Kornimate/medical-research-clean huggingface dataset:
fiber supplementation in heart failure with preserved ejection fraction (hfpef)

Conditions: Type2diabetes; Heart Failure With Preserved Ejection Fraction

Summary: the study team is studying how increasing dietary fiber, specifically through adding potato starch to participant's diet, may impact the species of bacteria in participant's gut microbiome. the study team also wants to understand if adding potato starch to participant's diet helps these bacteria make more short chain fatty acids, a byproduct the team thinks may benefit participant's health.


Eligibility criteria:
inclusion criteria: * a confirmed clinical diagnosis of stable hfpef on maximally tolerated heart failure (hf) medical regimen (without changes in dosage in the prior month) * left ventricular ejection fraction of \>50% documented in the prior 12 months * a confirmed clinical diagnosis of type ii diabetes (t2dm) with glycated hemoglobin \<10% without changes in medical regimen in the past month. exclusion criteria: * current usage of pre- or probiotic usage * antibiotic usage in the past 6 months * current participation in another interventional clinical trial * history of potato allergy or potato starch allergy, inflammatory bowel syndrome, inflammatory bowel disease, bowel resection, roux-en-y gastric bypass surgery, celiac disease, crohn's disease, or colorectal cancer * hypoglycemic episode with blood glucose 70 milligrams per deciliter (mg/dl) within the last month * stage iv-v chronic kidney disease * pregnancy (self-reported) * comorbidity limiting survival to \< 12 months

Keywords: fiber supplementation potato starch gut microbiome resistant starch
the healthy eating with app technology study

Conditions: Type 2 Diabetes Mellitus; Dietary Habits

Summary: the aim of this study is to investigate the effect of using new app-based technology to improve dietary habits, compared to usual care in patients with type 2 diabetes. the hypothesis is that the intervention, i.e. using the new technology an an app-based course for healthy eating habits, will have a greater positive effect on dietary habits and biological markers, including hba1c and serum lipids, than usual care.


Eligibility criteria:
inclusion criteria: * have a diagnosis of type 2 diabetes * 18 years of age or older * ability to communicate in swedish * own and use a smartphone with a personal digital id exclusion criteria: - no specific exclusion criteria apply

Keywords: smartphone application hba1c blood lipids dietary intake
maqui berry extract and omega-3 fatty acids for cytokine reduction

Conditions: Inflammation

Summary: the purpose of this trial is to determine the effect of maqui extract plus omega-3 fatty acids compared to a placebo for reducing inflammatory cytokine levels in older, obese adults.

anthocyanins, a subclass of flavonoids, are plant pigments that provide the rich color of many plants, fruits, and flowers. health benefits of anthocyanins have been widely reported in the research literature, particularly for disease conditions associated with oxidative stress, such as cardiovascular and neurodegenerative diseases. emerging evidence suggests that anthocyanins may also modulate gut microbiota, which can impact a wide variety of health conditions. maqui berries (aristotelia chilensis), indigenous to chile, have one of the highest concentrations of anthocyanins in the plant world; moreover, the dominant anthocyanin in maqui berries is delphinidin. delphinidin is more bioavailable than most flavonoids, with intact molecules absorbed in appreciable amounts in less than an hour after consumption. systemic effects of delphinidin include reduced inflammation due to downregulation of nf-kb, the transcription factor that initiates the generation of pro-inflammatory cytokines. the omega-3 fatty acid eicosapentaenoic acid \[epa\], a component of omega-3 fatty acid concentrates, also has anti-inflammatory properties. there is much empirical evidence demonstrating beneficial effects of epa supplementation, linked mainly to reductions in inflammation. it has been demonstrated the dietary supplementation with epa-rich marine oil concentrations reduces cytokine levels up to 15%.

Eligibility criteria:
inclusion criteria: * males and females 50-85 years old * generally healthy, non-smoker * able to provide informed consent * bmi: 30-40 kg/m2 exclusion criteria: * existing auto-immune conditions * use of warfarin or other blood thinners * use of anti-inflammatory drugs, cardiovascular medications, lipid-altering drugs, and hormone replacement therapy * individuals engaged in vigorous exercise (\>2 x 30 min/week), vegetarians, and people who routinely take multivitamins or herbal supplements.

