bioihbjkbjnl/mcl2 huggingface dataset:
The Addition of Whole Grains to the Diets of Adults: A Study of Digestive Health and Natural Defenses
Condition: Digestive Health and Immune Function
Study type: Interventional

Summary: 
      The purpose of this study is to determine if substituting whole grains for refined grains in
      the diets of healthy adults over a period of 6 weeks alters the composition of the bacteria
      in the gut, and has beneficial effects on immune function, digestive health, cardiovascular
      health, regulation of body weight and composition, and vitamin K status.

      The investigators hypothesize that whole grain consumption over a period of 6 weeks will
      alter the gut microflora toward a more beneficial bacterial profile, improve the immune
      response while reducing oxidative stress and inflammatory markers, have favorable effects on
      factors influencing the regulation of body weight and composition,increase bacterial vitamin
      K synthesis, and beneficially effect surrogate markers of cholesterol synthesis/absorption,
      vitamin D concentrations, and whole genome DNA methylation patterns. In statin users it is
      hypothesized that, consumption of whole grains will alter statin pharmacokinetics by
      decreasing rate of statin absorption, resulting in more sustained plasma concentrations.
    

Detailed description: 
      This study is a randomized parallel-arm trial using a six-week dietary intervention following
      a 2 week run-in period. Healthy volunteers will be randomized to two groups (n=40/group), and
      consume either a diet rich in whole grains or a diet rich in refined grains provided at
      estimated energy requirements for 6 weeks. Outcomes will be measured during the run-in period
      and at week 6 of the intervention. To control for variation in microbiota an additional 10
      volunteers will serve as "negative controls" and not undergo any diet intervention.
    

Intervention name(s): Whole grains; Refined grains
Intervention type(s): Other; Other
Intervention description(s): Following completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks.; Following completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: digestive health and natural defenses
A Study to Investigate the Effect of Administration of Ceftazidime-avibactam (CAZ-AVI) and Ceftaroline Fosamil -Avibactam (CXL) on the Intestinal Flora of Healthy Volunteers
Condition: Pharmacokinetics; Open Label; CAZ-AVI; CXL; Effect on Intestinal Flora; Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effect of administration of CAZ-AVI and CXL
      on the intestinal flora of male and female healthy volunteers after multiple administrations
      over 7 days. An assessment of the effect on intestinal flora is an important aspect to
      understand for the safe clinical use of the investigational products and is expected by
      regulatory agencies.
    


Intervention name(s): CAZ-AVI; CXL
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion; IV infusion
Other intervention name(s): Cohort 1; Cohort 2
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase I,; open label,; CAZ-AVI,; CXL,; healthy volunteers,; intestinal flora.
Levetiracetam and Memory Function in Amnestic Mild Cognitive Impairment (MCI)
Condition: Mild Cognitive Impairment (MCI)
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to find out if daily use of the drug levetiracetam can improve
      memory function in individuals with memory problems like those associated with Mild Cognitive
      Impairment (MCI) and Alzheimer's disease (AD).
    

Detailed description: 
      Increasing research is focused on conditions that precede the clinical diagnosis of
      Alzheimer's disease (AD) in order to detect patients at risk for early intervention. One such
      condition is mild cognitive impairment (MCI). Functional magnetic resonance imaging (fMRI)
      studies in this group of patients have reported increased activation in the Medial Temporal
      Lobe (MTL) during performance of memory tasks. The functional significance of increased
      activation is unclear. One possibility is that greater activity reflects the increased effort
      needed in order to maintain performance, and as such would be a compensatory response. An
      alternative possibility is that increased activation reflects aberrant physiology related to
      the disease process itself and as such would be a sign of greater underlying disease severity
      and would interfere with brain function.

      Data in animal models suggest the possibility that low dose levetiracetam (well-tolerated
      anti-convulsant) treatment may reduce the observed hyperactivity and improve memory
      performance among individuals with MCI. The investigators are therefore conducting a
      within-subjects trial of 8 weeks duration, involving 144 subjects and low dose treatment with
      levetiracetam. During the course of the study, each subject may receive both drug and placebo
      for two weeks, with the order of administering those treatments counterbalanced. Cognitive
      testing and fMRI imaging will be obtained after 2-weeks on drug/placebo. The overall goal of
      the study is to determine if treatment of MCI subjects with low dose levetiracetam reduces
      hyperactivity within the MTL and improves memory performance.
    

