Kornimate/medical-research-clean huggingface dataset:
midodrine effect on the mortality rates in septic shock patients

Conditions: Septic Shock

Summary: assessing the safety and efficacy of the adjunctive use of midodrine as a vasopressor in septic shock patients by measuring the difference in the mortality rates between control and intervention groups.


Eligibility criteria:
inclusion criteria: * adult aged 18 years or older diagnosed with septic shock. * hypotensive and require iv vasopressor for more than 24 hours. exclusion criteria: * hypovolemic shock. * severe organic heart disease (ejection fraction \<30 percent). * bradycardia (hr\<50 b/m). * chronic kidney disease (serum creatinine \>2mg/dl). * thyrotoxicosis. * pheochromocytoma. * known allergy to midodrine. * unable to administer an oral medication.
pediatric international nutrition study 2018

Conditions: Pediatric Critical Illness

Summary: this is a multi-site study of how nutrition is delivered to critically ill patients in pediatric intensive care units (picus) around the world. each site will include mechanically ventilated children in their respective picus and record the details of what type and amount of nutrition was received. these details will be compared to goals designated by the clinicians caring for each patient. data will be entered in a secure online remote data capture tool and managed by the lead researchers in pediatric critical care nutrition at boston children's hospital, nilesh mehta, md and lori bechard, phd, rd. data will be analyzed to better understand how different types and amounts of nutrition impact important picu outcomes such as length of stay, ventilator time, incidence of infections, and mortality.

specific aim 1: to examine the impact of energy and protein adequacy on clinical outcomes. specific aim 2: to describe world-wide patterns of nutritional therapies in the picu.environment: use of guidelines/use of adjuncts (acid suppression, motility, etc.)/glycemic control strategy/etc. to describe these practices in subgroups of: cardiac, surgical, medical, oncology/stem cell transplant patients in the picu. specific aim 3: to examine enteral nutrition practices, including timing, route (gastric vs. post pyloric), adjuncts, and enteral nutrition (en) intolerance definitions, in picu patients worldwide specific aim 4: to examine the current practices around parenteral nutrition prescription during the first week of critical illness in the picu; time of initiation (early vs. late), rationale, threshold for initiation. primary predictor: nutritional adequacy (energy, protein) secondary predictors: nutritional status, use of guidelines/site level indicators (location, staffing), use of adjuncts (acid suppression, motility, etc.), en intolerance, subgroups (cardiac, surgical, medical, oncology/stem cell transplant), en route/timing

Eligibility criteria:
inclusion criteria: * sites with at least 8 picu beds with the capacity to designate a site-specific clinician for data collection, preferably a clinician with an interest in nutrition or a dietitian, are eligible to participate. * patients 1 month to 18 years of age, admitted to the picu and requiring mechanical ventilation with an anticipated length of picu stay of 3 days or more. exclusion criteria: * sites with \< 8 picu beds and/or no available clinician for data collection * subjects \ 18 years, picu length of stay \< 3 days, not mechanically ventilated, receiving compassionate care only towards end of life, or enrolled in a nutrition intervention trial

Keywords: nutrition
bioequivalence of a diabetes specific tube feed

Conditions: Postprandial Glucose Response

Summary: nutricia has a range of nutritionally complete tube feeds on the market including some specific for diabetes patients. a new product is currently under development. the aim of the present study is to assess whether the postprandial glucose response of the new product is equivalent to the postprandial glucose response of an original product. in addition, the glycaemic index (gi) and glycaemic load (gl) of the adapted product will be determined. the study will have a crossover design with healthy volunteers taking one serving of both products in a randomized order. to determine gi and gl of the adapted product subjects will also receive a reference product. subjects will visit the study site six times: one screening visit, three study visits to measure the glucose response to the reference product and two study visits to measure the glucose response to the test and control product.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 65 years 2. body mass index (bmi) ≥ 18.5 and ≤ 27.0 kg/m2 3. written informed consent 4. willingness and ability to comply with the protocol 5. judged by the investigator to be in good health exclusion criteria: 1. known diabetes mellitus type i or type ii, rebound hypoglycaemia and/or any other medical condition that interferes with glucose metabolism 2. any use of anticoagulants, systemic steroids, protease inhibitors or antipsychotics and/or any medication known to affect glucose tolerance and/or to influence digestion and absorption of nutrients within 1 week of screening, in opinion of the investigator 3. any known disease which influences digestion and absorption of nutrients within 1 week of screening (in the opinion of the investigator) 4. allergy to soy and/or any other known relevant food allergy or intolerance in opinion of the investigator 5. adherence to a strict vegan diet 6. adherence to a weight loss program 7. picky/fussy eater (being very selective about what to eat) or eating disorder 8. known pregnancy and/or lactation 9. current smoking or stopped smoking for \< 1 month prior to screening (except for incidental smoking of ≤ 3 cigarettes/cigars/pipes per week on average in the last month) 10. average alcohol use of \> 21 glasses per week for men or \> 14 glasses per week for women (on average during the last 6 months) 11. drug or medicine abuse in opinion of the investigator 12. any known bleeding disorder 13. active participation in any other clinical study with investigational or marketed products concomitantly or within 4 weeks before study visit 1, in the opinion of the investigator 14. major medical or surgical event requiring hospitalization within the preceding 3 months and/or scheduled in the period of study participation relevant in the opinion of the investigator 15. investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements 16. employees of nutricia research and/or family members or relatives of employees
neurodevelopmental therapy for spastic cerebral palsy

