Kornimate/medical-research-clean huggingface dataset:
prednisone plus tripterygium wilfordii treatment of adult patients with idiopathic focal segmental glomerulosclerosis

Conditions: Proteinuria; Focal Segmental Glomerulosclerosis

Summary: the purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated focal segmental glomerulosclerosis (fsgs).

primary fsgs is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. steroids, which are currently used to treat the disease, are effective in part of patients. over the past decade, a number of studies have reported therapeutic efficacy for treatment with high-dose and over 6mo prednisone in patients with fsgs. these studies show that the total effective rates were only around 50%. but this therapy had taken some side effects of prednisone. except these studies, in recent studies suggest that tripterygium wilfordii may be effective for passive heymann nephritis, podocyte injury in nephrosis rats induced y puromycin aminonucleoside, and so on. fsgs is a podocytepathy. there was no-data of prednisone and tripterygium wilfordii treatment of chinese adult patients with idiopathic fsgs.

Eligibility criteria:
inclusion criteria: * age 18-60 years at onset of signs or symptoms of fsgs * urine protein ≥ 3.5 g/24 h * estimated glomerular filtration rate (gfr) ≥ 40 ml/min/1.73 m2, serum creatinine\<2.5mg/dl * biopsy confirmed as idiopathic fsgs (including all subtypes) * willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures exclusion criteria: * secondary fsgs * prior therapy with sirolimus, cyclosporine, mmf, azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days * active/serious infection * malignancy * previously diagnosed as diabetes mellitus type 1 or 2, or abnormal carbohydrate tolerance * peripheral white blood cells \< 3000/ul * clinical evidence of cirrhosis or chronic active liver diseases * history of significant gastrointestinal disorder * allergy to study medications, and inability to consent/assent

Keywords: focal segmental glomerulosclerosis prednisone tripterygium wilfordii
screening of celiac disease in scholar children in italy

Conditions: Celiac Disease; Dental Caries

Summary: the main aim of the study is to currently define the prevalence of celiac disease (cd) in children aged 5-10 years in 2 italian cities (ancona and verona). the screening protocol is based on a 1st line genetic test (searche of hla dq2/dq8 genotypes) followed by a serological diagnosis (iga ttg and igg dgp).

all scholar children aged 5-10 years living in the cities of ancona and verona will be invited to partecipate. children enrolled will be investigated as follows: 1. hla dq2/dq8 genotyping (by a rapid test) 2. in children genetically predisposed to cd serological investigations will be performed (both iga ttg and igg dgp antibodies) 3. the overall population will be evaluated for the prevalence and severity of dental caries (by using the dmft/dmft index)

Eligibility criteria:
inclusion criteria: age 5-10 - exclusion criteria: celiac disease, on a gluten free diet -

Keywords: celiac disease children caries hla dq2 hla dq8 screening
a study of jnj-90014496 in participants with b-cell non-hodgkin lymphoma

Conditions: Lymphoma, Non-Hodgkin; Lymphoma, B-Cell

Summary: this is a phase ib multicenter, open-label study of jnj-90014496, an autologous bi-specific chimeric antigen receptor (car) t-cell therapy, targeting both cluster of differentiation (cd) cd19 and cd20 for the treatment of adult participants with b-cell non-hodgkin lymphoma (b-nhl).


Eligibility criteria:
inclusion criteria: * participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent * tumor must be histologically confirmed cluster of differentiation (cd)19 and/or cd20 positive * must meet the following indications for each subtype: relapsed or refractory mature aggressive large b cell non-hodgkin lymphoma (nhl) and follicular lymphoma grade 3b: participants must have had \>= 2 lines of systemic therapy or \>= 1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous hematopoietic stem cell transplantation (hsct); relapsed or refractory follicular lymphoma grade 1-3a and marginal zone lymphoma: participants must have had \>= 2 prior lines of anti-neoplastic systemic therapy. participants also must have prior exposure to an anti-cd20 monoclonal antibody * frontline high-risk diffuse large b cell lymphoma (dlbcl): participants must have dlbcl or high-grade b-cell lymphoma (hgbcl) with residual lymphoma by positive interim positron emission computed tomography 2 or 3 cycles of frontline chemoimmunotherapy. participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for dlbcl * measurable disease as defined by lugano 2014 classification * eastern cooperative oncology group (ecog) performance status of either 0 or 1. ecog of 0 to 2 is allowed in frontline high-risk dlbcl cohort exclusion criteria: * diagnosis of human herpes virus (hhv) 8-positive dlbcl or t cell/histiocyte-rich large b-cell lymphoma * any prior solid organ or allogeneic stem cell transplantation * autologous stem cell transplant within 12 weeks of chimeric antigen receptor (car) t cell infusion * uncontrolled active infections * history of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis \[dvt\]) * history of stroke, unstable angina, myocardial infarction, congestive heart failure new york heart association (nyha) class iii or iv, severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening * history of a seizure disorder, dementia, cerebellar disease or neurodegenerative disorder * known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system * current active liver or biliary disease (except for gilbert's syndrome or asymptomatic gallstones)

Keywords: cd19/cd20-directed car-t cells
optimal catheter placement during sonohysterography: comparison of cervical to uterine placement

Conditions: Catheter Placement and Perceived Pain

Summary: the primary objective of this investigation was to evaluate if the location of placement of the sis balloon into either the uterine cavity or the cervical canal affected discomfort perceived during the examination.

the use of sonography combined with intrauterine saline instillation, termed sonohysterography

Eligibility criteria:
inclusion criteria: * female patients undergoing sis for diagnostic uterine cavity evaluation at our university's reproductive endocrine infertility program. exclusion criteria: * previous hysterectomy, current pregnancy, active pid, patulous or stenotic cervical os noted on previous history or physical exam.

Keywords: sonohysterography, catheter placement
comparing dosing intervals of nivolumab or pembrolizumab in locally advanced or metastatic cancers

Conditions: Metastatic Cancer

Summary: a randomized research study of drugs nivolumab and pembrolizumab in patients with locally advanced or metastatic cancers. based on data from earlier studies it appears that the drugs can be given less often then the currently approved schedule. this trial will compare drug levels from the blood from standard interval dosing levels versus taking the drugs less often.


Eligibility criteria:
inclusion criteria: * patients with locally advandced or metastatic cancer whose physician has determined they are candidates for treatment with nivolumab or pembrolizumab * 18 years old or older * measurable disease per recist criteria exclusion criteria: * patients who have previously received immune checkpoint inhibitors or investigational monoclonal antibody therapy. * patients whose treatment plan is to receive ipilimumab or other anti-ctla4 monoclonal antibody in combination with either nivolumab or pembrolizumab. * ipilimumab and nivolumab combination are not eligible for this trial. * (note: patients whose planned treatment is the combination of anti-pd-1 and tyrosine kinase inhibitor such as pembrolizumab-axitinib or the combination of traditional cytotoxic chemotherapy and anti-pd-1 are eligible)
evaluation of fluciclovine uptake in patients with cervical, ovarian epithelial or endometrial cancers.

Conditions: Cervical Cancer; Endometrial Cancer; Ovarian Epithelial Cancer

Summary: an important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, mri (magnetic resonance imaging), ct (computerized tomography), and ultrasound. each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease. one of the techniques used in cancer imaging is pet/ct. this technique combines a nuclear medicine study (pet or positron emission tomography) with ct performing both scans at the same time. pet/ct most commonly uses a radioactive sugar (fdg or fluorodeoxyglucose) to detect the cancer. the problem with fdg is that it is excreted by the kidneys and collected in the bladder. even though the bladder is emptied prior to the scan, the fdg activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. it is because of this that pet/ct using fdg is infrequently used in gynecological cancers. this purpose of this study is to evaluate if 18f-fluciclovine can be used to help determine the extent of gynecological cancers. 18f-fluciclovine (also known as axumin) is a radioactive tracer which has been approved by the fdafood and drug administration (fda) for use in patients with prostate cancer. 18f-fluciclovine has much less excretion through the kidneys which improves the pet/ct imaging of the pelvis.


Eligibility criteria:
inclusion criteria: * gyn cancer (ovarian, endometrial, or cervical) was biopsy-proven and/or schedule for subsequent surgery based on clinical presentation (imaging, markers) * age ≥ 18 years. * can tolerate 18f-fluciclovine pet/ct exam (can lie on her back for the duration of the scan). * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * ongoing systemic therapy for cancer * systemic therapy for cancer in the past 3 months * inability to tolerate 18f-fluciclovine pet/ct exam * pregnant or lactating women
filgrastim with or without plerixafor in treating patients with multiple myeloma previously treated with lenalidomide

Conditions: Refractory Multiple Myeloma

Summary: this clinical trial studies filgrastim (g-csf) with or without plerixafor in treating patients with multiple myeloma (mm) previously treated with lenalidomide. giving colony-stimulating factors, such as g-csf, and plerixafor helps stem cells move from the patient's bone marrow to the blood so they can be collected and stored

primary objectives: i. ability to reach target collection of 5 x 10\^6 cd34+ cells/kg with =\< 2 days of leukaphereses using one of two mobilization regimens. secondary objectives: i. percentage of patients achieving target goal cd34+ cell dose (as above) in =\< 5 days of leukaphereses. ii. compare collections between different mobilization regimens in those patients who are crossed over from one mobilization regimen to the other. iii. compare days of apheresis, need for hospitalization during mobilization, and need for remobilization between mobilizing groups. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive g-csf subcutaneously (sc) once daily (qd) on days 1-8. arm ii: patients receive g-csf sc qd on days 1-7 and plerixafor sc qd on days 4-7. after completion of study treatment, patients are followed up at 14 days.

Eligibility criteria:
inclusion criteria: * diagnosis of mm by international myeloma working group criteria * in first or second complete or partial remission or stable refractory but not actively progressing myeloma according to the classifications provided by the center for international blood \& marrow transplant research * received at least 2 cycles of lenalidomide therapy * patients with mm scheduled to undergo stem cell harvest for possible allogeneic stem cell transplant (asct) * at least 2 weeks since last exposure to lenalidomide * eastern cooperative oncology group performance status of 0 or 1 * prior to the start of mobilization: * white blood cell count \>/= 2.5 x 10\^9/l * absolute neutrophil count \>/= 1.2 x 10\^9/l * platelet count \>/=100 x 10\^9/l * creatinine clearance \>/= 30ml/minute * if childbearing potential, must either agree to complete abstinence from heterosexual intercourse or effective means of contraception during stem cell mobilization; female patients will undergo pregnancy test prior to stem cell mobilization therapy exclusion criteria: * had prior autologous or allogeneic transplantation * received pegfilgrastim within 3 weeks or g-csf within 14 days of first dose of g-csf for mobilization * failed previous hematopoietic stem cell collections or collection attempts * received radiation therapy to the pelvic area * received lenalidomide within 2 weeks of first dose of g-csf for mobilization * had received experimental therapy within 4 weeks of enrolling in study * current or prior history of other malignancies, excluding basal cell carcinoma of the skin
study on the relationship between periodontitis and renal disease

Conditions: Periodontitis

Summary: analysis of inflammatory markers in periodontitis and patients with early and middle stage renal disease.

a total of 200 population is recruited, individuals are divided into four groups according to a periodontal examination and a general physical examination: healthy individuals ,periodontitis, renal disease patients with healthy periodontium, and renal disease patients wth peridontitis. fasting blood samples and gingival crevicular fluid are collected from all individuals, and inflammatory markers are analysed for the four groups.

Eligibility criteria:
inclusion criteria: * all participants were in general good health(except renal disease) and non-smoking exclusion criteria: * less than 20 teeth in the dentin * hypertension * the presence of systemic disease (e.g., diabetes mellitus ,coronary heart disease, liver, or lung disease) * a history or the symptom of any other acute or chronic infections * systemic antibiotic treatment within previous 4 weeks * periodontal treatment within1 month

Keywords: biomarkers renal disease periodontitis
effects of a lifestyle intervention on body mass index in patients with bipolar disorder

Conditions: Bipolar Disorder

Summary: patients with bipolar disorder are at increased risk of weight gain, which in turn, increases the risk for somatic disease and non-adherence to maintenance therapy. therefore, interventions addressing weight gain are expedient for the management of this disorder. the investigators set out to evaluate the effects of a lifestyle intervention on body mass index, cardiovascular, glycemic and metabolic parameters in patients with bipolar disorder under mood stabilizing pharmacological treatment. 50 outpatients with bipolar disorder under mood stabilizing treatment participated in a randomized controlled trial (waiting control group n=24 and multimodal lifestyle intervention n=26). each experimental group consisted of two cohorts. the intervention lasted five months and consisted of eleven group sessions and weekly fitness training. body mass index (bmi), body weight as well as cardiovascular, glycemic and metabolic parameters were determined as baseline (march and september 2005) and after five (july 2005 and january 2006) and eleven months (january and july 2006).


