Kornimate/medical-research-clean huggingface dataset:
the effects probiotic has on gastromicroecology and combined with quadruple regimen for h pylori infection

Conditions: Efficacy; Gastric Microbiota; Safety

Summary: this study assesses the efficacy and safety of treatment with two-week probiotics followed by a 10-day tetracycline- and furazolidone-containing quadruple regimen as rescue treatment for h. pylori infection. eradication was evaluated using the 13c-urea breath test at 4 weeks after the end of therapy, and side effects were recorded. besides study gene-level changes in the gastric microbiota following use of probiotics.

currently the infection rate of h. pylori is high. h. pylori infection has a close relationship with human diseases , among the patients with h. pylori infection, 100% have active gastritis, \<10% show h. pylori related dyspepsia, 15%\~20% develop into peptic ulcer, \<1% ultimately evolve into gastric malignant tumor. h. pylori gastritis has been defined as an infective disease. eradication of h. pylori plays an important role in the cure, reversal and delay of these diseases. with the widespread eradication of h. pylori, antibiotics resistance rates are increasing seriously. the resistance of antibiotics results in the increase of h. pylori eradication failure rate. choosing a safe and effective scheme for patients who have failed multiple times is a challenge for the clinicians. besides, both domestic and international consensuses point that the application of some probiotics can reduce adverse effects through regulating gastric microenvironment, and it is still controversial about whether probiotics can inhibit h. pylori to increase the eradication rate. investigators previously retrospectively analyzed 30 patients with h. pylori eradication failures at least two times given two-week compound lactobacillus acidophilus followed with 10-day tetracycline- and furazolone- containing quadruple regimen, the itt eradication rate was 92.1%, and 94.6% pp analysis. side effects were mild mainly including dizziness, dry mouth and skin rash occurred in eight patients.

Eligibility criteria:
inclusion criteria: * all included patients were 18 to 70 years-old; negative for the urea breath test at least 4 weeks after last eradication treatment; and experienced at least 2 h. pylori eradication failures. exclusion criteria: * patients were excluded if they presented with a severe comorbidity or a malignant tumor; had a known history of allergy to the drugs in the therapeutic regimen; used nonsteroidal anti-inflammatory drugs (nsaids), antibiotic therapy, or bismuth salts up to 4 weeks before study inclusion; or were pregnant or breast-feeding.

Keywords: helicobacter pylori probiotics efficacy safety gastromicroecology
an extension study to evaluate the long-term safety and clinical activity of mrna-3705 in participants previously enrolled in other clinical studies of mrna-3705

Conditions: Methylmalonic Acidemia

Summary: the primary objective of this study is to evaluate the long-term safety of mrna-3705 administered to participants with isolated methylmalonic acidemia (mma) due to methylmalonyl-coenzyme a mutase (mut) deficiency who have previously participated in other clinical studies of mrna-3705.

participants with isolated mma due to mut deficiency who were previously enrolled in other clinical studies of mrna-3705 will have the option to enroll into this extension study provided all eligibility criteria have been met. the study will include 2 periods: 1) treatment period and 2) follow-up period (up to 2 years after the last dose of study drug). treatment period will continue unless one of the following occurs: mrna-3705 receives marketing approval and reimbursement in the country of origin of the participant (following market approval and access being in place, all participants who wish to continue treatment will be offered mrna-3705 through market access, with the intent to prevent treatment interruption. safety monitoring will be performed for all participants under treatment per market access requirements), the participant discontinues study drug, the participant is no longer receiving clinical benefit (in the opinion of the investigator), or sponsor discontinues the development of mrna-3705.

Eligibility criteria:
inclusion criteria: * completed the assigned dose regimen treatment time period in other clinical studies of mrna-3705 or is eligible for early transition to this study because they missed more than 3 consecutive doses of study drug due to coronavirus disease 2019 (covid-19) vaccination during the mrna-3705-p101 study. * completed the end of treatment (eot) visit in study mrna-3705-p101 within 10 days of first dose of mrna-3705 in the current study. exclusion criteria: * not expected to receive clinical benefit from continued mrna-3705 administration, in the opinion of the investigator. * any clinical or laboratory abnormality or medical condition that, at the discretion of the investigator, may put the individual at increased risk by participating in this study. * history of liver and/or kidney transplant. note: other inclusion and exclusion criteria may apply.

Keywords: isolated methylmalonic acidemia isolated methylmalonic aciduria elevated methylmalonic acid (mma) metabolism, inborn errors genetic diseases moderna mrna mrna-3705
candesartan and candesartan/ hydrochlorothiazide in the treatment of patients with hypertension and lvh

Conditions: Essential Hypertension; Left Ventricular Hypertrophy

Summary: the candle study with at maximum daily dose of 32 mg candesartan or 16/12.5 mg candesartan/hydrochlorothiazide has the objective to evaluate under naturalistic conditions, i.e. under routine medical care conditions, the impact of the antihypertensive therapy with candesartan or candesartan/hct on relevant medical parameters related to the left ventricular hypertrophy (lvh) as well as the efficacy and tolerability of candesartan or candesartan/hct in subjects suffering from essential hypertension..


