Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of the combined ablation procedure to treat longstanding persistent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.

the purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure using the ncontact numeris®-af guided coagulation system with visitrax® epicardially and the st. jude medical therapy™ cool path™ ablation catheter endocardially to treat longstanding persistent atrial fibrillation (af) patients.

Eligibility criteria:
inclusion criteria: * age \> 18 years; \< 80 years * left atrium less than or equal to 6.5 cm (tte) * history of af for less than or equal to 10 years * provided written informed consent * symptomatic longstanding persistent atrial fibrillation (af). exclusion criteria: * patients requiring concomitant surgery * left ventricular ejection fraction \< 30% * pregnant or planning to become pregnant during study * co-morbid medical conditions that limit one year life expectancy * measured left ventricular wall thickness \> 1.5 cm * history of coagulopathy * previous cardiac surgery * history of pericarditis * previous cerebrovascular accident (cva), excluding fully resolved tia * patients who have active infection or sepsis * patients who have uncorrected reversible cause(s) of af * patients who are contraindicated for anticoagulants * patients who are being treated for arrhythmias other than af * patients who have had any previous af or left atrial catheter ablation * current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment * not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).

Keywords: longstanding persistent atrial fibrillation af chronic af rf ablation ncontact surgical therapy cool path ablation catheter st. jude medical
role of genexpert in extra pulmonary tuberculosis

Conditions: Extra Pulmonary Tuberculosis

Summary: diagnosis of extra pulmonary tuberculosis remains especially challenging since the number of mycobacterium tuberculosis bacilli present in tissues at sites of disease is often low and clinical specimens from deep-seated organs may be difficult to obtain. histology is time-consuming to undertake and establishing a diagnosis of tuberculosis with high specificity remains difficult. tissue microscopy after special staining is often negative and when mycobacteria are seen, it is impossible to distinguish mycobacterium tuberculosis from non tuberculous mycobacterial disease. reliance on culture, the mainstay of diagnosis, often leads to considerable delays, compromising patient care and outcomes. evidence from 138 studies published before 2008 suggested that nucleic acid amplification technologies could not replace conventional mycobacterial tests (microscopy, culture) for diagnosing pulmonary and, especially, extra pulmonary tuberculosis

only a few years later, genexpert technology has changed this paradigm, with a recent systematic review showing pooled sensitivity of 88% and pooled specificity of 98% for diagnosis of pulmonary tuberculosis, but evidence (as of march 2012) for using xpert mtb/rif for diagnosing extra pulmonary tuberculosis is still comparatively weak globally, there is still a dearth of studies involving the use of xpert mtb/rif in extra pulmonary tuberculosis specimens, and few provide definitive answers. this is due mostly to the studies having small sample sizes across a range of various specimen types and differences in pre-processing methodologies and in input volumes and to studies having been conducted in different populations (adults, children, human immunodeficiency virus infected).

Eligibility criteria:
inclusion criteria: * all patients with extra pulmonary tuberculosis exclusion criteria: * severe co morbid diseases. * pulmonary tuberculosis * patients refuse to do genexpert or refusing
bright light therapy for non-motor symptoms in parkinson's disease

Conditions: Parkinson Disease

Summary: this is a randomized placebo- and active-controlled trial for assessing the efficacy of bright light therapy for sleep and mood symptoms in patients with parkinson's disease

the primary aim of this study is to compare the efficacy of timed-blt (blt group) in reducing excessive daytime sleepiness in patients with parkinson's disease, when compared to a timed-inactivated negative ion generator (active-control group). the secondary aims of the study are to examine the effect of timed-blt on other non-motor symptoms, including depression, fatigue; and the quality of life. additional analyses will be carried out to examine the efficacy of the timed-placebo as compared to the random-time placebo (placebo group).

