Kornimate/medical-research-clean huggingface dataset:
norwegian microbiota study in anorexia nervosa

Conditions: Anorexia Nervosa; Mental Health Issue; Microbiota; Diet; Gastrointestinal Problems

Summary: anorexia nervosa (an) is a serious mental disorder occurring mainly in women. an is characterized by severely restricted food-intake and subsequent low weight. the disease burden for the individual is high with medical complications and psychiatric comorbidities. despite decades of research, there are large gaps in the understanding of the biological aspects of an and lack of effective interventions. current clinical treatment is associated with gastrointestinal problems, high rates of relapse and poor outcome causing long-term sickness absence and disability. during the covid19 pandemic the prevalence and severity of an has spiked. therefore, there is great need of novel strategies for an treatment, that can be easily implemented in the clinic without adding complexity to the standard care of treatment. during the resent years it has been proposed that mental disorders might be treated via manipulating the composition and function of the microbes that live in the gut (the microbiota) by adding or restricting fermentable nutrients (prebiotics) in the diet. however, in order to use prebiotics to treat the microbiota in an patients, more knowledge is needed on how the an microbiota is affected by the current standard care treatment. whether prebiotics can be useful for normalizing an microbiota remains to be established. the overall aim of the "norwegian study of microbiota in anorexia nervosa" (norma) is to join forces of researchers, clinical health care services and voluntary sector in a transdiciplinary approach to improve the understanding of the role of the gut microbiota in an patients. the current project will include a clinical trial in an patients and experimental studies to screen novel prebiotics for their ability to modify and normalize an derived microbiota. the long-term goal of the project is to pave the way for a targeted and clinically feasible individualized treatment for better tolerable weight-restoration and improved health in an patients.


Eligibility criteria:
inclusion criteria an group 1. sex: female 2. age: 16-50 years 3. bmi: \<18.5 kg/m2 4. fulfilling icd-10 criteria for an 5. currently referred to specialized inpatient nutritional treatment for an 6. able to understand the norwegian questionnaires. exclusion criteria and group: 1. history of inflammatory bowel disease, celiac disease, or gi tract surgery; 2. treatment with oral antibiotics the past two months 3. high intake of probiotic supplements over the past two months. inclusion criteria control group 1. sex: female 2. age: 16-50 years 3. bmi: \>= 18.5 \& \< 27 4. able to understand the norwegian questionnaires. exclusion criteria and group: 1. history of inflammatory bowel disease, celiac disease, or gi tract surgery; 2. treatment with oral antibiotics the past two months 3. high intake of probiotic supplements over the past two months.
use of simulation to improve vad self-management

Conditions: Heart Failure

Summary: this study will evaluate the performance of a curriculum using medical simulators to train patients with advanced heart failure and their caregivers to master the self-management of ventricular assist devices (a device implanted into the heart to help circulate the blood). the investigators expect this training will improve self-management skills, and reduce vad-related infections and re-hospitalizations. in addition to providing innovative training to the patients and their caregivers, the study will advance our knowledge of the effects of simulation-based training on patient self-management and safety.


Eligibility criteria:
patient inclusion criteria: * being a previous or current vad implantation patient, * age \>18, * english-speaking, * receiving implantation and vad care at northwestern memorial hospital (nmh), * meet hospital criteria for vad implantation. caregiver inclusion criteria: * being a caregiver identified by a previous or current vad implantation patient, * age \>18, and * english-speaking. exclusion criteria: * vulnerable populations of patients will not be included in this study (including fetuses, neonates, children, pregnant women, prisoners, mentally retarded or incompetent individuals, institutionalized individuals, or individuals unable to give consent due to their medical condition). fetuses and neonates are not the focus of our study. * pregnant women will not be included since pregnancy is a contraindication to vad implantation it is possible that vad caregivers may be pregnant at the time of the study. * patients with mental retardation, mental incompetence, or patients who are unable to give consent due to their medical condition will not be included as they will not be able to complete measures. * lastly, institutionalized individuals will not be included as access will be a problem, and these individuals are rarely referred for vad implantation