Eligibility criteria:
inclusion criteria: * essential hypertension * left ventricular hypertrophy * under candesartan treatment exclusion criteria:

Keywords: essential hypertension arb left ventricular hypertrophy candesartan
fish oil and folate supplementation during pregnancy

Conditions: Perinatal DHA and Folate Status; Neurological Development

Summary: pregnant women are randomised to supplementation with fish oil, methyl tetrahydro folic acid, both or a placebo during the second half of pregnancy. biochemical measures are determined in maternal blood during pregnancy and in cord blood. non invasive follow up examinations of infants at ages 4, 5.5, 6.5, 7.5, 8, 9 and 9.5 years focus on long term effects of supplementation anthropometric development, neurological development and allergy risk.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestation \<20 week at enrollment * intention to deliver in one of the study centers * body weight at time of enrollment from 50 kg to 92 kg exclusion criteria: * serious chronic illness (eg, diabetes, hepatitis) * use fish oil supplements since the beginning of pregnancy * use of folate or vitamin b-12 supplements after gestation week 16

Keywords: docosahexaenoic acid folate neurological development allergies long term consequences for the offspring allergy risk
effect of vitamin c on allergy skin test

Conditions: Rhinitis, Allergic; Allergy

Summary: this study will assess the effect of taking vitamin c on allergy skin test.

allergic rhinitis (ar) is an immunoglobulin e (ige) mediated inflammation of the nasal cavity. house dust mite is the most common causative allergen. the skin prick test is the preferred method to confirm allergy. this test is interpreted by measuring the skin wheal reaction in response to allergen application and histamine. prior studies have shown that vitamin c may have antihistamine effect that may reduce the wheal reaction in skin prick test thus cause difficulties to interpret the results. current guidelines do not recommend cessation of vitamin c prior to skin prick test. this will require further study in order to further understand the effect of vitamin c in commercially available dose on the skin prick test wheal reaction. in this randomized placebo controlled trial, consecutive participant visiting the ent clinic with allergic rhinitis and prior positive skin prick test towards dust mite will be screened for inclusion and exclusion criteria. participants will either receive vitamin c 1000mg daily for 7 days or placebo. the skin prick test will be performed after one week of intervention and the area of the wheal reaction area (mm2) and longest diameter (mm) recorded. this will be compared between the two groups. the expected outcome is that participants with oral supplementation of vitamin c will have reduced spt wheal reaction compared to placebo group.

Eligibility criteria:
inclusion criteria: * participants above 18-years old * participants with history at least 2 symptoms of rhinitis triggered by dust * positive spt to dermatophagoides pteronyssinus with wheal reaction of at least 5 mm done within the past 1 year. exclusion criteria: * prior skin prick test result form do not include a tracing of the wheal reaction. * prior skin prick test was not performed in hctm. * participants who are actively smoking or who have smoked cigarette or vaped in the past 6 months * participants with skin conditions affecting the volar aspects of the arm. * participants on beta-blockers * participants contraindicated for skin prick test (pregnancy, history of anaphylaxis, poorly controlled asthma) * participants on long term supplements (multivitamin, traditional supplement) * participants contraindicated for vitamin c (vitamin c allergy, kidney dysfunction, history of kidney or bladder stones, hyperuricemia, thalassemia, g6pd deficiency, sickle cell disease, hamatochromatosis) * participants at risk of vitamin c deficiency (hyperthyroidism, elderly, beastfeeding, diarrhoea, restricted diet secondary to inflammatory bowel disease, anorexia or cancer)

Keywords: ascorbic acid skin prick test vitamin c antihistamine
effect of favipiravir on mortality in patients with covid-19 at a tertiary center intensive care unit

Conditions: Mortality; Intensive Care Unit

Summary: effect of favipiravir and lopinavir-ritonavir on mortality in a tertiary center intensive care unit: single center experience

many agents have been given for treatment of covid-19 infection. "covid-19 diagnosis and treatment guideline" by ministry of health was advised nationwide use of favipiravir or lopinavir-ritonavir although evidence was scarce for the nationwide use of lopinavir-ritonavir or favipiravir to treat covid-19 at the time of publication date of detailed guideline favipiravir is a rna dependent rna polymerase inhibitor and approved for treatment of influenza in japan at 2014 the aim of the study was to compare icu and hospital mortality in patients with favipiravir or lopinavir-ritonavir treatment and compare other laboratory parameters in patients treated with these two antiviral agents.

Eligibility criteria:
inclusion criteria: * 18 years and older exclusion criteria: * patients younger than 18 years old * patients who have received both lopinavir-ritonavir and favipiravir sepuentially

Keywords: covid 19 favipiravir
light treatment of vaginal infections in reproductive age women

Conditions: Bacterial Vaginosis; Vulvovaginal Candidiases

Summary: antimicrobials have helped in managing vaginal dysbiotic conditions such as bacterial vaginosis (bv) and vulvovaginal candidiasis (vvc). however, their increasing inefficiency and rise in antimicrobial resistance (amr) is a challenge and threat to public health. therefore, this study will investigate the safety and efficacy of light as an antimicrobial to treat vulvovaginal infections.

bacterial vaginosis (bv) and vulvovaginal candidiasis (vvc) are two of the most common vaginal infections, affecting millions of women worldwide. these infections can cause significant discomfort, reduced quality of life, and, in some cases, negative reproductive outcomes. despite their prevalence, challenges remain in accurate diagnosis, effective treatment, and long-term management, highlighting the need for new treatment methods and solid clinical evidence. bv occurs when there is an imbalance in the normal vaginal microbiota with symptoms of vaginal discharge and irritation. bv also increases the risk of sexually transmitted infections and negative pregnancy outcomes. treatments with antibiotics have varying effectiveness and high recurrence rates. vvc is caused by an overgrowth of candida albicans and presents as itching, burning, and thick, cottage cheese-like discharge. although antifungal medications are often effective, recurrent vvc (rvvc) is a significant challenge requiring long-term treatment. there is also a risk of resistance to antibiotic and antifungal medications. self-diagnosis and self-treatment are common, which can lead to misdiagnosis and ineffective treatment. overuse of antimicrobial medications can cause side effects and resistance. therefore, there is a need for new treatment methods to improve patient outcomes and quality of life. this clinical trial represents a first in human pilot, efficacy study of the effectiveness of vaginal light therapy in women with bv and/or vvc. the study will also evaluate the safety and tolerability of the treatment, as well as examine the underlying vaginal microbial dynamics.

Eligibility criteria:
inclusion criteria: * age 18-45 years of age * normal gynecological status * diagnosed for bv or vvc * not pregnant * no signs of other genital tract infections exclusion criteria: * current signs of other genital tract infection including std * concomitant medication for treatment of vaginal infections or use of any intravaginal medication during the clinical investigation * pregnancy * current genital malignancies, chemotherapy for any reason within the last 6 months, previous radiotherapy in the genitourinary system. cervical dysplasia diagnosis or treatment within the last 3 months (where applicable)
the effect of air pollution on lung health among children living in haifa bay region, israel

Conditions: Bronchial Asthma; Signs and Symptoms, Respiratory; Allergy

Summary: haifa bay region is located close to a major industrial zone. the aim of the study is to evaluate the health status of children living in haifa bay region. the health status will be evaluated using health questionnaires and spirometry.

haifa bay is located close to a major industrial zone. the aim of the study is to evaluate the health status of children living in haifa bay region. the health status will be evaluated while using health questionnaires and spirometry. objective: to evaluate the respiratory health of haifa bay region children with comparatives, with respect to local air pollution levels. material and methods: children from haifa bay region from 10 different communities (1200 children) will be included in the study, after both parents and the children (above 12 years of age) will sign an informed consent form. first step: a health questionnaire (based on hebrew version of isaac questionnaire) will be filled in by the parents. second step: spirometry checking of the children. in parallel, air pollution levels will be measured and provided by a network of ground monitoring stations maintained by the haifa district municipality association for the environment (hdmae). the station provides half-hourly measurement of mean concentrations of gaseous (nox, so2, o3) and particular (pm 10) pollutants over the entire investigation window. additional meteorological data are also collected. risk maps: using a gis platform, we are developing a multi-layer risk mapping procedure which accounts for ambient concentrations of selected pollutants and the heterogenic spatial distribution of several demographic and socio-economic indexes in the region. the prevalence of pulmonary disease will be evaluated according to the risk maps the health status of the children will be documented from the children's primary clinic files as well.

Eligibility criteria:
inclusion criteria: * living in haifa bay region, israel. * parents signed informed consent. exclusion criteria: * children that their parents did not signed the informed consent * chronic disease except of asthma: diabetes mellitus, cystic fibrosis, cardiac diseases, renal, rheumatic and chronic gastrointestinal diseases, mental retardation.

