Kornimate/medical-research-clean huggingface dataset:
an effectiveness and safety study of intravenous golimumab in patients with active rheumatoid arthritis despite treatment with methotrexate therapy

Conditions: Arthritis, Rheumatoid

Summary: the purpose of this study is to evaluate clinical effectiveness and safety of golimumab with methotrexate (mtx) in the treatment of rheumatoid arthritis (ra) when compared to mtx alone.

this is a randomized (study medication is assigned by chance), double-blind (neither physician nor participants knows the treatment that the participant receives), placebo-controlled (an inactive substance is compared with a medication to test whether the medication has a real effect in a clinical study), multicenter, 2-arm (2 groups) study of golimumab in participants with active ra despite concurrent mtx therapy. approximately 564 participants will be randomly allocated to 1 of 2 treatment groups in a 2:1 ratio ie, group 1(approximately 376 participants will receive golimumab + mtx) and group 2 (approximately 188 participants will receive mtx + placebo). total duration of study for each participant is 112 weeks. safety will be evaluated by assessment of adverse events, tuberculosis testing and blood testing.

Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) for at least 3 months prior to screening * have been treated with and tolerated methotrexate (mtx) at a dose of at least 15 mg/week for at least 3 months prior to screening, and have been on a stable mtx dose of 15 mg/week to 25 mg/week for at least 4 weeks prior to screening * have an active ra, as defined by disease activity with at least 6 swollen and 6 tender joints, at the time of screening and at baseline * c-reactive protein greater than or equal to 1.0 mg/dl at screening * no history of latent or active tuberculosis prior to screening exclusion criteria: * other inflammatory diseases, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, or lyme disease * treated with disease modifying agents (other than methotrexate)/systemic immunosuppressives (eg, d-penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, sulfasalazine, leflunomide, azathioprine, cyclosporine, mycophenolate mofetil) during the 4 weeks prior to first administration of study agent * received intra-articular (in the joint), intramuscular (in the muscle), or intravenous corticosteroids, including adrenocorticotropic hormone, during the 4 weeks prior to first administration of study agent * known allergy to human immunoglobulin proteins or other components of golimumab * received any commercial or investigational anti-tumor necrosis factor alpha therapy such as but not exclusively infliximab, golimumab, adalimumab or etanercept

Keywords: arthritis, rheumatoid active rheumatoid arthritis golimumab cnto148 anti-tnfalpha monoclonal antibody methotrexate intravenous
tretinoin in treating patients with mycosis fungoides or sezary syndrome

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of tretinoin in treating patients who have any stage mycosis fungoides or sezary syndrome.

objectives: i. determine the efficacy of tretinoin (tra) in patients with mycosis fungoides/sezary syndrome. ii. evaluate the spectrum of toxicity of tra in this patient population. outline: nonrandomized study. single-agent chemotherapy. tretinoin, all-trans-retinoic acid, tra, nsc-122758. projected accrual: if 1 or more of the first 15 evaluable patients experience an objective response, then 20 additional patients will be entered. it is anticipated that the accrual rate will be 1-2 patients per month.

Eligibility criteria:
disease characteristics: biopsy-proven mycosis fungoides/sezary syndrome stage i-iv disease no cns involvement at least 1 measurable lesion required (skin, lymph nodes, visceral lesion, or peripheral blood counts) patient characteristics: age: over 18 performance status: ecog 0-3 hematopoietic: wbc at least 3,000/mm3 platelet count at least 75,000/mm3 hepatic: bilirubin no more than 2.0 mg/dl transaminases no more than 2 x normal alkaline phosphatase no more than 2 x normal renal: creatinine no more than 2.0 mg/dl other: no active systemic infection no significant organ failure uncontrolled with medication no pregnant or lactating women effective contraception required of fertile women prior concurrent therapy: biologic therapy: at least 4 weeks since prior systemic therapy chemotherapy: at least 4 weeks since prior topical chemotherapeutics or systemic therapy endocrine therapy: at least 4 weeks since prior topical (including steroid) therapy or systemic therapy radiotherapy: not specified surgery: not specified

Keywords: stage i cutaneous t-cell non-hodgkin lymphoma stage ii cutaneous t-cell non-hodgkin lymphoma stage iii cutaneous t-cell non-hodgkin lymphoma stage iv cutaneous t-cell non-hodgkin lymphoma
feasibility of the gamification of incentive spirometry in trauma patients

Conditions: Thoracic Trauma

Summary: gamification may be one solution that can increase the compliance in the use of devices like incentive spirometry.

recently, there has been much interest in the gamification of healthcare, such as virtual incentive spirometry gaming. several studies have examined the addition of gamification e.g. virtual incentive spirometry devices. there is a paucity of data regarding the gamification of incentive spirometry, and there is no data involving trauma patients. previous studies have enrolled either healthy volunteers or patients with specific lung pathology. this study to assess the safety, feasibility and efficacy of respiratory interventions in chest trauma patients using a therapeutic gamification platform.

Eligibility criteria:
inclusion criteria: * patients will be included if informed consent can be obtained from patient themselves and first session of incentive spirometry gamification can be performed within 48 hours of trauma intensive care unit (ticu) admission * adult patients (≥ 18 years of age) in the ticu with rib fractures or flail segment or a sternal fracture exclusion criteria: * trauma patients in the ticu who are mechanically ventilated or requiring bilevel positive airway pressure (bipap) * glasgow coma scale (gcs) \< 15, at the time of enrollment * facial fractures precluding the use of incentive spirometry * any organ injury that precludes use of respiratory therapies in the clinical judgement of the clinical team * patients who are expected to be transferred out of the ticu or discharged from the ticu in the next 24 hours based on treating physicians judgment * patients who are transitioning to palliative care or expected to die in the next 48 hours based on treating physician's judgment will not be included * patients unable to consent for themselves * patients unable to use the mouthpiece of the omniflow system, and those who have visual or hearing impairments that could limit their ability to evaluate the games

Keywords: pulmonary therapies incentive spirometry pulmonary complications pulmonary function gamification
to improve the rate of mother's own milk feeding of premature infants in nicu

Conditions: Quality Improvement; Breast-feeding; Premature Infant

Summary: thirteen hospitals in china will participate in the study, which objectives of this study is to improve the rate of mother's own milk feeding of premature infants in neonatal intensive care unit(nicu), evaluate the effectiveness of improving the quality of breastfeeding in clinical use ,form standardized process and improve clinical medical quality of premature infants.

in this study, the cluster randomized controlled matching design was used. considering that evidence-based practice for improving quality(epiq) method is not only to improve the quality of individual, but also to improve the quality of breast-feeding of the whole neonatal intensive care unit(nicu), so a hospital was chosen as a cluster. the supervision unit is used for the quality control , coordination and technical support in the whole study process.the two nicu with similar number of premature infants, the same scale of nicu and little difference in the recognition of breast-feeding quality improvement measures that meet the inclusion criteria are taken as the a floor, and then randomly divided into two groups, taking the nicu as intervention group or the control group can avoid the individual influence of the intervention. in this study, recruited 12 nicus. the purpose of study is to to increase the consumption of mother's own milk of premature infants through the existing measures of improving the breastfeeding quality, and then to improve the quality of life of the premature infant, and to further evaluate whether this model of improving the breastfeeding quality can be promoted in other nicu.

Eligibility criteria:
inclusion criteria: * weight less than 1500g or gestational age less than 32 weeks; * admission to nicu. exclusion criteria: * pregnancy with serious diseases, infectious diseases or other medical contraindications for breast-feeding (such as galactosemia); * infants did not survive were excluded.

Keywords: quality improvement breast-feeding premature infant cluster randomized controlled
angiography derived index of microcirculatory resistance in patients with acute myocardial infarction

Conditions: Acute Myocardial Infarction (AMI)

Summary: coronary microcirculatory dysfunction has been known to be prevalent even after successful revascularization of acute myocardial infarction (ami) patients, and has been shown to be associated with poor prognosis. angiography derived index of micro-circulatory resistance (angio-imr) is a novel pressure-wire free approach to assess coronary microvascular disease with great diagnostic performance. the current study will further investigate the prognostic value of angio-imr in patients with ami in multicenter retrospective cohort.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction patients who underwent successful percutaneous coronary intervention exclusion criteria: * no appropriate coronary angiography images (inferior image quality, image loss, severe arteries overlap, or significant artifact) * previous coronary artery bypass graft
pnf and bfr affect on pain, rom & functional outcome in post-op acl

Conditions: Sports Physical Therapy

Summary: a randomized controlled trial investigated the effects of hold relax technique (hrt) with and without blood flow restriction (bfr) on pain, range of motion (rom), and functional disability in patients with post-operative acl rehabilitation. this study includes all types of genders with age limit is 25-45 years. but the aim is to infer the answers to the following questions; does hrt has better effects than hrt with bfr? how much effect should be noted ? the research will show that if both hrt and hrt with bfr groups had significant pain reduction, the hrt with bfr group demonstrated greater rom improvement and significant enhancement in functional ability compared to the hrt and control groups.

a randomized clinical trial will be conducted under riphah international university guidelines and nonprobability convenient sampling will be used to collect data from the 48 participants from the ghurki trust and teaching hospital setting. participants will go through acl reconstruction specifically the usage of a hamstring graft. the participants were allocated into two groups by using randomization through computer-generated software a and b. in a group only hrt will be applied to check the effects on pain, rom, and functional disability. in the b group hrt with bfr will be utilized to note the effects on pain, rom, and functional disability.

