Kornimate/medical-research-clean huggingface dataset:
a study evaluating the efficacy and safety of ckd-506 in adult subjects with moderate-to-severe rheumatoid arthritis and inadequate response to methotrexate

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to evaluate the effects of ckd-506 on signs and symptoms of ra in subjects with moderate-to-severe ra who are inadequate responders to methotrexate.


Eligibility criteria:
inclusion criteria: * diagnosis of ra for at least 6 months prior to screening, currently meet the 2010 american college of rheumatology (acr)/european league against rheumatism (eular) criteria for ra, and are acr functional class i-iii. * have active ra * ongoing treatment with a stable dose of mtx as described below: 1. use of oral or injectable mtx on a continuous basis for at least 12 weeks prior to baseline and on a stable dose and route of administration between 15 mg and 25 mg/weekly for at least 8 weeks prior to baseline and planned during the study. 2. subjects should be on an adequate and stable dose of folic acid for at least 4 weeks prior to first administration of study treatment and planned during the study. * women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study treatment. * women of childbearing potential must have a negative serum pregnancy test at screening and urine pregnancy test at baseline * sexually active men, if not surgically sterile, must agree to use a medically acceptable form of contraception during the study and continue its use for at least 12 weeks after the last dose of study treatment. exclusion criteria: * treatments for ra as follows: jak inhibitors at any time; use of any currently licensed biologics with dmard properties at any time. * use of oral steroids at a dose \>10 mg/day of prednisone or prednisone equivalent or at a dose that has not been stable for at least 4 weeks prior to screening. * use of nonsteroidal anti-inflammatory drugs (nsaids) which have not been at a stable dose or route of administration for at least 2 weeks prior to baseline and planned during the study. * history of tuberculosis (tb) infection. * positive serology for human immunodeficiency virus 1 or 2, hepatitis b virus or hepatitis c virus. * currently active infection or history of infection within the last 2 weeks of screening or baseline
multimodal prehabilitation in colorectal cancer patients

Conditions: Colon Cancer; Prehabilitation

Summary: postoperative complications can occur in up to 50% of individuals undergoing colorectal resection and are associated with poor prognosis, increased costs, and lower health-related quality of life. even in the absence of complications, after major surgery, patients reduce their physiological and functional capacity by 20-40% and show a higher level of fatigue for 6-8 weeks. many of these negative effects can be decreased by applying specific eras (enhanced recovery after surgery) programs which, by attenuating the neuro-endocrine response induced by surgical trauma, accelerate patients\&#39; post-operative convalescence and facilitate their return to functional activities. in this study, the research group hypothesizes that a prehabilitation program based on physical exercise, nutritional optimization and psychological support (trimodal) carried out by patients in the 4 weeks before elective colorectal resection surgery can determine: 1) better physical performance 8 weeks after surgery (measured by the 6-minute walk test), 2) a possible decrease in postoperative complications, and 3) a reduction in in-hospital (direct) and post-hospital discharge (indirect) costs.

this study aims to determine the effect of prehabilitation on patients\&#39; functional capacity and postoperative complications. it is a randomized trial including 112 patients undergoing colorectal surgery for cancer. patients will be allocated to intervention group receiving 4 weeks trimodal prehabilitation (n=56) or control group receiving no prehabilitation (n=56). after surgery, both groups will follow 8 weeks rehabilitation based on enhanced recovery after surgery (eras) guidelines. the primary endpoint is functional capacity, secondary outcomes include postoperative complications and a cost-effectiveness analysis. multimodal prehabilitation is expected to increase functional capacity and lower postoperative complications.

Eligibility criteria:
inclusion criteria: * patients of age \&gt;18 years; * elective colorectal resection for colonic cancer. exclusion criteria: * metastatic disease; * severe walking impairments; * renal failure stage \&gt;2; * asa score \&gt;3; * preoperative chemo-radiation therapy.

