Kornimate/medical-research-clean huggingface dataset:
an observational study to evaluate the safety and efficacy of folfiri / folfox plus cetuximab as first-line therapy in patients with kras wild-type metastatic colorectal cancer

Conditions: Colorectal Neoplasms

Summary: this is an open-label, non-randomized, prospective, multicentric, phase iv study evaluating folfiri/ folfox plus cetuximab in the first-line therapy of subjects with kras wild-type metastatic crc.

cetuximab, a chimeric immunoglobulin g1 (igg1) monoclonal antibody, has been found to potentiate the effects of chemotherapy and radiotherapy in experimental systems. the findings from clinical trials suggest a favorable risk-benefit ratio of the combination of irinotecan or oxaliplatin, infusional 5-fu/fa and biweekly cetuximab, and support the current study to demonstrate the therapeutic value of the biweekly cetuximab regimen as a combination partner for those regimens in subjects with kras wild-type mcrc in the first-line setting. the purpose of this study is to generate post marketing surveillance (pms) data for cetuximab in first-line mcrc, which is mandated by the licensing authorities. this is an open-label, non-randomized, prospective, multicentric phase iv study evaluating folfiri/ folfox plus cetuximab in the first-line therapy of subjects with kras wild-type metastatic crc. the study plans to enroll 100 subjects with kras wild type crc at 20 centres across india. tumour status, physical and laboratory examinations will be performed during the baseline visit. subjects will be administered folfiri/ folfox and cetuximab according to the clinical condition in the following treatment visits. regular safety assessments and all adverse events (aes) will be documented throughout and until the end-of-study visit. the outcome of aes ongoing at the final tumour assessment visit will be followed up at the end-of-study visit (if possible, 6 weeks after the last administration of study medication but before second-line anticancer treatment, and not earlier than 30 days after the end of study treatment). skin toxicity present at the end-of-study visit will be followed up until outcome is known. objectives primary objective: * to evaluate the safety and tolerability of cetuximab in combination with standard chemotherapy such as folfox or folfiri as first-line therapy of patients with kras wild-type metastatic colorectal cancer. secondary objective: * to evaluate the efficacy of cetuximab in combination with standard chemotherapy as first-line therapy of patients with kras wild-type metastatic colorectal cancer.

Eligibility criteria:
inclusion criteria: * subjects with histologically confirmed, adenocarcinoma of the colon or rectum (mcrc) * subjects with kras wild-type status of tumour tissue * chemotherapy naïve subjects * subject who have signed written informed consent (as per institutional protocol) exclusion criteria: * as per summary of product characteristics of cetuximab

Keywords: colorectal neoplasms intestinal neoplasms neoplasms cetuximab erbitux
adjunctive 5% lidocaine patches for acute non-radicular low back pain in emergency department patients

Conditions: Low Back Pain

Summary: this study will evaluate the addition of lidocaine % transdermal patches to standard therapy in the treatment of acute non-radicular low back pain in patients discharged from the emergency department. in addition to standard therapy, half of the participants will receive medicated patches while the other half will receive non-medicated patches.

low back pain is a common emergency department (ed) chief complaint. multiple therapies have been evaluated in the treatment of ed patients with low back pain including acetaminophen, nsaids, opioids, steroids, and muscle relaxants. lidocaine is a local anesthetic that can be administered by various routes. it is used in a transdermal patch for the treatment of pain. it is commonly used for focal causes of pain, including low back pain. the addition of lidocaine 5% patches to standard low back pain therapy has not been rigorously evaluated, although it is frequently used.

Eligibility criteria:
inclusion criteria: * pain originating between the lower border of the scapulae and the upper gluteal folds * treating ed physician plan for discharge of the patient exclusion criteria: * radicular pain defined as pain radiating below the gluteal folds * direct trauma to the back within previous month * pain of greater than 2 weeks duration or greater than 1 lbp episode per month in the past 3 months * patient being pregnant or lactating; no access to phone or ability to participate in follow-up phone calls * known allergy to lidocaine or skin breakdown over site of pain * treating physician plan for opioid prescription (tramadol, codeine, hydrocodone) * personal history of malignancy, fever (temperature greater than 37.9ºc), or previous spinal surgery * patients who are detainees * previous enrollment in the study

Keywords: lidocaine
the use of oral n-acetyl cysteine for the treatment of chronic sinonasal symptoms

Conditions: Chronic Sinonasal Symptoms

Summary: chronic sinonasal symptoms (csns), such as coughing, throat clearing, nasal obstruction, crusting, dryness and discharge are extremely common in the general population. although the physical symptoms are readily apparent, the psychosocial impact is often overlooked. depression, anxiety, fear of social interaction, impaired personal relationships and decreased performance at work have all been associated with csns, often leading to multiple, frequent visits to the patient's primary care physician. a variety of clinical studies have shown that health-related quality of life (hrqol) is significantly impaired in people with csns, with depressive symptoms being particularly common. csns may be due, in part, to tenacious nasal and paranasal secretions. it is therefore conceivable that a mucolytic may thin these secretions and improve mucociliary clearance, thereby reducing csns. n-acetylcysteine (nac) is the most widely used mucolytic agent, particularly in patients with cystic fibrosis (cf), and has been documented as the most effective of the mucokinetic agents. our group wishes to examine the use of nac as a treatment for csns by testing the hypothesis that oral nac reduces symptoms of csns compared to placebo.


Eligibility criteria:
inclusion criteria: * one or more the following symptoms: nasal stuffiness, nasal dryness or crusting, nasal congestion, discolored nasal discharge, or thick nasal discharge, for four or more days a week in the preceding two weeks exclusion criteria: * poorly controlled asthma * cystic fibrosis * chronic obstructive pulmonary disease (copd) * severe coronary artery disease * vasculopathy * poorly controlled diabetes * poorly controlled hypertension * women who are breastfeeding
a four-period, four-treatment, four-way relative bioavailability study of cl-108 under fed and fasted conditions

Conditions: Healthy

Summary: this study will compare the relative bioavailability of hydrocodone, acetaminophen, and promethazine in cl-108 (hydrocodone 7.5mg/ acetaminophen 325 mg/ promethazine 12.5 mg) manufactured by charleston laboratories, inc. to hydrocodone in vicoprofen (hydrocodone 7.5 mg /ibuprofen 200 mg), promethazine 12.5 mg, and acetaminophen in ultracet (tramadol hcl 37.5 mg/acetaminophen 325 mg) under fasted and fed conditions.


Eligibility criteria:
inclusion criteria: * written informed consent * subject's body mass index (bmi) must be between 18 and 30kg/m2 (inclusive), and subject must weigh a minimum of 50 kg (110lb) * abide by study restrictions * acceptable birth control measures * ability to attend all study visits * vital signs as per protocol * willing to consume high calorie meals within designated time frame exclusion criteria: * clinically significant medical history * clinically significant abnormal findings * history or presence of allergic or adverse response to hydrocodone, ibuprofen,acetaminophen, any non-steroidal anti-inflammatory drugs (nsaids), promethazine, or related drugs. * has smoked or used tobacco products within 60 days prior to the first dose of study medication * has donated blood or plasma within 30 days prior to the first dose of study medication * has participated in another clinical trial (randomized subjects only) within 30 days prior to the first dose of study medication.

Keywords: plasma concentration time to plasma concentration elimination rate constant elimination half life area under the curve
a phase iii, randomized, multi-center study to determine the efficacy of the intercalating combination treatment of chemotherapy and gefitinib or chemotherapy as adjuvant treatment in nsclc with common egfr mutations.

Conditions: Completely Resected NSCLC With Common EGFR Mutations

Summary: this study aims to compare the efficacy of intercalating chemotherapy (gefitinib and pemetrexed/cisplatin) and chemotherapy (navelbine/cisplatin) in completely resected nsclc with common egfr mutations.


Eligibility criteria:
inclusion criteria: 1. completely resected non-squamous cell nsclc with stage iia to iiib (excluding n3) according to version 8 of the iaslc staging manual in thoracic oncology 2. tumors with common egfr mutations (19del or l858r) 3. adequate oran function exclusion criteria: 1. patients who were exposed to the chemotherapy or egfr tkis for nsclc. 2. patients with interstitial lung disease

Keywords: nsclc egfr adjuvant gefitinib intercalating
belgian central sleep apnea registry

Conditions: Central Sleep Apnea

Summary: this study evaluates different factors that determine the treatment choice and treatment compliance in patients with central sleep apnea. all patients will receive routine care (registry).

central sleep apnea (csa) is characterized by intermittent cessation or decrease of airflow and effort of breathing during sleep. the diagnostic criteria for csa varies according to the type of csa (e.g. csa due to cardiac failure, due to a medication, ...). csa is defined as: (1) an apnea/hypopnea index ≥ 15 per hour of sleep and (2) the number of central apneas and/or hypopneas is \> 50% of the total number of apneas and hypopneas. presence of csa is associated with excessive daytime sleepiness and poor sleep quality. furthermore, in patients with heart failure, presence of csa was found to be related to mortality. as yet, however, there is insufficient knowledge on the clinical features, pathophysiological background and consecutive algorithms for treatment. currently, it is not fully clear whether csa or the treatment of csa is related to disease progress. the aim of this trial is to evaluate the current treatment choices for csa in belgium and compliance with and effects of these treatments.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * an apnea/hypopnea index ≥ 15/h of sleep and proportion of non-obstructive events \> 50%, derived from polysomnography (diagnostic or during (pap) treatment) * written informed consent provided exclusion criteria: - patients with mental disability making it impossible to understand the study protocol
safety and efficacy of stsp-0601 in adult patients with hemophilia a or b with inhibitor

Conditions: Hemophilia

Summary: this study will assess the safety and efficacy of multiple-dose of stsp-0601 for the treatment of bleeding episodes in hemophilia a or b patients with inhibitor.


Eligibility criteria:
inclusion criteria: 1. 18 ≤age≤70 years of age,male. 2. hemophilia a or b patients. (no less than 3 patients with hemophilia b) 3. peak historical inhibitor titer ≥ 5 bu and apositive inhibitor test when enrolled. 4. establish proper venous access. 5. there were at least 3 bleeding events that requiring treatment occurred in the past 6 months before screening (only applicable to the on-demand treatment stage). 6. agree to use adequate contraception to avoid pregnancy. agree not to donate sperm or eggs. 7. provide signed informed consent. exclusion criteria: 1. have any coagulation disorder other than hemophilia. 2. plan to receive prophylactic treatment of coagulation factor during the trail. 3. patients plan to receive emicizumab during the trial. 4. patients received anticoagulant or antifibrinolytic therapy 7 days before enrollment or plan to receive these drugs during the trial.patients received anticoagulation therapy (such as coagulation factor replacement therapy, prothrombin complex, plasma, etc.) 7 days before enrollment. 5. have a history of arterial and/or venous thrombotic events. 6. platelet \<100×109/l. 7. hemoglobin\<90g/l. 8. severe liver or kidney disease. 9. severe bleeding event occurred within 4 weeks before enrollment. 10. accepted major operation or blood transfusion within 4 weeks before enrollment. 11. have a known allergy to stsp-0601. 12. pregnant, lactating, or blood pregnancy test positive female subjects 13. participate in other clinical research within 4 weeks before enrollment(except for participating in prothrombin complex, fvii, fviia, fviii, fix trails). 14. within 1 day prior to enrollment, fvii, fviia, tranexamic acid, and aminocaproic acid were used. within 3 days prior to enrollment, prothrombin complex, fviii, and fix were used. within 4 weeks prior to enrollment, treatment with amisulumab was received. 15. patients not suitable for the trail according to the judgment of the investigators.
car t-cell therapy in combination with glofitamab for relapsed/refractory large b-cell lymphoma with high-risk prognostic factors

Conditions: Large B-cell Lymphoma

Summary: the aim of this study is to evaluate the efficacy and safety of car t-cell therapy in combination with glofitamab for the treatment of relapsed/refractory large b-cell lymphoma with high-risk prognostic factors.


Eligibility criteria:
key inclusion criteria: * signed informed consent form * histologically confirmed large b-cell lymphoma with cd19 and cd20 expression, including diffuse large b-cell lymphoma (dlbcl) not otherwise specified (nos); primary mediastinal large b-cell lymphoma (pmbcl); high-grade b-cell lymphoma (hgbl); and transformed follicular lymphoma * patients who have relapsed or are refractory to at least prior first-line therapy, including anthracycline-containing chemotherapy regimens and anti-cd20 monoclonal antibody therapy * patients must be willing to receive car-t and glofitamab therapy and be deemed suitable for car-t and glofitamab treatment by the investigator * presence of at least one high-risk prognostic factor: (1) extranodal involvement; (2) maximum tumor diameter \> 4 cm; (3) tp53 mutation * ecog performance status of 0, 1, or 2 * life expectancy ≥12 weeks * adequate hematologic function (unless due to underlying disease, such as extensive bone marrow involvement, or secondary to lymphoma-related splenomegaly as determined by the investigator, but transfusion of blood products is allowed) and adequate liver, renal, pulmonary, and cardiac function key exclusion criteria: * hypersensitivity to any study drug or excipient * history of allogeneic stem cell transplantation * patients with active viral hepatitis requiring treatment as determined by the investigator: chronic hepatitis b virus carriers with hbv dna ≥ 500 iu/ml (2500 copies/ml) (hbv dna testing only for patients who test positive for hepatitis b surface antigen or core antibody); patients who test positive for hcv rna (hcv testing only for patients who test positive for hcv antibody) * presence of uncontrolled infection, cardio-cerebrovascular disease, coagulopathy, or autoimmune disease, etc * history of hiv infection * presence or concurrence of other malignancies within the past 2 years, with the exception of cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors * previous anti-cd19 car-t therapy is not allowed * pregnant or lactating women * other uncontrollable medical condition that may interfere the participation of the study
system accuracy of 12 bloog glucose monitoring systems

Conditions: Diabetes Mellitus

Summary: the system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with din en iso 15197:2015 in the course of the year 2022.


Eligibility criteria:
inclusion criteria: * male or female, with clinical indication for blood glucose measurement * signed informed consent form * minimum age of 18 years * subjects are legally competent and capable to understand character, meaning and consequences of the study. exclusion criteria: * pregnancy or lactation period * severe acute disease (at the study physician's discretion) * severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion) * current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) * a current constitution that does not allow participating in the study (e.g. hematocrit out of bgm specifications, medication known to influence blood glucose measurements; see appendix a of iso 15197) * being unable to give informed consent * \< 18 years * legally incompetent
predictive nomogram for postoperative acute kidney injury (aki) in elderly patients following liver resection

Conditions: Postoperative Acute Kidney Injury

Summary: acute kidney injury (aki) is a severe complication after liver resection and is associated with morbidity and mortality. the incidence of postoperative aki is significantly higher in elderly patients, especially in those with comorbidities. there is currently limited evidence on the incidence and associations of postoperative aki in elderly patients following liver resection. this study will evaluate the incidence and associations of aki in elderly patients after liver resection and its impact on postoperative mortality.

