Kornimate/medical-research-clean huggingface dataset:
translation and validation of stroke impact scale 3.0 in urdu for pakistan

Conditions: Stroke

Summary: background knowledge about the perceived impact of stroke on survivors' lives is still scarce in pakistan due to the lack of translated and culturally adapted self-rating scales. the stroke impact scale is a comprehensive self-reported outcome measure designed to assess the quality of life following the stroke. although the psychometric properties of sis found to be superior to the conventional generic quality of life scales, it has not been translated and tested in pakistan. objective to translate and cross-culturally validate the urdu version of stroke impact scale 3.0 for pakistan material and methods established guidelines were followed for translation and adaption of the stroke impact scale 3.0. a prospective cohort of 116 patients with mild to moderate stroke self-reported their recovery on the urdu version of sis 3.0. the patients were concurrently evaluated on the established scales to assess the validity using the spearman correlation coefficient. anova was used to determine the discriminant validity. ninety patients were consecutively re-evaluated to determine the test-retest reliability, precision, minimal detectable change (mcd) and clinically minimally important difference. the coefficients of icc, cronbach's alpha, and weighted kappa were calculated to establish the stability and consistency of the scale. the receiver operating curve was used to estimate the mcid of sis-16 using global rating scale as an anchor. keywords: stroke, stroke impact scale, outcome measures, quality of life


Eligibility criteria:
inclusion criteria: * patients with acute, subacute or chronic stroke * patients with hemorrhagic or ischemic or recurrent stroke attack * age of patients between 50-80 * ability to read and write urdu with minimum education to 5th grade exclusion criteria: * patients with severe neurological comorbidities * patients having communication difficulties, such as patients with global aphasia or reduced consciousness.
evaluating the efficacy and safety of co-administrated rosuvastatin/ezetimibe and telmisartan/amlodipine

Conditions: Hypercholesterolemia; Hypertension

Summary: the purpose of this study is to evaluate the efficacy and safety of co-administrated rosuvastatin/ezetimibe and telmisartan/amlodipine in patients with primary hypercholesterolemia and essential hypertension.

this trial is a phase 3 study to evaluate efficacy and safety of co-administrated rosuvastatin/ezetimibe and telmisartan/amlodipine in patients with primary hypercholesterolemia and essential hypertension. in "rosuvastatin/ezetimibe+telmisartan/amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "rosuvastatin/ezetimibe+telmisartan/amlodipine" for 8 weeks. in "rosuvastatin/ezetimibe +telmisartan " treatment group, 48 subjects will be assigned and the subjects administer "rosuvastatin/ezetimibe+telmisartan" for 8 weeks. in "telmisartan/amlodipine" treatment group, 48 subjects will be assigned and the subjects administer "telmisartan/amlodipine" for 8 weeks.

Eligibility criteria:
inclusion criteria: * signed informed consent * subjects with hypertension and hyperlipidemia exclusion criteria: * patient with known or suspected secondary hypertension * other exclusions applied
effect of oral feeding on patients with chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this is a prospective, randomized controlled clinical trail that involved patients with chronic obstructive pulmonary disease.the goal of this clinical trial is to compare the clinical effect of oral tubes vs nasogastric tubes in patients with chronic obstructive pulmonary disease. the main questions it aims to answer are: compared to nasogastric tube feeding, can the oral esophageal tube feeding better improve the nutritional status and pulmonary infection

this is a prospective, randomized controlled clinical trail that involved patients with chronic obstructive pulmonary disease.the goal of this clinical trial is to compare the clinical effect of oral tubes vs nasogastric tubes in patients with chronic obstructive pulmonary disease. the main questions it aims to answer are: compared to nasogastric tube feeding, can the oral esophageal tube feeding better improve the nutritional status and pulmonary infection participants will be divided into two groups randomly, with different nutritional support respectively.

Eligibility criteria:
inclusion criteria: * a diagnosis of copd confirmed by spirometry * ≥18 years of age * sinus rhythm ≥50/min and \< 120/min at inclusion * written informed consent exclusion criteria: * known hypersensitivity to metoprolol or related derivatives * sinus bradycardia (resting heart rate \< 50/min) * sick sinus syndrome unless treated with a pacemaker * atrial fibrillation/flutter * clinical signs or previous diagnosis of heart failure, angina pectoris, myocardial infarction, cerebrovascular disease, or critical peripheral ischemia
a study of acalabrutinib in combination with rituximab versus ibrutinib versus acalabrutinib in subjects with relapsed or refractory mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: this study is evaluating the efficacy of acalabrutinib in combination with rituximab (arm 1) versus ibrutinib (arm 2) versus acalabrutinib (arm 3) for the treatment of relapsed or refractory (r/r) mantle cell lymphoma (mcl).


