Kornimate/medical-research-clean huggingface dataset:
visual reconstitution therapy after optic neuritis

Conditions: Optic Neuritis; Multiple Sclerosis

Summary: incomplete remission after an optic neuritis attack is not uncommon. visual reconstitution therapy is a software-based approach that has been shown to substantially improve residual visual field deficits in patients with pre- and postchiasmatic lesions. the primary hypothesis of this randomized, controlled clinical trial is, that visual reconstitution therapy is superior to active comparator treatment in improving the visual field after optic neuritis.

patients with an acute optic neuritis (between 60 and 180 days before screening) or with residual visual deficits after a past optic neuritis are randomized in two treatment groups. group a is instructed to perform software-based visual reconstitution therapy on a home pc daily and regularly for 30 minutes over a period of six month. group b will perform a similarly, also software-based training program, developed to improve saccadic eye movements rather than visual fields. patients are blinded to the respective treatment.

Eligibility criteria:
inclusion criteria: * definite optic neuritis within 60-180 days or \< 12 months before screening * visus \> 0.05 * visus \< 0.7 or confirmed visual field deficit * ability to give informed consent exclusion criteria: * systemic treatment with glucocorticosteroids within 30 days prior to screening * additional significant ophthalmological disease * pregnancy * history of epilepsy * significant arterial hypertension

Keywords: history of patients acute
vr interventions to reduce the prevalence of delirium in icu patients

Conditions: Delirium

Summary: the goal of this clinical trial is to learn the effect of vr-based family support system (vrfs) on reducing delirium in icu mechanically ventilated patients. the main question it aims to answer is: ·using vrfs for participant intervention, can it reduce the incidence of delirium and improve clinical outcomes? researchers will investigate whether the implementation of vrfs can reduce the number of delirium days and improve clinical outcomes. participants will: * receive the vrfs intervention until the endotracheal tube (ett) is removed. * have physiological data collected, including eeg, oxygen saturation levels, ecg, and blood pressure. * keep a diary of delirium, dosage of sedative and analgesic drugs, the duration of mechanical ventilation, and icu stays.

during the vrfs interventions, researchers will fit participants with a vr headset and noise-canceling headphones, shielding them from the icu environment while allowing family members to be present and offer companionship and comfort.

Eligibility criteria:
inclusion criteria * mechanical ventilation duration is expected to be greater than 24 hours; * icu stay duration is expected to be greater than 72 hours; * age is 18 years or older, with no upper age limit; * language: chinese. exclusion criteria * severe visual or auditory impairments (diplopia, low vision due to macular degeneration, retinopathy; severe hearing loss or deafness); * cognitive and consciousness disturbances prior to icu admission; * severe motion sickness; * head trauma or surgery that prevents the wearing of equipment; * a history of long-term use of antipsychotic and/or benzodiazepine medications.

Keywords: icu virtual reality delirium family support
the safety and effectiveness of r-huepo in patients with aids and anemia caused by aids and treatment with azt

Conditions: HIV Infections; Cytopenias

Summary: to determine the safety and efficacy of erythropoietin administered subcutaneously to aids patients with anemia secondary to their disease and/or concomitant zidovudine (azt) therapy. efficacy will be assessed by correction of anemia and decrease in transfusion requirements.


Eligibility criteria:
exclusion criteria co-existing condition: patients with the following are excluded: * history of any primary hematologic disease. * clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying aids. * aids-related dementia. * uncontrolled hypertension (diastolic blood pressure \> 100 mmhg). * presence of concomitant iron deficiency. * anemia attributable to factors other than aids or zidovudine (azt) therapy. * acute opportunistic infection. * history of seizures. patients with clinically significant disease / dysfunction of the pulmonary, cardiovascular, endocrine, neurologic, gastrointestinal, or genitourinary systems not attributable to underlying aids are excluded. * patients who have previously participated in any other r-huepo clinical study are excluded. prior medication: excluded within 30 days of study entry: * experimental drug or experimental device. * cytotoxic chemotherapy. * excluded within 2 months of study entry: * androgen therapy. clinical diagnosis of aids related anemia. * clinical diagnosis of aids. * clinically stable for 1 month preceding study entry. * maintenance dose of zidovudine (azt) of at least 400 mg daily. substance abuse.

