Kornimate/medical-research-clean huggingface dataset:
intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy.

Conditions: Iron Deficiency Anemia of Pregnancy

Summary: intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy

iron deficiency (id) in pregnant women can cause iron deficiency anaemia (ida). id is defined by low iron stores, measured by a low level of s-ferritin. iron is essential for the synthesis of haemoglobin (hb). anaemia is defined by a low hb level (\<11.0 g/dl in 1st trimester, \<10.5 g/dl in 2nd, and \<10.5 - 11.0 g/dl in 3rd trimesters). in danish pregnant women, who do not take iron supplementation approximately 50 % have id and 21 % have ida. according to who anaemia, defined as hb \<11.0 g/dl, regardless the cause is estimated to occur in 24 % of danish pregnant women. this trial is designed to evaluate and compare the effect of iv iron isomaltoside to a fixed dose of oral iron administered as tablet ferrous fumarate with ascorbic acid as correction of ida in pregnant women after 4 weeks of standard treatment.

Eligibility criteria:
inclusion criteria: 1. women aged ≥18 years 2. pregnancy at ga 14+0 - 19+0 3. ferritin \<30 μg/l after 4 weeks of standard treatment in a clinical setting 4. willingness to participate and attend all planned follow-up visits, and signing the in-formed consent form exclusion criteria: 1. history of anaemia caused by e.g. thalassemia, hypersplenism or haemolytic anaemia (known haematologic disorder other than iron deficiency) 2. iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 3. drug hypersensitivity (i.e. previous hypersensitivity to iv iron) 4. known hypersensitivity to any excipients in the investigational drug products 5. history of active asthma within the last 5 years 6. history of multiple allergies 7. known decompensated liver cirrhosis or active hepatitis 8. active acute or chronic infections (assessed by clinical judgement) 9. rheumatoid arthritis with symptoms or signs of active inflammation 10. treated with iv iron products or blood transfusion within 4 weeks prior to inclusion 11. treated with erythropoietin (epo) within 4 weeks prior to inclusion 12. participation in any other interventional trial where the trial drug has not passed 5 half-lives prior to inclusion 13. any other medical condition that, in the opinion of the investigator, may cause the subject to be unsuitable for the completion of the trial or place the subject at potential risk from being in the trial 14. meeting rbc-transfusion criteria (hb ≤6.9 g/dl= 4.3 mmol/l with intolerable symptoms of anaemia like severe palpitations, severe dizziness, shortness of breath at rest or syncope or an hb ≤6.4 g/dl (4.0 mmol/l) without intolerable symptoms of anaemia) 15. multiple pregnancies 16. inability to read and understand the danish language
beer for endurance exercise recovery

Conditions: Hyponatremia

Summary: athletes who are participating in the keys100 ultramarathon event in key west, fl are eligible, based on inclusion criteria, to participate in this research study that is seeking to determine whether supplementation of beer (alcohol) immediately following a long distance ultramarathon race can positively impact exercise-associated hyponatremia \[eah\].


Eligibility criteria:
inclusion criteria: * completed informed consent * ability to read and speak english language * age 21 years or older * not considered a vulnerable population, such as pregnant (by history) or cognitively impaired. * able to tolerate needle exposure for blood draw * willing to drink alcoholic or nonalcoholic beer * willing not to eat or drink other than the study fluid during 1 hour study period * participating in 100 mile or 50 mile race * to participate in the controlled part of the study the individual must have fully completed either the 100 mile or the 50 mile race. exclusion criteria: * under age 21 years * vulnerable population, such as pregnant (by history) or cognitively impaired * subjects who are alcohol-naive (i.e first exposure to alcohol) * subjects with known familial and/or genetic backgrounds at higher risk for the development of alcohol dependence * subjects should not be seeking treatment for alcohol or drug abuse * subjects who are in general high risk for abuse such as those completing or participating in alcohol or drug abuse programs * subjects who have had a sustained period of abstinence, with history of heavy drinking problems, while living in the community

Keywords: body water/physiology hyponatremia/etiology physical exertion/physiology running/physiology sodium/blood ethanol
impact of pillboxes on medical adherence

Conditions: Chronic Disease; Medication Adherence

Summary: this study uses an experimental design to test the impact of different types of pillboxes on medication adherence. participants in this study will randomized to receive one of the three pillbox interventions: 1) a standard seven day a week, one-dose per day pillbox with training 2) an off-the-shelf pillbox that was purchased specifically for the individual's needs with training and education, or 3) a customized 3d printed pillbox that was designed and manufactured specifically to the individual's needs with training and education. participants will have three visits with the research team to collect baseline data, receive the pillbox, and collect follow up data. risks to the study include loss of time, boredom, invasion of privacy, and medication errors. the investigators have taken precautions to mitigate these risks. this study will improve understanding of medication adherence and potentially help us better address poor medication adherence which needlessly causes morbidity, mortality, and costs over $300 million in unnecessary healthcare costs each year.


