Kornimate/medical-research-clean huggingface dataset:
psychological impact of institutional quarantine

Conditions: Quarantine

Summary: quarantine separates persons who have been potentially exposed to an infectious agent (and thus at risk for disease) from the general community. however, it may create psychological, emotional, and financial problems for some persons. the experience of those placed under quarantine in terms of compliance, difficulties, emotional response and psychological impact remains under-researched. in view of the increasing cases of covid-19 in india and the rising numbers of people being quarantined as a precautionary measure, it was imperative to assess those quarantined for the psychological impact of the concerns regarding this illness and the quarantine procedure. in india, no such study had been undertaken and our study thus filled the research gap. the cross-sectional observational study aims at assessing the psychological impact of quarantine on indian bsf jawans (n=100). they would be assessed for depression, anxiety, perceived stress level of impact, and impact of life events using beck depression inventory, state trait anxiety inventory, perceived stress scale, and impact of events scale-revised. a qualitative interview schedule will also be carried out. data would be analysed.

institutional quarantine separates persons who have been potentially exposed to an infectious agent (and thus at risk for disease) from the general community. this may create psychological, emotional, and financial problems for some persons. the experience of those placed under quarantine in terms of compliance, difficulties, emotional response and psychological impact remains under-researched. in view of the increasing cases of covid-19 in india and the rising numbers of people being quarantined as a precautionary measure, it was imperative to assess those quarantined for the psychological impact of the concerns regarding this illness and the quarantine procedure. in india, no such study had been undertaken and our study would thus fill the research gap. the cross-sectional observational study is aimed at assessing the psychological impact of quarantine on indian border security force (bsf) soldiers (n=100). the participants will be assessed for depression, anxiety, perceived stress level of impact, and impact of life events using beck depression inventory, state trait anxiety inventory, perceived stress scale, and impact of events scale-revised respectively. a qualitative interview schedule will be carried out.

Eligibility criteria:
inclusion criteria: * indian-origin adults between the age of 18-60 yrs quarantined at border security force facility * both genders would be included exclusion criteria: * any chronic co-morbid medical condition * current diagnosis of covid-19
aquaresis utility for hyponatremic acute heart failure study

Conditions: Heart Failure

Summary: hyponatremia is a common finding in acute heart failure (hf) patients and is associated with worse prognosis. in addition to its prognostic value, hyponatremia may have importance during the acute management of hf. we've recently shown that acute or chronic hyponatremia, especially \<130 meq/l, was associated with higher loop diuretic dose requirements and more frequent need for escalation of the diuretic regimen to achieve the same level of diuresis as normonatremic hf patients. aquaresis with tolvaptan represents a potentially advantageous approach to the management of volume overload in hf, especially in patients presenting with concomitant hyponatremia. the purpose of the current study is to prospectively evaluate the comparative efficacy and safety of a tolvaptan-based diuretic regimen compared to conventional diuresis with a furosemide-based regimen on short-term clinical and treatment outcomes in hyponatremic acute hf patients. this will be a prospective, open-label, parallel-group, randomized study comparing a tolvaptan-based aquaretic regimen to a conventional continuous infusion loop diuretic-based regimen of furosemide. up to 55 (target sample size of 50) adult subjects admitted with acute hf and signs of volume overload, and serum sodium less than 135 meq/l will be randomized to tolvaptan or furosemide treatment arms. the initial 24 hours of study treatment will compare tolvaptan monotherapy to furosemide monotherapy. after the initial 24 hours, treatment regimens may be altered to achieve desired clinical goals. patients will be followed for up to 96 hours and at discharge for study purposes.


Eligibility criteria:
inclusion criteria: * acute hf with signs or symptoms of volume overload \[i.e. elevated jugular venous pulsation (jvp), rales, edema\] * serum sodium \< 135 meq/l at time of or within first 48 hours of hospitalization * randomized within 48 hours of presentation to hospital * ≥ 18 years of age * informed consent exclusion criteria: * severe symptomatic hyponatremia requiring acute treatment * severe renal impairment upon admission (creatinine clearance \< 20 ml/min) * renal replacement therapy dependent, or requiring upon admission * acute coronary syndrome on admission * requires or has a mechanical circulatory support device * evidence of cardiogenic shock requiring intravenous vasopressors * pregnancy * patient requiring concomitant use of strong cyp3a4 inhibitors (clarithromycin, ketoconazole, itraconazole, ritonavir, indinavir, nelfinavir, saquinavir, nefazodone, and telithromycin)
a phase 2 study of ds-8500a in japanese subjects with type 2 diabetes mellitus (t2dm)

Conditions: Type2 Diabetes Mellitus

Summary: the objectives of the study is to evaluate the efficacy, safety, and dose of ds-8500a compared with placebo in patients with type 2 diabetes mellitus.

the objectives of the study is to evaluate the efficacy, safety, and dose of ds-8500a compared with placebo in patients with type 2 diabetes mellitus after a 12-week oral administration of ds-8500a at 25, 50, or 75 mg in a double-blind, parallel-group comparison study. in addition, the clinical positioning of ds-8500a relative to an existing drug will be investigated using sitagliptin as a comparator.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 20 years at the time of informed consent * japanese patients with type 2 diabetes * patients who have hba1c ≥ 7.0% and \< 10.0% exclusion criteria: * patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis * patients receiving or requiring treatment with insulin * patients with a body mass index (bmi) of \< 18.5 kg/m2 or ≥ 35.0 kg/m2 * patients with clinically evident renal impairment (estimated glomerular filtration rate \[egfr\] of \< 45 ml/min per 1.73 m2) or clinically significant renal disease * patients with fasting plasma glucose ≥ 240 mg/dl

Keywords: type 2 diabetes mellitus adult developmental phase ii
mechanisms of disability in peripheral arterial disease

Conditions: Cardiovascular Diseases; Arterial Occlusive Diseases; Peripheral Vascular Diseases

Summary: to determine the mechanisms by which atherosclerotic peripheral artery disease (pad) causes functional impairment and to define the degree to which peripheral artery disease associated pathophysiologic findings change over time.

background: research demonstrates that men and women with lower extremity peripheral arterial disease (pad) have poorer functioning than men and women without pad. preliminary data also indicate that more severe pad at baseline, as measured by the ankle brachial index (abi), is associated with a greater incidence of functional loss. however, the pathophysiologic mechanisms in the lower extremities responsible for pad-related functional impairment and functional loss are not well defined. design narrative: the study cohort will consist of 790 individuals identified from three chicago-area medical centers, of whom 500 will have pad. participants will undergo a baseline and two annual follow-up visits. pathophysiologic findings in the lower extremities refer to reduced muscle mass, reduced muscle quality, and reduced peripheral sensory and motor function. quality of muscle tissue is defined as the ratio of muscle force to muscle mass. muscle mass will be measured with computed tomography (ct). peripheral nerve function will be determined using surface electroneurography (eng). lower extremity functional measures will consist of measures pertinent to functioning during daily living and include six minute walk distance, seven-day physical activity level (assessed by accelerometer), walking speed, balance tests, and lower extremity muscle power. the cross-sectional study will test the hypotheses that a) chronic lower extremity arterial ischemia is associated with specific pathophysiologic findings in lower extremity muscle and nerve and that b) these ischemia-related pathophysiologic findings are associated with lower extremity functional limitation.the longitudinal study will test the hypotheses that a) greater baseline lower extremity arterial ischemia as measured by abi is associated with greater progression of pathophysiologic findings over two year follow-up and that b) greater ischemia-related pathophysiologic findings in the legs at baseline is associated with greater functional decline over two year follow up. results will be used to develop interventions designed to improve lower extremity functioning and prevent functional decline in persons with pad.

