Kornimate/medical-research-clean huggingface dataset:
magnitude of the antibody response to and safety of a gbs trivalent vaccine in hiv positive and hiv negative pregnant women and their offsprings

Conditions: Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections

Summary: the study compared the magnitude of the antibody response and safety of a gbs trivalent vaccine in hiv positive and hiv negative pregnant women and their offspring. in addition the study investigated the maternal to fetal transfer of antibodies induced by the investigational vaccine.


Eligibility criteria:
inclusion criteria: * pregnant women 18-40 years of age between 24-35 weeks gestation * women who were hivneg or hivpos with who stage i or ii disease and with cd4+ counts \> 50 cells/µl exclusion criteria: * women who had cd4+ count ≤ 50 cells/µl * women who were hivpos with who stage iii or iv disease, history of severe allergic reactions after previous vaccinations

Keywords: group b streptococcus gbs vaccine prevention of group b streptococcus infection
hydroxychloroquine for thrombosis prevention and antiphospholipid antibody reduction in primary antiphospholipid syndrome

Conditions: Antiphospholipid Syndrome

Summary: this is an interventional drug study designed as a pilot for a randomized clinical trial, aimed at assessing the effect of hydroxychloroquine on the incidence rate of thrombosis in patients with primary antiphospholipid syndrome as the main outcome, as well as the safety of hydroxychloroquine administration in this population. in addition, the effect of hydroxychloroquine on antiphospholipid antibody titers will be assessed.

patients with primary antiphospholipid syndrome (either thrombotic or obstetric) on regular follow-up at our outpatient rheumatology department and being treated with standard care (systemic anticoagulants and/or antiplatelet agents), are randomized to receive either hydroxychloroquine plus standard care, or standard care alone, on a 1:1 ratio using block size 2 randomization, after exclusion of patients with contraindications to hydroxychloroquine or prior hydroxychloroquine use within 12 months of consideration for enrollment. patients are monitored clinically every 3 months and the development of thrombosis and/or adverse effects attributable to hydroxychloroquine is recorded. antiphospholipid antibody titers (anti-cardiolipin immunoglobulin g (igg)/immunoglobulin m (igm) and anti-beta2-glycoprotein i igg/igm isotypes) are measured semi-annually. intention-to-treat survival analysis is applied for assessing the effect of hydroxychloroquine on the incidence of thrombosis. longitudinal mixed linear models are applied for assessing the effect of hydroxychloroquine on longitudinal titers of antiphospholipid antibodies.

Eligibility criteria:
inclusion criteria: adult patients diagnosed with primary antiphospholipid syndrome (paps) \[updated sapporo criteria: miyakis et al, j thromb haemost. 2006 feb;4(2):295-306. pubmed 16420554\] exclusion criteria: 1. ≥4 american college of rheumatology (acr) classification criteria for systemic lupus erythematosus (sle) 2. acr classification criteria for other systemic autoimmune disorders 3. active malignancy 4. treatment with hydroxychloroquine (hcq) in the previous 12 months 5. history of serious adverse events or contraindication to hcq including a history of hcq allergy, hcq eye toxicity, or glucose-6-phosphate dehydrogenase deficiency, uncontrolled seizure disorder, liver enzyme elevation \>2-fold the upper normal limit, and creatinine clearance \<30ml/min

Keywords: antiphospholipid antibody titers thrombosis prevention hydroxychloroquine antimalarials antiphospholipid syndrome
study on the correlation between fat soluble vitamins and non-alcoholic fatty liver disease

Conditions: Non-Alcoholic Fatty Liver Disease; Fat Soluble Vitamin Deficiencies and Disorders

Summary: excessive or insufficient levels of vitamins in the body can affect health. with the prevalence of obesity and mets, nafld has become the leading cause of chronic liver disease and abnormal liver biochemical indicators in health examinations in china. the current research results on serum vitamin a, d, and e levels in nafld patients are controversial. therefore, this study mainly explores the correlation between serum fsv levels and nafld, providing reference for nutrition and clinical management of nafld patients.

this is a single center cross-sectional study. in this study, 4000 eligible patients will be recruited and demographic information and clinical data of all study subjects will be collected. according to the results of abdominal ultrasound, the patients were divided into nafld group and non nafld group. the levels of fat soluble vitamins in the two groups were compared to explore the correlation between different concentrations of fat soluble vitamin levels and the risk of nafld.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old, both male and female; 2. voluntarily participate in this study and sign an informed consent form; 3. diagnosed nafld through abdominal ultrasound; exclusion criteria: 1. acute and chronic infections, severe cardiovascular and cerebrovascular diseases, respiratory system diseases, urinary system diseases, rheumatic diseases, tumors, and pituitary dysfunction; or have hepatitis b, hepatitis c virus, or acquired immunodeficiency syndrome; 2. surgery was performed within 6 months, and blood donation, transfusion, or significant blood loss occurred within 4 months; 3. have taken vitamin supplements within 2 weeks; 4. women are in pregnancy, lactation, or within one year after childbirth; 5. alcohol abuse (alcohol intake ≥ 140 g/week for males and ≥ 70 g/week for females) 6. the serum creatinine (scr) exceeds twice the following abnormal values, with the standard of abnormal values being: male (20-59 years old)\>97 μ mol/l, male (60-79 years old)\>111 μ mol/l; female (20-59 years old)\>73 μ mol/l, female (60-79 years old)\>81 μ mol/l.

Keywords: cross-sectional study correlation dose-response relationship
effects of cholecalciferol supplementation on bone health and muscle strength in adults during post-burn period

Conditions: Vitamin D; Burn Injury

Summary: vitamin d has pleiotropic effects. burn patients are at risk of hypovitaminosis d and may experience post-injury osteopenia and sarcopenia. investigators hypothesized that vitamin d supplementation during one year can improve bone and muscle health in post-burn period.


Eligibility criteria:
inclusion criteria: * occurrence of injury between 2005 and 2011 * burn surface area (bsa) greater than 10% exclusion criteria: * pregnancy, renal or liver failure, hypo or hyperparathyroidism, prior vitamin d substitution, treatment using systemic corticosteroids or antiepileptic drugs, regular exposure to ultraviolet b radiation (solarium), unstable cardiovascular disease or acute muscle or skeletal injury prohibiting physical exercise
anti-mullerian hormone (amh) and antral follicle count as markers of ovarian reserve- prospective followup of young cancer patients

Conditions: Infertility

Summary: young female cancer patients have improving chances of survival. the main risk is a chronic damage to their ovarian reserve. this may lead to future infertility.

our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.

Eligibility criteria:
inclusion criteria: * all females prior and after chemotherapy exclusion criteria: * do not consent

Keywords: chemotherapy cancer amh gonadotoxicity ovarian reserve patients exposed to chemotherapy
steroid diabetes in patients with kidney disease

Conditions: Nephrotic Syndrome

Summary: if steroid diabetes is not recognized in time, it will cause irreversible damage to the body. nephropathy patients are more likely to have steroid diabetes ,the incidence rate up to 25%,due to hypoalbuminemia, high-dose hormone and other reasons, so they need to be closely followed up, identified and intervened in time.

1. patients with nephrosis who had taken glucocorticoid for the first time were followed up, and those who had diabetes themselves were excluded. 2. regularly follow up and record information on glucocorticoid medication, medications that have an impact on blood sugar, fasting blood sugar, 2-hour postprandial blood sugar, and glycated hemoglobin. 3. notify relevant doctors of any cases of elevated blood sugar. 4. the total follow-up time is 1 year.

