Kornimate/medical-research-clean huggingface dataset:
multiple doses escalation study of shr0302 in rheumatoid arthritis (ra) patients

Conditions: Rheumatoid Arthritis

Summary: condition: rheumatoid arthritis intervention: drug: shr0302; drug: shr0302 placebo comparator phase: phase 1 study type: interventional study design: treatment, parallel assignment, double blind (subject, caregiver, investigator, outcomes assessor), randomized


Eligibility criteria:
inclusion criteria: * male or female subjects who are 18\~70 years of age on the day of signing informed consent, * have a diagnosis of ra meeting the 1987 acr/eular criteria of ra and acr functional class i-iii, * body mass index (bmi = weight/height squared (kg/m2)) within the range of 19 to 30, * have agreed to not use any anti- rheumatic drug except for study drugs during the study period. exclusion criteria: * current therapy with any disease modifying anti-rheumatic drug (dmard), with the exception of methotrexate (mtx), leflunomide, sulfasalazine, antimalarials, gold preparations, penicillamine, which must have discontinued for a period of at least 7 t1/2s prior to dosing, * previous ra treatment with dmards or drugs with strong immunosuppressive effect in 3 months prior to dosing (12 months for rituximab or other b cell depleting agents), * previous therapy with nsaids or oral glucocorticoids in 2 weeks before dosing, * any parenteral (intramuscular or intravenous injection) or intra-articular corticosteroids therapy in 4 weeks before dosing, * previous treatment with interferons in 4 weeks before dosing.
study of telaprevir in subjects with hepatic impairment

Conditions: Hepatic Insufficiency

Summary: the purpose of this study is to assess the safety and pharmacokinetics of telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.


Eligibility criteria:
inclusion criteria: * clinically diagnosed with child pugh score of 7-9 or greater than 10 * women of non-childbearing age exclusion criteria: * tested positive for hiv, hepatitis c, hepatitis b

Keywords: liver disease
stem cell transplantation with identical donors for patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: this protocol studied the effect of administration of a myeloablative pretransplant preparative regimen followed by an infusion of donor stem cells in children with severe sickle cell disease. the donor graft consisted of bone marrow or cord blood derived from a genetically matched sibling. the primary aim of the study was to evaluate how well the donated cells migrated to the bone marrow and begin producing healthy red blood cells, white blood cells and platelets (engrafted), how well the recipients immune system recovered, and assess any regimen related toxicities including a potentially life-threatening transplant related complication called graft-versus-host-disease or gvhd.

the secondary objectives of this protocol evaluated the effect of this transplant procedure on the subsequent clinical course of patients with severe scd. specifically, to determine whether pre-transplant organ dysfunction (brain, heart, lung, kidney, liver, spleen, etc) resultant from sickle hemoglobinopathy can be reversed following this particular transplant procedure.

Eligibility criteria:
inclusion criteria: diagnosis of severe' disease is denoted by one of the following: * previous central nervous system vaso-occlusive episode with or without residual neurologic findings or * frequent painful vaso-occlusive episodes with significant interference with normal life activities and which necessitates chronic transfusion therapy or * recurrent scd chest syndrome events which necessitate chronic transfusion therapy. exclusion criteria: * patient with scd chronic lung disease greater than or equal to stage 3 * patient with severe renal dysfunction defined as creatinine clearance \< 40 ml/min/1.73m2. * patient with severe cardiac dysfunction defined as echocardiogram shortening fraction \< 25%. * patient with hiv infection. * pregnant or lactating. * patient with unspecified chronic toxicity that in the opinion of the principal investigator is serious enough to detrimentally affect the patient's capacity to tolerate sct. * patient or patient's guardian(s) unable to understand the nature and risks inherent in the bmt process

Keywords: anemia sickle cell
a study to assess the levels of two antibiotics in the blood when given together and separately

Conditions: Healthy

Summary: this is a randomised study divided into 2 parts. part a investigates the effect of prolonged dosing (ten days) with avibactam and ceftazidime when given together and how this will effect how much avibactam and ceftazidime enters the blood. part b investigates how much avibactam (nxl104) and ceftazidime enter the blood when avibactam and ceftazidine are given separately or together intravenously.

a phase i, 2-part, open-label, pharmacokinetic and drug-drug interaction study of caz104 (avibactam and ceftazidime in healthy subjects)

Eligibility criteria:
inclusion criteria: * provision of signed and dated, written informed consent prior to any study specific procedures * healthy male and female subjects aged 18 to 50 years with veins suitable for cannulation or repeated venepuncture; female subjects must be postmenopausal or surgically sterile. female subjects must have a negative pregnancy test at screening and on admi * male subjects should be willing to use barrier contraception ie, condoms, from dosing to 3 months after dosing with the ip (investigational product). * have a body mass index (bmi) between 19 and 30 kg/m2 * as judged by the investigator, all the subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements exclusion criteria: * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study * history or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the investigator or history of hypersensitivity to drugs with a similar chemical structure or class to avibactam, ceftazidime, and/or excipients * any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of ip prolonged qtcf (\>450 ms) or shortened qtcf (\<350 ms) or a family history of long qt syndrome

Keywords: phase 1 open label ceftazidime pharmacokinetics urinary tract infection intra-abdominal infection
prognostic factors influencing the recurrence rate and survival of patients with colorectal cancer: a single institution experience

Conditions: Colorectal Cancer

Summary: over the past decade colon cancer has emerged as the second most deadly and the third most common type of cancer in the world with increasing incidence in egypt due to life style and diet change. some research showed relation between colon cancer recurrence and advanced tumor staging. to investigators knowledge, this is the first time to be done in zagazig university. data was collected from records in a retrospective cohort study


Eligibility criteria:
inclusion criteria: * adult patients with newly diagnosed colorectal cancer * age \> 18 years old * recurrent cases of colorectal cancer exclusion criteria: * pediartric patient less than 18 yr * in operable or metastatic cancer colon * no other malignancies

Keywords: colorectal cancer recurrence prognosis
cbd-based therapy to attenuate non-bacterial prostatitis symptoms

Conditions: Prostatitis

Summary: efficacy and safety of the medical device rectal canneff® sup suppositories containing two active ingredients cannabidiol (cbd) and hyaluronic acid (ha) in alleviating non-bacterial prostatitis symptoms and improving quality of life in men will be evaluated.

chronic non-bacterial prostatitis/chronic pelvic pain syndrome (cp/cpps) is the third most common urogenital diagnosis in men, following benign prostatic hyperplasia and prostate cancer, with an estimated prevalence reaching 8.2%. clinically, cp/cpps often presents with persistent pelvic pain, lower urinary tract symptoms (luts), and sexual dysfunction, all of which can substantially diminish quality of life. psychological comorbidities, including anxiety, stress, and depression, further amplify the burden on patients. despite its considerable socioeconomic impact, no definitive treatment consensus exists for cp/cpps. this study assessed the effects of rectal administration of cannabidiol (cbd)-based therapy in men with cp/cpps. a single-arm, open-label pilot trial on men with cp/cpps (nih chronic prostatitis symptom index \[nih-cpsi\] \>10, pain subscore ≥4). the participants self-administered rectal canneff® suppositories containing cbd (100 mg) and hyaluronic acid (ha = 6.6 mg) as active ingredients, nightly for 30 days. outcome measures included changes in nih-cpsi total score, international prostate symptom score (ipss), and international index of erectile function (iief-5). safety and tolerability were assessed.

Eligibility criteria:
inclusion criteria: * men aged 18-50 years * reported pelvic pain for ≥3 months in the past 6 months * reported the national institutes of health chronic prostatitis symptom index (nih-cpsi) total score \>10 with a pain subscore ≥4 * clinically and laboratory diagnosed cp/cpps exclusion criteria: * confirmed genitourinary infections (e.g., escherichia coli, enterococcus faecalis, chlamydia spp.) * recent antibiotic use (within 6 months) * cannabis use * alpha-blockers or phytotherapeutics in the preceding 4 weeks * no history of pelvic trauma, surgery or radiotherapy, neurogenic bladder, post-void residual \>50 ml, or psychiatric disorders affecting compliance

Keywords: prostatitis chronic pelvic pain cannabidiol and hyaluronic acid rectal delivery
whole body vibration in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the whole body vibration offers better treatment adherence among the elderly, minimizing effort and additional stress to the cardiovascular system and skeletal muscles compared to conventional exercise programs. hypothesis: patients with copd undergoing a training program on the whole body vibration show better performance in the 6mwt and improvement in muscle strength.

in the elderly and in copd patients weight loss includes sarcopenia, resulting from aging itself or due to disuse or disease states associated with and represents the reduction in muscle mass, leading to decreased strength and endurance, with repercussions on the functional abilities of the same. it reduces the power and muscle strength with aging which represent decreasing to carry out daily physical tasks. in copd, exacerbations worsen the loss of muscle mass, affecting the respiratory and peripheral muscles, exercise capacity and survival rates, and in the case of severe malnutrition in advanced cases of the disease, the implications of this state are disability which occur between 10-15% in those with mild obstruction and 25% in moderate to severe obstructive and are associated with worse prognosis. the whole body vibration could be an efficient combination of training methods for elderly patients and is based on the generation of sinusoidal vibrations offered by a platform, which stimulates the muscle spindles resulting in activation of neurons α engines and develop muscle contractions, presenting itself as an alternative to conventional treatment for muscular endurance as well as improving physical fitness

Eligibility criteria:
inclusion criteria: * smoking history, occupational or environmental exposure to pollutants and / or cough, hypersecretion or dyspnea, * fev1 \<80% predicted and postbronchodilator fev1/fvc \<70% to confirm the diagnosis of airway obstruction air not fully reversible bronchodilator therapy, * have the ability to perform the walk test, 6 minutes, absence of comorbidities that preclude the achievement of effort (hypertension, severe pulmonary hypertension, myocardial infarction, congestive heart failure, severe dyspnea) * preserved cognitive functioning, * clinically stable during the study period exclusion criteria: * have cognitive impairment, hearing or visual compromise the response to the questionnaires used in this study * make modifications to the appliance neuro-musculo-skeletal system that prevents the completion of the 6mwt * be participating in physical activity programs.

Keywords: chronic obstructive pulmonary disease (copd) muscle strenght aged
vitamin d supplementation on cardiovascular risk factors

Conditions: Type 2 Diabetes

Summary: the purpose of the present pilot study is to determine the effect of vitamin d supplementation (4000 iu or 6000 iu once daily for 6 months) on reducing heart disease risk and in improving blood glucose control in type 2 diabetes subjects . the investigators are working with hispanics and african americans living in miami, florida.

insufficient vitamin d levels have been found in subjects with type 2 diabetes (t2d). similarly, a negative association between serum vitamin d levels and insulin resistance has been reported in a large sample representative of the adult us population and in subjects at risk for t2d. in addition, a strong association between hypovitaminosis d and hypertriglyceridemia has been demonstrated in studies done in us adult population. literature has indicated that subjects with t2d and insulin resistance (ir) are more likely to develop arteriosclerosis and all of the complications related to this condition, such as myocardial infarction and stroke. these findings have increased the interest about the effect of vitamin d on metabolic abnormalities grouped under the term "cardiovascular disease (cvd) risk factors", which includes hypertension, dyslipidemia, obesity, glucose intolerance, inflammation and t2d which is in itself a risk factor for cvd. therefore, the purpose of the present pilot study will be to determine the effect of supplemental vitamin d intake (4000 iu or 6000 iu of cholecalciferol daily for 6 months) on cvd risk markers and glycemic control; primarily lipid panel, insulin resistance, and glycosylated hemoglobin (a1c), in a sample of hispanics and african-americans with t2d and vitamin d insufficiency. if repletion of vitamin d level improves insulin resistance, glycemic control, inflammation, hypertension, dyslipidaemia or kidney functions, it may prevent the development of cvd events and decrease t2d complications.

Eligibility criteria:
inclusion criteria: * type 2 diabetes * african american or hispanic * able to ambulate on their own * aged between 30 - 70 years exclusion criteria: * taking supplemental vitamin d * pregnant or lactating women * receiving insulin therapy * not participating in other drug trials * hiv/ hepatitis/ cancer/ liver disease/ heart failure/ any recent surgery/ mental illness/ epilepsy/ any gi or malabsorption disorders * kidney failure or on dialysis

Keywords: type 2 diabetes cholecalciferol vitamin d insulin resistance cardiovascular disease risk minorities
post-thrombectomy intra-arterial tenecteplase for acute management of non-retrievable thrombus and no-reflow in emergent stroke

Conditions: Ischemic Stroke, Acute; Cerebrovascular Disorders; Brain Disorder; Central Nervous System Diseases

Summary: multicentre, prospective, multi-arm multi-stage (mams) seamless phase 2b/3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation lvo receiving mechanical thrombectomy within 24 hours of symptoms onset.


Eligibility criteria:
inclusion criteria: * adult participants (age≥18 years) presenting with ischemic stroke with arterial lvo on ct/mr angiogram of the intracranial internal carotid or middle cerebral artery (mca) first segment (m1) or proximal second segment (m2) committed to thrombectomy using standard criteria within 24 hours of onset: * for 0-6 hours of symptom onset: presence of arterial occlusion as defined above and aspects≥3 on ncct * for 6-24 hours of symptom onset: additional imaging criteria on ctp or mri perfusion of core volume \<100ml. * qualifying ct/mr within 4hrs of randomisation (repeat ct for transferred participants required if \>4hr) * pre-stroke modified rankin scale (mrs) score of ≤2 (mild pre-existing disability permitted) * local legal requirements for consent have been satisfied. exclusion criteria: * intracranial hemorrhage identified by ct or mri * aspects 0-2 on ncct * ctp or mri perfusion ischemic core volume \>100ml if presenting within 6-24 hours from symptoms onset * anticipated endovascular stenting required for intracranial or extracranial atherosclerotic stenosis/occlusion. * more than six retrieval attempts in the same vessel * alteplase being infused within 30 minutes (\~5x half-life) of anticipated trial drug administration * contraindication to imaging with contrast agents * any condition (eg.mid-arterial phase early venous filling) that in the judgment of investigators could impose hazards if study therapy is initiated * pregnant women. * current participation in another intervention research study that includes experimental interventions beyond standard-of-care. * anticoagulation. inr ≤1.7 if on warfarin, and dabigatran reversal by idarucizumab are permitted. * other standard contraindications to thrombolysis apart from time window. * known terminal illness such that the participants would not be expected to survive a year. * planned withdrawal of care or comfort care measures.

Keywords: tenecteplase fibrinolytic agents thrombectomy no-reflow
ss-gcc1- screening study of genetic changes in colorectal cancer

Conditions: Colorectal Cancer

Summary: the principal research objective is to form a database of tissue samples from patients with colorectal (bowel) cancer. the tissue samples that will be used for this research will have already been taken for diagnostic or therapeutic reasons. we will also be asking for consent for a research blood sample. the database will be used to improve our understanding of the molecular genetics and gene expression patterns in colorectal cancer.

all patients at the royal marsden with a diagnosis of colorectal cancer will be eligible to enter this study. this will include patients both with early and advanced disease, provided they give informed consent. they will give written consent to participate, to include consent for analysis of existing tumour tissue and consent for collection of demographic and clinicopathological data relating to their case and its future outcome, and consent for a blood sample to be taken for research purposes. additionally, old samples of material surplus to clinical requirements may be collected without specific consent if there is no possibility that it would affect the patient's interest (eg the patient has died).

Eligibility criteria:
inclusion criteria: * adults who have a terminal illness * 18 and over * confirmed diagnosis of colorectal carcinoma * ability to give informed consent * paraffin embedded histological material available for analysis exclusion criteria: * medical or psychiatric conditions * impairing ability to give informed consent

Keywords: colorectal cancer gene expression biomarker genomic mismatch repair
dose-response and variability of inhaled insulin in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: pharmacokinetic (pk) and pharmacodynamic (pd) dose-response investigation of dance-501 inhaled human insulin

this study investigated the pharmacokinetic (pk) and pharmacodynamic (pd) properties of dance-501, a novel inhaled human insulin liquid formulation (inh) and device. twenty-four subjects with type 2 diabetes (t2dm) received 3 inh doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (lis). the medium dose was repeated to determine within subject variability. pd was investigated during a 12 hour euglycemic clamp.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 u/kg/day. * body mass index 25-40 kg/m2 * hemoglobin a1c 6.5-9.5% * forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values. * fasting c-peptide less than 1 nmol/l exclusion criteria: * any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke. * active or chronic pulmonary disease. * any major disorder other than type 2 diabetes. * decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months. * proliferative retinopathy or maculopathy or severe neuropathy.
effects of peep and fio2 in ali and ards

Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury; Acute Respiratory Failure

Summary: current american-european consensus conference (aecc) definitions for ali and ards are inadequate for inclusion into clinical trials due to the lack of standardization for measuring the oxygenation defect. we questioned whether an early assessment of oxygenation on specific ventilator settings would identify patients with established ards (persisting over 24h).

we designed this study to determine whether standard ventilator settings applied on the day ards is identified (day 0) or 24 hours (day 1) later: (1) would have an impact on the reclassification of patients into ali or ards, and (2) would identify groups with different clinical outcomes. our hypothesis was that the assessment of pao2/fio2 on standard ventilator settings 24 hours after patients originally met the aecc definition of ards would identify patients with established ards (persisting over 24 h) from others with different degrees of lung injury. if this hypothesis is supported, it would suggest that patients with a better outcome could have been preferentially entered into one group of previously conducted clinical trials, resulting in a viable therapy being proved useless or useless therapy proven viable.

Eligibility criteria:
inclusion criteria: * all patients meeting american-european consensus conference (aecc) ards criteria were approached for enrollment regardless of their current status or past medical history. exclusion criteria: * the only patients excluded were those in which \>24 hrs had pasted after initially meeting the aecc ards criteria before consent and results of initial standard ventilator settings could be obtained.

Keywords: ards ali mechanical ventilation outcome