Kornimate/medical-research-clean huggingface dataset:
tiotropium / respimat one year study in copd.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of the study is to evaluate the long-term (one year) efficacy and safety of tiotropium delivered by the respimat inhaler in patients with copd. specifically, the study will examine the effect of treatment on copd exacerbations.


Eligibility criteria:
inclusion criteria: 1. male or female 2. at least 40 years old 3. smoker or ex-smoker 4. smoking history \> 10 pack-years 5. forced expiratory volume in 1 second (fev1) \< 60% predicted exclusion criteria: 1. recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure 2. history of asthma or allergic conditions. 3. malignancy requiring treatment within past 5 years 4. life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis 5. known active tuberculosis 6. known hypersensitivity to anticholinergic drugs.
ultrasound imaging-based measurement of intra-osseous vascular response

Conditions: Blood Circulation Disorder; Bone Diseases, Metabolic

Summary: blood circulation within bone is thought to have a key role in bone growth, in fracture healing and in the development of bone diseases like osteoporosis. current medical imaging techniques such as conventional ultrasonography fail to detect blood circulation within bone. the investigators propose to develop a new type of ultrasonography called intraosseous functional ultrasonography that will enable the detection and the characterization of blood circulation in solid bone tissue, marrow and soft tissues surrounding bone (muscle for instance). because most soft tissues are essentially made of water, the speed of sound in soft tissues is close to that in water and it varies only a little between different types of soft tissues. for this reason, clinical ultrasound scanners used for ultrasonography assume that the speed of sound in the human body is the same for all types of soft tissues. this assumption is reasonable in soft tissues, but it does not hold in bone because solid bone tissue is much stiffer than soft tissues. seismologists have extensive experience in producing images of the structure of the earth based on the analysis of elastic waves which follow the same laws of physics as ultrasound waves. the subsurface of the earth contains layers of solid materials and liquids, consequently it is very similar to a region of the human body containing bone and soft tissues. therefore the investigators will first work on the adaption of time-tested seismic imaging methods to make ultrasonography of bone possible. once a correct image of bone is obtained, the investigators will use an ultrasound scanner dedicated to research to repeat this image hundreds of times per second, very much like a slow motion video. because blood is moving while bone is still, the intensity in the image is being slightly changed where blood is moving. thus the analysis of these changes makes it possible to detect and characterize blood flow within bone. in this way the investigators expect to be able to detect blood flowing with a speed as low as a few millimeters per second. finally the sensitivity of the technique to detect and characterize blood circulation in bone will be evaluated in patients at the hospital and in healthy volunteers. the success of this work will help gaining knowledge on the role of blood circulation within bone. in the long term, it may help in the diagnosis of bone diseases.


Eligibility criteria:
inclusion criteria: * be 18 years old or older * speaks good french * have an affiliation to a french healthcare system (health insurance) * sign the informed consent exclusion criteria: * bone fracture at the tibia or at the forearm less than one year ago * injury or wound still present at the tibia or at the forearm * pregnant women * protected persons
trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization

Conditions: Epilepsy

Summary: a randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover trial to evaluate the effect of eslicarbazepine acetate on cardiac repolarization in healthy adult men and women

the purpose of this randomized, double-blind, placebo-controlled and open label active-controlled, 4 period crossover study was to evaluate the effect of therapeutic and supra-therapeutic doses of eslicarbazepine acetate on the placebo corrected time-matched change from baseline using individually corrected qt (qtci) interval durations in adult healthy volunteers.

