Kornimate/medical-research-clean huggingface dataset:
effectiveness and safety study of generic imatinib in chronic myeloid leukemia patients in egypt

Conditions: Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Chronic Phase

Summary: the purpose of this observational study is to evaluate the effectiveness and safety of generic imatinib under usual clinical practice in patients of philadelphia chromosome-positive (ph+) chronic myeloid leukemia (cml) patients in chronic phase (cp) in egypt

an observational, multi-center, prospective cohort study to assess the effectiveness and safety of generic imatinib (carcemia®) in patients with ph+ cml who are newly diagnosed or patients who will be switched from the reference product (glivec® ) to carcemia® where treatment will be prescribed by the investigator in accordance with clinical practice where no visits or intervention(s) additional to the daily practice will be performed. eligible ph+ cml patients in both cohorts will be followed up for a total of 18 months.

Eligibility criteria:
inclusion criteria: first cohort (newly diagnosed patients): * age ≥18 years * newly diagnosed patients with ph+ cml in cp, with or without the presence of other cytogenetic abnormalities at the time of diagnosis * treatment naïve patients with confirmed diagnosis within 3 months of study enrolment * levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range * written informed consent second cohort (switched patients): * age ≥18 years * ph+ cml patients in cp currently treated with glivec®, with or without the presence of other cytogenetic abnormalities at the time of switch * levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range and serum creatinine ≤1.5 times the upper limit of the normal range * written informed consent exclusion criteria: * cml in accelerated phase (ap) at enrollment except patients in ap with the presence of other cytogenetic abnormalities at the time of diagnosis * cml in bp at enrollment * patients who meet any of the contraindications to the administration of the study drug according to the approved summary of product characteristics

Keywords: imatinib generic imatinib leukemia chronic myeloid leukemia philadelphia chromosome-positive chronic phase observational study switched patients tyrosine kinase inhibitor
brain aging in veterans (brave) training: a cognitive training pilot trial in older veterans with traumatic brain injury

Conditions: TBI (Traumatic Brain Injury)

Summary: the purpose of this study is to conduct a pilot trial investigating cognitive training in older veterans with a history of traumatic brain injury (tbi) to assess training effects, acceptability of training to participants, and to explore whether other factors influence training effects.

a study of older veterans (60-85 years old) who have 1) a history of repetitive mild tbi or at least one moderate tbi and 2) subjective cognitive complaints. participants will be randomized to one of three conditions for 4 weeks: project:evolution (evo) multitask video game, evo words video game, or an assessment only control condition. participants will complete assessment visits at baseline, post-intervention (1 month after baseline), and 3 months post-intervention (4 months after baseline).

Eligibility criteria:
inclusion criteria: 1. ages 60-85 2. have experienced more than one mild tbi or at least one moderate tbi over their lifetime 3. have current cognitive problems based on self-report 4. vision adequate to see test stimuli 5. hearing adequate to understand the examiner 6. fluent in english in order to understand task instructions 7. demonstrate capacity to consent to participate in research 8. mini-mental status exam (mmse) score ≥ 25 exclusion criteria: 1. history of penetrating brain injury 2. active disabling neurological condition (e.g., stroke, brain tumor, multiple sclerosis) 3. history of severe psychiatric illness (i.e., schizophrenia, bipolar disorder, schizoaffective disorder) 4. active drug use or active heavy alcohol use 5. history of severe tbi 6. history of a dementia diagnosis 7. individuals who are physically unable to use an ipad for 30 minutes at a time per day will be excluded, such as individuals with debilitating arthritis or tremor

Keywords: traumatic brain injury (tbi) aging cognitive training cognitive aging
management of major bleeding events in atrial fibrillation patients using pradaxa

Conditions: Atrial Fibrillation; Hemorrhage

Summary: this study is being conducted to collect data on the management of major bleeding events occurring in patients with atrial fibrillation taking dabigatran etexilate.

purpose:

Eligibility criteria:
inclusion criteria: * greater than or equal to 18 years of age; * confirmed diagnosis of non valvular atrial fibrillation (nvaf) (diagnosis of af is considered confirmed if there is medical chart documentation that the patient has atrial fibrillation or af or the icd-9 or icd-10 code for af is documented); * nvaf is defined as follows: nonvalvular atrial fibrillation is restricted to cases in which the rhythm disturbance occurs in the absence of rheumatic mitral stenosis or a prosthetic heart valve. * documentation that the patient presented to an emergency department/emergency room (ed/er) for a major bleeding event (index event); * major bleeding is defined by international society on thrombosis and haemostasis (isth) as: * fatal bleeding and/or * symptomatic bleeding in a critical area/organ such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome, and/or * bleeding causing a fall in hemoglobin of 20g per liter or more, or leading to transfusion of 2 or more units of whole blood or red blood cells * documentation that the index event occurred in a patient who reported having taken at least one dose of dabigatran within the 5 days prior to the index event. exclusion criteria: * confirmed diagnosis of valvular af (diagnosis of valvular af is considered confirmed if there is medical chart documentation that the patient has valvular af or vaf. in the absence of documentation to indicate whether the patient has non-valvular or valvular af,); * documentation that the patient was taking dabigatran with a concomitant anticoagulant (contemporaneous parenteral anticoagulant or another oral anticoagulant) within 72 hours of the index event; * the concomitant administration of antiplatelet medications prior to the onset of the index event is not exclusionary; * documentation of the patient receiving thrombolytic therapy within 48 hours of the onset of the index event; * documentation that the patient was enrolled in an interventional investigational or other bi observational clinical trial at the time of the onset of the index event; * medical record was not retrievable, was missing or empty.
rinascimente, an internet-based self-help intervention for people with psychological distress due to covid-19

Conditions: Psychological Disease

Summary: this study aims is the evaluation of the efficacy and feasibility of rinascimente, the randomized controlled clinical trial compared with a waiting list control group.

a sample of 128 participants, who experience psychological discomfort due to covid-19, will be recruited. after initial screening, participants will be randomly assigned to either an experimental group or a waiting list group. measures will be taken at the baseline (t0), at the end of the treatment (t1) and 12 months follow-up (t2).

Eligibility criteria:
inclusion criteria: * 18 years old or over and both gender * italian mother-tongue * score 14 or less on patients health questionnaire-9 (phq-9) * internet access and basic informatic ability to navigate the internet platform * must be able to complete a phone interview exclusion criteria: * having severe and mental impairments, psychiatric condition and neurological disorder * not be able to use a computer or do not have internet access * not be able to complete a phone interview * score 15 or more on phq-9

Keywords: covid-19 internet-based intervention cognitive-behavioral therapy
a one-year, open-label study with teduglutide for subjects who completed study cl0600-021

Conditions: Short Bowel Syndrome

Summary: this study is a 1-year open label extension study to collect long term efficacy and safety data from patients who have completed approximately 2 years of dosing in study cl0600-021.

this study served as a 1-year extension study for those us patients who have completed the cl0600-021 study.

Eligibility criteria:
inclusion criteria: * at completion of study cl0600-021, subjects will be invited to participate in this trial if they meet the following criteria: 1. completion of the 24-month study, cl0600-021, regardless if fully weaned from pn/i.v. support 2. signed and dated informed consent form (icf) to participate before any study-related procedures of study ted-c11-001 are performed exclusion criteria: * none

Keywords: parenteral nutrition tpn hpn pn sbs short bowel syndrome
phase iii hallmark dual: asv+dcv (nulls/partials, intolerants/ineligibles. naives)

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to estimate efficacy, as determined by the proportion of subjects with sustained virologic response at post-treatment week 12 (svr12), defined as hepatitis c virus (hcv) ribonucleic acid (rna) \< limit of quantitation (loq) at post-treatment week 12, for subjects who are prior null or partial responders to p/r or who are treatment-naive.

allocation: treatment naive cohort: randomized controlled trial, null/partial responder and intolerant/ineligible cohorts: n/a (single arm study) masking: treatment naive cohort: double blind, null/partial responder and intolerant/ineligible cohorts: open intervention model: treatment naive cohort: parallel, null/partial responder and intolerant/ineligible cohorts: single group

Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * males and females, ≥ 18 years of age * hcv genotype 1b who previously failed treatment with peginterferon alfa and ribavirin, classified as previous null or partial responders based on previous therapy, or intolerant or ineligible to p/r due to neutropenia, anemia, depression or thrombocytopenia with fibrosis/cirrhosis, or treatment naive * hcv rna ≥ 10,000 iu/ml * seronegative for human immunodeficiency virus (hiv) and hepatitis b surface antigen (hbsag) * subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 25% of treated population) exclusion criteria: * prior treatment of hcv with hcv direct acting antiviral (daa) * evidence of a medical condition contributing to chronic liver disease other than hcv * evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy * diagnosed or suspected hepatocellular carcinoma or other malignancies * uncontrolled diabetes or hypertension
physiotherapy program for cluster headache

Conditions: Cluster Headache

Summary: this study evaluates the effectiveness of physiotherapy program in the treatment of cluster headaches. half of participants will receive a program of physiotherapy and usual drugs, while the other will receive an exercise program and usual drugs.

previous studies have shown positive effects of physical therapy in patients with primary headache. however, so far no study that assessed the effect of a physiotherapy program combined with regular medication in patients with cluster headache.

