bioihbjkbjnl/mcl2 huggingface dataset:
Booster and Catch-up Vaccination With Vaccine GSK1024850A
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a
      booster dose of pneumococcal vaccine GSK1024850A administered either at 9-18 months or 15-18
      months of age in children primed in primary study NCT00814710.

      This study also aims to assess the persistence of antibodies induced following primary
      vaccination with pneumococcal vaccine GSK1024850A in primary study NCT00814710 prior to
      booster vaccination and following vaccination in the present study at approximately 24 months
      of age.

      The study is also designed to evaluate the immunogenicity, safety and reactogenicity of
      pneumococcal vaccine GSK1024850A when administered as a catch-up vaccination (2+1) in the
      second year of life in children unprimed with vaccine GSK1024850A in study NCT00814710.
    

Detailed description: 
      The study is randomized for primed subjects and non-randomized for unprimed subjects.

      The protocol posting has been updated according to the amendment of the protocol dated 16
      April 2010. The age range at the time of randomization of subjects primed in study
      NCT00814710 and the age range for booster vaccination of one of the groups has been extended.
    

Intervention name(s): Pneumococcal vaccine GSK1024850A; Pneumococcal vaccine GSK1024850A
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, administered as a single dose; Intramuscular injection, 3 doses
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Catch-up vaccination; Safety; Pneumococcal vaccine; Pneumococcal disease; Booster vaccination; Immunogenicity
Determining Metabolic Effects of Valproate and Antipsychotic Therapy
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study will determine the metabolic processes responsible for high levels of blood
      glucose, metabolism disorders, and weight gain in people with schizophrenia who have been
      treated with antipsychotic medications in combination with valproate.
    

Detailed description: 
      This project aims to study the whole-body metabolic processes responsible for hyperglycemia,
      dyslipidemia and increased adiposity in schizophrenia patients treated with antipsychotic
      medications in combination with valproate. The project hypothesizes that combined treatment
      with valproate and antipsychotic medications will decrease insulin sensitivity at the level
      of skeletal muscle, liver and adipose tissue, in comparison to antipsychotic monotherapy. The
      decrease in insulin sensitivity is hypothesized to be associated with defects in glucose and
      lipid metabolism and increased adiposity

      Treatment effects of antipsychotic/valproate combination therapy on different components of
      insulin secretion and action, and treatment effects on abdominal versus peripheral adiposity,
      are unknown despite the availability of gold-standard methods and the prognostic significance
      of these issues. Relevant data are needed to target basic research, to identify the potential
      for acute and long-term complications, and to plan therapeutic interventions. The following
      specific aims will be addressed in non-diabetic schizophrenia patients treated with atypical
      antipsychotics who will be randomized to open label treatment with either valproate or no
      adjuvant. Evaluations are performed at baseline and 3 months of treatment.
    

Intervention name(s): Valproate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Depakote ER 500 mg to 3000 mg taken every night; Placebo given at same frequency as Valproate
Other intervention name(s): Depakote ER
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diabetes; Metabolic
Brief Behavioral Treatment for Anxiety in Young Children
Condition: Obsessive-compulsive Disorder; Social Phobia; Generalized Anxiety Disorder; Specific Phobia; Separation Anxiety Disorder; Selective Mutism; Anxiety Disorder, Not Otherwise Specified
MeSH terms: Mutism; Anxiety Disorders; Compulsive Personality Disorder; Obsessive-Compulsive Disorder; Phobic Disorders; Phobia, Social; Anxiety, Separation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Behaviorally and cognitive-behaviorally based therapeutic techniques (BT; CBT) that
      incorporate exposure therapy useful for treatment of anxiety disorders among typically
      developing children. Although a large amount of data demonstrate the effectiveness of of BT
      and CBT approaches for treating anxious youth, there is a gap in the literature for the
      effectiveness of these approaches for children under the age of seven. Evidence increasingly
      suggests that family factors such as accommodation and parenting style contribute
      significantly to the presence of anxiety symptoms as well as treatment outcomes, particularly
      in young children. These findings stress the importance of using a treatment approach in
      which parents are directly involved in education, parent training, and generalization of
      treatment effects. Therefore, this study aims to evaluate a new treatment program, parent-led
      behavioral treatment, for children ages 3 to 7 years of age who have a principal anxiety
      disorder diagnosis.
    


Intervention name(s): Parent-Led Exposure Therapy; Treatment As Usual
Intervention type(s): Behavioral; Other
Intervention description(s): Therapists will work with families for 10 sessions, twice weekly. The first treatment session will be a 90 minute parent only psychoeducation and treatment preparation session. Each subsequent session will last up to 60 minutes and will consist of exposure therapy using developmentally appropriate modulated behavioral approaches such as Participant modeling (PM) and Reinforced practice (RP).; Patients randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice. These participants may also elect to receive no treatment at all during the TAU period.
Other intervention name(s): Brief Behavioral Treatment for Anxiety in Young Children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: obsessive-compulsive disorder; Social phobia; Generalized anxiety disorder; Specific phobia; Separation anxiety disorder; Selective Mutism; Anxiety Disorder, Not Otherwise Specified; Counseling; Behavioral therapy; Psychotherapy; Exposure; Young Children
Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information
Condition: Alcohol Drinking; Problem Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      This study aims to develop a brief intervention that incorporates ecological momentary
      assessments (EMAs; i.e., four brief surveys per day for 17 days) to create personalized
      feedback targeting high-risk alcohol use among young adult drinkers. The intervention mainly
      focuses on providing feedback on individuals' drinking desire and how it varies as a function
      of a number of real-world factors. Other psycho-educational alcohol-related content is also
      provided in the intervention including strategies for decreasing exposure to cues that
      increase drinking desires and how to cope with increased desire to drink. This brief
      intervention will be used in a randomized controlled trial (RCT) comparing young adults who
      receive the intervention with those who only complete identical assessments.
    

Detailed description: 
      The purpose of this study is to develop and test a brief intervention that provides
      personalized feedback to young adults using participants' own event-level, real-world
      experiences. The aim of the intervention is to increase young adults' awareness of their
      desire to drink as it varies as a function of a number of real-world factors including
      alcohol cues, social context, physical context, anticipation of later drinking, mood, and
      time of day. The intervention also aims to equip young adults with strategies for reducing
      exposure to factors that increase their desire to drink, how to cope with an increased desire
      to drink, and how to reduce potential harms from drinking.

      This brief personalized feedback intervention will be used in a randomized controlled trial
      comparing young adult drinkers who receive the intervention with those who complete the EMAs
      but do not receive any personalized feedback. Assessments include an eligibility survey,
      baseline assessment, 17 days of EMAs and follow-up assessments occurring 2-weeks and 3-months
      post-intervention. The intervention will be examined for its feasibility, acceptability, and
      its effects in reducing alcohol-related outcomes at the follow-up assessments.
    

Intervention name(s): Alcohol Cue Reactivity Personalized Feedback Intervention
Intervention type(s): Behavioral
Intervention description(s): This online brief intervention provides personalized feedback using EMA data focused on alcohol cue reactivity to reduce alcohol misuse among young adults.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to one of two conditions (Personalized feedback and assessment-only control group).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alcohol; Intervention; Young Adults; Personalized Feedback
Follow Up on Freestyle Valves in Children
Condition: Right Ventricle; Pulmonary Valve Stenosis; Pulmonary Valve Atresia
MeSH terms: Pulmonary Valve Stenosis; Pulmonary Atresia
Study type: Observational

Summary: 
      The purpose of this study is to determine if the Medtronic Freestyle porcine valve is
      effective over a long period of time when it is used to replace the valve that normally
      allows blood to flow from the right lower pumping chamber of the heart to the lungs.
    