Eligibility criteria:
inclusion criteria: 1. patients who need to use glucocorticoids due to the following diseases: nephrotic syndrome, immunoglobulin a nephropathy, membranous nephropathy, anti-neutrophil cytoplasmic antibodies (anca)-associated vasculitis (aav), systemic lupus erythematosus； 2. initial daily dose of glucocorticoids greater than or equal to 10mg of prednisolone； exclusion criteria: 1. patients with diabetes； 2. those who are unable to communicate through language； 3. uremic patients； 4. unable to perform blood glucose monitoring and follow-up as required； 5. those who have used glucocorticoids within the past 3 months and have accumulated a dose of 10mg or more of prednisone； 6. participated in other clinical studies。

Keywords: steroid diabetes
mechanisms of insulin resistance in critical illness: role of systemic inflammation and glp-1

Conditions: Hypoglycaemia

Summary: the purpose of this study is to determine the role of inflammation and the insulin regulating hormone glp-1 during critical illness.

critically ill patients often exhibit hyperglycaemia. although the cause of this hyperglycaemia is probably multifactorial, peripheral insulin resistance is a major contributor, similar to type 2 diabetes mellitus (t2d). there are several similarities between critical illness and t2d, including the presence of systemic inflammation and increased plasma free fatty acids (ffa), all of which may induce insulin resistance in healthy volunteers. in critical illness, elevated catecholamines, cortisol, growth hormone and glucagon may also contribute to insulin resistance. the degree of hyperglycaemia correlates with mortality in icu patients. van den berghe et al. found that iv infusion of insulin to obtain strict normoglycaemia reduced mortality as well as morbidity in critically ill surgical patients and in some medical icu patients. however, insulin increases the risk of hypoglycaemia; this is a major obstacle to strict euglycaemia in icu patients and may explain the inability of others to reproduce the benefits reported by van den berghe et al. thus, alternatives to insulin for controlling plasma glucose (pg) in icu patients are warranted. aim: to study the role of the incretin hormone, glucagon-like peptide (glp)-1 for glycaemic, metabolic, hormonal and inflammatory profile in * critically ill patients in the intensive care unit (icu) and * healthy volunteers exposed to a standardised systemic inflammation

Eligibility criteria:
inclusion criteria healthy subjects: * healthy (assessed by medical history and clinical examination) * age 18-40years * bmi \< 30kg/m2 exclusion criteria healthy subjects: * previous resection of the small intestine (not including the appendix) * presence of any inflammatory illness during the fortnight preceding the study inclusion criteria critically ill patients: * age\>18 years * hba1c\<6,5% * admission to the icu within the last 72 hours

Keywords: glp-1 inflammation glucose
effects of capsimax on appetite, energy intake and blood pressure

Conditions: Obesity; Body Weight; Weight Loss; Overweight

Summary: obesity is an ongoing major public health problem in most countries of the world for which the agrifood industry still remains criticized because of the abundant offer of high sugar-lipid-energy dense foods, particularly in the fast-food sector. the resulting societal pressure on the food industry probably explains in part the efforts that have been deployed to seek natural active ingredients and to develop functional foods favorably influencing energy balance. capsaicin is a food non-nutrient constituent that was shown to decrease appetite sensations and subsequent energy intake. the measurement of heart rate variability revealed an association between the increase in sympathetic nervous system (sns) activity and the satiating effects induced by capsaicin. this is concordant with the observation that pre-prandial intake of capsaicin, be it in capsules or diluted in tomato juice, increased satiety and reduced energy intake. the objective of this study is to evaluate the long effects of capsimax on appetite sensations and energy expenditure under conditions of moderate energy restriction and to evaluate the long-term effects of capsimax on energy intake and expenditure under conditions of moderate energy restriction.


Eligibility criteria:
inclusion criteria: * premenopausal women * between 18 and 50 years * healthy * non-smoker * bmi between 25 and 35 kg/m2 * weight stability exclusion criteria: * pregnant or menopausal woman * history of losing and gaining weight (yo-yo) * taking medication for diabetes, hypertension, depression, or hypothyroid * taking a supplement for weight loss * vegetarian, vegan, intolerant to gluten or pepper (investigational product), and severe allergy to peanuts or nuts * suffers from irritable bowel syndrome or gastro-oesophageal reflux * suffers from stomach ulcers or inflammation * other serious conditions such as cardiovascular, renal, liver, and lung diseases * history of drug abuse and current alcohol abuse * use of any medication (including over-the-counter medications and herbal remedies) such as grapefruit juice, piperine, nsaids, etc.
lutonix dcb versus standard balloon angioplasty for treatment of below-the-knee (btk) arteries

Conditions: Critical Limb Ischemia

Summary: to assess the safety and efficacy of the lutonix drug coated balloon (dcb) for treatment of stenosis or occlusion of native below-the-knee arteries.


