Kornimate/medical-research-clean huggingface dataset:
a phase ib/ii study of recombinant anti-il-1β humanized monoclonal antibody injection in chinese participants with acute gout

Conditions: Acute Gout

Summary: the purpose of this study is to determine the target dose of phase ii and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-il-1β humanized monoclonal antibody injection at different doses in chinese participants with acute gout.

the phase ib study is a multi-center, open label, dose escalation study examining the effect of recombinant anti-il-1β humanized monoclonal antibody injection and to determine the target dose of phase ii for the treatment of acute flare in chinese gout patients in whom non-steroidal anti-inflammatory drugs (nsaids) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. there are 3 dose groups (100 mg、200 mg and 300 mg) in phase ib and 10 participants in each group. the phase ii study is a dose-ranging, multi-center, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of 2 dose regimens (200 mg and 300 mg, based on the outcome of phase ib) of recombinant anti-il-1β humanized monoclonal antibody injection versus compound betamethasone injection for the treatment of acute flare in chinese gout patients in whom nsaids and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response. the phase ii recommended dose of ssgj-613 in subjects with acute gouty was determined according to the phase ib interim analysis results.

Eligibility criteria:
inclusion criteria: * must be 18 years to 65 years, both male and female * meeting the american college of rheumatology (acr) 2015 criteria for the classification of acute arthritis of primary gout. * presence of acute gout flare for no longer than 7 days * baseline pain intensity \> or = to 50 mm on the 0-100 mm vas * contraindicated for, intolerant or unresponsive to nsaids, colchicine or both exclusion criteria: * secondary gout (such as gout caused by chemotherapy, transplant gout, etc.) * evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis * presence of severe renal function impairment * intolerance of subcutaneous and intramuscular injection * known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment * history of malignant tumor within 5 years before screening * live vaccinations within 3 months prior to the start of the study * use of forbidden therapy
online physical therapy management for physiotherapists to cope psychological distress during covid-19 pandemic

Conditions: Psychological Distress

Summary: this project is aimed at physiotherapists and physiotherapy students who have been psychologically affected during the covid 19 pandemic. the objective of the approach is to generate a free intervention programme in virtual modality, from the approach of physiotherapy in mental health, which would help them to alleviate the negative effects of the pandemic, offer them coping tools and collaborate to improve their state of well-being.

the intervention group will consist of the ínsula method. insula method will be developed twice a week for 12 weeks online form through videoconference platform. the intervention will consist of twelve individual treatments. it is a program of physiotherapy in mental health, created by the physiotherapists eugenia de león (guatemala) and moisés magos (mexico) in conjunction with the psychiatrist roberto martínez porras (guatemala). it has a progressive design, seeking to strengthen emotional self-regulation skills, connection with others and the environment, and to guide a self - knowledge process. all these objectives are worked through body resources, like conscious movement, breathing, posture, contact, relaxation exercises, etc. the program has influence of various other disciplines such as tai - chi, chi kung, sensorimotor therapy, somatic education, mindfulness, bbat, among others. likewise, its principles and progression are based on theoretical models of neurosciences

Eligibility criteria:
inclusion criteria: * they are physiotherapist with a moderate or severe psychological distress self-perceived regarding covid-19 pandemic * age \>18 years * they can manage to stand from the position of "lying", "sitting", and "standing" without assistance * they can have smartphone, laptop or device and internet access to follow the intervention exclusion criteria: * they could not follow the intervention due to cognitive or physical health

Keywords: physical therapy covid-19 anxiety depression body awareness
radicle rest 2: a study of health and wellness products on sleep and health outcomes

Conditions: Sleep; Sleep Disturbance; Sleep Disorder

Summary: a randomized, blinded, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on sleep and other health outcomes.

this is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the united states. eligible participants will (1) endorse a desire for improved sleep, (2) indicate an interest in taking a health and wellness product to potentially help their sleep, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. those taking certain medications will be excluded. self-reported data are collected electronically from eligible participants over 7 weeks. participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. all study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study.

Eligibility criteria:
inclusion criteria: * adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities * resides in the united states * endorses better sleep as a primary desire * selects sleep, looking to improve their sleep, and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product * expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study exclusion criteria: * reports being pregnant, trying to become pregnant, or breastfeeding * unable to provide a valid us shipping address * the calculated validated health survey (pro) measurement result is less than mild severity/impairment * reports a diagnosis of liver or kidney disease * reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) * unable to read and understand english * reports current enrollment in a clinical trial * lack of reliable daily access to the internet * reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection * reports taking medications with a known moderate or severe interaction with any of the active ingredients studied: anticoagulants, a medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or monoamine oxidase inhibitors (maois) * reports a diagnosis of heart disease when a known contraindication exists for any of the active ingredients studied: new york heart association (nyha) class iii or iv congestive heart failure, atrial fibrillation, uncontrolled arrhythmias
evaluation of blood pressure monitor with afib screening feature

Conditions: Atrial Fibrillation

Summary: this study aims to evaluate the safety and effectiveness of the omron blood pressure (bp) monitor with afib screening feature. the primary outcome is to validate if the omron bp-monitor with afib screening feature meets acceptance criteria in sensitivity and specificity. the acceptance criteria of the sensitivity and specificity should be statistically non-inferior to those of primary predicate device.


Eligibility criteria:
inclusion criteria: * subjects are eligible to participate in the study if they meet all of the following criteria. afib participants must meet criteria 1-5. non-afib participants must meet criteria 1-3 and 6-7. 1. age ≥ 22 years old 2. arm size within 22 cm to 42 cm in circumference 3. participants who have an adequate understanding about the study and have given informed written consent before participation 4. participants who were diagnosed with afib and have regularly seen a cardiovascular specialist 5. participants who have atrial fibrillation symptoms on ecg at the time of data collection 6. participants who have never been diagnosed with atrial fibrillation 7. participants who do not have afib symptoms on ecg at data collection time exclusion criteria: * participants will be excluded from the study if they meet any of the following criteria. 1. subjects who have difficulty in ecg or blood pressure measurement due to skin rashes or wounds on the chest or arm 2. women who are pregnant at the time of study participation. 3. subjects who have had a mastectomy. 4. subjects with pacemakers and/or defibrillators. 5. subjects who have difficulty in measuring blood pressure or ecg measurements in the sitting position. 6. subjects who are hospitalized (in-patients) 7. subjects whose pulse rate is less than 40 beats/minute or more than 180 beats/minute. 8. subjects who have had an arterio-venous shunt or an intravascular access on either arms. 9. subjects who have heart failure class iii or iv. 10. subjects who at the beginning of the scheduled study time experience any of the following newly developed conditions within the past 3 hours: chest pain, paralysis or numbness (face, arm or leg), trouble speaking or understanding, visual field loss in one or both eyes.
sk-1401 (rhgm-csf agent for inhalation) gm-csf inhalation pharmacokinetic study

Conditions: Pulmonary Alveolar Proteinosis, Autoimmune

Summary: objective: evaluate pharmacokinetics and determine the safety of gm-csf single dose inhalation. study design: pharmacokinetic open study


Eligibility criteria:
inclusion criteria: 1. subjects judged to be appropriate for the study by the attending physician 2. can provide signed informed consent. apap patient must meet the following 3. apap patient aged over 20 and below 80 years old (as of the date of registration) 4. apap severity is mild or moderate. (not severe) healthy volunteer must meet the following 5. japanese healthy male subject aged over 20 and below 45 years old (as of the date of registration). 6. bmi (body mass index) is between 18 and 25. exclusion criteria: 1. wbc of 12,000/mcl or more 2. fever of 38 degree celsius or more 3. history of malignant disease within recent 5 years (not applied to the treated cases of local basal cell carcinoma) 4. complication of severe cardiovascular diseases including congestive heart failure, angina pectoris, hemorrhagic tendency, etc. 5. complication of respiratory diseases such as pulmonary infectious disease(incl. pulmonary tuberculosis), interstitial pneumonitis, lung fibrosis or bronchiectasis, in which the evaluations of safety of gm-csf therapy are considered to be difficult. 6. history or complication of infectious diseases which require systemic administration of antibiotics, antifungal or antiviral agents within recent 2 weeks. 7. liver dysfunction 8. renal dysfunction 9. previous experience of severe and unexplained adverse events during aerosol delivery of any kind of medicinal product 10. positive for hiv-ab, hbs-ag, hcv-ab, sts or tpha 11. allergic to gm-csf. 12. addicted to illegal drugs 13. participation to other clinical trials within 12 weeks before registration. 14. smoking within 5 years 15. cannot follow the procedure defined in this protocol apap patient must exclude the following 16. pregnant or possibly pregnant women, lactating women, and women who desire to become pregnant during the study period 17. patients who have been treated with whole-lung lavage, repeated segmental-lung lavage, gm-csf or rituximab within 6 months before the start of the study. 18. taking other inhalation. healthy volunteer must exclude the following 19. taking any medicines (incl. otc).
one year study of rifaximin delayed release (dr) in crohn's disease

Conditions: Crohn's Disease

Summary: the primary objective is to determine the efficacy of rifaximin dr also referred to as extended intestinal release (eir) tablets vs. placebo for the induction of clinical remission and endoscopic response following 16 weeks of treatment in participants presenting with active moderate crohn's disease. a key secondary objective is to evaluate clinical and endoscopic remission following an additional 36 weeks of treatment.

recd3126 is a double-blind, placebo-controlled, parallel-group, multicenter, multiregional, 52-week study to assess the efficacy and safety of rifaximin dr tablets for the induction of clinical remission and endoscopic response at 16 weeks followed by clinical and endoscopic remission after 52 weeks of continuous therapy in participants with active moderate crohn's disease. participants will be randomized in a 1:1 allocation to rifaximin or placebo at the beginning of the treatment period and will maintain treatment assignment throughout the duration of the study. ileocolonoscopy will be performed on all participants at baseline, between weeks 16 and 17 (end of the induction phase), and following completion of the 36-week long term treatment phase (week 52).

Eligibility criteria:
major inclusion criteria: * moderate, non-fistulizing crohn's disease in the ileum and/or colon prior to randomization; and a ses-cd score of ≥7 (confirmed by centralized endoscopy reading). * during the screening period, the participant will need to have certain average daily scores for abdominal pain and average number of liquid/very soft stools. major exclusion criteria: * pregnant or lactating females. females of childbearing (reproductive) potential must have a negative serum pregnancy test at screening and agree to use a highly effective method(s) of contraception throughout their participation in the study. diagnosis of ulcerative or indeterminate colitis. * diagnosis of celiac disease. * bowel surgery within 12 weeks prior to screening and/or has surgery planned or deemed likely for crohn's disease during the study period. * presence of an ileostomy or colostomy. * known fixed symptomatic stenosis/stricture of the small or large bowel. * had more than one segmental colonic resection. * had more than 3 small bowel resections or symptoms associated with short bowel syndrome. * current evidence of peritonitis. * history or evidence of colonic mucosal dysplasia. * history or evidence of adenomatous colonic polyps that have not been removed. * unwilling to be tapered off corticosteroids by week 8 or the participant is known by the investigator to be steroid-dependent. * has used a biologic within 12 weeks of randomization. * used cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or similar drugs within 8 weeks prior to randomization. * had rectal administration of 5-aminosalicylic acid (5-asa) or corticosteroid enemas/foams/ suppositories within 2 weeks prior to screening visit.

Keywords: crohn's disease rifaximin clinical remission with endoscopic response inflammatory bowel disease
correlation between carbon dioxide measured in end of exhalation and arterial blood

Conditions: Correlation Between Exhaled Carbon Dioxide and in Arterial Blood

Summary: the purpose of this study is to study the correlation between carbon dioxide measured by capnography at the enf of exhalation and arterial blood in copd patients with nasal cannula in critical care unit.


Eligibility criteria:
inclusion criteria: * adults * copd patients exclusion criteria: * under-aged * pregnant * major burns
aerobic training and diet on the immune system in postmastectomy patients receiving chemotherapy

Conditions: Immune Deficiency; Diet, Healthy; Breast Cancer

Summary: the purpose of the study was to investigate the impact of aerobic exercise combined with diet protocol on the immune system in post-mastectomy patients receiving chemotherapy.

chemotherapy reduces circulating lymphocytes levels, which affect lymphocytes in breast cancer patients during the therapy itself or up to 3 months after the last chemotherapy cycle, so the study is developed to investigate the impact of aerobic exercise combined with diet protocol on the immune system in post-mastectomy patients receiving chemotherapy. sixty post-mastectomy women were receiving chemotherapy and aged from 40-60 years selected from the outpatient clinic of the oncology department in the new cairo hospital in the police academy. they will be assigned randomly into three equal groups, the aerobic exercises and diet protocol group, the diet protocol group, and the aerobic exercises group. the immunological markers; total lymphocyte count (tlc), neutrophil-to-lymphocyte ratio(nlr), and platelet-to-lymphocyte ratio(plr) will be measured at baseline and after twelve weeks of intervention.

Eligibility criteria:
inclusion criteria: * female post-mastectomy patients. * age range is between 40-60 years old. * all patients will enter the study after having their informed consent. * all patients are undergoing chemotherapy treatment with ac protocol (adriamycin with endoxan) for four cycles (every 21 days ). * all patients have finished the first stage of chemotherapy treatment exclusion criteria: * cardiac disease patients. * uncontrolled hypertension patients. * patients with thyroid disease. * patients with lymphatic complications.

