Kornimate/medical-research-clean huggingface dataset:
zinc supplementation effect on immune recovery in hiv patients

Conditions: HIV; AIDS; Immunological Deficiency; Inadequate Immune Recovery; Viral Replication

Summary: introduction: an adequate zinc supplementation is essential for a good immunological function. however, zinc deficiency is seen in more than 50% of adults infected with hiv. the safety and efficiency of zinc supplements in the progression of hiv is evaluated in the short-term. hypothesis null hypothesis: zinc supplementation does not improve the immunological recovery of hiv patients after three months of daily consumption. alternate hypothesis: zinc supplementation improves the immunological recovery of hiv patients after three months of daily consumption

goal: to assess the effect of zinc supplementation in the natural history of hiv, emphasizing on the immunological recovery of patients in a health care provider program in medellín in 2012. methods: a prospective, randomized, double-blind, controlled clinical trial will be conducted. the selected group will consist of male and female patients over 18 years of age, who comply with the inclusion criteria, with digital clinical history, in an hiv/aids program of a health care provider in medellín. they will receive zinc supplements for 3 months. a comparison will be made between the immunological recovery among those patients taking the zinc supplement and those who are not. the cd4 lymphocytes value will be taken as an independent variable.

Eligibility criteria:
inclusion criteria: * adults suffering from hiv/aids, over 18 years of age with first- and second-line antiretroviral therapy. * patients with two viral loads less than 40 copies/ml (viral supression) and a stable or inferior cd4 lymphocyte count. * patients with body mass index over 18.5 kg/m2. * patients without opportunistic diseases. exclusion criteria: * pregnant women. * hospitalized patients with cognitive disability evaluated by a doctor. * patients who are unwilling to participate. * patients taking zinc supplements.

Keywords: hiv aids zinc zinc supplement immunological deficiency
a study to evaluate ocrelizumab in patients with nephritis due to systemic lupus erythematosus (belong)

Conditions: Lupus Nephritis; Systemic Lupus Erythematosus

Summary: this is a phase iii, randomized, double-blind, placebo-controlled, multicentre, parallel-group study designed to evaluate the efficacy and safety of ocrelizumab added to soc (corticosteroid plus one of two immunosuppressant regimens) compared with placebo added to soc in patients with who or isn class iii or iv lupus nephritis.


Eligibility criteria:
inclusion criteria: * age 16 years or above at the time of the screening * ability and willingness to provide written informed consent and to comply with the schedule of protocol requirements * diagnosis of sle * active lupus nephritis exclusion criteria: * currently active retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia, or dementia * severe renal impairment * lack of peripheral venous access * pregnancy or breast feeding mothers * history of severe allergic or anaphylactic reactions to humanized, chimeric or murine monoclonal antibodies or i.v. immunoglobulin * known severe chronic pulmonary disease * evidence of significant uncontrolled concomitant diseases in any organ system not related to sle, which, in the investigator's opinion, would preclude patient participation * concomitant condition which has required treatment with systemic corticosteroid (excluding topical or inhaled steroids) prior to screening * known hiv or chronic active hepatitis b or chronic active hepatitis c infection * known active infection of any kind prior to day 1 * history of serious recurrent or chronic infection * history of cancer, including solid tumors, hematological malignancies and carcinoma in situ (except basal cell carcinoma of the skin that has been excised and cured). * history of alcohol or drug abuse prior to screening * major surgery prior to screening, excluding diagnostic surgery * previous treatment with campath-1h * previous treatment with a baff directed treatment (e.g. anti-blys) prior to screening * previous treatment with a b-cell targeted therapy other than one directed at baff (e.g. anti-cd20, anti-cd22) * treatment with any investigational agent prior to screening * receipt of any live vaccines prior to day 1 * intolerance or contraindication to oral or i.v. corticosteroids * positive hepatitis bsag or hepatitis c serology. patients who are hbsag negative but hbcab positive may be enrolled with a negative dna test

Keywords: sle lupus belong
a phase 1b study to evaluate the safety of xen-101

Conditions: Obesity

Summary: this phase 1b study will evaluate the effects of xen-101 in subjects with obesity

this study will assess the safety, tolerability and weight loss associated with xen-101 in obese men and women.