Eligibility criteria:
inclusion criteria: * adults between 18 and 70 years of age were considered for inclusion if they: 1. fulfilled the diagnostic criteria for bipolar disorder according to dsm-iv-tr,27; 2. were on treatment with medication for at least three months with one of the following substances: lithium, valproic acid carbamazepine, oxcarbazepine, olanzapine, quetiapine, risperidone, amisulpride; and 3. were not underweight (bmi \> 20 kg/m2). exclusion criteria: * pregnancy * actual breast feeding * a diagnosis of anorexia nervosa or bulimia nervosa * diabetes type i or ii or another serious physical disease * use of substances that reduce weight (e.g., topiramate, lamotrigine as mood stabilizer in monotherapy) * participants with comorbidity of acute psychosis, drug addiction, personality disorder, suicidal tendencies or a current severe manic or depressive episode were excluded only if attending the program was not possible due to the respective disorder
evaluation of clinical ranges of whole blood clotting times of patients on anticoagulants

Conditions: Blood Coagulation Disorder

Summary: whole blood clotting time measurements are to collect the clotting time ranges for doac-anticoagulated patients and assess their correlation with plasma drug levels (via anti-fxa assay).

primary objectives of the planned whole blood clotting time measurements are to collect the clotting time ranges for doac-anticoagulated patients and assess their correlation with plasma drug levels (via anti-fxa assay).

Eligibility criteria:
inclusion criteria: * in general, study participants must: 1. be informed of the nature of the study and provide written informed consent before any study-specific procedures are performed. 2. be 18- to 80-years-of-age, inclusive, at time of consent. 3. have suitable venous access for at least a single venipuncture. 4. eligible patients on anticoagulants must have taken their prescribed anticoagulant regularly at least for one month prior to study participation for inclusion exclusion criteria: * eligible patients on anticoagulants must not: 1. other than the condition for which a doac was prescribed , have a personal or family history of clotting disorder or hematologic abnormality, such as excessive bleeding, joint hematoma, thrombovascular disease, thrombocytopenia, or any chronic condition requiring treatment with transfusions. 2. have a bmi\> 40 or weight \> 120kg. 3. suffer from renal or hepatic insufficiency. 4. suffer from any pathology that would contra-indicate in general doac medication. 5. have a history of unexplained syncope. 6. have a history within 6 months prior to screening of peptic ulcer or gastrointestinal bleeding (including hematemesis, melena, or rectal bleeding). 7. consume more than 5 cigarettes per day. 8. if female, have a history of excessive or dysfunctional uterine bleeding (unless the subject had a subsequent hysterectomy). 9. if female is pregnant, breastfeeding, or planning to become pregnant during study
treatment of patients suffering from a progressive pancreas carcinoma with everolimus (rad001) and gemcitabine

Conditions: Advanced or Metastatic Pancreatic Adenocarcinoma

Summary: a dose finding study in locally advanced and/or metastatic pancreatic cancer patients


Eligibility criteria:
inclusion criteria: 1. histologically confirmed locally advanced, irresectable pancreatic adenocarcinoma (head, corpus, tail) with or without distant metastases 2. adequate bone marrow, liver and renal function on everolimus treatment 3. at least one measurable lesion according to recist criteria that has not been previously irradiated. 4. patients must be at least 4 weeks since prior major surgery and recovered, at least 2 weeks and recovered since prior minor surgery, completion of radiation, or completion of all prior systemic anticancer. 5. age \>18 years exclusion criteria: 1. women who are pregnant or breast feeding. 2. documented intolerance or history of allergy to everolimus or gemcitabine. 3. history of another malignancy within 5 years prior to study entry, except curatively treated non-melanotic skin cancer or in-situ cervical cancer 4. known or symptomatic central nervous system (cns) metastases or leptomeningeal involvement 5. chronic treatment with systemic steroids or another immunosuppressive agent 6. impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of everolimus 7. patients with an active, bleeding diathesis or on oral anti-vitamin k medication (except low dose coumarin). quick-value \< 50 % or prothrombine time more than 1,5 fold higher other protocol defined inclusion/exclusion criteria may apply

Keywords: advanced or metastatic pancreas carcinoma gemcitabine everolimus
an inpatient study of the efficacy, safety, and tolerability of pf-02545920 in the treatment of acute exacerbation of schizophrenia

Conditions: Schizophrenia

Summary: this study aims to evaluate whether pf-02545920 is safe and effective in the treatment of acute exacerbation of schizophrenia during a 4-week inpatient treatment period. the study will use the positive and negative syndrome scale (panss) to measure change in symptoms for pf-02545920 compared to risperidone and placebo treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia with acute exacerbation of illness * the current acute exacerbation of schizophrenia must be less than 4 weeks duration prior to the initial evaluation. exclusion criteria: * subjects with evidence or history of clinically significant uncontrolled medical illness * subjects with a current diagnosis of schizoaffective disorder, major depression, bipolar disorder, or obsessive compulsive disorder. * subjects who meet diagnostic and statistical manual-iv (dsm-iv)defined diagnostic criteria for psychoactive substance dependence (excluding nicotine dependence) within 12 months of screening or dsm-iv defined substance abuse within 3 months prior to screening.

Keywords: schizophrenia acute exacerbation inpatient