bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox
Condition: Varicella; Chickenpox Vaccines
MeSH terms: Chickenpox; Herpes Zoster; Rubella
Study type: Interventional
Phase: Phase 3

Summary: 
      An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella
      vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in
      the prevention of varicella disease in children. The Protocol Posting has been updated in
      order to comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      According to treatment group allocation, participants will receive study vaccines and be
      followed for antibody titres and occurrence of varicella disease.

      This study is conducted in 2 phases. Phase A includes the vaccination period and an
      observation period for efficacy. The efficacy endpoints will be evaluated over at least two
      years after vaccination. During this period, the immunogenicity endpoints will be evaluated
      with respect to the immune response 43 days after vaccination and the persistence of
      antibodies over two years to varicella (for all subjects) and to measles, mumps and rubella
      (for a subset of subjects). Regarding the safety endpoints, SAEs (including any complicated
      varicella cases if observed) will be assessed for all subjects during the whole Phase A
      duration, whereas, solicited (local and general) and unsolicited adverse events will be
      assessed in a subset of subjects within a 43-day period after vaccination.

      Phase B is an extension of Phase A. It is a long-term follow-up until Year 10 to examine the
      long-term efficacy of the study vaccines against clinical varicella disease as well as the
      long-term persistence of antibodies to varicella (for all subjects) and to measles, mumps and
      rubella (in a subset of subjects) after vaccination.
    

Intervention name(s): Priorix-tetra™; Priorix™; Varilrix™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group; 2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group; 1 dose administered subcutaneously at Day 42 to subjects in OKAH Group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Pharmacokinetic Study of Abiraterone Acetate in Male Participants With Impaired Renal Function Compared to Individuals With Normal Renal Function
Condition: Renal Insufficiency
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetic (how the drug concentrations
      change over time) profile of abiraterone acetate 1000 mg when administered as a single dose
      in male participants with impaired renal function compared to individuals with normal renal
      function.
    

Detailed description: 
      This is an open-label (identity of assigned study drug will be known) pharmacokinetics study
      evaluating a single dose of abiraterone acetate 1000 mg administered in male participants
      with end-stage renal disease compared to matched-control (matched for age and body mass
      index) participants with normal renal function. There will be approximately 8 participants in
      each cohort (group). The total study duration for each participant will be 36 days.
      Abiraterone acetate 1000 mg will be administered orally (by mouth) as a single dose in the
      fasted state on Day 1. No food will be ingested for 4 hours post-dose. Participants will be
      confined to the clinical research center from the day prior to dosing (Day -1) to Day 5 and
      will return to the clinic on Days 8, 15, and 22 for follow up. Serial pharmacokinetic samples
      will be collected and safety will be monitored throughout the study.
    

Intervention name(s): Abiraterone acetate: participants with end-stage renal disease; Abiraterone acetate: matched control participants with normal renal function
Intervention type(s): Drug; Drug
Intervention description(s): abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1; abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
Intervention MeSH terms: Abiraterone Acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal insufficiency; Renal impairment; End-stage renal disease; Abiraterone acetate; Pharmacokinetics
Effects of Testosterone Replacement on Pain Sensitivity and Pain Perception
Condition: Pain; Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      Naturally occurring opiates (endorphins) decrease testosterone levels by inhibiting the
      synthesis of gonadotropin releasing hormone (GnRH) and also inhibiting testosterone synthesis
      by the testes. Similarly, men with addiction to narcotics and those on exogenous opioids for
      pain control have decreased serum testosterone levels. Indeed, these men complain of
      decreased libido, erectile dysfunction and impaired quality of life. Animal studies have
      shown that gonadectomy results in a decrease in pain threshold in rats and repletion of
      testosterone elevates that threshold. These observations suggest that testosterone may
      possess analgesic properties. Hence, the investigators hypothesize that hypogonadism
      developing in men on opioids results in an increased sensitivity to pain and requirement of
      higher doses of opioids. In this study, the investigators plan to administer testosterone to
      men with opioid-induced hypogonadism and evaluate their pain perception, pain sensitivity in
      response to noxious stimuli and changes in the requirement of opioids in response to
      testosterone administration.

      Hypothesis:

      Testosterone replacement in men with opioid-induced hypogonadism will improve pain tolerance,
      pain perception and quality of life.

      Specific aims:

        1. To evaluate the effects of testosterone replacement on pain sensitivity, pain tolerance,
           and pain modulation in men with opioid-induced hypogonadism.

        2. To determine the effects of testosterone replacement on health-related quality of life.

        3. To determine whether testosterone replacement in hypogonadal men induces changes in the
           dosage requirements of opioid medications for pain control.

      To accomplish our specific aims, the investigators propose a randomized, double blind,
      placebo-controlled, parallel arm study in which hypogonadal men with non-cancer chronic back
      pain syndrome on chronic opioids and low testosterone levels (<300 ng/dl) will be randomized
      to exogenous testosterone replacement therapy vs placebo. Our primary outcome is change in
      pain tolerance using various external painful stimuli. Secondary outcomes are change in pain
      sensitivity and modulation, quality of life and opioid requirements.
    