Keywords: prehabilitation colorectal surgery functional capacity six-minute walking test post-operative outcomes
pain reduction and changes in upper limb function produced by different treatments in carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: in the present investigation the pain reduction effects of a physiotherapy technique will be compared to those produced by two different pharmaceutical treatments and also by the absence of treatment, in subjects who suffer the signs and symptoms of carpal tunnel syndrome.

the present randomized clinical trial will perform a comparison of the pain reduction effects produced by the application of a non invasive and non pharmacological median nerve neural mobilization (physiotherapy treatment), to those effects produced by an oral ibuprofen arginine pharmacological treatment, an oral gabapentin pharmacological treatment and the lack of treatment in subjects diagnosed with carpal tunnel syndrome. additionally, effects over the functionality of the affected upper limb will be evaluated and compared. subjects will be invited to participate and randomly allocated to 4 different groups.

Eligibility criteria:
inclusion criteria: * participants must be medically diagnosed with unilateral carpal tunnel syndrome (with confirmative electrodiagnostic findings). * full understanding of written and spoken spanish (language). * participants must freely consent to participate. * the presence of positive phalen an tinel sings. * the presence of carpal tunnel syndrome signs and symptoms exclusion criteria: * the lack to meet inclusion criterions, the presence of cognitive impairment, tumors, cancer, recent (affected) upper limb surgery or trauma, pregnancy, kinesiophobia, deformities of the (affected) upper limb, recent skin injuries or infections (in the affected upper limb), autoimmune inflammatory conditions or flu type symptoms, allergy to gabapentin, allergy to ibuprofen arginine, and also: participants must not be (during the present investigation) under any type of pain reducing treatment (conservative, homeopathic, invasive or not invasive).

Keywords: ibuprofen arginine gabapentin median nerve neural mobilization physiotherapy pain management
effect of gut microbiota and its metabolites on the efficacy of immunotherapy in metastatic colorectal cancer

Conditions: Colorectal Neoplasms Malignant

Summary: the purpose of this observational study is to understand the effect of gut microbiota on the efficacy of immunotherapy in patients with metastatic colorectal cancer and to explore the specific mechanisms of this process. in this way, it provides new ideas for the clinical treatment of colorectal cancer.

this study is a single-center, prospective, observational study. this study plans to enroll 50 patients with mcrc who received immunotherapy. stool and blood samples were collected from patients with mcrc before receiving immunotherapy (baseline) and after one cycle of immunotherapy and stored immediately in a -80°c freezer. six months after treatment with a pd-1 inhibitor in combination with fruquintinib, patients with mcrc were evaluated radiographically according to the modified recist1.1 criteria for immunotherapy (irecist) and were divided into responsive and non-responsive groups. in this study, we intend to use metagenomic sequencing to screen the key intestinal microbiota that affect the efficacy of pd-1 inhibitors and predict their possible functional pathways in patients with metastatic colorectal cancer receiving anti-pd-1 immunotherapy. then, proteomics and metabolomics methods were used to screen differential proteins and metabolites, and the correlation analysis with key intestinal microbiota was carried out, and the efficacy of immunotherapy in patients with mcrc was evaluated. finally, the above findings were verified in animal models, and then the specific mechanism of intestinal microbiota affecting the efficacy of pd-1 inhibitors was explained by taking the changes in body metabolism and immunity as the starting point.

Eligibility criteria:
inclusion criteria: * clinical and pathological diagnosis of metastatic colorectal cancer * 35-75 years old (both ends inclusive) * complete clinical information * signed informed consent exclusion criteria: * combined with severe respiratory and circulatory diseases * combined with other malignant tumors * recent severe active bleeding, uncontrolled active infection or active peptic ulcer * moderate to severe renal insufficiency * other circumstances that are judged by the investigator to be unsuitable for participating in this study

Keywords: metastatic colorectal cancer immunotherapy gut microbiota prognosis metabolism
efficacy of an intraoperative periradicular application of platelet rich fibrin (prf) on the intensity of residual post-surgical neuropathic pain after a surgery for disc herniation

Conditions: Neuropathic Pain; Chronic Postsurgical Pain

Summary: the prevalence of post-surgical lumbar neuropathic radiculopathy is approximately 30%. poor response to the treatments recommended for neuropathic pain, namely antidepressants and/or gabapentinoids, requires the development of new techniques to prevent this chronic pain. certain well-tolerated techniques, such as the administration of plasma enriched with platelets and fibrin (prf), are increasingly used in regenerative medicine for their anti-inflammatory and analgesic properties. thus, a periradicular intraoperative application of prf may have an analgesic effect on the intensity of residual postsurgical neuropathic pain after disc herniation surgery.

a superiority study, phase iii, prospective, single-center, randomized in parallel groups and conducted in a single-blind manner, with evaluation by a blind outcome assessor. patients will be randomized to one of two treatment groups: experimental group (surgery and periradicular administration of prf) or control group (reference treatment, surgery alone).

Eligibility criteria:
inclusion criteria: * patient, male or female, \>18 years old at the time of signing informed consent; * patient for whom a diagnosis of radiculopathy on lumbar disc herniation has been made, and for whom surgery has been scheduled in the neurosurgery department; * patient affiliated to a social security health insurance scheme; * patient able to understand the objectives and risks of research and to give informed, dated and signed consent; * patient having been informed of the results of the prior medical examination; * women of childbearing age provided that a negative blood pregnancy test is recorded at the inclusion visit and effective contraception used throughout the study. exclusion criteria: * patient with a history of lumbar spinal surgery (multiple herniated discs, herniated disc other than lumbar); * patient with hiv, active cancer, hbv, hcv (verified by interview); * patient on long-term systemic corticosteroid therapy; * patient with an asa score \> 3 during the consultation with the anesthesiologist; * inability to give the patient informed information (patient in an emergency or life-threatening situation, difficulties in understanding); * patient in exclusion period (determined by a previous or ongoing study); * subject under safeguard of justice; * subject under curatorship; * pregnancy; * breastfeeding.

Keywords: neuropathic pain chronic postsurgical pain prevention intraoperative platelet rich fibrin disc herniation surgery
a study of tepotinib plus osimertinib in osimertinib relapsed met amplified nsclc (insight 2)

Conditions: Non-small Cell Lung Cancer

Summary: this study was to assess the antitumor activity, safety, tolerability, and pharmacokinetics (pk) of the mesenchymal-epithelial transition factor (met) inhibitor tepotinib combined with the 3rd generation egfr inhibitor osimertinib in participants with advanced or metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * locally advanced or metastatic non-small cell lung cancer (nsclc) histology (confirmed by either histology or cytology) with documented activating epidermal growth factor receptor (egfr) mutation * eastern cooperative oncology group (ecog) performance status of 0 or 1 and a minimum life expectancy of 12 weeks * acquired resistance on previous first-line osimertinib. participants must meet both of the following 2 criteria: * radiological documentation of disease progression on first-line osimertinib * objective clinical benefit documented during previous osimertinib therapy, defined by either partial or complete radiological response, or durable stable disease (sd) (sd should last greater than (\>) 6 months after initiation of osimertinib * have received only first-line osimertinib as a prior line of therapy in the non curative advanced or metastatic nsclc setting * met amplification as determined by either fish testing (central or local) on tumor tissue (tbx) or central blood-based next generation sequencing (lbx). tumor and blood samples must be collected following progression on prior first-line osimertinib at prescreening * submission of tumor tissue and blood sample obtained after progression on first-line osimertinib, is mandatory for all patients for met amplification testing * submission of tumor tissue during prescreening or screening is mandatory for patients with tumor tissue tested by local fish, to confirm met amplification status. central confirmation is not mandated prior to the start of study treatment * other protocol defined inclusion criteria could apply exclusion criteria: * spinal cord compression or brain metastasis unless asymptomatic, stable or not requiring steroids for at least 2 weeks prior to start of study intervention * any unresolved toxicity grade 2 or more according to national cancer institute common terminology criteria for adverse events( nci-ctcae) version 5, from previous anticancer therapy with the exception of alopecia * inadequate hematological, liver and renal function * impaired cardiac function * history of interstitial lung disease(ild) or interstitial pneumonitis including radiation pneumonitis that required steroid treatment * hypertension uncontrolled by standard therapies (not stabilized to \< 150/90 millimeter of mercury (mmhg) * contraindication to the administration of osimertinib * other protocol defined exclusion criteria could apply.

Keywords: tepotinib osimertinib non-small cell lung cancer insight 2 met amplified
quantitative pupillometry

Conditions: Hydrocephalus; Critical Care

Summary: the aim of this study is to assess the diagnostic ability of quantitative pupillometry for the early detection of hydrocephalus during the weaning process of the external ventricular drain.

acute hydrocephalus is an emergency often requiring the insertion of an external ventricular drain (evd). in the aftermath, the patient is transferred to an intensive care unit (icu) for close monitoring. ensuring optimal cerebral perfusion through efficient drainage of cerebrospinal fluid while minimizing drainage duration are the objectives of care. assessing pupillary light reflex is a key test for the detection of neurological deterioration. for long, this assessment has been grossly performed via a qualitative approach (present/absence of pupillary light reflex). for a more precise assessment, quantitative pupillometry has been proposed. pupil size and constriction speed in response to a standard light are recorded by an automatic portable and user-friendly device. this device is increasingly used in the icu, mostly for prognostication after acute brain injury. we hypothesized that quantitative pupillometry parameters may vary when hydrocephalus occurs. the aim of this study is to assess whether quantitative pupillometry parameters vary when hydrocephalus occurs. the investigators focused on the early detection of hydrocephalus during the evd weaning process.

Eligibility criteria:
inclusion criteria : * patient older than 18 years old * admitted to the icu * with an external ventricular drain * consenting to participate (or consent from his/her next of kin, if unable to consent). exclusion criteria : * patient with pre-existing bilateral pupillary pathology * pregnant or breast-feeding patient * moribund patient or patient with decision of withholding or withdrawing life-sustaining treatment * patient with no health insurance * patient under guardianship

Keywords: pupillometry external ventricular drain weaning brain injury pupillary reactivity
finding the patient's voice diabetes prevention programs

Conditions: Diabetes Mellitus, Type 2; Prediabetic State

Summary: this study uses patient engagement to develop a diabetes prevention program focused on adolescents and families.

due to increases in obesity, the onset of type 2 diabetes is occurring at an ever-younger age, and is associated with poor outcomes and rising costs, which emphasizes the need for prevention at earlier ages. to address this need, the investigators designed the encourage healthy families curriculum; a program based on the scientifically proven u.s. diabetes prevention program, and while data demonstrate a reduction in obesity and diabetes risk for mothers and their children, the investigators have encountered several barriers to widespread implementation, including: 1. helping youth/families understand the importance of prevention, 2. on-going interest and participation, and 3. differing personal beliefs. patient-centered research is needed to better understand what adolescents/families want in prevention initiatives, who should deliver program content, where and when to deliver programs in the community, and how adolescents/families wish to be informed of results. the investigators believe that by engaging patients and the community in the development process, the investigators will be able to obtain workable answers to these questions at a population level for high-risk youth/families in "real world" settings.

Eligibility criteria:
inclusion criteria: 1. overweight (bmi \>85th percentile for age and sex, weight for height \>85th percentile, or weight \>120% of ideal \[50th percentile\] for height) 2. at least two of the following risk factors: * have been diagnosed with prediabetes; * have a family history of t2dm in first- and second-degree relatives; * belong to a minority race/ethnic group (native americans, african-americans, hispanic americans, asians/south pacific islanders); * have conditions associated with insulin resistance; and/or * have had gestational diabetes or were exposed to gestational diabetes in utero. 3. a family support person who is also willing to participate in the study. this person would preferably be a parent also at risk for diabetes (history of gestational diabetes, prediabetes, or with t2d). exclusion criteria: 1. type 2 diagnosis

Keywords: diabetes prevention type 2 diabetes prediabetes family
best regimen for phenylephrine administration during cesarean section

Conditions: Cesarean Section; Cardiac Output; Hypotension

Summary: during cesarean delivery, phenylephrine is used to maintain the patient's blood pressure. low blood pressure is the most common side effect of the spinal medication used to anesthetize the patient prior to the start of surgery. this low blood pressure can also trigger unpleasant side effects such as nausea, vomiting and low apgar scores for the baby. currently there are 2 methods of phenylephrine administration during cesarean section. one method is by intermittent bolus and the other is by continuous infusion. it is ideal to have a regimen for phenylephrine administration that maintains blood pressure without compromising cardiac output. in this study, cardiac output and blood pressure will be measured by transthoracic bioimpedance, which is a new technique of noninvasive continuous cardiac output monitoring. the hypothesis of this study is that the continuous infusion of phenylephrine will be equally effective in maintaining blood pressure as compared to the intermittent injection, and will induce less hemodynamic changes.


Eligibility criteria:
inclusion criteria: * ability to communicate in english * elective cesarean delivery under spinal anesthesia * normal singleton pregnancy beyond 36 weeks gestation * asa physical status i/ii * weight 50-100 kg, height 150-180 cm * age over 18 years exclusion criteria: * patient refusal * inability to communicate in english * allergy or hypersensitivity to phenylephrine * preexisting or pregnancy-induced hypertension * cardiovascular or cerebrovascular disease * fetal abnormalities * history of diabetes, excluding gestational diabetes * contra-indications for spinal anesthesia

Keywords: transthoracic bioreactance noninvasive monitoring vasopressor blood pressure
comparison of two thoracic manipulation techniques to improve neck pain in dentistry students

Conditions: Neck Pain

Summary: this study is designed to compare the short term effects of two different thoracic spine thrust manipulation techniques on neck range of motion, pain, and self-reported disability in a sample of dental students experiencing neck pain. the hypothesis of the study is that there will be a difference between the two thoracic spine thrust manipulation techniques for short term effects on neck range of motion, pain, and self-reported disability in a sample of dental students experiencing neck pain.


Eligibility criteria:
inclusion criteria: * current student at the arizona school of dentistry and oral health (asdoh) at a. t. still university * primary complaint of neck pain with or without symptoms that spread down into one arm * overall rating of neck pain intensity is at least 3/10; the overall rating is the overall average of the participant's rating of current, least, and worst pain experienced over the previous 24 hours on separate numeric pain rating scales where 0 corresponds to "no pain" and 10 corresponds to "worst pain possible". * neck disability index (ndi) score \> 10 points (measure of self-reported disability with a 0 to 50 point scale where higher scores indicate higher levels of disability. * proficient in speaking and reading english to complete outcome questionnaires exclusion criteria: * neck pain related to a motor vehicle accident or other trauma within the previous 6 weeks * neck pain that spreads down into both arms * low back pain or thoracic origin of pain * nerve root involvement; defined as the presence of two or more neurological findings (e.g. decreased strength, diminished deep tendon reflex, or decreased sensation) at the same nerve root level * diagnosis of cervical spine stenosis (narrowing of the central canal that contains the spinal cord) * history of spinal tumors, spinal infection, cervical spine fracture, or previous neck surgery * pending legal action related to current episode of neck pain * contraindications to thoracic spine thrust manipulation 1. serious pathologies or conditions (tumor, fracture, metabolic diseases, rheumatoid arthritis, osteoporosis, history of prolonged steroid use) 2. hyperreflexia 3. unsteadiness during gait 4. nystagmus 5. loss of visual acuity 6. impaired sensation of the face 7. altered taste 8. the presence of pathological reflexes 9. pregnancy or considering pregnancy

Keywords: neck pain thoracic spine thrust manipulation osteopathic manipulation dentistry range of motion