Kornimate/medical-research-clean huggingface dataset:
vaccines and dietary oats in the treatment of ulcerative colitis

Conditions: Ulcerative Colitis

Summary: ulcerative colitis is a chronic inflammatory bowel disease caused by an imbalance between natural defence mechanisms in the intestinal mucosa and microbes in the intestinal lumen. we hypothesise that an improvement or even normalisation of this balance may be achieved by the use of vaccines and dietary oats. the combined use of oral typhoid vaccine and cholera/etec-vaccine is supposed to stimulate mucosal defence factors, while dietary oats modifies the microbial environment inside the intestinal lumen. or study aim is to show if such treatment brings symptom relief to patients with ulcerative colitis.


Eligibility criteria:
inclusion criteria: * ulcerative colitis of at least 4 months duration * disease activity index score (walmsley) \>5 and \</=13 * patients taking no ulcerative colitis relevant medicine, or stable doses of aminosalicylates or maximum 10mg prednisolon daily the last 2 weeks before study entry. they must remain on the same dose throughout the study (6 months). * stool examination negative for enteric pathogens, clostridium difficile toxin and parasites exclusion criteria: * ulcerative colitis disease activity index \>13 * symptoms of bowel obstruction * other serious medical condition * use of any of the study vaccines during the last two years * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first vaccine dose, or planned use during study period * pregnant or planning to become pregnant * breastfeeding * chronic administration of prednisolone more than 10mg per day or steroids of equivalent dose the last 2 weeks before the first vaccine dose * treatment with anti-tumor necrosis factor within 3 months prior to the first vaccine dose * use of other immunosuppressants or immune modifying drugs within 30 days prior to the first vaccine dose

Keywords: ulcerative colitis vaccines oats
use of imsi in poor responders to ivf

Conditions: Female Infertility

Summary: this is a pilot study which aims to determine the role of imsi in poor responders.

this is a pilot study which aims to determine the role of imsi over icsi in poor responders to ivf, without a background of teratozoospermia.

Eligibility criteria:
inclusion criteria: * poor ovarian response exclusion criteria: * body mass index (bmi) ≥ 30 kg/m2 * presence of endocrinopathies (e.g., diabetes, hyperprolactinemia, hypothyroidism) * altered karyotype or documented genetic defects in one or both partners * history of chronic, autoimmune or metabolic diseases * altered meiosis in testicular biopsy or altered sperm-fish * teratozoospermia * participation, simultaneously or within the previous 6 months, in another clinical trial with medication

Keywords: por imsi
code registry - cardiac arrest outcomes data evaluation

Conditions: Cardiac Arrest

Summary: the purpose of this study is based on method utstein, registering all recommended items of that model, in addition to adding more information, characterizing this way using a template utstein modified for the epidemiology of pcr-hospital in brazil. objectives: establish a registry of patients suffering from respiratory (pcr)-hospital to assess demographic and clinical variables such as morbidity, mortality and standard practice in cardiopulmonary resuscitation (cpr). in addition, assess independent predictors associated with survival in several times and survival curves.

bedding: despite of ongoing advances and standardizing worldwide trumpeted by cpr guidelines, yet is little knowledge of the effectiveness of procedures for intra and extra-hospital cpr, so vast are the opportunities for documentation of these results in the field of clinical and epidemiological research. utstein style emerged, then as a proposed methodology for the pcr during the conference held at the former monastery utstein, norway. the "utstein style" was also the model for the construction of the national registry of cardiac pulmonary resuscitation (nrcpr), sponsored by the american heart association (aha). the proposal of this study is based on method utstein, registering all recommended items of that model, in addition to adding more information, characterizing this way using a template utstein modified for the epidemiology of pcr-hospital in brazil. objectives: establish a registry of patients suffering from respiratory (pcr)-hospital to assess demographic and clinical variables such as morbidity, mortality and standard practice in cardiopulmonary resuscitation (cpr). in addition, assess independent predictors associated with survival in several times and survival curves. methods: observational study of prospective registration type, to document the clinical practice of cardiopulmonary resuscitation in-hospital effect in 17 hospitals and institutes of public and private brazilian specialties. additionally the longitudinal follow-up will be conducted until discharged, and measurement of mortality at 6 months and 12 months.