Eligibility criteria:
inclusion criteria: * male or non-pregnant female ≥18 years of age; * rutherford clinical category 3, 4 \& 5; * life expectancy ≥ 1 year; * significant stenosis (≥70%) * a patent inflow artery; * target vessel(s) diameter between 2 and 4 mm; * target vessel(s) reconstitute(s) at or above the ankle exclusion criteria: * pregnant or planning on becoming pregnant; * history of stroke within 3 months; * history of mi, thrombolysis or angina within 30 days of enrollment; * planned major amputation (of either leg) * prior major amputation if amputation occurred less than one year prior to enrollment and if patient is not independently ambulating; * gfr ≤ 30 ml/min per 1.73m2; * acute limb ischemia; * in-stent restenosis of target lesion
safety and tolerability of kh631 gene therapy in participants with neovascular age-related macular degeneration

Conditions: Age-Related Macular Degeneration

Summary: van-2201 is phase i clinical trial to assess the safety and tolerability of kh631 in subjects with neovascular amd. kh631 is gene therapy designed to deliver a protein which targets and blocks vegf via an adeno-associated viral vector. the standard of care for patients with neovascular amd are anti-vegf treaments, which have demonstrated improvement in vision and reduction in fluid. a one time placement of a product which inhibits vegf has the potential to reduce the patient burden of regular intraocular injections.

the van-2201 clinical trial is a multicenter, open-label, dose-escalating clinical study. the primary objective of the study will be to establish a safe and tolerable dose range in subjects with neovascular amd. five dose cohorts are planned to be included in the study, with approximately five subjects per cohort. subjects who meet the eligibility criteria (i.e. all the inclusion and no exclusion criteria) will be enrolled to receive kh631. kh631 will be delivered at the dose level according to the cohort via intraocular injection. subjects will be seen monthly until the primary outcome measurement at 24 weeks and through week 52. the subjects will be continued to followed with regular visits until they complete the 104 week visit.

Eligibility criteria:
inclusion criteria: 1. males and females ages 50 to 85 (inclusive) with a study eye which meets the following criteria: a. previously received ivt treatment of anti-vegf for neovascular amd, with documented response to anti-vegf therapy during the first 2 weeks of screening b. active macular cnv lesion secondary to amd evidenced by sd-oct c. have a etdrs bcva letter score of 63 to 19 (approximately 20/63 to 20/400 snellen equivalent) in the study eye at screening for the first subject in each cohort (sentinel subject), followed by etdrs bcva letter score of 73 to 19 (approximately 20/40 to 20/400 snellen equivalent) for the rest of the subjects each cohort; d. pseudophakia in the study eye, with ocular media to permit high quality fundus imaging at screening and allow planned vitrectomy and subretinal injection; e. are willing and able to sign the study written informed consent form (icf). exclusion criteria: 1. have had any prior ocular or systemic treatment (investigational or approved) or surgery for the treatment of neovascular amd except ivt anti-vegf 2. retinal pigment epithelial tears or rips at screening 3. any history or presence of vitreous hemorrhage; 4. have any condition preventing visual acuity improvement; 5. have any other cause of cnv; prior pars plana vitrectomy or scleral buckling or retinal detachment surgery; macular hole, epiretinal membrane or vitreo-macular traction; full thickness macular hole; 6. history of intraocular or periocular surgery in the prior 3 months; 7. prior trabeculectomy or other filtration surgery ; 8. any use of long-acting intraocular steroids, including implants, within six months prior;
safety and effectiveness of mesenchymal stem cells in the treatment of pneumonia of coronavirus disease 2019

