Kornimate/medical-research-clean huggingface dataset:
high dose interval vitamin d supplementation in patients with inflammatory bowel disease receiving biologic therapy

Conditions: Inflammatory Bowel Disease; Crohn Disease; Ulcerative Colitis; Vitamin D Deficiency

Summary: the investigators will be administering oral high dose interval vitamin d, concurrently when participants are receiving biologic therapy for their inflammatory bowel disease. the investigators will be collecting some additional bloodwork and questionnaires at the time of participants infusions.

the investigators will be administering oral high dose interval vitamin d3 concurrently when participants with inflammatory bowel disease (ibd) are receiving biologic therapy every 4-8 weeks. the investigators will collect additional bloodwork when participants are getting clinical labwork in order to assess markers of bone health and inflammation in response to vitamin d treatment. the investigators will serially assess with questionnaires associated measures, including dietary vitamin d and calcium intake, sunlight exposure, physical activity, fracture history, ibd disease activity, and overall health.

Eligibility criteria:
inclusion criteria: * existing diagnosis of ibd, including crohn disease, ulcerative colitis, and indeterminate colitis * receiving treatment with infliximab or vedolizumab every 4-8 weeks * age 5-25 years old, at study entry * measured serum level of 25-ohd of less than 40 ng/ml in the last 4-8 weeks and no changes in vitamin d supplementation in the interim. of note, 25-ohd levels are evaluated routinely as part of standard clinical care for ibd exclusion criteria: * history of any underlying kidney disease * history of preexisting liver disease * history of granulomatous disease * inability to take oral vitamin d3 as a pill * history of hypercalcemia or hypercalciuria * currently, or within the past 3 months, taking an anti-epileptic medication or lasix
effects of electrotherapy on pain, anxiety, motion and disability in adults with neck or upper body pain.

Conditions: Chronic Pain

Summary: this will be a prospective randomized controlled trial with sixty adults, 20 to 40 years of age. there will be three groups as follows: the normal group, control group, and intervention group where subjects will receive instructions for home use of tens for pain reduction. the aim is for an equal distribution of males and females in each group.

this will be a prospective randomized controlled trial with sixty adults, 20 to 40 years of age. there will be three groups as follows: twenty subjects with no pain in the normal group; forty subjects with chronic subclinical neck or upper quadrant pain will be randomized into two groups: twenty subjects in the control group, and twenty subjects in the intervention group. the aim is for an equal distribution of males and females in each group. data will be collected for each subject using the noraxon® myomotion™ system, the visual analog scale (vas), the state-trait anxiety inventory (stai), and the neck disability index (ndi); all assessments will be made by a clinician. normal group (20 subjects): initial assessment on day one and post assessments on day eight and on day thirty. control group (20 subjects): initial assessment on day one and post assessments on day eight and on day thirty. intervention group (20 subjects): initial assessment on day one pre-intervention and post-intervention assessment of high-frequency sensory tens (gate control theory of pain) for thirty minutes followed by post-assessments in day eight and day thirty. the intervention group will receive a thirty-minute high frequency tens (gate control theory of pain) once a day for seven days and twenty-one days after the initial seven days to measure immediate and short-term effects on the dependent variables further described below. subjects will be educated on tens usage by a licensed physical therapist. a daily log will be given to all subjects in the intervention group to assure compliance with treatment. in addition, the tens device will keep track of date, time and day of usage, and tens parameters.

Eligibility criteria:
inclusion criteria for subjects without pain group: * \> 19 and \<41 years of age * currently enrolled as students at loma linda university. * no pain exclusion criteria for control group: * neck and/or upper quadrant pain * \ 40 years of age inclusion criteria for subjects with pain groups: * \>19 and \<41 years of age * currently enrolled as students at loma linda university * no acute pain * with neck and/or upper quadrant chronic pain * with \<5/10 pain on the visual analog scale (vas) exclusion criteria for subjects with pain groups: * \ 40 years of age * acute pain * with \>5/10 pain on the visual analog scale (vas) * currently receiving clinical pain treatment * pain medications within six hours of data collection * contraindications for the use of electrotherapy

