Kornimate/medical-research-clean huggingface dataset:
"physiological vs right ventricular pacing outcome trial evaluated for bradycardia treatment" (protect-hf)

Conditions: Bradycardia; Pacing; Right Ventricular Pacing; His Bundle Pacing; Left Bundle Branch Area Pacing

Summary: the protect-hf multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. in it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (his and left bundle area pacing) in 2600 patients. patients will be allocated at random to receive either right ventricular pacing or physiological pacing. endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. treatment allocation will be blinded to the endpoint assessor and the patient. recruitment and pacemaker implantation will be carried out at each participating centre. the primary analysis will be intention to treat. the investigators will also perform an on-treatment analysis. 2048 patients are needed to detect the expected effect size with 85% power. a total of 2600 patients will be recruited to allow for patient drop-out and crossover. 500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of picm (pacing induced cardiomyopathy).

patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing. patients at sites participating in echo sub-study will be informed of and given opportunity to consent to echo sub-study, this will be optional to them, even if they have consented to the main study.

Eligibility criteria:
we will recruit patients who are referred for clinically indicated pacemaker implantation inclusion criteria: 1. adults aged over 18 with left ventricular ejection fraction \>35% and one or more of the following guideline based ventricular pacing indications: 1. permanent or intermittent 3rd degree av block 2. permanent or intermittent mobitz type ii av block 3. first degree av block with a pacing indication 4. slow chronic atrial fibrillation or proposed av node ablation 5. bifascicular block with a pacing indication 6. trifascicular block with a pacing indication 7. wenckebach with a pacing indication exclusion criteria: 1. patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome. 2. pregnant women. 3. unable to provide informed consent. 4. those with comorbidity leading to a life expectancy \<1year.
functional consequences of t-bet expression in flu-specific memory b cells after live attenuated influenza vaccine (laiv)

Conditions: Influenza, Human

Summary: as yet the investigators do not understand if there are biomarkers of immune protection after the flumist or live attenuated flu vaccine (laiv). here the investigators test the hypothesis that the t-bet expressing fraction of flu-specific b cells after live attenuated influenza vaccination also serves as an early biomarker of long-lived antibody responses after vaccination. in this study the investigators will be providing the laiv to up to 10 healthy subjects and assaying their immune response and then providing the intramuscular influenza vaccination and testing to see if the immune protection after the laiv also protects after the intramuscular influenza vaccination. update: we have amended this protocol to study the antigen-specific b cell populations that circulate after laiv or iiv prime and laiv or iiv boost.

previously (1) the investigators established that a fluorochrome labeled reagent with the influenza antigen hemagglutinin accurately identified flu-specific b cells after inactivated influenza vaccination and we established that a subset of these flu-specfiic b cells that express the lineage defining master transcriptional regulator, t-bet, correlate with long lived antibody responses. as yet the investigators do not understand if there are biomarkers of immune protection after the flumist or live attenuated flu vaccine (laiv). here the investigators test the hypothesis that the t-bet expressing fraction of flu-specific b cells after live attenuated influenza vaccination also serves as an early biomarker of long-lived antibody responses after vaccination. in this study the investigators will be providing the laiv to up to 10 healthy subjects and assaying their immune response and then providing the intramuscular influenza vaccination and testing to see if the immune protection after the laiv also protects after the intramuscular influenza vaccination. update: we have amended this protocol to study the antigen-specific b cell populations that circulate after laiv or iiv prime and laiv or iiv boost.

Eligibility criteria:
inclusion criteria: * missed getting the flu vaccine in the last year * no history of reactive airway disease * no history of allergy to laiv * no history of allergy to iiv * self-identify as healthy without an immunocompromising condition defined as cancer, autoimmune disease, organ transplant or receipt of steroids. exclusion criteria: * history of reactive airway disease * history of allergy to laiv or iiv * do not self-identify as healthy

Keywords: vaccine influenza efficacy
cue2walk, cost-effectiveness of automated freezing detection and provision of external cues in comparison to usual care in people with parkinson's disease

Conditions: Parkinson Disease

Summary: the majority of people with parkinson's disease incur freezing of gait (fog), which is not addressed adequately by medication. cueing is a proven strategy to overcome fog. the cue2walk is a device with automated detection of fog and provision of rhythmic cues. in this study, the (cost-)effectiveness of the cue2walk device as compared to usual care is investigated.