Detailed description: 
      During the time between June 1998 and June 2006, the Medtronic Freestyle® porcine aortic root
      (Medtronic, Minneapolis, MN) was used for reconstruction of the right ventricular outflow
      tract in children that underwent surgery at Children's Healthcare of Atlanta. These children
      were born with heart problems that made it difficult for blood to flow from the lower right
      chamber of the heart to the lungs where it would normally pick up oxygen to be used by the
      body. Consequently, these children required surgery to repair the valve and eliminate this
      restriction of blood flow to the lungs in order to preserve life. In this case, the Freestyle
      valve was used. It is a relatively new valve and it is not known how it functions and how it
      impacts overall heart function over a long period of time. We are requesting permission to
      recruit volunteers that have received the Freestyle valve for this purpose in order to
      determine its long term performance. Specifically, we are seeking volunteers that are willing
      to have an echocardiogram performed. It is through the evaluation of a recent echocardiogram,
      as it compares to previous echocardiograms performed on the same patient, that the usefulness
      of the Freestyle valve will be evaluated for its durability and its long term impact on heart
      function.
    

Intervention name(s): Echocardiogram
Intervention type(s): Procedure
Intervention description(s): 2D echocardiogram with Doppler flow
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that have received the Medtronic Freestyle® porcine aortic root for right
        ventricular outflow tract reconstruction that have not had a standard of care
        echocardiogram performed in the last 12 months.
      
Keywords: Cardiology; Echocardiograms; Surgery; Valve Disease; Heart Valve Disease
A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of guselkumab
      (CNTO 1959) in the treatment of participants with moderate to severe plaque-type psoriasis.
    

Detailed description: 
      This is a randomized (assignment of study drug by chance), double-blind (neither the
      participant or study staff will know the identity of study drugs), placebo- (inactive
      substance identical in appearance to study drug) and active-comparator-controlled (use of an
      approved drug to compare with study drug) study of guselkumab in participants with moderate
      to severe plaque-type psoriasis (scaly skin rash). The active comparator study drug is
      adalimumab, an approved drug for the treatment of moderate to severe plaque psoriasis.
      Participants who satisfy all inclusion and exclusion criteria will be randomly assigned in a
      2:1:2 ratio to one of three treatment groups (arms): Group I (guselkumab 100 mg dose
      regimen), Group II (placebo then crossover to guselkumab at Week 16), or Group III
      (adalimumab at standard psoriasis dosing). All participants will receive guselkumab every 8
      weeks (q8w) from Week 52 through Week 252 (open label treatment period).The end of the study
      is defined as the time the last participant completes the Week 264 visit. Participants will
      primarily be assessed for Investigator's Global Assessment (IGA) Score of 0 or 1 and
      Psoriasis Area and Severity Index (PASI) 90 Response at Week 16. The total duration of the
      study will be approximately 268 weeks (includes a 4-week screening period). Participants will
      be monitored for safety throughout the study.
    

Intervention name(s): Guselkumab 100 mg; Placebo for guselkumab; Adalimumab; Placebo for adalimumab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).; Subcutaneous injections to maintain the blind.; 80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.; Subcutaneous injections to maintain the blind.
Other intervention name(s): CNTO 1959; HUMIRA®
Intervention MeSH terms: Adalimumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Plaque-type psoriasis; Guselkumab; Adalimumab; CNTO 1959; Monoclonal antibody
The Effect of Q10 and Selen Supplement on Muscular Adverse Events in Statin Therapy
Condition: Statin Therapy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether supplements of Q10 and Selen are effective
      in reducing muscular adverse events (AE) in statin therapy.
    

Detailed description: 
      Statins inhibit the synthesis of cholesterol by inhibiting the enzyme HMG-CoA reductase. The
      reduction of intracellular cholesterol leads to an increase in the number of LDL-receptors,
      and subsequent increased uptake and metabolism of LDL in the liver. Several large clinical
      trials have shown that the use of statins decreases morbidity and mortality in patients with
      risk factors for atherosclerotic disease. Unfortunately, 5% of statin users experience
      adverse events (mainly gastrointestinal [GI] and muscular).

      Statins inhibit not only cholesterol synthesis, but also synthesis of other substances in the
      mevalonate pathway. Among these other substances are Q10 and selenoproteins.

