Kornimate/medical-research-clean huggingface dataset:
lenalidomide combined with g-chop in the treatment of newly diagnosed dlbcl with fl

Conditions: DLBCL - Diffuse Large B Cell Lymphoma; Follicular Lymphoma

Summary: to evaluate the efficacy and adverse effects of lenalidomide combined with g-chop(lo-chop) in the treatment of newly diagnosed diffuse large b-cell lymphoma with follicular lymphoma (cdlbcl-fl).

this is a phase 2, open-label clinical trial study that aims to evaluate the efficacy (complete response, overall survival, progression free survival) and adverse effects of lenalidomide combined with g-chop(lo-chop) in the treatment of newly diagnosed diffuse large b-cell lymphoma with follicular lymphoma (cdlbcl-fl).

Eligibility criteria:
inclusion criteria: 1. age: 18-70 years old, gender is not limited; 2. according to the real/who classification, the newly diagnosed diffuse large b-cell lymphoma with follicular lymphoma (cdlbcl-fl): the same lymph node specimen showed diffuse large b-cell lymphoma and follicular lymphoma, or the tissue specimen showed diffuse large b-cell lymphoma and indolent lymphoma in bone marrow pathology; or the different group specimens suggested diffuse large b-cell lymphoma and/or follicular lymphoma, respectively, with stage ii-iv. 3. using the lugano 2014 lymphoma response evaluation criteria, there must be at least one measurable or evaluable lesion: pet/ct can evaluate the lesion, ct or mri can evaluate the lesion in the node with a diameter greater than 1.5 cm, a short diameter greater than 1.0 cm, or an extranodal lesion with a diameter greater than or equal to 1.0 cm 4. ecog 0-2 5. left ventricular ejection fraction (lvef) was less than 45% 6. hbv-positive serology (occult carriers: anti-hbeag +, anti-hbsag-, anti-hbsag +/-) can only be enrolled if the hbv-dna test is negative. 7. normal major organ function: liver function: serum bilirubin ≤2.0 × uln, serum alt and ast ≤2.5 × uln, renal function: serum cr ≤2.0 × uln; (unless caused by lymphoma) 8. absolute neutrophil count (anc)≥1.0 × 109 l, platelet count (plt)≥100 × 109 l, hemoglobin content (hgb)≥80 g l, if myeloma was involved, anc ≥0.75 × 109 l, platelet count (plt)≥50 × 109 l, hgb content (hgb) was not required. 9. life expectancy ≥6 months 10. informed consent (all studies had to sign a patient's informed consent form) exclusion criteria: 1. dlbcl of primary and secondary centers; 2. hiv-positive patients and/or hcv-active infections (recorded through hcv-rna-positive testing) 3. clinically evident secondary cardiovascular diseases such as uncontrollable hypertension (resting diastolic pressure\>115 mmhg), uncontrolled arrhythmias, symptomatic angina pectoris, or nyha iii-iv congestive heart failure. 4. severe chronic obstructive pulmonary disease complicated with hypoxemia. 5. active bacterial, fungal, and/or viral infections beyond the control of systemic therapy 6. except for cured skin basal cell carcinoma or cervical carcinoma in situ, or early prostate cancer that does not require systemic treatment or early breast cancer only requires surgery. other malignant tumors have occurred within the past 3 years or at the same time
effect of high caloric intake at lunch against dinner on weight loss

Conditions: Obesity; Overweight

Summary: the purpose of the present study is to evaluate the effect of consuming higher caloric intake at lunch in contrast to dinner on weight loss of obese and overweight female adults when they are in a multidisciplinary weight loss plan .


Eligibility criteria:
inclusion criteria: * must have body mass index (bmi) between 27-35 kg/ m². * must be able to have moderate exercise. * must be interested to have weight loss. exclusion criteria: * participating in a research project involving weight loss or physical activity in the previous six months. * pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months. * taking medication that could affect metabolism or change body weight. * report heart problems, chest pain, and cancer within the last five years. * smoking * menopause * diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Keywords: meal pattern weight loss high caloric intake dinner lunch
safety and tolerability of vortioxetine (lu aa21004) in adults with major depressive disorder

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine the long-term efficacy and safety of vortioxetine, once daily (qd), in adults with major depressive disorder.

the drug that was tested in this study is called vortioxetine. vortioxetine is being tested to treat depression in people who have major depressive disorder (mdd). this study looked at mdd relief in people who took vortioxetine. the study enrolled 836 patients that had completed one of two other vortioxetine studies. participants received 5 mg of vortioxetine for the first week of treatment. after completing the first week of treatment, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day based on participant's response as judged by the doctor. all participants were asked to take one encapsulated tablet at the same time each day throughout the study. this multi-center trial was conducted worldwide. the overall time to participate in this study was up to 56 weeks. participants made 13 visits to the clinic, and were contacted by telephone 4 weeks after the last dose of study drug for a follow-up assessment.

Eligibility criteria:
inclusion criteria: * has completed the double blind treatment period of either study lu aa21004_304 (nct00672620) or luaa21004_305 (nct00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol). * suffers from a major depressive episode as the primary diagnosis according to diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria (classification code 296.xx) at entry into the prior lu aa21004_304 or lu aa21004_305 study. exclusion criteria: * in addition to meeting the exclusion criteria for studies lu aa21004_304 or lu aa21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to lu aa21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply: * has major depressive disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study. * the participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the montgomery åsberg depression rating scale. * the participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. * has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study. * has used/uses disallowed concomitant medication.

Keywords: major depressive disorder depression melancholia mood disorder dysthymic disorder drug therapy
the impact of a prevention program on sun risks in primary school in tropical french region

Conditions: Melanoma

Summary: sun exposure during childhood can cause the development of skin cancer in later years, in particular melanoma, which is the most lethal.the worldwide incidence of melanoma is on the rise, with nearly 290,000 new cases diagnosed in 2018. the country with the highest age-standardized incidence rate is australia, where 40.4 cases per 100,000 men and 27.5 cases per 100,000 women were reported in 2018. since 2008, however, this incidence has decreased by 11% in the 14-49 age group following the implementation of effective sun safety campaigns. in the french overseas department of reunion island, which is characterized by a great diversity of skin phototypes due to multiple migratory flows, the ultraviolet (uv) index is very high - equivalent to that in australia. the age-standardized incidence rate of melanoma reunion island increased fourfold between 1995 and 2015. in 2015, it was estimated at nearly 30.0 new cases per 100,000 inhabitants in people with skin phototypes i-iii, compared to 13.5 in metropolitan france. over the course of a lifetime, 80% of exposure to uv radiation and 50% of skin damage occur before the age of 21, mainly in the school environment. in spite of this, knowledge of the risks associated with sun exposure remains insufficient among children and adolescents. similar quantitative data have been reported for reunion island by the local association misolré (mission soleil réunion), which has been running sun safety campaigns in elementary schools since 2017. however, methodological limitations compromise the validity and extrapolation of the results. and the question arises as to the type of programme to be implemented: strengthening individual skills through health education methods? community reinforcement through training activities involving peers? improving access to prevention? thus, it seems necessary to rigorously evaluate the effectiveness of different actions such as the educational programme "vivre avec le soleil" alone or associated with the visit of professionals in the field with or without distribution of photoprotection material. the aim of this randomized controlled trial is to evaluate the effectiveness of three awareness-raising programmes on the risks linked to sun exposure, delivered in primary school classes in reunion island, on the pupils' knowledge of sun prevention.


Eligibility criteria:
inclusion criteria: * students in a primary school in reunion island, drawn by lot for the study and whose school director agrees to participate in the program * in a primary school with more than 10 classes * within a class from the second and the third cycle: ce (elementary course) 1, ce2, cm (average course) 1 or cm2 * whose 2 parents have given their consent exclusion criteria: * in a school that has already benefited from the awareness program by the misolré association in 2016/2017, 2017/2018, 2019/2020, 2020/2021 * in cp (preparatory course) class * in a multi-level class

Keywords: school environment preventive medicine and public health children's health sun protection factor
helping older people with very severe chronic obstructive pulmonary disease towards the end of their lives: developing, piloting and refining a practical intervention (help-copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this study is to develop, refine and pilot a novel complex (help-copd) assessment, undertaken during or immediately after a hospital admission, which addresses the holistic care needs of people with severe chronic obstructive pulmonary disease (copd).


Eligibility criteria:
inclusion criteria: * registered with lothian general practice * admitted with an exacerbation of copd as their primary diagnosis at royal infirmary of edinburgh exclusion criteria: * people with lung cancer * people unable to give informed consent and complete questionnaire booklets in english

Keywords: copd holistic pilot intervention
a study of lenalidomide versus placebo in subjects with transfusion dependent anemia in lower risk myelodysplastic syndrome (mds) without del 5q

Conditions: Anemia

Summary: the purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (rbc) needed in anemic (rbc transfusion-dependent) participants with low or intermediate-1 risk mds without a deletion 5q chromosome abnormality. the study also investigated the safety of lenalidomide use in these participants. two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.


Eligibility criteria:
inclusion criteria: * 18 years or older * diagnosis of low or intermediate-1 risk myelodysplastic (mds) with any chromosome karyotype except del 5q\[31\] * anemia that requires red blood cell transfusions * resistant to erythropoiesis stimulating agents (esas) or blood erythropoietin level \> 500 mu/ml * eastern cooperative oncology group (ecog) performance status (ps) ≤ 2 * must agree to follow pregnancy precautions as required by the protocol. * must agree to receive counseling related to teratogenic and other risks of lenalidomide * must agree not to donate blood or semen * must be willing to consent to two or more bone marrow aspirate procedures to be completed during study exclusion criteria: * subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or deoxyribonucleic acid (dna) modulation agents * allergic reaction to thalidomide * renal insufficiency creatinine clearance (crc1)\<40 ml/min by cockcroft-gault method) * prior history of cancer, other than mds, unless the subject has been free of the disease for ≥ 5 years. (basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage tumor (t) 1a or t1b prostate cancer is allowed) * absolute neutrophil count (anc) \< 500/ul * platelets \< 50,000/ul * aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 3x upper limit of normal * uncontrolled hyperthyroidism or hypothyroidism * significant neuropathy * prior stem cell transplantation * anemia due to reasons other than mds * history of deep venous thrombosis (dvt) or pulmonary embolus (pe) within past 3 years * significant active cardiac disease within the past 6 months * known human immunodeficiency virus (hiv) infection; known hepatitis c infection or active hepatitis b infection

Keywords: myelodysplastic syndromes mds transfusion dependent anemia erythropoiesis stimulating agents non-del 5q
a clinical study to evaluate the pharmacokinetics, safety and tolerability of ckd-355

Conditions: Alzheimer's Disease (AD)

Summary: the purpose of this study is to evaluate the pharmacokinetics, safety and tolerability of ckd-355.

an open-label, randomized, multiple-dosing parallel study to evaluate the pharmacokinetics, safety and tolerability of ckd-355 with d797 and d324 in healthy subjects

Eligibility criteria:
inclusion criteria: 1. healthy adult older than 19 years and less than 55 years at the time of screening 2. bmi 18.5\~29.9 kg/m2 and body weight more than 50kg 3. subjects who have consented to the use of appropriate double- pregnancy contraceptive methods up to two months after the last investigational product and not to provide sperm for men 4. subjects who sign on an informed consent form willingly exclusion criteria: 1. subjects who have a clinically significant disease such as respiratory, hepatic, kidneys, blood, gastrointestinal, endocrine, immune system, skin, nercous and mental disease. 2. subjects who have acute disease within 28 days prior to the first administration 3. subjects who have history that may affect the adme 4. subjects who have clinically significant chronic disease 5. women who are nursing, pregnant or positive on pregnancy test 6. subjects who have clinically significant allergic diseases 7. subjects with genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption 8. subjects who are known to be hypersensitive to the drug or its components 9. subjects who have been found to be positive in serological tests (hbs antigen, hcv antibody and hiv antibody) 10. subjects with creatinine clearance \<60 ml / min 11. subjects whose ast or alt levels exceeded 2.5 times of upper limit of normal range 12. subjects who taked etc(ethical drug), oriental medicine within 2 weeks and otc(over-the-counter drug), vitamin within 1 week prior to the first administration 13. subjects who can not eat standard meals provided by the institution. 14. subjects who donated whole blood within 60 days, donated the components within 20 days or received blood within 30 days 15. subjects who taked medication for the induction and inhibition of metabolizing enzymes such as barbiturate drugs within 30 days before the first administration 16. subjects who have had abnormal diets that can affect the adme of the drug within 30 days before the first administration (eg, ingestion of grapefruit juice\>1 l / day) 17. subjects who participate in the other clinical trial within 90 days prior to the first administration 18. subjects who have a history of regular alcohol(alcohol\>210g/week) or caffeine(caffeine\>5 cups/day) 19. subjects who smokes more than 10 cigarettes per day within 3 months or cannot discontinue smoking during the clinical trial 20. subjects who is determined unsuitable to participate in this clinical trial by the investigator

Keywords: alzheimer's disease ckd-355
cefoperazone/sulbactam in the treatment of serious intra-abdominal and hepatobiliary infections.

Conditions: Abscess, Intra-Abdominal; Cholecystitis; Wound Infections; Peritonitis; Appendicitis

Summary: the primary objective is to collect data on treatment outcomes (clinical and microbiological cure), safety and tolerability of treatment with cefoperazone/sulbactam in patients with serious intra-abdominal and hepatobiliary infections in slovakia.


Eligibility criteria:
inclusion criteria: * male or female patient of age 18 years or older. * patient with intraabdominal/hepatobiliary infection.? exclusion criteria: * patients with known hypersensitivity to penicillins, cephalosporins, cefoperazone or to sulbactam.
cross-over evaluation of two lubricating eye drops

Conditions: Dry Eye

Summary: to evaluate the efficacy of two lubricating eye drops for the treatment of dry eye signs and symptoms.


Eligibility criteria:
inclusion criteria: 1. patients 18 yrs or older 2. males or females 3. any race or ethnic background 4. patients with present ocular surface discomfort and a sesod score of at least 2 exclusion criteria: 1. corneal refractive surgery within 6 months of this study. 2. contact lens use on day of examination. 3. corneal ectasia. 4. current use of restasis
a study of bms-512148 (dapagliflozin) in patients with type 2 diabetes with inadequately controlled hypertension on an acei or arb and an additional antihypertensive medication

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to learn if bms-512148 (dapagliflozin), after 12 weeks, can improve (decrease) blood pressure in patients with type 2 diabetes with uncontrolled hypertension who are on an angiotensin-converting enzyme inhibitor (acei) or an angiotensin receptor blocker (arb).the safety of this treatment will also be studied


Eligibility criteria:
inclusion criteria: * written informed consent * males and females, 18 to 89 years old, with type 2 diabetes with inadequate glycemic control hba1c between 7-10.5% and uncontrolled hypertension systolic blood pressure (sbp) 140-165 and diastolic blood pressure (dbp) 85-105 * subjects must have a mean 24 hr blood pressure ≥ 130/80 determined by ambulatory blood pressure monitoring (abpm) within 1 week prior to day 1 visit * stable dose of oral antidiabetic agent (oad) for at least 6 weeks \[12 wks for thiazolidinedione (tzd)\] or a stable daily dose of insulin, as a monotherapy or in combination with another oad, for 8 weeks, and a stable dose of acei or arb and 1 additional antihypertensive medication for at least 4 weeks * c-peptide ≥ 0.8 ng/ml * body mass index ≤ 45.0 kg/m2 * serum creatinine \< 1.50 mg/dl for men or \< 1.40 mg/dl for women exclusion criteria: * aspartate aminotransferase (ast) and /or alanine aminotransferase (alt) \> 3.0\*upper limit of normal (uln) * serum total bilirubin ≥ 1.5\*uln * creatinine kinase \> 3\*uln * symptoms of severely uncontrolled diabetes * history of malignant or accelerated hypertension * currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases

Keywords: diabetes mellitus, type 2 diabetes mellitus endocrine system diseases glucose metabolism disorders metabolic diseases angiotensin receptor inhibitors angiotensin-converting enzyme inhibitors antihypertensive agents cardiovascular agents pharmacological actions
a trial to assess efficacy and safety of octreotide subcutaneous depot in patients with acromegaly

Conditions: Acromegaly

Summary: the purpose of this trial is to assess the efficacy and safety of cam2029 in patients with acromegaly. patients will be randomized to either cam2029 or placebo administered subcutaneously once monthly during 6 months.


Eligibility criteria:
inclusion criteria: * male or female patients, ≥18 years at screening * able to provide written informed consent to participate in the trial prior to any trial related procedures are performed * diagnosis of acromegaly by historical evidence of (persistent or recurrent) acromegaly * treatment with a stable dose of octreotide lar or lanreotide atg for at least 3 months as monotherapy prior to screening * igf-1 levels ≤1xuln at screening * adequate liver, pancreatic, renal and bone marrow functions * normal ecg exclusion criteria: * gh ≥2.5 μg/l at screening (cycle) * have received medical treatment for acromegaly with pasireotide (within 6 months prior to screening), pegvisomant (within 3 months prior to screening), dopamine agonists (within 3 months prior to screening) or other investigational agents (within 30 days or 5 half-lives prior to screening \[whichever is longer\] * patients who usually take octreotide lar or lanreotide atg less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks) * patients with compression of the optic chiasm causing any visual field defect for whom surgical intervention is indicated * patients who have undergone major surgery/surgical therapy for any cause within 1 month from screening * patients who have undergone pituitary surgery within 6 months prior to screening * patients who have received prior pituitary irradiation * patients with poorly controlled diabetes mellitus (hemoglobin a1c \>8.0%)

Keywords: acromegaly octreotide cam2029 phase 3
multinational survey of epidemiology, morbidity, and outcomes in intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: the aim of this project is development of a comprehensive, prospective, multinational, multicenter, hospital-based, data repository for patients with intracerebral hemorrhage.

mnemonich is a disease-specific registry of prospectively collected data obtained from the integration and harmonization of preexisting single-center data sets. it was formed to provide clinician-scientists around the world a comprehensive database to direct future studies toward better understanding of ich. mnemonich will help examine global variability in the prevalence of ich and identify research priorities. new data for mnemonich will be prospectively collected on a wide range of features including demographics, medical history, dates and times of symptom onset, presentation symptoms, hemodynamic signs, initial and chronic medical therapy, diagnostic imaging, laboratory and genetic analyses, pathological data, and surgical and medical management. future research will be based upon ad hoc analysis of this data.

Eligibility criteria:
inclusion criteria: * diagnosis of spontaneous intracerebral hemorrhage (ich) met by clinical and imaging criteria * age 18 and above * able to consent exclusion criteria: * ich due to trauma * ich due to vascular malformation or aneurysm * ich due to brain tumor * ich due to underlying infectious lesion (e.g., abscess)

Keywords: intracerebral hemorrhage hemorrhagic stroke intraparenchymal hemorrhage cerebrovascular disease stroke