bioihbjkbjnl/mcl2 huggingface dataset:
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
Condition: Diabetic Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is provide confirmation of the safety and efficacy of
      Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic
      gastroparesis in adult women.
    

Detailed description: 
      Diabetic women with clinical symptoms attributed to diabetic gastroparesis and documentation
      of delayed gastric emptying who meet the protocol-specified entry criteria will be randomized
      to Metoclopramide Nasal Spray 10 mg or placebo administered as a single intranasal spray four
      (4) times daily; 30 minutes before meals and at bedtime for a total of four (4) weeks.
    

Intervention name(s): Metoclopramide Nasal Spray; Placebo Nasal Spray
Intervention type(s): Drug; Drug
Intervention description(s): nasal spray formulation of metoclopramide; nasal spray formulation with vehicle only
Other intervention name(s): EVK-001; EVK-001 Placebo
Intervention MeSH terms: Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroparesis; Diabetic; Delayed gastric emptying; Gastric stasis; Nausea; Vomiting; Bloating; Abdominal pain; Early satiety; Gastropathy
ARVAC-A New Recombinant Coronavirus Disease 2019 (COVID-19) Vaccine
Condition: COVID-19 Vaccine
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The goals of this clinical trial are:

        1. Phase 2: to test a gamma adapted recombinant vaccine against SARS-CoV-2 in healthy adult
           volunteers, previously vaccinated against the SARS-CoV-2 virus.

        2. Phase 3 (first volunteer enrollement on March 25, 2023): to test a recombinant vaccine
           against SARS-CoV-2 comparing three different versions (Gamma Variant RBD-based ARVAC-CG
           vaccine, Omicron Variant RBD-based ARVAC-CG vaccine, Bivariant Gamma/Omicron RBD-based
           ARVAC-CG vaccine), in adult volunteers previously vaccinated against the SARS-CoV-2
           virus

      The main questions to be answered are:

        1. Phase 2:

             1. What si the immune response after one dose of vaccine?

             2. What is the safety and tolerability profile of this vaccine?

        2. Phase 3 :

             1. What is the immune response triggered by each vaccine formulation against Wuhan,
                gamma, and omicron variants.

             2. What is the safety and tolerability profile of this vaccine?

      In phase 2, participants will receive one dose of the study vaccine and one dose of placebo
      28 days apart, in a cross-over design.

      In phase 3 (not yet recruitment), participants will be randomized to receive one of the three
      possible types of vaccines and all of them will receive one dose of the corresponding vaccine
      and 1 dose of placebo 28 days apart, in a cross over design.
    


Intervention name(s): Gamma Variant RBD-based ARVAC-CG vaccine; Omicron Variant RBD-based ARVAC-CG vaccine; Bivalent RBD-based ARVAC-CG vaccine; Placebo (Alum)
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Vaccine containing 50 µg of antigen + Alum. Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection; Vaccine containing 50 µg of antigen + Alum. Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection; Vaccine containing 25 µg of gamma antigen + 25 µg of omicron antigen + Alum Schedule: One booster dose of vaccine Administration route: intramuscular (IM) injection; Schedule: One dose of placebo in a crossover design Administration route: intramuscular (IM) injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In phase 2, participants will receive one dose of vaccine and one dose of placebo 28 days apart, in a cross over design.
In phase 3, participants will be randomized to receive one of the three possible types of vaccines and all of them will receive one dose of the corresponding vaccine and 1 dose of placebo 28 days apart, in a cross over design.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Effect of Vibrating Tourniquet and Distraction Cards on Pain and Anxiety in Children
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of the study was to observe the effect of the use of vibrating tourniquet and
      distraction card on the pain, fear and anxiety levels felt during the blood collection
      process in children. The study was conducted between July 2021 and March 2022 as a randomized
      controlled study with totally 120 children in three groups. The 'Child and Parent
      Identification Form' was used for socio-demographic data about the child and the parent
      before phlebotomy. The 'Visual Analog Scale (VAS)', 'Child Fear Scale (CFS)' and 'Child
      Anxiety Scale-State Scale (ÇAS-D)' were used before, during and after the phlebotomy.
      Vibrating Tourniquet Group (intervention group 1) consists of a total of 40 children.
      Distraction Cards Group (intervention group 2) consists of a total of 40 children. Control
      group consists of a total of 40 children.
    


Intervention name(s): Intervention; Distraction card
Intervention type(s): Other; Other
Intervention description(s): Vibrating tourniquet; Distraction card
Other intervention name(s): Vibrating tourniquet
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled study
Masking: None (Open Label)
Primary purpose: Other
Keywords: pain; anxiety; children; nurse; phlebotomy
Evaluation of the Effectiveness and Safety of Diluted RADIESSE® in the Treatment of Décolleté Wrinkles
Condition: Décolleté Wrinkles
Study type: Interventional

Summary: 
      Trial to confirm the effectiveness and demonstrate the safety of treatment with diluted
      Radiesse for correction of Décolleté Wrinkles.
    


Intervention name(s): Treatment with diluted Radiesse
Intervention type(s): Device
Intervention description(s): Injection of Décolleté Wrinkles with diluted Radiesse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Two Part Trial Investigating the Safety of NN9925 in Healthy Male Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2; Healthy
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety,
      tolerability and bioavailability (exploring absorption of drug in body) of NN9925 in healthy
      male subjects.
    


Intervention name(s): NN9925 (oral); NN9925 (i.v.); placebo; NN9925 (oral); placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation; As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit; Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels; Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1; Subjects will be randomised to receive a single dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Konjac-mannan in Individuals With Insulin-Resistance Syndrome
Condition: Insulin Resistance Syndrome
MeSH terms: Insulin Resistance; Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To study whether a diet high in fiber from Konjac-mannan (KJM) has an effect on metabolic
      control in individuals with insulin resistance syndrome.
    


Intervention name(s): konjac glucomannan; wheat bran
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Konjac-mannan fiber-enriched biscuits (0.5 g/412KJ [100kcal] of glucommanan); Wheat bran (hard red wheat bran) fiber enriched biscuits
Intervention MeSH terms: (1-6)-alpha-glucomannan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: insulin resistance syndrome; fiber; konjac
Glycemic Evaluation of Novel Staple Foods
Condition: Diabete Type 2; Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In this study, the combined effects of functional foods (i.e. Anthocyanin fortified bread,
      Microfluidic co-flow noodles, 5ibrePlus™-fortified white rice) is investigated in an
      ad-libitum diet and their contributions to diabetes management.
    

Detailed description: 
      Research has confirmed that a food's glycemic effect cannot be accurately predicted from the
      type and amount of carbohydrates it contains, as the rate at which the carbohydrates is
      digested and released into the bloodstream is influenced by many factors such as the food's
      physical form, its fat, protein and fibre content, and the chemical structure of its
      carbohydrates. For these reasons, it is possible to produce food from the same group with
      different effects on blood glucose. Consumption of low GI food has shown to improve glycemic
      control, lipid profile and reduce systemic inflammation. With bread, noodles and rice being
      the staple food for many Singaporeans, functional staple food alternatives offer a lower GI
      alternative without greatly affecting the population's dietary preference. Preliminary
      studies for each functional staple food alternative (for bread, noodles, and rice) had
      reflected improved glycaemic responses compared to their staple counterparts.
    

Intervention name(s): Modified Functional Foods; Control Functional Foods
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will be provided with ABREP-fortified bread, microfluidic co-flow noodles, and 5ibrePlus™-fortified white rice served in a mixed meal.
ABREP-fortified bread: Anthocyanins are known to exert anti-diabetic effects through modulating digestion, glucose uptake, insulin secretion and sensitivity. Moreover, inhibitory effects of anthocyanins on various carbohydrases, including a-glucosidase and a-amylase have been widely reported.
Microfluidic co-flow noodles: Microfluidic technology is employed to design noodle-food structures consisting of a mix of soy protein isolate and alginate as gelling agents to offer a type of novel noodles with proteins and negligible carbohydrate content.
5ibrePlus™-fortified white rice: 5ibrePlus™ is a patented novel fibre grain product by Alchemy Foodtech Pte. Ltd (WO 2017/142477) with reduced GI. Its main constituents are insoluble resistant starch and soluble fibre.; Subjects will be provided with control function foods including white bread, beehoon noodles, and jasmine white rice served in a mixed meal.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A within-subject crossover study design is used to assess the effectiveness of incorporating novel staple food into people's diet to improve their glycemic control. Subjects will undergo two study arms: Treatment and Control. The duration of each arm is 14-days, with a 1-week washout period in between.
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of the Biosimilar Natalizumab PB006 in Comparison to Tysabri®
Condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, parallel arm, double-blind study with a total duration of
      subjects' participation of 48 weeks. Approximately 260 participants with relapsing-remitting
      multiple sclerosis will be randomized to receive 12 doses of either PB006 or EU-licensed
      Natalizumab.
    

Detailed description: 
      This is a Phase 3 multicenter, double-blind, active-controlled, randomized, parallel-group
      study to assess the equivalence in efficacy and similarity in safety of biosimilar PB006
      compared to Tysabri in patients with RRMS.

      All eligible patients will be randomly assigned to one of two treatment groups in a 1:1
      ratio, to receive a total of twelve intravenous (IV) infusion of either PB006 or Tysabri at a
      dose of 300 mg at each intravenous (IV) infusion administered with every single one
      intravenous (IV) infusion administered every 4 weeks of either PB006 or Tysabri at a dose of
      300 mg starting at visit 1 (week 0) through visit 12 (week 44), for a total of 12 infusions.
      The End-of-Study Visit (visit 13, week 48) will be performed 4 weeks after the last infusion
    

Intervention name(s): Intravenous (IV) infusions
Intervention type(s): Biological
Intervention description(s): Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Obeticholic Acid in Bariatric and Gallstone Disease
Condition: Obesity; Gallstones
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Interventional
Phase: Phase 2

Summary: 
      By binding to the nuclear receptor FXR, bile acids not only regulate their own turn-over but
      presumably also pivotal steps in cholesterol, triglyceride and glucose metabolism as shown in
      laboratory animals. Obeticholic acid (OCA) is a semisynthetic bile acid with very high
      affinity to FXR. In a pharmacodynamic study the effects of OCA on bile acid, lipid and
      glucose turn-over are studied in 20 morbidly obese and 20 gallstones patents, respectively,
      that are administered OCA at 25 mg/day in three weeks before bariatric (BS) or gallstone (GS)
      surgery where in addition to blood samples also biopsies are taken from the liver and in the
      case of BS, omental and subcutaneous adipose tissue and in case of GS, gallbladder bile.
    

Detailed description: 
      In a placebo-controlled double-blind randomized trial, 20 otherwise healthy morbidly obese
      patients scheduled for bariatric surgery, and 20 otherwise healthy gallstone patients will be
      administered 25 mg/day INT-747 or placebo for three weeks until the day before surgery. Serum
      from days 1 and 21 will be analyzed for routine liver tests, bile acids, a complete lipid
      profile including FA and in addition for 7α-hydroxy-4-cholesten-3-one and FGF-19, markers for
      bile acid synthesis and its intestinal stimulation. For the evaluation of insulin resistance
      and possible pre-diabetes, plasma will be taken for the estimation of HOMA index and oral
      glucose tolerance test (OGTT) will be performed at days 1 and 21. At surgery, a liver biopsy
      (0.5-1 g) and a white adipose tissue (WAT) specimen (1 cm2) will be taken and immediately
      frozen in liquid nitrogen for mRNA and protein preparation for quantitative RT-PCR and
      Western analysis, respectively, histopathological NAFLD grading, and measuring of hepatic and
      WAT lipase activity. In gallstone patients, gallbladder bile will be sampled for the
      measurements of biliary lipids (cholesterol, phospholipids, bile acids) and the calculation
      of the cholesterol saturation index.
    

Intervention name(s): Obeticholic acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Obeticholic acid 25 mg/day in three weeks; Placebo to obeticholic acid
Other intervention name(s): INT-747; Placebo INT-747
Intervention MeSH terms: Chenodeoxycholic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Morbidly obesity; Gastric bypass; Cholecystolithiasis
Myocardial Protection of Exenatide in AMI
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      Experimental evidence suggests exenatide, a glucagon-like peptide 1 receptor analogue, has
      significant cardiovascular protective effects in various conditions. The investigators
      examined whether conventional use of exenatide at the time of primary percutaneous coronary
      intervention would reduce the infarct size in patients with ST-segment elevation myocardial
      infarction (STEMI).
    

