Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness of drop-free small incision cataract surgery

Conditions: Cataract; Ocular Inflammation; Ocular Hypertension; Post-Op Complication

Summary: this is a randomized control trial comparing the effects of subconjunctival triamcinolone administration during surgery to topical prednisolone drops on the development of post-operative inflammation and macular edema in manual small incision cataract surgery.

eye drops given following cataract surgery for prevention of post-operative inflammation carry many disadvantages, such as cost and poor medication adherence. to eliminate these barriers, the emerging technique of single dose of subconjunctival triamcinolone delivered during surgery has been shown an effective and safe alternative. the goal of this study is to build on this evidence, utilizing subconjunctival triamcinolone in conjunction with a different surgical technique and population as what was previously studied. this is a randomized control trial comparing the effects of single-dose subconjunctival triamcinolone administration at the time of surgery to the standard 4-week taper of topical prednisolone drops following manual small incision cataract surgery in guatemala. patients will be evaluated at post-operative weeks 6 and 12 with the primary outcome variables of intraocular pressure and best corrected visual acuity. data on presence and amount of corneal edema, anterior chamber inflammation, and development of macular edema will also be obtained.

Eligibility criteria:
inclusion criteria: * presence of a visually significant cataract: nuclear sclerotic, posterior subcapsular and/or cortical * best corrected visual acuity or 20/40 or worse exclusion criteria: * axial length \ 26 mm * cataract which is traumatic, subluxated, or morgagnian * presence of ocular comorbidity: including corneal or retinal abnormalities (corneal opacities, macular degeneration, macular scars, epiretinal membrane, retinal detachment, retinal vascular occlusion), glaucoma, ocular hypertension, glaucoma suspect (cup-to-disc ratio of 0.7 or more, history of steroid response, history of uveitis, pseudoexfoliation * history of endophthalmitis or macular edema in the fellow eye * personal history of diabetes mellitus or uncontrolled hypertension * currently pregnant or lactating women * current use of systemic steroids for asthma, rheumatoid arthritis or other illness or history of steroid use by any route in the prior 3 months. * intraoperative complications including posterior capsular rupture, iris prolapse, zonular dialysis, retained nucleus, vitreous loss, iris trauma resulting in hemorrhage, descemet dehiscence of more than 1 mm x 1 mm
impact of therapist change on dropout in a naturalistic sample of inpatients with borderline pathology receiving dbt

Conditions: Borderline Personality Disorder; PostTraumatic Stress Disorder; Psychotherapy; Dropout

Summary: participants with borderline pathology (≥ 3 dsm-iv-criteria) receiving an inpatient dialectical behavior therapy (dbt) program completed a quality assurance questionnaire set assessing demographic information and pretreatment psychopathology during the days of their inpatient stay. beyond that, changes of therapists were documented.


Eligibility criteria:
inclusion criteria: * three or more criteria for bpd as defined by dsm-iv (borderline personality characteristics; bpc) exclusion criteria: * inability to contract and consent, * other severe mental disorders (bipolar disorder, acute psychosis), * current alcohol, * illicit or not prescribed drug use, * simultaneous participation in other treatment studies, * pregnancy or breastfeeding, * an inability to negotiate a non-suicide agreement, * ongoing traumatic contact with the perpetrator, and * a body mass index \< 16.5.
malaria survey in mbarara district, uganda 2010

