bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Food Study to Evaluate the Effect of KB174 on the Gut Microbiome in Subjects With Well-compensated Cirrhosis
Condition: Early Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      This randomized, double-blind, controlled, clinical food study aims to explore KB174, a novel
      mixture of oligosaccharides, and maltodextrin, an easily digestible polysaccharide, on gut
      microbiome structure and function in subjects with well-compensated cirrhosis.
    


Intervention name(s): KB174; Maltodextrin
Intervention type(s): Other; Other
Intervention description(s): KB174 is a novel mixture of oligosaccharides.; Maltodextrin is a commercially available easily digestible polysaccharide.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Efficacy of Levodopa/Carbidopa/Entacapone vs Levodopa/Carbidopa in Parkinson's Disease Patients With Early Wearing-off
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in
      patients with Parkinson's disease and early wearing-off with levodopa
    


Intervention name(s): Levodopa/carbidopa/entacapone; Levodopa/carbidopa
Intervention type(s): Drug; Drug
Intervention description(s): Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.; Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
Intervention MeSH terms: Levodopa; Carbidopa; Entacapone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living
Study to Evaluate Safety and Pharmacokinetics of GS-4059 (Tirabrutinib) in Healthy Volunteers and Participants With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will consist of two parts: Part A will evaluate the safety, tolerability,
      pharmacokinetics (PK), and pharmacodynamics (PD) of tirabrutinib in healthy participants.
      Part B will evaluate the safety, tolerability, and the effect of tirabrutinib on
      disease-specific clinical markers and outcomes in participants with rheumatoid arthritis
      (RA).
    


Intervention name(s): Tirabrutinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules administered orally.; Capsules administered orally.
Other intervention name(s): GS-4059
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of CYR-101 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase II study will test whether CYR-101, a CNS-active compound with novel
      pharmacological profile and devoid of dopamine D2 receptor binding properties, is efficacious
      when administered orally in the management of patients with a diagnosis of DSM-IV
      schizophrenia.
    


Intervention name(s): CYR-101; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental arm; Placebo comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Investigation Into The Impact Of Enteric Coated Of Aspirin In Patients With Newly Diagnosed Ischemic Stroke.
Condition: Stroke, Ischemic
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Uncertainty remains regarding the impact of enteric-coated (EC) aspirin as it relates to the
      reduction of CV risk. We hypothesize that EC formulation based on the previous report may
      blunt aspirin response as evidenced by reduced Thromboxane A2 (TXA 2) levels in diabetic
      patients.
    


Intervention name(s): Enteric Coated Aspirin Tablet; Plain Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Study participants will be assigned to receive either EC Aspirin and will be required to continue taking them throughout the study (three days).; Study participants will be assigned to receive either Plain Aspirin and will be required to continue taking them throughout the study (three days).
Intervention MeSH terms: Aspirin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Impact of Liraglutide on Sensory Perception, Sensory Specific Satiety, Liking and Wanting in Type 2 Diabetic Patients
Condition: Type 2 Diabetes Mellitus; Overweight
MeSH terms: Diabetes Mellitus, Type 2; Overweight
Study type: Interventional

Summary: 
      Besides their potential action in the treatment of type 2 diabetes mellitus (T2DM), GLP-1
      analogues decrease satiety and food intake leading to a significant weight loss in patients.
      However, little is known about their effects on food hedonic sensations and taste perception.

      The aim of this study is to investigate the impact of Liraglutide on the liking and wanting
      components of the food reward system, taste sensitivity and sensory specific satiety in type
      2 diabetes mellitus (T2DM) patients. According to the review of literature in animal models,
      it is expected that Liraglutide will modify food preference and gustative perception in
      humans.

      Thirty T2DM patients will be studied before and after 3 months of treatment with Liraglutide
      (1.2 mg/day). Same tests will be carried out on two consecutive days before and after the
      treatment administration. Olfactory liking, recalled liking and wanting for several food
      items will be assessed. Sensory specific satiety will be measured as well as detection
      thresholds for salty, sweet and bitter tastes. Subjects will also answer questionnaires on
      hunger, pleasure in eating, and food intake.
    