Eligibility criteria:
no eligibility criteria
s90652 in paediatric hypertension

Conditions: Hypertension

Summary: the aim of the study is to assess the long-term safety and effects on blood pressure of a paediatric formulation of perindopril in hypertensive children


Eligibility criteria:
inclusion criteria: * hypertensive children, who have been treated for four months at least with s90652, with safety and efficacy exclusion criteria: * poorly controlled hypertension * girls with signs of pubescence
the role of doppler ultrasound in assessment of local factors affecting maturation of arteriovenous fistula in hemodialysis patient

Conditions: Doppler Ultrasound in Arteriovenous Fistula Preoperative Evaluation and Post-operative Periodic Monitoring

Summary: the long term survival of the chronic kidney disease (ckd) patients depends on the adequacy of dialysis via good vascular access. the arteriovenous fistula (avf) is the preferred vascular access for hemodialysis. pre-operative evaluation and periodic monitoring of the avf after creation with well-defined applied criteria by color doppler ultrasound (cdus) will help to reduce rate of access failure and achieve better cumulative patency rate of fistulas.

in recent years, the improvement in the diagnosis and treatment of chronic kidney disease (ckd) has led to increase the number of patients who need hemodialysis, adequacy of which depends upon the appropriately placed vascular access. although the arteriovenous fistula (avf) is the preferred vascular access for hemodialysis, there is still a high rate of failure to mature in clinical practice. to increase the use of avfs, especially in the co-morbid patients, a thorough pre-operative evaluation and periodic monitoring after avf creation by color doppler ultrasound (cdus) allows placement of avf in higher proportion of patients, and early detection of access dysfunction with subsequent intervention that reduce the rate of access failure. doppler ultrasound is the main imaging modality for assessment of dialysis access circuits as its gives information on the morphological criteria and evaluates the inflow and outflow flows. cdus is non-invasive modality, of low cost, not using ionizing radiation or iodinated contrast media.

Eligibility criteria:
inclusion criteria: ckd and esrd patients on hemodialysis, in whom native arteriovenous fistula operation is needed * both sexes are included. * age group from 15-80years * upper limb arteriovenous fistula only. * native arteriovenous fistula. * surgically succeeded avf exclusion criteria: we will exclude: * patients refused to be in the research. * patients with avf not in the upper limbs. * patient of age less than 15years and above 80years. * patients with synthetic grafts.

Keywords: hemodialysis in ckd. avf. cdus
trial to evaluate safety and immunogenicity of a vaccine against hcmv

Conditions: Cytomegalovirus Infection

Summary: the objectives of this first-in-human is to evaluate the safety and the immunogenicity of three administrations of a bivalent vaccine candidate against human cytomegalovirus, at three different dose levels.

hookipa biotech ag is developing a replication-deficient lymphocytic choriomeningitis virus (rlcmv) vector platform. hb-101 is a bivalent vaccine containing two recombinant, replication-deficient lymphocytic choriomeningitis virus (rlcmv) vectors, one expressing the pp65 protein of the human cytomegalovirus (hcmv) and one expressing the gb protein of human cytomegalovirus (hcmv). this phase 1 will enroll three successive cohorts of 18 healthy volunteers. each cohort will receive either a low dose, a middle dose or a high dose of the vaccine (n=14 volunteers), or placebo (n=4). a dsmb will review the safety data for the low dose cohort, before progressing to the middle, and so before high dose. eight dsmb meetings have been planned for the whole study. the subjects will be followed up to 12 months post first administration.

Eligibility criteria:
inclusion criteria: * signed informed consent * male or female, aged 18-45 years, in good health. * negative for hcmv * body mass index between 19 and 32 kg/m² * willing to forego receipt of other routine vaccinations (with the exception of seasonal influenza vaccination) for five months after study entry. * for female volunteers: use of effective birth control for at least 2 months prior to study entry and willing to use effective birth control measures up to the month 12 visit * comply with the requirements of this protocol (e.g. return for follow-up visits), as judged by the investigator. exclusion criteria: * works as a childcare provider. * pregnant or breastfeeding woman. * any screening safety laboratory value that is 2 times above the upper limit of normal value. * any confirmed or suspected immunodeficiency or autoimmune disorder. * treatment with any chronic immunosuppressive medication or other immuno-modifying drugs within 6 months prior to study entry. however, inhaled and topical steroids are allowed. * any vaccination other than for seasonal influenza within 3 months prior to study entry. * previous vaccination with an investigational hcmv vaccine. * receipt of blood, blood products and/or immunoglobulins within 3 months prior to study entry. * history of severe allergic reactions and /or anaphylaxis * allergy to any component of the vaccine preparation. * expected to be unavailable to complete study follow up. * tested positive for hiv, hbsag and/or anti-hcv. * participating in another clinical trial. * subject with a rash, dermatological condition or tattoos in the area of the injection site, as these may interfere with administration site reaction rating.

