bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Oral Trigonella Foenum-graecum Seed Extract Vs Placebo in Treatment of None Alcoholic Fatty Liver Disease
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study design to examine performance of trigonella foenum-graecum (TFG) in treatment of
      non-alcoholic fatty liver disease. Base on inclusion and exclusion criteria, 50 patients
      select and then randomize into intervention and control groups. Two group use capsules which
      contain TFG or placebo, respectively.
    

Detailed description: 
      This study design to examine performance of trigonella foenum-graecum in treatment of
      non-alcoholic fatty liver disease. Patients 18-70 year old with the levels of ALT and AST
      greater than 1.5 and less than 10 times normal level, and ultrasound evidence confirm fatty
      liver disease include in study. Patients with alcohol consumption, other liver disease and
      taking medications that cause liver injury, exclude. Base on inclusion and exclusion
      criteria, 50 patients select and then randomize into intervention and control groups. Control
      group, in addition to diet and exercise recommendations take placebo capsules for 3 months.
      Intervention group, in addition to diet and exercise recommendations, use capsules containing
      hydro-alcoholic extract of fenugreek 1g/d for 3 months. At baseline and 6 and 12 weeks after
      intervention, the investigators measure FBS, insulin, insulin resistance, Albumin, Aspartate
      transaminase, Alanine Aminotransferase, Alkaline phosphatase, Total bilirubin, Direct
      bilirubin, HbA1c, total cholesterol, LDL, HDL, TG, High sensitivity C reactive protein and
      Creatinine. At baseline and 12 weeks after intervention fibroscan perform to evaluate the
      amount of fat in liver. In order to decrease bias, patient, physician who performs fibroscan
      and the person analyzing the data are blind to group drugs.
    

Intervention name(s): Trigonella Foenum-graecum Seed Extract; Drug: Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Closed Loop Control in Adolescents Using Heart Rate as Exercise Indicator
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to see if the Artificial Pancreas (AP) Platform can successfully
      control blood sugar in people with type 1 diabetes mellitus on insulin pump therapy in a
      hospital setting. Investigators will also be studying to see if the heart rate informed
      Control To Range (hrCTR) can improve the performance of the system during and immediately
      after exercise.
    

Detailed description: 
      The artificial pancreas (AP), known as Closed-Loop Control of blood glucose in diabetes, is a
      system combining a continuous glucose monitor (glucose sensor), a control algorithm (complex
      mathematical formulas), and an insulin pump. The algorithms are intended to maintain your
      blood glucose level within a certain range. This is called Control-to-Range. The algorithms
      are intended to maintain your blood glucose level within a certain range. The algorithms run
      on a portable AP platform on an Android smart phone, called the Diabetes Assistant (DiAs)
      Medical Platform.

      In this study, researchers hypothesize that the heart rate informed Control To Range (hrCTR)
      will limit the risk for hypo and hyperglycemia during and immediately after exercise in
      adolescents 12 - 17 years of age and assess if the hrCTR will improve additional measures of
      overall short term glycemic control in this population.

      This trial will be performed at both Virginia Commonwealth University and the University of
      Virginia. IRB approvals have been obtained at both institutions.
    

Intervention name(s): heart rate Control to Range System (hrCTR) using DiAs Platform; DiAs Control-to-Range System not informed for heart rate
Intervention type(s): Device; Other
Intervention description(s): Diabetes Assistant (DiAs) Medical Platform System
A smart-phone medical platform (DiAs);
Continuous Glucose Monitor;
Insulin pump;
Bluetooth connection;
Remote Monitoring Server.; Not informing system of heart rate during exercise.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial Pancreas Project; Diabetes Assistant (DiAs) Medical Platform System; Artificial Pancreas Platform; Insulin Pump; Continuous Glucose Monitor; Closed-Loop Control; heart rate Control to Range System (hrCTR)
Study To Investigate The Relative Bioavailability of OZ439 Formulations In Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess prototype formulations compared to the aqueous dispersion of
      Active Pharmaceutical Ingredient used in Phase I and Phase IIa studies to date. It is hoped
      that the bioavailability of OZ439 can be enhanced in the fasted state to be close to that
      observed when given after food. This will improve the utility of OZ439 in the field as well
      as decreasing the cost of treatment (by decreasing the dose of OZ439 required) which is very
      important for an antimalarial drug product destined for use in developing counties.
    

Detailed description: 
      This study was a single centre, open-label, pharmacokinetic, randomized cross-over study in
      healthy male volunteers and post-menopausal women. This study was conducted over three
      different cohorts as follows:

      Cohort 1: Subjects received a single 800 mg (as free base) dose of five different treatment
      regimes (treatments A, B, C, D and E) on five occasions.

      Cohort 2: Subjects received a single 800 mg (as free base) dose of four different treatment
      regimes (treatments F, G, H and I) on four occasions.

      Cohort 3: Subjects received a single dose, 800mg (as free base) of prototype solution
      formulation 1 (treatment J) and 400mg (as free base) of prototype solution formulation 1
      (treatment K) on two occasions. The treatments were administered under the fasted state.
    

Intervention name(s): OZ439 mesylate 800mg Powder in Bottle for Oral Suspension; OZ439 mesylate 400mg Prototype Solution Formula 1; OZ439 mesylate 800mg Prototype Solution Formula 1; OZ439 mesylate 800mg Prototype Solution Formula 2
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): OZ439 800 mg (as free base) as powder in a bottle for reconstitution in a suspension prior to oral administration; OZ439 400 mg (as free base) as a prototype solution formulation 1; OZ439 800 mg (as free base) as a prototype solution formulation 1; OZ439 800 mg (as free base) as a prototype solution formulation 2
Other intervention name(s): OZ439 PIB; OZ439 400mg Prototype 1; OZ439 800mg Prototype 1; OZ439 800mg Prototype 2
Intervention MeSH terms: Artefenomel; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OZ439; Bioavailability; Food Effect
A Study to Evaluate the Efficacy of MEDI-528 on Late Asthmatic Response With Atopic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a, randomized multicenter study to evaluate the efficacy of MEDI-528 on LAR
      in adult patients with atopic asthma.
    

Detailed description: 
      This study (MI-CP138) is a Phase 2a, randomized, double-blind, placebo-controlled,
      multicenter study to evaluate the efficacy of MEDI-528 on LAR in adult patients with atopic
      asthma. Approximately three investigative sites in Canada will participate in this study,
      with up to 40 evaluable patients randomized in a 1:1 ratio to receive MEDI-528 (9.0 mg/kg) or
      placebo as a single IV infusion.
    

Intervention name(s): MEDI-528 9 mg/kg; Placebo
Intervention type(s): Biological; Other
Intervention description(s): MEDI-528 at a single dose of 9 mg/kg administered as an intravenous infusion; Placebo administered as a single intravenous infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Secondary PRevention in Cardiovascular Disease by a Nursing Guided Program (SPRING)
Condition: Acute Coronary Syndrome; Nutrition; Physical Activity; Secondary Prevention
MeSH terms: Neoplasm Metastasis; Acute Coronary Syndrome
Study type: Interventional

Summary: 
      DESIGN: Controlled clinical trial with single randomization, unmasked, open and multicentric.

      CENTERS: University Hospital of A Coruña and University Hospital of Ferrol CONDITION TO
      STUDY: Acute Coronary Syndrome (ACS). INTERVENTION:monitored outhospital not inhospital
      supervised. MAIN OBJECTIVE: To determine the incidence of major adverse events (total
      mortality, new ACS, coronary revascularization, all-cause hospitalization) during the
      one-year period after hospitalization for ACS.
    

Detailed description: 
      The SPRING study aims to learn whether a remote, nurse-guided secondary prevention program
      reduces adverse events in patients who suffer an infarction during the subsequent one-year
      period. The SPRING study focuses not only on adverse events but also on the patients' state
      of life in terms of diet, physical exercise, emotional state, tobacco use, and adherence to
      medical treatment. Nursing is a profession in charge of preserving the health of patients,
      which is why the remote secondary cardiovascular prevention program of this study is
      coordinated by a nurse.
    