Intervention name(s): Levetiracetam 62.5mg; Levetiracetam 125mg; Levetiracetam 250mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 62.5mg twice daily (2 weeks); 125mg twice daily (2 weeks); 250mg twice daily (2 weeks); placebo capsule twice daily (2 weeks)
Other intervention name(s): Keppra; Keppra; Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Mild Cognitive Impairment; Amnestic Mild Cognitive Impairment; Functional Magnetic Resonance Imaging; Levetiracetam; Keppra; Medial Temporal Lobe; Memory Impairment; Alzheimer's Disease; AD
Study to Assess Efficacy and Safety of Bone Marrow Derived Stem Cells in Patients With Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and efficacy of intra-arterial infusion and intramuscular
      injection of an autologous, bone marrow-derived stem cell preparation (ASCT01) in patients
      with critical limb ischemia who have exhausted all medical and surgical therapeutic options.
      The safety and tolerability will be evaluated by regular monitoring of the general physical
      condition, vital signs, and the occurrence of AE and SAE, respectively. Furthermore, the
      standard biochemical and blood variables (red and white blood cell counts, Hb, Ht, platelets,
      sodium, potassium, chloride, calcium, phosphor, ASAT, ALAT, bilirubin, total protein,
      albumin, AP, cholesterol (LDL,HDL), triglycerides, urea and creatinine, immunoglobulins,
      HBA1c, C-peptide) will be checked before the treatment as well as 30 and 90 days after the
      treatment.
    

Detailed description: 
      Efficacy will be determined by number of collateral arteries as assessed magnetic resonance
      angiography at baseline and again at 3 months, rate of major amputation (above the ankle) of
      the affected limb within 3 months or an unchanged critical limb ischemia of the affected limb
      after 3 months defined as less than 15% change in tcPO2 or ABI or absolute ankle
      pressure.Efficacy endpoint is at 3 months. Clinical endpoints and safety will be measured
      through 12 months.
    

Intervention name(s): ASCT01 (Autologous Stem Cell Transplantation)
Intervention type(s): Biological
Intervention description(s): Single Administration of the entire ASCT01 preparation at rate if 10million CD45+ cells per milliliter at 5 ml per minute via the intra- via intra-arterial infusion route and 6 or more injections of approximately 0.2 ml each intramuscular route
Intervention model: Single Group Assignment
Intervention model description: Autologous treatment for CLI open label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLI
Laparoscopic Splenectomy in Children
Condition: Laparoscopic Splenectomy; Children; Benign Blood Diseases
MeSH terms: Hematologic Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Laparoscopic splenectomy (LS) gained popularity since it has been described for the
      first-time during nineties of past century. It has become "golden method" for splenectomy in
      all ages including children
    

Detailed description: 
      Background: laparoscopic splenectomy (LS) gained popularity during the last years in
      pediatric age group. Benign hematological diseases represent the main indications of that
      procedure. There are some score systems of difficulty of the technique but they are for adult
      patients. The aim is to develop a prognostic score system of LS in children with benign
      hematological diseases.

      Methods: LS was performed in all children with benign hematological diseases. LS was done by
      the same team. They operated children in lateral decubitus position. The control of pedicle
      was achieved using bipolar sealing devices, polymer clips or endoscopic linear staplers.
      Preoperative, operative, and postoperative data were recorded and analyzed. Children were
      divided into two groups A and B according to the development of complications.
    

Intervention name(s): laparoscopic splenectomy
Intervention type(s): Other
Intervention description(s): surgical
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: laparoscopic splenectomy,; children; prognostic score; benign hematological diseases
Assessment of Vitamin D Supplementation and Immune Function
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      Hypothesis:

      Volunteers with vitamin D insufficiency (serum 25(OH)D 25-50 nmol/L) given intermediate or
      high dose vitamin D supplements (2,000 or 5,000 IU per day) will have increased production of
      anti-bacterial peptides and interleukin-1, decreased production of other pro-inflammatory
      cytokines, increased production of regulatory cytokines and an enhanced T- and B-cell
      response to a tetanus vaccine compared to vitamin D insufficient subjects given low dose
      vitamin D supplements (400 IU per day).
    

Detailed description: 
      Specific Aim 1:

      Determine if high dose vitamin D supplements decrease the production of proinflammatory and
      increase the production of regulatory cytokines and chemokines by innate immune cells
      stimulated ex vivo.

      Specific Aim 2:

      Determine if high dose vitamin D supplements decrease serum markers of inflammation and
      increase serum and cellular levels of defensive molecules (e.g., cathelicidin).

      Specific Aim 3:

      Determine if high dose vitamin D supplements decrease blood levels of proinflammatory
      T-helper type 1 (Th1) and Th17 cells and increase levels of anti-inflammatory T-regulatory
      (Treg) and Th2 cells.

      Specific Aim 4:

      Determine if high dose vitamin D supplements increase antigen specific T cell and B cell
      responses after tetanus vaccination.
    

Intervention name(s): Vitamin D - Treatment 1; Vitamin D - Treatment 2; Vitamin D - Treatment 3
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.; Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.; Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Vitamin D; Immune function
Diffuse Optical Imaging With Indocyanine Green Solution in Imaging Pelvic Lymph Nodes in Patients With Stage II Prostate Cancer Undergoing Surgery
Condition: Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial studies diffuse optical imaging with indocyanine green solution in
      imaging pelvic lymph nodes in patients with stage II prostate cancer undergoing surgery.
      Indocyanine green solution is a special dye that can help doctors see the lymph nodes and
      blood vessels during surgery when visualized under diffuse optical imaging. Indocyanine green
      solution may improve the ability to detect lymph nodes and may lead to improved accuracy of
      lymph node removal.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the ability of indocyanine green (indocyanine green solution) (ICG) to
      highlight pelvic lymphatic tissue with fluorescence during robot assisted radical
      prostatectomy using near infrared fluorescence (diffuse optical imaging).

      SECONDARY OBJECTIVES:

      I. To evaluate the ability of this technique to improve lymph node yield, providing a
      potential therapeutic benefit to these patients by removing additional lymph nodes that may
      otherwise have been missed.

      OUTLINE:

      Patients receive indocyanine green transperineally and undergo diffuse optical imaging during
      robot-assisted laparoscopic radical prostatectomy with bilateral lymph node dissection using
      the da Vinci Robotic Surgical System.

      After completion of study treatment, patients are followed up for 1-2 weeks.
    

Intervention name(s): indocyanine green solution; diffuse optical imaging; robot-assisted laparoscopic surgery; therapeutic lymphadenectomy
Intervention type(s): Drug; Other; Procedure; Procedure
Intervention description(s): Given transperineally; Undergo near infrared fluorescence imaging; Undergo robot-assisted laparoscopic radical prostatectomy; Undergo lymphadenectomy
Other intervention name(s): IC-GREEN; ICG solution; diffuse optical spectroscopy; diffuse optical tomography; DOI; near infrared optical tomography
Intervention MeSH terms: Pharmaceutical Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pupillary Unrest in Ambient Light, and Relationship to Opioid-Induced Respiratory Depression
Condition: Opioid; Intoxication, Perception Disturbance (Acute); Acute Pain; Overdose of Opiate; Respiratory Depression; Safety Issues
MeSH terms: Respiratory Insufficiency; Acute Pain; Opiate Overdose; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      Volunteers will receive a weight-based opioid (remifentanil) infusion for 10 minutes. In the
      first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be taken at
      baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery period
      afterwards. After a washout period, the experiment will be repeated in each subject (second
      run). The two runs differ only by presence versus absence of verbal interaction.
    

Detailed description: 
      Healthy volunteers aged 20-55 will receive a weight-based opioid (remifentanil) infusion for
      10 minutes. Vital signs including SpO2, transcutaneous CO2, and respiratory rate will be
      continuously measured.

      In the first run, serial pupillary measurements (pupillary unrest, pupil diameter) will be
      taken at baseline, and at 2.5-minute intervals during the infusion and a 25-minute recovery
      period afterwards. After a washout period, the experiment will be repeated in each subject
      (second run). The two runs differ only by presence of ongoing verbal interaction versus
      complete avoidance of verbal interaction.

      Incidence of respiratory depression will be compared in the two protocols with or without
      verbal interaction. Correlation between pupil diameter and pupillary unrest with estimated
      opioid concentrations will be determined by regression. Difference between pupil measurement
      versus opioid concentration regressions will be compared by chi2.
    

