Kornimate/medical-research-clean huggingface dataset:
study to evaluate maintenance of sustained remission of axspa with czp compared to placebo

Conditions: Axial Spondyloarthrithis; Ankylosing Spondylitis

Summary: patients receive study drug for one year (part a). if, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (part b). the maintenance of the sustained remission will be analyzed.


Eligibility criteria:
inclusion criteria: * documented diagnosis of adult-onset axial spondyloarthritis (axspa) with at least 3 months' symptom duration and meet the assessment of spondyloarthritis international society (asas) criteria for axspa and symptom duration of less than 5 years prior to the participation of this study * active disease at screening as defined by * ankylosing spondylitis disease activity score (asdas) ≥ 2.1 * bath ankylosing spondylitis disease activity index (basdai) score ≥ 4 * spinal pain \> 4 on a 0 to 10 numerical rating scale (nrs) (from basdai item 2) * for modified new york (mny) -negative subjects only: c-reactive protein (crp) \> upper limit of normal (uln) and/or current evidence for sacroiliitis on the screening magnetic resonance imaging (mri) * inadequate response to, or contraindication to, or intolerant to at least 2 nonsteroidal anti-inflammatory drugs (nsaids) exclusion criteria: * presence of total spinal ankylosis ('bamboo spine') * diagnosis of any other inflammatory arthritis * prior treatment with any experimental biological agents for treatment of axial spondyloarthritis (spa) * exposure to more than 1 tnf-antagonist or primary failure to tnf antagonist therapy * history of or current chronic or recurrent infections * high risk of infection * recent live vaccination * concurrent malignancy or a history of malignancy * class iii or iv congestive heart failure - new york heart association (nyha) * demyelinating disease of the central nervous system * female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product * subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

Keywords: axial spondyloarthritis axspa ankylosing spondylitis anti tnf-alpha certolizumab pegol remission spondylarthropathies arthritis spinal diseases immunosuppressive agents
s. aureus, skin and soft tissue infections

Conditions: Skin and Soft Tissue Infections (SSTIs)

Summary: methicillin-resistant staphylococcus aureus (mrsa) is reported as one of the main causative pathogen of community acquired sstis. in the usa, high prevalence of mrsa among skin and soft tissue infections (sstis) is known to be due to the spread of the usa300 clone \[moran et al. 2006\]. among s. aureus sstis infections in europe, data regarding the prevalence of mrsa in sstis and the causative genotypes remain scarce. the paucity of literature on the prevalence of mssa, mrsa and pvl-producing s. aureus strains in ssti in europe is probably due to the fact that culture and antimicrobial susceptibility testing is not a routine component of ssti management. setting-up a prospective multi-centre study involving patients presenting to emergency departments with sstis in several european countries would allow drawing a picture on the role and the respective contribution of mssa, mrsa and pvl-producing s. aureus strains as a cause of sstis. however, the roles of emergency rooms and local policies with regard to performing microbiological analysis after surgical drainage of sstis vary between countries. in order to evaluate the feasibility of such multicenter european study, we aim at performing a pilot study based on few european clinical laboratories (five to seven) which will: i) evaluate the prevalence of mssa, mrsa and s. aureus pvl-positive strains in community-acquired sstis; and ii) determine molecular characteristics of the isolated strains. the main objectives of this pilot study are to collect some preliminary information on the role of s. aureus in sstis and to determine factors that need to be harmonized or taken into consideration for the set-up a larger prospective cross-sectional study involving more european countries with several centers per country to cover different geographical areas per country.


Eligibility criteria:
inclusion criteria: - all patients (adults and children) presenting to emergency department with purulent skin and soft tissue infections (sstis) of less than one week duration are eligible exclusion criteria: - patients (adults and children) presenting to emergency department with others type of infections than sstis

Keywords: sstis methicillin-resistant staphylococcus aureus (mrsa) methicillin susceptible staphylococcus aureus (mssa) the toxin panton-valentine leukocidin (pvl) emergency departments
prognostic significance of fatty liver disease in bariatric patients

Conditions: Non-Alcoholic Fatty Liver Disease; Metabolic Encephalopathy; Obesity, Morbid; Non-alcoholic Steatohepatitis

Summary: prospective non-randomized intervention case control study on patients with a bmi \> 35. the intervention group/cases (n=600) is comprised of bariatric patients who undergo bariatric surgery and the control group (n=600) of age, weight and comorbidity matched patients who choose not to undergo bariatric surgery. the overall aim is to examine prevalence of the spectrum of fatty liver disease (nafld) in these patients and the prognostic significance of nafld.


Eligibility criteria:
inclusion criteria case group: * age \> 18 years * bmi \>35 kg/m2 and referred for bariatric surgery at hospital of south west jutland, denmark * able to give written informed consent. inclusion criteria control group: * age \> 18 years * bmi \>35 kg/m2 with no wish to undergo bariatric surgery. * able to give written informed consent. exclusion criteria: * active viral hepatitis * not willing or able to consent * contraindications to liver biopsy
evaluating quebec's red-cross intervention

Conditions: Social Isolation; Aging

Summary: with the covid-19 pandemic, elderly people (ep) living at home have seen their health deteriorated, thus increasing their needs in support and care. indeed, while it was estimated that before the pandemic120 000 unattended living at home ep required care and services (taking bath, access to medication and food, etc.), the number doubled after covid-19. therefore, the waiting list for socio-medical services for unattended vulnerable clientele without a family doctor grew from 1300 to 1715 ep in a couple of months during the pandemic. with these numbers, it becomes clear that an intervention is needed. truly, the institut national d'excellence en santé et services sociaux (inesss) concludes that it was pivotal to first identify the most vulnerable ep and second re-orient them according to their needs. thus the principal investigator developed the évaluation et orientation socio-gériatrique (esoger) questionnaire available on a secure digital platform enabling both a rapid evaluation and intervention to asses ep needs and provide the adequate ressources. the principal investigator's previous research has demonstrated that esoger is one of the rare clinical tools of first contact in telehealth while being global, multidimensional, and equitable. hence, the principal investigator hypothesizes that esoger is a clinical tool enabling first line care by the red-cross to vulnerable ep without a family doctor, which will lead to an improvement in their health, autonomy and quality of life. moreover, the principal investigator also hypothesizes that for a better deployment, the tool needs to be adapted to red-cross' need and ep service providers.


Eligibility criteria:
inclusion criteria: * aged 65 and more * living at home * be registered at the waiting list of gaco at the ciusss-centre-sud de l'île-de-montréal (ccsmtl) exclusion criteria: * principal address outside of the ccsmtl territory * participate at another clinical trial, to avoid interferences * not understand written or spoken french or english, questionnaires are only available in french and english.
registry protocol- melphalan percutaneous hepatic perfusion for the treatment of unresectable hepatic malignancy

Conditions: Hepatic Malignant Neoplasm Primary Non-Resectable

Summary: collection of safety, efficacy and resource utilization information in patients who have received melphalan php with the delcath hepatic delivery system for the treatment of unresectable hepatic malignancy

post marketing study: the chemosat kit containing gen 2 filters has been used to treat patients since april 2012. this registry study is designed to collect safety, resource utilization and treatment outcomes in patients who receive this treatment with chemosat by healthcare professionals. the safety and efficacy data from patients treated with chemosat is important in updating the safety profile and for collection of treatment information. the resource utilization information is essential in planning treatment strategy for patients. this registry does not follow any pre-determined protocol with respect to diagnosis, treatment or follow-up of the patient. the data collected will be gathered exclusively from current medical practice at participating institutions. delcath holds a list of authorized customer hospitals to whom it supplies the chemosat system. to date these hospitals have treated over 300 patients with cancers of the liver. the decision to treat with chemosat is clearly separated from the decision to collect data in the registry. no specific procedures or tests are required in this protocol.

Eligibility criteria:
1. have received chemosat treatment per ifu within the last 6-months or are planned to receive treatment with chemosat. 2. have provided written informed consent according to institutional and regulatory guidelines
follow-up study evaluating the long term outcome of chondromimetic in the treatment of osteochondral defects in the knee

Conditions: Osteochondral Defect

Summary: to investigate the long-term efficacy and safety of the medical device, chondromimetic, in subjects who were treated in the interventional study 0mcm0107 for osteochondral defects of the knee.

this is an open-label, single center, extension study to the previous interventional study 0mcm0107 designed to investigate the long-term efficacy and safety of the medical device, chondromimetic, in the treatment of osteochondral defects of the knee. follow-up to 6-months was completed as part of study 0mcm0107. all 17 subjects who received chondromimetic in study 0mcm0107 are eligible for enrolment into this extension study regardless of their current follow-up period.

Eligibility criteria:
treated with a chondromimetic device under protocol 0mcm0107 and completed the required follow-up.
effects of thoracic erector spinae plane blockade on acute and chronic pain after video assisted thoracoscopic surgery (vats)

Conditions: Thoracic

Summary: this is a prospective randomized study intended to assess the efficacy of erector spinae plane analgesia on acute and chronic postoperative pain for vats procedures. it will include 72 patients presenting to severance hospital for a vats procedure. patients will be randomized 1:1 to receive either esp block and intravenous patient-controlled analgesia (iv pca) or iv pca only. ropivacaine will be used in nerve block, and injected at the end of surgery. the primary outcome will be to compare analgesic efficacy between the two groups as defined by immediate postoperative pain scores on the numeric pain rating scale. secondary outcomes include total opioid consumption, paindetect score, and chronic pain scores.

postoperative pain control for thoracic surgery is key to allow faster recovery and diminish postoperative complications. poorly controlled acute pain may contribute to the impairment of respiratory function and the development of chronic post-thoracotomy pain. recently, an increasing number of erector spinae plane (esp) nerve blocks are being performed as it has been demonstrated, and via case reports that the blocks provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block and epidural analgesia. moreover, there is an advantage for novice because esp block is simpler and safer to proceed than conventional nerve blocks.

Eligibility criteria:
inclusion criteria: 1. male and female participants providing written informed consent, 2. asa grade 1-3, 3. aged over 20 and under 80, 4. primary lung cancer participants scheduled segmentectomy or lobectomy c mlnd, 5. undergoing a vats procedure under general anaesthesia exclusion criteria: 1. absence of informed written consent, 2. chemotherapy before or after surgery, 3. pre existing infection at block site, 4. severe coagulopathy, 5. pre existing neurological deficit, 6. previous history of opiate abuse, 7. pregnancy, 8. pre existing chronic pain condition,

Keywords: thoracic surgical procedures
waterinmotion aquatic exercise program compared to land-based rehabilitation on low-back pain relief and quality of life

Conditions: Low Back Pain; Obesity; Sedentary Behavior

Summary: this randomized controlled trial compares the efficacy of an 8-week waterinmotion aquatic exercise program versus land-based rehabilitation for reducing low-back pain (lbp) and improving quality of life in sedentary, overweight/obese middle-aged women (n=45). outcomes include pain intensity (vas), functional disability (odi), and health-related quality of life (sf-36).

participants (aged 45-65, bmi ≥25 kg/m², chronic lbp ≥3 months) were randomized to aquatic exercise (n=45) or land-based rehabilitation (n=45). both groups completed three 60-minute sessions/week for 8 weeks. assessments occurred at baseline, post-intervention, and 3-month follow-up. primary outcomes: vas and odi; secondary outcomes: sf-36 and satisfaction.

Eligibility criteria:
inclusion criteria: * women aged 45-65, bmi ≥25 kg/m². * sedentary (\<150 min/week moderate activity). * chronic lbp (≥3 months, vas ≥4). exclusion criteria: * contraindications to exercise (e.g., severe cardiovascular disease). * spinal surgery history or inflammatory conditions (e.g., rheumatoid arthritis).

Keywords: hydrotherapy exercise therapy middle aged quality of life disability evaluation
bimatoprost 0.03% solution with nb-uvb versus their use with fractional carbon dioxide laser in treatment of generalized vitiligo

Conditions: Generalized Vitiligo

Summary: vitiligo is a chronic disorder of pigmentation characterized by the development of white macules on the skin due to loss of epidermal melanocytes. it affects approximately 0.5%-2% of general population world-wide, without predilection for sex or race.vitiligo can be classified into segmental or non-segmental. non-segmental or generalized vitiligo is the most common clinical presentation and often involves the face and acral regions. multiple monotherapy modalities are established to treat vitiligo but the response is variable, unsatisfactory, and requiring a prolonged course. this problem is exaggerated by the multifactorial and polygenic nature of the pathomechanism of the disease. these facts pave the way to combination therapy that showed better and safe repigmentation response than monotherapy.

bimatoprost 0.03% ophthalmic solution is a synthetic prostaglandin f2 alpha analog that is approved for the treatment of glaucoma and eyelashes hypotrichosis (lee et al, 2017). cutaneous hyperpigmentation of the treated sites has been reported as a side effect with this agent. phototherapy (narrow band ultraviolet b (nb-uvb)) of wavelength 308 nm, is considered as a successful method of treatment of vitiligo. the cytotoxic t-cells accountable for the destruction of melanocytes and disappearance of melanin are eliminated by phototherapy through apoptosis (diffuse repigmentation) and uvb does stimulate melanocytic proliferation and their migration to the epidermis from nearby follicular units (follicular repigmentation) and perilesional active melanocytes (marginal repigmentation). in recent years, fractional carbon dioxide laser has been introduced as an add-on treatment for vitiligo. it represents a new modality for skin resurfacing based on the theory of fractional photothermolysis. the beneficial effect of fractional carbon dioxide laser on vitiligo is the release of cytokines and growth factors that act as mitogens for melanogenesis. it also alters the skin barrier, which results in increased penetration of topical drugs and ultraviolet (uv) radiation, so it can be used in combination therapy.

Eligibility criteria:
inclusion criteria: 1. patients older than 12. 2. patients with non-segmental vitiligo. 3. lesions stable for at least one year. 4. patients who were unresponsive to medical treatment or photo therapy for at least 3 months. 5. no sex or site predilection. 6. bilateral and symmetrical lesions with maximum size of 10×10 cm. exclusion criteria: 1. patients with active infection. 2. patients with sensitivity to bimatoprost or photosensitivity. 3. patients with history or active skin cancer. 4. pregnant or lactating females.
a clinical study of tqb3912 tablets in patients with advanced malignant tumor

Conditions: Advanced Malignant Neoplasm

Summary: this is a study to evaluate the maximum tolerated dose (mtd), occurrence of all adverse events (aes) and serious adverse events (saes), pharmacokinetic parameters and antitumor effect of tqb3912 tablets in chinese adult patients with advanced malignant neoplasm. the study was divided into phase ia and phase ib, phase ia: dose escalation period, to evaluate the safety and tolerability of tqb3912 tablets, determine mtd; phase ib: effectiveness exploration period, to expand the safe and effective dose group, and to recommend appropriate dosage and method for subsequent clinical research.


Eligibility criteria:
inclusion criteria: * subjects who voluntarily join the study, sign the informed consent form, and have good compliance. * aged from 18 to 75 years; eastern cooperative oncology group performance status score: 0-2; at least 3 months of expected survival period. * subjects with relapse advanced malignant solid tumors clearly diagnosed by pathology and/or cytology. * the function of main organs is normal. * subjects need to adopt effective methods of contraception. exclusion criteria: * subjects with other malignancies currently or suffered within 3 years. * subjects with grade 1 or above unhealed toxicity reaction of common terminology criteria for adverse events version 5.0 due to previous antitumor treatment. * subjects who have received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before first administration. * subjects with long lasting wounds or fractures. * subjects with a history of psychotropic drug abuse unable to quit or with mental disorders. * subjects with any severe and/or uncontrolled disease. * subjects who have received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks before the first administration. * subjects who have taken chinese patent medicines with anti-tumor indications in the drug instructions that national medical products administration approved within 2 weeks before the first administration. * subjects with pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage. * subjects who have participated in other clinical studies within 4 weeks before the first administration. * according to the judgment of the investigators, there are accompanying diseases that seriously endanger the safety of patients or affect the completion of the study.
phil in the treatment of intracranial davf.

Conditions: Arteriovenous Dural Fistula

Summary: this study is a prospective, multicenter, single-arm study. patients with dural arteriovenous fistulas (davf) have a few choice for safe treatment. in this study, all patients with qualifying davfs will be treated with phil® liquid embolic material.


Eligibility criteria:
inclusion criteria: * age 22 - 80 years. * subject is willing and capable of complying with all study protocol requirements, including specified follow-up period. * subject or authorized legal representative must provide written informed consent prior to initiation of any study procedures. * subject has an intracranial davf exclusion criteria: * subject having multiple davfs to be treated. * subject with a history of life threatening allergy to contrast media (unless treatment for allergy is tolerated). * subject has known allergies to dimethylsulfoxide, iodine. * subject is currently participating in another clinical study * female subject is currently pregnant. * subject has co-morbid conditions that may limit survival to less than 24 months.

Keywords: fistula intracranial dural arteriovenous liquid embolic
developing a decision tool for diverticulitis in the emergency department using ultrasound

Conditions: Diverticulitis

Summary: the purpose of this study is to create a decision tool using ultrasound, patient history, and laboratory values to predict a diagnosis of complicated diverticulitis and whether the patient requires further imaging. the accuracy of the decision tool will be evaluated. this study will also assess the ability of ultrasound to diagnose complicated and simple diverticulitis, and the inter-provider reliability of ultrasound interpretation of diverticulitis


Eligibility criteria:
inclusion criteria: * emergency department patient * provider suspicion of diverticulitis * ct scan ordered exclusion criteria: * pregnant patient * prisoner * non-english speaking * inability to provide informed consent * hemodynamically unstable as determined by provider * previous abdominal surgery within last 7 days * unable to lay flat for ultrasound exam
safety and efficacy of exenatide as monotherapy

Conditions: Type 2 Diabetes Mellitus

Summary: this phase 3 trial is designed to compare the effects of twice-daily exenatide and twice-daily placebo with respect to glycemic control in drug-naive patients with type 2 diabetes treated with diet and exercise.


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * treating diabetes with diet and exercise * hba1c between 6.5% and 10.0%, inclusive * body mass index (bmi) between 25 kg/m\^2 and 45 kg/m\^2, inclusive exclusion criteria: * have previously completed or withdrawn from this study * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry * have been treated with any antidiabetic agent * have used drugs for weight loss (for example, xenical, meridia, acutrim, or similar over-the counter medications) within 3 months of screening * are currently treated with any of the following excluded medications: \* drugs that directly affect gastrointestinal motility; \* systemic corticosteroids (excluding topical and inhaled preparations) by oral, intravenous, or intramuscular route used regularly (longer than 2 weeks) or used within 2 weeks immediately prior to screening for this study

Keywords: diabetes exenatide amylin lilly monotherapy