Kornimate/medical-research-clean huggingface dataset:
the effect of enhanced external counter pulsation on left ventricular systolic and diastolic function

Conditions: Ischemic Heart Disease

Summary: enhanced external counter pulsation (eecp) is a procedure performed on patients with ischemic heart disease. the treatment improves physical capacity and relieves angina pectoris. it is suitable for patients with persistent angina pectoris despite and for patients not amendable for coronary revascularization. some studies demonstrate a relationship between diastolic and systolic blood pressure ratio (d/s ratio) and the effect of eecp. the aim of the investigators study is to understand the effect of eecp on left ventricular systolic and diastolic function assessed by trans-thoracic echocardiography (tte). hypothesis: eecp improves left ventricular systolic and diastolic function. there is a relationship between d/s ratio and aortic arterial stiffness eecp improves left ventricular diastolic function standard tte would be performed prior the eecp procedure, which lasts 60 min., and repeated every 15 minutes. moreover the investigators would measure pulse wave velocity, a measure of aortic arterial stiffness, in order to investigate the relationship between the d/s ratio and arterial stiffness. the patients would be recruited among former study patients who have undergone eecp before. 20 patients with the best acoustic conditions would be selected and invited to enroll into the study.


Eligibility criteria:
inclusion criteria: * angina pectoris, ccs-class 2-4 * reversal ischemia * pathological coronary angiogram without the possibility of revascularization * sinus rhythm exclusion criteria: * cancer * dementia * pregnancy * blood pressure \> 180/110 * severe valvular disease * ejection fraction \< 25% * acute coronary syndrome the last 3 months * history of aortic aneurism * pacemaker * diabetes mellitus * cardiac arrythmia that prevents the eecp procedure * bleeding * active venous thrombosis

Keywords: ischemic heart disease
a trial of immunological outcomes of sublingual immunotherapy for house dust mite (d. pteronyssinus) allergy

Conditions: Allergic Rhinitis; Asthma

Summary: allergic diseases represent a major health issue worldwide. mainstay treatment is allergen avoidance and pharmacotherapy for symptom relief. allergen immunotherapy offers the advantages of specific treatment with long lasting efficacy, and can modify the course of disease. however, use of this treatment is restricted by the high risk of adverse events especially in asthmatics. other, better tolerated, routes of allergen administration than the current conventional subcutaneous route (scit) have been investigated including sublingual (slit). however, the immune parameters of slit have not been examined. we propose conducting a randomised, placebo-controlled study of a commercially-available slit for house dust mite (hdm) allergy to investigate induction of relevant t cell regulatory immune mechanisms. the first year will be followed by an optional open label extension period. immunoregulatory cytokine synthesis and t cell phenotype and function (real time pcr and flow cytometry) will be examined. this project will provide important fundamental knowledge on which to base improved and greater application of this potentially curative treatment for allergy. slit has the potential advantage of home administration and suitability for patients with asthma who are currently unable to access many of the allergen desensitising regimens.


Eligibility criteria:
inclusion criteria: * allergic rhinitis and/or * mild stable asthma * house dust mite allergic * positive hdm-specific ige as determined by skin prick test (wheal diameter \>6 mm to d. pteronyssinus) or cap-pharmacia score \> 2 exclusion criteria: * immunodeficiency diseases * severe or uncontrolled asthma * previous immunotherapy with house dust mite (hdm) extract within the last five years or ongoing immunotherapy with hdm or other allergens * continuous oral corticosteroids * subjects on treatment with beta-blockers * pregnant women

Keywords: rhinitis asthma atopy house dust mite immunotherapy slit
randomized clinical trial of sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in non-cirrhotic subjects infected with chronic hepatitis c virus genotype 1 (tnt)

Conditions: Hepatitis C, Chronic

Summary: the purpose of the study is to study the combination of sofosbuvir in combination with daclatasvir or simeprevir for 12 weeks in non-cirrhotic subjects infected with chronic hepatitis c virus (hcv) genotype 1.

in this open-label, single-center, head-to-head non-inferiority trial, treatment-naive or pegylated interferon treatment-experienced patients with gt1 infection were randomized to receive once-daily sof 400 mg plus dcv 60 mg or sim 150 mg for 12 weeks.

