Kornimate/medical-research-clean huggingface dataset:
the activation on prefrontal cortex with acupuncture and moxibustion for major depressive disorder: a study of functional near infrared spectroscopy

Conditions: Depressive Disorder, Major

Summary: this study evaluates the activation on prefrontal cortex with acupuncture and moxibustion for major depressive disorder.half of participants will receive the treatment of acupuncture and moxibustion, while the other participants will receive the fluoxetine.

major depressive disorder (mdd) is a psychiatric condition with high morbidity, disability, suicide and recurrence rate and become the hot and difficult topics in the medical study. given the unsatisfactory response rates of many fda-approved antidepressants, acupuncture is increasingly considered an important alternative therapy. a large number of clinical trials have confirmed that acupuncture is a generally safe, effective, and well-tolerated therapy for depression, but for mdd, the acupuncture clinical trials were only reported out of china. according to the clinical symptoms in patients with mdd, the chief tcm patterns are liver qi constraint and heart yang insufficiency, and the secondary tcm patterns are blood stasis, qi and blood deficiency. so we propose to combine acupuncture with moxibustion and select baihui (du20), shenting(du24), neiguan (pc6), hegu (li4), taichong (lv3), zusanli(st36), zhongwan (rn 12) and gaunyuan (rn4) to soothe the liver, regulating the heart, warm the yang qi, boost qi and invigorate blood for mdd. we hypothesize that the acupuncture's antidepressant effect is based on the neural network reconstructing mechanism through studying the cerebral cortex function, hippocampal synaptic plasticity, neurons electrophysiological change. we will employ multi-disciplinary methods in neuropsychology, neuroimaging, computer science, and electrophysiology to explore the important mechanism underlying acupuncture and moxibustion treating mdd.

Eligibility criteria:
inclusion criteria: * diagnostic criteria of ccmd-3 and dsm-4 depression; * the score of phq-9 should be equal to or more than 15 points; the score of hamilton depression rating scale should be more than 18 points; * without any drug treatment over the past 3 months

Keywords: acupuncture moxibustion major depressive disorder mdd neural network reconstruction cerebral function functional near infrared spectroscopy (fnirs) imaging
peanut allergy oral immunotherapy study of ar101 for desensitization in children and adults (palisade)

Conditions: Peanut Allergy

Summary: the purpose of this study is to demonstrate the efficacy and safety of ar101 through reduction in clinical reactivity to peanut allergen in peanut-allergic children and adults.

this is an international, multicenter, randomized, double-blind, placebo-controlled study of the efficacy and safety of ar101 in a characterized desensitization oral immunotherapy regimen in peanut-allergic individuals.

Eligibility criteria:
key inclusion criteria: * age 4 through 55 years * clinical history of allergy to peanuts or peanut-containing foods * serum immunoglobulin e (ige) to peanut ≥0.35 kua/l (kilos of allergen-specific units per liter, determined by unicap™\* within the past 12 months) and/or a skin prick test (spt) to peanut ≥3 mm compared to control * experience dose-limiting symptoms at or before the 100 mg challenge dose of peanut protein (measured as 200 mg of peanut flour) on screening dbpcfc conducted in accordance with practall\*\* guidelines * not be residing at the same address as another subject in this or any peanut oit study unicap™\*: a laboratory system for routine diagnostic testing of allergy and tool for basic studies on allergens and antibodies practall\*\*: practical issues in allergology joint united states/european union initiative key exclusion criteria: * history of cardiovascular disease, including uncontrolled or inadequately controlled hypertension * history of severe or life-threatening episode of anaphylaxis or anaphylactic shock within 60 days of screening dbpcfc * history of chronic disease (other than asthma, atopic dermatitis, or allergic rhinitis) that is, or is at significant risk of becoming, unstable or requiring a change in chronic therapeutic regimen * history of eosinophilic esophagitis (eoe), other eosinophilic gastrointestinal disease, chronic, recurrent, or severe gastroesophageal reflux disease (gerd), symptoms of dysphagia or recurrent gastrointestinal symptoms of undiagnosed etiology * history of severe asthma (nhlbi criteria steps 5 or 6), or mild to moderate asthma (2007 nhlbi criteria steps 1-4) that is uncontrolled or difficult to control * history of steroid medication use * history of a mast cell disorder, including mastocytosis, urticarial pigmentosa, and hereditary or idiopathic angioedema * developing dose-limiting symptoms in reaction to the placebo part of the screening dbpcfc * having the same place of residence as another subject in the study

Keywords: ar101 (characterized peanut allergen) characterized peanut allergen cpna (characterized peanut allergen) oit (oral immunotherapy) oral immunotherapy peanut allergy allergy peanut-allergic children peanut-allergic adults desensitization
early goal-directed nutrition in icu patients - eat-icu trial

Conditions: Critical Illness; Intensive Care (ICU) Myopathy; Muscle Wasting; Loss of Physical Function; Mechanical Ventilation

Summary: an increasing number of patients survive critical illness and intensive care, but describe having impaired physical function several years after discharge as a consequence of extensive loss of muscle mass. reasons for loss of muscle mass and physical function are multiple, but insufficient nutrition is likely to contribute. this randomised trial will investigate the effect of an optimised nutrition therapy during intensive care, on short term clinical outcome and physical quality of life. we hypothesise, that early nutritional therapy, directed towards patient-specific goals for energy and protein requirements, will improve both short- and long-term outcomes.