Conditions: Cerebral Palsy; Spastic; Diplegia, Spastic

Summary: this study was conducted to find out the effects of neurodevelopment therapy (a rehabilitative program designed by bobath) on gross motor function and postural control in children with spastic cerebral palsy. to investigate either there was a significant difference between the effects of neurodevelopment therapy and routine physical therapy on gross motor function and postural control in children with spastic cerebral palsy.

a randomized controlled trial was conducted at department of pediatric rehabilitation, sher e rabbani hospital, sheikhupura. sample size was 66 and purposive sampling technique was adopted to collect data. sample selection was completely based on inclusion and exclusion criteria. a diagnosed spastic cerebral palsy patient aged 2-6 years with no other severe abnormalities such as seizure were recruited. while patients with mental retardation or undergone medical procedures likely to affect motor function such as botulinum toxin injections, orthopedic remedial surgery were excluded. data was collected at baseline, 4th, 8th and 12th week of the treatment sessions. gross motor function measure scale (gmfm-88) and posture and postural ability scale (ppas) were used as data collection tools.

Eligibility criteria:
inclusion criteria: * • a diagnosed spastic cerebral palsy (patient's diagnosis of cp confirmed by an expert pediatrician neurologist) * spastic cp * no other severe abnormalities such as seizure * aged 2-6 years * both genders exclusion criteria: * medical procedures likely to affect motor function such as botulinum toxin injections * orthopedic remedial surgery * mental retardation, or a learning disability.

Keywords: neurodevelopmental therapy ndt spastic cerebral palsy physical therapy rehabilitation neurorehabilitation
study to evaluate an aflibercept (eylea®) prefilled syringe

Conditions: Chorioretinal Vascular Disease

Summary: the primary objective of the study is to determine if the pre-filled syringe (pfs) supports successful preparation and accurate administration of an aflibercept injection. the secondary objective of the study is to assess ocular safety in the study eye.


Eligibility criteria:
key inclusion criteria: * participants who have neovascular age-related macular degeneration (amd), diabetic macular edema (dme), retinal vein occlusion (rvo), or diabetic retinopathy (dr) with diabetic macular edema (dme) in the study eye key exclusion criteria: * evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye * any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (ivt) injections with any agent in either eye * history of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after ivt injection or intraocular procedures in either eye * any intraocular surgery in the study eye at any time during the past 3 months * current systemic infectious disease or a therapy for active infectious disease * pregnant or breastfeeding women note: other inclusion/ exclusion apply
study of lonafarnib versus placebo in subjects with either myelodysplastic syndrome (mds) or chronic myelomonocytic leukemia (cmml) (study p02978am3)(terminated)

Conditions: Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic; Myelodysplasia; Myelomonocytic

Summary: the purpose of this study is to assess the benefit of lonafarnib (versus placebo) in patients with myelodysplastic syndrome (mds) or chronic myelomonocytic leukemia (cmml). benefit will be measured by achievement of platelet transfusion independence for at least 8-consecutive weeks, and without simultaneous worsening of hemoglobin and/or need for red blood cell (rbc) transfusion. additional endpoints will be hematologic response (which includes complete remission, partial remission, hematologic improvement), number of rbc transfusions, bleeding events, infections and safety.


Eligibility criteria:
inclusion criteria: * confirmed mds (ra, rars, raeb, raeb-t) or cmml according to fab classification. * platelet transfusion dependence (requiring 1 to 8 platelet transfusion events every 4 week period (day 84 to day 57, day 56 to day 29, and day 28 to day 1) over an 8-week retrospective and 4-week prospective screening period). * the individual number of platelet transfusion events during the three 4-weekly periods (day 84 to day -57; day -56 to day 29; day -28 to day -1) must not differ by greater more than 2 from the average number of platelet transfusion events during the 12 week screening period. * if the subject is rbc transfusion dependent, the number of rbc transfusion events during the three 4-weekly periods (days -84 to -57; day -56 to day 29 and day -28 to day -1) must not differ by more than 2 from the average number of rbc transfusion events during this 12 week screening period. ecog ps 0-2. exclusion criteria: * subjects with chemotherapy/radiotherapy-associated secondary mds. * \<12 weeks (prior to day-1 randomization) from any investigational drug use, any chemotherapy, radiotherapy, immunotherapy and any other treatment or mds/cmml other than best supportive care. * hx of bone-marrow or peripheral stem-cell transplantation or treatment with donor lymphocyte infusion. * hx of aml. * known hx of immune thrombocytopenic purpura. * marked baseline prolongation of qtc interval, ctcae grade \>=1. * use of ketokonazole within 72 hours prior to study drug administration.

