Kornimate/medical-research-clean huggingface dataset:
comparison between outcomes of pregnant women treated with ferinject vs. venofer for iron deficiency anemia

Conditions: Anemia, Iron Deficiency; Pregnancy Anemia

Summary: the purpose of this study is to compare maternal outcomes such as increased hemoglobin need for blood transfusion and hemoglobin level before and post partum in women with hemoglobin \<9 gr/dl , treated with venofer and women treated with ferinject.


Eligibility criteria:
inclusion criteria: pregnancy\>24 weeks of gestation anemia with hb\<8 anemia with hb\<9 if symptomatic anemia of previous postpartum hemorrhage exclusion criteria: * allergy to one of the study's drugs * iv iron treatment in the last month * chronic anemia- thalassemia, renal failure twins pregnancy * non iron deficiency anemia
diagnosis of microaspiration in intubated critically ill patients: pepsin vs 99m technetium

Conditions: Critical Illness

Summary: microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients. technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. the investigators hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard.

microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. we hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard

Eligibility criteria:
inclusion criteria: * age \> or = 18 years * hospitalised in icu * tracheal intubation using a polyvinyl chloride tube and mechanical ventilation * predictable mechanical ventilation \> or = 6 hours after inclusion * enteral nutrition by a nasogastric tube exclusion criteria: * refuse to participate to the study * no informed consent * pregnant * contra-indication for enteral nutrition * tracheotomy * intubation or re-intubation done in 6 hours preceding the inclusion

Keywords: microaspiration mechanical ventilation enteral feeding 99m technetium pepsin
amd 3100 for treatment of myelokathexis

Conditions: Neutropenia

Summary: this is an initial study to determine if cxcr4 inhibitor amd 3100 or plerixafor may be a potential treatment for neutropenia due to cxcr4 mutations, the myelokathexis or whim (warts, hypogammaglobulinemia, immunodeficiency and myelokathexis) syndrome. this is the initial study of this concept and will involve up to 6 patients to receive increasing doses of plerixafor administered subcutaneously or on an alternate day basis. it is unknown if these patients will be highly sensitive to a blockade of cxcr4 activity and release more white blood cells than normal volunteers or cancer patients given the same dose of this drug. therefore doses will begin at a level 12 fold less than currently used to mobilize stem cells and will be increased stepwise to achieve an acceptable circulating level of neutrophils.

this is an open label, single center, phase i study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of cxcr4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. the subjects will be patients at the university of washington general clinical research center for up to 10 days; the study requires subject be available for up to 14 days. patients will be monitored for hematological effects of plerixafor and observed for adverse effects. if a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.

Eligibility criteria:
inclusion criteria: * age over 18 years, wbc (white blood count) less than 3.0 x 10\^9 per liter, * absolute neutrophil count less than 2.0 x 10\^9 per liter, * platelets greater than 100 x 10\^6 per liter, creatinine less than 2.0/milligrams per/deciliter, * creatinine clearance \> 60 ml/min calculated, * aspartate aminotransferase-got (sgot), alanin aminotransferase-gpt (sgpt), bilirubin \< 2.5 upper limit of normal, * eastern cooperative oncology group (ecog) status 0 or 1, * mutation identified and confirmed in cxcr4, * on no granulocyte-colony stimulating factor (g-csf), granulocyte-macrophage-colony stimulating factor (gm-csf) within 3 weeks of the study drug * patient signs consent, accepts contraception exclusion criteria: * greater than 18 years of age, * sensitivity to plerixafor, * pregnant, * prisoner, * decisionally impaired, * judged unlikely to comply, * illness that may interfere with interpretation of results, * leukemia, * malignancy, * active infection requiring antibiotics within one week of study drug administration, * history of cardiac conduction or electrocardiogram (ekg) abnormality, * previous experimental therapy within one week.

Keywords: neutropenia myelokathexis whim syndrome amd 3100 plerixafor myelokathexis syndrome neutropenia due to mutations of cxcr-4
cardiac toxicity of hypo fractionated radiotherapy in left breast cancer

