Kornimate/medical-research-clean huggingface dataset:
rt001 in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: rt001-014 is a randomized, double-blind, placebo-controlled, phase 2 study to assess efficacy, long term safety and tolerability of rt001 in subjects with amyotrophic lateral sclerosis

forty subjects at 4 eu sites will undergo baseline examination, and then be randomized 1:1 to receive either rt001 or placebo. repeat visits will occur every 2 months. the final visit will be at 6 months.

Eligibility criteria:
inclusion criteria: 1. male or female subject with age 20 years to 75 years at the time of signed consent 2. patients who are defined as "definite als," "probable als" or "probable-laboratory-supported als," met diagnostic criteria revised el escorial for airlie house. 3. alsfrs-r \> 20 4. patients who can eat a meal, excrete, or move with oneself alone, and do not need assistance in everyday life 5. patients of less than 3 years after the onset of als 6. subject has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend) 7. if patients are duly capable of study consent but are unable to sign by themselves due to aggravation of disease condition, written informed consent can be obtained from a legally authorized representative who can sign on behalf of the patients after confirming the patients' agreement to study participation exclusion criteria: 1. received treatment with other experimental therapies within the last 30 days prior to the first dose 2. previously received treatment with rt001 3. refusal to discontinue fish oils or other oil-based supplements for the duration of the study (screening till last study procedure completed) 4. svc \< 70 at screening 5. subject has a feeding tube or the need for a feeding tube is anticipated within the first 24 weeks after enrollment 6. subject resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period 7. evidence of any clinically significant neurological disorder other than als 8. the subject has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to dsm-v or icd-10 criteria 9. the subject has a significant pulmonary disorder not attributed to als or who require treatments that might complicate the evaluation of the effect of als on respiratory function 10. subject has had a significant illness or infection requiring medical intervention in the past 30 days 11. female who is breastfeeding or has a positive pregnancy test 12. male participant or female participant of childbearing potential, who is sexually active and unwilling/unable to use a medically acceptable and effective double barrier birth control method throughout the study 13. unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to return for visits as scheduled 14. history, within the last 2 years, of alcohol abuse or physical opioid dependence
unmasking concealed arrhythmia syndromes

Conditions: Brugada ECG Patterns; Brugada Syndrome (BrS)

Summary: this study seeks to evaluate whether using non-invasive electrocardiograph (ecg) techniques, including long term ecg monitoring with wearable ecgs, can improve the detection of concealed brugada syndrome.

application of long term continuous ecg monitoring via ecg wearables and ambulatory ecg monitors to detect manifestations of brugada syndrome. this approach will be combined with development of an ai (artificial intelligence) enabled ecg platform to automate brugada ecg detection and analysis. the protocol will comprise the following parts: study a: brugada ecg ai development. this will automate the recognition of the type 1 brugada ecg pattern on 12 lead ecgs. study b: remote arrhythmia diagnostics. a prospective observational study whereby recruited participants will be fitted with a wearable ecg or cardiac monitor to undergo continuous long term ambulatory ecg monitoring. the algorithms developed in study a will be applied to long term ecg data captured in this study. study c: arrhythmic risk stratification using ultra-high-frequency ecg. this exploratory study will look for markers of arrhythmic risk in patients with manifest and concealed arrhythmia syndromes.

Eligibility criteria:
inclusion criteria: * adults willing to take part * able to give consent exclusion criteria: * unable to give consent * children age \ 100 years old

Keywords: brugada syndrome ambulatory ecg wearable ecg long term continuous monitoring ai ecg
ct for diagnosis of implant stability in revision arthroplasty

Conditions: Hip Arthroplasty; Knee Arthroplasty; Osteolysis

Summary: all patients over 18 who undergo a revision of hip or knee arthroplasty will be included. patients undergo a ct of the hip joint. a radiologist will mark the presence of cysts and bone loss and will assess implant stability. after the surgery, the surgeon will fill a similar form.


Eligibility criteria:
inclusion criteria: * patients admitted for hip or knee revision arthroplasty * age over 18 exclusion criteria: * fractures * dislocations
balance impairment and falls risk in people with lower limb arthritis, and can these be improved with exercise?