Keywords: lonafarnib
early patient access treatment use protocol ca204-220

Conditions: Multiple Myeloma

Summary: the objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at japanese sites where licensed physicians determine clinical need.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com. inclusion criteria * men and women 20 years and older. * active, relapsed or refractory multiple myeloma by international myeloma working group (imwg) criteria as assessed by the treating physician and have received at least 1 prior line of multiple myeloma therapy. * progression from a most recent line of therapy. * prior lenalidomide exposure is permitted only if they fulfill all of the following:. i) were not refractory to prior lenalidomide, defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. patients progressing on lenalidomide maintenance dose are eligible for enrollment. ii) patient did not discontinue lenalidomide due to a grade ≥ 3 related ae. exclusion criteria * all adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved to nci ctcae (v. 3.0) grade ≤ 2. * significant cardiac disease as determined by the treating physician including cardiac amyloidosis. * hiv infection or active hepatitis a, b, or c. * any medical conditions that, in the attending physician's opinion, would impose excessive risk to the patient. * other protocol-defined inclusion/exclusion criteria apply.
assessment of ca 19-9 in patients' with thyroid malignancies

Conditions: Thyroid Cancer

Summary: thyroid cancer is a rare disease that represents approximately 3.8% of all new cancer cases.incidence of thyroid cancer in north africa about 2.8% of all new cancer cases with mortality rate about 0.73%.thyroid malignancies are classified into different groups as follows:papillary thyroid cancer which is the most common form of thyroid cancer form about 80-90% of all thyroid cancers,follicular thyroid cancer that forms about 10-15% of all thyroid cancers,anaplastic thyroid cancer that forms less than 2% of all thyroid cancers,medullary thyroid cancer that forms about 5-10% and other rare types include thyroid lymphoma, and thyroid sarcoma. medullary thyroid carcinoma (mtc) is a rare disease, and its classic tumor marker is calcitonin. however, recently, very aggressive cases have been reported to also secrete carbohydrate antigen 19-9 (ca19-9), and its role as a marker of worse prognosis has been questioned.

thyroid cancer is a rare disease that represents approximately 3.8% of all new cancer cases.incidence of thyroid cancer in north africa about 2.8% of all new cancer cases with mortality rate about 0.73%.thyroid malignancies are classified into different groups as follows:papillary thyroid cancer which is the most common form of thyroid cancer form about 80-90% of all thyroid cancers,follicular thyroid cancer that forms about 10-15% of all thyroid cancers,anaplastic thyroid cancer that forms less than 2% of all thyroid cancers,medullary thyroid cancer that forms about 5-10% and other rare types include thyroid lymphoma, and thyroid sarcoma. medullary thyroid carcinoma (mtc) is a rare disease, and its classic tumor marker is calcitonin. however, recently, very aggressive cases have been reported to also secrete carbohydrate antigen 19-9 (ca19-9), and its role as a marker of worse prognosis has been questioned. ca19-9 was originally described as a gastrointestinal system and pancreas specific tumor marker. immunohistochemical studies have demonstrated that ca19-9 is expressed in both differentiated and anaplastic thyroid carcinomas. increased serum levels of ca 19-9 were reported in few patients with anaplastic thyroid cancer.the idea that ca19.9 could be predictive of mortality in mtc stems from early research which showed that serum creatinine and increased carcinoembryonic antigen levels were not important markers in mtc, but that ca19.9, which is secreted in mtc, was significantly associated with progressive disease.

Eligibility criteria:
* inclusion criteria: patients with malignant thyroid tumors. * exclusion criteria: patients with benign thyroid tumors ,patients not known to have pancreatic disease.

Keywords: ca19-9
an observational cohort study to characterize the effectiveness and safety of hemgenix® in patients with hemophilia b

Conditions: Hemophilia B

Summary: this observational, post-authorization, long-term follow-up study aims to investigate the short and long-term effectiveness and safety of hemgenix in patients with hemophilia b. the study will also include a cohort of patients with hemophilia b treated with fix prophylaxis to enable interpretation of relevant efficacy and safety findings of hemgenix.


