Kornimate/medical-research-clean huggingface dataset:
the safety of a high-dose, rapid infusion of iron sucrose

Conditions: Iron Deficiency

Summary: iron sucrose infusion is an iron replacement used to treat iron deficiency anemia (not enough iron in the body to make hemoglobin). iron is a mineral that the body needs to produce hemoglobin, which carries oxygen in the blood. when the body does not get enough iron, it cannot produce enough hemoglobin and you become anemic. the research study is looking at the side effects of using a higher dose and faster rate of iron sucrose infusion than what is used in standard of care. the purpose of this study is to see if infusion with 500 mg of iron sucrose over a one hour time period can be done safely. if this can be done safely, it may reduce the total number of infusions required and the time for each infusion. this may be less costly and less burdensome to patients.


Eligibility criteria:
inclusion criteria: * any patient requiring iron infusion exclusion criteria: * patients will be excluded from enrollment if they are under the age of 18, unable to give signed consent, are pregnant, have end-stage renal disease, are on hemodialysis (hd), or have a history of clinically significant adverse reactions to iron sucrose.
dual task aerobic exercise for older adults with cognitive impairment (hm2)

Conditions: Cognitive Impairment

Summary: the investigators proposed research will establish whether combining aerobic exercise with cognitive challenges is feasible and effective in community dwelling older adults with early signs of cognitive impairment.

to determine the effects of dual-task aerobic exercise training on community dwelling older adults with early signs of cognitive impairment. we will compare an exercise intervention (e-i) versus an exercise control (e-c) group. each week, both groups will accumulate a minimum of 120 minutes of exercise (target 150 minutes) from community-based group classes (50 minutes of aerobic exercise) and also complete 45 minutes of beginner-level square stepping exercise (sse). the e-i group will also answer cognitively challenging questions while doing sse (dual-task training). this study will determine whether a combined multiple modality (primary component being aerobic exercise) and dual-task exercise program is both feasible and effective for improving cognitive and mobility status, as well as vascular compliance, in older adults who may be at risk for cognitive and mobility decline.

Eligibility criteria:
inclusion criteria: * male/female 55-90 years old. * montreal cognitive assessment score ≤27 * preserved instrumental activities of daily living (based on lawton-brody instrumental activities of daily living sale) exclusion criteria: * dementia (i.e., mini-mental examination score \<24 or self-reported physician diagnosis) * major depression (\>=16 on the center for epidemiologic studies - depression scale combined with clinical judgment by primary study physician) * other neurological or psychiatric disorders * recent history of severe cardiovascular conditions * significant orthopedic conditions * have blood pressure \>180/100 mmhg or \<100/60 mmhg * unable to comprehend questionnaire material/study procedures

Keywords: aerobic exercise cognition dual task gait training group-based exercise older adults
evaluation of the efficacy of electroacupuncture in the treatment of functional dyspepsia

Conditions: Functional Dyspepsia

Summary: brief summary template for the study: the goal of this clinical trial is to evaluate whether electroacupuncture can treat functional dyspepsia (fd) in adult participants aged 18 to 65 years, including both males and females, who have been diagnosed with functional dyspepsia based on the rome iv criteria. the main questions it aims to answer are: * does 5 hz electroacupuncture improve symptoms in functional dyspepsia patients? * does 100 hz electroacupuncture improve symptoms in functional dyspepsia patients? * are there differences in the efficacy between 5 hz and 100 hz electroacupuncture in treating functional dyspepsia and its subtypes (pds and eps)? researchers will compare the effects of 5 hz electroacupuncture, 100 hz electroacupuncture, and sham electroacupuncture to determine which approach provides more significant symptom relief and whether different frequencies have varying impacts on fd subtypes. participants will: * receive electroacupuncture treatment at specific acupoints (such as liangmen, tianshu, zusanli, and xiajuxu) for 30-minute sessions, 3 times a week for 4 weeks. * be randomly assigned to one of the following groups: 5 hz electroacupuncture, 100 hz electroacupuncture, or sham electroacupuncture (control). * have their functional dyspepsia symptoms, quality of life, and any adverse effects monitored and evaluated throughout the study.


Eligibility criteria:
inclusion criteria: * diagnosed with functional dyspepsia based on rome iv diagnostic criteria. * aged 18 to 65 years, inclusive, with no gender restrictions. * normal endoscopy results within the past year, showing no structural explanation for symptoms. * no acupuncture treatment in the last month. * not participating in any other clinical trials in the past 2 months. * able to understand and provide informed consent. exclusion criteria: * presence of serious or malignant diseases (e.g., cirrhosis, heart failure, gastrointestinal tumors) that could explain dyspepsia symptoms. * chronic atrophic gastritis detected in endoscopy results. * positive for helicobacter pylori infection based on c-13 urea breath test or gastric biopsy. * history of gastrointestinal surgery. * recent use (within 2 weeks) of medications affecting dyspepsia, including prokinetics, proton pump inhibitors, antacids, or antidepressants. * presence of severe mental or physical conditions, such as dementia or illiteracy, that could interfere with study participation. * severe coagulation disorders. * substance abuse or alcohol dependence. * pregnant or breastfeeding women.

