Kornimate/medical-research-clean huggingface dataset:
biological standardization of lolium perenne allergen extract

Conditions: Allergy to Grass Pollen

Summary: the objective of this study is to determine the biologic activity of a lolium perenne allergen extract in histamine equivalent prick (hep) units, in order to be used as in-house reference preparation (ihrp).

four concentrations of lolium perenne allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.

Eligibility criteria:
inclusion criteria: * subject has provided written informed consent, appropriately signed and dated by the subject (or legal representative, if applicable). * subject can be male or female of any race and ethnic group. * age \> 18 years and \< 50 years at the study inclusion day. * positive skin prick test with a standardized commercially available preparation of lolium perenne allergen extract. the skin prick test will be considered positive if the test results in a wheal major diameter of at least 3 mm and at least the size of the positive control. positive skin prick test results are valid if performed within one year prior to the inclusion of the subject in the study * a positive test for specific ige to lolium perenne (cap-rast ≥ 2). ige results are valid if performed within one year prior to the inclusion of the subject in the study. * allergic symptoms during the pollen season of lolium perenne. * mean of the forearm major diameters of the wheals provoked by histamine dihydrochloride (10 mg/ml) ≥ 3 mm. exclusion criteria: * immunotherapy in the past 5 years with an allergen preparation known to interfere with the allergen to be tested (e.g., grass group extracts). * use of drugs that may interfere with the skin reactions (e.g., antihistamines). see appendix 1 * treatment with any of the following medications: tricyclic or tetracyclic antidepressants, β-blockers or corticosteroids (\> 10 mg/day of prednisone or equivalent). * pregnancy. * dermographism affecting the skin area at the test site at either study visit. * atopic dermatitis affecting the skin area at the test site at either study visit. * urticaria affecting the skin area at the test site at either study visit. * participation in another clinical trial within the last month.

Keywords: standardization immunotherapy skin prick test
effect of hepatic impairment on m2951 (btk inhibitor) pk

Conditions: Hepatic Impairment

Summary: this study is to investigate the pharmacokinetic (pk) and safety of m2951 (bruton's tyrosine kinase \[btk\] inhibitor) in participants with different degrees of hepatic impairment compared to participants with normal hepatic function.


Eligibility criteria:
inclusion criteria: * participants with normal hepatic function only will be overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion or * participants with moderately impaired hepatic function only will be considered to have moderately (child-pugh class b and confirmed liver cirrhosis) impaired hepatic function and has been clinically stable for at least 1 month prior to screening or * participants with mildly impaired hepatic function only will be considered to have mildly (child-pugh class a and confirmed liver cirrhosis) impaired hepatic function and has been clinically stable for at least 1 month prior to screening * have a body weight within 50.0 and 120.0 kilogram (kg) and body mass index (bmi) within the range 19.0 and 36.0 kilogram per square meter (kg/m\^2) * female participants are not pregnant or breastfeeding, and at least one of the following conditions applies * not a woman of childbearing potential (wocbp) * other protocol defined inclusion criteria could apply exclusion criteria: * clinical history of autoimmune disorder with hepatic influence (hashimoto thyroiditis and rheumatic diseases allowed) * history of any malignancy * diseases and surgeries of the gastrointestinal tract, which could influence the gastrointestinal anatomy and mobility. prior history of cholecystectomy or inflammatory bowel disease, and any clinically relevant surgery within 6 months prior to screening * history of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to screening and at any time between screening and admission, or hospitalization due to infection within 6 months prior to screening * history of shingles within 12 months prior to screening * history of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the trial per the investigator's discretion * participants with impaired hepatic function will be excluded who had primary and secondary biliary cirrhosis. * participants with impaired hepatic function will be excluded with clinical evidence of severe ascites. * participants with impaired hepatic function will be excluded with hepatic encephalopathy grade greater than 1 * other protocol defined exclusion criteria could apply

Keywords: hepatic impairment pharmacokinetics
ibi343 combined with sintilimab plus chemotherapy in gastric cancer

Conditions: Gastric Cancer

Summary: this is a single-arm, open-label, phase 1b/2 study of ibi343 combined with sintilimab plus chemotherapy in previously untreated, claudin (cldn) 18.2-positive, her2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma

this trial is a phase ib/ii study to evaluate the safety, tolerability and efficacy of ibi343 in combination with sintilimab and chemotherapy in patients with advanced gastric or gastroesophageal junction (g/gej) adenocarcinoma. in dose-escalation stage, patients with cldn 18.2-positive, her2-negative were treated with ibi 343, sintilimab, and chemotherapy (oxaliplatin, s-1) as first-line therapy, which followed a 3+3 design. the dose expansion stage aimed to further investigate the safety and preliminary efficacy of recommended phase ii dose (rp2d), including cohort 1 and cohort 2. in cohort 1, 25 patients with cldn18.2-positive, her2-negative advanced g/gej adenocarcinoma will be enrolled. in cohort 2, 15 patients with cldn18.2-positive, her2-negative gastric signet-ring cell carcinoma will be enrolled.

Eligibility criteria:
inclusion criteria: * 1. able and willing to sign a written informed consent form (icf) and to comply with protocol-specified visits and related procedures. 2. age was 18-75 years at the time of signing the icf, and gender was unlimited. 3. has histopathologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the gastric/gastroesophageal junction (g/gej ac). 4. no received systemic therapy. 5. has histopathologically confirmed cldn18.2-positive disease. 6. has an eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1. exclusion criteria: * 1. has her2-positive (defined as immunohistochemistry \[ihc\] 3+, or ihc 2+ and positive by in situ hybridization) disease. 2. is currently participating in another interventional clinical study, except when the subject is during survival follow-up of an interventional clinical study. 3. has a history of treatment with topoisomerase inhibitor-based antibody-drug conjugate(s).

Keywords: gastric cancer ibi 343 sintilimab
exercise and nutrition recommendations for patients using glucocorticoids (enrg)

Conditions: Systemic Lupus Erythematosus

Summary: this parallel-group randomized, controlled, clinical trial aims to investigate the influence of a 6-month home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with systemic lupus erythematosus who have undergone glucocorticoid pulse therapy.

glucocorticoid treatment is a frequently prescribed to individuals with autoimmune diseases, such as systemic lupus erythematosus, due to its anti-inflammatory effects. this treatment strategy has proven clinical benefits, but it can also adversely influence musculoskeletal health. glucocorticoid pulse therapy is a particularly intensive treatment strategy, commonly used when the disease state is at its most active. patients who undergo pulse therapy have a high risk of muscle and bone loss, and exercise training is a promising adjunct therapy to potentially ameliorate these adverse effects, but the feasibility and efficacy of this approach has yet to be investigated. the aim of this study, therefore, is to conduct a parallel-group, controlled, randomized clinical trial, to investigate the feasibility and efficacy of a home-based, remotely-monitored, exercise training intervention on musculoskeletal health in patients with systemic lupus erythematosus who have undergone glucocorticoid pulse therapy.

Eligibility criteria:
inclusion criteria: * premenopausal women aged 18 to 45 diagnosed with systemic lupus erythematosus according to slicc criteria; * medical indication and prescription for glucocorticoid pulse therapy; * access to internet and any device that allows for participation in exercise training online lessons (such as smart phone, laptop or personal computer); * willingness to participate in an exercise training program. exclusion criteria: * any physical, mental, neurological or musculoskeletal health impairment that contra-indicates exercise training. * use of medical therapy that alters bone metabolism, such as bisphosphonates, teriparatide and denosumab; * receiving prescription for multiple glucocorticoid pulse therapies mid-intervention; * being currently enrolled or having enrolled in a structured exercise training program in the last 6 months (defined as at least 2 planned, structures sessions of exercise training per week); * having a vertebral fracture at the moment of enrollment (identified by vertical fracture assessment), or high risk for fracture (defined as low hip or spine bone mass \[z-score \< -3\] or history of fragility fractures).

Keywords: exercise autoimmune training glucocorticoids
comparative effects of frenkel's and core stability exercises in children with cerebral palsy

Conditions: Cerebral Palsy (CP)

Summary: the aim of this study is to determine and compare the effects of frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy.

cerebral palsy (cp) is a brain injury that manifests as a mobility and posture impairment in infancy or early childhood. frenkel exercises are series of movements with increasing difficulty that can be performed by ataxic patients in order to regain coordinated, smooth and rhythmic movement. the core stability exercises are for the spine, pelvis, and kinetic chain to all balance properly under stress, core stability is necessary. the aim of this study is to determine and compare the effects of frenkel's and core stability exercises on the motor function, postural stability and core muscle strength in children with cerebral palsy. this will be a randomized clinical trial in which 50 participants with cerebral palsy will be included as per sample size calculation through non probability convenience sampling technique. the study will be single blinded. participants that achieve the required standards of inclusion and exclusion criteria will be randomly allocated using online randomization tool into two groups. group a will receive frenkel's exercises and group b will receive core stability exercises, both groups will receive the treatment for 40 minutes with the routine physical therapy for 20 minutes and short-term rest intervals in between for 3 alternative days per week for 12 weeks. participants initial screening will be done through gross motor function classification system (gmfcs). the balance will be assessed through the pediatric balance test (pbs), coordination will be assessed through finger and nose test, heel shin test, catching and throwing tasks.

Eligibility criteria:
inclusion criteria: * the participants fulfilling the given criteria will be included. * age: 6 to 12 years * gender: both male and female * children with ataxic cerebral palsy * children having level ii and iii on gross motor functional classification system (gmfcs) * children able to understand the test instruction, able to sit and stand. * children with and without using botulinum toxin injections * the pediatric balance scale (pbs) of 54.6 exclusion criteria: * severe cognitive dysfunction * visual problems * vestibular dysfunction * uncontrolled epilepsy * severe orthopedic condition affecting lower limbs mobility

Keywords: cerebral palsy core stability balance frenkel exercises
detecting respiratory viruses in upper and lower respiratory tract samples

Conditions: Respiratory Viruses

Summary: background: - bronchoalveolar lavage (bal) is a procedure where a tube is passed through the mouth or nose into the lungs. fluid is squirted through the tube into a part of the lung and then collected for examination. it is used to detect respiratory viruses. bal is a relatively invasive procedure, and researchers want to test the accuracy of other procedures that do not involve collecting fluid from the lungs. the nasopharynx is the area of the upper throat that lies behind the nose. researchers want to see if a swab taken from this area is as accurate as a bal sample. objectives: - to see if a nasopharynx swab can be used to detect respiratory viruses as well as bal samples. eligibility: - individuals at least 12 years of age who will have a bronchoscopy to collect a bal sample to test for respiratory viruses. design: * participants will be screened with a physical exam and medical history. * participants will have a bal sample collected. * participants will then have a nasopharynx swab. the swab will be inserted into the nose, left in place for up to 10 seconds, and then removed

bronchoalveolar lavage (bal) specimens can be used for the detection of respiratory viruses. although bronchoscopy is relatively safe, it still has inherent risks to the subject. nasopharyngeal (np) swab specimens are easy to collect and are minimally invasive for the subject. we will use a rapid multiplex polymerase chain reaction (pcr) to detect respiratory viruses in paired bal and np specimens to determine if either specimen is more likely to be positive. the study population will include all patients undergoing bronchoscopy for clinical indications at the clinical center. this is a prospective observational study.

Eligibility criteria:
* inclusion criteria: * age 12 years or above * scheduled for clinically indicated bronchoscopy for the collection of a bal specimen and will have respiratory virus pcr ordered on the bal specimen as part of their ongoing care at the nih clinical center. * must agree to allow the storage of their samples (bal and np) for use in future research. exclusion criteria: none

Keywords: specificity bronchoalveolar lavage film array assay nasopharyngeal swab sensitivity
intraoperative oxygen concentration and neurocognition after cardiac surgery

Conditions: Hyperoxia; Normoxic; Delirium

Summary: this is a randomized, prospective controlled trial in patients undergoing cardiac surgery, specifically on-pump coronary artery bypass grafting, comparing level of administered oxygen and partial pressure of arterial oxygen in the operating room and its impact on a widely-used and validated neurocognitive score, the telephonic montreal cognitive assessment (t-moca), throughout the hospital stay and at 1 month, 3 months, and 6 postoperatively. it is hypothesized that cardiac surgical patients who undergo normoxic conditions throughout the intraoperative period will have better neurocognitive function than those with maintenance of hyperoxia.


Eligibility criteria:
inclusion criteria: * males and females aged 65 years and older * undergoing elective or urgent on-pump coronary artery bypass graft (cabg) only exclusion criteria: * off-pump or any other procedure in addition to cabg * emergent procedure * one-lung ventilation * non-english speaking * baseline tmoca score \<10 * preoperative inotrope use * preoperative vasopressor use * intra-aortic balloon counterpulsation * mechanical circulatory support (intra-aortic balloon pump (iabp)/ ventricular assisted devices (vad)/extracorporeal membrane oxygenation (ecmo)) * active cardiac ischemia * acute decompensated arrhythmia * o2 sat \< 90% on supplemental oxygen * use of continuous vasopressor or inotrope infusion medications * significant physician or nurse concern cessation criteria * development of significant intraoperative hemodynamic compromise as a result of cardiac surgery * oxygen desaturation \ 3 min * significant physician or nurse concern

Keywords: hyperoxia delirium normoxic t-moca
safety, performance of cereglide 92 intermediate catheter in treatment of acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the device is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease


Eligibility criteria:
inclusion criteria: * diagnosis of acute ischemic stroke. * nihss ≥6 * baseline mrs ≤ 2 * completed informed consent. exclusion criteria: * known pregnancy. * life expectancy less than 90 days prior to stroke onset. * known diagnosis of dementia * treatment with heparin within 48 hours. * clinical history, past imaging or clinical judgement suggest that the intracranial occlusion is chronic. * computed tomography (ct) or magnetic resonance imaging (mri) evidence of recent/ fresh hemorrhage on presentation. * baseline ct or mri showing mass effect * concurrent sino-venous thrombosis * currently participating in an investigational (drug, device, etc.) clinical trial, excluding trials in observational, natural history, and/or epidemiological studies not involving intervention and that will not confound study endpoints. sponsor approval is required.
effect of prophylactic administration of oxytocin in uniject™ on postpartum hemorrhage at home births in ghana

Conditions: Postpartum Hemorrhage

Summary: this study is designed to test the hypothesis that the intramuscular administration of 10 iu of oxytocin in uniject™ during the third stage of labor by a community health officer (cho) at home births in ghana will reduce the risk of postpartum hemorrhage by 50 percent relative to home births attended by the same type of provider who does not provide a uterotonic drug.


Eligibility criteria:
inclusion criteria: * home delivery * presence of community health officer at time of delivery exclusion criteria: * none

Keywords: hemorrhage uterotonic oxytocin blood loss community ghana randomized trial
a phase 1 study of bms-833923 (xl139) in subjects with advanced or metastatic cancer

Conditions: Hedgehog Pathway; Smoothened; Basal Cell Carcinoma (BCC); Basal Cell Nevoid Syndrome (BCNS)

Summary: the purpose of this study is to determine the safety of bms-833923 (xl139) in patients with advanced or metastatic cancers and determine the recommended phase 2 dose range and schedule


Eligibility criteria:
for additional information, please contact the bms oncology clinical trial information service at 855-216-0126 or email mycancerstudyconnect@emergingmed.com. please visit www.bmsstudyconnect.com for more information on clinical trial participation. inclusion criteria: * advanced or metastatic cancer (excluding cancer in the blood) or uncontrolled basal cell nevoid syndrome or sporadic basal cell carcinoma * primary or metastatic tumor site accessible for biopsy * ability to swallow capsules * subjects with histologically confirmed, advanced stage iiib or stage iv non-small cell lung cancer (nsclc) with a primary histology of squamous carcinoma who have received prior systemic therapy for advanced nsclc will be enrolled in part 3 exclusion criteria: * uncontrolled brain metastasis * significant cardiovascular disease * inadequate blood counts * inadequate liver, kidney or lung function * gastrointestinal disease within last 3 months * infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c or exposure to attenuated active immunizations
patience trial: prospective algorithm for treatment of ntm in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: isolation of nontuberculous mycobacteria (ntm) from the sputum of individuals with cf is an increasingly common finding, and the lack of an evidenced-based approach to treatment of ntm disease has been identified as one of the greatest unmet needs within the cf community. current evidence predicts that the prevalence of ntm will remain relatively high in the cf population. approaches to ntm disease treatment differ widely between centers, and expected outcomes are not known. this study is observational and follows current best practices. the study will help define response to treatment, and collect relevant data associated with treatment of ntm disease to build a framework for future therapeutic trials.


Eligibility criteria:
inclusion criteria: 1. previous participation in predict and diagnosis of ntm disease for the same species of ntm 2. intention to treat for ntm disease for m. avium complex or m. abscessus complex 3. written informed consent (and assent when applicable) obtained from participant or participant's legal representative 4. signed informed consent to participate in data submission to the cff patient registry 5. be willing and able to initiate treatment for ntm and to adhere to study procedures in the context of clinical care, and other protocol requirements exclusion criteria: 1. pregnant or breastfeeding 2. has any other condition that, in the opinion of the site investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Keywords: nontuberculous mycobacteria