Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and efficacy of the bl-8040 and atezolizumab for maintenance treatment in subjects with acute myeloid leukemia (aml)

Conditions: Acute Myeloid Leukemia

Summary: a phase ib/ii, multicenter, single arm, open-label study, to evaluate the safety, tolerability and efficacy of the bl-8040 and atezolizumab combination for maintenance treatment in subjects with acute myeloid leukemia- the battle study the main goal of this clinical trial is to assess the safety and tolerability of the treatment combination of bl-8040 and atezolizumab as maintenance treatment in subjects with acute myeloid leukemia. additional objectives are: assessment of the effect of combination of bl-8040 and atezolizumab on relapse free survival (rfs) assessment whether the treatment combination of bl-8040 and atezolizumab can reduce the minimal residual disease (mrd) as compared to baseline assessment of the overall survival (os) time in subjects treated with the combination of bl-8040 and atezolizumab for maintenance assessment of the event free survival (efs) time in subjects treated with the combination of bl-8040 and atezolizumab for maintenance

this study will assess the safety and effectiveness of a combination of bl-8040 and atezolizumab to find out what is the safety, tolerability and efficacy of this treatment combination for maintenance treatment in subjects with acute myeloid leukemia. this is a single arm, open label, phase ib/ii study in which eligible subjects will receive maintenance treatment consisting of intravenous (iv) infusion of atezolizumab on day 2 of each 21-day cycle and subcutaneous (sc) injections of bl-8040 on days 1, 2 and 3 of each 21-day cycle. cycles will be repeated for up to 2 years (a maximum of 34 treatment cycles), until early discontinuation for any reason or until disease relapse, whichever comes first. approximately 60 patients will take part at multiple centers worldwide. the duration of the treatment period of the study will be up to 2 years and will be followed by one year safety follow up. the study will consist of: * a screening period of 21 days to allow your doctor to assess your suitability for enrollment into the study * a treatment period of combination regimen of 21 day cycles for up to 2 years * a follow-up period of up to 30 days after completion of combined treatment with bl-8040 + atezolizumab * an additional follow up period for up to one year after the completion of the treatment

Eligibility criteria:
inclusion criteria: aml confirmed subjects aged ≥ 60 years who have achieved complete remission (cr or cri) after induction/consolidation ara-c based therapy, that have mrd positive status and are not planned for stem cell transplantation. exclusion criteria: subjects diagnosed with acute promyelocytic leukemia or with extramedullary aml or subjects who have achieved cr or cri following treatment for aml. subjects who have received treatment with hypomethylating agents.
psychosocial support for pre-operative pain and distress

Conditions: Acute Pain

Summary: the purpose of this randomized study is to determine the impact of three different types of psychosocial support delivered by mental health professionals to pre-operative joint replacement patients. this study will examine the differential effects of brief mindfulness training, hypnostic suggestion, and cognitive behavioral pain psychoeducation for pre-operative patients, with a supplemental nonrandomized usual care comparison group.


Eligibility criteria:
inclusion criteria: * english-speaking males or females * 18 years old or older * patients within the university of utah hospital system * patients attending the joint replacement academy to prepare for either hip or knee replacement surgery exclusion criteria: * altered mental status due to delirium, psychosis, or pharmacological sedation as determined by clinical assessment.
vaginal co2 laser therapy for genitourinary syndrome in breast cancer survivors

Conditions: Genitourinary Syndrome of Menopause

Summary: this project will be based on three studies over a period on three years. the first study is a dose response study that includes 30 breast cancer survivors. they will receive a total of 5 laser treatments with 4-6 weeks intervals the second study is a double-blind randomized controlled trial, that includes 60 breast cancer survivors. 30 of those will receive active intervention and 30 will receive placebo laser treatment and act as controls. based on the results of the dose response study, a treatment consists of three to five laser treatments every 3 weeks. the third and last study is a one-year follow-up on study two. the conditions are evaluated before and after each treatment by questionnaires, vaginal fluid ph values, punch biopsies and vaginal and urine microbiome. the studies is conducted at the department of obstetrics and gynaecology at randers regional hospital in collaboration with department of obstetrics and gynaecology and department of oncology at aarhus university hospital.


Eligibility criteria:
inclusion criteria: * breast cancer survivor in endocrine therapy * symptomatic genitourinary symdrom of menopause with vaginal discomfort and/or dyspareunia * able to read and understand danish * able to give written informed consent exclusion criteria: * pelvic organ prolapse ≥ stage 2 according to the pelvic organ prolapse quantification staging system * use of non-hormonal/hormonal vaginal therapies (1 and 12 months prior to the baseline visit, respectively) * use of chemotherapy (6 months prior to the baseline visit) * acute urinary tract infection or active genital infection * history of vaginal reconstructive surgery

Keywords: laser mamma cancer
study to see how safe curcumin is and how well it works when used to treat mucositis in patients getting chemotherapy

Conditions: Mucositis

Summary: oral mucositis is a common side effect from cancer treatment. patients receiving chemotherapy and radiotherapy can get very painful sores in their mouth that compromise nutrition and oral hygiene as well as increase risk for infection, and can last for weeks. currently, the only treatment for mucositis is oral hygiene to try to support recovery. curcumin (also known as turmeric) is a frequently-used spice in india and southeast asia. studies in cells and animals have shown that it can reduce the amount of bacteria and can prevent inflammation. in this study, the investigators want to learn if a mouthwash made with curcumin is safe for people to use and if it can help their mucositis.

this is a phase i/ii study involving 2 parts; a dose escalation to determine the maximum tolerated dose (mtd) of curcumin and an expansion at the mtd. oral mucositis is a common and often debilitating complication associated with cancer treatment. treatment of mucositis is mainly supportive - oral hygiene is the means of treatment. curcumin (turmeric), a frequently-used spice in india and southeast asia, can reduce bacterial load and prevent inflammation in cultured epithelial cells and prevent chemotherapy- and radiotherapy-induced mucositis in animal models. the primary objective of this phase i/ii study is to determine the maximum tolerated dose (mtd) of oral curcumin in patients who have chemotherapy-induced mucositis. the secondary objectives of this study are to determine whether or not oral curcumin has an acceptable safety profile or impacts oral mucositis health outcomes.

Eligibility criteria:
inclusion criteria: * ≥ grade 2 oral mucositis related to chemotherapy for cancer * ability to understand and the willingness to review and sign a written informed consent document. * ≥ 18 years of age * willingness to use adequate contraception prior to study entry, for the duration of study participation and for 30 days after the last dose for women of child-bearing potential and men exclusion criteria: * current use of therapeutic doses of anticoagulants such as warfarin or antiplatelet agents (prophylactic doses and agents are acceptable) * biliary tract obstruction or cholelithiasis * history of gastric or duodenal ulcers or hyperacidity syndromes * ast or alt \> 2 x uln * total bilirubin ≥ 2 x uln * inr \> 1.5 * previous stem cell transplant (allogeneic or autologous) * preexisting oral disease, such as active oral infection, trauma to the oral mucosa or oral - ulceration prior to chemotherapy * known allergy/hypersensitivity to curcumin, yellow food coloring, or other members of the - zingiberaceae (ginger) family * pregnant or breastfeeding

Keywords: mucositis neoplasms cancer curcumin drug therapy antineoplastic agents
a long term study of a medication for adults with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: lydo is a multi-center study that will enroll approximately 1925 adult outpatients with attention deficit/hyperactivity disorder (adhd). patients will receive, under open label conditions, atomoxetine up to 100 mg/day during the acute, open-label part of the study. those patients that meet the response criteria will continue the blind phase of the study up to a year. during that period, patients that respond to atomoxetine will be randomized to continue the treatment with atomoxetine or with placebo (neither the patients nor investigators know if patients receive atomoxetine or placebo).


Eligibility criteria:
inclusion criteria: * adults * male or female * must meet attention-deficit/hyperactivity disorder (adhd) according to diagnostic and statistical manual of mental disorders, fourth edition text revision™ (dsm-iv-tr™) criteria exclusion criteria: * comorbidity with major psychiatric disorder * clinically significant depression or anxiety * patients with significant medical conditions * current alcohol/drugs abuse/dependence * concomitant excluded medications

Keywords: adhd adult long term maintenance of response attention deficit hyperactivity disorder
probiotics as adjuvant therapy in the management of irritable bowel syndrome

Conditions: Irritable Bowel Syndrome; Irritable Bowel Syndrome With Diarrhea

Summary: studying the effects of adding probiotics to the drug regimen of patients with diarrhea predominant ibs

irritable bowel syndrome (ibs) is a common highly prevalent functional gastrointestinal (gi) disorder that places an enormous burden on resource-challenged healthcare systems. although many drugs have been advocated in the treatment of ibs, including psychotropic agents, antispasmodics, bulking agents, and 5-ht receptor antagonists. however, in the vast majority of instances, these medications have failed to provide adequate symptom alleviation, presumably due to the disease's diverse pathophysiology. probiotics are "live bacteria that confer a health benefit on the host when administered in suitable doses". in ibs, a decrease in bifidobacterium and lactobacillus species, as well as an increase in gamma-proteobacteria species (a family of pathogens), has been described in ibs studies. therefore, the ability of probiotics to repair dysbiosis (qualitative and quantitative changes in the microbiota) or stabilize the host microbiota is the reason for their use in the treatment of ibs.

Eligibility criteria:
inclusion criteria: 1. age 16-55 2. both genders 3. patients diagnosed clinically with ibs based on rome's criteria 4. ibs-diarrhea only with pain \& distention 5. duration of symptoms 6 months exclusion criteria: 1. age \> 55 2. celiac disease 3. inflammatory bowel disease (ulcerative colitis \& crohn's) 4. thyroid disease 5. colonic ca 6. lactose intolerance 7. alarming features (anemia, blood in the stool, weight loss, abdominal masses, dysphagia, family history of git malignancy) 8. preexisting use of antibiotics in the previous 3 months. 9. preexisting systemic diseases

Keywords: ibs ibs-d abdominal pain abdominal distention probiotic lactobacilli mucus l. plantarum l. acidophilus
comparison of effect of carvedilol compared to bisoprolol on central pulse pressure in hypertension (artist) study

Conditions: Hypertension

Summary: the purpose of this study is to compare of carvedilol, a vasodilating beta-blocker and bisoprolol, a beta1- selective beta-blocker for reducing the central pulse pressure and thereby left ventricular (lv) mass in never-treated hypertensive patients.

carvedilol and bisoprolol are established beta-blockers for treating hypertension or chronic heart failure because these beta-blockers have cardio-protective effects. recent studies have shown that the change in central pulse pressure is more closely associated with the change in cardiac load than the change in brachial pressure during hypertension treatment. vasodilating beta-blockers may decrease central pulse pressure more than beta1- selective beta-blockers, because vasodilators reduced the magnitude of reflection wave by dilating peripheral muscular arteries. the investigators hypothesized that carvedilol, a vasodilating beta-blocker, would be more effective than bisoprolol, a beta1- selective beta-blocker in reducing central pulse pressure and thereby lv mass, through the reduction in the magnitude of reflection wave. the aim of the present study was to test this hypothesis in an active controlled, 2-arm parallel group comparison, prospective randomized open blinded end-point (probe) design study. at least 100 patients will be enrolled in each group and the follow up duration will be 48 weeks. the primary endpoint is to compare the change in central pulse pressure between the two groups.

Eligibility criteria:
inclusion criteria: * never-treated hypertensive subjects, aged 20-80 years (at the time of informed consent), regardless of sex * clinic systolic bp/diastolic bp \> 140/90 mmhg in a sitting position. exclusion criteria: * beta-blocker contraindications(asthma, copd...) * heart rate less than 55 bpm * subjects treated with nitrates * grade 3 hypertension (≥180 and/or ≥110 mmhg) * secondary hypertension or malignant hypertension * history of heart failure, coronary artery disease, and stroke * arrhythmia * renal dysfunction (serum creatinine ≥2.0 mg/dl) * hepatic dysfunction (ast and/or alt ≥100 iu/l) * a history of or a suspected malignant tumor within 5 years of enrollment * chronic inflammatory disease * pregnancy, childbearing potential with inadequate contraception, breast feeding * inability to give informed consent

Keywords: hypertension, carvedilol, bisoprolol, central pulse pressure, pulse pressure amplification, reflection magnitude, lv mass index, lv diastolic function
early risk stratification of patient hospitalized for sars-cov2 infection: critical covid-19 france ccf

Conditions: Infection Viral; Infection, Hospital; COVID

Summary: the covid-19 pandemic of sars cov2 (severe acute respiratory syndrome, covid-19) infection, which is currently evolving in france, raises many questions about the clinical and biological profile of infected hospitalized patients. if certain biological factors like troponin, bnp (brain natriuretic peptid), or clinical factors like cardiovascular history or oncological history are associated with a worse prognosis, available data comes from studies in asia for the majority, or including a limited number of patients. patient stratification remains a major issue for patient sorting and early referral of patients.

this study is observational, multicenter and retrospective, and is conducted in hospitals in france. clinical data relating to history, comorbidities, risk factors, previous treatments, treatments during the hospitalization and treatments at the discharge from hospital, clinical parameters, biological and ultrasound cardiological data, procedures and events during hospitalization will be recorded, in order to identify the early predictors of clinical worsening in patients hospitalized for covid-19 in cardiology or conventional medicine department.

Eligibility criteria:
inclusion criteria: - patients hospitalized in cardiology unit or medicine conventional sector with diagnosis of covid-19 (positive pcr (polymerase chain reaction) or diagnosis presumed by the clinical and radiographic picture) exclusion criteria: * minors * pregnant women

Keywords: cardiology department medicine conventional department
effect of the combination of plant extracts (bsl_ep025) in cardiovascular health

Conditions: Cardiovascular Disease

Summary: the objective of the study is to evaluate the ability of a combination of plant extracts (bsl_ep025) to reduce the levels of ldl-cholesterol and oxidized ldl-cholesterol in individuals with ldl-cholesterol levels between 100 and 190 mg/dl.

there is a strong relationship between serum cholesterol levels and cardiovascular diseases, especially between coronary artery disease and ldl-cholesterol (ldl). ldl is the lipoprotein responsible for delivering cholesterol to cells. however, in recent years, special attention has been given to modified ldl, especially oxidized ldl, since it plays a very important role in the initiation and progression of the atheroma plaque. there are environmental and genetic factors that can influence the type and levels of blood lipoproteins. among the modulable factors (environmental) it has been observed that some phytochemical compounds found in several plant extracts may reduce cardiovascular risk, due to their antioxidant and anti-inflammatory properties. the objective of the present study is to evaluate the possible effect of the intake of a combination of plant extracts (bsl_ep025) on the levels of ldl-cholesterol and oxidized ldl-cholesterol in healthy individuals with ldl-cholesterol levels between 100 and 190 mg/dl.

Eligibility criteria:
inclusion criteria: * men or women between 18 and 65 years of age. * levels of ldl-cholesterol between 100 and 190 mg/dl. * accept freely to participate in the study and sign the informed consent document. exclusion criteria: * be pregnant. * have planned to carry out a dietary intervention or exercise practice with the aim of losing weight in the coming weeks. * suffer from a serious illness. * have diabetes. * having a cerebrovascular disease. * be taking products or drugs to control cholesterol levels or with antioxidant activity.

Keywords: plant extract ldl cholesterol dietary supplement
single dose escalation study of 131i-sibrotuzumab in patients with advanced or metastatic non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: study to determine the maximum tolerated dose (mtd) and safety profile of a single-dose administration of sibrotuzumab (50 mg) conjugated to an increasing dose of 131 i isotope.


Eligibility criteria:
inclusion criteria: * evidence of advanced, non-resectable, and/or metastatic non-small cell lung cancer and at least one previous conventional treatment for advanced disease * eastern cooperative oncology group (ecog) performance status of 0 or 1 * measurable or evaluable disease, determined by world health organization (who) criteria using standard imaging modalities, including ultrasound, x-ray, ct and/or magnetic resonance imaging (mri). bone scans and/or antibody scans are not to be used to determine the extent of the disease * expected survival of ≥ 16 weeks * at least 18 years of age * platelet count ≥ 100 x 10\*\*9/l * absolute neutrophil count ≥ 2.0 x 10\*\*9/l * aspartate aminotransferase (ast) ≤ 3 x upper limit of normal or \< 5 x upper limit of normal if liver metastases are present * total bilirubin ≤ 2mg/dl * serum creatinine ≤ 2mg/dl * ability to provide written informed consent exclusion criteria: * known brain metastases * exposure to an investigational agent within 30 days prior to receiving the scout dose * incomplete recovery from surgery or incomplete healing of an incision site or evidence of infection * treatment with cytotoxic chemotherapy, radiation or immunosuppressive therapy within the 30 days (42 days for nitrosoureas and/or mitomycin c) of the scout infusion. patients using inhaled corticosteroids are considered eligible for enrollment * serious illnesses, i.e., active infections requiring antibiotics, bleeding disorders or other serious illnesses precluding the use of either 131i or sibrotuzumab * women who are breast-feeding or pregnant * men and women who were sexually active and are unwilling to utilize a medically acceptable method of contraception * hypertrophic skin disease or autoimmune disease that possibly involves over-expression of fibroblast activation protein (fap), which can be targeted by the antibody. these diseases include active inflammatory arthritis, cirrhosis, and keloids * unstable angina pectoris. patients prescribed medication to control their angina pectoris must have been on a fixed dose for at least 1 month prior to screening to be eligible for trial enrollment * myocardial infarction within 3 months prior to screening * new york heart association (nyha) heart failure stage iii or iv, or a left ventricular ejection fraction of ≤ 40 % * impaired lung function, measured by a decrease in forced expiratory volume at one second (fev1) to less than 50 % of the predicted normal value
impact of pretreatment with metformin on colorectal cancer stem cells (ccsc) and related pharmacodynamic markers

Conditions: Colon Cancer

Summary: metformin is drug that is normally used to treat people with diabetes. new research has discovered that metformin may also kill cancer stem cells. these cancer stem cells make up only a small portion of a cancer, but may be responsible for resistance to chemotherapy or for causing recurrence of the cancer. the purpose of this study is to determine the effect of metformin on colorectal cancer tumors. the study is designed to develop the methods to test tumors for cancer stem cells and then to determine the difference between treating with metformin and not treating with metformin with regard to the cancer stem cells. this research is investigational because the effect of metformin on cancer stem cells is not known in humans. also, in patients who are not diabetic, metformin would normally not be given prior to surgery.


Eligibility criteria:
inclusion criteria: * histologically documented colorectal cancer * intent to undergo disease resection or biopsy at least 7days from the treatment start date (allowing for a minimum of 5 days of treatment plus 2 days break) * medically fit for resection of their primary tumor or for biopsy * age 18-79 years * adequate renal function (serum creatinine levels \ = 60 ml/min) * adequate hepatic parameters, including aspartate aminotransferase (ast) and alanine aminotransferase (alt) levels ≤ 2.5 x upper limit of normal (uln), total bilirubin ≤ 1.5 x uln, and alkaline phosphatase levels ≤ 2.5 x uln * ability to understand and willingness to sign a written informed consent document exclusion criteria: * intent to administer neoadjuvant chemotherapy or radiation therapy prior to the surgery or biopsy; * intent to perform surgery or biopsy within 7 days of study treatment start; * any situation where participation in this trial would alter, or cause significant risk of altering the ability or timing of a subject to undergo resection of their tumor * current use of metformin (within the past month); * blood glucose using point of care test \< 70mg/dl; * renal disease or renal dysfunction not meeting inclusion criteria; * significant medical conditions such as cardiovascular collapse (shock), acute myocardial infarction, septicemia, acute or chronic metabolic acidosis * history of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), conditions associated with hypoxemia and pancreatitis * severe dehydration * clinical or laboratory evidence of hepatic disease * congestive heart failure requiring pharmacologic treatment, or unstable or acute congestive heart failure * known hypersensitivity to metformin hydrochloride * pregnant or lactating women * psychiatric illness or social situation that would limit compliance with study requirements and/or obscure results