Kornimate/medical-research-clean huggingface dataset:
the high initial dose of monitored vitamin d supplementation in preterm infants.

Conditions: Vitamin D Deficiency; Osteopenia of Prematurity; Nephrolithiasis; Metabolic Bone Disease; Late-Onset Neonatal Sepsis

Summary: the aim of this study will be to assess the effectiveness of monitored vit d supplementation in a population of preterm infants and to identify whether the proper vit d supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.

vitamin d deficiency can escalate prematurity bone disease in preterm infants and negatively influence their immature immunology system. infants born at 24+0/7 weeks to 32+6/7 weeks of gestation will be considered for inclusion. cord or vein blood samples will be obtained within 48 h after birth for 25-hydroxyvitamin d level measurements. parathyroid hormone and interleukin-6 levels will be measured. infants will be randomized to the monitored group (i.e., initial dose of 1000 iu/day and possible modification) or the controlled group (i.e., 250 iu/day or 500 iu/day dose, depending on weight). supplementation will be monitored up to postconceptional age 35 weeks. the primary endpoint is the percentage of infants with deficient or suboptimal 25-hydroxyvitamin d levels at 28±2 days of age. 25-hydroxyvitamin d levels will be measured at postconceptional age 35±2 weeks. secondary objectives include the incidence of sepsis, osteopenia, hyperparathyroidism, and elevated interleukin-6 concentration. the aim of this study will be to assess the effectiveness of monitored vitamin d supplementation in a population of preterm infants and to determine whether a high initial dose of monitored vitamin d supplementation in preterm infants can reduce the incidence of neonatal sepsis and incidence of metabolic bone disease.

Eligibility criteria:
inclusion criteria: * preterm infants with a gestational age of 24+0/7 to 32+6/7 born at our clinic * preterm infants with a gestational age of 24+0/7 to 32+6/7 outborn and admitted to our intensive care unit within 48h after delivery * written informed consent form caregivers for the mother and the child to participate in the study exclusion criteria: * infants born at \>32 weeks of gestation * infants with major congenital abnormalities or other severe congenital malformations * infants with genetic disorders (diagnosed before and after birth) deemed incompatible with survival * infants with diagnosed cholestasis * the absence of written informed consent and challenges in communication with caregivers

Keywords: vitamin d preterm infants osteopenia of prematurity late-onset sepsis metabolic bone disease
attachment and biobehavioral catch-up for depression

Conditions: Depressive Symptoms; Anxiety Symptoms

Summary: the overarching goal is to pilot the attachment and biobehavioral catch-up (abc) intervention for mothers with heightened depressive symptom and their children with heightened internalizing symptoms.

exposure to maternal depressive symptoms increases children's risk for developing anxiety and depressive symptoms ("internalizing symptoms"). maternal depressive symptoms and children's internalizing symptoms may be reciprocally related over time. optimal interventions for children's internalizing symptoms may involve treatment components for mothers, children, and the maternal-child relationship. the attachment and biobehavioral catch-up (abc) intervention is a empirically-supported, family-based treatment program that has been shown to be beneficial for children in varied high-risk family environments, but has yet to be tested among mothers and children recruited on the basis of heightened depressive and internalizing symptoms, respectively. the overarching goal is to examine the acceptability, feasibility, and preliminary effects of the abc program on a sample of mother-child dyads (n = 20) with heightened depressive and internalizing symptoms. our specific aims are: 1. to evaluate the feasibility and acceptability of abc for mothers with depressive symptoms and their offspring with internalizing symptoms 2. to explore whether children who receive abc show improvement in internalizing symptoms from pre- to post-intervention 3. to explore whether mothers who receive abc show improvement in depressive symptoms from pre- to post-intervention 4. to explore whether parents and children who receive abc show more adaptive physiological responses to stress from pre- to post-intervention

Eligibility criteria:
inclusion criteria: 1. mothers between 18 and 50 years of age with heightened depressive symptoms as determined by a score of 16 or higher on the center for epidemiologic studies depression scale-revised (cesd-r) 2. biological children (of mothers described above) between 2 and 4 years old with heightened internalizing symptoms as determined by a t-score of 60 or higher on the childhood behavior checklist (cbcl) exclusion criteria: * self-reported history of psychosis or active suicidality as defined by self-report of a specific suicide plan or recent attempt * current pregnancy * child diagnosis of autism * pacemaker implant, cardiac problems, cardiac medication
optical coherence tomography to improve clinical outcomes during coronary angioplasty

Conditions: Angina

Summary: coronary artery stenting has evolved as an effective treatment for angina and involves stretching up narrowings within the heart arteries using a balloon (coronary angioplasty) before implanting a small metal scaffold (stent) to splint the artery open. it is imperative that stents are fully expanded when they are deployed. if not, then patients are exposed to the serious risk of a blood clot forming in the stent (stent thrombosis), or the stent renarrowing (restenosis). one fifth of patients experiencing stent thrombosis will die and 70% will suffer a heart attack. restenosis is associated with recurrent angina and heart attacks. arguably, visualising stents and ensuring adequate stent expansion is most challenging in patients with extensive hardening, or calcification, of the heart arteries. optical coherence tomography is a novel technique that utilises near-infrared light to look inside small blood vessels in fine detail. it is 10 times more powerful than the best existing technique, intravascular ultrasound. the purpose of this study is to compare the utility of optical coherence tomography with intravascular ultrasound in patients with heavily calcified heart arteries undergoing rotational atherectomy and coronary stent insertion. it is hoped that the results of this pilot study will provide proof-of-principle and justification for a larger clinical trial to formally assess the role of optical coherence tomography to guide coronary angioplasty and stenting in patients with heavily calcified coronary arteries.

twelve patients undergoing rotational atherectomy and coronary stenting for angina in lothian will be recruited. rotational atherectomy and stent implantation will be performed as part of routine clinical care. immediately following stent implantation paired intravascular images of the implanted stent will be obtained using both intravascular ultrasound and optical coherence tomography. the stent will then be further dilated at high pressure with a non compliant balloon and the intravascular images repeated with both intravascular ultrasound and optical coherence tomography. the images obtained will be available to the operator to guide further treatment.

Eligibility criteria:
inclusion criteria: * patients undergoing percutaneous coronary intervention requiring rotational atherectomy and coronary stent implantation for calcified coronary artery disease. * ability to give informed consent. exclusion criteria: * inability to provide informed consent. * acute myocardial infarction. * cardiogenic shock. * renal failure (egfr \<30 ml/min) in patients who are not on dialysis. * pregnancy. * contrast allergy.

Keywords: rotational atherectomy angina optical coherence tomography intravascular ultrasound coronary stent
ivus-guided des implantation in coronary calcification

Conditions: Coronary Artery Disease

Summary: coronary calcified lesion is associated with a poor clinical outcome. intravascular ultrasound (ivus) provides anatomic information in detail about reference vessel dimensions and lesion characteristics including severity of diameter stenosis, lesion length, and morphology. both randomized and observational studies have reported the clinical benefits of ivus guidance for patients with chronic total occlusion (cto), long lesions, acute coronary syndrome (acs) with complex bifurcation lesions. our previous ultimate trial has demonstrated that ivus-guided drug-eluting stent (des) implantation significantly improved clinical outcome in all-comers, particularly for patients who had an ivus-defined optimal procedure, compared with angiography guidance. however, the benefit of ivus guidance in coronary severe calcification still remains unknown in the modern des era.


Eligibility criteria:
inclusion criteria: 1. silent ischemia, stable or unstable angina, non-st-segment elevation myocardial infarction \> 48 hours, or st-segment elevation myocardial infarction \> 7 days; 2. de novo coronary lesion eligible for drug-eluting stent implantation; 3. target lesion with severe calcification; exclusion criteria: 1. age less than 18-year-old; 2. comorbidity with a life expectancy \<12 months; 3. intolerant of antithrombotic therapy; 4. significant anemia, thrombocytopenia, or leucopenia; 5. history of major hemorrhage (intracranial, gastrointestinal, and so on); 6. chronic total occlusion lesion not recanalized; 7. scheduled major surgery in the next 12 months; 8. left ventricular ejection fraction \< 25%; 9. uremia dependent on dialysis treatment; 10. previous drug-eluting stent implantation in target vessel;
randomized study of preoperative dexamethasone for quality of recovery in vats lung resection patients

Conditions: Lung Cancer

Summary: the proposed study is a randomized, double-blind, placebo-controlled evaluation if a small dose of iv dexamethasone during induction anesthesia in association to pre and postoperative intercostal nerve block, improves quality of recovery of thoracoscopic lung resection patients.

this is a study composed by 2 groups of 50 patients undergoing vats for lung cancer. all subjets will receive intraoperative intercostal nerve block with a maximum dose of 2 mg/kg of bupivacaine with epinephrine 1:200.000 at the beginning and at the end of procedure. the control group will receive a bolus dose of dexamethasone (0.1 mg/kg) and the placebo group saline solution. the study drug or placebo will be administered at the time of anesthetic induction (approximately 30 minutes before surgical incision). patients will be evaluated daily with the quality of recovery questionary, visual analogue pain and portable spirometry. and, the patients will have pulmonary lung function assessed by portable spirometry.

Eligibility criteria:
inclusion criteria: * resectable stage i and ii lung cancer patients submitted to vats * american society of anesthesiology classification (asa) i or ii exclusion criteria: * chronic pain; * chronic analgesic consumption; * severe renal or liver disease; * endocrine or mental diseases; * poorly controlled diabetes; * allergy to bupivacaine; * previous thoracotomy; * systemic use of corticosteroids; * morbid obesity; * poor french comprehension precluding completion of the qor-40 questionnaire; * patient refusal.

Keywords: dexamethasone quality of recovery questionnaire qor-40 lung cancer video-assisted thoracoscopic
a study of the safety and effectiveness of infliximab (remicade) in patients with pancreatic cancer related cachexia

Conditions: Cachexia; Pancreatic Neoplasms

Summary: the purpose of this study is to evaluate the effectiveness and safety of infliximab, the active ingredient in remicade, for the treatment of cachexia in pancreatic cancer patients who are receiving chemotherapy with gemcitabine.

cachexia is a condition that occurs in cancer patients and other chronically ill patients and is characterized by rapid loss of fatty tissue and skeletal muscle. the key feature of this condition is weight loss, but other symptoms, such as anorexia (loss of appetite), fatigue, vomiting and anemia (low numbers of red blood cells) may also occur.the purpose of this study is to evaluate the effectiveness and safety of infliximab, the active ingredient in remicade, for the treatment of cachexia in pancreatic cancer patients who are receiving chemotherapy with gemcitabine. in cycle 1 (8wks), patients will receive weekly infusions of gemcitabine from wk 0 to 6 and infusions of infliximab or placebo at wks 0, 2, and 4. for additional cycles, patients will receive an infusion of gemcitabine for the first 3wks and infliximab or placebo at wk 0 of each 4 wk cycle for a maximum of 5 cycles. patients with stable disease may receive extended dosing if qualified.safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures. in cycle 1 (8wks), patients will receive weekly infusions of gemcitabine from wk 0 to 6 and infusions of infliximab or placebo at wks 0, 2, and 4. for additional cycles, patients will receive an infusion of gemcitabine for the first 3wks and infliximab or placebo at wk 0 of each 4 wk cycle for a maximum of 5 cycles.