Eligibility criteria:
inclusion criteria: * men and women ≥ 18 years of age. * pathologically confirmed mantle cell lymphoma (mcl). * eastern cooperative oncology group (ecog) performance status of ≤ 2. * agreement to use highly effective forms of contraception during the study and for 90 days after the last dose of acalabrutinib or ibrutinib or 12 months after the last dose of rituximab (whichever is longest). * disease that has relapsed, or been refractory to, ≥ 1 prior treatment regimen for mantle cell lymphoma (mcl). * willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty. * ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations). exclusion criteria: * any history of central nervous system (cns) lymphoma or leptomeningeal disease. * prior exposure to ibrutinib or to a b-cell receptor (bcr) inhibitor. * significant cardiovascular disease. * malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. * uncontrolled active systemic fungal, bacterial, viral, or other infection. * known history of infection with human immunodeficiency virus (hiv). * history of hepatitis b (hbv) infection or active infection with hepatitis c (hcv). * breastfeeding or pregnant.

Keywords: bruton tyrosine kinase inhibitor btk acp-196 mantle cell lymphoma mcl
adolescent idiopathic scoliosis (ais) gold standard for blood loss

Conditions: Adolescent Idiopathic Scoliosis

Summary: the purpose of this study is to establish a benchmark for measuring blood loss by directly measuring the change in red cell volume before and after surgery and to compare established blood loss estimators to this benchmark in order to determine the most accurate and precise method for estimating blood loss in adolescent idiopathic scoliosis surgery patients

bleeding is a necessary and unavoidable part of spine surgery. it is important to the surgeons and anesthesiologists to know how much blood a patient has lost during surgery in order to care for them in the best way possible. different methodology has been employed to estimate how much blood is lost during surgery, but unfortunately none of the methods used have been reliable. the study will calculate surgical blood loss by determining perioperative change in red cell volume that is directly measured by using a special method that relies on radioisotope i-131-labeled albumin administration (bva-100) during the surgery. this benchmarked blood loss estimate will then be compared to estimates calculated using the gross equation, the bourke and smith equation, and the camarasa formula. in addition, blood loss will be estimated volumetrically by utilizing formulas based on the amount of salvaged blood produced by an intraoperative salvaging system (cell saver®). blood loss estimates based on salvaged blood volume will also be compared to the benchmark.

Eligibility criteria:
inclusion criteria: * ages 10-17 years old * surgery scheduled for posterior spinal fusion correction of idiopathic scoliosis exclusion criteria: * congenital or neuromuscular scoliosis * known coagulopathy or platelet dysfunction

Keywords: scoliosis pediatric surgery orthopedics blood loss
telephone delivery of cognitively augmented behavioral activation (caba)

Conditions: Traumatic Brain Injury; Posttraumatic Stress Disorder

Summary: traumatic brain injury (tbi) is highly prevalent and frequently comorbid among veterans and service members. many of these individuals sustain more than one tbi over the course of their military careers, often with little recovery time between exposures placing them at increased risk for persistent cognitive, psychological, and psychosocial difficulties that impact daily functioning and life satisfaction. the short-term objective of this study is to examine the efficacy of the manualized, 10-week, telephone delivery of tele-caba for improving cognitive and adaptive functioning. the long-term objective of this study is to develop an accessible and acceptable intervention that can be broadly disseminated to address the complex rehabilitation needs of veterans and service members. the overall goal of the tele-caba intervention is to reduce negative cognitive and psychiatric health outcomes for veterans and service members with a history of tbi, promote personal resilience, and to design an intervention that is accessible and acceptable to patients struggling to recover from tbi.


Eligibility criteria:
inclusion criteria: * veterans * active duty service members * history of tbi (confirmed by tbi interview) * self-reported cognitive complaints (as indicated on the nsi) * able to communicate by telephone exclusion criteria: * active suicidal intent * history of bipolar disorder * history of psychotic disorder * decisionally impaired * non-english speaking
nutritional outcomes after vitamin a supplementation in subjects with scd

Conditions: Sickle Cell Anemia in Children; Vitamin A Deficiency in Children

Summary: this study establishes the safety and efficacy of vit a supplementation doses (3000 and 6000 iu/d) over 8 weeks in children with scd-ss, ages 9 and older and test the impact of vit a supplementation on key functional and clinical outcomes. additionally, vitamin a status is assessed in healthy children ages 9 and older to compare to subjects with scd-ss.

suboptimal vitamin a (vit a) status is prevalent in children with type ss sickle cell disease (scd-ss) and associated with hospitalizations and poor growth and hematological status. preliminary data in children with scd-ss show that vit a supplementation at the dose recommended for healthy children failed to improve vit a status, resulting in no change in hospitalizations, growth or dark adaptation. this indicates an increased vit a requirement most likely due to chronic inflammation, low vit a intake and possible stool or urine loss. the dose of vit a needed to optimize vit a status in subjects with scd-ss is unknown.

Eligibility criteria:
inclusion criteria: * sickle cell disease, ss genotype (subjects with sickle cell disease only) * usual state of good health (no hospitalizations, emergency room visits, or unscheduled acute illness clinic visits for two weeks prior to screening) * commitment to a 119-day study (subjects with sickle cell disease only), or a 4-day study (healthy volunteers only) exclusion criteria: * hydroxyurea initiated within the previous 6 weeks (subjects with sickle cell disease only) * history of stroke (subjects with sickle cell disease only) * other chronic conditions that may affect growth, dietary intake or nutritional status * retinoic acid (topical or oral), weight loss medication and/or lipid lowering medications * subjects with a bmi greater than 98th percentile for age and sex * pregnant or lactating females (subjects who become pregnant during the course of the study will not continue participation) * liver function tests \>4 x upper limit of reference range * participation in another study with impact on vitamin a status (subjects with sickle cell disease only) * use of multi-vitamin or commercial nutritional supplements containing vitamin a (those who are willing to discontinue these supplements, with the approval of the medical care team, will be eligible for the study after a 1 month washout period. subjects taking nutritional products without vitamin a will be eligible) * inability to swallow pills (subjects with sickle cell disease only)

Keywords: retinol stable isotope dilution dxa retinyl palmitate
a study of ly3493269 in participants with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to determine the side effects related to ly3493269 in participants with type 2 diabetes. blood tests will be performed to check concentrations of ly3493269 in the bloodstream. each enrolled participant will receive ly3493269, dulaglutide, or placebo. the study will last up to approximately 16 weeks for each participant and may include up to 11 visits.


Eligibility criteria:
inclusion criteria: * are male or female not of childbearing potential * have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening * have had a stable body weight (\<5% body weight change) for the 3 months prior to screening * have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening * have type 2 diabetes mellitus (t2dm) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening * have an hba1c of at least 7.0% and no more than 10.5% at screening * have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator exclusion criteria: * have type 1 diabetes mellitus or latent autoimmune diabetes in adults * have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening * have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment * have had more than 1 episode of severe hypoglycemia, as defined by the american diabetes association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. * have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea * have a history of acute or chronic pancreatitis * have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2a or type 2b, thyroid c-cell hyperplasia, or medullary thyroid carcinoma * have calcitonin levels of 20 picograms per millilitre (pg/ml) or more at screening
efficacy of bromopride and simethicone versus bromopride in functional dyspepsia

Conditions: Dyspepsia

Summary: multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride on research participants diagnosed with functional dyspepsia.

multi-center, randomized, superiority, double blind clinical trial to asses the efficacy of fixed-dose combination of bromopride and simethicone versus isolated bromopride in the relief os dyspepsia symptoms on research participants diagnosed with functional dyspepsia.

Eligibility criteria:
inclusion criteria: * signed informed consent; * participants aged 18- 70 years; * clinical diagnosis of functional dyspepsia according to rome iii criteria; * minimum score of 22 points in padyq questionnaire exclusion criteria: * diagnosis of gastroesophageal reflux disease, irritable bowel syndrome, inflammatory bowel disease, gallstones, strongyloidiasis, giardiasis or ascariasis, clinical disease or significant psychological; * positive diagnosis for helicobacter pylori; * clinically significant organic diseases in the hde (high digestive endoscopy) prior to randomization; * history of esophageal surgery, gastrointestinal or other intra-abdominal surgery; * hypersensitivity to the components of the formulations; * allergy tartrazine yellow dye; * allergy to aspirin; * use of ppis, h2 blockers, prokinetics, antibiotics, prostaglandins or bismuth salts in the last week before the screening visit; * use of nsaids or aspirin more than two days a week (except aas \<325mg / day), other drugs that induce gastrointestinal symptoms; * pregnant women or women without adequate contraception; * advance participation in clinical trial protocols in the last twelve (12) months (cns resolution 251 of august 7, 1997, part iii, subsection j), unless the investigator considers that there may be direct benefit to it; * changes in hematological and biochemical tests: hemoglobin less than 12 g / dl, results with value 2 times the reference for ast, alt, gamma gt and alkaline phosphatase; * diagnosis of neurological or psychiatric diseases or decompensated diabetes; * use of drugs with anticholinergic action, narcotic analgesics, sedatives, hypnotics or tranquilizers; * alcoholism or sporadic use of alcohol and illicit drug use.

