Kornimate/medical-research-clean huggingface dataset:
open versus laparoscopic left-sided hepatectomy trial

Conditions: Neoplasm, Liver

Summary: open versus laparoscopic left-sided hepatectomy (olleh) trial multi-institutional, prospective and randomized trial in patients undergoing left sided hepatectomy through laparoscopic versus open procedure. primary endpoint: functional recovery secondary endpoint: hospital duration, estimated blood loss, operation time, resection margin status, postoperative complication, mortality, liver function laboratory test, re-admission, quality of life, cosmesis, cost effectiveness

laparoscopic left-sided hepatectomy is widely performed for the treatment of various hepatic neoplasms. many studies have reported that laparoscopic left-sided hepatectomy is safe and effective compared with open conventional left-sided hemihepatectomy. however, prospective study is rare and there is no randomized controlled trial. the surgeons who are affiliated at a medical center in capital area of korea launched the open versus laparoscopic left-sided hepatectomy (olleh) trial to verify the surgical outcome of laparoscopic left-sided hepatectomy. laparoscopic surgery has benefits that less wound and less pain. the hypothesis of the study is 'the laparoscopic left-sided hemihepatectomy is better than open surgery from functional recovery.

Eligibility criteria:
inclusion criteria: 1. patient who underwent open or laparoscopic left-sided hepatectomy for benign or malignant neoplasm of the liver 2. child-pugh a without portal hypertension * no portosystemic shunt * no splenomegaly * platelet count \>100,000/ul 3. age 18 to 80 4. eastern cooperative oncology group performance status: 0 or 1 5. american society of anesthesiology class: i or ii 6. informed consent exclusion criteria: 1. additional intervention to the liver (radio frequent ablation, percutaneous ethanol. injection therapy or others) 2. combined hepatectomy 3. bile duct reconstruction 4. intrahepatic duct stone 5. upper abdominal laparotomy history 6. previous hepatectomy 7. combined operation for extrahepatic disease 8. vulnerable population (mental retardation, pregnancy) 9. patient who participated in other clinical trial within 6 months
effects of vitamin d on lipids

Conditions: Hypercholesterolemia; Vitamin D Deficiency

Summary: the purpose of this study is to examine whether oral vitamin d supplementation in people with inadequate vitamin d concentrations will lower ldl-cholesterol and total cholesterol concentrations.

data from previous trials suggest a protective role of vitamin d in cardiovascular disease. a recent meta-analysis of trials with at least 5 years of follow-up of vitamin d supplementation concluded that intake of vitamin d supplements may decrease total mortality, but that the relationship between baseline vitamin d status, dose of vitamin d supplements, and total mortality rates remains to be investigated. an even more recent analysis of vitamin d concentrations found that participants with vitamin d deficiency and hypertension were about twice as likely as people without hypertension and vitamin d deficiency to have a cardiovascular event during the study. the main hypothesis to be tested is that normalization of vitamin d levels will lower ldl-cholesterol and total cholesterol concentrations in people with inadequate vitamin d concentrations as determined by circulating 25-oh vitamin d. subhypotheses are that hdl-cholesterol, triglycerides, lipoprotein(a), hs c-reactive protein and hemoglobin a1c will not be affected, and that cyp3a-metabolized medication levels will decrease with vitamin d replacement. this is a 12-week randomized double-blind dose titration study of the effects of supplementation with 1000-2000 iu vitamin d on lipid and vitamin d concentrations. dietary intake of vitamin d will be estimated by dietary recall questionnaire or analysis of three non-consecutive 24-hour dietary intake logs.

