Kornimate/medical-research-clean huggingface dataset:
radiation therapy and tamoxifen in treating children with newly diagnosed brain stem glioma

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. tamoxifen may kill tumor cells by blocking the enzymes necessary for cell growth. combining radiation therapy with tamoxifen may be effective in treating newly diagnosed brain stem glioma. purpose: phase ii trial to study the effectiveness of combining radiation therapy and tamoxifen in treating children who have newly diagnosed brain stem glioma.

objectives: * determine whether high-dose tamoxifen with radiotherapy increases the median survival and overall survival of children with newly diagnosed brain stem gliomas. * determine the time to neurologic or radiographic progression in patients treated with this regimen. * determine the acute and chronic toxicity of high-dose tamoxifen in these patients. outline: this is a multicenter study. patients undergo radiotherapy once daily 5 days a week for 6 weeks. within 2 weeks after the initiation of radiotherapy, patients receive oral high-dose tamoxifen once daily. tamoxifen continues in the absence of disease progression or unacceptable toxicity. projected accrual: approximately 60 patients will be accrued for this study within 4 years.

Eligibility criteria:
disease characteristics: * newly diagnosed tumor of the brain stem (diffuse intrinsic lesion centered on the pons) * radiological and clinical diagnostic criteria allowed (biopsy not required) * the following astrocytic tumors are allowed if histologically confirmed: * diffuse astrocytoma (all subtypes) * anaplastic astrocytoma * glioblastoma * pilocytic astrocytoma (grade i) * less than 6 months since diagnosis * at least 1 of the following signs of brain stem tumor: * cranial nerve deficit * long tract signs * ataxia * no focal lesions of the brain stem (either clearly marginated or cystic), cervicomedullary tumors, tumors predominately exophytic, or pontine tumors diagnosed as pilocytic on biopsy patient characteristics: age: * under 20 performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * not specified renal: * not specified other: * not pregnant or nursing * no frequent vomiting or other medical condition that would preclude oral medication intake prior concurrent therapy: biologic therapy: * not specified chemotherapy: * no prior chemotherapy for brain stem glioma endocrine therapy: * concurrent steroids allowed radiotherapy: * no prior radiotherapy for brain stem glioma surgery: * not specified other: * concurrent anticonvulsants allowed

Keywords: untreated childhood brain stem glioma
a dose-finding study of subcutaneous herceptin (trastuzumab) in healthy male volunteers and human epidermal growth factor receptor 2 (her2)-positive females

Conditions: Breast Cancer

Summary: this two-part study is designed to select the subcutaneous (sc) dose of herceptin that results in comparable exposure to intravenous (iv) herceptin in healthy male participants and in her2-positive female participants. the study will also assess the safety and tolerability of the sc and iv formulations. in part 1 of the study, four cohorts will be treated with a single dose of herceptin as follows: cohort 1 (6 milligrams per kilogram \[mg/kg\] iv in healthy male participants); cohort 2 (6 mg/kg iv in her2-positive female participants); cohort 3 (6 mg/kg sc in healthy male participants); cohort 4 (10 mg/kg sc in healthy male participants). an additional cohort of healthy volunteers (cohort 5) will be opened if both sc dose levels from cohorts 3 and 4 result in herceptin exposures different from the target concentration produced by a single iv dose, or if the variability in pharmacokinetic (pk) parameter values cannot be used to define the target sc dose level. in part 2 of the study, her2-positive female participants will receive a single dose of sc herceptin at the dose level defined in part 1. participants from part 1 are eligible to enter part 2 provided they receive the second (part 2) study dose of herceptin a minimum of 22 days after their first (part 1) dose.


Eligibility criteria:
inclusion criteria: * healthy participants (part 1 only) * males 18 to 45 to years of age * baseline left ventricular ejection fraction (lvef) greater than (\>) 60 percent (%) * her2-positive females (parts 1 and 2) * females greater than or equal to (≥) 18 years of age * eastern cooperative oncology group (ecog) performance status of 0 * previous non-metastatic operable primary invasive her2-positive breast cancer * baseline lvef \>55% exclusion criteria: * healthy participants (part 1 only) * clinically significant abnormalities in laboratory test results or electrocardiogram * history of significant allergies, gastrointestinal, renal, hepatic, cardiovascular, or pulmonary disease * history of hypersensitivity or allergic reaction, spontaneous or following drug administration * history of cardiac conditions * her2-positive females (parts 1 and 2) * metastatic disease * concurrent other malignancy requiring therapy of any modality which may interfere with pk investigations or result in unexpected toxicity * use of herceptin in previous 5 months * serious cardiac illness
screening for lung cancer in the hiv patient

