Kornimate/medical-research-clean huggingface dataset:
study to evaluate diphenhydramine in children and adolescents

Conditions: Allergic Rhinitis

Summary: to characterize the pharmacokinetics of diphenhydramine in two pediatric populations: children, ages 2 to \< 12 years, and adolescents, ages 12 to \< 18 years.

this study has an open-label, single-dose classical pharmacokinetic design with no comparator treatment or group. twenty-four (24) children, ages 2 to \< 12 years, and 12 adolescents, ages 12 to \< 18 years, with symptoms due to hay fever or other upper respiratory allergies will complete the study. to ensure that younger children are represented, at least 35% (8) of the children enrolled will range from 2 to \< 6 years of age.

Eligibility criteria:
inclusion criteria: * male and female children and adolescents, ages 2 to \ 5th percentile and \< 95th percentile for weight based on age and gender. * subjects will have a body mass index (bmi) \> 5th percentile and less than or equal to 90th percentile for age and gender. * subjects who have a history of allergic rhinitis and who are experiencing symptoms due to hay fever or other upper respiratory allergies will be included. * subjects who do not use concurrent medications, except for low-dose inhaled glucocorticosteroids for allergic rhinitis or mild concurrent asthma, if dose is stabilized before entry in the study (ie, dose is not changed for 1 month prior to entry or during the study), and inhaled short-acting beta-2 adrenergic agonists for concomitant asthma, as needed; exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease. * findings from the medical history or physical examination with vital sign measurements that are not within the range of clinical acceptability. * have a known sensitivity or allergy to diphenhydramine or emla cream. * have a known sensitivity or allergy to red dye. * have asthma symptoms at the time of study entry or requiring medications other than allowed in inclusion criterion 4; * took any prescription (other than allowed in inclusion criterion 4) or nonprescription medication, within seven days or five half-lives (whichever is longer) before the study's start date. * took any herbal supplements or drank grapefruit juice with 28 days of the study's start date. * participated in, or completed, another clinical trial within seven weeks before the study's start date. * have a history of drug, alcohol, and tobacco use (older children and adolescents) * have a history of hepatitis b, a previous positive test for hepatitis b surface antigen, or a previous positive hepatitis c antibody. * have a history of hiv infection or previous demonstration of hiv antibodies. * pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception from at least three months prior to the first dose of study medication until completion of follow-up procedures.
osteoporosis and fall prevention high risk population intervention and follow up in the metropolitan area

Conditions: Osteoporosis; Fracture

Summary: background: the deterioration of musculoskeletal system imposes significant impact on physical activity in older adults. methods: this was a randomized, parallel-group, prospective study. all participants received education program including home-based exercise. the ic group consisted of different modalities of exercise while the lee group performed machine-based exercise. body composition, muscle strength, and physical performance were measured at their baseline and 3 months follow-up.


Eligibility criteria:
inclusion criteria: 1. older than 50 years of age 2. high risk as defined from one of the following criteria * score\>=1 on one minute osteoporosis risk questionnaire * 10 year predicted fracture risk \>=20% for major osteoporosis fracture or \>=3% for hip fracture from frax * fall\>=2 times in pass 1 year 3. having a bone mineral density test within one year period 4. having the capability to understand the study and complete the study interventions 5. willing to participate for the intervention and study follow ups exclusion criteria: 1. if patients were unable to meet at least the above inclusion criteria.

Keywords: osteoporosis fall fracture sacopenia body composition
efficacy and mechanisms of pharmacologic treatment of fecal incontinence

Conditions: Fecal Incontinence

Summary: the purpose of this study is to evaluate and compare treatment with fiber and loperamide for fecal incontinence.

fecal incontinence (fi) affects 4-24% adults in the community and greatly impacts quality of life. both fiber and loperamide are common, first-line treatments for diarrhea-associated fi in primary care. no known studies exist that compare fiber and loperamide for diarrhea-predominant fi. further knowledge is needed to define which treatment is more effective and to compare drug tolerability (side effects) for fi. this study will also look at changes in quality of life with treatment and potential mechanisms of drug treatment.

Eligibility criteria:
inclusion criteria: * weekly fecal incontinence exclusion criteria: * fecal impaction * inability to complete a baseline 1-week bowel diary * rectal prolapse * any prior radiation to the pelvis * colo-rectal cancer * rectal fistula * inflammatory bowel disease * neurological diseases (spinal cord injury, multiple sclerosis, parkinson's disease) * constipation (\<2 bowel movements/week) or total colectomy

Keywords: fecal incontinence adults diarrhea
a pilot study to evaluate the safety and immunogenicity of low dose flu vaccines

Conditions: Influenza, Human

Summary: the purpose of this study is to determine whether low dose flu vaccines delivered with microneedles into the skin (intradermally) are effective.

influenza vaccination is the primary method for preventing influenza and its severe complications. previous clinical studies demonstrated that delivery of vaccines intradermally (into the skin) can achieve good efficacy even with lower doses of the vaccine. comparison: low dose flu vaccine delivered intradermally with a microneedle device compared to the standard dose flu vaccine delivered intramuscularly (into the muscle) with a regular needle.

Eligibility criteria:
inclusion criteria: * signed an informed consent * no previous immune-related disease important exclusion criteria: * significant illness within the previous 4 weeks * subjects who have received an influenza vaccine within the previous 6 months * an active viral diseases * pregnant or nursing women * any known contraindication to the study vaccine or vaccine ingredients
interest of simulation training on the announcement of early pregnancy loss on the psychological impact of the patients

Conditions: Early Pregnancy Loss; Spontaneous Miscarriage

Summary: early pregnancy loss (or spontaneous miscarriage) is the loss of a pregnancy before 14 weeks of amenorrhea. its incidence is estimated at between 10 and 15%, and increases with maternal age. early pregnancy loss can have major psychological consequences for the woman, her partner and the couple in the aftermath, as well as on the experience and progress of a future pregnancy. in france, the vast majority of miscarriages are diagnosed in gynecological emergencies by interns still in training. interns, sometimes at the beginning of their training, may find it difficult to announce a miscarriage, and may do so in a way that is clumsy or not adapted to the woman's emotions, which can lead to a bad experience for her. this bad experience could lead to psychological distress, post-traumatic stress and/or impair future fertility. the initiators of this project have already carried out a before-and-after, single-center study, showing a significant improvement in the specific perinatal grief scale score following specific training for interns in first-trimester pregnancy loss. to date, no multicenter randomized study has been conducted to assess the impact of first-trimester pregnancy loss on women's psychological experience.


Eligibility criteria:
inclusion criteria: * adult patient * patient presenting to gynaecological emergency department with metrorrhagia and/or pelvic pain * patient with a diagnosis of terminated pregnancy or spontaneous expulsion of a pregnancy \< 14 weeks' amenorrhea * patient whose spontaneous miscarriage was announced by an intern * patient affiliated to or benefiting from a social security scheme * patient having signed an informed consent form exclusion criteria: * unwanted pregnancy * spontaneous hemorrhagic miscarriage requiring surgical management * ectopic pregnancy * miscarriage resulting from assisted reproduction treatment * patient with history of miscarriage ≥ 3 * poor understanding of the french language * person deprived of liberty by judicial or administrative decision * person under forced psychiatric care * person subject to a legal protection measure * person unable to give consent

Keywords: spontaneous miscarriage early pregnancy loss training for interns
a phase 2b clinical study with a combination immunotherapy in newly diagnosed patients with glioblastoma

Conditions: Glioblastoma

Summary: the purpose of this study is to assess progression-free survival (pfs) and overall survival (os) in newly diagnosed glioblastoma (gbm) participants treated with igv-001 as compared with placebo.


Eligibility criteria:
key inclusion criteria: * has a karnofsky performance scale (kps) score ≥ 70 at screening * has a new diagnosis of gbm (who grade iii or grade iv gbm) based on the treating neurosurgeon's best clinical judgement * has a diagnostic contrast-enhanced magnetic resonance imaging (mri) scan with fluid attenuated inversion-recovery (flair) sequence of the brain at screening. participants must have a confirmed measurable disease pre-operatively with at least 1 lesion measuring a total bi-perpendicular product of 4 centimeter square (cm\^2) in 2 different planes (axial, sagittal, or coronal) * the tumor must be located in the supratentorial compartment * has adequate bone marrow and organ function at screening key exclusion criteria: * has bi-hemispheric disease, multicentric disease, or disease burden involving the brain stem or cerebellum based on mri post-gadolinium enhancement * has received any previous surgical resection or any anticancer intervention for glioma * has any history of glioma, a concurrent malignancy, or malignancy within 3 years of randomization, unless definitive therapy is completed, with the exception of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has completed curative therapy * has any severe immunocompromised condition (eg, human immunodeficiency virus (hiv) with a cluster of differentiation \[cd\] 4+ cell count \<200\*10\^6/liter \[l\]) or any active uncontrolled autoimmune disease (eg, crohn's disease) * has an active cardiac disease or a history of cardiac dysfunction * is receiving any other investigational agent(s) or has received an investigational agent within 30 days or 5 half-lives of investigational agent use, whichever is longer, prior to screening * is partaking in another interventional study. participants who are partaking in an observational study are eligible * has received a live vaccine within 30 days of screening * has active and uncontrolled/untreated hepatitis b virus (hbv), hepatitis c virus (hcv), hiv, or any other active infections that, in the investigator's opinion, would impair or prohibit a participant's participation in this study. * is receiving treatment with tumor treating fields or optune®

Keywords: newly diagnosed
efficacy, safety, and tolerability study of rp-g28 in subjects with lactose intolerance

Conditions: Lactose Intolerance

Summary: rp-g28 is being investigated for treatment of moderate to severe lactose intolerance and its potential to improve the tolerance of lactose (dairy products).

lactose intolerance is a common gastrointestinal (gi) disorder that develops in lactose maldigesters when consuming lactose or when lactose is added to a previously low-lactose diet. lactose intolerance is characterized by one or more of the cardinal symptoms that follow the ingestion of lactose-containing foods. these symptoms include; abdominal pain, cramping, bloating, flatulence \[gas\] and diarrhea. as such, most lactose intolerant individuals avoid the ingestion of milk and dairy products, while others substitute non-lactose containing products in their diet. currently, there are no approved treatments for this condition. based on the health implications from insufficient calcium intake over a lifetime, including increased risk of osteoporosis and hypertension, there is need in the medical community for a tolerable and convenient treatment that allows for all levels of milk and dairy product consumption in people suffering from mild to severe lactose intolerance. study objective: to access efficacy of two rp-g28 dosing regimes on symptoms related to lactose intolerance relative to placebo after 30 days of treatment. the 30 day post-treatment phase will further evaluate the treatment's potential to prolong relief from symptoms. study design: the participants will take about 60 days to complete the study. the study consists of 3 distinct phases: screening, a 30-day treatment phase, and a 30-day post-treatment phase (off study treatment observation period). a participant will need to visit the clinical only 6 times throughout the study.

Eligibility criteria:
inclusion/exclusion criteria: * female subjects must be non pregnant, and non lactating. females of childbearing potential must use adequate birth control during study participation * medical history of intolerance to milk and other dairy products, and/or confirmed physician diagnosis of lactose intolerance. * must be free from any disorder known to be associated with gastrointestinal disease: irritable bowel syndrome (ibs), inflammatory bowel disease (ibd), ulcerative colitis (uc), crohn's disease (cd), celiac disease, diverticulitis, chronic constipation, chronic pancreatitis, pancreatic insufficiency, symptomatic biliary disease, small intestine bacterial overgrowth syndrome (sibo), active gastric or duodenal ulcers, or history of severe ulcers. * must be nicotine free.

Keywords: lactose maldigestion dairy intolerance intolerance to milk intolerance to dairy milk intolerance gi disorder lactose metabolism gi symptoms after dairy ingestion
thrombophilia in beta thalassemia

Conditions: Beta-Thalassemia

Summary: β-thalassemia disease is one of the most common congenital hemolytic anemia commonly found in the malarial belt areas including the mediterranean, the middle east, africa, southeast asian countries, and china.

β-thalassemia represents a major public health problem in egypt, it is estimated that there are 1000/1.5 million per year live births born with β-thalassemia. the average life expectancy of patients with β-thalassemia has improved over the last few years as compared to that of in the previous millennium. this has led to the discovery of new set of problems such as increased hypercoagulable state in β-thalassemia like micro infarcts in spleen and lung indicating an activated coagulation pathway. the, incidence of thromboembolism in patients with thalassemia disease is approximately 10 times higher than normal population, it accounts between 1.7 and 9.2%. on the other hand, a study conducted by chaudhary and ahmad, 2012 showed decreased aggregation in majority of β-thalassemia patients. another study conducted by ibrahim, 1999 had noticed few patients to have bleeding manifestations in the form of epistaxis. mussumeci et al., 1987 noted that both thrombophilic and anti-thrombophilic proteins were reduced as a consequence of liver damage. the net clinical outcome depends on the fine balance between the prothrombotic and antithrombotic pathways.

Eligibility criteria:
inclusion criteria: 1. all blood samples from thalassemia patients before blood transfusion. 2. in splenectomized patients taking aspirin, the tests will be performed 7 days after discontinuation of the drug. exclusion criteria: 1. patients with other hemoglobinopathies other than beta-thalassemia. 2. patients suffering from hepatic or cardiac dysfunctions of another aetiology. 3. patients with history of familial thrombophilia or use of anticoagulant therapy.
leflunomide + methotrexate in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to determine the efficacy and safety of the combination of leflunomide and methotrexate for treating active rheumatoid arthritis (ra) in an open noncomparative multicenter trial.


Eligibility criteria:
inclusion criteria: * male or female between ages of 18 and 75 years old. * female subjects must be of nonchildbearing potential (i.e., surgically sterile or at least 2 years postmenopausal) or their participation is contingent upon the following: * they are practicing a medically accepted contraceptive regimen (acceptable methods must include one of the following: systemic contraceptive, oral or implanted estrogen/progestin; diaphragm with intravaginal spermicide; cervical cap; intrauterine device; or condom with intravaginal spermicide) and * they are demonstrated not to be pregnant (by serum pregnancy test) or breast-feeding at the time of study entry and * they intend to continue the contraceptive regimen and remain not pregnant throughout the study and * they are willing to undergo pregnancy testing (serum) at screening and (urine) monthly thereafter and * they are fully informed as to the risks of entering the trial and provide written consent to enter the trial; female patients not sexually active should also be adequately informed about appropriate methods of contraception and * they agree to not get pregnant for 24 months after discontinuation of treatment with study medication or they undergo a washout procedure with cholestyramine or charcoal. * male subjects must consent to practice contraception during the study. the subject needs to have clinically diagnosed rheumatoid arthritis including diagnosis of ra by acr criteria greater than or = to 6 months prior to enrollment active disease by acr criteria . men wishing to father a child should consider discontinuing use of study drug and taking cholestyramine 8 gm 3 times daily for 11 days. in addition, males should consider discontinuation of methotrexate treatment and waiting an additional three months. * active disease by acr criteria despite methotrexate therapy for three of the following four criteria: * greater than or = to 9 tender joints * greater than or = to 6 swollen joints * greater than or = to 45 minutes of morning stiffness * esr greater than or = to 28mm/hr * subject must remain on unchanged doses of nsaids for at least 4 weeks prior to study drug administration and throughout the timecourse of the study. * concomitant therapy will be permitted with corticosteroids at a dose of less than or = to 10 mg prednisone daily (or the steroid equivalent administered orally), provided the dose has been stable for at least 4 weeks prior to the study drug administration; dose must remain constant throughout the timecourse of the study. * subjects must not receive intramuscular, intra-articular or intravenous corticosteroids within 4 weeks prior to initiating study participation or during the study. * subjects must be able and willing to comply with the terms of this protocol. informed consent must be obtained for all subjects before enrollment in the study.
mortality reductions based on aud/heavy alcohol use, hiv risk, and cardiovascular risk

Conditions: Cardiovascular Disease; Alcohol Use Disorder; HIV Risk; Substance Use Disorders

Summary: the purpose of this research study is to investigate if a personalized intervention including parts such as navigation (focus on patient outreach efforts, missed and completed encounters), personalization (individual health benefits) and compensation (value health-related costs borne by patients) will help people reduce their chances of dying from preventable causes, including heart attacks, strokes, drinking alcohol, substance abuse, hiv, and other conditions.


Eligibility criteria:
inclusion criteria: 1. age 35 to 64 2. low ses (≤ $38,000 annual income, based on 2019 20th percentile nyc income, adjusted for family size) 3. expected mortality ≥1% per year (based on age, sex, race/ethnicity), with ≥1 of the following contributors: 1. 10-year cardiovascular risk ≥10% (assessed by ascvd risk tool) 2. heavy alcohol consumption (defined using samhsa binge drinking definition, drinking \>4 standard drinks for men and \>3 standard drinks for women on same occasion in past month) 4. willing to be navigated to health and hospitals corporation of new york health system. 5. ability to provide written informed consent in english or spanish exclusion criteria: 1. receives regular care elsewhere than health and hospitals corporation of new york 2. already diagnosed with high mortality-condition(s) that are not included in the simulation model.
the effect of ticagrelor or clopidogrel on endothelial function during acute and chronic treatment

Conditions: Ischemia

Summary: to investigate if treatment with ticagrelor can mitigate the transient loss of endothelium-dependent vasodilatation of the resistance vasculature following a short period of ischemia, compared with clopidogrel at standard clinical doses. the effect of ticagrelor or clopidogrel will be studied after a loading dose and after a two weeks period of regular intake on fbf in response to the vasodilators acetylcholine or nitroglycerin before and 10 min after a 20 min forearm ischemia, respectively.

ischemia-reperfusion (ir) causes tissue injury. preclinical animal data suggest that ticagrelor but not clopidogrel protects against ir injury due to inhibition of cellular adenosine uptake and no-synthase stimulation. it is unclear if this action is part of the beneficial clinical effect of ticagrelor in patients with a history of acute coronary syndrome. the preventive action of ticagrelor on ir injury may also be of interest for the peripheral vasculature, where ir injury is known to result in endothelial dysfunction. this study aims to investigate if treatment with ticagrelor can mitigate the transient loss of endothelium-dependent vasodilatation of the resistance vasculature following a short period of ischemia, compared with clopidogrel at standard clinical doses. we will study the effect of ticagrelor or clopidogrel after a loading dose and after a two weeks period of regular intake on forearm blood flow (fbf) reactivity in response to the vasodilators acetylcholine (ach; endothelium-dependent agonist) or nitroglycerin (gtn; endothelium-independent vasodilator) before and 10 min after a 20 min forearm ischemia, respectively

Eligibility criteria:
inclusion criteria: * healthy male subjects; 18 - 40 years of age * body mass index between 18 and 27 kg/m2 * written informed consent * normal findings in medical \& bleeding history * non-smoking exclusion criteria: * regular intake of any medication including otc drugs and herbals within 2 weeks before imp administration * known coagulation disorders (e.g. haemophilia, von willebrand´s disease) * known disorders with increased bleeding risk (e.g. peridontosis, haemorrhoids, acute gastritis, peptic ulcer, intestinal ulcer) * known sensitivity to common causes of bleeding (e.g. nasal) * history of thromboembolism * history of occlusive vascular diseases * history of vascular anomalies * impaired liver function (ast, alt, ggt, bilirubin \>2 x uln) * impaired renal function (serum creatinine \> 1.3 mg/dl) * any other relevant deviation from the normal range in clinical chemistry, haematology or urine analysis * hiv-1/2-ab, hbsag or hcv-ab positive serology * systolic blood pressure above 145 mmhg, diastolic blood pressure above 95 mmhg * known allergy against any test agent under study * regular daily consumption of more than on litre of xanthine-containing beverages or more than 40g alcohol * participation in another clinical trial during the preceding 3 weeks