bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the effect of telaprevir on early hepatitis
      (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who
      are chronically (lasting a long time) infected with genotype 2 or 3 HCV.
    

Detailed description: 
      This is a Phase 2a multicenter (when more than one hospital or medical school team work on a
      medical research study), partially blinded, randomized (study drug assigned by chance)
      stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for
      genotype, multiple dose study. The trial will consist of Screening period (6 weeks),
      Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will
      include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All
      the eligible participants who were never treated for HCV will be enrolled for the trial and
      will receive the investigational treatment regimen to which they have been randomly assigned
      for 2 weeks. After this in the standard treatment phase participants will receive the
      standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram
      once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be
      evaluated by HCV viral load quantification. Participant's safety will be monitored throughout
      the study.
    

Intervention name(s): Telaprevir; Peg-IFN-alfa-2a + Ribavirin (Standard Treatment); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.; Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 & PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.; Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.
Other intervention name(s): VX-950
Intervention MeSH terms: Ribavirin; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C, Chronic; Genotype 2; Genotype 3; Telaprevir
Study of the Impact of Cheese Matrix on Postprandial Lipemia: a Clinical Study
Condition: Healthy
MeSH terms: Hyperlipidemias
Study type: Interventional

Summary: 
      Dairy products consumption is widely recommended in a healthy diet not only for bone growth
      and maintenance, but also as a protein, calcium and magnesium sources for an adequate diet.
      However, dairy products are a major dietary source of saturated fat that is associated with
      increased risk of coronary heart disease. ln this context, dietary guidelines still advocate
      a restriction in dietary saturated fat for optimal heart health. Nevertheless, the
      association between saturated fat and the risk of heart disease remains highly controversial
      within the scientific community. There is also emerging evidence that the impact of dietary
      saturated fat will be significantly influenced by the food matrix through which it is
      provided. Recent studies indicate that cheese could have a major influence on intestinal fat
      absorption and the magnitude of the after meal release of fat in blood circulation. This is
      of interest because substantial evidence exists indicating that elevated levels of the after
      meal fat levels are associated with increased cardiovascular risk. Therefore, the improvement
      of the after meal fat levels produced by cheese consumption could well be part of novel
      therapeutic approaches contributing to improve cardiovascular risk.

      The general objective of the proposed research is to investigate how cheese consumption
      affects the after meal release of fat in blood circulation in healthy subjects. Our
      hypothesis is that, compared to butter, cheese consumption will have a beneficial impact on
      the after meal fat levels in healthy subjects. Favourable results from the proposed study
      will provide novel and much warranted evidence on the importance of considering changes in
      the after meal fat levels, not only bad cholesterol, as part of the on-going saturated
      fat-heart disease debate and that cheese should indeed be part of a healthy diet.
    


Intervention name(s): Test meal (butter); Test meal (cheddar cheese); Test meal (cream cheese)
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will eat one meal test containing 33g of lipids from butter (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).; Subjects will eat one meal test containing 33g of lipids from cheddar cheese (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).; Subjects will eat one meal test containing 33g of lipids from cream cheese (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study of Gantenerumab in Participants With Prodromal Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This multi-center, randomized, double-blind, placebo-controlled parallel-group study will
      evaluate the effect of gantenerumab (RO4909832) on cognition and functioning and the safety
      and pharmacokinetics in participants with prodromal Alzheimer's Disease. Participants will be
      randomized to receive subcutaneous (SC) injections of either gantenerumab or placebo.
      Participants who consent to be part of the sub study will undergo positron emission
      tomography (PET) scanning to assess brain amyloid. The anticipated time on study treatment is
      104 weeks in Part 1, with an option for an additional up to 2 years of treatment in Part 2,
      followed by an open-label extension (Part 3) until July 2020.

      The dosing for Parts 1 and 2 was stopped after a planned futility interim analysis showed a
      low probability of meeting the primary outcome measure with the doses studied. The study has
      converted to open-label to investigate higher gantenerumab doses.
    


Intervention name(s): Gantenerumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants received Gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection Q4W.; Participants received Placebo SC injection Q4W.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bingocize: A Novel Mobile Application for Older Adult Health
Condition: Activities of Daily Living; Accidental Fall; Sarcopenia; Arteriosclerosis; Diabetes Mellitus, Type 2; Hypertension; Cognitive Decline; Executive Function; Cognitive Aging
MeSH terms: Sarcopenia; Arteriosclerosis; Diabetes Mellitus, Type 2; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study tests the effectiveness of using a new mobile application (Bingocize®) to improve
      older adults' (a) adherence to an engaging exercise program, and (b) aspects of functional
      performance, health knowledge, dietary habits, and cognition.
    