Keywords: asthma allergy respiratory pollution children air pollution
measurement of body weight using shoe insole pressure sensors

Conditions: Effect of Different Weights

Summary: the purpose of this study is to create a dataset to help accelerate machine learning (ml) based solutions for applications such as activity recognition, detect changes in weight and predict weight of carried load. the research will further help in the development of novel machine learning-based algorithm for accurately predicting the body weight of an individual in real-time and within few ounces error margin, using sampled data from smart insole sensors.


Eligibility criteria:
inclusion criteria: * age range of 18-70 years exclusion criteria: * refusal to adhere to covid19 safety guidelines
hdac inhibitor augmentation to clozapine

Conditions: Schizophrenia

Summary: the main goal of this pilot study is to test the extent to which adjunctive treatment with the histone deacetylase (hdac) inhibitor vorinostat improves brain plasticity and cognition in a pilot placebo-controlled trial in patients with schizophrenia who are on clozapine.

the goal of this study is to perform a pilot clinical study with a small sample of subjects to evaluate the safety and tolerability of vorinostat when combined with clozapine treatment in patients with schizophrenia. the investigators will also evaluate the potential translation of our preclinical data into a clinical use of vorinostat for cognitive impairment in clozapine-treated schizophrenic patients. potential participants will be receiving stables doses of clozapine for a minimum period of 6 months before entry into the study. clozapine was selected because i) the majority of our studies in mouse models were performed after chronic treatment with this atypical antipsychotic, and ii) the investigators' data in postmortem human brain samples of subjects with antemortem diagnosis of schizophrenia suggest up-regulation of hdac2 in frontal cortex of schizophrenic subjects treated with atypical, but not typical, antipsychotic drugs. the hdac inhibitor vorinostat was selected because preliminary data suggest that chronic treatment with vorinostat improves hdac2-dependent cognitive function in rodent models. additionally, vorinostat is the first hdac inhibitor approved by the u.s. food and drug administration (fda) for the treatment of cutaneous t-cell lymphoma. dose(s) of vorinostat have been selected based on previous clinical studies in such patients with brain metastasis.

Eligibility criteria:
inclusion criteria: * diagnosed with dsm-5 schizophrenia * receiving stable dose pf clozapine (≥ 300 mg per day) for at least 6 months before entering the study exclusion criteria: * taking specific psychotropic medications (lamotrigine and valproic acid) * current or recent (12-months) substance use or induced disorder * history of significant neurological or medical disorders * intellectual disability * known contraindications to the administration of vorinostat per product labeling * women currently pregnant, planning to become pregnant, or receiving hormone therapy and refusing any form of birth control

Keywords: schizophrenia clozapine vorinostat hdac histone deacetylase inhibitor
the neu-prem trial: neuromonitoring of preterm newborn brain during birth resuscitation

Conditions: Neurologic Manifestations; Premature Birth; Hypoxia-Ischemia, Brain

Summary: the purpose of this study is to characterize the normal brain function of premature infants (23 to 31+6 weeks ga) during birth transition and through the first 72 hours of life.

the investigators will measure components of brain function using two sophisticated, non-invasive technologies. first, amplitude integrated electroencephalography (eeg), a "simplified" eeg with four sensors (single channel), enables continuous non-invasive monitoring of cerebral activity. second, near-infrared spectroscopy (nirs) is another non-invasive technology that allows continuous real-time measurement of regional tissue oxygen utilization of the brain. both technologies have been used in newborns and have been predictive of brain injury or neurodevelopmental impairment.

Eligibility criteria:
inclusion criteria: * 23 to 31+6 weeks gestational age at birth exclusion criteria: * known congenital anomalies * parents refuse consent * neonatologist declined due to subject instability

Keywords: premature infant amplitude integrated eeg near-infrared spectroscopy
cardiac rhythm abnormalities in patients with refractory epilepsy at high risk for sudden death

Conditions: Refractory Epilepsy; Arrhythmia; Sudden Death

Summary: people with epilepsy are at a higher risk for sudden unexpected death than the general population. sudden unexpected death in epilepsy (sudep) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. the risk for sudep is particularly high for those with refractory epilepsy. several lines of evidence support a cardiac mechanism for sudep. this study plans to determine: 1. the frequency and types of cardiac arrhythmias that occur in this population and 2. whether these are increased above the general population in the same age group. additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

by employing long-term electrocardiographic monitoring, this study plans to determine: 1. the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and 2. whether these are increased above the general population in the same age group. the specific aims: 1. identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data. 2. correlate abnormal heart rates and rhythms to specific clinical data: 1. seizure type, 2. seizure frequency, 3. probable location of seizure onset in the brain, when such data are available, 4. duration of seizures, and 5. type(s) and number of anticonvulsant medications being used. 3. correlate cardiac arrhythmias to clinical symptoms

Eligibility criteria:
inclusion criteria: * refractory epilepsy exclusion criteria: * other pre-existing heart conditions

Keywords: epilepsy