Kornimate/medical-research-clean huggingface dataset:
patient real-world clinical, neurological, tolerability, and safety outcomes for tecfidera® and rebif®

Conditions: Relapsing-remitting Multiple Sclerosis

Summary: the purpose of this study is to evaluate the proportion of patients who demonstrate no medical need to discontinue therapy among dmt-naïve patients with relapsing forms of multiple sclerosis after 1 year of treatment with rebif 44 mcg tiw or with tecfidera 240 mg bid based on real-world data.


Eligibility criteria:
inclusion criteria: 1. diagnosis of clinically isolated syndrome (cis) or a relapse remitting multiple sclerosis (rrms). 2. age between 18 - 55 years at the time of index. 3. no evidence of prior disease modifying therapy for ms. 4. initiated treatment with either rebif or tecfidera at the time of index. patient is considered to have initiated treatment if they took at least one dose. treatment must have been initiated after the product was approved by the fda. 5. availability of a high quality baseline mri brain scan, which must have occurred between 6 months prior to the index date to 2 weeks after the index date. 6. availability of clinical data in the patient's record for the full study observation period, as defined in the primary objective. exclusion criteria: 1. pregnant at any time during the study observation period. 2. presence of pre-existing medical conditions known to be associated with brain pathology (cerebrovascular and neurodegenerative diseases, presence of active alcohol or substance abuse). 3. patient discontinued initial therapy prior to completing 1 year of treatment due to a reason other than disease activity, tolerability, or safety (e.g. financial, convenience, preference, etc.). 4. phase iii registrational trial patients
clinical effectiveness of boxing training in individuals with elevated blood pressure or stage 1 hypertension

Conditions: Elevated Blood Pressure; Hypertension

Summary: the goal of this clinical trial is to determine whether boxing training reduces cardiovascular risk in elevated blood pressure or hypertension stage 1 individuals. the main questions it aims to answer are (1) if boxing training reduces peripheral and central blood pressure and (2) if boxing training improves cardiovascular function in elevated blood pressure or hypertension stage 1 individuals. participants with elevated blood pressure or hypertension stage 1 will be randomly divided into a control group or an intervention group. the latter group will be involved in boxing training, 3 days per week for 6 weeks. researchers will compare clinical and cardiovascular outcomes between the control and the intervention group.


Eligibility criteria:
inclusion criteria: * ≥18 years old. * systolic blood pressure between 120-139 mmhg and/or diastolic blood pressure between 80-89 mmhg obtained from 2 different days. * an estimated 10-year risk of cvd ≤10%, calculated by the acc/aha pooled cohort equations. * no current participation in 3 or more days per week of endurance or resistance exercise training. exclusion criteria: * non-controlled cardiac, pulmonary, or metabolic diseases. * smoking, consumption of nutritional supplements containing antioxidants. * any physical impairment to exercise.
could intrathecal fentanyl prevent shoulder tip pain (stp) during and after caesarean section

Conditions: Shoulder Pain

Summary: shoulder pain is a commonly observed, annoying and mostly neglected consequence of cesarean section and little is known as well as explored about intraoperative shoulder pain. this study will explore the factors precipitating shoulder pain during cesarean section, preventive analgesia and treatment modalities

the most common surgery performed on women around the world is caesarean section. the majority of caesarean sections these days are carried out under regional analgesia, though some need to be carried out under general anesthesia, particularly in emergency situations or when there is a contraindication to the use of regional anesthesia. benefits of spinal anesthesia include an awake mother at birth, minimizing or avoiding the risk of general anesthesia (aspiration, difficulty intubation, etc.) and minimal side effects to the newborn. shoulder tip pain (stp) is a usual complication after laparoscopy with the incidence reported varying between35% to 80%. recent studies suggest that this type of pain is also seen after cesarean section shoulder pain is commonly observed, but is largely ignored complication of caesarean section, and little is understood or studied regarding intraoperative shoulder pain. shoulder pain can be more excruciating in some patients than the pain from the surgical incision. this pain may be associated with diaphragmatic irritation/injury from local acidosis, the irritating effects of carbon dioxide during pneumoperitoneum, or stretching forces on the diaphragm. ( although carbon dioxide is not used in cesarean compared to laparoscopic surgeries, stretching forces on the diaphragm during cesarean can be one of the causes of shoulder pain in these patients. it is believed that seepage of blood or amniotic fluid into the abdomen accumulation during cesarean section and subdiaphragmatic may be the cause of stp. retained blood clots in patients undergoing cs can induce diaphragmatic discomfort and stimulate the phrenic nerve. peritoneal cleaning and visceral manipulation also may play a part. fentanyl is a commonly used lipophilic opioid for spinal anesthesia with relatively approved intraoperative anti-nociceptors effect.