Intervention name(s): Continuous conversational interaction; Remifentanil infusion
Intervention type(s): Behavioral; Drug
Intervention description(s): Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.; 10 minute remifentanil infusion
Other intervention name(s): Environmental stimulation
Intervention MeSH terms: Remifentanil
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Each subject is his/her own control.
Masking: None (Open Label)
Primary purpose: Diagnostic
Effect of NN5401 in Japanese Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Japan. The aim of this clinical trial is to investigate the blood
      sugar lowering effect of NN5401 (insulin degludec/insulin aspart (IDegAsp)) in Japanese
      subjects with type 1 diabetes. Each subject will be randomised to one of the two possible
      treatment sequences (NN5401 followed by biphasic insulin aspart (BIAsp) 30 or biphasic
      insulin aspart 30 followed by NN5401).
    


Intervention name(s): insulin degludec/insulin aspart; biphasic insulin aspart 30
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 0.5 U/kg body weight injected s.c. (under the skin); Single dose of 0.5 U/kg body weight injected s.c. (under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate a Skeletal-muscle Microbiopsy Technique With Dynamic Proteomic Measurement in Healthy Male Volunteers
Condition: Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-blind, randomized placebo-controlled, parallel study, where the study
      volunteers will be blinded to testosterone/placebo treatment. This study will test a
      relatively new, less invasive method for collecting muscle tissue to determine if this method
      is appropriate for collecting muscle samples for the assessment of the fractional synthetic
      rates (FSR) of muscle-derived proteins. This study will also investigate whether the FSR of
      proteins may serve as early biomarkers for muscle anabolism, a known anabolic agent
      (testosterone) will be administered to healthy, elderly male subjects over a 3 week period.
      The fractional synthetic rate of several muscle-derived proteins will be analyzed at Baseline
      and during the period of testosterone treatment using deuterium labelling of these proteins
      by the incorporation of deuterium from deuterated water (D2O).
    


Intervention name(s): Deuterated Water; Testosterone enanthate; Placebo to match testosterone enanthate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): D2O 70% will be supplied as clear liquid, provided in 50 millilitre (mL) unit dose vials; administered per orally.; Testosterone enanthate 125mg injection will be supplied as colorless to pale yellow liquid; administered intramuscular (IM).; Placebo to match testosterone enanthate 0.625 mL injection will be supplied as greenish yellow, bright and clear oily liquid; administered intramuscular (IM).
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: muscle mass; dynamic proteomics; Duke University; Microbiopsy; D2O; testosterone; skeletal muscle
Hepatic Insulin Sensitivity and Very Low Density Lipoprotein Triglyceride (VLDL-TG) Kinetics
Condition: Obesity; Dyslipidemia
MeSH terms: Obesity; Dyslipidemias; Insulin Resistance
Study type: Interventional

Summary: 
      Obesity is associated with dyslipidemia, which is a major risk factor for coronary heart
      disease. Triglycerides (TG) and cholesterol are transported in the system of lipoproteins,
      and the metabolism of these lipids in plasma is closely interrelated. Evidence suggests that
      increased concentration of very low-density lipoprotein triglyceride (VLDL-TG) is a central
      pathophysiological feature of the lipid and lipoprotein abnormalities in dyslipidemia.

      The primary objective of this study is to investigate VLDL-TG kinetics and hepatic insulin
      sensitivity in age-matched obese and lean, healthy men in the postabsorptive state and during
      acute hyperinsulinemia using VLDL-TG and glucose tracers.
    

Detailed description: 
      Extensive description not included.
    

Intervention name(s): Glucose clamp
Intervention type(s): Other
Intervention description(s): 450 min hyperinsulinemic euglycemic glucose clamp, 0,5 mU / kg lean body mass / min
Other intervention name(s): Human insulin
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Evaluate SAGE-217 in Participants With Bipolar I/II Disorder With a Current Major Depressive Episode
Condition: Bipolar Disorder I; Bipolar Disorder II; Major Depressive Episode
MeSH terms: Bipolar Disorder; Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an open-label study evaluating the safety, tolerability, pharmacokinetics, and
      efficacy of SAGE-217 in the treatment of participants with bipolar I/II disorder with a
      current major depressive episode.
    

Detailed description: 
      This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the
      trial was transferred to Biogen.
    

Intervention name(s): SAGE-217; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAGE-217 capsule; SAGE-217 matching placebo capsule
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment