Kornimate/medical-research-clean huggingface dataset:
european long-acting antipsychotics in schizophrenia trial-ii

Conditions: Schizophrenia

Summary: schizophrenia is a chronic psychiatric illness with a heterogeneous disease course, varying from periods of symptomatic remission to relapse. relative to the wealth of scientific data on the course of schizophrenia during the two years following the first psychotic episode, the outcome of schizophrenia patients over the first decade of their illness has been studied to a lesser degree. in this follow-up cohort study the aim is to investigate the long-term outcome of schizophrenia patients who participated in the previously conducted eulast-i clinical trial, in the first decade after being diagnosed.

at this point, given the heterogeneity of published studies, it remains unclear if depot medication can reduce relapse rates and improve clinical outcome when offered to all patients in need of continuation treatment with antipsychotics. before anyone can conclude whether or not all schizophrenia patients could benefit from a switch to depot formulations, several questions remain to be answered. is depot medication associated with better continuation rates and outcome? how are depot medications tolerated as compared to oral medication? in order to clarify these important issues this study aims to perform a large multi-center trial in which schizophrenia patients in need of continuous treatment who are randomized 1:1:1:1 to two different depot preparations or to two different oral medications; patients will be followed up for a total of 19 months. the primary objective of this trial is to compare all cause discontinuation rates in patients with schizophrenia randomized to oral antipsychotic medications (i.e., aripiprazole or paliperidone) versus depot antipsychotic medications (i.e., paliperidone palmitate or aripiprazole depot) over an 18 month follow-up period.

Eligibility criteria:
inclusion criteria: 1. capable of providing written informed consent / have a legal representative to provide written informed consent. \* 2. having been randomized to one of the four treatment arms (aripiprazole oral, aripiprazole depot, paliperidone oral, paliperidone depot) in the 2014-002765-30 eulast-i clinical trial or having participated in the eulast-i naturalistic cohort study. * unless prohibited by local law (e.g. due to incarceration). exclusion criteria: no exclusion criteria are applicable in this study.
chlorhexidine dressings for hemodialysis catheter exit site care: comparative study

Conditions: Hemodialysis Catheter Infection

Summary: the objective of this study is to compare the rate of hemodialysis catheter-related infections according to the treatment regimen: chlorhexidine gluconate dressing or chlorhexidine solution.

introduction: the use of cvc as a vascular access for haemodialysis is associated with increased morbidity and mortality (up to 10 times higher in a patient with a cvc compared to an arteriovenous fistula), contributing to poorer patient outcomes and increased haemodialysis-related costs. aim: to compare the rate of catheter-related infections (bacteraemia, exit site infection and tunelitis) between haemodialysis catheter exit site dressing with 2% chlorhexidine gluconate self-adhesive semi-permeable polyurethane dressings (agcd); and dressing with 2% chlorhexidine solution and covered with self-adhesive semi-permeable polyurethane dressing (pd). methods: a randomized clinical trial will be conducted to compare the occurrence of local and systemic infections related to hemodialysis catheter. two care groups will be formed in which agcd and pd dressings will be used. in addition, other clinical variables, patient satisfaction and dressing-related skin alterations will also be analyzed. scientific relevance: infectious complications related with hemodialysis catheter have an increased morbidity, mortality and incremented costs. key words: hemodialysis, central venous catheters, bacteremia, exit site infection, tunnel infection, chlorhexidine gluconate dressing.

Eligibility criteria:
inclusion criteria: * be included in the haemodialysis programme in our unit. * being a carrier of a tunneled central venous catheter as vascular access. * remain on haemodialysis treatment for at least 3 months in our unit. * consent to participate in the study. exclusion criteria: * allergy or hypersensitivity to chlorhexidine or intolerance to polyurethane dressing * active catheter-related infection.
study to assess efficacy of besifovir and l-carnitine in chronic hepatitis b patients with nonalcoholic fatty liver

Conditions: Hepatitis B

Summary: pilot study to assess the antiviral activity and safety of besifovir dipivoxil 150mg and l-carnitine 660mg compared to tenofovir alafenamide 25mg in chronic hepatitis b patients with nonalcoholic fatty liver


Eligibility criteria:
inclusion criteria: * 20 years of age and older, male or female patients * chronic hepatitis b patients with nonalcoholic fatty liver * patients who use oral anti-diabetic drug or drugs for hyperlipemia without any change in drug dosage within 2 month before screening visit * patients who have been explained about the trial and agreed to the consent * patients who agree with the approved method of contraception during the clinical trial exclusion criteria: * patients with hepatitis c virus, hepatitis d virus or human immunodeficiency virus * patients who has a history of liver transplantation or child-pugh score \>=8 * alpha-fetoprotein (afp) \> 50 ng/ml or hepatocellular carcinoma (hcc) patients * patients who have taken besifovir or vemlidy * among the patients treated with immunosuppressive drug within 6 months before screening, suspected case of the declined immunity in the opinion of the investigator * chronic alcoholism (significant alcohol consumption: male \> 210 g/week, female\> 140 g/week) * patients who take drugs that can cause hepatic steatosis * patient diagnosed with a malignant tumor within 5 years before screening or relapsed patient * patients with uncontrolled diabetes mellitus (hba1c \> 9%) or using insulin * patients who participate in other clinical trials or is supposed to do so during the study period * pregnant or breast-feeding women or women who have plan to be pregnant. * patients with a history of hypersensitivity to the test drug or the components of the test drug * patients with moderate or severe renal impairment * patients with genetic problems such as galactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption. * history within the past one years or presence of drug abuse or alcoholism. * patient has serious disease judged by investigator such as heart failure, renal failure, and pancreatitis * patient has liver diseases except chronic hepatitis b (i.e. hematochromatosis, alcoholic liver disease, nonalcoholic fatty liver disease, alpha-1 antitrypsin deficiency etc.) * patient has history of organ transplantation * patient concerned about the decline in daily activity or not able to understand the objectives and methods due to the psychiatric problems * patients who are considered to be unacceptable in this study under the opinion of the investigator.
push with lower uterine segment support

Conditions: Dystocia

Summary: the study aims to compare maternal and early neonatal outcomes of abdominal disimpaction with lower uterine segment support in comparison to the classic "push" method for delivery of impacted fetal head during cesarean section for obstructed labor.

obstructed labor refers to failure of labor progress in spite of good uterine contractions and is attributed to mismatch between the size of the presenting part of the fetus and the mother's pelvis. approximately 8% of maternal deaths worldwide are attributed to obstructed labor and subsequent puerperal infection, uterine rupture, and postpartum hemorrhage. in these situations, cesarean section could minimize maternal and neonatal morbidity. however, cesarean section is challenging when the head is deeply impacted and is associated with high risk of maternal injuries and perinatal injuries. the most common complication is extension of uterine incision which could involve the vagina, bladder, ureters and broad ligament. neonates are also at risk of skull fractures, cephalhematoma, and subgaleal hematoma mainly due to manipulations. currently, the most popular approaches for fetal head delivery are the push and pull methods. although push method seems to be more convenient and does not necessitate extensive experience, it is more significantly associated with extension than the pull method. although pull method seems to be more safe, it is more difficult to perform and usually warrants an aggressive uterine incision to deliver the fetus. in 2013, investigators published a case series on abdominal disimpaction with lower uterine segment support which basically allows obstetricians to deliver the fetal head through a transverse uterine incision with minimal risk of extensions and neonatal complications. in this study, investigators aim to validate this approach in comparison to the classic push method.

Eligibility criteria:
inclusion criteria: * singleton term pregnancy, 37 to 42 weeks of gestation. * cephalic presentation. * the cervix is fully dilated. * ruptured membranes. * adequate uterine contractions. * impacted fetal head in maternal pelvis exclusion criteria: * intrauterine fetal death * major fetal anomalies * non-cephalic presentation * multiple pregnancy * preterm caesarean \< 37 weeks * abnormal placentation.

Keywords: obstructed labor c section. push method reverse breech
to investigate the safety, toleration and pharmacokinetics of single oral doses of pf-04531083 in healthy male subjects

Conditions: Pain

Summary: the purpose of the study is to investigate the safety, toleration and pharmacokinetics of single oral doses of pf-04531083 in healthy male subjects.


Eligibility criteria:
inclusion criteria: * young * healthy * male exclusion criteria: * elderly * unhealthy * female

Keywords: inflammatory pain
effect of omalizumab (xolair) in treatment of patients with aerd and allergy asthma

Conditions: Asthma; Allergic Rhinitis

Summary: double blind protocol treatment of 2/3 of the patients with omalizumab and 1/3 placebo administer for 4 months. patients selected for the study must have both aspirin exacerbated respiratory disease and allergic asthma and rhinitis. they must also have completed aspirin desensitization and be taking aspirin on a daily basis for the treatment of aerd.

60 patients with aspirin exacerbated respiratory disease will be screened to determine if they also have allergic respiratory tract disease as a co-morbid complication. this will involve history, allergy skin tests and a serum ige level. they must also have been desensitized to aspirin and be taking aspirin 325 or 650 mg morning and night. 40/60 patients will receive omalizumab injections every month for the next 4 months and the other 20 patients, via a random program, will receive placebo injections. monthly visits with the nurse co-ordinator will involve the following assessments: daily symptom scores, daily use of medications (particularly prednisone and rescue albuterol inhalers), lung function tests, nasal breathing test, measurement of smell and quality of life scores pre and post study.

Eligibility criteria:
inclusion criteria: aspirin exacerbated respiratory disease and allergic asthma exclusion criteria: * pregnant females,starting immunotherapy in the past 3 months, prior treatment with xolair, negative allergy skin tests,unable to participate in lung function tests, unable to complete data forms,low platelets, serum ige greater than 700 iu,cancer,another uncontrolled medical condition, unacceptable concomitant medication, under the age of 18 years.

Keywords: aerd aspirin allergy omalizumab
a study of zanubrutinib (bgb-3111) versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia

Conditions: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma

Summary: this study is designed to compare the overall response rate of zanubrutinib versus ibrutinib in participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.

this is a global, phase 3, randomized study of zanubrutinib versus ibrutinib in 652 participants with relapsed/refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. the primary efficacy endpoint is overall response rate determined by investigator assessment. participants were randomized in a 1:1 manner to either zanubrutinib or ibrutinib. treatment with zanubrutinib and ibrutinib was open label.

Eligibility criteria:
key inclusion criteria 1. confirmed diagnosis of cll or sll that meets the 2008 international workshop on chronic lymphocytic leukemia (iwcll) criteria 2. cll/sll requiring treatment per 2008 iwcll criteria 3. relapsed or refractory to at least 1 prior systemic therapy for cll/sll 4. measurable disease by computerized tomography (ct)/magnetic resonance imaging (mri) 5. eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 6. life expectancy ≥ 6 months 7. adequate bone marrow function 8. adequate renal and hepatic function key exclusion criteria 1. known prolymphocytic leukemia or history of, or currently suspected, richter's transformation 2. clinically significant cardiovascular disease. 3. prior malignancy within the past 3 years, except for curatively treated basal or squamous cell skin cancer, non-muscle-invasive bladder cancer, carcinoma in situ of the cervix or breast 4. history of severe bleeding disorder or history of spontaneous bleeding requiring blood transfusion or other medical intervention 5. history of stroke or intracranial hemorrhage within 180 days before first dose of study drug 6. severe or debilitating pulmonary disease 7. active fungal, bacterial, and/or viral infection requiring systemic therapy 8. known central nervous system involvement by leukemia or lymphoma 9. known infection with hiv or active viral hepatitis b or c infection 10. moderate or severe hepatic impairment, ie, child-pugh class b or c 11. major surgery within 4 weeks of the first dose of study drug 12. prior treatment with a (burton's kinase) btk inhibitor 13. toxicity from prior anticancer therapy that has not recovered to ≤ grade 1 14. pregnant or lactating women 15. vaccination with a live vaccine within 35 days prior to the first dose of study drug 16. hypersensitivity to zanubrutinib, ibrutinib, or any of the other ingredients in either drug 17. concurrent participation in another therapeutic clinical trial note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: chronic lymphocytic leukemia small lymphocytic lymphoma cll sll relapsed refractory
emotion regulation training via telehealth during the covid-19 pandemic

Conditions: Distress, Emotional; Emotional Dysfunction; Anxiety; Depression

Summary: this study is an open trial designed specifically to address the need for evidence-based treatment delivered via telehealth to individuals that are currently struggling with mental health issues during the covid-19 pandemic, with the overarching goal of helping residents of new york adversely impacted by the pandemic to effectively manage their anxiety, stress, and depression during this unprecedented time in human history.

the present study is evaluating whether this ert treatment program delivered via telehealth demonstrates efficacy in: 1) reducing symptoms of psychological distress (e.g., anxiety, depression, worry, rumination); 2) improving outcomes specific to the ert mechanism-based model (e.g., attentional control, decentering, reappraisal); 3) improving quality of life and functioning, for adults aged 18-65 years old.