Eligibility criteria:
inclusion criteria: * be a healthy male or female 18 to 45 years of age. women were required to be postmenopausal (more than 12 months since last period); surgically sterile (hysterectomy or tubal ligation at least 6 months prior to enrollment); using an intrauterine device; or double barrier (i.e. diaphragm or spermicide plus male condom) non-hormonal contraceptive therapy for the duration of the trial and were required to have a negative pregnancy test at screening and upon each check-in to the study facility. * have a bmi within the range of 18-30 kg/m2. * be able to communicate effectively with the study personnel. * have no significant disease or abnormal laboratory values as determined by medical history, physical examination or laboratory evaluations, conducted at the screening visit and on each admission to the clinic. * have a normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction. * be nonsmokers defined as not having smoked in the past 6 months. * be adequately informed of the nature and risks of the study and give written informed consent prior to study entry. exclusion criteria: * known hypersensitivity or allergy to moxifloxacin, eslicarbazepine acetate or related compounds such as carbamazepine, oxcarbazepine, or licarbazepine. * women who were pregnant or breast feeding. * any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise the hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or placed the subject at increased risk. * a sustained supine systolic blood pressure \> 140 mmhg or \ 95 mmhg at screening or baseline. * a resting ecg heart rate of \ 100 bpm.
a trial comparing treatment with tiotropium inhalation capsules to combivent inhalation aerosol in copd patients.

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotropium handihaler 18 micrograms (mcg) daily compared to combivent metered dose inhaler (mdi) chlorofluorocarbon inhalation aerosol 2 actuations four times a day in chronic obstructive pulmonary disease (copd) patients currently prescribed combivent® mdi.


Eligibility criteria:
inclusion criteria: diagnosis of chronic obstructive pulmonary disease (copd) age: greater than or equal to 40 years * current or ex-smoker with a \>= 10 pack-year smoking history * use of combivent® metered dose inhaler (mdi)for \>= 1 month prior to visit 1 spirometric criteria (determined at study visits): * post-bronchodilator forced expiratory volume in one second (fev1) \<= 70% (visit 1) * pre-bronchodilator fev1 \<= 65% of predicted and fev1/forced vital capacity (fvc) \<= 70% (visit 2) exclusion criteria: clinical history of asthma * history of thoracotomy with pulmonary resection * history of cystic fibrosis, alpha 1 antitrypsin deficiency or interstitial lung disease * daytime use of oxygen therapy for \> 1 hour per day or if unable to abstain fr om using oxygen during pulmonary function tests * any respiratory tract infection or copd exacerbation in 6 weeks prior to visit 1 * recent history 6 months or less of myocardial infarction * unstable or life-threatening cardiac arrhythmias * hospitalization for congestive heart failure during past year * malignancy for which patient is receiving chemo or radiation therapy * pregnant or nursing women * known hypersensitivity to ipratropium or carrier substances, including related food products such as soybean, peanuts, or lactose * use of spiriva® 3 months prior to visit 1 * symptomatic of prostatic hypertrophy or bladder neck obstruction * known narrow- angle glaucoma * participating in a pulmonary rehab program within 4 weeks of visit 1
energy protector aids for improving the lower back pain, sports and autonomic nerve

Conditions: the Effect of Infrared Rays Devices on Lower Back Pain

Summary: the purpose of this study is to explore the impact of protective gear irradiated by infrared rays intervention on back pain, motor protection and autonomic nerves.

before and after the experimental control study design, each case, using the chinese version of the simple pain scale and autonomic nerve measurement and exercise protection knowledge as a research tool, before and after the test (3 months after using the protective gear), collected lower back pain level: changes in pain intensity and pain effects, and changes in autonomic and motor protection knowledge before and after testing. the research data uses spss for windows 25.0 software package english version for data processing and analysis. the main statistics are independent t test, pair samples t test, chi-square test and odds ratio etc. it is expected that in the future, patients will be able to provide a safe and effective pain care and improve the quality of life, thereby reducing the recurrence rate of back pain and reducing the social cost of medical treatment

Eligibility criteria:
inclusion criteria were: (1) individuals aged 20 to 80 with self-determined lower back pain who scored 3 points or higher on a brief pain scale; and (2) individuals accustomed to using far infrared devices for lower back pain. excluded criteria were: unconscious individuals were excluded.
placebo controlled phase iv study to compare the efficacy and safety of a single dose of oral talcid, a single dose of oral famotidine and a single dose of placebo in patients with acute heartburn episodes

Conditions: Heartburn

Summary: the purpose of this study is to compare the efficacy and safety of a single oral administration of 1000 mg talcid® (study medication), a single oral administration of 10 mg famotidine and a single oral administration of placebo (comparator without an active substance) in treating the symptoms of acute heartburn episodes. the study is designed to collect more efficacy data on talcid® in patients using self-medication to relief the symptoms of acute heartburn.


Eligibility criteria:
inclusion criteria: * male or female between the age of 18 to 65 years * a minimum of 6 months history of heartburn * history of relief of heartburn episodes after self-medication (otc use) within at least 2 hours * occurrence of heartburn episodes at least twice a week during the previous two months * severity of heartburn episodes at least 5 on an 11-category heartburn severity scale exclusion criteria: * history of 'alarming symptoms' e.g. weight loss, vomiting, dysphagia, anemia, hematemesis or melaena * history of gastric ulcer or gastroesophageal reflux disease requiring regular or intermittent therapy with h2-antagonists or proton pump inhibitors within the previous year * history of significant gastrointestinal hemorrhage or gastrointestinal surgery * gastrointestinal odynophagia (pain during swallowing) * history or concurrent known duodenitis, pyloric dysfunction with alkaline reflux, motility disturbances, heliobacter pylori gastritis, or cholelithiasis * pregnant or lactating women, or sexually active women of child-bearing potential unless using effective contraception

Keywords: acute heartburn episodes
raltegravir one thousand two hundred vs darunavir-cb in immnunosupressed patients: rotdip study

Conditions: HIV Infections

Summary: multicenter, randomized, open label pilot clinical trial with two parallel arms aimed to compare the efficacy of raltegravir (ral) 1200mg qd vs darunavir/cobicistat (drv-cb) 800-150mg qd both in combination with alafenamide/emtricitabine (taf/ftc) in patients with human inmunodefficiency virus (hiv) infection and cd4\<200 cells/microl

the trial consists of two parallel arms to study the therapeutic success of 48 weeks, tolerability, immunological recovery, persistence of treatment, safety and results reported by the subject in severely immunocompromised hiv infected patients (with an initial cd4 count \<200 cells/μl) naive to antiretroviral therapy. included subjects will be randomized two to one (2:1) to ral 1200mg qd plus ftc/taf or drv/cb (800-150mg) plus ftc/taf.

Eligibility criteria:
inclusion criteria: * subjects ≥ 18 years of age. * hiv-1 infection. * naive to antiretroviral treatment. * cd4 count at the beginning of the study \<200 cells/μl. * estimated glomerular filtration ≥ 50 ml / min, according to the formula ckd-epi. * grant informed consent in writing to participate in the study exclusion criteria: * breastfeeding, pregnant or women in childbearing age who do not commit to maintain barrier contraceptive measures during the trial. * concomitant use of any drug with possible pharmacological interaction with the study drugs that it is advisable to "avoid" through the database for interactions at the university of liverpool (www.hiv-druginteractions.org). * previous use of any antiretroviral for hiv infection. * resistance to the study drugs, or presence of any contraindication to use it. the inclusion in the study can be carried out before receiving the result of the resistance test. once it is received, in case of presenting any mutation of resistance to drugs of the indicated regimen, the patient will be removed from the study and will be offered the best available treatment for their medical condition at that time. * therapies that include interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressants at the entrance to the study. * current consumption of alcohol or other substances that at the discretion of the investigator may interfere with subject's treatment compliance. * subjects who currently participate in any other clinical trial using a research product, with the exception of studies in which the treatment studied has been stopped for more than 12 weeks. * aids event in diagnosis of hiv infection or in the 3 months prior to the inclusion of the study. * suspected severe hepatopathy (grades b or c of the child-pugh classification), of any origin, according to the clinician. * any other clinical condition or previous treatment that, in the investigator's judgment, makes the subject unsuitable for the study or unable to comply with the dosage requirements.
early detection of neuropathy in attrv

