Kornimate/medical-research-clean huggingface dataset:
resistance exercise in patients with ocular melanoma

Conditions: Ocular Melanoma

Summary: choroidal melanoma (cm) is one of the most common intraocular cancers worldwide. during treatment with episcleral brachytherapy, patients require a week of hospitalization in isolation. the primary aim of this study will be to investigate the effects of resistance training during hospitalization on health-related blood biomarkers in cm patients. our secondary aim will be to assess changes in physical function tests, quality of life and anxiety and depression. candidates for this study will be patients undergoing cm treatment at the "hospital universitari i politècnic la fe" of valencia.

candidates of the present study will be adults with cm diagnose and treated with plaque brachytherapy undergoing in "hospital universitari i politècnic la fe" (valencia). all the participants will be informed about the objectives and content of the investigation and written informed consent will be obtained. participants will be excluded if they (1) present a health status that forbids high intensity resistance training, (2) have any unsteady cardiac illness, (3) have serious metabolic disorder or if (4) they have any important orthopaedic disorder impeding exercise. the study will conform to the declaration of helsinki and will be approved by the ethical committee of "hospital universitari i politècnic de la fe". a randomized controlled trial with two parallel groups is planned: a control group following the hospital's standard protocol (usual care) and an intervention group in which patients will complete a daily resistance training session during hospitalization. during the 5-7 days of treatment, where participants are going to be isolated in a room without human contact, are going to perform a daily session of exercise during about 30 minutes. the exercises will be supervised by a trained physician. to carry out the training session, elastic resistance bands will be used. on each day, each exercise will start with 3 sets of two repetitions as a warm-up and to calculate the appropriate intensity. the intensity will be that at which the patient reports a perceived exertion of 5-6 of 10 at the borg cr10 scale after two repetitions. for each exercise, one set will be completed until task failure is achieved.if in any of the exercises the patient perceives this intensity only with the weight of his own limb or body weight, the exercise will be performed without elastic bands. to observe the effects of the intervention, various blood tests, functional, quality-of-life and anxiety and depression assessments will be conducted before and after the program, as well as one-month post-hospital discharge.

Eligibility criteria:
inclusion criteria: * adults with choroidal melanoma diagnose and treated with plaque brachytherapy undergoing in "hospital universitari i politècnic la fe" (valencia). exclusion criteria: * present a health status that forbids high intensity resistance training. * have any unsteady cardiac illness. * have serious metabolic disorder. * have any important orthopaedic disorder impeding exercise.
eeva 12-well dish study

Conditions: Infertility

Summary: the purpose of this study is to demonstrate that the eeva™ system is compatible with the eeva 12-well dish.

this study is designed to demonstrate that the eeva system software successfully tracks the embryo images and identifies the timing of key developmental events using the eeva 12-well dish. this is a prospective, observational, blinded, single arm, nonrandomized, single center clinical study. images of developing embryos and eeva predictions will be blinded to embryologists and physicians

Eligibility criteria:
inclusion criteria: * women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs. * subject is at least 18 years of age. * subject has basal antral follicle count (bafc) ≥ 12 prior to stimulation cycle. * subjects has basal fsh \< 11 iu * fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm. * subject has at least 8 normally fertilized eggs (2pn) * willing to have all 2pn embryos monitored by eeva * willing to comply with study protocol and procedures and able to speak english. * willing to provide written informed consent. exclusion criteria: * reinseminated eggs. * history of cancer. * gestational carriers. * planned preimplantation genetic diagnosis or preimplantation genetic screening. * previously enrolled in this study * concurrent participation in another clinical study. * any other reason the investigator believes the subject should not participate in the clinical study.

Keywords: in vitro fertilization assisted reproduction techniques noninvasive imaging of embryos time lapse imaging of embryos traditional morphological grading of embryos prediction of blastocyst formation infertility male factor female factor embryo viability
physical training during hospital admission with community-acquired pneumonia

Conditions: Community-acquired Pneumonia

Summary: the purpose of this study is to assess the effect of standard usual care combined with daily supervised physical training during hospitalization with community-acquired pneumonia (cap) compared to standard usual care alnone.

community-acuired pneumonia (cap) is a leading cause of hospitalization worldwide. despite increased focus on mobilization, hospitalization is associated with bed rest. bed rest with low levels of physical activity leads to functional deline as well as increased risk of complications. this study is a randomized controlled trial, which investigates the effect of standard usual care combined with daily supervised physical training in patients hospitalized with cap compared to standard usual care alone.