Eligibility criteria:
inclusion criteria: * acutely admitted to the icu * expected length of stay in icu \> 3 days * mechanically ventilated, which enables indirect calorimetry * have central venous catheter wherein tpn can be administered * written proxy consent obtained (proxy consent defined as consent from two doctors, who are independent of the trial) * must be able to understand danish exclusion criteria: * contraindications to use enteral nutrition * contraindications to use parenteral nutrition, eg. hypersensitivity towards fish-, egg or peanut protein, or any of the active substances in the pn products * receiving a special diet * burns \> 10% total body surface area * severe hepatic failure (child-pugh class c) or severe hepatic dysfunction: bilirubin ≥ 50 µmol/l (3 mg/dl) + alanine aminotransferase ≥ 3 times upper reference value * traumatic brain injury * diabetic ketoacidosis * hyperosmolar non-ketotic acidosis * known or suspected hyperlipidemia * bmi below 17 or severe malnutrition * pregnancy * the clinician finds that the patient is too deranged (circulation, respiration, electrolytes etc.) or that death is imminent

Keywords: intensive care unit critical illness mortality reduced quality of life loss of lean body mass loss of physical function optimised nutritional support early initiation of nutrition indirect calorimetry
study of the efficacy and safety of tezosentan in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing open heart surgery

Conditions: Heart Diseases; Hypertension, Pulmonary

Summary: endothelin-1 is a powerful substance that may be involved in causing hemodynamic instability (problems related to unstable blood pressure) during and after open heart surgery. tezosentan is an investigational intravenous drug that blocks the endothelin receptors. this clinical trial will assess the potential benefit of tezosentan compared with placebo in the treatment of patients undergoing open heart surgery with cardiopulmonary bypass (cpb). treatment time is from the start of surgery up to 24 hours.

endothelin-1 levels are increased during and after cardiac surgery with cardiopulmonary bypass (cpb), and are associated with many deleterious consequences, including increased pulmonary arterial pressure (pap), increased pulmonary vascular resistance (pvr), reduced myocardial contractility, and ultimately right ventricular failure. right ventricular failure during weaning from cpb increases the risk of mortality and morbidity, especially in patients with elevated pap prior to cardiac surgery. endothelin receptor antagonists (eras) have been shown to decrease pvr and pulmonary arterial pressure (pap), and improve right ventricular function in patients with pulmonary arterial hypertension. in animal models, eras have been shown to decrease the incidence of post-bypass pulmonary hypertensive crises. the primary objective of this trial is to demonstrate that tezosentan, a dual era, reduces the incidence of clinically relevant right ventricular failure in patients with pre-operative pulmonary hypertension, due to left heart disease, undergoing cpb.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 years of age * male or female patients (females of child-bearing potential must have been surgically sterilized or use a reliable method of contraception). * patients undergoing complex\* cardiac surgery on cpb and having systolic pap \> 40 mmhg or mean pap \> 30 mmhg (\*surgery on 2 valves, 1 valve and revascularization, or reoperation of a valve) * patients undergoing cardiac surgery on cpb and having pre-operative pulmonary hypertension due to left heart disease with systolic pap \> 60 mmhg * signed written informed consent exclusion criteria: * systolic blood pressure \< 100 mmhg * significant chronic lung disease * emergency surgery * pregnant/breast-feeding * investigational drug use within 28 days prior to randomization * complex adult congenital heart disease. * severe concomitant illness limiting life expectancy to \< 6 months * participation in a device study that will affect the outcome of the study * pre-operative use of balloon pump, inotropes/vasopressors, treatment of pulmonary arterial hypertension * known hypersensitivity to tezosentan or drugs of the same class, or any of their excipients * severe liver impairment

Keywords: left sided heart disease elevated pulmonary arterial pressure right ventricular failure cardiac surgery heart-lung machine cardiopulmonary bypass tezosentan actelion
balance rehabilitation after hip fracture surgery

Conditions: Hip Fractures

Summary: the overall functional gain by balance rehabilitation after hip fracture surgery has not yet been fully investigated. therefore, clinical studies should be conducted to evaluate the effectiveness of systematic and safe balance rehabilitation in patients after hip fracture. investigators aim to evaluate the effect of computer-based balance specific exercise on the performance and balance ability of the elderly women who underwent hip fracture surgery. investigators also investigate the intervention can reduce their fear of falling and coping ability. this study was designed as a prospective, open-label, single-center trial at a tertiary hospital setting. during the 2-week postoperative intervention period, patients will participate in the hospital's exercise program beginning 5-7 days after hip fracture surgery. all participants will follow the computer-based balance specific exercise program. functional outcomes will be measure periodically for 6 months after surgery.


