Kornimate/medical-research-clean huggingface dataset:
pain prevention and treatment through the enhancement of the anti-nociceptive component of pain modulation profiles

Conditions: Pain

Summary: to utilize the plasticity of the central pain pathways in order to (i) shift individuals with a pro-nociceptive pain modulation profile towards an anti-nociceptive one, and (ii) assess its relevance in minimizing pain-derived morbidity.

in the project proposed here our main aim is to shift pain modulation towards anti-nociception as a novel approach to pain prevention and treatment. our first hypothesis is that individual's modulation profile, when not anti-nociceptive, can be pharmacologically shifted into being anti-nociceptive. we assert (the first hypothesis) that such shift can be optimized by coupling the drug's mode of action with the individual's pain modulation profile; based on limited available data, it is suggested that less efficient inhibitory pain modulation will be modified best by serotonin-norepinephrine reuptake inhibitors (snris), whereas enhanced facilitatory modulation will be modified best by ca++ channel ligands. pain modulation will be assessed by psychophysical tools, and will include dynamic tests of pain modulation. the conditioned pain modulation (cpm) test protocol will be used for assessing pain inhibition, and the temporal summation (ts) test protocol will be used for assessment of pain facilitation. our second hypothesis is that snris will be most efficacious in shifting individuals into being antinociceptive if these individuals had lower activation of the anterior brain pain network in the cpm test paradigm. in turn, ca++ channel ligands will be most efficacious for individuals showing enhanced activation of the posterior pain network sites in response to the ts test protocol. our third hypothesis is that an anti-nociceptive pain modulation profile protects individuals from acquiring pain. the model we chose for this study is surgery for coronary artery bypass grafting (cabg). individuals scheduled for surgery, who are pain free, will be assigned to 3 arms - (1) duloxetine (dul) (snri), (2) pregabalin (pgb) (ca++ channel ligand) and (3) placebo. drugs will be taken for 48 hours prior to surgery in a double-blind non cross-over parallel design. pain modulation will be assessed before treatment, 2-4 hours prior to surgery and at its end, 6 weeks before surgery. post operative acute and chronic pain will be assessed up to 2 month after surgery.

Eligibility criteria:
inclusion criteria: * otherwise healthy, age 18-75. exclusion criteria: * regular use of analgesia for any purpose, including snris, gabapentins, cox inhibitors. * presence of diagnosed chronic pain disorders, psychiatric disorders, cognitive and /or neurological deficit. * inability to give informed consent, communicate and understand the purpose and instructions of this study. * pregnant or nursing women.

Keywords: endogenous pain modulation coronary artery bypass grafting quantitative sensory testings duloxetine pregabalin preemptive treatment
cochleural alternating acoustic beam therapy (caabt) versus masking intervention for tinnitus

Conditions: Tinnitus, Subjective

Summary: this study is to compare the effectiveness of caabt and masking therapy in the management of subjective tinnitus in adults.half of participants will receive caabt, while the other half will receive masking therapy.

masking intervention was a standard monophone tinnitus masking therapy. it was usually a narrow-band noise matched with tinnitus frequency (tf). caabt was an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli.

Eligibility criteria:
inclusion criteria: * unilateral tinnitus * ages between 18-80 years * tinnitus undergone for more than 6 months * hearing loss of the tinnitus ear not affect communication * the main tinnitus frequency is less than 8 khz * primary tinnitus exclusion criteria: * secondary tinnitus * hyperacusis * patients were accepting any therapy about tinnitus * those who have serious mental illness * patients who can't fit the audiological examination and tinnitus tests * most of the hearing loss in the middle and severe hearing loss of the tinnitus ear * any mri contraindications
multifactorial strategies for the prevention of the risks of ulceration in patients affected by diabetic foot (dare-diafoot)

Conditions: Diabetes Mellitus Foot Ulcer

Summary: this is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2.

this is a no-profit, multicentre, national, clinical trial for the prevention of the complications of the diabetic foot in two populations of patients with diabetes mellitus type-2. a first population has no previous history of foot ulceration, but has a moderate ulcerative risk (grade 2); a second population is affected by diabetic foot, had foot ulcers (grade 3), but these must have been resolved from at least six months. one centre provides thorough biomechanical and functional analyses also based on modern computed tomography in weight-bearing; another centre performs state-of-the-art clinical assessments and metabolic analyses; the third centre performs the latter, together with advanced biological and biochemical analyses. comparisons of all these multi-instrumental measurements between the two populations are performed at baseline and at 12 month follow-up, with multidisciplinary investigative approach. a mix of risk and predisposition factors should emerge combining the three groups of measures, in the two populations, along the two times of data collection.