Detailed description: 
      Health-promoting interventions designed to improve physical and mental fitness can help
      reduce health care costs; they can also help maintain, or even improve, older adults' quality
      of life. However, getting older adults to adhere to health-promoting exercise interventions
      remains difficult because such programs are often perceived as being time-consuming, painful,
      or unenjoyable. The present study's objective is to investigate the effectiveness of a novel
      technological exercise intervention program for older adults (Bingocize); in doing so, the
      program has the potential to improve older adults' independence and quality of life. Older
      adults will participate in a pre/post-intervention design with random assignment to either
      the experimental or one of three comparison/control groups; each group will play Bingocize in
      a social setting with other older adults. Participants in the experimental group will use the
      app to engage in twice-weekly Bingocize sessions for twelve weeks (i.e.,
      Bingo+Exercise+Health Education); control groups will also use the app for twelve weeks but
      for either health education-only, exercise-only, or bingo-only.
    

Intervention name(s): Socially-Based Exercise Intervention for Older Adults
Intervention type(s): Behavioral
Intervention description(s): A socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors
Other intervention name(s): Bingocize
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In each wave of the study (14 weeks per wave), participant groups are randomly assigned to one of four conditions (A,B,C,D). Condition A receives exercise + health education. Condition B receives exercise only. Condition C receives health education only. Condition D receives nothing.
Masking: None (Open Label)
Primary purpose: Prevention
Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces
Condition: Healthy
Study type: Interventional

Summary: 
      As a direct consequence of exposure to microgravity, astronauts experience a number of
      physiological changes which can lead to serious medical implications. Most immediate and
      significant is the headward shift of body fluids and the removal of gravitational loading
      from bone and muscles, resulting in progressive changes of the cardiovascular and
      musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has
      been demonstrated in studies of short term (shuttle) and long term missions to Skylab and
      MIR.

      Our main hypothesis is that there is a linear relationship between the gravity level (0G,
      0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate
      variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral
      analysis of HRV and BPV.
    


Intervention name(s): Parabolic flight; Cardiovascular parameters measurements
Intervention type(s): Other; Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: volunteers
Virtual Reality Application in Chemotherapy Administration in Nurse Staff
Condition: Chemotherapy Training
Study type: Interventional

Summary: 
      The present study wants to design a training program for chemotherapy with using VR among
      nurse staff. Then the investigators design a protocol to compare the training effects in the
      VR program and ISO document.
    

Detailed description: 
      As technology advances, mobile devices have gradually turned into wearable devices.
      Furthermore, virtual reality (VR), augmented reality (AR), and mixed reality (MR) are being
      increasingly applied in medical fields such as medical education and training, surgical
      simulation, neurological rehabilitation, psychotherapy, and telemedicine. Research results
      demonstrate the ability of VR, AR, and MR to ameliorate the inconveniences that are often
      associated with traditional medical care, reduce incidents of medical malpractice caused by
      unskilled operations, and reduce the cost of medical education and training. What is more,
      the application of these technologies has enhanced the effectiveness of medical education and
      training, raised the level of diagnosis and treatment, improved the doctor-patient
      relationship, and boosted the efficiency of medical execution. The present study wants to
      design a training program for chemotherapy with using VR. Then the investigators design a
      protocol to compare the training effects in VR program and ISO document.
    

Intervention name(s): VR training program; usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Use VR software to make a training education program.; Chemotherapy training as usual care (for training chemotherapy skill).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: 3D virtual reality; administration
Assessment of a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC) (PPA)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle
      Point Model Predictive Control : SP-MPC)
    

Detailed description: 
      Ten patients will be assessed during a closed-loop night and an open-loop night in random
      order.

      The primary objective is to assess the ability of SP-MPC controler to maintain euglycemia and
      avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients
      treated by insulin pump.
    

Intervention name(s): open-loop night; closed-loop night
Intervention type(s): Other; Other
Intervention description(s): During the open-loop night the patient is using his insulin pump as usual; During the closed-loop night glucose values measured by the sensor are collected every 15 minutes. The data are entered into the SP-MPC controler that calculate the insulin dose to be delivered. A diabetologist validates the insulin dose before the infusion (manually bolus infusion)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Artificial pancreas, closed loop glucose control, model predictive control
Myoinositol Plus L-tyrosine, Selenium and Chromium in PCOS
Condition: Polycystic Ovary Syndrome; Menstrual Problem; Hirsutism
MeSH terms: Polycystic Ovary Syndrome; Hirsutism; Menstruation Disturbances
Study type: Interventional

Summary: 
      PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg
      L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients
      underwent, before starting the therapy, after 3 months and 6 months, hormonal evaluation ,
      hirsutism scoring and ovulation assesment. Most of them during the treatment improved their
      symptoms.
    


Intervention name(s): Myo-inositol+L-tyrosine
Intervention type(s): Dietary Supplement
Intervention description(s): PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment.
Intervention MeSH terms: Inositol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
Condition: Apathy; Behavior; Frontotemporal Dementia
MeSH terms: Dementia; Frontotemporal Dementia; Aphasia, Primary Progressive; Pick Disease of the Brain
Study type: Interventional

Summary: 
      The purpose of this study is to provide relevant quantitative evaluation of apathy close to
      real life situation by means of a multimodal sensor system integrated.
    

Detailed description: 
      The investigators try to measure the amount of goal-directed behaviour and to detect the
      pattern of apathy. The main objective of this pilot phase is to select the variables of
      goal-directed behaviour from the list of metrics providing by the multimodal acquisition
      system in healthy subjects and patients with frontotemporal dementia.
    

Intervention name(s): Evaluation of Apathy Close to Real Life Situation
Intervention type(s): Behavioral
Intervention description(s): Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Apathy; Goal-directed behavior; Quantitative evaluation; Sensor; Ethogram
ANC & Malaria Diagnostic in Pregnancy
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The program's overall objective is to assess the impact of a package of interventions aimed
      at reducing malaria-related mortality and morbidity in pregnant women and newborns by
      ensuring access to a package of interventions designed to optimise the detection and
      treatment of malaria during pregnancy as well as improving the early detection and treatment
      of malaria during the third trimester.
    

Detailed description: 
      This is a cluster-randomised study in which the health facility is the unit of randomisation.
      16 health facilities will be randomised to intervention and control. At the community level
      women will be encouraged to access ANC early in the pregnancy, attend follow-up antenatal
      visits throughout the pregnancy and deliver at the facility. The current recommended standard
      of care will be provided to all women attending antenatal and obstetric care. In the
      intervention area, obstetric, medical, drug-exposure histories will be collected at ANC
      visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women
      will be systematically evaluated with selected diagnostic test for whether they have malaria
      parasites and treated effectively. Skilled birth attendants at the facility will be trained
      in emergency obstetric and neonatal care and the assessment of neonates for danger signs, low
      birth weight and external/observable birth defects. In the control area, women will be
      provided with standard practice of care. In both areas, women will be diagnosed and treated
      at delivery if they are positive.
    

Intervention name(s): ASAQ
Intervention type(s): Drug
Intervention description(s): In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women will be systematically evaluated with malaria RDT for whether they have malaria parasites and treated effectively with ASAQ.
Other intervention name(s): Coarsucam, ASAQ Winthrop
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malria diagnosis; Malaria prevention in pregnancy; ANC services improvement
ATI-450 vs Placebo in Patients With Moderate to Severe Hidradenitis Suppurativa (HS)
Condition: Hidradenitis Suppurativa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2a study to investigate the efficacy, safety, tolerability, pharmacokinetics,
      and pharmacodynamics of ATI-450 vs placebo in patients with moderate to severe Hidradenitis
      Suppurativa (HS).
    

Detailed description: 
      This is a Phase 2a, randomized, double-blind, placebo-controlled study to investigate the
      efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of ATI-450 vs placebo
      in patients with moderate to severe Hidradenitis Suppurativa (HS).
    

Intervention name(s): ATI-450; Placebo oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral, small molecule MK2 inhibitor; Placebo tablet manufactured to match ATI-450 in appearance
Other intervention name(s): Zunsemetinib; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hidradenitis; Suppurativa; HS; Acne inversa
Processed Orange and the Glycemic Response
Condition: Maximum Observed Plasma Glucose Concentration (Cmax)
Study type: Interventional

Summary: 
      Randomized, placebo controlled, double blind, postprandial crossover study in male subjects.
      3 intervention arms, consisting of a control (Product A), a low dose processed whole orange
      (Product B) and a high dose processed whole orange (Product C), to determine the effect of
      the interventions on the primary endpoint of postprandial glycemia. Secondarily, plasma
      insulin concentrations will be quantified.
    

Detailed description: 
      The study design is a randomized, placebo controlled, double-blind, crossover. This trial
      will include 33 subjects randomized to receive products A, B or C [240 mL (255 g)]. Subjects
      will be randomly assigned to one of 6 sequences of 3 interventions. After the initial
      screening visit, subjects will visit the Clinical and Translational Research Center (CTRC)
      the Tufts Translational and Clinical Science Institute (CTSI) on three separate occasions.
      Following each intervention day there will be a two week wash out period.
    

Intervention name(s): Orange flavored beverage
Intervention type(s): Other
Intervention description(s): Intervention involves consumption of one beverage of 240ml following baseline measurements
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Phase-I Study Evaluating the Pharmacokinetic Profile of RhuDex®
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The drug that is under investigation during this study is RhuDex® and is expected to be used
      as an oral treatment for rheumatoid arthritis. Normal stomach juices contain acid and
      previous studies have shown that this acidity reduces the solubility and therefore the
      absorption of RhuDex®. Administering the alkaline buffer meglumine with RhuDex® has shown to
      increase the solubility of RhuDex® by decreasing the stomach acidity.

      The purposes of this study are to determine:

        -  the optimum level of meglumine which is required to achieve the best uptake of RhuDex®
           from the stomach into the blood

        -  to determine the concentration of RhuDex® in the blood in the presence of the optimum
           level of meglumine

        -  to investigate further the safety and tolerability of RhuDex®. The study will be
           conducted in healthy male volunteers.
    

Detailed description: 
      RhuDex® is a novel, orally bioavailable, low molecular weight modulator of co-stimulation of
      T lymphocytes. RhuDex® binds to the protein CD80 on the surface of antigen-presenting cells
      and inhibits its interaction with CD28 (but not with CTLA-4) presented by CD4+ T lymphocytes.
    

Intervention name(s): RhuDex®
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Rheumatoid Arthritis; RhuDex®; Meglumine; Oral Bioavailability