Kornimate/medical-research-clean huggingface dataset:
safety and performance of miami innfocus drainage implant (midi arrow) glaucoma drainage implant

Conditions: Primary Open Angle Glaucoma

Summary: to assess the safety and performance of the midi arrow in patients suffering from glaucoma that is inadequately controlled on maximum tolerated medical therapy with intraocular pressure ≥ 18 mm hg and ≤ 40 mm hg

this will be a monocentric, non-randomized, single arm clinical study in which each patient meeting the inclusion criteria and not excluded per the exclusion criteria will be implanted with a midi arrow in the anterior chamber of the eye. patients will be followed for at least 24 months with an expected enrollment period of up to 24 months. safety of the shunt will be evaluated with indirect and direct microscopic evaluation of the implanted and non-implanted eyes pre and post operatively, and at defined follow-up intervals for hypotony, inflammation, infection, migration of the shunt, visual acuity, as well as a number of other defined potential complications. the effectiveness of the shunt will be evaluated by measurement of intraocular pressure at defined intervals.

Eligibility criteria:
inclusion criteria: 1. male or female patient, age 18 to 85 years, inclusive 2. patient has primary open angle glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm hg and less than or equal to 40 mm hg 3. patient must have signed and dated the informed consent form exclusion criteria: 1. unwilling or unable to give informed consent or unable to return for scheduled protocol visits. 2. pregnant or nursing women. 3. no light perception. 4. active iris neovascularization or active proliferative retinopathy. 5. iridocorneal endothelial syndrome. 6. epithelial or fibrous downgrowth. 7. pseudoexfoliative glaucoma 8. aphakia. 9. vitreous in anterior chamber for which a vitrectomy is anticipated. 10. corneal disease 11. acute, chronic or recurrent uveitis. 12. severe posterior blepharitis. 13. unwilling to discontinue contact lens use after surgery. 14. previous ophthalmic surgery, excluding phacoemulsification (cataract) surgery or corneal refractive surgery. 15. prior cataract surgery involving a conjunctival incision 16. need for glaucoma surgery combined with other ocular procedures except for cataract surgery or anticipated need for additional ocular surgery during the investigational period. 17. less than 0.1 (20/200) visual acuity in the non-test eye. 18. infectious conjunctivitis, a narrow-angle glaucoma, endophthalmitis, orbital cellulitis one, infection, severe dry eye, severe myopia, conjunctivitis fine.
low volume colon preparation for ibd

Conditions: Inflammatory Bowel Disease

Summary: comparison of two peg-based bowel cleansing regimens in patients with inflammatory bowel disease.

low-volume preparations are gaining attention for higher acceptability. this study compares efficacy, safety and tolerability of a 2l peg solution plus bisacodil with a 4l peg solution in patients with inflammatory bowel disease-related colitis. this will be a multicenter, randomized, single-blind study. adult outpatients with ibd colitis undergoing colonoscopy will receive either 2l peg plus biscodil or 4l peg. bowel cleansing will be assessed using the ottawa scale and rated as adequate if \<6. patient acceptance, satisfaction, and related symptoms will be also recorded. the study will also focus on the factors affecting quality of preparation in inflammatory bowel disease patients such as disease characteristics and administration regimen

Eligibility criteria:
inclusion criteria: -adult outpatiets with ibd colitis undergoing colonoscopy exclusion criteria: * previous colon resection, ileus, intestinal obstruction, toxic megacolon, severe heart failure (nyha class iii or iv), acute cardiovascular disease, uncontrolled arterial hypertension (systolic pressure \>170 mmhg, diastolic pressure \>100 mmhg), severe liver cirrhosis (child-pugh score c) or renal failure (creatinine clearance\<30 ml/minute), ascites, phenylketonuria, and glucose-6-phosphate dehydrogenase deficiency * pregnant or breastfeeding women were also excluded

Keywords: colon preparation; colonoscopy; inflammatory bowel disease
exercise training improves coronary endothelial dysfunction in diabetes mellitus type 2 and coronary artery disease

Conditions: Type 2 Diabetes Mellitus; Coronary Artery Disease

Summary: patients with type 2 diabetes mellitus suffer from accelerated coronary artery disease. we will assess the effects of exercise training on coronary endothelial function, vascular structure, and inflammation both in serum and skeletal muscle biopsies, as well as expression of diabetes candidate genes.


