Kornimate/medical-research-clean huggingface dataset:
exubera large simple trial to evaluate long-term pulmonary and cardiovascular safety

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the long-term pulmonary and cardiovascular safety of exubera in routine clinical practice.

pfizer announced in october 2007 that it would stop marketing exubera. at that time, pfizer committed to continued marketing until it returned the licensing rights for the technology to nektar. following the announcement, enrollment was halted. subjects already enrolled and receiving treatment at the time of the halt in enrollment could continue in the study in accordance with the protocol. nektar, the company from which pfizer licensed exubera, announced on april 9, 2008 that it had stopped its search for a new marketing partner. accordingly, there will be no commercial availability of exubera. as a result, an amendment was filed on april 16, 2008 specifying that all subjects randomized to exubera had to be transitioned to usual diabetes care, and all study subjects followed for serious adverse events for 6 months. in accordance with this amendment, study a2171069 was terminated on april 29, 2009. neither safety nor efficacy reasons were the cause of the study termination.

Eligibility criteria:
inclusion criteria: * eligible for receiving exubera treatment based on the approved local label exclusion criteria: * pregnant or lactating * have a progressive fatal disease or a life expectancy that prohibits them from participating in a five-year research study

Keywords: large simple trial
reducing fetal exposure to maternal depression to improve infant risk mechanisms

Conditions: Depression

Summary: this study evaluates interpersonal therapy (ipt) in the treatment of depression among pregnant women with elevated depressive symptoms. half of the women will be randomized to receive ipt, and the other half will get treat as usual, provided via behavioral health in the hospital.

exposure to maternal depressive symptoms is one of the most well established risk factors for the development of later child psychopathology. accumulating evidence from naturalistic observational studies documents that fetal exposure to maternal depressive symptoms is associated with risk for later child mental health problems. maternal depression is one of the most common prenatal complications with approximately 40% of women experiencing elevated levels of depressive symptoms. the majority of past research has been correlational, so potential causal conclusions have been limited. this project will break new ground by testing the hypothesis that manipulating maternal depressive symptoms will benefit infant outcomes. in this project, maternal depressive symptoms will be reduced using brief interpersonal therapy (ipt), a well-established and efficacious treatment, and testing whether this reduction leads to an improvement in the development of infant mechanisms associated with risk for later psychopathology. the investigators propose to assess 300 pregnant women who report elevated levels of depressive symptoms and their infants. prior to the intervention, maternal measures of depressive symptoms will be collected. then half of the women will be randomized to receive ipt and the other half will receive enhanced usual care (tau). after completion of the intervention, maternal measures will be collected longitudinally through 14 months postpartum. infants will be evaluated at birth and two other times. infants will be assessed across four units of analysis (brain structure and function, physiology, behavior, and maternal-report).

Eligibility criteria:
inclusion criteria: * adult women (over 18 years of age) * a singleton intrauterine pregnancy * english speaking * elevated depressive symptoms based on screening with the edinburgh postnatal depression scale (epds) with score \> 9 exclusion criteria: * bipolar disorder and psychosis based on the structured clinical interview for dsm-iv axis i disorders (scid-np) * current psychotropic medication use or current cbt/ipt usage * an hpa axis or an endocrine disorder * maternal substance use \[assessed using maternal report and urine toxicology * corticosteroid medication use during this pregnancy * invitto fertilization * presence of cervical or uterine abnormalities
atrial fibrillation prior and post elective cardioversion

Conditions: Atrial Fibrillation

Summary: cardioversion from atrial fibrillation (af) to sinus rhythm (sr) is performed primarily to improve patient symptoms. however, due to the intermittent nature of af, patients may have converted to sr prior to elective cardioversion and the recurrence rate of af after cardioversion can be high. the aims of this study are to assess the rate of spontaneously conversion to sr in patients with af scheduled for elective cardioversion, as well as the rate of early recurrence of af after elective cardioversion.


Eligibility criteria:
inclusion criteria: * planned elective cardioversion of af * informed written consent for participation exclusion criteria: * lack of ability to cooperate * pacemaker/crt device * no smart phone
study of the effects of risperdal consta on brain reward circuitry function, craving and cocaine use in active cocaine dependence

Conditions: Cocaine Dependence

Summary: the purpose of this study is to examine the effects of the administration of risperidal-consta on the brain's reward circuitry using magnetic resonance imaging (mri), behavioral tests and measuring cocaine craving and use among people with active cocaine dependence.


