Kornimate/medical-research-clean huggingface dataset:
left atrial appendage closure as secondary prevention of atrial fibrillation-related embolic events

Conditions: Non-valvular Atrial Fibrillation; Embolic Stroke

Summary: this clinical study is a prospective, multi-center, non-interventional study designed to investigate the safety and effectiveness of percutaneous laa appendage closure by using lambre™ left atrial appendage occluder system. 579 patients with valvular af complicated with previous af-related embolic events (including ischemic stroke, tia and systemic embolism) were enrolled at about 20 study sites nationwide. the baseline data, operation process and relevant follow-up information of subjects were recorded at 7 months after operation or before discharge and at 1, 3, 6, 12 and 24 months after operation.

study population patients with non-valvular atrial fibrillation and previous af-related embolic events purpose to assess the feasibility and safety of percutaneous laa closure as secondary prevention for patients with non-valvular atrial fibrillation (nvaf) and previous atrial fibrillation (af) related embolic events (including ischemic stroke, transient ischemic attack (tia), and systemic embolism).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, male or female; * patients who are able to understand the purpose of the study, voluntarily participate in and sign the informed consent form (icf), and are willing to complete the follow-up as required by the protocol; * indications for left atrial appendage closure; * patients with non-valvular af complicated with previous af related embolic event and meeting one of the following conditions; 1. has-bled bleeding risk score ≥ 3 points; 2. not suitable for long-term oral anticoagulant therapy; 3. poor compliance with oral anticoagulants; 4. cha2ds2-vasc score ≧ 2 points; exclusion criteria: * valvular af (after moderate to severe mitral stenosis or mechanical valve replacement) * initial af, reversible af with clear cause * presence of adherent thrombus in the left atrium or left ventricular aneurysm thrombus * st elevation myocardial infarction, ≤ 3 months * grade-iv of cardiac function (nyha) * allergy or contraindication to metal nitinol, aspirin, clopidogrel, heparin, and other anticoagulants * pregnant or with plan of pregnancy during the study * participation in another drug or medical device clinical trial or study that has not been completed * experience new stroke or ti within 30 days or major bleeding events within 14 days * contraindication to laa closure or deemed unsuitable for study participation by the investigator * had a definite thromboembolic event

Keywords: af-related embolic events non-valvular atrial fibrillation left atrial appendage closure
unguided sacroiliac injection: effect on refractory buttock pain in patients with spondyloarthropathies

Conditions: Spondylarthropathy

Summary: this study is designed to evaluate the efficacy and safety of guide-free sacroiliac joint (sij) injection in refractory sacroiliac pain due to spondyloarthropathies.

a 20 weeks open-label clinical trial study of 35 patients, with different subtypes of spondyloarthropathies, is conducted in spondyloarthropathy's patients with refractory inflammatory buttock pain (fulfilling inclusion criteria), we performed outpatient guide-free sacroiliac injection of triamcinolone acetonide 40 mg in each joint. patient (pain, stiffness, sleep disturbance) and clinician assessments (sacroiliac tenderness, finger to floor and schober tests ) are recorded at baseline and every 4 weeks until the end of the study. mri scoring of sacroiliac joint is recorded according to the spondyloarthritis research consortium of canada (sparcc) magnetic resonance imaging (mri) index for scoring inflammatory lesions in the sacroiliac joints, at baseline and in the end of the study.

Eligibility criteria:
inclusion criteria: patients had to fulfill the european spondylarthropathy study group criteria for spa. 1. the presence of inflammatory buttock pain for at least 4 months (typical night pain and morning stiffness) despite of receiving nsaids, corticosteroid and dmards (disease modifying anti-rheumatic drugs) such as: methotrexate, sulfasalazin and azathioprine. 2. tenderness over sacroiliac joint: pain over the sacroiliac sulcus with 4-5 kg/cm2 direct pressure. exclusion criteria: 1. spinal infections (such as brucellosis). 2. local infection in the site of injection. 3. sacroiliac ankylosis based on pelvic x-ray (sacroilitis grade iv). 4. patients who had received anti tnf, corticosteroid pulse or an investigational drugs during 4 months before.

Keywords: spodyloarthropathy guide-free sacroiliac injection
a study of effects of canagliflozin as add-on therapy to insulin in the treatment of participants with type 1 diabetes mellitus (t1dm)

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to assess the effects of administration of canagliflozin 100 mg and 300 mg, compared with placebo as an addition to insulin therapy for the treatment of type 1 diabetes mellitus (t1dm).

this is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin therapy for participants with type 1 diabetes mellitus and inadequate glycemic control. approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. about 90 participants (30 per treatment group) will be selected for a substudy with a purpose of a continuous glucose monitoring (cgm) assessment for 7 days at baseline and 7 days at the end of treatment. the total duration of the participation will be about 22 weeks, during which participants will need to return to investigational sites for approximately 9 visits. during the study participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis (dka), as well as on compliance with diet and exercise.

