Kornimate/medical-research-clean huggingface dataset:
regorafenib plus pd-1 inhibitor in patients with colorectal cancer

Conditions: Colorectal Cancer; Immunotherapy

Summary: this study is intended to evaluate efficacy and safety of the combination of regorafenib and nivolumab as third-line or later therapy in patients with microsatellite stable (mss) colorectal cancer (crc).


Eligibility criteria:
inclusion criteria: * advanced colorectal cancer diagnosed histologically; * patients with microsatellite stable (mss) * patients have no any standard choice after multiple line of therapy( ≥ 2 lines); * expected survival ≥ 3 month; * ecog / ps score: 0-2, and the main organ function to meet the following criteria: hb ≥ 90g / l, anc ≥ 1.5 × 109 / l, plt ≥ 80 × 109 / l,bil \<1.5 times the upper limit of normal (uln); liver alt and ast \<2.5 × uln and if liver metastases, alt and ast \<5 × uln; serum cr ≤ 1 × uln, endogenous creatinine clearance ≥50ml/min exclusion criteria: * patient still has standard treatment therapy based on nccn guidance; * patient can not comply with research program requirements or follow-up;

Keywords: colorectal cancer immunotherapy regorafenib nivoluamb microsatellite stable
adolescent idiopathic scoliosis and mental health

Conditions: Scoliosis

Summary: the purpose of this pilot study is to determine the presence, frequency, and severity of mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.

this study is a cross-sectional pilot study investigating the prevalence of psychiatric illness at various time points in the course of treatment of ais. three independent sets of questionnaires will be administered during a single scheduled clinical visit. there will be no clinical visits for the exclusive purpose of completing questionnaires. the first questionnaire will be the srs outcome instrument. the second questionnaire will be the achenbach ysr, completed by the adolescents, and the parents will be asked to complete the cbcl. finally, a generic outcome measure specific to children and adolescents, the pediatric outcome data collection instrument, will be administered. the time requirement to complete these questionnaires is anticipated to be approximately 45 minutes. the achenbach questionnaires will be scored promptly after each is completed using the provided scoring templates. this data will be used to identify those at risk and make appropriate resources available. this would provide appropriate care for adolescents at high risk of mental health disorder by identifying those at risk via a non-invasive screening tool.

Eligibility criteria:
inclusion criteria: * all patients diagnosed with ais, between the ages of eleven and sixteen, who are scheduled to undergo surgical intervention, will be eligible to participate in the study. the patient and one parent will be required to complete the questionnaires in their entirety at the predetermined time points. there are several different methods of surgical intervention for ais, however there will be no selection on the basis of the type of intervention. curve pattern and severity will, similarly, not be used as inclusion criteria. exclusion criteria: * all types of scoliosis besides ais will be excluded. this includes neuromuscular, congenital, infantile idiopathic, and childhood idiopathic scoliosis. * children younger than eleven years or older than sixteen years will be excluded. * those with additional chronic disease will be excluded, due to the possibility of confounding. * those unable to complete the entire questionnaire, for any reason, or those unable to complete the questionnaires at each time point will be excluded. * existence of psychiatric disorder prior to treatment will not be cause for exclusion from the study.

Keywords: observation mental health scoliosis screening adolescent idiopathic scoliosis
comparison of combination of proximal acb and ipack with large-volume distal acb for early mobilization after tkr

Conditions: Adductor Canal Block; Postoperative Pain; Regional Anesthesia

Summary: large-volume distal acb is not superior to combination of proximal acb and ipack in facilitating early mobilization after tkr. block performing time of distal acb was significantly shorter compared to the combination of proximal acb and ipack

adductor canal block (acb) and infiltration between popliteal artery and capsule of knee (ipack) are popular block methods for analgesia after total knee replacement (tkr), covering both anterior and posterior knee. adductor canal serves as a passageway, local anesthetic injected here will spread both to proximal and distal to posterior. study was a single-blinded, randomized controlled trial between june 2023 and january 2024. large-volume distal acb is not superior to combination of proximal acb and ipack in facilitating early mobilization after tkr. block performing time of distal acb was significantly shorter compared to the combination of proximal acb and ipack

Eligibility criteria:
inclusion criteria: * patients aged 50 - 80 years who underwent total knee replacement surgery exclusion criteria: * systemic allergy, anaphylactic reaction, and occurrence of cardiac arrest * intraoperative fracture * change to general anesthesia * patient who decides to withdraw from the study.