Conditions: Breast Cancer Female

Summary: worldwide, breast cancer is the most common cancer in women,where 1.7 million new cases diagnosed in 2012 . in 2020 number doubled as 2.3 million women diagnosed with breast cancer. according to acs 1 in 8 women in united states will develop breast cancer in her life . similarly again, in egypt breast cancer is the most common malignancy in women about 22,700 new cases recorded in 2020. accounting for 38.8% of cancers in this population and forecasted to be approximately 46,000 in 2050 . post-operative radiotherapy is fundamental part of treatment after either conservative surgery or mastectomy . conventionally fractionated radiation therapy (cfrt) ,delivering 45-50 gy in 1.8-2 gy daily fractions for 5 days per week over 5-7 weeks was the standard schedule to eradicate sub clinical disease ,sparing normal tissues .after the publication of long term results of randomized controlled trials (rcts) comparing safety and effectiveness of hypo fractionated rt (hfrt)delivered in3 weeks ,vs. cfrt in node negative bc has been implemented . in 2008 numerous international guidelines recommended hfrt as the new standard being cost effectiveness ,limited resources ,excessively long rt waiting lists ,another important argument for hfrt utilization ,even assuming alpha/beta of 1.5gy ,is biologically milder or isoeffective for healthy tissues compered to cfrt . cardiac toxicity is potentially long or short term complication of various anticancer therapies systemic therapy as anthracyclines or biological agent implicated in causing irreversible cardiac dysfunction. radiotherapy also have cardio toxic effect through different mechanisms


Eligibility criteria:
inclusion criteria: * 1. age 18-75 years old 2. histopathology diagnosed 3. left sided breast cancer 4. receiving 3d hypofractionated radiotherapy 5. patients should be non metastatic 6. performance status 0-2 exclusion criteria: * • patient \> 75 years old * non histological diagnosed * metastatic patient * patient with cardiac or other co morbidity. * ecog performance status \>2 * pregnant or lactating patients
effect of pioglitazone on ambulatory blood pressure

Conditions: Hypertension; Diabetes Mellitus Type 2

Summary: the anti-diabetic pioglitazone has been found to reduce casual blood pressure. to date, no data are available looking at this effect in detail. especially, ambulatory blood pressure has not yet been utilized to confirm the hypothesis that pioglitazone has blood pressure lowering effects.


Eligibility criteria:
inclusion criteria: * age 45-75 years * diabetes mellitus type 2 (hba1c 7 - 8.5%) * casual blood pressure \> = 130/80 mmhg, \< 160/100 mmhg exclusion criteria: * therapy with insulin * combination therapy of sulfonyl-urea und metformin * therapy with nateglinid, repaglinid or an other substance of this drug family * allergy against pioglitazone or other composites of the tablet * history of heart failure (nyha i bis iv) * hepatic insufficiency * transaminases \> 2.5-fold of the upper normal limit * end-stage renal failure * syndrome of polycystic ovaries * absence of effective contraception in women of childbearing potential * pregnancy or breast-feeding

Keywords: hypertension
internet-based video-conferencing to address alcohol use and pain: a pilot trial

Conditions: Alcohol Drinking and Chronic Pain Intervention; Control Condition

Summary: this pilot study seeks to provide effect size estimates and test feasibility of a novel, integrated behavioral approach to reduce heavy drinking and chronic pain among patients in hiv-care delivered via internet-based videoconferencing.

this pilot study is a between-groups design to compare a novel integrated behavioral video telehealth intervention for heavy drinking plwh with chronic pain to a control condition. forty-eight heavy drinking patients in hiv-care with moderate or greater pain will be recruited for the study. following baseline assessment, participants will be randomly assigned to either intervention or control conditions. participants will complete assessment measures of heavy drinking and pain interference/severity at 3 and 6 months post-baseline. secondary alcohol outcomes will include alcohol-related consequences

Eligibility criteria:
inclusion criteria: * engaged in hiv care, heavy drinking defined as more than 7/14 drinks per week for women/men or by a single episode of 4/5 (women/men), chronic (at least 3 months duration) moderate or greater (4 or more on the severity scale of the bpi, and non-cancer related pain exclusion criteria: * psychoactive medication for pain or alcohol use for fewer than 2 months * history of bipolar disorder or schizophrenia * current expressed suicidal intent * prior history of alcohol withdrawal related seizures or delirium tremens * current behavioral treatment for pain or alcohol use * any scheduled surgery within the next 6 months or acute life threatening illness that requires treatment
intra-venous zoledronic acid once yearly

Conditions: Post-Menopausal Osteoporosis

Summary: the study will assess the real life effectiveness of zoledronic acid in the management of patients with osteoporosis over 4 years of treatment. zoledronic acid will be compared to oral bisphosphonates (obp) with respect to the change in bone mineral density (bmd) and incidence of fractures.


