Kornimate/medical-research-clean huggingface dataset:
iatrogenic chronotropic incompetence and exercise tolerance in heart failure

Conditions: Chronic Heart Failure

Summary: patients with chf benefit from heart rate lowering, and the investigators have previously demonstrated that this does not adversely affect exercise tolerance. in a pacemaker population we also have shown that preventing heart rate lowering is detrimental in terms of symptoms and prognosis. the aim of the study is to therefore to establish whether heart rate limitation in patients with heart failure has a negative impact on exercise capacity. if the investigators establish that this is not the case, physicians will be able to confidently prescribe heart rate lowering agents, and programme pacemakers to allow bradycardia without the concern that there will be detrimental effects of symptom.


Eligibility criteria:
inclusion criteria: * able to walk on a treadmill able to provide consent heart failure (or not) depending upon the arm. patients with atrial fibrillation to have had an av node ablation (or very slow response to af) exclusion criteria: * cognitive impairment, known reaction to ivabradine, musculoskeletal issues limiting walking on a treadmill.
voriconazole for chronic bronchopulmonary aspergillosis

Conditions: Aspergillosis

Summary: to evaluate the efficacy of voriconazole (vfend(r)) as first line treatment for proven chronic bronchopulmonary aspergillosis, in minimally immunocompromised or non-immunocompromised patients after 6 months of treatment i.e. chronic necrotizing pulmonary


Eligibility criteria:
inclusion criteria: * patients with a chronic bronchopulmonary aspergillosis assessed by a compatible chest imagery (ct scan) and/or an endoscopic lesion sourced by photo, would it be: * complex aspergilloma non primarily operable, * chronic necrotizing pulmonary aspergillosis, * tracheo-bronchial aspergillosis, obstructive or necrotizing/pseudo-membranous. exclusion criteria: * patient with risk factor(s) of cardiac arrhythmia, symptomatic arrhythmia, treated by medication known to prolong qt interval, or prolongation of qtc interval \> 450 msec in men and \> 470 msec in women. * simple aspergilloma with primary indication of surgical treatment.
central venous saturation (scvo2) monitoring in pediatric patients undergoing cardiac surgery

Conditions: Congenital Heart Defects; Cardiac Surgery

Summary: children (ages 0-12) that have heart surgery are often at a high risk of developing complications and have to be continuously monitored. part of the routine care at ucla includes using a monitor (continuous central venous oxygen saturation-scvo2) to measure the amount of oxygen saturation in the tissues (indirectly) during surgery and in the intensive care unit. however, there is not much data on the use and effectiveness of this monitor in comparison to other monitors used for children. the purpose of this study is to further evaluate the effectiveness of the continuous central venous oxygen saturation (scvo2) monitor in children and compare it with other monitors during a heart surgery. this is an observational study and the patients will not undergo any research specific procedures in the operating room (or). the investigators will observe and record de-identified information, such as vital signs (heart rate, blood pressure, etc.), to evaluate the importance of the monitor. this study will also look at the demographics (age, gender, diagnosis, etc.) and treatments (type of surgery) received children undergoing heart surgery to improve quality of care. the investigators will also observe the same parameters in the icu. the investigators hypothesized that low central venous saturations are associated with worse clinical outcomes.


Eligibility criteria:
inclusion criteria: * pediatric patients (age 0-12 years) scheduled for cardiac surgery and requiring placement of a central venous catheter. exclusion criteria: * patients with contraindications for placement of a central venous catheter will be excluded from this study.
endoleak repair guided by navigation technology

Conditions: Aortic Aneurysm; Endoleak

Summary: the study is aimed at investigating whether repair of endoleak type ii can be improved by adding navigation technology. can this technology increase precision by guiding the needle that punctures through the skin as used during the repair procedure? can the procedure logistics be improved by using navigation technology instead of computed tomography (ct) guidance of the needle puncture? parameters logged during the procedure: * was the needle placement successful? * number of needle punctures? * time used on guidance procedure * x-ray exposure dose


Eligibility criteria:
inclusion criteria: * detected endoleak exclusion criteria: * n/a

Keywords: image guided therapy endovascular procedures angiography vascular surgical procedures
genetic markers of cardiovascular disease in epilepsy

Conditions: Epilepsy; Seizures; Syncope; Channelopathy; Cardiomyopathies

Summary: epilepsy is a common condition which affects over 3 million people in the us. patients with uncontrolled epilepsy have a lifetime risk of sudden unexpected death (sudep) of 35%, which is greatest in those under 40 years of age. the exact mechanisms and causes are not understood but can be due to underlying conditions which affect the heart and brain, which may lead to dangerous heart rhythms and death. some of these conditions which affect heart and brain have an identifiable genetic cause. this study aims to identify known genetic causes of heart rhythm and sudden death related disorders in patients with epilepsy.

the overall goals are to determine whether patients with epilepsy who have the highest risk of sudep have an underlying genetic cardiovascular disorder. the investigators are seeking patients with epilepsy who have a high risk of sudep identified by using a risk scoring tool called sudep-7 and/or have blood-relatives with a history of epilepsy, seizure, cardiac arrest, sudden death, drowning/near-drowning, syncope or heart rhythm disorder. the investigators may also include blood-relatives of patients with epilepsy and invite them to participate by providing a blood sample and/or buccal cells (from a swab or saliva) for genetic testing.

Eligibility criteria:
inclusion criteria: * adults ages 18 - 50 with a diagnosis of epilepsy or seizures, or syncope or drowning or cardiac arrest or sudden death or an abnormal ecg suggestive of an arrhythmia * blood-relatives (aged 18+) of a patient with a history of epilepsy, seizure, cardiac arrest, sudden death, drowning, syncope or arrhythmia exclusion criteria: * those who are unable to provide written consent. * prisoners (vulnerable population) * seizures secondary to ischemic events * traumatic brain injury resulting in seizures * history of cranial surgery * history of brain tumor

Keywords: sudden unexpected death in epilepsy sudep sudden cardiac arrest sudden cardiac death sleep ion channel disease long qt syndrome brugada catecholaminergic polymorphic ventricular tachycardia
clinical performance of gynecare prosima* pelvic floor repair system for symptomatic pelvic organ prolapse

Conditions: Pelvic Organ Prolapse; Stage II-III

Summary: the purpose of this study is to evaluate the safety and effectiveness of the gynecare prosima\* pelvic floor repair system as a device in women with symptomatic pelvic organ prolapse.

the gynecare prosima\* system is a new technique and now available in china. it provides a simplified unanchored mesh repair, making surgery much simpler to perform and reduces the risk of the specific complications that may occur when tunneling devices beyond the pelvic cavity. in clinical practice, many women have symptomatic prolapse, which requires surgical correction. they are relatively young, and therefore care more about the long-term outcomes and quality of life after procedure. the purpose of this multicenter and prospective study is to evaluate the effectiveness and safety of the gynecare prosima\* system in the treatment of symptomatic pop-q stage ii-iii pelvic organ prolapse.

Eligibility criteria:
inclusion criteria: * candidates with symptomatic pelvic organ prolapse of ics pop-q stage ii or iii, suitable for surgical repair. vaginal hysterectomy and mid-urethral sling procedures for incontinence may be performed concurrently. * age ≥ 18 years. * agrees to participate in the study, including completion of all study-related procedures, evaluations and questionnaires, and documents this agreement by signing the ethics committee approved informed consent. exclusion criteria: * additional surgical intervention concurrent to the procedure (e.g. sacrocolpopexy, paravaginal repair, tubal sterilisation). * previous repair of pelvic organ prolapse involving insertion of mesh. * previous hysterectomy within 6 months of scheduled surgery. * experimental drug or experimental medical device within 3 months prior to the planned procedure. * active genital, urinary or systemic infection at the time of the surgical procedure. surgery may be delayed in such subjects until the infection is cleared. * coagulation disorder or on therapeutic anticoagulant therapy at the time of surgery. * history of chemotherapy or pelvic radiation therapy. * systemic disease known to affect bladder or bowel function (e.g. parkinson's disease, multiple sclerosis, spinal cord injury or trauma). * current evaluation or treatment for chronic pelvic pain (e.g. interstitial cystitis, endometriosis, coccydynia, vulvodynia). * nursing or pregnant or intends future pregnancy. * chronic cough not well-controlled. * bmi≥30. * in the investigator's opinion, any medical condition or psychiatric illness that could potentially be life threatening or affect their ability to complete the study visits according to this protocol.
study to evaluate vadadustat for anemia in subjects with dialysis-dependent chronic kidney disease (dd-ckd) who are hyporesponsive to erythropoiesis stimulating agents

Conditions: Anemia; Dialysis-Dependent Chronic Kidney Disease

Summary: this is a phase 2, randomized, open-label study to evaluate vadadustat versus epoetin alfa for the treatment of anemia in subjects with dialysis-dependent chronic kidney disease (dd-ckd) who are hyporesponsive to erythropoiesis stimulating agents (esas.)


Eligibility criteria:
inclusion criteria: * male and female subjects ≥18 years of age * receiving chronic maintenance hemodialysis for end-stage kidney disease * currently receiving epoetin alfa for anemia * hb between 8.5 and 10.0 g/dl during screening exclusion criteria: * anemia due to a cause other than ckd or presence of active bleeding or recent blood loss * sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia * red blood cell transfusion within 4 weeks prior to or during screening * anticipated to recover adequate kidney function to no longer require hemodialysis during study participation

Keywords: anemia kidney dialysis-dependent chronic kidney disease ckd dd-ckd renal vadadustat akb-6548 hypoxia-inducible factor hif hypoxia-inducible factor prolyl-hydroxylase inhibitor hif-phi hyporesponder hyporesponsive epoetin alfa hemoglobin erythropoiesis stimulating agent esa
study to compare the effect of hormone replacement therapy (hrt) on breast and cardiovascular metabolic markers in postmenopausal women

Conditions: Menopause

Summary: this study is to evaluate the effects of continuously combined 17b-estradiol/dydrogesterone in comparison with tibolone on the breast metabolic markers, in particular the total insulin-like growth factor-1 (igf-1), in postmenopausal women.


Eligibility criteria:
inclusion criteria: * natural or surgical postmenopausal amenorrhea since ≥ 12 months, * non hysterectomized women, complaining of at least 14 hot flushes per week exclusion criteria: * known, suspected or history of breast cancer or hormone-dependent neoplasia, * undiagnosed genital bleeding, * venous or arterial history or presence of thromboembolism, * cerebrovascular disease

Keywords: menopause, igf-1, hrt
fluorouracil filtering surgery study (ffss)

Conditions: Glaucoma

Summary: to determine whether postoperative subconjunctival injections of 5-fluorouracil (5-fu) increase the success rate of filtering surgery in patients at high risk for failure after standard glaucoma filtering surgery.

filtering surgery adequately lowers intraocular pressure in most glaucoma patients. however, the prognosis is less favorable for aphakic patients with glaucoma or glaucoma in phakic eyes following unsuccessful filtering operations. failure of filtering surgery is usually attributed to the proliferation of fibroblasts at the filtering site. the use of 5-fu, an antimetabolite, has been shown to inhibit the proliferation of fibroblasts in tissue culture, and in preliminary studies it has increased the success of filtering surgery in a nonhuman primate model. the fluorouracil filtering surgery study (ffss) was a randomized, controlled clinical trial comparing the success rate of standard glaucoma filtering surgery to the success rate of standard surgery with adjunctive 5-fu treatment. another element of this study was to evaluate the frequency and severity of possible adverse effects related to 5-fu injections. detailed preoperative and postoperative examinations of the cornea, lens, and retina were performed. systemic toxicity was assessed by preoperative and postoperative hematologic studies. after the investigators performed the filtering surgery and determined that the new outlet channel was working, patients were randomized to receive either 5-fu injections or standard postsurgical care without 5-fu. the patients treated with 5-fu received subconjunctival injections of 5 mg of 5-fu twice daily on postoperative days 1 through 7 and once daily on postoperative days 8 through 14. there were 213 patients recruited into the study, 162 with previous cataract extraction and 51 with previous filtering surgery. all patients were examined at 1 month, 3 months, 6 months, 1 year, 18 months, and 2 years postoperatively and at yearly intervals thereafter until 5 years postoperatively. possible concomitant risks of 5-fu treatment, such as toxic effects to the cornea, lens, or retina, were monitored.

Eligibility criteria:
men and women with uncontrolled intraocular pressure greater than 21 mm hg in one or both eyes despite maximal tolerated therapy and who were aphakic or had undergone previous filtering surgery were eligible to participate.
apatinib as first -line treatment for advanced esophagus cancer

Conditions: Advanced Esophagus Cancer

Summary: an exploratory study of amapinib for patients with advanced esophagus cancer .

an exploratory study of amapinib for patients with advanced esophagus cancer . eligible are patients with advanced esophagus cancer. apatinib (500mg) is given daily as follows: metastasis after primary treatment : apatinib + yew + platinum. local recurrence after previous surgery/radiotherapy: apatinib alone or in combination with platinum-based chemotherapy one therapy cycle has 28 days. tumor response is evaluated every 2 cycles.

Eligibility criteria:
inclusion criteria: * 1. age: 18 to 75 years old, men and women; * 2. patients diagnosed with esophageal squamous cell carcinoma by histopathology and immunohistochemistry; * 3. ecog performance status: 0-2; * 4. life expectancy ≥ 12 weeks; * 5. clinical stage iiib-iv; metastatic patients who have not initially received chemotherapy or patients who have local recurrence after surgery or radiochemotherapy (no local treatment indication) ; * 6. function of the major organs is normal, criteria referred are as follow: 1. blood routine examination: hb ≥ 90g/l (no blood transfusion within 14 days); anc ≥ 1.5 × 109/l; plt ≥ 80 × 109/l; 2. biochemical examination: alb ≥ 29 g / l (alb did not lose within 14 days); alt and ast \<5 uln; tbil ≤ 1.5 uln; 3. plasma examination cr ≤ 1.5 uln; * 7. subjects voluntarily participated in the study, signed informed consent, have good compliance and cooperate with follow-up; * 8. patients that the investigator believes can benefit. exclusion criteria: * 1. those who have had other malignant tumors in the past or at the same time; * 2. pregnant or lactating women; * 3. patients with high blood pressure and can't get a good control after antihypertensive drug therapy (systolic blood pressure\>150mmhg, diastolic blood pressure\>100mmhg); patients with grade ⅱ or more myocardial ischemia or myocardial infarction, poorly controlled arrhythmia (including qtc interval≥450ms) and ⅲ\~ⅳ grade cardiac insufficiency according to nyha; cardiac color doppler ultrasonography: lvef \<50%; * 4. unable to swallow, chronic diarrhea, and intestinal obstruction, which significantly affects drug taking and absorption; * 5. have a clear risk of gastrointestinal bleeding concerns (such as local active ulcer lesions, fecal occult blood + or more), a history of gastrointestinal bleeding within 6 months; * 6.with coagulation abnormalities (pt\>16 s, aptt\>43 s, tt\>21 s, fbg \<2 g/l), hemorrhagic tendency or receiving thrombolysis or anticoagulant therapy; * 7. have a mental illness, or history of abuse of psychotropic substances; * 8. with anastomotic recurrence and tracheal fistula; * 9. patients who participated in other drug clinical trials within 4 weeks; * 10. patients who have concomitant diseases that are seriously compromise the patient's safety or affect the patient to complete the study according to the researcher's judgment; * 11. researchers believe that it is not suitable for inclusion.
effect of global postural reeducation on low back pain patients with lower cross syndrome

Conditions: Low Back Pain, Postural

Summary: this study will be conducted toinvestigate the effect of global postural re-education on low back pain patients with lower cross syndrome

lower cross syndrome is common, with up to 85% of low back pain cases due to long-term postural faults (lower crossed syndrome) and it has a negative result on our society. global postural re-education (gpr) is an intervention that is used frequently for chronic low pain to improve pain and function. 50 low back pain patients with lower cross syndrome will be assigned randomly into 2 groups, group a will receive a global postural re-education approach and consists of 15 treatment sessions of global postural re-education approach, performed 2times/week for 1 hour including patient education. each treatment is individualized for every patient and for his/her pain-related limitation. each session includes only 2-3 postures to increase the standardization of treatment. group b will receive the conventional treatment in form of exercise program of (abdominal and pelvic floor strengthening) and (stretching exercise of back and hip flexor muscles) to improve pain and function in chronic low back pain patients

Eligibility criteria:
inclusion criteria: * 50 patients. * both sexes will be included. * patients' age range will be 25 to 40 years old (esakowitz., 2014). * participants will have to meet the criteria for lower crossed syndrome indicating tight hip flexors and erector spinae together with weak glutei and abdominals with low back pain will be presented three months or longer and level of pain intensity more than 3 on vas. exclusion criteria: * on other forms of treatment that may interfere with the study including other physical therapy or medication specific to back pain. * enrolled in another interventional clinical research trial * pregnancy * nerve entrapment, bowel or bladder dysfunction and kidney disease. * surgery on the back, pelvis or sacrum is indicated or has previously occurred.
working on rapid language development in toddlers

Conditions: Language Developmental Disorders

Summary: the goal of the study is to examine the effects of teaching parents to use language support strategies on language skills in toddlers with language delays. we hypothesize that children whose parents who learn to use language support strategies at home will have greater language skills than those children whose parents do not learn the strategies.

the goal of the proposed project is to conduct an efficacy trial to determine whether enhanced milieu teaching (emt) significantly improves language deficits in young children at high risk for persistent language delays. the target population is children ages 24 -36 months who exhibit significant co-occurring delays in productive and receptive language skills, who have cognitive skills within the range of normal development, and who do not have other identified disabilities. an empirically based and manualized language intervention, enhanced milieu teaching (emt), implemented by therapists and parents will be compared to community based "business as usual" services in a randomized experiment enrolling 120 children and their parents. children assigned to the emt group will receive 24, 1-hour sessions of direct intervention at home that will include teaching their parents to implement emt procedures across activities. children will be assessed at 4 time points (before and after intervention, at 6 months and 12 months post-intervention) allowing the description and comparison of individual language growth trajectories over a period of 18 months. in addition, we will examine the relation between language growth and emergent problems in behavior and social skill development to determine whether early language intervention can prevent these difficulties frequently associated with early language delays. results from this study will determine the efficacy of parent-plus-therapist implemented emt with a new population of children, provide evidence about the potential for preventing persistent language delays and secondary social effects of early language delays, and expand developmental theory linking persistent language delays to specific risk factors and behavioral outcomes. the results of this study will have specific policy implications related to early identification and the inclusion of young children with language delays as a target population for early intervention.

Eligibility criteria:
inclusion criteria: * language delay exclusion criteria: * hearing loss * language other than english as the home language * additional disabilities (e.g., autism, down syndrome)

Keywords: language impairment language disorder language delay late talkers late talking
asciminib rmp study

Conditions: Chronic Myeloid Leukemia

Summary: this study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of asciminib in the real-world clinical setting in korean chronic myeloid leukemia (cml) patients.

the dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of asciminib. this study will enroll all patients by total enumeration for those prescribed with asciminib at physicians' discretion as per locally approved label under usual clinical practice for 2 years after the market launch.

Eligibility criteria:
inclusion criteria 1. adult patients diagnosed with ph+ cp-cml and currently receiving or going to receive scemblix® treatment according to locally approval label 2. patients who are willing to provide written informed consent prior to study enrollment exclusion criteria 1. patients with contraindication according to locally approved label of scemblix® 2. patients who receive or are going to receive any investigational medicine during the observation period

Keywords: scemblix asciminib cml chronic myeloid leukemia