Keywords: electroacupuncture functional dyspepsia
comparative validation of "blinq" and "2win" vision screeners

Conditions: Strabismic Amblyopia; Refractive Amblyopia; Strabismus

Summary: after 28 years of development, the binocular birefringence screener ("blinq," "rebion") was commercially released. it need to be validated with aapos (american association for pediatric ophthalmology and strabismus) criteria in part because the next uniform standards document is pending. adult and children pediatric and strabismus patients were screened with blinq and "2win" photoscreener with "cr" corneal reflex alignment test and then compared to confirmatory exam with age-appropriate determination of binocular status.

as a part of a new or follow-up comprehensive eye examinations, patients were screened with two novel objective devices according to aapos uniform guidelines. following the refractive, alignment and sensory testing, cycloplegic refraction was performed 30 or more minutes after cyclopentolate 1% drops. in cooperative patients, sensory tests including worth 4-dot, stereo fly and "pdi check" were performed to characterize binocularity. for younger patients, binocular function was estimated by bruckner test, 4- base out prism cover and the cr corneal reflex component of "2win" photoscreener ("adaptica," padova italy). each patient was screened with a recently commercially released blinq screener according to manufacturer's recommendations. if an initial interpretation of "pass" or "refer" was not achieved, then repeat efforts with "timed out" or "inconclusive" were accomplished and results evaluated as if a "refer." an example of blinq birefringent screening is shown in \[video\]. patients were screened with the binocular infrared autorefractor "2win" according to manufacturer guidelines. refractive referral criteria were not age-stratified. the "rebion blinq" is a unique screening method and therefore we sought to provide appropriate validation. in addition to non-age stratified aapos 2003 uniform guidelines, we collected all cases characterized by constant or persistent strabismus whether large- or small angle employing cover test, 4 base out test, bruckner test and "2win cr" function. we did not employ any method of retinal videographic analysis of fixation instability. de-identified patient data recorded for sharing on study website.

Eligibility criteria:
inclusion criteria: children in pediatric ophthalmology practice adult strabismus patients - exclusion criteria: patients with enucleations patients with eviscerations patients with exenterations -

Keywords: vision screening, amblyopia
efficacy of pregnenolone in patients with schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: four-month trial of pregnenolone or placebo, as an additional medication, to treat negative symptoms and cognitive decline in schizophrenia. after four months the scores on the negative symptom scale should be lower and the scores on the cognitive tests should be higher than they were at study entry, compared with people who do not take any additional medication.

pregnenolone is a steroid health supplement which is readily available in health food stores. we are using it in this study at higher doses than you would normally take as a health supplement because preliminary studies have indicated that negative symptoms improve and certain aspects of cognition improve at these doses. we do not require you to stop your existing treatment in order to enter the study. after four months we will test your symptoms and cognition and ask if you would like to continue taking pregnenolone, at no cost, in a follow-up study designed to determine the long-term costs and benefits of taking pregnenolone.

Eligibility criteria:
inclusion criteria: * age 18-65 * diagnosis of schizophrenia or schizoaffective disorder * no new medication for past 3 months and stable dose for past 4 weeks * sans (negative symptom) score of 20 or above exclusion criteria: * significant dementia or head trauma. * seizure during past year. * substance dependence in past 6 months or positive urine drug screen. * history of hormone-sensitive cancer such as breast, testicular, prostate, ovarian or uterine cancers. * steroid metabolism disorder, e.g.cushings or addison's disease. * taking steroids other than birth control or post-menopausal hormones. * women who are pregnant or nursing.

Keywords: schizophrenia schizoaffective disorder negative symptoms cognition
observational, passive surveillance program to collect information on women and their offspring exposed to menquadfi® during pregnancy, in united states (us)

Conditions: Meningococcal Infection

Summary: primary objective: to assess maternal, obstetrical, pregnancy, and neonatal and infant outcomes among women vaccinated with menquadfi® during pregnancy or in the 30 days preceding their last menstrual period (lmp).

this study is a prospective pregnancy registry to collect and analyze the outcome of exposure to menquadfi™ during pregnancy or within 30 days prior to their lmp. the registry will encourage prospective registration, which is defined as registration of a pregnancy exposure prior to knowledge or perceived knowledge of the pregnancy outcome. exposed pregnant women will be followed up to the end of their pregnancy, and the offspring(s) will be followed up to 1 year of age.

Eligibility criteria:
inclusion criteria: the eligible population will include pregnant women and their offspring residing in the us and its territories who are exposed to menquadfi® during their pregnancy or within 30 days prior to their lmp, for whom the exposure is reported to the pregnancy registry. reports of menquadfi® pregnancy exposure must contain the following information: * sufficient evidence to confirm that vaccination occurred during the pregnancy or in the 30 days preceding the lmp; * vaccine name (brand or generic) is provided (i.e., menquadfi®, meningococcal vaccine, menacwy conjugate vaccine), or not specified (eg, meningococcal vaccine from an unknown manufacturer). exclusion criteria: only post-marketing spontaneous case reports will be included; reports from clinical trials will not be part of the registry. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
swiss early intervention project in autism: an evaluation of early intervention outcome

Conditions: Autism Spectrum Disorder

Summary: this study aims to investigate the effectiveness of early (before the age of 5 years) and intensive intervention for children with autism spectrum disorders.

this study aims to investigate the effectiveness of early (before the age of 5 years) and intensive intervention for children with autism spectrum disorders. the type of intervention proposed in switzerland differs greatly depending on where people live. several international studies show positive outcomes in children with autism after receiving early behavioural intervention. however, disability insurance (di) in switzerland does not fully cover these scientifically proven interventions. since january 2014 they cover 45 000 chf per child for only two years of early treatment across five centres chosen by the federal social insurance office. the remaining costs are covered by the parents, foundations or by the cantons. in addition, families benefit from this early intervention only if their child is enrolled in one of the five selected centres. there are currently various types of support for children with autism in switzerland before age five, early intensive behavioural interventions, eclectic early intervention and less intensive interventions with a treatment that is not specific to autism (about 3 hrs./week), which includes occupational therapy, speech therapy and early curative education. some children do not receive any treatment. this research aims to evaluate the efficacy of these interventions (early intensive behavioural/ eclectic/treatment as usual) as has been done previously in international studies. the study also aims to include centres other than those selected by the swiss federal social insurance office.

Eligibility criteria:
inclusion criteria: * for all groups: * parents speak english, german or french * diagnosis of autism or pervasive developmental disorder not otherwise specified * 5 years or younger at the start of intervention * parents consent * experimental group: * family was accepted by one of the participating service providers exclusion criteria: * experimental group: * receipt of a second intervention that either interferes with the intensive intervention or is also intensive (more than 10 hours a week) * comparison group: * receipt of any intervention that is more than 10 hours a week

Keywords: early intervention
study of bosutinib in japanese adult patients with newly diagnosed chronic phase chronic myelogenous leukemia

Conditions: Leukemia, Chronic Myelogenous

Summary: phase 2, single-arm, open-label trial. patients will receive bosutinib for the duration of the study.

the study will be open for enrollment until the planned number of approximately 60 philadelphia chromosome positive (ph+) patients have been registered. all patients will be treated and/or followed for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination. patients who discontinue study therapy early due to disease progression or intolerance to study medication will continue to be followed yearly for survival for up to approximately 3 years (144 weeks) after registration of the last patient or until study termination.

Eligibility criteria:
inclusion criteria: * diagnosis of cp cml of ≤6 months (from initial diagnosis); diagnosis of cp cml with molecular confirmation by detection of bcr-abl rearrangement at screening (cytogenetic assessment for ph is not required for enrollment; however, patients with known ph- cml prior to registration are not eligible for this study) * age ≥20 years * eastern cooperative oncology group (ecog) performance status (ps) 0 or 1 * adequate liver and renal function exclusion criteria: * any prior medical treatment for cml, including tkis, with the exception of hydroxyurea treatment, which is permitted for up to 6 months prior to registration * any past or current cns involvement, including leptomeningeal leukemia * extramedullary disease only * major surgery or radiotherapy within 14 days prior to registration * history of clinically significant or uncontrolled cardiac disease * patients with active, uncontrolled bacterial, fungal, or viral infection * recent or ongoing clinically significant gi disorder * history of another malignancy within 5 years prior to registration * uncontrolled hypomagnesemia or uncorrected hypokalemia due to potential effects on the qt interval * known prior or suspected severe hypersensitivity to study drugs or any component in their formulations * participation in other studies involving investigational drug(s) within 30 days or 5 half-lives of investigational product, whichever is longer, prior to registration and/or during study participation * other severe acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or laboratory abnormality that may increase the risk associated with study participation or interfere with the interpretation of study results * investigational site staff members directly involved in the conduct of the study and their family members, or pfizer employees, including their family members, directly involved in the conduct of the study

Keywords: leukemia, chronic myelogenous
study to evaluate the safety, tolerability, and efficacy of lx7101 in subjects with primary open-angle glaucoma or ocular hypertension

Conditions: Primary Open-angle Glaucoma; Ocular Hypertension

Summary: this phase 1/2a study is intended to assess the safety, tolerability, and effects on intraocular pressure of two dose levels and two dose frequencies of lx7101 when administered topically in the eyes of patients diagnosed with primary open-angle glaucoma or ocular hypertension.


Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * documented diagnosis of poag or oht, in both eyes * willing and able to provide written informed consent exclusion criteria: * history of any form of glaucoma in either eye, other than poag * subjects who are unwilling or unable to discontinue contact lens wear prior to and during study * history of ocular trauma in either eye \<6 months prior to screening * history of ocular infection or ocular inflammation in either eye \<3 months prior to screening * history of chronic or recurrent severe inflammatory eye disease, any severe ocular pathology, or clinically relevant or progressive retinal diseases in either eye * clinically relevant, severe central visual field loss, or documented significant progression of a visual field defect within 6 months prior to screening in either eye * use of any ocular hypertensive medications (if applicable), in either eye, during the washout period and for the duration of the study * use of any glucocorticoid medications \<2 weeks prior to screening and throughout the duration of the study * use of any medication or substance on a chronic basis which has not been taken at a stable dose for at least 30 days prior to screening * use of any nondiagnostic, topical, ophthalmic preparations, in either eye, other than artificial tears * the presence of any concurrent condition or clinically significant laboratory findings at screening that may interfere with any aspect of safety, study conduct, or interpretation of results * women who are pregnant or breast feeding * inability or difficulty instilling eye drops
a brief mindful drinking/eating intervention for hemodialysis patients with fluid restrictions

Conditions: Kidney Failure; Quality of Life; Fluid Restriction; Interdialytic Weight Gain; Hemodialysis; Mindfulness

Summary: the purpose of this pilot study is to find out whether mindful drinking/eating activities can improve quality of life and help make it easier for people on dialysis to follow their fluid restrictions. the pilot study is a randomized controlled trial with an intervention group and a wait list control group, randomized by cohort days. the intervention occurs during dialysis sessions once a week for 4 weeks. during each intervention session, participants are guided through a mindful eating exercise focused on foods recommended for controlling thirst (e.g., hard candy, frozen grapes) and a mindful drinking exercise. participants are asked to practice mindful drinking/eating at least once daily at home.


Eligibility criteria:
inclusion criteria: * receiving hemodialysis * able to speak english exclusion criteria: * missed more than one dialysis treatment in the past month
phase iv clinical study of recombinant mycobacterium tuberculosis fusion protein

Conditions: Latent Tuberculosis Infection

Summary: cohort 1 was a randomized, double-blind, controlled clinical trial with a planned enrollment of 500 patients. cohort 2 is a non-randomized, open-label clinical trial with a planned enrollment of approximately 60000 patients. cohort i was injected with ec and tb-ppd in both arms, and cohort ii was injected with ec only

assessment of effectiveness: in cohort 1, the injection site reaction was examined at 0min, 24h, 48h and 72h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. any blisters, necrosis, lymphangitis should be faithfully recorded. in cohort 2, the injection site reaction was examined at 0min and 48-72 h after skin test, and the transverse and longitudinal diameters of the erythema and induration were measured and recorded in millimeters (mm), the larger the erythema or induration. any blisters, necrosis, lymphangitis should be faithfully recorded. safety assessments: the safety assessment included all expected and unexpected medical events that occurred during the observation period of the clinical trial (within 72 hours after the skin test) and were related or unrelated to the injection of the investigational drug. these included specific reactions such as redness, induration, blister, necrosis, and lymphangitis at the injection site (palmar forearm). common and occasional adverse reactions include: local adverse reactions: injection site pruritus, injection site pain, injection site rash; systemic adverse reactions included fever, headache, nausea, fatigue, myalgia, diarrhea, vomiting, paresthesia.

Eligibility criteria:
inclusion criteria: * people aged 6 months and above (≥6 months). * normal armpit body temperature (body temperature below 37.5℃ from 6 months to 14 years old, body temperature below 37.3℃ from 15 years old and above). * i or my guardian agree to participate in this study and sign the informed consent, willing and able to comply with the requirements of this clinical study protocol. exclusion criteria: * patients with acute infectious diseases (such as measles, pertussis, influenza, pneumonia, etc.), acute eye conjunctivitis, acute otitis media, extensive skin diseases and allergic diseases * a pure protein derivative or similar product was used within 3 months prior to the initiation of this trial. * participated in other new drug clinical trials within 3 months prior to clinical trials. * any circumstances were considered by the investigators to have the potential to influence the assessment of the trial.