Eligibility criteria:
inclusion criteria: * patient is an ambulatory female 45 years of age or older * postmenopausal women with diagnosis of osteoporosis * prescription of zoledronic acid or any obp as per the current canadian monograph * must provide informed consent exclusion criteria: * any prior use of iv bisphosphonates within the last 2 years * known secondary osteoporosis of any aetiology (hypogonadism in premenopausal women or premature menopause, malabsorption, chronic liver disease, inflammatory bowel disease) * metabolic bone diseases such as primary or secondary hyperparathyroidism, hypoparathyroidism, paget's disease of bone, fibrous dysplasia.. * non-corrected hypocalcaemia at the time of zoledronic acid infusion * creatinine clearance \< or = 30 ml/min * unwillingness or inability to comply with the study requirements * concurrent participation in a clinical trial of an investigational drug, or within the last 30 days other protocol-defined inclusion/exclusion criteria may apply.

Keywords: osteoporosis bone mineral density fragility fractures zoledronic acid. treatment
levacor™ ventricular assist device (vad) bridge to transplant study

Conditions: Refractory Heart Failure

Summary: the levacor™ ventricular assist device (vad) has been designed for mechanical circulatory support in heart failure patients. the purpose of this clinical study is to determine its safety and efficacy as a bridge to transplant (btt) in cardiac transplant candidates with presumed non-reversible left ventricular failure.


Eligibility criteria:
inclusion criteria: 1. patient must be at least 18 years of age at the time of vad implantation. 2. listed for cardiac transplantation as unos status 1a or 1b at the time of vad implantation or within 72 hours of vad implantation. 3. body surface area (bsa) 1.2 m2 or greater. 4. if female of childbearing potential must have negative pregnancy test. 5. patient has signed an informed consent. exclusion criteria: 1. unacceptable surgical risk according to principal investigator. 2. intolerance or contraindication to anticoagulation or antiplatelet therapies. 3. excessive risk of bleeding as evidenced by inr \> 2.3, or ptt \> 45 sec, or platelet count \< 50,000 u, unresponsive to treatment. 4. excessive neurologic risk documented as tia within the last 3 months or stroke within the last 6 months. 5. evidence of any of the following indicators of end-organ dysfunction: total bilirubin \> 4 mg/dl, alt/ast \> 3 times upper limit normal, serum creatinine \>3.5 mg/dl. 6. fixed pulmonary hypertension with a most recent pvr \> 5 wood units unresponsive to pharmacological intervention. 7. severe chronic obstructive pulmonary disease as evidenced by an fev1 \ 48 hours) intubation. 8. presence of mechanical aortic valve that will not be converted to a bioprosthesis during vad implantation. 9. planned concomitant surgical procedures other than aortic valve repair or tissue valve placement to treat moderate to severe aortic insufficiency, tricuspid valve repair, mitral valve repair, critical lesion cabg, lv thrombectomy (apical), closure of persistent foramen ovale, atrial septal defect. 10. cardiogenic shock secondary to acute myocardial infarction. 11. presence of ongoing mechanical circulatory support other than intra-aortic balloon counterpulsation. 12. presence of uncontrolled infection. 13. bmi \> 40 kg/m2. 14. significant peripheral vascular disease accompanied by pain at rest, extremity ulceration or disabling claudication. 15. illness, other than heart disease, that would limit survival to less than 1 year. 16. pulmonary embolus \< 2 weeks before vad implant. 17. poor/compromising nutritional status in judgment of principal investigator. 18. participation in another clinical trial that, according to the principal investigator, is likely to affect the study outcome or confound the results.
patient preference for radial versus femoral vascular access

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to determine the preference of patients regarding the vascular access site in future coronary procedures. we hypothesize that patients prefer the lesser invasive procedure via radial access.

rationale: to explore patient preference for vascular access site in percutaneous coronary procedures, by assessing the perceived importance of benefits and risks of both transradial access and transfemoral access. in addition, direct preference for vascular access and preference for shared decision-making were evaluated. objective: to investigate the patient preference of vascular access -transradial versus transfemoral- in future percutaneous coronary procedures, by use of the best-worst scaling. study design: single-center, prospective, observational registry study population: a consecutive series of patients, who between june and august 2014, underwent elective coronary procedures at thoraxcentrum twente in enschede. intervention: all subjects will receive a questionnaire containing basic baseline questions and a best-worst scaling scenario in which they were asked to indicate the most and least desirable characteristics of the vascular access approach. furthermore, their direct preference was asked and to which extent they preferred to participate in the decision-making process regarding the choice for vascular access route in future percutaneous coronary procedures. main study endpoints: * the primary endpoint is the patient preference on specific treatment characteristics with regard to vascular access in coronary procedures. * secondary endpoints include 1. direct patient preference for transradial access or transfemoral access 2. the valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist.

