Kornimate/medical-research-clean huggingface dataset:
effects of brazil nut supplementation in patients with chronic kidney disease undergoing conservative treatment

Conditions: Chronic Kidney Diseases; Chronic Kidney Disease stage3; Chronic Kidney Disease Stage 3A; Chronic Kidney Disease Stage 3B; Chronic Kidney Disease stage4; Inflammation; Inflammatory Response; Oxidative Stress; Intestinal Microbiota

Summary: the aim of this study is to evaluate the effects of brazil nut supplementation on inflammation, oxidative stress and intestinal microbiota in patients with chronic kidney disease undergoing conservative treatment.

complications such as inflammation and oxidative stress are common in chronic kidney disease (ckd) and directly influence the rate of disease progression. patients with ckd also have intestinal dysbiosis, which aggravates the inflammatory process and oxidative stress, forming a vicious circle between inflammation, oxidative stress and intestinal dysbiosis. nutritional strategies try to alleviate this circle and brazil nuts, rich in bioactive compounds, have already been proven effective in mitigating inflammation and oxidative stress in ckd patients on dialysis. however, to date, the effectiveness of brazil nuts in patients with ckd in stages prior to dialysis (conservative treatment) has not been tested. the bioactive compounds in brazil nuts are expected to contribute positively to the redox balance, reduction of inflammation and intestinal eubiosis in patients with ckd undergoing conservative treatment.

Eligibility criteria:
inclusion criteria: * patients with more than three months of nutritional monitoring at the renal nutrition outpatient clinic of the universidade federal fluminense (uff), between stages g3a and g4, will be included, according to kdoqi 2020 guidelines, and authorized by the medical and nutritionist team. exclusion criteria: * current use or in the last three months of antibiotics, anti-inflammatories and/or antioxidant supplements. patients who are allergic, intolerant, or regularly ingest brazil nuts; pregnant/lactating women, smokers; undergoing cancer treatment, hiv-positive, or with any clinical condition that compromises the accuracy of the intervention.

Keywords: chronic kidney diseases conservative treatment inflammation oxidative stress intestinal microbiota brazil nut
summer weight and environmental assessment trial

Conditions: Childhood Obesity

Summary: the consequences of childhood obesity are devastating, affecting the physical and mental health of children. disadvantaged school-age children are at risk for unhealthy gains in bmi during the summer months and there is a dearth of information regarding the causal health behaviors and environmental factors. the overall objective of this application is to provide an in depth examination of key dietary and physical activity behaviors as well as the food, physical activity, and social environments of low-income, racial/ethnic school-age children. to achieve this goal, an observational study utilizing a multi-state prospective cohort design will be conducted with the goal of examining the weight gain trajectory among a racially and ethnically diverse convenience sample of disadvantaged school-age children who routinely attend structured programming during the summer months and those who don't participate in structured programming. in addition, a subset of these children will be evaluated to learn their daily health behaviors, as well as their food, physical activity, and social environments during the summer. identification of determinants of program participation and factors that may enhance the beneficial effects of program participation will also occur. a social ecological framework approach will guide the research. this study can be expected to have a significant positive impact by providing information on the factors that protect disadvantaged children from unhealthy weight gain during the summer which can be used by stakeholders at the local, state, and federal level to reform current policy that will increase child participation in health promoting programming during the summer window of risk.


Eligibility criteria:
inclusion criteria: * school-aged children (rising kindergartners through rising 5th graders) attending schools in the target neighborhoods. exclusion criteria: * none
thoracic trauma intubation risk score for blunt trauma

Conditions: Trauma Chest

Summary: the primary objective of this study is the evaluation of risk factors associated with orotracheal intubation in blunt chest trauma patients not intubated on the field and not fulfilling the criteria for intubation based on the glasgow coma scale score with the building of a predictive score based on those findings taking into account the clinical, laboratory and radiologic tests performed within 6 hours from hospital admission.

multicentre, prospective, observational study. all the consecutive blunt thoracic trauma patients consecutively admitted at the participating institutions' emergency department (ed) will be considered for enrolment. the primary outcome measure will be the need for orotracheal intubation for primary respiratory failure lasting at least 48 hours within 7 days after trauma. the secondary outcome measures related to analgesia are: the basal analgesia protocol received during the first 7 days from ed admission and the median cumulative dose of morphine-equivalents received as rescue therapy during the first 7 days after trauma. the secondary outcome measure related to the sonographic evolution of thoracic lesions is the global and regional lus.