Conditions: Malaria

Summary: malaria is one of the major public health problems in sub-saharan africa. in response to this threat, roll back malaria (rbm) has rolled back a strategy using act as first line therapy for malaria episode, a wide distribution of insecticide treated bednet (itn), intermittent presumptive treatment of pregnant women and indoor residual spraying. recent epidemiological observations suggested a decline in malaria prevalence in some countries but further evidences are still needed to confirm this evolution. the rbm strategy requires the use of reliable rapid diagnostic test (rdt) for which an operational assessment is necessary. lastly, home-based management of malaria is also an important compound of this strategy. however, a better understanding of the actual use of antimalarial drugs, of the use of bednet and of the barrier to the use of health care is important to implement good quality strategies for malaria control. this study is a cross-sectional community based survey made of two rounds (one in january 2010 and the second in june 2010). the general objective is to measure the prevalence of infection with plasmodium falciparum at two periods of the year (at the moment of lowest and highest transmission based on the seasonal rainfalls) and to compare it with the prevalence estimated in 2004 after the rainy season for the same area. specific objective are the estimation of the prevalence by age stratum, the analysis of the geographical distribution of the infection, the description of the parasitological characteristics, the assessment of three rdt, the description and the analysis of the prevention and care seek behaviours related to malaria. the study area is the great mbarara district located in south-west of uganda. a three-stage cluster sampling method will be used. spatial information will be collected with global positioning system and imported to geographical information system. behaviour information will be collected through face to face interview.


Eligibility criteria:
inclusion criteria: * males and females * ages 1 month to 59 months exclusion criteria: * none

Keywords: prevalence transmission knowledge attitude practice
study to collect high-resolution ecg data and patient insights on heart failure care

Conditions: Heart Failure

Summary: the purpose of this study is to establish an electrocardiogram (ecg) data library to facilitate future studies on heart disease. additionally, the study will be used to monitor changes in the patient's standard of care throughout the study period and gather patient perspectives on routine diagnostic procedures and disease monitoring and feedback on the design of heart failure trials.

patients with heart failure with mildly reduced or preserved ejection fraction will be invited to participate in this patient observational study. after providing informed consent, participants will then undergo a series of clinical assessments, and the participants' ecgs will be used to contribute to establishing an ecg library for future heart disease research. additionally, patients' perspectives on the current standard of care clinical procedures will be gathered. patient preferences will be gathered in relation to factors around routine clinical investigations for heart failure to better design a disease monitoring tool to include clinical and patient preferences. also, the patients may be updated on the latest therapy options. additionally, participants may be invited to review and provide feedback on the study design of heart failure trials under development, helping to ensure alignment with patient needs. their input can identify potential procedure challenges and enhance the clarity of study materials, improving overall patient engagement. a follow-up call with a research physician will provide the opportunity to discuss any issues identified in the clinical baseline assessment and allow the participant to ask any additional questions.

Eligibility criteria:
inclusion criteria: 1. male or female participants aged 45 to 80 years (inclusive) at the date of signing the informed consent. 2. diagnosed with heart failure. 3. able and willing to provide informed consent to participate. exclusion criteria: 1. diagnostic test results positive for: 1. hiv-1 or hiv-2 infection 2. hepatitis b or hepatitis c infection 2. mental incapacity, language barriers or unwillingness to comply with the requirements of the protocol, which may preclude adequate understanding or cooperation during the study as judged by the investigator. 3. any condition judged by the investigator to pose an undue risk while participating in the trial 4. diagnostic results which are inconsistent with heart failure with mildly reduced or preserved ejection fraction as judged by the investigator.
association of apolipoprotein b-48 level and large artery atherosclerotic ischemic stroke(abyss)

Conditions: Acute Ischemic Stroke

Summary: the purpose of this study is to evaluate whether the serum apob48 level is associated with atherosclerotic ischemic stroke.


