Kornimate/medical-research-clean huggingface dataset:
the meal tray as a tool and platform to change eating habits among hospitalized diabetic patients - an intervention study

Conditions: Type 2 Diabetes

Summary: this protocol is intended to test whether a focused nutritional intervention in hospitalized patients with type 2 diabetes can have an impact on long term eating habits, physical activity and anthropometric parameters. the rational is to use the food tray as a means of conveying simple and practical nutritonal and behavioral messages.

patients hospitalized at hadassah medical center who have type 2 diabetes will relieve a focused nutritional intervention using mainly the food tray during the hospitalization. the intervention will be administered by the hospital nutrition team. at baseline (upon admission) - medical data will be collected as well as nutritional and behavioral questionnaires will be administered. the intervention will take place during the hospitalization period. follow up using the same tools will be performed at 3 and 12 month. we believe that the hospitalization period, even for reasons non related to diabetes, is a window of opportunity to implement lifestyle changes.

Eligibility criteria:
inclusion criteria: * age 20-80 years * diagnosis of type 2 diabetes * speaking and reading hebrew exclusion criteria: * chronic medical condition requiring a specific diet * non hebrew speaking * pregnant women

Keywords: type 2 diabetes nutrition lifestyle modifications
bariatric surgery and pharmacokinetics of losartan

Conditions: Obesity, Morbid

Summary: changes to gastric ph, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. these factors are potentially influenced by bariatric surgery. little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. in this study the pharmacokinetic effects of bariatric surgery on losartan are investigated.


Eligibility criteria:
inclusion criteria: * preparing to undergo gastric bypass or sleeve gastrectomy in central norway * being a norwegian citizen exclusion criteria: * having previously undergone resections in the gi-tract

Keywords: bariatric surgery gastrointestinal tract biological availability pharmacokinetics losartan
biphasic insulin aspart 30 in type 2 diabetes failing oad therapy

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in the united states of america (usa). the aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing oad therapy.


Eligibility criteria:
inclusion criteria: * insulin naive type 2 diabetes * currently treated with oads alone or combined with other treatment for at least 3 months * bmi below 40 kg/m2 and body weight below 125 kg * hba1c greater than or equal to 8% exclusion criteria: * inability to tolerate metformin or contradictions to its use * pregnant, breastfeeding or intention of becoming pregnant * allergy to any of the trial products * inability or unwillingness to perform smbg
drug use investigation for rotarix®

Conditions: Infections, Rotavirus

Summary: this study aims to assess the safety of oral rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in japan.

this is non-interventional study conducted in one group received oral rotarix®. this surveillance is abbreviated as smiler (surveillance and monitoring in living clinical experience for rotarix).

Eligibility criteria:
inclusion criteria: • infants who receive rotarix for the first time to prevent rotavirus gastroenteritis, an indication of rotarix, will be included in the investigation. exclusion criteria: • all infants included in the special drug use investigation of oral rotarix will be excluded.

Keywords: rotavirus rotarix drug use investigation safety
dose-finding and safety study of shr4640 in subjects with hyperuricemia

Conditions: Hyperuricemia

Summary: the objective of the study is to assess efficacy and safety of shr4640 in subjects with hyperuricemia.


Eligibility criteria:
inclusion criteria: 1. 18-70 years, male or female; 2. subject meets one of the following conditions: 1) subject with a history of gout has a serum uric acid ≥480μmol/l at screening; 2) subject with a history of hyperuricemia has a serum uric acid ≥540μmol/l at screening, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3) subject with a history of hyperuricemia has a serum uric acid≥480μmol/l at screening, on stable treatment for hypertensive, hyperlipidemia or diabetes for at least 3 month, and requiring long-term uric acid-lowering therapy per the investigator's judgment; 3. 18kg/m2≤ bmi ≤32kg/m2. exclusion criteria: 1. subject who is pregnant or breastfeeding; 2. alanine aminotransferase or aspartate aminotransferase or total bilirubin\>1.5 upper normal limit; 3. estimated glomerular filtration rate (mdrd formula) ˂60ml/min; 4. hba1c˃8%; 5. subject with known hypersensitivity or allergy to shr4640 or any component of shr4640; 6. subject with a history of malignancy; 7. subject with a history of urolithiasis, or positive findings on ultrasound examination at screen 8. subject within the last 3months has: myocardial infarction, angina, percutaneous transluminal coronary angioplasty, coronary artery bypass grafting, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, or transient ischemia attack; 9. subject has acute gout flares within 2 weeks before randomization; 10. subject who is taking any other urate-lowering medication (allopurinol, febuxostat, probenecid and benzbromarone) that is indicated within 2 weeks before randomization and can not stop during the study; 11. subject who is taking more than 100mg once daily or unstable dosage aspirin within 2 weeks before randomization and can not stop during the study; 12. subject who is taking any diuretic within 2 weeks before randomization and can not stop during the study.

Keywords: shr4640, phase ii, monotherapy, dose-finding
educational intervention to increase the emotional competence of patients with oesogastric and bronchopulmonary cancers

Conditions: Digestive System Neoplasms; Thoracic Neoplasms

Summary: the aim of this study is to test whether a short educational intervention about emotional skills can improve survivor cancer patient emotional skills and quality of life. half of participants will follow the educational intervention about emotional skills, while the other half will practice relaxation followed by a non-directive talking group. the educational intervention should give better results on patient emotional skills and quality of life than the control group.

after the end of treatments, cancer patients face a difficult time because it is expected that they return to normal, but at the same time they still have to struggle with the aftermath of cancer and fear of recurrence. this is why there is room in this period for an intervention designed to help patients to cope with their emotions. . patient emotional skills are patient abilities to identify, express and manage their emotions for the best possible psychological adjustment. in general population, emotional skills have been shown to be highly related to a better quality of life. in this randomized controlled study, bronchopulmonary and oesogastric cancer patients between 6 months and 2 years after the end of treatments will undergo either the emotional skills intervention (intervention group) or the relaxation group (control group).

Eligibility criteria:
inclusion criteria: * ≥18 ans, * oesogastric or bronchopulmonary cancer patients between 6 months and 2 years after the end of cancer treatments * patient of the chru (regional teaching hospital) of lille, * registered with a social security scheme * speak and understand french language * signature of the informed consent to participate in the study. exclusion criteria: * cognitive disorders or unstabilized psychiatric disorders that may impair the ability of reasoning and thinking necessary to complete the questionnaires and attend workshops * difficulty or deficiency that prevent the patient from a good understanding of the imperatives of the research * any situation likely to significantly affect emotional competence during the study according to the investigator's judgment (in particular, ongoing psychotherapy ) * patients under judicial protection (guardianship or curators).

Keywords: emotional intelligence quality of life
low back pain and antibiotic treatment

Conditions: Low Back Pain

Summary: clinical trial using antibiotic treatment, namely rulid, after onset of low back pain.

clinical trial using antibiotic treatment, namely rulid, after onset of low back pain.

Eligibility criteria:
inclusion criteria: - must be able to swallow tablets exclusion criteria: - allergy to antibiotics

Keywords: low back pain
remote yoga nidra for anxiety and sleep

Conditions: Insomnia Due to Anxiety and Fear

Summary: the goal of this application is to collect survey data indicating the effects of a digital yoga nidra practice on anxiety and sleep during covid-19. we will explore effects on momentary anxiousness, as well as on sleep. participants will be consented through redcap during the yoga nidra class, then asked to complete an intake form, a sleep questionnaire (composed of questions from the post sleep questionnaire (psq)) and a pre/post state trait anxiety (stai) index, surrounding the practice. participants will receive an email the next morning, inquiring about their sleep (\~2 min survey), and again the following week, the morning of the yoga nidra class, in order to remind them about the weekly class offering and also to collect sleep data for a night that did not include pre-bed yoga nidra. we will additionally report feasibility measures including enrollment, retention, qualitative feedback, and challenges of using the digital platform. using this data, we will gain valuable feasibility data for implementation of this type of mind-body practice using digital platforms. we will also gain important data on the effects of this practice on anxiety and sleep.


Eligibility criteria:
inclusion criteria: * adults * can understand a recording in english while resting comfortably exclusion criteria: na
intravenous immunoglobulin and plasma exchange in myasthenia gravis

Conditions: Myasthenia Gravid

Summary: immunomodulation is effective in treating patients with myasthenia gravis (mg), but prior studies have not adequately defined if plasma exchange (plex) in superior to intravenous immunoglobulin (ivig) in the treatment of myasthenia gravis. this study aimed to determine if plex was superior to ivig in the treatment of patients with myasthenia gravis. patients with mg requiring immunomodulation are randomized to ivig or plex and treated with a full course of immunomodulation. the quantitative myasthenia gravis score (qmgs) will be evaluated as the primary efficacy parameter at day 14 to determine if plex is superior to ivig.


