Kornimate/medical-research-clean huggingface dataset:
placebo-controlled trial of 5-hydroxytryptophan and creatine for ssri or snri augmentation in treatment resistant depression in females

Conditions: Major Depressive Disorder

Summary: the investigators propose to determine if 8 weeks of dietary augmentation with oral 5g creatine monohydrate daily and 100 mg of 5-hydroxytryptophan (5-htp) twice daily reduces hypoxia-related depressive symptoms measured by the 17-item hamilton depression rating scale (ham-d) in women with ssri- or snri-resistant depression, combined with the examination of changes in functional connectivity based on resting-state fmri and changes in brain metabolism inferred from phosphorus-31 magnetic resonance spectroscopy.

serotonin and creatine are processed separately in the brain, and deficits in these brain biochemicals lead to distinct clinical problems. therefore, investigators believe that treatment with a combination therapy, which could correct both deficits, would have a synergistic effect in the treatment of hypoxia-related depression and possibly other forms of treatment-resistant depression. thus, investigators propose to investigate antidepressant efficacy of dietary 5-hydroxytryptophan (5-htp) and creatine, as a means to restore the brain neurotransmitter and metabolic imbalances linked to chronic hypoxia caused by high altitude residence.

Eligibility criteria:
inclusion criteria: * female gender, ages 25-40 years inclusive * current diagnosis of major depressive disorder identified by the scid-i * current ham-d17 score of \> 16 * adequate adherence to any fda approved ssri or snri for at least 8 weeks * right-handed healthy controls inclusion criteria: * female gender, ages 25-40 inclusive * no current or past dsm-5 diagnosis, as determined by clinical and structured interviews exclusion criteria: * any non-mdd and non-anxiety psychiatric diagnosis, as identified by the scid-i * history of or current diagnosis of renal disease, such as chronic renal failure, acute renal failure or end stage renal disease * diabetes type i or ii * current colitis or diverticulitis * history of or current pulmonary disease * history of cardiac disease or qtc \> 500ms * history of fibromyalgia, lupus, eosinophilia-myalgia syndrome, dermatomyositis, polymyositis, rheumatoid arthritis, psoriatic arthritis, mixed connective tissue disease, ankylosing spondylitis, or other related rheumatological condition * history of or current seizure disorder * current serious suicide risk identified by the columbia severity suicide rating scale * current treatment with an antipsychotic, mood stabilizer, or non-ssri antidepressant * positive pregnancy test, pregnancy, failure to use adequate birth control method * previous diagnosis of serotonin syndrome or evidence of serotonin syndrome * use of any excluded drugs or medications including serotonergic drugs or medications (table 2) * pre-existing eosinophilia (absolute eosinophil count \> 500/ul) * contraindications to mri: ferromagnetic implants, implanted devices, claustrophobia
assessment of balance and function after lateral ankle ligament repair

Conditions: Complete Tear, Ankle, Lateral Ligament; Postural Balance; Physical Functional Performance

Summary: approximately 85% of ankle injuries are lateral region injuries.surgical repair of lateral ligaments is indicated if there is more than 20 degrees of varus or more than 15 mm translation, if conservative treatment is ineffective and degree of damage is high and chronic instability has developed.after the surgery in addition to pain and edema control, weight transfer is not performed on the ankle for 6 weeks.therefore, this process may adversely affect the muscle strength and range of motion of the ankle, and lower extremity performance and muscular synergies of balance.although pathological changes caused by ligament damage have been investigated very well in the literature, it is not clear how surgical repair affects these changes. in our study we aim to investigate post-surgical changes. primary aim of the study is to evaluate the balance parameters of individuals who have undergone anterior talofibular ligament and / or calcaneofibular ligament repair, and its secondary purpose is to evaluate lower extremity performance, ankle functionality, pain, range of motion and muscle strength and compare them with healthy individuals. our hypothesis is that the balance, lower extremity performance and functionality, pain, range of motion and muscle strength of patients who have undergone ankle lateral ligament repair are worse than healthy individuals.


Eligibility criteria:
inclusion criteria: * patients who have passed at least 1 year after the operation unilateral arthroscopic atfl repair volunteer to participate in the study exclusion criteria: * any orthopedic conditions, neuromuscular disease, balance disorder, cognitive disorder, history of fracture and surgical operation of the lower extremity

Keywords: lateral ankle ligaments repair postural balance physical functional performance
correlation between haptoglobin phenotypes and infectious and other complications in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: cystic fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. usually severity is determined by the class of cf mutations, but even among patients with the same severity of mutations there is a variation of the severity of cf. haptoglobin has several types (phenotypes), one of them was found to be related to infectious complications. in this study the investigators aim to find a correlation between haptoglobin phenotypes in patients with cf and frequency of infectious complications. to this end the investigators will collect serum from cf patients, and determine their haptoglobin protein phenotype. the investigators will correlate haptoglobin phenotype to retrospectively gathered data on infectious complications.

cystic fibrosis is a genetic disease with variable severity, and a predisposition for lung infection. the severity of the disease is determined by genetic factors (type of mutation), environmental factors (exposure to bacteria) and behavioral (adherence with therapy). even among patients with the same severity of mutations there is a variation of the severity of cf. haptoglobin is a protein responsible for collecting iron from senescent red blood cells. there are two genes of haptoglobin, numbered 1 and 2, and combinations between the two genes create three forms of proteins: 1-1, 1-2, and 2-2. the 1-1 phenotype was found to be associated with a predisposition to infection. in this study the investigators aim to find a correlation between haptoglobin phenotypes in patients with cf and frequency of infectious complications. to this end the investigators will collect serum from cf patients, and determine their haptoglobin protein phenotype by gel- electrophoresis. the investigators will correlate haptoglobin phenotype to retrospectively gathered data on infectious complications. fev1- forced expiratory volume in 1 second.

Eligibility criteria:
inclusion criteria: patients diagnosed with cf according to diagnostic criteria , between the ages of 0 and 50, who are themselves, or their parents or guardians, able to give informed consent. two known severe (class i , ii and iii) mutations exclusion criteria: none

Keywords: cystic fibrosis haptoglobin
double-blinded clinical trial using apatone®b for symptomatic postoperative total joint replacements

Conditions: Edematous; Synovitis; Foreign Body Reaction; Osteolysis

Summary: this research study is being conducted to determine if taking oral (by mouth in pill form) apatone®b (a combination of vitamins c and k3) will reduce chronic joint discomfort and improve function of non-infected symptomatic postoperative total joint replacements.

to perform a prospective, randomized, double-blind clinical trial to determine if oral apatone®b, an amalgam of vitamins c and k3, has a therapeutic efficacy beyond the conservative care customarily used to reduce inflammatory synovitis and to increase the functional capacity of proven non-infected symptomatic postoperative total joint replacements.

Eligibility criteria:
inclusion criteria: * postoperative total joint replacement with osteoarthritis as the underlying pathology * proven non-infected symptomatic total joint arthroplasty (tja) (joint implanted for \>12 months post-op) * age (50 to 85 years of age); based on a 10% trim of the age distribution for summa health system tjas (7/1/08-6/30/2009). exclusion criteria: * an infection of any kind (prior to, or during the study) * rheumatoid arthritis as the underlying pathology * cortisone injection received \<6 months prior to study enrollment * insulin dependent diabetes * diagnosed immunodeficiency * on dialysis or have poor kidney function * anti-coagulant medication (e.g., coumadin or \>100mg of aspirin daily) * anti-seizure medication (e.g., dilantin) * steroidal medication (e.g., prednisone, advair or symbicort) * nsaids (e.g., celebrex or toradol); a 14-day washout period will be allowed * bisphosphonates (e.g., fosamax, actonel, aredia, didronel, boniva or reclast) * hormonal therapy (e.g., estrogen, progesterone or testosterone) * cancer (active or in remission) * planned concurrent vitamins exceeding a standard daily multivitamin or exceeding the recommended daily allowance (rda) for individual vitamins if used alone; a 72 hour wash out period will be allowed * a glucose-6-phosphate dehydrogenase (g6pd) deficiency * pregnant or lactating; females who are in their reproductive years must have a negative serum pregnancy * lactose intolerant * citric acid intolerant

Keywords: total joint arthroplasty synovitis alval (aseptic lymphocyte-dominant vasculitis-associated lesion) osteolysis periprosthetic metallosis
the influence of gender on dual task performance in young healthy adults

Conditions: Cognitive Change; Motor Activity

Summary: dual tasking (dt), or the act of conducting multiple, simultaneous tasks, is wide spread in daily life .in particular, the vast majority of mobility tasks we complete (e.g., standing, walking, stepping, etc.) occur while distracted by another motor and/or cognitive task. a common feature of dt is that performance on one or both tasks is diminished when completed together .understanding the relationship between gender and dual task performance is important because this knowledge could help inform us the development of interventions or training programs that target these differences and improve overall performance. aims: to investigate the gender-related differences in single task performance through motor torque, cognitive tasks and walking speed, and the combined dual-task costs considering both motor and cognitive performance in a sample of young adults

gender differences on dual task performance in young healthy adults. dual task performance refers to the ability of an individual to perform two tasks simultaneously, which can be a challenging cognitive task because the human brain has a limited capacity for attention and processing. when an individual attempts to perform two tasks at once, they must divide their attention and resources between the two tasks, which can lead to decreased performance and increased errors. the study will evaluate motor performance, muscle force production, and average speed through a walking test. sixty non-athlete participants (30 female and 30 male) will be recruited, and ancova will be used for statistical analysis.the participants will perform the following tasks: single mobility tasks (average speed through walking test for 45 seconds), single muscle force production, single cognitive task, dual-task condition: walking test and cognitive task, and dual-task condition: muscle torque test and cognitive task

Eligibility criteria:
inclusion criteria: * age 18-30 * bmi 18-25 * normal knee range of motion at time of test exclusion criteria: * participants had been excluded if they were taking any medications, showed a musculoskeletal injury to the leg, had a cognitive impairment, had a history of surgery, had a cardiovascular condition, or had any other health issue that would have an impact on their physical ability.

Keywords: gender, dual task, cognition, muscle torque, speed
effect of nivolumab vs placebo in patients with acute myocardial infarction: a randomized clinical trial

Conditions: Acute Anterior ST Segment Elevation Myocardial Infarction

Summary: myocardial infarction (mi) is a major contributor to morbidity and mortality in china. the goal of this interventional, randomised controlled clinical trial is to evaluate the effectiveness and safety of a single administration of nivolumab to the patients presenting with an acute anterior st-segmental elevated myocardial infarction. researchers will investigate if nivolumab treatment can effectively and safely reduce infarct size as well as improve cardiac function of the patients with acute myocardial infarction.

the efficacy and safety of nivolumab as compared with placebo in the treatment of acute anterior st segment elevation myocardial infarction are not known. in this phase 1/2, randomized, placebo-controlled, open-label trial, we randomly assigned adults with acute anterior st segment elevation myocardial infarction to receive either nivolumab (5mg/kg for single administration) or placebo. the primary end points were difference in infarct size/lv mass% from baseline to 3 months after nivolumab administration and the incidence of adverse events during 3 months after nivolumab administration. secondary end points included difference in lvef%, lvesv/body surface area, lvedv/body surface area, trponin t and probnp from baseline to 3 months after nivolumab administration.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 80 years; 2. signed informed consent and expected compliance with protocol; 3. acute anterior st segment elevation myocardial infarction; 4. emergency coronary angiography for revascularization of occlusive vessels within 24 hours of chest pain onset; 5. left ventricular ejection fraction is less than 45% (lvef≤45%) as revealed by echo within 72 hours after revascularization. exclusion criteria: 1. cardiogenic shock; 2. cardiac arrest/ventricular fibrillation; 3. history of severe renal failure, glomerular filtration rate (egfr) \< 30ml/min; 4. history of severe infection, hepatobiliary obstruction or malignant tumor; 5. receiving immunosuppressive therapy; 6. women who are pregnant or may become pregnant; 7. there are contraindications to study drugs or magnetic resonance examination; 8. no written informed consent was obtained.

Keywords: nivolumab acute anterior st segment elevation myocardial infarction
study to evaluate the effects of two doses of seladelpar (mbx-8025) in subjects with primary biliary cirrhosis (pbc)

Conditions: Primary Biliary Cirrhosis (PBC)

Summary: the primary objective of this study is to evaluate the effect of seladelpar (mbx-8025) on alkaline phosphatase (ap) levels in participants with primary biliary cirrhosis (pbc).

primary: to evaluate the effect of mbx-8025 on alkaline phosphatase (ap) levels secondary: to evaluate the safety and tolerability of mbx-8025 in subjects with primary biliary cirrhosis (pbc) to evaluate the effects of mbx-8025 on primary biliary cirrhosis (pbc) response criteria to evaluate the effects of mbx-8025 on other markers of liver function, lipids, pruritus and quality of life (qol)

Eligibility criteria:
inclusion criteria: 1. must have given written informed consent (signed and dated) and any authorizations required by local law 2. 18 to 75 years old (inclusive) 3. male or female with a diagnosis of pbc, by at least two of the following criteria: * history of ap above upper limit of normal (uln) for at least six months * positive anti-mitochondrial antibodies (ama) titers (\>1/40 on immunofluorescence or m2 positive by enzyme linked immunosorbent assay (elisa) or positive pbc-specific antinuclear antibodies * documented liver biopsy result consistent with pbc 4. on a stable and recommended dose of udca for the past twelve months 5. ap ≥ 1.67 × uln 6. for females of reproductive potential, use of at least one barrier contraceptive and a second effective birth control method during the study and for at least two weeks after the last dose. for male subjects, use of appropriate contraception (e.g., condoms), so their female partners of reproductive potential do not become pregnant during the study and for at least two weeks after the last dose exclusion criteria: 1. a medical condition, other than pbc, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer on active treatment) 2. aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3 × uln 3. total bilirubin \> 2 × uln 4. auto-immune hepatitis 5. primary sclerosing cholangitis 6. known history of alpha-1-antitrypsin deficiency 7. known history of chronic viral hepatitis 8. creatine kinase above uln 9. serum creatinine above uln 10. for females, pregnancy or breast-feeding 11. use of colchicine, methotrexate, azathioprine, or systemic steroids in the two months preceding screening 12. current use of fibrates, including fenofibrates, or simvastatin 13. use of an experimental treatment for pbc 14. use of experimental or unapproved immunosuppressant 15. any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the investigator

Keywords: pbc
effect of dexmedetomidine on postoperative renal function in infective endocarditis patients undergoing open heart surgery

Conditions: Infective Endocarditis

Summary: acute kidney injury is major complication after open heart surgery. the cause of acute kidney injury following open heart surgery is related to activation of sympathetic nervous system, decrease of renal blood flow, ischemia-reperfusion injury and systemic inflammatory response. infective endocarditis patients undergoing open heart surgery have systemic inflammatory response associated with infective endocarditis. and the inflammatory response can be aggravated by cardiopulmonary bypass. the incidence of acute kidney injury following open heart surgery due to infective endocarditis was 50% in a previous report. and this acute kidney injury was related to the poor outcome and high mortality. thus, the preventive method to protect kidney function will be needed in the patients with infective endocarditis undergoing open heart surgery. dexmedetomidine is a selective α2-agonist and has sedative, analgesic, and cns depressive effect. and several experimental study demonstrated the renal protective effect. intraoperative dexmedetomidine administration can reduce the amount of anesthetics needed and suppress the sympathetic response resulted by surgical stimulation. and dexmedetomidine was reported to reduce the level of serum cortisol, epinephrine and norepinephrine during the operation. thus, these effects of dexmedetomidine can be expected to reduce the incidence of acute kidney injury. therefore, the investigators hypothesized that dexmedetomidine has renal protective effect and this effect might be related to the suppression of inflammatory response. thus, the investigators will evaluate the incidence of acute kidney injury and the incidence of major adverse kidney events (make) after open heart surgery due to infective endocarditis and the level of inflammatory mediators. the primary end point of this study is the incidence of acute kidney injury after open heart surgery due to infective endocarditis. and secondary end point is the incidence of make, the level of cystatin c which is related to the renal function, the level of inflammatory mediator and the postoperative morbidities.


Eligibility criteria:
inclusion criteria: * patients with infective endocarditis * patients who are scheduled to undergo open heart surgery exclusion criteria: * chronic kidney disease * taking high dose steroid (\>10mg/day prednisolone or equivalent) * age under 20 years * cognitive dysfunction * disabling mental change disorder * unable to communicate or speak korean

Keywords: infective endocarditis acute kidney injury dexmedetomidine
treatment of symptomatic bph patients undergoing anticoagulant therapy using the plasmabutton vaporization electrode

Conditions: Benign Prostatic Hyperplasia

Summary: the purpose of this observational study is to evaluate the outcomes of using the plasmabutton electrode in the treatment on benign prostatic hyperplasia (bph) while on anticoagulation medication.


Eligibility criteria:
inclusion criteria: * men with obstructive symptoms due to benign prostatic hyperplasia who are also on anticoagulant regimen. * anticoagulant regiments include: aspirin 81mg, aspirin 325mg, adenosine diphosphate (adp) receptor inhibitors, cilostazol, dabigatran, dipyridamole, or warfarin. the patient will be stable on their dosage regimen for at least 3 months. * maximum flow rate \<15ml/s by uroflowmetry. * international prostate symptom score (ipss)≥10. exclusion criteria: * patients with coagulopathy, inr exceeding 3. * anti-coagulation dose changes within 3 months of surgery. * patients not medically cleared to undergo surgery for medical reasons. * patients with neurogenic bladder (bladder affected due to a neurologic cause). * urethral stricture, obstruction due to stricture. * suspected bladder or prostate cancer. * prostate size greater than 80 cc.

Keywords: benign prostatic hyperplasia transurethral vaporization of prostate