Eligibility criteria:
inclusion criteria: large artery atherosclerotic ischemic stroke group(laa group) * age over 20 years * patients with symptomatic stenosis in the eligible vessels(the middle cerebral artery, anterior cerebral artery, or internal carotid artery) as assessed by mra or cta corresponding to the acute ischemic stroke * patients without the occlusion of corresponding artery by mra or cta * the fasting and postprandial serum apo b-48 level can be assessed within 72 hours after the symptom onset of ischemic stroke small vessel occlusive ischemic stroke group (svo group) * age over 20 years * patients with acute ischemic stroke of basal ganglia, internal capsule, or corona radiata * patients without both symptomatic and asymptomatic arterial occlusion or stenosis by mra or cta * patients without a history of systemic atherosclerosis(for example, acute myocardial infarction, angina, peripheral arterial disease, aortic aneurysm) * the fasting and postprandial serum apo b-48 level can be assessed within 72 hours after the symptom onset of ischemic stroke exclusion criteria: both laa group and svo group * patients with cardioembolic ischemic stroke * patients treated with lipid lowering agents or steroid within the previous 30 dsys * patients with severe liver disease (ast \>100 or alt \>100) at the time of randomization * patients with endocrine disease except diabetes mellitus at the time of randomization (for example, thyroid disease, adrenal disease) * patients with severe renal disease (serum creatinine \>2.0mg/dl)at the time of randomization * chronic alcoholics or drug user * patients with infection at the time of randomization * patients, in the opinion of the investigator, unlikely to comply with the clinical study or unsuitable for the any other disease or reason * informed consent has not been obtained

Keywords: acute ischemic stroke atherosclerosis apolipoprotein b48
pharmacokinetic linearity and comparative bioavailability of treprostinil diethanolamine

Conditions: Pulmonary Arterial Hypertension

Summary: this study will compare the bioavailability and pharmacokinetics of the 0.5 mg, 1 mg and 2.5 mg treprostinil diethanolamine tablet strengths in healthy volunteers.

this study was designed to assess the pharmacokinetic linearity and comparative bioavailability of ut-15c sr (treprostinil diethanolamine) following the administration of a single tablet containing 0.5 mg, 1 mg and 2.5 mg ut-15c in healthy volunteers.

Eligibility criteria:
inclusion criteria: * subject is healthy and between the ages of 18 and 55 years * female subjects must weigh between 55 and 100 kg, inclusive, with a bmi between 19.0-29.9 kg/m2, inclusive at screening. male subjects must weigh between 55 and 120 kg, inclusive, with a bmi between 19.0-32.0 kg/m2, inclusive at screening. * subject has a medical history, physical examination, vital signs, ecg and clinical laboratory results within normal limits or considered not clinically significant by the investigator at screening. exclusion criteria: * subject has any clinically relevant abnormality identified during the screening physical examination, 12-lead ecg, or laboratory examinations. * subject has a history of anaphylaxis, a documented hypersensitivity reaction, or a clinically significant idiosyncratic reaction to any drug. * subject has a clinically significant history of neurological, cardiovascular, respiratory, endocrine, hematological, hepatic, renal, gastrointestinal, genitourinary, pulmonary and/or musculoskeletal disease; glaucoma; a psychiatric disorder or any other chronic disease, whether controlled by medication or not.

Keywords: pulmonary arterial hypertension treprostinil pharmacokinetics
a study to determine if identification of undiagnosed atrial fibrillation in people at least 70 years of age reduces the risk of stroke

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: the purpose of this study is to determine if an af detection intervention in men and women at least 70 years of age with undiagnosed atrial fibrillation (af) or atrial flutter (afl) reduces the person-years incidence rate of stroke compared to usual care (no af detection intervention).

this a prospective, randomized study in primary care practices.

Eligibility criteria:
inclusion criteria: * men and women at least 70 years of age who are new or established participants in the primary care practice * willing to provide consent to participate in the study and to use personal health information to ascertain endpoints from the center for medicare \& medicaid services (cms) medicare claims database and to access data from health records * health insurance by medicare parts a \& b (medicare fee-for-service) exclusion criteria: * oral anticoagulation (oac) for any indication at the time of enrollment * history of atrial fibrillation (af) or atrial flutter (afl) as documented in the participant's current medical problem list * any condition the investigator considers a contraindication to oac, e.g., bleeding that required medical attention or severe renal impairment * any condition the investigator considers will prevent compliance with study instructions * implanted cardiac devices (pacemakers, implantable cardiac defibrillators, or cardiac resynchronization therapy, and implantable loop recorders) * history of allergy to adhesive * not able to wear the zio®xt monitor or not able to apply the monitor by herself/himself or with the help of a caregiver other protocol-defined inclusion/exclusion criteria could apply
a single-centre clinical trial to assess steroid induced skin atrophy on healthy skin

Conditions: Skin and Connective Tissue Diseases

Summary: the purpose of this study is to assess steroid induced skin atrophy by sonography.