Intervention name(s): INTERVENTION GROUP
Intervention type(s): Behavioral
Intervention description(s): Offer recommendations of healthy living habits and control of pharmacy administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
PRF Pulpotomy Using Different Bioceramic Materials in Permanent Molars
Condition: Irreversible Pulpitis
MeSH terms: Pulpitis
Study type: Interventional

Summary: 
      this study aimed to compare the clinical and radiographic outcomes of full pulpotmy after
      application of Biodentine, or MTA, or Portland cement above PRF membrane In permanent molars
      with irreversible pulpitis
    


Intervention name(s): portland cement; Mineral trioxide aggregate; Biodentine
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): pulpotomy with PRF and white Portland cement; pulpotomy with PRF and white Mineral trioxide aggregate; pulpotomy with PRF and Biodentine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: permanent molar with symptomatic irreversible pulpitis
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PRF; Vital pulp therapy; pulpotomy; bioceramics
HD18 for Advanced Stages in Hodgkins Lymphoma
Condition: Hodgkins Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to test:

        1. in patients with negative positron-emission tomography (PET) after 2 cycles of
           BEACOPPesc chemotherapy: whether the number of cycles can be reduced without
           compromising progression free survival (PFS) (2 further cycles vs. 6 further cycles)

        2. for patients with positive PET after 2 cycles: whether intensifying BEACOPPesc
           chemotherapy by adding Rituximab improves PFS.
    


Intervention name(s): Rituximab; BEACOPP escalated
Intervention type(s): Drug; Drug
Intervention description(s): addition of Rituximab to BEACOPP escalated; chemotherapy with BEACOPP escalated
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin lymphoma; PET; advances stages; Rituximab
Safety of an Inactivated Enterovirus Type 71 Vaccine in Healthy Adults
Condition: Infection; Viral, Enterovirus
MeSH terms: Enterovirus Infections; Virus Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A blind, randomized and placebo-controlled clinical trial with Inactivated Enterovirus Type
      71 Vaccines in healthy adults
    

Detailed description: 
      A total of 36 eligible subjects aged from 18 to 49 years will be enrolled in the study, they
      will be randomized to receive two different dosage of vaccine candidate or placebo to
      evaluate the safety of this vaccine in adults
    

Intervention name(s): Inactivated Enterovirus Type 71 Vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit); Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
Other intervention name(s): EV71 Vaccine; EV71 Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Antioxidant and Anti-inflammatory Effects of Yogurt Enriched With Polyphenols
Condition: Oxidative Stress; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the possible antioxidant and anti-inflammatory
      effects of yogurt enriched with polyphenols after 2-week consumption by healthy individuals.
    

Detailed description: 
      Eighteen healthy adult volunteers of both sexes consumed yogurt (400g per day) enriched with
      polyphenols (10mg/100g yogurt) or yogurt (400g per day) not enriched with polyphenols for two
      weeks in a double-blind, crossover, randomized manner.There was a washout period of at least
      10 days. Physiological data and blood samples were collected before and after consumption of
      each yogurt.
    

Intervention name(s): Yogurt enriched with polyphenols; Yogurt not enriched with polyphenols
Intervention type(s): Other; Other
Intervention description(s): Yogurt enriched with polyphenols extracted from grape seeds; Yogurt not enriched with polyphenols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: antioxidant; oxidative stress; inflammation; polyphenols; yogurt
Ergometer Training in Patients With OSA
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Patients with suspected OSA (obstructive sleep apnoea syndrome) are asked to use a standard
      bike ergometer which is additionally equipped with a system to gather training data and the
      ability to send daily training time to an internet server to which the physician has access.
      Training time of two groups is compared. Group one is not motivated while group two benefits
      from telephone feedback when training time declines. It is presumed that training time
      increases with better information and response to training behaviour.
    


Intervention name(s): Motivation by Telephone Call
Intervention type(s): Behavioral
Intervention description(s): Telephone call not exceeding 10 minutes according to a protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ergometer; training; motivation; telemonitoring; sleep apnea
Evaluation of an Altered Peptide Ligand (NBI-5788) in Patients With Relapsing Multiple Sclerosis (MS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      We are studying this investigational drug treatment, comparing it with placebo, to evaluate
      whether it is effective in reducing the number of MRI lesions with a minimum number of side
      effects. The investigational drug will be administered in the clinic weekly for 5 injections
      (induction phase) then monthly for 8 additional injections (maintenance phase).

      Approximately 150 male and female patients (100 active and 50 placebo), aged 18 to 55 years,
      with relapsing MS and at least one but no more than 10 total Gd-enhancing lesions on cranial
      MRI scans during the run-in phase will be randomized into this study.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled trial in which qualifying
      patients will be randomized 2:1 to receive active drug or placebo. Eligible patients must
      have MS with relapse, have had one or more relapses during the prior 2 years, 1-10 gadolinium
      (Gd)-enhancing lesions on the Run-in MRI, and an EDSS of 6.5 or less. There are exclusions
      for certain prior MS treatments and medical / psychiatric conditions. Following a 4-week
      run-in phase in which patients will have a baseline MRI, patients will enter a 4 week
      induction phase, during which they will be receive injections weekly (5 doses), then a
      32-week maintenance phase during which injections are monthly (8 doses). A final follow-up
      visit will be conducted 4 weeks after the last injection. The primary efficacy parameter is a
      summary change score of the mean number of total Gd-enhancing lesions at weeks 36 and 40
      minus the mean number for the two baseline scans. Safety monitoring will include AE/SAE
      reporting, physical exams, vital signs, ECG. CXR, laboratory tests, neurologic evaluations,
      and systemic hypersensitivity and injection site assessments. All study medications will be
      administered by study personnel and patients will remain under observation for a minimum of 2
      hours post-injection. An independent Data Safety and Monitoring Board will oversee the safety
      of the trial.
    

Intervention name(s): NBI-5788
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: MS; Autoimmune disease; relapsing; progressive; Myelin; Myelin Basic Protein; MBP; acute fulminating; chronic progressive; Altered Peptide Ligand; APL; Neurocrine; NBI-5788; Relapse
Effect of Nano Care Gold on Marginal Integrity of Resin Composite
Condition: Caries Class Ii
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study to detect the effect of Nano Care Gold on marginal integrity of resin
      composite restoration
    

Detailed description: 
      This study will be divided into 3 groups (control, Nano Care Gold, Chlorhexidine). Both
      materials will be used as a surface pre-treatment. Their effect on marginal integrity will be
      evaluated through evaluation of marginal adaptation, marginal staining, post-operative
      sensitivity. The follow up period is one year
    

Intervention name(s): Nano Care Gold; No intervention; Chlorhexidine
Intervention type(s): Other; Other; Other
Intervention description(s): Mixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group.; No intervention will be applied in this group. It will be the negative comparator. In this group only the standard of care will be applied, which means the steps will be cavity preparation followed by adhesive system then resin composite without any surface pre-treatment; 2 % chlorhexidine gluconate. This group will be compared with no intervention group.
Other intervention name(s): Silver and Gold nano particles; Negative control; chlorhexidine gluconate
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: marginal adptation; marginal staining; post operative sensitivity; recurrent caries
Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research is to demonstrate immunologic equivalence of three consecutive
      production lots of the subunit influenza vaccine compared to egg-derived inactivated
      influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to
      show how safe and well tolerated a conventional inactivated subunit influenza vaccine,
      licensed in many countries outside the United States, is compared to an inactivated influenza
      vaccine, licensed in the United States.
    


Intervention name(s): Lot A of Influenza virus vaccine; Lot B of Influenza virus vaccine; Lot C of Influenza virus vaccine; Comparator influenza virus vaccine; All 3 consecutive lots of influenza virus vaccine pooled
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 1 injection of the trivalent subunit influenza virus vaccine (lot A) administered intramuscularly; 1 injection of the trivalent subunit influenza virus vaccine (lot B) administered intramuscularly; 1 injection of the trivalent subunit influenza virus vaccine (lot C) administered intramuscularly; 1 injection of the trivalent subunit influenza virus vaccine administered intramuscularly; 1 injection of the pooled trivalent subunit influenza virus vaccine administered intramuscularly
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Influenza; adults; different lots; trivalent subunit influenza virus vaccine (IVV); trivalent subunit influenza vaccine
A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study follows an open-label, single arm design with two periods with rosuvastatin,
      digoxin and ABBV-CLS-7262
    

Detailed description: 
      Period 1: One single dose of rosuvastatin and one single dose of digoxin on Day 1.

      Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one
      single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on
      that day.
    

Intervention name(s): ABBV-CLS-7262
Intervention type(s): Drug
Intervention description(s): Drug: ABBV-CLS-7262 Drug: Digoxin Drug: Rosuvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Digoxin; Rosuvastatin; Molecular Mechanisms of Pharmacological Action; Physiological effects of drugs