Kornimate/medical-research-clean huggingface dataset:
strategy for prompt and effective thoracentesis in the emergency department

Conditions: Pleural Effusion; Pleural Diseases; Heart Failure

Summary: the speedtap-trial is a prospective, randomised, investigator-initiated, multicenter, clinical superior trial investigating two thoracentesis methods in four emergency departments (ed) in central denmark region. patients are randomised to either manual fluid removal in the ed or passively fluid drainage using gravity in the radiology department (standard of care). primary outcome: time from clinical indication to complete drainage and 188 patients will be included. key secondary outcomes include length of stay, ed admission to ed discharge and safety end-points.


Eligibility criteria:
inclusion criteria: * patients ≥ 18 years admitted to the ed * pleural effusion detected by any imaging modality (e.g., bedside ultrasound, chest x-ray, computed tomography) * clinically justified need for thoracentesis ( symptomatic relief and/or define the etiology of the effusion * without contraindication for thoracentesis in the emergency department (e.g., anticoagulant treatment) exclusion criteria: * life-threatening respiratory distress * not able to give consent * previous pleurodesis * effusion does not appear free-flowing due to septations or loculations / suspected empyema * prior enrollment in the trial * if randomization is not possible because decision to insert a pigtail catheter is made in the radiology department

Keywords: thoracentesis emergency department treatment methods
open-label, randomized study evaluating the absorption and systemic pharmacokinetics of topically applied idp-126 gel in comparison with control gel

Conditions: Acne Vulgaris

Summary: this will be an open-label study designed to assess the safety and plasma pk of topically applied idp-126 gel compared to control gel.

to evaluate the safety and plasma pharmacokinetics (pk) of clindamycin and adapalene in idp-126 gel compared with that from control gel in subjects with moderate to severe acne vulgaris (acne) during once daily topical application of idp-126 gel for 28 days.

Eligibility criteria:
inclusion criteria: 1. male or female, at least 9 years of age (at least 12 years of age for control gel); 2. verbal and signed written informed consent must be obtained. subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit); 3. subject must have a score of 3 (moderate) or 4 (severe) on the evaluator's global severity assessment at the screening and baseline visit exclusion criteria: 1. use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study; 2. any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis, dermatitis, eczema; 3. any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 4. subjects with a facial beard or mustache that could interfere with the study assessments; 5. subjects with more than two (2) facial nodules; 6. evidence or history of cosmetic-related acne
serum neurofilament-light chain and gfap levels in patients from the ofsep cohort at different landmarks of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the investigators hypothesize that serum neurofilament-light chain (nfl) levels can provide information about the level of activity and progression of multiple sclerosis at different stages and landmarks of the disease. in addition, glial fibrillary acidic protein (gfap) has also been identified as another serum biomarker of disability in ms.


Eligibility criteria:
inclusion criteria: * the patient has been correctly informed. * the patient must have given their informed and signed consent. * the patient must be insured or beneficiary of a health insurance plan. * the patient is at least (≥)15 years old. * the patient has ms according to diagnosis criteria (thompson et al. 2017) and: * participates to the ofsep-hd cohort (ancillary study); * has a expanded disability status scale score comprised between 0 - 7.0; * with or without disease modifying drug; * for work package 3: patients enrolled in any ofsep-hd centre that meet landmark criteria for an active ms (relapse, or expanded disability status scale progression, or active mri) during follow-up; * for work package 4: patients with a stable disease enrolled in ofsep-hd study in nîmes or nantes university hospitals. exclusion criteria: * within the past three months, the patient has participated in another interventional study that may interfere with the results or conclusions of this study. * the patient is in an exclusion period determined by a previous study. * the patient is under judicial protection. * the patient refuses to sign the consent. * it is impossible to correctly inform the patient (inability to understand the study, language problem). * the patient is pregnant or breast-feeding. * the patient is under 15 years old. * inability to answer questionnaires. * clinically isolated syndrome (cis) that does not meet the criteria of ms. * radiologically isolated syndrome (ris). * patient with neuromyelitis optica spectrum disorder.