freezing of gait (fog) is one of the most common and disabling motor symptoms of parkinson's disease and is associated with poorer quality of life. however, current pharmacological or even surgical treatments do not address fog adequately and innovative rehabilitation strategies are needed. cueing is a proven strategy to overcome fog episodes and an essential part in the management of fog. the cue2walk, a medical device class i ce-certified leg-worn device, addresses the debilitating effects of fog episodes at home with 'smart cueing' by combining automatic detection of a freezing episode with manual or automatic rhythmic cues (auditory or vibro-tactile). this study aims to investigate the (cost-)effectiveness of the cue2walk device as compared to usual care. this study is a multicenter randomized clinical trial with 2 parallel groups (24-week intervention group and 24-week 'waiting list' group). after 24 weeks, an 8-week naturalistic follow-up will be implemented for the intervention group, while participants in the waiting list group will also receive the intervention, but for 8 weeks. frequently repeated assessment of outcomes measures will be conducted.

Eligibility criteria:
inclusion criteria: * diagnosis of parkinson's disease according to uk brain bank criteria * daily freezing of gait * hoehn-yahr stage 2-4 * stable medication regime and/or dbs settings as determined by the treating neurologist * ability to walk 5 minutes while unassisted by another person exclusion criteria: * participation in another clinical study * use of a personal cueing device at home * previous use of the cue2walk medical device * presence of co-morbidities that would hamper participation * cognitive impairment preventing understanding of therapeutic instructions (montreal cognitive assessment (moca) score \<16)

Keywords: parkinson's disease freezing of gait (smart) cueing costeffectiveness
effects of colesevelam on how the body responds to insulin in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this study is designed to assess the potential mechanism of action by which welchol® (colesevelam) may improve blood glucose control in patients with type 2 diabetes


Eligibility criteria:
inclusion criteria: * patients between the ages of 18 - 75, inclusive * diagnosed with type 2 diabetes * hemoglobin a1c value greater than or equal to 8.0% * antidiabetic treatments may include sulfonylurea agents (non-sulfonylurea agents must be withdrawn) * overweight, obese (body mass index 25-45 kg/m2) exclusion criteria: * change of dose of lipid or blood pressure lowering therapy within past three months * previous treatment with colesevelam for hyperlipidemia * serum triglyceride greater than 500 mg/dl * serum low density lipoprotein-cholesterol less than 60 mg/dl

Keywords: mechanism of action insulin sensitivity
a study of avastin (bevacizumab) in patients with inflammatory or locally advanced breast cancer

Conditions: Breast Cancer

Summary: this single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and bevacizumab (avastin), before surgery and/or radiotherapy, in participants with inflammatory or locally advanced operable breast cancer. participants will receive 5-fluorouracil, epidoxorubicin and cyclophosphamide (fec), followed by paclitaxel, given concomitantly with bevacizumab. the anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria:
inclusion criteria: * female participants, \>=18 years of age; * stage iii, or inflammatory breast cancer; * estrogen receptor/progesterone receptor (er/pgr) positive or negative and human epidermal growth factor receptor 2 (her-2) negative; * normal left ventricular ejection fraction (lvef). exclusion criteria: * previous chemotherapy/endocrine therapy; * evidence of distant metastatic disease; * other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer); * chronic daily treatment with \>325 milligram per day (mg/day) aspirin, or \>75mg/day clopidogrel.
medication adherence and outcomes among patients in united states with hiv

Conditions: Human Immunodeficiency Virus; Medication Adherence

Summary: with support from the nih, this pilot study will assess the feasibility of using wireless devices and financial incentives to motivate medication adherence among hiv-positive adults in the u.s., focusing on those with non-suppressed viral loads. while daily lotteries using wireless devices may have great potential for improving adherence to art regimens, substantial questions exist as to whether it is: 1) possible to achieve high rates of uptake for a pilot offering wireless devices to high-risk populations; 2) achieve high rates of sustained engagement.

the goal of this study is to explore the feasibility of using wireless devices and financial incentives to motivate medication adherence among high-risk hiv positive patients. by partnering with the drexel partnership comprehensive care clinic at drexel university, the investigators will be able to identify such patients using clinic patient data, use clinic and physician communication channels to enroll them, and maintain high levels of ongoing participation through the use of incentives. the aim is to improve antiretroviral medication adherence among high-risk hiv positive patients by providing patients with a adheretech device (electronic pill bottle), daily adherence notifications tracked by the way to health platform, as well as daily lotteries and financial incentives. upon completion, this study will answer questions important to the feasibility of conducting well-powered randomized controlled trials to improve adherence among hiv patients within the u.s. who have sub-optimal adherence.

