Kornimate/medical-research-clean huggingface dataset:
a study of amivantamab and mfolfox6 or folfiri versus cetuximab and mfolfox6 or folfiri as first-line treatment in participants with kras/nras and braf wild-type unresectable or metastatic left-sided colorectal cancer

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to compare how long the participants are disease-free (progression-free survival) when treated with amivantamab and chemotherapy with 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, oxaliplatin (mfolfox6) or 5-fluorouracil, leucovorin calcium (folinic acid) or levoleucovorin, and irinotecan hydrochloride (folfiri) versus cetuximab and mfolfox6 or folfiri in adult participants with kirsten rat sarcoma viral oncogene homolog (kras)/ neuroblastoma ras viral oncogene homolog (nras) and v-raf murine sarcoma viral oncogene homolog b1 (braf) wild type (wt) unresectable or metastatic left-sided colorectal cancer.


Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed adenocarcinoma of the left-sided colorectal cancer. participants must have unresectable or metastatic disease * be diagnosed to have kirsten rat sarcoma viral oncogene (kras), neuroblastoma ras viral oncogene homolog (nras), and v-raf murine sarcoma viral oncogene homolog b (braf) wild-type (wt) tumor as determined by local testing * must agree to the submission of fresh tumor tissue * have measurable disease according to recist v1.1 * have an eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1 exclusion criteria: * has medical history of (noninfectious) interstitial lung disease (ild) /pneumonitis/pulmonary fibrosis or has current ild/pneumonitis/pulmonary fibrosis, or where suspected ild/pneumonitis/pulmonary fibrosis cannot be ruled out by imaging at screening * has known allergies, hypersensitivity, or intolerance to excipients of any of the following: (a) amivantamab or cetuximab, (b) any component of mfolfox6 and, (c) any component of folfiri * has a prior or concurrent second malignancy other than the disease under study or one whose natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment(s) * participant with known mismatch repair deficiency (dmmr)/ high microsatellite instability (msi-h) status and human epidermal growth factor receptor 2 (her2)-positive/amplified tumor * has prior exposure to any agents that target epidermal growth factor receptor (egfr) or mesenchymal epithelial transition (met)
lentiviral gene therapy for cgd

Conditions: Chronic Granulomatous Disease

Summary: this is a phase i/ii clinical trial of gene therapy for treating chronic granulomatous disease using a high-safety, high-efficiency, self-inactivating lentiviral vector tyf to functionally correct the defective gene. the objectives are to evaluate the safety and efficacy of the tyf-cgd gene transfer clinical protocol.

chronic granulomatous disease (cgd) is a rare disorder caused by inherited defects in the nadph oxidase multienzyme complex. it is associated with severe and life-threatening bacterial and fungal infections. approximately two-thirds of all cgd cases result from mutations within the x-linked gp91phox gene (cybb), followed by the autosomal recessive forms of cgd, with defects in the gene coding for p47phox (ncf1) accounting for 10-30% of all cgd cases. the primary objectives are to evaluate the safety of the advanced self-inactivating lentiviral vector tyf-cybb and tyf-ncf1, the ex-vivo gene transfer clinical protocol and the efficacy of immune reconstitution in patients overcoming frequent infections present at the time of treatment, assessment of vector integration sites, and finally the long-term correction of immune dysfunctions.

Eligibility criteria:
inclusion criteria: 1. cgd patients \>= 0 years of age 2. molecular diagnosis confirmed by dna sequencing and supported by laboratory evidence for absent or significantly reduced biochemical activities of the nadph-oxidase 3. karnofsky-index \> =70% 4. at least one prior, ongoing or refractory severe infection and/or inflammatory complications requiring hospitalization despite drug intervention 5. written informed consent for adult patient, and assent for pediatric subjects seven years or older exclusion criteria: 1. contraindication for leukapheresis (anaemia hb \<8g/dl, cardiovascular instability, severe coagulopathy) or for administration of conditioning medication 2. female patients who are pregnant or lactating as determined by history and/or positive pregnancy test

Keywords: chronic granulomatous disease lentiviral vector
the effect of probiotic supplementation on sars-cov-2 antibody response after covid-19

Conditions: Covid19

Summary: this study will explore how a well-known probiotic strain l. reuteri dsm 17938 impacts sars-cov-2 specific antibody response upon and after infection in healthy adults.

after giving their informed consent, the study subjects will complete screening procedures to assess their eligibility for the study (visit 1). participants deemed suitable for the study will be randomized into two study arms (placebo, probiotic) before undergoing a baseline visit (visit 2) before the start of the intervention period. during the 6-month intervention period, the participants will attend study visits at 3 months (visit 3) into the intervention as well as at the end of intervention (at 6 months, visit 4). blood, saliva, and faecal samples will be collected at visits 2-4. in addition to sampling, during the whole intervention period, the participants will fill out a weekly questionnaire in which they are asked to record any possible symptoms of covid-19. the participants' dietary habits are assessed via a food frequency questionnaire (ffq) before the start of the intervention period. also, the participants are asked to maintain their habitual diet and lifestyle as well as not to consume any other probiotic or prebiotic supplements.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. age between 18-60 exclusion criteria: 1. previous diagnosis of covid-19 (by positive pcr) or previous confirmation of seropositivity to sars-cov-2 2. body mass index over 35 or under 16 3. current diagnosis of cancer or ongoing cancer treatment in the last 12 months 4. diabetes mellitus 5. cardiovascular disorder in need of pharmaceutical treatment 6. chronic kidney disease 7. chronic lung disease with decreased lung capacity 8. chronic liver disease with liver cirrhosis 9. current diagnosis of dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation 10. chronic neurological/neurodegenerative disease (e.g. parkinson's disease) 11. decreased function of the adrenal cortex (e.g. addison's disease) 12. autoimmune disease (e.g. rheumatoid arthritis) 13. chronic pain syndromes (e.g. fibromyalgia) 14. pregnancy or breast-feeding 15. immunodeficiency due to disease or ongoing medical treatment 16. regular intake of anti-inflammatory and/or other immunosuppressive medication within the last 3 months 17. use of anti-depressants within the last 3 months 18. antimicrobial treatment within the last 12 weeks before baseline sampling 19. regular intake of probiotics, as well as nutritional supplements or herb products that might affect intestinal function within the last 4 weeks if the investigator considers that those could affect study outcome 20. inability to maintain current diet and lifestyle during the study period 21. alcohol or drug abuse 22. any clinically significant present or past disease/condition which the investigator considers to possibly interfere with the study outcome or increase the risk for severe form of covid-19
epidemiology of acute self-poisoning in emergency services in france

Conditions: Suicide Attempts

Summary: acute self poisoning is a leading cause of suicide attempts and leads to frequent emergency department visits. however, the exact epidemiology of acute self poisoning is not known. the description of the clinical pathway and the characteristics of patients with acute self poisoning could lead to an improvement in emergency care. the investigators will conduct a 48h observational study in emergency services in france. investigators primary objective is to gathered epidemiological clinical and treatment data during emergency dispatch, prehospital care and inhospital emergency care.

acute self poisoned patients will be prospectively and anonymously recruited by emergency physicians in charge during two days. acute self poisoning is define as follow: intentional medicine intake in the 24h hours before emergency department admission. epidemiological, clinical, toxicological and treatment data will be gathered. outcome of patient will be prospectively assessed at 30days. all data will be transmitted to the principal investigators. then, 20% of the data will be monitored by an independent committee. exhaustivity will be retrospectively assessed by the number of inclusions in 10 emergency centers divided by the total number of possible inclusions in these centers. finally, an independent statistician will be in charge of the analysis.

Eligibility criteria:
inclusion criteria: * acute self poisoning defined as the intentional intake (oral, nasal, injection etc.) of medicines during the 24h before first medical contact exclusion criteria: * cardiac arrest at first medical contact (dispatch or physician) * acute self poisoning without any medication intake * non intentional poisoning

Keywords: emergency department epidemiology prehospital care dispatch acute self poisoning
genetics study of wet age-related macular degeneration (amd) non-responders to vascular endothelial growth factor (vegf) therapy

Conditions: Wet AMD

Summary: to obtain a genotypic analysis of patients with chronic exudative age-related macular degeneration noted to have subretinal or intraretinal edema despite continuous monthly anti-vegf therapy.


Eligibility criteria:
inclusion criteria: * ability to provide written informed consent for participation in this study * subjects diagnoses of neovascular amd who are on a monthly anti-vegf regimen (have had \>10 or more ranibizumab and/or bevacizumab injections within the last year) and who still have intra-retinal or subretinal fluid as confirmed by the investigator exclusion criteria: * subjects with a pigment epithelial detachment exclusively * subjects with serous pigment epithelial detachments * subjects with history of the following: idiopathic polypoidal choroidal vasculopathy * pathologic degenerative myopia * central serous chorioretinopathy * familial drusen * adult onset foveal pattern dystrophy

Keywords: wet amd anti-vegf genetic analysis of patients with wet amd who have not responded fully to anti-vegf treatments
study to evaluate the role of plasmajet in patients undergoing groin node dissection for vulval cancer

Conditions: Vulvar Cancer; Groin Node

Summary: surgery for vulvar cancer involves removal of the central tumour as well as groin node dissection as indicated depending on the stage of tumour. groin node dissection is associated with significant complications including lymphorrea, lymphocyst formation, wound breakdown as well as long term complications including lymphedema. this study has been designed with each patient acting as their own control to investigate if using the plasmajet during surgery is associated with a reduction in the above mentioned complications.

vulvar malignancy is the fourth most common malignancy of the female genital tract. surgical excision achieves excellent local control and remains the mainstay of treatment. surgical excision depends on the extent of disease and may be in the form of wide local excision or radical vulvectomy. lymphadenectomy in the form of bilateral groin node dissection (bgnd) is performed for all central tumors with depth of invasion greater than 1 mm, unless there is significant comorbidity contraindicating this, but is known to cause significant postoperative morbidity. immediate postoperative complications include breakdown and lymphocyst formation in more than 50% of cases. the plasmajet is a novel device that produces a jet of pure argon plasma by heating pressurized argon gas. energy from the argon plasma transfers to tissue as light, heat, and kinetic energy. following ethical approval, a prospective, crossover, doubleblind, randomized, control trial to assess the pj system, with the primary outcome being the possibility of reduction in wound breakdown and lymphocyst and lymphedema formation following bgnd for vulvar cancer was opened.

Eligibility criteria:
inclusion criteria: * to be included in this study, all women should undergo bgnd during their treatment pathway for histologically confirmed vulval cancer. * participant is willing and able to provide informed consent. * aged 18 years or above. * participant willing to allow general practitioner and other health care professionals, if appropriate, to be notified of participation in study. exclusion criteria: * women with vulval cancer who do not undergo bgnd. * women with any previous groin surgery * women with any previous radiotherapy to the pelvic area including the groins * patient choice * women who are pregnant, lactating or planning pregnancy during the course of the study

Keywords: vulvar cancer groin node dissection bilateral groin node dissection lymphedema lymphocyst lymphorrea
advanced nurses vs. general practitioners for the management of outpatient alcohol detox: a safety and cost comparison

Conditions: Alcohol Dependence

Summary: the samba study aims to assess the safety and cost comparison of the management of outpatient alcohol detoxification, between an advanced nurse protocol on the one hand (experimental group), and a gp-based treatment on the other hand (standard-of-care group). in the advanced nurse (an) group, nurses manage alcohol detox using a predefined protocol based on both the cushman and ciwa-ar scales. depending on the cushman and ciwa-ar scores, which are calculated at every consultation, advanced nurse can adjust the diazepam dosing. in case of any serious adverse event or uncontrolled withdrawal complication, an addiction specialist stands in back-up and can be appealed to decide whether the outpatient detox can be continued or whether the patient has to be hospitalized. in the gp group, gps can manage patients as they wish.


Eligibility criteria:
inclusion criteria: * dsm-iv-tr criteria for alcohol dependence * clinical indication for alcohol detoxification * social insurance * signed consent form for participation exclusion criteria: * previous history of seizures * previous history of delirium tremens * acute or chronic liver failure * contraindication for using diazepam * average daily alcohol use of 300g of ethanol * sadq score of 30 or more * chronic treatment with baclofen or disulfiram * current dms-iv-tr criteria for major depressive episode, or lifelong history of bipolar or psychotic disorder * any physical, cognitive, or psychiatric disorder that expose the subjects to enhanced risks (at the discretion of the investigator) * previous participation in the samba study * social isolation of homelessness (at the discretion of the investigator) * pregnancy or breastfeeding * guardianship or curatorship * previous participation in a biomedical study over the previous month

Keywords: detoxification outpatient advanced nursing health services
antithrombin to improve thromboprophylaxis and reduce the incidence of trauma-related venous thromboembolism

Conditions: Trauma Injury; Thromboembolism; Venous Thromboembolism

Summary: the purpose of this study is to determine if additional interventions will assist with decreasing the risk and/or severity of thromboembolism (clotting complications) in patients who have experienced a major traumatic event.


Eligibility criteria:
inclusion criteria: * admission to trauma service * polytraumatic injuries or pelvic/long bone fracture * planned admission to trauma icu or step-down/simu setting (this includes sticu, simu/timu, bicu, and bimu) * informed consent obtained exclusion criteria: * prisoners (defined as those directly admitted from correctional facility) * known or suspected pregnancy * ≥ 20% total body surface area (tbsa) burned * nonsurvivable head injuries * known hematologic or immunologic disorders * known prehospital anticoagulant use * patients initially placed on unfractionated heparin for thromboprophylaxis * known allergy to antithrombin or it's components * enrollment in another interventional study unless approved by trial principal investigator
combination therapy of different antidepressants with dietary supplements

Conditions: Depression

Summary: the aim of this clinical trial is to compare the effect of antidepressants in combination with different dietary supplements in patients with depression. our main objective is to compare the efficacy of antidepressants in combination with either l-methyl folate, vit b12, or magnesium) in patients with depressive disorders. the levels of depressive symptoms as measured by the patient health questionnaire (phq-9) at base level and during follow-up.

this is an open-label study assessing the comparative efficacy of antidepressants in combination therapy of either l-methylfolate, mecobalamin, or magnesium in patients with depressive disorder. the plan is to enroll 84 patients with depression based on patient health questionnaire (phq-9) score of 9 and above, which is a valid and reliable structured clinical interview. the investigators will collect data from the enrolled patient populations. the participants will be able to receive their results, on request, upon completion of the study. the investigators hypothesize that depressive symptoms can be improved by the addition of above mentioned nutritional supplementations with antidepressant medication.

Eligibility criteria:
inclusion criteria: * patients with depressive disorder having phq-9 score 9 and above * age 12 and above * patients having low/marginal and low normal levels for arms 2 and 3 of respective supplements * patients having low/normal serum magnesium for arm 4 exclusion criteria: * patients having psychiatric diagnosis other than depressive disorder according to the international classification of diseases 11th revision (icd-11) * history of kidney disease, myasthenia gravis * mentally handicapped or terminally ill patients * age less than 12 years * patients already taking multiple nutritional supplements * patients on polypharmacy with potential interactions with antidepressants and supplements in this study.

Keywords: depression magnesium vit b12 l-methylfolate
sensitivity and specificity of xpert mtb/rif ultra

Conditions: Tuberculosis

Summary: to estimate diagnostic accuracy of xpert ultra and xpert mtb/rif for extrapulmonary tuberculosis and rifampicin resistance in adults suspected to be infected with mycobacterium tuberculosis. in addition, this study will estimate the pattern of rifampicin resistance among tb cases in assiut population.

xpert mtb/rif was introduced recently and added great benefit in management of tb. xpert mtb/rif revolutionized the management of mycobacterium tuberculosis (mtb) infections by providing faster and more accurate mtb diagnosis that detects mtb and rifampicin (rif) resistance simultaneously. following world health organization (who) endorsement in 2010, xpert mtb/rif has helped improve tb programs in over 130 countries5. building on this success, faster and more accurate detection of mtb from the first point of encounter in the community is critical. partnered with genexpert® systems, xpert mtb/rif ultra was delivered with the advantages of improved performance and faster time to result (results within 80 minutes). it has higher sensitivity especially in smear-negative tb cases. the processing of the new assay is easy to use and does not need special expertise5. xpert mtb/rif ultra has increased accuracy of rifampicin results and improved detection of mixed infections. recently published recommendations by global experts demonstrate the efficiency of using xpert mtb/rif ultra as a frontline test over smear microscopy or line probe assays followed by culture-based methods for drug susceptibility testing. thus, a single modification of the diagnostic algorithm to detect smear-positive and smear-negative tb patients improves active case management, is more cost-efficient and could potentially reduce the relative rate of transmission. using xpert mtb/rif ultra has the potential to reduce the number of missed smear-negative tb patients and may lead to a decrease in total costs of patient care due to the detection of mtb in patient specimens and rif-resistance in a single test. there is great need for further research to assess the diagnostic value of xpert mtb/rif ultra in patients with pulmonary tuberculosis.

Eligibility criteria:
inclusion criteria: - patients presented to chest department with suspected pulmonary or extrapulmonary tuberculosis will be sequentially included exclusion criteria: * age: less than 18 years. patients who received anti tuberculous drugs in the past 6 months. unstable patients or need for icu admission
follow-up patients with end stage renal disease receiving zemplar to prevent and treat secondary hyperparathyroidism

Conditions: Chronic Kidney Failure; Secondary Hyperparathyroidism

Summary: the aim of this post-marketing observational study is to obtain further data on the long term use, safety and efficacy of zemplar as it is prescribed in the normal clinical setting and according to the approved summary of product characteristics for the treatment of secondary hyperparathyroidism in hemodialysis patients in greece.

the primary objective of this study is to evaluate the safety of zemplar® in the treatment of secondary hyperparathyroidism (iparathormone\>300 pg/ml) in subjects on hemodialysis treated in conditions of usual clinical care. the primary safety endpoints of this study are to evaluate the safety of zemplar by recording the number of hospitalizations and days hospitalized. a secondary efficacy endpoint will be the proportion of subjects achieving therapeutic success. therapeutic success with zemplar® will be defined as: * 40% reduction in the base ipth level is achieved, and/or; * serum iparathormone level \< 300 pg/ml. additional secondary endpoints are the incidence (proportion of patients) of clinically meaningful hypercalcemia (defined as corrected serum calcium (ca) \> 11.0 mg/dl taken at 2 consecutive measurements), hyperphosphatemia (defined as serum phosphorous (p)\>6.5 mg/dl taken at 2 consecutive measurements), and elevated ca x p product (defined as serum ca x p\>65 mg\^2/dl\^2 taken at 2 consecutive measurements). safety also will be assessed through adverse event monitoring and evaluation of laboratory variables and vital signs.

Eligibility criteria:
inclusion criteria: * subject is \>= 18 years of age and diagnosed with secondary hyperparathyroidism and a pretreatment iparathormone \> 300 pg/ml. * subject is receiving chronic hemodialysis. * subject for which treatment with zemplar injection is indicated clinically according to the criteria of participating investigator. * subject has provided their informed consent to participate. exclusion criteria: * subject has a corrected serum calcium \> 10.5 mg/dl, serum phosphorus \>= 6.5 mg/dl or subjects with corrected ca x p \>= 65 mg\^2/dl\^2. * subject has known hypersensitivity and/or toxicity to vitamin d metabolites and/or other product ingredients. * subject has participated in clinical study within the last month. * zemplar is contraindicated according to the summary of product characteristics.

Keywords: chronic kidney failure secondary hyperparathyroidism paricalcitol iv treatment safety and efficacy assessment