Keywords: maqui berry extract omega-3 fatty acids cytokines blood lipids
to determine the role of adding campath-1h or atg given in-vivo in addition to fludarabine and low dose busulfex on outcome in patients treated with reduced intensity conditioning

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndrome

Summary: multi-institutional randomized phase iii trial of a non-myeloablative preparative regimen with fludarabine and busulfex with or without anti-lymphocyte antibodies (monoclonal humanized campath-1h administered s.c. or polyclonal rabbit anti-t lymphocyte antibodies (atg), combined with low dose and short course cyclosporine a (csa) and methotrexate (mtx) as the sole agent for prevention of graft-vs-host disease (gvhd) for patients with acute myelogenous leukemia or myelodysplastic syndrome undergoing allogeneic stem cell transplantation from an hla compatible donor.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of aml or mds, with no lower or upper age limit: * a) induction failure * b) first or subsequent remission * c) untreated first relapse * patients must have an hla compatible donor willing and capable of donating peripheral blood stem cells (first choice) or bone marrow progenitor cells using conventional techniques and blood lymphocytes if indicated (hla compatible defined as 5/6 or 6/6 matched related or 10/10 molecular matched unrelated donor (a,b,c,dr,drb1). exclusion criteria: * donor contraindication (hiv seropositive confirmed by western blot, hepatitis b antigenemia). * evidence of bone marrow disease. * unable to donate bone marrow or peripheral blood due to concurrent medical condition.
mri in multiple myeloma: analysis of the axial skeleton versus whole body. what is the required analysis?

Conditions: Myeloma

Summary: the investigators wish to determine which anatomic regions need to be explored in order to correctly diagnose myeloma: whether axial skeletal mri alone is sufficient or whether it is necessary to perform a total skeletal mri.


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * the patient is at least 18 years old * patient has been diagnosed with multiple myeloma (\> 10% medullary plasma cells + monoclonal protein) or symptomatic myeloma (myeloma + crab symptoms (hypercalcemia, renal failure, anemia, bone lesions), or indolent myeloma (myeloma with symptomatic criteria). exclusion criteria: * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * the patient is pregnant or breast feeding * the patient has an absolute contra-indication for mri (pace-maker, claustrophobic patient, metal heart valve)
a study of argx-110 in combination with azacytidine in participants with newly diagnosed acute myeloid leukemia (aml) or high risk myelodysplatic syndrome (mds)

Conditions: Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Summary: the purpose of this study is to determine the maximum tolerated dose (mtd) of argx-110 and/or the recommended phase ii dose (rp2d) in combination with a standard dose of azacytidine (aza) in phase 1; and to evaluate efficacy of argx-110 when administered at a rp2d level established in phase i in combination with a standard dose of aza (proof-of concept) by evaluating overall response rate (orr) in phase 2.


Eligibility criteria:
inclusion criteria: * signed informed consent form (icf) indicating an understanding of the purposes, risks, and procedures required for the study and willingness and ability to participate in the study * acute myeloid leukemia (aml) or high risk myelodysplastic syndrome (mds) (according to 2016 world health organization \[who\] classification definition of greater than or equal to \[\>=\] 20 percent \[%\] blasts) (bone marrow) unsuitable for intensive treatment (including stem cell transplantation) with a curative intent, but eligible to receive azacytidine (aza) treatment * expected life expectancy \>= 3 months, at the discretion of the investigator * eastern cooperative oncology group (ecog) performance status of 0, 1, or 2 * women of childbearing potential having a negative serum pregnancy test at screening and within 48 hours before infusion of argx-110 on day -14, and willing to use an effective contraceptive method (intrauterine devices, hormonal contraceptives, contraceptive pill, implants, transdermal patches, hormonal vaginal devices, infusions with prolonged release) during the study and for at least 3 months after the last study drug administration exclusion criteria: * prior or concurrent malignancy, except for the following: (1) adequately treated basal cell or squamous cell skin cancer; (2) carcinoma in situ of the cervix; (3) carcinoma in situ of the breast; (4) incidental histological finding of prostate cancer (tumour, node, metastasis \[tnm\] stage t1a or t1b), or; (5) any other cancer from which the subject has been disease-free for more than 2 years * any previous aml or mds chemo- or radiotherapy (with the exception of hydroxyurea/litalir for leukocyte control which should be discontinued by the first day of aza, local radiation therapy, therapy for basal or squamous cell carcinoma of the skin) * treatment with any investigational product within 4 weeks before the first administration of argx-110 * any known active or chronic infection, including human immunodeficiency virus (hiv) and hepatitis b or c virus infection * any other concurrent disease or medical condition that is likely to interfere with study procedures or results, or that in the opinion of the investigator would constitute a hazard for participating in this study
an open-label extension study to evaluate subcutaneous zilucoplan in pediatric participants with generalized myasthenia gravis

Conditions: Generalized Myasthenia Gravis

Summary: the purpose of this study is to assess the long-term safety and tolerability of an additional 52 weeks of zilucoplan treatment administered by subcutaneous injection once daily in pediatric study participants


Eligibility criteria:
inclusion criteria: united states of america (usa) specific inclusion criterion: - participant must be ≥ 12 years of age at the time of signing the informed consent/assent according to local regulation. rest of world (row) specific inclusion criterion: - participant must be ≥ 2 years of age at the time of signing the informed consent/assent according to local regulation. global specific inclusion criteria: * participant has completed the mg0014 according to the protocol, and further treatment with zilucoplan is in the interest of the participant in the investigator´s opinion * participant agrees to receive booster vaccinations against meningococcal infections during the study, if clinically indicated according to the local standard of care exclusion criteria: * study participant met any mandatory investigational medicinal product (imp) withdrawal or mandatory permanent discontinuation criteria in mg0014 or permanently discontinued imp * participant has known positive serology for muscle-specific kinase * participant has known hypersensitivity to any components of the imp * participant has a prior history of meningococcal disease

Keywords: generalized myasthenia gravis gmg ra101495 zilucoplan pediatric mg0015
evaluate performance and safety of hyalo4 skin in acute and chronic wounds

Conditions: Wound Heal

Summary: evaluate the performance and safety of the use of hyalo4 skin gel in terms of wound management

ths clinical investigation study is to evaluate the performance and safety of hyalo4 skin gel in the management of acute or chronic wounds of different etiology, according to the indication for use, the prescriptions of the clinicians and the standard procedures of the sites. a maximum of 7 visits will be performed, with the first 4 visits performed over a 4-weeks period for each patient and the last visit after 8 weeks from the first visit. the schedule treatment will consist of daily medication changes, according to the instruction for use and the clinical practice.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent. 2. male or female ≥18 years. 3. patients selected to be treated with hyalo4 skin gel. 4. patients with wound of the following etiology: first and second degree burns; surgical wounds; vascular ulcers; metabolic ulcers; pressure ulcers. 5. patients followed on an outpatient or home basis. 6. wound area ≥ 10 cm2 and ≤ 100 cm2 exclusion criteria: 1. patients \< 18 years. 2. patients with acute or chronic infected lesions. 3. hospitalized patients. 4. women who are pregnant or breastfeeding or women who could become pregnant and are not using effective contraception. 5. patients with acute or chronic lesions at high risk of infection, presenting at least one of the following criteria: * stalled wound, without any clinical sign of healing progression * immune system disorders * protein-energy malnutrition * alcohol, smoking and drug abuse (50ml of spirit, 0,5l of wine and 10 cigarettes/day) * conditions associated with hypoxia and/or poor tissue perfusion * corticosteroid, cytotoxic or immunosuppressive therapy. 6. subjects unable to understand informed consent or having a high probability of non-compliance with the study procedures and or non-completion of the study according to investigator's judgement
evaluation of depression in chronic obstructive pulmonary disease

Conditions: Depression in Patients With Chronic Obstructive Pulmonary Disease

Summary: background: several clinical studies show high rates of anxiety and depressive disorders in chronic obstructive pulmonary disease (copd), that suggest common underlying pathogenetic mechanisms of copd and depressive disorders. the aim of this study is to evaluate the effects of aerobic exercise, proposed in the context of pulmonary rehabilitation, in a sample of copd depressed patients without psychopharmacological treatment, through the correlation of some psychopathological variables and physical/pneumological parameters. methods: the investigators have designed an observational longitudinal trial. the trial will be prospective 6-weeks randomized clinical study to evaluate the impact of aerobic exercise on depressive symptoms in 154 patient affected by copd and depression, assessed by hamilton depression rating scale (hdrs). the investigators will also monitor anxiety, quality of life and neurocognitive function. outcome measures: the investigators compare the variation of hdrs total score, as primary outcome measure, in two groups (a, b) of copd depressed patients matched for: copd status; depressive status; age; gender. only the participants randomized in study group a will receive a 6-weeks aerobic exercise intervention. statistical analysis: all tests are two-tailed and a p value 0.05 was considered significant. the difference between the two groups will be evaluated with student's t test for normally distributed data, and with mann-whitney's u test, for those with not normal distribution. the normality of distribution will be evaluated with the kolmogorov-smirnov test. any correlations among the variables under evaluation will be assessed by spearman r correlation. variables will be compared using the chi-squared test or fisher exact test for categorical variables. discussion: there is a strong correlation between physical activity and mental health. several data have suggested that aerobic exercise shows significant effects, comparable to pharmacotherapy and to psychotherapy, on reducing depressive symptomatology. the goal of our study is to propose an effective intervention to reduce the risk of severe depression in this special population, evaluating the variation of hdrs total score after the aerobic exercise intervention.


Eligibility criteria:
inclusion criteria: diagnosis of copd and depression, eligibility to perform pulmonary rehabilitation according to ats and ers guidelines. exclusion criteria: indication to restoring treatment of airway patency and current psychopharmacological treatment (including sleeping-pills).

Keywords: depression copd aerobic exercise anxiety quality of life neurocognitive functioning
the relationship between pes planus, diaphragm, postural control, and plantar pressure

Conditions: Pes Planus; Diaphragm Issues; Plantar Pressure; Postural Control

Summary: our primary aim is to compare diaphragm function (resting thickness, activity/resting thickness ratio indicating contractility), postural control, and plantar pressure between individuals with pes planus and healthy controls without pes planus.

pes planus deformity, by causing pronation during standing, affects the biomechanics of the lower extremities. improper foot positioning can lead to changes in load distribution under the sole, and consequently, abnormal tensions in the soft tissues of the feet can spread to the upper body parts through the myofascial system. in light of all this information, our primary aim is to examine the diaphragm function and thickness in individuals with pes planus deformity and healthy individuals, and to investigate the relationship between diaphragm thickness and balance. additionally, our secondary aim is to evaluate the relationship between pes planus, diaphragm thickness, and balance.

Eligibility criteria:
inclusion criteria: inclusion criteria for individuals with pes planus deformity * willing to participate in the study voluntarily * having a navicular drop test value of 10mm or above * being between the ages of 18-30 * having the physical capacity to perform assessments and tests * having a body mass index of 18-25 kg/m² exclusion criteria: * exclusion criteria for individuals with pes planus deformity: * termination of voluntariness * those with rigid flatfoot, pes cavus, hallux valgus, hallux rigidus, or calcaneal spur deformity * those with chronic systematic and metabolic diseases (e.g., diabetes mellitus, rheumatoid arthritis, etc.) and musculoskeletal problems (e.g., pes planus) that may affect foot functions and gait * those with any surgical history likely to affect balance, lower extremity strength, and postural control * those with any visual/vestibular, musculoskeletal, or neurological problems" inclusion criteria for healthy participants: * willing to participate in the study voluntarily * being between the ages of 18-30 * having the physical capacity to perform assessments and tests * having a body mass index of 18-25 kg/m² * having the ideal height of the medial longitudinal arch of the foot (not having pes planus) exclusion criteria for healthy participants: * termination of voluntariness * those with chronic systematic and metabolic diseases (e.g., diabetes mellitus, rheumatoid arthritis, etc.) and musculoskeletal problems (e.g., pes planus) that may affect foot functions and gait * those with any surgical history likely to affect balance, lower extremity strength, and postural control * those with any visual/vestibular, musculoskeletal, or neurological problems"
the benefits of early initiation of continual renal replacement therapy in patients with severe sepsis

Conditions: Severe Sepsis

Summary: the study will evaluate the benefit of early initiation of crrt in the initial phase of severe sepsis in patients admitted to the icu. primary evaluated end-point is 28-day mortality. secondarily evaluated end-point is length of icu-stay, length of stay in hospital, duration of mechanical ventilation. there are two groups. one group of participants with early crrt initiation and another group with late crrt initiation. reference group no crrt.

the aim is to determine the optimal timing of initiation of crrt with respect to the degree and duration of acute kidney injury (aki) in icu patients. the crrt parameters and the duration of therapy will be monitored, depending on initial biochemical and clinical values of the patient. part of the study is the follow-up of patients with a 3-month delay.

Eligibility criteria:
inclusion criteria: * reaching criteria of severe sepsis, icu admission exclusion criteria: * pregnant women, younger than 18 years, reaching contraindications for initiation of renal replacement therapy
a study to evaluate the safety, tolerability, and pharmacokinetics of pb-119 injection in chinese obese subjects

Conditions: Obesity

Summary: the trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. to evaluate the safety, tolerability, pharmacokinetics(pk) characteristics, efficacy and immunogenicity of pb-119 injection in chinese obese subjects.

the trial is conducted in a single-center, randomized, double-blind, placebocontrolled, dose-increasing design. to evaluate the safety, tolerability, pk characteristics, efficacy and immunogenicity of pb-119 injection in chinese obese subjects. the study consists of 1-2 cohort . 32 patients are planned to be included in each cohort (24 patients receive study drug，8 patients receive placebo) subjects will receive treatment for 20 weeks after screening and complete 4 weeks of safety follow-up.

Eligibility criteria:
inclusion criteria: 1. chinese male or female subjects aged 18-60 years (both inclusive). 2. body weight ≥70 kg(male) or 60 kg(female), and body mass index (bmi) ≥30.0 kg/m2 at screening. 3. weight change \<5% in the past 3 months before screening. exclusion criteria: 1. fasting plasma glucose（fpg） ≥7.0mmol/l or glycosylated hemoglobin (hba1c) ≥6.5% or diagnosed diabetes 2. fpg \<3.9 mmol/l at screening and/or a history of hypoglycemia. 3. history of cushing's syndrome, polycystic ovaries, or other hereditary endocrine disorders, or obesity caused by secondary factors such as cortisol hormones. 4. abnormal thyroid-stimulating hormone(tsh), serum free triiodothyronine（ft3）, serum free thyroxine（ft4） or diagnosed thyroid dysfunction 5. history of multiple endocrine neoplasia syndrome type 2 (men-2) , medullary thyroid carcinoma (mtc) or category 4 and above thyroid nodules by thyroid ultrasound chinese ultrasound thyroid imaging reporting and data system （c-tirads） 6. diagnosed cardiovascular and cerebrovascular diseases with obvious clinical significance within 6 months before screening 7. systolic blood pressure \> 160 mmhg and/or diastolic blood pressure \> 100 mmhg at screening or randomization. 8. time history from the starting point of p-wave to the starting point of qrs wave（pr intervals ）\> 210 msec and/or qrs complex（qrs） \> 120 msec and/or corrected qt interval（qtcf） \> 450 msec at screening or randomization. 9. serum amylase or lipase \> 3× upper limit of normal (uln) at screening or before randomization, or previously diagnosed acute/chronic pancreatitis. 10. low density lipoprotein cholesterol(ldl-c) ≥4.40 mmol/l or triglyceride (tg) ≥5.65 mmol/l. 11. use of any approved or unapproved drugs or products that have an effect on body weight within 3 months prior to screening 12. history of bariatric surgery for weight loss before screening.