bioihbjkbjnl/mcl2 huggingface dataset:
Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline
Condition: Subjective Cognitive Decline (SCD)
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of this study is to examine the effect of polyamine supplementation on
      cognitive performance and further characterization of individuals with subjective cognitive
      decline.
    

Detailed description: 
      Memory abilities are known to decline during aging, a process that is accelerated in
      pathological conditions like mild cognitive impairment (MCI) and Alzheimer's disease (AD),
      all of which are a growing public-health concern with devastating social and economical
      effects. Polyamines supplementation and corresponding up-regulation of autophagy (i.e.,
      cellular protein degradation pathways) may be a key target of intervention against
      age-related memory decline. The study will investigate whether a polyamine-enriched dietary
      supplementation (through capsule intake) could provide positive effects on cognitive function
      and biomarkers of elderly individuals (60-90 years old) with subjective cognitive decline
      (SCD).
    

Intervention name(s): Polyamine; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 12 months of polyamine supplementation (6 capsules/day); 12 months of placebo intake (6 capsules/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: subjective cognitive decline; Alzheimer's disease, dementia; dietary supplement; polyamine; prevention; treatment; lifestyle; memory; autophagy
Increase in Temperature in Children Undergoing MRI
Condition: Magnetic Field Exposure; Temperature Change, Body; Children, Only
MeSH terms: Body Temperature Changes
Study type: Observational

Summary: 
      An increasing number of children undergo Magnetic Resonance Imaging (MRI). In MRI, radio
      waves and magnetism are used to form images of the body's interior, to diagnose and
      monitoring diseases in children. Many children are sedated to be able to collaborate with the
      MRI procedure. Sedation and general anesthesia cause the child to some extent to lose the
      ability to regulate his or her own bodytemperature. MRI rooms are most often cold due to the
      function of the magnet, leading to a risk of hypothermia in young children. Conversely, the
      MRI scanner generates radio frequencies that are absorbed by the body and converted to heat,
      which especially in small children due to their large surface area can potentially result in
      an increase in bodytemperature. In this study we therefore want to investigate changes in
      bodytemperature in children who are undergoing MRI- scanning within the Neuroanesthesiology
      Clinic. Furthermore, we want to define possible risk factors for possible temperature
      changes. Our hypothesis: Children undergoing MRI scanning increase in bodytemperature.
    

Detailed description: 
      Ear temperature is measured as we are primarily interested in describing temperature changes
      in the individual child and because this method is less invasive than the alternatives.
    

Intervention name(s): Braun thermoscan /, IRT 6520
Intervention type(s): Device
Intervention description(s): The temperature will be measured in both ears with an ear thermometer. Practically, we will measure the temperature twice when generel anaesthsia is established, and immidiately before and after the MRI scan.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children 12 weeks to 12 years of age undergoing MRI procedure with the assistance of
        anesthesiologists from the Neuroanesthesiology Clinic may be included. Oral and written
        consent from the parent or relatives of the child will be obtained in accordance with
        science ethical rules.
      
Keywords: magnetic resonance Imaging; paediatrics; temperature
A Pharmacokinetic Study of Abiraterone Acetate in Patients With Severe Hepatic Impairment Compared to Patients With Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate systemic exposure of abiraterone acetate in adult
      male patients with severe hepatic impairment and is being conducted to collect information
      that will support clinical dosing recommendations for this subpopulation.
    

Detailed description: 
      This is a non-randomized (individuals will not be assigned by chance to study treatments),
      open-label (individuals will know the identity of study treatments), single dose, 2-cohort
      study of abiraterone acetate in approximately 16 adult men. Participants will either have
      severe hepatic impairment (Cohort 1) or qualify for the control group with normal hepatic
      function (Cohort 2). This study will consist of a screening period followed by a 4-day
      open-label treatment phase and subsequently a 28-day follow up after the study dose of
      abiraterone acetate suspension. Patients will be admitted to the study center on Day -1, a
      single dose of study drug will be administered on the morning of Day 1, and patients will
      remain at the study center until completion of the 72-hour pharmacokinetic (PK; study of what
      the body does to a drug) blood sample collection in the morning of Day 4. Enrollment will
      begin sequentially with patients in the severe hepatic impairment cohort. Enrollment for
      Cohort 1 will be staggered in order to evaluate safety and tolerability. The study will not
      proceed if >=Grade 3 toxicity or serious adverse events considered related to abiraterone
      acetate are observed. Additional patients may be enrolled if at least 8 patients in each
      cohort do not complete the required assessments, including the PK blood sample collections.
      The aim will be to treat the remaining patients in Cohort 1 at a suspension dose yielding an
      exposure equivalent to 1000 mg tablet in healthy individuals. If the dose is adjusted after
      Study Evaluation Team review, additional patients may be enrolled to ensure at least 8
      patients complete the study at the final dose. Once enrollment of patients in the severe
      hepatic impairment cohort is completed, the matched-control cohort will be dosed. Serial PK
      samples will be collected during the open-label treatment phase as detailed in the protocol.
      Safety will be monitored throughout the study.
    