Eligibility criteria:
inclusion criteria: 1. male or female, age 18 to 60 years, inclusive, at screening 2. body mass index of 30 to 45 kg/m2 3. stable body weight for at least 3 months (i.e., fluctuation of ≤5%) 4. if a female of childbearing potential, must agree to use double barrier contraception (e.g., condom and 1 additional form of adequate contraception) from the date of signing of the icf, throughout the study, and for 4 weeks after the final dose of study drug. in addition, she must be advised not to donate ova during this period. if a non-sterilized male is sexually active with a female partner of childbearing potential, he must use double barrier contraception from the date of signing of the icf, throughout the study, and for 8 weeks after the final dose of study drug. in addition, he must be advised not to donate sperm during this period 5. if a female of childbearing potential, must have a negative pregnancy test at screening and on day 1 (baseline) 6. able to provide informed consent 7. willing and able to comply with this protocol and procedures, including feces collection, and be available for the entire duration of the study exclusion criteria: 1. currently enrolled in another investigational device or drug study, or less than 30 days or 5 times the half-life of the drug candidate (whichever is longer) has passed between screening for this study and the end of the treatment period of the previous investigational device or drug study 2. diagnosed with type 1 diabetes or type 2 diabetes (t2d) (resolution of t2d \>3 years before screening is allowed) 3. laboratory evidence during screening of t2d, including glycated hemoglobin (hba1c) ≥6.5% or fasting glucose ≥126 mg/dl (≥7.0 mmol/l) 4. evidence of clinically significant cardiac, neurologic, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, or gastrointestinal disease that, in the investigator's opinion, would compromise the safety of the subject, interfere with the interpretation of the study results, or otherwise preclude subject participation 5. female who is pregnant, nursing, or intends to become pregnant during the study. 6. positive result for hepatitis b virus surface antigen, hepatitis c virus ribonucleic acid, and human immunodeficiency virus (hiv) antibody at screening 7. use of anti-obesity medications (e.g., glucagon-like peptide-1 analogues, stimulants, bupropion/naltrexone) within 6 months before screening
use of electronic personal health records to improve medication adherence

Conditions: Atrial Fibrillation; Medication Adherence

Summary: the purpose of this pilot study is to examine the use of a personal health record to improve medication adherence among patients with non-valvular atrial fibrillation taking dabigatran for primary prevention of embolic stroke.

three brief newsletters will be sent by the research staff to the study patients in the form of secure messages through their mychart account. the newsletters will describe dabigatran tolerability, adverse effects, patient monitoring, warnings/precautions, and administration. newsletters will be developed through a review of the fda-approved prescribing information, general tertiary references, and a search of pubmed and drafted with guidance from a drug information specialist at manchester university college of pharmacy as well as reviewed by the research staff. descriptive analysis will be used to analyze the survey to assess patient attitudes and beliefs about dabigatran and personal health records, as well as to assess the level of patient engagement. difference-in-difference regression analysis will be used to evaluate the impact of the personal health record on dabigatran adherence by comparing the differences between times (pre-post) and interventions. patient medication adherence will be correlated from the pharmacy refill data to determine if the intervention group is more compliant than the control group. multivariate analysis will be used to explore factors influencing personal health record use and dabigatran adherence.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient of parkview physicians group-cardiology * currently on dabigatran for non-valvular atrial fibrillation * out-patient status * ability to read and understand english * access to the internet * ability to utilize the computer and internet * willingness to enroll in a mychart account exclusion criteria: * physical or cognitive disability hindering provision of the informed consent process or performance of study tasks * unable to physically or cognitively carry out the tasks necessary for activating and/or utilizing a personal health record * designated as part of a vulnerable subject population that the investigator or designee identifies to have compromised autonomy related to potential study participation * currently part of another study involving another type of personal health record (other than mychart)

Keywords: personal health record medication knowledge anticoagulants patient engagement
study of capecitabine to treat recurrent high grade gliomas

Conditions: Malignant Glioma

Summary: the purpose of this study is to determine if capecitabine is effective in the treatment of high grade gliomas that have returned after completing treatment.

high grade gliomas (hggs) represent a heterogenous group of primary brain tumors that share who grade iii or iv classification (anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma multiforme). despite the upfront use of surgery, radiation, and chemotherapy, high grade gliomas uniformly result in recurrence and death. palliative chemotherapy offers an improvement in time to progression, symptom control, quality of life, and potential survival; however, no established chemotherapy regimen for recurrence exists and new treatments are needed. oral capecitabine is a rationale strategy for therapeutic palliation of recurrent high grade gliomas given its oral administration, its well-known kinetics and toxicities, its non-competitive toxicities to other high grade glioma treatments, its well established management algorithms, its established evidence of entry into the central nervous system, and its evidence of safety and efficacy in malignancies in the central nervous system.

