Kornimate/medical-research-clean huggingface dataset:
diabetes intervention trial with vitamin d in subjects of nordic and sub-indian ethnicity

Conditions: Diabetes Mellitus Type 2; Hypovitaminosis D

Summary: the aim of this 6 months study is to evaluate the metabolic effects of 400.000-600.000 iu of vitamin d supplementation in subjects with type 2 diabetes and hypovitaminosis d. the main hypothesis is that subjects with low levels of 25-oh-vitamin d will benefit from supplementation with cholecalciferol in sufficient doses to optimize serum levels.

accumulating evidence suggests that hypovitaminosis d may be associated with the development of type 2 diabetes and disturbances in glucose and insulin metabolism. there is lack of data from randomized, controlled studies of sufficient duration and with the use of sufficient doses of vitamin d to assess the importance of vitamin d supplementation in glucose metabolism in type 2 diabetes.

Eligibility criteria:
inclusion criteria: 1. moderate (s-25ohd 25-50 nmol/l) to severe (s-25ohd \< 25 nmol/l) vitamin d deficiency measured at visit 1. 2. patients with type 2 diabetes, including drug naïve subjects, subjects using oral anti-diabetic medication and subjects on insulin treatment. all medication must be in stable doses during the 4 week lead-in period. 3. hba1c \< 11 % at visit 1. 4. able to communicate in norwegian. 5. men and women ≥ 18 years. 6. norwegian or south asian ethnicity. 7. women of childbearing potential (wocbp) must be using an adequate method of contraception to avoid pregnancy throughout the study. all wocbp must have negative serum or urine pregnancy test at enrollment, randomization, titration visit and final study assessment. 8. antihypertensive medication, lipid lowering drugs, oral contraceptives, hormone replacement therapy, multivitamin supplements and nutritional supplements are allowed if the subjects adhere to the same regimen during the study exclusion criteria: 1. subjects not having type 2 diabetes. 2. sbp ≥ 160 or dbp ≥ 95 at visit 1. 3. significant renal disease or chronic renal impairment, gfr\< 30 ml/min. 4. significant liver disease or asat or alat \>3x unl. 5. malignancy during the last five years. 6. hypercalcemia at visit 1. 7. a history of kidney stone disease 8. wocbp unwilling or unable to use an acceptable method to avoid pregnancy. 9. pregnant or breastfeeding women. 10. chronic inflammatory disease in active phase 11. long term (\>2 weeks) use of corticosteroids last 3 months 12. mental condition (psychiatric or organic cerebral disease) rendering the subject unable to understand the nature, scope and possible consequences of the study. 13. drug or alcohol abuse. 14. bmi \> 45 kg/m2 or bariatric surgery (\<5 years). 15. anemia 16. cardiovascular disease (myocardial infarction, unstable angina pectoris or stroke) during the last 6 months. 17. any medical condition that in the judgment of the investigator would jeopardize the subject's safety or evaluation of the study drug for efficacy and safety.

Keywords: insulin resistance insulin secretory dysfunction inflammation vascular stiffness
validation of accexible's automated speech analysis method for the early detection and monitoring of patients with mild impairment or dementia in primary care

Conditions: Mild Cognitive Impairment; Dementia

Summary: dementia, especially dementia caused by alzheimer's disease, is considered one of the most severe health problems of our time. it is currently known that the disease begins many years before clinical symptoms appear. the sooner the patient is diagnosed, the sooner the patient will be in a position to prevent further deterioration. a recent orientation is the analysis of language in relation to the description of images with a high and varied semantic and emotional content. it can be studied that changes in the description of an image check if these changes are associated with the evolution of a person with probable impairment both in memory and cognitive as well as emotional, psychiatric, behavioral and even in their interaction with environmental factors especially those associated with socialization and loneliness. thus, the purpose of this study is to validate speech analysis ai models.


Eligibility criteria:
inclusion criteria: * adult patients 55+ years of age with suspected mci or diagnosis of dementia and obtains a score greater than 20 on the mmse. * patients must have agreed to participate in the study and have voluntarily signed the informed consent. * (healthy) participants without a diagnosis neurological, or psychiatric disorders. or taking medication that can affect cognitive abilities. exclusion criteria * to have received a diagnosis of a significant psychiatric disorder or other cognitive impairment not due to neurodegeneration. * to have significant vision problems that would affect the ability to perceive visual stimuli. * to have significant hearing problems that would affect the ability to understand verbal cues.
a pivotal safety and efficacy study of ocs-01 eye drops in participants with diabetic macular edema (diamond 1)

Conditions: Diabetic Macular Edema

Summary: the primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of ocs- 01 as compared to vehicle in participants with diabetic macular edema (dme).

a phase 2/3 pivotal double-masked, randomized, vehicle-controlled, 2 stage, multicenter study of the efficacy and safety of ocs-01 eye drops in participants with diabetic macular edema stage 1: to select a dose and dosing regimen for ocs-01 in participants with dme and evaluate the efficacy and safety of ocs-01 as compared to vehicle in participants with dme. stage 2: to evaluate the efficacy and safety of ocs-01 as compared to vehicle at week 52 in participants with dme.

Eligibility criteria:
inclusion criteria (selection) - stage 1: 1. have a signed informed consent form before any study-specific procedures are performed. 2. have dme with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (cst) of ≥310 µm by sd-oct at screening (visit 1) (as assessed by an independent reading center). 3. have a documented diagnosis of type 1 or type 2 diabetes mellitus at visit 1 (screening). inclusion criteria (selection) - stage 2: 1. have a signed informed consent form before any study-specific procedures are performed. 2. have dme with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (cst) of ≥310 µm by sd-oct at screening (visit 1) (as assessed by an independent reading center). 3. have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to visit 1 (screening). exclusion criteria (selection) - stage 1 and stage 2: 1. have macular edema considered to be because of a cause other than dme. 2. have a decrease in bcva because of causes other than dme. 3. have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Keywords: topical ophthalmic suspension eye drop
healey als platform trial - regimen a zilucoplan

Conditions: Amyotrophic Lateral Sclerosis

Summary: the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. regimen a will evaluate the safety and efficacy of a single study drug, zilucoplan, in participants with als.

the healey als platform trial is a perpetual multi-center, multi-regimen clinical trial evaluating the safety and efficacy of investigational products for the treatment of als. this trial is designed as a perpetual platform trial. this means that there is a single master protocol dictating the conduct of the trial. the healey als platform trial master protocol is registered as nct04297683. once a participant enrolls into the master protocol and meets all eligibility criteria, the participant will be eligible to be randomized into any currently enrolling regimen. all participants will have an equal chance of being randomized to any currently enrolling regimen. if a participant is randomized to regimen a - zilucoplan, the participant will complete a screening visit to assess additional regimen a eligibility criteria. once regimen a eligibility criteria are confirmed, participants will complete a baseline assessment and be randomized in a 3:1 ratio to either active zilucoplan or matching placebo. regimen a will enroll by invitation, as participants may not choose to enroll in regimen a. participants must first enroll into the master protocol and be eligible to participate in the master protocol before being able to be randomly assigned to regimen a. for a list of enrolling sites, please see the healey als platform trial master protocol under nct04297683.

Eligibility criteria:
inclusion criteria: * the following inclusion criterion is in addition to the inclusion criteria specified in the master protocol (nct nct04297683). 1. vaccination with a quadrivalent meningococcal vaccine and meningococcal serotype b vaccine at least 14 days prior to the first dose of study drug at the baseline (day 0) visit. meningococcal vaccines (including boosters) should be administered in accordance with the study's vaccination worksheet. exclusion criteria: * the following exclusion criteria are in addition to the exclusion criteria specified in the master protocol (nct nct04297683). 1. history of meningococcal disease. 2. prior treatment with a complement inhibitor.

Keywords: als placebo-controlled double-blind regimen-specific appendix lou gehrig's disease zilucoplan ra pharmaceuticals
zonisamide versus topiramate in migraine

Conditions: Migraine

Summary: investigators aim to compare the effect of zonisamide versus topiramate in migraine by assessing the absolute reduction in mmd in each group, the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency

investigators will enroll 600 migraine patients who are diagnosed according to ichd3-beta criteria in our study and will use a questionnaire to detect their demographic and clinical features (disease duration, attack frequency, and duration, pain intensity assessed by the visual analogic scale and we have two groups the first group will include 300 patients and will receive 100mg zonisamide daily and acetaminophen 500-1000 mg in acute attack, and the second group will receive topiramate100 mg per day and acetaminophen 500-1000 mg in acute attack for at least three months. investigators will assess the number of migraine days after three months of treatment and the percentage of patients who achieved ≥ 50% reduction in the monthly headache days frequency compared to the baseline frequency. hit-6 score reduction in each group after three months of treatment. the safety of lacosamide was evaluated by monitoring and documenting treatment-emergent adverse events (teae) in patients through regular follow-up procedures for three months.

Eligibility criteria:
inclusion criteria: * migraine patients, according to the international classification of headache disorders 3rd edition, * age from 10 to 55 years, exclusion criteria: * patients with major neurological disorders such as ( epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, brain tumors, and patients with essential tremors. * patients with major systemic diseases such as malignancy, collagen, liver, and renal diseases. * patients with cardiovascular diseases, such as hypertension (systolic blood pressure of more than 130 and/or diastolic blood pressure of more than 85 mm/hg on at least three different occasions), diabetes (fasting plasma glucose level \>126 mg/dl and/or casual plasma glucose \>200 mg/dl), and/or hba1c more than 6.5. * patients with valvular and ischemic heart diseases, bradycardia or heart blocks, congestive heart failure patients who received prophylactic treatment for migraine, patients with any contraindications to drugs used in the study patients with bronchial asthma, chronic obstructive pulmonary disease

Keywords: zonisamide topiramate migraine
effect evaluation of a workplace intervention targeting subjective health complaints

Conditions: Mental Disorders; Back Pain; Anxiety; Depression

Summary: mental disorders is one of the most frequent causes of long-term sick leave and disability pensions in norway, and there is a need for a comprehensive, coordinated response from health and social sectors at the country level to address the burden of mental disorders. the aim of this project is to investigate if a workplace intervention with the aim to increase coping of common mental health complaints and social support can reduce sick leave and improve health.

the atwork intervention was established in 2007 as a new stepped-care approach to musculoskeletal complaints. the intervention consisted of workplace information meetings about musculoskeletal complaint to all employees and peer support. the atwork intervention targeting musculoskeletal complaints reduced sick leave and improved health in a randomized controlled trial. the atwork intervention has now been further developed with the aim to increase effect on sick leave and health. the intervention is now extended to include information about mental health complaints, in addition to a management course. the major societal costs and the negative consequences common mental health complaints induce underline the importance of testing if atwork is an effective way of reducing these consequences.

Eligibility criteria:
inclusion criteria: * norwegian primary education unit. * participants must be employed in one of the norwegian primary education units participating in the study. * participants must have sufficient norwegian reading and writing skills. exclusion criteria: * the organization has received the atwork intervention at an earlier time. * participants are not employed in one of the participating organizations. * participants do not have sufficient norwegian reading and writing skills.

Keywords: sick leave mental health coping social support subjective health complaints
food collection from type 1 diabetic patients practicing insulin functional therapy

Conditions: Diabetes Type 1

Summary: a food collection will be performed in this study with type 1 diabetic patients trained to carbohydrate counting, to collect data on the meals consumed daily and their quantities for a period of 1 month.


Eligibility criteria:
inclusion criteria: * type 1 diabetic patients * using carbohydrate counting and functional insulin therapy * patient with social security or beneficiary * patient able to read and understand the procedure, and able to express consent for the study protocol exclusion criteria: * patient abusing substances * person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure -- patient having a psychological conditions making him unable to follow and understand study protocol

Keywords: diabetes functional insulin therapy carbohydrate counting
integrated diagnostic for heart failure

Conditions: Heart Failure

Summary: a prospective post-market study to evaluate the performance and clinic usability of heart failure risk status (hfrs) feature on carelink.

patients with systolic heart failure (hf) implanted with medtronic wireless implantable cardiac defibrillator (icd) or cardiac resynchronization therapy device with defibrillation capabilities (crt-d) devices will be enrolled in the study. the purpose of the study is to evaluate the usability of carelink hfrs to manage a patient's heart failure.

Eligibility criteria:
inclusion criteria: * patient is 18 years of age or older * patient ( or patient's legally authorized representative) is willing and able to provide written informed consent * patient is willing and able to comply with the required study follow up visits * patient is implanted with a medtronic wireless icd or crt-d device capable of optivol fluid monitoring feature * patient is on medtronic carelink network or is willing to be enrolled on the carelink network * patient is being managed, or has been managed, by a hf clinician * patient has signed an informed consent for carelink network services * patient is implanted with device for at least three months * patient is willing and able to transmit data using the carelink home monitor (2490c). exclusion criteria: * patient is participating in another study that may interfere with triage-hf protocol required procedures * patient with an implantable cardiac device that is indicated to reach eri in less than 12 months

Keywords: heart failure hfrs optivol icd crt-d
online mindfulness-based stress reduction intervention for people with chronic pain waiting for health services

Conditions: Chronic Pain

Summary: the goal of this project is to explore the feasibility and the efficacy of a online mindfulness-based stress reduction intervention for people with chronic pain waiting for secondary or tertiary health care services


Eligibility criteria:
inclusion criteria: * men and women aged 18-85 * self-reported diagnosis of chronic non-cancer pain * chronic non-cancer pain duration of 3 months or more * chronic non-cancer pain experienced during 4 days or more per week * average pain intensity of 4 or more out of 10 in the last seven days * french or english fluency * access to wi-fi * be able to attend a weekly two-hour mbsr virtual session for eight consecutive weeks exclusion criteria: * cancer-related chronic pain * currently receiving or have received in the last 24 months coordinated care in pain clinics, hospitals or rehabilitation centers. * current or recent participation (in the last 12 months and more than 12 sessions) of cognitive-behavioral therapy or mbsr program * having an unstable psychological conditions such as depression, bipolar disorder, post-traumatic stress disorder, psychotic disorder

Keywords: mindfulness-based stress reduction intervention
the effect of mindfulness meditation and loving-kindness and compassion meditation on psychological distress

Conditions: MM Group; LKCM Group; Waitlist Group

Summary: the purpose of the study is to explore the effect of of mindfulness meditation and loving-kindness and compassion meditation on psychological distress (i.e., anxiety, depression, stress), and explore the mechanism from the perspective of reinforcement sensitivity theory.

participants were randomly assigned to three groups: mindfulness meditation group (mm, n = 51), loving-kindness and compassion meditation group (lkcm, n = 51), and waitlist group (n = 50). participants in mm group and lkcm group received four weeks intervention, and data was collected before the intervention and after the intervention.

Eligibility criteria:
inclusion criteria: (1) have not attended structured meditation intervention; (2) have not diagnosed psychiatric diseases; (3) not currently receiving or has never received psychological counseling; (4) not currently taking or has never taken psychotropic medication; (5) age is less than 18. exclusion criteria: (1) have attended structured meditation intervention; (2) have diagnosed psychiatric diseases; (3) receiving or have received psychological counseling; (4) taking or have taken psychotropic drugs; (5) age is more than 18.

Keywords: mindfulness, loving-kindness and compassion
linked color imaging (lci) for colorectal adenoma detection

Conditions: Colon Adenoma; Colonic Polyp

Summary: linked color imaging (lci) is newly developed image-enhancing endoscopy technology that differentiates the red color spectrum more effectively than white light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. this technology, combined in the latest generation fujifilm's endoscopes (fujifilm co, tokyo, japan) with new high-performance led illumination system, enhances the visibility of colonic mucosal vessels and might increase the detection rate of colorectal polyps. data available regarding colorectal polyp or adenoma detection with lci are encouraging but are scanty and limited to back-to back studies. this two parallel arms, randomized, multicenter trial is aimed at evaluating whether lci is superior to wl endoscopy in terms of adenoma detection

50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (fit) and meeting all eligibility criteria are randomised 1:1 to lci (lci group) or wli (wl) during insertion and withdrawal phase of colonoscopy. a randomisation list for each participating center was produced by the coordinating center via computer-generated treatment code list. randomisation is stratified by gender, age (50-60, 61-729 years) and screening history (first vs subsequent test) through an online centralised study database.all procedures are performed with a high-definition eluxeo 700 series videocolonscopes with or without magnification (ec-760r, ec-760zp, fujifilm co., tokyo). the primary outcome measure is the adr, defined as the proportion of participants with at least one adenoma (per-patient analysis).

Eligibility criteria:
inclusion criteria: * 50-75 years-old subjects participating in the regional screening program undergoing their first colonoscopy following a positive immunochemical fecal occult blood test (fit) exclusion criteria: * subjects not eligible for invitation in the screening program (colonoscopy already performed in the previous 5 years, personal history of crc, colonic adenomas or ibd, severe comorbidity, including end-stage cardiovascular, pulmonary, liver or renal disease) * patients with inadequate bowel preparation (defined as boston bowel preparation scale \> 2 in any colonic segment) * patients with previous colonic resection * patients on antithrombotic therapy, precluding polyp resection * patients who were not able or refused to give informed written consent.

Keywords: adenoma detection rate linked color imaging colonoscopy
trilostane for androgen-independent prostate cancer

Conditions: Prostate Cancer; Prostate Adenocarcinoma

Summary: the main purpose of this study is to test the safety of trilostane by looking at what effects, good and bad, it has on patients with androgen-independent prostate cancer.

* patients will take trilostane orally once a day for three days, then twice a day thereafter. * patients will complete a daily drug log recording the date, time and number of capsules taken. * trilostane may moderately decrease the production of steroids by the adrenal glands. in order to prevent any symptoms related to decreased steroid production, patients will also take hydrocortisone at the same time as the trilostane. * while the patients are on treatment blood work will be done after 2 weeks and then every 4 weeks to test the levels of psa in the blood. on weeks 4 and 8 of treatment additional blood work will be done to check hormone levels. blood pressure and pulse rate will also be taken every 4 weeks. * depending upon disease status, radiological testing (ct scan, x-rays, and/or bone scan) may be repeated every 12 weeks. * patients will remain on study treatment as long as their disease responds and they do not experience any severe side effects.

Eligibility criteria:
inclusion criteria: * histologically confirmed prostate adenocarcinoma * disease progression despite androgen depravation therapy and antiandrogen withdrawal * progressive measurable disease or bone scan progression or psa progression * serum total testosterone \< 50ng/ml * creatinine \< 2.0 mg/dl * alt \< 2 x uln * calgb performance status of 0,1, or 2 exclusion criteria: * radiation therapy within 4 weeks * antiandrogen within 8 weeks * other secondary hormonal therapy or investigational agents within 4 weeks * prior chemotherapy for androgen-independent prostate cancer * history of adrenal insufficiency * known brain metastases * severe liver or renal disease

Keywords: trilostane androgen-independent prostate cancer