Keywords: neurofilament-light chain glial fibrillary acidic protein (gfap)
a clinical trial testing the efficacy of pdt in preventing amputation in diabetic patients

Conditions: Diabetic Foot Infection; Osteomyelitis; Photo Antimicrobial Chemotherapy

Summary: the feet of diabetic patients continue to be an important problem in medicine. in general, patients with diabetic foot have some sort of amputation, especially in underserved populations. it is clearly necessary to develop novel treatment strategies for this worldwide health problem. photodynamic therapy (pdt) , is a low cost and highly effective alternative treatment concerning infections avoiding amputations in the diabetic foot.

patients with infected diabetic foot were grouped according to the wagner system for classifying foot lesions. all patients presented wagner grade 3 classification, with osteomyelitis in one or more toes. the study included only patients who had circulatory viability. for pdt treatment the fistula and/or ulcer was used as a gateway to the bone. the treated area (bones and fingers) was irrigated with a solution of phenothiazinium salts. after that, light irradiation was performed with optical fibers or led device above the wound. pdt treatment always in outpatients, once or twice a week.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * diabetes * diabetic foot * wagner grade iii exclusion criteria: * age \< 18 years old * non-diabetic * wagner iv and v * ischemia

Keywords: diabetic foot osteomyelitis pact pdt singlet oxygen antimicrobial diabetes wagner scale
the sleep improving effects of orange phenolics

Conditions: Polyphenols; Sleep; Fatigue

Summary: this study aims to determine whether a citrus flavonoid or a citrus flavonoid formulation can improve objective sleep duration and/or quality, and/or improve perceived sleep quality and feelings of rest. participants will complete a total of 9 test nights, which consist of sleeping with the sleep monitoring system after ingestion of the test product or a placebo, and filling out sleep-related questionnaires. the study has a crossover design, meaning that all participants receive all three interventions (citrus flavonoid, citrus flavonoid formulation, placebo) three times, in a randomized order.


Eligibility criteria:
inclusion criteria: * age 18-75 * non-smoking * healthy * lightly disturbed sleep for at least six months, on a regular basis exclusion criteria: * severe sleep disorders (sleep apnea, restless legs syndrome) * an apparent cause for the sleep disorders (pain, etc.) * clinically significant abnormal liver functioning * clinically significant abnormal serum creatinine * bmi lower than 18 or higher than 30 kg/m2 * use of concomitant medications or supplements

Keywords: polyphenols orange sleep fatigue
augmented cbgt for perinatal anxiety during a global pandemic (covid-19)

Conditions: Perinatal Anxiety; Covid19

Summary: this study will evaluate the effectiveness of an augmented version of our current evidence-based cognitive behavioural group therapy (cbgt) for perinatal anxiety protocol with cognitive and behavioural strategies composed of critical covid-related anxiety, worry, and impact content.


Eligibility criteria:
inclusion criteria: * females, aged 18-45 years * pregnant or up to six months postpartum * primary diagnosis of an anxiety disorder, as per the mini for dsm-5, with or without comorbid depression * no concurrent psychological treatment * not taking psychoactive medication or medication is stable in dose and type for at least 8 weeks prior to the study (as per canadian psychiatric guidelines) and throughout study duration (participants will not be excluded from treatment if medication/dose changes during the study duration, however, they must notify the study team immediately) * fluent in english in order to understand the consent and group material exclusion criteria: * severe depression/suicidality * primary diagnosis other than an anxiety disorder * psychotic or current substance/alcohol use disorder
safety and efficacy study of empagliflozin and metformin for 24 weeks in treatment naive patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2; Hyperglycemia

Summary: this study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (t2dm). study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.


Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes mellitus prior to informed consent 2. male and female patients on diet and exercise regimen who are drug-naive, defined as absence of any oral antidiabetic therapy for 12 weeks prior to randomization 3. hba1c \>=7.5% and \ =58.5 mmol/mol and \<=107.7 mmol/mol) 4. body mass index (bmi) \<= 45 kg/m2 at screening exclusion criteria: 1. uncontrolled hyperglycemia with a glucose level \>240 mg/dl (\>13.3 mmol/l) after an overnight fast during placebo run-in and confirmed by a second laboratory measurement (not on the same day) 2. any antidiabetic drug within 12 weeks prior to randomization 3. impaired renal function, defined as estimated creatinine clearance rate (eccr) \<60 ml/min (cockcroft-gault formula) as determined during screening and/or run-in period 4. contraindications to metformin according to the local label
adductor canal versus femoral nerve block for analgesia post total knee arthroscopy

Conditions: Knee Osteoarthritis

Summary: total knee arthroplasty or replacement (tka) is a surgery performed for osteoarthritis of the knee which is increasingly performed as the population ages. it is a painful surgery and one of the methods to reduce post-operative pain is performing a regional anaesthesia technique. the current practice is to perform a femoral nerve block (fnb) which blocks the nerves supplying the knee joint and the thigh muscles (quadriceps). this provides effective analgesia. however, it also results in weakness of the quadriceps and may result in falls post-operatively. adductor canal block (acb) is a new, alternative regional anaesthesia technique which is hypothesised to provide as effective analgesia, with less quadriceps weakness compared to fnb, hence potentially reducing the risk of falls post-operatively. investigators aim to study if the analgesia provided by acb is as good as fnb while preserving quadriceps strength.


