Kornimate/medical-research-clean huggingface dataset:
study of apixaban for the prevention of thrombosis-related events in patients with acute medical illness

Conditions: Venous Thrombosis; Pulmonary Embolism

Summary: the purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[dvt\]) and lung (pulmonary embolism \[pe\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (lovenox®) for preventing these clots. the safety of apixaban will also be studied.


Eligibility criteria:
inclusion criteria: * men and non-pregnant, non-breastfeeding women * 40 years or older * hospitalized with congestive heart failure or acute respiratory failure * infection (without septic shock) * acute rheumatic disorder * inflammatory bowel disease exclusion criteria: * patients with venous thromboembolism (vte) * active bleeding or at high risk of bleeding * unable to take oral medication * with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.

Keywords: prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients
impact of structured physical activity education delivery in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the objective of this study is to assess whether a structured exercise program compared to routine recommendation for exercise has any positive impact on disease outcome in patients with type 2 diabetes. this study aims to assess whether a structured exercise program has an impact on the following determinants of the disease in type 2 diabetes: hba1c, blood pressure, lipids, body mass index and waist circumference. it also aims to assess the compliance and retention of patients with type 2 diabetes in a structured exercise program.


Eligibility criteria:
inclusion criteria: * man or woman with type 2 diabetes * ready to begin regular physical activity * age equal to or greater than 18 * age equal to or less than 64. exclusion criteria: * any vascular disease * exhibits symptoms of coronary artery disease (cad) * history of losing balance because of dizziness * history of losing consciousness * has a bone or joint problem that could be made worse by a change in physical activity * pregnant * has been excluded by the patient's physician for any other health-related reason not stated under these exclusion criteria.
phase i dose escalation study of intravenous vcn-01 with or without gemcitabine and abraxane® in patients with advanced solid tumors

Conditions: Locally Advanced Solid Tumors; Metastatic Solid Tumors; Pancreatic Adenocarcinoma

Summary: the purpose of this study is to determine the safety and tolerability of vcn-01 either administered alone or in combination with abraxane®/gemcitabine, and to determine the recommended phase ii dose of vcn-01 alone or in combination with abraxane®/gemcitabine.

the study consists of three parts: * part i is a dose escalation study to determine the safety and tolerability of a single intravenous injection of vcn-01 alone * in part ii the safety and tolerability of the two highest vcn-01 tolerable doses from part i will be evaluated in combination with abraxane®/gemcitabine. * in part iii the safety and tolerability of the two highest vcn-01 tolerable doses from part i will be evaluated in combination with abraxane®/gemcitabine in a "delayed" schedule compared with part ii.

Eligibility criteria:
inclusion criteria: * male/female patients aged 18 years or over * patients must provide written informed consent * part i: patients with histologically confirmed, locally advanced or metastatic solid tumors. part ii and part iii: patients with histologically confirmed, pancreatic adenocarcinoma for which the established therapy is abraxane®/gemcitabine (clinical standard of care) * life expectancy above 3 months * patients willing to comply with treatment follow-up * ecog performance status 0 or 1 * adequate baseline organ function (hematologic, liver, renal and nutritional) * use a reliable method of contraception in fertile men and women exclusion criteria: * active infection or other serious illness or autoimmune disease * treatment with live attenuated vaccines in the last three weeks * known chronic liver disease (liver cirrhosis, chronic hepatitis) * treatment with another investigational agent within its five half-lives prior to vcn-01 infusion * viral syndrome diagnosed during the two weeks before inclusion * chronic immunosuppressive therapy * concurrent malignant hematologic or solid disease * pregnancy or lactation. patients must agree to use effective contraception or be surgically sterile. * patients receiving full-dose anticoagulant / antiplatelet therapy * adequate levels of neutralizing antibodies against adenovirus * patients with li fraumeni syndrome or with previous known retinoblastoma protein pathway germinal deficiency

Keywords: cancer solid tumors gemcitabine oncolytic virus metastatic pancreatic cancer
the diameter of the middle cerebral artery measured with magnetic resonance angiography

Conditions: Headache; Migraine; MR-Angiography; Healthy Volunteers; GTN; Middle Cerebral Artery

Summary: to examine the ability of mra to measure the effect of gtn on the intra-cranial vascular response during the gtn-induced headache in healthy volunteers.

the only intra cranial structures innervated by sensory nerves, and therefore a possible source of the headpain are the meninges and the large intracerebral arteries. the dilatation of the cerebral vessels may not be the origin of the head pain per se, but measurements of the intra cerebral vascular bed in the past has proven valuable in the migraine-research, and has helped elucidate the basis for the migraine aura (olesen, friberg et al. 1990). the effects of different signal molecules on the intra cerebral vasculature continue to be an important field in the migraine research, in the search for possible pain causing signaling molecules. therefore we have set up at study to examine if mr-angiography (mra) can be used for monitoring of the vascular response after challenge with the known vasodilator gtn. this drug was chosen because it is well characterized and a large body of evidence from earlier studies could serve as background data (thomsen 1997).

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * history of migraine or any other type of primary headaches; any kind of daily medication (including prophylactic headache therapy but not oral contraceptives); excessive use of analgesics (corresponding to \>2 g aspirin/day), pregnancy and all known contraindications for mr-examinations incl. claustrophobia.

Keywords: headache migraine mr-angiography healthy volunteers gtn middle cerebral artery
cpap to improve swallow function post total laryngectomy

Conditions: Oropharyngeal Dysphagia; Laryngectomy; Status

Summary: investigator initiated prospective study to determine whether use of continuous positive airway pressure (cpap) can improve the swallow function in patients who underwent total laryngectomy and are experiencing difficulty swallowing

total laryngectomy is a procedure that involves surgical removal of the larynx and separation of the digestive and airway tracts. the procedure is typically conducted for cases of laryngeal cancer and intractable aspiration. following this procedure, patients are no longer at risk for aspiration; however some patients continue to experience difficulties in propulsion of food or drink throughout the pharynx. previous research has demonstrated a reduction in pharyngeal contractile pressure and increased pharyngeal transit time in patients post laryngectomy. continuous positive airway pressure (cpap) may assist bolus propulsion in these patients by increasing pressure in the direction of bolus flow. this study aims to evaluate the utility of a cpap mask to improve pharyngeal swallow outcomes during video fluoroscopic swallowing exam (vfse) in patients with dysphagia following total laryngectomy. this specific population could be well-suited for this application, since the digestive tract and airway are completely separate and there is no risk of the aspiration into the airway.

Eligibility criteria:
inclusion criteria: * patients at least 2 months after total laryngectomy * undergoing video fluoroscopic swallowing examination exclusion criteria: * patients with 100% neopharyngeal stenosis * patients with active cancer within 2 months of the study * patients with pharyngocutaneous fistula * vulnerable population: adults unable to consent, pregnant women, and prisoners

Keywords: dysphagia oropharyngeal dysphagia total laryngectomy video fluoroscopic swallowing exam (vfse)
pressure wire guided cardiac resynchronisation therapy

Conditions: Heart Failure

Summary: heart failure patients may benefit from having a special pacemaker implanted that can make the heart pump in a more coordinated and efficient way cardiac resynchronisation therapy (crt). for the heart to pump well it is necessary for the pacing wires to be placed in optimal positions. only two thirds of people respond to crt and this may be because of non-ideal pacing wire position. a potential marker for response is the change in heart pump pressure change over time. the aim of this study is to use a specialised wire in the main pumping chamber of the heart to record the pressure changes with the pacing lead in various positions to determine the optimal position. it is postulated that the improved pressure changes will increase the proportion of responders. pilot study work has shown that the work is technically feasible and safe. the initial data has been published in a highly regarded scientific journal. this main study will be a multicentre randomised controlled trial whereby patients will be randomised to either standard treatment or pressure wireguided treatment. the patients in the pressurewire guided arm will have a specialised wire implanted into the main pumping chamber of their heart via a blood vessel at the top of the leg (or less commonly a blood vessel in the wrist). this will measure acute pressure changes over time and the pacing lead will be positioned in the site that gives the greatest change in pressure. if the patients in the pressurewire guided arm fare better than those receiving standard treatment it may alter how a large proportion of heart failure patients are treated around the world. the study requires 282 patients and is likely to take two years to complete.


Eligibility criteria:
inclusion criteria: * patients fulfilling standard criteria for crt * ischaemic or non-ischaemic heart failure exclusion criteria: * contraindication to pressure wire assessment including: * severe aortic valve disease * mechanical aortic valve replacement * severe peripheral vascular disease * lv thrombus

Keywords: heart failure cardiac resynchronisation therapy acute haemodynamic response responder
organization of the dietetic service in a hospital

Conditions: Nutritional Disease; Malnutrition

Summary: in denmark the dieticians can be organized centrally and called upon if needed, or locally in larger units, or very locally related to bed-units. the organization form is based on tradition not on measurements of quality. we wanted to compare the very local form with the traditional centralized. methods: randomized, unblinded, parallel design. the intervention group (it) was nutritionally handled by the dietician, and the control group (c) by the nurses as previously with the possibility for dietetic help from the center.

all patients were screened by nrs-2002 and had their estimated needs calculated (equations in it, tables in c). the it was in addition assessed for adapted weight-loss, counseled with a plan for nutrition and followed-up daily by the dietician if at nutritional risk. all patients were re-screened weekly and had their intake registered. hand-grib-strength (hgs) was measured in both groups at admittance and discharge, and weight three times weekly. the primary endpoint was re-admission rate to hospital within 2 months.

Eligibility criteria:
inclusion criteria: * adult * acutely admitted to hospital exclusion criteria: * dementia * unable to comply with the protocol

Keywords: dietitic service, organization of service
to evaluate the efficacy and safety of caep-01 on eye strain in children with heavy screen use

Conditions: Vision Disorders

Summary: several recent clinical trials have highlighted the potential role of product in promoting eye health.product whose structural and functional characteristics make it a promising bioactive compound in the prevention of several human diseases as well as in the maintenance of a good health status. it might relieve eyestrain in people using computer monitors as suggested who conducted a double-blind randomized clinical trial by enrolling visual display terminal workers and prescribed them product or placebo. study outcomes were objectively evaluated by using a proper instrumentation to measure eye muscle endurance. subjects receiving product experienced a significant relief from eyestrain compared to the placebo group.


Eligibility criteria:
inclusion criteria: 1. girls and boys between the ages 10 to 14. 2. participants who have a history of using a digital device (phone, tablet, computer, etc) at least 4 hours per day, for minimum of last 3 months prior to screening. 3. participants who have complained of eye strain on use of digital device. 4. participant with cvs-q score ≥ 8. 5. participants who have history of playing video game for least 6 hours per week. 6. best corrected visual acuity (bcva) of 20/20. 7. participants with ≤ 12.5 cm and ≥ 6 cm amplitude on accommodation test. 8. participants with parents who are literate enough to understand the essence of study, are informed about the purpose of the study, and understand their rights. 9. participants with parents who are able to give written informed consent and willingness to participate in the study and comply with its procedures exclusion criteria: 1. participant with cvs-q score ≥ 19. 2. asthenopia visual fatigue likert scale score ≤ 2 for each symptom. 3. near point convergence (npc) no further than 10 cm 4. stereopsis of ≥ 40 arc/sec 5. not diagnosed with amblyopia 6. refractive error less than -3 or more than +2 7. participants who wear contact lenses. 8. participants with any diagnosed ocular motility disorder or accommodative/binocular vision issues. 9. participants with a history of eye alignment or binocularity issues. 10. participants who are color-blind. 11. participant on any antioxidant, retinols and carotenoid supplements. 12. participants who have used eye care products within 3 months prior to the screening visit. 13. participants who have been diagnosed with type i diabetes. 14. participants who have been diagnosed with covid-19 one month before the screening visit. 15. participants scheduled to receive any vaccination during the study period. 16. participants who have immunosuppressive disorders or are taking immunosuppressive medication.
the uk caviar study

Conditions: Iron Deficiency; Cardiac Patients; Anaemia; Vascular Patients

Summary: caviar is a multicentre prospective observational study. centres for cardiac and vascular surgery assess and manage patients in different ways before surgery. some centres have introduced the use of intravenous iron therapy for patients with anaemia in the preoperative setting. consequently regional variation exists in the assessment and management of patients before cardiac and vascular surgery. we aim to observe and measure these differing pathways and observe if there is variation in iron deficiency and anaemia and the impact of these variables on patient cardiorespiratory function as well as post-operative outcomes. \[sub-study\] for patients who are receiving intravenous iron therapy as part of their routine clinical care, we wish to observe this effect in more detail. we will assess the impact of the treatment on well-being, blood count and fitness. information will be collected through quality of life questionnaires, total haemoglobin mass test (via blood collection) and fitness testing.


Eligibility criteria:
inclusion criteria: 1. male and female adults aged 18 years or older 2. screening \[hb\] \< 120 g/l (for females) or \< 130g/l (for males) 3. undergoing elective cardiac or vascular surgery: * coronary artery bypass (cabg), or valvular surgery, or combined cabg and valve surgery. * repair or replacement of thoracic or abdominal aorta (open or endovascular). 4. able to provide informed consent 5. (if applicable) able to perform cpet or 6mwt if consented to take part in the sub study exclusion criteria: 1. pregnancy or lactation 2. adults with known underlying history of learning disabilities, or adults who do not have mental capacity to consent for themselves 3. prisoners 4. renal dialysis (current or planned within the next 12 months)
comparison of penetrating keratoplasty and deep lamellar keratoplasty with the big bubble technique for keratoconus

Conditions: Keratoconus

Summary: it is a randomized clinical trial to compare deep lamellar keratoplasty (dlk) using big bubble technique and penetrating keratoplasty (pk) in patients with keratoconus

in this randomized clinical trial 50 keratoconic eyes of 50 patients randomly assigned in two groups: 25 patients underwent dlk with the big bubble technique and the other 25 patients underwent pk with the standard technique using hessburg - barron trephine. one surgeon performed all operations using a 16 bites separate 10-0 nylon sutures. we used a-scan ultrasonic biometry for measuring vitreous length (vl) before surgery. if vl≥15.50mm, a trephine 0.25mm larger than recipient and if vl was \<15.50mm, a trephine 0.50 mm larger than recipient were considered. selective suture removal was started 3 months after operation. quality of vision endothelial cell changes and correlation between refractive outcome and vl in relation to donor-recipient disparity, were measured and analyzed in both pk and dlk 15 mos postoperatively.

Eligibility criteria:
inclusion criteria: * moderate to severe keratoconus * contact lens intolerance * low visual acuity due to anterior stromal scar * age between 15 to 50 years exclusion criteria: * posterior stromal scar with descemets membrane involvement * history of hydrops * fuchs endothelial dystrophy * glaucoma * cataract * history of intraocular surgery * history of vernal keratoconjunctivitis * intraoperative complications * reoperation (resuturing- regraft)

Keywords: keratoconus, penetrating keratoplasty, deep lamellar keratoplasty big bubble technique
effect of variable volume ventilation on lung compliance

Conditions: Lung Injury

Summary: randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation with a constant volume decelerating flow (pressure controlled volume guarantee) ventilation.

randomized controlled trial comparing low inspiratory and expiratory flow during variable volume ventilation (vvv) with a constant volume decelerating flow (pcv pressure controlled volume guarantee) ventilation. after anesthesia induction patients are vvv or pcv ventilated with a positive end expiratory pressure (peep) of 10 cm h2o. average tidal volume is set at 6 ml/kg and end tidal co2 is kept between 30 and 50 mmhg in both groups by adapting breaths per minute between 10 and 16. i/e ratio is set at 1/1 in vvv and at the standard ½ in pcv. dynamic lung compliance is measured before and during pneumoperitoneum. if dynamic lung compliance is less than 40 or decreases below 40 a first lung recruitment (10 sec of 30 up to 40 cmh2o) is given till dyn compliance rises above 40. dynamic lung compliance is further monitored and when value decreases again below 40, a new lung recruitment (lrm) is given and the peep is increased to 15 cm h2o after the second lrm. all patients get an opioid free general anesthesia with anti inflammatory agents and deep nmb with full reversal at end of surgery. the moment and number of lrm performed after induction of anesthesia with the averaged reached lung compliance is used to compare both ventilation methods. the oxygen saturation without oxygen at arrival of pacu and the need for oxygen when saturation drops below 95 % are compared between both groups.

Eligibility criteria:
inclusion criteria: * laparoscopic bariatric surgery requiring mechanical ventilation exclusion criteria: * lung disease requiring oxygen before anesthesia * emergence procedure * spontaneous or assisted ventilation
peripheral arterial disease biomarkers

Conditions: Peripheral Arterial Disease

Summary: the study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression.

several studies have identified markers in the blood (called biomarkers) that are associated with peripheral arterial disease, or clogging up of the blood supply to the leg. there is little understanding however regarding how these respond to intervention, and how they are related to walking distance. this study will increase the understanding of the relationship between peripheral arterial disease state and biomarker expression and enable us to work towards the development of new targets for treatment. participants will be invited to undertake questionnaires and dedicated walking tests alongside regular blood tests to check their biomarker levels. these will be undertaken on a regular basis so the investigators can see what happens over time, such as after a surgical procedure, and see if these markers go back towards normal following intervention.

Eligibility criteria:
inclusion criteria: * aged \> 50 years * symptomatic pad * abpi \<0.8 or tbpi \<0.7 exclusion criteria: * aged \<50 years * current malignancy * rheumatological condition * previous surgical or endovascular intervention for pad * abpi \>0.8 or tbpi \>0.7

Keywords: peripheral arterial disease claudication
study of chemo-immunotherapy in head and neck cancer patients

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to determine safety and feasibility of chemo-immunotherapy using cyclophosphamide, docetaxel, ok-432, and autologous immature dendritic cells for patients with relapsed and refractory head and neck squamous cell carcinoma.


Eligibility criteria:
inclusion criteria: 1. the patients with relapsed and refractory head and neck squamous cell carcinoma 2. 20 years and older 3. ecog performance status 0-1 4. more than 4 weeks must have elapsed from the time of radiation therapy and the last dose of chemotherapy 5. tumor lesions are accessible to intratumoral dendritic cells injection 6. patients who are able to do oral ingestion 7. patients must have normal organ and marrow functions as follows: * hb\>9.0 mg/dl * ht\>25% * wbc\>4000/mm3 * platelet count\>100,000/mm3 * t-bil\<1.5mg/dl * got\<x2.5 institutional upper limit of normal * gpt\<x2.5 institutional upper limit of normal * creatinin\<1.5mg/dl 8. signed informed consent exclusion criteria: 1. less than 20 years 2. patients who test positive for hepatitis b virus, hepatitis c virus or hiv. 3. patients with clinically active infection 4. patients with uncontrolled concurrent illness including cardiovascular disease, pulmonary disease, and bleeding tendency 5. concomitant malignant diseases, brain metastases 6. psychiatric illness 7. treatment with steroids 8. decision of unsuitableness by physician