Eligibility criteria:
inclusion criteria: * asa physical status i-ii, * uncomplicated, singleton pregnancies of at least 36 weeks gestation. exclusion criteria: * cardiac, liver or renal disease * allergy to amide local anesthetics * history of epilepsy or any other neurological problem * any contraindication of regional anesthesia, or patient refusal * intrauterine growth restriction or fetal compromise
prevalence of psoriasis and vitiligo in assiut governorate, egypt

Conditions: Psoriasis; Vitiligo

Summary: psoriasis is a chronic, immune-mediated inflammatory skin disease, which ranges in severity from a few scattered red, scaly plaques to involvement of almost the entire body surface. it may progressively worsen with age, or wax and wane in its severity; the degree of severity depends on inheritance and environmental factors. it is a complex disease, multiple exogenous and endogenous stimuli incite already stimulated innate immune responses in genetically predetermined individuals. the disease process is a result of a network of cell types including t cells, dendritic cells and keratinocytes that, with the production of cytokines, generate a chronic inflammatory state. vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes. its pathogenesis is still unclear, many mechanisms and theories have been suggested including autoimmunity, auto cytotoxicity, biochemical and neuronal mechanisms.

there are multiple patterns of psoriasis including plaque, guttate, pustular, inverse and erythrodermic, approximately 80% of patients present with plaque psoriasis which is clinically characterized by well demarcated erythematous plaques with overlying scales. these plaques can be intensely pruritic and bleed when manipulated, referred to as the auspitz sign. lesions are usually distributed symmetrically and frequently occur on the elbows, knees, lower back and scalp. prevalence of psoriasis is around 2-3% of the general population. a high prevalence of psoriasis at the rate of 11.8% has been reported from kazach'ye, located in the arctic region of the former soviet union. in egypt, the prevalence reported is around 3%. a study was done in hospitals of damietta governorate reveals that prevalence of psoriasis is about 5%. up to the investigator's knowledge the prevalence of psoriasis at assuit governorate is not known till now. vitiligo can be classified into segmental or non-segmental. non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions. prevalence of vitiligo is 0.5%-2% of general population world-wide, without predilection for sex or race. a previous study on skin diseases i assiut governorates reveals that prevalence of vitiligo was about 1.22%.

Eligibility criteria:
inclusion criteria: * the study will performed on people who live in rural areas in assuit governorate (all households) regardless of sex or age. exclusion criteria: * no exclusion criteria
physical activity intervention trial to mitigate muscle loss and increase muscle strength

Conditions: Oesophageal Cancer

Summary: this intervention study will be conducted on patients included in a nationwide and prospective cohort, the oesophageal surgery in cancer patients: adaptation and recovery study (oscar). the oscar includes patients operated on for oesophageal cancer in sweden between 2013-2018, identified through pathology departments and included in the cohort 1 year after surgery. a comprehensive interview is conducted by a research nurse during a home visit using patient reported outcomes on several hrqol, psychosocial, emotional and nutritional aspects. regular follow-ups are carried out at 1½, 2, 2½, 3, 4 and 5 years postoperatively. all patients within oscar are invited to the intervention trial. half of the eligible patients will be randomised to intervention and half to standard care (control group) by means of block randomisation method. the intervention group will be encouraged to adhere to a physical activity regimen of 150 minutes of weekly minimum intensity activities and 5 simple strength training exercises twice a week as instructed by the research nurse. the control group will follow their routine daily physical activity. hrqol measures, height and weight, body composition, muscle strength, functional mobility and strength, and dietary intake are assessed before and after the intervention. compliance will be ensured by means of a daily physical activity dairy and a weekly follow up on telephone with all patients.


Eligibility criteria:
inclusion criteria: * all patients from the nationwide prospective cohort the oesophageal surgery in cancer patients: adaptation and recovery study (oscar) with willingness to participate exclusion criteria: * current malignancies or co-morbidities, psychological or social conditions that prevent participation * patients with pacemakers; cochlear or other electrical implants cannot be screened using the bio-impedance scale for safety reasons

Keywords: body composition muscle strength health related quality of life
post-marketing surveillance study of nalmefene hydrochloride hydrate in patients with alcohol dependence

Conditions: Alcohol Dependence

Summary: the purpose of this study is to investigate the safety and the prognosis after achieving reduced alcohol intake in patients with alcohol dependence who received treatment for the reduction of alcohol intake in the routine clinical setting in japan.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of alcohol dependence * must agree to follow-up during the first year of prescription and publication of survey results * patients whose goal of treatment for alcohol dependence is to reduce alcohol consumption * patients receiving psychosocial treatment aiming to promote treatment adherence and reduction of alcohol consumption * patients who have chronic heavy drinking * patients who have confirmed that they are willing to receive treatment to reduce their alcohol consumption exclusion criteria: * patients who has ever been treated with nalmefene hydrochloride hydrate * patients who are contraindicated
oral triple combination antiviral drug therapy for treatment of influenza a in immunocompromised subjects

Conditions: Influenza

Summary: this phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (tcad) versus oseltamivir monotherapy for the treatment of all strains of influenza a in immunocompromised adult and pediatric subjects.


Eligibility criteria:
inclusion criteria: * confirmed influenza a by rapid antigen testing * immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, hiv positive * clinical diagnosis of influenza * onset of illness within 5 days * male and female subjects agree to contraception through 24 weeks after last dose exclusion criteria: * received more than 1 dose of antiviral agents * critically ill * creatinine clearance less than 80 mg/ml * females who are pregnant and males whose female partners are pregnant * received live attenuated virus vaccine within 3 weeks

Keywords: influenza immunocompromised hiv history of transplant
quadruple fortified salt clinical trial

Conditions: Anemia

Summary: anaemia is the world leading cause of disability and is responsible for about more than 115,000 maternal deaths and 591,000 perinatal deaths per year, of which 3/4 occur in africa and asia. despite the fact that there are several causes of anemia, the most important causes are due to micronutrients deficiency, namely iron, folic acid and vitamin b12. low intakes of these micronutrients consequently affect a woman's health, pregnancy outcome and the nutritional status of breast-fed children. with these in mind we wish to test the effectiveness of salt fortified with these four micronutrients (iodine, iron, folic acid and vitamin b12) in raising the hemoglobin levels among the non-pregnant and non-lactating women of reproductive age.

anaemia is the low level of haemoglobin based on the location. as per who a woman is termed anaemic if has hb \<11g/dl but in high attitude is =\<13g/dl

Eligibility criteria:
inclusion criteria: * adult with relative low haemoglobin (hb level 8g/dl to 13g/dl) * able to eat food cooked with salt * able to give consent exclusion criteria: * planning to become pregnant within the study period, * chronically ill, * have haematological diseases during study time, * restricted to use salt in food
data registry following patients using supera stent in the femoral arteries

Conditions: Peripheral Artery Disease; Femoropopliteal Artery Stenosis; Peripheral Vascular Disease

Summary: long-term, observational, prospective, multicenter registry following patients who have been implanted with the supera interwoven self-expanding nitinol stent for treating stenosis in the superficial femoral and/or femoropopliteal arteries.

this registry follows up to 200 patients for at least 5 years. the strong data registry will follow patients under real world conditions, evaluating restenosis rates, periprocedural/postprocedural complications, patency, target lesion revascularization, walking distance, stent fractures, and adverse events/serious adverse events.

Eligibility criteria:
exclusion criteria: (clinical) * patient or legal guardian understands registry procedures and has voluntarily signed an informed consent in accordance with institutional and local regulatory policies. (note: retrospective data may be collected and entered into the edc system after a fully executed informed consent has been provided). * rutherford-becker classification 2 through 5 only * patient is at least 18 years of age and of legal age of consent. * patient must be willing to participate in the registry for at least 5 years. (angiographic) * target lesion is a single de novo or restenotic (outside a stent) sfa or popliteal artery lesion ≥ 1 cm from origin of another stent; additional lesions may be present., but there is only one target lesion * all sfa target lesions are to be located with the proximal point at least 2 cm below the origin of the profunda femoris artery. * all popliteal artery target lesions are to be located with the most distal point at least 1 cm proximal to the bifurcation of the anterior tibial artery and the tibioperoneal trunk. * target lesion length 1-20 cm (visual estimate) * target lesion stenosis ≥50% (visual estimate) * popliteal artery patent if the lesion is in the sfa * sfa patent if the lesion is in the popliteal artery * at least one widely patent (\< 50% stenosis) infrapopliteal artery (for distal run-off) exclusion criteria: (clinical) * evidence of heparin induced thrombocytopenia (hit), or intravenous tpa, plavix, ticlid, or aspirin therapy sensitivities * patient is participating in a clinical study that could confound results * patient is pregnant/breastfeeding at time enrollment or plans to become pregnant during the course of participation in the registry. (angiographic) * target lesion length \> 20 cm * instent restenotic / reoccluded target lesion * acute (≤ 4 weeks) thrombotic occlusion * untreated ipsilateral pelvic stenosis

Keywords: femoral artery stenosis peripheral vascular disease
taxus arrive 2: a multi-center safety surveillance program

Conditions: Cardiovascular Disease; de Novo Coronary Lesions

Summary: the taxus arrive 2 study is a multi-center safety and surveillance study designed to to compile safety surveillance and clinical outcomes data for the taxus™ express2™ paclitaxel-eluting coronary stent system in routine clinical practice and to identify low frequency taxus related clinical events.