Keywords: functional dyspepsia
hereditary cerebral small vessel diseases registry-trial ready cohort

Conditions: Cerebral Small Vessel Diseases; Hereditary

Summary: we took hereditary cerebral small vessel disease (hcsvd) patients as our main subjects, aiming to establish a platform for a comprehensive evaluation and long-term follow-up. deeply explore the pathophysiological mechanism of hcsvd, which may render the theoretical basis for the treatment and management of hcsvd.

cerebral small vessel disease is a series of clinical, imaging, and pathological syndromes caused by a variety of risk factors affecting cerebral arterioles, arterioles, capillaries, and venules, accounting for 20% of stroke and 45% of dementia. although the incidence rate of hereditary small cerebral vascular disease is low, because of its early onset, high disability rate, and lack of effective treatment, it also brings a heavy burden to the patients and their families. therefore, it is important to study the pathogenic gene, pathogenesis, clinical characteristics, and imaging manifestations of hereditary cerebrovascular disease to provide a theoretical basis for the treatment and prevention of hereditary cerebrovascular disease in the future. this multi-center, prospective, continuous, registry study, runs from 2022 to 2027. the study is expected to recruit 100 subjects, according to the sample size design of the registry study. we recruited patients with the hereditary cerebral small-vessel disease (hcsvd) intending to establish a platform for a comprehensive assessment and long-term follow-up by collecting genetics, imaging, and clinical symptoms of the primary disease and its relatives. with long-term follow-up of the development and prognosis of imaging and clinical symptoms combined with genetics, we will work on the correlation between genes and phenotype and deeply explore the pathophysiological mechanism of hcsvd, which may render the theoretical basis for the treatment and management of hcsvd.

Eligibility criteria:
inclusion criteria: 1. all ages, male or female 2. carriers of the pathogenic genes mutation (mutation with unknown clinical significance/ suspected pathogenic mutation/ pathogenic mutation) of hcsvd confirmed by the gene tests, including but not limited to notch3, htpa1, ctsa, gla, trex1, col4a1/2, or highly-suspected hcsvd2 3. csvd related abnormalities on brain mri, any 1 or more of: 1. white matter hyperintensities, fazekas score3 ≥1 2. ≥1 newly-occurred lacunar infarcts 3. ≥1 old lacunar infarcts 4. ≥3 cerebral microbleeds 4. informed consent signed exclusion criteria: 1. diagnosis of mental disorders according to dsm-v and unable to be compliant to the research 2. patients with life expectancy less than one year due to any advanced disease, e.g., malignant tumor 3. patients unable to return for follow-up visits due to some reasons

Keywords: hcsvd multi-center prospective continuous registry
study to investigate the immune response to influenza vaccine in patients with multiple sclerosis on teriflunomide

Conditions: Multiple Sclerosis

Summary: primary objective: assess the antibody response to influenza vaccine in patients with relapsing form of multiple sclerosis (rms) treated with teriflunomide compared to a reference population. secondary objectives: * assess the effect of teriflunomide on immunoglobulin levels; * assess the safety of influenza vaccination in patients with rms treated with teriflunomide. the reference population was defined as multiple sclerosis (ms) patients with a stable treatment with interferon-β-1. antibody response was measured using hemagglutination inhibition assay (hia) and the hemagglutinin antigens representing the stains of h3n2, h1n1, and b as present in the influenza vaccine used.

the maximum duration of the study period for a participant was approximatively 49 days broken down as follows: * screening period of up to 21 days; * influenza vaccination at day 1; * follow-up period of 28 days (±2 days). ms treatment (teriflunomide or interferon-β-1) was to be continued during the course of the study.

Eligibility criteria:
inclusion criteria: - male or female patient \<60 years old with relapsing multiple sclerosis (rms) either treated for at least 6 months with 7 or 14 mg teriflunomide in one of the studies lts6048 or lts6050, or treated with a stable dose of interferon-β-1 for at least 6 months. exclusion criteria: * concomitant infectious pathology at the time of vaccination; * ms relapse within 1 month before vaccination; * systemic corticosteroids within 1 month before the vaccination; * any contraindication to influenza vaccine; * any vaccination within the last 6 months; * prior use of any investigational drug or participation to a clinical trial within 1 year (only for patients under interferon-β-1); * prior or concomitant use (for a minimum of 1 year before study entry) of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate, mycophenolate, natalizumab (tysabri®), leflunomide or fingolimod or other immunomodulator/immunosuppressant in development; * prior or concomitant use of glatiramer acetate within 1 year before study entry; * prior or concomitant use of intravenous immunoglobulins within 3 months before study entry; * pregnant or breast feeding women; * woman of childbearing potential without adequate contraception. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.