Detailed description: 
      In this proof-of-concept trial, we assessed the effects of acute-phase adjunctive exenatide
      therapy in patients with STEMI.

      Infarct size after STEMI was evaluated by both cardiac magnetic resonance image and cardiac
      biomarkers compared with standard treatment.

      LV function was assessed by conventional and speckle tracking echocardiography. During
      6-month follow up, the safety/tolerability of exenatide and clinical outcomes were also
      assessed.
    

Intervention name(s): exenatide BYETTA® (Amylin-Lilly); Saline
Intervention type(s): Drug; Drug
Intervention description(s): After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group.
Patients assigned to exenatide were treated with 10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.; After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group.
Patients assigned to saline were treated with 10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days.
Other intervention name(s): Saline; Exenatide
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: myocardial infarction; percutaneous coronary intervention; exenatide; reperfusion injury; cardiac magnetic resonance
What Matters to You?
Condition: Behavioural, Emotional, and Psychosocial Problems
Study type: Interventional

Summary: 
      Procedures for systematic user involvement in primary mental health services are lacking, and
      several adolescents are dissatisfied with their opportunities to influence the service
      provided. The research on the effects of user involvement is scarce, especially regarding
      user involvement for children and adolescents. Hence, we suggest introducing an idiographic
      assessment tool in a selection of Norwegian primary mental health services. Idiographic
      assessment is a way of measuring psychological constructs, by using tools specifically
      adapted for each individual respondent.

      This protocol describes the implementation and evaluation of a user involvement tool called
      'Assert', in Norwegian primary mental health services. Assert is a simple tool where the
      adolescents themselves decide the goals or themes that they would like to address in
      collaboration with their service provider. Assert is scored each time the adolescent and the
      service provider meet, to monitor progress toward the goal. A randomised controlled trial
      design is proposed for this study. Assert will be implemented in 5-10 Norwegian
      municipalities, and will include 250 participants between 12 and 23 years. The objective of
      the study is to examine the relationship between Assert and perceived user involvement. Are
      idiographic measures an adequate way to operationalise user involvement on an individual
      level? And if so, can user involvement (i.e. Assert) have an effect on quality of life and
      mental health in adolescents? And lastly qualitative analyses of the adolescents' themes and
      goals will be conducted to explore what matters to the adolescents that visit primary mental
      health services in Norwegian municipalities.
    


Intervention name(s): Assert
Intervention type(s): Other
Intervention description(s): The Assert-method is a counselling method used to assess and systematically follow up the individual adolescents' perceived needs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Histocompatibility Leukocyte Antigen (HLA)-A*2402 Restricted Peptide Vaccine Therapy in Patients With Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and time to progression of HLA-A*2402
      restricted epitope peptides URLC10, TTK, and KOC1, emulsified with Montanide ISA 51.
    

Detailed description: 
      URLC10, KOC1 and TTK have been identified as cancer specific molecules especially in non
      small cell lung cancer using genome-wide expression profile analysis by cDNA microarray
      technique. In a prior study, it has been shown that URLC10, KOC1 and TTK are upregulated in
      human esophageal tumors. We identified that peptides derived from these proteins
      significantly induce the effective tumor specific CTL response in vitro and vivo. According
      to these findings, in this trial, we evaluate the safety, immunological and clinical response
      of those peptides. Patients will be vaccinated twice a week for 8 weeks. On each vaccination
      day, the URLC10 peptide (1mg), KOC1 peptide (1mg), and TTK peptide (1mg) mixed with Montanide
      ISA 51 will be administered by subcutaneous injection. Repeated cycles of vaccine will be
      administered until patients develop progressive disease or unacceptable toxicity, whichever
      occurs first. In the phase I study, we evaluate the safety and tolerability of these peptide
      vaccines. In the following phase II study, we evaluate the immunological and clinical
      response of this vaccine therapy.
    

Intervention name(s): URC10, TTK, KOC1
Intervention type(s): Biological
Intervention description(s): Patients will be vaccinated twice a week for 8 weeks. On each vaccination day, the URLC10 peptide (1mg), KOC1 peptide (1mg) and TTK peptide (1mg) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Peptide Vaccine; URLC10; TTK; KOC1