Kornimate/medical-research-clean huggingface dataset:
analysis of peripheral blood ilc2s and th2 cells in response to anb020

Conditions: Asthma

Summary: this exploratory laboratory only study will assess alterations in immune cells in blood samples that may be responsive to an inflammatory mediator in asthma called il-33 (innate lymphoid type 2 cells, basophils and th2 cells) in response to treatment with anb020/placebo (a drug that targets il-33, in the linked clinical trial anb020-004). the study will involve additional 10ml blood draws on scheduled study visits in the anb020-004 clinical trial at baseline, 1 week, 5 weeks, 18 weeks (4 visits total). total number of subjects is 24 at the same 3 participating uk sites as the main linked clinical trial anb020-004. blood samples will be sent on the same day to a flow cytometry laboratory at the nihr leicester biomedical research centre (brc) - respiratory. a dedicated post doctoral, trained laboratory scientist will analyse the blood samples for the required cell types using a technique called flow cytometry - this technique identifies cell surface and intercellular markers, that together provide a unique cell identity. the experiments will be supervised by a senior research scientist and flow cytometrist professor dave cousins, at the university of leicester and results of the experiments will be fed back to anaptysbio (the linked clinical trial sponsor). professor salman siddiqui at the university of leicester will oversee the clinical conduct of this laboratory study and act as the chief investigator. professor siddiqui is also the local site lead principal investigator at leicester for the linked anb020-004 clinical trial described below. the linked study (anb020-004) is a double-blind placebo-controlled proof of concept study to investigate anb020 (a drug that targets an inflammatory mediator called il-33) activity in adult patients with severe eosinophilic asthma. the expected duration of the study is up to 141 days. screening period of 7-14 days and treatment and follow-up period of 127 days.


Eligibility criteria:
inclusion criteria: consenting participant in the anb020-004 clinical trial (eudract 2017-000647-40) - exclusion criteria:1) unwilling to have four additional blood samples (10 mls per sample) for flow cytometry as part of the flow cytometry biomarker study linked to existing anb020-004 study. (eudract 2017-000647-40) -
evaluation of a new formulation useful for the osteoarthrosis treatment

Conditions: Osteoarthritis

Summary: abstract kondrium, is a pharmaceutical composition for the treatment of osteoarthritis (oa). this study was designed to evaluate the efficacy and safety of kondrium in the treatment of oa of knee. a 3 month, randomized, double-blind, active-controlled, parallel-group study will be carried out. 117 patients with oa of the knee will be randomized to receive 1 intra-articular monthly injection of 5 ml of one of the following: 75 mg/ml of kondrium, 82.5 mg/ml of kondriumf or 8 mg/ml of methylprednisolone once a month during 3 months. the primary efficacy variable will be the change from baseline to final assessment in the western ontario and mcmaster university oa index (womac subscale score for pain), and lequesne´s functional index.

the womac osteoarthritis index is a validated, multidimensional, disease specific, health status measure. it probes clinically important patient relevant symptoms in the areas of pain, stiffness and physical function in patients with hip and/or knee osteoarthritis. it consists of 24 questions in three separated subscales (5 questions on pain subscale, 17 questions on physical function subscales and 2 questions on stiffness subscale), each scored in analog scale from 0 to 10 points (0 representing no pain, 10 representing extreme pain). each subscale score was weighed 10 points, thus 30 was the maximum punctuation for womac total score. the lequesne index is a 10-question interview-style survey given to patients with osteoarthritis of the knee. it has 5 questions pertaining to pain or discomfort, 1 question dealing with maximum distance walked, and 4 questions about daily activities. the total questionnaire is scored on a 0 to 24 scale, with lower scores meaning less functional impairment.

Eligibility criteria:
inclusion criteria: * age \> 40 years * symptomatic evidence of oa in the knee for at least 1 year * radiographic evidence of kellgren and lawrence grade ii to iv oa of the knee * no intra-articular injection of corticosteroids within the last 3 months exclusion criteria: * any history of adverse reaction to the study drugs * current pregnancy status * uncontrolled hypertension * active infection * undergone surgery/arthroscopy within three months * diagnosis of radiographic oa of kellgren and lawrence grade i

Keywords: knee osteoarthritis
combined ipsilateral liver lobe devascularization and alcohol treatment of the large hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: assessment of the long-term outcome of combined ipsilateral liver lobe devascularization (ilad) and alcohol injection of the large hepatocellular carcinoma (hcc): single center non-randomized trial.

assessment of the overall (os); one year; two years and three years' survival rates; the disease free survival (dfs) and the tumor response rate in the patients undergoing combined ipsilateral liver lobe devascularization and alcohol treatment (cildat) of the large hcc. this is a prospective non randomized trial carried out at the ribat university hospital between may 2017 to april 2020.

Eligibility criteria:
inclusion criteria: * review and sign informed consent; * between 15 and 80 years of age at time of trial enrollment; * documented pathological and/or radiological diagnosis of hepatocellular carcinoma; * radiologically documented tumor size of \> 5 centimeters; * radiologically documented liver cirrhosis. exclusion criteria: * american anesthesia association (asa) class iv or v and/or any contraindications to general anesthesia; * uncontrollable ascites; * deep persistent jaundice; * hepatic encephalopathy; * coagulopathy; * severe uncorrectable thrombocytopenia; * unable or unwilling to attend follow up visits and examinations;

Keywords: hepatocellular carcinoma ipsilateral liver lobe devascularization alcohol treatment cildat
invisalign® system with mandibular advancement

Conditions: Class II Malocclusion; Mandibular Advancement; Mandibular Retrognathism; Excessive Overjet

Summary: the goal of this clinical trial is to observe study participants' comfort and fit of their aligners with occlusal blocks, as well as evaluate the engagement of the blocks using the invisalign® system with mandibular advancement featuring occlusal blocks


Eligibility criteria:
inclusion criteria: • subject must be eligible for invisalign treatment with mandibular advancement exclusion criteria: * subject's dentition not compatible with device or allergy to device materials * subject who is pregnant, has active caries, periodontal disease, tmd, root resorption, has hae (hereditary angioedema), has been diagnosed with epilepsy or any other seizure disorder

Keywords: class ii malocclusion mandibular advancement invisalign orthodontics occlusal blocks growing patients
metabolic syndrome and non-alcoholic fatty liver during pregnancy

Conditions: Fatty Liver; Gestational Diabetes

Summary: the aim of this study is to evaluate the prevalence of metabolic syndrome, liver function abnormality and non-alcoholic fatty liver disease in early pregnancy patients, and the risk of pregnancy complications.

in cases in which metabolic syndrome and non-alcoholic fatty liver are risk factors of obstetric complications, such as gestational diabetes (gdm) or preeclampsia (pe), we are able to offer systematic clinical results from determining the independent risk factor and developing a predictable model. recently, obstetric complications, especially gdm and pe, have increased due to the growth of elder pregnancy. in addition, as liver dysfunction has been known to be an independent risk factor of diabetes, cardiovascular disease, high blood pressure and renal dysfunction, its clinical importance has risen. metabolic syndromes, such as obesity, hypertension, type ii diabetes and abnormal lipid profile, have been known for its importance in development of non-alcoholic fatty liver disease. considering abnormal liver function being an independent risk factor of diabetes, cardiovascular disease, high blood pressure and renal dysfunction in normal adult patients, we are able to predict that liver dysfunction might be a high risk factor of obstetric complications in pregnant women. in previous studies, the frequency of liver dysfunction in normal pregnant women was obtained. the purpose of this current study was to investigate the prevalence of metabolic syndrome, abnormal liver function and non-alcoholic fatty liver in early pregnancy and the related risks of obstetric complications.

Eligibility criteria:
inclusion criteria: * outpatient clinic patients of seoul national university hospital, seoul metropolitan government boramae medical center, incheon seoul woman hospital * agree with this study * do not drink excess amount of alcohol for recent 2 years exclusion criteria: * do not agree with this study * do not perform blood tests * have underlying hepatobiliary diseases * take medications which can cause liver abnormalities
the hanapū study: incentivized partnerships to reduce diabetes disparities

Conditions: Diabetes

Summary: the hanapū study: incentivized partnerships to reduce diabetes disparities is a randomized control trial that will test the effectiveness of partnership incentives plus evidence-based education to optimize glycemic outcomes among diabetic patients compared with usual care.

the hanapū study will use a block randomization study design to enroll 100 diabetic patients in each arm (n = 200) followed over 9 months. providers will identify diabetic patients. after the baseline visit is completed, patient(s) and their provider will be randomized to either intervention or usual care arm as partners. the intervention arm will receive diabetes self-management education and modest financial incentives (gift cards) for completing diabetes process and glycemic outcomes according diabetes "best practices". usual care patients will receive an equal number of educational materials on diabetes self-management via mail and will receive usual care through their provider but will not receive additional incentives for reaching glycemic outcomes. both arms of the study will complete outcome visits at baseline, 4.5 and 9 months.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of diabetes mellitus * hba1c \>7% * not planning to move out of the state * able to fully participate in either intervention or usual care arms. exclusion criteria: * pregnancy * end stage renal disease requiring dialysis * any medical condition that would prevent participation in all aspects of the study protocol (including major psychiatric diagnosis) or with \< 6 month expected survival, as determined by the patient's physician.
the effect of soy protein on neuropathic pain

Conditions: Neuralgia

Summary: neuropathic pain is one form of chronic pain lacking effective pharmacotherapy. interest in the role of complementary and alternative medicine is growing and diet is at the forefront of the search for alternative treatments for pain. soy protein is one of the most promising dietary ingredients tested for its pain-relieving properties. results from animal studies show that soy-enriched diets reduce pain due to nerve injury. the purpose of this study is to determine the effects of soy protein supplementation on facial pain.

neuropathic pain is a complex disorder with mixed results in response to pain medication due to a high degree of variability between patients. to address this issue, we are implementing a unique methodology using a series of n-of-1 or single subject randomized, double blind, controlled studies. with this, we will explore the role of soy protein supplementation in neuropathic pain patients. each patient will be exposed in 3-week intervals to soy protein and a control, milk protein, in three paired treatment periods for a total of 18 weeks. this method allows for the measurement of treatment efficacy in individual distinct patients and has the potential for immediate and continued medical benefit using a simple and readily available dietary ingredient.

Eligibility criteria:
inclusion criteria: * male or female, age ≥ 18 years old * chronic neuropathic pain with tactile allodynia \> 6 months * suboptimal pain pharmacotherapy (i.e. additional pain control felt by patient and physician to be necessary) * pain intensity score ≥ 5 on 11-point numerical rating scale (nrs) during 1-week screening period prior to randomization * stable medication use (if any) over 4 weeks before starting the trial. current medication use will be maintained and no additional pharmacotherapy may be introduced during the trial. * up to date mammogram and gynecological evaluations. exclusion criteria: * history of significant heart, gastro-intestinal, liver or kidney disease * history of alcohol/narcotic abuse or current excessive alcohol consumption * history or diagnosis of cancer * history of breast tumors, predisposition to breast cancer or a family member with breast cancer * history of hormonal or gynaecological disease * current use of hormonal replacement therapy (hrt), except thyroid hrt * pregnant or breastfeeding women * use of any anticoagulant or blood thinner except acetylsalicyclic acid * malabsorption of any kind * diagnosed lactase deficiency; * known allergy to any of the dietary products * known allergy to acetaminophen * daily consumption of soy protein in quantities exceeding 10 g/day * strict vegetarians (i.e. no animal derived dietary sources) * antibiotic use within the last 3 months * any previous psychiatric diagnosis before pain onset * body mass index \> 35

Keywords: soy protein milk protein neuropathic pain
the effect of sensory integration balance training on children with abi

Conditions: Children With Acquired Brain Injury

Summary: this study aim to investagte the effectivness of sensory integartion balance training during gait training with obstecles and stimulation to different sensation, in comparission to gait training with obstecles without sensory stimulation among children with acuired brain injury


Eligibility criteria:
inclusion criteria: * children with abi, able to walk with or without assistance, gmfcs level i-iii, aged 4-12 years old, with subjective symptoms of balance impairments, fear of falling and/or history of falls exclusion criteria: * botox injections or tendon release surgery in the past six months
the analgesic duration of dexmedetomidine compared to dexamethasone as adjuncts to single shot interscalene block

Conditions: Opioid Use, Unspecified

Summary: the purpose of the study is to determine if perineural dexmedetomidine can provide increased prolongation of analgesia when compared to perineural dexamethasone in patients receiving regional block for shoulder surgery. if so, dexmedetomidine may serve as a superior adjunct to peripheral nerve blocks in a rapidly evolving, ambulatory-centered surgical setting.

currently, the most commonly employed adjunct to peripheral nerve blockade is perineural dexamethasone. in general, at the doses used in regional anesthesia, dexamethasone has a minimal side effect profile. however, while it has been shown to increase duration of analgesia, there have been concerns regarding its neurotoxicity in animal studies. in addition, dexamethasone has the potential to cause hyperglycemia in patients with impaired glucose metabolism as well as perineal pain and pruritis when administered peripherally. dexmedetomidine is a highly selective alpha-2 agonist that is commonly used in patients undergoing anesthesia or requiring sedation in a non-operative setting. as a peripherally administered medication, it has both sedating and analgesic properties, as well as the added benefit of avoidance of respiratory depression. although it can rarely produce cardiac depression at high doses, its side effect profile is otherwise minimal and is generally very well tolerated by most patients. when administered peripherally, dexmedetomidine has most commonly been associated with side effects such as hypotension, respiratory depression, and bradycardia - although all at significantly higher doses than planned in our study. the safe use of perineural dexmedetomidine together with local anesthetics has been described on numerous occasions. nevertheless, although it has been shown to potentiate peripheral nerve blockade and prolong duration of analgesia in various studies , it remains rarely used as an adjunct to regional anesthesia.

Eligibility criteria:
inclusion criteria : * asa 1 and 2 * 18-60 years old * patients scheduled for ambulatory arthroscopic or open surgery exclusion criteria: * asa 3 and 4 * pre-existing pain disorder * regular consumption of chronic pain medication * anatomical abnormalities of upper extremity * known allergy or hypersensitivity to ropivacaine or other amide local anesthetics * known allergy to dexmedetomidine * coagulopathy * uncontrolled diabetes

Keywords: post operative pain, dexmedetomidine, regional anesthesia
a 12-week post-marketing, observational study to confirm the safety and efficacy of zetia alone or in combination with other lipid-lowering drugs in japanese subjects with hypercholesterolemia (study p05244)

Conditions: Hypercholesterolemia; Familial Hypercholesterolemia; Homozygous Sitosterolemia

Summary: this study is a non-interventional (observational) study in japan to confirm the safety and efficacy of zetia when administered alone or in combination with other lipid-lowering drugs in daily medical practice throughout a 12-week period. it is being conducted as a post-approval commitment, in accordance with the ministry of health, labour and welfare's guideline on good post-marketing study practice. post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. the results will be submitted to public health officials as required by applicable national and international laws.

the population will be selected from 2,000 institutions in japan.

Eligibility criteria:
inclusion criteria: * subjects who have hypercholesterolemia, familial hypercholesterolemia, or homozygous sitosterolemia will be considered for this study. zetia monotherapy patients must be treated with zetia alone. zetia combination therapy patients must be treated with zetia in combination with other lipid-lowering drugs for hypercholesterolemia. exclusion criteria: * patients with a history of hypersensitivity to any ingredient in zetia * patients with serious hepatic function disorder should not be treated with zetia in combination with an hmg-coa reductase inhibitor.
a phase 3 study to confirm the efficacy and safety of linzagolix to treat endometriosis-associated pain

Conditions: Endometriosis

Summary: the primary objective of this study is to demonstrate the efficacy and safety of linzagolix administered orally once daily for 3 months at a dose of 75 mg alone or of 200 mg in combination with add-back hormone replacement therapy (abt: estradiol (e2) 1 mg / norethisterone acetate (neta) 0.5 mg) versus placebo, in the management of moderate to severe endometriosis-associated pain (eap).

this is a prospective, randomized, double-blind, placebo-controlled study to demonstrate the efficacy and safety of linzagolix administered orally once daily at doses of 75 mg alone and 200 mg in combination with low dose abt (e2 1 mg/neta 0.5 mg) versus placebo in the management of moderate to severe eap in 450 women. eligible subjects who have completed the 6-month treatment period may enter a separate extension study for 6 additional months of active treatment (no placebo control). subjects who do not continue in the extension study will enter a 6 month treatment-free follow-up phase.

Eligibility criteria:
key inclusion criteria: the subject must have: * her most recent surgical and - if available - histological diagnosis of pelvic endometriosis up to 10 years before screening. * moderate to severe endometriosis-associated pain during the screening period. * regular menstrual cycles. * bmi ≥ 18 kg/m2 at the screening visit. key exclusion criteria: the subject will be excluded if she: * is pregnant or breast feeding or is planning a pregnancy within the duration of the treatment period of the study. * is less than 6 months postpartum or 3 months postabortion/ miscarriage at the time of entry into the screening period. * has had a surgical history of any major abdominal surgery within 6 months or any interventional surgery for endometriosis performed within a period of 2 months before screening. * did not respond to prior treatment with gnrh agonists or gnrh antagonists for endometriosis. * has a history of, or known, osteoporosis or other metabolic bone disease. * has chronic pelvic pain that is not caused by endometriosis and requires chronic analgesic or other chronic therapy which would interfere with the assessment of endometriosis-associated pain.

Keywords: dysmenorrhea dyspareunia dyschezia non-menstrual pelvic pain
biomarkers, genomics, physiology in critically ill and ecmo patients

Conditions: Acute Respiratory Distress Syndrome; Cardiac Failure; Extracorporeal Membrane Oxygenation Complication; Respiratory Failure; Renal Failure; Critical Illness; Pulmonary Disease

Summary: patients in end-stage cardiac failure and/or respiratory failure may be started on a rescue therapy known as extracorporeal membrane oxygenation (ecmo). one of the major clinical questions is how to manage the ventilator when patients are on ecmo therapy. ventilator induced lung injury (vili) can result from aggressive ventilation of the lung during critical illness. vili and lung injury such as acute respiratory distress syndrome (ards) can further increase the total body inflammation and stress, this is known as biotrauma. biotrauma is one of the mechanisms that causes multi-organ failure in critically ill patients. one advantage of ecmo is the ability to greatly reduce the use of the ventilator and thus vili by taking control of the patient's oxygenation and acid-base status. by minimizing vili during ecmo we can reduce biotrauma and thus multi-organ failure. since the optimal ventilator settings for ecmo patients are not known, we plan to study the impact of different ventilator settings during ecmo on patient's physiology and biomarkers of inflammation and injury.


Eligibility criteria:
inclusion criteria * patient currently on ecmo (veno-venous or venous-arterial or venous-arterial-venous) * patient that is a potential ecmo candidate. exclusion criteria * history of lung or cardiac transplantation * patient is not committed to full support * treating clinician refusal, or unwillingness to commit to controlled ventilation for at least 4-6 hours (if patient is mechanically ventilated) * inability to get informed consent from the patient or surrogate.

Keywords: ecmo ards ventilator induced lung injury heart failure pulmonary failure biomarkers