Keywords: neck, upper quadrant, upper body, chronic pain, sub-clinical pain, mild pain
the effects of dexamethasone administration on jaundice following liver resection

Conditions: Liver Dysfunction; Hepatectomy; Bilirubinaemia; Jaundice

Summary: the investigators were aiming to evaluate whether dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and decreases the rates of post-hepatectomy liver failure and its safety in the subjects who developed elevated serum total bilirubin.

post-operative jaundice is one of the most common complications after hepatectomy for various liver tumors. glucocorticoids, including dexamethasone, prednisolone, and methylprednisolone, were widely used to treat jaundice in the patients with severe hepatitis, liver dysfunction or liver failure. it was reported that glucocorticoids decrease the rates of liver dysfunction or mortality in those patients. however, whether post-operative glucocorticoids administration alleviated jaundice or deceased the rates of post-hepatectomy liver failure (plf) yet to be determined. in this study, the investigators were aiming to evaluate whether dexamethasone administration accelerates the recovery from hepatectomy-related jaundice and decreases the rates of plf and its safety in the subjects who developed elevated serum tb.

Eligibility criteria:
inclusion criteria: * patients underwent open hepatectomy for liver tumors * preoperative liver function was child-pugh a, and the liver shear wave elastography (swe) \< 30 kpa * postoperative serum total bilirubin \> 2.5 uln in 7 days after hepatectomy exclusion criteria: * patients with hilar cholangiocarcinoma or other disease with obstructive jaundice * complicating disease with severe dysfunction in respiratory or circulation system or kidney. * patients with contraindication of glucocorticoids, including severe infection, active gi bleeding

Keywords: dexamethasone liver dysfunction hepatectomy bilirubinaemia jaundice
abscopal effect of sbrt in combination with rhgm-csf and inf-α 2b for metastatic thymic epithelial tumors

Conditions: Thymic Epithelial Tumor

Summary: the purpose of this study is to determine whether stereotactic body radiotherapy (sbrt) combined with recombined human granulocyte-macrophage colony stimulating factor(rhgm-csf) and peginterferon alfa-2b is safe, effective in the treatment of patients with metastatic thymic epithelial tumors.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years; 2. histologically proven thymic epithelial tumors； 3. stage iv according to uicc stage system(version 8,2017), at least with two evaluable abscopal lesions (≥1cm)（excluding intestinal metastasis）; 4. evaluated as effective or stable disease after first-line chemotherapy or progressed after second-line chemotherapy (progression sites were no more than three sites); 5. ecog performance status: 0-1; 6. life expectancy ≥ 3 months. 7. adequate baseline organ and marrow function: absolute neutrophil count greater than 1500 cells per μl, platelet concentration of greater than 50 000 per μl, total bilirubin less than 1•5 times the upper limit of normal (uln), aspartate aminotransferase and alanine aminotransferase less than 2•5 times the uln, and serum creatinine less than 1•5 times the uln; 8. female subjects have a negative urine or serum pregnancy test within 1 week prior to treatment if of childbearing potential; 9. asymptomatic subjects with brain metastasis can be included, but the sites of brain cannot be considered as target sites; 10. asymptomatic subjects with bone metastasis can be included, but the sites of bone cannot be considered as target sites. exclusion criteria: 1. having received immunotherapy within 4 weeks prior to inclusion; 2. allergic to gm-csf, inf-α2b or diagnosed with immune system disease, receiving immunosuppressant, such as prednisone, dexamethasone, methylprednisolone, methotrexate, hydroxychloroquine, cyclophosphamide, azathioprine and so one; 3. receiving treatment of other trials; 4. any unstable systemic disease, including active infection, symptomatic congestive heart failure,myocardial infarction onset six months before included into the group, unstable angina, and severe arrhythmia, uncontrolled chronic lung disease; 5. unwilling to sign consent; 6. women in pregnancy or lactation; 7. other malignancy except for non-melanoma carcinoma of the skin or in situ carcinoma of the cervix.
qol of women with hr-positive metastatic bc treated in the first-line setting: comparison between public and private institutions.

Conditions: Quality of Life; Breast Neoplasm Female

Summary: assess the quality of life in patients with hormone receptor positive, human epidermal growth factor receptor-type 2 negative metastatic breast cancer treated in first line (patients with new metastasis or recurrence during adjuvant endocrine therapy): comparison between public and private institutions. the hypothesis to be evaluated is that patients treated in private institutions have a better quality of life when compared to patients treated in public institutions.

the main objective of the study is to assess the quality of life using the eortc-qlq-c30 (eortc quality of life questionnaire) and the eortc-qlq-br23 (eortc quality of life questionnaire - breast cancer) of a patient with metastatic breast cancer hormone receptor positive human epidermal growth factor receptor-type 2 negative receiving treatment in the first-line scenario, comparing public and private institutions.

Eligibility criteria:
inclusion criteria: * patients who agree to participate by signing a document of free and informed consent (icf), indicating that the research participant was informed about all relevant aspects of the study; * female patients ≥ 18 years of age; * patients diagnosed with hormone receptor positive, human epidermal growth factor receptor-type 2 -negative metastatic breast cancer; in first-line treatment (metastatic de novo disease or patients with recurrence during adjuvant endocrine therapy). * first-line treatment can be considered as cytotoxic chemotherapy, isolated endocrine therapy or endocrine therapy in combination with 4/6 cyclin inhibitors. * patients on treatment for at least three (3) months and no more than eighteen (18) months. * have performance status eastern cooperative oncology group (ecog scale) of 0-2. * do not present other concomitant neoplasms. exclusion criteria: * patients who refuse to participate. * illiterate patients, with low levels of education or cognitive deficits that make it difficult to answer the questions of the data collection instrument. * patients with life expectancy \<3 months. * treatment with any product under investigation during the last 28 days.
a study of haploidentical bone marrow transplant for patients with hematologic malignancies

Conditions: Hematologic Malignancies

Summary: the primary objective is to determine overall survival 180 days after transplantation involving hla-haploidentical stem cell/bone marrow graft, and post-transplant cy.

study design: this is a single center phase 2 study of myeloablative (ma) and nonmyeloablative (nma) conditioning, transplantation of partially hla-mismatched bone marrow or peripheral blood stem cells and post-transplantation cyclophosphamide (cy) in patients with hematologic malignancies including: 1. acute lymphoblastic leukemia/lymphoma, acute myelogenous leukemia, and burkitt's lymphoma in remission. 2. relapsed lymphoma, including marginal zone b cell lymphoma, follicular lymphoma, and chemotherapy-sensitive large-cell or hodgkin lymphoma. 3. myelodysplastic syndrome (mds) 4. blastic plasmacytoid dendritic cell neoplasm primary objective: the primary objective is to determine overall survival 180 days after transplantation involving myeloablative and non myeloablative conditioning, hla-haploidentical marrow or peripheral blood stem cell grafts, and post-transplant cyclophosphamide as gvhd prophylaxis. secondary objectives: secondary objectives include estimating overall and progression-free survival at 100 days, 180 days, and one year after transplantation, treatment-related mortality, incidence of neutrophil and platelet recovery or engraftment, incidence of graft failure, cumulative incidence of acute and chronic graft versus host disease (gvhd), incidence of infections, and cumulative incidence of relapse/progression. the investigators will also examine the amount of time to transplant (day of unrelated search initiation to day 0).

Eligibility criteria:
inclusion criteria: 1. age: subjects 18-70 years old. 2. donor must be 18 years of age. 3. hla typing will be performed at high resolution. a minimum match of 5 out of 10 is required. 4. patients must have received multi-agent chemotherapy within 3 months of consent date (measured from the start date of chemotherapy). 5. acute leukemias. * acute lymphoblastic leukemia in high risk 1st complete response (cr1) * acute myelogenous leukemia in high risk 1st complete response (cr1) * acute leukemias in 2nd or subsequent complete response (cr) * biphenotypic/undifferentiated leukemias in 1st or subsequent complete response (cr). 6. burkitt's lymphoma: second or subsequent complete response (cr). 7. lymphoma 8. patients with adequate physical function 9. performance status: karnofsky score 70-100%. exclusion criteria:

Keywords: hematologic malignancies
comparison of thiopental and propofol as anaesteticum during ect

Conditions: Depression

Summary: electroconvulsive therapy is the most effective treatment in severe depression and the effect is related to the generalized seizure induced by the treatment. general anesthesia is used during the treatment. since only a brief period of unconsciousness is required anesthetics with a rapid recovery profile are used. methohexital, a barbiturat, is internationally considered "the golden standard", bot other short-acting anesthetics are used. in denmark the most frequent used anestheticum for ect is thiopental, a barbiturat, but also propofol, a non-barbiturat, is used in many psychiatric departments. several studies have shown that propofol reduce seizure duration in comparison with barbiturates. so far, no studies have demonstrated any clinical implications of the reduced seiziure duration. however, these studies have included rather few patiens, most have been retrospective, and in the only prospective study conducted, uni-lateral ect was used. the aim of this study is to compare the clinical effect of ect in patients anesthesized with either propofol or thiopental. the hypothesis is that the shorter duration of seizures found with propofol as anestheticum will increase the number of treatments needed to clinial respons. furthermore we want to study differences in eeg-relate parameters previously shown to have prognostic value. hospitalized patients with major depression, who is to be treated with ect, are randomized to anesthizia with either thiopental or propofol. they are rated with hamilton depression scale and bdi before treatment, after six treatments and when treatment is concluded. when treatment is ended the patients are furthermore rated with mmse to evaluate their degree of cognitive impairment.


Eligibility criteria:
inclusion criteria: * major depression, hospitalized exclusion criteria: * age under 18, allergi to anestheticum, out-clinic patients, ect because of other diseases

Keywords: ect depression anesthiticum propofol thiopental
early aerobic training program after ischemic stroke

Conditions: Stroke; Cerebrovascular Accident

Summary: the purpose of this study is to examine the feasibility and efficacy of an early supervised aerobic exercise program for patients following a minor ischemic stroke.

the purpose of this study is to examine the feasibility and efficacy of an early supervised aerobic exercise program for patients following a minor ischemic stroke. patients after a minor ischemic stroke would be randomized within 1-3 weeks of stroke onset to a control group (6 weeks of low intensity stretching and coordination exercises followed by a supervised aerobic training program) or an experimental group (immediate aerobic training program). patients will be evaluated for measures of ambulation endurance, mobility, gait, functional assessment and clinical follow-up after 6 weeks and again 3 months later.

Eligibility criteria:
inclusion criteria: * minor ischemic stroke exclusion criteria: * unstable angina * severe lung disease * severe symptomatic peripheral vascular disease * dementia or other severe neurological disease * other severe uncontrolled medical problem

Keywords: exercise rehabilitation aerobic training
visceral leishmaniasis and malnutrition in amhara regional state, ethiopia

Conditions: Visceral Leishmaniasis; Malnutrition

Summary: the project visceral leishmaniasis and malnutrition is a cohort study that aimed to assess the association between malnutrition and visceral leishmaniasis (vl). it was conducted in libo kemkem and fogera districts of the amhara regional state in ethiopia. clinical, anthropometric, biochemical, immunological, parasitological and sociodemographic data of school age children from vl high prevalence communities were collected in december 2009, may 2010 and february 2011.


Eligibility criteria:
inclusion criteria: * reported age between 4 and 15 years of age * currently living in the selected household exclusion criteria: * to be ill of visceral leishmaniasis at the time of the survey * to be positive to visceral leishmaniasis infection tests at the time of the first survey * to be under treatment for visceral leishmaniasis at the time of the survey * to be extremely ill of any other condition

Keywords: visceral leishmaniasis kala azar malnutrition stunting thinness leishmania donovani
all-case surveillance of ofev in patients with ipf in japan

Conditions: Idiopathic Pulmonary Fibrosis

Summary: this is a non-interventional study based on new data collection to gather real-world information (i.e., data under routine medical practice) on safety and effectiveness of the ofev® capsules treatment. the study will consist of a baseline visit and follow-up visits at week 4, 13, 26, 39, 52, 65, 78, 91 and 104 for patients who have newly initiated ofev® capsules. the patients will be followed up until discontinuation of ofev® capsules treatment. as this is an observational study, no specific treatment is mandated or withheld from the patients. the choice of maintenance treatment for ipf must be according to regular medical practice and at the discretion of the physician (i.e., no randomised assignment of patient to treatment is performed). all patients administrated ofev® capsules after the launch at the sites contracted with the sponsor will be registered. the case report forms (crfs) of 1000 patients will be collected. however the patient registration continues until the approval condition has been removed. patients participating in the subsequent follow-up will undergo regular observations. these observations should be reported after approximately week 4, 13, 26, 39, 52, 65, 78, 91 and 104 since the initiation of ofev® capsules as long as they continue to receive the treatment. patients will not be followed any longer once they are reported to have discontinued the ofev® capsules treatment.


Eligibility criteria:
inclusion criteria: essentially, patients are diagnosed with ipf based upon the most recent the american thoracic society (ats), the european respiratory society (ers), the japanese respiratory society (jrs), and the latin american thoracic association (alat) guideline.
pharmacokinetics in morbid obesity after bariatric surgery

Conditions: Morbid Obesity; Overweight

Summary: morbid obesity (mo) is associated with several disorders such as hypertension, type 2 diabetes, dyslipemia and degenerative arthropathy that require pharmacological treatment. drug bioavailability and metabolism in patients with mo is altered compared to population controls. bariatric surgery is the gold standard treatment for mo when conventional therapy fails. bariatric surgery techniques can modify drug absorption in mo patients. these modifications depend on the drug absorption characteristics and on the bariatric surgery technique used. the changes in weight and body composition caused by bs at middle term can alter drug bioavailability and metabolism. the kinetics of the "normalization" process in patients with mo after bariatric surgery is unknown objectives. to analyze the changes in drug metabolism and pharmacokinetics. to establish drug dosing criteria in the post-intervention period in patients with mo after bariatric surgery. to determine the relationship between changes in drug bioavailability and metabolism in mo after bariatric surgery (longitudinal gastrectomy and y-roux gastric by-pass).

patients and methods. a prospective study of two cohorts of patients in a program of bariatric surgery (gastric by-pass and sleeve gastrectomy). study "before and after". evaluations. study on drug metabolism and pharmacokinetics using a modified "karolinska cocktail" (dextromethorphan, caffeine, losartan, omeprazole and paracetamol) before bariatric surgery and at 4 weeks and 6 months post-intervention.

Eligibility criteria:
inclusion criteria: * adults (from 18 to 55 years) * morbid obesity bmi \> 40 or bmi\> 35 plus co-morbidity * healthy controls (non-overweight and overweight groups) exclusion criteria: * allergy to study drugs * liver diseases
safety and immune response study of an investigational pneumococcal vaccine.

Conditions: Prophylactic Pneumococcal Diseases

Summary: the purpose of this study is to evaluate the safety and immunogenicity of two doses of gsk biologicals' 11 pcv vaccine when given to healthy subjects aged 18 to 40 years .

the study is open and subjects will receive two vaccine doses of gsk biologicals' 11 pcv vaccine. five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Eligibility criteria:
inclusion criteria: * healthy male or female between 18 and 40 years of age * 23-valent pneumococcal polysaccharide vaccine naive adults. exclusion criteria: * previous vaccination against streptococcus pneumoniae. * history of pneumonia within 3 years prior to the first vaccination * any confirmed or suspected immunosuppressive or immunodeficient condition * all malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years. * subjects with documented anaemia or iron-deficiency (hemoglobin level more than 10% below lower limit of normal) * history of administration of an experimental/licensed vaccine containing similar adjuvants. * history of chronic alcohol consumption and/or drug abuse. * pregnant or lactating female. * female planning to become pregnant or planning to discontinue contraceptive precautions.