the occurrence of postoperative aki is independently associated with increased morbidity and mortality. advanced age reduces renal autoregulatory capacity due to physiological and functional changes, thus render the elderly to suffer postoperative aki and probably the consequent chronic kidney disease. although elderly patients account for approximately 25% of surgical procedures, the incidence and associations of aki in this group of patients are rarely understood. thus, it is essential to identify those patients at high risk to develop postoperative aki to optimize perioperative prevention and protection strategies. this study is a retrospective cohort study, aim to access risk factors of postoperative aki and its association with outcomes. the investigators will develop and validate a predictive model for postoperative aki. the principal clinical outcome of the study is postoperative aki, defined as an absolute increase in serum creatinine of 0.3 mg/dl within 48 hours or a 1.5-fold increase from preoperative baseline within seven days after surgery, according to the kidney disease: improving global outcomes (kdigo) criterion.

Eligibility criteria:
inclusion criteria: * elderly patients aged ≥65 years * benign and malignant liver diseases exclusion criteria: * emergency operation * liver transplantation

Keywords: acute kidney injury predictive nomogram elderly liver resection
balance study on icu-acquired hypernatremia and sodium handling (bias)

Conditions: ICU-acquired Hypernatremia

Summary: the goal of this study is to find differences between patients who do and do not develop icu-acquired hypernatremia (iah). therefore extended sodium and fluid balances will be performed. also a couple of other factors that possibly contribute to the development of iah and/or could give clues about the mechanisms in the development of iah will be investigated.

icu-acquired hypernatremia (iah) is common in critically ill patients, but it's aetiology is still not fully understood. sodium overload and inadequate fluid administration are generally considered important factors, but a previous retrospective study did not reveal differences in sodium or fluid balances between patients who did and did not develop iah. because this was retrospective these balances will be prospectively studied in this study to be more sure about the importances of these balances in the development of iah. previous studies indicated that (a lot) more factors contribute to the development of iah. in this study these factors will be investigated, hoping to find differences between patients who do and do not develop iah.

Eligibility criteria:
inclusion criteria: * predicted duration of icu-admission \>48 hours exclusion criteria: * renal replacement therapy * reason for admission necessitates actively elevation of serum sodium concentration * electrolyte disturbance as reason for admission * icu re-admission within 30 days * referral from another icu * serum sodium concentration on admission 143mmol/l or above

Keywords: aetiology
assessment of the effects of extensive somatosensory training on pain processing

Conditions: Musculoskeletal Pain

Summary: persistent pain may lead to several alterations in the brain activity and sensory perception (i.e. pain). around 80% of professional musicians experience prolonged episodes of musculoskeletal pain throughout their careers, a percentage that is four times higher than in the general population. with this background, the intended experiment aims at understanding the role of several biological factors associated to sensorimotor training that can lead to alteration of the brain activity and, consequently, pain processing.


Eligibility criteria:
inclusion criteria: healthy men and women speak and understand english. general exclusion criteria are: * pregnancy * drug addiction defined as the use of cannabis, opioids or other drugs * previous neurologic or mental illnesses * presence of a history of trauma or neurologic entrapment syndromes to the arm regions. * lack of ability to cooperate * frequent computer gamer ( \> 9 hours/week)
comparison of dental pain response in children

Conditions: Dental Anxiety

Summary: study involves the observation of the child's behavior during a dental treatment procedure. this allows for the evaluation of the child's experience of pain and discomfort through their facial expressions, body movements, and vocalizations during the procedure.


Eligibility criteria:
inclusion criteria: * age range: children aged between 6-12 years old (or any other specific age range) will be included in the study. * dental pain: participants who have been diagnosed with dental pain by their dentist will be included. * consent: informed consent must be obtained from the child and their parents or guardians before the study. exclusion criteria: * participants with existing medical or psychological conditions that could affect the pain response for instance, children with chronic pain conditions or with a history of anxiety or depression. * participants who have taken any pain medication within the past 24 hours as this could interfere with the pain response.