Kornimate/medical-research-clean huggingface dataset:
a study of roactemra/actemra (tocilizumab) given subcutaneously in combination with traditional dmards in patients with moderate to severe active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this randomized, parallel-group, placebo-controlled, multicenter study will evaluate the reduction in disease activity and the safety of tocilizumab (roactemra/actemra) in combination with traditional disease-modifying anti-rheumatic drugs (dmards) in patients with active, moderate to severe rheumatoid arthritis. in the double-blind part of the study, patients will be randomized to receive either 162 mg tocilizumab or placebo subcutaneously every 2 weeks for 24 weeks using a pre-filled syringe. in the open-label part of the study, patients will be randomized to receive 162 mg tocilizumab subcutaneously every 2 weeks from week 24 to week 96 using a pre-filled syringe or an auto-injector.


Eligibility criteria:
inclusion criteria: * adult patients, ≥ years of age. * moderate to severe rheumatoid arthritis of ≥ 6 months duration. * receiving treatment on an outpatient basis. * swollen joint count (sjc) ≥ 6 (66 joint count) and tender joint count (tjc)≥ 8 (68 joint count) at screening and study start. * on a stable dose of disease-modifying anti-rheumatic drugs for at least 8 weeks prior to study start. exclusion criteria: * major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization. * rheumatic autoimmune disease other than rheumatoid arthritis, secondary sjögren's syndrome with rheumatoid arthritis is allowed. * functional class iv as defined by the american college of rheumatology (acr) classification of functional status in rheumatoid arthritis. * diagnosis of juvenile idiopathic arthritis or juvenile rheumatoid arthritis and/or rheumatoid arthritis before the age of 16 years. * prior history of or current inflammatory joint disease other than rheumatoid arthritis. * history of malignancy, active or recurrent infections, positive to hepatitis b surface antigen or hepatitis c antibody, active tuberculosis, serious allergy to biologics, or a history of diverticular disease or other symptomatic gi conditions that might predispose to perforations. other inclusion and exclusion criteria applied to the study.
a study to evaluate the pharmacokinetics and the safety after administration of "br1017-1" and co-administration of "br1017-1a" and "br1017-1b"

Conditions: Essential Hypertension; Primary Hypercholesterolemia

Summary: the objective of this clinical study is to evaluate the pharmacokinetics and the safety after administration of "br1017-1" and co-administration of "br1017-1a" and "br1017-1b" in healthy volunteers


Eligibility criteria:
inclusion criteria: * those who weigh 50 kg or more and have body mass index (bmi) within the range of 18.0 to 30.0kg/m² at screening visit. * those who sign written consent spontaneously after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken drugs concerned about affecting this clinical trial within 10 days prior to the first day of administration. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs, etc.) * those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 6 months prior to the first administration date.(however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * those who have a medical history of gastrointestinal surgery or gastrointestinal diseases that may affect the absorption of drugs. (except for simple appendectomy, hernia surgery) * those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or its products) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours prior to the first day of administration. * in the case of a female subject, those suspected pregnancy, pregnant woman, lactating woman.
packing of perianal abscess cavities

Conditions: Perianal Abscess; Perianal Infections; Peri Rectal Abscess; Abscess; Anus; Abscess Anorectal

Summary: the aim of this trial is to compare internal wound packing to no packing in postoperative management following incision and drainage of perianal abscess. participants will be randomised 1:1 to either the packing or non-packing arm.

perianal abscess is common, affecting 18,000 patients annually in england. management has remained largely unchanged for over 50 years, and comprises surgical incision and drainage followed by continued internal wound dressing (packing) until healed. packing is thought to reduce the rate of recurrent abscess and perianal fistula; a known complication of perianal abscess. perianal fistula frequently requires multiple operations to resolve. the evidence for postoperative packing is limited¹ and may expose patients to painful procedures with no clinical benefit, and at considerable increased cost². a multi-centre observational study of outcomes after drainage of perianal abscess (ppac²) (n=141) found packing to be painful (2-3 fold increase in visual analogue score pain scores during packing) and costly (estimated cost of £280 per patient; overall cost in the united kingdom of £5 million annually). fistula rate was 27%. this study is a randomised controlled trial designed to assess whether there are differences between non-packing and packing of the perianal abscess cavity in terms of the short term negative effects of packing (pain, quality of life, return to work) whilst assessing the impact on key clinical outcomes (wound healing, fistulae formation) and resource use/cost. all participants will be required to complete pain diaries following discharge from hospital. clinical follow up to assess healing and other key clinical outcomes will take place at 4, 8 (if not healed at 4 weeks) and 26 weeks. further data will be collected from national health service registries at 52 weeks in order to assess abscess recurrences and fistulae formation.

