Kornimate/medical-research-clean huggingface dataset:
cereals and intestinal function

Conditions: Endotoxemia; Diet, Healthy

Summary: the aim of the present study is to determine the effect of dietary fiber on intestinal function in healthy subjects.

in the intervention study normal weight participants will receive defined amounts of different cereal flakes for several days. before and after intervention parameters of intestinal function will be assessed.

Eligibility criteria:
inclusion criteria: * bmi \<25 kg/m2 * daily alcohol consumption \<20g (men) or \<10g (women) exclusion criteria: * food allergies or intolerances * instable body weight * bmi \ 25 kg/m2 * bariatric surgery within the last 5 years * intake of antibiotics within the last month or during the study * daily alcohol consumption \>20g (men) or \>10g (women) * pregnancy and/or lactation period * viral or bacterial infection during the last three weeks * increased inflammatory markers of unknown reason * chronic or acute disease of gastrointestinal tract
computer based assessment and treatment

Conditions: Neoplasms; Pain

Summary: this study aims to investigate computer based symptom assessment in an outpatient cancer population, and the use of a computer based decision support system to facilitate the diagnosis and treatment of cancer related pain. primary hypothesis is, that this approach improves pain control and pain management in an unselected group of cancer patients in an outpatient setting. * improvement of average pain last 24 hours by at least 1.5 points on a 0-11 scale * improvement of worst pain last 24 hours by at least 1.5 points on a 0-11 scale * an alteration in the prescribing dose of opioids in equipotent opioid dosage secondary hypothesis is, that this system improves overall symptom control and symptom management in an unselected group of cancer patients in an outpatient setting.

the traditional way of symptom assessment is by the paper-and-pen method, which suffers from several limitations. the assessment items are not individually adjusted to each patient and his/her subjective symptoms, the collected data is rarely used in clinical practice, and decision-support for the physician is not possible. although the body of evidence is accumulating regarding the benefits of computerised symptom assessment in cancer patients, there is still insufficient knowledge of the impact of computerised assessment tools on the management of cancer pain and other cancer related symptoms. the combat study aims to investigate if a computer based assessment of cancer related symptoms, and a computerized decision support can improve treatment of pain and other symptoms in cancer patients. this is an open, comparative study with a sequential design with two consecutive study periods, the non-intervention period and the intervention period. the computer-based clinical decision support system will utilize the following data to generate one or several treatment options: 1. data from self assessment of cancer related symptoms 2. data from relevant variables reported by the physician 3. revisited guidelines on treatment of cancer pain

Eligibility criteria:
inclusion criteria: * attending the outpatient clinic at the cancer clinic, st. olavs hospital trondheim * histologically verified malignancy * able to follow study instructions * able to read the information on the computer screen in the intervention period of the study * able to use a touch screen in the intervention period of the study * cancer related pain measured as average pain in last 24 hours of 4 or above on a numeric rating scale * elective or emergency consultation with a physician

Keywords: decision support systems, clinical decision making, computer assisted evidence based practice practice guidelines as topic
impact of milk on erosion/abrasion of enamel and dentin - an in situ study

Conditions: Erosion Protection

Summary: this in situ study aims to investigate * the protective potential of milk and fluoridated milk on erosive wear of enamel * the protective potential of milk and fluoridated milk on erosive wear of dentin * to compare to protective potential of milk and fluoridated milk with products containing casein phosphopeptide-amorphous calcium phosphate * to compare the protective potential of milk and fluoridated milk with a fluoridated toothpaste or stannous-chloride containing fluoride solution (sncl2/amf/naf)

dental erosion is defined as the pathogenic, chronic, chemical removal of dental hard tissues due to the frequent contact to extrinsic or intrinsic acids. the dissolution process is determined by the ph, the chelating properties, mineral content and kind of acid, but in the same time modified by various biological (e.g. saliva, pellicle) and behavioural factors. the anticariogenic properties of milk are widely investigated, but information of the effects of milk or milk components on the development of erosion are limited. it is suggested that the demineralisation process is reduced by the presence of calcium and phosphate, but also that casein proteins affect the demineralisation by adsorbing to the hydroxyapatite surface and inhibiting its dissolution. initial studies suggest that milk is able to increase rehardening of acid-softened enamel, but information about the effects of milk on dentin erosion are not available yet. particularly, the effect of fluoridated milk on dental erosion was not investigated yet. in contrast, recent studies analysed the effects of products containing casein phosphopeptide-amorphous calcium phosphate (cpp-acp) on erosion, as it is suggested that cpp-acp promotes a supersaturated state and increased remineralisation of demineralised dental hard tissue. however, in situ studies on the effect of cpp-acp on erosion are limited to one study, which compared microhardness of enamel after treatment with cpp-acp and cpp-acp and 900 ppm fluoride, but failed to use appropriate controls in form of other products containing calcium and phosphate or fluoride. in summary, the effects of milk, in particular fluoridated milk, and products containing milk proteins, such as casein phosphopeptide-amorphous calcium phosphate, on erosive wear were not analysed in an in-situ-model so far.