Eligibility criteria:
inclusion criteria: * written informed consent * preserved left ventricular function (left ventricular ejection fraction ≥ 50%) * a physical work capacity ≥ 50 w * at least one significant coronary stenosis \> 50%, whereas either the left anterior descending (lad) or circumflex artery (rcx) has to be free from disease or stenoses ≤ 25% for the assessment of intracoronary flow measurements exclusion criteria: * diseases further affecting endothelial function * untreated hypertension (systolic blood pressure \> 160 mm hg or a diastolic blood pressure of \> 90 mm hg) * cigarette smoking during the previous six months * ldl-cholesterol \> 4.3 mmol/l * ventricular tachyarrhythmias * chronic obstructive pulmonary disease * severe renal or hepatic dysfunction * valvular heart disease * myocardial infarction within the previous 4 weeks
a trial on contrast-enhanced ultrasound versus conventional ultrasound guided biopsy of liver neoplasms

Conditions: Liver Neoplasms

Summary: the purpose of this study is to estimate the clinical value of contrast-enhanced ultrasound in percutaneous biopsy for liver occupied lesion.

the patients with liver neoplasms who need receive percutaneous biopsy were randomized into contrast-enhanced ultrasound(ceus) group and conventional ultrasound(us) group.the aims include: 1. comparison the diagnostic accuracy rate, specificity and sensitivity between ceus and us group. 2. comparison the diagnostic accuracy rate specificity and sensitivity between smaller(\<3cm) and larger(≥3cm) nodule group. 3. to explore operating strategy of contrast-enhanced ultrasound guided biopsy. 4. to evaluate economic efficiency of contrast-enhanced ultrasound guided biopsy compared with conventional ultrasound guided biopsy.

Eligibility criteria:
inclusion criteria: * patients with liver occupied lesion who cannot be diagnosed by imaging examination or need pathological results exclusion criteria: * severe anemia * plt\<60000/mm3,prothrombin activityprothrombin time activity\<70% * women during menstruation, pregnancy, child birth and baby nursing period * patients with severe mental disorder * cardiopulmonary failure

Keywords: contrast-enhanced ultrasound biopsy
the study of omalizumab (cmab007 and xolair) in healthy subjects to compare the pk, pd and safety

Conditions: Asthma

Summary: a phase 1, randomized, double-blind, parallel group, single-dose study to compare the pharmacokinetics, pharmacodynamics and safety of two formulations of omalizumab (cmab007 and xolair) in healthy subjects.


Eligibility criteria:
inclusion criteria: * healthy subject between the ages of 18 and 45 years. * subject with a body weight of ≥50 kg and ≤ 75kg and a bmi between 19.0\~26.0 kg/m2 (both inclusive). exclusion criteria: * subject has a medical history and/or current presence of disease * subject has undergone surgery within three months before signing the informed consent; * alcoholics or regular drinkers within 3 months before the test, i.e. those who drink more than 14 unites of alcohol per week (14 bottles of 360 ml beer or 630 ml spirits with 40% alcohol), or whose alcohol breath test is positive; * those who have used soft drugs within 3 months prior to signing the informed consent or hard drugs within 1 year prior the trial; those who have positive drug abuse test results; * those who smoke more than 10 cigarettes per day on average in the 6 months before signing the informed consent; or those who have positive nocotine results; * those who have a history of drug or food allergy, or who have special allergy history (asthma, urticaria, etc.); those who have allergic rhinitis, or are known to be allergic to any component of the test drug or latex (contained in the syringe needle cover); * those who drinking too much tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250 ml) every day; * those who have received any drug treatment (including prescription drugs, over-the-counter drugs, biological products, traditional chinese medicine, etc.) and health care products within 4 weeks befor signing the informed consent; * those who have a blood donation over 400 ml within 3 months, or 200 ml within 1 month before signing the informed consent, or plan to donate blood during the trail; * those who accept any biological drugs within 3 months, or anti-ige biological drugs within 12 months before signing the informed consent; * those who plan to donate sperm within 6 months after the administration of the test drug; * participants in other clinical trails within 3 months before signing the informed consent; * any one of hiv antibody, hbsag, hbeag, hbcag, hcv antibody and treponerma pallidum antibody is positive; * the results of medical examination (ecg, x-ray, b-ultrasonic, physical and laboratory examination) are clinical significant abnormalities according to the judgment of the researcher; * anti-nuclear antibody or fecal parasite test is positive; * those who have undergone surgery within 1 months before signing the informed consent, or plan to undergo surgery during the trail period;
mirror medacta shoulder system pivotal trial

Conditions: Arthritis Shoulder; Post-traumatic Arthrosis of Other Joints, Upper Arm

Summary: the purpose of this study is to demonstrate safety and efficacy of the mirror medacta shoulder system in total shoulder arthroplasty.


Eligibility criteria:
inclusion criteria: * age ≥ 18 yr * clinical indication for anatomic primary total shoulder replacement due to osteoarthritis and/or posttraumatic arthritis * willingness and ability to comply with study protocol exclusion criteria: * medical condition or balance impairment that could lead to falls * prior rotator cuff surgery * cuff tear arthropathy/insufficient rotator cuff * insufficient bone quality which may affect the stability of the implant * neuromuscular compromise of shoulder or other disabilities affecting the maximum functional outcomes * weight bearing shoulder due to wheel chair, crutches, rollator at the time of operation * active metastatic or neoplastic disease at the shoulder joint * chemotherapy treatment/radiotherapy within 6 mo before surgery * \>5 mg/day of corticosteroids, excluding inhalers, within 3 years before surgery * pregnancy or plan to become pregnant during study period * inability to understand study or a history of noncompliance with medical advice * alcohol or drug abuse * current enrollment in any clinical research study that might interfere with this study * metal allergies or sensitivity. * previous or current infection at or near the site of implantation. * current distant or systemic infection * patient, whose infomed consent form should be taken in an emergency situation * only for women of childbearing age: a positive pregnancy test (urine / blood)
myovista measurements in patients with atherosclerosis and cad

Conditions: Coronary Artery Disease (CAD); Atherosclerosis

Summary: the myovista system is a novel electrocardiogram technology that provides non-invasive assessment of myocardial abnormalities by analyzing energy changes at the cellular level of the myocardium.

the myovista iecg electrocardiograph is a diagnostic device used to process electrical signals transmitted through electrocardiograph electrodes and to detect ischemia abnormalities based on electrical waveform, patient data, demographics, algorithmic sensitivity and software based informatics. the myovista provides the clinician with a standard ecg conventional waveform, along with an additional report derived from the proprietary informatics exclusive to the myovista. the device holds a lot of promise for early intervention to properly diagnose and treat patients under risk timely and effectively. the myovista captures and amplifies signals from the myocardial tissue. these signals are then processed and compared to an algorithm that looks for certain changes occurring in these processed waveforms. the changes that have been identified occur much sooner than those processed by a traditional electrocardiogram (ecg). these recordings focus on early detection of myocardial abnormalities by non-linear analysis of electrical activity and physiological phenomenon. this novel assessment might be capable of detecting subclinical myocardial dysfunction in a variety of heart diseases. the study would compare myovista results to subclinical measures of atherosclerosis (cac and ct angiography) in 200 subjects at risk for coronary disease. correlations between the myovista reading and the presence of calcified plaque, soft plaque, cta stenosis, will be determined. this study has the potential to confirm myovista as a reliable and sensitive marker of atherosclerosis. findings may provide a strong indication for the value of a myovista test to confirm cad in clinical practice, and for the clinical application of myovista in management of coronary disease and atherosclerosis.

Eligibility criteria:
inclusion criteria: * male or female gender * from (and inclusive of) ages of 18 to 80 years * body mass index (bmi) between 18 and 39.9 (kg/m2) * able to lie (supine) still comfortably on the back for at least 20 minutes exclusion criteria: * known history of cancer, other than non-melanoma skin cancer * known history of heart disease or heart rhythm abnormalities * known history of cardiovascular disease * known history of peripheral artery disease (pad) * known history of claudication * history of amputation or loss of limb(s)
diagnosis and treatment of co-infection with human immunodeficiency virus /latent tuberculosis infection (hiv/tbl)

Conditions: Human Immunodeficiency Virus (HIV); Tuberculosis (TB); Latent Tuberculosis Infection (LTI)

Summary: the purpose of this study is to determine of once identified to the subjects infected with human immunodeficiency virus (positive vih), to diagnose latent tuberculosis, and to treat her with isoniazid for six months, measuring the production of interferon range pre and posttreatment, to evaluate this way the result of the treatment on the immune response

a descriptive analysis of the data will be made. means and standard deviations for continuous data frequencies for categorical data will be performed. wilcoxon test mann-whitney u test chi square will be used for frequency analysis of responders data analysis and statistical software(stata).

Eligibility criteria:
inclusion criteria: * accept to participate. informed consent. * human immunodeficiency virus positive test, documented by western blot * have not received treatment for latent tuberculosis * have not been diagnosed pulmonary tuberculosis (tbp) * normal two chest x-rays, postern-anterior and left lateral. exclusion criteria: * active tuberculosis * previous diagnosis of tuberculosis * antecedent of treatment for active o latent tuberculosis * contact with tb patient harboring multidrug resistance or isoniazid resistant isolates of mycobacterium tuberculosis. * abnormal liver enzyme levels * hemoglobin below 8 gr/dl * allergy or intolerance to isoniazid * peripheral neuropathy * ingestion of drugs interacting with isoniazid

Keywords: latent tuberculosis infection human immunodeficiency virus (hiv) treatment isoniazid
craniosacral therapy in patients with chronic low back pain

Conditions: Low Back Pain; Musculoskeletal Manipulations

Summary: the purpose of the current randomized clinical trial was to analyze the effectiveness of craniosacral therapy on disability, pain intensity, kinesiophobia, quality of life, isometric endurance of trunk flexor muscles, mobility, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid in individuals with chronic low back pain.

objective: to analyze the effects of craniosacral therapy on disability, pain intensity, quality of life, and mobility in patients with chronic low back pain. design: a single blinded randomized controlled trial. setting: clinical setting. subjects: sixty-four patients (42 females) with chronic low back pain. interventions: patients were randomly assigned to an experimental group (craniosacral therapy group) or a control group (classic massage group). main measures: self-reported disability (roland morris disability questionnaire - primary outcome; and oswestry disability index), pain intensity (a 10-point numerical pain rating scale), scale of kinesiophobia (tampa scale of kinesiophobia), isometric endurance of trunk flexor muscles (mcquade test), lumbar mobility in flexion, and oxygen saturation, blood pressure, cardiac index, and biochemical estimation of interstitial fluid.

Eligibility criteria:
inclusion criteria: 1. lbp for/over three months. 2. age between 18 and 65 years. 3. score equal or superior of four points on the roland morris disability questionnaire. 4. not currently receiving physical therapy. exclusion criteria: 1. presence of lumbar stenosis 2. diagnosis of spondylolisthesis 3. diagnosis of fibromyalgia 4. treatment with corticosteroid or oral medication within the past two weeks 5. a history of spinal surgery 6. disease of the central or peripheral nervous system

Keywords: massage craniosacral disability evaluation randomized controlled trial
tutorial of clinical trial registration

Conditions: Behavior; Anxiety

Summary: the present study aimed to determine whether infants disorders of regulation of states are associated with perinatal anxiety, and further to explore the efficacy of the behavioral intervention in enhancing positive interactions between mothers and their infants and thus ameliorating infants' disorders of regulation of states.

the subjects were recruited from the hospitalized pregnant women waiting for delivery from the department of gynecology and obstetrics of the first affiliated hospital of xi'an jiaotong university. a total of 200 perinatal anxiety women were divided to two group(behavioral intervention group and control group) according to mental health assessment. inclusion criteria were applied: 1. mother aged 18-40 years; 2. first-time mother, full-term and singleton pregnancy; 3.the hamilton anxiety scale(hama) score ≥14; 4.birth with no intrapartum complications; and 5. apgar score \> 8 at the first, fifth, and tenth minutes after birth. exclusion criteria were as follows: any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke,atrial fibrillation, peripheral arterial disease, and other severe diseases.preterm infants (\< 37 weeks gestation) and multiple births were excluded from the current analysis. all the subjects completed the infants behavior and regulation of states assessment by the nbas and were followed to 8 weeks postpartum. mother-newborn pairs were randomly divided into nbo intervention group and control group. nbo intervention was performed once a week until 2 months. 2 ml peripheral blood was collected in the pregnant woman before delivery and in the newborns within 3 days postpartum.the serum fraction was removed after centrifugation and stored at -20°c. levels of serum cortisol in mothers and newborns were determined using chemiluminescence analysis (clia) and a radio immunoassay. all sample analyses were performed by the first affiliated hospital of xi'an jiaotong university chemistry laboratory. laboratory personnel were blinded to mother and infant outcomes.

