Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of bolus comparing with continuous drip of 3% nacl in patients with severe symptomatic hyponatremia.

Conditions: Hyponatremia; Osmotic Demyelination Syndrome

Summary: to compare between intermittent bolus and traditional continuous drip of 3%nacl in patients with severe symptomatic hyponatremia in rajavithi hospital.

background: hyponatremia is the most common electrolyte imbalance in clinical practice, associated with increased mortality and length of stay. in 2014,european guideline have recommended promp infusion of 3%nacl 150 ml in 20 minutes to raise plasma na to 5 mmol/l and improve symptoms. the recommendation was the result of studies with small numbers of patients, and expert opinions. methods: a single center opened-label randomized controlled-trial,we will randomly assign 40 patients with severe symptomatic hyponatremia (plasmana\<125mmol/l) in rajavithi hospital into two groups: first group receive intermittent bolus of 3%nacl 150 ml in 30 minutes and follow plasma sodium until achieve target of goal plasma sodium = 5 mmol/l in 6 hours (no more than 12 mmol/l in 24 hr and 18 mmol/l in 48 hr),another receive traditional continuous drip of 3%nacl start with rate = 1ml/kg/hr and follow plasma sodium every 1 hour until achieve target of plasma sodium 5 mmol/l in 6 hours .the primary end point is change in plasma sodium in 6 hours and improvement of glasglow coma scale.the secondary end points are change in plasma sodium in 24,48 hours,overcorrection rate in 24 and 48 hours ,ods rate ,hospitality days and mortality rate.

Eligibility criteria:
inclusion criteria: * patients in rajavithi hospital * age from 18 years * plasma na \< 125 mmol/l with glucose-corrected * severe symptomatic hyponatremia (vomitting ,coma ,somnolence) exclusion criteria: * systolic bp \< 90 mmhg or map\< 70 mmhg * pregnancy or lactation * congestive heart failure or volume overload * lung congestionfrom cxr * chronic renal failure patients with edema * cirrhosis patients with edema * patients with coronary artery disease * patients with brain injuries * deny consent
phototoxicity potential of natrova creme rinse - 1%

Conditions: Head Lice

Summary: this study will evaluate the primary irritation potential of natrova creme rinse - 1% in humans, after exposure to uv radiation.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 18-65 years of age and in good health. 2. fitzpatrick skin type i, ii or iii exclusion criteria: 1. history of severe reactions from exposure to sunlight 2. known allergies or sensitivities to adhesives in patches 3. inability to evaluate the skin in and around the test sites 4. diabetes requiring medication 5. clinical significant skin disease 6. asthma or other severe respiratory disease 7. known immunological disorders such as hiv, aids, lupus,rheumatoid arthritis 8. history or current skin cancer 9. mastectomy for cancer involving removal of lymph nodes draining the test sites 10. epilepsy 11. pregnancy, lactation, or planned pregnancy during study period 12. chronic use of systemic antihistamine medication within 14 days of screening 13. use of anti-inflammatory drugs within 2 days of screening visit 1 14. currently receiving allergy injections 15. use of immunosuppressive drugs 16. topical drugs used at the test site within 7 days of screening visit 1 17. current participation in any clinical trial 18. participation in any patch test for irritation or sensitization or uv exposures within 4 weeks of study start 19. use of any investigational drug therapy within 4 weeks of study start.

Keywords: head lice
technology interventions for youth alcohol use

Conditions: Alcohol Drinking

Summary: the purpose of this study is to evaluate the effects of two programs to prevent/reduce alcohol misuse among youth primary care patients. depending on their study condition, youth will receive a brief web-based computer program or the web program + 8 weeks of supportive text messages. parents/caregivers of youth are encouraged to use a freely available app to guide conversations with their child about drinking. this study will have significant impact by evaluating response to these scalable interventions which can be deployed widely in clinical care settings.


Eligibility criteria:
inclusion criteria: * patients age 12-17 within the michigan medicine pediatric care system who had an appointment date within the past 2 years; and * past 12-month alcohol use; and * patient has a phone that can receive text messages exclusion criteria: * patients who do not understand english; or * patients deemed unable to provide informed consent due to conditions that preclude understanding of assessment or intervention content; or * parent/guardian consent is not obtained; or * another child in household already enrolled in the study; or * ongoing participation in another behavioral health research study
safety, tolerability, and efficacy of at101 in patients with relapsed or refractory b-cell non-hodgkin's lymphoma

Conditions: B-cell Non Hodgkin Lymphoma

Summary: determine mtd based on the safety and tolerability of at101 and the rp2d for patients with recurrent or non-reactive b-cell nhl.

determine the maximum tolerant dose (mtd) based on the safety and tolerability of at101 and the recommended dose 2 dose (rp2d) in phase 2 trials for patients with recurrent or non-reactive b cell non-hodgkin lymphoma (b-cell nhl).

Eligibility criteria:
inclusion criteria: * b cell non-hodgkin lymphoma based on who classification 2017 * incompatible with existing standard therapies or have had disease progression, and whose standard therapies do not currently have available standard therapies due to reasons such as intolerance/inadequacies or rejection * the eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 * adequate hematological, kidney, liver, lung, heart and bone marrow function without blood transfusion within two weeks prior to screening * those with a minimum life expectancy of 12 weeks or more * in women with childbearing, clinical response tests (serum- or ure-hcg) were negatively identified during this trial * those who have agreed in writing to participate voluntarily in this trial exclusion criteria: * those who have previously had a history of treating homologic autologous hemoblastitis (allogeneic hsct) * at101/adcidmilisers, anticancer chemotherapy/adcidms for lymphodeletion or those who are hypersensitive to tocilizumab * those who cannot take autologous blood * those who have received chemotherapy or radiotherapy, excluding lymphodeletion, within two weeks prior to ip administration * persons who have not been recovered (ctcae grade ≤1 or baseline) due to previous treatment * those who have identified a condition that, at the test's discretion, may affect safety and validation during the trial period. * those who have identified the following forces at the time of screening: 1. those who have been clinically aware of heart disease within 6 months prior to screening 2. those identified as thromboembolic disease, pulmonary embolism or bleeding bleeding diatheses within 6 months prior to screening 3. those who have identified a history of malignant tumors other than b-cell non-hodgkin's lymphoma within five years prior to screening 4. those who have undergone major surgery within 4 weeks prior to screening 5. those who have undergone non-critical surgery within two weeks prior to screening * childbearing women or men who do not have the will to use effective contraception for a longer period of time, either 12 months after clinical trial period and at101 administration or when at101 in the body is not identified * those who have been administered or applied to other ip/id within 4 weeks of screening * those who are addicted to alcohol and/or medication * those who are unfit or unable to participate in this trial when judged by pi

Keywords: anti-cd19 chimeric antigen receptor t cell
postpartum weight retention

Conditions: Obesity; Hypertension; Depression

Summary: the postpartum weight management study is a true community-academic collaboration, bringing together maternity care coalition (mcc) staff and the investigator, dr. charmaine smith wright from the university of pennsylvania to address the needs of postpartum moms. the project is an innovative intervention to help moms lose weight after the birth of their baby. helping mothers control their weight during pregnancy and beyond can help both mother and baby avoid later obesity and cardiovascular disease. although all women are at risk for retaining the weight gained during pregnancy, this problem is amplified for low-income, minority women. the holistic approach aims to prevent postpartum weight retention and increase breastfeeding duration with a multi-component, low-cost intervention that provides: 1) motivational appeals delivered in text message format; 2) environmental aides, such as a baby carrier to combine exercise with infant care, and a pedometer to accurately measure exercise at home; 3) enhanced peer support, including home visits and group classes with other mothers; and 4) task-oriented professional support from nutrition and lactation experts, who assist women in developing a personalized health plan. the effectiveness of the intervention will be evaluated using a randomized control methodology among clients of mcc.


Eligibility criteria:
inclusion criteria: * all women who speak english, and are within six weeks of delivering a live, term, single infants exclusion criteria: * women who have multiple births or preterm (\<38 weeks gestation) infants

Keywords: intervention study maternal obesity nutrition maternal child health
a trial to study the effects of group versus individual dietary counseling in pediatric obesity

Conditions: Obesity

Summary: aim 1 - the primary aim of the study is to assess whether group counseling is a non-inferior intervention compared to the usual care of individual counseling in the management of childhood obesity. in order to achieve this aim, the investigators will compare the mean change in bmi after 6 months of intervention in the two study arms. aim 2 - the secondary aim of the study is to determine if the change in bmi is associated with changes in the dietary composition, physical activity and metabolic profile.

this is a non-inferiority study to determine the sample size needed for a larger study to explore an intervention strategy focused on nutrition counseling to maximize weight loss and minimize cardiovascular risk factors in obese children and adolescents. this is a prospective parallel arm, randomized trial, to study the impact of nutritional counseling in an individual vs. group setting. there will be a total of four groups. obese pre-adolescents (ages 9-12) and adolescents (ages 13-17) will be randomized into two interventions: individual nutrition counseling or group nutrition counseling. subjects will receive the same information in both interventions. all content will be developed prior to starting the intervention. each group session will have a maximum of 7 children with 1 parent/caregiver per child and a minimum of 5 children with a caregiver. group sessions will be one time a month for 60 minutes (30 minutes for dietetic session and 30 minutes for discussion/questions) and individual sessions will be one time a month for 30 minutes. there will be 6 sessions for each group. all groups will receive standard of care for physical fitness counseling which includes recommending 1 hour of physical activity a day and limiting screen time to less than 2 hours a day. all groups will be evaluated for depression and appropriately referred if found to be depressed. behavioral strategies, like mindful eating, will be included in the nutrition education.

Eligibility criteria:
inclusion criteria: * subjects 9-17 years of age with a bmi percentile for age of ≥95 * subjects must be able to attend monthly sessions with a parent and/or guardian. exclusion criteria: * subjects with diabetes at baseline, mental or psychological disease that would interfere with understanding, disease or medication causing obesity or weight loss, and participants in an alternative weight management program will not be included in the study. * subjects with impaired glucose tolerance will not be excluded from participation. * non-english speaking subjects will not be excluded.

Keywords: obesity nutritional counseling physical activity food diary
follow up of intravesical n-803 plus bcg in bcg-naive non-muscle invasive bladder cancer (nmibc)

Conditions: Non Muscle Invasive Bladder Cancer

Summary: the purpose of this clinical trial is to obtain long-term follow-up information and status of bladder cancer for patients who received study treatment in the quilt-2.005 study.

all 9 subjects that completed quilt-2.005 phase 1b are planned to be enrolled in this study. thus, the maximum enrollment for this study is 9 subjects. all enrolled subjects will be followed every 12 months for life, or until withdrawal of consent, or if the sponsor closes the study.

Eligibility criteria:
inclusion criteria: * enrolled and treated with intravesical n-803 plus bcg in the phase 1b portion of quilt-2.005. exclusion criteria: * not applicable
retinal photoreceptor outer segment length before and after light stimulation - a pilot study

Conditions: Macular Degeneration, Dry; Primary Open-angle Glaucoma

Summary: it has been shown that reactions of human retinal photoreceptors to a light stimulus can be measured with custom-made, research prototype optical coherence tomography (oct) systems. this can be used as a biomarker for the function of the photoreceptors. due to the high technical demands on the system, however, the technique is currently not available for clinical purposes. in this pilot study a protocol to measure changes in retinal photoreceptor layer thickness before and after light stimulation shall be developed based on a commercial oct system and newly developed algorithms. other variables, such as circadian processes shall be investigated as well. after measurements in healthy volunteers, the protocol is planned to be applied in patients with primary open angle glaucoma (poag) and age-related macular degeneration (amd) to test for feasibility of the method in these patient groups.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * signed informed consent form * ametropia below 3 diopters * ability and willingness to follow instructions for healthy volunteers: * normal ophthalmologic findings for primary open angle glaucoma patients (poag): * diagnosed poag * md \<= 10 db for age-related macular degeneration (amd): * diagnosed dry amd * diagnosed stage ii or stage iii amd exclusion criteria: * presence of any abnormalities preventing reliable measurements * ocular inflammation and ocular disease interfering with the study aims * use of photosensitizing medication (phototoxic drugs, photoallergic drugs) in the 3 months preceding the study * presence of any condition with the possibility of causing photosensitivity, including systemic lupus erythematosus sle, porphyria, vitiligo, xeroderma pigmentosum and albinism * presence of any form of epilepsy * ocular surgery in the 3 months preceding the study * pregnancy, planned pregnancy or lactating * any medical or surgical history, disorder or disease such as acute or chronic severe organic disease

Keywords: light stimulation retinal photoreceptors light adaptation functional optical coherence tomography optophysiology intrinsic optical signals
bay98-7196, dose finding / poc study

Conditions: Endometriosis

Summary: purpose of the study is to test efficacy and safety of bay98-7196 intravaginal ring as a new treatment option for patients with endometriosis-associated pelvic pain