Eligibility criteria:
inclusion criteria: * elderly female patients (≥ 65 years old) who have undergone surgery for femoral neck, intertrochanteric, or subtrochanteric fracture, regardless of surgery type (internal fixation, bipolar hemiarthroplasty, or total hip arthroplasty) exclusion criteria: * 1) hip surgery for infection, arthritis, implant loosening, or avascular necrosis; * 2) femoral shaft fracture, acetabular fracture, isolated fracture of the greater or lesser tuberosity, or periprosthetic fracture; * 3) pathologic fracture; * 4) combined multiple fracture; * 5) revision surgery; * 6) severe cognitive dysfunction (obey command ≤ 1 step); * 7) cannot stand by supporting a fixed walker at 5 days after operation; * 8) patients who refuse to participate in a clinical trial
stat3 decoy in head and neck cancer

Conditions: Head and Neck Cancer

Summary: the primary goal of this study is to evaluate the safety of a transcription factor decoy targeting signal transducer and activator of transcription 3(stat3) in patients with head and neck cancer. the rationale for targeting stat3 using this approach is to decrease stat3-mediated gene regulation. the study has the following scientific objectives: 1. to assess the safety of a single dose of intratumoral stat3 decoy. 2. to estimate the effect of stat3 decoy therapy on stat3 activation levels, stat3-mediated gene expression, and apoptosis in treated tumors.

the decision to proceed with an exploratory ind study to be conducted in a phase 0 setting was based upon the expectation that the trial will involve very limited human exposure to the stat3 decoy, and as administered, will have no therapeutic or diagnostic intent. rather, the trial is designed to determine if intratumoral administration of the stat3 decoy in human head and neck tumors inhibits stat3 target gene expression. given the cumulative evidence supporting stat3 as a therapeutic target in cancer, and the absence of any clinical trial to date using a stat3 inhibitor, it was felt that there would be utility in a proof of principal study to determine if the stat3 decoy inhibits the expression of stat3 target genes in human head and neck cancers. to support the proposed study design, the grandis lab carried out a kinetic study in a xenograft model of scchn. preliminary results demonstrated that administration of the stat3 decoy, but not the mutant control decoy, decreased expression of stat3 target genes (bcl-xl and/or cyclin d1) at time points ranging from 1 to 6 hours.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of head and neck squamous cell carcinoma(primary or recurrent) amenable to surgical resection. * ecog performance status of 0, 1, or 2. * adequate organ function * age greater than or equal to 18 years * written informed consent. * patients with second primary lesions will be eligible for this trial. * negative pregnancy test, nonlactating, and using effective means of contraception if childbearing potential. exclusion criteria: * subjects who fail to meet the above criteria. * subjects who are pregnant. * subjects with an ecog performance status \>2. * subjects with tumors that are too small to biopsy prior to resection and reserve a portion of the resected specimen for research purposes. * subjects who receive neoadjuvant radiotherapy and/or chemotherapy within four week prior to enrollment

Keywords: stat 3 decoy
follow-up of adolescent bariatric surgery

Conditions: Morbid Obesity

Summary: very little information is available about extremely obese (body mass index \[bmi\] \> 40 kg/m2) adolescents. the purpose of the follow up of adolescent bariatric surgery (fabs) study is to collect information obtained during the clinical care of obese adolescents from all over the country that can be used by researchers to study obesity, the complications of obesity, and the outcomes of obesity treatment during adolescence. this information will be used to describe the experience of the obese adolescent, including how obesity during adolescence and its treatment impacts health and well-being. the information may also be used to study causes of obesity, to determine the predictors of successful obesity treatment and for other obesity related research. because of the importance of understanding the outcome of obesity and obesity treatments (surgical and non-surgical) on the patient over time, the data included in the study will be collected before, during and after any treatments rendered. for those who do not undergo a treatment which results in major weight change, it will be critical to determine the natural history of adolescent severe obesity as the adolescent transitions into adulthood. finally, another important purpose of the fabs research study is to obtain patients' consent to be contacted for possible participation in future research studies. specific aims: 1. to describe the natural history of morbid obesity among adolescents who seek treatment for their obesity 2. to describe major outcomes following bariatric surgery in adolescents evaluated at 3, 6, 12, and annually for 10 years post-operatively and compare these to outcomes to patients managed non-surgically 3. to organize a national cohort of severely obese adolescents who agree to be contacted in the future for research studies


Eligibility criteria:
inclusion criteria: * all patients seeking treatment for obesity at cincinnati exclusion criteria: * currently enrolled in teen labs study.

