in two national dietary surveys: the us nhanes 2011, and the french inca2 2006-07.

background: the nestlé nutritional profiling system (nnps) has been developed to guide food and beverage reformulation. it is not known whether products passing the nnps standards have a higher overall nutritional density, and whether the higher consumption of nnps pass products is associated with a higher dietary quality. objective: the objectives were (i) to compare the classifications derived from the nnps and the validated uk ofcom nutrient profiling system; and (ii) to assess the nnps construct validity against healthy and unhealthy diets in french (individual and national survey on food consumption 2006-2007) and the us (national health and nutrition examination surveys 2011-2012) nationally representative dietary surveys. design: nnps outcomes (pass, fail, out-of-scope) of foods were compared to uk ofcom outcomes. contributions of nnps outcomes to energy intakes were compared between diets nutritional quality classes defined by two methods: based on a food-based quality indicator (pnns-gs in france, hei-2010 in the us), or on a combination of three nutrient-based indicators (mar, mer, energy density).

Eligibility criteria:
inclusion criteria: * all participants of inca2 and nhanes 2011-12 surveys exclusion criteria: * missing dietary intake data

Keywords: nutrient profiling
gore tex implants in the treatment of atrophic rhinitis

Conditions: Atrophic Rhinitis

Summary: this is a retrospective study, involving patients with atrophic rhinitis, that underwent gore tex® implants in the nasal fossa. the fetid rhinitis or atrophic ozena is a chronic illness characterized by yellowish secretion in the initial phase and the other phases with fetid crusts and atrophy of the mucous bone covering. diverse theories exist that try to explain the appearance of this pathology, such as: hereditary factors, immunological alterations, viral infection and nutritional lack. currently, its etiology remains unknown. as there isn't any ideal treatment already established, this technique improves the options of treatment. all patients have improved after the procedure.

data about 5 patients that underwent surgery to implant polytetrafluoroethylene in the nasal fossa was collect. the symptoms and complications were described.

Eligibility criteria:
inclusion criteria: * symptoms of atrophic rhinitis, with previous clinical treatment without good results exclusion criteria: * patients with mental illness

Keywords: atrophic rhinitis implants polytetrafluoroethylene
safety and efficacy study of cyclosporine ophthalmic emulsion in post-lasik patients

Conditions: Dry Eye Syndromes

Summary: this study will evaluate the safety and efficacy of cyclosporine ophthalmic emulsion administered twice daily following lasik surgery


Eligibility criteria:
inclusion criteria: * patient is scheduled for bilateral lasik surgery * patient is in good general health * eye glasses prescription of -1 to -8 exclusion criteria: * significant dry eye * presence of eye disease * uncontrolled systemic disease

Keywords: lasik
an evaluation of the safety and performance of the cathvision ecgenius® system.

Conditions: Cardiac Arrhythmia

Summary: the primary objective is to evaluate the safety and technical performance of the cathvision ecgenius® system. the secondary objective is to benchmark the intracardiac electrogram signal quality compared to commercially available systems in patients undergoing assessment and ablation of cardiac arrhythmias.

a prospective, single center, open-label, single arm study to evaluate the safety and technical performance of the cathvision ecgenius® system. patients undergoing assessment and ablation of cardiac arrhythmias during an electrophysiology (ep) procedure, and who meet all inclusion criteria will be enrolled in the study and undergo the ep procedure. intracardiac signals will be passively recorded using the cathvision ecgenius® system in parallel with a commercial ep recording system and later compared and evaluated. the investigational device will not be used for direct clinical care decisions or therapy. the ep procedure will be guided by the study site standards of care.

Eligibility criteria:
inclusion criteria: * patient is scheduled for catheter ablation or diagnostic electrophysiology procedure. * at least 18 years of age. * able and willing to provide informed consent or obtain consent from a legally authorized representative (lar). exclusion criteria: * patient inability to understand or refusal to sign informed consent. * patient is a prisoner or under incarceration * patients who in the opinion of the physician are not candidates for this study.

Keywords: electrophysiology atrial fibrillation cardiac ablation
evaluation of the effect of the training program based on the precede-proceed model on guality life style

Conditions: Hemodialysis Patient

Summary: this study was conducted to evaluate the effect of a precede-proceed model-based (ppm-based) training program on treatment adherence, healthy lifestyle behaviors, and quality of life of hemodialysis patients.

the precede proceed model includes structured training phases to bring positive behavior change. the model, which consists of training phases, provides the researcher with the opportunity to identify the problem and the deficiencies that cause the problem, evaluate the quality of life with these deficiencies and develop a health program for its solution. in order to apply the nine-phase model, the individual-patient's voluntary cooperation, determination and active participation in health practices are required.

Eligibility criteria:
inclusion criteria: * 18 years of age or older, * hemodialysis treatment for at least 6 months, * a total score of 1 or more from the dialysis diet and fluid restriction non-compliance scale, * a score between 1 and 7 on the scale of compliance with medical treatment, * place, time, person orientation, * does not have a psychiatric illness or a problem that prevents written or verbal communication, exclusion criteria: * diagnosed with psychiatric illness individuals with a diagnosis of malignancy wanting to leave research * those who do not attend all of the trainings / do not want to continue * individuals whose general condition is deteriorated

Keywords: adherence to treatment healthy lifestyle behavior hemodialysis nursing precede-proceed model quality of life
the relationship between covid-19 and autoimmune diseases, lessons from practice

Conditions: Covid19

Summary: the study explore the relationship between covid-19 and the induction of autoimmune diseases. this study comprises both retrospective and prospective components. the retrospective arm (2016-2019) was conducted to establish baseline incidence rates of autoimmune diseases (aids) prior to the covid-19 pandemic. the prospective arm (2020-2024) involves the identification and longitudinal follow-up of newly diagnosed aid cases to evaluate disease progression, therapeutic response, and recurrence. based on these data, the study will yield four distinct analyses: 1. trends in aid incidence before and after the covid-19 pandemic, 2. the demographic and clinical profile of aid patients in the post-covid-19 era, 3. the association between covid-19 vaccine status and the development of aids, and 4. the clinical course, response to therapy, and long-term outcomes of aids in post-covid patients compared to pre-pandemic cases.

it has been suggested that the shared pathogenetic mechanisms and clinical-radiological aspects between the hyper-inflammatory diseases and covid-19 may suggest that sars-cov-2 could act as a triggering factor for the development of a rapid autoimmune and/or autoinflammatory dysregulation, leading to the severe interstitial pneumonia, in genetic predisposed individuals. the study is designed to investigate four primary objectives: 1. the incidence and trends of autoimmune diseases (aids) before and after the covid-19 pandemic, 2. the association between covid-19 vaccine status and the development of aids, 3. the clinical progression, treatment response, and recurrence of aids in post-covid patients, and 4. the demographic and clinical profile, contributing factors, and spectrum of aid types identified during the post-pandemic period. retrospective data from 2016 to 2019 will be analyzed to establish baseline incidence rates, while prospective data from 2020 to 2024 will focus on new cases, vaccine exposure, clinical course, and patient characteristics. the investigators hypothesize that: 1. the incidence of aids has increased in the post-covid-19 era compared to the pre-pandemic period, 2. there is a positive association between covid-19 vaccination and the onset of aids, 3. the clinical course and therapeutic response of aids in post-covid patients differ from historical cases, and 4. unique demographic and clinical patterns characterize aid cases arising during the post-covid period. accordingly, the study will yield four distinct analyses, each to be reported in a separate manuscript corresponding to the above objectives.

Eligibility criteria:
inclusion criteria: * all gender * all age exclusion criteria: * those who refused to participate
the "level of resilience" influencing self-care in heart failure patients

Conditions: Congestive Heart Failure

Summary: adaptation to the new health condition and self-care skills allow people to be able to adhere to the therapeutic treatment in the most correct way possible, but there are many cases in which subjects do not show adherence to it, and for this reason the risk increases to manifest acute complications and also to develop long-term ones

primary objective -evaluate levels of resilience in subjects suffering from heart failure. secondary objectives * evaluate the levels of self-care in subjects suffering from heart failure. * evaluate the correlation between the level of resilience and the level of self-care; * evaluate which characteristics positively influence the level of resilience and the degree of self-care of the person with heart failure. consecutive patients suffering from heart failure followed at the cardiology department of the agostino gemelli irccs university polyclinic foundation of rome will be included

Eligibility criteria:
inclusion criteria: * subjects suffering from heart failure; * subject aged between \>18 years and \<90 years; * ability to understand the italian language; * clinical conditions that allow the questionnaire to be completed; * ability to provide written informed consent. exclusion criteria: * subjects suffering from other forms of diabetes; * subjects suffering from serious psychiatric disorders; * serious clinical conditions that do not allow the questionnaire to be completed; * inability to provide written informed consent.
a study to evaluate lbl-007 in combination with tislelizumab plus chemotherapy in participants with unresectable locally advanced or metastatic esophageal squamous cell carcinoma

Conditions: Esophageal Cancer; Esophageal Squamous Cell Carcinoma; Esophageal Squamous Cell Carcinoma by AJCC V8 Stage

Summary: this is a randomized, open-label study to compare how well lbl-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (escc).


Eligibility criteria:
inclusion criteria: * able to provide written informed consent and can agree to comply with the study requirements. * participants with metastatic escc or unresectable, locally advanced escc. * histologically confirmed diagnosis of escc. * can provide a tumor sample. * at least 1 measurable lesion as defined by recist v1.1. * eastern cooperative oncology group (ecog) performance status ≤ 1. exclusion criteria: * prior treatment for advanced or metastatic escc within the past 6 months * locally advanced escc that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator * palliative radiation treatment for escc within the past 4 weeks * participants with an esophageal/bronchial or esophageal/aorta fistula * prior treatment with programmed cell death protein-1 (pd-1) or other immune-oncological drugs note: other protocol defined inclusion/exclusion criteria may apply.
continuous wound catheter analgesia associated with intravenous morphine pca after thoracotomy

Conditions: Pain; Thoracotomy

Summary: objective: epidural analgesia is the gold standard for post-thoracotomy pain relief but is contraindicated in certain patients. an alternative is continuous wound catheter analgesia. we will investigate whether ropivacaine, administered through a wound catheter placed by the surgeon, will reduce postoperative pain. methods: in a randomized double-blind study, adult patients with a wound catheter placed by the thoracic surgeon after thoracotomy will be randomly assigned to receive through this catheter, either a 0.1 ml/kg bolus of 0.75% ropivacaine, followed by a continuous infusion of 0.2% ropivacaine at 10 ml/h for 48 h, or saline at the same scheme of administration. patients will also benefit from patient-controlled analgesia with intravenous morphine (bolus 1 mg, lockout time 7 min), paracetamol, and nefopam. the primary endpoint will be total morphine consumption. secondary endpoints will be pain intensity on a visual analog scale at rest and on coughing and side effects during the first 48 postoperative hours. surgeons, anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. solutions of saline and ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.


Eligibility criteria:
inclusion criteria: patients scheduled for thoracotomy who presented with contraindications to tea. contraindications to tea are : * patient's refusal after informations about advantages and risks of the technique * anti platelets treatment that can't be discontinued * anticoagulants at a curative dosage * haemostasis and/or coagulation disorders: thrombopenia \ 1,5 / control, ptt \< 75% * systemic or local infection of the puncture point * 2 and 3 grade atrio-ventricular heart block without pacing * severe aortic valve stenosis * kyphoscoliosis * certain neurological disorders exclusion criteria: * patient's refusal to participate in the study * psychiatric disorder (impossibility to collect the informed consent) * patient under juridical protection * on going an other study * pregnancy, breastfeeding * non balanced epilepsy * 3 grade auriculo-ventricular heart block without pacing * severe hepatocellular insufficiency * anti arrhythmic treatment : class iii of the vaughan william's classification * skin infection of the puncture point * allergy to aminoamides local anaesthetic * surgical difficulties to insert paravertebral catheter
comparison of mirror therapy and modified constrain induced movement therapy on risk of fall, balance and gait in stroke

Conditions: Stroke

Summary: there will be a difference between modified constraint induced movement therapy and mirror therapy on lower limb for risk of fall, balance and gait in stroke patients.


Eligibility criteria:
inclusion criteria: * a hemiplegia due to unilateral stroke * sub-acute and chronic stroke * stroke survivors between 21 and 70 years old will be recruited * both genders * nih stroke scale below 20 * mini-mental state examination above 24 * function in sitting test (fist) above 42/56 exclusion criteria: * patients with depression who will be unable to cooperate during treatment * patients who cannot perform the active movement of limb due to prestroke muscoskeletal problems * cardiopulmonary diseases which could hinder their ability to participate in rehabilitation * spasticity of modified ashworth scale (mas) ii or higher * patients with any neuron disease and patients with lower-limb impairment caused by other neurological diseases or inability to comply with study protocol will be excluded. * visual and auditory abnormalities

Keywords: cimt mirror therapy
study of a high-dose aflibercept in participants with diabetic eye disease

Conditions: Diabetic Macular Edema; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Summary: the primary objective of the study is to determine if treatment with high-dose aflibercept (hd) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (bcva) compared to aflibercept dosed every 8 weeks. the secondary objectives of the study are as follows: * to determine the effect of hd vs. aflibercept on anatomic and other visual measures of response * to evaluate the safety, immunogenicity, and pharmacokinetics (pk) of aflibercept


Eligibility criteria:
key inclusion criteria: * diabetic macular edema (dme) with central involvement in the study eye * best corrected visual acuity (bcva) early treatment diabetic retinopathy study (etdrs) letter score of 78 to 24 (approximate snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of dme * willing and able to comply with clinic visits and study-related procedures * provide informed consent signed by study participant or legally acceptable representative extension phase: all randomized patients that complete visit 26, week 96, as long as the patient 1) provides informed consent and 2) no treatment for dme has been given in the study eye other than the randomized study treatment. key exclusion criteria: * evidence of macular edema due to any cause other than diabetes mellitus in either eye * active proliferative diabetic retinopathy in the study eye * ivt anti-vegf treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (prp) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye * prior ivt investigational agents in either eye (eg, anti-ang-2/anti-vegf bispecific monoclonal antibodies, gene therapy, etc.) at any time * treatment with ocriplasmin (jetrea®) in the study eye at any time note: other protocol defined inclusion/exclusion criteria apply
clinical trial of integrated treatment for pain and opioid dependence

Conditions: Opiate Dependence; Chronic Pain

Summary: this study is designed to develop an effective psychotherapy for chronic pain and opioid dependence.

this study aims to develop a novel manualized intervention using tailored cognitive-behavioral treatment (cbt) and buprenorphine medication to effectively treat the co-occurring disorders of non-malignant pain and opioid dependence (pod). specific aims: 1. to conduct a pre-pilot phase with 16 patients with pod receiving buprenorphine maintenance treatment (bmt). in the pre-pilot phase, we will also explore the effects of different daily buprenorphine dosages on pain and opiate use. 2. to conduct a pilot randomized, clinical trial to obtain data regarding the feasibility, acceptability and efficacy (compared to physician management(pm) only) of manual-guided cbt or educational counseling (ec) for patients with pod treated with bmt (n=75). the secondary outcomes: development of a treatment manual and development and modification of initial therapy training and process rating measures were process measures and not been to be included as measures associated with rct. these outcomes were removed when the rct results were entered. in addition, outcomes were renamed for clarification. at results entry, the timeframe (16 weeks) was also corrected to account for the actual timeframe used for analysis in the study. the 16-week study period listed in the protocol included a 2-week buprenorphine induction period (before randomization) and up to a 2-week post-conclusion of the clinical trial continuation on buprenorphine and referral to continuing treatment. in prior studies with buprenorphine, the study team had observed an artificially high attrition during the last 2 weeks of the planned study protocol, when participants were attempting to transition to available clinical treatments outside of the study. consequently, as per the original study protocol for this study, the plan was to analyze intake and induction data (as baseline data) and then the data from the first 12-weeks post-randomization.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * prescription opioid addiction criteria * moderate to severe chronic pain * seeking or interested in buprenorphine maintenance * understand english exclusion criteria: * methadone maintenance at a dose greater than 40 mg daily * current suicide or homicide risk * life-threatening or unstable medical problem * pregnancy