Kornimate/medical-research-clean huggingface dataset:
multi-factor model constraction for early warning and diagnosis of mdd

Conditions: Major Depressive Disorder; Bipolar Disorder; Omega-3 Fatty Acids

Summary: current research on the pathogenesis of depression shows that imbalanced inflammatory factors are closely related to major depressive disorder(mdd). as reported, physical exercise, ω-3 fatty acids, and sulforaphane can be complementary therapies for moderate-to-severe depression. in addition, imaging studies have found changes in the structure and functional connectivity of the brain. therefore, this study intends to collect clinical and biological information from patients with depression and healthy controls to establish a multi-factor model for early warning and diagnosis of major depressive disorder

the immune imbalance has been reported in patients with unipolar and bipolar depression. there is no unified conclusion in the field and severity of the immune imbalance, and the cause of cognitive impairment is unknown, which may be related to many factors. omega-3 fatty acids are immune modulators that possess antidepressant effects. this study includes three steps. 1. we will enroll bipolar and major depressive disorder patients who are in a depressive episode and enroll healthy controls. all subjects will be assessed at baseline 2. we will give omega-fatty acid treatment based on immune indicators 3. the follow-up will last for one year with five sessions.

Eligibility criteria:
inclusion criteria: * outpatients in main-center and sub-centers * age between 18-65 years old * meet the dsm-iv diagnosis of depressive episode * hamd-17 score\>17 at baseline * no antidepressant treatment within 6 weeks prior to enrollment * adequate cognition level to complete the tests necessary for the study * willing to sign the informed consent form exclusion criteria: * have any contraindications to ω-3 fatty acids * severe physical disease * diagnosed with schizophrenia, or other mental illness spectra * have received physical therapy
effect of antioxidants on oxygen induced vasoconstriction in lipopolysaccharide (lps) induced inflammatory model in humans

Conditions: Healthy

Summary: oxidative stress has been implicated in playing a pathogenic role in many disease processes, especially in age-related disorders. it has been hypothesized that antioxidative agents such as vitamins and minerals, which are capable of scavenging free radicals, may reduce oxidative stress and may, in turn, be beneficial for patients with age-related disorders. based on this hypothesis, several different combinations of vitamins have been introduced, all targeting at reducing oxidative stress. however, the in-vivo determination of the antioxidative properties of a certain drug or vitamin combination are hard to determine. in the current study, the researchers propose to investigate the effect of vitamac®, a combination of vitamins and minerals, in a systemic in-vivo inflammation model. in the present study, the infusion of lps, which is a cell wall component of gram-negative bacteria and a major mediator in the pathogenesis of septic shock, will be used as a standardized experimental model of systemic inflammation in humans. given that inflammation is associated with enhanced oxidative stress and widespread endothelial dysfunction, the lps model is well suitable for determination of the antioxidative effects of vitamac®. as a main outcome parameter, the vascular reactivity of retinal vessels to systemic hyperoxia (induced by breathing 100% oxygen) will be tested in presence or absence of the antioxidant combination.


Eligibility criteria:
inclusion criteria: * men aged between 18 and 35 years, nonsmokers * body mass index between 15th and 85th percentile (must et al. 1991) * normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant * normal laboratory values unless the investigator considers an abnormality to be clinically irrelevant * normal ophthalmic findings, ametropia \< 3 dpt exclusion criteria: * regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study * treatment in the previous 3 weeks with any drug, vitamins and minerals supplements as well * symptoms of a clinically relevant illness in the 3 weeks before the first study day * history of hypersensitivity to the trial drug or to drugs with a similar chemical structure * history or presence of gastrointestinal, liver or kidney disease, or other conditions known to interfere with, distribution, metabolism or excretion of study drugs * blood donation during the previous 3 weeks

Keywords: endotoxin, escherichia coli retina regional blood flow
multi-country post-marketing observational study on maintenance of effectiveness of adalimumab (humira®) in patients with ankylosing spondylitis and psoriatic arthritis