Eligibility criteria:
appropriate patient criteria: * patient is eligible to receive a boston scientific taxus stent inappropriate patient criteria: * known sensitivity to paclitaxel. * known allergy to stainless steel. * patients in whom antiplatelet and / or anticoagulant therapy is contraindicated. * patients judged to have a lesion that prevents complete inflation of an angioplasty balloon or proper placement of the stent or delivery device. * patients with unresolved vessel thrombus at the lesion site. * patients with coronary artery reference vessel diameters less than 2.5 mm or greater than 3.75 mm. * patients with lesions located in the left main coronary artery, ostial lesions, or lesions located at a bifurcation. * patients with diffuse disease or poor overflow distal to the identified lesions. * patients with tortuous vessels in the region of the obstruction or proximal to the lesion. * patients with a recent acute myocardial infarction where there is evidence of thrombus or poor flow.

Keywords: de novo coronary coronary artery disease coronary disease
optimizing electronic alerts for acute kidney injury

Conditions: Acute Kidney Injury

Summary: this study will enroll hospitalized adults with acute kidney injury (aki) and randomize them to usual care versus an electronic alert coupled to a "best practices" order set.

acute kidney injury (aki) carries a significant, independent risk of mortality among hospitalized patients. recent studies have demonstrated increased mortality among patients with even small increases in serum creatinine concentration. international guidelines for the treatment of aki focus on appropriate management of drug dosing, avoiding nephrotoxic exposures, and careful attention to fluid and electrolyte balance. early nephrologist involvement may also improve outcomes in aki. without appropriate provider recognition of aki, however, none of these measures can be taken, and patient outcomes may suffer. aki is frequently overlooked by clinicians, but carries a substantial cost, morbidity and mortality burden. the investigators conducted a pilot, randomized trial of electronic alerts for acute kidney injury in 2014. the trial, which randomized 2400 patients with aki as defined by an increase in creatinine of 0.3mg/dl over 48 hours or 50% over 7 days, found that alerting physicians to the presence of aki did not improve the course of acute kidney injury, reduce dialysis or death rates. however this study was conducted in a single hospital, and the alert itself did not describe specific actions that a provider could take. in the present proposal, the investigators seek to expand upon their prior study to determine both the modes of alerting that would be most effective and to determine if targeting alerts (such as to patients on medications that may worsen acute kidney injury) will improve effectiveness. this study will be a randomized, controlled trial of an electronic aki alert system. using the kidney disease: improve global outcomes creatinine criteria, inpatients at several hospitals will be randomized to usual care versus electronic alerting. the primary outcome will be a composite of progression of acute kidney injury, dialysis and death.

Eligibility criteria:
inclusion criteria: * adult ≥ 18 years admitted to a participating study hospital * acute kidney injury as defined by kdigo consensus creatinine criteria (0.3mg/dl increase in serum creatinine over 48 hours or 50% relative increase over 7 days). exclusion criteria: * eskd diagnosis code * dialysis order prior to aki onset * initial creatinine \>=4.0mg/dl * prior admission in which patient was randomized. * admission to hospice service or comfort measures only order * kidney transplant within 6 months
wise social psychological interventions to improve outcomes of behavioral weight control in children with obesity

Conditions: Obesity, Childhood

Summary: a 2-arm, parallel group, randomized controlled trial to evaluate overall differences in body mass index (bmi) trajectories over 6 months between 10-16-year-old children with obesity randomized to receive the wise social psychological interventions plus a usual care behavioral intervention for weight management compared to children randomized to receive additional education plus a usual care behavioral intervention.


Eligibility criteria:
inclusion criteria: * 10-16 year old children with obesity (bmi ≥ 95th percentile on the 2000 centers for disease control and prevention bmi reference) on the date of randomization. participation in a behavioral weight control program. standard behavioral weight control program eligibility criteria will apply: child and at least one parent/guardian must agree to participate exclusion criteria: * medical conditions affecting growth - diagnosed with a genetic or metabolic disease/syndrome associated obesity, type 1 diabetes, type 2 diabetes taking medication, chronic gastrointestinal diseases, chronic renal diseases, uncorrected structural heart disease, heart failure, heart transplant, anorexia nervosa or bulimia nervosa or binge eating disorder (present or past), aids or hiv infection, pregnancy medications affecting growth - systemic corticosteroids more than 2 weeks in the past year, insulin, oral hypoglycemics, thyroid hormone, growth hormone conditions limiting participation in the interventions - e.g., unable to participate in routine physical education classes at school, requiring oxygen supplementation for exertion, developmental or physical disability preventing participation in interventions, children or parents/guardians who cannot medically participate in mild dietary restrictions and/or increased physical activity for any reason conditions limiting participation in the assessments - child or primary caregiver not able to read surveys in english or spanish, child two or more grade levels delayed in school for reading and writing in his/her native language unable to read, understand or complete informed consent in english or spanish