Eligibility criteria:
inclusion criteria: * patients 18 years of age or older admitted to hospital with cap defined as a new infiltrate on chest x-ray/ct and minimum one of the following symptoms: temperature \<35˚c or ≥38˚c, cough, pleuritic chest pain, dyspnea, or focal chest signs on auscultation. * patients should have an expected admission length of ≥72 hours. * patients should be able to move their legs. exclusion criteria: * patients unable to give written consent. * hospital admission within the last 14 days. * severe immunosuppression (cancer chemotherapy ≤28 days, neutropenia ≤1000 cells/μl, ≥20 mg prednisolone-equivalent/day \>14 days or other immunosuppressive drugs, hiv infection, former transplant).

Keywords: physical training
comparison of gsk measles-mumps-rubella-varicella (mmrv) vaccine versus priorixtm

Conditions: Varicella; Rubella; Mumps; Measles

Summary: the purpose of this study is to assess non-inferiority of two different vaccination regimens using gsk biological's mmrv vaccine (two doses at 9 and 15 months) or priorix™ (9 months) and one dose of mmrv vaccine (15 months) to the current standard of care which is priorix™ administered at 9 months of age followed by concomitant administration of priorix™ with varilrix™ at 15 months of age in a measles endemic environment such as india.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * male or female subjects between and including 9 and 10 months of age at the time of the first vaccination. * written informed consent obtained from the the parent or guardian of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis a vaccine and oral poliovirus vaccine . * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-registered product. * previous vaccination against measles, mumps, rubella and varicella. * history of measles, mumps, rubella and/or varicella diseases. * known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * a family history of congenital or hereditary immunodeficiency. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin. * major congenital defects or serious chronic illness. * history of any neurologic disorders or seizures. * acute disease at the time of enrolment. * axillary temperature \> 37.5°c (99.5°f) / rectal temperature \> 38°c (100.4°f). * administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. * presence of a susceptible high-risk person in the same household during the study period.

Keywords: mumps immunogenicity vaccines safety rubella combined vaccine varicella vaccine children measles humans
a study of bms-582664 in patients with advanced or metastatic solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to assess the dose limiting toxicity (dlt) of bms-582664 and the maximum tolerated dose(mtd) in subjects with advanced or metastatic solid tumors.


Eligibility criteria:
inclusion criteria: * patients must have measurable disease * documented failure to standard therapies exist, or which are determined to be inappropriate by the investigator * ecog ps: 0-1 exclusion criteria: * subjects with centrally located squamous cell carcinoma of the lung
randomized controlled trial between auto-titration and manual titration of non-invasive ventilation in obesity hypoventilation syndrome

Conditions: Chronic Hypercapnic Respiratory Failure; Obesity Hypoventilation Syndrome

Summary: primary objectives: to evaluate the effectiveness in the obesity hypoventilation syndrome (ohs) treatment with non-invasive ventilation (niv) set manually by polysomnography compared to the same treatment with a respirator with automatic niv adjustment, analyzing as primary variable paco2 and as operational variables dropout rate for medical reasons and mortality. secondary objectives: cost-effectiveness, clinical and functional improvement in wakefulness and during sleep, quality of life, blood pressure monitoring for 24 hours, incidence and evolution of cardiovascular events and use of health resources. other objectives: 1) effectiveness of treatments in the following subgroups of patients: gender, age, socioeconomic status, severity of sleep apnea, vni compliance, quality of life and comorbidities; 2) to evaluate the profile of patients with poor adherence to niv based on clinical severity, gender, age and socioeconomic status in the whole sample and in both intervention groups.

method: prospective, blind researchers, randomized, controlled non-inferiority and cost-effectiveness relationship, with two parallel open groups. 200 ohs patients will be divided into two groups by simple randomization 1:1 and followed for one year. the premise of non-inferiority is -2 at the lower limit of the confidence interval 95% for the change in pco2 between the arms being assessed by analysis of covariance, adjusted for 2-sided, age, sex, body mass index in intention-to-treat and per-protocol analysis. the cost-effectiveness will be performed by bayesian techniques with sensitivity analysis.

Eligibility criteria:
inclusion criteria: 1. obesity hypoventilation syndrome defined by obesity (imc≥30) and hypercapnic respiratory failure (pco 2\> 45 mm hg) in stable phase (ph≥7.35 without clinical signs of worsening in at least one previous month). 2. age between 18-80 years. 3. absence of other diseases causing hypercapnia as moderate or severe chronic obstructive pulmonary disease (fev1\> 70% predicted if fev1 / fvc \<70), neuromuscular, thoracic wall or metabolic disease; d) absence of narcolepsy or restless legs syndrome. 4. overcome correctly a 30 minutes test of treatment with vni in wakefulness. exclusion criteria: 1. psychophysical disability for questionnaires. 2. patients who cannot be evaluated by quality of life questionnaires because they present debilitating chronic disease. 3. chronic nasal obstruction that prevents the use of niv. 4. pregnancy. 5. no informed consent obtained.