Eligibility criteria:
inclusion criteria: genotype 1 hcv infection confirmed a positive test for anti-hcv antibody and detectable serum hcv rna by pcr never taken daas for hcv patients must be able to understand and agree to/comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications no liver cirrhosis liver fibrosis metavir f3 apri \> 1,5 fib4 \> 3,25 exclusion criteria: infection with hcv other than gt-1 or subjects with mixed infections of any genotype liver cirrhosis evidence of decompensated liver subjects infected with hiv-1 hepatitis b virus (hbv) coinfection liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair current or known history of cancer documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy pregnancy or impossibility to use birth control methods by the couple, or breastfeeding regular use of: erythromycin, clarithromycin, rifampicin, rifabutin, telithromycin, itraconazole, ketoconazole, posaconazole, fluconazole, voriconazole, dexamethasone, cisapride, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, st. john's wort (hypericum perforatum), silymarin (silybum marianum) and some antiarrhythmic drugs such as amiodarone
shockwave: disruption for a better fit

Conditions: Peripheral Arterial Disease

Summary: recent clinical trial results demonstrate that ivl can increase lumen area by emitting sonic pressure waves, with less inflation pressure as compared to traditional angioplasty balloon dilation and resulting in minimal trauma to the vessel. therefore, the use of ivl prior to placement of a stent for severely calcified femoral popliteal arteries may be associated with more successful stent implants and better long-term patency, resulting in a decrease in cardiovascular events. the investigator will evaluate the success by defining as lesion stenosis less than 30% and no evidence of major adverse cardiac event including death or any amputation of the index limb within 30 days of the procedure.

the purpose of this study is to evaluate the immediate and long term effectiveness of using intravenous lithotripsy followed by the placement of a supera stent for the treatment of calcified femoral popliteal arteries. the use of ivl and supera stent will be predetermined by the investigator according to inclusion criteria and the need for treatment and stenting combined, will be confirmed through the use of intravascular ultrasound and the investigators judgment for best practice. following enrollment and index procedure, the subject will be followed prospectively for one year.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * treatment for de novo, densely calcified femoral popliteal arteries with 70-100% stenosis as measured by ivus. * lesion lengths up to 140 mm. * planned follow-up within the health clinic. exclusion criteria: * calcified femoral popliteal arteries that show \<70% stenosis by angiography. * calcified femoral popliteal arteries with 100% stenosis in which the lesion cannot be crossed after pre-dilation with a 2-3mm balloon. * unable or unwilling to provide informed consent, including but not limited to cognitive or language barriers (reading or comprehension). * thrombophlebitis or deep venous thrombus, within the previous 30 days. * evidence of end stage renal disease (esrd) or stage 5 chronic kidney disease (ckd). * currently receiving treatment in an investigational device or drug study or anticipate participating in an investigational device or drug study for the duration of this study. * anticipated life expectancy less than 6 months. * lack of phone or email for contact.
intermetatarsal bursitis in patients with rheumatoid arthritis

Conditions: Intermetatarsal Bursitis; Rheumatoid Arthritis

Summary: the aim of the study is to investigate the incidence and clinical implications of intermetatarsal bursitis (imb) in patients with rheumatoid arthritis (ra). the hypothesis is that imb is a cause of pain in patients with ra.

within the recent years more research have focused on imb in patients with rheumatologic disorders. there is emerging evidence that imb is an inflammatory alteration in line with synovitis in patients with ra, and presence of imb have been linked to the early stages of ra, especially due to the focus of the published literature. the clinical implications of the presence of imb for the patients are yet to be understood. limited studies have linked the occurrence of imb to foot impairment, but no studies have been conducted investigating the direct association between forefoot pain and the presence/absence of imb.

Eligibility criteria:
inclusion criteria: * age \> 18 years * forefoot pain and diagnosed with ra (patient group) * diagnosed with an axial arthritis (control group) exclusion criteria: * age \<18 years * open wounds or ongoing infection in the forefoot at the time of examination * persons with a history of significant trauma in the forefoot, e.g. any fracture or previous surgeries in the forefoot * persons who have previously received intermetatarsal treatment (morton's neuroma or imb) in the same foot, e.g. injection within 6 months or operation at any time * exclusion from mri scan only: * persons with contraindications to participate in mri scan * persons with severely impaired renal function (gfr \<30 ml/min)

Keywords: forefoot pain
a phase 1 study to examine the drug-drug interaction of ciprofloxacin, itraconazole, and rifampin on the combination of lumacaftor with ivacaftor in healthy adult subjects

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to examine the drug-drug interaction effects of ciprofloxacin, itraconazole, and rifampin on the pharmacokinetics of lumacaftor in combination with ivacaftor as well as to evaluate the potential effects of lumacaftor in combination with ivacaftor on lung function.