Eligibility criteria:
inclusion criteria: * age group 25-45 years. * both gender male and female. * patient underwent arthroscopic acl repair procedure. * patients in 6 weeks of rehabilitation phase. * grafts of hamstring muscle were used in repair. * max range achieved after post-op day 1. * low- moderate pain intensity. exclusion criteria: * any form of bone carcinoma. * any post-op active infectionous patients. * any circulatory effects. * dvt and pulmonary embolism. * loose implant placement. * non co-operative patient. * hyperasthetic patient. * polytraumatic post-op patient.

Keywords: acl reconstruction hamstring graft hold relax technique blood flow restriction knee joint
shr-a1811 combined with bevacizumab in her2-positive breast cancer with brain metastases

Conditions: Breasr Cancer

Summary: this study aimed to evaluate the use of shr-a1811 and bevacizumab in her2-positive breast cancer with brain metastases


Eligibility criteria:
inclusion criteria: 1. ≥18 years old; 2. pathologically confirmed her2-positive breast cancer; 3. at least one measurable intracranial lesion according to rano-bm criteria, which had not received local treatment; 4. more than 2 weeks from last systemic treatment; patients with new brain lesions after craniocerebral surgery were admitted if no radiotherapy was performed. 5. prior her2-target treatment, endocrine therapy and chemotherapy was allowed; 6. adequate function of major organs- exclusion criteria: 1. previous treatment with trastuzumab deruxtecan (ds-8201a) or any other antibody drug conjugate (adc) which consists of an exatecan derivative that is a topoisomerase 1 inhibitor; 2. previous treatment with bevacizumab; 3. participated in other drug clinical trials within 4 weeks before admission; 4. history of clinically significant lung disease； 5. other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years. 6. according to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.). 7. any other conditions that researchers believe that patients are unsuitable for this study. -
porh and response to cold in raynaud's phenomenon.

Conditions: Raynaud Disease; Hyperemia; Cold

Summary: the main objective of the study is to determine if implication of epoxy-eicosatriénoïc acids (eets) and no during cutaneous post-occlusive hyperemia differs between patients with raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and l-nmma at the dorsal side of the fingers.

the main objective of the study is to determine if implication of epoxy-eicosatriénoïques acids (eets) and no during cutaneous post-occlusive hyperemia differs between patients with raynaud phenomena and healthy volunteers, by studying hyperaemic postocclusive response after microinjection of fluconazole and l-nmma at the dorsal side of the fingers. healthy controls and patients will undergo 3 visits

Eligibility criteria:
inclusion criteria: * neither raynaud's phenomenon or chronic disease for healthy volunteers * raynaud's phenomenon without connective tissue disease for patients in the group "raynaud" exclusion criteria: * history of axillary dissection , trauma or surgery * history of thromboembolic disease or thrombophilia * minor or law-protected major * exclusion period in another study * no affiliation to medicare * pregnant, parturient or breasting woman * concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor * smoking in the 6 last months * person deprived of liberty by a legal or administrative decision, person under legal protection * maximal annual indemnification reached.

Keywords: post-occlusive hyperaemia laser-speckle contrast imaging epoxyeicosatrienoic acid nitrous oxide
first aid by laypersons - effect on mortality and length of stay

Conditions: Wounds and Injury; First Aid; Bystander; Trauma

Summary: the study aims to assess the effect of first aid from bystanders on survival, admission length, and need of icu-stay for trauma victims.

all ambulance services in norway will be invited to participate. in the participating ambulance services, the personnel of first unit to reach the scene of accident for any emergency response to trauma will register what first aid measures (if any) are indicated and have been performed by the bystanders on the scene up til the point where the ambulance arrives. hospital data for each case will be retrieved. those patients who did receive correct first aid will then be compared to those patients who did not receive first aid, and those where first aid was attempted but not correct for differences in share of survivors, length of hospital stay, and need for admission to icu.

Eligibility criteria:
inclusion criteria: * all emergency response calls to trauma (drownings and hangings included) exclusion criteria: * no injury to patient * non-traumatic condition * poisonings

Keywords: wounds and injury trauma first aid bystander laypersons
functional remediation for bipolar disorder

Conditions: Bipolar Disorder

Summary: bipolar disorder is a major mood disorder with periodic mood episodes that may be very distressing, both to the individual and to others. when ill, the person is at particular risk for disruptions to social and occupational functioning, physical health, and even premature death. when not in an episode, individuals with bd may still be feeling well but have ongoing neurobiological processes, as well as the psychological sequelae from illness episodes, that can lead to subtle neurocognitive impairment that impedes overall functioning. this study is a test of an existing, published intervention that ameliorates deficits in functioning in euthymic bipolar individuals.


Eligibility criteria:
inclusion criteria: * diagnosis of bipolar i or ii disorder (bd), as determined by a structured diagnostic interview * at least three months of clinical remission (euthymia or minimal symptoms), based on the phone screen assessing mood episodes in the prior three months * score greater than 11 on a measure of everyday functioning (fast; described in measures section) indicating at least mild impairment * use of a standard bipolar mood-stabilizing medication at the same, adequate dose (according to canmat treatment guidelines) for at least 3 months prior to screening, with ability to continue that dose during the study. exclusion criteria: * history of neurological illness or injury (e.g., stroke, brain tumor) * documented intellectual disability * inability to provide written informed consent * substance dependence within last 3 months or substance abuse in last 30 days * inability to complete the six-month intervention * received ect in the past 12 months

Keywords: cognition cognitive remediation mood disorder functional impairment psychosocial intervention
effectiveness of multi-target fit-dna analysis as a colorectal cancer screening test

Conditions: Colorectal Cancer; Adenoma Colon

Summary: colorectal cancer is one of the most common cancer in hong kong. in 2018, crc accounted for 17.4%, 5,780 cases, of the total new cancers. crc claimed 2,279 lives (15.8%) making it the second most deadly killer in the population. since 2010, the cancer expert working group (cewg) has recommended that asymptomatic average-risk individuals aged 50 to 75 years should consider one of the screening methods: fecal occult blood test (fobt) every one to two years; or flexible sigmoidoscopy every 5 years; or colonoscopy every 10 years. however, it poses great challenges for large scale crc screening using colonoscopy, such as bowel preparation difficulties, complications of procedure and poor compliance. coloclear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated dna markers and for the presence of occult hemoglobin in human stool. it has the potential of increasing the sensitivity of detecting crc as compared to fobt or faecal immunochemical test (fit), which detects the presence of hemoglobin in stool alone. a positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. coloclear® is not intended as a replacement for diagnostic colonoscopy. a positive result in coloclear®, as with any screening test, should be followed by colonoscopy. coloclear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer.

the objective of this study is to evaluate the clinical performance of coloclear test in early screening of colorectal cancer in hong kong. other outcomes to analyze include, but are not limited to the point estimate of the sensitivity of coloclear for the detection of advanced adenoma (aa) in hong kong.

Eligibility criteria:
inclusion criteria: * subject is at average risk for development of crc. * subject is male or female (all asian), 40-74 years of age. * subject is able to comprehend, sign and date the written informed consent form to participate in this study, undergo study procedures described in the informed consent form and authorizes release of relevant protected health information through signing an informed consent form. exclusion criteria: * subject undergone colonoscopy and removal of lesions within 5 years. * subject with familial adenomatous polyposis (fap) and inflammatory bowel disease (ibd) including chronic ulcerative colitis (cuc) and crohn's disease. * subject with overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. * any condition which, in the opinion of the investigator should preclude participation in the study.
comparison of propofol-fentanyl and midazolam-fentanyl for conscious sedation

Conditions: Emergencies

Summary: sixty patients who refer to the emergency ward and need any painful procedure in the ward are randomized into 2 groups. one group is sedated before the procedure using propofol-fentanyl and the other with midazolam-fentanyl, with the same depth of sedation. the two groups will be compared regarding recovery time and other parameters described below.


Eligibility criteria:
inclusion criteria: * age more than 18 * candidate for a painful procedure * negative past history of a serious medical condition * asa score 0 and 1 exclusion criteria: * deep sedation making the patient unable to answer the questions * pregnancy * allergy to drugs * hemodynamic instability * failure to consent

Keywords: propofol midazolam duration of recovery emergency procedure