Eligibility criteria:
inclusion criteria: * any medically stable person able to swallow pills * inadequate vitamin d status at screening visit exclusion criteria: * clinical instability of underlying disease process (e.g., recent hospitalization, change of dosages of medications within the prior two weeks, or new medications within one month) * recent transfusion * severe renal failure or dialysis * hypercalcemia * malignancy under active treatment * feeding tube * intestinal bypass surgery * inability to swallow tablets

Keywords: cholesterol ldl-cholesterol cholecalciferol lipids c-reactive protein
pbr28 pet and inflammatory arthritis

Conditions: Rheumatoid Arthritis; Psoriatic Arthritis

Summary: the importance of the detection of early inflammatory arthritis is recognised as being essential to the prevention of permanent joint damage. furthermore, drug development in inflammatory arthritis is in increasing need of imaging that is able to sensitively and accurately detect and quantify inflammation in a reproducible and objective manner. there is an increasing body of evidence to support the role of pet-ct for these indications. the pet tracer 11cpbr28 is specific to the translocator protein (tspo) highly expressed on activated macrophages. in this proof of principle study, the investigators aim to ascertain whether or not the pet tracer 11cpbr28 is taken up in inflamed joints. the investigators also aim to explore the significance of tspo to inflammatory arthritis, through blood and joint lining samples.

the investigators aim to recruit a minimum of 12 patients with known, active rheumatoid or psoriatic arthritis in the feet and ankles. patients will first undergo a screening genotyping test; low affinity binders for pbr28 pet will be excluded from this pilot study. those patients meeting inclusion criteria, will then undergo a pet-ct localised to feet and ankles that have been identified to be clinically inflamed (on examination and ultrasound at the screening visit). after pet-ct, patients will undergo synovial biopsy of one joint imaged. after 6 patients have undergone pet-ct, an interim analysis will be undertaken, to optimise pet scan duration and to alter the group of joints being imaged with ct.

Eligibility criteria:
inclusion criteria: * patients with known rheumatoid arthritis or psoriatic arthritis, with at least one swollen joint, with evidence of joint inflammation in the feet and/or ankles (on clinical examination and/or ultrasound) exclusion criteria: * pregnant and breastfeeding patients those with metalwork in feet/ankles patients unable to lie on their back patient has been identified as a low affinity \[11c\]pbr28 binder according to peripheral blood genotyping assay the patient has any significant co-morbidity precluding participation as judged by the study doctor
sea swimming for treatment of depression and anxiety

Conditions: Depression, Anxiety

Summary: there is a developing evidence to suggest that open cold water swimming could have an impact on depression and anxiety: * anecdotal reports of benefits to mental wellbeing as a result of regular open water bathing * research suggesting exercise is as effective as medication and talking therapies in the treatment of depression * ecotherapy (offering therapeutic intervention in nature) has a developing evidence base * cold water may have an impact on the inflammatory system which has been linked to depression the aim of this study is to recruit 10 people with mild to moderately severe depression to a sea swimming course, alongside their standard care. the course would involve two groups of 5, participating in eight sea sessions under the guidance and supervision of swim instructors and lifeguards. the primary aim of the course is to determine the recruitment rate and compliance with the course. the secondary aims of the course are to determine the impact on mental health through questionnaires for depression (phq9), anxiety (gad7), functioning in daily life (wsas). the inflammatory marker - c- reactive protein (crp), will also be measured to monitor the inflammatory process in relation to psychological outcomes and the timeline of the course. participants will need to commit to two sessions a week. it is anticipated that participants will need to commit around 2 hours of their time to the study each week. it would take around ten months from recruitment to follow-up. participants would be able to leave the study at any time. participants would engage in routine care alongside the course. sea swimming can be a dangerous activity but participants would be well supported, in small groups and would only sea swim in safe conditions. participants will be asked to report any medical conditions to ensure they could not be adversely effected.