Eligibility criteria:
inclusion criteria: * patients must have documented diagnosis of pancreatic cancer that is newly diagnosed * patients must have documented loss of \>=10% body weight compared to weight prior to diagnosis, or \>=5% weight loss within 90 days prior to randomization * patients must have karnofsky performance status of 70 to 100 * eligible according to country specific tuberculosis (tb) screening rules. exclusion criteria: * patients must not have received any previous chemotherapy, biologic therapy or radiation therapy for pancreatic cancer * patients must not have a history or current evidence of active tb, skin test or screening evidence of latent tb, or history of treated tb, active or latent * patients must not have evidence or history of congestive heart failure * patients must not have any opportunistic infection within 6 months prior to screening * patients must not be pregnant, nursing or planning pregnancy * patients must not have ongoing use of tube feedings or tpn

Keywords: cachexia pancreatic cancer infliximab anorexia anemia remicade.
crlx101(nlg207) in combination with bevacizumab for metastatic renal cell carcinoma (mrcc) versus standard of care (soc)

Conditions: Metastatic Renal Cell Carcinoma

Summary: this study to evaluate treatment in patients with metastatic renal cell carcinoma (rcc) which has progressed through 2 to 3 prior lines of therapy, with the investigational drug crlx101 in combination with bevacizumab compared to treatment with a standard of care therapy. the study will compare which treatment resulted in longer time before progression of the rcc. patients will be treated and followed for progression of their disease on average for up to 6 months.


Eligibility criteria:
inclusion criteria: * must have histologically confirmed renal cell carcinoma of any pathologic subtype. * must have unresectable metastatic disease, and have tumor(s) present that is (are) evaluable by the recist, v1.1; may have spinal-associated metastases but must have concluded dexamethasone therapy and be evaluated by the investigator to have stable cns disease. * must have received 2 or 3 prior lines of conventional molecularly targeted therapy * must have full recovery from any toxicities from prior therapy ctcae grade 1 or less with the exception of grade 2 alopecia) prior to randomization. * ecog performance status 0 or 1. * age 18 years and older. * life expectancy of at least 3 months. * must have normal organ and marrow function reported within 14 days prior to randomization * ability to understand and willingness to sign a written informed consent document. * able to comply with study visit schedule and assessments. exclusion criteria: * any conventional molecularly targeted therapy within 2 weeks or, chemotherapy or radiotherapy within 2 weeks (local) or 4 weeks (systemic) prior to entering the study. * failure to recover to grade 1 or less all prior adverse events. * any major surgery within 4 weeks of study randomization. * any prior treatment with topoisomerase i therapy. * prior treatment with any drugs or therapies that will be administered during the course of this trial including crlx101, any topoisomerase 1 inhibitor, bevacizumab or the conventional molecularly targeted agent intended for use as standard of care treatment. * patients receiving any other current investigational therapeutic agent. * other active malignancies * patients with brain metastasis treated or untreated, or other cns disease * any clinically significant cardiac disease defined as nyha class iii or iv. * uncontrolled hypertension * uncontrolled concurrent illness * history of non-healing wounds or ulcers. * pregnancy, or inadequate contraception for men or women of childbearing age, or lactating / breast-feeding * patients with known hiv or with solid organ transplant

Keywords: nanopharmaceutical,
fish oil and alpha lipoic acid in treating alzheimer's disease

Conditions: Alzheimer's Disease; Oxidative Stress; Dementia; Hyperlipidemia; Inflammation

Summary: the purpose of this study is to determine the effect of fish oil and the antioxidant alpha lipoic acid on factors in the blood that are associated with the progression of alzheimer's disease (ad).

alzheimer's disease (ad) is a serious condition associated with increased inflammation, cholesterol, and oxidative stress (a condition involving an excess of free radicals and a decrease in antioxidant levels). fish oil and alpha lipoic acid, which have few side effects, may help relieve these problems; therefore, these supplements may slow the progression of ad, particularly when given in combination. this study will evaluate the effect of fish oil and alpha lipoic acid on inflammation, lipid levels, and oxidative stress. participants in this study will be randomly assigned to receive fish oil alone, fish oil and alpha lipoic acid, or placebo for 1 year. ad rating scales as well as urine and blood tests will be used to assess participants. participants will have monthly clinic visits during the study to monitor adverse events and to undergo various laboratory tests.

Eligibility criteria:
inclusion criteria: * diagnosis of probable alzheimer's disease or mild cognitive impairment * mini mental state examination (mmse) score between 18 and 26 * clinical dementia rating (cdr) of 0.5 or 1.0 * fluent in english exclusion criteria: * use of lipid lowering medications * consumption of fish of more than twice a week * use of omega and alpha lipoic acid supplements * use of systemic corticosteroids, neuroleptics, anti-parkinsonian agents, or narcotic analgesics * depression * any other serious health conditions that may interfere with the study * enrollment in another clinical trial

Keywords: fish oils thioctic acid antioxidants dietary supplements
clinical study of autologous tumor infiltrating lymphocyte injection (gt316) in the treatment of advanced solid tumors (gynecological tumors)

Conditions: Solid Tumor; Gynecological Tumors

Summary: this study is a single-arm, open clinical trial.this trial consists of two phases, dose-escalation and expansion, and the study process is divided into: a screening period, a sampling and production period, a nma-ld chemotherapy period, a treatment and observation period, and a follow-up period.


Eligibility criteria:
inclusion criteria: * 1. the patients (or legally authorized representative) patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (icf) approved by an institutional review board/independent ethics committee (irb/iec), must have the ability to understand the requirements of the study; * 2.must have a confirmed diagnosis of malignancy of their receptive histologies or cytologies: unresectable recurrent or metastatic solid tumor; * 3.at least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. the separated tissues ≥1.0cm\^3 (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. minimally invasive treatment where possible; exclusion criteria: * 1. subjects with ≥3 untreated cns metastases at screening (if the subject has ≤3 cns metastases with a maximum diameter of \<1cm, and there is no peritumor edema on brain imaging (mri or ct).no evidence of progressive cns disease on brain imaging at least 3 months after treatment, then subjects will be included.); * 2.the patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone); * 3. arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring * 4. patients who have refractory or intractable epilepsy, poorly controlled hydrothorax, hydrops abdominis,pericardial effusion, active gastrointestinal bleeding or il-2 contraindications; * 5. participate in other clinical trials within 4 weeks prior to screening, or planning to participate in this study and other clinical trials at the same * 6. patients who have received allogeneic bone marrow transplantation or an organ allograft; * 7.patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, il-2, dimethyl sulfoxide (dmso), human serum albumin (hsa), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
fatigue in rheumatoid arthritis - longitudinal study

Conditions: Fatigue; Rheumatoid Arthritis

Summary: to investigate how the fatigue vary over time in persons with rheumatoid arthritis (ra) and which factors that may influence the fatigue.


Eligibility criteria:
inclusion criteria: * diagnose of ra, age 20-65 years, exclusion criteria: * other serious physical or mental illness
metformin vs conjugated linoleic acid and an intervention program with healthy habits in obese children

Conditions: Obesity

Summary: the purpose of this clinical trial is to examine the effects of conjugated linoleic acid (cla) vs metformin along with an intervention program with healthy habits on body composition, weight, m value in clamp and clinical laboratory values, as well as molecular and genetic changes in obese children. patients from the pediatric service of the hospital from 8 to 18 years old with a body mass index ≥ pc 95 and 35kg/m2 are randomized to either interventional group for 4 months.


Eligibility criteria:
inclusion criteria: * patients of both sexes between 8 and 18 years old * pc bmi ≥ 95 and \<35kg/m2, * no endocrine diseases, including diabetes mellitus * no systemic diseases * no genetic diseases * no pharmacological treatment affecting lipid metabolism or glucose * no history of acute or prolonged immobilization * normal aminotransferases * signed informed consent and assent

Keywords: pediatric obesity conjugated linoleic acid cla metformin