Kornimate/medical-research-clean huggingface dataset:
fractional flow reserve in cardiovascular diseases

Conditions: Coronary Artery Disease; Acute Coronary Syndrome

Summary: the florida (fractional flow reserve in cardiovascular diseases) study sought to investigate outcomes of ffr-guided versus angiography-guided treatment strategies in a large, real-world cohort.

the objective of the florida study was to investigate mortality outcomes of ffr-guided versus angiography-guided treatment strategies in a large, real-world patient cohort, including patients with different stages of coronary artery disease as well as patients with acute coronary syndrome (acs). all patients were followed for a period of 3 years after the index date. the analysis period extended from the individual index date to the date of death or the end of the 3-year follow-up period. patients were matched for sex, presence of acute coronary syndrome, age ± 5 years, and propensity scores estimated with logistic regression based on 72 variables , with each ffr patient matched to the closest angiography-only patient

Eligibility criteria:
inclusion criteria: * at least one inpatient coronary angiography for suspected coronary artery disease between january 2014 and december 2015. exclusion criteria: * loss to follow-up of other reasons than death (i.e. change of insurance)
buprenorphine/naloxone micro-dosing for postoperative pain management in opioid-tolerant patients

Conditions: Post-operative Pain

Summary: a randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.


Eligibility criteria:
inclusion criteria: 1. opioid tolerance, defined as the daily use of greater than or equal to 60mg of oral morphine or an equianalgesic dose of any other opioid for more than 7 days immediately prior to the surgery 2. undergoing orthopedic or general surgery 3. 18 years of age or older 4. willing and able to adhere to the study protocol and follow-up schedule 5. able to provide written informed consent to participate in the clinical trial 6. if female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study exclusion criteria: 1. buprenorphine or buprenorphine/naloxone use in the last two weeks 2. patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia 3. patients receiving postoperative ketamine or lidocaine boluses or infusions 4. patients receiving postoperative nonsteroidal anti-inflammatory drugs (nsaids) for pain control 5. diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment 6. liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function 7. anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx 8. positive pregnancy test for women of childbearing potential 9. known allergy or sensitivity to bup/nx 10. anticipation that the subject may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion 11. current participation in additional pharmacologic research study 12. active suicidal ideation as determined by pi or study clinician

Keywords: pain pain management
the effect of transauricular electrical vagal nerve stimulation on temporal summation of pain in patients with back pain

Conditions: Pain Intensity

Summary: the effect of transauricular electrical vagal nerve stimulation (tavns) will be studied on temporal summation of heat pain (tsp) in 30 patients with chronic low-back pain and in 30 heathy volunteers. participants will receive either tavns or sham stimulation before and during tsp induction in a randomized crossover manner. the participants will be unaware regarding the type of intervention.


Eligibility criteria:
inclusion criteria: * patients with chronic low-back pain * age 30-60 yrs old * without heart disease * low-back pain intensity at least 4 out of 10 points measured using nrs-10 * without cognitive deficits (mini mental state shake \< 23) exclusion criteria: * opioid medication * more than 1 low-back surgery * sensory of motor neurological deficits at the level of back pain * spinal stenosis * diabetic polyneuropathy * skin pathology at the site (cymba conchae) of stimulation
impact of omega-3 fatty acid oral therapy on healing of chronic venous leg ulcers in older adults

Conditions: Chronic Venous Leg Ulcers

Summary: the purpose of this study is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil to promote healing of chronic venous leg ulcers (cvlus) by reducing the chronic inflammation at wound sites that prevents healing progression. if this systemic, nutrient intervention is found to alter the microenvironment of cvlus, the science of wound healing and care of patients with cvlus will be vastly improved.

the pathogenesis of cvlu involves high numbers of activated polymorphonuclear leukocytes (pmn) that are associated with persistent inflammation in the wound bed. the proposed research is to test the efficacy of an oral, nutrient intervention containing the bioactive components of fish oil (eicosapentaenoic acid - epa + docosahexaenoic acid - dha) to assuage pmn activity and promote healing. the study plans to include 248 successive eligible adults ≥ 55 years of age with cvlus who continue to receive standard care at two university out-patient wound clinics. participants will be randomized to 2 groups: 12 weeks of daily oral therapy with epa+dha (1.87 g/d of epa + 1.0 g/d of dha) or daily oral therapy with placebo. at 0, 4, 8 and 12 weeks, across the 2 groups, three specific aims will be pursued: aim 1. compare levels of epa+dha-derived lipid mediators, and inflammatory cytokines in blood and cvlu fluid. subaim 1a. compare inflammatory cytokine gene expression by pmns in blood (neutrophils and monocytes). aim 2. compare pmn activation (blood, cvlu fluid), and pmn-derived protease levels (cvlu fluid). aim 3. compare reduction in wound area, controlling for key factors known to affect healing, and determine relationships with lipid mediators, cytokines and pmn activation. subaim 3a. compare frequency of cvlu recurrence and levels of study variables in blood between 2 subgroups within the epa+dha group with healed cvlus (after 3 additional months of epa+dha therapy versus placebo therapy beyond week 12 time point). subaim 3b. compare the symptom of pain at all time points and quality of life at first and last study visits across the 2 groups and 2 subgroups.

