Kornimate/medical-research-clean huggingface dataset:
telemedicine intervention in patients with chronic pain in pd

Conditions: Parkinson's Disease

Summary: pain is a very common and disabling symptom in parkinson's disease, yet it is often untreated. this study will assess the impact of home-based physical and cognitive exercise interventions to reduce pain in this disease. this approach would offer an easily implemented and affordable way to encourage and maintain use of these interventions by patients virtually indefinitely through remote access technology. the study findings may help va clinicians provide optimal care for the many veterans with parkinson's disease and chronic pain.

project background/rationale: pain is one of the most disabling and common nonmotor symptoms in parkinson's disease (pd), with a prevalence of 40-85%. research indicates that undertreatment of pain is particularly high in the pd population. only about one-half of patients with pd who report pain receive regular pain medications. there is increasing interest in nonpharmacological treatments for chronic pain in pd to supplement pharmacological approaches. while there is evidence to support the utility of physical exercise to improve chronic pain management, relatively less is known about the role of cognitive exercise. project objective: the investigators propose to conduct a pilot randomized, controlled trial in patients with chronic pain in pd to assess the impact of physical and cognitive exercise interventions on pain outcomes. project methods: a total of 166 community-dwelling veterans, 40 years of age or older, with chronic pain in mild-to-moderate pd will be randomly assigned in a 2 x 2 factorial design to one of four groups (1 - combined cognitive and physical intervention, 2 - physical intervention only, 3 - cognitive intervention only, 4 - health education). the investigators will test the effects of the interventions at 3 months for the outcome of pain severity.

Eligibility criteria:
inclusion criteria: * physician diagnosis of idiopathic pd * at least 2 of the 3 cardinal signs of pd (resting tremor, rigidity, bradykinesia) * response to dopaminergic medication exclusion criteria: * angina pectoris * history of myocardial infarction (mi) within 6 months * history of ventricular dysrhythmia requiring current therapy

Keywords: parkinson's disease pain
in-hospital portable sleep monitoring for the evaluation of obstructive sleep apnea (osa)

Conditions: Obstructive Sleep Apnea

Summary: hypothesis: portable sleep testing of hospitalized medical inpatients suspected of having osa is accurate in determining the need for positive airway pressure (pap) therapy when compared to outpatient laboratory-based polysomnography. * hospitalized medical inpatients referred for suspected osa will be tested with a portable sleep apnea testing device during hospitalization. * these patients will then undergo an outpatient laboratory-based attended polysomnography after hospital discharge. * results of the inpatient portable sleep apnea test will be compared to the outpatient laboratory-based polysomnography in terms of diagnostic accuracy.


Eligibility criteria:
inclusion criteria: - hospitalized inpatients referred for evaluation of suspected obstructive sleep apnea exclusion criteria: * patients admitted to surgical or obstetrics/gynecology services * patients with certain medical conditions (altered mental status not related to respiratory failure, septicemia, unstable psychiatric disorder, narcotic abuse and prior diagnosed sleep apnea) * patients with certain social histories (prisoners) * patients unable to use cpap (facial deformity and traumatic facial injuries).

Keywords: portable sleep apnea testing positive airway pressure therapy polysomnography
praxbindtm india pms program

Conditions: Thromboembolism

Summary: this program will be initiated after the commercial availability of praxbindtm in india. it will include patients administered with praxbindtm into the surveillance program after commercial availability in 2 years at selected centres approved by the regulatory authority.


Eligibility criteria:
inclusion criteria: - patients treated with pradaxa (dabigatran etexilate) capsules with requirement of rapid reversal of the anticoagulant effects of dabigatran: for emergency surgery/urgent procedures (or) in life-threatening or uncontrolled bleeding - written informed consent in accordance with international conference on harmonization good clinical practice (gcp) guidelines and local legislation and/or regulations exclusion criteria: -participation in a praxbindtm clinical trial
vx-770 expanded access program

Conditions: Cystic Fibrosis

Summary: the purpose of this expanded access program is to provide vx-770 prior to its commercial availability to people with cystic fibrosis (cf) who have at least one copy of the g551d-cftr mutation and who are in critical medical need and who are not eligible for participation in other vertex-sponsored studies.

vx-770, a compound being developed by vertex pharmaceuticals incorporated (vertex) for the treatment of cf, is an orally bioavailable small molecule that targets the underlying defect in cf, the dysfunctional cftr protein. in phase 3 studies of vx-770 in patients with cf and a g551d cftr mutation, improvements in cftr function (measured by reduction in sweat chloride concentration) and improvements in lung function were observed. patients who are interested in the vx-770 expanded access should contact their cf physician about participation. physicians interested in participating as a site should contact 800-745-4484.