Eligibility criteria:
inclusion criteria: 1. aged 18 or over 2. undergoing surgical incision and drainage of a primary perianal abscess exclusion criteria: 1. suspected inflammatory bowel disease 2. fournier's gangrene 3. horseshoe (bilateral) abscess 4. fistula-in-ano 5. multiple abscess

Keywords: incision and drainage packing
rectal acetaminophen use during oocyte retrievals to reduce post-operative opioid utilization

Conditions: Opioid Use

Summary: the primary aim of this study is to evaluate the administration of rectal acetaminophen to current and standard anesthesia and analgesia protocol in oocyte retrievals would reduce postoperative utilization of opioids (tylenol with codeine) in fertility patients.

as the opioid epidemic shows no sign of abating, this national crisis deserves careful attention from all medical subspecialties. this includes reproductive endocrinology and infertility (rei), where opioids are primarily utilized for intraoperative and postoperative pain management for outpatient procedures such as oocyte retrievals, operative hysteroscopy, and laparoscopic myomectomy. the purpose of this study is to evaluate whether the administration of rectal acetaminophen in addition to the current, standard anesthesia and analgesia protocol in oocyte retrievals can help decrease utilization of prescribed opioid at home following oocyte retrieval. rectal acetaminophen will be used rather than conventional iv acetaminophen because of the lack of access to iv acetaminophen at the study institution. rectal acetaminophen is appealing because it is cheap, readily available in most medical centers and there is the potential for increased analgesic benefit due to the proximity to the vaginal and ovarian tissue, as well as the possible benefit from the partial avoidance of hepatic first-pass metabolism. this trial has the potential to provide practice-changing clinical information to the field of rei. the information gained can even translate to other ambulatory procedures and guide clinical practice. the investigators hypothesize that participants given rectal acetaminophen in addition to standard anesthesia/analgesia at the end of their oocyte retrieval will use less amount of prescribed tylenol with codeine 3 days after discharge from the surgery center compared those receiving standard anesthesia/analgesia for oocyte retrieval.

Eligibility criteria:
inclusion criteria: * any female patient undergoing oocyte retrieval by transvaginal ultrasound-guided ovarian puncture exclusion criteria: * patients with chronic pain conditions such as fibromyalgia and sickle cell anemia. * patient with bmi greater than 40 * patients that required general endotracheal intubation anesthesia in prior oocyte retrieval * patients with documented allergic reaction to acetaminophen * patient with contra-indication to the use of acetaminophen (liver disease) * patients with a history of past or current alcohol, drug or opioid abuse * patients with ulcerative colitis, crohn's disease, or severe rectal hemorrhoids

Keywords: egg retrieval oocyte retrieval opioid dependence rectal acetaminophen rectal tylenol pain opioid use opioid abuse
treatment evaluation of neuromodulation for tinnitus (tent-a)

Conditions: Tinnitus

Summary: this is a three arm, patient subtyping and parameter optimisation study for a neuromodulation treatment for tinnitus.

participants with chronic tinnitus will be provided with a ce marked neuromodulation device. devices will be programmed with one of 3 stimulation parameter settings. after 12 weeks of use, differences in tinnitus severity scores will be compared between the 3 arms and within the arms for patient subtype analysis.

Eligibility criteria:
inclusion criteria: * 18 to 70 years of age * the ability to read and understand english/german * willing and able to provide informed consent * willing to commit to the full duration of the study * have been experiencing tinnitus 3 months to 5 years * experiencing subjective tinnitus * baseline tinnitus handicap inventory (thi) score of 28 to 76 points * baseline minimum masking level (mml) of 20 to 80 dbhl * maximum ac pure-tone audiometry hearing loss of 80 db hl at any test frequency in the range of 2 to 8 khz or of 40 db hl in the range of 250 to 1000 hz either unilaterally or bi-laterally exclusion criteria: * if participant has been diagnosed with objective tinnitus * commenced usage of hearing aid within the last 90 days * cases where pulsatility is the dominant feature of tinnitus * patients whose tinnitus cannot be masked during mml assessment * meniere's disease * significantly severe loudness discomfort level (ldl), \<30 db sl * depression or neuro-psychological condition, previously diagnosed or identified from the state-trait anxiety inventory (stai) scores greater than 120 * diagnosed with somatic tinnitus resulting from head or neck injury * temporomandibular joint disorder (tmj) * current or previous involvement in medico-legal cases * pregnancy * oral piercings * neurological conditions that may lead to loss of consciousness (e.g. epilepsy) or is considered to be the dominant feature of the tinnitus, as assessed by audiologist or ent consultant * severe cognitive impairment based on mini mental state examination (mmse), less than 20 * pacemakers or other electro-active implanted devices * have used neuromod devices products in the past * participants currently prescribed drugs for a central nervous system pathology, i.e. epilepsy, multiple sclerosis (ms), parkinson's, bi-polar disorder. * the site principal investigator does not deem the candidate to be suitable for the study for other reasons not listed above * self-reporting episodes of auditory hallucinations * abnormal otoscopy as assessed by the audiologist, including active otitis media, perforation and hearing loss that is identified as completely conductive * abnormal tympanometry as assessed by the audiologist

Keywords: bi-modal neuromodulation
atrial fibrillation feasibility certoparin trial - affect

Conditions: Persistent Nonvalvular Atrial Fibrillation

Summary: this trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation


Eligibility criteria:
inclusion criteria: * persistent af (electrical cardioversion is planned) * written informed consent exclusion criteria: * acute clinical signs of venous thromboembolism * current oral anticoagulation * indication for medical cardioversion
study on the correlation between treg immune cells on the muscle content and cognitive functions of the elderly

Conditions: Cognitive Disorder Patients and Cognitive Assessment

Summary: in order to explore the impact of the level of the elderly treg immune cells and the effects of different fat distribution and muscle content, the impact of the level of treg immune cells on cognitive functions is explored. the correlation between visceral fat content, subcutaneous fat content and cognitive function.


Eligibility criteria:
inclusion criteria: - aged 40-90 years old exclusion criteria: - previous diagnosis of dementia (including alzheimer's disease, lewy body dementia, parkinson's disease, or other dementias) were excluded.
d-dimer as predictor of disease outcome in intensive care unit in covid-19m patients

Conditions: Critical Illness; Pneumonia, Viral

Summary: evaluating value of d-dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in sars.cov.2 patients.

evaluating value of d-dimer blood level of icu admitted patients on admission and 48 hours later as outcome predictor in sars.cov.2 patients. it has been reported that covid 19 is associated with hemostatic abnormalities and elevated d-dimer level, so its level is used to predict severity of disease.

Eligibility criteria:
inclusion criteria: * patients of both sex admitted in icu * positive pcr * requiring oxygen therapy exclusion criteria: * ward patients * negative pcr

Keywords: d dimer sars-cov-2
pneumoproteins expression in the organ donor

Conditions: Primary Graft Dysfunction

Summary: primary graft dysfunction, a form of reperfusion pulmonary edema that occurs early after lung transplantation, shares key clinical and pathological features with acute lung injury and its more severe form, the acute respiratory distress syndrome. however, in contrast to acute lung injury/acute respiratory distress syndrome, in which biomarkers in plasma, urine and lung edema fluid have prognostic and pathogenetic value, the role of biomarkers in primary graft dysfunction has been less thoroughly explored. we will try in this study de determine the rule of pneumoproteins in the donor organ on the pulmonary edema in the recipient.


Eligibility criteria:
inclusion criteria: all the organ donors for lung grafts. exclusion criteria: none
long-term surgical outcomes of scaphoid proximal pole fracture nonunion

Conditions: Orthopedic

Summary: the treatment for scaphoid proximal pole nonunion remains challenging due to the poor vascularity in the proximal pole fragment, associated sl injury and the technique of fixation. vascularized bone grafts and non-vascularized iliac bone graft have been used in patients with scaphoid proximal pole nonunion, but the indication has not been well clarified. alternatively, we have been treating such patients with vascularized bone graft , or non-vascularized bone graft with screw or k-wire fixation with considerable success. the purpose of this study is to evaluate and analyze retrospectively the surgical efficacy of our procedure.

scaphoid nonunion are common and operative treatment with bone graft was reported to have good result. however, the treatment for proximal pole nonunion remains controversial. there are some patterns of pathoanatomy combined with scaphoid fracture, like sl ligament tears, which could not be easily identified or treated initially. the proximal pole nonunion was near sl joint. therefore, proximal pole nonunion may result in disi instability. furthermore, proximal pole nonunion was identified as a poor prognostic factor in scaphoid nonunion. in the past 10 years, we have some different technique, like vbg, arthroscopic bone graft to achieve good results. some studies revealed that significantly better sl stability was achieved with arasl. we also used arasl with bg to improve proximal pole union. however, it is not clear which method would be appropriate for proximal pole nonunion. we retrospectively investigated the functional outcome and radiological results after at least 2-year follow-up to clarify the surgical efficacy of these procedures.

Eligibility criteria:
inclusion criteria: * (1) chronic nonunion (wrist pain for more than 3 months after injury) as defined by preoperative radiographs; and (2) combined positive sl instability measured by intraoperative arthroscopy exam test; (3) grade i snac. exclusion criteria: * (1) skeletally immature patients; (2) previous wrist trauma or surgery.

Keywords: fracture
efficacy and safety of aliskiren/ramipril/amlodipine compared with ramipril/amlodipine and aliskiren/amlodipine in patients with metabolic syndrome

Conditions: Hypertension With Metabolic Syndrome

Summary: this proof of concept study is designed to evaluate the efficacy and safety of the combination therapy of aliskiren and ramipril as add-on to amlodipine in the treatment of patients with essential hypertension and metabolic syndrome who do not respond adequately to amlodipine monotherapy.


