Kornimate/medical-research-clean huggingface dataset:
the relationship between brain injury biomarkers in cerebrospinal fluid and blood of patients after cardiac arrest and prognosis

Conditions: Cardiac Arrest (CA); Brain Injuries, Acute

Summary: this study is a single-center, prospective, observational study. after successful cardiopulmonary resuscitation for patients with cardiac arrest, they will be transferred to the emergency intensive care unit for further standardized targeted temperature management. when evaluating that the patient meets the indications for lumbar puncture and there are no contraindications for lumbar puncture, lumbar puncture examinations will be completed immediately after return of spontaneous circulation (rosc), at 24 hours of hypothermia, at 72 hours of hypothermia, and after rewarming. routine cerebrospinal fluid examinations such as cerebrospinal fluid routine, cerebrospinal fluid biochemistry, and cerebrospinal fluid lactate will be sent for inspection. at the same time, 6 ml of cerebrospinal fluid will be retained and stored in a refrigerator at -80°c. after sample collection is completed, enzyme-linked immunosorbent assay (elisa) will be used to detect markers such as nse, hch-l1, nfl, tau, mbp, gfap, and s100β. while performing the lumbar puncture examination, peripheral blood will be collected. after centrifugation for 10 minutes (4000 revolutions), serum will be retained and stored in a refrigerator at -80°c to complete the examination of the above markers. after 3 months, the patient\&#39;s neurological function prognosis will be followed up according to the pittsburgh cerebral performance category (cpc) scale.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old. * still lack of directive movements after restoration of spontaneous circulation through cardiopulmonary resuscitation. * advanced life support and targeted temperature management are carried out within 6 hours after return of spontaneous circulation (rosc). exclusion criteria: * patients with contraindications for lumbar puncture (severe cerebral edema indicated by brain imaging, disappearance of basal cisterns or occult intracranial mass lesions, receiving antiplatelet and anticoagulant therapy, and those with coagulation disorders). * pregnant patients. * patients with concomitant traumatic brain injury, stroke, cerebral hemorrhage and other diseases. * patients whose families do not agree to be enrolled.

Keywords: cardiac arrest brain injury cerebrospinal fluid biomarkers
an observational study of avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer (otilia)

Conditions: Peritoneal Neoplasms

Summary: this observational study will evaluate the safety, efficacy, quality of life and predictive/selection factors for avastin (bevacizumab) in combination with carboplatin/paclitaxel in first line in patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer in clinical practice. data of eligible patients will be collected during up to 15 months of treatment and 12 months of follow-up. a second recruitment phase has been opened to focus on patients \>/= 70 years.


Eligibility criteria:
inclusion criteria: * study phase 1: patients aged \>/= 18 years * study phase 2: patients aged \>/= 70 years * newly diagnosed advanced epithelial ovarian cancer, fallopian tube carcinoma or primary peritoneal cancer with indication for a first-line carboplatin/paclitaxel chemotherapy in combination with avastin exclusion criteria: * contraindications to avastin according to summary of product characteristics
liquid protein preloads with different carbohydrate types effects on the glycaemic and insulinaemic response

Conditions: Diabetes; Impaired Glucose Tolerance; Obesity

Summary: this study hypothesizes that milk protein consumed together or shortly before a white rice or white bread carbohydrate meal exerts different influence on the glycaemic, insulinaemic responses.

consumption of milk proteins increase satiety and reduce glucose response when consumed alone or with carbohydrate. milk proteins are of interest because proteins are more satiating than either carbohydrate or fat, and they regulate food intake and metabolic functions by the intact protein, encrypted peptides and amino acids on gastrointestinal and central pathways. white rice and white bread are two common carbohydrates types mostly consumed in asia. both of them are known to result in high glycaemic and insulinaemic responses. however, in most meals, they are accompanied by other foods such as soy milk, cow milk products. the glyceamic and insulinaemic responses are determined by the type of protein and the type of carbohydrates. and also the consumption time of protein and carbohydrate. recent research points to an intrinsic value of small amounts of milk protein or dairy consumed shortly before a meal can reduce the glycemic response to carbohydrate and that this is not at the cost of increased demand for insulin. the objective of the present study is to investigate how glycaemic, insulinaemic and satiety responses to a white rice or white bread meal changed when a soy milk or cow milk consumed together or shortly before the meal. whole soy milk and whole cow milk will be added to the meal. healthy subjects (n 15) will ingest the test meals once. the meals will be provided as breakfasts, on 10 different occasions, in random order with ≥ 7 days between each. blood samples (from the cannula and finger pricks) will be then drawn for 3 h, and glucose and serum insulin, plasma glucagon, satiety markers, inflammation markers, amino acids et.al will be analysed. the objective of the study is determining if different liquid protein consumed shortly before or with carbohydrate has different effects on metabolism. and also we will compare the difference of white rice and white bread. determining the consuming time effect, milk protein type and carbohydrate type on glycaemic and insulinaemic are critical for the provision of dietary advice and formulation of public health guidelines.

Eligibility criteria:
inclusion criteria: * chinese ethnicity * age between 21-40 years * not on prescription medication known to affect glucose and satiety related metabolism * do not partake in sports at the competitive and/or endurance levels * weight of at least 45kg * body mass index between 18.0 to 24.9 kg/m2 * normal blood pressure (120/80 mmhg) exclusion criteria: smoker * fasting blood glucose\>5.5 mmol/l * any major medical conditions including diabetes, hypertension, cardiovascular disease, thyroid disorders * allergic or intolerant to foods presented in the study
masitinib in the treatment of patients with primary progressive or non-active secondary progressive multiple sclerosis

Conditions: Progressive Multiple Sclerosis

Summary: to evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.

masitinib is a selective tyrosine kinase inhibitor, targeting innate immune cells (mast cells and microglia) that are involved in the pathophysiology of progressive multiple sclerosis (ms). this is a multicenter, double-blind, randomized, placebo-controlled, comparative study of oral masitinib in the treatment of patients with progressive ms who were progressing but not clinically active.

Eligibility criteria:
main inclusion criteria include: * patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before baseline and with no relapse diagnosed according to the 2017 revised mcdonald's criteria at least two years before screening * patients with expanded disability status scale (edss) score between 3.0 to 6.0 (both inclusive) at screening and baseline * patients with an edss score progression ≥1 point with no improvement during 2 years * absence of t1 gadolinium-enhancing brain lesions as measured by mri at screening main exclusion criteria include: * patients suffering from a disease other than ms that would better explain the patient's neurological clinical signs and symptoms and/or mri lesions observed at screening * inability to complete screening mri (contraindications for mri) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic * patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline * patients with lymphocytes \<1.0 × 10\^9/l at screening and at baseline

Keywords: primary progressive ms non-active secondary progressive ms tyrosine kinase inhibitor ppms spms
a study of shr-1210± shr-1020 versus chemotherapy in patients with recurrent or metastatic cervical cancer

Conditions: Recurrent or Metastatic Cervical Cancer

Summary: this is a randomized, open-label, 3-arm phase 2 study to evaluate the efficacy and safety of shr-1210 alone or with shr-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. all enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or shr-1210 treatment for up to 2 years.

this is a randomized, open-label, 3-arm phase 2 study to evaluate the efficacy and safety of shr-1210 alone or with shr-1020 versus physician's choice chemotherapy in recurrent or metastatic cervical cancer patients. all enrolled patients will be randomly divided into 3 groups and receive treatment until disease progression, intolerable toxicity，any criterion for stopping the study drug or shr-1210 treatment for up to 2 years.the primary study hypotheses are that the combination of shr-1210 plus shr-1020 is superior to shr-1210 or physician's choice chemotherapy with respect to: 1) progression free survival(pfs) in recurrent or metastatic cervical cancer patients(shr-1210+shr-1020 versus shr-1210；2) overall survival(os) in recurrent or metastatic cervical cancer patients(shr-1210+shr-1020 versus physician's choice chemotherapy).

Eligibility criteria:
inclusion criteria: 1. voluntarily agree to participate by giving written informed consent. 2. histologically or cytologically confirmed diagnosis of squamous-cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix. 3. the patients relapsed after a platinum-based treatment regimen for recurrent or metastatic disease. 4. patients must provide a fresh biopsy. if not, sufficient and adequate tumor tissue sample from the most recent biopsy of a tumor lesion will be required for pd-l1 expression. 5. has measurable lesion on imaging based on recist version 1.1. 6. have a life expectancy of at least 3 months. 7. ecog performance status 0-1. 8. if childbearing potential, female patients must be willing to use at least 1 adequate barrier methods throughout the study, starting with the screening visit through 6 months after the last dose of study treatment. exclusion criteria: 1. has any malignancy \ 3 years. 2. has received prior therapy with: anti-pd-1, anti-pd-l1, or anti-cytotoxic t-lymphocyte antigen 4 (ctla-4) antibodies; famitinib; patient is allergic to monoclonal antibody. 3. known to have autoimmune disease. 4. recived other anticancer therapy 4 weeks before randomization. 5. known to be human immunodeficiency virus positive, active hepatitis b virus, or active hepatitis c virus. 6. untreated and/or uncontrolled brain metastases. 7. with high risk of vaginal bleeding or gastrointestinal perforation.
safety and performance of the penumbra liberty stent in the treatment of wide-neck, saccular, intracranial aneurysms

Conditions: Wide Neck Intracranial Aneurysms

Summary: the purpose of this study is to assess the safety and performance of the penumbra liberty stent system as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.


Eligibility criteria:
inclusion criteria: * patient from 18 to 85 years old * a symptomatic unruptured saccular intracranial aneurysm with a neck ≥4mm (or a dome to neck ratio \<2) and a parent vessel diameter between 2.5 to 5.0 mm (inclusive) in both the anterior and posterior circulation of the brain, that is amenable to stent-assisted coiling. "symptomatic" is defined as any neurological symptoms attributed to the target aneurysm. * life expectancy \>6 months * signed informed consent exclusion criteria: * aneurysm with branches from the aneurysm base * rapidly growing aneurysm * daughter aneurysm * aneurysm with partial or complex calcifications * females who are nursing, pregnant or intend to become pregnant during the study. females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment and use an approved highly efficient contraceptive method during the study * multiple untreated cerebral aneurysms at study entry * recent history of stroke, tia, subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment * previous brain surgery or irradiation of the target treatment territory that would, in the opinion of the investigator, interfere with the treatment of the target aneurysm * admission platelet \<150,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy * underlying unstable coronary artery disease, cardiac insufficiency or myocardial infarction * contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast * contraindication to ct and/or mri scans * known allergy to the metal component of the penumbra liberty stent system * evidence of active infection (wbc \>10x109/l) * any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases) * current substance-abuse/illicit drug use * angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment * contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts) * patients unable to sign informed consent due to the emergency conditions of the intervention
ophthalmological emergencies and covid-19 pandemia

Conditions: Trauma; Infections; Vision; Loss, Both Eyes

Summary: to analyze how the covid 19 pandemia has affected the patient's accesses to the ophthalmological emergency department of a tertiary referral center in northern italy, during the lockdown period. we will collect data from different periods in 2020, in which the italian governement called the total lockdown to same periods of the 2019. the charts of all patients will be evaluated to analyze demographics and clinical data

since the end of 2019, an outbreak of the severe acute respiratory syndrome coronavirus 2 (sars-cov-2), originating in the chinese city of wuhan has spread rapidly worldwide causing thousands of deaths. coronavirus disease (covid-19) is supported by sars-cov-2 and represents the causative agent of a potentially fatal disease that is of great global public health concern. italy has been the first european country recording an elevated number of infected forcing the italian government to call for total lockdown. the lockdown had the aim to limit the spread of infection through social distancing. the purpose of this study is to analyze how the pandemic has affected the patient's accesses to the ophthalmological emergency department of a tertiary referral center in northern italy, during the lockdown period. the charts of all patients that came to the emergency department during the lockdown period (february -may, 2020 and october - december 2020) will be retrospectively collected and compared with those in the same periods of 2019 . all demographics and clinical data will be analyzed and compared to evaluate differences and type of accesses.

Eligibility criteria:
inclusion criteria: access to emergency room in the definite periods completed patients charts - exclusion criteria: access to emergency room in other periods demographics and clinical data not completed -

Keywords: ocular emergency vision loss
prospective controlled and randomized study of the genitourinary function after rectal cancer surgery in relation to the dissection of the inferior mesenteric vessels

Conditions: Rectal Cancer

Summary: purpose: the "total mesorectal excision" (tme) is the standard surgical technique for the treatment of rectal cancer. up to 50% of sexual dysfunction is described after tme and up to 30% of urinary dysfunction. the main objective of the study is to compare pre- and post-tme sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the ima or from the inferior mesenteric vein (imv) to the ima. methods: multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. the main variable is pre and postoperative sexual dysfunction. the sample to be included will be 90 patients, 45 per group.

purpose: the "total mesorectal excision" (tme) is the standard surgical technique for the treatment of rectal cancer. up to 50% of sexual dysfunction is described after tme and up to 30% of urinary dysfunction. although there are other factors, the main cause of postoperative genitourinary dysfunction is intraoperative injury of the autonomic pelvic nerves. one of the regions with more risk is the inferior mesenteric artery (ima). the main objective of the study is to compare pre- and post-tme sexual dysfunction according to the approach of the inferior mesenteric vessels, directly on the ima or from the inferior mesenteric vein (imv) to the ima. methods: multicenter, prospective, controlled and randomized study of patients with rectal adenocarcinoma with neoadjuvant chemoradiotherapy, who will be randomized into two groups depending on the approach of the inferior mesenteric vessels. the main variable is pre and postoperative sexual dysfunction. the secondary variables are visualization and preservation of the pelvic autonomic nerves, pre- and postoperative urinary dysfunction, pre and postoperative quality of life. the sample to be included will be 90 patients, 45 per group.

Eligibility criteria:
inclusion criteria: * males; * age greater (or equal) to 18 years * diagnosed of rectal adenocarcinoma at ≤ 15 cm from the anal margin (by rigid rectoscopy) * candidate for neoadjuvant (chemoradiotherapy). * scheduled laparoscopic radical tme surgery carried out by colorectal surgeons; * asa i, ii or iii; * informed consent present. exclusion criteria: * women * under 18 years old; * not candidate for neoadjuvant (chemoradiotherapy); * emergency surgery; * recurrent neoplasms * ct4 * patient with a history of infra-abdominal, or pelvic surgery of the prostate, or radiotherapy prior to the current process; * patients with severe sexual dysfunction and neurological alterations before surgery * patients with neurogenic bladder before surgery. * not to sign the informed consent

Keywords: rectal cancer sexual dysfunction urinary dysfunction rectal nerves damage total mesorectal excision
a clinical trial evaluating the efficacy and safety of dasatinib in refractory metastatic gist

Conditions: Gastrointestinal Stromal Tumor

Summary: the purpose of this study is to determine whether dasatinib is effective and safe in the treatment of refractory metastatic gastrointestinal stromal tumor


Eligibility criteria:
inclusion criteria: * histologically confirmed recurrent/metastatic gastrointestinal stromal tumor (gist). immunohistochemically, the detection kit and/or dog-1 are/is positive * patients must have measurable disease meeting the requirement of recist 1.1 * received the gene mutation detection of c - kit/pdgfra * subjects with mutation in exon 11, in exon 9 and wild type c-kit/pdgfra have failed to imatinib and sunitinib * subjects with primary mutation in exon 17 or 18 have failed to imatinib * subjects with primary mutation in exon 11 and secondary mutation in exon 17 or 18 have failed to imatinib * subjects with mutation in exon 18 of pdgfra,have received tki or not * eastern cooperative oncology group (ecog) performance status = 0-2 * expected os ≥3 months * ability to understand and the willingness to sign a written informed consent document * subject will comply with the study procedures and therapy exclusion criteria: * local or metastatic gist is resectable * unable to receive the gene mutation detection of c-kit (c-kitproto-oncogeneprotein)/pdgfra * ast and/or alt \> 2.5 times uln, or bilirubin \>1.5 times upper limit of normal (uln) * neutrophil count \< 1.5 x 10\^9/l, or platelet count \<75 x 10\^9/l, or hemoglobin\<90g/l * cr \>1.5×uln * other malignancy within the past 5 years except for adequately treated carcinoma in situ of the cervix or cutaneous basal cell carcinoma * known brain metastasis, spinal cord compression, carcinomatous meningitis, or cerebral or soft meningeal disease through ct or mri during screening stage * within the past 5 years, subjects have one of the following disease: myocardial infarction, serious/instable angina pectoris, symptomatic congestive heart failure or cerebrovascular accident from coronary/peripheral artery bypass grafting * known human immunodeficiency virus positivity * joining in other trail * women who are pregnant or lactating; no contraception for subject during childbearing period * subject with other serious acute and chronic physical or mental problems, or laboratory abnormality, will increase the risks associated with trail or drug. it will also interference the judgment of the results. in the judgment of the investigator, subject is inadequate to participant the study
ipilimumab and all-trans retinoic acid combination treatment of advanced melanoma

Conditions: Melanoma

Summary: the purpose of this study is to assess the safety and efficacy of combined treatment with ipilimumab and all-trans retinoic acid (atra) in melanoma patients.

the successful treatment of melanoma with immune checkpoint inhibitors, such as anti-cytotoxic t-lymphocyte-associated protein 4 (ctla-4) and programmed cell death protein 1 (pd-1) antibodies, has altered our thinking and approach to immunotherapy for solid tumors. despite these advances, only a portion of patients experience a durable response suggesting that there is room for improvement via enhanced immunomodulatory approaches. anti-ctla-4 (ipilimumab) significantly improves overall survival and achieves long-lasting complete responses in some melanoma patients, the number of patients that achieve durable clinical benefit is limited and could be improved by a combined immunomodulatory approach. the objectives of this study are to assess the safety and efficacy of combined treatment with ipilimumab and all-trans retinoic acid (atra) in melanoma patients. we hypothesize that combined treatment with ipilimumab and atra will improve patient responses, increase tumor antigen-specific t cell responses, and decrease immunosuppressive myeloid-derived suppressor cells (mdscs) in melanoma patients compared to patients treated with ipilimumab alone.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 year. * patients diagnosed with advanced melanoma. * patients that are considered candidates for ipilimumab therapy. * patients able to understand and willing to sign a written informed consent documents. * patients willing to have regular blood draws, one before treatment and four during or after treatment. exclusion criteria: * patients under the age of 18. * patients with stage i or ii, melanoma who are not candidates for ipilimumab. * patients that have received systemic treatments within four weeks prior to the beginning of treatment. * women that are pregnant or nursing. * patients taking immunosuppressive medications. * patients with active autoimmune disease. * patients with known sensitivity to retinoic acid derivatives. * patients with aspartate aminotransferase (ast), alanine aminotransferase (alt), or bilirubin \> 2.5 × uln.

Keywords: melanoma malignant melanoma