Eligibility criteria:
inclusion criteria: 1. healthy male volunteers, 25 to 40 years old inclusive. 2. healthy skin on volar arms with a hairless area sufficient for measurements exclusion criteria: 1. clinical skin atrophy, telangiectasia or striae on volar arms. 2. presence of any skin condition or colouration that would interfere with test sites or the response or assessment. 3. fitzpatrick skin type iv - vi. 4. history or current evidence of infection, eczema or other relevant skin disease.
at-home genital nerve stimulation for sci bowel

Conditions: Spinal Cord Injury

Summary: the purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. current bowel treatments either involve diet and medications or surgery. this study will evaluate whether electrical stimulation can be an alternate option for bowel management. researchers will: * use an fda approved transcutaneous electrical nerve stimulation (tens) device off-label * compare a target stimulation level to a placebo stimulation level participants will: * use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home * visit the research center 3 times to participate in exams and answer questions * keep a daily diary of their bowel symptoms and stimulation times

the objective of this proposal is to determine how genital nerve stimulation (gns) acutely modulates neurogenic bowel dysfunction (nbd) in individuals with different severities of spinal cord injury (sci) and to determine the key study design and methodology parameters of daily at-home administration of gns. this study will determine the feasibility of daily application of gns as an intervention for nbd. key feasibility measures related to dosage and adherence will be evaluated.

Eligibility criteria:
inclusion criteria: 1. traumatic sci. 2. minimum of 6 months' post-injury. 3. aged 18 years and older. 4. neurological level of injury t12 or higher and ais grade a-d, as defined by the isncsci. 5. score of 14 or higher on the isci bf bds v2.1. 6. response to genital nerve stimulation able to be elicited upon screening. 7. able to understand and provide informed consent. exclusion criteria: 1. currently enrolled in another functional electrical stimulation (fes) research trial. 2. females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report). 3. presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with gns. 4. in the judgment of the pi and co-investigators, presence of medical complications that may interfere with the execution of the study.

Keywords: fecal incontinence neurogenic bowel tetraplegia paraplegia paralysis electrical stimulation neuromodulation bowel feasibility anorectal manometry
dose-escalation trial of the safety, pharmacokinetics, and pharmacodynamics of iron isomaltoside (monofer®)

Conditions: Anemia; Deficiency Diseases; Anemia, Iron Deficiency; Hematologic Disease; Iron Metabolism Disorders

Summary: the trial is an open-label, 4 cohorts, sequential, dose-escalating, single dose trial.

ida is highly prevalent in subjects with cancer and gastrointestinal diseases such as inflammatory bowel diseases, menstruating or pregnant women, and subjects who have undergone bariatric procedure. ida can have a substantial medical and quality of life (qol) burden on the subjects, and treatment of these subjects includes controlling the bleeding and replenishing lost iron.