Eligibility criteria:
inclusion criteria: * outpatients 18-75 years of age. * male or female patients are eligible. * patients with a diagnosis of hypertension: * newly diagnosed patients or patients who have not been treated for hypertension within the 4 weeks prior to visit 1 must have a mean sitting systolic blood pressure (mssbp) \> 150 mmhg and \< 180 mmhg at visit 1. * patients treated with antihypertensive monotherapy must have a mssbp ≥ 140 mmhg and \<180 mmhg at visit 1. * patients taking amlodipine monotherapy mssbp \> 140 mmhg and \< 180 mmhg at visit 1. * all patients must have a mssbp ≥ 140 mmhg and \< 180 mmhg at visit 3, the end of the amlodipine run-in period. * metabolic syndrome. * patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written inform consent form). exclusion criteria: * severe hypertension (office cuff msdbp ≥ 115 mmhg and/or mssbp ≥ 180 mmhg). * history or evidence of a secondary form of hypertension. * history of hypertensive encephalopathy or cerebrovascular accident, transient ischemic cerebral attack (tia), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (pci). * serum sodium \< 135 mmol/l at visit 1 if confirmed on repeat sample. * serum potassium \< 3.5 mmol/l or ≥ 5.3 mmol/l at visit 1, if confirmed on repeat sample. * type 1 diabetes mellitus. * type 2 diabetes if oral hypoglycaemic therapy changed (dose change or medication change) in previous 3 months. * pregnant or nursing (lactating) women. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: hypertension metabolic syndrome dual combination therapy triple combination therapy aliskiren direct renin inhibitor
evaluate safety and efficacy of abt-335 in combination with atorvastatin in subjects with multiple abnormal lipid levels in the blood

Conditions: Mixed Dyslipidemia; Coronary Heart Disease; Dyslipidemia

Summary: the purpose of this study is to compare the safety and efficacy of fenofibric acid (abt-335) + atorvastatin combination therapy with abt-335 and atorvastatin monotherapy in subjects with multiple abnormal lipid levels in the blood.


Eligibility criteria:
inclusion criteria: * subjects with mixed dyslipidemia * subjects must agree to utilize adequate birth control methods and to adhere to the american heart association (aha) diet exclusion criteria: * subjects with unstable medical conditions or medical conditions considered inappropriate in a clinical trial. * patients who are taking certain medications or unstable dose of specific medications. * women who are pregnant or plan on becoming pregnant, or women who are lactating.

Keywords: mixed dyslipidemia coronary heart disease dyslipidemia
study by magnetic resonance imaging in the progressive forms of multiple sclerosis

Conditions: Progressive Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Summary: the goal of this study is to show pattern differences of vasoreactivity and connectivity between progressive multiple sclerosis and relapsing remitting multiple sclerosis, by the use of methods of advanced brain mris and the diffusion tensor imaging , and correlate these differences with clinical disability and cognitive disorder results.

the goal of this study is to show pattern differences of vasoreactivity and connectivity between progressive multiple sclerosis and relapsing remitting multiple sclerosis, by the use of methods of advanced brain mris, and correlate these differences with clinical disability and cognitive disorder results. the modification of the diffusion tensor imaging are well known in these two groups, as well as their link with the occurrence of movement and cognitive disorder. the study of the vasoreactivity during mri aims to confront our results to the available data sources.

Eligibility criteria:
inclusion criteria : * for both patients and healthy volunteers : * age limits ≥ 30 et ≤ 50 years * subject able to understand the nature, the aim and the methodology of the study. * collection of the informed consent * affiliation or recipient with the mode of social security. * for the patients : * suffering from progressive multiple sclerosis (primary progressive forms or secondary progressive forms) or * suffering from relapsing-remitting multiple sclerosis exclusion criteria : * for both patients and healthy volunteers : * systemic pathology with neurological manifestations * antecedent of psychiatric disorders including psychosis (except anxious depressive disorder) * subject presenting contraindications in mri (ferromagnetic foreign bodies, pace-maker) * claustrophobia * women pregnant or breast-feeding * person with majority age protected by the law (supervision, trusteeship or under safeguard of justice). * subject unable to understand the nature and the aim of the study and/or communication difficulties with investigator * antecedent of serious cranial trauma (according to classification) of ischaemic stroke ou intracranial hematoma. * for the patients : * antecedent of serious cranial trauma (according to classification), anterior or evolutive neurologic disease other than multiple sclerosis * recent relapse of multiple sclerosis * for the healthy volunteers : * antecedent of serious cranial trauma (according to classification), anterior or evolutive neurologic disease * antecedent of neurological disease * in period of exclusion relative to another protocol or which the annual amount of the allowances maximum of 4500 € was reached.