Eligibility criteria:
inclusion criteria: * mother aged 18-40 years; * first-time mother, full-term and singleton pregnancy; * the hamilton anxiety scale(hama) score ≥14; * the birth with no intrapartum complications; * apgar score \> 8 at the first, fifth, and tenth minutes after birth. exclusion criteria: * any mental illness besides anxiety, maternal medical illness, hypertension, advanced liver disease, renal failure, cancer, valvular heart disease, heart failure, stroke, atrial fibrillation, peripheral arterial disease, and other severe diseases; * preterm infants (\< 37 weeks gestation); * multiple births; * infants with congenital anomalies, signs of illness, or high-risk factors.

Keywords: anxiety regulation of states nbo hama
plasma adiponectin concentration, activity and isoforms in newly diagnosed and untreated type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the objective of present study were to compare plasma adiponectin isoform status, their bioactivities newly diagnosed chinese with healthy volunteer.

adiponectin, circulates as trimer, hexamer and high molecular weight form (hmw) in human blood, is a promising biomarker for indication diabetes and cardiovascular disease. both adiponectin complexes concentration and their bioactivities are decreased in pathological state. disulﬁde-bond a oxidoreductase-like protein (dsba-l) is a key regulator for adiponectin biosynthesis and its expression level is down-regulated in obese mice and humans. however, the alteration of circulating adiponectin multimers distribution, their bioactivities and adiponectin regulator, dsba-l level, in newly diagnosed chinese type 2 diabetes patients are unknown. the objective of present study were to compare plasma adiponectin isoform status, their bioactivities and dsba-l concentration in newly diagnosed chinese with healthy volunteer.

Eligibility criteria:
inclusion criteria: * having a diabetic history within 12 months * bmi smaller than 30kg/m2 exclusion criteria: * having any kinds of treatment affecting glucose * pregnant * uncontrolled hypertension, active cardiac disease, or other major liver, kidney disease

Keywords: diabetes mellitus
shock wave therapy in individuals with lateral epicondylitis

Conditions: Lateral Epicondylitis

Summary: a sample of 40 patients poststroke (24 males) was randomly allocated to either eswt experimental (n=18) or conventional physiotherapy control group (n=20). all patients received 5 sessions during the treatment program. the visual analog scale (vas) and taiwan version disabilities of the arm, shoulder, and hand (dash) questionnaire, and dynamometer (maximal grip strength) for each participant were assessed before and after the treatment program.

the participants in the experiment group received 5 consecutive sessions of eswt for 5 minutes. treatment parameters for the shock wave therapy group were set similar to a previous study (devrimsel et al., 2013) 2000 shock waves with 1.6 bar intensity and 16 hz frequency were applied for five sessions using the swiss dolorclast master (ems, nyon, switzerland). the participants in the control group received 5 sessions of conventional physical therapy intervention for 5 minutes. the control group intervention consists of a 1-minute friction massage over the common extensor tendon of the elbow, followed by 3 minutes therapeutic ultrasound with a frequency of 1.5 hz, and a 1-minute ice massage over the common extensor tendon of the elbow. all participants used 10-cm lateral epicondyle bandages in the treatment period, while none of them received analgesic or anti-inflammatory drugs and received exercise programs.

Eligibility criteria:
inclusion criteria: * an inclusion criterion was a confirmed diagnosis of lateral epicondylitis with lateral elbow pain lasting more than 6 months and less than 1 year. exclusion criteria: * participants were excluded from this study if they had cervical radiculopathy, elbow deformity, history of diabetes mellitus, hypo- or hyperthyroidism, history of malignancy, chronic inflammatory diseases, and pregnancy. patients who received corticosteroid injections to the lateral epicondyle within 6 weeks were also excluded.

Keywords: pain function