Kornimate/medical-research-clean huggingface dataset:
vitdal@icu - correction of vitamin d deficiency in critically ill patients

Conditions: Critical Illness; Vitamin D Deficiency

Summary: study hypothesis: high-dose vitamin d leads to a shorter hospital stay in critically ill patients vitamin d deficient patients will be randomized to receive either 540,000 iu cholecalciferol or placebo.

inclusion criteria * age ≥18 years * expected icu stay ≥48 hours * vitamin d deficiency: 25(oh)d ≤ 20 ng/ml * feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible exclusion criteria * moribund patient expected to die within 24 hours * hypercalcaemia (total calcium \>2.65 or ion. calcium \>1.35 mmol/l) * severely impaired gastrointestinal motility (ileus, residual gastric volume \> 400 ml) * known history of recent kidney stones (≤ 1 year) * known granulomatous diseases (tuberculosis, sarcoidosis) * pregnancy primary endpoint * hospital stay (hours; starting from icu admission) secondary endpoints * percentage of patients with 25(oh)d ≥ 30 ng/ml at day 7 * serum calcium; phosphorus; 25(oh)d; 1,25(oh)d; pth; osteocalcin; balp; trap; urinary calcium

Eligibility criteria:
inclusion criteria: * age ≥18 years * expected icu stay ≥48 hours * vitamin d deficiency: 25(oh)d ≤ 20 ng/ml * feasibility of study drug application via nasogastric tube in cases where oral food intake is not possible exclusion criteria: * moribund patient expected to die within 24 hours * hypercalcaemia (total calcium \>2.65 or ion. calcium \>1.35 mmol/l) * severely impaired gastrointestinal motility (ileus, residual gastric volume \> 400 ml) * known history of recent kidney stones (≤ 1 year) * known granulomatous diseases (tuberculosis, sarcoidosis) * pregnancy
the oslo acute reperfusion stroke study (oscar)

Conditions: Acute Ischemic Stroke

Summary: prospective registry of clinical and radiological data in acute ischemic stroke patients after endovascular treatment.


Eligibility criteria:
inclusion criteria: * age 18 years or older * patients with ischemic stroke and cerebral arterial occlusion treated with endovascular revascularization. * all stroke severities and vascular distributions are eligible. * informed written consent signed by the patient, verbal consent from the patient as witnessed by a non-participating health care person or consent by the signature of the patient's family must be provided before inclusion. patients for whom no informed consent can be obtained will not be included in the study but will be treated according to standard guidelines. exclusion criteria: • patient not eligible for the study or not available for follow-up assessments (e.g. non- resident).
a study of two dual pi3k/mtor inhibitors, pf-04691502 and pf-05212384 in patients with recurrent endometrial cancer

Conditions: Endometrial Neoplasms

Summary: this study will investigate the individual safety and efficacy of two dual pi3k/mtor inhibitors in patients with recurrent endometrial cancer.

the study was prematurely discontinued due to lack confidence in the stathmin assay as a patient selection criteria and subsequent lack of confidence in the efficacy signal that was observed. the decision to terminate the study was made on january 23, 2014. it should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility criteria:
inclusion criteria: * recurrent endometrial carcinoma * disease progression following one or two lines of prior treatment with platinum containing chemotherapy * tumor tissue available at time of screening for pi3k analysis * adequate performance status * adequate glucose control, bone marrow, kidney, liver, and heart function exclusion criteria: * more than 2 prior cytotoxic chemo regimens for endometrial carcinoma * prior therapy with an agent known to be a pi3k, and or mtor and or akt inhibitor * active brain metastases

Keywords: uterine neoplasms endometrial uterine cancer pi3k mtor pi3k/mtor recurrent metastatic
early bolus surfactant replacement therapy versus standard care in term neonates with meconium aspiration syndrome

Conditions: Meconium Aspiration Syndrome; Surfactant Dysfunction

Summary: the objective of the study is to compare the total duration of respiratory support in term neonates (≥37weeks) with meconium aspiration syndrome, who are provided early(≤2hr) bolus surfactant therapy versus standard care.

enrolled participants will be randomly assigned to one of two study groups: 1. early(≤2hr) bolus surfactant replacement therapy or 2. standard care intervention group: the neonates enrolled in this group will receive early bolus surfactant replacement therapy within 2hr of life. control group: the neonates enrolled in this group will receive standard care according to standard unit protocol

Eligibility criteria:
inclusion criteria: * gestation age ≥ 37 week * cephalic presentation * singleton pregnancy * age \< 2 hours * baby delivered through meconium stained amniotic fluid * presence of respiratory distress (downe's score ≥4) exclusion criteria: * major congenital malformation * antenatal diagnosed chd * hydrops fetalis * air leaks before enrolment
wear behavior of milled posterior crowns fabricated from the new monolithic zirconia 5y-tzp/3y-tzp compared to lithium disilicate

Conditions: Posterior Teeth; Worn Posterior Teeth; Endodontically Treated Teeth; Crowned Posterior Teeth

Summary: in-vitro studies do not represent the actual masticatory environment and cannot simulate the intricate chewing pattern. hence, there is a need for an in vivo study evaluating the wear potential of the newly introduced strength - color gradient multilayered zirconia ips e.max zircad prime (5y-tzp/3y-tzp) and compare it to lithium disilicate ips e.max cad which has proven to have favorable wear patterns.

* there will be no difference in wear caused by monolithic zirconia (5y-tzp/3y-tzp) ips e-max zircad prime and lithium disilicate ips e.max cad to the antagonist. * there will be no difference in the wear of the new monolithic zirconia ips e.max zircad prime and lithium disilicate ips e.max cad.

Eligibility criteria:
inclusion criteria: * all subjects are required to: 1- be aged 21-50 years old, be able to read and sign the informed consent document. 2- psychologically and physically able to withstand conventional dental procedures. 3- patients with mutilated posterior teeth indicated for full coverage restorations. 4- patients with sound natural antagonists. 5- able to attend punctually for preplanned visits and evaluation. 6- have no active periodontal or pulpal diseases. 7- there should be no apparent loss or wear in opposing enamel. exclusion criteria: 1. patient with active resistant periodontal diseases. 2. patients with parafunctional habits and bruxism. 3. patients with poor oral hygiene, high caries risk and uncooperative patients. 3- pregnant women. 4. patients in the growth stage with partially erupted teeth. 5- psychiatric problems or unrealistic expectations. 6- lack of opposing dentition in the area of interest. 7- restored occlusal surface opposing the planned restoration. 8- the presence of a removable or fixed orthodontic appliance.
immune response to varicella vaccination in children with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad) causes people to be susceptible to skin infection and inflammations. the purpose of this study is to determine the immune response to chicken pox vaccine in children with or without ad who received the vaccine 2 to 16 weeks prior to the study visit.

ad is a chronic inflammatory skin disorder characterized by recurrent viral skin infections. children with ad given the smallpox vaccine could develop a life-threatening condition known as eczema vaccinatum. this immune response is not currently understood. the purpose of this study is to understand the immune response to a viral vaccine in children with ad. this will be accomplished by studying immune response to the chicken pox vaccine in children with ad in comparison to those without ad. this study will consist of one study visit occurring about 2 to 16 weeks after the child received the chicken pox vaccination. during this visit, physical and skin exams will occur. personal and family medical histories and blood collection will also occur. the chicken pox vaccine will not be given as a part of this study. subjects will receive the results of radioallergosorbent (rast) testing that will tell if they are allergic to some common items (e.g., mold, grass).

Eligibility criteria:
inclusion criteria: * parent/guardian has signed informed consent * male or female of any race or ethnicity * 12 to 36 months of age, inclusive * healthy subjects with no systemic disorders and subjects with moderate to severe ad including a group of subjects with adeh+ * previously vaccinated for varicella by a physician 3 weeks prior to the study visit (subjects receiving the vaccine 2-16 weeks prior will also be accepted) exclusion criteria: * history of infection with chicken pox * oral, intravenous, or intramuscular corticosteroids within 30 days prior to chicken pox immunization * asthmatics receiving more than 500 micrograms per day of inhaled budesonide or more than 220 micrograms per day of inhaled fluticasone * antiherpes antiviral agents within 7 days prior to immunization * suspected immune deficiency or family history of primary immunodeficiency * history of or active cancer * active untreated tuberculosis (tb) * respiratory illness at the time of chicken pox vaccination * receipt of blood products or chicken pox zoster immune globulin within the last 5 months prior to study entry
extension study to evaluate the immunogenicity and safety of the second dose of gbs trivalent vaccine in healthy non-pregnant subjects.

Conditions: Bacterial Infection Due to Streptococcus, Group B; Streptococcus Agalactiae

Summary: the objective of this extension study is the initial assessment of safety and immunogenicity of the second dose of gbs trivalent vaccine following the time interval that is close to the inter-pregnancy interval observed in the general population.


Eligibility criteria:
inclusion criteria: 1. healthy, non-pregnant subjects who have received a single 5 µg dose of gbs trivalent vaccine or placebo in the v98_06 study and healthy non-pregnant female subjects aged 22-46 years inclusive on the day of informed consent who have not received any gbs vaccine in the past 2. individuals in good health as determined by the outcome of medical history, physical examination and clinical judgment of the investigator 3. females of childbearing potential who are using an effective birth control method which they intend to use until the end of the study (day 181 visit) or females of non-childbearing potential exclusion criteria: 1. progressive, unstable or uncontrolled clinical conditions, or clinical conditions representing a contraindication to intramuscular vaccination and blood draws 2. abnormal function of the immune system 3. received immunoglobulins or any blood products within 180 days prior to informed consent 4. received an investigational or non-registered medicinal product within 30 days prior to informed consent 5. any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study 6. individuals who received any other vaccines within 14 days for inactivated vaccines or 28 days for live vaccines prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. exception - an inactivated influenza vaccine may be administered up to 7 days prior to study vaccination or 7 days after study vaccination 7. individuals who anticipate becoming pregnant prior to the end of the study, or individuals who are breastfeeding 8. individuals who have had a previous immunization with a vaccine containing group b streptococcus antigens that was not part of v98_06 study 9. individuals with a fever (oral temperature ≥ 38°c) within 3 days prior to day 1 or use of antipyretics and/or analgesic medications within 24 hours prior to day 1 10. individuals with acute or chronic infection(s) that require systemic antibiotic treatment or antiviral therapy, within 7 days prior to day 1
arsenic exposure and lung cancer incidence

Conditions: Incident Cases of Lung Cancer (Code ICD-O C340-C349)

Summary: aim of the study was to assess any associations between chronic exposure by drinking water to arsenic and onset of lung cancer, using a retrospective cohort study design. incident cases of lung cancer from 1st january 2006 to 31st december 2012, recorded by viterbo cancer registry, occurring during the period, were considered as primary outcome. people residing in municipalities with arsenic drinking water concentrations over legal threshold (10 µg/l) were considered as exposed.

arsenic and its compounds were classified as human carcinogens by iarc, because of their role in the onset and the progression of several neoplasms: liver, lung, bladder, prostate and skin cancer. if many studies shed to light on the existence of a strong association between as and cancer at chronic exposure to high metalloid concentrations (\>150 µg/l), much remains to be clarified on the effects of low-moderate exposure, such as those occurring in italy. the aim of this retrospective cohort study is to focus on the role of arsenic in the pathogenesis of lung cancer, as one of the most impacting neoplasms in terms of incidence and prevalence (40.000 new diagnoses in italy in 2017), in viterbo province, central italy. because of its high toxicity and its ubiquitous distribution, that earned the metalloid the first in the priority list by atsdr, thus being a main issue in public health. materials and methods from 1st january 2006 to 31st december 2012 all the inhabitants, residing in one of the 60 municipalities of viterbo province (around 320,279 people) were enrolled. incident cases of lung cancer, recorded by viterbo cancer registry, occurring during the period, were considered as primary outcome. people residing in municipalities with arsenic drinking water concentrations over legal threshold (10 µg/l), as provided by arpa lazio, were considered as exposed. risk difference in developing lung cancer among exposed and not exposed was estimated by relative risk (rr) and attributable risk (ar).

Eligibility criteria:
inclusion criteria: from 1st january 2006 to 31st december 2012 all the inhabitants, residing in one of the 60 municipalities of viterbo province were enrolled. exclusion criteria: no exclusion criteria were applied
do iron and vitamin b12 injections given together, improve hemoglobin in patients on hemodialysis?

Conditions: Iron Deficiency Anemia; B12 Deficiency Anemia

Summary: a parallel group, quadruple blind, placebo-controlled, randomized control trial with 2x2 factorial design to determine the effect of simultaneous iv ferric carboxymaltose and im hydroxycobalamin supplementation in anemic indian hd patients


Eligibility criteria:
inclusion criteria: * all adult prevalent hd patients on hd for at least 3 months with hemoglobin \< 11 g/dl exclusion criteria: * blood transfusion, blood loss, infection, surgery or change in haemoglobin by \> 1 g/dl in the last 1 month * hemoglobinopathy * cirrhosis * hematological malignancy or myeloproliferative disorder * hiv, hbv or hcv infection * any chronic inflammatory disorder * iv iron or oral/im b12 received in the last 3 months * severe hyperparathyroidism (intact parathyroid hormone \> 1,000 pg/ml) * pregnancy * age \< 18 years * history of asthma or eczema, any history of drug allergy, including allergy to iron preparations * history of exposure to chemotherapy or cytotoxic drugs - 5-fu, hydroxyurea, hydroxycarbamide, methotrexate, trimethoprim, colchicine, azathioprine * history of g-csf use in the last 1 month * general anaesthesia with nitrous oxide in the last 1 month
impact of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on cosmetic outcome and patient-reported outcomes in early-stage breast cancer

Conditions: Breast Cancer

Summary: this study aim to investigate the effect of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis in early-stage breast cancer.


Eligibility criteria:
inclusion criteria: * pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (dcis) * women who underwent breast-conservating surgery and have a plan to undergoing partial or whole breast irradiation * good performance status (ecog 0-1) exclusion criteria: * recurrent breast cancer * history of ipsilateral breast irradiation * positive resection margin status after breast surgery
diabetes-specific nutritional formulas versus oatmeal

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: diabetes-specific nutritional formulas (dsnfs) are frequently used as part of medical nutrition therapy for patients with type 2 diabetes in order to improve glycemic control and enhance weight reduction. the mechanism through which dsnfs improve postprandial (pp) plasma glucose is not yet known. the aim of this study is to compare the effects of 2 dsnfs versus oatmeal on pp plasma glucose, serum insulin and serum active glucagon-like peptide-1 (glp-1), serum free fatty acids (ffa) and serum triglycerides (tg).


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes treated with oral diabetes medications exclusion criteria: * type 1 diabetes
ltp+cacbt for treating postnatal depression and improving child wellbeing in jos nigeria

Conditions: Postnatal Depression

Summary: the project aims to test the feasibility, acceptability, cultural appropriateness and effectiveness of ltp+cacbt for treating postnatal depression and to enhance the mental health and wellbeing of mothers and their children in the low-income areas of jos nigeria. this project also aims to provide primary healthcare workers with culturally sensitive requisite skills and support to embed the proposed intervention into routine care practice and increase access to evidence-based intervention.

participants who scored 10 or above on patient health questionnaire (phq-9) and tested positive for postnatal depression on the edinburgh postnatal depression scale (epds) would be recruited randomly assigned into two groups in each of the four primary health care (phc) facilities designated for the present study. groups one will receive the ltp+cacbt treatment - the intervention will consist of a total of 12 (social distancing) group training sessions (60-90 minutes). groups two will receive routine treatment as usual (tau) currently available in the phc facilities (e.g. antidepressants) in the selected communities. each group will comprise of approximately 10 mother-child pairs.