Eligibility criteria:
inclusion criteria: 1. idiopathic parkinson's disease diagnosed by neurologist according to the uk parkinson's disease society brain bank clinical diagnostic criteria 2. capable to give informed consent 3. maintained on stable dose of medications for parkinson's disease/psychotropic drugs for at least four weeks prior to entry of the study 4. score 14 or more on the epworth sleepiness scale exclusion criteria: 1. a current or past history of manic or hypomanic episode, schizophrenia, mental retardation, or substance use disorder. (subjects with depression or anxiety disorders will not be excluded) 2. unstable medical or psychiatric condition 3. presence of substantial suicidal risk as judged by the clinician and/or screening instruments 4. presence of active psychotic symptoms that might impair the ability to consent or validity of the interview 5. cognitive impairment with score of 19 or below by the hong kong version of montreal cognitive assessment (hk-moca) 6. contraindication to bright light therapy: history of light induced migraine. epilepsy, current use of photosensitizing medications, presence of eye disease, e.g. retinal disease, severe cataract, glaucoma and blindness 7. significant medical condition/ hearing impairment/ speech deficit lead to incapability in completing clinical interview 8. regular shift worker or trans-meridian flight in the past three months 9. enrolment in another clinical trial of an investigational medicinal product or device 10. subjects who are on exogenous melatonin 11. patients with deep brain stimulation (dbs) implant 12. patients with known sleep disorders, eg. untreated severe sleep apnea, restless leg syndrome

Keywords: parkinson disease light therapy daytime sleepiness non-motor symptom
turkish version of breast edema questionnare: validity and reliability study

Conditions: Breast Edema

Summary: this study was planned to investigate the complaint of breast edema after breast conserving surgery and radiotherapy, which are considered as the main treatment modalities for breast cancer. the incidence of breast edema after these treatments ranges from 0% to 90.4%. in contrast to arm lymphedema, which has been described in detail in the literature, only a few studies have investigated breast edema. there is no survey study that comprehensively examines the presence of lymphedema and its clinical features (duration, severity, location). studies to assess breast edema after breast cancer treatment have revealed the need for a condition-specific scale. therefore, the "breast edema questionnaire" was developed to assess breast edema in women who have undergone breast cancer surgery. the original language of this questionnaire is german and its reliability and validity has not been studied in another language. in this study, the validity and reliability of this questionnaire, which specifically assesses breast edema, will be tested in turkish women.


Eligibility criteria:
inclusion criteria: * individuals with a diagnosis of breast cancer who have undergone breast-conserving surgery * individuals who have signed the informed consent form exclusion criteria: * illiterate individuals

Keywords: radiotherapy breast cancer lymphedema
cognitive behavioral therapy, modafinil, or both for multiple sclerosis fatigue

Conditions: Multiple Sclerosis

Summary: this clinical trial will compare the effectiveness of 3 treatments for fatigue in multiple sclerosis: 1) a commonly used behavioral treatment strategy (telephone-based cognitive behavioral therapy), 2) a commonly used medication (modafinil), and 3) a combination of both therapies. each participant will receive one of these 3 treatments for a total of 12 weeks. hypotheses are that, at 12 weeks, treatment with combination therapy will overall lead to greater reductions in fatigue impact, fatigue severity, and fatigability compared to monotherapy, and that comorbid depression, sleep disturbances, and baseline disability level will be important effect modifiers that influence treatment effect and adherence.