Eligibility criteria:
inclusion criteria: * aged 18-65 years during the time of participation * endorses distress and worry/rumination exacerbated by the covid-19 pandemic * access to a mobile device (e.g., smartphone, personal computer, laptop, tablet) connected to the internet exclusion criteria: * active suicidal intent * current substance dependence disorder (within the past year) * current or past psychotic disorder, bipolar-i disorder, or dementia * primary dsm-5 diagnosis of borderline or narcissistic personality disorder * currently receiving any other form of psychosocial treatment

Keywords: emotion regulation distress disorders anxiety depression covid-19 pandemic telehealth
bioequivalency study of valacyclovir hydrochloride 1000 mg under fed conditions

Conditions: Herpes Zoster; Shingles; Genital Herpes

Summary: the objective of this study was to prove the bioequivalence of valacyclovir hydrochlorothiazide caplet under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to valacyclovir hydrochloride or any comparable or similar product.
covid-19 biological samples collection

Conditions: Infection Viral

Summary: the coronavirus disease 2019 (covid-19) outbreak is now considered as a public health emergency of international concern by the world health organization. in the context of the health emergency, research on the pathogen (the sars-cov-2 coronavirus), the disease and the therapeutic care is being organized. research projects require the use of biological samples. this study aims at setting up a collection of biological samples intended for application projects in any discipline. the main objective of the study is to collect, process and store biological samples from patients and caregivers infected with sars-cov-2 (covid-19) at the biological ressources center of the bordeaux university hospital.


Eligibility criteria:
inclusion criteria: * patients / caregivers treated at bordeaux university hospital for asymptomatic or symptomatic infection by sars -cov-2 * men and women, adults and minors as well as pregnant or breastfeeding women * patients who died following infection with sars-cov-2 (specific criterion for post-mortem biopsies) * be affiliated with or beneficiary of a social security scheme * free and informed consent obtained and signed by the patient exclusion criteria: * under guardianship or curatorship

Keywords: covid-19 sars-cov-2 coronavirus biological samples
phase 3 study to evaluate the efficacy and safety of her2/neu peptide glsi-100 (gp2 + gm-csf) in her2/neu positive subjects

Conditions: Breast Cancer

Summary: this is a prospective, randomized, double-blinded, placebo-controlled, multi-center, phase 3 study of glsi-100 immunotherapy in hla-a\*02 positive and her2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. treatment consists of 6 intradermal injections, primary immunization series (pis), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. a third open-label arm will explore glsi-100 immunotherapy in non-hla-a\*02 positive and her2/neu positive subjects.


Eligibility criteria:
inclusion criteria: * hla-a\*02-positive, unless being enrolled in the third non-hla-a\*02 arm * histologically confirmed diagnosis of her2/neu positive primary breast cancer for all tumors biopsied (multifocal, multicentric, or synchronous contralateral disease) * completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy * stage i, ii, or iii at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy -or- stage iii at presentation with pathologic complete response (pcr) at surgery following completion of neoadjuvant therapy * the subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but, study therapy can be administered concurrently with endocrine therapy. * no clinical evidence of residual or persistent breast cancer per treating physician assessment * ecog 0-2 * adequate organ function * negative pregnancy test or evidence of post-menopausal status * if of childbearing potential, willing to use a form of highly effective contraception * subject must both reside in and have been treated for their cancer in the country in which the clinical site is located. exclusion criteria: * stage iv cancer or metastatic breast cancer at any time * inflammatory breast cancer * receiving other investigational agents * receiving chemotherapy * requiring long-term systemic treatment with corticosteroids or other immunosuppressive therapy * history of immunodeficiency or active autoimmune disease * a history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived products, or any component of the investigational product * other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin * active infection * known hiv infection with a detectable viral load within 6 months of the anticipated start of treatment. note: subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.

Keywords: her2/neu positive residual disease pcr extended adjuvant gp2 immunotherapy hla type