Eligibility criteria:
inclusion criteria: hemgenix cohort: * treatment with commercial hemgenix. * have provided signed written informed consent within 3 months before or within 6 months after hemgenix treatment, or within 6 months of when the study is initiated at the participating site. fix prophylaxis cohort: * adult patients (≥ 18 years) with hemophilia b who have consented and enrolled in athn transcends hemophilia cohort (or a similar registry) and are receiving fix prophylaxis therapy. exclusion criteria: hemgenix cohort: * the patient population that will be observed in this study must not have been treated with etranacogene dezaparvovec in a clinical trial.

Keywords: hemophilia b hemgenix
comparing the efficacy of tiotropium + olodaterol (5/5 µg) fixed dose combination (fdc) over tiotropium 5µg in reducing moderate to severe exacerbations in patients with severe to very severe chronic obstructive pulmonary disease.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the overall objective is to assess the effect of once daily tiotropium + olodaterol fixed dose combination compared to 5 µg tiotropium (both delivered with the respimat® inhaler) on moderate to severe copd exacerbation in patients with severe to very severe copd.


Eligibility criteria:
inclusion criteria: * male or female patients, 40 years of age or older. * diagnosis of copd with a documented post-bronchodilator forced expiratory volume in one second (fev1)\< 60% of predicted normal and a post-bronchodilator fev1/ forced vital capacity (fvc) \<70% at visit 1 * documented history of at least one moderate to severe copd exacerbation in the previous 12 months requiring treatment with systemic corticosteroids and/or antibiotics and/or related hospitalization. * symptomatically stable as defined by: no evidence of copd exacerbation requiring use of either antibiotics and/or steroids 4 weeks prior to visit 1 and no evidence of change in their usual copd medication 4 weeks prior to visit 1. * current or ex-smokers with a smoking history of more than 10 pack years. exclusion criteria: * significant disease other than copd. * clinically relevant abnormal baseline haematology, blood chemistry or creatinine \> x2 uln will be excluded regardless of clinical condition. ( a repeat laboratory evaluation can be conducted if deemed necessary by the investigator.) * current documented diagnosis of asthma. for patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma * a diagnosis of thyrotoxicosis * a history of myocardial infarction within 6 months of screening visit. * life-threatening cardiac arrhythmia. * known active tuberculosis. * any malignancy unless free of disease for at least 5 years (patients with treated basal cell carcinoma or squamous cell skin cancers are allowed). * a history of cystic fibrosis. * clinically relevant bronchiectasis. * patients with severe emphysema requiring endobronchial interventions within 6 months prior to screening * a history of significant alcohol or drug abuse in the opinion of the investigator. * patients who have undergone thoracotomy with pulmonary resection * patients being treated with oral or patch ß-adrenergics. * patients being treated with oral corticosteroid medication at unstable doses * patients being treated with antibiotics for any reasons within 4 weeks of screening visit * patients being treated with pde4 inhibitors within 3 months of screening visit * patients who have taken an investigational drug within one month or six half-lives * pregnant or nursing women. * women of childbearing potential not using a highly effective method of birth control.
insulin stimulated vasodilation in patients with type 2 diabetes

Conditions: Type2 Diabetes

Summary: this study evaluates the role of endothelin in insulin stimulated vasodilation and glucose uptake. the subjects will complete an hyperinsulinemic euglycemic clamp with and without blockade of the endothelin receptors.


Eligibility criteria:
inclusion criteria: * type 2 diabetes or healthy control (no type 2 diabetes) * bmi\<32 exclusion criteria: * heart disease * pregnancy or birth within 3 month * smoking * kidney disease * beta-blockers * insulin treatment (for type 2 diabetics)
effects of isotretinoin on the gonads and hirsutism

Conditions: Adverse Effects of Medical Drugs

Summary: the investigators consider that there are some rising concerns about the use of isotretinoin by women of reproductive age with depleted ovarian reserve, hence it is important to detect the effect of isotretinoin on ovarian reserve. there has not been a well-designed study evaluating its effects on the human ovarian reserve, hormone levels and menstrual cycles in women with polycystic ovary syndrome (pcos). for this reasons, this study was administered to determine whether there is an effect of isotretinoin on the gonads and hirsutism in women with acne and pcos.


Eligibility criteria:
inclusion criteria: * consisted of 40 volunteers women with pcos (aged 18- 40 years, bmi, 18-44kg/m2) who attended our obstetrics and gynecology clinic for the treatment menstrual irregularities and hirsutism exclusion criteria: * 1)presence of any dermatologic disorder besides acne 2) presence of any systemic disease 3) exposure to any systemic treatment in the last three months that could alter ovarian reserve 4) pregnancy or lactation 5) infection diseases 6) use of antidepressants, steroidal hormone drugs, mood stabilizers, caffeine, alcohol, or tobacco 7) histories of abdominal surgery for endometriosis or ovarian surgery

Keywords: isotretinoin pcos acne vulgaris