Keywords: bmi > 40 obesity adolescents weight loss surgery
modulation of metabolic rate by inorganic nitrate

Conditions: Resting Metabolic Rate

Summary: the purpose of this study is to determine the effects of sodium nitrate on resting metabolic rate, glucose uptake and formation of reactive oxygen species in humans.


Eligibility criteria:
inclusion criteria: healthy volunteers exclusion criteria chronic medication vegetarian nicotine users known metabolic disease

Keywords: nitrate nitrite nitric oxide resting metabolic rate glucose uptake insulin sensitivity reactive oxygen species production inorganic nitrate sodium nitrite infusion
efficacy and safety of guduchi ghan vati in the management of asymptomatic covid-19 infection

Conditions: Covid19

Summary: the emergence of asymptomatic patients poses a significant challenge to the prevention and treatment of the epidemic.there have not been any treatment options that reduce the viral load or preventive options that reduce the risk of developing severe conditions.therefore, present feasibility study of the safety and efficacy of guduchi ghan vati was conducted in asymptomatic patients with covid-19


Eligibility criteria:
inclusion criteria: * all hospitalised cases above 18 years of age, * diagnosed with covid-19 * asymptomatic at the time of admission * agree to give consent exclusion criteria: * symptoms relating to covid-19 * severe vomiting * respiratory failure or requiring mechanical ventilation * patients having alanine transaminase (alt) or aspartate transaminase (ast) \> 5 times the upper range of normal limits * patients with covid-19 in critical condition or ards or niad 8 -point ordinal score-2 * patients with uncontrolled diabetes mellitus * malignant, * chronic renal failure or * on immunosuppressive medication
study of modified constraint-induced aphasia therapy schedule to treat patients following sub-acute stroke

Conditions: Aphasia

Summary: the purpose of this study is to assess the feasibility of modified constraint-induced aphasia therapy (ciat) in the early sub-acute stage and to examine the efficacy of modified ciat versus standard treatment with the same intensity of intervention.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of first-ever stroke * aphasia in sub-acute stage * german speakers exclusion criteria: * presence of residual aphasia * dysarthria and apraxia of speech

Keywords: aphasia rehabilitation of speech and language disorders
bioequivalence study of zidovudine 300 mg tablets, usp under fed conditions

Conditions: Healthy

Summary: the objective of this study was to assess the single-dose relative bioavailability of ranbaxy and glaxosmithkline (retrovir ®) 300 mg zidovudine tablets, under fed conditions

this was an open label, randomized, single dose, 2-way crossover, comparative bioavailability study performed on 68 healthy adult volunteers. in each period, subjects were housed from at least 10 hours before dosing until after the 12 hour blood draw. single oral dose 300 mg zidovudine doses were separated by a washout period of 7 days. a total of sixty-eight (68) healthy adult subjects (29 males and 39 females) were enrolled in the study, of which sixty five (65) subjects (29 males and 36 females) completed the clinical portion of the study.

Eligibility criteria:
inclusion criteria: 1. healthy adult male or female volunteers, 18-55 years of age 2. weighing at least 52 kg for males and 45 kg for females within 15 % of their ideal weights (table of 'desirable weights of adults', metropolitan life insurance company, 1983) 3. medically healthy subjects with clinically normal laboratory profiles, vital signs and ecgs 4. females of child bearing potential were either sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or were using one of the following acceptable birth control methods: surgically sterile (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) 6 months minimum; iud in place for at least 3 months; barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study surgical sterilization of the partner (vasectomy for 6 months minimum) hormonal contraception for at least 3 months prior to the first dose of the study other birth control method deemed acceptable 5. postmenopausal women with amenorrhea for at least 2 years 6. given voluntary written informed consent to participate in this study. exclusion criteria: 1. history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic or psychiatric disease 2. in addition history or presence of alcoholism or drug abuse within the past year, or hypersensitivity or idiosyncratic reaction to zidovudine or to any other nucleoside analogue 3. female subjects who were pregnant or lactating 4. subjects who tested positive at screening for hiv, hbsag or hcv 5. subjects who have used any drugs or substances known to be strong inhibitors of cyp enzymes (formerly known as cytochrome p 450 enzymes) within 10 days prior to the first dose 6. subjects who have used any drugs or substances known to be strong inducers of cyp enzymes (formerly known as cytochrome p 450 enzymes) within 28 days prior to the first dose and throughout the study 7. subjects who through completion of the study would have donated in excess of 500 ml of blood in 14 days, 1500 ml of blood in 180 days or 2500 ml of blood in 1 year 8. subjects who have participated in another clinical trial within 28 days prior to the first dose.

Keywords: bioequivalence