Eligibility criteria:
inclusion criteria: * blunt thoracic trauma with a documentable lesion (t-ais ≥ 2) * age ≥ 18 years * gcs \> 8 at ed admission * total body ct scan available performed within 6 hours from ed admission exclusion criteria: * - penetrating thoracic trauma * age \< 18 years * gcs \<= 8 at ed admission * patients already intubated at ed arrival * do not intubate order, for any reason * intubation for urgent/emergent surgery within 24 hours from hospital arrival

Keywords: trauma; chest trauma
prospective pro/qol registry for patients with bone metastases of breast or prostate cancer

Conditions: Breast Cancer; Prostate Cancer; Bone Metastases

Summary: evaluation of patient reported outcomes (pro) / qol regarding typical ailments in real-life patients with bone metastases treated with osteoprotective agents.

the pro bone project will recruit a representative cohort of patients with breast or prostate cancer suffering from bone metastases. the aim of this study is to collect data on patient reported outcomes (pro)/quality of life regarding bone pain and the impact of bone pain on quality of life and daily activities. pros are assessed by a questionnaire consisting of a visual analog scale for bone pain, two questions regarding bone pain management, the bone pain module of fact questionnaire (fact-bp) and four questions addressing the impact of treatment on daily life (overall, social life, ability to work and ability to perform routine tasks)

Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic breast or prostate cancer * start of first systemic osteoprotective treatment * ability to read and understand german * written informed consent exclusion criteria: • none

Keywords: patient reported outcomes
diagnosis and response to treatment using a reliable gastroesophageal reflux disease (gerd) questionnaire: an in clinical practice study

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of the study is to determine the applicability and utility of gerd q in the diagnosis of gerd and in the assessment of treatment response.


Eligibility criteria:
inclusion criteria: * patients of either gender aged between 18-79 years of age * patients must be having symptoms of gastroesophageal reflux disease exclusion criteria: * none

Keywords: gerd questionnaire
the relationship between pet therapy and "well-being" in geriatric rehabilitation in-patients

Conditions: Cerebrovascular Accident; Hip Fracture

Summary: in -patients in a geriatric rehabilitation unit, will participate in structured therapy with guinea-pigs on the assumption that the therapy will reduce anxiety and improve the outcome of their rehabilitation.

measurement of anxiety before and after pet therapy using standardized questionaire.

Eligibility criteria:
inclusion criteria: willingness to touch the pets,- exclusion criteria: blindness,deafness,aphasia, lack of knowledge of hebrew language,allergy or phobia to animals.mmse less than 21,duration of admission lessthan two weeks.-

Keywords: pet-therapy guinea-pigs rehabilitation elderly
sequential therapy versus quadruple therapy as second line treatment after failure of the standard triple therapy for h pylori infection

Conditions: Optimization of Second Line Treatment Protocol for H Pylori Eradication

Summary: the aim of this study is to evaluate the efficacy of sequential therapy, i.e. 5 days of ppi + amoxicillin followed by 5 days of ppi + two antimicrobial drugs( clarithromycin and tinidazole ) versus quadruple drug regimen( i.e.-14 days of ppi+ bismuth + metronidazole + tetracycline ) as second line treatment of h. pylori .

a total of 101 patients were randomized to 2 groups : 50 in sequential group and 51 patients in quadruple group . mean age was 43 in both groups. in sequential therapy group 42 patients(84%) completed the treatment , 39 patients returned to follow up . in quadruple group only 33 patients (64.7%) completed the treatment , 29 of them returned to follow up. compliance to the treatment was significant better in sequential group comparative to quadruple .sides effects connected to gastro-intestinal tract were reported in 27(65.9%) of quadruple group patients and in 19(43.2%)of sequential group. the h pylori was eradicated in 23 of 39 patients in sequential group(59%), and in 19 of the 29 patients in quadruple group(65.5%). no comorbidities like smoking, diabetes or other influenced the efficacy of eradication. sequential therapy showed the same eradication rate as second line treatment of h pylori as quadruple one, but was associated with better compliance and less adverse effects. both treatments protocols failed to show an appropriate eradication rate in population of southern israel .

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. age at least 18 years 3. persisting h.pylori infection after at least one course of first-line standard triple therapy (amoxycillin, clarithromycin or metronidazole based) exclusion criteria: 1. history of gastrectomy 2. gastric malignancy, including adenocarcinoma and lymphoma 3. previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole, tetracycline) and proton pump inhibitors 4. active upper gastrointestinal bleeding within the previous 1 week 5. contraindications to the treatment drugs 6. pregnant or lactating women 7. severe concurrent disease or malignancy

Keywords: sequential therapy second line treatment h pylori
fetal cell analysis from maternal blood

Conditions: Prenatal Screening; Pregnancy Related; Genetic Disease

Summary: the aim of this clinical study is the evaluation of clinical performance of a cell-based non-invasive test technology for fetal aneuploidies and segmental imbalances detection in a high-risk pregnancies population.


Eligibility criteria:
inclusion criteria: * participant has a viable singleton or twin pregnancy * women who have already been selected by their treating physician to undergo an invasive fetal diagnostic procedure * participant is at least 18 years old and can provide informed consent exclusion criteria: * unable to provide informed consent * prenatal diagnosis of clinical chorioamnionitis * intake of drugs or exposure to teratogenic agents * infections that carry a risk of vertical transmission * known maternal viral diseases: hiv and hcv, hbv
a novel reconstruction device for osteonecrotic femoral head efficacy evaluation

Conditions: Osteonecrosis

Summary: numerous studies describing surgical treatments to preserve hip replacements has several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (onfh). with developing a newly approach osteonecrotic device surgical procedure to support the regeneration of necrotic bone and articular cartilage in vivo, this will be the first randomized-controlled feasibility study to determine its safety in onfh patients.

total of 20 patients were enrolled and randomized in this study. there are two groups, 10 patients in osteonecrotic device group; 10 incore decompression group. after their baseline data has been collected and their surgical procedure has been completed, the following postoperative data collection are then continued to 6 weeks, 12 weeks, 6 months, one year, and two years' prior from the start of their surgery, in order to understand the new approach of the osteonecrotic device's safety in comparison to the core decompression surgical procedure.

Eligibility criteria:
inclusion criteria: * skeletally matured between age 20 to 70 (epiphyses of the femoral head are confirmed to be closed on the radiography, ct, or mri scan * patients without any allergies or major systemic or organ diseases * patient's affected hip diagnossied as the 3rd stage of onfh by mri exclusion criteria: * other lower lib fractures * pregnancy * extensive degenerative arthritis in hip * severe osteoporosis in the head and/or neck of the femoral bone * rheumatoid immunity or metabolic arthritis that appears to have severe cartilage damage in the hip * stiffness in the hip due to other reasons or medical history with its range of motion clinically measures less than 20 degrees in the abduction and less than 90 degrees flexion * diagnosed with either stage 4, 5, or 6, of onfh classification by either radiography, mr, ct scan.

Keywords: osteonecrosis osteonecrotic repair device
application of epiduo(r) pump in daily practice in patients with inflammatory acne

Conditions: Acne Vulgaris

Summary: the purpose of this observational trial is to assess application and convenience of epiduo® pump under daily clinical practice conditions in patients with moderate to severe inflammatory acne.

the objective of this observational trial is to assess application and convenience of epiduo® pump under daily clinical practice conditions in patients with moderate to severe inflammatory acne using this drug in topical monotherapy or in combination with other drugs. in addition, efficacy of epiduo® and incidence of adverse events will be assessed under marketed conditions. also, patients' body beliefs will be recorded using the dysmorphic concern questionnaire. the observational study is designed as a multicentre study, covering all parts of germany. participating investigators are dermatologists with an adequate patient pool of acne patients. the observation time per patient will up to 3 months.

Eligibility criteria:
inclusion criteria: * age ≥9 years * the patient has been diagnosed with moderate to severe inflammatory acne (leeds grade 4-12) * chest/back affected allowed, but not required * topical therapy of acne with epiduo® is indicated, the decision about treating the patient with epiduo® has been made independently from this study exclusion criteria: * pregnancy or breastfeeding * acne inversa * acne with preferential manisfestation of microcysts, macrocysts and macrocomedones * hypersensitivity to the medication or any of the ingredients * other contraindications mentioned in the epiduo® spc
study of aripiprazole to reduce medical risks in bipolar disorder

Conditions: Bipolar Disorder; Metabolic Syndrome

Summary: the proposed study is a non-randomized, open label trial that will examine the potential to reduce metabolic risk factors in patients with bipolar i disorder and improve psychiatric and functional outcomes. to accomplish our objective, we plan to conduct a 5-month intervention of 50 obese or overweight adults diagnosed with bipolar disorder. the study will be divided in three steps: screening, baseline period (cross taper to aripiprazole, up to 2 months in duration), months 1-3 (continued aripiprazole treatment). subjects will be assessed and meet with their study psychiatrist at least bi-monthly throughout their participation, more frequently when clinically necessary (e.g. during medication tapering or if manic/depressive symptoms emerge). brief clinical assessments will be conducted at each visit. more thorough assessments will be conducted at baseline, week 2, and month 3.


Eligibility criteria:
inclusion criteria: 1. age 18 to 65 years 2. body mass index (bmi) \>=25; 3. currently taking a regimen of medications for bipolar disorder likely to cause, sedation, weight gain or undesirable metabolic effects; 4. able to give basic informed consent 5. meets dsm-iv criteria for lifetime bipolar i or ii disorder and are presently in sustained remission (cgi bp\<3 in the previous 8-week period measured through a complete psychiatric history at screening and patient report.) 6. epworth scale score \> 7 7. women of childbearing potential must agree to use a doctor-approved birth control throughout participation in the study exclusion criteria: 1. unwilling or unable to comply with study requirements (i.e., complete forms, attend scheduled evaluations) 2. not competent to provide informed consent in the opinion of the investigator 3. ultra-rapid cycling (\>4 episodes per month) bipolar i disorder 4. unstable and severe medical illness that requires immediate and intensive medical attention, when appropriate, the patients can be reconsidered for inclusion in the study if/when their medical condition becomes compatible with participation in a protocol-driven research study 5. women who are planning to become pregnant, currently pregnant, or breast-feeding; 6. current substance dependence; however, if a subject only has substance abuse/use, after the first positive drug screen, another drug screen will be repeated. if that drug screen is positive, the subject will be excluded. if the second drug screen is negative, the subject will be considered for the study; 7. subjects who have previously failed an adequate trial of aripiprazole. 8. subjects with a suicide attempt in the past 2 years; 9. subjects with a history of inpatient admission in the past 1 year; 10. subjects with a history of homicidal ideation; 11. any subject for whom the pi deems that the potential risks in participating in the study outweigh the potential benefits.

Keywords: bipolar disorder sedation overweight abilify medication
postoperative skin surface tension relaxing in prevention of facial surgical skin scarring

Conditions: Scar

Summary: the purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery.

primary measurement: the mean scar width calculated by standard photos with rulers. secondary measure: the probability of scar hyperplasia.

Eligibility criteria:
inclusion criteria: * the incision is not shorter than 3cm * skin type is iii/iv exclusion criteria: * any medical history of facial surgery, not included injection therapy, external medication or fat graft * unsuitable for device use due to anatomical location of incision, eg. lips, eyelids and ear * patients with a history of keloid or family history of keloid * patients with serious skin disorders, eg. serious psoriasis or dermatitis * patients with severe systemic or congenital disease which may affect the patient's safety in this study

Keywords: tension reduction
combination of nimotuzumab and radiotherapy for recurrent uterine cervical squamous carcinoma

Conditions: Recurrent Cervical Carcinoma; Radiotherapy; Epidermal Growth Factor Receptor; Nimotuzumab; Objective Response Rate; Progression-free Survival; Overall Survival

Summary: patients with recurrent or metastatic uterine cervical squamous carcinoma have very poor prognosis. for eligible patients, radiotherapy remains the choice, which has the most effective impact on the survival periods. on the hand, anti-angiogenic therapy has been proved to be promising treatment for recurrent or advanced cervical carcinomas. this study aims to discover the objective response of combination therapy with nimotuzumab (an anti-epidermal growth factor receptor \[egfr\] igg1 humanized monoclonal antibody) and radiotherapy in recurrent or metastatic uterine cervical squamous carcinoma in a single-arm, open, phase 2 clinical trial. the primary endpoint is the objective response rate evaluated by imaging methods. the second endpoints are the progression-free survival and overall survival. the treatment toxicity is regarded as one the second endpoint.


Eligibility criteria:
inclusion criteria: * female aged more than 18 years * eastern cooperative oncology group score 0-1 * pathological confirmed of uterine cervical squamous carcinoma * an interval of 3 months or more since the fulfilling of last treatment * at least one measurable lesion defined by response evaluation criteria in solid tumors (recist) guideline 1.1 * anticipative survival period of 3 months or more * lab testing within reference ranges * with appropriate contraception * provided consents of participating the trial exclusion criteria: * with a history of exposure to other antiangiogenic agents * with other malignancies within past 3 years * with vital complications * with uncontrolled hypertension despite of medical treatment * with brain metastasis * with addiction to psychiatric medications or with mental disorders
study to evaluate the effect of a very low carbohydrate diet on gastroesophageal reflux disease

Conditions: Gastroesophageal Reflux Disease; Overweight; Acid Reflux Disease

Summary: the purpose of this research study is to learn if a very low carbohydrate (sugar) diet or traditional low fat diet is able to reduce symptoms related to gastroesophageal reflux disease (gerd) in people who are overweight. patients with gerd may experience all or some of the following symptoms: stomach acid or partially digested food re-entering the esophagus (which is sometimes referred to as heartburn or regurgitation) and belching. in this study, the investigators also hope to find out if acid in the esophagus is reduced more by a low carbohydrate diet than a low fat diet.


Eligibility criteria:
inclusion criteria: * 18 to 70 years old * bmi between 30 kg/m2 and 45 kg/m2 exclusion criteria: * known history of barrett's esophagus or esophageal adenocarcinoma * previous surgical anti-reflux procedure * previous weight loss surgery, including gastric bypass * diabetes * pregnancy * heart disease * unwillingness to discontinue use of proton pump inhibitors (ppi's) or h2-receptor antagonists per study protocol

Keywords: low carbohydrate low fat diet overweight gerd gastroesophageal reflux disease acid reflux heartburn
sacral neuromodulation in neurogenic patients

Conditions: Neurogenic Bladder; Neurogenic Bowel; Urge Incontinence; Overactive Bladder; Retention, Urinary; Fecal Incontinence

Summary: the goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. \[. the main question\[s\] it aims to answer are: * determine efficacy and safety of the therapy in neurogenic patients. * compare outcomes of the therapy to idiopathic patients. if there is a comparison group: researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.


Eligibility criteria:
inclusion criteria: * patients who underwent interstim ii advanced evaluation for approved indication exclusion criteria: * n/a

Keywords: sacral neuromodulation neurogenic bladder neurogenic bowel