Eligibility criteria:
inclusion criteria: * male and female subjects must be between the ages of 18 and 55 years, inclusive * body mass index (bmi) of 18 to 31 kg/m2, inclusive, and a total body weight \>50 kg. exclusion criteria: * history of any illness that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug(s) to the subject. this may include, but is not limited to, a history of relevant drug or food allergies; history of cardiovascular or central nervous system disease; history or presence of clinically significant pathology; or history of mental disease. * history of febrile illness within 5 days before the first dose. * history of gilbert's syndrome * abnormal renal function as defined at screening * blood donation of approximately 1 pint (500 ml) within 56 days before study drug administration * treatment with an investigational drug within 30 days or 5 half-lives (or as determined by the local requirements, whichever is longer) preceding the first dose of study drug * known hypersensitivity or prior adverse reaction to ciprofloxacin, or any member of the quinolone class of antimicrobial agents (cohort 1 only); itraconazole, or to any of the other azoles (cohort 2 only); rifampin, or to any of the rifamycins (cohort 3 only)
a prospective study of patients with hypoplastic left heart syndrome (hlhs) following stage ii surgical palliation

Conditions: Hypoplastic Left Heart Syndrome

Summary: hypoplastic left heart syndrome (hlhs) is a severe form of congenital heart disease that consists of multiple obstructions to flow through the left heart and aorta, as well as hypoplasia of the left ventricle. most patients require a three-stage surgical protocol starting within days of birth. stage i of this process is the norwood reconstruction (within the first few days of life), stage ii (usually required within 3-8 months) involves creation of a direct connection between the patient's superior vena cava and the pulmonary arterial confluence (bidirectional glenn anastomosis), and the last stage is creation of a fontan circulation (typically within the first 2-4 years). this "single ventricle" approach requires the right ventricle to perform as the only circulatory pump for the entire body. our long-term goal is to develop regenerative strategies to strengthen and augment the right ventricular muscle of the single-ventricle heart following surgical palliation in hlhs patients. to determine the safety and feasibility of a cell-based therapeutic intervention at the stage ii surgery, we aim to document the natural history of post-surgical care in hlhs patients having undergone standard of care with protocol specific follow-up over the course of a 6-month period. this prospective study will document the natural history in patients with hlhs after planned stage ii surgical palliation with a focus on cardiovascular parameters within 6 months following surgery in 10 patients.


Eligibility criteria:
inclusion criteria: * individuals with hlhs having undergone stage i surgical palliation and undergoing planned stage ii palliative glenn surgery. * individuals up to 18 months of age are eligible if written informed consent can be obtained from both parents and/or legal guardians, unless one parent is not reasonably available. exclusion criteria: * severe chronic diseases, extensive extra-cardiac syndromic features, or history of cancer the following complications of congenital heart disease: * any condition requiring urgent, or unplanned procedure within 15 days prior to stage ii surgical repair. * severe pulmonary hypertension (reported in the medical record as \>70% systemic pressure). * other clinical concerns as documented by a site investigator that would predict (more likely to happen than not to happen) a risk of severe complications or very poor outcome during or after stage ii surgical repair.

Keywords: hypoplastic left heart syndrome stage ii palliative surgery glenn procedure congenital heart defect congenital heart disease underdeveloped left ventricle
pivotal study of the inap® in adults with osa

Conditions: Obstructive Sleep Apnea

Summary: a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of inap® sleep therapy system in adults with obstructive sleep apnea (osa)

obstructive sleep apnea (osa) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat osa. to this end, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of inap® sleep therapy system (inap®), a tongue and soft palate retaining intraoral device, in adults with osa.

Eligibility criteria:
inclusion criteria: * patients able to read and sign on the informed consent form and able to comply with study requirements. * body mass index (bmi) \<33 kg/m2 * ahi between 15\~55 * pass a device feasibility test exclusion criteria: * obstructed nasal passages * hypoxemia (spo2 \<80%) * primary insomnia or other suspected sleep disorder other than osa * muscle diseases, e.g. csa * patients with potential complications of sleep apnea that, in the opinion of the investigator, may affect the study interpretation or the health or safety of the patients
observational study of nivolumab in participants in germany with squamous cell carcinoma of the head and neck (scchn) progressing on or after platinum-based therapy

Conditions: Head and Neck Cancer

Summary: this is a german, observational study in adult participants diagnosed with squamous cell carcinoma of the head and neck (scchn) progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab in 1st line (cohort 2) or ≥2nd line (cohort 1) for the first time, and are treated within the market authorization approval. participants are to be enrolled into the study no earlier than the decision to initiate treatment with nivolumab and no later than the first dose of nivolumab treatment.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: - adult participants (at least 18 years of age at time of treatment decision) * diagnosis of squamous cell carcinoma of the head and neck (scchn) and participants are progressing on or after platinum-based therapy, administered for locally advanced, metastatic or recurrent disease (cohort 2: prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting, e.g. radiotherapy) * diagnosis of scchn has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease) * treatment decision to initiate a treatment with nivolumab for the first time for the treatment of scchn (according to the label approved in germany) has already been taken exclusion criteria: * current primary diagnosis of a cancer other than scchn, ie, a cancer other than scchn or cancer of unknown primary (cup-syndrome) that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator) * previously treated with nivolumab and/or ipilimumab, an anti-pd-1, anti-programmed death ligand 1 (anti-pd-l1), anti-pd-l2, anti-ctla-4 antibody, or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways (applicable for any indication) * currently included in an interventional clinical trial for their scchn. participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for overall survival (os) can be enrolled
postoperative pain after bupivacaine supplementation in mandibular fracture surgery

Conditions: Postoperative Pain; Mandible Fracture; Analgesia; Anesthesia, Local

Summary: pain following open reduction of mandibular fractures is the most reported complaint during the first 24 post-operative hours. the goal of this clinical trial is to evaluate the impact of inferior alveolar nerve block with bupivacaine 0,5% in patients with mandibular fractures. the main question it aims to answer are: * does the inferior alveolar nerve block with bupivacaine reduce the intensity of pain after mandibular fracture surgery? * does the inferior alveolar nerve block with bupivacaine decrease the consumption of analgesics during the first 24 postoperative hours? participants with bifocal mandibular fractures will be enrolled in the study (a fracture should be located on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible). each patient will receive either a right or left inferior alveolar nerve block. the patient: * will be asked to estimate the pain score by the numerical rating scale during the first 24 postoperative hours for each fracture. * they will be given rescue analgesia in case of intense pain. the number of uses of rescue analgesia will be noted. researchers will compare a group of fracture that will receive the inferior alveolar nerve block with bupivacaine with a group of fracture that will not receive the inferior alveolar nerve block, to see if regional anesthesia improve postoperative pain management of mandibular fractures.


Eligibility criteria:
inclusion criteria: * patients with bifocal mandibular fractures ( with one fracture on the dentate portion of the right hemi-mandible, and a second fracture located on the dentate portion of the left hemi-mandible ) * proposed for open reduction and internal fixation of their fractures under general anesthesia; * having provided their informed and documented consent on a consent form. exclusion criteria: * pathological mandibular fractures; * history of mandibular fractures; * patients with bone involvement in the facial skeleton other than the two fractures of the mandibular dentate portion; * patients suffering from trigeminal neuralgia; * dental care performed in the month preceding the trauma; * patients who have not undergone surgical treatment with open reduction and internal fixation of their mandibular fractures; * patients on anticoagulants; * porphyrias; * history of malignant hyperthermia; * known allergy to local anesthetics; * pregnancy or breastfeeding; * severe heart failure; * atrioventricular conduction disorders; * uncontrolled epilepsy; * hemostatic disorders; * non-cooperative patients.

Keywords: mandibular fracture, postoperative pain, inferior alveolar nerve block, analgesia
drug discrimination in methadone-maintained humans study 1

Conditions: Drug Dependence

Summary: this study involves giving psychoactive drugs intramuscularly (injected into the muscle of the upper arm or the hip) and/or orally, and measuring the subject's ability to tell the difference between one drug and another, as well as measuring the effects of the drugs on mood, physiology (e.g., heart rate, blood pressure, respiration rate) and behavior. each subject will receive 2-4 of the listed interventions.


Eligibility criteria:
inclusion criteria: 1. must be between the ages of 18-65. 2. participation in the uams substance abuse treatment clinic methadone maintenance program or the catar clinic little rock with maintenance on a stable dose of methadone (+ or - 10 mg) for at least 1 month prior to study entry. 3. subjects would have to be in "good standing" in the methadone maintenance program in order to participate; i.e., compliance with scheduled medication and group therapy session hours. this would be defined as \< 3 missed methadone medications and missed \< 3 group or \<3 individual therapy sessions in the two months prior to study participation 4. subjects must submit a urine sample negative for illicit drugs prior to study entry. 5. subjects must be able to read and understand english. exclusion criteria: exclusion criteria 1. ill health (major cardiovascular, renal, endocrine, hepatic disorder, to be determined by history provided by the prospective subject or laboratory evaluation as outlined below). 2. current diagnosis of other drug or alcohol physical dependence (other than tobacco). 3. history of major psychiatric disorder (psychosis, schizophrenia, bipolar, depression) 4. pregnancy, plans to become pregnant or inadequate birth control. 5. present or recent use of over-the-counter psychoactive drug, prescription psychoactive drug or drug that would have major interaction with drugs to be tested. 6. history of severe reaction to narcan challenge, which may have been given as part of admission into the methadone maintenance program or to reverse overdose. 7. liver function tests greater than 3 times normal, bun and creatinine outside normal range, or thyroid function tests outside normal range. 8. ekg abnormalities including but not limited to: bradycardia (\ 420 msec); wolff-parkinson white syndrome; wide complex tachycardia; 2nd degree, mobitz type ii heart block; 3rd degree heart block; left or right bundle branch block.

Keywords: opioid dependence methadone opioid