Keywords: recombinant proteins injections, subcutaneous erythropoietin acquired immunodeficiency syndrome anemia zidovudine
ras quantification in patients with aliskiren or candesartan

Conditions: Hypertension; Chronic Kidney Disease; Proteinuria

Summary: forced blockade of the renin-angiotensin-system (ras) by using direct renin inhibition (dri) has long been propagated to effectuate beneficial outcomes. however, recent large clinical trials have outlined harmful effects for dri in combination with other forms of ras blockade. to date, information regarding dri as ras-blocking monotherapy is very limited. furthermore, it remains to be elucidated how dri and angiotensin receptor blockers affect the so-called 'classical' and 'alternative' ras molecularly. as components of the 'alternative' ras (e.g. ang 1-7) have moved into research focus, it would be of importance to determine angiotensin regulation with medical ras blockade. in this prospective, single-center randomized trial over 10 weeks, 24 patients with chronic kidney disease (ckd) stage iii-iv (egfr 15-59 ml/min) will be randomized to take either aliskiren (up to 300 mg per day) or candesartan (up to 16 mg per day) after a two week run-in phase where all ras-blockers are eliminated. the investigators will then employ a novel mass spectrometry-based quantification method (after run-in and 10 weeks) to capture the concentrations of ten different angiotensin peptides (including angiotensin i and ii, angiotensin 1-7 and angiotensin 1-5). the investigators hypothesize that significant differences exist between angiotensin levels in ckd patients with dri compared to angiotensin receptor blockers. specifically, the investigators expect to determine the regulation of the alternative ras represented by angiotensin 1-7 with proximal versus distal blockade of the system. our data might contribute to a more profound understanding of results from registries and clinical trials beyond the clinical effects of ras blockade. further, the study's results might help to individualize and optimize ras-blocking therapy strategies in ckd patients.


Eligibility criteria:
inclusion criteria: * chronic kidney disease stages iii-iv (defined by modification of diet in renal disease (mdrd) formula) * urinary albumin to creatinine ratio (uacr) \>300mg/g, uacr \>200mg/g if already receiving ras blockade * arterial hypertension exclusion criteria: * age \<18 years * diabetes mellitus type 2 (defined by who criteria) * chronic kidney disease stage v (end-stage renal disease) * uacr \>3500mg/g * severe hypertension (systolic blood pressure \>180mmhg) * pregnancy

Keywords: renin-angiotensin-system ras blockade
safety of intravenous thrombolytics in stroke on awakening

Conditions: Stroke

Summary: the primary objective of this study is to evaluate the safety of intravenous tissue plasminogen activator (iv tpa) in patients waking up with symptoms of acute stroke and presenting to the emergency department (ed) within 4.5 hours from awakening, and meeting standard criteria for treatment with iv tpa for acute stroke. the hypothesis is that patients that wake up with stroke symptoms may have developed the stroke at the time of awakening, and may be within the 4.5 hour window if they arrive to the ed within that time, therefore iv tpa should be safe and effective in this population.


Eligibility criteria:
inclusion criteria: * age greater or equal to 18 years, and lower or equal to 80 years. * signs and symptoms of acute ischemic stroke. * symptoms present upon awakening. * arriving to the emergency department within 4.5 hours of awakening. treatment with iv tpa must be initiated prior to 4.5hours from waking up. * nihss \>3 * a non-contrast head ct without hemorrhage and without hypodensity more than 1/3 of the middle cerebral artery (mca) territory; or mri demonstrating no hemorrhage, and with a diffusion-weighted imaging (dwi) lesion no greater than 70 ml and flair without a well defined hyperintense lesion that is more than 1/3 of the mca territory. * pre-morbid modified rankin score of 0 or 1. exclusion criteria: * rapidly improving deficit to an nihss less than 3. * sustained systolic blood pressure greater than 185 mmhg or diastolic blood pressure greater than 110 mmhg despite treatment. * glucose less than 50 mg/dl. * stroke or head trauma within last 3 months. * history of intracranial hemorrhage. symptoms of subarachnoid hemorrhage. * major surgery within 14 days. * gastrointestinal (gi)/genito-urinary (gu) hemorrhage within 21 days. * international normalized ratio (inr) \> 1.7. * heparin within 48 hours with an elevated activated partial thromboplastin time (aptt). * platelet count less than 100,000. * presumed septic embolus or suspicion of bacterial endocarditis. * suspicion of aortic dissection. * use of anticoagulants such as dabigatran, rivaroxaban, apixaban, enoxaparin. * pregnant or lactating women. * known allergy or sensitivity to tpa.

Keywords: stroke wake up iv tpa thrombolytic
v/q matching in pressure support ventilation

Conditions: Acute Respiratory Failure; ARDS; Electrical Impedance Tomography

Summary: the aim of this study is to describe the effects of different levels of pressure support on ventilation-perfusion matching in patients recovering from ards, using electrical impedance tomography.

spontaneous breathing during mechanical ventilation has been attributed to both protective and negative effects on patient outcomes, largely varying based on the severity of lung injury. indeed, in severe ards the avoidance of spontaneous efforts has an established protective role. however, spontaneous breathing promotes the distribution of tidal volume towards the dependent lung, and low levels of support pressure determine more homogeneous ventilation in patients recovering from ards, compared to higher support levels. physiology supports the potential of spontaneous breathing to increase lung perfusion, through the decrease of intra-thoracic pressure leading to an increased venous return. this mechanism, in absence of right ventricular dysfunction, may lead to increased global lung perfusion. furthermore, gas exchange improvements in experimental lung injury models during pressure support vs. controlled ventilation have been explained with redistribution of lung perfusion to nondependent lung areas and improvement of v/q matching even in absence of significant lung recruitment. electrical impedance tomography has been clinically used as a non-invasive tool to assess v/q matching in patients with ards and to compare v/q matching prior to and after a cycle of prone position in spontaneously breathing patients with covid-19. the aim of this study is to describe the effects of different levels of pressure support on ventilation-perfusion matching in patients recovering from ards, using electrical impedance tomography.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * need for invasive mechanical ventilation and icu admission * diagnosis of ards at icu admission or during icu stay * informed consent * presence of central line in the internal jugular vein exclusion criteria: * any contraindication to electrical impedance tomography monitoring (e. g. severe chest trauma or wounds) * cardiogenic pulmonary edema * pulmonary embolism * chronic obstructive pulmonary disease * pulmonary fibrosis * asthma exacerbation * pneumothorax and/or chest drainages * pre-existing diaphragmatic function impairment * neuro-muscular disease or impairment * moribund patients with limitation of care or expected survival \<48h according to the treating physician

Keywords: electrical impedance tomography ards v/q matching
a study to evaluate the relative bioavailability and food effect of a new tablet formulation of vx-548

Conditions: Pain

Summary: the purpose of this study is to evaluate the relative bioavailability and food effect of a new tablet formulation of vx-548 in healthy adult participants.

this clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (that is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4) (a) of the public health service act and 42 cfr 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the public health service act or 42 cfr 11.24 and 11.44.).

Eligibility criteria:
key inclusion criteria: * body mass index (bmi) of 18.0 to 32.0 kilogram per meter square (kg/m\^2) * a total body weight greater than (\>)50 kg key exclusion criteria: * history of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug * any condition possibly affecting drug absorption * female participants of childbearing potential * male participants with a female partner who is pregnant, nursing, or planning to become pregnant during the study * history of cardiovascular disease, cardiac dysrhythmias or central nervous system disease other protocol defined inclusion/exclusion criteria may apply.
effectiveness and safety of early intramuscular botulinum toxin injections to prevent shoulder deformity in babies with obstetrical brachial plexus palsy

Conditions: Obstetrical Brachial Plexus Palsy

Summary: in children population with obstetrical brachial plexus palsy (obpp), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. some uncontrolled studies shows that early injections of botulinum toxin (bti) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatment for the prevention of bony deformity. the main objective of this study will be the evaluation of the effectiveness of bti in the internal shoulder rotator muscles at the age of 12 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with obpp (evaluated at the ages of 11 months and 18 months), compared to the sham group.


Eligibility criteria:
inclusion criteria: * male and female babies with unilateral obpp * age between 10 and 11 months * presenting one of 2 risk factors for posterior subluxation of the humeral head (10° less passive external rom of the affected shoulder compared with the contralateral shoulder and/or a score strictly less than 6 on the ams for shoulder external rotation and abduction, elbow flexion or supination) * signature of the consent form by (the) parent(s) over the age of majority exclusion criteria: * bilateral obpp * microsurgery or secondary muscle surgery planned between 12 and 18 months of age * contraindications to the use of botulinum toxin * contraindications to mri * mri not possible in the paediatric day hospital setting because of contraindications to the sedation protocol or due to organisational constraints * parents inapt to provide consent for the participation of their child * parents under the age of 18 years

Keywords: physiotherapy children shoulder deformation obstetrical brachial plexus palsy
topical treatment and prevalence of p. acnes

Conditions: Surgical Site Infection

Summary: this study is about preventing surgical site infections of the shoulder. we hope to learn if clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can affect growth of propionibacterium acnes in the dermal layer.

p. acnes are skin pathogens known to cause surgical site infections despite proper preoperative surgical preparation. lee et al. showed 70% growth rate of p. acnes despite the application of choraprep prior to sampling. however, this study was limited as it failed to utilize a control group and only investigated one preparatory technique. meanwhile, there remains to date no study investigating the effect of topical treatments. the purpose of this study is to investigate how specific topical treatments affect growth in the dermal layer. 12 volunteers who are normal volunteers, students, or employees of usc will each receive 4 punch biopsies from their back above the scapular spine, with each biopsy taken from a region of the skin treated with a different topical (topical clindamycin alone, topical benzoyl peroxide alone, topical clindamycin and benzoyl peroxide together, and a control). a 3df overall test of the treatment indicators will test for any differences in positivity for p acnes among the treatments; pairwise comparisons among the treatments will adjust for multiple comparisons. a two-tailed statistical test will be performed, testing at an alpha of 0.05, and analyses will also be performed based on hemolytic subtypes.

Eligibility criteria:
inclusion criteria: * healthy volunteer * age \> 18 exclusion criteria: * history of antibiotic use in the last month * active acne on the back * non-english speakers (the study personnel do not have adequate training to converse and consent in other languages)

Keywords: propionibacterium acnes surgical site infection shoulder
utilizing qualitative and quantitative methods to understand a new model of type 1 and 2 systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this study is to pilot test sle@duke, a set of tools to implement the type 1 \& 2 sle model in a clinical setting, as well as to gain an in-depth understanding of providers experiences using the intervention during clinic visits with patients with systemic lupus erythematosus. this record represents aim 3 of this study.


Eligibility criteria:
inclusion criteria: * all providers in duke rheumatology who practice outside of the duke lupus clinic are eligible. * patients are eligible to participate if they have an established diagnosis of sle and are followed in duke rheumatology. * all patients with a sle diagnosis will be included in the analysis. sle diagnosis will be based on an icd-10 code for sle (m32.1\*, m32.8, m32.9) in the emr. exclusion criteria: * new patients will be excluded

Keywords: systemic lupus erythematosus
phase 2 trial of ped-1 and ped-2 in male patients with premature ejaculation

Conditions: Premature Ejaculation

Summary: the purpose of this study is to evaluate whether ped-1 (15mg) and ped-2 (30mg) are tolerable and effective in the treatment of premature ejaculation.

this study is to evaluate whether ped-1 and ped2 are tolerable and effective in the treatment of premature ejaculation. the patients will be randomized and allocated to three treatment groups into placebo, ped-1, and ped-2. the creteria for ielt for enrollment will be \> or =2 min in the at least 75% of the sexual intercourse. to diagnosis premature ejaculation, the pedt will be used. the patients ungone drug free baseline line period will take test drugs for 4 weeks.