Eligibility criteria:
inclusion criteria: * 18 years and above * a mother with a child (0-3 years) * able to provide full consent for their participation * a resident of the trial catchment areas * able to complete a baseline assessment * score 10 or above on patient health questionnaire (phq-9) and tested positive for postnatal depression on the edinburgh postnatal depression scale (epds). exclusion criteria: * less than 18 years * medical disorder that would prevent participation in a clinical trial such as tuberculosis or heart failure * temporary residents are unlikely to be available for follow up * active suicidal ideation or any other severe mental disorder * non-residents of jos and environs * unable to consent * patients currently undergoing severe mental health treatment * unable to speak english language fluently * other significant physical or learning disability
investigation on routine follow-up in congestive heart failure patients with remotely monitored implanted cardioverter defibrillators (icd) systems

Conditions: Heart Failure

Summary: it's the aim of this study to analyze the benefit of personal patient / physician contacts in heart failure patients with remotely monitored implanted cardioverter defibrillators (icd) or icd with cardiac resynchronization therapy (crt-d). the personal follow up (in clinic or phone calls) will be compared to completely automatic remote follow ups. all patients will receive remote monitoring for automatic daily alarm checks and will undergo in clinic follow ups in 12 months intervals


Eligibility criteria:
inclusion criteria: * indication for implantation (new, boxchange, upgrade) of icd/ crt-d * written informed consent * ejection fraction \<= 35% * new york heart association (nyha) class i-iii * age \>=18 and \<=80 years * in patient's home environment sufficient infrastructure (analog phone line or sufficient strength of gsm (global system for mobile communication) mobile phone network) for running a merlin@home transmitter is available exclusion criteria: * arterio ventricular (av) block iii / av block ii type mobitz * severe renal insufficiency * coronary angiology intervention within previous 3 months * myocardial infarction within previous month * life expectancy \< 1 year * expected poor data quality / compliance * pregnancy * patient is already participating to another study with active therapy arm

Keywords: icd crtd remote care remote monitoring heart failure
an efficacy study of adjuvant treatment with the personalized cancer vaccine mrna-4157 and pembrolizumab in participants with high-risk melanoma (keynote-942)

Conditions: Melanoma

Summary: the purpose of this study is to assess whether postoperative adjuvant therapy with mrna-4157 and pembrolizumab improves recurrence free survival (rfs) compared to pembrolizumab alone in participants with complete resection of cutaneous melanoma and a high risk of recurrence.


Eligibility criteria:
key inclusion criteria: * resectable cutaneous melanoma metastatic to a lymph node and at high risk of recurrence * complete resection within 13 weeks prior to the first dose of pembrolizumab * disease free at study entry (after surgery) with no loco-regional relapse or distant metastasis and no clinical evidence of brain metastases * has an formalin fixed paraffin embedded (ffpe) tumor sample available suitable for sequencing * eastern cooperative oncology group (ecog) performance status 0 or 1 * normal organ and marrow function reported at screening key exclusion criteria: * prior malignancy, unless no evidence of that disease for at least 5 years prior to study entry * prior systemic anti-cancer treatment (except surgery and interferon for thick primary melanomas. radiotherapy after lymph node dissection is permitted) * live vaccine within 30 days prior to the first dose of pembrolizumab * transfusion of blood or administration of colony stimulating factors within 2 weeks of the screening blood sample * active autoimmune disease * immunodeficiency, systemic steroid therapy, or any other immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab * solid organ or allogeneic bone marrow transplant * pneumonitis or a history of (noninfectious) pneumonitis that required steroids * prior interstitial lung disease * clinically significant heart failure * known history of human immunodeficiency virus (hiv) * known active hepatitis b or c * active infection requiring treatment

Keywords: mrna-4157 individualized neoantigen therapy int pembrolizumab moderna