Eligibility criteria:
inclusion criteria: * ages 45-85 * american society of anaesthesiologists physical status 1-3 * bmi 18-35 kg/m2 exclusion criteria: * inability to give consent, communicate, cooperate * patients with regular consumption of strong opioids (morphine, oxycodone) or steroids * patients with allergy to local anaesthetics or any drugs included in the study * patients with lower limb surgery in the preceding year * patients with pre-existing neurological deficits * patients who are unsuitable for general anaesthetics (eg difficult airway)

Keywords: total knee arthroplasty total knee replacement femoral nerve block adductor canal block
the effect of rhubarb on sepsis and post-traumatic gastrointestinal function failure

Conditions: Sepsis

Summary: random grouping by computer, divided into two groups, a group of rhubarb treatment group, another group for the placebo group.

patients were randomly divided into two groups, using rhubarb powder or placebo. rhubarb is commercially certified rhubarb(rheum palmatum, sichuan origin, provided by the pharmacy of my hospital), ground into a powder, over 80 mesh steel mesh, two days before 6g, three times / day, oral or nasal feeding, two days later reduced to 3g, three times / day, oral or nasal feeding; another group of patients taking placebo, with the same dose of rhubarb; the overall course of the two drugs was a week.

Eligibility criteria:
inclusion criteria: 1. age:18-65 year old; 2. diagnosis: sepsis with gastrointestinal dysfunction (ii-iii grade agi); gastrointestinal dysfunction after trauma (ii-iii agi); 3. complete gastrointestinal tract anatomic structure（including the ileum and colon stoma） exclusion criteria: 1. hemodynamic instability; 2. underlying diseases: cardiac function iii\~iv, chronic liver dysfunction child-pugh score \>9 points; 3. less than 5 days after surgery for stomach and small intestine，less than 7 days after colonic surgery, postoperative gastrointestinal leakage; 4. abdominal compartment syndrome; 5. mechanical ileus 6. active gastrointestinal hemorrhage

Keywords: gastrointestinal dysfunction sepsis trauma
evaluation of minimal hepatic encephalopathy in patients with cirrhosis and portal hypertension

Conditions: Cirrhosis; Portal Hypertension

Summary: minimal hepatic encephalopathy (mhe) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (he). portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as he. the consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (spss). the relationship between the spss and their characteristics and the prevalence of mhe in patient with cirrhosis is poorly known. the main objective of this study is to evaluate the mhe in patients with cirrhosis and portal hypertension.

minimal hepatic encephalopathy (mhe) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (he). it is a frequent complication of the liver disease, affecting up to 80% of tested patients. mhe affects severely the lives of patients by altering their quality-of-life and their socioeconomic status and is strongly associated to the development of overt he. portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as he. the consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (spss). their presence has been associated with recurrent or persistent he. the relationship between the spss and their characteristics and the prevalence of mhe in patient with cirrhosis is poorly known. patients with compensated cirrhosis and portal hypertension will be considered for inclusion. after written inform consent, the serum ammonia, psychometric hepatic encephalopathy score (phes) and the animal naming test (ant) will be performed to evaluate the presence of mhe. patients diagnosed with mhe will be treated and a new evaluation will be performed 6 months later.

Eligibility criteria:
inclusion criteria: * patient with cirrhosis and portal hypertension older than 18 old * patient who underwent a ct scan or mri in the last 3 months * the mini-mental state (mms) test \>25. * patient capable of receiving and understanding information relating to the study and of giving his written informed consent. * patient affiliated to the french social security system exclusion criteria: * cirrhotic patient with overt he or history of persistent or recurrent he. * hepatocellular carcinoma beyond milan criteria. * portal vein thrombosis. * previous transjugular intrahepatic portosystemic shunt (tips) or surgical shunt. * presence of neurological or psychiatric disorder. * patient with treatment by benzodiazepines or opioid substitution. * pregnant or nursing women * patient in exclusion period of a previous study * patient under guardianship, trusteeship or the protection of justice or incapable of giving their own informed consent

Keywords: cirrhosis portal hypertension minimal hepatic encephalopathy spontaneous portosystemic shunts sarcopenia myosteatosis
mechanisms and treatment of post-amputation neuropathic pain

Conditions: Neuropathic Pain; Phantom Limb Pain; Amputation

Summary: phantom and residual limb pain are types of peripheral neuropathic pain that are difficult to treat and where the underlying mechanisms are still not fully understood. repetitive transcranial magnetic stimulation (rtms) of the motor cortex is an increasingly studied technique for the treatment of neuropathic pain and has shown modest effects in pain intensity reduction for the treatment of neuropathic pain. newer rtms coils provide the opportunity to stimulate larger brain areas, which could provide a better treatment option compared to conventional coils. the aims of this study are to investigate whether the peripheral nervous system is a necessary driver of phantom limb pain and/or residual limb pain in patients with lower limb amputation using spinal anaesthesia, and to assess the analgesic efficacy of deep h-coil rtms compared to sham stimulation in the same patients.


Eligibility criteria:
inclusion criteria: * 18-80 years of age * unilateral or bilateral lower limb amputation resulting in residual limb pain and/or phantom pain, fulfilling the criteria for definite neuropathic pain * usual pain intensity at least 4/10 over the past 24 hrs using the numerical scale of the bpi at screening * daily pain * pain for at least 3 months * stable pharmacological treatment for pain or no pharmaceutical treatment at least 1 month prior to the study * patients who can be followed for the whole duration of the study * minimum 4/10 pain intensity at the time of spinal anaesthesia for sub-study 1 exclusion criteria: * any clinically significant or unstable medical or psychiatric disorder * subjects protected by law (guardianship or tutelage measure) * history of or current substance abuse (alcohol, drugs) * pending litigation * contraindications to spinal anaesthetic block (e.g. use of prescribed or non-prescribed medication that can increase risk of bleeding such as anticoagulants, non-steroidal anti-inflammatory drugs and acetylsalicylic acid) * contraindication to rtms (past severe head trauma, history of epilepsy or ongoing epilepsy, active cerebral tumour, past neurosurgical intervention, intracranial hypertension, implanted devices not compatible such as cardiac pacemaker and neurostimulator, cochlear implants, pregnancy or lactation. all women of childbearing age will be required to have negative pregnancy test at inclusion and to be using contraception) * other pain conditions more severe than phantom and residual limb pain. * inability to understand the protocol or to fill out the forms * other ongoing research protocol or recent past protocol within one month before the inclusion

Keywords: repetitive transcranial magnetic stimulation spinal anaesthesia
prevention of catheter associated lower urinary infections using the oxys indwelling catheter

Conditions: Urinary Infections

Summary: the safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.

this study is an open randomized controlled trial of 4 weeks duration. the intervention is a novel urinary catheter with an electromagnetic therapy to prevent catheter associated infections. the catheter is used in patients which require longterm urinary catheterization over at least 1 month. the endpoint is bacteriological exam and the laboratory is blinded to the therapy status. weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed to detect and characterize the biofilm. a colonization rate of \>95% is anticipated in the control arm. therefore a 50% reduction in colonization can be detected with 54 patients, a 90% reduction in colonization can be detected with 20 patients with a power of 0.9.

Eligibility criteria:
inclusion criteria: * patient with need for an indwelling urinary catheter to be placed at least for 4 weeks, which are willing and capable to provide informed consent. most patients have spinal cord injury and are treated by the prinicpal investigator. exclusion criteria: * need for antibiotic treatment for any infections * urological intervention or need for catheter change within study duration of 4 weeks

Keywords: foley infection hospital acquired catheter associated urinary
effects of methylprednisolone after total hip arthroplasty

Conditions: LOS; Postoperative Pain; Postoperative Nausea and Vomiting; Sleeping Quality; Fatigue; Inflammatory Response

Summary: the purpose of the study is to compare the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome after hip arthroplasty. the hypothesis is that pre-operative methylprednisolone (125mg iv) will reduce time to fulfill discharge criteria.

in spite of being one of the last century's most successful surgical procedures in treatment of advanced osteoarthritis total hip arthroplasty is still associated with postoperative pain and delayed rehabilitation. the investigators therefore decided to evaluate the effects of pre-operative methylprednisolone (125mg iv) versus placebo on postoperative outcome in a well defined fast-track setup after hip arthroplasty.

Eligibility criteria:
inclusion criteria: * elective total hip arthroplasty * able to speak and understand danish * able to give informed consent exclusion criteria: * alcohol or medical abuse * allergies to local anesthetics or methylprednisolone * age \< 18 years * daily use of opioids or glucocorticoids * pregnancy or breastfeeding (fertile women)

Keywords: hip arthroplasty methylprednisolone post-operative pain