bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Resveratrol and Lipoic Acid Transdermal Patch for Lipolysis in Overweight Volunteers
Condition: Lipolysis
MeSH terms: Overweight
Study type: Interventional

Summary: 
      To evaluate the lipolysis effect of resveratrol and lipoic acid transdermal patch in
      overweight volunteers
    

Detailed description: 
      66 participants with overweight received a resveratrol and lipoic acid transdermal patch
      treatment. The treatment areas have been treated including left and right arms. Subjects were
      evaluated using standardized measurements of body weight and circumference of arms at
      baseline and 2 weeks follow-up visits. Evaluation of physician were also measured.
    

Intervention name(s): Resveratrol lipoic Acid; Placebo
Intervention type(s): Other; Other
Intervention description(s): Transdermal patch loaded with resveratrol and lipoic acid; Transdermal patch loaded with normal saline
Intervention MeSH terms: Thioctic Acid; Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Drug Interaction Study of LY3154207 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety and side effects of
      LY3154207 and fluconazole (anti-fungal medication), when taken together by healthy
      participants. The study will last from nine to 11 weeks for each participant.
    


Intervention name(s): LY3154207 Capsule; LY3154207 Tablet; Placebo; Fluconazole Tablet
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally as capsule; Administered orally as tablet; Administered orally as tablet; Administered orally as tablet
Other intervention name(s): Placebo Tablet
Intervention MeSH terms: Fluconazole
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
IL-32 Isoforms Levels in GCF and Plasma of the Patients With Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      Interleukin (IL)-32, which has been recently reported to be associated with periodontitis,
      has been suggested to have pleiotropic effect due to its 9 different isoforms. The aim of
      this study was to investigate the levels of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in
      gingival crevicular fluid (GCF) and plasma before and after nonsurgical periodontal treatment
      in patients with periodontitis (P).Twenty-seven P and 27 periodontally healthy controls (C)
      were recruited in this study. Periodontitis patients were performed nonsurgical periodontal
      treatment. GCF and plasma sampling and clinical periodontal parameters were evaluated before
      and 1 month after treatment. Enzyme-linked immunosorbent assay was used to analyze the levels
      of IL-32α, IL-32β, IL-32γ, IL-32δ isoforms in GCF and plasma samples.
    


Intervention name(s): Non-surgical periodontal treatment
Intervention type(s): Other
Intervention description(s): Conventional non-surgical periodontal treatment were performed
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        1. group (Control): Periodontally and systemically healthy

          2. group: Systemically healthy and periodontitis
Single Ascending Dose Study (SAD) iv Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to study the safety of AZD1305, how AZD1305 is tolerated and how the
      medication is metabolised by the body (how it is taken up into the body, distributed around
      the body and disappears from the body
    


Intervention name(s): AZD1305; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for iv infusion , single dose; NaCl solution for iv infusion, single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: AZD1305; SAD; safety; pharmcokinetics; Safety and tolerability
Comparison of Safety, Immuno- and Reactogenicity of MPL-Adjuvanted Recombinant Hepatitis B Vaccine to That of Engerix™-B
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare the safety, reactogenicity and immunogenicity of
      different formulations of adjuvanted recombinant hepatitis B vaccine to that of Engerix™-B
      when administered at 0, 2 months with a booster at month 12 if necessary
    

Detailed description: 
      At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former
      name SmithKline Beecham
    

Intervention name(s): MPL-Adjuvanted recombinant hepatitis B vaccine; Engerix™-B
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 2 or 3 doses, 2 different formulations; Intramuscular injection, 2 or 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Hepatitis B; Engerix™-B; Adjuvanted recombinant hepatitis B vaccine
The Clinical Study of the Effect of Highland Barley Diet on Blood Glucose in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The clinical study of the effect of highland barley diet on blood glucose in patients with
      type 2 diabetes mellitus
    

Detailed description: 
      The clinical study of the effect of highland barley diet on blood glucose in patients with
      type 2 diabetes mellitus.

      Approximately 40 patients will be enrolled in the study from China and randomized in a 1:1
      ratio to one of the 2 treatment arms: highland barley diet + metformin; or +common diet
      metformin.

      Study treatment will continue for 12 weeks. The primary efficacy measure is the change in
      HbA1c at 12 weeks. The study consists of 3 periods: a 1-week screening (period A), a 4-week
      run-in period (period B) and a 12-week treatment period (period C).
    

Intervention name(s): Highland Barley Diet; ADA diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Highland Barley Diet; ADA diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: highland barley diet
Chromosomal and Morphological Structure of Mature and Immature Male Germ Cells and Recognition of IL-18 in Testicular Tissue of Azoospermic Men
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      To develop a biotechnological assay which will be able to recognize germ cells of the
      spermatogenic lineand and to identify the chromosomal and morphological structure of mature
      and immature male germ cells, in cases of of sperm production disorders(azoospermic
      patients).

      To recognize IL-18 in testicular tissue of azoospermic men compared to control group as it
      has been suggested that this cytokine may serve as a paracrine defense factor in the male
      gonad associated to spermatogenesis.
    

Detailed description: 
      A new biotechnological assay was developed by adapting an existing computerized system which
      scans cell morphology and chromosomal ploidy in the same cell of hematologic line using
      digital technology, to recognize germ cells of the testis by their morphology and
      cytogenetics. Testicular tissues which obtained from 15 men were enzymatically digested and
      the cells received were fixed on slides. The cells were stained by Giemsa May Grinwald
      staining and scanned automatically in a bright field for cell morphology. Fluorescence in
      situ hybridization (FISH) using centromeric probes for chromosomes X, Y and 18 was performed
      on the same slide after destaining. The cells were automatically scanned and classified
      according to the ploidy of the chromosome signals. The presence of IL-18 in the same men's
      testis was examined parallelly, by immunohistochimical staining using specific antibody for
      human IL-18.
    

Time perspective: Prospective
Keywords: azoospermia FISH IL-18 TESTICULAR BIOPSY
Effect of Omega-3 LCPUFA Intervention on Learning, Cognition, Behaviour and Visual Processing.
Condition: Cognitive Function; Academic Performance; Mental Health
Study type: Interventional

Summary: 
      The brain is primarily developed in the third trimester of pregnancy, but continues maturing
      through the late twenties, especially the prefrontal cortex. Omega-3 long-chain
      polyunsaturated fatty acids (LCPUFA) are important structural components of neural cell
      membranes, influence membrane fluidity and signal transduction, and thus learning, cognition
      and behaviour. Levels of omega-3 LCPUFA have been found to be low in individuals with
      limitations in these complex brain functions. Previous studies suggested that such functions
      could be improved by increasing LCPUFA. The adolescent brain, however, has been largely
      neglected. This study investigates the effect of one-year daily omega-3 LCPUFA
      supplementation, in particular krill oil, in healthy 14-15 year old adolescents in lower
      general secondary education (MAVO/VMBO) on learning, cognition, and behaviour. The majority
      of the omega-3 PUFA in krill oil is incorporated into phospholipids, favouring tissue uptake
      of its omega-3 PUFA. In a double blind, randomised controlled trial, 300 adolescents
      preselected from a population of 700 adolescents with low omega-3 index (<5%) will receive
      daily omega-3 LCPUFA supplementation or matching placebo. The omega-3 LCPUFA dose will be
      adjusted individually to reach a target level of 8-11%. The effects on learning (academic
      achievement, objective cognitive performance), behaviour (mood, self-esteem, motivation,
      goal-orientation, absenteeism), and in a subsample cognitive processes, in particular
      perceptual processes measured by eye-tracking will be evaluated after 6, 12, and 24 months.
      This study will yield important insights in the effects of omega-3 LCPUFA supplementation, a
      safe intervention, on a large variety of complex brain functions.
    


Intervention name(s): Krill oil capsules; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1 year supplementation with Krill oil provided by Aker BioMarine Antarctic AS equalling almost the daily recommended amount of 450 mg of EPA/DHA intake per day.; Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Omega-3 fatty acids; Cognitive function; Academic performance; Mental health; Eye tracking; Krill oil; LCPUFA
Characterization and Durability of COVID-19 Vaccine Induced Immune Responses in Healthcare/Frontline Workers
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Rationale: Early in the covid-19 pandemic, it was unclear whether and how individuals and
      populations would develop protective and enduring immunity against SARS-CoV-2, either after
      infection or vaccination. It is still not clear what role might immune cellular responses
      play in the development of immunity to SARS-CoV-2 infection and what are the implications for
      vaccines? As T cells recognise and respond to viral antigens they produce many protective
      reactions and effector molecules. One such molecule is the cytokine interferon γ, secreted by
      CD4+ and CD8+ T cells and their memory cells. This can be measured means of documenting
      specific T cell responses to viral antigens. Published studies offered a strong evidence that
      T cell immune responses are sustained, even in the face of declining or undetectable
      antibodies, implying that some immunity persists. The evidence from new studies, interim
      results from phase III vaccine trials, and previous data from phase I and phase II trials
      support the notion that memory T cell responses to the vaccines, along with B cell antibody
      responses, should provide good and possibly enduring immunity to SARS-Cov-2. We propose to
      describe and characterize the humoral, innate and long-term adaptive immune responses and the
      neutralization potential generated by COVID-19 vaccination (Covaxin, Covishield) among
      healthcare and frontline workers.
    

Detailed description: 
      Study objectives i. To estimate the neutralizing antibodies titre against SARS CoV-2 by
      vaccine type.

      ii. To estimate the proportion of vaccine recipients developing effective antibody response
      for SARS-CoV-2 specific IgG, IgM, and total IgE and IgA antibodies pre- and post-COVID-19
      vaccination on day zero, day 28, month 2, 3, 6, 12, 18 and 24 by vaccine type.

      iii. To identify and characterize the immune biomarkers for long term innate and adaptive
      immune response by vaccine type.

      iv. To estimate the ratio of immune biomarker levels between pre- and post- COVID-19
      vaccination at days 28, month 2, 3, 6, 12, 18 and 24 by vaccine type
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthcare/frontline workers working in the ICMR-NIRT and ICMR-NIE aged 18 to 60 years
DAR-901 TB Booster Vaccine to Prevent TB in Adolescents
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      DAR-901 booster vaccine or placebo will be administered to adolescents in Tanzania primed
      with BCG to determine if immunization reduces the risk of TB infection
    

Detailed description: 
      DAR-901 whole cell booster vaccine to prevent TB infection in adolescents ("DAR-PIA")

      This is a Phase II, 3-injection, randomized, controlled trial of DAR-901 to be conducted in
      13-15 year old adolescents in Tanzania previously immunized with BCG. DAR-901 is a whole cell
      inactivated non-tuberculous mycobacterial vaccine manufactured from the Master Cell Bank of
      SRL-172 that was used in the successful Phase III DarDar Trial in Tanzania. The goals are to
      establish the safety and efficacy of DAR-901 in preventing infection with TB. The 1 mg dose
      was selected during the current Phase I dose-escalation trial of DAR-901 in the US being
      conducted by Dartmouth and Aeras. The 1 mg dose corresponds to the dose of SRL 172 used in
      the DarDar Trial.

      All subjects will be screened by the T-spot® IGRA (Oxford Immunotec, Oxford, England) for
      evidence of TB infection. All screened subjects will have a structured interview to identify
      risk factors for TB infection (=positive IGRA). IGRA-positive subjects will be referred for
      further evaluation and will not be entered in the immunization phase of the trial.

      It is estimated that 1000 adolescents will need to be screened to identify a total of 650
      IGRA-negative adolescents in the immunization phase of the trial. Subjects will be and
      randomized 1:1 to DAR-901 or saline control at 0, 2 and 4 months. Doses will be administered
      by intradermal (ID) injection in the deltoid area. IGRA testing will be repeated before dose
      2, at 14 months, and again at 24 months.

      This three year study began in the first quarter of 2016 in Dar es Salaam, is funded by
      GHIT-Japan and will be directed by Geisel School of Medicine at Dartmouth (PI, F. von Reyn)
      with collaborators at Muhimbili University of Health and Allied Sciences (MUHAS) in Tanzania
      and Tokyo Medical and Dental University in Japan.
    

Intervention name(s): DAR-901; Sterile saline placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccine
Activity of MK-8504 in Anti-retroviral-naïve, Human Immunodeficiency Virus 1 (HIV-1) Infected Participants (MK-8504-002)
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the safety, tolerability, pharmacokinetics (PK), and
      anti-retroviral therapy (ART) activity of monotherapy with MK-8504 (a tenofovir pro-drug), in
      ART-naïve Human Immunodeficiency Virus (HIV)-1 infected participants. The primary hypothesis
      is that MK-8504, at a dose that is sufficiently safe and well tolerated, has superior
      antiretroviral activity compared to placebo, as measured by change from baseline in plasma
      HIV-1 ribonucleic acid (RNA) at 168 hours post-dose.
    


