Kornimate/medical-research-clean huggingface dataset:
intensive dietary education to lower serum phosphorus in patients with chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: a low phosphorus diet is recommended for patients with chronic kidney disease who exhibit high levels of phosphorus. the purpose of this study is to determine the effects of a more intensive, innovative dietary phosphorus educational intervention on reducing serum phosphorus levels, as well as improving dietary adherence, dietary satisfaction and phosphorus knowledge level in patients with chronic kidney disease.

high serum phosphorus concentration (hphos) commonly occurs in chronic kidney disease (ckd) secondary to declining renal function. hphos increases the risk of developing metastatic calcification, secondary hyperparathyroidism, renal osteodystrophy and cardiovascular complications. patients with hphos are advised to restrict their dietary phosphorus intake to 800-1000mg/d, as per national kidney foundations'kidney disease quality outcomes initiative (kdoqi). adherence to a phosphorus restricted diet is often challenging for ckd patients, as they may be required to follow various dietary restrictions, and there is significant quantities of hidden phosphorus in processed foods. this randomized controlled trial is designed to compare the effectiveness of more intensive phosphorus education (ipe) using the innovative phosphorus point system tool© versus standard phosphorus education (spe) using the choose/avoid list on 1) serum phosphorus levels (primary outcome) 2) dietary adherence, dietary knowledge and satisfaction in patients with pre-dialysis ckd. we hypothesize that patients receiving ipe will have lower serum phosphorus than those receiving spe. fifty patients attending a pre-dialysis ckd clinic with serum phosphorus \> 1.49 mmol/l will be randomly assigned to ipe or spe and followed over 12 weeks. serum phosphorus, dietary intakes using the 5-pass repeat 24-hour dietary recall method, dietary knowledge and satisfaction by validated questionnaires, will be measured at baseline, 6 weeks and 12 weeks. the study's findings on the impact of more intensive innovative dietary phosphorus education in patients with pre-dialysis ckd will serve towards developing best practice of care and potentially reduce long-term complications.

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * patient with pre-dialysis ckd attending the progressive renal disease clinic (prdc) at st. michael's hospital * six-month mean serum phosphorus \> 1.35 mmol/l * able to provide informed consent exclusion criteria: * currently on dialysis * current malignancy * inability to use phosphorus point system (pps) tool

Keywords: chronic kidney disease predialysis hyperphosphatemia dietary intervention intensive dietary education low phosphorus diet
phase ii study of combined modality treatment in primary testicular non-hodgkin's lymphoma

Conditions: Lymphoma, B Cell

Summary: the primary objective assess the clinical activity of combination doxorubicin-containing chemotherapy plus monoclonal antibody anti-cd20 (rituximab) plus intrathecal prophylactic chemotherapy and loco-regional radiotherapy in primary localised testicular dlcl and to assess the toxicity of this therapeutic strategy


Eligibility criteria:
inclusion criteria: 1. age = 18 years. 2. ecog performance status 0-2 3. histologically proven primary testicular cd20-positive diffuse large b-cell non-hodgkin's lymphoma, untreated 4. ann arbor stage ie or iie. bilateral testicular involvement at presentation will not be considered stage iv. in these patients the final ann arbor stage will be determined by the extent of nodal involvement. 5. bidimensionally measurable or evaluable disease. patients who have had all disease removed by surgery are eligible. 6. adequate bone marrow reserve (anc \> 1.000/l, plt \> 100.000/l) 7. cardiac ejection fraction ≥ 50% by muga scan or echocardiography 8. no previous therapy with monoclonal antibody anti-cd20. 9. no psychiatric illness that precludes understanding concepts of the trial or signing informed consent 10. no other major life-threatening illnesses that may preclude chemotherapy 11. have given written informed consent prior to any program-specific screening procedure, with the understanding that the consent may be withdrawn by the patient at any time without prejudice exclusion criteria: 1. impairment of renal function (creatinine \> 2 mg/dl) or liver function (bilirubin \> 2 mg/dl) unless due to lymphoma involvement 2. hiv positive patients 3. evolutive malignancy within 5 years with the exception of localized non-melanomatous skin cancer
chs 828 in treating patients with solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of chs 828 in treating patients who have solid tumors.

objectives: * determine the maximum tolerated dose of oral chs 828 in patients with solid tumors. * determine the qualitative and quantitative toxic effects of this regimen in these patients. * determine a safe dose of this regimen for phase ii evaluation. * determine the pharmacokinetic profile of this regimen in these patients. * determine any antitumor activity in these patients. outline: patients receive oral chs 828 every 3 weeks. treatment continues for at least 2 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-6 patients receive escalating doses of chs 828 until the maximum tolerated dose (mtd) is reached. the mtd is defined as the dose at which 2 of 6 patients experience dose limiting toxicity. patients are followed for up to 4 weeks. projected accrual: a total of 30 patients will be accrued for this study within 12 months.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed solid tumor not amenable to standard therapy * no symptomatic brain or leptomeningeal involvement patient characteristics: age: * 18 and over performance status: * who 0-2 life expectancy: * at least 3 months hematopoietic: * wbc at least 4,000/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin less than 1.5 mg/dl * other liver function tests no greater than 2 times upper limit of normal (unless related to liver metastases) renal: * creatinine no greater than 1.4 mg/dl other: * not pregnant or nursing * fertile patients must use effective contraception * no active bacterial infection * no other nonmalignant disease * no alcoholism, drug addiction, or psychiatric disorders * able to take oral medication prior concurrent therapy: biologic therapy: * at least 4 weeks since prior immunotherapy chemotherapy: * at least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) * no other concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * at least 4 weeks since prior radiotherapy (6 weeks since extensive radiotherapy) * no concurrent radiotherapy (except palliative radiotherapy) surgery: * not specified other: * no other concurrent investigational drugs * no other concurrent antitumor drugs

Keywords: unspecified adult solid tumor, protocol specific
effects of an oral gh secretagogue (mk-677) on body composition and functional ability of older adults

Conditions: Aging

Summary: the purpose of this study is to determine whether treatment of healthy older men and women with oral mk-677 for 12 months will enhance pulsatile gh release and increase mean gh and igf-i concentrations into the range of young adults and will have favorable effects on body composition and functional ability on older adults.

this is a two year, double-blind, placebo-controlled cross-over trial of once daily administration of mk-677, an oral gh secretagogue, to healthy older adults. during the first year, subjects will be randomized to mk-677 or placebo treatment. in each of three subgroups of subjects (men, women off and women on hormone replacement therapy), 16 subjects will receive mk-677 and 8 will receive placebo. after 1 year, the subjects who received placebo will be switched to mk-677 treatment; the subjects who received mk-677 for the first year will be randomized to either placebo or mk-677 for the second year of the study.the study will test changes in gh, igf-i, body composition and function.

Eligibility criteria:
inclusion criteria: * healthy men and women  60 years of age, with a body mass index of \< 35 kg/m2. exclusion criteria: * medication known to affect gh secretion, other than estrogen replacement therapy * coronary artery disease, * congestive heart failure, * peripheral vascular disease, * diabetes mellitus (requiring insulin or an oral hypoglycemic agent), * significant hypertension (bp \>180 systolic or \>100 diastolic at rest); * renal, hepatic, pulmonary disease; * untreated hypothyroidism, untreated hyperthyroidism; * history of seizure disorder; * history of malignancy (other than some skin cancers), history of active chronic infections (e.g., hiv, tuberculosis). * hematocrit \< 40%, men, \< 36%, women * history of daily tobacco use within past 3 months * chronic alcohol abuse * strenuous exercise for average of more than 60 min/day * investigational drug within past 6 weeks * psychiatric history, especially anorexia nervosa * transmeridian travel within 2 weeks prior to or during study

Keywords: growth hormone secretagogue body composition functional ability aging sarcopenia
effect of diosmin and hesperidin in treatment of patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: evaluating the effect of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis

evaluation of the anti inflammatory and antioxidant effects of the flavonoids combination (diosmin and hesperidin) as adjuvant therapy on patients with rheumatoid arthritis. clinical and functional assessment of disease activity. evaluation of hepatoprotective effect against methotrexate induced liver adverse events.

Eligibility criteria:
inclusion criteria: * patients with mild to moderate disease activity. * patient age must be more than 18 years. exclusion criteria: * pregnant and lactating females. * patients with liver, renal impairment or any other inflammatory diseases. * patients on tnf-α (tumor necrosis factor- α) or il-1β (interleukin-1β) antagonists.
a clinical research of cd70-targeted car-nkt cells (cgc738) therapy in rcc

Conditions: Advanced Clear Cell Renal Cell Carcinoma

Summary: this is a phase i, open-label, single-arm study conducted to evaluate the efficacy, safety and pk of cgc738 in the treatment of advanced clear cell renal cell carcinoma (ccrcc).

this is a single-arm, open-label study. this study will include two parts, dose escalation phase (3+3 design) followed by a dose expansion phase. all eligible participants will receive a conditioning chemotherapy regimen of fludarabine and cyclophosphamide followed by car-t cell injection. additional patients will be enrolled in the dose expansion phase to further characterize the safety profile and evaluate the efficacy of anti-cd70 car-t cell injection.

Eligibility criteria:
inclusion criteria: * 1. age 18 to 75 years. * 2.ecog 0-1 points. * 3. the expected survival time is more than 3 months. * 4. patients with advanced ccrcc confirmed by histology or cytology to be recurrent or metastatic after at least first-line treatment. * 5. ihc: cd70 positive. * 6. at least one measurable lesion at baseline per recist version 1.1. * 7. the functions of important organs are basically normal: * 8. pregnancy tests for women of childbearing age shall be negative, both men and women agreed to use effective contraception. exclusion criteria: * 1. use of cell therapy within the previous one month. * 2. subjects with other malignant tumors within the past 2 years, except basal or squamous skin cancer, superficial bladder cancer, and breast cancer in situ, have been completely cured and do not need follow-up treatment. * 3. patients with leptomeningeal metastasis or central nervous system metastasis, and definite central nervous system underlying diseases with significant symptoms. * 4. immunotherapy, targeted drug therapy or chemotherapy within 5 drug half-lives within 2 weeks before cell infusion. * 5. active hepatitis b, hiv positive and hcv positive. * 6. active infection or uncontrollable infection. * 7. uncontrollable or significant heart disease. * 8. unstable respiratory diseases, including interstitial pneumonia. * 9. uncontrolled ascites and pleural effusion. * 10.known to have active or uncontrolled autoimmune diseases, such as crohns disease, rheumatoid arthritis, systemic lupus erythematosus, etc. * 11.subjects who are using systemic steroids or steroid inhalers for treatment. * 12.pregnant or lactating female subjects. * 13.other investigators deem it unsuitable to participate in the study
a study of carboplatin plus etoposide with or without atezolizumab in participants with untreated extensive-stage (es) small cell lung cancer (sclc)

Conditions: Small Cell Lung Carcinoma

Summary: this randomized, phase i/iii, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[pd-l1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with es-sclc. participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (pd) as assessed by the investigator using response evaluation criteria in solid tumors version 1.1 (recist v1.1). treatment can be continued until persistent radiographic pd or symptomatic deterioration.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed es-sclc (per the veterans administration lung study group \[valg\] staging system) * no prior systemic treatment for es-sclc * eastern cooperative oncology group performance status of 0 or 1 * measurable disease, as defined by recist v1.1 * adequate hematologic and end organ function * treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage sclc exclusion criteria: * active or untreated central nervous system (cns) metastases as determined by computed tomography (ct) or magnetic resonance imaging (mri) evaluation * malignancies other than sclc within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome * pregnant or lactating women * history of autoimmune disease * history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest ct scan. history of radiation pneumonitis in the radiation field (fibrosis) is permitted. * positive test result for human immunodeficiency virus (hiv) * active hepatitis b or hepatitis c * severe infections at the time of randomization * significant cardiovascular disease * prior treatment with cluster of differentiation (cd) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (pd-1), and anti-pd-l1 therapeutic antibody * history of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation.
efficacy of chinese herbal medicine xiaojidaozhi decoction in the treatment of childhood constipation

Conditions: Constipation; Chinese Herbal Medicine

Summary: constipation is the most common complaint in childhood gastrointestinal disease,affecting an estimated 20% of the global children.the treatment strategies consist of diet control,behavioural intervention and oral and sometimes rectal laxatives. given higher success rate and fewer side effects,the laxative peg3350 has been considered the first choice in childhood constipation.however, effectiveness of peg 3350 laxative is not lasting, additional treatment interventions are still necessary.with an unsatisfactory response to current treatments, many patients seek help from chinese herbal medicine.in view of the traditional theory, childhood constipation is derived from weakness of gastric and splenic function.the functional weakness is characterized by food stagnation and further pathological heat accumulation in the gastrointestine. the food stagnation can slow the gastrointestinal motility while heat causes constipation by drying the intestines and their content. therefore, the therapeutic principles and practices for childhood constipation must focus on the pathophysiological basis accordingly. in the documented traditional medicine dictionary(pi wei lun), xiaojidaozhi decoction is well described in improving the gastric and splenic function, eliminating food stagnation and removing pathological heat accumulation, and it has always been used in treatment of constipation throughout asia since the first description in pi wei lun in 1249. it comprises twelve herbs. through the combined action of these herbs, xiaojidaozhi decoction can increase fluid in the intestines and facilitate the gastrointestinal motility, relieving the symptoms of constipation. despite of the long history of successful use of xiaojidaozhi decoction in childhood constipation, a large randomized placebo-controlled trial is still not available.the aim of this study was to explore the clinical efficacy and safety of chinese herbal medicine xiaojidaozhi decoction in the treatment of childhood constipation.


Eligibility criteria:
inclusion criteria: 1. clinical diagnosis of childhood constipation 2. criteria of constipation meets the rome iv criteria(h3a) 3. must be able to swallow capsules exclusion criteria: 1. digestive tract diseases 2. neurologic diseases 3. endocrine diseases 4. metabolic diseases 5. gastrointestinal surgery 6. using drugs which can take impact on bowl motility
placebo-controlled study of atomoxetine hydrochloride in the treatment of adults with adhd and comorbid social anxiety disorder

Conditions: Attention Deficit Hyperactivity Disorder; Comorbid Social Anxiety Disorder

Summary: to investigate the effect of atomoxetine hydrochloride in treating adults who have attention deficit hyperactivity disorder with comorbid social anxiety disorder


Eligibility criteria:
inclusion criteria: * you must be 18 to 65 years old. * you must have been diagnosed with attention deficit hyperactivity disorder and social anxiety disorder. * you must be able to visit the doctor's office at least 8 times over a 16 week period. * you must agree to participate with all tests and examinations that are required for this study. exclusion criteria: * you are a woman and pregnant or breastfeeding. * you presently have an acute or unstable medical illness. * you have a history of allergic reaction to atomoxetine hydrochloride. * you are taking medications that are not permitted in this study. your physician will discuss these with you. * you have taken part in another clinical research trial within the last 30 days or have received treatment with a drug in the last 30 days that has not received regulatory approval.
therapeutic drug monitoring - targeting improved effectiveness

Conditions: Pneumonia; Sepsis; Infection, Bacterial

Summary: severe infections can be caused by various organisms, such as bacteria or viruses, and lead to otherwise healthy people getting very unwell, sometimes needing treatment in hospital or even intensive care. for the treatment of bacterial infections to be successful, the correct antibiotics need to be given promptly. early in the course of illness, clinicians often do not know exactly which bacteria are causing the infection. furthermore, patients differ in terms of how their bodies process the antibiotics they are given; this means that some may get too much and others too little. this can in turn lead to some patients not being fully cured, and others coming to harm due to side effects of higher doses of these drugs. for certain types of antibiotics, clinicians are able to measure their levels in the bloodstream, which can help guide dosing. this is called therapeutic drug monitoring, and is commonly used in clinical practice. one of the problems with therapeutic drug monitoring is that it is often not available outside of regular working hours, is costly, and most importantly, provides clinicians with useful information only after a few days of treatment have already been completed. this may be too late to treat these severely ill patients with life-threatening infections, where early and appropriate treatments matter. the aim of our study, called tdm-time, is to look at how long it takes for blood samples to get from the patient to the laboratory to be measured, with the results then communicated back to clinicians. we are further looking to investigate whether steps can be taken to improve these timings, which would lead to shorter times until treatments can be improved. as our study is observational, we will not change anything about the treatment of our patients, but will only be measuring levels of antibiotics in their blood.


Eligibility criteria:
inclusion criteria: * age \> 18 years; * admitted to intensive care; * treated for presumed or confirmed lower respiratory tract infection; * receiving or about to receive the first dose of intravenous antimicrobials (either meropenem of piperacillin/tazobactam); * valid informed consent or enrolment through deferred consent appropriate. exclusion criteria: * severe anaemia (haemoglobin level \< 70 g/l); * unlikely to survive 24 hours as judged by the treating physician; * study antimicrobial course started more than 24 hours ago.

Keywords: drug monitoring sepsis antibacterial agents respiratory tract infections antimicrobial stewardship