Conditions: Arthritis

Summary: arthritis has been reported as a risk factor for falls. few studies have investigated the effect of balance training on balance performance in women with lower limb arthritis. the aim of this study was to evaluate the effectiveness of a four-month individualised home exercise programme in improving gait stability and balance for women with arthritis.


Eligibility criteria:
inclusion criteria: * lower limb osteoarthritis or lower limb rheumatoid arthritis exclusion criteria: participants were excluded if they: * did not have lower limb arthritis, * were bed bound, * had additional co-morbidities that confer risk of falls (such as parkinson's disease, stroke, multiple sclerosis, history of cardiac syncope, epilepsy), * had undergone lower limb surgery within the previous twelve months, and/or * had synvisc or a corticosteroid injection within the last six months.

Keywords: arthritis exercise balance - postural control
laparoscopic bariatric surgery and erector spinae plane block

Conditions: Obesity; Postoperative Pain; Bariatric Surgery

Summary: the aim of the study is to evaluate the effect of erector spinae plane (esp) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

laparoscopic sleeve gastrectomy is one of the most common surgical procedure that is chosen for bariatric surgery. postoperative pain after bariatric surgery can de significant. narcotic analgesics are often used to manage the postoperative pain in patients undergoing bariatric surgery. however, these drugs causes many undesirable adverse effects such as nausea, constipation, and respiratory depression. the ultrasound (usg) guided esp block was first defined in 2016. with the administration of local anesthesia between the transverse process of the vertebra and the erector spinae muscle, it is stated that the effect mechanism of esp is that spread blocks the ventral and dorsal rami to the paravertebral area. in the literature, it has been shown that bilateral usg guided esp block provides effective analgesia after bariatric surgery. the aim of the study is to evaluate the effect of esp block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery

Eligibility criteria:
inclusion criteria: * elective bariatric surgery * american society of anesthesiology (asa) ii-iii * 18 - 65 years * body mass index (bmi) 40-60 kg/m2 exclusion criteria: * asa ≥4 * under 18 years of age or over 65 years of age * declining to give written informed consent * have neurological and/or psychiatric disorders * cooperation cannot be established * accompanying laparoscopic cholecystectomy or paraumbilical hernia repair * history of bariatric surgery * the block cannot be applied due to bleeding disorders or localized skin infection at the injection site * with hepatic, neuromuscular, cardiac and/or renal failure * history of allergy to the local anesthetics * patients undergoing open surgery

Keywords: erector spinae plane (esp) block laparoscopic bariatric surgery obesity postoperative pain
objective assessment of sensory nerve fiber sensitivity

Conditions: Nerve Pain

Summary: this pilot study utilizes a unique technology to determine nerve fiber sensitivity. this will allow us to determine whether this method and device can discern changes in pain intensity and type, which is predicated on differing nerve fiber sensitivities.


Eligibility criteria:
inclusion criteria: 1. the subject is 18 to 65 years of age 2. the subject is willing to have a tourniquet applied as part of the study 3. the subject is willing and able to provide written informed consent to the study participation 4. the subject is willing and able to comply with all study procedures exclusion criteria: 1. eye pathology precluding pupillometry 2. subjects who have ongoing pain requiring medical attention 3. subjects who are not normotensive 4. subjects with peripheral vascular disease 5. subjects who are morbidly obese (bmi \>40) 6. subjects with diabetes or diabetic retinopathy 7. subjects who are or may be pregnant 8. subjects with cardiac disease 9. subjects with neuropathic disease states
comparison of the pao2/fio2 ratio to other oxygenation indexes for the classification of severity of acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: in mechanically ventilated patients the pao2/fio2 ratio might not be the best reflection of the severity of ards. it does not incorporate variables and settings used during mechanical ventilatory support such as the positive end expiratory pressure (peep), inspiratory time to expiratory time ratio (ti:te), and the peak alveolar pressure (palv). the aim is to identify a new oxygenation index for stratification of severity of ards