Eligibility criteria:
inclusion criteria: * adults living in north devon and able to attend the course. * phq-9 score 5-19 * able to swim two lengths of a 25m pool exclusion criteria: * physical health problems that would make cold water immersion a risk including significant heart problems, inadequately treated high blood pressure e.g. new diagnosis not on stable medication, significantly reduced mobility. * experience of other mental health problems at a significant level * not able to swim or very anxious about getting into water * suicide risk * unable to speak english (as the sea swimming course will be conducted in english) * unable to consent due to lack of capacity
tomvasc - vascular effects of tomato extract

Conditions: Ischemic Heart Disease; Transient Ischemic Attack; Stroke; Peripheral Vascular Disease

Summary: does tomato extract improve blood vessel function in healthy people and people with cardiovascular disease? atherosclerosis ('furring' of the arteries) affects the functioning of blood vessels, narrowing and eventually blocking them, causing conditions like heart attack and stroke. the mediterranean diet, which is rich in tomatoes and tomato-based products, has been shown to be associated with a reduced risk of blood vessel damage. in this double blind, placebo-controlled randomised study, the investigators will investigate whether a food supplement containing a standardised extract of tomato improves blood vessel function in both healthy people (aged 40-80), and people with a history of cardiovascular disease. the food supplement is on sale to the public, and the investigators are testing the standard dose. approximately 72 people will take part at the clinical pharmacology unit at the acci building, cambridge university hospitals nhs trust. after they have passed screening tests, participants will be allocated by chance to receive either the tomato extract product (ateronon), or a matching placebo (a dummy capsule with no active ingredients), which they will take once a day for 8 weeks. at the beginning and end of the treatment period, the investigators will test blood vessel stiffness using an ecg machine and external probe. the investigators will also measure forearm blood flow, which involves infusing 3 separate agents that affect how the lining of the blood vessel wall works, and helps to assess whether this is affected by the study treatment. blood tests will also be used to look at how the food supplement is working and its effects on cholesterol and markers of inflammation. including the screening period, and a follow-up telephone call two weeks after the end of treatment, participants will be in the study for 14 weeks.


Eligibility criteria:
healthy group inclusion criteria: * aged between 30 and 80 years * non-smoking exclusion criteria: * hypertension or other cardiovascular disease * significant renal, respiratory or neurological disease * diabetes mellitus * bmi\>32, bmi\<18 * use of vasoactive medication * use of heparin or warfarin * allergy/intolerance to study substance ingredients stable cardiovascular disease group inclusion criteria: * aged between 40 and 80 years * previous ischaemic heart disease (any of previous myocardial infarction, coronary stent, angina), transient ischaemic attack or stroke disease or peripheral vascular disease * if taking a statin, dose must have been stable over preceding 2 months exclusion criteria: * uncontrolled hypertension * bmi\>33 * use of heparin or warfarin * allergy/intolerance to study substance ingredients

Keywords: healthy adults
korus: a device to prevent sudden unexpected death in epilepsy (sudep)

Conditions: Epilepsy

Summary: the goal of this feasibility study is to test the korus smart mattress in healthy volunteers. the main questions it aims to answer are: * can korus accurately detect body position in bed (left, right, supine, prone) * can korus reposition the subject from a prone to recovery (sideways) position? participants will be asked to lie down on korus and turn into various positions; when the prone position is detected, they will be repositioned.

korus is a a smart mattress consisting entirely of pneumatically inflatable smartcells with embedded sensors. it is designed to detect a subject's body position an inflate the proper smartcells to reposition a subject from the prone to the recovery (sideways) position. healthy control subjects will be recruited to test korus' sensing system and its performance in repositioning the subject. korus will utilize specialized sensors and a computer learning algorithm to detect the subject's body position. based on this data, korus will activate the appropriate smart cells to reposition the subject.

Eligibility criteria:
inclusion criteria: • adults age 18-65; at least 30% of subjects will be self-identified as prone sleepers exclusion criteria: any significant medical history for which body movements will potentially be harmful, including but not limited to: * history of neurological dysfunction, including spinal cord abnormalities * history of psychiatric disorder, including anxiety * history of cardiac dysfunction * history of osteoporosis or osteopenia * history of significant orthopedic dysfunction * history of falls * history of sleep disorder * taking neuroactive medications * taking anticoagulants * current recreational drug use * bmi under 18 or over 30 * systolic bp \>180 or \<90 * open wounds
a phase 2a dose escalation study with slv334 in patients with traumatic brain injury.

Conditions: Traumatic Brain Injury

Summary: a randomized, double blind, placebo controlled, phase 2 dose escalation study to investigate the safety and pharmacokinetics after single and multiple i.v. doses of slv334 in sequential cohorts of patients with moderate and severe traumatic brain injury.


Eligibility criteria:
inclusion criteria 1. male or female patients, age between 16 and 70 years, inclusive. 2. sustained a closed \[non-penetrating\] head trauma no more than 8 hours before initiation of drug treatment with study drug at the study hospital; 3. tbi diagnosed by history, clinical examination with gcs of 12 or less. 4. evidence of tbi confirmed by abnormalities on ct scan 5. clinical indication to monitor icp 6. informed consent is given. exclusion criteria 1. any spinal cord injury; 2. pregnant or lactating women; 3. patients with penetrating head injury; 4. bilaterally fixed dilated pupils at the time of randomization; 5. coma suspected to be primarily due to other causes than head injury such as drug or alcohol overdose; 6. severe multiple trauma or major organ failure (uncontrolled visceral bleeding, unstable cardio-respiratory or renal function); 7. known treatment with another investigational drug therapy within 30 days of injury. 8. life expectancy of less than 24 hours.

Keywords: brain injury
a post-approval study of the linx® reflux management system

Conditions: Gastroesophageal Reflux Disease (GERD)

Summary: a post-approval study of the linx® reflux management system in a prospective, multicenter, single-arm study, with patients as their own control to monitor the safety and efficacy of the linx implant procedure and device in a post-approval environment to supplement existing safety and efficacy data.


Eligibility criteria:
inclusion criteria: * patient is a candidate for treatment with the linx reflux management system * patient has provided written informed consent for participation in the post-approval study. * patient has indicated a willingness to comply with study requirements and the follow-up schedule and assessments. * patient has been diagnosed with gerd as defined by abnormal ph testing. * patient continues to have chronic gerd symptoms despite maximum medical therapy for the treatment of reflux. exclusion criteria: * patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials. * known circumstances that would make it unlikely for the patient to complete follow-up through 60 months.
the wire-free invasive functional imaging (wifi) study

Conditions: Coronary Artery Disease

Summary: quantitative flow ratio (qfr) is a new method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections. the purpose of the wifi study is to evaluate feasibility of qfr when performed during coronary angiography and compare diagnostic accuracy to standard ffr.

background: patients at high risk of having one or more coronary stenosis are evaluated routinely by invasive coronary angiography (cag) and often in combination with measurement of fractional flow reserve (ffr) to assess the functional significance of identified stenosis. ffr is assessed during cag by advancing a wire with a pressure transducer towards the stenosis and measure the ratio in pressure between the two sides of the stenosis during maximum blood flow (hyperaemia) induced by adenosine infusion. the solid evidence for ffr evaluation of coronary stenosis and the relative simplicity in performing the measurements have supported adoption of an ffr based strategy in many centers but the need for interrogating the stenosis by a pressure wire and the cost of the wire and the drug inducing hyperaemia limits more widespread adoption. quantitative flow ratio is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure in the vessel based on two angiographic projections. the purpose of the wifi study is to evaluate feasibility of qfr when performed during coronary angiography and compare diagnostic accuracy to standard ffr. hypothesis: qfr can be assessed during cag for stenosis interrogated by ffr methods: proof-of-concept, prospective, observational, single arm study with inclusion of 100 patients. clinical follow-up by telephone call after one year. a stenosis with indication for ffr is identified and at least two angiographic projections rotated at least 25 degrees around the target vessel are acquired during resting conditions. qfr is calculated on-line using the medis suite application and simultaneously to the operator performing the ffr measurement using i.v. adenosine. the qfr observer is blinded to the ffr measurement. qfr is reassessed off-line by internal observer and by an external core laboratory. both blinded to ffr results. ffr is assessed in core laboratory by a different blinded observer all data are entered and stored in a protected and logged trial management system (trialpartner).

Eligibility criteria:
inclusion criteria: * stable angina pectoris and secondary evaluation of stenosis after acute myocardial infarction (ami) * age \> 18 years * signed informed consent exclusion criteria: * myocardial infarction within 72 hours * severe asthma and chronic obstructive pulmonary disease * severe heart failure (nyha≥iii) * s-creatinine\>120µmol/l * allergy to contrast media or adenosine * stenosis in vein graft * ostial left main stenosis * severe tortuosity * atrial fibrillation

Keywords: fractional flow reserve coronary artery disease
effect of walking on brain fuel consumption in mild alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the aim of this study is to evaluate the effect of a 3-month walking program on brain energy metabolism in patient with mild alzheimer's disease (ad). two groups of sedentary patients with mild ad are followed and compared over a 3-month period of time: control (non-active) and walking (from 15 to 45 minutes of exercise on a treadmill, 3 times a week for 12 weeks) groups. all the participants are evaluated on their cognition, brain volumes (mri) and brain fuel consumption (pet scan with 18-fdg and 11c-acac) at the beginning and at the end of the study.


Eligibility criteria:
inclusion criteria: * diagnosis of mild alzheimer's disease (nincds-adrda criteria) * taking cholinesterase inhibitors * sedentary * ability to do physical exercise exclusion criteria: * parkinson disease * down syndrome * epilepsy or concussion * drug or alcohol abuse * past psychiatric history * vitamin b12 deficiency * uncontrolled diabetes or thyroid function
the first therapeutic intervention in malignant pleural effusion trial

Conditions: Malignant Pleural Effusion; Pleural Effusion

Summary: fluid caused by cancer cells may accumulate in the lining of the lung. draining the fluid with a chest tube may relieve pain and shortness of breath. to stop the fluid from coming back again, patients are given a medicine (talc) into the chest drain to seal up the space around the lung. this procedure is known as pleurodesis. this sometimes causes pain and discomfort, and the investigators do not know the best way of preventing this. the investigators hope to find the best way to prevent pain during pleurodesis.

patients with metastatic cancer often have fluid collecting around the lung as a result of cancer cells spreading to the membranes adjacent to the lung (malignant pleural effusion). the standard way of treating this condition, which may cause unpleasant symptoms such as breathlessness and cough, is to drain the fluid off and then seal the cavity, using a drug (talc) given into the chest drain. talc causes inflammation in the lining of the lung and chest wall, sticking the two surfaces together and preventing fluid from recurring. this procedure is often very painful; the pain may be partly related to the size of the chest tube used and the type of analgesia taken by the patient during the procedure. reducing the amount of pain associated with this procedure would be a substantial benefit for patients undergoing this procedure. this trial is looking at which of two different drug regimens is more effective in preventing pleurodesis pain, and whether the size of chest tube influences pain. it will also address whether either of these influences success rate of pleurodesis. we hope to learn whether the size of chest drain or the type of pain medication given (ibuprofen or morphine) influences the amount of pain felt after the pleurodesis procedure. we hope to find the best way of preventing pain during this procedure.

Eligibility criteria:
inclusion criteria: 1. clinically confident diagnosis of malignant pleural effusion requiring pleurodesis. the diagnosis may be established by one of: * histologically proven pleural malignancy or * typical features of pleural malignancy seen on direct vision during thoracoscopy or * pleural effusion in the context of histologically proven cancer elsewhere 2. expected survival more than 1 month 3. written informed consent exclusion criteria: 1. age \< 18 years 2. primary lymphoma or small cell lung carcinoma 3. patients who are pregnant or lactating 4. inability to give informed consent 5. history of gi bleeding or of untreated peptic ulceration 6. known sensitivity to non-steroidal anti-inflammatory drugs (nsaids)/opiates/acetaminophen 7. hypercapnic respiratory failure 8. known intravenous drug abuse 9. severe renal or liver disease 10. known bleeding diathesis 11. warfarin therapy 12. current or recent (within 2 weeks) corticosteroid steroid therapy

Keywords: pleural malignancy pleural effusion pleurodesis chest tube cancer cancer pain management