Eligibility criteria:
inclusion criteria: * must have type 1 diabetes mellitus (t1dm) for at least 1 year * must have have inadequate glycemic control (as defined by glycosylated hemoglobin level of \>= 7.0% to \<= 9.0%) on basal plus bolus insulin at screening * must have body mass index 21 to 35 kg/m2 inclusive * must be on a total daily dose of insulin \>= 0.6 iu/kg at screening * must be on a stable insulin regimen for at least 8 weeks prior to screening exclusion criteria: * history of t2dm, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * severe hypoglycemia (defined as an event required assistance from another person, or which resulted in seizure or loss of consciousness) within 6 months prior to study start * diabetic ketoacidosis within 6 months prior to study start * history of hereditary glucose-galactose malabsorption or primary renal glycosuria * an ongoing, inadequately controlled thyroid disorder

Keywords: diabetes mellitus, type 1 canagliflozin continuous glucose monitoring
comparison of salmeterol and fluticasone propionate absorption from salmeterol/fluticasone easyhaler and seretide diskus

Conditions: Asthma

Summary: the purpose of this study is to compare the test product salmeterol/fluticasone easyhaler with the reference product seretide diskus in terms of drug absorbed in the bloodstream.


Eligibility criteria:
inclusion criteria: * healthy males and females aged 18-60 years * normal weight, at least 50 kg exclusion criteria: * evidence of clinically significant cardiovascular, renal, hepatic, haematological, gi, pulmonary, metabolic-endocrine, neurological or psychiatric disease. * any clinically significant abnormal laboratory value or physical finding that may interfere with the interpretation of study results or constitute a health risk for the subject if he/she takes part in the study. * any condition requiring regular concomitant treatment (including vitamins and herbal products) or likely to need any concomitant treatment during the study. * known hypersensitivity to the active substance(s) or the excipient of the drug. * pregnant or lactating females.
itch sensation induced by multiple applications of pruritogens (temporal summation)

Conditions: Histamine; Cowhage

Summary: in this experiment, the investigators would like to design a new itch model based on the temporal summation of pruritic stimuli. the hypothesis behind this study (temporal summation) is that two overlapped applications of pruritogens will result in a higher itch sensation compared with a single application.

chronic itch affects approximately a fifth of the global population and is associated with substantial negative consequences for the affected individuals. furthermore, there is a lack of efficient treatment options for chronic itch. in order to mimic a clinical itch condition as presented in patients, the aim of the project is to investigate a new itch model based on the multiple applications of pruritogens (temporal summation). in particular, the purpose is to evaluate if a single application of cowhage/histamine (non-histaminergic and histaminergic itch, respectively) results in a lower itch sensation compared with two overlapped applications of the pruritogens on the same area.

Eligibility criteria:
inclusion criteria: * healthy men and women * 18-60 years * speak and understand englis exclusion criteria: * pregnancy or lactation * drug addiction defined as any use of cannabis, opioids, or other addictive drugs * previous or current history of neurological (e.g. neuropathy), immunological (e.g. asthma, immune deficiencies, arthritis), musculoskeletal (e.g. muscular pain in the upper extremities,), cardiac disorder, or mental illnesses that may affect the results * lack of ability to cooperate * current use of medications that may affect the trial such as antihistamines, antipsychotics, and pain killers, as well as systemic or topical steroids * skin diseases (e.g. atopic dermatitis, pruritus nodularis, eczema, psoriasis) * moles, scars, or tattoos in the area to be treated or tested. * consumption of alcohol or painkillers 24 hours before the study days and between these * acute or chronic pain * participation in other trials within one week of study entry (four weeks in the case of pharmaceutical trials)
targeted navigation in hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma; Cholangiocarcinoma; Hepatobiliary Cancer

Summary: the investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. the investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. the investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment.


Eligibility criteria:
inclusion criteria: * hcc patients: * enrolled or eligible for enrollment in unified prospective registry and biorepository of patients with chronic liver disease or hepatobiliary cancers including hepatocellular carcinoma (hcc) and cholangiocarcinoma. * diagnosis of hepatocellular carcinoma, confirmed by clinical chart review and international classification of diseases, tenth revision (icd-10) c22.0. * adults, age 18 or older * able to provide informed consent * all other interviewees: * advocates who will self-identify as having had hcc. * others who self-identify as either a caregiver or support person of an hcc patient. physicians/licensed independent practitioners, social workers, nurse navigators, and research coordinators will all self-identify as being involved in the care of hcc patients. exclusion criteria: * unable to speak spanish or english * west haven grade 2 or higher hepatic encephalopathy19 or other cognitive impairment. * adults unable or unwilling to consent * individuals who are not yet adults (infants, children, teenagers) * prisoners * given that this study is minimal risk and there are no risks to a potential fetus, investigators will not exclude pregnant women; however, no data about pregnancy or their fetus is being collected
genital hpv infections before and after renal transplantation

Conditions: Human Papillomavirus Infections

Summary: the purpose of this study is to examine the prevalence, incidence and genotype of anogenital hpv infections in women before and after renal transplantation. with this information the investigators can determine the value of vaccination in patients waiting for renal transplantation in the future.

each year about 800 renal transplantations are performed in the netherlands. the current immunosuppressive strategies have led to a 1-year patient and graft survival of more than 90%. this high survival rate urges medical specialists to pay increasing attention to the long-term side effects of immunosuppressive medication, such as virus-associated cancers. an example of an oncogenic virus is the high risk human papillomavirus (hrhpv) which is related to (pre)malignancies of the anogenital tract e.g. cervix, vulva and anus. these malignancies are among the most common malignancies in renal transplant recipients (rtrs). the incidence of hrhpv-related cervical and vulvar malignancies is increased up to a 100-fold in rtrs compared to the general population. there is limited literature on the exact behaviour of hpv infection related anogenital (pre)malignancies in rtrs. a part of these (pre)malignancies are probably already present at the time of transplantation while others develop in the years after transplantation. with gynaecological examination the investigators can diagnose anogenital (pre)malignancies before transplantation so treatment, if necessary, can commence before transplantation. knowledge about hpv status before and after transplantation gives insight in the natural course of the hpv infection in this group of patients and with this information the investigators can determine the value of vaccination in patients waiting for renal transplantation in the future.

Eligibility criteria:
inclusion criteria: * female sex; * age ≥ 18 years at start of the study; * eligible for renal transplantation; * operation at the radboud university nijmegen medical centre; * signed informed consent; * mentally capable to understand and comprehend the study and its implications; * sufficient knowledge of the dutch language to read, fully understand and complete the questionnaire. exclusion criteria: * patient not willing to sign and/or return the informed consent form; * patient refusing additional treatment in case of abnormal findings at the first visit; * patient being pregnant, or within a period of 3 months after delivery; * patient being within a period of 3 months after miscarriage.

Keywords: human papillomavirus renal transplantation
staging classification of severe tricuspid regurgitation using novel cardiac imaging techniques

Conditions: Tricuspid Regurgitation

Summary: the purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (mri).

40 patients with moderate or more tr on echocardiography will undergo cmr/mre with contrast to assess tr severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

Eligibility criteria:
inclusion criteria: * moderate or more tricuspid regurgitation exclusion criteria: 1. prior tricuspid valve prosthesis 2. pacemaker/defibrillator that would impede mri imaging 3. planned tricuspid valve surgery 4. primary liver pathology
a post market evaluation of chronic intractable pain and the efficacy of drg stimulation in the nordic region

Conditions: Chronic Pain

Summary: 11-smi-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available axium neurostimulator in the management of intractable, chronic pain


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old 2. subject is able and willing to comply with the follow-up schedule and protocol 3. chronic, intractable pain for at least 6 months 4. failed conservative treatments for chronic pain including but not limited to pharmacological therapy, physical therapy and interventional pain procedures for chronic pain 5. minimum baseline pain rating of 60 mm on the vas in the primary region of pain 6. subject is able to provide written informed consent exclusion criteria: 1. female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the study duration 2. escalating or changing pain condition within the past month as evidenced by investigator examination 3. subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days 4. subject has had radiofrequency treatment of an intended target drg within the past 3 months 5. subject currently has an active implantable device including icd, pacemaker, spinal cord stimulator or intrathecal drug pump 6. subject is unable to operate the device 7. subjects currently has an active infection 8. subject has participated in another clinical investigation within 30 days 9. subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation 10. subject has been diagnosed with cancer in the past 2 years.
a first-in-human study of hcr-188 in overweight or obese otherwise healthy volunteers without type 2 diabetes

Conditions: Obesity and Overweight

Summary: this is a first-in-human study evaluating the safety, tolerability, pharmacokinetics, immunogenicity and pharmacodynamics of single and multiple doses of hcr-188 administered as subcutaneous injection(s).

this is a phase 1, randomized, double-blind, placebo-controlled, single ascending dose (sad) and multiple ascending dose (mad) study in overweight or obese volunteers without type 2 diabetes mellitus. up to 5 sad cohorts and up to 5 mad cohorts may be enrolled. multiple dosing regimens are planned to be evaluated in the mad portion of the study. the duration of the study will be approximately 20 weeks per each participant completing the entire study.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 27 to 40 kg/m2, inclusive * except for overweight or obese, otherwise healthy as determined by the investigator * stable body weight, defined as a \< 5 kg change during the 8 weeks prior to screening * females of childbearing potential must agree to use highly effective methods of contraception during the participation in the study * males must be surgically sterile, abstinent, or must agree to use highly effective methods of contraception during participation in the study exclusion criteria: * history of or active cardiovascular (cv) disease * history of active pulmonary diseases * history of immunosuppressive, chemotherapeutic, or radiation treatment within the last 12 months prior to screening * history of malignancy in the past 12 months or active malignancy * history of bariatric surgery or use of gastric balloons * history of diabetes mellitus type 1 or 2 * history of chronic liver disease * pregnant or breastfeeding, or a positive pregnancy test at screening * treatment with medications that may cause significant weight gain or weight loss
rate adaptive atrial pacing in heart failure

Conditions: Chronotropic Incompetence; Heart Failure; ICD

Summary: the adaption trial is an investigator initiated prospective randomized doubleblind cross-over pilot study in a multi-center setting. aim: to assess the ability of minute ventilation (mv) sensor driven rate adaptive atrial stimulation to restore functional capacity and quality of life in heart failure patients with chronotropic incompetence. methods: heart failure patients (left ventricular ejection fraction ≤35% \& new york heart assessment ii or iii) who were implanted with a 2-chamber implantable cardioverter defibrillator (icd) device equipped with a mv sensor that are diagnosed with chronotropic incompetence will be included in the study. patients will be randomized in a 1:1 fashion to rate responsive pacing (mv sensor only) function on (aair mode) or off (ddi mode). after 3 months the pacing mode will be switched to the opposite mode.


Eligibility criteria:
inclusion criteria: 1. chronotropic incompetence as assessed by a modified heart rate score (mhrs) 2. implanted with a boston scientific dual chamber icd equipped with minute ventilation sensor 3. symptomatic congestive heart failure (nyha class ii-iii) 4. left ventricular systolic dysfunction (lvef \<35%) 5. optimal medical therapy 6. sinus rhythm 7. subjects should be able to perform normal daily activities exclusion criteria: 1. age \<18 or incapacitated adult 2. documented atrial fibrillation in the last 3 months prior to inclusion 3. indication for pacing (sss, av conduction abnormalities requiring pacing) 4. respiratory rate abnormalities (hyperventilation) or use of a mechanical ventilator 5. patients who are unable to tolerate increased pacing rates 6. indication for cardiac resynchronization therapy beta-blocker / ivabradine / amiodarone therapy is not an exclusion criterion

Keywords: chronotropic incompetence rate adaptive pacing minute ventilation sensor primary prevention icd therapy implantable cardioverter defibrillator heart failure exercise intolerance
long-term follow up of cln6 batten disease subjects following gene transfer

Conditions: CLN6; Batten Disease

Summary: this is a long-term safety and efficacy study in subjects with cln6 batten disease who previously received a single intrathecal administration of at-gtx-501.

this is a long-term safety and efficacy study in subjects with cln6 batten disease (also know as variant late infantile neuronal ceroid lipofuscinosis associated with mutation(s) in the cln6 gene \[vlincl6\] disease),who previously received a single intrathecal administration of at-gtx-501. the assessments described in this long-term follow-up (ltfu) study (at-gtx-501-02) are performed following and in addition to the initial 2 years of post-treatment assessments in the treatment study (at-gtx-501-01). in this ltfu study, subjects complete safety and efficacy assessments throughout the study's 3-year duration. combining the duration of the initial treatment study and this ltfu study, the overall duration reflects a follow-up period up-to 5 years since gene transfer via at-gtx-501. the primary outcome for this study is to assess the long-term safety of at-gtx-501 in subjects with cln6 batten disease. the secondary outcome measure of this study is to assess the long-term efficacy of at-gtx-501 in subjects with cln6 batten disease.

Eligibility criteria:
inclusion criteria: * subject received at-gtx-501 (scaav9.cb.cln6) in the study "phase i/iia gene transfer clinical trial for variant late infantile neuronal ceroid lipofuscinosis, delivering the cln6 gene by self-complementary aav9." * subject completed or prematurely discontinued from the study "phase i/iia gene transfer clinical trial for variant late infantile neuronal ceroid lipofuscinosis, delivering the cln6 gene by self-complementary aav9." * subject has a legally authorized representative who has provided written informed consent and authorization for use and disclosure of personal health information or research-related health information. exclusion criteria: * none

Keywords: neuronal ceroid lipofuscinosis ncl gene transfer vlincl6