Kornimate/medical-research-clean huggingface dataset:
effect of physical activity in women with manifest osteporosis

Conditions: Osteoporosis

Summary: objectives: to investigate if a physical activity intervention (one year) can reduce the risk of falls (primary endpoint), improve physical function (balance and muscle strength) and cortical bone geometry as well as trabecular microarchitecture (secondary endpoints) in women, 70-80 years old, with manifest osteoporosis, treated with zoledronic acid, calcium and vitamin d. strategic goal: to include 200 patients (100 intervention and 100 controls) during 2010 and 2011 and randomize 100 patients to a one year physical activity intervention (3 hours weekly). the results will be published in an international scientific peer-review journal. all patients will receive standard medical treatment with calcium, vitamin d and yearly zoledronic acid. study rationale: the role of physical activity intervention has not previously been evaluated in patients with manifest osteoporosis and zoledronic acid treatment. methodology: randomized controlled trial. all included patients (women 70-80 years of age) will have manifest osteoporosis, be treatment naïve, and will be treated on clinical indication with yearly infusions of zoledronic acid (approved treatment, for this patient category, by the swedish medical products agency). patients with secondary osteoporosis, with disabilities, and with high levels of exercise at the baseline visit will be excluded. intention to treat analysis will be used. physical activity intervention includes 3 hours of weight bearing aerobic exercise per week, using a standardized program. patients in both groups will be contacted monthly and asked about their exercise habits. frequency of falls, physical activity level will be ascertained using questionnaires. balance and muscle strength will be assessed using standardized tests. bone geometry at the tibia diaphysis will be determined using an xct2000 pqct device (stratec, germany) and trabecular microarchitecture at the tibia metaphysis will be determined using an xtremect device (scanco medical ag, switzerland). these examinations will be performed on all patients prior to the intervention and after the completion of the study.


Eligibility criteria:
inclusion criteria: * 70-80 years of age * manifest osteoporosis, bmd t-score ≤2.5 sd at the lumbar spine and/or hip * female * walk without walking aid exclusion criteria: * male * high level of exercise, ≥2 times/week, at baseline * secondary osteoporosis * previous treatment with bisphosphonate or other osteoporosis induced medicine
stressor-evoked brain and cardiovascular responses to acute psychological stress

Conditions: Acute Psychological Stress

Summary: the present study will examine the relationship between metabolically excessive cardiovascular and neural responses to acute psychological stress using a cross-sectional approach.

all participants in this study will undergo an acute psychological stress paradigm, there will be no randomization or assignment since all participants will complete the same tasks. sample size was calculated based off of recent papers examining multivariate pattern brain responses predicting cardiovascular responses to stress.

Eligibility criteria:
inclusion criteria: 18-30 years old exclusion criteria: chronic medical or neurological condition pregnant current illness or infection any condition that would prohibit engaging in physical exercise any metal implants in body claustrophobia
regional lymph node irradiation for high-risk pn0 breast cancer

Conditions: Breast Cancer

Summary: this study is a non blind, randomized controlled study, whose hypothesis was that chest wall/whole breast combined regional lymph node radiotherapy can improve the 5-year disease-free survival rate of clinical high-risk pn0 breast cancer patients.


Eligibility criteria:
inclusion criteria: voluntarily participate and sign an informed consent form; age\>18 years old, female； received radical surgery for breast cancer, including breast conservation surgery or mastectomy, combined with sentinel lymph node biopsy or axillary lymph node dissection； invasive cancer, postoperative axillary lymph node negative, with pathological staging of t1-3n0m0 stage (stage ia, iia, iib)； including two or more high-risk factors based on four clinical high-risk recurrence factors \[tumor size (\>2cm), tumor site (medial and central quadrants), ki-67 level (\>14%), and vascular status (positive)\]; kps ≥ 80, estimated survival time \>5 years; complete healing of surgical incision, no incision infection, etc; reproductive period women should undergo contraception for at least one month before study, and promise to use contraception throughout the entire study period and continue until the specified time after the end of the study exclusion criteria: pregnant or lactating women; received neoadjuvant therapy; with serious non neoplastic medical complications that affect the implementation of radiotherapy; history of malignant tumor in the past 5 years (excluding previous lobular carcinoma in situ, skin basal-cell carcinoma, skin carcinoma in situ, cervical carcinoma in situ and lung carcinoma in situ); simultaneous contralateral breast cancer; previous history of neck, chest, or ipsilateral axillary radiotherapy; active collagen vascular disease; distant metastasis confirmed by pathology or imaging;
programme for intervention in paediatric obesity

Conditions: Obesity, Childhood

Summary: the pinpo program aims to carry out a comprehensive intervention for children aged 6 to 12 years with childhood obesity (with a bmi greater than the 99th percentile), fostering motivation and encouraging changes toward healthy lifestyle habits to achieve greater adherence and improved health. the program comprises 9 educational sessions designed by specialized professionals from various disciplines (pediatrics, psychology, nursing, nutrition), for a group of 10 children and another group of 10 family members and/or caregivers. these sessions are conducted in a hospital setting every 15 days, each lasting 90 minutes.


Eligibility criteria:
inclusion criteria: * children between 6 and 12 years old, with a bmi greater than the 99th percentile according to cole criteria (2004). exclusion criteria: * children \ 12 years. * children with chronic diseases or following a therapeutic diet. * children with intervention in other centers.

Keywords: obesity childhood grupal intervention
medi4736 (anti pd-l1) combined with gefitinib in subjects with non-small cell lung cancer(nsclc).

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this a phase i, open-label, multicentre study to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of gefitinib in combination with medi4736 (anti pd-l1) in subjects with non-small cell lung cancer (nsclc). the study consists of two phases: escalation phase and an expansion phase to be conducted in locally advanced or metastatic nsclc subjects

in escalation phase: medi4736 and gefitinib in nsclc subjects in expansion phase: subjects with egfr mutation positive locally advanced or metastatic nsclc will be enrolled in expansion arms. initiation of expansion arms with the recommended dose of medi4736 in combination with gefitinib will be based on an adequate safety and tolerability profile of the combination from the escalation phase.

Eligibility criteria:
key inclusion criteria: 1. provision of signed and dated, written informed consent 2. male or female aged 18 years and older. 3. subjects must have a. in the escalation phase, locally advanced or metastatic nsclc subjects who have either failed to respond or relapsed following any line of standard treatment, were unable to tolerate, or were not eligible for standard treatment b. in the expansion phase, histologically or cytologically confirmed locally advanced or metastatic nsclc that is egfr mutation positive, naïve to egfr tki therapy, and sensitive to egfr tkis therapy 4. a.for escalation phase: at least one lesion (measurable and/or non-measurable) b.for expansion phase: at least one measurable lesion. 5. eastern cooperative oncology group (ecog) performance status of 0 or 1. * for japan escalation - the same as the global escalation i/e criteria except patients must be egfr mutation positive key exclusion criteria: 1. any concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment. 2. any investigational agent, chemotherapy, immunotherapy, biologic, hormonal within 28 days of the first dose of study treatment 3. inadequate bone marrow reserve or organ function

Keywords: nsclc
iron absorption from iron-enriched aspergillus oryzae

Conditions: Iron-deficiency; Absorption; Iron; Anemia, Iron Deficiency; Bioavailability; Serum Iron

Summary: ferrous sulfate is rapidly absorbed and the bolus of iron enters blood rather quickly possibly leading to higher concentrations of non-transferrin bound iron which induces oxidative stress. the objective of this study was to determine how quickly iron enters into blood stream from the iron-enriched asperigillus oryzae (aspirontm, asp) in contrast to ferrous sulfate. seventeen healthy, female subjects (18-35 y) were randomized, double blind, cross-over experimental design with three treatments: 10 mg iron as feso4 and asp as well as 20 mg iron as asp.

in a double-blinded cross-over design, 17 research participants were randomly given one of three iron-treatments : ferrous sulfate (10mg), aspirontm (10mg), and aspirontm (20mg). each iron treatment was given with a test meal consisting of cabbage, green peas, green beans, soy sauce, peanut oil, 40 g baby carrots, steamed rice, and orange juice. each subject consumed a meal with one of the three iron supplements in a random order and all participants consumed the three supplements 2 weeks in between each treatment. prior to consuming the test meal with iron supplement for each treatment, blood was collected for baseline serum iron measuremt. following consumption of the meal with iron, subsequent blood draws were taken every 30 minutes over the time period of 4 hours to assess the incease in serum iron. ferritin, hepcidin, iron , and c-reactive protein concentrations were measured in the serum at baselime. after two weeks other treatments were administered to each participant. the serum iron response curves for each treatment were constructed and the area under the curve (auc) was calculated with the change of serum iron from baseline.

Eligibility criteria:
inclusion criteria: * non-pregnant * non-lactating * non-smoker * not taking medications * not taking dietary supplements (vitamins or minerals) * no history of gastrointestinal conditions exclusion criteria: * any history of gastrointestinal conditions * on medications that interfere with iron absorption * unwilling to stop taking dietary supplements (vitamins or minerals) * pregnant * lactating * smoker

Keywords: anemia iron deficiency anemia iron fortification ferrous sulfate aspergillus oryzae iron supplementation auc
genotyping of metastatic colorectal cancer patients for precision medicine clinical trials

Conditions: Metastatic Colorectal Cancer

Summary: the goal of delivering the right drug to the right cancer patient (precision medicine) requires a detailed understanding of how genomic alterations are linked to drug response. the purpose of this study is to intercept at point-of-care a large cohort of newly diagnosed mcrc patients to determine if it is possible to obtain personalized genetic information from each subject's tumor (tissue and blood) to triage treatment choices. in case of target positivity, patients will be conveyed, whenever possible, to self-standing, independent, hypothesis-driven poc trials as soon as they exhibit resistance to standard of care treatment.


Eligibility criteria:
inclusion criteria: * histological confirmed adenocarcinoma of the colon or rectum with metastatic disease not amenable to salvage surgery. * planned primary treatment at funnel center or funnel center referring hospital. * availability of fresh tissue or a paraffin block for genotyping not older than 1 year. * age ≥18. * ecog ps 0-1. * no major comorbidities that would preclude the potential enrolment of the patient in a clinical trial. * signed informed consent. exclusion criteria: * symptomatic brain metastases. * gastro-intestinal abnormalities, inability to take oral medication, any condition affecting absorption. * history of another neoplastic disease (except basal cell carcinoma of the skin or uterine cervix carcinoma in situ adequately treated), unless in remission for ≥ 5 years. * no major comorbidities that would preclude the potential enrolment of the patient in a clinical trial.
comparing cytokines, toxins adsorbing oxiris filter to st150 filter during crrt in patients with septic shock

Conditions: Septic Shock; Acute Kidney Injury

Summary: the oxiris® filter is a registered product for crrt already safely used in routine care. in in vitro experiments, the oxiris® filter has been demonstrated to adsorb endotoxin and cytokines. compared to conventional filters this may be advantageous in patients with severe sepsis but neither decreased levels of endotoxin and cytokines nor an improved outcome has been demonstrated with clinical use. but there are so far little clinical data on the oxiris® filter on humans. the oxiris® filter will be investigated in a double blind randomized crossover setting against a traditional filter (st150). either filter will be used for 24 hours after which it will be changed to the opposite filter for another 24 hours. arterial blood samples will be drawn at start and then 1, 3, 8, 16 and 24 hours after the start of each filter, and analyzed for endotoxin (eaa assay), tnf-α, il-1β, il-6 and il-10 (elisa) levels. standard blood tests will be analyzed simultaneously. data concerning mode and settings of crrt, heart rate, blood pressure, medication, data concerning ventilatory support and pathogen will be registered. primary endpoint: levels of endotoxin and cytokines will be compared using student's paired t-test on auc values for each 24-hour period.


Eligibility criteria:
inclusion criteria: 1. patients admitted to intensive care unit (icu) of age \>18 years with decision based on the clinical situation of the patient taken by the physician in charge that continuous renal replacement therapy will be started. 2. vasoconstrictor and volume dependent septic shock with known gram-negative infectious agent in blood culture. 3. vasoconstrictor and volume dependent septic shock suspected to be caused by a gram-negative agent and with positive plasma endotoxin test. exclusion criteria: 1. infected with hepatitis b or c or hiv. 2. dependence on dialysis treatment before the actual icu episode.
effect of limaprost in combination with transforaminal epidural steroid injection

Conditions: Lumbar Spinal Stenosis

Summary: the purpose of this study was to compare the effects of limaprost(opalmon® ) on walking ability, low back pain and leg pain after transforaminal epidural steroid injection (tfesi) was administered compared to the placebo group.

this study is a prospective, randomized, comparative clinical study that is assigned to a placebo group or a trial group before transforaminal epidural steroid injection (tfesi) is performed. the subjects of the study will receive an explanation of the study and decide to participate voluntarily in patients who have decided to undergo tfesi for neurogenic claudication and low back pain or leg pain due to lumbar spinal canal stenosis (lss). all study subjects are presented with tfesi at the level appropriate for their symptoms in the operating room and then returned to the recovery room. all participants will be monitored for non-invasive blood pressure, electrocardiography, heart rate, and peripheral oxyven saturation during and after the procedure. patients assigned to the placebo group will take placebo three times a day and one tablet once from the first day after receiving tfesi. patients assigned to the trial group will take limaprost (opalmon®) three times a day, one tablet once from the first day after receiving tfesi. in both groups, the drug was administered for 12 weeks. in both groups, during the first 4 weeks, no drug changes or additional procedures were observed, and only acetaminophen was allowed as a rescue drug. after tfesi, visits at 4 weeks, 8 weeks and 12 weeks to collect each measurement variable.

Eligibility criteria:
inclusion criteria: patients aged 18 to 85 years patients with a new or known diagnosis of lumbar spinal stenosis on magnetic resonance imaging (mri) patients scheduled to undergo tfesi due to low back pain or leg pain exclusion criteria: refusal of a patient coagulopathy systemic infection or local infection at the needle injection site patients with lumbar instability neoplasms in the needle path allergy to amide-type local anesthetics decreased cognition to the extent that nrs is incomprehensible patients with peripheral vascular disease (including peripheral arterial disease) patients taking anticoagulant or antiplatelet drugs patients with severe cardiovascular disease or liver or kidney disease patinets with cerebral infarction patinets with a history of gastrointestinal bleeding patinets who have had lumbar spine surgery or are expected to receive it within 12 months patients who show positive in the straight leg elevation test patients who are allergic or sensitive to limaprost (opalmon®) and placebo or their ingredients
imaging the effects of bihemispheric transcranial stimulation and motor training after stroke.

Conditions: Stroke

Summary: functional and structural magnetic resonance imaging (mri) will be used to investigate neural correlates of bihemispheric transcranial direct current stimulation (tdcs) associated with upper limb rehabilitation in chronic stroke patients. for this purpose, patients included will be submitted to 10 sessions with active or sham bihemispheric tdcs associated with intensive and individualized rehabilitation. neuroimage will be employed before and after the intervention to investigate neural correlates of expected changes in motor function.


Eligibility criteria:
inclusion criteria: * chronic stroke (\> 12 months) * upper limb sensorimotor sequelae due to stroke affecting only one cerebral hemisphere * the structural integrity of the corpus callosum sensorimotor * showing ability to perform some movement with the paretic upper limb: at least minimal active mobility of the wrist and two fingers of the paretic hand. * score ≥ 18 at folstein mini-mental state examination exclusion criteria: * score ≥ 4 at ashworth scale * mri or tdcs contraindications (cardiac pacemakers; implanted medication pumps; cochlear, or eye implants; craniotomy, skin lesions at the site of stimulation; surgical clips in or near the brain; claustrophobia, history of seizures, permanent makeup or tattoos with metallic dyes...) * prior neurological diseases * hemodynamic instability * pregnancy * traumatic or orthopedic lesion limiting the range of upper limb motion * severe comprehension deficits, apraxia or neglect that would interfere with performing the study tasks * score \> 59 at the fugl-meyer assessment of motor recovery after stroke

Keywords: stroke rehabilitation transcranial direct current stimulation neuroimaging neuronal plasticity
infant mortality reduction by the mass administration of azithromycin

Conditions: Child Mortality

Summary: this trial will investigate the supplementation of azithromycin distribution to the "child health days" platform in burkina faso for child mortality reduction. this distribution will pair door-to-door administration of vitamin a and azithromycin or placebo with acute malnutrition screening among children 1-11 months old.

the mordor clinical trial funded by the bill \& melinda gates foundation in malawi, tanzania, and niger demonstrated that biannual oral azithromycin distributions to children aged 1-59 months significantly reduced child mortality. the investigators hypothesize that biannual administration of azithromycin to children aged 1-11 months will reduce mortality in this age group. the aim of the project is to demonstrate that this intervention can be scaled up and produce the same benefits on mortality as those documented in smaller, more controlled studies. since 1986, to reduce child mortality, burkina faso has been administering high-dose vitamin a supplementation to children aged 6-59 months on a biannual basis through the "child health days" platform. the "child health days" are a door-to-door distribution of vitamin a coupled with screening for acute malnutrition in children aged 6-59 months and deworming of children aged 12-59 months. this approach has been successful but expensive. a new strategy implemented since september 2017 relies on community-based health workers (cbhws) to distribute vitamin a in rural areas, and on community-based distributors (cds) in urban areas. based on expert opinion and the preliminary findings of formative research conducted by the ministry of health and helen keller international, it was agreed that the child health days platform was the most appropriate platform to implement the biannual administration of azithromycin to children aged 1 to 11 months. in this trial, mortality will be measured via complete birth history which will be collected in a subset of villages in the study area before the first treatment distribution. the study team will also conduct a baseline census of the study areas for treatment coverage estimations. sixty villages (30 azithromycin, 30 placebo) will contribute to the macrolide resistance outcomes, where the study team will collect rectal and nasal swabs from children 1-59 months.

Eligibility criteria:
inclusion criteria: community eligibility criteria: * located in one of the three selected regions: sudouest, centre-ouest, hauts-bassins * verbal consent of the community leader is obtained inclusion criteria for children: * aged 1 to 11 months * living in one of the communities participating in the study exclusion criteria: community exclusion criteria: • inaccessible or unsafe for the study team exclusion criteria for children: • known allergy to macrolides

Keywords: azithromycin mass drug administration child mortality
evaluation of physiological and biomechanical efficiency of the papaw

Conditions: Spinal Cord Injuries

Summary: the main objective is to quantify energy expenditure when using the smartdrive system during manual wheelchair propulsion in external conditions (slope, straight line). for this two comparisons are performed: comparison of energy expenditure with and without the use of a system smartdrive 6 minute propulsion test. comparison the risk of musculoskeletal disorders of the wrist during a 6 minute propulsion test.

prospective study mono-centric, controlled, randomized cross over. randomization of the equipment (without and with smartdrive). 22 sci manual wheelchair users. 22 caregivers (healthy subjects)

Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 70 years * spinal cord injury * having given free and informed consent exclusion criteria: * no affiliation to a social security scheme * refusal to participate in the clinical trial * patient under guardianship * major cognitive disorder * bedsores * acute complication or systemic organ
user evaluation of bgm vgm77

Conditions: Diabetes

Summary: performance evaluation by the user of the blood glucose monitoring system vgm77compliant with din en iso 15197:2015


Eligibility criteria:
inclusion criteria: * male or female patients with hypo-, eu- or hyperglycaemia * the written informed consent had to be signed * the volunteers must be older than 18 years * the volunteers have legal capacity and are able to understand meaning, nature and possible consequences of the procedures involved exclusion criteria: * pregnancy or lactation * acute or chronic diseases with the risk of aggravation by the measure * a current constitution that does not allow participating in the study * participation in another study or activity with the blood glucose measuring system evaluated in the present study * application of substances listed in appendix a of din en iso 15197:2015