Intervention name(s): Liraglutide
Intervention type(s): Drug
Intervention description(s): 3 months of treatment by Liraglutide (self-administration). The initial dose was 0.6 mg/day subcutaneously during five days, then uptitrated to a daily dose of 1.2 mg during three months.
Other intervention name(s): Novonordisk (Puteaux, France)
Intervention MeSH terms: Liraglutide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Liraglutide; GLP-1 analogue; Food preference; Gustative perception; Liking; wanting; T2DM; body mass composition; leptin; ghrelin
Efficacy of an U-shape Automatic Electric Toothbrush in Plaque Removal
Condition: Dental Plaque; Toothbrushing
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      Over time, many different types of manual and electric toothbrushes have been produced. A
      systematic review has shown that some electric toothbrushes are more effective at removing
      bacterial plaque than manual toothbrushes. A new U-shaped electric toothbrush with silicone
      bristles has recently been produced that has a fully automatic and simultaneous action on
      both arches. However, its efficacy in removing bacterial plaque is not clear at the moment,
      as no randomized study has been published on this type of toothbrush.

      The aim of this study is to compare the efficacy in terms of bacterial plaque removal in a
      single use of a new automatic U-shaped electric toothbrush, compared with the usual home
      toothbrushing procedure, a conventional electric toothbrush, and negative control (no
      toothbrushing) in a group of volunteer students of the School of Dentistry of the University
      of Florence, Italy.

      Primary endpoint will be the difference in "full mouth plaque score" between before and after
      brushing. Secondary endpoints will be feeling of "clean mouth" evaluated on a VAS (Visual
      Analogue Scale) scale from 0 to 10 where 0 indicates no feeling of clean mouth and 10 maximum
      feeling of clean mouth.

      This study will be a monocentric, randomized, controlled, superiority, cross-over study, with
      blind examiner and 4 therapies (U-shaped electric toothbrush, usual home toothbrushing
      procedure, conventional electric toothbrush, no toothbrushing), carried out in a single
      session with an interval of one week between the 4 therapies.

      Study population will be students of the School of Dentistry who are healthy volunteers.
      Number of patients to be enrolled: 22. Inclusion criteria: age between 18 and 30 years; no
      fixed orthodontic appliance; presence of at least 20 teeth; Full mouth plaque score (FMPS)
      above 40%.

      Exclusion criteria: subjects with manual disabilities to perform normal oral hygiene
      maneuvers; subjects allergic to silicone.
    


Intervention name(s): U-shape Automatic Electric Toothbrush; Usual home toothbrushing procedure; Conventional Electric Toothbrush
Intervention type(s): Device; Other; Other
Intervention description(s): The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.; Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.; The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
National Prevalence and Impact of Noninvasive Prenatal Testing
Condition: Aneuploidy
MeSH terms: Aneuploidy
Study type: Observational

Summary: 
      Information on pregnant women undergoing non-invasive prenatal testing (NIPT) at one of the
      Obstetrix Medical Groups Outpatient Centers between January 2012 and June 2014 will be
      retrospectively gathered and an analysis of the impact and prevalence of NIPT. This will be
      compared to a control group of pregnant women in those same practices undergoing prenatal
      testing during the months of January 2010-July 2010.
    

Detailed description: 
      Information regarding the frequency of non-invasive testing (NIPT), the impact of screening
      on the need for and frequency of invasive testing, and the indications for testing are
      important for the clinicians in this country to not only understand the impact that this
      testing has had but also to plan for allocation of personnel and resources in their prenatal
      testing units, as well as many other more subtle changes including describing changes to
      referring clinicians and patients and projecting financial impacts. Information on pregnant
      women undergoing NIPT at one of the Obstetrix Medical Groups Outpatient Centers between
      January 2012 and June 2014 will be retrospectively gathered and compared to a control group
      of pregnant women in those same practices undergoing invasive prenatal diagnostic testing for
      fetal karyotype (IDTFK) during the months of January 2010-July 2010. An analysis of the
      impact of NIPT will be done.
    

Intervention name(s): non-invasive prenatal testing
Intervention type(s): Other
Intervention description(s): Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation
Other intervention name(s): NIPT
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All pregnant women at participating Obstetrix Outpatient centers who are undergoing IDTFK
        between January 2012 and June 2014.
      
Keywords: aneuploidy; Trisomy 21; NIPT
Trial of IMO-8400 in Adult Patients With Dermatomyositis
Condition: Dermatomyositis
MeSH terms: Dermatomyositis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine how safe and effective IMO-8400 is in adults with
      dermatomyositis.
    

Detailed description: 
      This study will evaluate the safety and efficacy of IMO-8400 in adults with active
      dermatomyositis (DM).
    

Intervention name(s): IMO-8400 Dose Group 1; IMO-8400 Dose Group 2; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.; IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.; normal saline subcutaneous injections once a week for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: dermatomyositis; IMO-8400; Pioneer
A Single Dose Metabolism and Mass Balance Study of 14C-ABR-215050 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single site, open label, single dose, non-randomized study in healthy male and
      female subjects. The subjects will be evaluated for plasma, urine and feces levels of
      14C-ABR-215050 during 21 days.
    

Detailed description: 
      As a part of the pharmacokinetic documentation, the metabolism and mass balance of
      14C-ABR-215050 will be studied in healthy subjects. Female healthy subjects are included in
      the study in case of expanding the indication to female forms of cancer. In this study a
      single dose of 1.0 mg of the study drug will be administered orally as a solution under
      fasted conditions. The absorption and safety profiles for the oral water solution will also
      be documented.
    

Intervention name(s): ABR-215050
Intervention type(s): Drug
Intervention description(s): 1 mg ABR-215050
Other intervention name(s): tasquinimod
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: 14C ABR 215050 Metabolism and Mass Balance Study; tasquinimod; Metabolic pattern of 14C ABR-215050
Intravenous n-3 Fatty Acids and Sudden Cardiac Death in Hemodialysis Patients
Condition: Renal Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Death, Sudden, Cardiac; Death
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to investigate whether intravenous infusion of a lipid
      emulsion with a high content of n-3 polyunsaturated fatty acids can improve heart rate
      variability and ventricular repolarization and reduce ventricular arrhythmias in hemodialysis
      patients.
    

Detailed description: 
      Cardiovascular disease is the most common cause of death in haemodialysis (HD)patients, and
      half of these deaths are due to sudden cardiac death caused by ventricular arrhythmias. HD
      patients have an attenuated heart rate variability (HRV) and a high frequency of ventricular
      arrhythmias, both of which are predictors of sudden cardiac death(SCD). n-3 polyunsaturated
      fatty acids (PUFA) improves HRV and reduces the risk of SCD. n-3 PUFAs are obtained from
      fatty fish and fish oil and are incorporated into cell membranes after long-term ingestion.
      However, it is not known if this incorporation is essential or merely serves as storage for
      n-3 free PUFAs to be release during for instance myocardial ischaemia.

      The study hypothesis is that intravenous infusion of a lipid emulsion with a high content of
      n-3 PUFAs will improve HRV and ventricular repolarization and reduce ventricular arrhythmias
      via an acute increase in free non-esterified n-3 PUFAs in plasma.

      In a randomized, placebo-controlled design a n-3 PUFA rich emulsion (or placebo) will be
      administered during hemodialysis treatment. The two study groups will be compared with
      respect to heart rate variability, ventricular repolarization parameters, ventricular ectopic
      beats and arrhythmias and the content of n-3 PUFA in plasma and cell membranes will be
      compared.
    

Intervention name(s): lipid emulsion with a high content of n-3 fatty acids
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Renal failure, chronic; Death, sudden, cardiac; Heart rate variability; Tachycardia, ventricular; Ventricular premature complexes; Ventricular repolarization; Eicosapentaenoic acid; Docosahexaenoic acid
Bioavailability of Folate From a Mixed Diet Using a Stable Isotope Method
Condition: Folate Bioavailability; Healthy
Study type: Interventional

Summary: 
      The main objectives of this project are:

        1. to determine the relative bioavailability of dietary folate from a total diet, compared
           with synthetic folic acid and

        2. to determine the bioavailability with a higher precision than previous methods.