Eligibility criteria:
inclusion criteria: * healthy volunteers exclusion criteria: * non-treated caries lesions * orthodontic treatment which does not allow to wear an intraoral device * hyposalivation * allergy against milk or milk proteins

Keywords: dental erosion enamel dentin
local application of autologous bone marrow cells for treatment of chronic diabetic ulcers

Conditions: Diabetic Foot; Diabetes Complications

Summary: bone marrow cells were previously shown to enhance wound healing in experimental diabetes. in this pilot study, patients with chronic diabetic ulcers not healing under conventional therapy, will be treated with local application of autologous bone marrow cells.


Eligibility criteria:
inclusion criteria: * diabetes mellitus * chronic non-healing foot ulcers (\>4weeks) exclusion criteria: * charcot foot * non-diabetic ulcers * ulcers healing under conventional therapy * sepsis * hematologic disorders * pregnancy * acute inflammatory disorders * chemotherapy
assessing treatment response in breast cancer with functional imaging

Conditions: Breast Cancer

Summary: patients with large primary operable breast cancers are offered chemotherapy prior to surgery to shrink the tumour and enable breast conserving surgery. conventional assessment of response to chemotherapy relies on a change in tumour size which does not always correlate with the change in amount of viable tumour. newer techniques such as functional mri, microbubble and optoacoustic ultrasound offer the potential to detect responses to chemotherapy by evaluating functional changes in tumour vascularity and oxygenation. neither modality utilises ionising radiation. although mri is widely used for detecting breast cancer, its ability in assessing functional responses to chemotherapy prior to surgery has not been fully exploited. dynamic contrast enhanced (dce) mri has a sensitivity around 90% and provides quantitative measurements of blood volume and flow. other functional techniques detect variation in tissue oxygenation: this is called the blood oxygen level-dependent (bold) mechanism. the bold technique uses a special magnetic resonance (mr) sequence called t2\* to measure the weakly magnetic effect of deoxygenated haemoglobin. the investigators wish to develop and validate t2\* measurements which relate to oxygenation of a tumour. the investigators also want to validate other mr sequences including diffusion weighted (dw) mri, which quantifies microcirculation of blood in the capillary network and the diffusion of water within tissues. microbubble ultrasound is an established technique that utilises an intravenous contrast agent comprising tiny microbubbles of gas that can increase the reflectivity of blood and enhance spectral and colour doppler signals obtained from routine ultrasound imaging. optoacoustic imaging is new technique where the output signal depends on the oxygenation of the tissues under study. it utilises a light signal input and measures ultrasound signal output. the investigators want to correlate our imaging findings with histopathology after surgical resection of the tumour.


Eligibility criteria:
inclusion criteria: * patients with breast cancer due for neoadjuvant chemotherapy exclusion criteria: * ferromagnetic implants within body in accordance with standard clinical practice * claustrophobia * age \ 90

Keywords: magnetic resonance imaging ultrasound breast cancer
home spirometry in primary care: an implementation study

Conditions: COPD Asthma

Summary: rationale: spirometry is essential in the diagnosis of airway disease and can be useful in monitoring patients. despite the essential role, spirometry remains largely underused in primary care. due to coronavirus disease (covid-19), the use of office spirometry is contraindicated in many countries. furthermore, spirometric devices are costly and personnel requires special training. referral for spirometry increases the cost for patients and lowers the feasibility. part of the reason for underdiagnosis of airway disease are the specific situations (such as exercise-induced asthma) in which spirometry in office setting might not reveal abnormalities. in recent years, handheld spirometry linked to phones/apps has been developed for study purposes and remote monitoring. objective: to study the feasibility, quality and added value of at-home spirometry for the diagnosis and monitoring of asthma and chronic obstructive pulmonary disease (copd) in primary care.


Eligibility criteria:
inclusion criteria: * age ≥ 16 years * spirometry indication * able and willing to use at-home spirometry exclusion criteria: * on the discretion of the recruiting clinician if he or she deems a patient not eligible. * inability to understand and sign the informed consent form * known previous inability to perform spirometry * contraindications to perform spirometry as listed in the standardization of spirometry 2019 update (graham et al., 2019)
a multistrain probiotic in patients with irritable bowel syndrome with predominant constipation

Conditions: Irritable Bowel Syndrome With Constipation

Summary: probiotics efficacy is mainly assessed by subjective endpoints such as the fda responder rate or global relief, which partly explain contradictory results obtained in clinical trials with probiotic bacteria. objective biomarkers of ibs will allow to measure the efficacy of probiotics. in the case of ibs-c, serum resolvin-d1 appears to be an interesting candidate due to its non-invasive and discriminating character compared to a healthy population. it is, inversely correlated with the severity of symptoms. resolvin-d1 modulates the duration and intensity of inflammation by regulating the transcription of cytokines, chemokines and their receptors as well as other proteins involved in inflammation. resolvin d1 could serve as a predictor of probiotic response based on its baseline value.

resolvin d1 levels will be measured in patients with ibs-c as defined by the rome iv criteria before 6 and 12 weeks after supplementation with a mixture of probiotics. the progression of ibs-c symptoms will also be assessed throughout the study. the correlation with resolvin d1 levels and the severity of ibs symptoms will be investigated. the efficacy of the probiotic mixture in relieving the symptoms of ibs-c will be measured and compared based on the levels of resolvin d1.

Eligibility criteria:
inclusion criteria: * irritable bowel syndrome with constipation (ibs-c) according to rome iv criteria ; * ibs-sss between 175-300 in the last 10 days ; * have experienced abdominal pain ≥ 40 according to the ibs-sss questionnaire (abdominal pain item) during the last 10 days ; * whose abdominal pain / discomfort has had a significant impact on daily life during the past 10 days (impact ≥2 on a 5-point likert scale (from 0: no impact to 5: extreme impact) ; * ability to understand instructions and complete questionnaires nurstrial app. * affiliate or beneficiary of a social security ; * having given their free, informed and written consent. exclusion criteria: * cpru \> 10 mg/l * pregnant or breastfeeding woman, woman planning a pregnancy during the study period ; * intolerance or proven food allergy ; * bmi \ 35 kg / m2 ; * diagnosis or known history of ibs-d, ibs-m, or unclassified forms of ibs, or other gastrointestinal pathologies ; * with current first-line ibs-c treatment or second-line treatment ; * alternative non pharmacological treatment ; * drug treatment affecting visceral sensitivity or intestinal transit ; * dietary modification (exclusion of fodmaps, prebiotic) or lifestyle ; * excessive smoking or drinking ; * having or planning bariatric surgery, * with known pathologies affecting gut function ; * with a deviant eating behavior, * treated with antibiotics in the 3 months preceding inclusion, * under legal protection, * already included in a clinical trial, * with severely impaired physical/psychological health may affect study participation.
community reinforcement and family training (craft)

Conditions: CRAFT; Concern Significant Others; Alcohol Use Disorder

Summary: the present study is dedicated to empowering individuals close to an addicted person (i.e. concerned significant others, csos) to create changes in their family environment: changes that increase the likelihood of the addicted person seeking treatment. the danish national clinical guideline for the treatment of alcohol dependence recommends that alcohol treatment centers offer interventions aimed at csos, providing them with the support and empowerment that will enable them to motivate the problem drinker to enter treatment. in the us, the community reinforcement and family training (craft) intervention has been shown to offer the most effective support to csos. craft has consistently demonstrated a two to three times' higher impact on getting individual with an alcohol use disorder (aud) to attend treatment, compared to other kinds of interventions. studies of the intervention so far have, however, been small, and the format used in the delivery of craft has not been fully investigated. the aim of the present cluster randomized controlled trial is to implement and investigate craft in a danish context and with sufficient sample size. consecutive csos will through cluster randomization be randomized to receive either craft in a group format, craft in an individual format, or a control condition, consisting of self-help material only. the primary outcome of the study will be the rate of individuals with aud entering treatment following the intervention targeted at the csos within three months from its initiation. data will be collected from all csos at baseline, three, and six months after baseline.