Eligibility criteria:
inclusion criteria: * current cocaine dependence who use cocaine at least every 2 weeks * non-treatment seekers who intend to continue using cocaine * male 18-60 years of age * potential participants must be literate in the english language, and be able to understand and complete rating scales and questionnaires accurately * able to provide informed consent * potential participants must be able to identify at least one "locator" person to assist in tracking the participant for follow-up assessments exclusion criteria: * other current substance dependence requiring immediate detoxification * diagnosis of schizophrenia, bipolar disorder, current major depressive disorder * currently suicidal or at high risk for suicide in the judgment of the investigator * carrying a medical device incompatible with mri (e.g., metal implants such as surgical clips or pacemakers and extensive dental work such as bridges) or suffering from significant claustrophobia that would make mri unfeasible. * size incompatible with mri procedures * serious medical illness including hiv-1 infection * hepatitis c + titer with liver enzymes more than 2x normal or a mini-mental status exam score of \<25/30 * insulin dependent diabetes mellitus (iddm) or non- insulin dependent diabetes mellitus (niddm) and abnormal hemoglobin a1c * severe hepatic or renal impairment * history of seizure disorder, delirium, dementia, or mental disorders due to general medical conditions * history of head trauma or stroke with lasting neurological sequelae * tardive dyskinesia, extrapyramidal movement disorder, parkinson's disease or history of neuroleptic malignant syndrome * clinical or laboratory evidence of uncontrolled hypothyroidism/hyperthyroidism * orthostatic hypotension, defined as a decrease of at \> 10 mm hg in systolic blood pressure and/or an increase in heart rate of \> 20 beats per minute, measured one minute following transition from a supine to a standing position. * history of allergy or hypersensitivity to risperidone * treatment with: neuroleptics, antidepressants, antiarrhythmics, carbamazepine, phenytoin, valproate, rifampin, phenobarbital, levodopa and other dopamine agonists, fluoxetine, interferon, propylthiouracil, methimazole, opiates. * treatment within 30 days prior to screening with an investigational drug or medication with the potential to influence cocaine use outcomes

Keywords: cocaine dependence risperidal mri
cellular immunity in adult hepatitis b-vaccinated serologic non-responders

Conditions: Hepatitis B

Summary: previous studies have shown that 5-10% of hepatitis b virus vaccine recipients produce none or to few antibodies after a standard immunization with 3 vaccines. these individuals are defined as non-responders. the investigators wish to investigate if mounting another kind of immune response, called the cellular immune (cmi) response, protects these non-responders. aim/hypothesis primary aims: 1. to estimate the cmi response in serologic non-responders after receiving a standard course of hbv immunization secondary aims: 2. to establish the prevalence of serological non-responders after a standard course of hbv vaccination. 3. to assess the safety of the vaccine. 4. evaluate predictors of serologic non-response in young, healthy individuals receiving a standard course of hbv immunization 5. to compare the immunological profile before and after a standard hbv vaccination regimen on non-responders and responders 6. establish a rapid test for measuring cmi after being hbv vaccinated. a total of 400 healthy volunteers receive a standard course of immunization with a combined hepatitis a and b vaccine (twinrix®) at 0, 1, and 6 months. blood is drawn at 0 and 8 months from all participants. the blood will be analysed to see if there is antibodies or/and if there is mounted a cellular immune response by measuring on parameters called cytokines.


Eligibility criteria:
inclusion criteria: * signed participant information and consent * age over 18 years * women of childbearing potential must use effective contraceptives exclusion criteria: * previous hbv infection * previous hbv immunization * pregnancy (or planned pregnancy within 6 months) * allergy to contents in the vaccine (formaldehyde).

Keywords: hepatitis b non responders cellular immune response cytokines predictors hbsag
a study to evaluate safety and feasibility of robotic liver resection

Conditions: Liver Diseases; Surgery

Summary: the robotic surgery system, the most advanced technology in minimally invasive surgery, overcame some shortcomings of laparoscopic surgery and improved the flexibility and precision of liver resection. several studies have demonstrated that the robotic system was safe and feasible in liver surgery and might be advantageous in complex hepatic vein and hilar dissection, operative bleeding control, and biliary reconstruction. previous comparative studies found limited evidence for significantly improved outcomes in robotic liver resection (rlr) over laparoscopic liver resection (llr) or open liver resection (olr), considering the various degrees of difficulty in liver surgeries. this study aimed to evaluate safety and feasibility of robotic liver resection, by comparing it with llr or olr, and gain veritable and relevant data on the benefits of rlr.


Eligibility criteria:
inclusion criteria: * the patients were diagnosed with a liver tumor. * the patients underwent robotic liver resection. exclusion criteria: * the patients underwent simultaneous malignancy resection of the colorectum or other organs (except gallbladder).