Conditions: Ankylosing Spondylitis; Psoriatic Arthritis

Summary: this 12-month postmarketing observational study (pmos) was a prospective, single-arm, multicenter, multi-country study, with follow-up visits at 3, 6, 9, and 12 months after the initial baseline visit. the study was conducted to determine the long-term effectiveness of treatment with adalimumab in routine clinical use in participants with ankylosing spondylitis (as) and psoriatic arthritis (psa) in central and eastern european countries.

additional study objectives were to evaluate as and psa with regard to extra-articular manifestations (eams), functional status, the use of concomitant nonsteroidal anti-inflammatory medication, and work productivity impairment. in addition, the ankylosing spondylitis disease activity score (asdas), a new disease activity index in as, was measured in parallel with the standard bath ankylosing spondylitis disease activity index (basdai) score to assess the effectiveness of adalimumab in treating axial symptoms.

Eligibility criteria:
inclusion criteria: patients will be enrolled in this postmarketing observational study pmos if they fulfill all of the below criteria: 1. adult patients with diagnosis of ankylosing spondylitis (as) or psoriatic arthritis (psa). 2. eligible for adalimumab therapy according to the local product label and prescription/reimbursement guidelines. 3. have been prescribed adalimumab within a maximum of one (1) month prior to the study enrolment. 4. have negative result of tuberculosis (tb) screening test or tb prophylaxis as per local guidelines. 5. are willing to provide authorization to the investigator to use and/or disclose personal and/or health data, or to provide informed consent if requested by the local regulations, before entry into the study. exclusion criteria: patients fulfilling below exclusion criteria will not be eligible for this postmarketing study (pmos): 1. meet contraindications for treatment with adalimumab as outlined in the latest version of the local summary of product characteristics (smpc)

Keywords: post-marketing observational study (pmos) protocol effectiveness of adalimumab (humira®) psoriatic arthritis ankylosing spondylitis
psychological counseling program for alzheimer's patients' caregivers

Conditions: Alzheimer Disease; Caregivers of Alzheimer&#39;s Disease or Memory Problem Patients; Perceived Stress; Well-Being (Psychological Flourishing); Care Burden

Summary: purpose: to investigate the effects of a psychological counseling program (psychocp) applied to caregivers of alzheimer's patients on perceived stress, psychological well-being and care burden. design: the study will be conducted in a pre-test post-test control group, randomized controlled experimental research design. method: the study is planned to be carried out in bağcılar municipality vefahâne life center, antalya alzheimer patients and patient relatives meeting center and osmaniye family and social policies directorate. the sample of the study will consist of 80 caregivers. they will be assigned to intervention (n=40) and control groups (n=40) by randomization. hypotheses hypothesis1: the perceived stress level of caregivers who received psychodp is lower than those who did not receive psychocp. hypothesis2: the psychological well-being levels of caregivers who received psychodp are higher than those who did not receive psychocp. hypothesis3: the care burden of caregivers who received psychodp is lower than those who did not receive psychocp.


Eligibility criteria:
inclusion criteria: * providing informal care to an individual with mild or moderate alzheimer's disease * being a primary caregiver * providing care to the patient for at least six months * providing care to the patient for at least six hours per day * being literate * being able to speak and understand turkish * being 18 years of age or older * being willing and able to participate in the study exclusion criteria: * not being able to understand questions and express ideas * having a psychiatric disorder * not receiving any therapy services during the study
dexpramipexole renal pk study

Conditions: Amyotrophic Lateral Sclerosis; Renal Insufficiency

Summary: this is a multicenter, open-label, single-dose, pk and safety study in subjects with various stages of renal impairment.

dexpramipexole (biib050, kns-760704; (6r)-4,5,6,7-tetrahydro-n6-propyl-2,6-benzothiazolediamine dihydrochloride monohydrate) is a synthetic amino-benzothiazole. data from multiple in vitro and in vivo assays have suggested that dexpramipexole is neuroprotective. it is being investigated for the treatment als. as dexpramipexole is principally eliminated from the body by the kidneys a single oral dose of dexpramipexole will be administered to subjects with various stages of renal impariment comprising the following categories: mild, moderate, severe and esrd subjects. healthy volunteers will be matched to each catergory of renal impaired subjects.

Eligibility criteria:
inclusion criteria: * adult males/females aged 18 to 75 years inclusive and between 19 and 36 kg/m2 inclusive bmi. * subjects with renal impairment must have stable renal disease (i.e., no change in disease status within the 28 days prior to dosing) as determined by the investigator with laboratory and clinical findings that support the diagnosis of renal impairment. * subjects with renal impairment (excluding esrd subjects), must have 2 separate estimates of creatinine clearance that are within 25% of each other, obtained \>5 days apart, but not \>6 months apart * subjects must have a gfr (estimated gfr; as defined by estimation of creatinine clearance using the mdrd formula) of ≥80 (healthy volunteers), between 50 and 79 (mild renal impairment), between 30 and 49 (moderate renal impairment), or \<30 (severe renal impairment), or must require dialysis ≤3 times a week (esrd). * healthy volunteers must be matched to renally impaired subjects for age (± 10 years), gender, and if possible bmi (± 20%). exclusion criteria: * healthy volunteers who have received prescription medication within the 14 days prior to dosing (except for birth control). * renally impaired subjects who have received prescription medication within the 14 days prior to dosing (except for birth control and medications taken at a stable dose for underlying conditions, as determined by the investigator).
evaluation of ultrasound of the heart in patients with low blood pressure

Conditions: Cardiopulmonary Failure

Summary: hypothesis: goal-directed echocardiography by trained critical care physicians is equivalent to that of echocardiography technicians/cardiologists for the purpose of determining etiology (reason) of cardiopulmonary failure.


Eligibility criteria:
inclusion criteria: * patients who present to the medical intensive care unit with cardiopulmonary failure exclusion criteria: * none

Keywords: goal-directed echocardiography cardiopulmonary failure critical care ultrasound
autonomic dysfunction in patients with pectus excavatum.

Conditions: Pectus Excavatum; Autonomic Dysfunction; Surgery

Summary: investigators conducted a pilot study to to evaluate the autonomic function in participants with pectus excavatum before and after nuss surgery.

since pectus excavatum can cause cardiac arrhythmia, the cardiac autonomic function in participants with pectus excavatum might be impaired. however, to our knowledge, there is no any study to evaluate the cardiac autonomic function in participants with pectus excavatum.

Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of pectus excavatum 2. agree to receive nuss surgery to correct pectus excavatum exclusion criteria: 1. major medical disease (asthma, heart failure, renal disease) 2. known psychiatric disease 3. known sleep-disordered breathing 4. skeletal disease 5. major surgery within 6 months

Keywords: pectus excavatum, heart rate variability
a study to compare pk, pd and safety of the ad-214 and ad-2141

Conditions: Gastroesophageal Reflux Disease

Summary: a study to compare safety, pharmacokinetics and pharmacodynamics of ad-214 to ad-2141 in healthy volunteers.

this study is to compare the safety, pharmacokinetic characteristics and pharmacodynamics characteristics of ad-214 compared with administration of ad-2141 in healthy volunteers.

Eligibility criteria:
inclusion criteria: * age 19\~50 years in healthy volunteers * bmi is more than 18.0 kg/m\^2 , no more than 27.0 kg/m\^2 * subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system * subjects who judged ineligible by the investigator
cirrus hd-oct measurement of area of increased light penetration under the retinal pigment epithelium (rpe)

Conditions: Age Related Macular Degeneration; Geographic Atrophy

Summary: the objective of this study is to compare cirrus hd-oct automated measurements of the illumination area under the retinal pigment epithelium (rpe) to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (faf) images.

specific objectives: 1. to compare cirrus hd-oct automated measurements of the illumination area under the rpe to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (faf) images. 2. to describe the differences and similarities between cirrus hd-oct and fundus autofluorescence images of subjects with geographic atrophy secondary to dry age-related macular degeneration (amd). 3. to determine the clinical factors that affect the cirrus hd-oct automated measurements of the illumination area under the rpe.

Eligibility criteria:
inclusion criteria: * males or females 50 years of age and older diagnosed to have advanced dry amd with geographic atrophy. * geographic atrophy lesions should: * not be greater than 5 mm at the widest diameter. the entire lesion(s) should fit into the 6x6 mm scan area of the cirrus hd-oct. * not be smaller than 1.25 mm2. * not be confluent with peri-papillary atrophy. * not be combined with other lesions such as cnvs. * able and willing to make the required study visit. * able and willing to give consent and follow study instructions. exclusion criteria: * history of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye. * evidence of other retinal diseases of the eye, including wet amd, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction upon dilated examination, or upon evaluation of retinal photos. * thick media opacity or inability to fixate that precludes obtaining acceptable scans. * concomitant use of hydrochloroquine and chloroquine. * unable to make the required study visit. * unable to give consent or follow study instructions.

Keywords: age related macular degeneration geographic atrophy imaging oct
stepping stones and creating futures intervention pilot

Conditions: Physical Violence; Sexual Violence; Livelihoods

Summary: this is a shortened interrupted time series pilot evaluation over a twelve month period to evaluate whether the combined stepping stones and creating futures intervention can reduce men's perpetration of ipv and women's experience of ipv, strengthen livelihoods and reduce gender inequality.


Eligibility criteria:
inclusion criteria: * over 18 * mentally competent * able to communicate in english, zulu, or xhosa * normally resident in the informal settlement exclusion criteria: * over 30 * unable to do informed consent
gene therapy for dme

Conditions: Diabetic Macular Edema

Summary: the goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of ft-003 in subjects with diabetic macular edema (dme). the study was divided into two phases, phase 1 dose escalation and phase ii dose expansion.


Eligibility criteria:
inclusion criteria: * subjects that are willing and able to follow study procedures; * female or male patients 18-74 years old at the time of signing the icf; * clinically diagnosed with ci-dme; * the best corrected visual acuity (bcva) of the studied eye is 24-73 letters; exclusion criteria: * presence of any other intraocular diseases other than dme in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.

Keywords: diabetic macular edema ft-003
safety and efficacy of autologous umbilical cord blood mononuclear cells transfusion in neonates

Conditions: Safety Issues; Effect of Drugs; Neonatal Death

Summary: to study the safety and efficacy of autologous umbilical cord blood mononuclear cells transfusion on clinical outcome in preterm infants

this is a phase 1 clinical trial that constitutes two time points cohorts with 100 participants per cohort who will receive intravenous doses of autologous umbilical cord blood mononuclear cells --25 million cells/kg, 48 hours after birth. and the placebo will be 0.9% sodium chloride.the investigator will proceed the groups during the same period. 1. demographic data and baseline characteristics of the studied groups were collected: * gestational age (weeks) * birth weight (g) * gender * cesarean section delivery * antenatal steroids * prolonged rupture of membrane * multiple pregnancies * apgar score at 5 minutes * thrombocytopenia before intervention * crp before intervention (mg/l) * tnf-α(tumor necrosis factor α ) before intervention (pg/ml) 2. assessment of clinical condition in the course by measurement of arterial blood pressure, heart and respiratory rates and skin temperature was recorded continuously 3. autologous cord blood mononuclear cells doses is 25 million cells/kg ，the infusion speed is 4ml/kg/h， 8-12h，and with same volume of 0.9% sodium chloride as placebo. 4. the following are monitored at 3、7、14、21 days after birth: * mortality, incidence of sepsis, neonatal respiratory distress syndrome (nrds), bronchopulmonary dysplasia (bpd), retinopathy of prematurity (rop), necrotising enterocolitis (nec), intraventricular haemorrhage (ivh), hypoxic ischemic encephalopathy (hie), anaemia, thrombocytopenia, neutrophil,tbnk cells subgroup, before hospital discharge. 5. long-term follow up: in 1m, 3m, 6m,1y: neurodevelopment \[bayley scales of infant\], asthma, anemia and physique growth.