Keywords: ventricular assist device (vad) heart failure simulation
a stage-matched intervention based on transtheoretical model of change in changing the videogaming behavior

Conditions: Video Game Addiction

Summary: a stage-matched randomized controlled trial seeks to change the problematic digital gaming behavior among high school male students.

the researchers will use two groups (study and control) in which participants will be randomly selected and assigned in each of the study and control groups using simple random sampling. the study intervention will be designed based on each stage of change of the transtheoretical model of change in that participants in each stage of change will receive the intervention that matches the stage of change they would be in. a 12-week interval would be considered between administering the intervention and posttest 1 and the same interval would be used between posttest 1 and posttest 2.

Eligibility criteria:
inclusion criteria: * high school male students who do not experience any psychiatric-mental disorder. exclusion criteria: * high school male students who experience any psychiatric-mental disorder.

Keywords: high school students problematic digital gaming transtheoretical model of change
treatment of women after severe postpartum haemorrhage

Conditions: Severe Postpartum Haemorrhage

Summary: the primary purpose of this study is to get explorative information about iv high single dose infusion of iron isomaltoside 1000 compared to rbc transfusion in the treatment of severe pp-ida evaluated as physical fatigue


Eligibility criteria:
inclusion criteria: 1. pph \> 1000 ml 2. hb ≥ 5.5 and ≤ 8.0 g/dl (≥ 3.5 and ≤ 5.0 mmol/l) 3. willingness to participate and signed the informed consent form exclusion criteria: 1. women aged \< 18 years 2. multiple births 3. peripartum rbc transfusion 4. known iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 5. known hypersensitivity to parenteral iron or any excipients in the investigational drug products 6. women with a history of active asthma within the last 5 years or a history of multiple allergies 7. known decompensated liver cirrhosis and active hepatitis 8. women with hellp (haemolysis elevated liver enzymes low platelet count) syndrome (defined according to "dansk selskab for obstetrik og gynækologi guidelines") 9. active acute infection assessed by clinical judgement 10. rheumatoid arthritis with symptoms or signs of active joint inflammation 11. history of anaemia caused by e. g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) 12. not able to read, speak and understand the danish language 13. participation in any other clinical study where the study drug has not passed 5 half-lives prior to the baseline 14. any other medical condition that, in the opinion of investigator, may cause the patient to be unsuitable for completion of the study or place the patient at potential risk from being in the study. for example, a malignancy, uncontrolled hypertension, unstable ischaemic heart disease or uncontrolled diabetes mellitus
diagnosing heart failure with preserved ejection fraction in patients with unexplained dyspnea (diagnose-hfpef)

Conditions: Dyspnea

Summary: invasive diagnosis of heart failure with preserved ejection fraction (hfpef) in patients with unexplained dyspnea nyha ii-iii compared to other diagnostic tools

multiple diagnostic tests, including stress tests and the invasive conduction of left ventricular pressure-volume loops via conductance catheter (as gold standard) will be performed in patients with unexplained dyspnea nyha ii-iii in order to identify patients with a heart failure with preserved ejection fraction (hfpef). the results will be compared to previously reported diagnostic scores such as the h2fpef and the hfa-peff score.

Eligibility criteria:
inclusion criteria: * dyspnea nyha ii-iii * age 18-90 years * left ventricular ejection fraction ≥ 50% * ability to give informed consent exclusion criteria: * unstable cardiac disease with acute decompensation * documented former lvef ≤ 40% * heart valve disease with medium or high grade insufficiency or stenosis * coronary heart disease with hemodynamically relevant coronary stenosis * specific cardiomyopathia * acute or chronic cardiac inflammation (myocarditis, pericarditis) * former heart transplantation * relevant pulmonary disease (e.g. copd) assumably causing the dyspnea * fev1/vc \< 70% * hemoglobin \< 5 mmol/l * pregnant or nursing women * contraindication for one of the diagnostic tests
causal effect of coenzyme q10 nutrition and cognitive dysfunction in the metabolic storm (hyperglycemia and sarcopenia) and brain-derived neurotrophic factor

Conditions: Mild Cognitive Impairment; Alzheimer Disease; Hyperglycemia; Pre-sarcopenia

Summary: the aim of the study is to investigate the effect of coenzyme q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme q10, glucose parameters, bdnf, myokines, and cognitive function in mild cognitive impairment (mci) and alzheimer's disease (ad) patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia.

alzheimer's disease (ad) is an aging-related disease and is considered to be a type 3 diabetes. brain-derived neurotrophic factor (bdnf) is a potential therapeutic biomarker for ad. studies have found that antioxidant supplementation could elevate the level of bdnf. coenzyme q10 is an antioxidant nutrient that participates in energy synthesis in mitochondria. studies have shown that coenzyme q10 has the potential to regulate blood glucose. however, there are few clinical studies to examine the effects of coenzyme q10 supplementation on glucose and muscular metabolism and bdnf status in ad. this study will conduct an intervention study to understand the effect of coenzyme q10 on bdnf and metabolic conditions (hyperglycemia and pre-sarcopenia) in patients with mild cognitive impairment (mci) and ad. the study will be designed as a randomized, double-blind, cross-over, placebo-controlled study. to investigate the effect of coenzyme q10 supplementation (150 mg/b.i.d, 300 mg/d, 12 weeks) on coenzyme q10, glucose parameters, bdnf, myokines, and cognitive function in mci and ad patients who combined with hyperglycemia but without sarcopenia, or with hyperglycemia and pre-sarcopenia. during the study, demographic data, mini-mental state examination, anthropometric measurements, dietary records, nutritional and muscle function assessment, quality of life, and depression assessment will be collected. blood specimens will be also collected before and after the intervention; then the levels of coenzyme q10, bdnf, oxidative stress, antioxidant capacity, myokines, and mitochondrial function will be analyzed. the study hopes to clarify the cause effects of coenzyme q10 supplementation on the regulation of glucose and muscle metabolism, and cognitive function in this prospective clinical study. the results of this study will provide a reference for aging nutrition and health care.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild cognitive impairment (mci). * clinical diagnosis of alzheimer's disease. * mci and ad patients with hyperglycemia ( fasting glucose \>=100 mg/dl). * mci and ad patients with pre-sarcopenia (low calf circumference, low hand grip, or low muscle endurance). * must be able to swallow tablets. exclusion criteria: * cancer patients. * severe heart, lung, liver, and kidney diseases. * severe disability or aphasia. * malnutrition (body weight changes \> 5% within one month). * using coenzyme q10 supplements. * warfarin therapy.
a study of intravenous mircera in hemodialysis patients with chronic renal anemia

Conditions: Anemia

Summary: this single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous mircera for the maintenance of hemoglobin levels in hemodialysis patients with chronic renal anemia. patients will receive 4-weekly intravenous injections of mircera, at a starting dose of 120, 200 or 360 micrograms. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>= 18 years of age; * chronic renal anemia; * continuous stable iv or sc maintenance epoetin therapy during previous 4 weeks; * regular long-term hemodialysis therapy with the same mode of dialysis for previous 3 months. exclusion criteria: * transfusion of red blood cells during previous 2 months; * poorly controlled hypertension requiring hospitalization or interruption of epoetin treatment in previous 6 months; * significant acute or chronic bleeding.
predictive value of pet scan with fdg performed during irradiation in patients treated for oesaphagus carcinoma

