bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effects of 3 Months Dosing With GW856553, as Assessed FDG-PET/CT Imaging
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to assess the potential anti-inflammatory effects of a 3-month
      treatment with GW856553, on the inflammatory activity within the aorta and carotid plaques,
      as assessed by FDG-PET/CT.
    


Intervention name(s): LOSMAPIMOD 7.5 MG; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GW856553 tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised GW856553X active substance. Tablets are available containing 7.5 mg of GW856553X and are packed into high-density polyethylene (HDPE) bottles.; Placebo tablets (wet granulation formulation) are available as white, film coated, round, convex tablets manufactured using micronised substance to visually match the active GW856553 tablets are also available. Tablets are packed into high-density polyethylene (HDPE) bottles.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: FDG-PET/CT, atherosclerosis
A Polysomnographic Study to Compare the Efficacy of Gastric Retentive Zaleplon Accordion Pill to Placebo in Subjects With Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi center, double blind placebo controlled, two-way crossover study in patients
      with Insomnia suffering from difficulty in falling asleep and staying asleep. This study
      intends to assess the efficacy of Zaleplon AP in improving sleep parameters, comparing to
      placebo.
    


Intervention name(s): Zaleplon AP formulation; Placebo capsule
Intervention type(s): Drug; Drug
Intervention description(s): Gastric retentive dual release Zaleplon; Identical placebo capsule
Intervention MeSH terms: Zaleplon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PSG; LPS; TST; WASO; Subjects With Insomnia characterized by both Difficulty in Falling Asleep and Staying Asleep
Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria
Condition: Malaria, Falciparum; Malaria, Vivax
MeSH terms: Malaria; Malaria, Falciparum; Malaria, Vivax
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2a trial recruits adult patients with uncomplicated P. vivax or P. falciparum
      blood-stage malaria mono-infection. The study drug SJ733 will be administered to examine its
      antimalarial efficacy, safety, and tolerability. This study also evaluates whether or not a
      fixed dose of the pharmacoenhancer cobicistat when given in combination with SJ733
      significantly improves drug efficacy.
    

Detailed description: 
      This is an adaptive open label Phase 2a study to examine the antimalarial efficacy, safety,
      and tolerability of SJ733 in adult patients with uncomplicated P. vivax or P. falciparum
      blood-stage malaria monoinfection. SJ733 will be administered orally once every day for three
      consecutive days, with or without a fixed dose of the pharmacoenhancer cobicistat. The Phase
      1 clinical data (completed under a US IND) and PK/PD models suggest that SJ733 is most likely
      to be curative as a 3-daily-dose pharmacoenhanced therapy, due to its moderately rapid
      clearance. There will be 1-3 cohorts with each cohort containing two treatment arms, P.
      falciparum (a) and P. vivax (b). Cohort progression will be managed independently for each
      treatment arm. Interim analysis will determine whether the data for a given treatment arm
      meets the success criteria, is inconclusive, or meets the failure criteria. Antimalarial
      efficacy will be examined over the period of 42 days. Additional aims are to characterize the
      safety and pharmacokinetics of SJ733. The results of this trial will identify active,
      well-tolerated doses for investigation in a larger Phase 2b clinical trial.
    

Intervention name(s): (+)-SJ000557733 (SJ733)
Intervention type(s): Drug
Intervention description(s): Anti-Malarial
Other intervention name(s): SJ733
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: There are 6 treatment arms (three cohorts, each with P. falciparum and P.vivax arms).Cohort progression will be managed independently for each treatment arm. Interim analysis will determine whether the data for each arm meets the success criteria
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of
      standard therapy CTX through analyzing overall remission rate after treatment.
    


Intervention name(s): Mizoribine (MZR); Cyclophosphamide (CTX)
Intervention type(s): Drug; Drug
Other intervention name(s): HE-69
Intervention MeSH terms: Mizoribine; Cyclophosphamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Ethanol Extract Physalis Angulata Linn. in Scleroderma Patients With Standard Therapy
Condition: Scleroderma
MeSH terms: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized
Study type: Interventional

Summary: 
      Study about the effect of ethanol extract physalis angulate in scleroderma patients with
      standard therapy to reduce skin fibrosis based on modified Rodnan Skin Score, reduce
      inflammation, immunological response and fibrosis: A Randomized Clinical Placebo
      ControlledTrial with a prospective cohort study on scleroderma outpatient clinic in Cipto
      Mangunkusumo Hospital in Jakarta and Hasan Sadikin Hospital in Bandung, from January 2016 to
      July 2017
    

Detailed description: 
      Background.

      Scleroderma is a systemic autoimmune disease that can not be cured, the progression of the
      disease still difficult to prevent and lead to increased morbidity and mortality.
      Disease-modifying anti-rheumatic drugs (DMARDs) as standard immunosuppressant drugs to
      reduce, eliminate, inhibit inflammation and fibrosis in scleroderma patient is still less
      effective.

      Objectives.

      To evaluate the effect of ethanol extract of Physalis angulate Linn to reduce skin fibrosis
      based on MRSS, ESR, BAFF, sCD40L, and P1NP in scleroderma patients with standard therapy

      Methods.

      A Randomized, Double-Blind, Placebo-Controlled Clinical Trial on scleroderma patients with
      standard therapy, who admitted to Cipto Mangunkusumo Hospital Jakarta and Hasan Sadikin
      Hospital Bandung, from January 2016 to July 2017.

      Patients must be controlled every month until three months for follow up. Subjects were
      divided into two parallel group, one of intervention group, and one of placebo group
    

Intervention name(s): Physalis angulata ethanol extract; Placebo
Intervention type(s): Other; Other
Intervention description(s): Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months; No active component at the same dosage of 3x250 mg/day given orally for 3 months
Other intervention name(s): Herba Ciplukan; Ethanol extract of Physalis angulata Linn; Ethanol extract of Physalis angulata; Amylum
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Physalis angulata Linn. ethanol extract 3 x 250 mg
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Erythrocyte sedimentation rate; Modified Rodnan Skin Score; B-cell Activating Factor; soluble-CD40Ligand; Procollagen Type-1 N-terminal Propeptide; Scleroderma
Platelet-Rich Plasma and Hip Osteoarthritis
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      To evaluate the effect of platelet-rich plasma (PRP) injection on pain, function and quality
      of life in patients with hip osteoarthritis.
    

Detailed description: 
      After being informed about the study and potential risk, all patients giving written informed
      consent will undergo study entry.

      Each patient received three times intra-articuler injections of PRP under ultrasound
      guidance, and they were administered once a week.

      Baseline: Visual Analog Scale (VAS) including movement, rest and night, the Western Ontario
      and McMaster University Osteoarthritis Index (WOMAC) and SF-36 assessment

      1st month: VAS, WOMAC and SF-36 assessment

      3rd month: VAS, WOMAC and SF-36 assessment

      6th month: VAS, WOMAC and SF-36 assessment
    

Intervention name(s): intra-articular PRP injection
Intervention type(s): Other
Intervention model: Single Group Assignment
Intervention model description: The patients with mono-lateral hip pain , grade 1 or 2 hip osteoarthritis according to the Kellgren-Lawrence classification
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hip osteoarthritis; platelet-rich plasma; ultrasound guidance
Dynamic Alterations of Tongue in Sleep Apnoea Hypopnea Syndrome During Sleep
Condition: Obstructive Sleep Apnoea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The aim of this study was to evaluate the dynamic changes of the tongue in patients with
      obstructive sleep apnoea hypopnea syndrome (OSAHS) during sleep and while awake by using
      Ultrafast Magnetic Resonance Imaging (UMRI)
    

Detailed description: 
      UMRI was undertaken on the upper airway in 21 OSAHS patients and 20 normal people after being
      deprived of sleep for one night. A series of midline sagittal images of the upper airway were
      obtained. The dynamic alterations of the tongue size and the distance from the tongue to X
      axis (an extended line from the anterior nasal spine to posterior nasal spine) and Y axis (a
      perpendicular line from the center of the pituitary to the X axis) were measured.Statistical
      comparisons between pairs of means were performed via t-tests using Spss10 software. A
      probability level of p<0.05 was considered to be statistically significant.
    

Intervention name(s): Ultrafast Magnetic Resonance Imaging
Intervention type(s): Device
Intervention description(s): MRI was performed with a 1.5 superconducting magnet (Gyroscan Intera type, Philips Co. Holland) in a posterior and anterior neck coil. The sequence used to perform the ultrafast MRI was a fast gradient- echo plus sequence. Technical parameters included: echo time, 12 msec; repetition time, 2.3 msec; flap angle, 250; matrix, 192 × 512; section thickness, 7 mm. The imaging time per slice for this sequence was 0.92 sec. A total of 120 consecutive images were obtained as a single section, with a total imaging time of 110.4 seconds. MRI scanning was carried out with the subject first asleep, then whilst awake after 20 minutes in quiet respiration. All images were inputted to the PACS workstation.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects are recruited prospectively from the Tenth Hospital Affiliated to Tongji
        University of Shanghai,with varying degrees of symptoms of OSAHS (daytime sleepiness,
        snoring and/or nocturnal apneas).
      
Keywords: Obstructive Sleep; Apnoea; tongue; alteration
A Clinical Study in Healthy Women Which Aims to Explore the Intestinal Uptake of Two Different Tablets of GRTA9906 Into the Body and the Effect of Food on it
Condition: Pain; Neuropathic Pain; Chronic Pain; Visceral Pain
MeSH terms: Neuralgia; Chronic Pain; Visceral Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this clinical study in healthy women is to explore the intestinal uptake
      (bioavailability) of two different tablets of GRTA9906 (formulations) into the body and the
      effect of food on it. The intake of food may considerably influence the bioavailability,
      either by interaction with the compound itself or, if a prolonged release (PR) formulation is
      used, with the components of the tablet-matrix. For these reasons, the relative
      bioavailability and the effect of food on the bioavailability of GRTA9906 given as PR tablets
      compared to immediate release (IR) capsules will be assessed in this study.

      During the 4 periods of the study, each participant will receive two 60 mg GRTA9906 PR matrix
      tablets and two 60 mg GRTA9906 IR capsules under fed conditions (after consumption of a
      high-fat and high-calorie test meal) and fasting conditions (10 hours before dosing until 4.5
      hours after dosing). In each period, the participant will receive the investigational product
      once.
    


Intervention name(s): GRTA9906 60 mg PR tablet; GRTA9906 60 mg IR capsule
Intervention type(s): Drug; Drug
Intervention description(s): GRTA9906 60 mg PR tablet; GRTA9906 60 mg IR capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Study to Assess Oxygen Saturation Predictive Power Related to Intradialytic Acute Hypotension
Condition: Acute Intradialytic Hypotension
MeSH terms: Hypotension
Study type: Observational

Summary: 
      The aim of the present work was to analyze the short-term variability of SO2 during
      hemodialysis in sessions with and without hypotension to correlate the SO2 variability to
      hemodynamic instability.
    

Detailed description: 
      During the last 40 years a lot has been achieved in dialysis regarding both monitors safety
      and membranes overall performances Anyway, intradialytic symptoms still remain a major
      concern for nephrologists: in particular, hypotension is the most frequent [1].

      Intradialytic hemodynamic monitoring systems have been developed to have continuous
      surveillance of the main hemodynamic variables (heart rate, body temperature, blood pressure
      itself, cardiac output, ecc…).

      In a second moment, the further evolution was towards the retroactive control systems, to
      force some of the variables involved in the genesis of the hemodynamic stability, along a
      pre-determined, ideal, trend. In this view, various bio-feedback mechanisms have been
      proposes along the years, for example, to tackle hypovolemia-related hypotension. Their
      scientific rationale is the control of either blood volume or directly natremia, in order to
      pilot plasma refilling towards the vascular compartment [2].

      Despite the great achievements obtained, the forecasting of acute hypotension during
      hemodialysis still remains a complex problem, likely involving more than one variable.

      SO2 can be considered an indirect expression of the hemodynamic stability. Moreover, in
      dialysis, it has always been regarded as a bio-compatibility marker for membranes [3].
      Nowadays, SO2 changes during dialysis are easy to measure with a fully, non-invasive sensor
      assembled on the arterial line.

      We planned this study to analyze on a large number of sessions the short-term variability of
      SO2 during hemodialysis in relationship with hemodynamic tolerance.
    

Intervention name(s): Hypotension-prone patients
Intervention type(s): Device
Intervention description(s): Hemox optical sensor equips the dialysis monitors used during this trial. It is able to measure continuously, on arterial blood line, oxygen saturation, hematocrit and blood volume reduction.
Other intervention name(s): Hemox
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ESRD patients on RRT with a recent clinical history of acute intradialytic hypotension.
      
Keywords: Dialysis; Monitoring; Cardiovascular stability; biosignals
A Study of Evacetrapib in Japanese and Non-Japanese Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to look at the effect of evacetrapib on pravastatin levels
      in the blood when both drugs are taken at the same time. The study will also assess how well
      the body handles evacetrapib and pravastatin when given at the same time.

      This study has two periods in fixed order. Each participant will enroll in both periods. This
      study will last approximately 25 days, not including screening.
    


Intervention name(s): Evacetrapib; Pravastatin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY2484595
Intervention MeSH terms: Pravastatin; Evacetrapib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Examine the Effect of a Thermogenic Energy Drink in Healthy Adults
Condition: Metabolism
Study type: Interventional

Summary: 
      This study is intended to examine the acute thermogenic effects of the active study product
      (energy drink), in healthy adults.
    

Detailed description: 
      The active study product and a control will be blinded with 3 digit codes. Human subjects
      will consume the coded products in a randomized manner. Measurements of rest energy
      expenditure via respiration will be performed throughout a 3 hour time span with controlled
      intervention an observation. Additional metrics will be gathered relating to benefits and/or
      side effects. The data gathered will be used to calculate the thermogenic impact of the
      active study product on healthy adults. The study is designed based on statistical
      confidence, with a minimum required number of active participants set to 26. 30 participants
      will be recruited.
    

Intervention name(s): Thermogenic Energy Drink - Active Study Product Formula; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The Thermogenic Energy Drink is the Active Study Product (ASP). This energy drink formula combines, caffeine, guarana, Vitamins C, B3, B6, B12, Magnesium, Potassium, L-Citrulline, L-Arginine HCl, L-Glutamine, and Chlorogenic Acids from green coffee bean extract. Participants will consume an assigned amount of the beverage (355 ml), under observation. They will be monitored for the following 180 minutes with measurements of respiration for Resting Energy Expenditure (RER) and other metabolic markers as well as satiety via Visual Analog Scale (VAS).; A carbonated soft drink with the same appearance, flavor and aroma as the active study product. Study participants will consume an assigned amount of the beverage (355 ml) under observation. They will then be monitored for the subsequent 180 minutes with measurements for respiration for Resting Energy Expenditure (RER) and other metabolic markers as well as satiety via a Visual Analog Scale (VAS).
Other intervention name(s): Energy Drink - Rowdy Energy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-Blind, Randomized, Crossover Study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Thermogenic
Single-dose Escalation Study of SQ-001 Infusion to Characterize the PK Profiles of Major Sentinel Compounds in Healthy Adult Volunteers in US
Condition: Solid Tumor Refractory to Standard Therapy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, double-blind, single-dose escalation study in healthy volunteers.
    

Detailed description: 
      This is a single-center, double-blind, single-dose escalation study in healthy volunteers
      consisting of a 14-day Screening Period, 1-day Predose period, a 2-day Dosing and Evaluation
      Period, and a 5-day Follow-up Period, with a single Follow-up call scheduled on Day 7 ± 1.
      Subjects will be confined to the study site for up to 3 days (admitted on Day -1 and
      discharged on Day 2 or 3, depending on cohort) and will be monitored for adverse events (AEs)
      and dose limiting toxicities (DLT) during the Dosing, Evaluation and Follow-up Periods.
      Subjects will also be monitored for concomitant medications and use of rescue medications
      throughout the study.

      Subjects will be allocated 1:4 to receive an infusion of saline control (0.9% saline for
      injection) or Shenqi Fuzheng Injection(SQ-001) continuously for about 1-4 hours. SQ 001 will
      be administered by intravenous route at a rate of 3 mL/min to one of four final dosages:
      Cohort 1 (125 mL/day/person), Cohort 2 (250 mL/day/person), Cohort 3 (500 mL/day/person), and
      Cohort 4 (625 mL/day/person). Each cohort will be enrolled sequentially. Per cohort, three
      subjects will be dosed initially on Day 1 and observed for 24 hours. If there are no observed
      AEs that meet the criteria under Stopping Rules, the remaining 7 subjects/cohort will be
      dosed. Dose escalation to the next higher dose will be based on the observation of results in
      safety and degree of AEs from the previous cohort and discussion between the Investigator and
      Sponsor.

      A maximum 17 PK samples will be collected over the course of the study in each cohort. The PK
      sampling time points will be grouped as (a) pre-infusion; (b) intra-infusion; (c) completion
      of infusion; and (d) post-infusion. See Table 10 for plasma PK sampling times. The last PK
      sample will be collected 24 hours after the end of infusion.
    

Intervention name(s): SQ001 125mL/day; SQ001 250mL/day; SQ001 500mL/day; SQ001 625mL/day; Saline 0.9%
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): SQ001 125mL/day will be administered by intravenous route at a rate of 3 mL/minute; SQ001 250mL/day will be administered by intravenous route at a rate of 3 mL/minute; SQ001 500mL/day will be administered by intravenous route at a rate of 3 mL/minute; SQ001 625mL/day will be administered by intravenous route at a rate of 3 mL/minute; Saline 0.9% will be administered by intravenous route at a rate of 3 mL/minute
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment