Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of subsequent cisplatin and docetaxel in ovarian cancer

Conditions: Ovarian Neoplasms

Summary: the purpose of this study is to assess the efficacy and the safety of the treatment.


Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed, optimally debulked stage iii-iv epithelial ovarian cancer excluding clear cell histology. * ecog performance status is 0-2 * no prior chemotherapy for this malignancy, * acceptable hematological profile (as defined by a leukocyte count ≥ 3000/mm3, a platelet count ≥ 100.000mm3 and hb ≥ 9g/100ml), and adequate renal function (as defined by serum creatinine ≤ 1.5mg/dl or creatinine clearance by formulation ≥ 60 ml/min), and hepatic function (as defined by bilirubin ≤ 1.5 x maximum normal value even with hepatic metastasis; transaminases (alt, ast) ≤ 1.5 x maximum normal value; alkaline phosphatase ≤ 2.5 x maximum normal value, except in case of a bone metastasis) exclusion criteria: * concomitant use of another anti-cancer therapy * unstable medical condition that makes the patient unable to take part in a clinical study (congestive heart failure, serious arrythmia, uncontrolled diabetes mellitus), history of myocardial infarction within last 3 months, massive pleural, peritoneal or pericardial effusion; or presence of serious uncontrolled infection. * presence of other tumours different from basal cell carcinoma of the skin. * pregnancy or breastfeeding. in women of childbearing potential and in men, an adequate contraceptive method must be used * social or psychological condition that render the patient inadequate for the follow-up of the study * contraindication for any of the study drugs (e.g. history of hypersensitivity to any of the ingredients of the study drugs) the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study of a novel antipsychotic iti-007 in schizophrenia

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate whether iti-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. patients will be randomly assigned to receive one of two doses of iti-007, placebo, or a positive control. the primary goal will be to assess the effects of iti-007 on psychosis. the safety of iti-007 will also be assessed.

the study will be conducted as a randomized, double-blind, placebo-controlled, multi-center study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. the efficacy and safety of two dose levels of iti-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control. upon completion of the inpatient 28-day study treatment period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. patients will be seen for a final outpatient safety evaluation at the end-of-study visit approximately 2 weeks after discharge.

Eligibility criteria:
inclusion criteria: * patient's age is 18-55 * patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis * patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years exclusion criteria: * any female patient who is pregnant or breast-feeding * any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma * any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features * any patient considered to be an imminent danger to themselves or others * any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol * any patient judged by the investigator to be inappropriate for the study
biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy

Conditions: Leukemia

Summary: rationale: studying samples of bone marrow and blood from patients with cancer in the laboratory may help doctors predict how well patients will respond to treatment. purpose: this research study is studying biomarkers in bone marrow and blood samples from older patients with acute myeloid leukemia treated with cytarabine-based therapy.

objectives: primary * to validate a pre-specified proteomic classifier to predict the likelihood of complete response (cr) to cytarabine-based induction chemotherapy in older patients with non-m3 acute myeloid leukemia. secondary * to identify signaling nodes associated with risk of relapse among these patients who achieve a cr to induction chemotherapy. outline: this is a multicenter study. previously collected bone marrow and peripheral blood samples are analyzed to validate the association of a pre-specified proteomic signature with clinical response via flow cytometry.

Eligibility criteria:
disease characteristics: * treated on est-1490, e-3993, or ecog-e3999 * bone marrow and peripheral blood samples collected at diagnosis and before induction chemotherapy available * no m3 disease patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: adult acute myeloid leukemia in remission recurrent adult acute myeloid leukemia adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b) adult acute megakaryoblastic leukemia (m7) adult acute minimally differentiated myeloid leukemia (m0) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) adult acute myeloblastic leukemia with maturation (m2) adult acute myeloblastic leukemia without maturation (m1) adult acute myelomonocytic leukemia (m4) adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with del(5q) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22)
emotion regulation group treatment for gambling disorder - a pilot trial

Conditions: Gambling Disorder

Summary: group cognitive behavioral therapy for gambling disorder (gd) with a focus on emotion regulation - a pilot study this pilot study will evaluate the feasibility and possible effectiveness of a novel treatment protocol developed within the research group including emotion regulation techniques for the treatment of gd.

the manual is based on principles from so called third wave cognitive behavioral therapy, which differs from current treatment within standard care in that focus is more on emotion regulation techniques. the treatment consists of an 8- session program delivered by weekly sessions. the study is an open trial in order to evaluate the possible benefit of components of emotion regulation in treating gambling disorder (gd). participants with psychiatric comorbidities will be included and symptoms of comorbidities will be measured as secondary outcomes. once included in the study the participant will be measured weekly on symptoms of gambling disorder. by increasing competencies in emotion regulation (such as active problem solving, acceptance and reappraisal of events in order to change their emotional impact) the hypothesis is that the participants will improve on measures of symptoms of gd as well as gambling expenditure in terms of time and money.

Eligibility criteria:
inclusion criteria: * gambling disorder according to dsm 5 exclusion criteria: * unable to speak and read swedish * symptoms of manic episode * severe psychiatric condition in need of urgent care

Keywords: gambling disorder psychiatric comorbidities emotion regulation
measurement of substance p in saliva of low back pain patients

Conditions: Low Back Pain

Summary: the purpose of this study is to compare the levels of substance p in saliva, in patients with severe chronic low back pain and in subjects without it. in addition, to explore a possible cutoff point, in order to define normal and pathological levels of substance p in saliva. the ultimate objective would be to design a measurement method for use in routine clinical practice.


Eligibility criteria:
inclusion criteria: * patients referred to the kovacs back pain unit in palma de mallorca for chronic low back pain * a pain level of 6 or greater on the pi-nrs scale (0=no pain, 10= worst pain possible) * seen at the unit between 9 and 13 hours (due to the circadian rhythm of substance p in saliva and to avoid great variability in the results) for healthy subjects: * volunteers with no pain (anywhere) * that in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain. exclusion criteria: * subjects with pain that is additional to or different from chronic low back pain

Keywords: low back pain chronic substance p
assessment of chronic obstructive pulmonary disease (copd) therapy from the physicians perspective using tiotropium as an example

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: documentation of successful therapy with tiotropium (spiriva respimat; spiriva (tiotropium 18 mcg capsules)) in copd patients requiring long-acting bronchodilators: description of the most important outcome parameters according to the physicians assessment to determine the success of therapy. such data are not yet available. also collection of physicians assessments and patients assessments of efficacy and tolerability of spiriva respimat, spiriva (tiotropium 18 mcg capsules).

study design: observational

Eligibility criteria:
inclusion criteria copd patients requiring long-acting bronchodilators according to approved summary of product characteristics (spc) and guidelines exclusion criteria patients cannot be recruited if any of the general or specific contraindications listed in the patient information leaflet or the summary of product characteristics applies.
a safety study to evaluate 12 weeks of treatment with clevudine in patients infected with hepatitis b virus.

Conditions: Hepatitis B

Summary: the purpose of the study is to evaluate the safety and effectiveness of 12 weeks of treatment with clevudine, at one of three doses, in patients chronically infected with hepatitis b virus.


Eligibility criteria:
inclusion criteria: * hbv dna positive with dna levels at screening greater than or equal to 3,000,000 copies/ml. * documented to be hbsag positive for \> 6 months or hbsag positive and igm anti-hbc negative and anti-hbs negative. patients may be hbeag positive, and anti-hbe negative or hbeag negative (pre-core mutant) and anti-hbe positive. * hbeag positive and anti-hbe negative or hbeag negative (pre-core mutant) and anti-hbe positive with positive hbsag for the previous 6 months * ast and alt levels which are less than or equal to 10 times the upper limit of normal. * bilirubin levels less than or equal to 1.5 x uln or bilirubin levels \> 1.5 x uln with diagnosis of gilbert's disease and conjugated bilirubin within normal limits. exclusion criteria: * currently receiving antiviral, immunomodulatory or corticosteroid therapy * previous treatment with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for hbv infection * previous treatment with interferon must have ended at least 6 months prior to screening visit * history of ascites, variceal hemorrhage or hepatic encephalopathy * co-infection with hcv or hiv * evidence of cirrhosis or hepatocellular carcinoma (alpha fetoprotein)

Keywords: clevudine hepatitis b
patient outcomes after hospitalization in acute geriatric unit

Conditions: Geriatric Disorder

Summary: three events can be considered of major importance for patients after a hospitalization in an agu: death, hospital readmission, and institutionalization. current published data do not allow the clinician to simultaneously estimate the risk of hospital readmission, institutionalization and death of an older patient according to his/her characteristics and various complications that occurred during the hospitalization. however, clinicians often need to estimate these risks at hospital discharge to adapt their therapeutic choices, their proposals post-hospital care, and provide reliable and fair information to the patient and his relatives. estimating simultaneously the hazard for each of these three events can be complex. indeed, a death event hinder the observation of re-hospitalization or institutionalization if death occurs before these events. the death should be considered a competing risk in these analyzes. hospital readmission may modify the risk of death or institutionalization and should be considered as an intermediate factor for these event. this complexity cannot be accounted with classical statistical models, like logistic regression models. the purpose of this study is to use more appropriate statistical models (multi-state models) to better estimate simultaneously the risks of hospital readmission, institutionalization, and death of a patient given after hospitalization in agu, and to show that accuracy of these estimations can be improved by taking into account complications that occurred during the stay in agu.


Eligibility criteria:
inclusion criteria: * age 75 years and over * hospitalized in acute geriatric unit * covered by a health insurance exclusion criteria: * refusal to participate to the study, as expressed by the patient or his/her next of kin

Keywords: aged patient readmission geriatric assessment mortality
non-small cell lung cancer with central nervous system metastasis

Conditions: Lung Cancer With Central Nervous System Metastasis

Summary: cerebrospinal fluid was obtained from the cerebrospinal cavity of non-small cell lung cancer patients with central nervous system metastasis, blood was obtained from veins, and metastatic lung cancer tumor tissue was obtained from surgically resected brain tumors or meningeal tumors. then comprehensively analyze the exosomes contained in the aforementioned samples, and compare and analyze the clinical data of the patients, so as to explore whether the cancer cell-related substances contained in the cerebrospinal fluid, blood and tumor tissue can be used to predict lung cancer metastasis and bioindicators of treatment effect.


Eligibility criteria:
inclusion criteria: - a. non-small cell lung cancer patients diagnosed with brain metastases or meningeal metastases on brain computed tomography (ct) or magnetic resonance (mri) images. b. patients with non-small cell lung cancer who are about to undergo surgical brain surgery, such as brain tumor resection, lumbar abdominal drainage, euclidean storage, or ventriculoperitoneal drainage. exclusion criteria: - a. non-small cell lung cancer patients without brain metastases or meningeal metastases. b. physical condition does not allow surgical removal of the tumor.
research for human umbilical cord mesenchymal stem cells (19#isclife®-mds) in the treatment of myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndromes

Summary: the purposes of the study is to determine the safety and efficacy of human umbilical cord mesenchymal stem cells (huc-msc) in treating myelodysplastic syndrome patients.

this is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (decitabine). patients in experimental group will receive huc-msc, while control group receive placebo (normal saline), four weeks as a course of treatment. all of the patients accept examination before treatment, including * diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and mds fusion gene test, etc.; * routine examination: blood, urine, and stool routine test, x-ray film in chest, electrocardiogram, etc.; * stem cell-based medicinal products usage, dosage, time, and course of treatment. then, patients will accept routine examination everyday, and after treatment, investigator will follow-up for 6 months, to evaluate the security and efficacy of huc-msc.

Eligibility criteria:
inclusion criteria: * mds patients with international prostate symptom score is moderate or severe symptoms exclusion criteria: * with serious renal function impaired * with other organ function abnormal: acute hepatitis b, ejection fraction \ 3mg/dl, liver function tests abnormal, central nervous system disease, mental disease * bad physical condition (karmofsky \< 60%) * without signing informed consent form * under other therapy that possibly influence msc security or efficacy * hiv or other serious disease infection * donor: hiv, active hepatitis b/c infection, syphilitic antibody positive * donor/ participants: alcoholism, drug addicted, mental disease

Keywords: myelodysplastic syndromes mesenchymal stem cells
weight management for improved pregnancy outcomes

Conditions: Obesity; Pregnancy

Summary: this study will examine the safety and effectiveness of a dietary intervention in pregnant women. women who are obese will be invited to participate. the control arm will receive routine prenatal care and one in-person nutritional and dietary counseling session to promote healthy eating during their pregnancy. the intervention arm will receive a more intensive dietary program that will include in-person counseling and group support sessions. the goal of the intervention will be weight maintenance (weight at 2 weeks after delivery should be within 3% of baseline weight) and avoidance of postpartum weight retention


Eligibility criteria:
inclusion criteria: * bmi 30 or more * less than 20 weeks gestation * member of kaiser permanente northwest (nw) * receive pre-natal care at kaiser permanente nw * speaks english exclusion criteria: * no current treatment for cancer * no bariatric surgery * no current renal disease * no multiple birth anticipated * no hyperemesis requiring hospitalization * no diabetes (type 1 or 2)

Keywords: obese pregnant large for gestational age large for gestational age baby
the patient-perspective of complications after colon and rectum surgery: a qualitative analysis

Conditions: Colorectal Cancer

Summary: the purpose of this study is to understand the patient experience with an adverse event after surgery. an adverse event is an undesirable experience or complication associated with your surgery.


Eligibility criteria:
inclusion criteria: * age 18 or older * patients who had elective surgery for a primary colorectal cancer within the last 90 days. * patients who either: * develop an eligible complication (appendix 1) within 30 days of surgery (n = 25 - 30) * do not develop any complication after surgery (n = 25 - 30) exclusion criteria: * multivisceral resections * metastatic or locally-recurrent disease * physical impairment that may prevent participation in an interview or survey setting * active psychiatric illness, cognitive or sensory impairment * inability to speak or understand english * refusal to participate in an audio-recorded interview * inability to participate in an audio-recorded interview for reasons not otherwise specified * any second surgical procedure unrelated to the complication within the 90-day period

Keywords: complications surgery
evaluation of a short version computerized test for processing speed to detect cognitive disorders in hiv+ patients

Conditions: HIV-1

Summary: the objective of this prospective study is to evaluate the prevalence of neurocognitive impairments in hiv infected patients comparing patients with and without haart. recent studies have demonstrated a specific hiv infected patients neurocognitive disorders profile. these cognitive disorders concern primarily information processing speed, memory recall, attentional abilities, work related memory, executive functions, and psychometrical speed. this cognitive profile is similar to another highly documented one, described for another central nervous system disease (cns): multiple sclerosis. in both cns diseases, the earliest and most severe disorder is the one related to the information processing speed. for the multiple sclerosis patients, a short cognitive test (sdmt) is actually used not only to identify cognitive disorders presence, but also in order to predict a long term disability worsening. a digital version of this test (csct), has recently been developed in order to make this early evaluation easier. we hypothesize that csct alteration would also predict hand, in hiv infected patients. a complete neuropsychological assessment is highly time and personal consuming. this short (approximatively 2 minutes) digital test would be highly helpful to identify patients, who will need a more extensive neuropsychological assessment.


Eligibility criteria:
inclusion criteria: * patients infected with hiv-1 * patients followed in outpatient service, over 18 years of age exclusion criteria: * patients infected with hiv-2 * patients with difficulty understanding the french language * patients present with progressive opportunistic infection * patients for whom a change of psychotropic treatment was performed in the last 3 weeks * patients with drug and / or alcohol addiction * patients with a history of psychiatric disorder * patients with stroke, endocarditis or meningoencephalitis with severe neurological sequelae
effects of rosiglitazone on the metabolic phenotype of impaired glucose tolerance in youth

Conditions: Obesity; Impaired Glucose Tolerance; Type 2 Diabetes Mellitus

Summary: the purpose of the study is to determine whether treatment of children and adolescents with impaired glucose tolerance (igt) with rosiglitazone will lead to improvements in insulin sensitivity and glucose tolerance.

impaired glucose tolerance (igt) is a prelude to diabetes, which is increasing in prevalence in obese children and adolescents with marked obesity. this condition tends to progress to type 2 diabetes mellitus (t2dm) at an alarmingly rapid tempo. the increased prevalence of childhood and adolescent obesity and greater risk of igt, and progression to diabetes, in this population set the stage for a series of studies aimed at understanding the metabolic phenotype and natural history of pre-diabetes in obese youth. the investigators found that obese children and adolescents with igt are characterized by marked insulin resistance related to altered lipid partitioning, favoring lipid deposition in the visceral and intramyocellular compartment. furthermore, the investigators found an impairment of the acute insulin response in these youngsters. follow-up revealed a rapid deterioration from igt to frank diabetes. based on these studies, there is a strong rationale for changing the balance between visceral and subcutaneous fat and muscle lipid content in a more favorable pattern in order to improve insulin sensitivity. the primary objective of this study is to determine, in a group of ethnically diverse children and adolescents with igt, whether treatment with rosiglitazone leads to improvements in insulin sensitivity and glucose tolerance. secondary objectives are to determine whether rosiglitazone is safe and well tolerated.

Eligibility criteria:
inclusion criteria: * good general health * aged 10 to 18 yrs (females: tanner stage ii-v;and males:testes size\>6ml) * igt based on 2-hr plasma glucose\>140mg/dl and \<200mg/dl during an ogtt. exclusion criteria: * baseline creatinine\>1.0mg * ast and alt\>2.5 uln * anemia (hct\<30) * pregnancy (females must have a negative urine pregnancy test during the study) * cardiac or pulmonary or other significant chronic illness * plans to increase the frequency or intensity of a regular exercise program * psychiatric disorder or substance abuse of anorexic agents.

Keywords: childhood and adolescent obesity metabolic phenotype impaired glucose tolerance type 2 diabetes mellitus insulin sensitivity insulin resistance abdominal fat partitioning impaired glucose tolerance (igt) type 2 diabetes mellitus (t2dm)