Eligibility criteria:
inclusion criteria: * premenopausal women18 years and above at the time of screening. * women with endometriosis confirmed by laparoscopy or laparotomy within the last ten years but not less than 8 weeks before the screening visit in japan, diagnosis based on imaging (transvaginal ultrasound or mri) also qualifies for inclusion. * moderate to severe endometriosis-associated pelvic pain (eapp) of ≥5 in the last 28 days before screening visit 1 measured on the numeric rating scale (nrs; i.e. 4-week recall period). * at randomization: adherence to the study procedures during the screening period, at least 24 diary entries of esd item 1 during the last 28 consecutive days before the randomization visit, and a sum of the available esd item 1 ('worst pain' on the daily nrs) entries during this period of at least 98 (corresponding to an average score of ≥ 3.5). * willingness to use only ibuprofen as rescue pain medication for eapp, if needed according to investigator's instruction. * use of a non-hormonal barrier method (i.e. spermicide-coated condoms) for contraception from screening visit until the end of the study. this is not required if adequate contraception is achieved by vasectomy of the partner exclusion criteria: * pregnancy or lactation (less than three months since delivery, abortion, or lactation before start of treatment) * any diseases or conditions that can compromise the function of the body systems and could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study drug * any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results. * any disease or condition that may worsen under hormonal treatment according to the assessment and opinion of the investigator. * undiagnosed abnormal genital bleeding * wish for pregnancy during the study * regular use of pain medication due to other underlying diseases * non-responsiveness of endometriosis associated pelvic pain (eapp) to gnrh-a or surgery (partial response is not exclusionary).
efficacy of fixed combination of beclometasone + formoterol + glycopyrrolate versus foster® in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: randomized,double-blind,multicenter,multinational,parallel-group,phase iii study to demonstrate the superiority of the triple fixed combination of beclometasone+formoterol+glycopyrrolate (bdp/ff/gb) administered via pmdi over the equivalent dose of foster® in copd (chronic obstructive pulmonary disease) patients after 52 weeks of treatment

this 52-week randomised 2 parallel groups study aimed at evaluating the superiority of fixed triple therapy with ics/laba/lama compared to ics/laba in severe to very severe copd patients. patients' eligibility was checked during the screening visit including the review of medical history, spirometry assessments, routine labs, physical examination, 12-lead ecg, vital signs measurement. this visit was followed by a 2-week open-label run-in period under foster® (bdp/ff 400/24 µg total daily dose). eligible patients were then randomised to either fixed triple therapy bdp/ff/gb or bdp/ff. during the 52-week treatment period, completing patients did have 5 subsequent visits post randomisation scheduled respectively after 4 (visit 3), 12 (visit 4), 26 (visit 5), 40 (visit 6) and 52 (visit 7) weeks of treatment. during these, pre-dose and post-dose spirometry, 12-lead ecg, vital signs, dyspnea assessments were performed. rescue medication use, compliance with the treatment and exact-pro questionnaire were recorded daily (via an electronic diary) during the run-in and randomised treatment periods.

Eligibility criteria:
inclusion criteria: * male or female adults aged ≥ 40 years with a diagnosis of copd * current smokers or ex-smokers * a post-bronchodilator fev1 \< 50% of the predicted normal value and a post- bronchodilator fev1/fvc \< 0.7 * at least one exacerbation in the 12 months preceding the screening visit exclusion criteria: * pregnant or lactating women * diagnosis of asthma or history of allergic rhinitis or atopy * patients treated with non-cardioselective β-blockers in the month preceding the screening visit * patients treated for exacerbations in the 4 weeks prior to screening visit * patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as prn * patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia * known respiratory disorders other than copd * patients who have clinically significant cardiovascular condition

Keywords: spirometry severe copd lung disease fixed combination
study on combined vaccination with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine

Conditions: Influenza and Pneumonia

Summary: this study is an open-label,single center phase ⅳ clinical trial of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine.the purpose of this study is to evaluate the safety and immunogenicity of combined immunization with quadrivalent influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in the elderly aged 60 years and above.

this study is an open-label,single center,phase iv clinical trial in the elderly aged 60 years and above.the experimental vaccines were manufactured by sinovac biotech co., ltd. a total of 3000 subjects will be enrolled,the safety and immunogenicity of combined immunization were evaluated in 480 subjects,and the safety observation of combined immunization was evaluated in the extended safety group, which included 2520 subjects.

Eligibility criteria:
inclusion criteria: * the elderly aged 60 and above; * the subjects and/or guardians can understand and voluntarily sign the informed consent form; * proven legal identity. exclusion criteria: * received any circulating seasonal influenza vaccine prior to enrollment; * have received any pneumococcal vaccine within 5 years; * history of severe allergic reactions to vaccines (such as acute anaphylaxis, angioneurotic edema, dyspnea, etc.); * history of uncontrolled epilepsy and other serious neurological disorders (e.g.transverse myelitis, guillain-barre syndrome, demyelinating disease, etc.) * fever,acute onset of chronic disease,severe uncontrolled chronic disease or acute disease at the time of vaccination; * receipt of other investigational drugs in the past 30 days; * receipt of attenuated live vaccines in the past 14 days; * receipt of inactivated or subunit vaccines in the past 7 days; * according to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.