Intervention name(s): AndroGel; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 5g gel, applied once daily to the upper arms, upper back or shoulders.; 5g gel, applied once daily to the upper arms, upper back or shoulders.
Other intervention name(s): testosterone gel
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Testosterone; Pain; Opioid; Hypogonadism
Role of Propolis Endodontic Irrigant on Post-Operative Pain
Condition: Post-operative Pain; Symptomatic Irreversible Pulpitis
MeSH terms: Pulpitis; Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to compare propolis and sodium hypochlorite as endodontic
      irrigants in patients presenting with symptomatic irreversible pulpitis.

      . The main question it aims to answer is:

      • if there is any analgesic effects of 20% Propolis compared with 5.25% NaOCl on the
      intensity of post-operative pain in patients with symptomatic irreversible pulpitis using VAS
      pain score. Participants will undergo root canal treatment of their teeth using either 20%
      propolis solution or 5.25% NaOCl in their first visit of a multi-visit root canal treatment.

      Researchers will compare 20% Propolis and 5.25% NaOCl to see reduction in Intensity of
      Post-Operative Pain using visual analogue scale over 72 hour duration.
    

Detailed description: 
      Sodium hypochlorite as an endodontic irrigant, poses problems of toxicity. Additionally, its
      unfavorable odor, taste, failure to remove the smear layer, and proteolytic effect have
      deleterious effects on the dentine, creating unfavorable structural and mechanical
      alterations . To get beyond NaOCl limits and adverse effects, it is necessary to look for a
      biocompatible, equally effective, and dentine friendly irrigant with greater patient
      acceptance in taste and odor.

      The literature lacks an in-vivo study that investigates the anti-inflammatory with analgesic
      characteristics of Propolis on post-endodontic pain as an irrigant, in patients with
      symptomatic irreversible pulpitis. This research will endeavor to fill this gap in
      literature.
    

Intervention name(s): Sodium hypochlorite 5.25%; Propolis 20%
Intervention type(s): Drug; Drug
Intervention description(s): The participants will be randomly divided into two groups using the sealed envelope method during the instrumentation process. The clinician will use the irrigation in accordance with the protocol. Between each instrument in group A, 3 ml of 5.25% sodium hypochlorite (NaOCl) will be used to irrigate each canal.; In group B, a 20% hydroalcoholic propolis solution of 3 milliliters will be used to irrigate each canal, between each instrument.
Other intervention name(s): NaOCl; Bee glue
Intervention MeSH terms: Propolis; Sodium Hypochlorite; Eusol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 interventional groups assigned. 1 will be receiving routine intervention and other is the experimental group.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Propolis; Endodontic Irrigant
Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the safety and effectiveness of sitagliptin in patients
      with type 2 diabetes.
    


Intervention name(s): Sitagliptin; Comparator: Rosiglitazone; Comparator: Placebo; Comparator: Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.; Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.; placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.; Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of >= 1500 mg.
Other intervention name(s): Januvia; Avandia
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pasireotide LAR in Severe Polycystic Liver Disease
Condition: Somatostatin Analogs; Polycystic Liver Disease; Autosomal Dominant Polycystic Kidney Disease; Autosomal Dominant Polycystic Liver Disease
MeSH terms: Cysts; Arthrogryposis; Liver Diseases; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare SOM230 treatment to placebo. The investigators will
      also assess the efficacy and safety of SOM230 in reducing total liver volume and improving
      quality of life.
    

Detailed description: 
      Pasireotide (SOM230) is a novel multi-receptor-targeted analog that has high affinity for
      four of the five SST receptor subtypes (SSTr1, SSTr2, SSTr3 and SSTr5); it has a 40-fold
      higher affinity and 158-fold higher functional activity for the SST5 receptor than
      octreotide. Because of its broad receptor binding profile, pasireotide may be more potent in
      Polycystic Liver Disease (PLD) than octreotide. In this randomized double blind placebo
      controlled trial the investigators will compare SOM230 treatment to placebo for 12 months in
      patients with PLD. The primary endpoints will be assessed at 12 months and patients receiving
      placebo then crossed over to SOM230, permitting all participants to receive SOM230 for the
      subsequent two years. Magnetic resonance imaging (MRI) will be used to assess liver volume -
      the primary endpoint, which will be assessed at baseline, end of years 1 and 3. This study
      will assess the efficacy and safety of SOM230 in reducing total liver volume and improving
      quality of life over 12 months. (The investigators will not be assessing efficacy at 24
      months.) The therapy way be effective in PLD but also may prove to be effective for many more
      patients with Polycystic Kidney Disease (PKD) which will be evaluated using eGFR and kidney
      volume using MRI.

      The investigators plan to add other sub-sites in other locations.
    

Intervention name(s): Pasireotide LAR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injectible, 60mg per month; To be injected once per month
Intervention MeSH terms: Pasireotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Polycystic Liver Disease; Autosomal dominant polycystic kidney disease; Autosomal dominant polycystic liver disease; Somatostatin analogs; Pasireotide LAR; SOM230
Reducing Youth Access to Firearms Through the Health Care Setting
Condition: Youth Access to Guns in the Home
Study type: Interventional

Summary: 
      The purpose of this project is to examine the implementation and effectiveness of an
      intervention, delivered in a health care setting, to decrease home firearm access by youth.
      The investigators hypothesize that:

        1. parents who receive means restriction education provided by their primary care provider
           will be more likely to report, at the one month and one year follow-up, that they are
           storing their guns locked compared to parents who do not receive means restriction
           counseling.

        2. parents who receive a free gun locking device(s) will be more likely to report, at the
           one month and one year follow-up, that they are storing their guns locked compared to
           parents who receive means restriction counseling alone;

        3. parents whose adolescents are assessed at high risk for violence (> 5 on the Violence
           Injury Protection and Risk Screen (VIPRS)) or depression (>9 on the Patient Health
           Questionnaire-9 (PHQ-9)) will be more likely to report storing their gun(s) locked at
           the one month follow-up compared to parents whose children are assessed as low risk,
           regardless of whether they receive the counseling alone or counseling plus free locking
           devices and 4) youth whose parents receive a free gun locking device(s) will be more
           likely to report less access to guns, at one year follow-up, compared to parents who
           receive means restriction counseling alone.
    


Intervention name(s): Means restriction counseling
Intervention type(s): Behavioral
Intervention description(s): Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: youth; gun; access; home
The Relationship Between Emotional Regulation Strategies And Cognitive Behavioral Treatment Effectiveness In Childhood Anxiety Disorders: A Longitudinal Prospective Study
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Observational

Summary: 
      The current study will focus on two phases of anxiety process: Generating Anxiety (reported,
      direct and physiological) and Emotional Regulation Strategies (Reappraisal, Mindfulness,
      Expressive Suppression and Rumination). The claim is that better understanding of these
      phases in relation to CBT treatment will lead to better understanding of remission in anxiety
      and to better treatments in the future. Objectives: To understand the relations between the
      four strategies of emotional regulation to anxiety disorder hence to understand the relation
      between these strategies to treatment effectiveness of children with anxiety disorder.
      Methods: In phase one, clinically anxious adolescence before treatment (N=40) and healthy
      controls (N=40) will be compared. Anxious adolescence are expected to have significantly
      higher levels of physical arousal and will use spontaneously more expressive suppression and
      rumination and less reappraisal and mindfulness then the healthy controls. In phase two,
      clinically anxious adolescence (N=40) before and after 8-12 weeks of CBT treatment will be
      compared. More specifically remitted patients will be compared with partially remitted
      patients. Remitted patients are expected to show better improvement in the physical arousal,
      then partially remitted. More, Decrease in levels of anxiety will be mediated by the four
      emotional regulation strategies, and the efficiency of using the Reappraisal will be higher.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The anxious group: children who will present to the Anxiety Disorder Outpatient Clinic at
        Schneider Children's Hospital in Israel.
      
Keywords: Anxiety,; Emotional Regulation
Bioequivalence Study on Loratadine Orally Disintegrating Tablets 10 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      To compare the single-dose oral bioavailability of loratadine 10 mg orally disintegrating
      tablets of Ohm Laboratories (a subsidiary of Ranbaxy Pharmaceuticals Inc., USA) with
      Claritin® Reditabs® (containing loratadine 10 mg) of Schering-Plough Healthcare Product Inc.,
      USA in healthy, adult, human male subjects under fasting condition.
    

Detailed description: 
      The study was conducted as an open label, balanced, randomized, two-treatment, two-sequence,
      two-period, single-dose, crossover, bioavailability study on loratadine formulation comparing
      loratadine 10 mg orally disintegrating tablets of Ohm Laboratories, Inc. (a subsidiary of
      Ranbaxy pharmaceuticals Inc, USA) with Claritin® Reditabs® 10 mg tablet (containing
      loratadine 10 mg) of Schering- Plough Healthcare Product Inc, in healthy, adult, male, human
      subjects under fasting condition.

      A single oral dose of loratadine 10 mg orally disintegrating tablets was orally administered
      under low light condition during each period of the study under the supervision of a trained
      Medical Officer. Subjects were instructed to let the tablets completely dissolve on the
      tongue before swallowing the saliva and then, 240 mL of water was administered 30 seconds
      after drug administration.

      During the course of the study safety parameters assessed were vital signs, clinical
      examination, medical history and clinical laboratory safety tests (hematology, biochemical
      parameters and urine analysis) at baseline. Laboratory parameters of hematology and
      biochemistry were repeated at the end of the study.

      A total of 80 subjects were randomized to receive a single oral dose of the test or reference
      formulation for loratadine 10 mg. Seventy-four subjects completed both the periods of the
      study.
    

Intervention name(s): loratadine 10 mg orally disintegrating tablets
Intervention type(s): Drug
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence loratadine 10 mg orally disintegrating tablets fasting