Kornimate/medical-research-clean huggingface dataset:
the combined effect of omega-3 fatty acid and vitamin d3 on lipid profile levels and oxidized low density lipoprotein

Conditions: Vitamin D Deficiency

Summary: the combined effect of omega-3 fatty acid and vitamin d3 on lipid profile levels and oxidized low density lipoprotein: a randomized controlled trial in males and females with vitamin d deficiency

nothing is published in the literature about the combined effect of vitamin d3 (vd3) and omega-3 fatty acids (omega-3fa) on on lipid profile levels and oxidized low density lipoprotein this study will be conducted to investigate effect of vd3 and omega-3fa alone and with each other on lipid profile levels and oxidized low density lipoprotein in jordanian people with vitamin d deficiency. this randomized, controlled clinical trial will be designed to test effects of 50,000 iu vd3 weekly and 300 mg omega-3fa daily for eight weeks, separately and with each other, on on lipid profile levels and oxidized low density lipoprotein

Eligibility criteria:
inclusion criteria: * jordanian people aged 25-55 medical diagnosis of vitamin d deficiency ( vd \<25 ng/ ml) exclusion criteria: * subjects with previously diagnosed with any chronic disease (cardiovascular disease, osteoporosis, cancer, kidney disease, endocrine disorder, thalassemia) or has a documented history of allergic reactions to n-3fa supplementations

Keywords: vitamin d3 vitamin d deficiency lipid profile oxidized low density lipoprotein omega-3 fatty acids
study of tissue samples from patients with stage i non-small cell lung cancer enrolled on research study calgb-140202

Conditions: Lung Cancer

Summary: rationale: studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is looking at tissue samples from patients with stage i non-small cell lung cancer enrolled on research study calgb-140202.

objectives: * determine whether the 64-gene signature can accurately predict the prognosis for survival of patients with stage i non-small cell lung cancer (nsclc). outline: rna is purified from tissue samples obtained by the calgb lung cancer study (calgb-140202). the rna samples are used for gene expression analysis using the 64-gene signature and an affymetrix-hg_u133a array. reverse-transcriptase pcr may also be performed on selected samples.

Eligibility criteria:
1. registration to calgb 140202 2. institutional review board (irb) review and approval at the institutions where the laboratory work will be performed is required 3. informed consent: the calgb does not require that a separate consent form be signed for this study * the subject population to be studied in this protocol includes patients selected from calgb 140202. all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial. * all samples to be studied were obtained and stored as part of calgb 140202. the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information. in no instance will the patient be contacted directly. * there should be no physical, psychological, social or legal risks associated with this study. no invasive procedures are recommended or requested. * all appropriate and necessary procedures will be utilized to maintain confidentiality. all patients who have had samples submitted for analysis will have their calgb study number used to identify specimens. * this study does not require direct patient contact and no specific risk or benefits to individuals involved in the trial are anticipated. it is likely however, that the information gained will substantially help similar patients in the future.

Keywords: stage i non-small cell lung cancer
rac pilot - the feasibility and effectiveness of a brief preventive intervention following psychological trauma

Conditions: Stress Disorders, Post-Traumatic

Summary: the investigators proposed to compare a modified prolonged exposure intervention to treatment as usual within a hospitalized injured trauma survivor sample, to determine with this intervention could prevent the development of ptsd.


Eligibility criteria:
inclusion criteria: * all consecutive motor vehicle crash (mvc), industrial accident, and physical assault trauma survivors (i.e. victims of gunshot wounds, stab wounds), ages 18-75, to include both men and women, without evidence of serious cognitive impairment, admitted to the trauma surgery service at froedtert hospital beginning at the start of the funding period will be considered for recruitment. exclusion criteria: * individuals who: 1. have evidence of moderate to severe cognitive impairment secondary to trauma-related head injury, 2. have self-inflicted injury, 3. are more than 2 weeks post-trauma, 4. do not meet the dsm-5 definition of a traumatic stressor for ptsd, 5. screen positive for a current substance abuse problem ((i.e. intoxication and memory loss upon arrival or a current substance use diagnosis), 6. are non-english speaking, 7. are not medically stable, 8. cannot identify a support person to attend a session with them 9. do not score a 2 or more on the 5-item ptsd subscale of the 9-item screen.
nebulized hypertonic saline (3%) versus nebulized adrenaline for treatment of bronchiolitis

Conditions: Bronchiolitis

Summary: the primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. the secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy. this trial was conducted at a tertiary care teaching hospital over a period of one year in children with bronchiolitis presenting to the out-patient department and emergency. after obtaining a signed informed consent from the parents, all eligible children were assessed for baseline characteristics. a complete hemogram, chest x-ray were done in all and arterial blood gas analysis where ever required. computer generated random numbers were used for enrolment in consecutive manner and patients were randomly assigned into two groups. the first group received one dose (4ml) of nebulized hypertonic saline (3%).the second group received one dose (0.1 mg/kg) of nebulized adrenaline diluted in normal saline to make it a 4ml solution. supportive care (nasal clearing, antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary. all children were reassessed 20 minutes after one dose of nebulization using the clinical score and a child was labelled as a "responder" if he showed an improvement in the clinical severity score by atleast 3 points after 20 minutes of nebulization. both responders and non-responders were given a repeat dose of nebulization according to the group to which the child had been randomized, if: a) severe audible wheeze with severe respiratory distress (severity score ≥9) b) inability to maintain saturation \>92% even on an o2 flow of 4 l/min. non responders were given a maximum of three continuous doses of nebulization. child was considered fit for discharge if he/she was feeding well orally, there was no need for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation \>92% on room air for a period of more than 12 hours.


Eligibility criteria:
inclusion criteria: • children aged 1 month to 2 years with moderate to severe bronchiolitis as per wang score exclusion criteria: * comorbidities such as congenital heart disease, bronchopulmonary dysplasia, cystic fibrosis, neurological diseases * known or suspected immunodeficiency * congenital malformations * history of use of steroids within one week prior to presentation * severe disease requiring admission to intensive care unit/mechanical ventilation

Keywords: nebulization adrenaline hypertonic saline bronchiolitis
clinical efficacy of fluoride toothpastes using an in situ caries model

Conditions: Dental Caries

Summary: the purpose of this study is to evaluate the effect of the test toothpaste containing 1150 parts per million (ppm) of fluoride (f) on the mineral content of demineralized enamel specimens, in an in situ caries model system, by comparing the differences in net remineralization change (δm) following use of the test toothpaste with a fluoride free (0 ppm f) reference control toothpaste.


Eligibility criteria:
inclusion criteria: 1. demonstrates understanding of the study. 2. aged 18 to 85 years. 3. understands and is willing, able and likely to comply with all study procedures and restrictions. 4. has good general health (in the opinion of the investigator or medically qualified designee). 5. currently living in the indianapolis, indiana area. 6. currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens. 7. have no current active caries or periodontal disease and all restorations in a good state of repair. 8. have a salivary flow rate in the range of normal values. exclusion criteria: 1. pregnant or breast feeding women. 2. known or suspected intolerance or hypersensitivity to the study materials or their stated ingredients. 3. currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit. 4. unable to measure product weights accurately using the assigned study scale as determined by the study staff as demonstrated. 5. participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit. 6. have received a professional fluoride treatment within 14 days of randomization to the first treatment. 7. recent history (within the last year) of alcohol or other substance abuse.
anesthesia during neurophysiologic monitoring in scoliosis patients

Conditions: Idiopathic Scoliosis

Summary: when patients have spinal surgery, electrodes are placed on the body to measure motor evoked potentials (mep) and somatosensory evoked potentials (ssep). many hospitals only use iv anesthesia because they feel that measuring mep and ssep is easier using iv anesthesia. at this hospital the investigators typically use inhaled anesthesia and are able to successfully measure mep and ssep. this is a study to find out if one method of anesthesia is better than the other for measuring mep and ssep.


Eligibility criteria:
inclusion criteria: * patients with idiopathic scoliosis. exclusion criteria: * patients with neuromuscular scoliosis.
comparing of the pharmacokinetic, pharmacodynamic, safety and immunogenicity of hs-20090 and xgeva® in healthy adults

Conditions: Bone Metastasis From Solid Tumors

Summary: a randomized, double-blind and parallel group study to compare the pharmacokinetic, pharmacodynamic, safety and immunogenicity of hs-20090 120mg（1.7ml）and xgeva® in healthy adults.

this is a phase i, single center, randomized, double-blind and parallel group clinical trial . the primary objective is to assess the pharmacokinetic similarity of single subcutaneously injection of hs-20090 or xgeva® in healthy volunteers. the secondary objectives are to assess the clinical safety and immunogenicity similarity of single subcutaneously injection of hs-20090 or xgeva® in healthy volunteers. meanwhile，observing the pharmacodynamic similarity of hs-20090 to xgeva® preliminarily.

Eligibility criteria:
inclusion criteria: * sign the informed consent form and fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the test plan requirements; * healthy males, aged ≥18 years or ≤50 years old(including the boundary value); * agree to take effective contraceptive measures throughout the study period until at least 6 months after the last drug is administered; * clinical laboratory examination, chest x-ray, abdominal b-ultrasound, electrocardiogram, physical examination, vital signs and various examinations are normal or abnormal without clinical significance. exclusion criteria: * occurred or suffering from osteomyelitis or onj (mandibular necrosis) previously; the dental or jaw disease that is active, requiring oral surgery; or planned for invasive dental surgery during the study; or dental or oral surgery wounds have not healed; * serum calcium levels are outside the normal range of the laboratory. * subject has positive pre-study hepatitis b surface antigen or positive hepatitis c antibody result viral hepatitis (including hepatitis b and hepatitis c), or positive hiv antibodies, or positive test for syphilis. * the subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 3 months or 5 half-lives (whichever is longer). * prior use of medications within 6 months before and during the study. this includes medications such as, but not limited to: bisphosphonates fluoride calcitonin strontium parathyroid hormone or derivatives supplemental vitamin d (\>1000 iu/day) glucocorticosteroids (topical corticosteroids administered more than 2 weeks prior to enrolment are allowed) anabolic steroids calcitriol diuretics
caudal block with bupivacaine and dexmedetomidine versus tap block with bupivacaine alone for postoperative analgesia in pediatric undergoing infraumbical surgeries

Conditions: Postoperative Pain

Summary: acute pain management for pediatric surgical patients intraoperatively and postoperatively is important for their comfort and psychological impact. children aged 3-9 years old are included in the study and are divided randomly into two groups (45 children in each): group d: caudal block with bupivacaine 0.25% in a dose of (1 ml / kg) and dexmedetomidine 1μg/ kg. group t: tap block with bupivacaine 0.25% in a dose of (0.5 ml / kg).


Eligibility criteria:
inclusion criteria: * children aged 3-9 years old * physical status i and ii class of the american society of anesthesiologists (asa) * unilateral elective surgeries below the umbilicus exclusion criteria: * parents or legal guardian refusal. * history of developmental delay or mental retardation * contraindications to regional anesthesia as known or suspected coagulopathy, a known allergy to any of the study drugs, signs of infection at the site of caudal block. * hemodynamic unstable patient.
descriptive analysis of serum immunological markers during an euploid frozen embryo transfer in a natural cycle.

Conditions: Infertility, Female

Summary: to describe the peripheral serum levels of the anti-inflammatory cytokines il-4 (interleukin-4), il-10 (interleukin-10), tgf-ß1 (transforming growth factor beta1), the pro-inflammatory cytokines il-17 (interleukin-17), ifγ (interferon gamma) and the immune mediator pibf (progesterone-induced blocking factor) along a single frozen euploid blastocyst transfer in a natural cycle (nc) or hormone replacement therapy (hrt).

this a prospective, observational study including 40 infertile patients undergoing a "single embryo transfer" (set). blood samples will be drawn for progesterone-induced blocking factor (pibf), interleukin 17 (il-17), interferon gamma (ifγ), interleukin 10 (il-10), interleukin 4 (il-4) and transforming growth factor beta 1 (tgf-ß1) measurement on the day of ovulation in the natural cycle (nc) or first day of progesterone in the hormone replacement therapy (hrt) protocol, on the day of embryo transfer (et) and 3 and 10 days later, coinciding with the early and late embryo invasion stages respectively. in case of pregnancy, an additional blood test for pibf, il-17, ifγ, il-10, il-4, tgf-ß1 and ßhcg (beta-human chorionic gonadotropin) will be performed at 5 weeks +/- 3 days. the study will be performed at art fertility clinics and the estimated completion time will be 12 months.

Eligibility criteria:
inclusion criteria: * women aged 18 years to 40 years * having at least one good quality (grade a or b for inner mass cell and trophectoderm) day 5 or 6 chromosomally normal cryopreserved blastocyst available for transfer * single embryo transfer in a natural cycle (nc) or an hormone replacement therapy (hrt) protocol * fresh ejaculate used for fertilization exclusion criteria: * body mass index lower than 18.5 or equal or higher than 29 kg/m2 * endometriosis or adenomyosis suspected by medical history (dysmenorrhea, dyspareunia, heavy or prolonged menstrual bleeding (\> 8 days), chronic pelvic pain, catamenial rectal or bladder symptoms) or diagnosed by imaging (magnetic resonance imaging or ultrasonography) * uterine abnormalities * hydrosalpinx * insulin resistance or diabetes mellitus diagnosed by hba1c 5.7 % * antiphospholipid syndrome * polycystic ovarian syndrome according to rotterdam criteria: presence of at least two of the following: irregular cycles (\ 35 days or \ 20 follicles per ovary on transvaginal scan) or anti-mullerian hormone \> 5,98 ng/ml * history of recurrent miscarriage, defined as the loss of 2 or more pregnancies according to eshre guidelines * history of implantation failure, considered as the lack of pregnancy after the transfer of 2 good-quality (grade a or b for inner mass cell and trophectoderm (29)) euploid embryos * history or suspicion of asherman syndrome * autoimmune disease * couple first degree consanguineous

Keywords: infertilty ivf progesterone estradiol cytokines immunology pharmacological effect of drugs hormones
evaluation of efficacy, safety and tolerability of targretin capsules in patients with advanced or metastatic non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: this study evaluates the use of targretin capsules (bexarotene) in combination with standard chemotherapy for the treatment of metastatic non-small cell lung cancer (nsclc) in patients who have not yet received chemotherapy for their lung cancer.

this study evaluates the use of targretin capsules (bexarotene) in combination with cisplatin and vinorelbine for the treatment of metastatic non-small cell lung cancer in patients who have not yet received chemotherapy for their lung cancer. every patient receives a platinum-containing chemotherapy every four weeks for at least four chemotherapy cycles (approximately four months). half of the patients are randomly assigned to receive targretin capsules once daily in addition to the chemotherapy. the other half is randomized to receive a standard platinum-containing chemotherapy without targretin capsules.

Eligibility criteria:
patients must have: * pathologic (histologic or cytologic) confirmation of nsclc * stage iiib with malignant pleural effusion or stage iv disease * at least one measurable or evaluable nsclc lesion that has not been previously irradiated unless radiation therapy was more than three weeks prior to entry in the study and the lesion has been shown to have progressed subsequent to the radiation therapy * ecog performance status 0 or 1 * adequate organ system function * fasting serum triglycerides that are within the age-adjusted normal range (or normalized with appropriate intervention such as antilipid therapy prior to the initiation of targretin capsule therapy). patients must be able to complete at least four cycles of combination chemotherapy (i.e., approximately four months) patients must not have had: * brain metastasis * prior chemotherapy for nsclc * prior platinum-based chemotherapy for any indication

Keywords: nsclc targretin retinoid bexarotene
association between self-reported web-based sccai and health-related quality of life index in uc patients

Conditions: Quality of Life; Ulcerative Colitis

Summary: an accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (uc). recent studies have reported that the simple clinical colitis activity index (sccai) correlates well with mayo score. a recent report demonstrated that sccai has a significant correlation with the degree of health-related quality of life in uc patients. it is also reported that the self-administered sccai through the web-based input tool at home is highly correlated with the sccai assessed by physician. the aim of this study was to investigate the relationship between self-administered web-based sccai and the health-related quality of life of uc patients.

an accurate assessment of disease activity is crucial for the treatment of patients with ulcerative colitis (uc). several indices have been used to assess disease activity in patients with uc. mayo score is the most widely used index for uc activity measurement. meanwhile, recent studies have reported that the simple clinical colitis activity index (sccai) correlates well with mayo score. sccai is consisted of only clinical items and includes items such as nocturnal diarrhea and urgent defecation which are more closely related to the quality of life of patients. in this regard, a recent report demonstrated that sccai has a significant correlation with the degree of health-related quality of life in uc patients. since sccai is composed of only clinical parameters, it can be evaluated by the patients themselves. according to recent research, the self-administered sccai was reported to have a high correlation with the sccai assessed by physician (correlation coefficient = 0.79). moreover, it is also reported that the self-administered sccai through the web-based input tool at home is highly correlated with the sccai assessed by physician (spearman's correlation = 0.79). these results suggest that the patient's self-reported sccai can be applied to actual clinical practice, and it will enable remote monitoring and flexible follow-up depending on the patient's disease activity. if self-administered sccai is to be applied as a more valid disease activity assessment tools, it also properly reflects patient's quality of life status. however, it is not yet known whether the self-administered sccai using web-based tools reflects the quality of life of patients. the aim of this study was to investigate the relationship between self-administered web-based sccai and the health-related quality of life of uc patients.

Eligibility criteria:
inclusion criteria: * diagnosis of uc for \>3 months * familiarity with online communication (e.g., use of the internet) * consent for study participation exclusion criteria: * previous colon resection or other uc related bowel surgery * psychiatric or intellectual disability * lack of ability for access or use online tools

Keywords: sccai health-related quality of life index
measuring motor imagery ability in patients with traumatic brain injury.

Conditions: Traumatic Brain Injury; Healthy

Summary: 1. validation of translated motor imagery ability questionnaire miq-rs 2. investigating the motor imagery ability in patients with traumatic brain injury

1. translation of the miq-rs following the who guidelines. followed by a validation of this translated questionnaire in patients with traumatic brain injury and in healthy volunteers. 2. investigating the motor imagery ability using 3 different test * miq-rs (movement imagery questionnaire) * tdmi (time dependent motor imagery) * mental chronometry test patients and controls will perform all 3 test twice with an interval of 2 weeks to measure the test-retest reliability.

Eligibility criteria:
inclusion criteria: * tbi minimum 3 months ago and maximal 1 year ago exclusion criteria: * other neurological disorders * severe cognitive deficits, unable to understand the study protocol * severe motor impairment, unable to perform the tdmi (time dependent motor imagery) screening test control group: matched for age, sex and educational level no neurological disorders present

Keywords: traumatic brain injury, motor imagery ability, validation