Keywords: total knee replacement adductor canal block postoperative pain regional anesthesia postoperative mobilization tug test
intentional pulpotomy to preserve hopeless molars

Conditions: Pulpitis; Dental Pulp Diseases; Tooth Diseases

Summary: when proximal carious lesions of primary molars are located in close proximity to the cementum enamel junction (cej), marginal seal is challenging and extraction is recommended. pulpotomy is indicated for vital primary teeth to preserve them in function. the goal of this study is to monitor the long-term effect of intentional bioactive cement pulpotomies and crown coverage performed on vital and asymptomatic carious primary molars with gingival margins close to or at the cej


Eligibility criteria:
inclusion criteria: * selected patients will have one or more primary molar teeth diagnosed clinically with large proximal carious lesions with the gingival extension of the cavity at or below the cemento-enamel junction. the tooth should be asymptomatic and must have no signs of swelling, fistula, abnormal mobility and sensitivity to percussion (ruling out food impaction), and adequate space for placement of a stainless steel crown restoration. the pre-operative periapical radiograph, taken as part of the new patient/recall routine visit, should reveal a lesion in close approximation to the pulp, but having at least 1-2 mm of sound dentin separating the deepest portion of the lesion and the pulp. in addition, no evidence of furcation and periapical pathology, internal or external root resorption and presence of half to two-thirds of root length remaining. exclusion criteria: * uncooperative patients * teeth with positive history of pain, abnormal mobility, signs of pulp necrosis such as presence of swelling or fistula, and significant space loss due to caries not allowing placement of a stainless steel crown restoration * radiographically, signs of furcation and periapical pathology, internal and external resorption, less than half to 2/3 of root length remaining * selected patients will be treated by pediatric dental residents in the regular dental clinic setting with or without nitrous oxide inhalation, as part of the standard of care * prior to the beginning of the study, all operators will be calibrated by the principal investigator on identifying the teeth in question, as well as on the restorative technique * selected patients may have one or more qualified teeth
heparin-binding protein and heparins

Conditions: Vascular Disease, Peripheral; Thromboprophylaxis; Cardiovascular Diseases

Summary: heparin-binding protein is a protein from primary and secretory granluae of white blood cells. it is released when white blood cells become activated and has been advocated as a biomarker for sepsis. the aim of this study is to find out if heparins in clinical doses can change the level of heparin-binding protein in plasma.

blood samples are taken from patients before and after heparins in clinical doses. the effects of heparins on heparin-binding protein concentration in plasma is measured. this is a small observational study.

Eligibility criteria:
inclusion criteria: * planned endovascular treatment of aortic aneurysm or peripheral vascular surgery where unfractionated heparin in \>3000 units are given perioperatively * planned subcutaneous low molecular weight heparin as a thromboprophylactic treatment after major surgery or on intensive care treated patients. * planned open heart surgery with cardiopulmonary bypass. exclusion criteria: * under 18 years * unable to get informed consent from patient or relative

Keywords: heparin-binding protein heparin biomarker
the effect of esketamine combined with pregabalin on chronic postsurgical pain in patients after craniotomy.

Conditions: Chronic Postsurgical Pain

Summary: chronic postsurgical pain (cpsp), which is one of the most common and serious long term complication of surgery，occurs in approximately 10% of patients after a surgical procedure. craniotomy was previously considered to have less chronic pain than other surgical procedures. contrarily, studies have reported incidences of chronic headache varies for type of craniotomy, ranging from 23% to 34% at three months and 12% to 16% at one year after surgery. in addition，cpsp is associated with adverse events, including postoperative morbidity, increased health-care costs, significant impaired on quality of life, prolonged opioid use. optimising perioperative pain management should reduce the incidence of cpsp; the non-opioid analgesics, such as ketamine and pregabalin, have also been used as components of multimodal anesthetic protocols. postoperative pain scores and opioid use are significantly reduced in thoracotomy surgical patients given ketamine and pregabalin compared to control groups.however, there is currently a lack of evidence regarding which therapeutic options are most effective in reducing the incidence of chronic post-craniotomy headache. the investigators hypothesis is that sketamine combined with pregabalin reduces significantly chronic postoperative pain after craniotomy and improves patient outcome.


Eligibility criteria:
inclusion criteria: * adults, age ≥18 years, male or female * american society of anaesthesiology (asa) status i-iii * patients undergoing elective craniotomy exclusion criteria: * patients unable to complete scale assessment * pregnant or lactating women * patients with preoperative chronic pain syndrome * patients with previous craniotomy history * patients with a history of mental illness who are receiving medication * patients with liver and kidney dysfunction * patients have taken pain medication within two weeks * patients with history of adverse reactions to pregabalin, ketamine and esticketamine * patients with history of drug abuse; * bmi\>35.0 kg · m - 2.

Keywords: esketamine pregabalin craniotomy chronic postsurgical pain
livrelief varicose veins cream in the treatment of varicose veins

Conditions: Varicose Veins

Summary: phase iv interventional design where all participants used the test product as per package instructions for 6-weeks. baseline observations were compared to those collected after 6-weeks of treatment.

the use of the marketed natural product, livrelief varicose veins cream, was observed in 32 patients with lower limb varicose veins. participants were recruited from the patient population at the mayer institute in hamilton ontario, canada. patients that agreed to participate in the study and met the eligibility criteria were provided with a 6-week supply of the cream to use at home as directed on the product packaging. the following study measures were performed at the clinic prior to the first use of the cream, then again at the clinic after 6 weeks of use: ceap (clinical, etiological, anatomical, pathophysiological) classification and vcss (venous clinical severity score). these are assessments performed by the doctor or nurse to determine the severity of their varicose veins and cvi (chronic venous insufficiency), measurements taken of the circumference of their legs to measure swelling of the legs, photographs of the varicose veins, a quality of life enjoyment and satisfaction questionnaire (qles-q-sf) completed by the subjects to describe their satisfaction with various aspects of their life over the last week and documentation of any reactions to the treatment. the cream was applied to their varicose veins twice a day for 6 weeks.

Eligibility criteria:
inclusion criteria: * at least 19 years of age. * presence of lower limb varicose veins. exclusion criteria: * allergy to witch-hazel or any allergies in the cream. * intent to undergo surgical treatment varicose veins within the next six weeks. * pregnant or breastfeeding or planning to be pregnant. * any dementia or major cognitive dysfunction that would preclude the individual's ability to provide informed consent or complete the case report form. * any unstable medical condition (including but not limited to cardiovascular, cardiac/hypertension disease, moderate to severe kidney disease, and moderate to severe liver disease) * any medical condition that would preclude the participant's or a caregiver's ability to administer the product on a daily basis for the time period required to complete the study. * an active ulcer at the site of product application (as evaluated during ceap screening).
senl-h19 car-t cell injection in the treatment of patients with relapsed or refractory acute lymphoblastic leukemia

Conditions: B-ALL

Summary: this study is an open, dose-escalating clinical study, taking patients with relapsed or refractory acute lymphoblastic leukemia as the test subjects, including mouse-derived car-t treatment failure or relapse, or for any reason cannot bridge the transplant r/r b-all.

main research objectives: to evaluate the safety and efficacy of senl-h19 car-t in patients with relapsed or refractory acute lymphoblastic leukemia secondary research purpose to investigate the cytokinetic characteristics of senl-h19 car-t in patients with relapsed or refractory acute lymphoblastic leukemia.

Eligibility criteria:
inclusion criteria: * 1. sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet; 2. a definite diagnosis of relapsed and refractory acute b-lymphoblastic leukemia meets one of the following criteria: a) mouse car-t treatment fails or relapses; b) unable to bridge the graft for any reason; 3. eastern cooperative oncology group (ecog) score ≤2; 4. age ≥2 years old, male or female 5. cd19 positive tumor cells were detected by immunohistochemistry or flow cytometry; 6. expected survival longer than 3 months; 7. the collection time of peripheral blood mononuclear immune cells must be at least 2 weeks from the last radiotherapy or systematic treatment of patients; exclusion criteria: * 1. severe cardiac insufficiency; 2. have a history of severe lung impairment; 3. complicated with other advanced malignant tumors; 4. complicated with severe or persistent infection that cannot be effectively controlled; 5. complicated with severe autoimmune diseases or congenital immune deficiency; 6. active hepatitis (hbvdna or hcvrna positive); human immunodeficiency virus (hiv) infection or syphilis infection; 8. have a history of severe allergy to biological products (including antibiotics); 9. the female patient is pregnant and lactating, or has a pregnancy plan within 12 months; 10. conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

Keywords: b-all，h19，car-t
a study of emb-02 in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the primary purpose of this study is to identify the recommended phase 2 dose(s) (rp2ds) and schedule assessed to be safe for emb-02 and to characterize the safety and tolerability of emb-02 at the rp2ds. pharmacokinetics (pk), immunogenicity, and the anti-tumor activity of emb-02 will also be assessed.

this is a phase i/ii, multi-center, open label, multiple-dose, first in human study, designed to assess safety and tolerability, and to identify the maximum tolerated dose (mtd) and/or recommended phase 2 dos(s)e (rp2d\[s\]) for emb-02 in patients with advanced solid tumors. pharmacokinetics, pharmacodynamics, immunogenicity, and response will also be assessed.

Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent. * phase i: patients with histologically or cytologically confirmed locally advanced/metastatic solid tumors and have failed (progressed on, or are intolerant of) standard therapies. moreover, the disease should be measurable or evaluable per recist v1.1 * phase ii cohort a: patients with histologically or cytologically confirmed locally advanced/metastatic melanoma, excluding uveal melanoma. \> 1 prior therapy, including prior treatment with pd-1/l1(mandatory) and/or ctla-4 inhibitors(optional). and the disease is measurable or evaluable per recist v1.1 * archival tumor samples available for retrospective analysis or biopsy will be taken. * ecog performance status 0 or 1 for phase i, and ≤2 for phase ii; life expectancy \> 3 months * adequate organ function to participate in the trial. * recovery from adverse events (aes) related to prior anticancer therapy. * highly effective contraception exclusion criteria: * patients who have active autoimmune disease or history of autoimmune disease * history of severe irae. * history of severe allergic reactions * use of systemic corticosteroids. * symptomatic central nervous system metastases. * patients with cardiac dysfunction * uncontrolled diabetes mellitus with hemoglobin a1c \> 8% (via medical history) * prior treatment with a lag-3 inhibitor * anticancer therapy or radiation \< 5 half-lives or 4 weeks (whichever is shorter) prior to study treatment; * prior organ or stem cell/bone marrow transplant. * concurrent malignancy \< 5 years prior to entry. * patients with active infections. * major surgery \< 4 weeks or minor surgery \< 2 weeks prior to study treatment * live virus vaccines \< 30 days prior to screening * pregnant or breast-feeding females * any investigational agents or study drugs from a previous clinical study within 30 days of the first dose of study treatment * any other serious underlying medical conditions * abuse on alcohol, cannabis- derived products or other drugs

Keywords: phase i/ii bispecific antibody pd-1 lag-3 emb-02 immuno-oncology dose escalation cohort expansion neoplasms neoplasm metastasis advanced solid tumor
a team-based care for hypertension management (tbc-hta)

Conditions: Hypertension

Summary: the purpose of this study is to determine whether a team-based care (tbc) intervention, combining physician, nurse and pharmacist care improves bp control compared to usual care at 6 months among outpatients with uncontrolled hypertension.


Eligibility criteria:
inclusion criteria: * treated patients with uncontrolled hypertension (defined as daytime systolic/diastolic ambulatory blood pressure monitoring (abpm) ≥135/85mmhg) taking one or two antihypertensive medications; * speak and understand french; * agree to use the same pharmacy's services for the whole duration of the study. exclusion criteria: * unable to understand the study aim; * pregnancy and lactating; * livimg in a nursing home; * hospitalization during the recruitment period; * participation in another study; * daytime abpm\>180/110 mmhg.

Keywords: hypertension team-based care collaboration healthcare professionals healthcare services
different endurance training protocols in cardiac rehabilitation

Conditions: Coronary Artery Disease

Summary: it is the aim of the study to compare the effects of 6 weeks of either high-intensity interval training (hit; carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients. the three exercise arms (isocaloric) are composed as follows: endurance training (n=15): 31min at 65-75% hrmax; hit (n=15): 4x4min intervals at 85-95% hrmax divided by 3x3min of active recovery at 60-70% hrmax, making it a total of 25min; pyramids (n=15): one pyramid consists of 8 one-minute blocks. those are grouped starting with one block of 70-75% hrmax, followed by one block at 75-80% hrmax and another one at 80-85% hrmax. the top of the pyramid are 2 blocks of 85-90% hrmax. intensity is lowered afterwards with one block at 80-85% hrmax, followed by one block at 75-80% hrmax and last one at 70-75% hrmax. two more pyramids follow, each divided by 2min of active recovery at 65-70% hrmax, making it a total of 28min. all protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% hrpeak. primary outcome: individual maximum power output in watt (pmax). secondary outcome: change of power output in watt at lactate thresholds at 2 and 4 mmol/l.


Eligibility criteria:
inclusion criteria: at least one of the following diagnoses within the previous 3 months: * acute coronary syndrome (stemi) * acute coronary syndrome (nstemi) * aortocoronary bypass surgery * pci * stable coronary heart disease exclusion criteria: * unstable angina pectoris * heart failure (nyha iv) * acute endomyocarditis or other acute infections * pulmonary artery embolism or phlebothrombosis within the previous 6 months * hemodynamically unstable arrhythmia * hypertrophic cardiomyopathy * participation in another study within the previous 6 months * medical conditions which prevent patients from complying with the exercise program
fiji integrated therapy (fit) - triple therapy for lymphatic filariasis, scabies and soil transmitted helminths in fiji

Conditions: Lymphatic Filariases; Scabies; Impetigo; Soil Transmitted Helminths

Summary: lymphatic filariasis (lf), scabies and soil transmitted helminths (sth) are common neglected tropical diseases affecting the people of fiji. there is a dedicated lf eradication program supported by the world health organization (who), however scabies and sth are currently managed on an individual level with symptomatic treatment as required. in an attempt to reduce the prevalence of lf globally, research is being undertaken into alternative, more effective treatment options. a recent study in papua new guinea demonstrated a new triple drug therapy (ivermectin, diethylcarbamazine and albendazole) is superior to the currently recommended two drug therapy (diethylcarbamazine and albendazole) used by who lf programs in the pacific. however, adverse events were more frequent. despite no serious adverse events being observed, it is necessary to conduct further studies to review the safety of this new triple therapy before it can be endorsed as an effective mass drug administration (mda) regimen for lf in endemic countries. fiji's burden of lf, that has been recalcitrant to previous mda with diethylcarbamazine and albendazole, make it an ideal site to obtain further efficacy and safety data of the triple therapy. ivermectin given to communities as mda has been proven to be effective in reducing the community prevalence of scabies. what is not known is the effects of one dose versus two doses of ivermectin as mda. this question will be reviewed within the design of the community randomized study. the prevalence of impetigo in a community is linked to scabies and this will also be reviewed. ivermectin and albendazole are both effective individually against sth. the effectiveness of this combination of treatment as mda in fiji for sth has not been studied. the effectiveness for the individual in the short-term and the community in the longer-term will be reviewed. in addition, the acceptability and feasibility of the new therapy in communities at risk of these three diseases will be reviewed.


Eligibility criteria:
inclusion criteria: * all community members that have given written informed consent to participate exclusion criteria: * no informed consent