Conditions: Hereditary Amyloidosis, Transthyretin-Related

Summary: the purpose of the study is to evaluate and compare different tools that are used to detect evidence of peripheral neuropathy in patients with ttrv.

early detection of peripheral neuropathy in patients with ttrv is important to support initiation of therapy that alters the course of the disease. current tools used to detect peripheral neuropathy may not be sensitive, especially in very early and distal peripheral neuropathy. this study will compare different methods of assessing for peripheral neuropathy including using in-vivo reflectance confocal microscopy to assess for meissner corpuscles, serum neurofilament light chain, quantitative sensory testing, neuropathy impairement scores, nerve conduction studies and quality of life and symptoms questionnaires.

Eligibility criteria:
inclusion criteria: patients with known ttr mutations and neuropathy 1. patients with ttr mutation and no symptoms within less than 10 years of typical onset of disease 2. age criteria must meet the following: * non v122i mutations, age 40 or older. * v122 i mutations, 55 or older. healthy persons without neuropathy 1. the following distribution of age ranges will be considered when enrolling healthy participants: * 5 patients age 30-40 * 5 patients age 40-50 * 5 patients age 50-60 * 5 patients age 60-70 2. healthy control subjects for this study are defined as subjects with no symptoms of neuropathy or risk factors for neuropathy such as family history of hereditary neuropathy, chemotherapy, diabetes, autoimmune disease, or vitamin deficiency. their status will be verified by medical records review. exclusion criteria: 1. patients with neuropathy other than ttr amyloid 2. subjects with risk factors for neuropathy (diabetes, history of neuropathy in the family, neurotoxic drugs) or with neurological disorder associated with elevated nfl

Keywords: transthryretin hereditary transthyretin amyloidosis ttrv familial amyloid polyneuropathy
azd2014 and fulvestrant in patients with er+ advanced metastatic breast cancer

Conditions: Advanced Metastatic Breast Cancer

Summary: the purpose of this study is to assess safety and tolerability of azd2014 when given in combination with fulvestrant

a phase i, open-label, multicentre, study to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of azd2014 administered orally in combination with intramuscular (im) fulvestrant to patients with estrogen receptor positive (er+) advanced, metastatic breast cancer.

Eligibility criteria:
inclusion criteria: * provision of signed and dated written informed consent prior to any study specific procedures, sampling analysis * aged at least 18 * at least one lesion (measurable and/or non-measurable) that can be accurately assessed at baseline by computerised tomography (ct) magnetic resonance imaging (mri) or plain x-ray and is suitable for repeated assessment * histological or cytological confirmation of an er+ advanced metastatic breast cancer tumour that is eligible for treatment with fulvestrant * eastern cooperative oncology group (ecog) performance status of 0 or 1 * patients must have evidence of non-child-bearing potential. exclusion criteria: * prior chemotherapy, biological therapy, radiation therapy, androgens, thalidomide, immunotherapy, other anticancer agents, and any investigational agents within 14 days of starting study treatment (not including palliative radiotherapy at focal sites) * major surgery within 4 weeks prior to entry to the study (excluding placement of vascular access), or minor surgery within 2 weeks of entry into the study. * patients with severe cardiac condition of ischemia, impaired ventricular function and arrhythmias, evidence of severe or uncontrolled systemic or current unstable or uncompensated respiratory or cardiac conditions. * patients with diabetes type 1 or uncontrolled type ii (hba1c \> 8% assessed locally)

Keywords: estrogen receptor positive advanced metastatic breast cancer estrogen receptor positive advanced metastatic breast cancer
a study of safety and efficacy of btd-001 in treatment of patients with idiopathic hypersomnia (ih) or narcolepsy type 2

Conditions: Idiopathic Hypersomnia; Narcolepsy Without Cataplexy

Summary: this is a randomized, placebo-controlled, double-blind, multiple cohort, fixed-dose multiple crossover, dose-finding study of oral btd-001 in adult patients with ih or narcolepsy without cataplexy (type 2).