Eligibility criteria:
inclusion criteria: * patients receiving mechanical ventilation in the intensive care unit. * patients in whom the managing medical team requested an arterial blood gas (abg) analysis. exclusion criteria: * patients in whom arterial blood gas could not be obtained or not ordered.
long-term results of bilateral thoracoscopic ablation for stand-alone atrial fibrillation

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (afib) represents the most frequent cardiac arrhythmia whose prevalence appears to be increasing in the general population. furthermore, this arrhythmia determines an increased risk of neurological complications (stroke) and, consequently, of mortality and morbidity. currently, the first choice for the treatment of afib is represented by the use of antiarrhythmic drugs. in patients who do not respond to pharmacological treatment, the esc 2016 european guidelines recommend the execution of transcatheter ablation (class i, level of evidence a). however, minimally invasive pulmonary vein isolation surgery (pvi) is recommended for subjects who are not even responsive to transcatheter ablation (class iia, level of evidence b). previous studies have demonstrated good short-term results of thoracoscopic afib ablation using pvi, with a 1-year freedom from atrial fibrillation recurrence without antiarrhythmic drugs of approximately 64-73%. however, only a few authors have described the medium-long term follow-up outcomes. the aim of this study is to report the long-term follow-up data of ablation of isolated, predominantly paroxysmal atrial fibrillation performed by isolation of the pulmonary veins by radiofrequency in bilateral thoracoscopy.


Eligibility criteria:
inclusion criteria: * age between 20 and 80 years old; * isolated atrial fibrillation (predominantly paroxysmal); * patients undergoing ablation of atrial fibrillation (both paroxysmal and persistent) by isolation of the pulmonary veins by radiofrequency in thoracoscopy. exclusion criteria: * age under 20 or over 80; * previous trauma/deformity of the rib cage limiting the thoracoscopic approach; * previous pleurisy or thoracic operations (e.g. lobectomies) conditioning the possible appearance of pleural adhesions limiting the thoracoscopic approach.
fructose-induced intestinal de novo lipogenesis

Conditions: Obesity

Summary: 8 healthy volunteers, 8 pre-bypass obese subjects, 8 subjects between 12-18 months post-bypass, and 8 subjects matched to the post-bypass patients will be studied in two sub-studies sub-study 1) after ingestion of two or three different of the following test-meals: a)cream and whey protein b)cream, whey protein and fructose + 13c6 fructose c)test meal with cream, whey protein, fructose and glucose + 13c6 fructose their intestinal de novo lipogenesis will be estimated by measuring 13c-palmitate on triglyceride-rich lipoprotein particles associated with apob48 in blood sub-study 2) after ingestion of two or three different of the following test-meals: a)cream labelled with 13c6 palmitic acid and whey protein b))cream labelled with 13c6 palmitic acid, whey protein, fructose and glucose their intestinal de novo lipogenesis will be estimated by measuring 13c-palmitate on triglyceride-rich lipoprotein particles associated with apob48 in blood in sub-study 1 their exogenous lipid absorption kinetics will be assessed by measuring 13c palmitate on triglyceride-rich lipoprotein particles associated with apob48 in sub-study 2


Eligibility criteria:
inclusion criteria: * age 18-50 years * sex male or female * less than 2 kg body weight change over the past 3 months subjects exclusion criteria: * antidiabetic and hypolipemic drugs * alcohol consumption \>20g/day * severe eating disorders * severe psychological problems * vegetarian diet or other specific diet * consumption of illicit substances * pregnancy * weight gain or weight loss \> 1 kg in the last 3 months

Keywords: de novo lipogenesis fructose roux-en-y gastric bypass post-prandial triglycerides
intermittent cefoxitin administration versus loading bolus followed by continuous infusion for the prevention of surgical site infection in colorectal surgery

Conditions: Antibiotic Prophylaxis; Colorectal Surgery

Summary: the goal of this prospective, multicentre, double-blind, randomized clinical trial is to compare intermittent cefoxitin administration to loading bolus followed by continuous infusion for surgical antibiotic prophylaxis in colorectal surgery. the main objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over standard of care boluses in reducing ssi within 30 days after colorectal surgery