Keywords: prevention
triamcinolone acetonide injections in primary cutaneous lymphoma plaques with a novel needle-free drug-delivery system.

Conditions: Mycosis Fungoides of Skin (Diagnosis); Cutaneous T-cell Lymphoma; Non Hodgkin Lymphoma; Lymphomatoid Papulosis; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Follicular

Summary: a study to compare pain differences between using medjet needle-free drug-delivery system with standard of care treatment for cutaneous t-cell lymphomas and cutaneous b-cell lymphomas in participants.

participants will undergo treatments on two morphologically and anatomically matched target lesions, preferably on opposing sides of the body. the first plaque will be treated using standard of care topical bexarotene or nitrogen mustard for participants with ctcl (cutaneous t-cell lymphomas) or intralesional tac (triamcinolone acetonide) using a syringe/needle with participants with cbcl (cutaneous b-cell lymphomas). the second plaque will be treated using a needle-free injector system. after the treatment, the participants will be followed for another three visits over the course of 4 months to see how the treated areas responded. in order to account for 20% dropout, 11 patients per group (a needle free and a traditional treatment group in cbcl patients and the same two groups in ctcl patients) will be recruited.

Eligibility criteria:
inclusion criteria: 1. \> 18 years of age 2. diagnosed with primary cutaneous lymphoma defined by either: * a board-certified dermatologist, or * dermatology nurse practitioner, or * skin punch biopsy 3. the presence of plaque-type primary cutaneous lymphoma lesions with at least two plaques that are at least two cm² in areas of the trunk, buttocks, or extremities that are either: * symmetrically located on contralateral body site or * within the same body site but separated by ≥ 1 cm * both plaques must be similar in size as much as possible 4. able to give informed consent under irb approval procedures exclusion criteria: 1. known allergy or hypersensitivity to triamcinolone acetonide 2. known allergy to topical bexarotene or topical nitrogen mustard 3. pregnant, breastfeeding, or planning to get pregnant 4 weeks before, during, and 4 weeks after the study. 4. inability to provide informed consent 5. diagnosis of erythrodermic mycosis fungoides or sezary syndrome 6. use of topical corticosteroids to target lesions within 1 week prior to baseline visit 7. use of radiation therapy to target lesions within 1 week prior to baseline visit
evaluation of glycemic range during acute coronary syndrome in nondiabetic patients (agreement)

Conditions: Acute Coronary Syndrome

Summary: to evaluate the glycemic variations during acute coronary syndrome in non-diabetic patients (euglycemic, or with impaired fasting glucose, or with impaired glucose tolerance)

all nondiabetic patients with dysglycemia (fasting plasma glucose between 100 and 125 mg/dl) will be monitored with a device (continuous glucose monitoring system) and all these patients will be undergone an oral glucose tolerance test after the discharge from this unit.

Eligibility criteria:
inclusion criteria: * nondiabetic patients * acute coronary syndrome exclusion criteria: * diabetic patients
study to evaluate the clinical and radiographic outcomes of the bee® ha cage for anterior cervical discectomy and fusion

Conditions: Cervical Disc Degeneration

Summary: observational data collection of information after undergoing standard cervical spine fusion surgery.


Eligibility criteria:
inclusion criteria: 1. subjects aged 18 years of age or older (≥ 18 years) and are skeletally mature. 2. subjects with discopathy, disc hernia with radiculopathy and/or myelopathy, or stenosis of the foramen and spinal canal with or without cervical radiculopathy/myelopathy, at one or two contiguous levels from c3 to c7, and confirmed by imaging studies (ct and/or mri will be taken according to standard local procedures and confirmed by the investigator that imaging represents the indication for surgery). 3. subjects with a documented individual history of neck and/or upper extremity pain and/or functional/neurological deficit associated with the cervical level to be treated. 4. subjects who are indicated for surgical treatment with the bee® ha cage with resorba® synthetic bone injectable bone substitute (resorba medical gmbh). 5. subjects who have completed at least 6 weeks of conservative non-operative treatment without obtaining adequate symptomatic relief. exclusion criteria: 1. subjects who have undergone previous spinal surgery either anterior or posterior. 2. subjects with evidence of tumour and/or malignant disease with resultant life expectancy of less than two years. 3. subjects with a known allergy to the material used in the instrumentation. 4. subjects with evidence of an active infection and/or with any condition that would compromise their participation and follow-up in this clinical study. 5. subjects who have known osteoporosis or severe osteopenia as determined by the investigator. 6. subjects who have any conditions outlined as contraindicated in the instructions for use.
synergy china: assess synergy stent in china

Conditions: Cardiovascular Diseases

Summary: prospective, multicenter, single-arm study, enroll 100 patients in no more than 10 sites across china, the primary endpoint is technical success.

the study is to evaluate clinical and peri-procedural angiographic outcomes for the synergytm monorailtm everolimus-eluting platinum chromium coronary stent system in the treatment of subjects with atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).

Eligibility criteria:
key inclusion criteria: 1. subject must be at least 18 -75 years of age 2. subject is eligible for percutaneous coronary intervention (pci) 3. target lesion(s) must be located in a native coronary artery with a visually estimated reference vessel diameter (rvd) ≥2.25 mm and ≤4.0 mm, length must be ≤34\* mm (by visual estimate), target lesion(s) must have visually estimated stenosis ≥50% and \ 1 key exclusion criteria: 1. planned pci (including staged procedures) or cabg after the index procedure 2. subject with out of range complete blood count (cbc) values that are determined by the study physician to be clinically significant. 3. subject is on dialysis or has baseline serum creatinine level \>2.0 mg/dl (177µmol/l) 4. planned treatment of more than 3 lesions, planned treatment of lesions in more than 2 major epicardial vessels, planned treatment of a single lesion with more than 1 stent 5. target lesion(s) is located within 3 mm of the origin of the left anterior descending (lad) coronary artery or left circumflex (lcx) coronary artery by visual estimate. 6. target vessel develops a dissection greater than national heart, lung, blood institute (nhlbi) type c following the pre-dilatation/pre-treatment of the first target lesion
comparative tests of flu vaccination phone messages

Conditions: Influenza, Human

Summary: this project is a partnership between emmi solutions, a private company that delivers health promotion messages to employees of client organizations, and the university of michigan and affiliated academic investigators. in particular, emmi sends out pre-recorded and interactive telephone calls on behalf of their healthcare clients to promote influenza vaccination each fall. the collaboration will design various scripts (based on established risk communication, behavior change, and behavioral economic principles) to be pre-recorded and sent out on these calls on a randomized basis (with approval by client organizations), with the number of arms to vary based on the size of each client's participant list (to ensure sufficient statistical power within each client's sample). emmi will deliver the calls and track individual responses to questions posed during the call. emmi will then provide a de-identified dataset to the academic research team for analysis to determine whether any scripts provided greater or lesser effects to people's their motivations to get a flu vaccination.


Eligibility criteria:
inclusion criteria: * patient of client organizations of emmi solutions * provided a phone number to their care team exclusion criteria: -
longterm influence of pediatric long covid syndrome

Conditions: COVID-19-Associated Encephalitis; Long COVID

Summary: we enroll pediatric patients who were diagnosed covid-19 for main observation target. we will perform brain mri and neuropsychiatric evaluation 4-6 months after covid-19 diagnosed. we also enroll healthy age- and gender-matched participant for cross-over comparison. we will perform same evaluation process one year later for longitudinal evaluation


Eligibility criteria:
inclusion criteria: * age 6-18 years old * has been diagnosed covid-19 before exclusion criteria: * history of neuropsychiatric disorders * have some device not allowed for mri

Keywords: pediatric neurology psychiatric evaluation long covid syndrome magnetic resonance image