Conditions: Oesophageal Cancer

Summary: the poor prognosis in the early-stage of oesophageal carcinoma cancer is due to potential worsening of the disease (local relapse, metastasis), to insufficient efficacy and toxicity of actual treatments. fdg-pet is a medical imaging modality allowing the quantification of the tumour glucose consumption. then, this exam is used for pathology staging, target volume definition for rt, and treatment efficiency few months after crt. our assumption is that an fdg-pet exam during the course of crt might be predictive of the treatment efficiency few months later. in this study, we propose to perform 4 fdg-pet: first "pet1" before chemo-radiotherapy, second "pet2" during the chemo-radiotherapy (see rtep1), third and fourth "pet3" "pet4" 3month and 12 month after the end of radiotherapy. we will investigate the performances of fdg-pet performed during crt for the prediction of the one-year patient heath outcome. if the predictive value of tep2 is confirmed, we would be able to optimize the planning treatment during the course of the therapy.


Eligibility criteria:
inclusion criteria: * carcinoma épidermoïde of the oesophagus histologically proved, uicc stage ii b, iii or iva (tnm on 2002) * decision of treatment by radio concomitant chemotherapy (radiotherapy in classic spreading of 50gy associated with a platinum chemotherapy. exclusion criteria: * presence of a second evolutionary cancer in the previous three years * index of performance oms \> 2 * patients badly balanced diabetics

Keywords: positron-emission tomography pet scan fdg oesophageal cancer chemo-radiation oncology suv
radiation therapy and combination chemotherapy for medulloblastoma

Conditions: Medulloblastoma

Summary: this phase ii trial is studying giving radiation therapy together with combination chemotherapy after surgery to see how well it works in treating children with newly diagnosed medulloblastoma.

outline: adjuvant induction chemoradiotherapy: beginning within 28 days after prior resection, patients undergo radiotherapy to the craniospinal axis 5 days a week for 4 weeks and then conformal radiotherapy to the tumor bed 5 days a week for 2 weeks. beginning 1 week after the initiation of radiotherapy, temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. the chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. maintenance chemotherapy: beginning 4 weeks after the completion of induction chemoradiotherapy, patients receive eight 4-week cycles of temozolomide (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again). projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed posterior fossa medulloblastoma 2. no residual tumor greater than 1.5 cm\^2 after resection by postoperative mri no tumor in the spinal or cerebral subarachnoid space by mri no tumor in the subarachnoid space by cerebrospinal fluid (csf) no failure to perform staging studies (spine mri and csf cytology) preoperatively or postoperatively 3. must begin radiotherapy on study within 28 days after surgery exclusion criteria: 1. prior radiotherapy and anti-tumor chemotherapy other than corticosteroids are not allowed. 2. patients must begin radiotherapy on protocol within 28 days of completion of surgery. exceptions need to be approved by the principal investigator. 3. patients with the following will not be eligible: \> 1.5cm3 residual tumor following resection as indicated by post-operative mri. tumor in spinal or cerebral subarachnoid space either by mri of brain and spine tumor in subarachnoid space by csf cytology failure to perform staging studies (spine mri, csf cytology) either pre- or post- operatively
a study comparing obinutuzumab (ro5072759; ga101) 1000 milligram (mg) versus 2000 mg in participants with previously untreated chronic lymphocytic leukemia (cll) (gage)

Conditions: Lymphocytic Leukemia, Chronic

Summary: this open-label, multicenter, randomized study compared the efficacy, safety and pharmacokinetics of obinutuzumab (ro5072759; ga101) 1000 mg versus 2000 mg in participants with previously untreated cll. participants were randomized to receive a maximum of 8 cycles (28-day cycle) of obinutuzumab (1000 mg intravenous \[iv\] infusion, on days 1, 8 and 15 of cycle 1 and day 1 of each subsequent cycle up to 8 cycles or maximum of 8 cycles of obinutuzumab (2000 mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of each subsequent cycle up to 8 cycles.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cd20-positive b-cell cll (per international workshop on chronic lymphocytic leukemia \[iwcll\] guidelines) * rai stage iii/iv or binet stage c disease, or rai stage i/ii or binet stage b disease that requires treatment according to iwcll guidelines * no previous treatment for cll chemotherapy, radiotherapy or immunotherapy; no previous rituximab treatment for autoimmune hemolytic anemia (aiha) or idiopathic thrombocytopenic purpura (itp); prior use of steroids for aiha or itp is allowed * eastern cooperative oncology group performance status of 0, 1 or 2 exclusion criteria: * confirmed diagnosis of transformation of cll to aggressive b-cell malignancy * history of severe allergic or anaphylactic reactions to monoclonal antibody therapy * evidence of severe, uncontrolled concomitant disease * known active infection or any major episode of infection requiring treatment with iv antibiotics or hospitalization within 4 weeks before the start of cycle 1 * seropositive for human immunodeficiency virus (hiv) * positive for chronic hepatitis b infection (defined as positive hepatitis b surface antigen \[hbsag\] serology) * positive for hepatitis c (hepatitis c virus \[hcv\] antibody serology testing) * pregnant or lactating women * concurrent (or within 7 days prior to first dose of study treatment) systemic corticosteroid use, except for low-dose corticosteroid therapy used to treat chronic medical conditions
clinical efficacy and safety of egfr-tki combined with nimotuzumab in the treatment of leptomeningeal metastases from lung cancer

Conditions: Leptomeningeal Metastasis; Lung Cancer

Summary: clinical efficacy and safety of egfr-tki combined with nimotuzumab in the treatment of leptomeningeal metastases from lung cancer.


Eligibility criteria:
inclusion criteria: * age 18 years or older, gender not limited; * a definite diagnosis of leptomeningeal metastases from lung cancer, including cerebrospinal fluid cytology and/or neuroimaging; * have a clear history of lung cancer, including histopathological diagnosis, or cytopathology combined with imaging diagnosis * patients who received any of egfr inhibitors (gefitinib, erlotinib, afatinib, osimertinib etc.) meet the diagnostic criteria for secondary resistance and were in a slow progression stage * detection results of cerebrospinal fluid, blood gene or lung tissue specimens showed egfr mutation, and immunohistochemistry results of cerebrospinal fluid, blood gene or lung tissue showed positive egfr expression * bone marrow, liver, kidneys and blood clotting function are relatively stable exclusion criteria: * eastern cooperative oncology group scored \> 2 points * patients had poor compliance, or for other reasons the investigator considered them unsuitable to participate in the study

Keywords: leptomeningeal metastasis ,nimotuzumab lung cancer egfr-tki
safety, tolerability and efficacy of switching from talipexole to pramipexole in patients with parkinson's disease

Conditions: Parkinson Disease

Summary: study to assess the safety, tolerability and effectiveness of a switching from domin® (talipexole) tablet to bi sifrol® (pramipexole) tablet in patients with parkinson's disease


Eligibility criteria:
inclusion criteria: 1. diagnosis of parkinson's disease (included juvenile parkinsonism) and treated with talipexole (domin®) 2. patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for parkinson's disease at least last 4 weeks 3. male or female patients aged 20 and over 4. in or out-patients 5. patient's severity characterized as stage 1 - 5 by modified hoehn \& yahr scale 6. ability to provide written informed consent in accordance with the good clinical practice (gcp), good post-marketing surveillance practice (gpmsp) and other relevant laws such as the pharmaceutical affairs law exclusion criteria: 1. history of hypersensitivity of pramipexole 2. psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior 3. subjective symptom derived from orthostatic hypotension 4. hypotension (systolic blood pressure; 100 mmhg or less) 5. complication such as clinically significant cardiac, renal and hepatic diseases 6. patients who drive a car, operate a machine, work on heights or engage in other hazardous activities 7. pregnant, possibly pregnant or female in lactation 8. patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study 9. other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study