bioihbjkbjnl/mcl2 huggingface dataset:
Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
Condition: Hyperuricemia; Gout
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in
      in normal healthy volunteers, in an ascending dose design.

      ALLN-346 is an (oral) enzyme that specifically degrades urate in the intestinal tract.
    

Detailed description: 
      This is a Phase I, 7-day, randomized, double-blind, placebo-controlled, multiple ascending
      dose study of orally administered ALLN-346 in normal healthy volunteers. Study will take
      place at a clinical pharmacology unit (CPU). Two sequential cohorts will be dosed and
      followed for safety through Day 28.

      The study will evaluate safety and tolerability (including inflammation and immunogenicity),
      and pharmacodynamics of ALLN-346.
    

Intervention name(s): ALLN-346; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration; It is a proprietary enzyme designed to degrade urate in the intestinal tract; Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
Other intervention name(s): Engineered urate oxidase; Matching placebo capsule
Intervention MeSH terms: Rasburicase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial of Toothpaste to Reduce Plaque and Inflammation
Condition: Plaque; Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Dental plaque causes caries and periodontal disease and data are sparse about toothpaste and
      plaque removal. Inflammation, caused by dental plaque, is a risk factor for cardiovascular
      disease. (CVD) The availability of (Plaque HD (TM), a plaque identifying toothpaste with
      targetol technology (TM)), afforded the unique opportunity to test whether there were
      statistically significant and clinically important reductions in plaque and inflammation in a
      randomized trial of apparently healthy individuals.
    

Detailed description: 
      The protocol was approved by the Institutional Review Board of the University of Illinois and
      the trial was posted on ClinicalTrials.gov. We screened all potentially eligible subjects
      from the Medical District of the University of Illinois which includes the Colleges of
      Dentistry, Medicine, Public Health and Pharmacy.

      All willing and eligible subjects signed informed consent forms and were instructed to
      refrain from brushing or flossing teeth, using any oral hygiene aids (such as mouthwash or
      chewing gum) the evening prior to and the morning of the data collection appointment. All
      subjects were be asked to complete the following procedures:

        1. Rinse for 10 seconds with 25 mL of phosphate buffer

        2. Rinse for 1 minute with 5.0 mL of 1240-ppm fluorescein in phosphate buffer

        3. Rinse 3 times (for 10 seconds) with 25mL of phosphate buffer

        4. Be positioned on a tripod chin rest 15 inches in front of the camera, retraction placed
           and intraoral images captured under UV LED light imaging.

        5. Provide a blood sample for hs-CRP.

        6. Use a 30 day supply of their assigned toothpaste and were instructed to follow the same
           brushing protocol for the entire month as well as a brushing diary to assist in
           recording daily participation.

      The identical procedures were repeated at the 30 day follow up visit.. In addition, the
      Plaque HD group was instructed to brush in front of a mirror for 1 minute and to concentrate
      on removing all visible dye. The placebo group was asked to brush their teeth for 1 minute in
      front of a mirror, using the provided manual toothbrush.

      .
    

Intervention name(s): Plaque identifying toothpaste; Non-plaque identifying toothpaste
Intervention type(s): Other; Other
Intervention description(s): Plaque identifying toothpaste with targetol; Non-plaque identifying toothpaste without targetol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: plaque identifying toothpaste; plaque score; C-reactive protein
Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this Phase I, single-dose, open-label trial is to evaluate the
      pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and
      Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib
      (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place
      serially through-out the duration of subject participation.
    


Intervention name(s): ivosidenib (AG-120)
Intervention type(s): Drug
Intervention description(s): A single-dose of ivosidenib (AG-120) administered in healthy Japanese and Caucasian subjects
Intervention MeSH terms: Ivosidenib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers; Japanese; Caucasian
Statin Contrast Induced Nephropathy Prevention
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This open-label study, prospective, randomized trial evaluating the acute (in-hospital)
      pleiotropic and clinical effects of a hydrophilic statin (rosuvastatin) in patients with
      acute coronary syndrome
    

Detailed description: 
      The primary purpose of this study is to determine whether, in patients with acute coronary
      syndromes not taking statins in chronic administration, high doses of a hydrophilic statin
      (rosuvastatin) administered before coronary angiography and/or angioplasty, may exert a
      renal-protective effect by reducing the incidence of contrast nephropathy. Contrast induced
      nephropathy is defined as increased values of creatinine >= 0.3 mg/dl from baseline values,
      within 72 hours after contrast medium exposure.

      Secondary end points: 1) verify if short-term (<48 hours)statin administration reduces the
      peak levels and the curve areas of markers of myocardial necrosis throughout the
      hospitalization period and if reduces the occurrence of periprocedural infarction.
      Biochemical markers (quantitative creatine kinase-MB (CK-MB) mass and Troponin I) are
      measured at admission and at 6, 12, and 24 hours during the first day then once daily,
      immediately before angiography, and 24 hours thereafter. In patients who underwent coronary
      angioplasty (PCI), biochemical markers were measured at 12 and 24 hours after the procedure.
      Data were fitted, peak values and curve areas calculated; the occurrence of periprocedural
      infarction was defined as a CK-MB mass elevation more than three times the upper limit of
      normal within 24 hours after PCI. 2) determine the distribution of peripheral lymphocytic
      populations at the entry and at discharge using the flow cytometric analysis; 3) analyze the
      clinical composite outcome of death, myocardial infarction, urgent revascularization,
      dialysis and stroke at 30 days and 6 months.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: statin; CIN; periprocedural damage
Interfacial Injection in Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Its effect on thoracolumbar fascia and low back pain has been investigated in different
      studies.These studies suggest that the anatomical and histological features of the fascia may
      have an effect on low back pain. This study aimed to investigate the effectiveness of
      interfacial injection in patients with chronic back pain.
    


Intervention name(s): interfacial injection; physical therapy
Intervention type(s): Procedure; Procedure
Intervention description(s): 10 ml of bupivacaine and steroid injection was applied between the leaves of the thoracolumbar fascia under the guidance of ultrasonography.; protocol including hot pack for 20 min/session, therapeutic continuous Ultrasound (frequency, 1 MHz; intensity 1.5 W/cm2) for 6 min/session, therapeutic exercises for low back muscles. Therapeutic exercises included stretching ,posterior pelvic tilt ,hyperextension ,bridge and cat-camel exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Rosuvastatin (Crestor) in Friedreich Ataxia
Condition: Friedreich Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study is an exploratory open-label clinical trial of Rosuvastatin in patients with
      Friedreich ataxia (FRDA). This is an outpatient trial with the goal of enrolling 10 evaluable
      adults with genetically confirmed FRDA who are between the ages of 18-65. Subjects will
      receive 10mg of oral Rosuvastatin daily for three months.
    

Detailed description: 
      Friedreich ataxia (FRDA) is a progressive neurodegenerative disease of children and adults
      for which there is presently no therapy. Much of the current work in FRDA is aimed at finding
      new targets for drug therapies. Recent work at the University of Pennsylvania has discovered
      that serum ApoA-1 protein levels are lower in people with FRDA when compared with control
      levels. ApoA-1 is the main protein found in high-density lipoprotein (HDL) cholesterol and
      individuals with FRDA frequently have low HDL levels; the current study proposes to assess if
      administration of HMG-CoA reductase inhibitors for 3 months alters ApoA-1 protein levels in
      FRDA. Although the significance of ApoA-1 levels among FRDA patients is currently unknown,
      this study is proposed as an exploratory study to further examine this protein. If ApoA-1
      protein levels increase over the course of treatment, future studies may additionally focus
      on examining this as a potential therapeutic treatment.
    

Intervention name(s): Rosuvastatin
Intervention type(s): Drug
Intervention description(s): Daily oral administration of Rosuvastatin (10 mg) for 3 months
Other intervention name(s): Crestor
Intervention MeSH terms: Rosuvastatin Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Friedreich Ataxia
Psychotherapy and Cardiovascular Risk Factors in Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Prospective studies indicate that patients with depression are at increased risk for
      cardiovascular disease. Depression is also associated with a number of hemodynamic features,
      which are known risk factors for cardiovascular morbidity such as increased heart rate,
      reduced heart rate variability and blood pressure alterations. These hemodynamic alterations
      may explain in part the increased cardiovascular risk associated with depression.

      The purpose of this study is to determine whether treatment for depression with cognitive
      behavior therapy (CBT) is effective in reducing hemodynamic cardiovascular risk factors.
      Hemodynamic assessments including heart rate, heart rate variability, continues blood
      pressure, blood pressure variability, baroreceptor sensitivity and peripheral vascular
      resistance will be conducted at baseline, after treatment and 2-month follow up. In addition,
      circadian hemodynamic variations such as 24-hour heart rate variability, nocturnal blood
      pressure dipping and immunological biomarkers will be assessed. Eighty patients with Major
      Depression will be randomly assigned to either a CBT treatment condition (14 hour-long,
      weekly sessions) or a waitlist condition, to control for potential changes in hemodynamic
      parameters without any intervention and the impact of repeated-measurement.
    


Intervention name(s): Cognitive behavioral therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive behavioral therapy; psychotherapy; cardiovascular health; psychoneuroimmunology
Pharmacokinetic Study of the HCV Protease Inhibitor Bo-cePRevir and the Proton Pump Inhibitor OMeprazOle (PROMO)
Condition: HCV Infections; Gastric Acid-related Disorders
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine the effect of multiple dose omeprazole on the
      pharmacokinetics of boceprevir and vice versa.

      Furthermore, the safety of steady state boceprevir combined with multiple dose omeprazole
      will be evaluated.
    

Detailed description: 
      It is known that some drugs can significantly influence the bioavailability of other drugs.
      For example the proton pump inhibitors decrease the absorption of some protease inhibitors
      used in HIV treatment or of some oral tyrosine kinase inhibitors used in oncology. Proton
      pump inhibitors increase the pH in the stomach and might therefore decrease the solubility of
      other drugs with decreased absorption as a consequence.

      Boceprevir (BOC) is an Hepatitis C (HCV) NS3 serine protease inhibitor that has recently
      received FDA approval for the treatment of chronic HCV infection. The drug substance is
      slightly soluble in water and administration with food increases the oral bioavailability of
      BOC relative to the fasted state, by 40% to 60% based on AUC.

      Omeprazole (OME) is the most frequently used proton pump inhibitor. It is the second most
      prescribed drug in The Netherlands, with 5 million prescriptions a year.

      OME is metabolized by CYP2C19 and CYP3A4 and is known to induce CYP1A2 and inhibit CYP2C19.
      BOC is a potent inhibitor of CYP3A4/5 and is not metabolised by CYP1A2 or CYP2C19. No
      interaction on metabolism of BOC is expected. However, an increase of OME levels may be
      expected due to the inhibition of CYP3A4 by BOC.

      As proton pump inhibitors are widely used it is relevant to know if a drug-drug interaction
      between proton pump inhibitors and BOC exists which might influence the bioavailability of
      BOC.

      This study is designed to determine the effect of multiple dose omeprazole on the
      pharmacokinetics of boceprevir and vice versa.

      Furthermore, the safety of steady state boceprevir combined with multiple dose omeprazole
      will be evaluated.
    

Intervention name(s): boceprevir; Omeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Boceprevir 800 mg TID for 4 consecutive days + a single dose of 800 mg on Day 5; Omeprazole 40 mg QD for 5 consecutive days
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HVC infection; gastric acid-related disorders; proton pump inhibitor; interaction; pharmacokinetics; boceprevir; omeprazole
A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial
Condition: Spasticity
MeSH terms: Muscle Spasticity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study
      with a nested crossover comparison to define the ECG effects of tizanidine compared to
      placebo and the positive control, moxifloxacin, in healthy men and women. The study will be
      conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the
      protocol.
    


Intervention name(s): Tizanidine; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Zanaflex
Intervention MeSH terms: Moxifloxacin; Tizanidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Re-exposure of EHMI-8 Human Volunteers to Live Malaria Sporozoites
Condition: P. Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional

Summary: 
      In the EHMI-8 study (CMO 2006/207) the investigators induced sterile protection against P.
      falciparum challenge in healthy Dutch volunteers by repeated exposure to infected mosquitoes
      whilst under chloroquine prophylaxis. The surprisingly efficient induction of protection in
      this study strongly supports the development of whole parasite vaccines and is therefore an
      important finding to malaria vaccine development. In this study (EHMI8B) the investigators
      would like to explore the longevity of the protective immune response and simultaneously
      further characterise immune mechanisms responsible for protection by re-exposing EHMI-8
      volunteers to infected mosquito bites.
    


Intervention name(s): Exposure to 5 P. falciparum infected mosquitoes
Intervention type(s): Biological
Intervention description(s): Five Anopheles Stephensi mosquitoes are infected with NF54 P.falciparum. volunteers are exposed to bites for 10 minutes.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: malaria; plasmodium; falciparum; human; experimental infection
The Effect Of Immediate Versus Early Oral Hydration On Caesarean Section Post Operative Outcomes
Condition: Cesarean Section
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the effect of immediate oral hydration initiated within
      2 hours after uncomplicated Caesarean section
    

Detailed description: 
      The aim of this study is to evaluate the effect of immediate oral hydration initiated within
      2 hours after uncomplicated Caesarean section on the following post-operative outcomes:

        1. Post-operative nausea, vomiting, abdominal distention and abdominal cramps.

        2. Return of intestinal movements.

        3. Duration of intravenous fluid administration.

        4. Duration of hospital stay.

        5. Participant satisfaction
    

Intervention name(s): Immediate hydration; Early hydration
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements; They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Behavioral and Brain Mechanism of IGD
Condition: Internet Gaming Disorder
MeSH terms: Internet Addiction Disorder
Study type: Interventional

Summary: 
      This project aims to investigate whether anodal tDCS of dlPFC enhances cognitive regulation
      over craving an emotions.
    


Intervention name(s): Craving behavioral intervention
Intervention type(s): Behavioral
Intervention description(s): The CBI was given once a week for 6 weeks, conducted by four therapists. A pair of therapists was randomly assigned to a CBI+ group. Each session included 5 parts in 2.5-3 hours: warming-up exercise, discussion about the homework from the last session, main structured activity, brief summary, and the homework assignment. There were 6 sessions with each focused on a topic: recognize craving and its relationship with IGD; reduce craving through ameliorating the salience of cues and irrational beliefs, withdrawal symptoms and other negative affects; enhance self-monitoring and control for craving through time management training; relieve fulﬁllment of psychological needs through Internet use and attenuate the relation between craving and gaming behaviors through coping skill training
Other intervention name(s): CBI
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Sleep Deprivation on Cerebrospinal Fluid (CSF) Amyloid-beta (Aβ) Dynamics
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Sleep Deprivation
Study type: Interventional

Summary: 
      Introduction: Alzheimer's disease (AD) is characterized by neurodegeneration of the brain in
      the form of neurofibrillary tangles and plaques containing the amyloid-beta protein (Abeta).
      Recent animal studies have shown that extended wakefulness is associated with increased
      production of these Abeta proteins and that sleep leads to a marked fall in their production.

      Aim: The investigators aim to distinguish a similar effect of sleep disturbance on
      cerebrospinal fluid (CSF) Abeta levels in humans, which may point out sleep disturbance as an
      important factor in AD development.

      Methods: a study in 26 healthy male volunteers, measuring CSF Abeta levels during a sleep
      deprivation night and before and after a control night with unrestricted sleep.

      Expected results: The investigators expect sleep deprivation to lead to an increase in CSF
      Abeta levels, as compared to the levels in the control night.
    


Intervention name(s): Sleep deprivation
Intervention type(s): Behavioral
Intervention description(s): subjects will undergo one night of full sleep deprivation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alzheimer Disease; Cerebrospinal fluid; Sleep; Abeta
Probiotic on Psychological and Cognitive Effects
Condition: Aging
Study type: Interventional

Summary: 
      This study will determine whether supplementation of probiotic Lactobacillus Rhamnosus GG
      improves psychological status in middle age and older adults through a 12-week, randomized,
      double-blind, placebo-controlled clinical trial. Secondary analyses will be conducted to
      examine the possible benefits of probiotic supplementation on cognitive function and markers
      of physical health.
    


Intervention name(s): Probiotic - Lactobacillus Rhamnosus GG; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 2 capsules per day for 90 days; 2 placebo capsules per day for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Probiotic, Cognitive Function, Mood