Keywords: chronic respiratory failure obesity non invasive mechanical ventilation
evaluating uti outcomes in at risk populations

Conditions: Urinary Tract Infections; Complicated Urinary Tract Infection

Summary: this is a multicenter, observational comparative cohort, study to evaluate the uti related adverse event rates between guidance® uti clinical pathway versus the current traditional clinical pathways for urine testing.

clinical sites will be identified by an internal database, prepared by the sponsor, based on previous experience with the sites. study allocation will based on their current usage of guidance® uti and the reporting pathway (described above) will be implemented. those who currently routinely use guidance® uti testing procedures will be over sampled 2:1 over those who do not routinely use guidance® uti. larger clinical care systems with multiple care sites may have locations allocated to different cohort. the basis for cohort allocation will be based on the availability and willingness of providers in these markets to implement infrastructure for collecting and reporting of guidance® uti clinical pathway. the comparative cluster cohort will be selected from select geographies within the u.s. based on size of general population served matching to those enrolled in the guidance® uti clinical pathway. the method of patient care and management (e.g., test ordering and antimicrobial initiation) is at the discretion of the treating physicians. specimens collected for suspected uti may be sent to pathnostics for standard bacterial identification and sensitivities. guidance® uti can only be performed at pathnostics, whereas urine cultures may be performed at any lab. trained and experienced clinical lab scientists at pathnostics are always available to assist the ordering provider with results interpretation or any other questions on the report they may have.

Eligibility criteria:
inclusion * male or female participants ≥ 65 years of age, no predetermined quotas or ratios for gender participation. * high suspicion of active uti * ability to provide/obtain a clean catch or sterile urine specimen * willing to adhere to follow-up schedule as stated in schedule of events * permanent residence in the same state in which they were consented for the study * able to provide informed consent exclusion * participation in another uti trial during the study period * patients in hospice-care or limited life expectancy of ≤1 month) * inability to provide informed consent and/or respond independently to follow up surveys * if the provider deems that a urine culture or guidance uti is not necessary in clinical management
study evaluating the safety and efficacy of varenicline and bupropion for smoking cessation in subjects with and without a history of psychiatric disorders

Conditions: Smoking Cessation

Summary: this study is being conducted to assess varenicline and bupropion as aids to smoking cessation treatment in subjects with and without an established diagnosis of major psychiatric disorder and to characterize the neuropsychiatric safety profile (pre-specified adverse events (aes) in both of these populations).


Eligibility criteria:
inclusion criteria: * male or female cigarette smokers, 18- 75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt. * smoked an average of at least 10 cigarettes per day during past year and during the month prior to the screening visit, and exhaled carbon monoxide (co) \>10 ppm at screening. * for neuropsychiatric cohort- subjects must have proper diagnosis as outlined in protocol. exclusion criteria: * subjects with a past or current diagnosis of one of the following disorders: a. psychotic disorders: * schizophreniform * delusional disorder * psychotic disorder nos b. all delirium, dementia, and amnestic and other cognitive disorders c. all substance induced disorders (other than nicotine)

Keywords: smoking cessation psychiatric disease
holmium laser versus thulium laser versus bipolar enucleation of the prostate.

Conditions: Prostate Hypertrophy; Holmium Laser; Thulium Laser; Bipolar Diathermy; Prostate Enucleation

Summary: because of the diversity of the studies and deficiency of those comparing various techniques of eep for treatment of luts secondary to bpo in patients with large sized prostate, we aim in this study at testing the non-inferiority of pkep and thulep to holep in relieving luts secondary to bpo in patients prostate size \>80ml. our hypothesis is to present an evidence that enucleation is a technique rather than a power dependent procedure through a rct.


Eligibility criteria:
inclusion criteria: * patients' age \>50 years * lower urinary tract symptoms luts secondary benigh prostatic obstruction bpo who failed medical treatment * international prostate symptom scores (ipss) \>15 and bother score quality of life (qol) \> 3 (according to ipss question 8) * maximum urinary flow rate (q max) \<15 ml/sec with at least 150 ml voided volume or cases with acute urine retention secondary to bpo who failed trial of voiding on medical treatment. * transrectal ultrasound trus estimated total prostate size 80-250cc exclusion criteria: * patient with neurological disorder which might affect bladder function as cerebrovascular stroke, parkinson disease * active urinary tract infection (positive urine culture) till treatment * presence of bladder cancer (within the last 2 years) * known prostate cancer patients will be excluded preoperatively on the basis of digital rectal examination, prostate specific antigen level, and trus imaging followed by prostate biopsies if necessary.

Keywords: holmium laser thulium laser bipolar diathermy prostate enucleation
erlotinib and docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) after failure of one chemotherapy regimen

Conditions: Non-Small Cell Lung Cancer

Summary: erlotinib has demonstrated efficacy as a single agent in patients with nsclc and the addition of erlotinib to chemotherapy has not achieved better results in the general population. however, several preclinical and phase i studies have shown that a sequential treatment of erlotinib and chemotherapy could avoid a possible negative interaction between both drugs when administrated concomitantly, and therefore, it could improve the benefit of the combination therapy. this study will investigate if the intermittent treatment of a chemotherapy drug, such as docetaxel, with erlotinib could achieve a clinical benefit.


Eligibility criteria:
inclusion criteria: * written informed consent. * age \>= 18 years. * histologically or cytologically documented inoperable, locally advanced (stage iiib with malignant pleural or pericardial effusion) or metastatic (stage iv) nsclc. * patients who have failed only one prior chemotherapy to treat the advanced disease and candidates to receive a second line treatment. * ecog ps 0-2. * adequate hematological function: hemoglobin =\> 9 g/dl; neutrophils count =\> 1.5 x 10(9)/l; platelet count =\> 100 x 10(9)/l. * adequate liver function: bilirubin \<= 1,5 x uln; ast and alt \<= x 3 uln when no hepatic metastases or \<=5 x uln if hepatic metastases; alkaline phosphatase \<=5 x unl except that there is hepatic metastases. * adequate renal function: calculated creatinine clearance =\> 40 ml/min (cockroft y gault) or serum creatinine \<= 1.5 x uln . * patient able to meet the requirements of the study and accessible for correct follow-up. * oral swallowing capability. exclusion criteria: * previous treated with more than one chemotherapeutic treatment for nsclc * concomitant treatment with another drug under investigation. * pregnancy or lactation. fertile women must provide a negative result of pregnancy test (in serum or urine) within 7 days prior to study treatment start. in addition, they must use an effective method of contraception (oral contraceptives, intrauterine device, barrier methods of contraception, together with spermicidal jelly or surgical sterilization) during the study. * evidence of other disease, metabolic or neurological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complications. * contraindication for the use of erlotinib or docetaxel.

Keywords: adenocarcinoma carcinoma, non-small cell lung neoplasms docetaxel erlotinib chemotherapy
evaluate safety as mono or combination therapies with anti-diabetes mellitus drugs in japanese subjects with type 2 diabetes mellitus

Conditions: Type2 Diabetes; High Blood Sugar

Summary: this is a long term, single arm, open label study to evaluate the safety and efficacy of dapagliflozin as monotherapy or in combination therapy with other anti diabetic drug in japanese subjects with type 2 diabetes mellitus who have inadequate blood sugar control on diet and exercise or on other anti-diabetic treatment will be included in this study.


Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * men or women age ≥20 years old (either gender needs to be 40% or higher of total number of treated subjects) * diagnosed with type2 dm ; ≥6.5% and ≤10% at 1 week before treatment started exclusion criteria: * type 1 diabetes mellitus, * fpg \>240 mg/dl before treatment started * subjects who have history of unstable or rapidly progressing renal disease * subjects who have severe hepatic insufficiency and/or significant abnormal liver function * significant cardiovascular history

Keywords: phase3 clinical trial type 2 diabetes mellitus
the adjunctive ventricular arrhythmia suppression trial (avast) pilot

Conditions: Arrhythmia

Summary: the purpose of this study is to learn if combination therapy with amiodarone and ranolazine (an approved drug for chest pain) can help prevent arrhythmias.


Eligibility criteria:
inclusion criteria: * patients with an icd who were on a stable dose of amiodarone for the past 60 days exclusion criteria: * patients with a life expectancy of less than 6 months * patients with moderate or severe hepatic impairment (child-pugh classes b or c) or requiring hemodialysis. * pregnancy or lactation. * treatment with potent cyp3a inhibitors, including ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, indinavir, and saquinavir * treatment with cyp3a inducers, including rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, and st. john's wort.

Keywords: arrhythmia