bioihbjkbjnl/mcl2 huggingface dataset:
A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia
Condition: Mild Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability,
      pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with
      mild dyslipidemia.
    


Intervention name(s): ETC-1002 or placebo; ETC-1002 or placebo; ETC-1002 or placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ETC-1002 (ascending dose), daily for 14 days; ETC-1002 (optimized dose), daily for 28 days; ETC-1002 (20 mg), daily for 14 days
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Self-monitoring of blood glucose (SMBG) is one of the important instruments in diabetes
      management. Most patients with type 1 diabetes and patients with type 2 using insulin,
      frequently measure their blood glucose in case of possible hypoglycemia, but also to evaluate
      the insulin treatment and get information about how to change the insulin regimen, if
      necessary. Without SMBG it is almost impossible to achieve this goal.

      The purpose of this study is to determine if self-monitoring in patients with type 2 diabetes
      not using insulin results in better glycemic control.
    

Detailed description: 
      Study Objectives:

      Primary: What is the effect of SMBG in patients with type 2 diabetes who are not using
      insulin on Glycemic control (as measured with glycosylated hemoglobin (HbA1c)?

      Secondary: What is the effect of SMBG in patients with type 2 diabetes who are not using
      insulin on the following parameters:

        -  Health status

        -  Diabetes related complaints

        -  Patient satisfaction

        -  Cumulative incidence of (necessity to start) insulin therapy / maximum dosage of oral
           blood glucose lowering drugs

        -  Dosage of oral blood glucose lowering drugs

        -  Bodyweight (BMI)

      Two treatment protocols are proposed. Treatment A consists of self-monitoring of blood
      glucose and treatment B consists of usual care. Patients in the A-group are instructed to
      measure their blood glucose values 4 times a day (1 fasting plasma glucose concentration and
      3 post-meal glucose concentrations), two times a week, on one week day, and one weekend day
      (no more, no less). Patients should record these glucose values in a diary. Patient will get
      one page with information in Dutch. No further education than for handling the device and
      interpreting the values is given, so that besides this intervention, there will be no
      differences compared with the control group like other forms of education.

      The duration fo the trial will be 12 months.
    

Intervention name(s): Self-monitoring of blood glucose (SMBG)
Intervention type(s): Behavioral
Intervention description(s): 2 times a week (one in weekend and one during week) self measurement of blood glucose: fasting and three times post prandial
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes mellitus, type 2; Blood Glucose Self-Monitoring; life style
μ-opioid Receptor Polymorphism and Opioid Analgesia
Condition: Pharmacogenetic and Duration of Labor Fentanyl Analgesia
MeSH terms: Agnosia
Study type: Observational

Summary: 
      In this prospective observational double-blind study, the investigators aim to assess the
      effect of the single nucleotide polymorphism of the μ-opioid receptor gene (OPRM1, p.118A/G)
      on the duration of epidural fentanyl labor analgesia.
    

Detailed description: 
      The single nucleotide polymorphism (SNP), p.118A/G of the µ -opioid receptor gene (OPRM1),
      may alter pain perception and individual response to opioid analgesia. This SNP leads to a
      variant µ-opioid receptor in which an asparagine is substituted for aspartate as the 102nd
      amino acid of the receptor protein (p.Asn102Asp). At the investigators' institution, it is
      common practice to initiate labor analgesia with epidural fentanyl. No data are available to
      determine how the µ-opioid polymorphism affects pain perception and response to opioids, such
      as fentanyl, in the investigators' population. The investigators aim to assess the effect of
      the single nucleotide polymorphism of the µ-opioid receptor gene (OPRM1, p.118A/G) on
      duration of epidural fentanyl labor analgesia.

      This is a prospective observational and double-blind study. Before initiation of epidural
      labor analgesia, venous blood will be drawn into coded EDTA tubes. DNA isolation and
      genotyping of OPRM1:p.118A/G will be performed at the American University of Beirut. In 250
      parturients, labor epidural analgesia will be initiated with 100 µg of epidural fentanyl
      following a test dose of lidocaine and epinephrine. No drugs will be injected until second
      request of analgesia. Patients will be divided into two groups based on their genetic groups:
      Group A consists of wild-type homozygote (A118), and Group G includes heterozygote and
      homozygote carrying the G118 allele. Duration of fentanyl analgesia (primary outcome) will be
      compared. Data will be presented as a mean ± SD or numbers and percentages. Statistical
      analysis will be performed with the Student's t-test, Chi-square or Fisher's exact test as
      appropriate. P value <0.05 will be considered significant.
    

Intervention name(s): Fentanyl
Intervention type(s): Drug
Intervention description(s): Epidural analgesia will be initiated with 100µg of epidural fentanyl
Intervention MeSH terms: Fentanyl
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Nulliparous parturients ≥ 37 weeks gestation, with ASA I or II, with an uncomplicated
        course of singleton vertex pregnancy requesting epidural analgesia for pain relief
      
Keywords: µ-opioid receptor polymorphism; Opioids; Opioid analgesia; Labor analgesia
DPP-4 Inhibition, Incretins and Islet Function
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis is that DPP-4 inhibition affects glucose levels through changes in incretin and
      islet hormones. The study examines this in relation to breakfast, lunch and dinner over an
      entire 24h study period by the use of three different DPP-4 inhibitors and placebo.
    

Detailed description: 
      The study is a single-center study with a cross-over design to examine glycemia, incretin
      hormones and islet hormones over a 24h study period with standardized breakfast, lunch and
      dinner after administration of placebo, saxagliptin, vildagliptin or sitagliptin.
    

Intervention name(s): Saxagliptin; Vildagliptin; Sitagliptin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Saxagliptin (5 mg) is given before breakfast; Vildagliptin (50mg) is given before breakfast and dinner; Sitagliptin (100 mg) is given before breakfast
Other intervention name(s): Onglyza; Galvus; Januvia
Intervention MeSH terms: Sitagliptin Phosphate; Vildagliptin; Saxagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Antibiotic Prophylaxis in Bariatric Surgery With Cefazolin: Concentration in Adipose Tissue
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      Eighteen patients were given a dose of 2g Cefazolin in anesthetic induction, supplemented
      with 1g delivered through continuous infusion during surgery. Adipose samples, obtained at
      the beginning and end of surgery, were analyzed using high performance liquid chromatography.

      Some published studies suggest that the dose of 2g does not supply the minimum inhibitory
      concentration for principal causal agents of surgical site infection.

      To determine the concentration of Cefazolin in adipose tissue of patients undergoing
      bariatric surgery and to evaluate the relationship between concentrations obtained and body
      mass index (BMI).
    


Intervention name(s): Cefazolin used in antimicrobial prophylaxis
Intervention type(s): Drug
Intervention description(s): Cefazolin administered a first dose of 2g in anesthetic induction, followed by continuous dosage of 1g diluted in 250mL of saline solution for two hours.
Two samples of subcutaneous tissue were collected for analysis: the first soon after the incision, and a second before skin synthesis.
The samples were processed by HPLC.
Intervention MeSH terms: Anti-Infective Agents; Cefazolin; Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Obesity; Bariatric surgery; Cefazolin; antimicrobial prophylaxis; administration and dosage
A Pharmacokinetic and Pharmacodynamic Study of Once-Daily and Twice-Daily Dosing With Canagliflozin in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effects of canagliflozin on glucose levels in
      the blood and urine when taken at 2 dose levels as a once-daily or twice-daily dosing regimen
      in healthy adult volunteers
    

Detailed description: 
      This is an open-label (volunteers will know the names of treatments they are assigned),
      single-center study of canagliflozin (JNJ-28431754) in healthy adult volunteers.
      Canagliflozin (a Sodium-Glucose Cotransporter 2 inhibitor) is currently under development to
      lower blood sugar levels in patients with type 2 diabetes mellitus (T2DM). Patients in Cohort
      1 will be randomized to receive Treatment A (one 300-mg tablet orally, by mouth [PO] once
      daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet PO
      twice daily for 5 days) or Treatment B followed by Treatment A. Patients in Cohort 2 will be
      randomized to receive Treatment C (one 100-mg tablet PO once daily for 5 days) followed 10
      days later by Treatment D (one 50-mg tablet PO twice daily for 5 days) or Treatment D
      followed by Treatment C.
    

Intervention name(s): Canagliflozin 300 mg once daily and 150 mg twice daily; Canagliflozin 100 mg once daily and 50 mg twice daily
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.; Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Canagliflozin; Pharmacokinetics; Pharmacodynamics
Two Strategies of Primary Prophylaxis of Spontaneous Bacterial Peritonitis in Severe Cirrhotic Patients With Ascites
Condition: Cirrhosis; Ascites; Peritonitis
MeSH terms: Peritonitis; Ascites
Study type: Interventional
Phase: Phase 3

Summary: 
      We wish to perform a multicenter, double-blind RCT with two parallel-group stratified on the
      center, comparing rifaximin to no rifaximin (placebo) for the primary prophylaxis of SBP in
      'severe' cirrhotic patients with large ascites. The primary outcome will be the 12-month
      survival.
    


Intervention name(s): Rifaximin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): twice daily administration of 1 tablet containing 550 mg of active rifaximin; twice daily administration of 1 rifaximin placebo tablet
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: primary prophylaxis; rifaximin
Study to Evaluatethe Bioavailability and Food Effect Lenalidomide as an Oral Suspension
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the amount of drug that reaches the circulation when a subject takes
      the test (liquid) formulation compared to the reference (capsule) formulation. The study will
      also examine the effect of a high fat meal on the levels of drug in blood.
    

Detailed description: 
      This is a phase 1, open-label, randomized, three-period, two-way crossover study in healthy
      subjects. The study will consist of a screening phase, a baseline phase, three treatment
      periods, and a follow-up phone call. Each period will be two days in duration (Day 1 through
      Day 2) for dosing and sample collection. There will be a minimum of four days washout between
      doses.

      Within no more than 21 days (Day -21) and no less than two days (Day -2) prior to the start
      of Period 1, subjects will undergo routine screening procedures including physical
      examination (PE), 12-lead electrocardiogram (ECG), vital signs, clinical laboratory safety
      tests (serum chemistry, hematology, and urinalysis), serology screen, and drug/alcohol
      screen.

      Eligible subjects will be admitted into the study center on Day -1 of Period 1 for baseline
      assessments. During each period, subjects will receive a single 25 mg oral dose of
      lenalidomide on Day 1 according to the assigned treatment sequence. Serial blood sampling for
      the determination of lenalidomide concentrations in plasma will be performed for 24 hours
      post dose, and safety will be evaluated. Subjects will be domiciled at the study center from
      Day 1 of Period 1 through Day 2 of Period 3, including the 4 day washout between each dose of
      IP. All subjects will be discharged from the study center on Day 2 of Period 3 following
      completion of required study procedures.

      A follow-up phone call will occur approximately four days (±2 days) after discharge from the
      study center.

      The study will be conducted in compliance with International Conference on Harmonisation
      (ICH) Good Clinical Practices (GCPs).
    

Intervention name(s): Lenalidomide
Intervention type(s): Drug
Other intervention name(s): Revlimid®
Intervention MeSH terms: Lenalidomide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Revlimid; lenalidomide; bioavailability; healthy volunteers; food effect; pharmacokinetics
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of
      three dosages (250, 500, and 1000 milligram [mg], or maximum tolerated dose [MTD]) of JNJ
      53718678 when administered as single dose in fasting conditions in healthy Japanese adult
      participants in 3 cohorts.
    

Detailed description: 
      This is a Phase 1, single center, double-blind (study in which neither the researchers nor
      the participants know what treatment the participants are receiving), placebo-controlled
      (study in which the experimental treatment or procedure is compared to placebo treatment),
      randomized (study medication assigned to participants by chance) study in healthy Japanese
      adult participants residing outside of Japan. The study will consist of a Screening phase, an
      In-clinic treatment phase, and a follow-up phase. The study duration for each participant
      will be approximately 6 weeks from Screening (Day -28 to Day -2) to follow up visit (Day 10
      to 14). Participants will be randomly assign to receive JNJ 53718678 or placebo, at planned
      dose of 250, 500 and 1000 milligram (mg). Planned doses will be stepwise escalated, if the
      safety and tolerability of the preceding dose(s) are found to be acceptable, and the maximum
      tolerated dose (MTD) is not reached. De-escalation may be performed in order to study an
      intermediate dose. The safety, tolerability and pharmacokinetic (PK) profile of JNJ-53718678
      will primarily be evaluated. Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ 53718678; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.; Placebo matching to JNJ 53718678 will be orally administered once on Day 1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ 53718678
Pilot Study of Rituximab Therapy for Systemic Lupus Erythematosus (SLE) and Vasculitis
Condition: Systemic Lupus Erythematosus; ANCA Associated Vasculitis
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      Lupus and vasculitis are autoimmune conditions which can be life threatening. In order to
      treat these conditions toxic therapies such as cyclophosphamide and steroids are often
      required. These standard treatments are associated with significant side effects. Furthermore
      a proportion of patient do not respond to these conventional therapies. Newer safer therapies
      are being sought. Rituximab is a drug that eliminates B cell from the blood. B cells are one
      part of the human immune system that helps prevent infections. Abnormal activity of the
      immune system is responsible for autoimmune disease although the exact mechanisms in lupus
      and vasculitis are not yet established. Rituximab is liscenced as a treatment for a form of B
      cell cancer called non-Hodgkins Lymphoma and has a good safety track record when used in this
      context. It has recently been used to treat some autoimmune conditions with positive results.
      In this pilot study we wish to assess the effectiveness and safety of rituximab in patients
      with lupus and vascultis that are resistant to conventional therpies.
    


Intervention name(s): Rituximab
Intervention type(s): Drug
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rituximab, ANCA, vasculitis, lupus,
Study of NeuroAid In Enhancing Recovery After Stroke
Condition: Stroke; Cerebral Infarction
MeSH terms: Stroke; Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 2

Summary: 
      TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in
      post-stroke recovery, and to assess the utility of the rehabilitation outcome measure
      instruments used.
    


Intervention name(s): Neuroaid; Neuroaid matched Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Neuroaid capsules, 4 capsules, three times per day, during one month; Neuroaid matched placebo 4 capsules three times per day during one month
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Cerebral infarct; Rehabilitation; Double blind Randomized; Placebo controlled; Traditional Chinese Medicine; Neuroaid
Clinical Application of BioCleanse Meniscus
Condition: Tear of Meniscus of Knee
Study type: Observational

Summary: 
      This study will follow patients after routine surgery of a meniscal allograft transplant.
    

Detailed description: 
      The BioCleanse meniscus is available to to all orthopedic surgeons for transplantation. The
      purpose of this registry is to allow close monitoring of a subgroup of patients receiving the
      BioCleanse Meniscus. All patients who have selected a BioCleanse Meniscus for their Meniscal
      Allograft transplant will be asked to join the registry. Outcomes will be measured by
      subjective subject questionnaires as well as X-rays and MRI.
    

Intervention name(s): BioCleanse Meniscus
Intervention type(s): Other
Intervention description(s): Subjects will undergo routine meniscal allograft transplant surgery.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients, between the ages of 18 and 55 years, who have selected meniscal allograft
        transplantation (MAT) using BioCleanse allografts will be eligible to participate in the
        MAT registry.
      
Keywords: Meniscus transplant; Meniscal allograft; MAT; Knee
Development of Biomarkers of Effect From Chronic Tobacco Usage
Condition: Cigarette Smoking
Study type: Observational

Summary: 
      This study was conducted to develop biomarkers of tobacco effect that would indicate
      potential harm related to tobacco consumption. To gain a better understanding of chronic
      effects of tobacco consumption, this cross-sectional clinical study enrolled generally
      healthy, adult male consumers of cigarettes (SMK), moist snuff (MSC), and no tobacco products
      (NTC).
    

Detailed description: 
      This single site, three-group (healthy, adult male smokers (SMK), moist snuff consumers
      (MSC), and non-tobacco consumers (NTC), single-blind, cross-sectional study, included one
      overnight confinement of study subjects for Test Visit (Visit #3). No lifestyle changes were
      required, inclusive of tobacco habits. In addition to the Screening Visit (Visit #1), two
      other visits (Acceptance Visit [Visit #2] and a Test Visit [Visit #3]) were conducted at the
      clinical study site.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The study target population included smokers (SMK), moist snuff consumers (MSC), and
        non-tobacco consumers (NTC), in generally good health, as determined by the Investigator.

        Exclusive tobacco smokers: n=40

        Moist Snuff consumers: n=40

        Non-tobacco consumers: n=40
      
Biospecimen description: 
      Blood, urine, buccal cells, and saliva
    
Keywords: Biomarkers; Metabolic Profiling; Metabolomics; Tobacco; Smokeless Tobacco; Moist Snuff
Pregnenolone for Cognitive and Negative Symptoms in Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will investigate adjunctive pregnenolone for patients with schizophrenia and
      schizoaffective disorder.
    


Intervention name(s): Dietary Supplement: Pregnenolone; Placebo
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pregnenolone; schizophrenia; cognitive; positive symptom; negative symptom; placebo control