Eligibility criteria:
inclusion criteria: * age \> 18 years old * patient in cardiac arrest in-hospital * consent form signed by subject's legally acceptable representative or by patient in case of survive exclusion criteria: * patient in cardiac arrest out-hospital * cardiac arrest induced (e.g: for cardiac surgery)
the effect of exclusion diet for crohn's disease plus enteral nutrition on children and adolescents with crohn's disease

Conditions: Inflammatory Bowel Diseases

Summary: in this study, children and adolescents with active crohn's disease are placed in two intervention groups, the first group receives only an exclusion diet and the second group receives an exclusion diet plus formula.


Eligibility criteria:
inclusion criteria: * children aged 4 to 18 years with active crohn's disease * pediatric crohn's disease activity index (pcdai) ≥10 and ≤40 exclusion criteria: * patients who receiving concurrent remission-inducing drugs such as steroids, 5-asa, methotrexate, or antibiotics, as well as patients receiving induction doses of a biologic

Keywords: pen
motor proficiency in relation to cognitive functions and severity in children with autism spectrum disorders

Conditions: Autism Spectrum Disorder

Summary: to investigate the relationship between cognitive function, the severity of autism spectrum disorder (asd), and the development of fine and gross motor skills in children with asd

a sample of 64 children with autism aged from 5 to 12 years recruited from centres and schools of special needs for intellectual and developmental disabilities to measure cognitive function using the raven's progressive matrices and measure the severity of autism using the childhood autism rating scale (cars). these assessments will then be compared with the children's fine and gross motor abilities

Eligibility criteria:
inclusion criteria: 1. children had been diagnosed with asd. 2. their chronological age ranged from 5 years to 12 years. 3. intelligence quotient (iq) ranged from 55 to 85. exclusion criteria: any child with the following criteria would be directly excluded from the evaluation for the consistency of the sample and statistically obtained results: 1. the child with asd and other motor disabilities. 2. visual or hearing impairment.

Keywords: autism asd raven cars bot2 fine motor skills gross motor skills
improvement of the health-related quality of life of patients with fibromyalgia using multidisciplinary treatment

Conditions: Fibromyalgia

Summary: the purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.

fibromyalgia (fm) is the most common cause of diffuse pain in the bones and joints, with a prevalence in general adult populations estimated at between 0.7% and 3.3%. in spain, the prevalence of fm is 2-3%; it affects mainly women, with new diagnoses peaking between the ages of 40 and 49 years. in certain populations, however, the prevalence may be much higher, as in 15% of patients referred from internal medicine units or 12% of patients referred to rheumatology specialists in spain. fibromyalgia produces various degrees of disability and pain. it also has a clear impact on health-related quality of life (hrqol). burckhardt et al. observed lower hrqol among patients with fibromyalgia than among healthy subjects. indeed, the hrqol for those with fm was similar to that of patients with insulin-dependent diabetes mellitus or chronic obstructive pulmonary disease. among patients with non-cancer chronic pain referred to the pain management unit at our institution, those with bone and joint pain and with fm had the worst progress 6 months after diagnosis as measured by hrqol. the characteristics of fm, such as its complex and unknown etiology, wide range of symptoms and signs, and multiple comorbidities make identifying effective therapies particularly difficult. as a result, no consensus yet exists regarding the best therapeutic approaches, and treatment of fm presents a challenge for clinicians. clinical research suggests that pharmacologic treatment alone is not the best approach for fm, and that an integrated biopsychosocial approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients. in our hospital, between 5% and 10% of patients newly diagnosed with fm are referred to the pain management unit. we established a clinical trial in this population to assess improvement in hrqol following 6 months of interdisciplinary treatment compared to the usual treatment, as well as to identify predictors for improvement in hrqol.

Eligibility criteria:
inclusion criteria: * a patient must have been diagnosed with fm according to diagnostic criteria of the american college of rheumatology * being 18 years or older and * having had continuous chronic pain for at least 6 months. exclusion criteria: * patients were excluded if they did not agree to participate in the study, * were suffering from a severe psychiatric or organic disorder, or * were involved in employment-related legal proceedings related to their fm. participants in the trial were required to sign an informed consent form.

Keywords: fibromyalgia, non pharmacological intervention
comparison of early and late therapy for adults with non-operatively treated proximal humerus fractures

Conditions: Proximal Humeral Fractures

Summary: the purpose of the study is to compare two common ways of rehabilitating after proximal humerus fractures treated non-operatively.

proximal humerus fractures with limited displacement and fractures that occur in older, less active or infirm patients are treated non-operatively. there is a general impression, supported by some data, that better function is obtained with immediate initiation of shoulder exercises. however, there is some concern that this may contribute to nonunion of the fracture and may be unnecessary. some researchers have demonstrated better outcomes with immediate rehabilitation with pendulum movements. others have shown similar functional outcomes when rehabilitation begins approximately a month after injury, or when radiographs show signs of bone healing, and this delay is associated with lower rates of non-union and malunion occurrence.

Eligibility criteria:
inclusion criteria: * male and female patients. * any race * older than 18y * diagnosed with proximal humeral fracture clinically and confirmed by imaging studies: x rays and/or ct scans. * any type of proximal humeral fracture according to the neer or ao classification system. * patient should have received non-operative treatment. exclusion criteria: * patients younger than 18 y. * patients with multiple other fractures. * patients that have received surgical treatment including closed reduction and percutaneous fixation, open reduction and internal fixation (plates, screws, pins, tension wire bands, cerclage wiring and/or intramedullary nailing) and/or articular shoulder prosthesis.

Keywords: proximal humerus fracture rehabilitation non-operative treatment dash and constant instruments
study of wnt974 in combination with lgx818 and cetuximab in patients with braf-mutant metastatic colorectal cancer (mcrc) and wnt pathway mutations

Conditions: Metastatic Colorectal Cancer

Summary: the purpose of this study is to assess the safety and anti-tumor activity of the triple combination of wnt974, lgx818 and cetuximab in brafv600-mutant mcrc with rnf43 mutations or rspo fusions. the design of this study is based upon the translational and pre-clinical data that suggest that wnt pathway signals, increased due to rnf43 mutations or rspo fusions, cooperate with the egfr and braf signals to maintain the growth of brafv600 crcs. inhibition of these signals with the triple combination of wnt974, lgx818 and cetuximab may result in anti-tumor activity.


Eligibility criteria:
inclusion criteria: * male or female aged ≥ 18 years * histological or cytological confirmed metastatic colorectal cancer * written documentation of kras wild-type status and brafv600-mutation with rnf43 mutation and/or rspo fusion * progression of disease after at least one prior standard of care regimen or intolerant to irinotecan based regimens * availability of a representative tumor specimen (primary or metastatic, archival or newly obtained) * measurable disease as per recist v1.1 * eastern cooperative oncology group (ecog) performance status ≤ 2 exclusion criteria: * phase ii only: prior treatment with raf inhibitors, wnt pathway inhibitors, cetuximab, panitumumab, and/or other egfr inhibitors * symptomatic brain metastasis. patients previously treated or untreated for these conditions that are asymptomatic in the absence of corticosteroid and anti-epileptic therapy are allowed to enroll * current treatment with medications or consuming foods that are strong inhibitors or inducers of cyp3a4/5 or herbal medications and that cannot be discontinued at least one week prior to the start of treatment. * symptomatic or untreated leptomeningeal disease * acute or chronic pancreatitis * clinically significant cardiac disease * patients with any of the following laboratory values at screening/baseline * absolute neutrophil count (anc) \<1,500/mm3 * platelets \< 100,000/mm3 * hemoglobin \< 9.0 g/dl * serum creatinine \>1.5 x uln or calculated or directly measured crcl \< 50% lower limit of normal * serum total bilirubin \>1.5 x uln * ast/sgot and/or alt/sgpt \> 2.5 x uln, (\> 5 x uln if liver metastases present) * patients with impaired hepatic function as defined by childs-pugh class b or c * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of oral wnt974/lgx818 other protocol-defined inclusion/exclusion criteria may apply

Keywords: metastatic, colorectal cancer, wnt974, lgx818, cetuximab, braf-mutant, mcrc, brafv600-mutant, kras
redel trial: reduced elective nodal dose for anal cancer toxicity mitigation

Conditions: Anal Cancer

Summary: to determine the efficacy of reduced elective nodal radiation in anal cancer patients undergoing chemoradiation in reducing toxicity compared to standard nodal irradiation.

this is a multi-center, single arm prospective trial to evaluate whether reduced elective nodal dose (30.6 gy) reduces toxicity as defined by the ctcae toxicity index compared to historic patients treated with standard nodal dose on nrg/rtog0529 and patient reported gi toxicity using the validated pro-ctcae scale for diarrhea compared to historic patients treated on uc-gi-1601.

Eligibility criteria:
inclusion criteria: 1. age ≥18 years. 2. patients must have stage t1-4n+m0 or t3/t4n0m0 locally advanced anal cancer as evidenced by a pet scan and either a ct with contrast of the abdomen/pelvis or an mri with contrast of the pelvis. all imaging must be from within 60 days prior to registration. 1. note: patients with t2n0 disease will be allowed if the primary tumor is \>4 cm. patients with stage i-t1n0m0 or stage ii-t2n0m0 (tumor ≤ 4cm) will be ineligible for participation. 2. patients with perianal cancer that is hpv associated (p16+) will be eligible if the tumor extends to the anal verge and the ctv will include the mesorectal, internal/external iliac, and inguinal lymph nodes. 3. patients with excision of the primary tumor but with node positive disease or residual disease at the primary if t3t4n0 will be eligible. 3. ecog performance status 0 or 1 (or karnofsky ≥70, see appendix a). 4. patients must be able to receive concurrent treatment with capecitabine and mitomycin c in the opinion of the investigator. 5. creatinine clearance must be \> 30 ml/min. 6. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: 1. any prior pelvic radiation. 2. history of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine. 3. patients with uncontrolled intercurrent illness that in the opinion of the investigator would prevent receipt of radiation or capecitabine. a. note: hiv-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 4. pregnant or breastfeeding women are excluded from this study. 5. patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen in the opinion of the investigator. 6. patients with active autoimmune or connective tissue disease requiring systemic treatment are excluded from this study.

Keywords: toxicity mitigation reduced elective nodal dose
open label study of 908/rtv in combination with other pis for the treatment of multi pi-experienced hiv subjects

Conditions: HIV-1

Summary: for hiv-infected individuals with highly resistant viruses, higher drug levels may be required to block the virus. this study investigates that concept by comparing the efficacy of standard fosamprenavir/ritonavir to an increased dose of boosted fosamprenavir and to a combination of fosamprenavir (increased dose)/lopinavir/ritonavir.


Eligibility criteria:
inclusion criteria: * multiple protease-inhibitors experienced hiv-1 infected individuals experiencing virological failure and who's virus is not fully resistant to boosted fosamprenavir and boosted lopinavir based on genotypic resistance tests. exclusion criteria: * no full resistance to fpv/r or lpv/r * planned use of nnrtis as part of the study salvage regimen * application of additional exclusion criteria as determined by physician.

Keywords: protease inhibitors-experienced hiv-1 infected patients highly-resistant hiv-1 dual boosted pis fosamprenavir lopinavir
liposomal-cisplatin analogue (l-nddp) in treating patients with malignant pleural mesothelioma

Conditions: Malignant Mesothelioma

Summary: rationale: patient abstract not available purpose: patient abstract not available

objectives: i. determine the antitumor efficacy of a liposomal-cisplatin analogue (l-nddp) administered into the pleural space in patients with malignant pleural mesothelioma. ii. determine the time to progression and overall survival in this patient population. iii. evaluate the quantitative and qualitative toxicity of intrapleural l-nddp. outline: all patients undergo a thoracoscopy under general anesthesia. the thoracoscope is removed and any collected fluid is drained from the chest cavity. the first treatment with liposomal-cisplatin analogue (l-nddp) is administered at this time into the intrapleural space over a 10 minute period. subsequent 10 minute intrapleural infusions of l-nddp through a percutaneous catheter are administered every 3 weeks. treatment continues unless unacceptable toxic effects or disease progression occurs. antitumor activity is assessed 2 months after the second course of therapy, and every 2 months thereafter. projected accrual: a total of 14-30 patients will be accrued for this study within 2.5 years.

Eligibility criteria:
disease characteristics: pathologically confirmed malignant pleural mesothelioma free flowing pleural effusion patient characteristics: age: 18 and over performance status: zubrod 0-2 life expectancy: at least 12 weeks hematopoietic: wbc greater than 4,000/mm3 granulocyte count greater than 1,500/mm3 platelet count greater than 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl sgpt no greater than 1.5 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl cardiovascular: no unstable angina no clinical evidence of congestive heart failure pulmonary: no postobstructive pneumonia other: fertile patients must use effective contraception not pregnant or nursing no serious concurrent infection no prior malignancies except basal cell or squamous cell skin carcinomas, stage i colon, cervical, breast, prostate, head and neck, or lung cancer, as long as there has been no evidence of tumor occurrence within the past 5 years prior concurrent therapy: biologic therapy: at least 3 weeks since prior biologic therapy no concurrent immunotherapy chemotherapy: no prior chemotherapy no concurrent chemotherapy endocrine therapy: at least 3 weeks since prior hormonal therapy no concurrent hormonal therapy radiotherapy: no prior chest radiotherapy at least 3 weeks since other prior radiotherapy no concurrent radiotherapy surgery: prior pleurodesis or chest surgery on the same side of the effusion is allowed as long as there is a free flowing pleural effusion without loculation at least 2 weeks since major surgery other than biopsy other: at least 3 weeks since use of any other investigational medication no concurrent use of any other investigational medications

Keywords: localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma
effect of long-term transcranial direct current stimulation (tdcs) on appetite control related brain regions

Conditions: Obesity

Summary: the purpose of this study is to investigate the long-term effect of transcranial direct current stimulation (tdcs) on appetite control related brain regions.

transcranial direct current stimulation (tdcs) is emerging tool for brain modulation in a variety of clinical conditions. in addition, recent neuroimaging studies suggest that modifying the activity of brain circuits involved in eating behavior could provide therapeutic benefits in obesity. the investigators aim to assess whether long-term modulation of the dorsolateral prefrontal cortex (dlfpc) using tdcs, modifies behavioral response and brain activity while watching visually presented food cues and taste cues in obese subjects. subjects will be randomly divided into sham and real tdcs arms. subjects will receive sham or real tdcs ten times. subjects will be investigated before and after sham or real tdcs interventions. subjects will perform functional mri experiments with visual and taste food cues. questionnaire with behavior measures, body compositions, blood tests will be performed.

Eligibility criteria:
inclusion criteria: * bmi \> 26 kg/m2 exclusion criteria: * history of brain trauma, epilepsy, or other neurological problems