Eligibility criteria:
inclusion criteria: * cluster headache diagnosed exclusion criteria: * other types of headaches. * neurostimulator implanted. * other chronic pain processes
motivations and barriers to participating in ophthalmology research projects

Conditions: Eye Diseases

Summary: the primary objective of this project is to understand the reasons why patients agree / disagree to take part in ophthalmology research. this will be done by asking participants to complete a research questionnaire.


Eligibility criteria:
inclusion criteria: * over 16 years old * willing to participate by completing the questionnaire * must be able to speak and read english exclusion criteria: * under 16 years of age * not willing to complete the questionnaire
fh detection in children by salivary test

Conditions: Hyperlipoproteinemia Type II

Summary: familial hypercholesterolemia is a common cause of premature coronary heart disease, it is present in 1 per 500 to 1 per 250 people of the general population. studies on families of hypercholesterolemia have shown that children with hypercholesterolemia have a major increase in risk of coronary heart disease after the age of 20. the difference between hypercholesterolemia and normal children in their atherogenic profil begin at the age of nowadays , systematic screening techniques are not well implemented whereas their are clear world health organization guidelines. international studies show treatment must be initiated early as at the age of eight years old. in pediatry, parents can be reluctant to practice blood test on their children. in order to allow more patients to be diagnosed and treated early enough to prevent major complications we need to find an non invasive test. the main objective is to define the level of detection of cholesterol in saliva with two enzymatic tests. furthermore we aim to evaluate the performance of salivary detection of cholesterol in children.


Eligibility criteria:
inclusion criteria : * children under 18 years old, with familial hypercholesterolemia * children under 18 years old, intending surgery * being able to spit exclusion criteria: * poor dental health * for control patients: to have a known cholesterol disease

Keywords: familial hypercholesterolemia healthy volunteers
physiotherapy approach for susac syndrome

Conditions: Susac Syndrome

Summary: susac's syndrome is a rare autoimmune disorder characterised by a triad of encephalopathy (brain dysfunction), branch retinal artery occlusion (loss of vision) and sensorineural hearing loss. this study presents the case of a patient undergoing intensive physiotherapy intervention following an injury, focusing on assessments such as volume and range of motion measurements, manual muscle tests, and pain intensity evaluations using various scales.

the patient, aged 17, initially presented with severe limitations in mobility, diagnosed with susac syndrome. requiring assistance to walk even short distances due to fear and insecurity. through a structured physiotherapy program spanning several months, various assessments were conducted, including manual muscle tests and circumference measurements. significant improvements were observed for muscle function, upper and lower limb circumferences, and performance in mobility tests.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of susac syndrome. * willingness and ability to participate in a 12-week intensive physiotherapy program. * stable medical condition that allows participation in physiotherapy without significant risks. * ability to provide informed consent for participation in the study. exclusion criteria: * presence of severe comorbidities or medical conditions that would interfere with participation in physiotherapy or confound the study outcomes. * inability to comprehend or follow the instructions for physiotherapy exercises. * pregnancy, as certain physiotherapy modalities may not be suitable during pregnancy. * any other condition or circumstance that, in the opinion of the investigator, would compromise the safety or validity of participation in the study.

Keywords: physiotherapy
a real-world study of the efficacy and safety of nimotuzumab in combination with chemoradiotherapy for lascchn

Conditions: Locally Advanced Head and Neck Squamous Cell Carcinoma

Summary: this study is a retrospective real-world study. in this study, we plan to collect the clinical data of lascchn patients who received chemoradiotherapy combined with or without nimotuzumab .

this study is a retrospective real-world study. the diagnosis and treatment of patients, disease management, and information collection are completely dependent on the daily medical practice. in this study, we plan to select 5 to 8 hospitals nationwide to collect the clinical data of lascchn patients who received chemoradiotherapy combined with or without nimotuzumab from january 2015 to december 2018. patients included in the study will be followed up for survival. the main endpoint is 3-year overall survival (os) rate; the secondary endpoint are 3-year progression-free survival (pfs) rate, 3-year local-regional control (lrc) rate, objective response rate (orr), disease control rate (dcr) and safety.

Eligibility criteria:
inclusion criteria: * age ≥18 years old, no gender limitation; * histopathologically or cytologically proved to be phase iii-ivb of head and neck squamous cell carcinomas (including oral cancer, oropharynx cancer, hypopharynx cancer, larynx cancer, but except for nasopharyngeal carcinoma). * patients who received chemoradiotherapy combined with or without nimotuzumab from january 2015 to december 2018; * patients in the study group received nimotuzumab, while patients in the control group did not receive nimotuzumab. and patients in the control group were collected 3 times as many cases as the study group in each center. if the number of patients in the control group were less than 3 times of the study group, all cases were collected. exclusion criteria: * complicated with primary malignancies other than head and neck tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * patients received other targeted therapy, immunotherapy, or traditional chinese medicine with anti-tumor effect, along with the application of nimotuzumab; * lack of critical evaluation information.
effectiveness of the hippotherapy simulator in children and adolescents with cystic fibrosis

Conditions: Cystic Fibrosis in Children

Summary: cystic fibrosis (cf) is a genetic disease that affects many organs and systems, especially respiratory system problems due to lung damage. patients often have difficulty in removing the sticky and viscous secretion that accumulates in the respiratory tract, and the risk of mortality increases with the development of respiratory failure. in patients with cf, exercise capacity, peripheral muscle strength, core endurance, flexibility, postural stability, physical activity level, and quality of life also decrease secondarily. recently published guidelines recommend respiratory physiotherapy for coping with cf-related symptoms and recommend referral of patients to physical activity and exercise. hippotherapy simulator is a mechanical exercise tool that imitates the walking movement of a real horse and is used to increase physical fitness parameters. this study aims to show the effects of exercises performed with a hippotherapy simulator in addition to respiratory physiotherapy on physical fitness, sputum production, physical activity and quality of life of children with cf.


Eligibility criteria:
inclusion criteria: * be in the 8-14 age range * to be diagnosed with cystic fibrosis according to the american cystic fibrosis association consensus report criteria * having mild (fev1 ≥ 70% predictive) lung disease according to the disease severity classification in the annual report of the american cystic fibrosis society * to be able to produce phlegm exclusion criteria: * contracture or deformity, * history of diagnosed orthopedic problems affecting mobility or musculoskeletal surgery * history of previous lung or liver transplant * have diagnosed vision, hearing, vestibular or neurological problems that may affect balance, * history of hospitalization in the last 1 month * patients who have participated in any exercise training program in the last 6 months

Keywords: cystic fibrosis hippotherapy simulator pulmonary functions sputum expectoration functional capacity 6-minute walk test postural stability motor performance respiratory physiotherapy
minocycline in acute spinal cord injury (masc)

Conditions: Spinal Cord Injuries

Summary: the objective of this study is to assess the efficacy of iv minocycline in improving neurological and functional outcome after acute non-penetrating traumatic spinal cord injury (sci). the primary hypothesis is that intravenous minocycline twice daily (800 mg initial dose tapered to 400 mg by 100 mg at each dose then administered to the end of day 7) administered to subjects with acute traumatic non-penetrating cervical sci starting within 12 hours of injury will improve motor recovery as assessed by the international standards for neurologic classification of spinal cord injury - isncsci (a.k.a. asia) neurological examination measured between 3 months and 1 year post-injury, compared to placebo. the secondary hypotheses are that the above minocycline treatment will also results in improvement in asia sensory improvement, in asia grade and in functional outcome as assessed by spinal cord independence measure (scim) and short form 36 (sf-36), compared to placebo. in addition the effect of minocycline on neurological and functional outcome after sci is expected to be more pronounced in those subjects with motor incomplete sci compared to those with motor compete sci. a subgroup analysis will be undertaken to examine this hypothesis.


Eligibility criteria:
inclusion criteria: * age 16 or over * acute traumatic non-penetrating cervical sci involving neurological levels as defined by the asia neurological examination between c0 and c8 and resulting in a detectable change in the asia motor assessment * patient english speaking and able to provide informed consent * randomization and administration of first dose (drug or placebo) within 12 hours of injury. exclusion criteria: * history of systemic lupus erythematosus (sle) * pre-existing hepatic or renal disease * tetracycline hypersensitivity * pregnancy or breast feeding * isolated radicular motor deficit * significant leucopenia (white blood cell count \< 1⁄2 times the lower limit of normal) at screening * elevated liver function tests (ast, alt, alkaline phosphatase, or total bilirubin \> 2 times the upper limit of normal) at screening * presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, lyme disease, clinically significant cardiac disease, hiv, htlv-1) * associated traumatic conditions interfering with informed consent or outcome assessment (e.g. closed head injury, liver contusion) * known uncorrected severe coronary artery disease or evidence of active coronary ischemia (ecg changes, positive troponin) will be excluded, as they may not tolerate the standardized protocol for hemodynamic management

Keywords: minocycline randomized control trial phase 3 spinal cord injury
laser-assisted icsi versus conventional icsi

Conditions: Infertility

Summary: degeneration rate after icsi is expectable but decreasing it is a goal. laser-assisted icsi can serve to decrease this degeneration rate.


Eligibility criteria:
inclusion criteria: * all icsi cycles exclusion criteria: * no exclusion