Eligibility criteria:
inclusion criteria: * all patients who undergoing an elective coronary procedure at thoraxcenteum twente in the period of june 2014 until august 2014 exclusion criteria: * language barrier

Keywords: percutaneous coronary intervention patient preference radial access femoral access coronary angiography shared decision making
mri evaluation of integrity bio-inductive implant for rotator cuff tears

Conditions: Rotator Cuff Tears

Summary: the goal of this observational study is to evaluate the effectiveness and safety of the integrity bio-inductive implant in treating partial and full thickness rotator cuff tears. the main questions it aims to answer are: * how does the application of the integrity implant affect patient-reported outcome measures (proms) such as ases, sane, and promis? * what are the imaging characteristics of the rotator cuff tears at 3 and 6 months postoperatively when using the integrity implant? postoperative mris will be obtained from 10 consecutive patients who have undergone rotator cuff repair using the integrity implant at 3 and 6 months after surgery. participants include those with partial and full thickness tears treated with different surgical techniques involving the implant. they may receive either isolated onlay use of the graft for partial tears or augmentation of a standard single or double row repair with the graft applied to the superior surface of the repair.

the aim of this prospective, non-randomized, open-label, single-arm study is to evaluate the safety and effectiveness of the newly fda-cleared integrity graft for various types of rotator cuff repairs. this study incorporates preoperative assessments as well as follow-up assessments at 3 months and 6 months postoperatively. the primary objective is to document the safety profile of the integrity graft by monitoring device-related adverse events throughout the study duration. additionally, the study aims to assess the post-market effectiveness of the integrity implant using patient-reported outcome measures and establish normal or standard findings on mri to aid surgeons in clinical decision-making.

Eligibility criteria:
inclusion criteria: * rotator cuff tear (both partial and full thickness) treated with integrity bio-inductive implant augmentation to the superior surface of partial rotator cuff tears or the superior aspect of rotator cuff repairs (both single or double row); * subject can read and understand the icf and has voluntarily provided written informed consent. exclusion criteria: * conditions which, in the opinion of the principal investigator, may limit the subject's ability or willingness to follow post- operative care or study instructions; * if patient is pregnant; * subject conditions which may hinder the healing process; * subject is a prisoner or member of another vulnerable population.
biologic treatment registry across canada

Conditions: Arthritis, Rheumatoid; Spondyloarthritis, Axial; Arthritis, Psoriatic

Summary: this registry is a multi-center, prospective, longitudinal, observational program that will gather and analyse data on participants treated with infliximab, golimumab, golimumab intravenous (i.v) or ustekinumab. treatment will be prescribed by the physician according to actual clinical practice or standard of care for rheumatoid arthritis (ra), axial spondyloarthritis (axspa) , psoriatic arthritis (psa); there will be no randomized assignments to treatment. at baseline and approximately every 6 months thereafter, information will be collected to assess safety, clinical outcomes, quality of life, comorbidities, pharmacoeconomics and treatment regimens among cohorts of participants receiving infliximab, golimumab, golimumab i.v or ustekinumab for the treatment of ra, axspa and psa.

participants will be selected for this registry using a non-probability sampling method.

Eligibility criteria:
inclusion criteria: * participant is starting infliximab, golimumab, golimumab intravenous (i.v) or ustekinumab at the time of enrollment and is biologic naive or has been treated with only one prior biologic (including infliximab, golimumab, golimumab i.v or ustekinumab) prior to enrollment * participant has signed the approved informed consent form * participant is diagnosed with ra, axspa or psa and is eligible for treatment with infliximab, golimumab, golimumab i.v or ustekinumab in accordance with routine clinical care and the canadian product monograph. exclusion criteria: - participant was treated with two or more biologics, for any period of time before enrollment

Keywords: rheumatoid arthritis; psoriatic arthritis; axial spondyloarthritis remicade® simponi® simponi® i.v stelara® registry biotrac
assistance multidisciplinary in hypertensive patient: randomized clinical trial

Conditions: Hypertension

Summary: the purpose of this study is to determine if multidisciplinary care improves the health condition of hypertensives.

a multidisciplinary approach in managing hypertensive patients has shown benefits in reducing blood pressure and risk factors for hypertension.

Eligibility criteria:
inclusion criteria: * above 18 years of age * diagnosis of hypertension exclusion criteria: * secondary hypertension * hypertensive patients with congenital cardiopathy * surgical patients * proven myocardial infarction

Keywords: ambulatory care, hypertension, health personnel, clinical trial