Eligibility criteria:
inclusion criteria: * 18 years and older * being a cso to a person with aud who is not currently in treatment for alcohol problems * having the intention to maintain the contact during the next 90 days * having had regular contact with the problem drinker for the last 90 days (face-to-face contact for several hours on at least a weekly basis) and having the intention to maintain the contact during the next 90 days. * being prepared support the problem drinker if he/she chooses to seek treatment, at least to some extent. exclusion criteria: * suffering from dementia or other cognitive disorders * not speaking danish * being psychotic or otherwise severely mentally ill * suffering from aud in the last three months * being concerned about a person who, according to the cso, mainly use illegal substances
effectiveness of coordinated care to reduce the prolonged disability risk among patients suffering from low back pain in primary care

Conditions: Low Back Pain

Summary: common low back pain affects about 23% of general population and can be associated with psychosocial difficulties and prolonged inability to work. its management in france mainly depends on general practioners, and sometime on physiotherapists. a coordinated care between general practioners, physiotherapists and occupational health services would help to improve the care pathway for patients and health professionals. the main objective is to assess the impact of coordinated primary care and deployed at the territories' level, in subacute or acute recurrent low back pain patients in comparison with the standard care.


Eligibility criteria:
inclusion criteria: * patient consulting an investigator gp for subacute low back pain or acute recurrent low back pain * patient with occupational activity (including sick leave) * patient depending of occupational health service * obtaining the signature of the consent to participate in this trial * patient registered with social security scheme non-inclusion criteria: * specific low back pain (fracture, infection, osteoporosis, inflammatory disease, tumor) * low back pain with sciatic, cruralgia * contraindication to active reeducation * impossibility to follow up during 12 months * patient planning to retire within the 12 months following the enrollment * disability to write or read french * adult patient protected under the law (guardianship), * pregnant, breastfeeding or parturient women * persons deprived of their liberty by judicial or administrative decision * persons subject to legal protection measures * persons unable to consent * persons on coercion psychiatric care * physiotherapy by a physiotherapist who don't participate in this trial
efficacy and safety of pulsed radiofrequency combined with platelet rich plasma to treat idiopathic glossopharyngeal neuralgia (gpn)

Conditions: Glossopharyngeal Neuralgia; Pulsed Radiofrequency; Platelet Rich Plasma

Summary: to investigate the efficacy and safety of the application of prf combined prp to the for the treatment of gpn.


Eligibility criteria:
inclusion criteria: 1. age \>18 years; 2. diagnosed with idiopathic gpn according to the third international classification of headache disorders (ichd) classification; 3. patients who failed pharmacotherapy or intolerable side effects of medication; 4. undergoing prf for gpn; 5. at least 1 month of follow-up recordings. exclusion criteria: 1. patients with bilateral gpn; 2. abnormalities in blood measurements, liver and kidney function, blood glucose, coagulation, electrocardiography or chest radiography; 3. infection at the puncture site; 4. previous mental illness; 5. previous history of narcotic drug abuse; 6. prior anticoagulant or antiplatelet therapy; 7. an implantable pulse generator; 8. current pregnancy or breast feeding. 9. patients with incomplete medical records (lack of baseline data or postoperative follow-up data).
comparison of blood sampling methods for hemoglobin measurement

Conditions: Anemia

Summary: this study is designed to inform the dhs program on whether there are variations in hemoglobin concentration using the dhs standard technique of a single drop of capillary blood and alternative blood sources (pooled capillary and venous blood) using the hemocue 201+ analyzer compared to venous blood using a clinical hematology autoanalyzer. research objectives: 1. to determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) and a pooled drop of capillary blood measured on the hemocue 201+ analyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled setting (i.e., blood specimens are collected in a laboratory setting). 2. to determine if there are differences in the hemoglobin concentration between a single drop of capillary blood (blood drop #3) measured on the hemocue 201+ analyzer against venous blood measured on hemocue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting. 3. to determine if there are differences in the hemoglobin concentration between a pooled drop of capillary blood measured on the hemocue 201+ analyzer against venous blood measured on hemocue 201+ analyzer and a clinical autoanalyzer in apparently healthy non-pregnant women age 15-49 and children age 6-59 months in a controlled and field setting. 4. to compare results of hemoglobin distribution and estimates of anemia prevalence using two types of capillary blood (single drop and pooled) and venous blood measured on the hemocue 201+ analyzer and a clinical autoanalyzer using venous blood in a controlled and field setting.


Eligibility criteria:
inclusion criteria: * children 6-59 months or non-pregnant women 15-49 * apparently healthy individuals * consent to participate in the study exclusion criteria: * children less than 6 months or over 59 months * women less than 15 years of age or greater than 49 years of age * pregnant women

Keywords: anemia dhs surveys point-of-care hemoglobin survey methods