Eligibility criteria:
inclusion criteria: women and men ≥ 55 years of age with: * a cvlu between the ankle and knee that has been present for at least 4 weeks, but not longer than 12 months, prescribed compression therapy with 1-4 layer bandaging; * ankle brachial pressure index (abpi) between 0.7 and 1.2; * target wound area of 2-60 cm2 who can * read and understand english or spanish, and * provide consent. exclusion criteria: * fish allergy; * corticosteroids or selective cyclooxygenase (cox)-2 inhibitors (e.g., celebrex); non- steroidal anti-inflammatory drugs (nsaids) \> 2x/week (exception: aspirin 81 mg/day); * autoimmune diseases; * chemotherapy within 6 months of week 0; * diabetes if hba1c \> 12% or ulcer complicated by cellulitis, exposed tendon or bone.

Keywords: leg ulcer, fish oil, wounds
chemo-radiotherapy boost treatment guided by perfusion mri on hypoxic zones in head and neck cancer

Conditions: Squamous Cell Tumors of the Head and Neck

Summary: to assess and localize hypoxic tumor subregions both at baseline and during the second week of radiotherapy. and to hypothesize that an intensified imrt regimen may ensure higher local response rates compared to the standard imrt approach.

a randomized, prospective, phase ii study conducted with the aim of evaluating whether the strategy of overdosing hypoxic sub-regions of the primary tumor is associated with better local control compared to standard chemoradiotherapy for squamous cell carcinomas of the head and neck. to evaluate whether side effects are influenced by the mrt approach. to search for initial (pre-treatment) hypoxic regions during treatment (at the 10th fraction of rt) in terms of volume and location. and finally to determine the prevalence and importance of pre-treatment hypoxic sub-regions and correlate the results with both clinical (primary site and tumor volume) and pathological (vegf, egfr and hif-α expression in the primary tumor) characteristics.

Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of the oropharynx, hypopharynx, or larynx; * ajcc stage iii or iv (ct2-4 n0-3 m0); * specific informed consent. exclusion criteria: * documented allergy to radiological contrast media or inability to receive contrast media due to concomitant pathology (e.g. renal); * inability to receive radiotherapy (e.g. previous radiotherapy in the same region) and/or chemotherapy (inadequate bone marrow and/or liver and/or renal function); * incomplete acquisition of mri images; * performance status 2 or more according to zubrod; * previous invasive neoplasm (except skin cancer), except for neoplasms controlled for at least three years; non-invasive tumors (e.g. carcinoma in situ of the breast) are admitted even if diagnosed and treated in a period less than 3 years prior; patients with simultaneous or bilateral primary tumors are excluded; * alcohol or drug abuse; * legal incapacity or limited legal capacity; * concomitant treatment with investigational drugs or participation in another clinical trial with use of investigational drugs within 30 days prior to screening for the study; * documented hypersensitivity to study drugs or any of their excipients; * pregnancy and/or breastfeeding.
hepatic rfa increases t cell infiltraion and pd-l1 expression in primary colorecatl cancer

Conditions: Colorectal Cancer

Summary: it has been shown that rfa induced systemic tumor antigen-specific t cell responses in human carcinoma. however, there are insufficient studies on the immune modulation of tumor microenviroment (tme) outside of the ablation zone. in order to study how rfa modifies tme in human cancer patients, investigators performed a retrospective study of a unique cohort of patients who suffered from synchronous crclm.

radiofrequency ablation (rfa) is widely used as a local treatment for tumors such as small hepatocellular carcinomas, renal cancer and solitary colorectal cancer liver metastases (crclm). rfa induces localized coagulation necrosis and leads to the release of large amounts of cellular debris in situ, which can serve as a source of tumor antigens to elicit host adaptive immune responses against tumors. several studies on preclinical animal models have shown that localized tumor ablation by rfa can induce systemic t-cell mediated antitumor immunity. antigen-specific t cell immune responses were also observed in patients with hepatic tumors after rfa therapy. however, the rfa-induced immune responses are not sufficient to prevent tumor recurrence. the underlying mechanisms remain obscure. programmed death-ligand 1 (pd-l1), an important immune checkpoint molecule, is often up-regulated on tumor cells and tumor associated myeloid cells. it impairs t cell-mediated immune responses upon engagement with its cognate co-inhibitory receptor pd-1, which is always highly expressed on tumor-infiltrating lymphocytes. pd-l1 expression can be induced by pro-inflammatory cytokines, especially type i interferon (ifn), as an important self-limiting mechanism to prevent rampant autoimmunity. recent studies show that pd-l1 expression on tumor cells is associated with t cell infiltration, suggesting pd-l1 is actively involved in suppressing antitumor immune responses in the tumor microenvironment (tme). whether the pd-l1/pd1 axis is involved in modulating the antitumor t cell immune responses induced by rfa is unclear. the objective of this investigation was to study the rfa-induced immune responses in tumor tissues from cancer patients.

Eligibility criteria:
inclusion criteria: patients with histologically confirmed asynchronous liver metastases received initial hepatic rfa or initial primary tumor resection. exclusion criteria: 1. preoperative ct, rt and other antitumor treatment 2. emergency surgery 3. initial hepatectomy 4. no qualified endoscopic biopsy
identification of asthma phenotypes in severe asthmatics

Conditions: Asthma

Summary: asthma is a heterogenous disease. different patients have different presentations, course of disease and response to treatment. the investigators would like to study our population of more severe asthma and find out about their profile - demographic, clinical and inflammatory.

asthma is a heterogeneous disorder presenting with many phenotypes. most asthmatics have mild to moderate disease. however, 5-20% of asthmatics belong to the "difficult-to-treat" or more severe group and they account for 50-80% of asthma health care costs. in a tertiary hospital like singapore general hospital, most of our asthmatics belong to the more severe group. they have more frequent healthcare visits, hospitalizations, medication use and higher risks of death. there is currently no local data on the phenotypic profile of our patients. asthma phenotypes which have been identified include those related to triggers ( eg. drugs such as aspirin or nsaids, environmental allergen, occupational allergens or irritants, exercise) or clinical physiological phenotypes ( eg. severity-defined, exacerbation-prone, chronic airflow limitation, steroid-resistant, age -of -onset) or inflammatory phenotypes ( eg. eosinophilic, neutrophilic, pauci granulocytic, mixed). with better understanding of their phenotypes, treatment can then be individually tailored to improve their asthma control and reduce future risks. we aim to improve the understanding of this group of asthmatics such that better treatment approaches can be developed in the future. this is not a clinical trial. its purpose is to gather information ranging from demographic data, medical history to responses to simple routine questions, to lung function, inflammation, allergy and blood testing results. the data are analyzed to improve our understanding of the clinical and inflammatory phenotypes ( or profiles) in this group of patients.

Eligibility criteria:
inclusion criteria: 1. difficult-to-treat severe asthma 2. treatment-resistant severe asthma patients who are partially or poorly controlled despite high dose inhaled corticosteroids ( ics) or a high-dose ics and long acting- beta-2- agonist combination ( laba) and frequent or chronic use of systemic corticosteroids or 3. treatment-resistant severe asthma who are well-controlled on the highest level of recommended treatment to maintain control (high dose ics or combination of high-dose ics with other medications such as laba, theophylline, montelukast, systemic corticosteroids, anti-ig e, etc.

Keywords: severe asthma, phenotype, data
dose study in growth hormone deficient adults investigating safety, pharmacokinetics and pharmacodynamics of nnc126-0083

Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency

Summary: this trial is conducted in europe. the aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of nnc126-0083 in growth hormone deficient adults


Eligibility criteria:
inclusion criteria: * ghda subjects as defined in the consensus guidelines for the diagnosis and treatment of adults with gh deficiency ii * fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion * gh replacement therapy for more than 3 months * body mass index (bmi, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive exclusion criteria: * females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods * malignant disease * proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes * heart insufficiency, nyha class greater than 2 * subjects with diabetes with an hba1c above 8.0% * diabetic receiving insulin treatment * stable pituitary replacement therapy for less than 3 months * impaired liver function * impaired kidney function
mbct for dm distress: a pilot qusai-experimental study

Conditions: Diabetes Mellitus, Type 2

Summary: background: diabetes-related distress (drd) is very common among people with type ii diabetes mellitus (dm). drd led to poorer dm control and may led to adverse prognosis. yet, there is no widely accepted or recommended drd treatment. mindfulness was shown to relieve psychological distress in various physical and mental conditions. aim: as a pilot project, we aim to determine if mindfulness-based cognitive therapy (mbct), which is one of the widely used mindfulness program, is feasible and acceptable and may improve drd in our chinese population. method: 20 chinese participants with suboptimally controlled dm and high drd will be recruited to a 8- week mbct group. pre-group and post-group (immediate and 2-month post-group) data including drd score, quality-of life measures will be compared.