Eligibility criteria:
inclusion criteria: * meets icsd-3 criteria for ih or narcolepsy type 2 and not undergoing pharmacologic treatment for the condition * usual nightly total sleep at least 6 hours as single major rest period without naps * epworth sleepiness scale of 10 or greater * males or females age 18 to 65 years exclusion criteria: * any disorder causing hypersomnia other than ih or narcolepsy type 2 * usual bedtime later than midnight * seizure disorder or history of syncope, unexplained loss of consciousness or seizure in the past 3 years * beck depression inventory score greater than 19 * beck anxiety inventory score greater than 15 * significant history of or current suicidal ideation or behavior * bmi less than 18 kg/m2 or greater than 39 kg/m2 * positive toxicology screen or breathalyzer test * clinically significant abnormal findings on safety assessments * any significant medical or psychiatric disease or any condition that would put the patient at risk by participating in the study
clinical evaluation of the effect of duodenal-jejunal bypass on type 2 diabetes

Conditions: Type II Diabetes

Summary: the aim of this study and the primary outcome is to clinically evaluate effect of laparoscopic duodenal-jejunal bypass on non-obese type 2 diabetes. secondary outcomes will evaluate cck, ffa, cholesterol ghrelin, c-peptide, and hba1c levels. patients will be followed closely to ensure the desired results are sustained in long term


Eligibility criteria:
inclusion criteria: * adults age 20-65 years * clinical diagnosis of type ii diabetes buy on of the following three criteria (american diabetes association) 1. a normal or high c-peptide level (to exclude type 1 diabetes) (\>.9ng/ml) 2. a random plasma glucose of 200mg/dl or more with typical symptom of diabetes 3. a fasting plasma glucose of 126mg/dl or more on more than one occasion * bmi 22-34 kg/m2 * patients on oral hypoglycemic medications or insulin to control t2dm * inadequate control of diabetes as defined as hba1c\>7.5 * no contraindication for surgery or general anesthesia as determined by multidisciplinary surgical team * ability to understand and describe the mechanism of action of ricks and benefits of the operation exclusion criteria: * patients who meet any of the following exclusion criteria will be exclusion criteria will be excluded from enrollment into the study * enrolled in another clinical study which involves and investigational drug * diagnosis type 1 diabetes * pregnancy (all female patients will have beta hcg) or planned pregnancy within 2 years of entry into the study or unwilling to use reliable contraceptive method * previous gastric or esophageal surgery * immunosuppressive drugs including corticosteroids * coagulopathy (inr\>1.5 or platelets\<50,000/ul) * anemia (hgb\<10.0g/dl)
preoperative and intraoperative factors related to the development of ptosis after retinal surgery

Conditions: Development of Ptosis After Vitreo-retinal Surgery

Summary: the purpose of this study to is to determine the incidence of post-operative ptosis in patients undergoing vitreoretinal surgery. an additional purpose is to identify pre-operative and intra-operative factors which correlate to the development of post-operative ptosis in vitreoretinal surgery cases.

this study will evaluate patients who will undergo vitreoretinal surgery at ucsf medical center and san francisco general hospital. after informed consent has been obtained, the measurement of eyelid parameters such as levator function, palpebral fissure height, upper eyelid crease height, mrd1 and mrd2 will be collected at pre-operative and post-operative follow up visits. external eye photographs taken at each visit will be evaluated by a masked reader who will calculate the eyelid parameters. dermographic data and intraoperative factors such as operative time and type of procedure will be collected. for statistical analysis, repeated anova, paired t-test, wilcoxon signed rank test, chi-square test and pearson's correlation analysis will be calculated with spss software.

Eligibility criteria:
inclusion criteria: * patients who have vitreoretinal surgery from january 2013 exclusion criteria: * minors, younger than age 18. * patients who have pre-existing ptosis at baseline in the operative eye. * patients who are not able to cooperate with eyelid ptosis measurements

Keywords: ptosis retina surgery droopy eye lid