Eligibility criteria:
inclusion criteria: * twenty-eight weeks to thirty-seven weeks exclusion criteria: * preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection

Keywords: cord blood mononuclear cells safety effect neonates
laser therapy in adhesive capsulitis

Conditions: Adhesive Capsulitis of Shoulder

Summary: adhesive capsulitis is an idiopathic disease characterized by a decrease in the volume of the glenoid capsule, the development of fibrosis and a progressive decrease in the range of joint movement with pain. shoulder pain and stiffness are accompanied by disability. the purpose of the study is to evaluate and compare the effects of high-intensity laser therapy on pain, disease - related disability and quality of life in patients with shoulder restriction and pain due to adhesive capsulitis.

adhesive capsulitis is an idiopathic disease characterized by a decrease in the volume of the glenoid capsule, the development of fibrosis and a progressive decrease in the range of joint movement with pain. shoulder pain and stiffness are accompanied by disability. it is thought that the incidence is 3% to 5% in the general population and 20% in people with diabetes. although usually reported to be self-limiting in 2 to 3 years, studies have reported that 40% of patients have persistent pain and stiffness for more than 3 years. therefore, various therapies are used to reduce pain and increase the range of motion more rapidly without waiting for spontaneous recovery. adhesive capsulitis treatment includes conservative and surgical treatment options. the options for non-surgical treatments are pharmacological treatments including intra-articular injection and physical therapy modalities. as for physical therapy modalities, various interventions are used. these include heat or ice, therapeutic ultrasound, transcutaneous electrical nerve stimulation and laser therapies. the aim of exercise programs consisting of joint range of motion (rom), strengthening and stretching exercises, proprioceptive neuromuscular facilitation and mobilization techniques is to alleviate pain caused by the capsular contracture and to improve glenohumeral rom. the purpose of the study is to evaluate and compare the effects of high-intensity laser therapy on pain, disease - related disability and quality of life in patients with shoulder restriction and pain due to adhesive capsulitis.

Eligibility criteria:
inclusion criteria: * subjects with adhesive capsulitis diagnosis by physical examination (compared with intact side, there is more than 25% limitation in at least two directions of shoulder range of motion) * subjects have complaints for at least 1 month * no pregnancy / breastfeeding exclusion criteria: * history of bilateral adhesive capsulitis * history of shoulder trauma, fracture, shoulder shoulder surgery, calcific tendinopathy, glenohumeral osteoarthritis, inflammatory rheumatic diseases, tumor, infection * history of corticosteroid injection in the shoulder during the last 3 months * history of recent lung, breast or bypass surgery * history of cervical radiculopathy / brachial plexus lesion * history of neuromuscular disease * history of physical therapy program for the same shoulder in the last 6 months

Keywords: adhesive capsulitis high-intensity laser therapy
mind-body medicine day care clinic in breast cancer patients undergoing endocrine therapy

Conditions: Breast Cancer

Summary: this randomized controlled trial aims to investigate the effectiveness of a mind body day care clinic program of breast cancer patients undergoing endocrine therapy.

breast cancer patients undergoing endocrine therapy are often suffering from side effects. this randomized controlled trial analyzes the effects of an 11-week day care clinic group program including mind body medical elements (yoga, relaxation, meditation, education) and acupuncture in breast cancer patients with menopausal symptoms under endocrine therapy.

Eligibility criteria:
inclusion criteria: * histological diagnosed breast cancer (stage i-iii), no metastases * current endocrine therapy (minimum 3 months) * score of 9 or greater on the menopausal rating scale (mrs) * signed informed consent exclusion criteria: * severe other somatic or psychiatric comorbidity * pregnancy * planned or existing chemotherapy, radiation or other cure treatment * participation in other clinical studies with behaviour-oriented, psychological or compementary medicine intervention.

Keywords: breast cancer meopausal syptoms mind body medecine yoga acupuncture