Eligibility criteria:
inclusion criteria: * received a clinical diagnosis of type ii dm * aged \>=18 * can provide valid consent * can speak cantonese * can read and write simple chinese * hba1c \>7% * have cdds score \>=3 exclusion criteria: * diagnosed active mental illness * have severe hearing loss * non-chinese * have active suicidal ideation as screened by q9 of phq-9 * unwilling to join at least 6 out of 8 session of mbct * received mindfulness training in the past year or having regular mindfulness practice * received psychotherapy last year * severe physical illness limiting them from coming repeatedly to the group

Keywords: diabetes-related distress mindfulness
retrospective evaluation of perampanel in a french neurology and epileptology department (hospices civil de lyon)

Conditions: Refractory Epilepsy

Summary: perampanel is a non-competitive antagonist of the ampa ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the european medicines agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. the aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy. the investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between may of 2014 and april of 2015. in total, one hundred and ten patients were included (mean age 41 \[sd = 15.2\]). the mean duration of epilepsy was 25 years (sd = 14.4). the mean perampanel dose was 5.7 mg/d (sd = 2.3). the retention rate was 77% at 6 months and 61% at 12 months. after 6 months, the responder rate was 35.5%. eight patients (7.3%) became seizure free. adverse effects were reported in 60 patients (54.5%). most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).


Eligibility criteria:
inclusion criteria: * patients with refractory focal epilepsy * initiation of perampanel between 05/2014 and 04/2015 exclusion criteria: * exact date of initiation of perampanel not defined * patients without follow-up data
growth and development study of alglucosidase alfa

Conditions: Pompe Disease; Glycogen Storage Disease Type II (GSD-II); Acid Maltase Deficiency Disease

Summary: pompe disease (also known as glycogen storage disease type ii) is a rare autosomal recessive metabolic muscle disease caused by the deficiency of acid α glucosidase (gaa), an enzyme that degrades lysosomal glycogen. as opposed to the exclusively cytoplasmic accumulation of glycogen that occurs in other glycogen storage disorders, pompe disease is characterized by organelle bound (lysosomal) and extra-lysosomal accumulation of glycogen in many body tissues, ultimately leading to multisystemic pathology. the overall objective of this study was to evaluate the long-term growth and development of participants with infantile-onset pompe disease with alglucosidase alfa before 1 year of age. participants were to be followed for a 10-year period.


Eligibility criteria:
inclusion criteria: * the participant or participant's legal guardian must have provided signed, informed consent prior to performing any study-related procedures. * the participant must have had a confirmed diagnosis of pompe disease as determined by deficient endogenous gaa activity or gaa mutation analysis. * the participant must be less than (\<) 1 year of age at time of study enrollment (and received alglucosidase alfa treatment before 1 year of age), or the participant must be between 1 year and 24 months of age and must have had initiated alglucosidase alfa treatment prior to turning 1 year of age. exclusion criteria: * the participant was participating in another clinical study using alglucosidase alfa or any investigational therapy.

Keywords: glycogenesis 2
the effect of medical grade honey formulation (l-mesitran) administration on recurrent vulvovaginal candidiasis symptoms

Conditions: Candidiasis, Vulvovaginal; Recurrent Candidiasis of Vagina

Summary: the aim of the study is to investigate the efficacy of fluconazol versus l-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. vaginal swabs will be analyzed after 1, 6 and 12 months. the study ends after 252 included patients completed the study.

the purpose of this study is to investigate the vaginal culture (positive or negative) after the application of a medical grade honey formulation (l-mesitran ®) in relation to the current standard of care (fluconazole) 1 month after starting treatment in patients with rvcc. as a secondary outcome, the effects on symptoms, including redness, irritation, itching, dysuria, dyspareunia and vaginal discharge will be analyzed. in addition, the vaginal culture after 6 months maintenance application and the number of relapses within 12 months will be investigated. moreover, information about side effects, discomfort, and quality of life will be collected and compared. the study ends after 252 included patients completed the study.

Eligibility criteria:
inclusion criteria: * women of at least 18 years old * recurrent vulvovaginal candidiasis (at least 3 episodes of clinical symptoms during the last year) * clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation * capacity to understand, consent, and comply with the trial procedures exclusion criteria: * mixed vaginal infections * pregnancy or the intention to become pregnant during the study period * women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion * known allergies or contra-indications for fluconazole or honey * candida with resistance for fluconazole * women giving breastfeeding

Keywords: l-mesitran fluconazol vaginal swabs medical grade honey antifungal activity