Eligibility criteria:
inclusion criteria for population 1: * male and female patients aged between 18 and 75 years. * diabetes mellitus type-2 patients with mild to moderate risk of ulceration at the foot (grade 2). inclusion criteria for population 2: * male and female patients aged between 18 and 75 years. * patients with diabetes mellitus type-2 and diabetic foot with an history of ulcerative lesions (grade 3), healed for at least 6 months. exclusion criteria for population 1: * history or evidence of ulcers at the foot * infections in progress, ongoing neoplasms * immunosuppressive therapies, and cortisone-based therapy * pregnancy and lactation * inability to provide informed consent exclusion criteria for population 2: * infections in progress, ongoing neoplasms * immunosuppressive therapies, and cortisone-based therapy * pregnancy and lactation * inability to provide informed consent
loss of control eating following weight loss surgery

Conditions: Loss of Control Eating

Summary: this study will test the effectiveness of two distinct behavioral treatments for loss of control eating following bariatric surgery: 1. behavioral weight loss treatment 2. cognitive behavioral therapy these treatments will be compared to standard-of-care.


Eligibility criteria:
inclusion criteria: * gastric bypass surgery or sleeve gastrectomy patients from yale bariatric/gastrointestinal surgery program * 5-8 months post-bariatric surgery * regular loss of control eating (once weekly during past month) * read english proficiently enough to read patient self-care materials and study assessments * available for duration of treatment plus follow-up period * agree to study procedures exclusion criteria: * current enrollment in a formal exercise program * medical status judged by the surgeon as contraindication (rare instances of need for additional surgery or medical instability) * unable to ambulate * current medications that influence eating/weight * current substance dependence or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment

Keywords: bariatric surgery weight loss surgery behavioral weight loss treatment cognitive behavioral therapy behavioral treatment obesity morbid obesity binge eating binge eating disorder loss of control eating overeating
safety, tolerability, and the body's ability to develop resistance to an investigational vaccine for shingles (v211-007)

Conditions: Shingles

Summary: the purpose of this study is to determine the immunity (the body's protection) against shingles after receiving two doses of an investigational vaccine or placebo (a look alike vaccine with no active ingredients).

the duration of treatment is 12 weeks.

Eligibility criteria:
inclusion criteria: * individuals who are at least 60 years of age with a history of varicella (shingles) * females must have been postmenopausal. exclusion criteria: * subjects who did not previously participate in the main study of this protocol. * subject had shingles since their 6 month follow-up visit in main phase of study.
tdcs for dual-task performance in patients with pd

Conditions: Parkinson Disease

Summary: the purpose of this study is to investigate the optimal stimulation location of transcranial direct current stimulation to improve the dual-task performance in patients with parkinson's disease.

parkinson's disease (pd) is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. it is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. in the early stages of parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. walking performance in a dual-task condition has been used to assess gait automaticity in patients with parkinson's disease. transcranial direct current stimulation (tdcs) is a non-invasive brain stimulation method that can be used to change cortical activity. recently, there has been growing attention on tdcs as an adjunct tool for rehabilitation. several tdcs studies in patients with pd have reported the positive results of tdcs on motor function. however, few studies have reported the therapeutic effect of tdcs on the dual-task performance in pd. in addition, inconsistent results have been reported because tdcs protocol has been applied in various way. therefore, this study aims to investigate an optimized stimulation site of tdcs that could improve the dual-task performance in patients with pd.

Eligibility criteria:
inclusion criteria: * clinically diagnosed as idiopathic parkinson's disease * modified hoehn \& yahr stage 2, 2.5, or 3 exclusion criteria: * history of seizure * metallic implants, such as cardiac pacemaker or an artificial cochlea * patients with inflammation, burns, or wounds in the stimulation area * parkinson's disease dementia; cut-off is \< 7 of korean-montreal cognitive assessment for illiterate patients, \< 13 for those educated for 0.5-3 years, \< 16 for 4-6 years of education, \< 19 for 7-9 years of education, and \< 20 for 10 or more years of education. * severe dyskinesia or severe on-off phenomenon * plan to adjust medication at the time of screening * sensory abnormalities of the lower extremities, other neurological or orthopedic disease affecting lower extremities, or severe cardiovascular diseases * vestibular disease or paroxysmal vertigo * pregnant or lactating patients * other comorbidities that make it difficult to participate in this study

Keywords: parkinson disease transcranial direct current stimulation dual-task performance
movement control exercises with and without specific breathing techniques for the treatment of chronic low back pain

Conditions: Chronic Low-back Pain

Summary: chronic low back pain (clbp) is a leading disability globally. exercise therapies are one of the most commonly prescribed treatment options for clbp. specific breathing techniques have been shown to enhance brain-based pain modulation and autonomic nervous system balance; these changes have been shown to improve clinical effectiveness in terms of pain management and psychological factors compared to general exercise. however, no previous studies have added a specific breathing technique protocol to an evidence-based exercise program for clbp.


Eligibility criteria:
inclusion criteria: * adults aged 18-68-years-old * low back pain lasting more than 3 months (pain sensation more than 3 days per week) * a numerical pain scale of more than 3 * ≥ 2/6 positive low back movement control tests (as described by luomajoki et al.) * roland-morris disability questionnaire score of five or greater * who are physically able to perform movement control tests and provide written informed consent. exclusion criteria: * any history of malignant cancer * neurological disease affecting the central nervous system (ms, dementia) * rheumatic disease (fibromyalgia, ankylosing spondylitis/rheumatoid arthritis) * chronic obstructive pulmonary disease, * spinal surgery in the last 12 months * a cardiac pacemaker * signs and symptoms of nerve root pathology during the clinic visits. * women who become pregnant during the data collection will also be excluded from the study.
how to be safe with alcoholic drinks in diabetes

Conditions: Type 1 Diabetes Mellitus; Hypoglycemia

Summary: the purpose of this study is to show that during and after drinking beer a treatment strategy by insulin bolus and reduction of basal rate reduces the rate of hyperglycaemia without an increase of hypoglycaemic events compared to a treatment strategy according to the standard recommendation without insulin bolus.

participants will get two times a height, weight an gender based amount of beer. one time (standard) there will be no insulin given for the beer. second time (intervention) half of the carbohydrates containing in the beer will be covered with insulin, additionally the basal rate will be set to 50% for 12 hours. all the time, glucose will be monitored by continuous subcutaneous glucose monitoring.

Eligibility criteria:
inclusion criteria: * signed informed consent by participants * signed informed consent by parent or legal guardian of adolescent participants \<18 years of age * age between16-21 years (both including) * \>1 year type 1 diabetes * continuous subcutaneous insulin infusion for at least 3 months * hba1c 7-10 % (both including) * bmi between10-95th percentile for gender and age (both including) for adolescents, \<95th percentile for adults * ability to wear glucose sensor * normal liver enzymes (alanine aminotransferase , aspartate transaminase , gamma-glutamyl-transferase, bilirubin) in age appropriate range by local lab exclusion criteria: * severe hypoglycaemia or diabetic ketoacidosis in the past 6 month * alcohol or drug abuse * psychiatric disorder * unstable other metabolic disease as judged by investigator * intake of glucocorticoids or growth hormone * allergy to adhesive * coeliac disease * women of child-bearing potential who have a positive pregnancy test at screening or plan to become pregnant during the course of the study

Keywords: type 1 diabetes mellitus hypoglycemia continuous subcutaneous insulin infusion alcohol continuous glucose monitoring system nutrition
multi-center imaging genetics studies in china

Conditions: Alzheimer Disease; Schizophrenia; Major Depressive Disorders

Summary: to study the impact of genetic and environmental factors on high-level cognition associated neural circuits among healthy young chinese han subjects.

the investigators plan to collect behavioral assessment and environmental factors data,peripheral blood sample, mri brain images in more than 10,000 healthy young chinese han individuals in order to build the pathway from gene to high-level cognitive phenotypes.

Eligibility criteria:
inclusion criteria: * aged 18-30 * chinese han * right-handed * without history of neuropsychiatric disease * no substance addiction * smoking exclusion criteria: * younger or elder than 18-30 year-old * other ethnics * with history of neuropsychiatric disease * with history of neuropsychiatric disease among first,second and third degree relatives

Keywords: genome-wide association studies environmental factors behavioral assessment pathway analysis
safety and tolerability of an intravenous infusion of acz885 in patients with wet age-related macular degeneration

Conditions: Wet Age-Related Macular Degeneration

Summary: this study evaluates the tolerability and safety of a single intravenous infusion of acz885. it also explores the efficacy of the compound in central macular edema and visual acuity in patients with wet age-related macular edema.


Eligibility criteria:
inclusion criteria: * male or female ≥ 50 years old, with aged related macular degeneration * patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration exclusion criteria: * active intraocular inflammation or ocular infection in the study eye * eye disease that may result in visual loss during the study * chronic therapy with topical, local or systemic corticosteroids. * pregnant or nursing (lactating) women.

Keywords: wet age-related macular degeneration acz885
establishment and preliminary evaluation of digital three level linkage whole process diabetes management system

Conditions: Diabetes Mellitus

Summary: this study used nan'an district of chongqing, china as a pilot project to improve the comprehensive compliance rate of diabetic patients in china, and reduce the physical and economic harm caused by complications.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of type 2 diabetes. 2. aged 18-70; 3. hba1c ≥ 8.0% exclusion criteria: 1. pregnancy; 2. chronic kidney disease (ckd stage 5); 3. senile dementia patients; 4. with malignant tumor; 5. moderate and severe anemia; 6. severe liver dysfunction; 7. hemolytic anemia, aplastic anemia, massive blood loss or transfusion, chronic malaria; 8. in the recent one week, large doses of salicylate, erythropoietin, antiretroviral drugs, ribavirin and other drugs that have an impact on the detection of glycosylated hemoglobin were used

Keywords: diabetes mellitus manage mobile app
an eight-week study of saredutant and escitalopram as combination treatment for major depressive disorder

Conditions: Major Depressive Disorder

Summary: the main purpose of this study is to evaluate the efficacy of saredutant 100mg once daily in combination with escitalopram 10mg once daily compared to saredutant placebo in combination with escitalopram 10mg once daily in patients with major depressive disorder. this study also includes a double-placebo group (saredutant placebo in combination with escitalopram placebo).


Eligibility criteria:
inclusion criteria: * outpatients with recurrent major depressive disorder exclusion criteria: * symptoms of current depressive episode for less than 30 days or more than 2 years * mild depression, as measured by standard clinical research scales * significant suicide risk * lack of sexual activity (including masturbation) * other psychiatric conditions that would obscure the results of the study * history of failure to respond to antidepressant treatment * pregnancy or breast-feeding the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: depression major depressive episode antidepressant
plantar fascia and achilles tendon thickness and flexibility in pes planus

Conditions: Pes Planus

Summary: the aim of this study is to examine the plantar fascia and achilles tendon thickness and flexibility in individuals with pes planus. individuals between the ages of 18-45 who have been diagnosed with pes planus by an orthopedist and healthy individuals with similar demographic characteristics will be included in the study as a control group. demographic information of the individuals will be recorded and clinical evaluations will be made. the foot posture of the individuals participating in the study will be evaluated with the foot posture index, and the degree of flat feet will be evaluated with the navicular drop test. the achilles tendon and plantar fascia thicknesses of the individuals participating in the study will be measured with ultrasound, and the plantar fascia and achilles tendon flexibility will be measured with a myotonometer.


Eligibility criteria:
inclusion criteria: * age 18 to 45 * mini mental state examination (mmse) score of 24 to 30 * diagnosed with pes planus by a physician exclusion criteria: * inability to communicate verbally * use of walking aids * any history of surgery involving the lower extremities * people with severe visual impairment, neurological disorders and/or congestive heart failure.
effect of adjuvant therapy by sorafenib, oxaliplatin and s-1

Conditions: Hepatocellular Carcinoma

Summary: the study is designed to investigate the effect of adjuvant therapy by sorafenib, oxaliplatin and s-1 to prevent the tumor recurrence for hepatocellular carcinoma after liver transplantation


Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma after liver transplantation * major organ (heart, lung and brain) function was normal exclusion criteria: * any active infectious process * the presence of clinically confirmed extrahepatic metastasis * postoperative dysfunction of any organ
preterm infant multicentre growth study

Conditions: Preterm Infant

Summary: the purpose of this study is to improve health professionals understanding of preterm infant growth patterns, and to determine if early growth patterns predict risks of adverse metabolic and cognitive outcomes.

the purpose of this study is: to improve health professionals understanding of preterm infant growth patterns, and to determine if growth patterns (rapid early growth in the first 2 weeks of life, weight less than the 10th percentile at the time of discharge) predict risks of adverse metabolic outcomes (measured as overweight at age 3) once the following variables are controlled for: size at birth (z-score), neonatal morbidities, social determinants of health, and nutritional adequacy in the neonatal intensive care unit (nicu). to assess diagnostic accuracy of 36-week anthropometric weight, length and head circumference \<10th and \<3rd percentiles to predict preterm infant cognitive impairment.

Eligibility criteria:
inclusion criteria: * \< 32 weeks gestational age at birth exclusion criteria: * infants who had congenital anomalies or those who died prior to discharge

Keywords: weight gain head circumference length neurodevelopment overweight
a single dose study investigating the elimination as well as the tolerability of pd 0332334 in healthy subjects as compared to patients with impaired kidney function.

Conditions: Renal Insufficiency; Pharmacokinetics

Summary: 1. to investigate the effect of kidney function on the elimination of a single dose of pd 0332334 from the body. 2. to investigate the safety and tolerability of a single dose of pd 0332334 in patients with impaired kidney function.

additional study purpose details: investigation of the pharmacokinetics, safety, and tolerability of a single dose of pd 0332334 in patients with impaired renal function. on february 23rd 2009, a decision to terminate further development for pd 0332334 was communicated to investigators in this study. the decision to terminate this study was not based on any safety concerns.

Eligibility criteria:
inclusion criteria: healthy volunteers or subjects with kidney impairment exclusion criteria: 1. receiving hemodialysis 2. clinically significant or unstable medical disease other than kidney disease

Keywords: pharmacokinetics of pd 0332334 in subjects with renal insufficiency