Conditions: Lung Cancer in the HIV Patient; HIV Infections; HIV Seropositivity; Lung Cancer

Summary: that computed tomography (ct) screening of hiv-seropositive heavy smokers will detect early stage lung cancer at significantly higher rates than what is currently being observed.

the study design is that of a prospective cohort study in which 200 smoking participants will be recruited from an existing hiv-seropositive cohort of 800 patients (the human oral papillomavirus etiology (hope) study). participants will be enrolled from the johns hopkins hiv (moore) clinic and the resources of the johns hopkins adult outpatient general clinical research center (gcrc) and pilot project funding from the lung cancer spore will be utilized to fund the costs of the ct scans. an interdisciplinary team with expertise in hiv-associated malignancy, ct screening, lung cancer surgery, hiv infection, epidemiology and biostatistics has been assembled to test the hypothesis by accomplishing the following specific aims:

Eligibility criteria:
* age over 25 years old. * confirmed hiv seropositive by elisa assay * no woman who has a positive serum pregnancy * current or previous cumulative cigarette smoking history of \> 20 pack years * former smokers must have quit smoking within the previous 15 years. * no medical or psychiatric condition precluding informed medical consent. * ability to lie on the back with arms raised over the head. * no metallic implants or metallic devices in the chest or back (pacemakers or harrington rods, etc.) that would cause sufficient beam hardening artifact. * no prior history of lung cancer. * no prior removal of any portion of the lung, excluding percutaneous lung biopsy. * no requirement for home oxygen supplementation for respiratory conditions. * no participation in cancer prevention trials except smoking cessation programs * no pneumonia or acute respiratory infection within 12 weeks of enrollment that was treated with antibiotics under physician supervision. * no individuals within 6 months of receipt of cytotoxic agents for any condition. * no chest ct scan within the preceding 6 months * signed study-specific informed consent prior to study entry.
effect of synbiotic on immune response, gut permeability and microbiota in patient with connective tissue disease

Conditions: Connective Tissue Diseases

Summary: this is a double blind randomized placebo controlled trial to determine the effect of synbiotic to foxp3 regulatory t cells, il-17, gut permeability and gut microbiota in patients with connective tissue disease. synbiotic can increase foxp3 regulatory t cells, decrease il-17 and improve gut permeability and gut microbiota in patients with connective tissue disease.

study showed gut microbiota has a role in the pathogenesis of autoimmune diseases. gut microbiota which can increase gut permeability affect the antigen presentation to the immune system. synbiotic supplementation is expected to improve immune system, gut permeability, and gut microbiota in patients with connective tissue disease. the subjects who fulfill inclusion criteria, willing to participate and sign informed consent will be randomized into two groups: the group receiving synbiotic containing probiotic (lactobacillus helveticus r0052 60%, bifidobacterium infantis r0033 20%, dan bifidobacterium bifidum r0071 20%) and 80 mg fructooligosaccharide (group i, n=23) and the group receiving placebo (group ii, n=23). both groups receive intervention for two months. patients continue to receive their immunosuppressive drugs (corticosteroids, hydroxychloroquine, mycophenolate mofetil, azathioprine, or cyclosporine). percentage of foxp3 regulatory t-cells, serum il-17, zonulin, high sensitivity c-reactive protein, and gut microbiota are evaluated at the beginning and at the end of the study. foxp3 regulatory t-cell is evaluated by flowcytometry. serum il-17 and zonulin are measured by elisa. gut microbiota is evaluated using 16s ribosomal rna gene next generation sequencing. the dna from the stool is isolated by dna stool mini kit (qiaamp). the results are presented in mean ± standard deviation, median (iqr 25-75%) and n (%). the kolmogorov-smirnov test is used to determine the normality of the data, assuming the normality of the data is fulfilled if p\> 0.05. bivariate analysis uses paired t test if the data has normal distribution. if the distribution is not normal, wilcoxon test will be used. differences are said to be significant when the value of p \<0.05.

Eligibility criteria:
inclusion criteria: * patients diagnosed with connective tissue disease * has gastrointestinal symptoms (abdominal pain, diarrhea, constipation, or bloating) * age between 18-60 years old exclusion criteria: * pregnant or breastfeeding * acute infection * on antibiotic treatment * taking yoghurt or probiotic supplementation in the last 3 weeks before recruitment * taking corticosteroid more than 20 mg prednison a day or equal\\ * refuse to join the study

Keywords: synbiotic probiotic lupus connective tissue disease
obex, a nutritional supplement, in overweight and obese spanish women

Conditions: Obesity; Overweight

Summary: the aim of the study is to evaluate the effects of a dietary supplement (obex®) on anthropometric and physiological variables in spanish women between 35 and 60 years who are overweight or obese.

the nutritional supplement consists of natural plant extracts such as caralluma fimbriata, phaseolus vulgaris, acai berry and other antiobesity agents: ornithine, carnitine fumarate, essential fatty acids and certain amino acids, vitamins and minerals.

Eligibility criteria:
inclusion criteria: * women aged between 35 and 60 years. * body mass index (bmi) greater than 27 kg/m² and lower than 35 kg/m² * ability to provide informed consent exclusion criteria: * presence of any endocrine, hepatic, renal or cardiovascular disease. * history of bariatric surgery * pregnancy or lactation * concomitant disease with reduced life expectancy * severe psychiatric conditions * drug dependence

Keywords: weight loss nutritional supplement waist body composition skinfolds
anti-tumor immunity induced by cryoablation of invasive breast cancers

Conditions: Breast Cancer

Summary: this protocol will study the impact of cryoablation on immune response in patients diagnosed with invasive breast cancers smaller than 1.5 cm. it will profile the immune response to cryoablation of invasive breast cancers. the intra-tumoral and systemic immune response to cryoablation will be determined and compared to pre-ablated breast cancer specimens and historical control specimens.

patients with small breast cancers will undergo cryoablation of their breast cancer. approximately six weeks after cryoablation, definitive breast surgery will be performed. blood will be drawn for research before cryoablation and surgery and at regular follow-up visits. blood and tissue samples will be used to determine immune responses.

Eligibility criteria:
inclusion criteria: 1. subjects with an invasive breast cancer 1.5 cm or less 2. the breast cancer must be of ductal histology, unifocal, estrogen receptor positive and her2/neu negative. 3. the tumor must be visible by ultrasound and the subject must not have had prior surgical resection of the primary lesion. 4. a clip marking the breast cancer must have been placed at the time of initial diagnosis or will be placed prior to cryotherapy. 5. the breast cancer must be amenable to cryoablation (visible by ultrasound and more than 2 mm from skin or chest wall). 6. subjects with metastatic disease at diagnosis who elect to have their primary tumor excised are eligible for enrollment. 7. for subjects with breast implants, the treating physician must document that adequate distance exists between the lesion and the implant to ensure that the ablated lesion with not contact or jeopardize the implant. 8. subjects must be able to provide consent. exclusion criteria: 1. subjects with breast cancers of lobular histology, with lymph vascular invasion or extensive intraductal component will be excluded. 2. subjects with multi-centric or multi-focal breast cancers 3. subjects with breast cancers that have invaded skin or have significant skin tethering (assessed clinically). 4. subjects receiving chemotherapy within one year or undergoing neoadjuvant chemotherapy are excluded. 5. subjects with metastatic disease at diagnosis will be excluded unless they elect definitive surgical therapy for their primary lesion. 6. subjects with breast cancers not amenable to cryoablation (lesions not visible by ultrasound, against the chest wall or within 2 mm of skin) will be excluded. 7. subjects diagnosed with another malignancy in the preceding 5 years will be excluded. 8. subjects diagnosed with simultaneous bilateral breast cancer. 9. subjects receiving immunosuppressive therapy within 6 months including oral steroids will be excluded.

Keywords: ductal histology unifocal estrogen receptor positive her2neu negative
vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material

Conditions: Vital Pulp Therapy

Summary: this clinical trial is designed to study and compare the effect of two different types of chelating agents on the vital pulp therapy of mature permanent teeth with irreversible pulpitis using bioceramic material.

1. the vital pulps exposed by caries process is treated by complete caries removal followed by full pulpotomy. 2. after hemostasis, application of apple vinegar and edta 17% will be used followed by mta application. finally teeth will be restored with resin composite restoration.

Eligibility criteria:
inclusion criteria: * presence of at least one tooth with carious pulp exposure and irreversible pulpitis. * cooperative behavior with no medical problem. * absence of tooth mobility , tenderness on percussion. * history of pain with cold and sweets. * radiographically, no internal or external resorption, no periapical or furcation radiolucency and no widening of the periodontal membrane space. exclusion criteria: * teeth with pulp necrosis. * presence of sinus tract. * teeth with open apices. * pregnant women. * history of intolerance of non- steroidal anti inflammatory drugs. * tenderness to palpation of adjacent soft tissues
the effect of foot care training given to diabetic hemodialysis patients on foot care behavior

Conditions: Diabetic Foot

Summary: diabetic foot causes hospitalization, amputation and serious health problems in individuals. this situation also leads to loss of productivity of the individual, negatively. diabetic foot can be reduced by 85% with good foot care, education and a multidisciplinary team approach. diabetes is observed in the majority of hemodialysis patients. foot care becomes even more important if you have more than one chronic disease. the aim of this study is; to determine the effect of "diabetic foot care training" given to diabetic hemodialysis patients on foot care behavior. the study was planned as a randomized controlled experimental study. it was planned for diabetic hemodialysis patients who were treated in a dialysis center with a study permit.

diabetic foot causes hospitalization, amputation and serious health problems in individuals. this situation also leads to loss of productivity of the individual, negatively affecting mental health and quality of life; it creates a serious economic burden on the family and healthcare system. however, it is stated that the development of diabetic foot can be reduced by 85% with good foot care, education and a multidisciplinary team approach. diabetes is observed in the majority of hemodialysis patients. foot care becomes even more important if you have more than one chronic disease. the aim of this study is; to determine the effect of "diabetic foot care training" given to diabetic hemodialysis patients on foot care behavior. the study was planned as a randomized controlled experimental study. it was planned for diabetic hemodialysis patients who were treated in a dialysis center with a study permit. the population of the research consists of 64 diabetic hemodialysis patients. the sample consists of individuals who agreed to participate in the study. number, percentage, mean and standard deviation will be used as descriptive statistical methods in the evaluation of the data. a normal distribution test will be applied to determine whether the research variables have a normal distribution. in case the research variables do not show normal distribution (p\<0.05). in the analysis of variables for which the normality assumption is not met, non-parametric analysis methods mann whitney u (for comparisons of two groups) and kruskal wallis (for comparisons of three or more groups) will be used. spearman correlation analysis will be performed to determine the relationship between the continuous variables of the research.

Eligibility criteria:
inclusion criteria: * being over 18 years old * having a diagnosis of diabetes * volunteering to participate in the study * good communication skills and the patient's ability to receive training himself exclusion criteria: * not willing to participate in conflict

Keywords: diabetic foot diabetes foot care hemodialysis
the effects of pilates in muscle strength of the pelvic floor as treatment of post prostatectomy urinary incontinence

Conditions: Prostate Cancer; Urinary Incontinence

Summary: the purpose of this study is to compare the efficacy between a pilates exercise program and a pelvic floor muscle training (pfmt) protocol combined with anal electrical stimulation (aes) in muscular pressure strength of the pelvic floor as conservative treatment of urinary incontinence after prostatectomy.

this randomized clinical trial includes 115 individuals with urinary incontinence one month after radical prostatectomy. one physiotherapist, with experience in urogynecology, was responsible for all the assessments. muscular pressure strength of the pelvic floor, 24-hour pad test and the international consultation on incontinence questionnaire - short form (iciq-sf) were the variables evaluated. the subjects were allocated in one of three treatment groups (g1: pilates; g2: anal electrical stimulation combined with pelvic floor muscle training and g3: control group).

Eligibility criteria:
inclusion criteria: * volunteers between 50 and 75 years old; * submitted to radical prostatectomy; * with complaints of urinary incontinence; * that completed one month of surgery; exclusion criteria: * history of incontinence; * transurethral resection of the prostate; * diagnosis of neurological or cognitive impairment; * subjects who were unable to attend treatment sessions, due to distance or physical limitations.
a study to investigate efficacy and safety of sar442970 in patients with crohn's disease

Conditions: Crohn's Disease

Summary: this is a phase 2, randomized, double-blind, 3-arm study for the treatment of crohn's disease. the primary objective of this study is to assess the efficacy of different doses of sar442970 compared with placebo in participants with moderate to severe crohn's disease. the total study duration is up to 168 weeks and the treatment duration is up to 158 weeks


Eligibility criteria:
inclusion criteria: * diagnosis of crohn's disease (cd) for at least 3 months prior to screening * confirmed diagnosis of moderate-to-severe cd * history of prior exposure to standard treatment (5-amino salicylates (5-asas), steroids, immunomodulators or antibiotics) or advanced therapies (ats) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies * on stable doses of standard treatments prior to screening (oral 5-asa compounds, oral corticosteroids, azathioprine (aza), 6-mercaptopurine (6-mp), or methotrexate (mtx), or antibiotics, etc.) * contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies exclusion criteria: * participants with active ulcerative colitis (uc), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome * participants with cd isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement * participants with following ongoing known complications of cd: * any manifestation that might require bowel surgery while enrolled in the study * participant with ostomy or ileoanal pouch * participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome * participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections * history of any other condition which, in the opinion of the investigator, would put the participant at risk by participation in the study the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial