bioihbjkbjnl/mcl2 huggingface dataset:
A Study of LGD-6972 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the change from baseline in hemoglobin A1c (HbA1c)
      during 12 weeks of treatment with 3 dose levels of LGD-6972 compared to placebo in subjects
      with Type 2 Diabetes Mellitus (T2DM)
    

Detailed description: 
      This will be a 12-week, randomized, double-blind, placebo-controlled, 4-arm, parallel group,
      multi-center study to evaluate the safety and efficacy of LGD-6972 in subjects with T2DM
      inadequately controlled on metformin monotherapy (a stable [≥12 weeks], daily dose of ≥1000mg
      at randomization). Subjects with T2DM will be treated with one of 3 dose levels of LGD-6972
      (5 mg, 10 mg, or 15 mg) or placebo once daily (QD) for 12 weeks. Randomization will be
      stratified by HbAlc ≤8.5% or >8.5% at the Placebo Lead-in Visit.

      Qualified subjects who require adjustment or stabilization of their metformin dose will
      participate in a run-in period of up to 12 additional weeks prior to randomization. Subjects
      will have the option to participate in an oral glucose tolerance test (OGTT) at baseline and
      end of treatment for assessment of exploratory endpoints.
    

Intervention name(s): LGD-6972-5 mg; LGD-6972-10 mg; LGD-6972-15 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 5 mg LGD-6972 QD; 10 mg LGD-6972 QD; 15 mg LGD-6972 QD; Placebo QD
Other intervention name(s): LGD-6972 sodium salt capsules; LGD-6972 sodium salt capsules; LGD-6972 sodium salt capsules
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Intra-articular PVA Hydrogel in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This multicentre, prospective, randomized, double-blind, active-controlled, parallel group
      clinical investigation is aimed to assess the safety and the clinical performance over 6
      months of a single intra-articular injection of PVA Hydrogel, novel polyvinyl alcohol
      preparation, as compared to hyalan G-F20, (Synvisc-One®) one of the most commonly used and
      best performing hyaluronic acid based products, in patients with symptomatic knee
      osteoarthitis (OA).
    

Detailed description: 
      To compare the effects of a single intra-articular injection of a novel polyvinyl alcohol
      preparation (PVA Hydrogel) and hylan G-F20 (Synvisc-One®) in patients with symptomatic knee
      OA.

      Patients with knee OA (ACR clinical and radiological criteria) symptoms for ≥6 months,
      insufficient/failed response to analgesics, K&L stage II-III (x-Rays within past 12 months),
      a knee pain score of 4-9 (0-10 NRS) in the target knee and <3 in the contralateral knee, will
      be enrolled in a randomised, controlled, double-blind, parallel group 26-week clinical
      investigation to receive a single intra-articular injection of PVA Hydrogel or Synvisc-One®.
      Safety (both at the injection site (primary end-point) and overall) and efficacy (change in
      pain in the target knee (0-10 NRS), WOMAC Osteoarthritis Index (total and subscales) and
      Patient's Global Assessment of knee OA (0-10 NRS)) will be evaluated.

      After signing an informed consent, patients will be screened at least 7 days before
      randomisation, when they will received a single intra-articular injection of either PVA
      Hydrogel or Synvisc-One® (1:1 allocation ratio) and will be then seen for follow-up 1, 2 and
      4 days (this latter just in case of AE occurrence at the target knee) and 2, 4, 8, 12, 18 and
      26 weeks after IA injection.
    

Intervention name(s): PVA Hydrogel; Synvisk-One®
Intervention type(s): Device; Device
Intervention description(s): PVA Hydrogel will be supplied in 2 mL sterile and endotoxins-free pre-filled syringes containing a biocompatible polyvinyl alcohol crosslinked (PVA CL, main component) and buffered water for injections.; Synvisc One® (comparator) will be supplied in a 6 mL sterile and non-pyrogenic syringe containing containing Hylan polymers (hylan A + hylan B) (main component), sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and water for injections.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
SNIF (Sniff Nasal Inspiratory Force) Reference Values Of Mediterranean Population
Condition: Healthy People Programs
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      SNIF test has been described as a method to explore the diaphragmatic function. But there are
      no defined the reference values of this test in healthy population. The investigators'
      hypothesis is that there is a variation on SNIF values in Mediterranean population depending
      on gender, age and anthropometric variables such as height and weight.

      The investigators will analyze 1000 SNIF test of healthy people. The investigators will
      divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the
      investigators will study 100 men and 100 women.

      All the subjects will perform a forced spirometry, maximal inspiratory pressure (MIP) and
      SNIF. If spirometry and MIP are correct the investigators will consider that person has a
      correct diaphragmatic function and strength. Then the investigators will measure the SNIF
      test. With all of these SNIF values the investigators will try to achieve the reference
      values of this test in the different groups of age in Mediterranean population. And the
      investigators will compare SNIF with MIP.

      Cross multicentric study. Hospitals involved: Hospital de Bellvitge, Hospital del Mar,
      Hospital Parc Taulí, Hospital de la Santa Creu i Sant Pau (coordinator center) and Hospital
      de la Vall d'Hebrón.
    


Intervention name(s): SNIF test (Sniff Nasal Inspiratory Force)
Intervention type(s): Other
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Community sample
A Study to Assess the Immunogenicity, Tolerability and Safety of a Malaria Vaccine and Also Its Protective Efficacy in a Malaria Challenge Model
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of two
      dose levels (1x10^10 and 5x10^10 virus particles (vp)) of the adenovirus serotype (Ad)
      Ad35.CS.01/Ad26.CS.01 prime-boost malaria candidate vaccine, followed by an evaluation of the
      protective efficacy of the higher dose level in an experimental malaria challenge.

      The study will be in 3 phases:

        1. a dose escalation / vaccination phase in which both dose levels will be tested

        2. a malaria challenge phase in which only subjects receiving the Ad35.CS.01/Ad26.CS.01
           5x10^10 vp dose level, together with six infectivity control subjects, will be exposed
           to experimental challenge with Plasmodium falciparum

        3. a long term follow up phase in which all subjects who received active vaccine from both
           dose levels and/or malaria challenge will be included
    


Intervention name(s): Ad35.CS.01/Ad26.CS.01 low dose (1 x 10^10 vp); Ad 35.CS.01/Ad 26.CS.01 high dose (5 x 10^10 vp); Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Prime-boost schedule: Each subject receives two injections of Ad35.CS.01 (on Days 0 and 28) followed by one injection of Ad26.CS.01 (on either Day 55 or 59).; Prime-boost schedule: Each subject receives two injections of Ad35.CS.01 (on Days 0 and 28) followed by one injection of Ad26.CS.01 (on either Day 55 or 59).; Each placebo subject receives in total three injections of placebo: Day 0, Day 28, and either Day 55 or 59
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Malaria; Plasmodium falciparum; Vaccination; Prophylaxis; Adenovirus
PKPD Study of Ticagrelor and Prasugrel in Healthy Korean Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to characterize the pharmacokinetic and pharmacodynamics of ticagrelor and
      prasugrel in healthy Korean male subjects.

      The study is open label, one sequence, crossover design. In period 1, a single oral dose of
      180 mg ticagrelor will be administrated. After at least 7 days washout period, in period 2, a
      single oral dose of 60 mg prasugrel will be administrated.

      After dosing each period, blood sampling for PK and PD assessment will be conducted.

        1. Blood Sampling Times

             1. PK :predose,10 min,15 min,25 min, 0.5,1,1.5,2,2.5,4,6,8,12 and 24h post-dose

             2. PD :predose,15 min,0.5,1,2,4,6,8,12 and 24h post-dose

        2. Bioanalysis

             1. plasma Ticagrelor

             2. plasma AR-C124910XX (active metabolite of ticagrelor)

             3. plasma R-95913 (inactive metabolite of prasugrel)

             4. plasma R-13727 (active metabolite of prasugrel)

        3. Platelet Aggregation Test using turbidometric Method Maximal Platelet Aggregation(MPA)

        4. PK-PD Modeling analysis
    


Intervention name(s): ticagrelor/prasugrel
Intervention type(s): Drug
Other intervention name(s): ticagrelor :2 tablets of Brilinta® 90 mg; prasugrel : 6 tablets of Effient® 10 mg
Intervention MeSH terms: Ticagrelor; Prasugrel Hydrochloride
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ph I Study of Alvocidib and Cytarabine/Daunorubicin (7+3) in Patients With Newly Diagnosed Acute Myeloid Leukemia (AML).
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I study is to determine the safety and tolerability including the
      maximum dose (MTD) and dose-limiting toxicities (DLTs) of alvocidib when administered over a
      range of doses on Days 1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults
      with newly diagnosed and previously untreated AML
    

Detailed description: 
      Primary Objective:

      • To determine the safety and tolerability including the maximum tolerated dose (MTD) and
      dose-limiting toxicities (DLTs) of alvocidib when administered over a range of doses on Days
      1-3 followed by cytarabine/daunorubicin (7+3) on Days 5-11 in adults with newly diagnosed and
      previously untreated AML

      Secondary Objectives:

        -  To observe patients for any evidence of antileukemic activity of alvocidib plus 7+3
           using the 2017 ELN response criteria

        -  To establish the Recommended Phase 2 Dose (RP2D) for future studies with alvocidib in
           combination with 7+3

      Exploratory Objective:

      • To assess levels of minimal residual disease (MRD) using standardized techniques (ie,
      multiparametric flow cytometry [MPFC] and next generation sequencing [NGS] and evaluate other
      potential biomarkers including, but not limited to, MCL-1 dependency.
    

Intervention name(s): Alvocidib; Cytarabine; Daunorubicin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV bolus followed by IV infusion; continuous infusion; IV bolus
Intervention MeSH terms: Cytarabine; Daunorubicin; Alvocidib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Optimizing IFN Beta - 1B Dose
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      BetaferonR is effective in reducing relapse rate and MRI T2-weighted lesion frequency in MS
      patients at the dose of 8 MIU on alternate days (THE IFNB MS Study Group, 1993). Relapse rate
      is reduced by 30-35% (The IFNB MS Study Group, 1993), MRI activity is decreased up to 100% in
      most cases (Stone et al 1995). In some patients, however, MRI activity still occurs or
      reappears during treatment (Stone et al 1995). MRI activity has been demonstrated to
      correlate with relapse occurrence (McFarland et al, 1992; Miller et al, 1996), and in some
      patients relapses still occur during IFN beta treatment. In other patients relapses may occur
      in association with the appearance, after 9-18 months of treatment, of anti-IFN beta NAB (The
      IFNB M S Study Group, 1995).

      This protocol hypothesizes that the dose of 12 MIU BetaferonR on alternate days has more
      pronounced MRI and clinical effects in MS patients than that of 8 MIU. MS patients who do not
      respond to 8 MIU may take advantage of a higher dose. We, therefore decided to assess MRI
      effects after increasing the Betaferon dose (12 MIU) in RRMS patients showing a residual MRI
      activity (at least one new Gd enhancing lesion) during six months of standard Betaferon dose
      treatment (8 MIU).
    

Detailed description: 
      Comparing the frequency of new Gd enhancing lesions in a group of patients presenting a
      residual MRI activity during the last four months of the six month standard dose (8MIU)
      Betaferon treatment randomized to continue the standard dose or to increase the dose to 12
      MIU Betaferon
    

Intervention name(s): Interferon Beta 1
Intervention type(s): Drug
Intervention MeSH terms: Interferons; Interferon-beta
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Interferon; Magnetic Resonance
The Effectiveness of "CARE Coaching Model" as an Effort to Empower Type 2 Diabetes Mellitus Patients
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In Indonesia and others countries, only 30.8% patients with type 2 diabetes mellitus (T2DM)
      achieved glycemic control with HbA1c <7%. Optimal pharmacological treatment alone does not
      guarantee an optimal outcome, therefore it should be combined with lifestyle management.
      Health coaching helps T2DM patients increase self awareness to improve and maintain behavior
      which play a role in self-management. This study aims to evaluate the impact of health
      coaching on glycemic control on T2DM patients.
    

Detailed description: 
      Subjects randomized into 2 groups: control and intervention group. All subject received
      education class in top of standard treatment. Intervention group received additional personal
      health coaching.

      Education and health coaching was given for 12 sessions every 2 weeks with 12 different
      themes for each session. Health coaching were given by International certified health coach.

      Laboratory examination and questionnaire collected at baseline, 3 and 6 months after
      intervention.
    

Intervention name(s): Health Coaching
Intervention type(s): Other
Intervention description(s): Health Coaching as face to face with a coach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diabetes Mellitus; Health coaching
Nicotinic Receptors and Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene
      anabaseine sustained release) will provide clinical improvement in cognition in patients with
      schizophrenia who are smokers and who are non-smokers. The study drug may also maintain
      abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.
    

Detailed description: 
      Patients with schizophrenia will be screened then enrolled for one week placebo trial in
      addition to their existing antipsychotic medication. If pill compliance is greater than 80%,
      then they will receive baseline clinical, cognitive, and brain imaging and all clinical
      laboratory examinations and a physical examination, vital signs, and cardiogram. Then
      patients will receive in a randomized double blind trial either DMXB-A-SR (3-2,4
      dimethoxybenzylidene anabaseine sustained release) or placebo comparator in addition to their
      existing antipsychotic medication. After one month patients will receive repeat clinical,
      cognitive, and brain imaging testing and all clinical laboratory examinations and a physical
      examination, vital signs, and cardiogram.
    

Intervention name(s): DMXB-A-SR; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR); Placebo Comparator
Other intervention name(s): GTS-21
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Random allocation to a treatment and placebo group.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug Trial; Smoking; Smoking Cessation; Cognition; Mental Focus
A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical trial is to learn about the safety and effects of the study
      vaccine for the potential prevention of influenza. The study vaccine is called
      Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants
      who:

        -  Are between the age of 18 to 49 years old.

        -  Are willing and able to comply with all scheduled visits, treatment plan, laboratory
           tests, lifestyle considerations, and other study procedures.

        -  Are healthy as determined by medical history, physical examinations, and the study
           doctor.

        -  For male participants, can father children and willing to use an acceptable method of
           contraception. Female participants who are not of childbearing potential; or male
           participant not able to father children.

        -  Are capable of giving signed informed consent. Participants will receive either the
           saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not
           know which vaccine they receive in advance. A placebo does not have any medicine in it
           but looks just like the study medicine. Participants will receive the study vaccines as
           a single shot in the arm. We will compare participant experiences to help us determine
           if the saRNA vaccine is safe and effective. Participants will take part in this study
           for 6 months. During this time, they will receive the study vaccine and participate in
           follow-up visits.
    


Intervention name(s): PF-07852352 Influenza saRNA 1; PF-07836391 Influenza saRNA; PF-07836394 Influenza saRNA; PF-07836395 Influenza saRNA; PF-07836396 Influenza saRNA; PF-07867246 Influenza saRNA; Placebo; Quadrivalent influenza vaccine (QIV); PF-07871987 Influenza saRNA; PF-07914705 Influenza saRNA; PF-07915048 Influenza saRNA
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Camphor; Menthol
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Grippe; Flu; Influenza; Vaccine; RNA vaccine; Self-amplifying
Anti-Tumor Immunity Induced by IRE of Unresectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      This protocol will study the impact of Irreversible electroporation (IRE) on immune response
      in patients diagnosed with unresectable pancreatic cancers smaller than 5.0 cm. It will
      profile the immune response to IRE of unresectable pancreatic cancers. The intra-tumoral and
      systemic immune response to IRE will be determined and compared to pre-ablated pancreatic
      cancer specimens and historical control specimens.
    

Detailed description: 
      Thirty patients with histologically confirmed locally advanced pancreatic adenocarcinoma
      (≤5.0cm) will undergo percutaneous irreversible electroporation of the tumor using CT and
      ultrasound guidance. Blood will be drawn for research before IRE. Blood and tissue samples
      will be used.

      After IRE, patients will be carefully monitored and systemic immune responses are registered.
      Follow-up will consist of frequent CT and MRI scanning, as well as serum CA19.9 tumor marker
      and quality of life questionnaires and overall survival (OS).

      The investigators hypothesize that IRE in the pancreas will induce good symptom palliation
      without causing severe complications as well as perfect systemic immune response.
    

Intervention name(s): NanoKnife LEDC System
Intervention type(s): Device
Intervention description(s): Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.
Other intervention name(s): NanoKnife
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment