Kornimate/medical-research-clean huggingface dataset:
long-term safety and efficacy study of fasinumab in patients with pain due to osteoarthritis (oa) of the knee or hip

Conditions: Osteoarthritis of the Knee or Hip

Summary: the primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (aesis), in patients with pain due to radiographically-confirmed oa of the knee or hip.


Eligibility criteria:
key inclusion criteria: 1. male or female ≥18 years of age at the screening visit 2. clinical diagnosis of oa of the knee or hip based on the american college of rheumatology criteria with radiologic evidence of oa (k-l score ≥2) for the index joint at the screening visit 3. moderate to severe pain in the index joint defined as a western ontario and mcmaster universities osteoarthritis index (womac) average pain subscale score of ≥4 4. a history of 12 weeks of analgesic use for oa of the knee or hip 5. history of regular use of analgesic medications for oa pain key exclusion criteria: 1. history or presence at the screening visit of non oa inflammatory joint disease 2. history or presence on imaging of arthropathy, stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fracture during the screening period 3. signs or symptoms of carpal tunnel syndrome within 6 months of screening 4. patient is not a candidate for mri 5. is scheduled for a joint replacement surgery to be performed during the study period 6. systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit. 7. history or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy 8. history or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy 9. pregnant or breast-feeding women 10. women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline note: other protocol defined inclusion/exclusion criteria apply
an open label trial to assess the safety and efficacy of oral r115866 in the treatment facial acne

Conditions: Acne

Summary: this study is looking at a new oral drug to treat acne. all patients in the study will get active drug, there is no placebo arm.


Eligibility criteria:
inclusion criteria: * male subject * presence of moderate to severe facial acne vulgaris: having a minimum of 15 papules and/or pustules and at least 2 nodulocystic lesions * in good general health and free of any disease state or physical condition which, in the investigator's opinion, might have impaired evaluation of acne or exposed the subject to an unacceptable risk by trial participation exclusion criteria: * subjects with types of acne other than acne vulgaris * significant coexisting hepatic, renal, or bone marrow disease, hyperlipidemia, chronic pancreatitis, osteoporosis, or a history indicating adrenal cortex dysfunction or any other serious disease (including cancer and subjects known to be hiv positive) * history of any malignancy in the past 5 years, except for adequately treated basal cell carcinoma of the skin * history of heart failure, myocardial infarction within the past six months, cardiac arrhythmia, or under treatment for heart disorders * clinically significant abnormal ecg-intervals or morphology of the ecg; qt or qtc \>470 ms in females or \>450 ms in males * use of vitamin a (\>1000 microgram/day), phenytoin, carbamazepine, warfarin, rifampicin, tetracyclines, ketoconazole, itraconazole, astemizole, terfenadine, cisapride, anti-psychotics, anti-depressants, lithium, antimalarials, alpha-blocking drugs, angiotensin-converting enzyme inhibitors, cyclosporin a, glucocorticosteroids and non-steroid anti-inflammatory drugs, non-potassium-sparing diuretics * use of oral retinoids 6 months prior to visit 1 * use of other oral/topical therapy for acne unless stopped at visit 1 * use of ultraviolet light (including artificial uva and uvb as well as excessive natural sun exposure) unless stopped at visit 1
pilot study of edaravone to treat acute myocardial infarction

Conditions: Myocardial Infarction; Reperfusion Injury

Summary: early reperfusion therapy has improved the clinical outcomes of patients with acute myocardial infarction (ami), but these benefits are limited in some patients by reperfusion injuries. there is now increasing evidence that reactive oxygen species cause reperfusion injury. this study was designed to examine the effects of edaravone, a novel free radical scavenger, in patients with ami.

initial ami patients were randomly assigned to receive 30 mg of edaravone or a placebo intravenously just before reperfusion. we compared infarct size, using serial determination of serum biomarkers and q wave formations, and the incidence of reperfusion arrhythmia between the groups. cardiovascular event-free curves were estimated by kaplan-meier method. in addition, we determined serum thioredoxin levels, an oxidative stress marker, to assess the antioxidant effect of edaravone.

Eligibility criteria:
inclusion criteria: * initial ami patients admitted to the investigators' institution within 6 hours of symptom onset and treated primary percutaneous coronary intervention. exclusion criteria: * renal insufficiency defined as serum creatinine \> 1.2 mg/dl and altered hepatic function defined as serum asparate aminotransferase \> 50 iu/l, alanine aminotransferase \> 50 iu/l and total bilirubin \> 1.2 mg/dl.

Keywords: edaravone randomized control trial st-elevation myocardial infarction coronary angioplasty
effect of nicotine on brain reward pathways

Conditions: Depressive Disorder

Summary: the investigators will determine whether an acute dose of nicotine, in the form of the nicotine lozenge, impacts brain and behavioral measures of mood and reward responsiveness in individuals with major depressive disorder.


Eligibility criteria:
inclusion criteria for subjects with major depressive disorder: 1. provide written informed consent; 2. both genders and all ethnic origins, age between 18 and 45; 3. meet dsm-iv diagnostic criteria for mdd (diagnosed with the use of the scid); 4. a baseline ham-d score of 16 or greater; 5. absence of pregnancy; 6. absence of any psychotropic medication for at least 2 weeks: 1. 6 weeks for fluoxetine 2. 6 months for neuroleptics 3. 2 weeks for benzodiazepines 4. 2 weeks for any other antidepressants inclusion criteria for healthy controls 1. absence of medical, neurological, and psychiatric illness (including alcohol and substance abuse); as assessed by subject history and a structured clinical interview (scid); 2. provide written informed consent; 3. both genders and all ethnic origins, age between 18 and 45; 4. absence of any medications for at least 3 weeks; 5. absence of pregnancy. exclusion criteria: 1. subjects with suicidal ideation where outpatient treatment is determined unsafe. these patients will be immediately referred to a licensed psychologist or psychiatrist to determine the appropriate clinical treatment; 2. serious or unstable medical illness 3. lifetime history of seizure disorder; 4. lifetime history or current diagnosis of any of the following dsm-iv psychiatric illnesses: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, adhd, patients with mood congruent or mood incongruent psychotic features; simple phobia, social anxiety disorder and generalized anxiety disorders will be allowed only if secondary to mdd; 5. patients with a lifetime history of electroconvulsive therapy (ect); 6. failure to meet standard mri safety requirements; 7. may not have used any nicotine product in the past year; must report fewer than 20 lifetime uses of nicotine 8. must have an expired carbon monoxide level of less than or equal to 10 ppm. 9. use of anticholinergic drugs in the past week 10. any past or present history of cardiac problems including known arrhythmias, acute coronary syndrome, or ischemic heart disease 11. uncontrolled hypertension 12. history of substance abuse in the past 6 months (other than caffeine), self-reported use of marijuana in past month, or history of treatment with methadone 13. heavy caffeine users (consume greater than 500 mg on a regular or daily basis) 14. subjects that cannot speak english

Keywords: nicotine depression
coronary interventions ulm - coronary chronic total occlusions

Conditions: Chronic Total Occlusion of Coronary Artery; Chronic Total Occlusion

Summary: the aim of the proposed project is to provide the long-term results after a recanalization attempt of chronically occluded coronary arteries. to investigate recanalization attempt of chronically occluded coronary arteries at the ulm university hospital. as shown, it is known that successful recanalization of a chronic occlusion is associated with a lower event rate (reduced mortality and the need for operative myocardial revascularization) compared to unsuccessful recanalization (drug therapy). the standard in the therapy of successfully recanalized chronic occlusions is the use of drug-releasing vascular supports.


Eligibility criteria:
inclusion criteria: * patients over 18 years coronary intervention in chronic coronary artery occlusion occlusion \> 3 months indication for ptca or recanalization according to guidlines such as: symptoms of the patient evidence of myocardial ischemia (stress ecg, scintigraphic methods, magnetic resonance imaging, stress echocardiography) pathological intracoronary flow reserve, prognostic exclusion criteria: * no chronic occlusion, * contraindication to anti-platelet therapy acetylsalicylic acid plus clopidogrel for at least 3 months such as e.g. with florid gastrointestinal ulcer disease, history of hemorrhagic stroke or urgent non-postponable surgical intervention. basic disease with a life expectancy of less than 12 months (here as a rule no indication for ptca or reopening available)
comparative study of three collagen membranes: 1 non-cross-linked and 2 cross-linked

Conditions: Bone Regeneration

Summary: this study is being done to compare how quickly three different types of collagen membranes break down when they are exposed to the mouth. these membranes are often used in dental and oral surgery to help with healing and tissue growth. the goal is to find out if one membrane lasts longer than the others, which may help doctors choose the best option for different procedures. in this study, the membranes will be placed in the mouth in a specific area near the gums of the upper back teeth. the study is designed so that neither the patients nor the researchers evaluating the results will know which membrane is which (this is called a double-blind study). over time, researchers will measure how much each membrane has broken down. this information may help improve treatment planning and patient outcomes in dental care.

the study was designed as a double-blinded, single-center, randomized clinical trial. three different types of collagen membranes, ribose cross-linked (rcl) ossix agile, glutaraldehyde cross-linked (gcl) - biomend extend, and non-cross-linked (ncl) jason mb gmbh, were selected for the study. during the first visit, digital intraoral impressions and clinical pictures will be taken, periodontal charts filled, and oral hygiene sessions conducted by trained hygienists. two weeks later, during the second visit, patients will be reexamined to exclude any signs of inflammation. membranes will be cut to a uniform size of 8\*10 mm by an assistant prior to placement. they will be placed in a randomized mesiodistal order on the buccal mucosa, apical to the gingival margins of maxillary premolar and molar teeth (the future position will be evaluated on the intraoral scanned model). to fix the membranes, a vestibular sling suture without any perforation (ptfe 3/0) will be used. a light-cured periodontal dressing (barricaid, dentsply caulk, dentsply int. inc., york, pa, usa) will be placed on the buccal site to fix a knot and two other points on the membrane to fix it to the suture. standard intraoral pictures will be taken. patients will be instructed to avoid hard foods, brushing in the area of the membrane, and excessive movements to prevent dislocation of the structure. the same oral hygiene products will be provided to all patients. follow-up visits will be scheduled at 3, 7 and 10 days. at the 10-day follow-up clinical evaluation will be performed to assess any perforation. a set of pictures will be taken. membranes integrity will be analyzed by two blinded examiners using a scale.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * good overall health (asa i or asa ii) * good oral health exclusion criteria: * patients with gingival pathologies * individuals with uncontrolled chronic diseases or immunocompromised. * pregnant patients * patients who are currently breastfeeding

Keywords: cross linked membrane non cross linked membrane degradation rate
multi-omics study of clinical endpoints in chd

Conditions: Coronary Heart Disease

Summary: this study aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences. it will enroll approximately 4000 coronal heart disease patients aged between 18 and 80 years in mainland china and follow-up for at least 1 years. questionnaires, anthropometric measures, laboratory tests, and biomaterials will be collected . the principal clinical outcomes of the study consist of ischemia attack , cardiac death, renal injury,and myotoxic activity.

the study is a multicenter prospective cohort study, aimed to explore underlying mechanisms of individual differences in drugs for coronary heart disease treatment and its association with adverse consequences.the genomic genotype, dna methylation and metabolome of 1000 patients with coronary heart disease were determined using illumina high-density genotyping chip, high-throughput sequencing and high-resolution mass spectrometry. blood exposures of statins and metoprolol and its metabolites was determined by uplc-ms/ms. the biological network using cross-omics analysis was reconstructed to identify potential causative key genes, bacteria, and endogenous metabolite targets that cause differences in individual responses. a machine identification algorithm selecting clinical factors and multi-omics targets was used to establish a predictive mathematical model. a multi-center clinical cohort of 3000 coronal heart disease patients was used to verify the effects of various levels of omic targets on drug blood exposures, efficacy and toxic side effects. a comprehensive model based on multi-target combination of individualized drugs was constructed, and the predictive effect was clinically analyzed.

Eligibility criteria:
inclusion criteria: * age: 18-80 years * chinese han patients with coronary artery disease * inpatients undergoing coronary angiography or percutaneous coronary intervention exclusion criteria: * renal insufficiency (defined as serum creatinine concentration \> 2 times the upper limit of normal \[230 μmol/l\], renal transplantation or dialysis) * hepatic insufficiency (defined as serum transaminase concentration \> 2 times the upper limit of normal \[80 u/l\], or a diagnosis of cirrhosis) * pre-existing bleeding disorders * being pregnant or lactating * advanced cancer or haemodialysis * history of thyroid problems, and use of antithyroid drugs or thyroid hormone medication * incomplete information about cardiovascular events during follow-up

Keywords: epigenome metabolome microbiome genome multi-omics targets individual drug use
breathwork for chronic musculoskeletal pain

Conditions: Pain; Chronic Pain; Pain, Chronic; Musculoskeletal Pain

Summary: this project is a single-site, single-arm, clinical feasibility trial examining the impact of a single-session, 2-hour connected consciousness breathing with breath retention (ccbr) training for chronic musculoskeletal pain.

ccbr is a breathwork style that involves breathing with no pause between inhalation and exhalation (also known as circular breathing). this breathing pattern is maintained for a given period of time, ranging from 5 minutes to over 2 hours. in the proposed project, the ccbr training will begin with a 15-minute introduction to ccbr, followed by an hour and 15 minutes of therapist-guided ccbr practice. the final 30 minutes will be used to discuss participant experiences during the ccbr practice. ccbr training sessions will occur in-person and in a small group format (5 participants each).

Eligibility criteria:
inclusion criteria: * having received a professional diagnosis of clinical levels of chronic pain * being able to not commit to another (new) treatment during the course of the study * understanding english instructions fluently * being 18 and above exclusion criteria: * having learned to practice breathwork any time in the past * being unable to perform most basic tasks due to pain or pain treatment.
digital confocal microscopy for real-time diagnosis of pancreatic solid lesion

Conditions: Pancreas Adenocarcinoma; Endoscopic Ultrasound; Digital Pathology

Summary: endoscopic ultrasound-guided (eus) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions but it is burdened by a non-negligible risk of non-diagnostic or inconclusive results. ex-vivo fluorescence confocal laser microscopy (fcm) with mavig vivascope® 2500m-g4 could allow real time assessment of adequacy and diagnosis of the sample.

endoscopic ultrasound-guided (eus) tissue acquisition is the current standard of care for the diagnosis of pancreatic solid lesions. however, eus-sampling is burdened by a non-negligible risk of non-diagnostic or inconclusive results, with an estimated negative predictive value not higher than 70-80%. rose could improve the diagnostic yeld of this procedure. data about the utility of rapid on-site evalutation (rose) are still controversial. without rose, current guidelines suggest performance of three to four needle passes with an fine needle aspiration (fna) needle or two to three passes with a fine needle biopsy (fnb) needle. potential drawbacks of rose are the considerable time commitment, costs and logistical and personnel issues that arise because of the "on demand" nature of these procedures with the need to have available technologists. ex-vivo fluorescence confocal laser microscopy (fcm) is an optical technology for rapid microscopic digital imaging of fresh unfixed biological specimens without any slide preparation. fcm involves no damage or cell/tissue loss during the examination and the sample can subsequently be recovered and formalin-fixed and paraffin-embedded (ffpe) for permanent histology. fcm allows both cellular and architectural details to be visualized, similar to standard histological analysis of paraffin-embedded or frozen samples. with fcm, multimodal confocal microscopy using different laser sources and fusion images can generate optical plans similar to those from hematoxylin/eosin (h\&e)- stained sections directly from native tissues. recently, the feasibility of fcm with mavig vivascope® 2500m-g4 in eus-fnb sample of pancreatic solid lesions has been investigated . this previous single-center study demonstrated good concordance between the fcm image-based evaluation and the final ffpe histology. however in this first study, a single type of fnb needle was used for all the procedures and the pathologist involved was expert in digital pathology and in pancreatic disease. therefore it might be not representative of the everyday clinical practice. in addition the first study was mainly focused on the adequacy assessment of the samples.

Eligibility criteria:
inclusion criteria: * pancreatic solid lesions exclusion criteria: * cystic lesions * not suitable acoustic window for needle biopsy * decline to give informed consent.
efficacy of antidepressants in chronic back pain

Conditions: Back Pain

Summary: this 12 week placebo controlled clinical trial tests the individual and combined effects of an antidepressant medication and cognitive behavioral therapy for chronic back pain.

this is a 4 arm 12 week randomized clinical trial comparing the efficacy of 1) low concentration desipramine (\< 60 ng/ml); 2) cognitive behavioral therapy; 3) low concentration desipramine + cognitive behavioral therapy; and 4) placebo medication (benzotropine mesylate).

Eligibility criteria:
inclusion criteria: * chronic back pain (daily pain for \> 6 months) exclusion criteria: * major medical conditions which might contraindicate antidepressant treatment

Keywords: chronic pain back pain antidepressants
effect of short-term mindfulness-based training for major depression disorder: an eye-tracking study

Conditions: MDD

Summary: the purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (mdd) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.


Eligibility criteria:
inclusion criteria: * meet diagnostic and statistical manual (dsm-iv) diagnosis of depression * consent to participate in the study and to be randomized to one of two groups exclusion criteria: * current or past substance abuse, psychotic disorder,obsessive compulsive disorder , post-traumatic stress disorder, in the past 6 months * history of epilepsy or head trauma * eye disorders * history of electroconvulsive therapy in the past 4 weeks.

Keywords: eye-tracking eye movement mindfulness
the willow study with m5049 in sle and cle (scle and/or dle) (willow)

Conditions: Systemic Lupus Erythematosus

Summary: the purpose of this proof of concept (poc) and dose-finding (df) basket study is to evaluate the efficacy and safety of orally administered enpatoran over 24 weeks in systemic lupus erythematosus (sle) and cutaneous lupus erythematosus (cle; subacute cutaneous lupus erythematosus \[scle\] and/or discoid lupus erythematosus \[dle\]) participants in a randomized, double-blind, placebo-controlled, parallel, adaptive and dose-ranging setting. study duration: 33 weeks visit frequency: every 2 or 4 weeks enpatoran is not available through an expanded access program.


Eligibility criteria:
inclusion criteria: * active cle (scle and/or dle) with a cle disease area and activity index (clasi-a) \>= 8 * active sle with presence of: clasi-a \>= 8 and bilag 2004 1b, c, d (that is \[i.e.\], no bilag 2004 a and no bilag 2004 \>= 2b) or bilag 2004 \>= 1a or 2b and 1 or 2 of the following: hybrid safety of estrogens in systemic lupus erythematosus national assessment (selena)-sledai \>= 6 at screening visit and confirmed clinical hybrid selena-sledai \>= 4 (excluding laboratory parameters) at day 1 visit and/or clasi-a \>= 8 * receiving a stable dose of at least one of the following standards of care therapies for lupus: immunomodulator/immunosuppressant, oral corticosteroids, and/or topical corticosteroids * other protocol defined inclusion criteria could apply exclusion criteria: * autoimmune or rheumatic disease other than sle or cle * dermatological diseases other than cutaneous manifestations of sle or cle * uncontrolled medical conditions including significant cardiovascular events, active lupus nephritis, and active neurological disorder * ongoing or active clinically significant viral, bacterial, or fungal infection * history of uncontrolled seizures or other neurological disorder * history of or positive for human immunodeficiency virus, hepatitis c virus, or hepatitis b virus * history of malignancy * other protocol defined exclusion criteria could apply

Keywords: toll-like receptor 7 toll-like receptor 8 willow adults sle cle lupus discoid lupus erythematosus subacute cutaneous lupus erythematosus m5049 enpatoran