Keywords: aerobic exercises diet therapy immune function mastectomy
investigation on the current situation and risk factors analysis of exocrine insufficiency in chronic pancreatitis

Conditions: Chronic Pancreatitis; Pancreatic Exocrine Insufficiency

Summary: pancreatic exocrine insufficiency (pei) is one of the common complications of chronic pancreatitis (cp). mild to moderate pei may present with atypical digestive tract symptoms such as abdominal distension and abdominal pain, while severe pei can lead to related complications such as foul-smelling stools, steatorrhea, weight loss, and malnutrition. currently, there is no relevant report on the status quo of pei in chinese cp patients. this study aims to analyze the status quo of pei and related risk factors in chinese cp patients, with the hope of providing safe and effective intervention and treatment methods to improve the quality of life of patients.

pancreatic exocrine insufficiency (pei) is one of the common complications of chronic pancreatitis (cp). mild to moderate pei may present with atypical digestive tract symptoms such as abdominal distension and abdominal pain, while severe pei can lead to related complications such as foul-smelling stools, steatorrhea, weight loss, and malnutrition. currently, there is no relevant report on the status quo of pei in chinese cp patients.this study aims to analyze the current status and related risk factors of pei in cp patients in china by detecting pancreatic exocrine function with fe-1, in order to provide safe and effective intervention and treatment methods and improve the quality of life of patients.

Eligibility criteria:
inclusion criteria: 1. patients who underwent inpatient care at shanghai changhai hospital (a who collaborating center for pancreatology) between june 2022 and september 2024. 2. patients diagnosed with chronic pancreatitis (cp) 3. voluntarily preserve feces for the detection of fecal elastase-1 (fe-1) exclusion criteria: 1. patients who were diagnosed with pancreatic cancer within 2 years after being diagnosed with chronic pancreatitis (cp) 2. patients with groove pancreatitis, 3. patients with autoimmune pancreatitis.

Keywords: chronic pancreatitis pancreatic exocrine insufficiency
long-term safety of drug eluting stents in the "real world" (freiburger stent registry)

Conditions: Stent Thrombosis

Summary: the freiburger stent registry (frist) is designed to determine the long term safety and efficacy of drug eluting stents (des) in a "real-world" patient population requiring stent implantation. frist included patients treated with des and bare-metal stents (bms) in the university hospital of freiburg, germany, according to a non-restrictive inclusion criterion, in which virtually all consecutive patient subsets were considered eligible.


Eligibility criteria:
inclusion criteria: * consecutive patients undergoing percutaneous coronary intervention exclusion criteria: * patient refusal or inability to provide written informed consent

Keywords: drug-eluting stent bare-metal stent long-term safety mortality stent thrombosis angioplasty transluminal percutaneous coronary
molecular basis of language development and associated disorders

Conditions: Developmental Language Disorder

Summary: developmental language disorder (dld) refers to children who present with language difficulties that are not due to a known biomedical condition or associated with autism spectrum disorder (asd) or intellectual disability. the prevalence of dld is \~7%-8% or 2% if severe forms are considered. however, the clinical heterogeneity of language disorders, the presence of co-morbidities and the inconsistent terminology used for many years have hindered research and clinical practice. distinguishing sub-groups of children with language problems is crucial when tackling the underlying genetic causes of this disease. recently, several studies using high-throughput sequencing have better define the genetic basis of cas but such studies focusing on dld are limited. the investigation of more homogeneous cohorts of individuals that clearly distinguish dld cases, from id and not including children with cas should improve our understanding of the genetic basis of this disorder. in this study, we aim to built and investigate a well-characterized cohort of dld patients using pangenomic approaches to better define the molecular basis of this disorder. all individuals will be analyzed using chromosomal microarray analysis and whole genome sequencing. multiple observations and preliminary results suggest strong links with the genetic basis of other neurodevelopmental disorders. the goal is to identify cnv or snv as causative allele or risk factor and already known to be involved in other neurodevelopmental disorders as well as potential new variants.


Eligibility criteria:
patients inclusion criteria: * eligible families included at least one child over five years old with a formal diagnosis of severe and isolated dld according to phase 2 catalise criteria . patients have undergone age-appropriate speech, language and reading evaluations by a speech-language physician and cognitive evaluations by a neuropsychologist, as well as evaluation by a pediatric neurologist to identify co-occurring developmental disorders (adhd, asd...) and a medical geneticist for known genetic disorders and genetic testing recommendations. all children included received appropriate speech therapy for at least one year, with a progress report indicating the persistence of language difficulties. exclusion criteria: * cognitive impairment with non-verbal intellectual quotient (iq) below 2 sd assessed with the wechsler preschool and primary scale of intelligence (wppsi), or the wechsler intelligence scale for children (wisc-iv or v) according to the age-appropriateness, asd, moderate to severe hearing loss, orofacial structural abnormalities, known neurological or genetic disorders at the initial assessment. none of the patients met the diagnostic criteria for cas according to the asha (american speech-language-hearing association, 2007. childhood apraxia of speech www.asha.org/policy).