Intervention name(s): Cohort 1; Cohort 2
Intervention type(s): Drug; Drug
Intervention description(s): 125 mg to 2000 mg abiraterone acetate suspension on Day 1; 2000 mg abiraterone acetate suspension on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic impairment; Pharmacology; Pharmacokinetics; Pharmacodynamics; Abiraterone acetate suspension; JNJ-212082
Insulin Deprivation on Brain Structure and Function in Humans With Type 1 Diabetes
Condition: Diabetes Mellitus, Type 1; Diabetes; Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Complications
Study type: Interventional

Summary: 
      What are the effects of transient insulin deprivation on brain structure, blood flow,
      mitochondrial function, and cognitive function in T1DM patients?

      What are the effects of transient insulin deprivation on circulating exosomes and metabolites
      in T1DM patients?
    

Detailed description: 
      Diabetes is associated with impaired cognition, abnormal brain development in children, and
      dementia in older adults, however the underlying mechanisms remain unclear. Little is known
      about the brain-specific effects of acute insulin deficiency. Our recent studies in diabetic
      mice show an overall down regulation of brain mitochondrial ATP production and up regulation
      of several key mitochondrial proteins, indicating that insulin withdrawal has a profound
      effect on brain mitochondria as well as proteins implicated in neurodegeneration.
      Hyperglycemia is known to alter cognitive function, but it is unclear if insulin deprivation
      independently alters cognitive function and has not been assessed in humans.

      In order to investigate the effects of insulin deprivation on the human brain, we propose a
      study involving temporary insulin deprivation in adolescents and adults with type 1 diabetes
      (T1DM). We will perform brain MRI, phosphorus31 spectroscopy, cognitive testing, circulating
      blood exosome measurements, and proteomics from muscle biopsy; comparing these measures
      during insulin treatment and deprivation between diabetic patients and age-, sex-,
      BMI-matched controls.

      Specific aim 1: Determine whether transient insulin deprivation in T1DM adults and
      adolescents alters brain structure, functions and blood flow as assessed by
      structural/functional MRI.

      Specific aim 2: Determine whether transient insulin deprivation in T1DM adults and
      adolescents alters cognitive function.

      Specific aim 3: Determine whether transient insulin deprivation in T1DM adults and
      adolescents alters the circulating blood exosome contents and metabolome that can potentially
      impact brain functions.

      Specific aim 4: Determine whether transient insulin deprivation in T1DM adults alters the
      skeletal muscle proteome homeostasis especially those involved in fission and fusion
    

Intervention name(s): Insulin Deprivation in Type 1 Diabetic Patients
Intervention type(s): Other
Intervention description(s): Type 1 Diabetic Patients requiring insulin will have insulin stopped for a short period of time (4-6 hours)
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: dementia; cognition; insulin; adolescent
Qing'E Formula Therapy on Menopausal Symptoms
Condition: Menopause
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to evaluate whether a Chinese medicine formula (Qing'E) is
      effective in alleviating menopausal symptoms and safety.
    

Detailed description: 
      This is a double-blind placebo-controlled randomized clinical trial to evaluate whether a
      Chinese medicine formula (Qing'E, composed of eucommia, psoralen, walnuts and garlic) is
      effective in alleviating menopausal symptoms. 240 Chinese women with menopausal symptoms will
      be recruited and randomized into two groups. One is treatment group with 12 weeks of Qing'E
      pills (well-controlled), the other is controlled group with 12 weeks of placebo. The
      treatment outcome measures include: 1) the severity of menopausal symptoms: self-recording of
      daily frequency of vasomotor symptoms (hot flushes), the Kupperman index. 2) NEI network
      indices. 3) Urine metabolomics. All measures are conducted at baseline and endpoint except
      the self-recoding of vasomotor symptoms, Kupperman index and urine metabolomics. Tyhe
      investigators expect this research will provide an effective and safe therapy for menopausal
      symptoms.
    

Intervention name(s): Qing'E pills; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): composed of eucommia, psoralen, walnuts and garlic; Containing 2% of Qing'E pills
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: menopausal syndrome; climacteric syndrome; Hot flashes; Sweat
Evaluation of Safety, Drug-Drug Interactions and Pharmacokinetic Profiles of Co-Administration of Betahistine With Olanzapine in Healthy Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a phase I, randomized, two-arm, double-blind, placebo-controlled, sequential
      study in up to 50 healthy female subjects. The study will be comprised of three treatment
      periods for a total of 4 weeks treatment duration:

      Period I 1 week (Days 1-7) administration of betahistine daily (three times per day; 144
      mg/day total) or matching placebo.

      Period II 1 week (Days 8-14) titration of olanzapine once daily (2.5 to 10 mg) and
      continuation of betahistine or matching placebo administration (daily; three times per day)
      Period III 2 weeks (Days 15-28) of continued co-administration of betahistine/matching
      placebo, three times per day, and olanzapine once daily (7.5 to 10 mg/day)
    


Intervention name(s): Betahistine
Intervention type(s): Drug
Intervention description(s): The study will be comprised of three treatment periods for a total of 4 weeks treatment duration:
Period I 1 week (Days 1-7) administration of betahistine 48 mg three times daily (144 mg/day total) or matching placebo Period II 1 week (Days 8-14) titration of olanzapine once daily (from 2.5 mg up to 10 mg) and continuation of betahistine or matching placebo administration (three times daily as in Period I) Period III 2 weeks (Days 15-28) of co-administration of betahistine or matching placebo (three times daily; as in Periods II and III) and olanzapine once daily (7.5 or 10 mg, as tolerated)
On Day 1, after a 7-day screening period, eligible subjects will be randomized to one of the two treatment groups in a 1:1 ratio:
Betahistine 48 mg TID; 08:00, 13:00 and 18:00 (144 mg/day total) Matching placebo TID; 08:00, 13:00 and 18:00
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Betahistine; Olanzapine; Safety of co-administration of Betahistien and Olanzapine
Effects of Chocolate in Patients With Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The aim of the present study is to investigate whether in patients with chronic heart failure
      endothelial dysfunction and baroreceptor function is altered by ingestion of a flavonoid-rich
      dark chocolate in comparison to placebo chocolate (Nestlé Placebo Chocolate) on top of
      standard medication.

      Moreover, we will evaluate the effect of chocolate on oxidative stress, platelet adhesion as
      well as systemic inflammatory response such as C-reactive protein and pro-inflammatory
      cytokines in patients with chronic heart failure.
    


Intervention name(s): Nestlé Noir intense 40 grx2; Nestlé Placebo Chocolate 40 grx2
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): daily intake of 40gr chocolate (Nestlé Noir intense or Nestlé Placebo Chocolate) in the morning and 40gr chocolate in the evening.; Nestlé Placebo Chocolate 40 gr in the morning and 40gr chocolate in the evening.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chocolate,; heart failure,; endothelial function,; platelet adhesion,; oxidative stress,; baroreceptor function,
Preventing Depression Recurrence in Diabetes
Condition: Major Depression; Diabetes
MeSH terms: Diabetes Mellitus; Recurrence; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the effectiveness of sertraline (Zoloft) in treating depression in adults with
      diabetes. The study will also determine whether depressed diabetic patients who have
      successfully responded to sertraline (Zoloft) are more likely to have depression recur if the
      sertraline (Zoloft) is discontinued.
    

Detailed description: 
      Part A: Prevention of Depression Recurrence in Diabetes

        1. To determine the efficacy of maintenance antidepressant medication in preventing or
           delaying recur-rence of major depression in diabetes.

        2. To determine the relationship of sustained depression remission to social, occupational,
           and global func-tioning, and to quality of life and compliance with diabetes treatment.

        3. To determine clinical features predictive of depression recurrence in diabetes.

      Part B. Longitudinal Study of the Interrelationship of Glycemic Control and Depression

        1. To determine the effects of depression remission and recurrence on glycemic control.

        2. To determine the efficacy of maintenance antidepressant medication in producing
           sustained benefits in glycemic control.

        3. To determine the interrelationship of daily mood with blood glucose and the effect of
           maintenance treatment on this relationship.
    

Intervention name(s): sertraline
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: depression; diabetes mellitus; depression recurrence
Oat and Cholesterol
Condition: Elevated LDL Cholesterol
Study type: Interventional

Summary: 
      The primary objective is to assess the effect of an oat ingredient provided over 4 weeks on
      serum LDL cholesterol in men and women with elevated LDL-cholesterol compared to a placebo.

