Kornimate/medical-research-clean huggingface dataset:
safety study of emd 72000 in combination with ecx (epirubicin, cisplatin and capecitabine) in oesophagogastric cancer

Conditions: Esophageal Cancer; Gastric Cancer

Summary: the main purpose of this study is to test the safety and tolerability and effectiveness of a new treatment, emd 72000 (matuzumab), for advanced oesophagogastric cancer in combination with the chemotherapy regimen ecx (epirubicin, cisplatin and capecitabine). in addition the study will look at pharmacokinetic (how the the body takes up the drug) and pharmacodynamic parameters (what the drug does in the body).


Eligibility criteria:
inclusion criteria: * advanced, recurrent or metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus * egfr positive tumor * kps greater than 60 * normal cardiac function * adequate liver and bone marrow function * gfr greater than 60 ml/minute exclusion criteria: * previous chemotherapy * uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrythmias * clinically significant ecg or cardiac history * radiotherapy or surgery within last 4 weeks

Keywords: emd 72000 matuzumab esophageal adenocarcinoma gastric adenocarcinoma
drive trial (dialysis patients' response to intravenous [iv] iron with elevated ferritin)

Conditions: Anemia, Iron-Deficiency; Kidney Failure, Chronic; Hemodialysis

Summary: this study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.


Eligibility criteria:
inclusion criteria: * chronic hemodialysis * elevated serum ferritin with low to normal transferrin saturation (tsat) * moderate to severe anemia * receiving epoetin alfa treatment exclusion criteria: * known sensitivity to ferrlecit® * medical conditions that would confound the efficacy evaluation * recent blood transfusion

Keywords: iron deficiency anemia ferritin hemodialysis sodium ferric gluconate epoetin alfa
vernakalant versus flecainide: atrial contractility

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is associated with decreased atrial contractility which is associated with stroke. decreased contractility becomes apparent after cardioversion of atrial fibrillation, a short period (weeks) during which stroke risk is increased. improved contractility immediately after cardioversion may prevent arrhythmia progression. in addition, it may reduce the stroke risk. vernakalant is a new antiarrhythmic drug able to convert atrial fibrillation to sinus rhythm and at the same time increase atrial contractility. the latter has not yet been shown in humans and is subject of the present investigation. our hypothesis is that in humans the contractility of the atria is higher after administration of vernakalant compared to flecainide. if indeed vernakalant improves atrial contractility after cardioversion further studies into the effect on long-term arrhythmia progression and stroke prevention may follow.


Eligibility criteria:
inclusion criteria: * persistent af or paroxysmal af * eligible for treatment with vernakalant or flecainide infusion to restore sinus rhythm * receiving adequate anticoagulant therapy (or having an episode of af lasting \< 24 hours) exclusion criteria: * refusal or inability to give informed consent to participate in this study * atrial flutter * contra-indications for receiving vernakalant or flecainide according to mumc+ protocol (unstable hemodynamic condition, lvef \< 40%, inadequate potassium levels, acute ischaemia, sinus node dysfunction) * age \< 18 years

Keywords: atrial fibrillation vernakalant flecainide echocardiography
serratus anterior plane block to prevent chronic postoperative pain in breast cancer

Conditions: Breast Neoplasms; Pain, Postoperative; Pain, Chronic; Post-Mastectomy Chronic Pain Syndrome

Summary: chronic postoperative pain (cpp) remains a disturbing and obscure clinical problem. the hypothesis of this trial is that a peripheral block of the serratus anterior plane block type preoperatively after a modified radical mastectomy makes it possible to reduce the intensity and incidence of chronic post-surgical pain in breast cancer.


Eligibility criteria:
inclusion criteria: * having an age greater than or equal to 18 years and less than 70 years * having given written consent for participation in the study and the use of personal and medical data * having a physical status of class i, ii or iii of the american society of anesthesiologists exclusion criteria: * patients who expressed their refusal to participate in the study * patients unable to express their non-objection to participation in the study * american society of anesthesiologists class \> iii patients * known allergy to local anesthetics * a contraindication to performing a peripheral nerve block (such as an acquired, constitutional or drug clotting disorder or infection at the nerve block injection site) * morbid obesity (body mass index greater than 40 kg/m²) * chronic use of opioids * inability to use the patient controlled analgesia device * the existence of preoperative pain * history of neuropathy or neurological pathology * the existence of catastrophism or anxiety diagnosed preoperatively
longitudinal study of the patients with medication-overuse headache or migraine that completed baseline mri

Conditions: Migraine Disorders; Medication-overuse Headache

Summary: this is a phone interview research study for patients with migraine or medication-overuse headache (moh) who have completed baseline mri scans. participants will be interviewed by phone at 3, 12, 24 months after the baseline mri scans. the purpose of this study is to potentially identify the baseline brain functional or structural signatures (functional connectivity, regional homogeneity, amplitude of low frequency fluctuation, and so such) that are predictive of the short- and long- term outcomes as well as treatment response of migraine and moh patients.

participants have been administered informed consent, taken medical history and performed a physical examination, and completed mri scans at baseline visit. this study only comprises the follow-up research procedure. after the mri scans, all included patients were treated at the headache center by headache specialists according to their clinical experience. the follow-up time points will be 3 months, 12 months, 24 months after baseline mri scans. the investigator will interview the patients by telephone to assess their headache features (duration, frequency, severity, accompany symptoms, migraine days per months, moderate to severe headache days per month, medications being used...) and patient health questionnaire 9 depression scale (phq-9), generalized anxiety disorder assessment 7-item scale (gad-7), quality and patterns of sleep using pittsburgh sleep quality index (psqi), and functional disability caused by migraine using the migraine disability assessment scale (midas) within the last 10 days at each time point.

Eligibility criteria:
inclusion criteria: * participants who are diagnosed with migraine or moh at baseline visit, signed the consent form, and completed mri scans. * participants who are willing to take the phone interview during follow-up. exclusion criteria: * refuse or unable to complete the phone interview procedure during follow-up.

Keywords: migraine medication-overuse headache mri
a long-term study for participants previously treated with ciltacabtagene autoleucel

Conditions: Multiple Myeloma

Summary: the purpose of this study is to collect long-term follow-up data on delayed adverse events after administration of ciltacabtagene autoleucel (cilta-cel), and to characterize and understand the long-term safety profile of cilta-cel.

cilta-cel (jnj-68284528/lcar-b38m chimeric antigen receptor t-cells \[car-t\]) is an autologous car-t therapy that targets b-cell maturation antigen (bcma), a molecule expressed on the surface of mature b lymphocytes and malignant plasma cells. there will be no treatment administered during the study and the data obtained from this study will help to assess whether there will be long-term cilta-cel-related toxicities. the study will consist of 2 phases: within the first 5 years after receiving the last dose of cilta-cel and year 6 to 15 years after last dose of cilta-cel. safety evaluations will include a review of adverse events, laboratory test results, and physical examination findings (including neurological examination). the duration of the study is up to 15 years after last dose of cilta-cel and participants will be followed at least once per year.

Eligibility criteria:
inclusion criteria: * participants who have received at least one dose of cilta-cel in a company-sponsored clinical study * participants who have provided informed consent for this study
the effectiveness of psychosocial skills training applied to individuals diagnosed with schizophrenia

Conditions: Schizophenia Disorder; Psychiatric Nursing; Psychosocial Skills Training

Summary: this study was conducted to investigate the effects of psychosocial skills training on subjective recovery, self-esteem and quality of life levels of schizophrenia patients. the research is a randomized controlled trial. the research was conducted with 48 schizophrenia patients (experimental: 24, control: 24) registered in the mental health and diseases outpatient clinic of a hospital. personal information form, subjective recovery assessment scale, rosenberg self-esteem scale, quality of life scale for schizophrenia patients were used to collect data. data were collected by the researcher using the self-reporting face-to-face interview method in the form of pre-test and post-test. psychosocial skills training was applied to the patients in the experimental group, one session per week, two days a week for 11 weeks, while the patients in the control group did not receive any intervention.


Eligibility criteria:
inclusion criteria: * being between the ages of 18-65, * having been diagnosed with schizophrenia for at least 6 months according to icd-10, * being registered with selçuk university medical faculty hospital mental health and diseases polyclinic, * coming to polyclinic check-ups regularly, * using antipsychotic medication regularly, * being at least a primary school graduate, exclusion criteria: * • having an organic mental disorder or mental retardation, * having a visual or hearing impairment, * participating in a program similar to the intervention to be implemented. * not attending at least two sessions of psychosocial skills training, * having an exacerbation period/hospitalization and experiencing a physical discomfort at a level that prevents attending sessions during the program process, * wanting to leave the study,

Keywords: schizophenia disorder psychiatric nursing psychosocial skills training quality of life self-esteem subjective improvement
the reset clinical trial: sprint® peripheral nerve stimulation for the treatment of back pain

Conditions: Low Back Pain; Back Pain

Summary: the purpose of this study is to compare standard of care treatments for back pain to electrical stimulation. stimulation is delivering small amounts of electricity to the nerves in your low back. this study will use a device called the sprint peripheral nerve stimulation (pns) system. the device is cleared by the fda for up to 60 days of use for the relief of chronic or acute pain (including back pain)


Eligibility criteria:
key inclusion criteria: * chronic low back pain key exclusion criteria: * body mass index (bmi) \> 40 * prior lumbar surgery * implanted electronic device * pregnant

Keywords: electrical stimulation neuromodulation
an evaluation of the clinical treatment and patient values and preferences of patients suffering from advanced non-small cell lung cancer (nsclc) undergoing chemotherapy

Conditions: Lung Cancer; Non-small Cell Lung Cancer

Summary: the main purpose of this study is the identification, description, and segmentation of non-small cell lung cancer (nsclc) patients based on their value appraisal of treatment outcomes and all intermediate states of health, to obtain patient preferences in direct correlation with clinical data from patients suffering from nsclc (stage iiib / iv) who are in transition from 1st to 2nd line treatment, and to gain utility scores by health state derived from patients' perceived value and taken from their perspective.


Eligibility criteria:
inclusion criteria: * patients suffering from non-small cell lung cancer (nsclc) with clinical stage iiib and iv tumours * patients with one chemotherapy regimen (first line treatment) (adjuvant chemotherapy following surgery is also regarded as first line treatment) * patients who are in transition from first to second line treatment * patients who signed an informed consent exclusion criteria: * chemotherapy naïve patients * patients ever enrolled in clinical studies treating non-small cell lung cancer (nsclc) with chemotherapy (during 1st and 2nd line chemotherapy) * patients who ever had chemotherapy for an indication other than nsclc

Keywords: patient preference oncology chemotherapy nsclc
the role of vitamin d in neuroinflammatory on drug resistant epilepsy

Conditions: Drug Resistant Epilepsy

Summary: the incident of epilepsy still very high in indonesia, thus many patients become drug resistant epilepsy. as vitamin d has some anticonvulsant effect, the investigators want to study if an additional dose of vitamin d can help with the therapy responses.

specifically the investigators want to study about : 1. correlation between serum vitamin d levels and seizure frequency change after vitamin d treatment 2. correlation between serum gdnf levels and seizure frequency change after vitamin d treatment 3. correlation between serum interleukin-1ß levels and seizure frequency change after vitamin d treatment 4. responder rate. percentage of patients change of at least 50% of the seizure frequency 5. remission rate after vitamin d treatment. percentage of patients without any seizure (seizure freedom) 6. effect of vitamin d according to epilepsy type. responder rate in focal and generalized epilepsy. 7. effect on global assesment of the severity of epilepsy (gase) 8. effect on hague seizure severity scale (hass) 9. effect on quality of life in epilepsy in children: (qolce 55)

Eligibility criteria:
inclusion criteria: 1. age 1 - 18 years 2. drug-resistant epilepsy 3. having at least 6 unprovoked seizures in the previous 3 months 4. no vitamin d treatment in the previous 6 months 5. medication compliance 6. agreeing to participate in the study 7. having a social insurance 8. parental agreement exclusion criteria: 1. treatments influencing the metabolism of vitamin d other than anticoagulants (rifamycin, isoniazid, ketoconazole, 5-fu fluorouracil, leucovorin) 2. known hypersensitivity to vitamin d 3. lost to follow up

Keywords: vitamin d gdnf interleukin
visual stimulation for pain relief

Conditions: Pain

Summary: the goal of this study is to investigate a novel neuromodulatory approach utilizing visual stimulation to impact pain perception in healthy participants.


Eligibility criteria:
inclusion criteria: * participants of both sexes * participants of diverse ethnic and racial backgrounds * participants who speak, read, and understand english and are willing and able to provide written informed * 18 to 50 years old exclusion criteria: * participants with neurologic, endocrine, renal, gastrointestinal, and chronic pain disease * participants who use unprescribed drugs or medications * chronically medicated participants * participants with photosensitivity and epileptic seizures * participants who have undergone major surgery within two months of the experiment date * participants with cardiac disorders * participants who are pregnant * prisoners * participants who are unable to provide consent * participants diagnosed with a psychiatric disorder that is likely to interfere with the conduct of the study * participants with implanted electronic devices of any kind, including pace-makers, electronic infusion pumps, stimulators, defibrillators
influence of covid-19 infection in thromboembolic venous disease: national cohort study

Conditions: COVID-19

Summary: there is an urgent need to understand the outcomes of covid-19 infected patients regarding the thromboembolic venous disease. capturing real-world data and sharing spanish national experience will inform the management of this complex group of patients, improving their clinical care. interventions are needed to reduce both the incidence and severity of covid-19. although it shares characteristics with other similar viruses that also arose in outbreaks, the physiological mechanisms of the virus and its responses on the host are not yet fully known. there are indications that the clinical picture of this disease is in a procoagulant state, with possible increase in episodes of thromboembolic disease. this study aims to analyze the influence of covid-19 on the incidence of deep vein thrombosis (dvt) in lower and upper limbs, and the variation in the clinical presentation of covid-19, as well as to provide new evidence applicable to the clinical management of these patients and the establishment of prognostic factors that help early take therapeutic decisions. to this end, an observational, multicenter, national cohorts study will be carried out, sponsored by the spanish society of angiology and vascular surgery (seacv) and the spanish chapter of phlebology and linfology through its vascular research network (riv), which will collect demographic variables, comorability, concomitant treatment, analytical status and complementary and ultrasound diagnostic tests, parameters of clinical evolution, therapeutic and complications and mortality to 30 days. all national centers you wish to participate through a secure server that will be accessed through the seacv and cefyl website. the global community has recognised that rapid dissemination and completion of studies in covid-19 infected patients is a high priority, so we encourage all stakeholders (local investigators, ethics committees, irbs) to work as quickly as possible to approve this project. this investigator-led, non-commercial, non-interventional study is extremely low risk, or even zero risk. this study does not collect any patient identifiable information (including no dates) and data will not be analysed at hospital-level.


Eligibility criteria:
inclusion criteria: * adults (age 18 years) considered as a case of covid-19 disease with suspected dvt in lower and/or upper limbs: (i) a laboratory test confirming covid-19 infection or (ii) a clinical diagnosis of covid-19 infection (without any testing) is considered. - suspected dvt: * patients with clinical data of suspected dvt * and/or patients with analytical data on suspected dvt * and/or patients with ultrasound data of suspected dvt exclusion criteria: -
zotarolimus vs sirolimus eluting stent in high bleeding risk

Conditions: High Bleeding Risk; Coronary Artery Disease; Percutaneous Coronary Intervention

Summary: randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (tlf) at 12 months in high bleeding risk patients who underwent elective coronary percutaneous intervention with a zotarolimus eluting stent versus a sirolimus eluting stent and short dual antiplatelet therapy (dapt).


Eligibility criteria:
inclusion criteria: patients 18 years old or older with an ischemic de-novo lesion(s) in coronary artery or coronary bypass graft suitable for percutaneous coronary intervention, in context of acute coronary syndrome or chronic coronary syndrome with evidence of ischemia by non-invasive study or pressure guidewire that can be treated by des, and has at least 1 major or 2 minor academic research consortium high bleeding risk criteria: major criteria: * 1. anticipated use of long-term oral anticoagulation * 2. severe or end-stage chronic kidney disease (ckd) (egfr \<30 ml/min) * 3. hemoglobin \< 11 g/dl * 4. spontaneous bleeding requiring hospitalization or transfusion in the last 6 months, or any time, if recurrent. * 5. moderate or severe baseline thrombocytopenia (\<100,000/ul) * 6. chronic bleeding diathesis * 7. liver cirrhosis with portal hypertension * 8. active malignancy (excluding nonmelanoma skin cancer) within the past 12 months * 9. previous spontaneous intracranial hemorrhage * 10. previous traumatic intracranial hemorrhage within the past 12 months * 11. presence of brain arteriovenous malformation (avm) * 12. moderate or severe ischemic stroke (nihss score equal or more than 5) within the past 6 months * 13. non-deferrable major surgery on dapt * 14. recent major surgery or major trauma within 30 days before pci minor criteria: * 1. age 75 years old and older * 2. moderate ckd (egfr 30-59 ml/min) * 3. hemoglobin 11 - 12.9 g/dl in men and 11 - 11.9 g/dl in women * 4. spontaneous bleeding requiring hospitalization or transfusion within the past 12 months, not meeting major criterion * 5. long term use of nsaids or steroids * 6. any ischemic stroke at any time not meeting major criterion exclusion criteria: * stemi undergoing primary pci * cardiogenic shock or resuscitation with uncertain neurological status at arrival to pci * unprotected left main lesion * reference diameter larger or shorter than available stents * life expectancy \< 12 months * in-stent restenosis o thrombosis of previous stent * inability to give written consent

Keywords: short dapt
dynamic cardio-vascular, cerebro-vascular and cortical interaction in healthy adult subjects

Conditions: Cardiac Disease

Summary: ideale aims to assess the status of autonomic function, cerebral autoregulation (ca) and cortical activity in healthy subjects and correlate these functions with the psychological dimension of the subjects. to this end, parameters of cardiac, cortical, vascular and cerebrovascular variability derived from electrocardiographic, electroencephalographic, respiratory movement, blood pressure, transcranial doppler signals will be acquired and analysed for each healthy volunteer (tcd) and laser-doppler transcutaneous, during a phase of clinostatism (rest) and one of active orthostatism (stand). in addition, volunteers will be submitted to psychometric tests (chieti affective action videos, caav) to assess the presence of depressive symptoms.


Eligibility criteria:
inclusion criteria: * age older than 18 years * spontaneous sinus rhythm * signed informed consent exclusion criteria: * definite diseases of the autonomic nervous system (sna) or the cardiovascular system * central nervous system disorders * subjects under drug therapy that may affect the cardiovascular system * pregnancy * previous diagnosis of depression