Eligibility criteria:
inclusion criteria: * \>18 years old * diagnosis of moderate-severe mg (defined as a quantitative myasthenia gravis score qmgs \>10.5) * worsening weakness requiring a change in therapy judged by a neuromuscular expert exclusion criteria: * worsening weakness secondary to concurrent medications (e.g. aminoglycosides) * worsening weakness secondary to infection * change in corticosteroid dosage in the 2 weeks prior to screening * other disorders causing weakness or fatigue * known absolute iga deficiency (risk of anaphylactic reaction to ivig) * history of anaphylaxis or severe systemic response to ivig or albumin * pregnancy or breastfeeding * active renal failure precluding volume of ivig (risk of volume overload with ivig) as judged by the investigators * clinically significant cardiac disease precluding ivig volume as judged by the investigators * known hyperviscosity or hypercoaguable state (risk of stroke with ivig) * known coagulopathy with bleeding * on another current study medication or protocol within 4 weeks of screening * patients with known refractory status to either ivig or plex * poorly controlled or severe hypertension (exacerbation by ivig) * patient refuses treatment with either ivig or plex * patient refuses follow-up with electrophysiological studies * patient unable or unwilling to give informed consent

Keywords: myasthenia gravis ivig plex
effectiveness of mometasone nasal irrigation for chronic rhinosinusitis

Conditions: Chronic Rhinosinusitis (Diagnosis); Allergic Rhinosinusitis; Chronic Eosinophilic Rhinosinusitis

Summary: chronic rhinosinusitis (crs) affects up to 12.5% of the us population and has a significant disease burden. the recommended medical management of crs includes large-volume, low-pressure saline lavage, systemic antibiotics, and intranasal corticosteroids (incs). while the efficacy and safety of incs are well-established for the long-term management of crs, penetration of incs beyond the nasal vestibule and into the paranasal sinuses is limited. the aim of this study is to evaluate the effectiveness of mometasone furoate large-volume, low-pressure nasal irrigation for surgery-naive crs patients.

mometasone furoate nasal spray (mfns) is a incs that is used in the management of crs. the overall goal of this proposed research project is to optimize topical delivery of mf to the paranasal sinuses in surgery-naive crs patients through the use of high-volume, low-pressure nasal saline irrigation. the investigators will be conducting a single-site, double-blinded, placebo-controlled randomized clinical trial (rct) in which we propose to evaluate the effectiveness of mf nasal irrigation compared to mf nasal spray.

Eligibility criteria:
inclusion criteria: 12-weeks or longer of two or more of the following signs and symptom consistent with crs: * mucopurulent drainage(anterior, posterior, or both) * nasal obstruction (congestion) * facial pain-pressure-fullness * and decreased sense of smell and inflammation documented by one or more of the following findings: * purulent mucus or edema in the middle meatus or ethmoid region * radiographic imaging showing inflammation of the paranasal sinuses. exclusion criteria: * inability to speak or understand english * nasal polyps * history of nasal or sinus surgery * comorbid mucociliary conditions * dependence on prolonged corticosteroid therapy for comorbid conditions, such as asthma and chronic obstructive pulmonary disease * history of oral or systematic antibiotic use in the past 2 weeks * history of allergy to mf or other topical steroids * pregnant or breastfeeding * participants with a baseline snot-22 score of 9 or less will be excluded due to inability to achieve a minimally clinically improved difference pre- and post-intervention.

Keywords: mometasone irrigation, mometasone spray, chronic rhinosinusitis
effects of pain scrambler therapy for the alterations of cerebral blood

Conditions: Pain, Neuropathic

Summary: prevalence of chronic pain has been shown to be high after thermal injury. post-burn neuropathic pain causes chronic disabilities that is often difficult to treat effectively. pain scrambler therapy is a patient-specific electrocutaneous nerve stimulation device. to study changes in the pain network associated with neuropathic pain, magnetic resonance imaging(mri) was used to evaluate cerebral blood volume(cbv) in patients who had been injuried by burn. participants (n=40, experimental 20 and control group 20) comprised patients with neuropathic pain after thermal injury. the subjects complained of severe neuropathic pain that was rated at least 5 on the visual analogue scale (vas), despite treatments with gabapentin medication and other physical modalities. each scrambler therapy with the mc5-a calmare® therapy device (competitive technologies, inc. fairfield, usa ) was performed for 40 min daily (monday through friday) for 10 consecutive days. the stimulus was increased to the maximum intensity bearable by the individual patient without causing any additional pain or discomfort. the intensity of neuropathic pain was measured using the visual analogue scale(vas). depressive mood was assessed using the beck depression scale. voxel-wise comparisons of relative cbv maps were made between before scrambler therapy and after 10 scrambler therapy sessions over the entire brain volume. the relationship between individual participant cbv(measured in voxels), bds and vas score was also examined. we observed decreased in the cerebral pain network of patients with burn injury. scrambler therapy is a non-invasive, non-medicinal modality that significantly reduced burn-associated neuropathic pain. scrambler therapy should be considered as a treatment option for burn survivors with severe neuropathic pain.

the groups (scrambler therapy and sham therapy) were randomly assigned. all subjects were recruited in scrambler thrapy and sham stimulation. main study outcomes included group differences in cbv changed and the the relationship between cbv changes and neuropathic pain intensity. these analyses were performed using the same framework of the general linear model, which was repeatedly applied to each voxel with the same coordinates.

Eligibility criteria:
inclusion criteria: * burn patients * severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (nrs) exclusion criteria: * cardiac arrest history * history of neurologi disease or brain surgery * unstable heart disease or presence of a cardiac pacemaker * pain resulting from other causes like as neuromuscular diseases * psychiatric disorder * diabetes mellitus * abnormal renal function * contraindication for mri, or pregnancy.

Keywords: burn pain scrambler
investigation of the clinical performance of silicone hydrogel contact lenses during continuous wear

Conditions: Myopia

Summary: the primary purpose of this study is to investigate the clinical performance of a new silicone hydrogel contact lens during continuous wear (up to 30 nights) over a period of 24 months.


Eligibility criteria:
inclusion criteria: * has had an oculo-visual examination in the last 2 years. * is correctable to at least 6/7.5 distance visual acuity in each eye with spherical contact lenses. * is a current soft contact lens wearer. * has no clinically significant anterior eye findings. * has no other active ocular disease. exclusion criteria: * has any systemic disease that might interfere with contact lens wear * is using any systemic or topical medications that will affect ocular health. * has any pre-existing ocular irritation that would preclude contact lens fitting. * has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. * has undergone corneal refractive surgery. * is pregnant, lactating or planning a pregnancy.
optimal effective local anesthetic volume for pain relief using brachial plexus block

Conditions: Post Operative Pain

Summary: prospective, patient-blinded study utilizing a novel continuous reassessment method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.

success or failure of the brachial plexus block for any given volume will be determined by the verbal analogue pain scale score obtained 60 minutes after surgical end time. volumes will be determined by continuous reassessment method.

Eligibility criteria:
inclusion criteria: * surgical candidate for arthroscopic rotator cuff surgery * asa i-iii * bmi\<40 * age \>18 exclusion criteria: * inability to give informed consent * inability to complete consent process in english * allergy to ropivacaine * neuropathy * contraindications to peripheral nerve block per asra guidelines * chronic opioid use * infection at the injection/catheter site * limb restriction due to medical history * history of moderate - severe lung disease.

Keywords: brachial plexus block
evaluation of the antibiofilmogramme® test during diabetic foot infections

Conditions: Diabetic Foot; Staphylococcus Aureus

Summary: this is an observational study that does not change routine care. the primary objective of this study is to investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of s. aureus strains and prescribed antibiotics) in the presence/absence of s. aureus strains at the end of a first regimen of antibiotics.

the secondary objectives are: a. should a first regimen of antibiotics fail, to describe the bacterial community present in the wound, and its potential to create biofilms. b. to investigate the role of antibiogramme-antibiofilmogramme concordance (in terms of s. aureus strains and prescribed antibiotics) in wound healing. c. to study the potential role of additional antibiofilmogramme data, as well as that of other pre-defined co-factors, in predicting wound changes. d. create an s. aureus strain collection for future ancillary studies.

Eligibility criteria:
inclusion criteria: * the patient must have given his/her informed and signed consent * the patient must be insured or beneficiary of a health insurance plan * the patient is available for 7 to 10 weeks of follow-up * patient with a foot wound (at least stage 2 or more) that is infected by at least 1 strain of s. aureus exclusion criteria: * the patient is participating in, or has participated in within the past 3 months, another interventional study, or is currently in an exclusion period determined by a preceding study * the patient is under judicial protection, under tutorship or curatorship * the patient refuses to sign the consent * it is impossible to correctly inform the patient * the patient is pregnant, parturient, or breastfeeding * emergency situation precluding correct study implementation

Keywords: antibiogramme antibiofilmogramme
71a/g hsd17b5 snp and effects of oral contraceptive pill in pcos women

Conditions: Polycystic Ovary Syndrome

Summary: an association of the single nucleotide polymorphism (snp) in the promoter gene that codify for 17b-hsd5 enzyme (71a\>g) with polycystic ovary syndrome (pcos) and hyperandrogenemia has been suggested in previous studies. given the role of 17b-hsd5 in androgenic metabolism producing testosterone from precursors, the investigators hypothesis is that women with pcos and with the variant allele g have a poor response on hirsutism and on hormonal and metabolic variables after oral contraceptive pill (ocp) treatment for 6 months.


Eligibility criteria:
inclusion criteria: * hirsute women with polycystic ovary syndrome exclusion criteria: * use of any drugs known to interfere with hormone levels for at least 3 months before the study * women with type 2 diabetes, homa index \> 3.8, liver or renal disease or thyroid dysfunction * other hyperandrogenic disorders than pcos

Keywords: pcos oral contraceptive pill polymorphisms