Eligibility criteria:
inclusion criteria: * male or female with confirmed diagnosis of cf, with a sweat chloride \>60 mmol/l or 2 cf-causing mutations and chronic sinopulmonary disease or gastrointestinal/nutritional abnormalities. * have the g551d-cftr mutation in at least 1 allele * will be aged 6 years or older on the date of signed informed consent form * highest fev1 in the 6 months prior to screening is ≤ 40% predicted value or patient is documented to be active on the lung transplant wait list exclusion criteria: * if female, currently pregnant * abnormal liver function, at screening on recent clinical laboratory testing, defined as \>3 × upper limit of normal (uln), of any 3 or more of the following: ast, alt, ggt, serum alkaline phosphatase, total bilirubin * is currently requiring invasive mechanical ventilation * is currently participating, or has participated in the past 30 days in another therapeutic or clinical study
effects of transcutaneous tibial nerve stimulation for overactive bladder symptoms in adults

Conditions: Overactive Bladder; Urge Incontinence; Nocturia

Summary: for overactive bladder symptoms, there are numerous physiotherapy techniques have been found to be beneficial. transcutaneous electrical stimulation of the tibial nerve is one of those treatment options, that is entirely a non-invasive, easy to apply, and cost-effective technique. transcutaneous stimulation of the tibial nerve targets the sacral nerve plexus that contracts the pelvic floor muscles and controls the bladder function. this research aims to study the effectiveness of transcutaneous tibial nerve stimulation in adults with overactive bladder symptoms along with the conventional physiotherapy for overactive bladder (pelvic floor muscle training through kegel's exercises) among 60 patients with overactive bladder symptoms on the basis of non-probability purposive sampling technique with screening for study criteria through a consultant urologist. after taking informed consent, all participants will be randomly allocated into two groups. group a will receive pelvic floor muscles training through kegels exercises along with transcutaneous electrical stimulation of the tibial nerve and group b will receive pelvic floor muscles training through kegels exercises. the treatment duration will of six weeks. outcomes will be assessed before the start of the treatment and after the end of the treatment sessions.


Eligibility criteria:
inclusion criteria: * clinically diagnosed overactive bladder * a total oabss score of 3 or more and an urgency score of 2 or more * 30-65 years old exclusion criteria: * pregnancy * acute urinary tract infection (within 15 days) * any surgical procedure for urinary incontinence * genito-urinary cancer history * stage ii pelvic organ prolapse according to pelvic organ prolapse-quantification system * lesion on the site of stimulation or around it * pelvic pacemakers * lower limbs prostheses * patients who will not be able to perform kegel's exercises * an impaired sensation at the site of stimulation. * patients receiving any treatment other than the prescribed medications by the referring physician (that will be the same for all patients of both groups) will be excluded.

Keywords: lower urinary tract symptoms (luts) urge incontinence overactive detrusor neuromodulation therapy nocturia pelvic floor disease
cardiovascular assessment of pediatric cancer survivors

Conditions: Left Ventricular Dysfunction; Heart Failure

Summary: the goal of this observational study is to evaluate cardiac and vascular health status of pediatric cancer survivors.

all pediatric cancer survivors were evaluated with cardiological examination, ecg, transthoracic echocardiography (transesophageal echocardiography when required), nt-probnp, ctni, kidney function tests, liver function tests, fasting blood glucose, cholesterol panel, iron, iron binding capacity, ferritin, transferrin saturation, b12, vitamin d, folic acid, urinanalysis, hemogram and a questionnaire about living with heart failure.