      Secondary endpoints are fasting serum total- and HDL-cholesterol, non-HDL-cholesterol,
      triglycerides, glucose, insulin, glycated albumin, HOMA-IR and Framingham risk score
    


Intervention name(s): Active oat beverage; Control rice beverage
Intervention type(s): Other; Other
Intervention description(s): Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month; Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Beverage; Beta glucan; Fiber; Oat; Hypercholesterolemia; LDL; Cholesterol
The Effect of Telephone and Video Counseling on Weight Loss and Quality of Life
Condition: Weight Loss; Obesity
MeSH terms: Body Weight; Weight Loss
Study type: Interventional

Summary: 
      Individuals with obesity are at higher risk for severe disease, hospitalizations, and death
      from the SARS-CoV-2 virus. Social distancing guidelines intended to prevent viral spread
      during the COVID-19 pandemic resulted in major changes to daily routines . Several studies
      have demonstrated that individuals with overweight/obesity reported worsening mental health,
      poor eating habits , less physical activity (PA) since the onset of the COVID-19 pandemic.
      Because of these pandemic rules, the use of phone/video consultancy applications and online
      classes for body weight control and diet monitoring is increasing. Therefore, in this study
      it is aimed to determine the effect of diet counseling via phone or video on weight loss and
      to compare it with the traditional follow-up method in the COVID-19 pandemic.
    

Detailed description: 
      The use of phone/video consultancy applications for body weight control and diet monitoring
      is increasing. One of the main reasons for this situation is that individuals care more about
      the social distance rule as a result of the increase in health concerns after the COVID-19
      (SARS-CoV-2) pandemic. In addition, due to the uncertainty of how long the pandemic will
      last, many people are adapting to online applications and programs quicly. However, it's
      unclear which method of phone/video-based diet counseling is more successful or preferable to
      traditional diet follow-up. Based on the above-mentioned information; in this study, it is
      aimed to determine the effect of diet counseling via phone or video on weight loss and to
      compare it with the traditional follow-up method in the COVID-19 pandemic.

      Individuals who meet the research criteria will randomize according to their file numbers
      (with the ramdomizer program) and divide into 3 groups: telephone counseling (15), video
      counseling (15) and traditional follow-up group (Figure 1.). Food consumption records,
      anthropometric measurements and quality of life scale scores of all individuals will record
      at the beginning and end of the study (Figure 2.). In order to prevent interaction between
      individuals, all diet programs will prepare at different times and individually.
    

Intervention name(s): Dietary intervention
Intervention type(s): Behavioral
Intervention description(s): Dietary intervention: Preparation and follow-up of diet program.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obesity; Weight Loss; COVID-19 pandemic
Borage Oil and Ginkgo Biloba (EGb 761) in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess clinical efficacy and/or adverse effects of dietary borage oil (which
      contains gamma-linolenic acid [GLA]) and Ginkgo biloba in patients with mild persistent to
      moderate asthma.
    

Detailed description: 
      The concept of asthma as a condition in which acute and chronic inflammatory changes in
      airways play a fundamental role is well established. The role of leukotrienes as a crucial
      element of these inflammatory processes is supported by abundant laboratory and clinical
      evidence. There is a potential for herbal medicinal approaches to ameliorate
      leukotriene-mediated inflammation in asthma based on data from the literature and our
      laboratory. Studies suggest that dietary GLA, found in borage and evening primrose oils, is
      unique among the (n-6) polyunsaturated fatty acid family members (linolenic acid, GLA and
      arachidonic acid) in its potential to attenuate inflammatory processes. For instance, there
      are randomized, placebo-controlled trials (RCT) demonstrating efficacy of dietary GLA in
      treating patients with rheumatoid arthritis and active synovitis. Ginkgo biloba, a
      flavonoid-rich extract of leaves of the Ginkgo biloba tree, has been studied in one RCT with
      asthma patients and is recommended by complementary and alternative practitioners as
      treatment for allergic inflammation and asthma. Ginkgo biloba supplements have no known
      adverse effects.

      We will assess clinical efficacies and/or adverse effects of dietary borage oil and Ginkgo
      biloba in patients with asthma in a 17 month RCT. We also propose to delineate whether or not
      the clinical course of treatment correlates with suppression of leukotriene B4 (LTB4), LTC4
      and LTD4 generated by activated polymorphonuclear cells. Additionally, in the Ginkgo biloba
      arms of study, the in vitro/ex vivo inhibition of histamine release will be assayed, since
      one of its major constituents, quercetin, is known to be structurally related to cromolyn
      sodium and has been shown in vitro studies to exhibit similar activities. Furthermore,
      anti-inflammatory activities of Ginkgo biloba will be compared to those of some of its
      individual constituents in a series of in vitro experiments. It is hoped that findings from
      these studies will evolve relatively non-toxic therapeutic alternatives for attenuating
      bronchial hyperresponsiveness and inflammation in patients with asthma.
    

Intervention name(s): Gingko biloba; Borage oil
Intervention type(s): Drug; Drug
Intervention MeSH terms: Borage oil
Allocation: Randomized
Primary purpose: Treatment