Eligibility criteria:
inclusion criteria: * histological confirmation of high grade glioma (who grade iii or iv: anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed glioma, and glioblastoma multiforme) * male or female 18 years of age or older * negative pregnancy test (if of childbearing potential) * any number of previous recurrences will be allowed * karnofsky performance status \> 60 * hematocrit \> 30,000 * white blood cell count \> 1,500 * platelet \> 100,000 * absolute neutrophil count \> 1,000 * bilirubin \< 1.5 x upper limits of normal * transaminases (alt and ast) \< 1.5 x upper limits of normal * creatinine \< 1.5 x upper limits of normal * adequate medical health to participate in this study * adequate documentation of menopause (natural/surgical) or patient commitment to routine use of reliable birth control (barrier/hormonal) * ability to read and understand the informed consent document * ability and willingness to follow all requirements of the study including following all directions, taking medication as prescribed and completing all diaries and forms exclusion criteria: * karnofsky performance status \< 60 * hematocrit \< 30,000 * white blood cell count \< 1,500 * platelet \< 100,000 * absolute neutrophil count \< 1,000 * bilirubin \>1.5 x upper limits of normal * transaminases (alt and ast) \> 1.5 x upper limits of normal * creatinine \> 1.5 x upper limits of normal * inability to undergo gadolinium-contrasted mris, including severe claustrophobia or insufficient allergy prophylaxis

Keywords: hgg anaplastic astrocytoma anaplastic oligodendroglioma anaplastic mixed glioma glioblastoma multiforme gbm xeloda capecitabine
dimethyl fumarate (dmf) observational study

Conditions: Multiple Sclerosis

Summary: the primary objective of the study is to determine the incidence, type, and pattern of serious adverse events (saes), including but not limited to infections (including opportunistic infections), hepatic events, malignancies, and renal events, and of adverse events (aes) leading to treatment discontinuation in patients with ms treated with dimethyl fumarate (dmf). secondary objectives of this study in this population are as follows: to determine dimethyl fumarate (dmf) prescription and utilization patterns in routine clinical practice in patients with multiple sclerosis (ms); to assess the effectiveness of dimethyl fumarate (dmf) on multiple sclerosis (ms) disease activity and disability progression in routine clinical practice as determined by the expanded disability status scale (edss) score and multiple sclerosis (ms) relapse information; and to assess the effect of dimethyl fumarate (dmf) on health-related quality of life, healthcare resource consumption, and work productivity.

patients aged 12 to under 18 may be included where enrollment of pediatric patients in this study is considered observational and is permissible by local regulations.

Eligibility criteria:
key inclusion criteria: - patients with multiple sclerosis (ms) who are newly initiating treatment with dimethyl fumarate (dmf) under routine clinical care are eligible to participate in the study. key exclusion criteria: * patients with previous exposure to dimethyl fumarate (dmf), fumaderm (fumaric acid esters), or compounded fumarates. * patients participating in other clinical studies. note: other protocol-defined inclusion/exclusion criteria may apply.
multiorgan multi-parametric mri study

Conditions: Type 2 Diabetes

Summary: to determine the reproducibility of a single quantitative multiparametric mri for the assessment of body composition and multiple organ structures.


Eligibility criteria:
inclusion criteria: * any person over 18 years of age. * participant is willing and able to give informed consent for participation in the investigation. * either: participant has type 2 diabetes or: person is a healthy volunteer exclusion criteria: * the participant may not enter the investigation if they have any contraindication to magnetic resonance imaging (incl. pregnancy, extensive tattoos, pacemaker, shrapnel injury, severe claustrophobia). * any other cause, including a significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the investigation, or may influence the result of the investigation, or the participant's ability to participate in the investigation
the effectiveness of multimedia education on hypoglycemic management.

Conditions: Type2diabetes; Hypoglycemia

Summary: the first phase of the research was to develop tools, including scales and multimedia, and the second phase was to carry out multimedia hypoglycemia education intervention measures. an experimental randomized controlled trial with a repeated measures design was conducted in second phase. participants in the experimental group receiving multimedia hypoglycemia education and participants in the contrast group receiving conventional hypoglycemia education. structural questionnaires were used for data collection. the study was to investigate the effectiveness of multimedia hypoglycemia education compared to conventional hypoglycemia education on knowledge, self-care behavior, fear of hypoglycemia, social support, quality of life, nursing hours, education satisfaction, and the recurrence rate of hypoglycemic events among patients with type 2 diabetes.

in the first phase, we created multimedia educational content on hypoglycemia and recruited 300 type 2 diabetes patients who had experienced hypoglycemic events from a medical center and a primary care clinic in southern taiwan. the participants completed consent forms and questionnaires, and we conducted statistical analyses to develop and evaluate knowledge and behavior assessment tools. we obtained consent from 83 participants to enter the second phase, where they received hypoglycemia education and were then randomly assigned by computer to either the experimental group or the contrast group.

Eligibility criteria:
inclusion criteria: * type 2 diabetes and blood glucose levels below 70 mg/dl exclusion criteria: * patients with cognitive impairment, those who are unable to perform activities of daily living and those with severe or unstable medical conditions.

Keywords: multimedia education hypoglycemia knowledge self-care behavior the recurrence rate of hypoglycemic events
epidemiological landscape of cervical cancer in latin america

Conditions: Uterine Cervical Neoplasms

Summary: a portrait of clinical and epidemiological aspects of cervical cancer in latin america is required to understand the high frequency of cervical cancer despite the existence of effective preventive tools. a better understanding of the current situation of this scenario will provide a valuable groundwork for the development of national and cooperative programs to improve cervical cancer prevention and treatment.


Eligibility criteria:
inclusion criteria: * women \> 18 years. * histologically proven cervical carcinoma * diagnosis of carcinoma of the cervix since january 2018 or newly diagnosis or recurrent disease during the period of study recruitment. * any histology of cervical cancer at time of diagnosis. * figo stage ib2-iva * have available and adequate medical records for data collection * accept to participate in the project and sign the informed consent (if applicable) exclusion criteria: * figo stage i and ib1 * non-invasive cervical cancer * synchronous tumor or second primary tumor in the last five years (exception for thyroid cancer or skin cancer non melanoma)

Keywords: cervical neoplasms
evaluation of the luteolytic effect of a gonadotropin releasing hormone (gnrh) agonist after the administration of human chorionic gonadotropin (hcg) in the initial follicular phase a its influence on the prognosis of in vitro fertilization treatment

Conditions: Infertility

Summary: this study was designed to evaluate the ability of gonadotropin releasing hormone (gnrh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (ivf) after the administration of human chorionic gonadotropin (hcg) on the first day of menses.

the aim of this study is to evaluate the efficacy of a gnrh agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hcg on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.

Eligibility criteria:
inclusion criteria: * age \>21 and \< 38 years old * polycystic ovarian syndrome * risk for ovarian hyperstimulation syndrome exclusion criteria: * recurrent abortion * endometriosis * more than 3 ivf failures * use of oral contraceptive pills in the preceding 3 months * low response to gonadotropins

Keywords: corpus luteum rescue gonadotropin releasing hormone (gnrh agonist) human chorionic gonadotropin (hcg) infertility pregnancy rate
assessing the safety of pregnancy in the coronavirus (covid-19) pandemic

Conditions: Corona Virus Infection; COVID; Pregnancy Related; Early Pregnancy

Summary: prospective nationwide cohort study of pregnant women enrolled early in gestation and followed for covid-19 exposure and infection, with follow up of obstetrical outcomes and infant development through the first year of life.

aspire is focused on the first trimester, a critical and vulnerable period when all of a baby's organ systems form and the placenta - the crucial connection between mom and baby - develops. currently, there are no data about the effects of covid-19 infections in the first trimester. the study will provide critical information to: 1. guide the care of pregnant women 2. protect the safety of their babies and families 3. help those considering pregnancy in the future understand what it means to be pregnant in this new era the investigators are recruiting 10,000 women from the start of pregnancy and will track covid-19 exposures using frequent serology testing. the investigators will collect information during and after the pregnancy to try to determine the effects of covid 19 for mom and baby. participants will be asked to do the following throughout pregnancy: * submit frequent, quick (\<1 minute each) symptom tracking reports using your mobile phone and/or computer. * collect finger-stick blood samples from home at several points throughout your pregnancy. * give permission to review medical records related to your pregnancy, delivery and baby's development. * complete questionnaires online about your health during your pregnancy and after delivery of your baby.

Eligibility criteria:
inclusion criteria: * over age 18 * participant is 4-10 weeks pregnant (gestation) exclusion criteria: - male (biologically unable to achieve pregnancy)

Keywords: covid-19 pregnancy coronavirus