Eligibility criteria:
inclusion criteria: * diagnosed cancer at pediatric age exclusion criteria: * having cancer after 18 years of age

Keywords: childhood cancer survivors cardiotoxicity cancer treatment related heart diseases
effects of milk derived from mountain-pasture grazing cows on risk markers of the metabolic syndrome compared to conventional danish milk

Conditions: Coronary Heart Disease; Type-2 Diabetes

Summary: to investigate the effect of milk delivered from mountain-pasture grazing cows on risk markers of the metabolic syndrome and type-2 diabetes with the effect of conventional danish milk. the study should reveal the importance of phytanic acid content for these effects.


Eligibility criteria:
inclusion criteria: * sign written consent * age: 50-70 * bmi: 20-30 * increased risk of developing ms * refrain from dietary supplements and blood donations prior to, and during the study exclusion criteria: * poor compliance * if they suffering from any chronic or long lasting illness * abuse of alcohol or medicine
tele-diab: electronic diary for patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus Type 2; Insulin Resistance

Summary: the purpose of the study is to show if telemonitoring and automated feedback regarding glucose management, physical activity, blood pressure, and body weight improves treatment of patients with insulin dependent type 2 diabetes mellitus.

in this clinical trial 50 patients with insulin dependent type 2 diabetes will be randomised in two study arms: monitoring of blood glucose and blood pressure using a telemedical device or in an arm with treatment as usual. patients will the following measurement devices: blood glucose, blood pressure. both devices can communicate with a mobile phone, which will also be provided to the patients. the mobile phone will transfer the data to a central, safe server. patients will receive automated reminder/feedback. caregivers can evaluate the transferred data whenever necessary via a web-based access. data will be presented in tables as well as trend figures.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 2, age 18-70 years, able to use a mobile phone exclusion criteria: * pacemaker, intracardial defibrillator, no cure planned within the active study period.

Keywords: diabetes mellitus type 2 telemedicine insulin
cetuximab/paclitaxel/cisplatin concurrent chemoradiotherapy followed by esophagectomy for loco-regional esophageal cancer

Conditions: Esophageal Cancer

Summary: we hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy (tp-ccrt) as the adjunctive therapy before esophagectomy or as a definitive crt would improve the therapeutic efficacy of tp-ccrt in patients with loco-regional esophageal squamous cell carcinoma (escc).

we hypothesize that the addition of cetuximab to twice weekly paclitaxel/cisplatin concurrent chemoradiotherapy as the adjunctive therapy before esophagectomy or as a definitive crt would improve the therapeutic efficacy of tp-ccrt in patients with loco-regional esophageal squamous cell carcinoma.

Eligibility criteria:
inclusion criteria: 1. pathologically proven squamous cell carcinoma of esophagus. 2. loco-regional diseases, which are defined by tnm system of american joint committee on cancer (ajcc) cancer staging system (6th edition) in 2002, fulfilling one of the following criteria: a. t3, n0, m0; b. t1-3, n1, m0; c. t1-3 or n0-1, m1a will be eligible provided the lesions could be covered by appropriate radiation fields. 3. age ≥ 18 years old. 4. performance status ecog 0\~2. 5. adequate bone marrow reserves, defined as: a. white blood cells (wbc) ≥ 4,000/µl or neutrophil count (anc) ≥ 2,000/µl; b. platelets ≥ 100,000/µl. 6. adequate liver function reserves, defined as: a. hepatic transaminases ≤ 2.5 x upper limit of normal (uln); b. serum total bilirubin ≤ 1.5 x upper limit of normal (uln). 7. adequate renal function: creatinine ≤1.5 mg/dl 8. written informed consent. exclusion criteria: 1. invasion to surrounding organ (t4 disease). 2. distant metastasis, except m1a disease listed in the inclusion criteria 2-c. 3. adenocarcinoma of gastroesophageal (ge) junction. 4. prior thoracic irradiation. 5. synchronously diagnosed squamous cell carcinoma of aerodigestive way, other than esophageal cancer. 6. prior malignancy, except for the following: a. adequately treated basal cell or squamous cell skin cancer; b. in-situ cervical cancer; c. note: previously treated aerodigestive squamous cell carcinoma is not allowed. 7. significant co-morbid disease, which prohibit the conduction of chemotherapy, concurrent chemoradiotherapy, or radical surgery, such as active systemic infection, symptomatic cardiac or pulmonary disease, or psychiatric disorders. 8. estimated life expectancy less than 3 months.