Keywords: robotic liver resection
wearable sensors and machine learning for the assessment of biomechanical risk in lifting tasks

Conditions: Wearable Devices

Summary: lifting loads can cause work-related musculoskeletal disorders. the national institute for occupational safety and health (niosh) established a methodology for assessing lifting actions by means of a quantitative method based on intensity, duration, frequency, and other geometrical characteristics of lifting. body-worn inertial sensor technology provides a number of opportunities to advance the safety and health of workers engaged in physical work. motion-tracking systems together with machine learning (ml) algorithms are used in the ergonomic field for biomechanical risk assessment by means of data acquired by wearable inertial systems. the investigators posed the question whether it is possible to classify lifting tasks belonging to different risk classes according to the value of li using a machine learning approach by means of features extracted from raw signals. aim of this study was to develop and validate, through ml algorithms, a non-invasive detection system of kinetic-kinematic parameters using imu and emg sensors, for the ergonomic assessment of the risk associated with a load lifting activity.

the study envisages the voluntary enrollment of healthy subjects, referring to treatment clinics for work-related pathologies (excluding subjects aged \ 65 years, and those with musculoskeletal pathologies or other disabling pathologies in progress), to carry out two repeated lifting tests. the two tests are set up to correspond respectively to the two niosh risk classes (li\ 1, risk). the imu sensors provide wirelessly a series of data from which it is intended to extract a number of features (feature extraction) that have a high predictive power, through the digital signal processing technique using dedicated software (i.e. matlab, spss). in a second step, data obtained from emg sensors will be added to the analysis. among the different artificial intelligence algorithms, the investigator will look for those most able to discriminate the various risk classes on the basis of the parameters extracted from the signals detected during the motor task.

Eligibility criteria:
inclusion criteria: * healthy subjects exclusion criteria: * subjects with musculoskeletal pathologies or other disabling pathologies in progress

Keywords: inertial measurement units accelerometers ergonomics exposure assessment lifting work-related musculoskeletal disorders machine learning digital signal processing risk prediction
safety and reactogenicity of gsk biologicals' inactivated poliomyelitis vaccine (ipv) (poliorix) in infants

Conditions: Poliomyelitis

Summary: the study will evaluate the safety and reactogenicity of poliorix given as primary vaccination course to chinese children at 2, 3 and 4 months of age.


Eligibility criteria:
inclusion criteria: * a male or female infant between, and including, 60 and 90 days of age at the time of the first vaccination. * born after a gestation period of 36 to 42 weeks inclusive. * 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. * written informed consent obtained from 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 vaccine(s) 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 since birth. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with exception of dtp, hib and/or hepatitis b vaccine(s). * 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-investigational product. * evidence of previous or intercurrent poliomyelitis disease or vaccination. * history of seizures or progressive neurological disease. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. the following condition is temporary or self-limiting and a subject may be vaccinated once the condition has resolved and no other exclusion criteria are met: * current febrile illness or axillary temperature \> 37.0 ºc or other moderate to severe illness within 24 hours of study vaccine administration.

Keywords: ipv
study of the natural history of ffr guided percutaneous coronary intervention

Conditions: Coronary Artery Disease

Summary: about 20,000 patients with ffr (fractional flow reserve) will be enrolled and evaluated for the natural history of coronary lesions at 2 years clinical and imaging follow-up.

this is a multicenter, prospective cohort. about 20,000 patients with ffr will be enrolled at multi centres in korea.

Eligibility criteria:
inclusion criteria: * age 35 years and older * ffr measurement on one and more coronary artery stenosis * willing and able to provide informed, written consent exclusion criteria: * stenosis with timi\<3 flow * graft vessel * ejection fraction \< 30% * angiographic evidence of extreme tortuosity or calcified coronary vessels * suspected coronary spasm even after sufficient nitrate injected * life expectancy \<2 year * planned cardiac surgery or planned major non cardiac surgery * woman who are breastfeeding, pregnant or planning to become pregnant during the course of the study imaging study specific exclusion criteria * visually-estimated angiographic reference segment diameter of \ 4.0mm * inappropriate for ivus/vh/oct procedures : inability for imaging wire or catheter to pass through the tight stenosis, severe calcification, angulation

Keywords: ffr
ultrasound in airway assessment of morbidly obese patients

Conditions: General Anesthesia of Morbid Obese Patients

Summary: the study aims to evaluate the role of airway ultrasound as a new evolving modality in assessment and management of airway in surgical patients


Eligibility criteria:
inclusion criteria: * all surgical list patients planned for general anesthesia from october 2015 to may 2016 exclusion criteria: * patient refusal
a nasal applicator for the treatment of trigeminal neuralgia

Conditions: Trigeminal Neuralgia

Summary: the pain from trigeminal neuralgia (tn) imposes a substantial burden on patients in daily function and reduces quality of life. the sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to tn, by blocking the sphenopalatine ganglion relieves patients from the symptoms. however, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures. the purpose of this study is to evaluate the efficacy of tx360™, a new nasal applicator device, in the treatment of tn. a local anesthetic will be delivered on the ganglion area. we are expecting that this new device will provide at least the same pain relief as the previously described approaches. however, this nasal applicator is intended to be an easy and non invasive method for office use.

the pain from trigeminal neuralgia (tn) imposes a substantial burden on patients in daily function and reduces quality of life. pain severity correlates with reduced measures of daily functioning, and overall health status. the sphenopalatine ganglion, located in the posterior part of the middle nasal turbinate, is involved in the pain associated to tn, by blocking the sphenopalatine ganglion relieves patients from the symptoms. however, methods currently in use to accomplish this are either cumbersome for the patient or invasive regarding the puncture of structures. the purpose of this study is to evaluate the efficacy of tx360™, a new nasal applicator device, in the treatment of tn. the tx360™ is a single use nasal applicator that can reach the sphenopalatine ganglion area. it is designed to dispense medications through a flexible canula. the patients with tn will receive a 0.5 ml spray of local anesthetic on the ganglion area, and measure the change in pain intensity and quality of life. we are expecting that this new device will provide at least the same pain relief as the previously described approaches. however, this nasal applicator is intended to be an easy and non invasive method for office use.

Eligibility criteria:
inclusion criteria: * 18- 80 years old * trigeminal neuralgia exclusion criteria: * nasal septal deformity such as: cleft lip and palate, choanal atresia * septal perforation * recent nasal/midface trauma (\< 3 months) * bleeding disorder such as von willebrand's disease or hemophilia * severe respiratory distress * neoplasm such as the following: angiofibroma, sinus tumors, granuloma * congestion has been present more than 10 days, fever (define as temperature≥ 100.4 f) * current cocaine user * skin around and inside the nasal passage is dry, cracked, oozing, or bleeding * allergy to marcaine * pregnancy
dose adaptation of capecitabine using mobile phone toxicity monitoring

Conditions: Metastatic Colorectal Cancer; Metastatic Breast Cancer

Summary: to develop a system to manage side effects and adjust chemotherapy dose such that a patient can receive their personal maximum tolerated dose.

patients with metastatic colorectal or breast cancer will be recruited. * metastatic colorectal cancer: capecitabine alone or capecitabine + oxaliplatin for 8 3-week cycles * metastatic breast cancer: capecitabine alone or capecitabine + docetaxel for 8 3-week cycles. all patients will be given a mobile phone onto which they will enter any side-effects experienced prior to taking capecitabine in the morning and evening. any grade 3 or 4 symptoms will trigger an alert to a pager held by the ward-staff for immediate attention. thus, patients' severe side-effects will be monitored in real time and the trial will allow real-time dose reductions during cycles and dose-increases at clinics. patient experience in the trial will also be evaluated during their participation in the trial. patients will already be receiving the drug prior to this study and will not be administered to patients as part of this study.

Eligibility criteria:
inclusion criteria: * metastatic colorectal or breast cancer patients commencing treatment on one of four specified regimens for metastatic colorectal cancer: * capecitabine 2000mg/m2 d 1-14, q 3 weekly and oxaliplatin 130mg/m2 d1 q 3 weekly (capox) * capecitabine 2500mg/m2 d 1-14, q 3 weekly for metastatic breast cancer: * capecitabine 2000mg/m2d 1-14, q 3 weekly * capecitabine 2000mg/m2 d 1-14, q 3 weekly and docetaxel 75mg/m2 d1 q 3 weekly * age \> 18 years * fit to start at full (100%) starting dose of all drugs * able and willing to use mobile phone * reasonable renal, liver and bone marrow function * absolute neutrophil count (anc) \>1.5 x 109/l * platelet count \> 100 x 109/l * total bilirubin \<1.5 uln * alt, ast \< 2.5 x uln * alkaline phosphatase \< 2.5 x uln * no obvious contra indications to capecitabine or oxaliplatin or docetaxel * patients must also be able to read, write and understand english. exclusion criteria: * patients who live in an area of no vodafone or orange mobile phone network - - patients participating in other cancer treatment trials * moderate or severe renal impairment \[creatinine clearance \<30ml/min (calculated according to cockroft-gault formula)\]

Keywords: colorectal cancer breast cancer capecitabine docetaxel mobile phone toxicity metastatic