Eligibility criteria:
inclusion criteria: * diagnosis of hiv, established in 2017 or earlier * patients at least 18 years of age or older * currently prescribed first or second line art medications * non-suppressed viral loads, with two consecutive non-suppressed viral loads (vl\>400 copies/ml) for the past two lab readings. exclusion criteria: * pregnant * prescribed maraviroc or fuzeon * more than 5 additional medications * diagnosed with insulin dependent diabetes * unable to provide consent * non-english speaker * cognitive impairment, per pi discretion * does not have stable residence
co-incubation of oocytes with sperm: defining the optimal incubation time

Conditions: Infertility

Summary: the current pilot study aims to evaluate the fertilization rates between sibling oocytes subjected to short incubation (2h) versus overnight incubation (16-20h). as secondary objectives, the abnormal fertilization, embryo development, blastocyst biopsy and euploid rates will be analyzed.

all patients for whom at least 6 cumulus oocytes complexes (cocs) are assigned to ivf, with normal sperm parameters, are eligible for the study. an electronically generated randomization list will allocate the first half of the oocytes to one arm and the other half of the oocytes to the second arm. in case an odd number of oocytes will be inseminated, one extra oocyte will be allocated to the first arm. in this prospective observational pilot study, the fertilization potential of 40 patients will be evaluated.

Eligibility criteria:
inclusion criteria: * sperm parameters * sperm concentration before capacitation: \>15 million per ml (who) total motility (pr+np %): \>40 (who) progressive motility (pr %):\>32 (who) * sperm concentration after capacitation: \>0.6 million per ml (not who defined) progressive motility (pr %):\>65 (who) * ≥6 cocs assigned to ivf * bmi ≤35 kg/m2 * female age 18 to ≤ 43 years * all ovarian stimulation protocols * fresh ejaculates * abstinence duration 2-5 days * presence or absence of sperm morphology data: as we do not have a diagnostic sperm analysis for all patients, the presence or absence of \>4% normal morphology (who) will not be taken into account, even with known low (\<4%) normal morphology * couples requesting preimplantation genetic testing for aneuploidies * arab population exclusion criteria: * if the volume to be added after ivf is insufficient to perform ivf on all needed oocytes * presence of \>1 million per ml round cells in the ejaculate * if a couple's previous cycle was included in the study * previous history of fertilization failure or \<50% fertilisation * globozoospermia * pco according to the rotterdam criteria * progesterone \>1.5 ng/ml on the day of trigger
a study to evaluate the use of cidofovir (an experimental drug) for the treatment of progressive multifocal leukoencephalopathy (pml) in aids patients

Conditions: HIV Infections; Leukoencephalopathy, Progressive Multifocal

Summary: the purpose of this study is to evaluate the safety, tolerance, and overall effectiveness of cidovir to treat pml in aids patients. pml is an opportunistic infection (hiv-associated, due to weak immune system) caused by a virus that attacks the brain. cidovir has been used effectively to treat cytomegalovirus (cmv) of the eye. cidovir could be an effective treatment for pml as well.

pml is a demyelinating disease of the brain's white matter, occurring when the jc virus infects the brain of patients infected with hiv-1. cidofovir is known to be an effective treatment for cytomegalovirus of the eye and, in laboratory and animal testing, has also been shown to be effective against several other viruses. however, cidofovir is considered investigational as a treatment for pml. in this multicenter, open-label study 24 patients receive cidofovir iv over 1 hr on days 0, 7, then every 2 wk for a total of 13 doses. oral probenecid is given 3h prior to and 2h and 8h following cidofovir administration. nucleoside and non-nucleoside reverse transcriptors are withheld on days of probenecid administration. protease inhibitors are continued during probenecid administration.

Eligibility criteria:
inclusion criteria you may be eligible for this study if you: * are hiv-positive. * have had symptoms of pml for no more than 90 days before study entry, or have had abnormal neurological exams related to pml. * have negative tests for bacterial or fungal infections. * agree to practice abstinence or use effective methods of birth control during the study. * are at least 18 years old. * have a life expectancy of at least 6 months. exclusion criteria you will not be eligible for this study if you: * have a history of uveitis. * are allergic to sulfa drugs or probenecid. * have had active opportunistic infections other than kaposi's sarcoma within 30 days before study entry. * have sickle cell anemia or trait. * are pregnant or breast-feeding.

Keywords: leukoencephalopathy, progressive multifocal probenecid hiv-1 central nervous system diseases acquired immunodeficiency syndrome dna, viral cidofovir anti-hiv agents neurologic examination renal agents
safety study of 3 mg/ml baclofen injection (intrathecal) using a programmable pump

Conditions: Severe Spasticity

Summary: safety study to assess the 3 mg/ml baclofen injection (intrathecal) using a programmable pump

this is a prospective 36-month phase iiib/iv clinical safety trial that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. all patients will be entered after signing an irb approved informed consent. patients will be followed for the duration of their treatment with gablofen® (baclofen injection) 3 mg/ml using the synchromed® ii programmable pump or until the study is terminated. patients will be evaluated for clinical complications associated with the use of intrathecal baclofen that are considered signs and symptoms of an inflammatory granuloma, specifically new radicular pain at the level of the catheter tip, and/or spinal cord compression. an mri scan with and without infusion will be performed (with consent of the patient) to evaluate the potential presence of an inflammatory granuloma if clinical signs exist. events that may be related to an inflammatory granuloma will be classified as a definite granuloma, possible granuloma, other catheter related problem (confirmed not caused by a granuloma), or other clinical sequelae caused by the underlying disease or other infusion system related event.

Eligibility criteria:
inclusion criteria: * 4 years of age or older * subjects must be clinically diagnosed with sever spasticity and be receiving intrathecal baclofen * subjects must have a synchromed® ii pump already implanted * current treatment with intrathecal baclofen should be at the 2 mg/ml concentration * life expectancy greater than or equal to 12 months * signed written informed consent * ability and willingness to comply with the study protocol for the duration of the study and with follow-up procedures exclusion criteria: * history or presence of malignancy, with the exception of adequately treated localized skin cancer (basal cell or squamous cell carcinoma) or carcinoma in-situ of the cervix, which is allowed * history of any allergic reaction to baclofen * history of inflammatory granulomas with an intrathecal infusion pump * any previous history of neuroleptic malignant syndrome or malignant hyperthermia * as a result of medical review and physical examination, the investigator considers the subject unfit for the study

Keywords: gablofen baclofen injection
validation of fenestrations positioning by numerical simulation

Conditions: Abdominal Aortic Aneurysms

Summary: fenestrated endovascular repair (fevar) is nowadays a recognized option to treat juxtarenal, pararenal or suprarenal abdominal aortic aneurysms in patients at high risk for conventional repair. the technique consists in deploying a custom-made stent-graft (sg) inside the patient aorta. part of the customization involves cauterizing a hole in sg fabric and reinforcing it with a nitinol stent ring, thereby creating a fenestration for each corresponding collateral artery. for this reason, preoperative planning is crucial to determine adequate positions of fenestrations, in order to obtain perfect alignment with the collateral arteries of the patient. inadequate positioning may result in failure to catheterize a collateral artery and subsequent organ damage, increased catheterizing time, increased irradiation dose, endoleaks... the current process of fenestrations positioning for fenestrated anacondatm sg involves: (i) anatomical measurements on patient preoperative ct-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with cad software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a sg prototype deployed inside a transparent anatomy model (3d-printed model of patient aorta and collateral arteries). the main limitations of this process are the costs and long sg delivery time.

the current process of fenestrations positioning for fenestrated anacondatm sg involves: (i) anatomical measurements on patient preoperative ct-scan by case planners using dedicated sizing software; (ii) designing an initial custom device scheme with its positioned fenestrations, created by engineers with cad software using the above cited measurements and (iii) validation of fenestrations position by in vitro testing using a sg prototype deployed inside a transparent anatomy model (3d-printed model of patient aorta and collateral arteries). the main limitations of this process are the costs and long sg delivery time. the goal of this study is to compare fenestrations positioning obtained by two different processes, the actual one at vascutek and the one by numerical simulation performed by predisurge company.

Eligibility criteria:
inclusion criteria: - abdominal aortic aneurysms suitable for treatment using fenestrated anacondatm (vascutek) device exclusion criteria: * failure to generate an adequate fe model of patient arteries (no preoperative multidetector contrast-enhanced ct-scan available, preoperative ct-scan slice thickness greater than 1mm, preoperative ct-scan with artifacts) * stent-graft setup implanted during the surgical procedure has been modified compared to preoperative planning * patient refusing to participate to the study

Keywords: endovascular fenestrated endovascular repair numerical simulation