Eligibility criteria:
inclusion criteria: 1. japanese man or woman ≥ 20 years, \< 65 years of age 2. hb of ≥ 9.0 g/dl, \< 12.0 g/dl for women and \< 13.0 g/dl for men 3. serum ferritin \< 25 ng/ml 4. tibc ≥ 360 μg/dl 5. body weight ≥ 50 kg 6. willingness to participate and signing the informed consent form exclusion criteria include: 1. anemia caused by conditions other than iron deficiency 2. cancer 3. iv or oral iron treatment, or blood transfusion 4 weeks prior to screening 4. erythropoiesis stimulating agent (esa) treatment prior to screening 5. imminent expectation of blood transfusion on part of treating physician 6. iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis) 7. known hypersensitivity reaction to iv iron preparations 8. decompensated liver cirrhosis or active hepatitis 9. active acute or chronic infections 10. pregnant or nursing women. 11. planned elective surgery during the trial
venous thromboembolism prophylaxis in medical and surgical icus in a single university hospital

Conditions: Venous Thromboembolism

Summary: venous thromboembolism(vte) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. vte often occurs in intensive care patients and there had been many efforts to prevent such complication. the american college of chest physicians (accp) had published evidence-based clinical practice guideline for vte prophylaxis. this study focuses on how vte prophylaxis is being performed in both medical and surgical icus in a single university hospital, and sees the differences in such prophylactic patterns.


Eligibility criteria:
inclusion criteria: * icu admitted patients exclusion criteria: * patients under 20 years old

Keywords: venous thromboembolism prophylaxis icu
symptomatic therapy for patients with huntington's disease

Conditions: Huntington Disease

Summary: based on the previous symptomatic treatment of chinese hd patients, this study intends to further optimize the treatment regimen of chinese hd patients so as to further improve the prognosis of patients.

the purpose of the study is to evaluate symptomatic treatment regimen efficacy based on different disease stages. we previously used symptomatic treatment on chinese hd patients and most of them got improved both in the motor symptoms and life quality. so this study intends to further optimize the treatment regimen, and set a control group to further evaluate the treatment efficacy.

Eligibility criteria:
inclusion criteria: 1. genetic diagnosis of huntington's disease 2. symptomatic patients with huntington's disease 3. disease duration less than 5 years - exclusion criteria: (1) movement disorder due to other definite causes instead of huntington's disease (2) severe lung, kidney or liver disease (3) neoplastic disease -
phase 1 clinical trial of cordstem-st

Conditions: Premature Ovarian Insufficiency

Summary: this clinical study will evaluate the safety and tolerability of cordstem-st after administering a single dose in patients with premature ovarian insufficiency (poi), as well as identify the maximum tolerated dose (mtd) and evaluate the potential therapeutic effects.

3 or 6 subjects will be enrolled sequentially by applying the "traditional 3+3 design" to evaluate the dose limiting toxicities (dlts) for 28 days from the first administration date of the investigational product according to the protocol. a dlt is defined as the occurrence of a grade 3 or higher adverse drug reaction (adr) according to the national cancer institute (nci)-common terminology criteria for adverse events (ctcae) version 5.0. first three subjects will be enrolled in study group 1 (low dose group) to be evaluated for dlts up to 28 days after ip administration. if none of three subjects develope dlt, three subjects for study group 2 (high dose group) will be recruited. if one out of three subjects in study group 1 develop dlt, additional three subjects in study group 1 will be enrolled to be evaluated for dlt. if two or more subjects develop dlt in initial three subjects, the study will be terminated. this study will be followed up by a long-term follow-up study under the separate protocol.

Eligibility criteria:
inclusion criteria: * females aged ≥ 25 years and \< 40 years * individuals diagnosed with premature ovarian insufficiency: individuals who have a follicle stimulating hormone (fsh) level of 40 iu/l or higher in the results of two tests conducted at least 4 weeks apart and are amenorrheic for at least 4 months * individuals who voluntarily decide to participate and provide written consent exclusion criteria: * individuals diagnosed with primary amenorrhea\* \* no secondary sex characteristics by age 13, absence of menarche for 5 years after initial breast development, or absence of menstruation by age 15 * individuals diagnosed with polycystic ovary syndrome * individuals with any other conditions that may affect the result of this study.

Keywords: stem cell therapy allogeneic stem cell umbilical cord derived mesenchymal stem cell