Eligibility criteria:
inclusion criteria: 1. patients with clinically definite multiple sclerosis (ms, all ms subtypes); 2. age 18 years or older; 3. presence of chronic, problematic fatigue that, in the opinion of the patient, has interfered with their daily activities for ≥ 3 months; 4. average fatigue severity scale (fss) score greater or equal to 4 at screening. exclusion criteria: 1. current shift work sleep disorder, or narcolepsy diagnosed with polysomnography and multiple sleep latency test 2. history of ms relapse within the last 30 days prior to screening (participants will be considered eligible after the 30-day window); 3. current stimulant or wake-promoting agent use (such as amantadine, modafinil, methylphenidate, or amphetamine) within 30 days of screening; 4. pregnancy or breastfeeding; 5. reliance on hormonal contraception and concomitant unwillingness to use alternative non-hormonal means of birth control (spermicide or condoms) during the course of the study; 6. current suicidal ideation (si) with intent or plan; 7. known hypersensitivity to modafinil or armodafinil or its inactive ingredients; 8. history of the following cardiovascular conditions: recent myocardial infarction (last 6 months prior to screening), unstable angina, left ventricular hypertrophy, mitral valve prolapse, nyha class iii or iv congestive heart failure; 9. history of prescription or illicit stimulant abuse (such as cocaine, amphetamine, methamphetamine); 10. any other medical, neurological, or psychiatric condition that, in the opinion of the investigators, could affect participant safety or eligibility.

Keywords: cognitive behavioral therapy modafinil provigil fatigue ms
investigation of the effect of orthosis use for control of knee hyperextension in chronic stroke patients

Conditions: Stroke

Summary: the aim of this study is to examine the effect of using foot-ankle orthosis at different angles on hyperextension control in stroke patients. the hypotheses of the study are: hypothesis 1: ho: the foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in stroke patients, has no effect on the control of knee hyperextension. h1: foot-ankle orthosis, which fixes the ankle at different angles (3 degrees of dorsiflexion - 5 degrees of dorsiflexion) in stroke patients, has an effect on the control of knee hyperextension.


Eligibility criteria:
inclusion criteria: * between the ages of 40 and 65 * six months must have passed since the stroke. * ambulation regardless of the use of a walking aid (walker, cane, or tripod) * obtaining between 0 and 3 modified rankin score points * a score of 24 or higher on the mini mental test is required to pass. * hyperextension during the stance phase of gait. * participating voluntarily in the study exclusion criteria: * having a history of more than one stroke * dementia is known to exist * having a diagnosed orthopedic, mental, or neurological condition * having a circumstance that impedes communication * having a history of lower extremity and gait-related surgeries

Keywords: gait analysis foot-ankle orthosis knee hyperextension kinematic analysis
a study on the efficacy and safety of nebivolol monotherapy in hispanic hypertensive patients

Conditions: Hypertension

Summary: this study will evaluate the efficacy and safety of nebivolol monotherapy in hispanic patients with stage 1 or stage 2 hypertension


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 to 80 years of age, self-identified as hispanic or latino ethnicity * females must be post-menopausal, or not pregnant and using an approved contraceptive regimen * meet criteria for stage i or ii hypertension * currently not treated, or being treated with no more than two anti-hypertensive medications exclusion criteria: * secondary hypertension * are taking three or more antihypertensive agents * have uncontrolled or poorly controlled diabetes mellitus type i or type ii * evidence of other concurrent disease or conditions that might interfere with the conduct of the study * participation in any investigational study within 30 days of screening (visit 1). * have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

Keywords: nebivolol bystolic ™ hypertension hispanic hypertension in hispanic patients
bimet study: evolution of metabolic and cardiovascular risks factors in patients with bipolar disorder

Conditions: Bipolar Disorder

Summary: to assess the prevalence of metabolic syndrome in spanish population with bipolar i or ii disorder. to analyse the clinical progress disease in patients with bipolar i or ii disorder for 12 months using the assessment of the symptoms disease and the progress of metabolic and cardiovascular risk. to analyse the health status, quality of life and functioning/disability of patients.

consecutive patient sampling. in any investigational site, five consecutive patients with diagnosis of bipolar disorder will be enrolled in the study

Eligibility criteria:
inclusion criteria: * patients with diagnosis of bipolar disorder (dsm-iv tr) * patients or their legal representatives have provided informed consent exclusion criteria: * patients are unable to complete or to understand health questionnaires in spanish language * patients enrolled in clinical trials or other studies

Keywords: metabolic syndrome, bipolar disorder and cardiovascular risk factors
a study to collect data on the treatment pattern of xarelto + acetylsalicylic acid in the routine clinical practice in patients who are suffering from a condition that narrows the blood vessels supplying the heart and / or a condition that most commonly narrows the blood vessel in the legs

Conditions: Coronary Artery Disease; Peripheral Artery Disease

Summary: the study will focus on effectiveness and safety of rivaroxaban (xarelto) when given together with acetylsalicylic acid (combination therapy) to patients suffering from coronary artery disease (a condition that affects the blood vessels supplying the heart) and / or peripheral artery disease (a condition that affects the blood vessels of the lower limbs) in the routine clinical practice. the study will help to collect data for prevention cardiovascular death, myocardial infarction (mi), stroke and major adverse limb events in adult patients. the study will focus on information on when and why physicians are starting to treat patients with combination therapy, treatment duration, reasons to discontinue treatment and previous therapies. the study will also investigate treatment outcomes for patients being treated with a combination therapy by their physicians.


Eligibility criteria:
inclusion criteria: * adult (≥18 years) patient (except taiwan ≥ 20 years old). * diagnosis of cad or symptomatic pad. * treatment according to local marketing authorization, rivaroxaban 2.5 mg \[bid\] plus acetylsalicylic acid (asa) 75-100 mg \[od\] started up to 4 weeks before or after the icf is signed. * only in those countries with a marketing authorization of rivaroxaban in the acute coronary syndrome (acs) indication, patients already on rivaroxaban treatment for acs for more than 4 weeks, who are subsequently fulfilling criteria for cad, are also allowed to be enrolled. exclusion criteria: * contra-indications according to the local marketing authorization. * patients who will be treated with chronic anticoagulation therapy other than rivaroxaban 2.5 mg given for cad/pad. * participation in an interventional trial. * enrolment in the xatoa study.

Keywords: thrombosis
a comparative phase 2 study assessing the efficacy of triheptanoin, an anaplerotic therapy in huntington's disease

Conditions: Huntington Disease

Summary: in the study the investigators plan to include 100 early affected hd patients (5 ≤ uhdrs ≤ 40) in a randomized, double-blind, controlled study in 2 centers (france and the netherlands). patients will receive either triheptanoin at 1g/kg of body weight per day (n = 50), or a control oil (n = 50) at 1g/kg of body weight per day for 6 months followed by an open label phase using triheptanoin for another 6 months. efficacy of triheptanoin will be evaluated by measurements of caudate volume using volumetric magnetic resonance imaging. clinical improvement will be evaluated by brain energy metabolism quantification as evaluated by the ratio of inorganic phosphate/phosphocreatine, during visual stimulation, using 31p-mrs, uhdrs, tfc, and pba-s scores as well as performance on the neuropsychological battery. patient quality of life will be evaluated with the sf-36 questionnaire before and after treatment; biological tolerance and compliance will be evaluated by routine biochemical blood tests, plasma and urine measurements of triheptanoin oil derivatives and patient report.


Eligibility criteria:
inclusion criteria: * positive genetic test with cag repeat length ≥39 in htt gene * at least 18 years of age * signature of informed consent * covered by social security * uhdrs score between 5 and 40 * ability to undergo mri scanning * bmi between 18 and 30 exclusion criteria: * hypersensitivity to triheptanoin or to one of its excipients * additional major comorbidities * history of severe head injury * participation in another therapeutic trial (3 month exclusion period) * for women of childbearing age, the absence of two forms of effective contraception (with the exception of those who are abstinent) * pregnancy or breastfeeding * inability to understand information about the protocol * persons deprived of their liberty by judicial or administrative decision * adult subject under legal protection or unable to consent * treatment with tetrabenazine
a study of morab-003 in patients with solid tumor

Conditions: Neoplasms; Solid Tumor

Summary: morab-003 is intravenously administered to japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.


Eligibility criteria:
inclusion criteria; 1. japanese male and female aged \>or=20 to \<80 years at obtaining informed consent 2. patient with histologically or cytologically diagnosed solid tumor 3. patient who is frα-positive confirmed by immunohistochemistry (ihc) (except for ovarian cancer that frα-positive is frequently reported) 4. patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have no other appropriate treatment 5. performance status (ps) is 0 to 1 by eastern cooperative oncology group（ecog）criteria exclusion criteria 1. brain metastasis presenting clinical symptoms or requiring medical treatment 2. serious and systemic infection requiring medical treatment 3. history of hypersensitivity to protein formulations including monoclonal antibody 4. with other active malignancy (except for carcinoma in situ) 5. with a large volume of pleural effusion or ascites requiring drainage

Keywords: cancer frα
weekly docetaxel and fixed-dose rate gemcitabine combination chemotherapy

Conditions: Sarcoma

Summary: to determine the activity of weekly docetaxel and gemcitabine in patients with advanced soft tissue sarcoma previously treated with anthracycline and/or ifosfamide 1. primary endpoint: response rate 2. secondary endpoint: progress-free survival, overall survival, safety


Eligibility criteria:
inclusion criteria: * histologically confirmed recurrent or metastatic, unresectable soft tissue sarcoma or bone sarcoma with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapy (e.g., alveolar soft part sarcoma, clear cell sarcoma, chondrosarcoma, chordoma, desmoid tumors) * bone sarcoma patients must have visceral metastatic disease (e.g., metastatic to lung or liver) * patients who were previously treated with anthracycline- and/or ifosfamide- containing chemotherapy, as a first-line chemotherapy for metastatic disease, or adjuvant therapy patients may have had up to 2 prior chemotherapies within 4 weeks of starting the study treatment * unidimensional measurable lesions * age ≥ 16 years * life expectancy of more than 3 months * ecog performance status ≤ 2 * adequate bone marrow function (anc≥1,500/mm3, and platelet count ≥100,000/mm3) * adequate kidney function (serum creatinine ≤ 1.5 mg/dl) * adequate liver function (bilirubin ≤ 2 mg/dl and transaminase level ≤ 3 times the upper normal limit, or \< 5 times for patients with liver metastasis, serum alkaline phosphatase \< 2.5 times the upper normal limit, or \< 5 times if liver metastases were present or \< 10 times if bone metastases were present). * adequate cardiac function (ejection fraction ≥ 50% by echocg or muga scan) * all patients are fully informed about the nature and purpose of this study and should give informed consent before the start of treatment. exclusion criteria: * pregnant or lactating patients * patients with resectable lung metastasis * presence or history of cns metastasis * prior history of other cancer within past 5 years, asides from basal cell and squamous cell carcinoma of skin, and carcinoma in situ of uterine cervix * any preexisting medical condition of sufficient severity to prevent full compliance with the study.
agreement study on ai-assisted smartphone-based monitoring tool for difficult-to-heal ischemic leg ulcers

Conditions: Chronic Limb-Threatening Ischemia

Summary: the purpose of the project is to investigate the agreement with bland-altman plots between an ai-supported automatic digital measurement method of wound area and depth and existing manual measurement methods in patients with arterial ulcers on the lower leg. the expectation is that the digital measurement tool can provide healthcare providers with better opportunities to objectively monitor and detect changes in the wound healing process in patients with peripheral arterial disease.


Eligibility criteria:
inclusion criteria: * adults with peripheral arterial disease. * arterial or arteriovenous ulcers on lower leg * age \<18 exclusion criteria: * adults with non-ischemic ulcers, * purely venous ulcers, * purely traumatic wounds, * wounds resulting from non-atherosclerotic chronic vascular conditions of the lower extremity (e.g.,vasculitis, buerger disease, radiation arteritis),

Keywords: wound healing artificial intelligence digital technology