Intervention name(s): MK-8504
Intervention type(s): Drug
Intervention description(s): After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ursodiol on Insulin Sensitivity, Gastric Emptying and Body Weight With Type 2 Diabetes on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Body Weight
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate whether bile acids are able to increase insulin sensitivity and
      enhance glycemic control in T2DM patients, as well as exploring the mechanisms that enhance
      glycemic control. These observations will provide the preliminary data for proposing future
      therapeutic as well as further mechanistic studies of the role of bile acids in the control
      of glycemia in T2DM.
    

Detailed description: 
      Background: Intra-jejunal administration of bile acids improves insulin sensitivity.

      Hypothesis: The bile acid, ursodeoxycholic acid (UDCA) in delayed (ileocolonic)-release
      formulation, stimulates bile acid membrane receptor (TGR-5) and farnesol X (FXR) receptors in
      the ileum and colon, increasing the secretion of Fibroblast growth factor 19 (FGF-19), GLP-1,
      oxyntomodulin (OXM), and Peptide (PYY3-36), improving insulin sensitivity and inducing weight
      loss.

      Aim: To study the effect of an ileocolonic formulation of UDCA on insulin sensitivity,
      postprandial plasma glycemia and incretin levels, gastric emptying and body weight in
      overweight or obese type 2 diabetic subjects on monotherapy with metformin.

      Study design: This is a single center, placebo-controlled, parallel group, single dose
      randomized controlled trial to study the effect of delayed (ileocolonic)-release UDCA 600 mg
      twice daily on insulin sensitivity, gastric emptying of liquids and solids (measured by
      scintigraphy)and weight loss in overweight or obese type 2 diabetic subjects. Participants
      will be receiving monotherapy with metformin. Blood samples will be collected at defined
      times to measure glycemia and the incretin (GLP-1, OXM, PYY3-36) fasting levels and responses
      to the meal.

      Anticipated Results: In comparison with placebo, UDCA will increase insulin sensitivity,
      enhance glycemic control, increase postprandial incretins, and delay gastric emptying (GE) of
      liquids.

      Significance: This study will prove that ileocolonic-release UDCA enhances glycemic control
      in T2DM patients.
    

Intervention name(s): Ursodiol
Intervention type(s): Drug
Other intervention name(s): Ursodeoxycholic acid
Intervention MeSH terms: Ursodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Parecoxib on Morphine Patient-controlled Epidural Analgesia (PCEA) After Gynecologic Surgery
Condition: Benign Female Reproductive System Neoplasm
MeSH terms: Genital Neoplasms, Female
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of parecoxib in combination with
      epidural morphine in providing analgesia for patients undergoing gynecological surgery.
    

Detailed description: 
      Researches have showed that the use of epidural and spinal block resulted in significant
      reduction in morbidity and mortality after surgery. Moreover, appropriate pain management
      results in better outcomes. Opioids therapy is recommended as the first choice medication for
      the management of postoperative pain but is associated with a number of undesirable adverse
      effects. A multimodal therapy for providing postoperative analgesia has advantages over the
      use of opioids alone. The use of NSAIDs and opioids together often improves analgesia and
      reduces the need for opioids in the postoperative period. Often, the combination of COX-2
      inhibitors with epidural analgesia is preferred. With epidural analgesia, addition of COX-2
      inhibitors may improve the analgesia and decrease the undesirable side effects.
    

Intervention name(s): Parecoxib Sodium; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Before incision, patients in Group P (n = 120) receive 40mg of parecoxib IV. Thereafter, parecoxib patients receive 40mg of parecoxib IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.; Before incision, patients in Group C (n = 120) receive 2 mL of normal saline IV. Thereafter, they receive 2 mL of normal saline IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.
Other intervention name(s): Dynastat; NS
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cyclooxygenase inhibitors; Morphine; Analgesia; patient-controlled; Gynecologic surgical procedures
Influence of the Restorative Cervical Margin Placement on the Supracrestal Tissue Attachment
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Observational

Summary: 
      The aim of the present study is to understand the influence that marginal/subgingival
      restorations exert on the surrounding periodontal tissues. Even though proximal restorations
      are routine in everyday clinical practice, few information is available as to whether or not
      they may have a detrimental effect on the supracrestal tissue attachment.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients coming to the Endodontic and Restorative department of Policlinico le Scotte-
        Siena, when eligible, were included in the study.
      
Biospecimen description: 
      Gingival crevicular fluid from the gingival sulcus
    
Keywords: subgingival restorations; proximal restorations; cytokine; biomarkers; GCF sampling