      The hypothesis is that the bioavailability of dietary folate within a confidence interval of
      +/-20% can be estimated.
    

Detailed description: 
      Folate plays a role in the prevention of certain birth defects and possibly also in
      prevention of neurocognitive diseases, cancer and cardiovascular disease. The proportion of
      dietary folate that is absorbed and becomes available for metabolic processes in the body has
      been estimated between 30 and 98%, but an accurate figure is lacking. Since subjects
      generally differ a lot in their folate or homocysteine response upon a change in dietary
      folate intake, the between-person variability in these responses is high. Therefore,
      bioavailability estimates derived from these responses have large confidence intervals. With
      this trial the researchers want to determine folate bioavailability with a higher precision
      than previous trials. A good estimate of folate bioavailability from the general diet is
      necessary to construct reliable dietary reference intakes for folate.
    

Intervention name(s): Controlled diet; folic acid supplement; 13C11-labelled folic acid supplement
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention MeSH terms: Folic Acid; Vitamin B Complex
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Folate; Bioavailability; Stable isotopes
A Trial to Learn How Safe Vericiguat (BAY1021189) is and the Way the Body Absorbs, Distributes and Gets Rid of Vericiguat in Participants With Kidney Disease and in Age-, Weight- and Gender-matched Healthy Participants
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      Vericiguat (BAY1021189) is under development to treat heart failure, a condition in in which
      the heart has trouble pumping blood through the body. Renal impairment which co-occurs in
      patients with heart failure is a common condition in which the kidneys are not filtering the
      blood as well as they should.

      The goal of the study was to learn more about the safety of vericiguat (BAY1021189), how it
      was tolerated and the way the body absorbed, distributed and excreted the study dug given as
      a single oral dose of 2.5 mg tablet in participants with renal impairment and healthy
      participants matched for age-, gender-, and weight.

      The participants stayed at the trial site for about 6 days. During this time, the doctors
      took blood and urine samples and checked the participants' health. About 7-14 days after the
      participants took vericiguat (BAY1021189), the researchers checked the participants' health
      again and asked about any medical problems they had.
    


Intervention name(s): Vericiguat (BAY1021189)
Intervention type(s): Drug
Intervention description(s): Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Blood Levels of Abacavir After One Dose in HIV-Infected Children and Adolescents
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to measure blood levels of abacavir in children and adolescents
      over a period of time following a single dose so that a dosage for adolescents can be
      determined.

      Little is known about how abacavir is cleared by the body in adolescents. It has been shown
      that young children require a higher abacavir dose based on weight than adults. Older
      children, or adolescents, may not require as high a dose. This study may provide information
      as to whether the children's dose or the adult dose is better for HIV-infected adolescents.
    

Detailed description: 
      Pharmacokinetic differences between children and adults have resulted in recommended doses of
      abacavir based on weight that are higher for children than for adults. There are insufficient
      data to determine whether the pediatric or adult dose is more appropriate for HIV-infected
      adolescent patients. This study measures pharmacokinetic data for abacavir in the adolescent
      population so that an appropriate dosage can be determined.

      Patients are evenly enrolled into 2 groups based on Tanner Stage. Group I patients are Tanner
      Stage 1 or 2 (pre-pubertal). Group II patients are Tanner Stage 3, 4, or 5 (pubertal). Each
      patient receives a single oral dose of abacavir given as the commercially available oral
      solution. Pharmacokinetic blood samples are collected before dosing and at 0.5, 1.0, 1.5,
      2.0, 2.5, 3.0, 4, 6, and 8 hours post dose for abacavir concentrations.
    

Intervention name(s): Abacavir sulfate
Intervention type(s): Drug
Intervention MeSH terms: Abacavir
Primary purpose: Treatment
Keywords: Administration, Oral; Drug Administration Schedule; Reverse Transcriptase Inhibitors; Anti-HIV Agents; Pharmacokinetics; abacavir