Kornimate/medical-research-clean huggingface dataset:
a study with ljpc-401 for the treatment of myocardial iron overload in patients with transfusion-dependent beta thalassemia

Conditions: Beta-Thalassemia

Summary: this study is a phase 2 multicenter, randomized, open-label, parallel-group study. the primary objective of the study is to evaluate the effect of ljpc-401 (synthetic human hepcidin) on iron levels in patients with transfusion-dependent beta thalassemia with myocardial iron overload.


Eligibility criteria:
inclusion criteria: * patients ≥ 14 years of age with transfusion-dependent beta thalassemia. * patients must have increased iron levels in the heart as measured by magnetic resonance imaging (mri). two separate cardiac t2\*mri from 6 to 35 msec; \<= 15% difference between the two. * patients must be receiving iron chelation therapy for a minimum of 1 year and be on a stable dose prior to study and expected to remain stable during study. * female patients of childbearing potential must not be pregnant, must have negative pregnancy tests, and must use an effective birth control method during the study. * male patients must be either surgically sterile or use an effective birth control method during the study. * patient must be willing and able to provide written informed consent. parent of legal guardian to patients younger than age of majority must be willing and able to provide informed consent. exclusion criteria: * any significant medical condition or lab abnormality that would prevent the patient from participating in the study. * pregnant or lactating women. * patients taking an immunosuppressive agent (except topical over-the-counter steroids, inhaled steroid medications, and non-steroidal anti-inflammatory drugs) or have a planned surgery (except dental surgery or simple dermatologic procedures). * patients participating in an unapproved investigational clinical trial within 30 days of this study. * patients with a disease, disability or condition which may interfere with the conduct of the study, or which would, in the opinion of the investigator, pose an unacceptable risk to the patient. * patients who are unwilling or unable to comply with the study requirements. * patients with known hepatitis b or hepatitis c, or being treated for a positive viral load or are noncompliant with hepatitis medications. * known and active human immunodeficiency virus (hiv) infection. * patients with child pugh class c cirrhosis or liver failure. * patients with severe congestive heart failure (nyha class 4). * use of erythropoiesis stimulating agents in the past 3 months prior to study entry. * history of allergic reaction to hepcidin or excipients. * contraindication to mri scanning.
study of whole-brain irradiation with chloroquine for brain metastases

Conditions: Brain Metastasis

Summary: background and purposes:chloroquine (clq), an antimalarial drug, has a lysosomatrophic effect associate with increase the sensibility of radiation through leakage of hidroliticenzimes, increase of apoptosis, autophagy mediated by lysosomalhidrolases and increase of oxidative stress "in vitro". in this phase ii study we evaluated the efficacy and safety as radiosensitizing of the chloroquine plus concomitant 30 gray (gy) of whole-brain irradiation (wbi)in patients with brain metastases (bm) from solid tumors.

seventy-three eligible patients were randomized. thirty-nine patients received wbi (30 gy in 10 fractions over 2 weeks) concomitant with 150 mg of clq for 4 weeks (the clq group). thirty-four patients received the same schedule of wbi concomitant with a placebo for 4 weeks (the control arm). all the patients were evaluated for quality of life (qol) using the eortc qlq-c30 questionnaire (mexican version) before beginning radiotherapy and one month later.

Eligibility criteria:
inclusion criteria: * 18 to 80 years of age * at leat one brain metastasis mri * kps 70 or more * rtog-rpa i or ii * basic laboratory requirements exclusion criteria: * candidates for radiosurgery, neurosurgery * patients treated with radiotherapy before entered to the study

Keywords: prophylactic cranial irradiation metastasis cloroquine
mortality reduction in septic shock by plasma adsorption

Conditions: Septic Shock

Summary: the study objective is to clarify whether the application of high doses cpfa (coupled plasma-filtration adsorption) in addition to the current clinical practice is able to reduce hospital mortality in septic shock patients in intensive care unit (icu).


Eligibility criteria:
inclusion criteria: * all patients admitted to the icu in septic shock * all patients that develop septic shock while in the icu exclusion criteria: * age less than 18 years * pregnancy * estimated life expectancy (due to comorbidities) less than 90 days * presence of relative or absolute contraindications to cpfa * absence of informed consen
virtual rehabilitation for the treatment of motivational deficits in schizophrenia

Conditions: Schizophrenia

Summary: the loss of motivation has emerged as a critical symptom in schizophrenia that is consistently linked to functional disability for affected individuals. despite advances in treatment, there have not emerged any effective treatments for this loss of motivation, which ultimately hinders our ability to promote recovery for individuals with schizophrenia. to address this critical unmet therapeutic need, this study aims to investigate a novel computerized motivation rehabilitation program using virtual reality to treat motivation loss in schizophrenia.

motivational deficits have emerged as a critical determinant of functional disability in schizophrenia (sz). despite significant advances in our understanding and treatment of the illness, effective therapeutic strategies for motivational deficits have remained elusive. this has ultimately hindered our ability to promote recovery for individuals with sz so that they can return to their premorbid level of functioning. an emerging therapeutic approach in sz has utilized computerized remediation strategies, with recent efforts focused on cognitive deficits. to date, however, such a therapeutic strategy has not been developed for the critical motivational deficits in sz. in light of the detrimental functional consequences of motivational deficits in sz, there is a clear need for effective therapeutic strategies for the treatment of these motivational deficits experienced by affected individuals. to address this unmet therapeutic need, this pilot therapeutic trial will investigate the efficacy of a novel virtual reality-based motivation rehabilitation program in schizophrenia.

Eligibility criteria:
inclusion criteria: 1. between 18 and 35 years old; 2. dsm-iv diagnosis of schizophrenia or schizoaffective disorder; 3. outpatients on a stable dose of antipsychotic and other psychotropic medications for the preceding 4 weeks; 4. minimum apathy evaluation scale (aes) score of 34. exclusion criteria: 1. diagnosis of other dsm-iv axis i disorders; 2. history of active substance abuse or dependence in the past 6 months, with the exception of nicotine; 3. history of neurological disease; 4. history of head trauma with loss of consciousness \>30 minutes 5. presence of significant akathisia (a rating of \>2 on the barnes akathisia rating scale (bars) global item); or 6. presence of significant extrapyramidal symptoms (a rating of \>2 on \>2 items of the simpson angus rating scale (sars)) 7. any mri contraindications.

Keywords: virtual reality negative symptoms
preliminary testing of the vitaliti cvsm wearable, vitaliti spirotoscope, and vitaliti ivd station

Conditions: Urinary Tract Infection; Diabetes Mellitus; Atrial Fibrillation; OSA; COPD; Pneumonia; Acute Otitis Media; Leukocytosis; Iron Deficient Anemia; Hypertension; Healthy Volunteers

Summary: the study objective is to satisfy the testing requirements for the qualcomm tricorder xprize competition. this requires an oversight model using the vitaliti cvsm wearable, vitaliti spirotoscope, and vitaliti ivd station to continuously monitor the patient's five core vital signs and to detect the health conditions required by the competition.


Eligibility criteria:
inclusion criteria: * age 18 to 65 years of age. * english speaking * established diagnosis of one of the thirteen required conditions with evidence in medical record. exclusion criteria: * lack of patient consent * has pacemaker or internal medical device * pregnancy * concurrent enrollment into a clinical trial that may affect subject treatment * age less than 18 or over 65 * physical disabilities affecting vision (eyeglasses or contact lenses will be allowed), manual manipulation, or use of a computer or mobile device
a study of hrs7415 tablets in patients with advanced malignant tumors

Conditions: Advanced Malignant Tumor

Summary: this study is a multicenter, open phase i clinical study of dose escalation and dose extension of hrs7415 in subjects with advanced malignant tumors. to evaluate the safety, tolerability, pharmacokinetics and efficacy of hrs7415 tablets.


Eligibility criteria:
inclusion criteria: 1. subjects volunteered to participate in the clinical study, understood the study procedure and was able to sign informed consent in person. 2. 18 to 75 years old, male or female. 3. ecog performance status of 0 or 1. 4. the estimated survival time is ≥12 weeks. 5. subjects with advanced or metastatic malignancy confirmed by histopathology or cytology. 6. solid tumor subjects had measurable lesions that met recist 1.1 criteria. 7. adequate hematology and terminal organ function, with vital organ function meeting the upper and lower limits required by the protocol. 8. male subjects and fertile female subjects must agree to use medically approved contraception during the study period and for 6 months following the study; fertile female subjects must have a negative serum human chorionic gonadotropin (hcg) test within 7 days prior to initial dosing and must be non-lactation blood pregnancy test must be negative and not lactation. exclusion criteria: 1. subjects plan to receive any other antitumor therapy during the study period. 2. subjects received chemotherapy, radiotherapy, biotherapy, targeted therapy, or immunotherapy within 4 weeks prior to initial dosing. 3. major surgery other than diagnosis or biopsy was performed within 4 weeks prior to initial dosing. 4. received any other investigational drug or treatment that is not on the market within 4 weeks prior to initial dosing. 5. the damage caused by any previous antineoplastic therapy has not recovered to grade ≤1. 6. imaging diagnosis showed tumor lesion or meningeal metastasis in the brain. 7. active heart disease in the 6 months prior to initial dosing. 8. had other malignancies within 5 years prior to first dosing. 9. subjects with poorly controlled hypertension and a previous history of hypertensive crisis or hypertensive encephalopathy. 10. having one of several factors affecting oral medication or having active gastrointestinal disease or other medical conditions that may result in significant influence on drug absorption, distribution, metabolism or excretion; 11. active hepatitis b and c; 12. serious infections that require intravenous antibiotics, antivirals or antifungals to control; 13. history of immune deficiency or organ transplantation; 14. comorbidities or any other conditions that, in the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study.
autologous fat augmentation of orbital volume using a closed cannula technique

Conditions: Orbital Fat Atrophy

Summary: after enucleation or evisceration with placement of a dermis fat graft or integrated orbital implant as a primary procedure, there can be secondary loss of orbital fat volume causing regression of periocular tissue and malpositioning of the cosmetic shell. current techniques for correction require open surgery to place a sheet/block of biocompatible material or a macroaggregate of fat into the orbit to augment orbital volume for permanent correction. alternatively, hyaluronic acid-base fillers (restylane, radiesse) have been injected, but these have proved to be temporary. the current study seeks to show that a permanent augmentation of orbital volume can be achieved using a closed cannula injection of autologous fat.

to date, 5 subjects have completed fat injections and 4/5 have acquired complete sets of 3 mris each. data analysis has begun. the study has been extended to include 5 more subjects (total 10) to increase the number of data for analysis. to date, the protocol has been expanded to include 10 subjects of which 6/10 have completed fat injections. the study period has been extended to include mris at 2 and 5 years after injection.

Eligibility criteria:
inclusion criteria: * subjects who have developed secondary orbital fat atrophy after enucleation/evisceration with or without dermis fat grafting * standard sphere or integrated orbital implantation * phthisis bulbi are candidates exclusion criteria: * class 3 or greater anesthesia risk * infection * inability to follow study protocol

Keywords: autologous fat orbit atrophy cannula
exogenous reinfection of tuberculosis in taiwan

Conditions: Tuberculosis

Summary: we hypothesize that exogenous reinfection is very important in the taiwan endemic. therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the taiwan endemic, and to realize the impact of exogenous reinfection. first, we will identify the patients with tb relapse after complete treatment. the m. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.

tuberculosis (tb) remains the most important infectious disease in the world. in taiwan, the incidence of tb increased in recent years. the failure of control implies the necessity to reevaluate the epidemiology of mycobacterium tuberculosis. it is widely thought that most cases of tb are caused by reactivation of a latent infection. treatment programs have therefore focused on cure rates rather than tracking of additional cases. but recent studies showed that exogenous reinfection plays an important role in the development of tb. in addition, it seems that the higher the local incidence, the more important exogenous reinfection is. the question of exogenous reinfection versus endogenous reactivation has an impact on the distribution of resources for the prevention and treatment of tb. based on these evidences, we hypothesize that exogenous reinfection is very important in the taiwan endemic. therefore, we design a series of studies to evaluate the individual contribution of exogenous reinfection and endogenous reactivation in the taiwan endemic, and to realize the impact of exogenous reinfection. first, we will identify the patients with tb relapse after complete treatment. the m. tuberculosis isolates responsible for their initial and recurrent episodes will then be genotyped to clarify the percentage of exogenous reinfection and endogenous reinfection.

Eligibility criteria:
inclusion criteria: * culture-proven tuberculosis with recurrence

Keywords: tuberculosis relapse reinfection reactivation dormancy tuberculin skin test
psychiatric disorders related to diabetes mellitus type 1

Conditions: Diabetes Mellitus Type 1; Adolescents; Psychiatric Disorders

Summary: the most common endocrine illness in children and adolescents is type 1 diabetes. it is distinguished by a lack of insulin synthesis and necessitates daily insulin injections to keep glucose levels under control. as a result, there are numerous medical approaches to its management, such as levels of glycosylated haemoglobin (hba1c) as a marker of glycemic control during the previous three months and monitoring of blood glucose levels, which affect the patient's mental health and quality of life. type 1 diabetes complications and poor quality of life are widespread. diabetes therapy is difficult during puberty and adolescence. adolescents with t1d have poor metabolic control and a higher rate of acute complications. because the onset of adolescence is frequently associated with decreased adherence to therapy and an increased risk of psychological illnesses.


Eligibility criteria:
inclusion criteria: 1. both males and females were included. 2. age ranges from 10 to 19 years. 3. willing of the parents or the caregivers to participate in the study. 4. duration of t1dm of at least 1 year. exclusion criteria 1. adolescents with an intelligence quotient below 70. 2. adolescents with a history of substance use or psychiatric disorders. 3. adolescents with medical or other neurological conditions.
holter monitoring of critically-ill childern in picu at sohag university hospital

Conditions: Critically Ill Childern in PICU

Summary: holter monitoring is a way to continuously check the electrical activity of the heart . continuous ecg recording show to be one of the most effective noninvasive clinical tools in the diagnosis of cardiac symptoms prognostic assessment and in the evaluation of many cardiac therapeutic intervention. the clinical utility of ambulatory ecg lies in its ability to examine continuously a patient over an extended period of time, permitting patient ambulatory activity and facilitating the diurnal electrocardiographic examination of a patient in a changing environmental conditions (both physical and psychological) .


Eligibility criteria:
inclusion criteria: * 1- children admitted to pediatric department as in : * pediatric intensive care unit (picu). * pediatric critical care unit (pccu). * emergency room (er). 2- age from 1 month- 12 years. 3- critical ill child fulfill these criteria: * persistent convulsions. * abnormal gcs * haemodynamic instability * foreign body inhalation * sever cardiac problem * irregular breathing * dka * others exclusion criteria:1-neonates 2-end-stage or those with end-organ failure . 3-whom gcs is below 6. 4-whom done cardiac catheterization for any purpose . 5-previously done holter. 6-multiple traumatized patient.
the role of nems for post icu rehabilitation

Conditions: Critical Illness

Summary: the purpose of this study is to investigate the role of nems as a rehabilitation tool for muscle weakness following critical illness. the investigators hypothesized that nems combined with exercise rehabilitation will have a beneficial role in restoration of muscle strength

survivors of critical illness are presented with significant physical impairment that is associated with reduced functional ability and health -related quality of life both in the short and long-term. neuromuscular electrical stimulation (nems) has been proposed as an alternative exercise modality in patients with severe chronic obstructive pulmonary disease and chronic heart failure, who cannot perform active exercise. nems has also been used as a preventive tool for intensive care unit (icu) acquired weakness (icuaw). its role as a tool for post icu rehabilitation has not been evaluated so far. a randomized intervention study was designed to assess the efficacy of nems, as a rehabilitative tool for critical illness survivors. the first day that patients are discharged from the icu after stratified randomization are assigned to the nems group or to the control group. in the nems group, nems will be applied to both lower extremities of the nems -group simultaneously (quadriceps femoris muscle and peroneus longus) on a daily basis, along with a personalized exercise program. nems sessions will continue until patient discharge from hospital. in the control group, sham nems will be applied along with standard care when it comes to physiotherapy. at hospital discharge patients of both groups of will receive a rehabilitation booklet. patients on the nems group that have significant muscle weakness will have nems sessions at home for a period of 2 months. patients are evaluated at 3 and 6 months after hospital discharge

Eligibility criteria:
inclusion criteria: * patients under mechanical ventilation for\> 72hours during icu stay * patients able to perform simple commands (able to be evaluated by mrc scale) exclusion criteria: * age \ 85 years * pregnancy * pre-existing neuromuscular disease (e.g. gravis) * fractures or skin lesions that do not allow the implementation of nems * presence of pacemaker or defibrillator * fractures of spine that so not allow mobilization * bmi \> 35 kg/m2 * terminal disease

Keywords: icu acquired weakness critical illness polyneuromyopathy post icu rehabilitation neuromuscular electrical rehabilitation handgrip
the impact of sarcopenia on copd exacerbation admission outcome and further exacerbation risk

Conditions: Sarcopenia; COPD Exacerbation

Summary: chronic obstructive pulmonary disease (copd) is more prevalent and has more impact on health status because of progressive air pollution, tobacco smoking and aging society. the copd prevalence investigation in 2013 by phone call showed at least 6% of the population with more than 40 years-old in taiwan. it also was the 7th ranking of death causes in taiwan then. apart from chronic inflammation in lung and deteriorated lung function, it had extrapulmonary complications, such as cardiovascular problems, osteoporosis and muscle wasting. the concept of sarcopenia was proposed at first in 1989. it increases the risk of falls, disability and lowering life quality. besides, it increased the mortality risk after admission from acute ward. thereafter, sarcopenia is one of copd co-morbidities, which should have great impacts of copd. the studies showed sarcopenia reduced exercise capacities and worsening dyspnea scores. on the other hand, copd exacerbation brings significant health burden. but there is limited data about the effect on sarcopenia on copd exacerbation. we conducted a prospective observational study. we measured skeletal muscle mass and the strength of the used hand grip within 3 days of admission and before discharge. mortality and exacerbation in one year are the primary end-points


Eligibility criteria:
inclusion criteria: patients more than 45 years-old, were admitted due to copd exacerbation. copd exacerbation criteria: 1. acute worsening respiratory symptoms without any other causes, and 2. smoking more than 15 pack-years or the history of noxious gas exposure, and 3. spirometry reports suggests obstructive ventilatory defect (fev1/fvc \<0.7) or 4. attending physicians diagnose as copd by clinical parameters if spirometry data are not available while enrolling. definite copd exacerbation: fulfill 1、2、3 probable copd exacerbation: fulfill 1、2、4 exclusion criteria: 1. significant fluid retention such as edema, pleural effusion or ascites, 2. patients with permanent pacemaker or implantable cardioverter defibrillator , 3. morbid obesity with bmi \>34