      It is well known that serum Q10 levels decrease during statin therapy, and that Q10
      supplement inhibits this decrease. One study has shown reduction of Q10 in blood-platelets
      during statin therapy. Q10 is an important element in the mitochondrial respiratory chain.
      Depletion of Q10 leads to a reduction of high energy phosphates, anaerobe metabolism and
      mitochondrial dysfunction. This is suggested to be the cause of muscular adverse events in
      statin therapy. There are several reports of individuals relieved from muscular adverse
      effects after Q10 supplement, but no randomized, placebo controlled studies have been
      conducted.

      Symptoms of selenoprotein deficiency are very similar to adverse events seen in statin
      therapy, but no clinical trials have been conducted to evaluate the effect of selen
      supplement on adverse effects of statin therapy.
    

Intervention name(s): Q10; Selen
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Q10; CoQ10; Coenzyme Q10; selen; selenoprotein; selenoproteins; adverse events; adverse effects; AE; myalgia; muscle; statin therapy; Indication for statin therapy
A First-in-Human Study of the RaniPill, an Oral Drug Delivery Platform
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to ascertain the safety, tolerability and performance of the
      RaniPill capsule in healthy volunteers
    

Detailed description: 
      The RaniPill device is capsule-like ingestible device, which injects a microneedle containing
      a microtablet (payload/drug) into the intestinal wall. This is a phase I (first-in-human)
      open-label study in healthy volunteers. In 6 subjects, 100 mcg of octreotide (Sandostatin®)
      will be injected intravenously. Three versions of the RaniPill (A, B and C) will be tested in
      additional three groups of healthy volunteers (N=20 each). All devices will contain 100 mcg
      of octreotide. The bioavailability of octreotide will be determined by serial blood sampling
      in Groups A and B. Performance of the RaniPill will be evaluated in all groups.
    

Intervention name(s): RaniPill capsule containing octreotide
Intervention type(s): Combination Product
Intervention description(s): Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
Intervention MeSH terms: Octreotide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy men and women volunteers
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RaniPill capsule, drug delivery, octreotide, pharmacokinetic
Clinical Study Comparing 7 ENDS Products and 1 Combustible Cigarette Using 2 Delivery Methods.
Condition: Nicotine Dependence; Nicotine Dependence, Cigarettes; Tobacco Use; Tobacco Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      A Randomized Study Comparing Nicotine Pharmacokinetics of Seven Electronic Cigarette Products
      and One Traditional Cigarette Across Two Delivery (10 puff and ad- libitum) Conditions, in
      Healthy Adult Smokers
    

Detailed description: 
      E- cigarettes may be an acceptable alternative to traditional cigarette smoking. By utilizing
      vaporization rather than combustion, the generation and inhalation of HPHCs, smoke, and
      carbon monoxide (CO) may be reduced or avoided. This study will provide an understanding of
      the in vitro levels of nicotine obtained with use of the company's ENDS products compared to
      competitor products marketed in the United States of America (USA), and to a popular brand of
      combustible cigarette smoked in the USA.
    

Intervention name(s): JUUL Virginia Tobacco flavored 5.0% ENDS; PMI iQOS Heat sticks; Reynolds VUSE Solo ENDS - Original; Imperial MyBlu ENDS - Original; Altria MarkTen ENDS - Bold Classic; MLV PHIX ENDS - Original Tobacco; NJOY Daily EXTRA ENDS - Rich Tobacco; Altria Marlboro combustible cigarette - Red
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum; PMI IQOS Heat sticks is administered using a controlled method and ad-libitum; Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum; Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum; Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum; MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum; NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum; Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Combustible Cigarettes; Nicotine
Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor
Condition: Drug Interaction Potentiation; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of
      the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A,
      given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations
      are given after a meal.
    


Intervention name(s): Mifepristone 300 MG; Itraconazole 100 MG
Intervention type(s): Drug; Drug
Intervention description(s): mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days; itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing
Intervention MeSH terms: Itraconazole; Mifepristone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other