Eligibility criteria:
inclusion criteria: * adult patients (≥18 years) * undergoing colorectal surgery (predictable duration \> 90 min) exclusion criteria: * patients with known history of hypersensitivity to cefoxitin or others beta-lactams * patients with extreme severe obesity (defined by a body mass index greater than 50 kg/m2) * patients with severe renal insufficiency (clearance creatinine \< 30ml/min) * active bacterial infection at the time of surgery or recent antimicrobial therapy (up to 2 weeks before surgery) except for oral surgical antibiotic prophylaxis

Keywords: cefoxitin
bion for occipital nerve stimulation

Conditions: Chronic Headaches

Summary: this is a prospective, single-centre, cross-over study designed to evaluate the safety and efficacy of using the bion, an implantable medical device, for the treatment of chronic headaches. the clinical study is proposed to determine the anticipated adverse event rate and treatment outcomes at the conclusion of the study. each trial subject will serve as his/her own control.


Eligibility criteria:
inclusion criteria: 1. be diagnosed with chronic migraine or primary chronic daily headache 2. have headaches characterized by pain 3. be 18 years of age or older; 4. be willing and able to follow all study-related procedures during course of study; 5. have exhibited refractoriness to two acute medication regimens and two prophylactic medications from two separate preventive classes. exclusion criteria: 1. have received a botulinum toxin (botox) injection for treatment of headache within the last 90 days; 2. have previously undergone destructive ganglionectomy 3. have had a previous surgery in the intended implant area; 4. have arnold-chiari malformation; 5. have participated within the last 30 days or plan to participate during this study in another device or drug trial; 6. be pregnant or planning on becoming pregnant during the study period; 7. have an implanted electrical device (e.g., pacemaker, spinal cord stimulator) that may interfere with this therapy; 8. demonstrate significant psychological signs, substance abuse symptoms, or behavioral problems on examination and/or history that, in the investigator's judgment, render them inappropriate for the study; 9. currently require, or be likely to require, diathermy; 10. have other medical conditions that the investigator believes would confound the study.

Keywords: chronic headaches greater occipital nerve stimulation
impact of early peri-operative use of polymyxin-b hemoperfusion in septic patients undergoing emergent abdominal surgery

Conditions: Abdominal Sepsis; Peritonitis; Colon Perforation

Summary: septic shock of intra-abdominal origin is likely due to gram-negative bacteria or mixed pathogens and associated with high levels of endotoxin. the injury to the endothelium results in an increase of endothelial permeability, interstitial edema and release of nitric oxide (no) that is a very potent vasodilatator. \[6\] polymyxins obtained from the gram-positive bacterium bacillus polymyxa are antibiotics known for their ability to bind lps in the outer membrane of the gram-negative bacterial cell wall as well as free endotoxins with high affinity. polymyxin-b has been shown to block the activation of cells by a wide variety of lps. studies converged to show an improvement in the treatment of septic shock by removing circulating endotoxin.starting polymyxin-b hemoperfusion during the operative time is to block the initiation of various deleterious biological cascades induced by endotoxemia such as systemic inflammation, disseminated coagulation disorders, and shock, leading to organ dysfunction and death.


Eligibility criteria:
inclusion criteria: * adults \> 18 years * severe sepsis\*or septic shock as define by the acccp/sccm consensus conference, of abdominal origin * need for emergent abdominal surgery procedure under general anesthesia with expected duration of ≥ 120 min (in and out patients) for bowel perforation, ileus or peritonitis exclusion criteria: * patients younger than 18 years * organ transplantation in the last year * terminally ill patients: do-not-resuscitate order, perceived to die within 48 hrs of admission * known pregnancy or diagnosed by us or ct-scan (\>14 weeks) * history of sensitivity to polymyxin-b or to anticoagulant ( heparin) * uncontrolled hemorrhage within the last 24h * severe granulocytopenia ( leukocyte count of \< 500/µl) * severe thrombocytopenia ( platelets count of \< 30'000/µl) * need for cpr pre-operatively

Keywords: hemoperfusion polymyxin-b emergency abdominal surgery sepsis endotoxin
allopurinol in acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the pathogenesis of coronary heart disease is closely related to inflammation. il-1 beta is an effective target for anti-inflammatory treatment of coronary heart disease. allopurinol is a drug used for treating hyperuricemia and gout for many years. recently, allopurinol has been proved to inhibit the production of nlrp3 in monocytes and reduce the level of il-1beta, resulting in the decrease of tnf-alpha, il-6 and crp. thus, in this study, the investigators aim to evaluate the efficacy and safety of allopurinol sustained-release capsules on improving the stability of coronary plaque in patients with acute coronary syndrome treated by conventional standardized therapy by the single-center, prospective, randomized, double-blind and controlled methods, which would provide new strategies for the treatment of coronary heart disease.


Eligibility criteria:
inclusion criteria: 1. the people who understand and would sign the informed consent voluntarily; 2. aged 18 to 80 years old; 3. hospitalized patients diagnosed as acute coronary syndrome in the past 1 months; 1. hscrp \> 2mg/l; 2. allopurinol allergy gene hla-b5801 was negative. exclusion criteria: 1. history of coronary artery bypass grafting; 2. allergy to allopurinol or any excipient; 3. administration of allopurinol or other uric-acid-lowering drugs within 7 days before randomization; 4. abnormal liver function (alt \>1.5 fold of the upper limit); 5. renal dysfunction (creatinine clearance rate \<45 ml/min); 6. thrombocytopenia (plt\<100g/l); 7. gout patients; 8. uncontrolled infectious diseases in screening period; 9. thyroid dysfunction, moderate to severe anemia (hemoglobin \< 90g/l), systemic lupus erythematosus, malignant hematopathy, leukopenia, asthma, inflammatory bowel disease and other immune diseases were found during the screening period; 10. non-steroidal anti-inflammatory drugs, steroid hormone, immunomodulatory and chemotherapeutic drugs not included in the study protocol should be taken for a long time during the study period; 11. the history of surgery or interventional operation within 6 months before the screening period; 12. patients with mental disorders such as anxiety or depression; 13. pregnant women, lactating women or women of childbearing age who did not use effective contraceptive measures ; 14. patients who participated in other clinical trials 3 months before the screening period; 15. the researchers judged that patients were not suitable for this clinical trials.
retrospective analysis of prismaflex hf20 set versus ppcrrt registry

Conditions: Acute Renal Failure (ARF); Acute Kidney Injury (AKI); Fluid Overload in Dialysis Patients

Summary: a retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (crrt) using the hf20 set. data will be compared with a similar population (weighting 8-20 kg) from the ppcrrt registry who received crrt with prismaflex m60 sets.

this study aims to compare patient outcomes after treatment with hf20 based crrt to the historical ppcrrt registry. data from eligible patient records will be collected, starting from january 2008 to most recent in canada and from january 2020 to most recent in the us. the ppcrrt registry used a prospective observational format whereby de-identified data on patients and crrt circuits were collected from 13 participating centers across the us between 2001 jan 01 and 2005 aug 31. the registry's primary outcome measure was patient survival to icu discharge.

Eligibility criteria:
inclusion criteria: 1. patient weighed between 8 and 20 kg (17.6 - 44.1 lb). 2. patient received medical care in an intensive care unit (icu) and was treated with hf20 based crrt. 3. patient had a clinical diagnosis of aki or arf or fluid overload requiring crrt. note: the cohort of patients treated with m60 sets from the ppcrrt registry (weighing 8 - 20 kg) are to meet inclusion criteria 1 and 3. exclusion criteria: there are no exclusion criteria for this study.

Keywords: continuous renal replacement therapy crrt
endocrinological and neuronal aspects of bariatric surgery

Conditions: Bariatric Surgery; Obesity

Summary: the overall aim of the proposed project is to investigate the contribution of changes in neuronal food processing, hypothalamic reactivity and hormonal factors to weight loss after bariatric surgery.


Eligibility criteria:
inclusion criteria: * planning to undergo bariatric surgery * planning to take part in a conservative diet exclusion criteria: * inability to undergo fmri * psychiatric disorders * metabolic disorders

Keywords: fmri hormonal satiety signaling hypothalamus weight loss