Eligibility criteria:
inclusion criteria: * informed consent for subjects and partdners * men 20-65 * stable monogamous relation at least for 6 mn * pedt more than 9 * at least 6 mn of premature ejaculation hx * ielt of =\ = 75% of evaluable events during 4 week secreening period exclusion criteria: * hx of medical or psychiartric illness * erectile dysfunction (\<21 iief ef domain score) or other forms of sexual dysfunction * partner sexual dysfunction * known hypersensitivity to clomipramine and contraindications for clomipramine

Keywords: pe ielt dcit
pilot psychoeducational intervention model to improve nutritional status in low resource settings

Conditions: Child Malnutrition; Child Overnutrition; Malnutrition in Children; Malnutrition, Child; Nutrition Disorders, Child; Malnutrition

Summary: the purpose of this study is to develop, implement and evaluate a psychoeducational intervention focused to improve nutritional status, specifically micronutrients, of mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities.

mexico's malnutrition problem goes beyond lack of food. nutrition transition in our country has modified dietary patterns in a way that now we observe more and more a decrease in consumption of micronutrient rich foods, like vegetables, and an increase in consumption of high energy-dense foods with low content of micronutrients (highly processed foods). in mexico, over 70% of the population presents an inadequate vegetable intake, with a higher prevalence in scholars (5 - 11 years), where only 17% of them consume \>50% of the recommended vegetable intake. a vegetable poor diet is related to malnutrition, poor cognitive development and low physical performance. added to this, mexican families have lost the tradition of cooking at home. it is well known that different factors contribute to a population's diet and cooking at home as well as eating with the family have been identified as fundamental factors to promote a healthy diet. therefore, the aim of this psychoeducational intervention in nutrition is to improve nutritional status in families, particularly mothers and caregivers of children between the ages of 5 and 13 years and their children through providing healthy cooking lessons in their communities where the optimal preparation and use of local foods based on vegetables is promoted at the same time the importance of cooking at home and eating as a family is highlighted.

Eligibility criteria:
inclusion criteria: * age 18 to 60 years * premenopausal * bmi \< 45 during enrollment * apparently healthy * with a child in her care between the ages of 5 and 13 years exclusion criteria: * pregnant or breastfeeding * with a hysterectomy in the past 3 months * alcohol consumption \> 14 drinks a week * use of vitamin supplements

Keywords: psychoeducational intervention nutrition intervention malnutrition micronutrient deficiency nutrition transition
gut microbiota as a therapeutic target for cvd

Conditions: Obesity

Summary: background: the mediterranean diet (md) is considered an healthy diet useful in the prevention of cardiovascular disease (cvd). high quality extra virgin olive oil (hq-evoo, \[1\]), an essential component of this diet, exerts a protective effect against cvd. moreover, the gut microbiota (gm) has recently been recognized as a key factor in driving metabolic activities and involved in the stimulation of host immunity \[2\]. in particular, lactic acid bacteria (lab) and their probio-active cellular substances produce beneficial effects in the gastrointestinal tract, thus representing important assets in pathological conditions such as obesity and cvd \[3,4\]. objective: the purpose of this study is to demonstrate that 3 months of treatment (md with 40g/die hq-evoo) in 36 subjects (cases: overweight/obese vs controls: normal weight) may change their gm and inflammatory panel.


Eligibility criteria:
inclusion criteria: * normal weight subjects (m and f) with body mass index (bmi) between 18.5 and 24.9 kg/m2 following md; * overweight/obese subjects with a bmi ≥ 25 kg/m2, not necessarily following md. exclusion criteria: * eating disorders; * recent or ongoing antibiotic therapy.