Eligibility criteria:
inclusion criteria: * 18 years of age or older * speak english * be prescribed to take two or more medications per day, and manage their own medications. exclusion criteria: * have a significant cognitive impairment * unwilling to use a novel pillbox * unable to meet with the research team

Keywords: assistive technology
study of efficacy and safety of cvaa489 in hypertensive patients

Conditions: Essential Hypertension

Summary: the population that will be included in this study, will be regular turkish hypertensive patients who are expected to consume sodium in high amounts. it is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (bp) control rate as expected from literature.


Eligibility criteria:
inclusion criteria: * male or female, above 18 years of age * diagnosis of essential hypertension * newly diagnosed, * previously untreated, or currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period) * written informed consent exclusion criteria: * known or suspected secondary hypertension * egfr lower than 30 ml/min * use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase * history of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide) * history of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. * use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected pd effect has returned to baseline, whichever is longer.pregnant or nursing (lactating) women * other protocol-defined inclusion/exclusion criteria may apply.

Keywords: essential hypertension
clopidogrel for the prevention of new onset migraine headache following transcatheter closure of atrial septal defects

Conditions: Migraine

Summary: the addition of clopidogrel on top of aspirin may reduce the occurrence of new-onset migraine headache episodes following transcatheter asd closure.

the objective is to evaluate the incidence and severity of new-onset migraine headache episodes following transcatheter asd closure in patients treated with aspirin alone compared to those on aspirin + clopidogrel therapy as antithrombotic treatment after the procedure. this is a prospective, randomized, double blind, multicenter study, including patients with no previous history of migraine attacks who have been diagnosed with an asd and for whom transcatheter asd closure has been clinically indicated. patients will be randomized either to aspirin (80 mg/day) or aspirin (80 mg/day) + clopidogrel (75 mg/day) for 3 months following asd closure. the occurrence and severity of migraine headaches will be evaluated by a neurologist using a structured headache questionnaire at 1 month and 3 months following asd closure. an additional 6 month and 1 year follow-up evaluation will be exploratory according to local feasibility.

Eligibility criteria:
inclusion criteria: * patients ≥ 18 year old undergoing transcatheter asd closure with the amplatzer septal occluder device (aga medical corp., mn, usa). * female subjects must be post-menopausal, surgically sterile, or using an effective method of birth control. * signed an informed consent document. exclusion criteria: * allergy or intolerance to any of the antithrombotic drugs (aspirin, clopidogrel) used in the study. * need for anticoagulation therapy. * use of asd closure devices other than the amplatzer septal occluder device. * history of migraine headaches (based on migraine headache questionnaire). * refusal to sign the informed consent. * pregnancy or breast-feeding or planning to become pregnant during the study. * previous stroke.

Keywords: migraine atrial septal defects transcatheter clopidogrel
skin protection during radiotherapy in patients with breast cancer

Conditions: Radiation Dermatitis

Summary: radiotherapy may cause severe skin changes that significantly interfere with the patient's quality of life and may reduce radiotherapy effectiveness. many skin care instructions and various topical agents are recommended to help patients in the management of radiation skin reactions, but evidence to support the value of the topical treatments of the irradiated skin is lacking. in the present study we investigated the effects of two topical agents used as supportive care to protect skin during radiotherapy.

women with breast cancer and were to receive breast radiotherapy to 50 gy were enrolled in a prospective randomized trial to compare the effectiveness of evoskin®) for protecting skin compared to trixiera. to account for individual differences in radiation each subject served as her own control, as each was to apply the experimental and control agents to the irradiated breast. each patient was randomly assigned to use evoskin on the half of the irradiated breast and to use the triexiera on the other half. dermatitis was graded weekly by means of a spectrophotometer.

Eligibility criteria:
inclusion criteria: * 18 years old or more * patients with breast cancer for which a treatment by radiotherapy is planned * no concomitant chemotherapy * signed informed consent exclusion criteria: * cutaneous neoplasia radiotherapy * total mastectomy * bilateral breast cancer * dark skindiseases enhancing radiosensitivity patient with a generalized skin disorder * pregnant, breast-feeding woman
e-health intervention in women with pregnancy distress

Conditions: Pregnancy Distress

Summary: the study aims to reduce the levels of distress (depression and anxiety) during pregnancy. the study investigates the effectiveness of an ehealth pregnancy distress-reducing mindfulness training in women with pregnancy distress.

during pregnancy, women are at risk for mental health problems: up to 20% present with distress symptoms (depression and/or anxiety). apart from the adverse effects on the woman herself, pregnancy distress negatively affects pregnancy outcome, infant health, postpartum mother-child interaction and child development. mindfulness-based interventions are a type of intervention that is increasingly being used to treat symptoms of stress, anxiety and depression. they are cheap and accessible to the whole population. current study aims to examine the effectiveness of a mindfulness training to reduce distress during pregnancy. women who score above cut off on the edinburgh depression scale (eds) and tilburg pregnancy distress scale (tpds) at 12 weeks of gestation, will be randomly allocated to the intervention or control group. women in the intervention group will be contacted and invited to participate in the mindfulness-based intervention, which consists of 8 weeks of internet mindfulness training. the control group will receive care as usual. the primary outcome of the study is: does the mindfulness internet training "ontspannen zwanger", offered during pregnancy, reduce pregnancy distress, compared to care as usual? the secondary outcome is: does the mindfulness internet training result in better mindfulness skills?

Eligibility criteria:
inclusion criteria: * pregnant women (18+y) who have their first antenatal visit \< 12 weeks; * score above cut off on the edinburgh depression scale (eds) and tilburg pregnancy distress scale (tpds) at 12 weeks of gestation; * dutch-speaking or understanding dutch. exclusion criteria: * gemelli pregnancy (or higher order pregnancy); * known endocrine disorder before pregnancy (diabetes-i, rheumatoid arthritis); * severe psychiatric disease (schizophrenia, borderline or bipolar disorder); * hiv; * drug or alcohol addiction problems; * any other disease resulting in treatment with drugs that are potentially adverse for the fetus and need careful follow-up during pregnancy; * no access to the internet.

Keywords: anxiety depression ehealth mindfulness pregnancy distress
tolerability, pharmacokinetics, and efficacy of apd371 in participants with crohn's disease experiencing abdominal pain

Conditions: Crohn's Disease; Abdominal Pain

Summary: the purpose of this randomized, open-label, parallel, phase 2a study is to determine the tolerability, pharmacokinetics, and efficacy of olorinab in participants with crohn's disease experiencing abdominal pain.


Eligibility criteria:
key inclusion criteria: * a clinical diagnosis of crohn's disease for at least 3 months prior to screening corroborated by prior endoscopic and histopathologic documentation consistent with crohn's disease. * quiescent to mildly active inflammatory crohn's disease defined with a total of simple endoscopy score for crohn's disease (ses-cd) score of \< 10 or fecal calprotectin \< 500 mcg/g within 4 weeks before screening. * moderate to severe abdominal pain as defined by average abdominal pain score (aaps) of \>/= 4points on 7 consecutive days of the screening period up to day -2. aaps will be based on the 11-point numeric rating scale where 0 (no abdominal pain) to 10 (worst possible abdominal pain). key exclusion criteria: * female participants who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on day 1 prior to study drug administration. * recent history (within 6 months of screening visit) of cerebrovascular disease, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, myocardial infarction, unstable angina. * other significant chronic pain conditions that in the opinion of the investigator may influence the abdominal pain score. * history of extensive colonic resection, subtotal or total colectomy. * history of \>3 small bowel resections or diagnosis of short bowel syndrome or who have undergone bowel resection within 6 months prior to randomization. * chronic active hepatitis b within the last year (unless shown at the time of study entry to be hepatitis b antigen negative) or any history of hepatitis c. * evidence of current gastro-intestinal infection (bacterial or parasitic) or significant infection within 45 days of screening. note: other protocol defined inclusion/exclusion criteria may apply.
neuraxial anaesthesia: does bmi relate to ease of neuraxial anaesthesia?

Conditions: Obesity; Neuraxial Ultrasound; Obstetric Anaesthesia

Summary: neuraxial anaesthesia can be more difficult and associated with more complications if the patient's bony landmarks are difficult to palpate. they are more likely to be difficult to palpate if a patient has a high body mass index (bmi), (\>30kg/m2). the depth that the spinal or epidural needle must be inserted is usually longer in these patients with high bmis. we wish to palpate the backs of at least 100 such patients to see how many of them have impalpable bony landmarks. we then wish to use ultrasound to measure the distance from skin to the posterior epidural complex to discover if this length is longer than the standard needle length. if it is longer in the majority of people we study, we will recommend changing standard practice to start using a longer needle for all first attempts at neuraxial anaesthesia in this patient population.

complications rates including failure are higher in obese patients undergoing anaesthesia procedures. anaesthetists have adopted the use of ultrasound to assist in overcoming these difficulties. neuraxial ultrasound is proving to be beneficial in those patients in whom identification of interspinous spaces is difficult and most of these patients are obese. in our institution, there is a 'standard practice' for neuraxial procedures, with a 'standard' needle used for first attempts (whitacre 25g 90mm for spinal, tuohy 18g 80mm for epidural). if the operator has not reached the desired space (spinal or epidural) with the needle inserted to 8cm, a longer needle is then considered for further attempts. this exposes the patient to at least one extra neuraxial needle insertion. studies have shown that increased needle insertions and redirections are associated with increased complications. we hypothesised that a large number of patients with bmi\>30kg/m2 would have a depth of spinal/epidural space that is greater than the length of the 'standard' needle used. therefore we suggest that practice should change to use the longer needle or a combined spinal-epidural on the first attempt in these patients. to test our hypothesis, we will assess the ease of palpation of the following anatomical landmarks: anterior and posterior iliac crests; lumbar spinous processes; scapulae; and sacral cornua. we will then perform neuraxial sonography of the lumbar spine, measuring depth to epidural space. finally we will measure waist circumference in those patients with bmi \<30kg/m2.

Eligibility criteria:
inclusion criteria: * recorded bmi \>30kg/m2; ability to give consent; non-emergency cases. exclusion criteria: * previous metal work to lumbar spine.

Keywords: bmi obstetric anaesthesia neuraxial anaesthesia neuraxial ultrasound difficult neuraxial anaesthesia
clinical impact of ipack block addition to suprainguinal fascia iliaca block

Conditions: Analgesia; Pain Management; Acute Pain

Summary: in our clinic, routine suprainguinal fascia iliaca block (sifib) has been administered for postoperative analgesia in patients undergoing knee arthroplasty. recently, we have introduced the ipack (infiltration between the popliteal artery and capsule of the knee) block to this regimen, and the aim of this retrospective study is to determine whether the addition of the ipack block enhances the quality of analgesia. knee arthroplasty, also known as knee joint replacement surgery, is a common procedure performed to alleviate pain and improve joint function in patients with knee osteoarthritis or other knee-related conditions. postoperative pain management is crucial for patient comfort and overall recovery. in this study, we aimed to compare the two techniques mentioned earlier, namely the sifib (suprainguinal fascia iliaca block) and the sifib+ipack, by examining the data of patients who underwent knee arthroplasty under spinal anesthesia at our clinic between january 1, 2023, and september 1, 2023.


Eligibility criteria:
inclusion criteria: * patients meeting the following criteria and whose postoperative follow-up forms were completed in full were included in the study * patients underwent total knee arthroplasty (tka) * asa class i to iii. * operated under spinal anesthesia * patient controlled analjgesia device was used for analgesia exclusion criteria: patients whose data were inaccessible or had incomplete follow-up forms were excluded from the study to ensure the accuracy and reliability of our analysis. * pca device problems in follow up in 24 hours * anesthesia plans were converted to general anesthesia * spinal anesthesia failure * peripheral blocks used other than protocol

Keywords: analgesia ipack sifib
predictors of outcome and natural history in patients with cervical spondylotic myelopathy

Conditions: Cervical Spondylosis With Myelopathy

Summary: cervical spondylotic myelopathy (csm) is the most frequent cause of myelopathy in those over the age of 50. they claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established. in order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.

cervical spondylotic myelopathy (csm) is the most frequent cause of myelopathy in those over the age of 50 \[1\]. it is believed to have a generally progressive course over a period of years, with sudden acceleration especially following a slight head and neck injury, leading to significant disability \[2, 3\]. the treatment of csm remains a problem, particularly in the mild and moderate forms without rapid progression. excellent outcomes for surgery have been presented in many studies. all of the studies, however, are retrospective, and many lack a clear design, standard criteria, control groups, and sufficient follow-up, so it is difficult to compare \[4, 5, 6\]. furthermore, several studies and critical reviews are not so optimistic. they claim that surgical treatment of myelopathy, especially of the mild and moderate forms, has not shown better results than conservative treatment in the long term, and criteria for the indication and the timing of the operation have not been established \[7, 8, 9\]. twenty-five percent of patients with laminoplasty suffer from severe neck and shoulder pain for more than 3 months \[10\], with significant morbidity from the iliac crest donor site etc. surgery to decompress and stabilize the spine is often advocated for severe or progressive symptoms, with mixed results. about two-thirds of patients improve with surgery, whereas surgery is not successful in 15% to 30% of cases \[11\]. in order to get some more reliable data, a long-term follow up observational study will be started to confirm the effects of long term for conservative treatment.

Eligibility criteria:
inclusion criteria: 1. clinical signs and symptoms of cervical cord dysfunction 2. magnetic resonance imaging (mri) criteria for cervical multisegmental cord compression and/or myelopathy due to spondylosis (including soft disc herniations) with or without developmentally narrow spinal canal 3. age under 75 years 4. patient's consent to conservative treatment it has been suggested that magnetic resonance imaging exclusion criteria: 1. spinal cord compression, without clinical symptoms 2. previous surgery on the cervical spine 3. uncertainty about the presence of significant additional diseases (such as motor neurone disease, progressive polyarthritis) 4. cervical cord dysfunction due to tumors, trauma, soft disc herniation or previous surgery 5. serious that require a surgical procedure