Conditions: COVID-19 Pneumonia

Summary: the outbreak of coronavirus disease 2019 (covid-19) at the end of 2019 has seen numerous patients experiencing severe acute lung injury (ali), which developed into severe respiratory distress syndrome (ards). the mortality was as high as 20% -40%. due to the lack of effective antiviral treatments, supporting treatment is the predominant therapy for covid-19 pneumonia. its cure is essentially dependent on the patient's immunity. while the immune system eliminates the virus, numerous inflammatory cytokines are produced and a cytokine storm occurs in severe cases. mesenchymal stem cells (mscs) play an important role in injury repair and immune regulation, showing advantageous prospects in the treatment of covid-19 pneumonia. mscs prevent cytokine storms by retarding the tnf-α pathway, alleviate sepsis by modulating macrophages, neutrophils, nk cells, dc cells, t lymphocytes and b lymphocytes. after infused, mscs aggregate in the lungs, improve the lung microenvironment, protect alveolar epithelia, and improve pulmonary fibrosis and pulmonary function.

in vitro, mesenchymal stem cells were revealed to inhibit the secretion of inflammatory cytokines by spleen lymphocytes and up-regulate regulatory t cells, thereby inhibiting the secretion of interferon-γ(ifn-γ) induced by lymphocytes and tumor necrosis factor(tnf) induced by macrophage. animal models and preclinical studies have shown that mesenchymal stem cells (mscs) were implanted into inflammatory lung tissues after infusion, which significantly improved the clinical manifestations and histopathological lesions caused by acute lung injury. mesenchymal stem cells inhibited the effects of interleukin-1 (il-1) through regulatory t cells (cd4 + cd25 + foxp3 + treg cells) and by antagonizing the expression interleukin-1 receptor (il1-ra). mesenchymal stem cells significantly down-regulated pro-inflammatory factors by inhibiting the expression of il-1, tnf and ifn-γ in lung tissue, and up-regulated anti-inflammatory factor by enhancing the expression of il -10 and regulatory t cells, respectively, thereby dampening the inflammatory response.

Eligibility criteria:
inclusion criteria: * patients with severe covid-19 pneumonia * willing to give informed consent exclusion criteria: * patients with mild covid-19 pneumonia * liver dysfunction * concomitant with other active infection * renal dysfunction * heart failure \>grade 2 * pregnant * history of copd
evaluating a nonessential amino acid restriction (neaar) medical food with total neoadjuvant therapy for locally advanced rectal cancer (larc)

Conditions: Rectal Cancer

Summary: this clinical study aims to assess feasibility, safety, tolerability, and compliance of a nonessential amino acid restriction (neaar) medical food in adult patients with locally advanced rectal cancer during standard of care short course radiotherapy followed by standard of care chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of adenocarcinoma of the rectum * clinical stage ii (ct3-4, n-) or stage iii (ct any, n+) based on mri * eligible for total mesorectal excision * no evidence of distant metastasis * no prior pelvic radiation therapy * no prior chemotherapy * age ≥18 years exclusion criteria: * patients unable to undergo mri * other anticancer or experimental therapy * body mass index (bmi) \ 40 kg/m2 * serious or refractive cachexia or anorexia * insulin-dependent diabetes taking or needs to take any protein or amino acid containing nutritional supplements (e.g., ensure®) patients with a condition where high-fat or fatty food is contraindicated history of confirmed food allergy active wound or skin graft that would require a significant increase in protein requirements for skin integrity and healing
methylphenidate raclopride positron emission tomography (pet) test - 11

Conditions: Cocaine-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to evaluate pet methodology to study in vivo synaptic dopamine release.

the objective of this study is to evaluate pet methodology to study in vivo synaptic dopamine release.

Eligibility criteria:
inclusion criteria: healthy normals exclusion criteria: history of head trauma or loss of consciousness. significant medical history. history of seizures.