Kornimate/medical-research-clean huggingface dataset:
effect of chia seeds (salvia hispanica l.) on glucose control in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to determine whether the addition of salvia hispanica l. alba (salba) to the conventional treatment for diabetes is associated with improvement in major and emerging cardiovascular risk factors in people with type 2 diabetes.

cohort studies have linked consumption of whole grain with a reduction in the risk of developing diabetes and heart disease. grain of the plant salvia hispanica alba (salba) contain a high concentration of ω-3 fatty acids in addition to being a rich source of vegetable protein, fiber, calcium and antioxidants which have cardiovascular protective effect. to address the paucity of randomized, well-controlled clinical studies supporting the long-term cardioprotective benefits of whole grain we investigated the effects of a novel grain salba in type 2 diabetes. comparison(s): participants on a conventional diabetes diet (50% carbohydrate, 20% protein, 30% fat) receive either addition of salba or matched control supplement for 12 weeks separated by a 4-week washout period.

Eligibility criteria:
inclusion criteria: * all men or postmenopausal women with type 2 diabetes optimally or suboptimally controlled (hba1c \< 9.0%) on oral hypoglycemic agents or diet only were asked to participate. exclusion criteria: * those receiving insulin, alpha-glucosidase inhibitors, or hormone replacement therapy, with bmi\>38 kg/m2, smoking or significant alcohol intake (\>2 drinks/day), serum tg \>4.0 mmol/l, and those with complications of diabetes were excluded. subjects were also excluded if they regularly took fish oil and flax seed supplements or used steroids. subjects were excluded during the course of the study if there were any changes to their regular antihypertensive, lipid, or oral hypoglycemic medications, if unable to consume \>50% of supplements provided, had a significant weight change (defined as \>2.5 kg), or if their level of physical activity did not remain constant over the course of the study.
assess safety and performance of the kronos electrocautery device for electrocautery procedures following coaxial biopsy procedures

Conditions: Hepatic Disease; Renal Disease

Summary: the primary objective for this study is to assess safety and performance of the kronos electrocautery device for electrocautery procedures following coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc.

the kronos electrocautery device is intended to be used in electrocautery procedures to control bleeding by use of electrical current to heat the device probe tip that is applied directly to the target tissue area of treatment. prospective, multi-center, single-arm study with consecutive, eligible subject enrollment at each site. patients who require a coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., will be eligible to participate in this study.

Eligibility criteria:
inclusion criteria: 1. patients undergoing a scheduled, elective, coaxial biopsy procedures on areas that include, but are not limited to, liver, kidney, lungs, breasts, soft tissue, etc., 2. patients have signed an informed consent 3. patients who are ≥ 18 years of age exclusion criteria: 1. patients with known bleeding disorder 2. significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study. 3. women of childbearing potential who are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation. 4. active illness or active systemic infection or sepsis.

Keywords: hepatitis liver disease hepatic disease
segmental exclusion of the upper limb and peri-personal space

Conditions: Patients With Musculoskeletal Disorders of the Upper Limb With Symptoms of Exclusion

Summary: this study is based on previous studies on the search of the limit of the peri-personal space. in a previous study, gouzien et al. (2017) evaluated the peri-personal space of action of patients with upper limb amputations and sought a link between this space and the level of integration of their myoelectric prosthesis. we have decided to implement part of this protocol to evaluate the peri-personal space for another population with upper limb patholog: segmental exclusion of the upper limb. exclusion is a phenomenon that is very little studied but known to orthopedic surgeons and physical medicine and rehabilitation physicians. it is characterized by the non-use or underuse of a limb segment in the absence of central nervous system involvement. this phenomenon is compared to peripheral neglect. most of the time, the patient is unaware of his disorder "he forgets his finger without realizing it", but this phenomenon can be reversible under verbal exhortation from a third party. the aim of this study is to observe if there is a change in peri-personal space in patients with unilateral segmental exclusion.


Eligibility criteria:
inclusion criteria: * adult (age greater than or equal to 18 years old). * person with a symptom of unilateral exclusion. * person with no contraindication to hard work in activities of daily living due to the lesions. * person who has given informed consent. exclusion criteria: * person under 18 years of age. * person with visual impairment * a person with a central neurological pathology. * a person with cognitive impairment related to a brain injury, psychiatric illness or intellectual disability. * a person who has difficulty understanding instructions. * a person of full age who is subject to a legal protection measure or who is unable to give consent.
prospective study to evaluate a digital regimen for fibromyalgia management

Conditions: Fibromyalgia

Summary: prosper-fm is a multi-center, randomized, non-significant risk device study to evaluate the safety and efficacy of two digital therapy smartphone applications in participants with fibromyalgia. eligible participants are randomized (1:1) to either the digital acceptance and commitment therapy (digital act) group or the digital symptom tracker group and receive assigned therapy for 12 weeks.


Eligibility criteria:
key inclusion criteria: 1. participant is 22 to 75 years of age, inclusive 2. participant has a diagnosis of primary fm as defined by the 2016 american college of rheumatology preliminary diagnostic criteria for fm 3. participants with ongoing treatments should be on stable therapy for 30 days prior to screening appointment. 4. participant is capable of reading and understanding english and has provided written informed consent to participate. key exclusion criteria: 1. lifetime history of bipolar or other psychotic disorder 2. severe depression at screening (measured by bdi-ii) 3. the participant is at increased risk of suicide on the basis of the investigator's judgment or the columbia-suicide severity rating scale ("c-ssrs") 4. participant has any other disease or medical condition that, in the opinion of the investigator or sponsor, could endanger the participant, interfere with the evaluation of the study device's efficacy or safety, or compromise the participant's ability to comply with/complete the study.
the effectiveness of upper extremity isokinetic strengthening in post-stroke hemiplegia

Conditions: Stroke Rehabilitation; Hemiplegia

Summary: this randomised controlled study will investigate the effectiveness of isokinetic strengthening on the upper extremity functionality and strength in post-stroke hemiplegic patients.


Eligibility criteria:
inclusion criteria: * active motion in upper extremity * brunnstrom's scale above 3 exclusion criteria: * unstable medical conditions * cognitive problems
monoamine transporter function and autonomic regulation during psychodynamic psychotherapy

Conditions: Depression

Summary: outcome of psychodynamic psychotherapy measured by \[123i\] nor-b-cit spet imaging background psychodynamic psychotherapy is a widely practised form of psychotherapy in the treatment of depression. there is evidence that serotonin transporter (sert) densities are altered in depression. preliminary observations have suggested that sert function may recover in connection with dynamic psychotherapy. the objective was to determine whether sert densities change in relation to clinical recovery during psychodynamic psychotherapy.

n=26 method twenty six drug-naïve currently depressed (moderate/severe) patients with no previous treatment were recruited for the study. the baseline study included a group of 18 healthy controls. the patients were randomised into psychotherapy and waiting-list control groups. for controls, psychotherapy was started after a 6-month waiting period. \[123i\] nor-b-cit spet imaging was performed at baseline and after 12 months of psychotherapy. for the controls, additional imaging was performed after the 6-month waiting period.

Eligibility criteria:
inclusion criteria: * depression exclusion criteria: * antidepressive medication

Keywords: psychotherapy depression
residual risk under intensive lipid-lowering therapy in coronary heart disease

Conditions: Coronary Heart Disease (CHD)

Summary: intensive lipid-lowering therapy is a cornerstone treatment for coronary heart disease (chd). however, coronary plaque progression persists in a subset of patients even under intensive lipid-lowering therapy, which may be associated with residual lipid and inflammatory risks. current research in this area remains largely confined to post hoc analyses of randomized controlled trials , with a notable scarcity of prospective follow-up cohorts. the investigators propose that establishing a prospective cohort will provide more authentic insights into the associations between residual risk factors and plaque progression. in this project, the investigators aim to establish a well-characterized chd cohort with comprehensive data collection, good compliance, and an appropriate sample size. by focusing on non-target lesions within the target vessel and utilizing intravascular ultrasound (ivus), the investigators will investigate the impact of residual lipid and inflammatory risks on plaque progression during intensive lipid-lowering therapy.