Keywords: esophageal cancer chemoradiotherapy paclitaxel cetuximab
a multicenter clinical trial of urine dna testing for bladder cancer in china

Conditions: Bladder Cancer; Urocystitis; Urinary Bladder Stone; Urothelial Carcinoma

Summary: the primary objective of this study is to assess the safety and effectiveness of human multigene methylation detection kit (fluorescent pcr method) for help diagnose bladder cancer by comparing with clinical standard method (includes medical imaging (mri, ct, etc.), cystoscopy, pathological examination).

in this clinical trial, the testing kit to be evaluated is a human multigene methylation detection kit (fluorescent pcr method), which is intended to qualitatively detect methylation levels of multiple genes in human urine specimen in vitro by fluorescent pcr method, and the standard method used in clinical diagnostic includes medical imaging, cystoscopy, pathological examination. subjects will provided urine specimen as required for the evaluation of the testing kit followed by a examination of standard method. technical personnel who conduct the evaluation of the testing kit will remain blinded to the results of the clinical diagnosis. the results of the testing kit will be compared with the standard method, and the effectiveness of the human multigene methylation detection kit (fluorescent pcr method) for bladder cancer detection under normal clinical use will be assessed through statistical analysis.

Eligibility criteria:
inclusion criteria: * subject must meet all three of the following criteria to be eligible for the study: 1. who without age and gender limit, and is participating voluntarily and willing to sign informed consent form; 2. who is willing to undergo or has completed medical imaging and/or cystoscopy and/or pathological examination; 3. any subject who is required to meet any of the following conditions: 1. who is diagnosed with or suspected of bladder cancer. 2. who has high risk factors for bladder cancer (such as engaged in contact with aromatic amines, dyes, rubber, aluminum, leather and other occupations, schistosomiasis infection, family genetic history, smoking, drinking, etc.). 3. who has hematuria symptoms (such as cystitis, stones, etc.). 4. who has other diseases that can be easily confused with bladder cancer. exclusion criteria: * subject with any of the following conditions shall be excluded: 1. who has undergone surgery or chemoradiotherapy. 2. who has other conditions that the investigator considers inappropriate to participate in this clinical trial.

Keywords: bladder cancer urine dna test gene methylation biomarkers multigene methylation detection cancer screening urothelial carcinoma
clinical evaluation of the physiological diagnosis function in the paradym crt device

Conditions: Heart Failure

Summary: this clinical investigation is a prospective, non-randomized, multi-center, pivotal trial.this trial is being performed in order to demonstrate the sensivity of the diagnostic feature "physiological diagnostic" (phd).

the purpose of this study is to evaluate the performance of a new sensor-based diagnostic feature, physiological diagnostic (phd)which as been implemented in the paradym crt cardiac resynchronization system with defibrillation capabalities (paradym crt system,model 8770.

Eligibility criteria:
inclusion criteria: * patient eligible for implantation of a crt-d device according to current available guidelines for cardiac resynchronization therapy * severe hf (nyha class iii or iv) at the time of enrollment * at least one hf-related event (as defined for primary objective) within the last 6 months before enrolment * subject continues to have heart failure symptoms despite receiving optimal medical therapy consistent with current practice guidelines for the pharmacological management of heart failure * scheduled for implant of a paradym 8770 * signed and dated informed consent exclusion criteria: * any contraindication for standard cardiac pacing * any contraindication for icd therapy * abdominal implantation side * hypertrophic or obstructive cardiomyopathy * acute myocarditis * unstable coronary symptoms (unstable angina or myocardial infarction) within the last month * recent (within the last month) or planned cardiac revascularization or coronary angioplasty * correctable valvular disease that is the primary cause of heart failure * mechanical tricuspid valve * receiving continuous intra-venous infusion of positive inotropic therapy or intermittent therapy (intra-venous infusion) more than twice per week * heart transplant recipient * renal insufficiency requiring dialysis * already included in another clinical study * life expectancy less than 12 months * inability to understand the purpose of the study or refusal to cooperate * inability or refusal to provide informed consent and, if not part of the informed consent, a health insurance portability and accountability act (hipaa) authorization * unavailability for scheduled follow-up at the implanting center * known sensitivity to 1 mg dexamethasone sodium phosphate (dsp) * under guardianship * age of less than 18 years * pregnancy (women of childbearing potential should have a negative pregnancy test prior to enrollment)

Keywords: hf, diagnosis
cost-effectiveness of outpatient versus hospital cardiac rehabilitation

Conditions: Coronary Heart Disease

Summary: the hypothesis is that home based clinical rehabilitation (cr) is less expensive than hospital based cr with similar clinical effectiveness. the investigators will compare the results of two forms of cr on 1. direct and indirect healthcare costs 2. effectiveness on mortality, morbidity, modifiable risk factors control, functional capacity measured by exercise testing, health related quality of life and satisfaction rate 3. cost/effectiveness analysis

the main reasons for patients not to participate in a cardiac rehabilitation program that usually develops by group in the hospital or in a gym, are problems of access to hospital, disgust for participating in a group activity and problems in reconciling their work and / or home with the program schedule. these problems could be overcome by outcome cardiac rehabilitation and thus could increase the number of patients benefit from treatment in either the environment extra or intra-hospital. low and medium coronary patients sent to cardiac rehabilitation program at our center within the first 12 weeks after presenting with acute coronary syndrome or been revascularized will be included in the study. the prescription of intensity of effort is based on heart rate reached during the stress test for the initial evaluation in all cases, although at home-program heart rate will be monitored using heart rate monitor and / or by the borg scale. in this way outpatient group patient could performed training sessions individually and at the time of day that best suits their capabilities. the other program components: control of risk factors, health education and counseling will be identical in both groups of patients.

Eligibility criteria:
inclusion criteria: * patients referred to cardiac rehabilitation program in the first twelve weeks after an acute coronary syndrome (myocardial infarction or unstable angina) or after percutaneous or surgical revascularization * who have no contraindication to participate in the program exclusion criteria: * contraindication to participate in the program * high-risk criteria for home cardiac rehabilitation.

Keywords: exercise therapy cost effectiveness cardiac rehabilitation home-based exercise
adnexal torsion markers study

Conditions: Adnexal Torsion; Laparoscopy

Summary: adnexal torsion , is a severe, though uncommon gynecological emergency, with a prevalence of 2.7-3%. the need for prompt diagnosis and treatment in order to save ovarian tissue has been realized a long time ago. a marker that will aid in the diagnosis of torsion and prevent missed diagnosis and unecessary loss of ovarian tissue, while not increasing the rate of unecessary laparoscopic interventions is much needed. to our knowledge, such marker has not been found. the purpose of this study is to find a marker using blood/serum from patients undergoing laparoscopy for suspected ovarian torsion

adnexal torsion, is a severe, though uncommon gynecological emergency, with a prevalence of 2.7-3% (taskin 1998; hibbard1985;burnett 1988). torsion commonly occurs in children and women of childbearing age (haskins 1986). the need for prompt diagnosis and treatment in order to save ovarian tissue has been realized a long time ago (ben-arie 1995). the accuracy of clinical diagnosis is low, with a false negative rate of up to 56% (cohen 2001, bar-on 2010,mashiach 2010). doppler ultrasound tests, do not "necessarily exclude an ovarian torsion; in fact, "the diagnosis of" torsion is missed in 60% of cases, and time to diagnosis in these cases is delayed" (pena 2001). therefore there is a need for a marker that will aid in the diagnosis of torsion and prevent missed diagnosis and unecessary loss of ovarian tissue, while not increasing the rate of unecessary laparoscopic interventions, which are often performed in an emergency setup, by unqualified personnel. to our knowledge, such marker has not been found. the purpose of this study is to find a marker, or marker combination, using blood/serum from patients undergoing laparoscopy for suspected ovarian torsion study type: a prospective, controlled, blind study study population: 200 women undergoing laparoscopy for ovarian torsion

Eligibility criteria:
inclusion criteria: * women undergoing laparoscopy for suspected ovarian torsion exclusion criteria: * elevated liver enzymes * suspected ovarian malignancy

Keywords: adnexal torsion laparoscopy