Eligibility criteria:
inclusion criteria: * diagnosed with cad and pci was successfully performed. * presence of non-target lesions near the target lesion (more than 5mm proximal or distal), with stenosis of 20% to 50% and identifiable anatomical markers (e.g., branches, calcifications, stent edges). * 18 to 75 years old. * written informed consent. exclusion criteria: * known autoimmune diseases, or taking immunosuppressive drugs for a long time before onset. * known familial hypercholesterolemia. * critical conditions (e.g., cardiogenic shock, acute heart failure). * severe renal insufficiency (egfr \< 30 ml /(min·1.73m2)), or severe hepatic insufficiency (alt or ast≥3 times the upper limit of normal). * severe underlying diseases (such as end-stage malignancies), life expectancy \< 1 year. * allergic to lipid-lowering medications. * pregnant, or trying to become pregnant, and breastfeeding women. * other conditions deemed unsuitable for inclusion by the researcher.
coenzyme q10 and chemotherapeutic toxicity in breast cancer patients

Conditions: Breast Cancer; Chemotherapeutic Toxicity

Summary: investigating the potential effect of coenzyme q10 in ameliorating and preventing the development of paclitaxel chemotherapeutic toxicity in breast cancer patients

1. ethical committee approval is obtained from ethics committee of faculty of pharmacy, damanhour university. 2. all participants should agree to take part in this clinical study and will provide informed consent. 3. forty female patients with newly diagnosed breast cancer who are candidates for will be recruited from damanhour oncology center. 4. all enrolled patients will be randomly assigned into two arms: * control arm (n=20): will receive 80 mg/m2 of paclitaxel chemotherapy weekly for 4 cycles (12 weeks) after receiving 4 cycles of adriamycin and cyclophosphamide (ac) protocol * treatment arm (n=20): will receive the same regimen as control arm in addition to coenzyme q10 400 mg daily (200 mg twice daily). 5. all patients will be submitted to: * full patient history and clinical examination. * routine follow up before and after each chemotherapy cycle (complete blood picture, liver function tests, renal function tests). * assessing the effect of coenzyme q10 on the following: fatigue, sleep disturbance, peripheral neuropathy, nausea , vomiting , mucositis, anemia , febrile neutropenia and pruritis using common terminology criteria for adverse event (nci-ctcae) version 5. * assessing of the patient's qol by the functional assessment of cancer therapy/gynecologic oncology group neurotoxicity (fact-gog-ntx) subscale

Eligibility criteria:
inclusion criteria: 1. women with newly diagnosed breast cancer r ≥18 years old. 2. naive to chemotherapy. 3. eastern cooperative oncology group (ecog) performance status from 0-2 exclusion criteria: 1. advanced liver disease (defined as liver enzyme elevation \>3-fold upper limit of normality, or cirrhosis); chronic kidney disease (ckd, defined as an estimated glomerular filtration rate (egfr) \<60 ml min-1 1.73 m-2). 2. patients with a history of allergy to coenzyme q10 and similar compounds. 3. concomitant use of opioids, anticonvulsants, tricyclic antidepressants, other neuropathic pain medication. 4. pregnancy or breast feeding. 5. hereditary muscle disorders.
evaluation of the restart survival programme

Conditions: Invasive Breast Cancer

Summary: the restart survivorship programme has been implemented in the care pathway for patients with localised breast cancer since 2022. in this project, investigators are going to evaluate the satisfaction of patients taking part in the restart programme, as well as measuring changes in quality of life and health literacy after participation in the restart programme.

prospective longitudinal, single-centre, non-randomised study for patients who have completed acute treatment (surgery, radiotherapy, chemotherapy) for localised breast cancer within the last 3 months. in this project, investigtors are going to evaluate the satisfaction of patients taking part in the restart programme, as well as measuring changes in quality of life and health literacy after participation in the restart programme. the primary objective is to assess satisfaction with participation in the restart programme and its various components. evaluation criteria associated with the primary objective: measurement of overall satisfaction and of the various components of the restart programme (likert scale and open questions) - evaluation criteria associated with the secondary objective: to measure before starting the restart programme and 1 and 12 months after the end of the programme: * patients' quality of life (qol) (using the eortc30 and br23 questionnaires for breast cancer) * health literacy (via the hlq questionnaire) * professional status * patients' physical activity level via the global physical activity questionnaire (gpaq) * psychological distress, anxiety and depressive symptoms via the generalized anxiety disorder - 7 (gad-7) and patient health questionnaire-9 (phq-9) questionnaires * fatigue (via the nrs) * patient sleep quality using the pittsburgh sleep quality index (psqi) to measure the rate of participation in the programme via the proportion of patients who participated in relation to the number of patients operated on for breast cancer located in bordet during the same period.

Eligibility criteria:
inclusion criteria: 1. age \>= 18 at the time of signing the icf 2. minimum understanding of french 3. signed study informed consent form obtained prior to any study-related procedure. 4. participation in the restart programme 5. patient with curative breast cancer (ajcc stage i-ii-iii) exclusion criteria: -
nepafenac once daily for macular edema - study 2

Conditions: Non-Proliferative Diabetic Retinopathy; Cataract

Summary: the purpose of this study is to demonstrate superiority of nepafenac ophthalmic suspension, 0.3% dosed once daily relative to nepafenac vehicle based upon clinical outcomes among diabetic participants following cataract surgery.


Eligibility criteria:
inclusion criteria: * planned cataract extraction by phacoemulsification with implantation of a posterior chamber intraocular lens; * history of type 1 or 2 diabetes and non-proliferative diabetic retinopathy (npdr) (mild, moderate, or severe) in the study eye; * best-corrected visual acuity (bcva) of 73 letters or worse in the study eye with expectation of improvement after surgery; * understand and sign an informed consent document; * other protocol-defined inclusion criteria may apply. exclusion criteria: * pre-existing macular edema in the study eye; * history in the study eye of retinal detachment, wet age-related macular degeneration, chronic or recurrent inflammatory eye disease, or prior procedures; * planned cataract surgery in the fellow eye prior to the day 90 postoperative study visit or through study exit; * planned multiple procedures for the study eye during the cataract/intraocular lens; * use of exclusionary medications, including nonsteroidal anti-inflammatory drugs (nsaids) and steroids, as specified in protocol. * participation in any other clinical study within 30 days of the screening visit; * females of childbearing potential who are breast feeding, have a positive urine pregnancy test at screening, are not willing to undergo a urine pregnancy test upon entering or exiting the study, intend to become pregnant during the study, or do not agree to use adequate birth control methods for the duration of the study; * other protocol-defined exclusion criteria may apply.

Keywords: diabetes type i diabetes type ii non-proliferative diabetic retinopathy macular edema cataract
evaluation of iodine supplementation in women with pregnancy associated with gestational diabetes

Conditions: Gestational Diabetes

Summary: iodine supplementation during pregnancy is recommended by the high health authority and by the world health organization during pregnancy. we would like to know if this supplementation is prescribed in a manner consistent with the recommendations in women diagnosed with gestational diabetes.

physiological iodine requirements are increased in pregnant women, from 150 μg / day to 250 μg / day. the iodine intake is assessed by the iodine concentration in the urine, the target of which in pregnant women is ioduria between 150 and 250 μg / l. the general french population is not deficient in iodine according to the national nutrition health study in 2006-2007, with a median ioduria of 136 μg / l (therefore greater than 100 μg / l) for all elderly adults aged 18-74. however, according to french studies, the median ioduria of pregnant women is between 50 and 100 μg / l, which suggests a moderate iodine deficiency. to maintain euthyroidism, the mother must increase her t4 production by 40- 50% (10-150%), which requires an additional iodine intake of 150-250 μg / d the thyroid contains a reserve of iodine, but this is depleted during pregnancy in the absence of supplementation. our study therefore aims to assess the amount of iodine supplementation prescribed in pregnant women diagnosed with gestational diabetes because this group of patients benefit from early specialized care for their pregnancies.

Eligibility criteria:
inclusion criteria: * pregnant woman with gestational diabetes * age ≥ 18 years * subject informed of the study and not having opposed it. exclusion criteria: * already known pathology of the thyroid

Keywords: iodine intake iodine supplementation gestational diabetes
ttp and ahus in complicated pregnancies

Conditions: Thrombotic Thrombocytopenic Purpura; Atypical Hemolytic Uremic Syndrome; Pre-Eclampsia; HELLP Syndrome; Thrombocytopenia; IUGR; Stillbirth; Thrombotic Microangiopathies

Summary: a single site observational study aiming to: (i) identify cases of previously undiagnosed thrombotic thrombocytopenic purpura (ttp) and atypical haemolytic syndrome (ahus) in a cohort of women with complicated pregnancies (ii) characterise the clinical features of these cases and (ii) identify clinical features or biomarkers which may help distinguish ttp/ahus from other complications of pregnancy such as preeclampsia


Eligibility criteria:
inclusion criteria: - women, either currently pregnant or recently postpartum, and affected by one or more of the following complications in the index pregnancy: (i) preeclampsia with evidence of end organ damage (renal/ liver/ haematological/ neurological) or uteroplacental dysfunction (fgr/iufd) (ii) hellp syndrome (iii) fetal growth restriction (fgr) (growth \ 85umol/l 1st trimester, or \>80umol/l 2nd trimester, or \>90 umol/l 3rd trimester\[32\]; or an increase in serum creatinine by (i) at least 1.5 times the baseline or (ii) of equal or greater than 26.5umol/l (as per kdigo criteria) (vi) unexplained new onset thrombocytopenia (platelets \<75x10\^9/l) exclusion criteria: * previous diagnosis of ttp or ahus * known disorder of complement dysregulation * patients not wishing to participate * patients aged less than 16 * patients lacking capacity to provide informed consent
controlled hyperventilation as prophylaxis for acute mountain sickness

Conditions: Altitude Sickness

Summary: this study evaluates the safety and efficacy of the voluntary ventilatory response as prophylaxis for acute mountain sickness, measured by the lake louise self-report score, comparing to a group using acetazolamide.

rationale: acute mountain sickness (ams) is a common condition among people who go to altitude and stay at altitude. acclimatization is the most important mechanism in order to reduce the risk of ams, however, this is not possible or adequate in a large part of the cases. recently, there are indications that adjustment of respiration by means of a voluntary increase in the respiratory minute volume can have a similar prophylactic effect. the purpose of this study is to measure the effect of the voluntary increase of the minute volume by means of controlled hyperventilation as prophylaxis for acute mountain sickness without prior acclimatization, with ams being expressed in the lake louise self-report score (llsrs). objective: to investigate the safety and efficacy of the voluntary increase in minute ventilation by means of controlled hyperventilation as prophylaxis for ams, measured by the llsrs in a randomized controlled trial ascending to 4954m altitude. study design: prospective randomized controlled trial, safety and efficacy. study population: 30 healthy subjects intervention: the investigational prophylaxis is controlled hyperventilation. participants in the interventional group will be trained to hyperventilate in a controlled fashion doing a series of exercises during the 4 days prior to the ascent. they will also be taught in a practical way to recognize early clinical signs and symptoms of hypocapnia. main study parameters/endpoints: safety and efficacy measured by comparing the llsrs between the two groups. target end-tidal co2 ( petco2) will be measured to objectify adequate hyperventilation. symptoms of hypocapnia due to the (pre-)intervention as well as any adverse events will be reported and analysed.

Eligibility criteria:
inclusion criteria: * living at lower altitude than 900 meters exclusion criteria: * cardiac or pulmonary comorbidity * smoking * infectious disease during the last 30 days * bmi\> 30 * pharmaceutical use as diuretics, corticosteroids, acetazolamide, or anti -inflammatory drugs during the 2 weeks prior to the study * a history of high altitude cerebral edema or high altitude pulmonary edema * cardiovascular risk factors such as a personal history of cardiovascular disease, familial history of major adverse cardiovascular events (mace) at age younger than 45 yrs, hypercholesterolemia and stroke.